FL22X • Florida Nurses 2022

Table of Contents

FL22X • Florida Nurses 2022

How to Receive Credit

NetCE 1 Hour Course #97500 • Imminent Death and Loss

97500 • Imminent Death and Loss

1. INTRODUCTION

2. THE PATIENT'S NEEDS

3. THE FAMILY'S NEEDS

4. GRIEF, MOURNING, AND BEREAVEMENT

5. CULTURAL CONSIDERATIONS

6. CONCLUSION

Works Cited

Evidence-Based Practice Recommendations Citations

NetCE 2 Hour Course #91333 • Medical Error Prevention and Root Cause Analysis

91333 • Medical Error Prevention and Root Cause Analysis

1. INTRODUCTION

2. DEFINING "MEDICAL ERROR"

3. ROOT CAUSE ANALYSIS PROCESS

4. ERROR REDUCTION AND PREVENTION

5. OTHER CONSIDERATIONS FOR PATIENT SAFETY

6. CONCLUSION

Works Cited

NetCE 2 Hour Course #97922 • Domestic Violence: The Florida Requirement

97922 • Domestic Violence: The Florida Requirement

1. INTRODUCTION

2. DEFINING DOMESTIC VIOLENCE

3. NATIONAL AND STATE STATISTICS AND LEGISLATION

4. IDENTIFYING GROUPS AT RISK FOR DOMESTIC VIOLENCE

5. CHARACTERISTICS OF PERPETRATORS OF DOMESTIC VIOLENCE

6. SCREENING FOR DOMESTIC VIOLENCE AND ABUSE

7. ASSESSING DOMESTIC VIOLENCE AND ABUSE

8. INTERVENTIONS FOR DOMESTIC VIOLENCE AND ABUSE

9. DOCUMENTATION AND FOLLOW-UP

Works Cited

Evidence-Based Practice Recommendations Citations

NetCE 2 Hour Course #31252 • Laws and Rules for Florida Nurses

31252 • Laws and Rules for Florida Nurses

1. INTRODUCTION

2. STANDARDS OF PRACTICE

3. CONTINUING LICENSURE IN FLORIDA

4. ETHICAL AND LEGAL ISSUES IN NURSING PRACTICE

5. DISCIPLINARY ACTIONS

6. EXCEPTIONS

7. CONCLUSION

Works Cited

NetCE 2 Hour Course #31111 • Recognizing Impairment in the Workplace: The Florida Requirement

31111 • Recognizing Impairment in the Workplace: The Florida Requirement

1. INTRODUCTION

2. SCOPE OF THE PROBLEM

3. UNIQUE RISK FACTORS

4. IDENTIFYING IMPAIRMENT IN THE WORKPLACE

5. REPORTING COLLEAGUES AND MANDATORY REPORTING LAW

6. TREATMENT PROGRAMS

7. PROMOTING SAFETY IN THE WORKPLACE AND PROVIDING ASSISTANCE

Works Cited

NetCE 2 Hour Course #97110 • Recognizing and Reporting Human Trafficking in Florida

97110 • Recognizing and Reporting Human Trafficking in Florida

1. INTRODUCTION

2. SCOPE OF HUMAN TRAFFICKING

3. DEFINITIONS OF HUMAN TRAFFICKING

4. FORMS OF TRAFFICKING

5. FACTORS THAT CONTRIBUTE TO HUMAN TRAFFICKING

6. THE TRAFFICKING EXPERIENCE

7. CONSEQUENCES OF HUMAN TRAFFICKING: IMPACT ON VICTIMS

8. IDENTIFICATION AND ASSESSMENT

9. REPORTING

10. INTERVENTIONS AND RESOURCES

11. CONCLUSION

Works Cited

Evidence-Based Practice Recommendations Citations

NetCE 3 Hour Course #91151 • Strategies for Appropriate Opioid Prescribing: The Florida APRN/PA Requirement

91151 • Strategies for Appropriate Opioid Prescribing: The Florida APRN/PA Requirement

1. INTRODUCTION

2. DEFINITIONS

3. EPIDEMIOLOGY OF CHRONIC PAIN AND OPIOID MISUSE

4. INITIATION AND MANAGEMENT OF THE PATIENT WITH PAIN

5. CRISIS INTERVENTION: MANAGEMENT OF OVERDOSE

6. COMPLIANCE WITH STATE AND FEDERAL LAWS

7. IDENTIFICATION OF DRUG DIVERSION/SEEKING BEHAVIORS

8. INTERVENTIONS FOR SUSPECTED OR KNOWN DRUG DIVERSION

9. CASE STUDY

10. CONCLUSION

Works Cited

Evidence-Based Practice Recommendations Citations

NetCE 15 Hour Course #30830 • Pituitary and Adrenal Disorders

30830 • Pituitary and Adrenal Disorders

1. INTRODUCTION

2. ANATOMY AND PHYSIOLOGY

3. NURSING ASSESSMENT

4. NURSING DIAGNOSES

5. DIABETES INSIPIDUS

6. SYNDROME OF INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION (SIADH)

7. GROWTH HORMONE DEFICIENCY

8. DISORDERS OF HYPERSOMATOTROPISM

9. ADDISON DISEASE

10. CUSHING SYNDROME

11. PRIMARY ALDOSTERONISM

12. PHEOCHROMOCYTOMA

13. PSYCHOSOCIAL/LIFESTYLE INFLUENCES AND EFFECTS

14. CASE STUDIES

15. CONCLUSION

Works Cited

Evidence-Based Practice Recommendations Citations

FL22X • Florida Nurses 2022

Lori L. Alexander, MTPW, ELS, MWC

Alice Yick Flanagan, PhD, MSW

Marjorie Conner Allen, BSN, JD

Nancy Campbell, RN, BSN, PHN

Mark Rose, BS, MA, LP

www.netce.com

Copyright © 2024 NetCE, All rights reserved.

FL22X • Florida Nurses 2022

Expiration Date: 07/31/2022

How to Receive Credit

To complete this Special Offer for continuing education credit please go to http://www.netce.com/specials in your browser.

For assistance with receiving continuing education credit, please contact us at help@netce.com.

97500 • Imminent Death and Loss

Lori L. Alexander, MTPW, ELS, MWC

Alice Yick Flanagan, PhD, MSW

www.netce.com

Copyright © 2021 NetCE, All rights reserved.

In the last days, the goals of the healthcare team are to ensure a peaceful death for the patient and to support the family during the dying process and throughout grief and mourning. The focus for the patient is management of symptoms and emotional and spiritual ease, and the focus for the family is education to prepare them for the dying process. This course will explore how care providers can best support the patient and family during and after death.

Table of Contents

97500 • Imminent Death and Loss

Course Overview

Audience

Accreditations & Approvals

Designations of Credit

Individual State Nursing Approvals

Individual State Behavioral Health Approvals

Special Approvals

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Division Planners

Division Planners Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

Implicit Bias in Health Care

1. INTRODUCTION

2. THE PATIENT'S NEEDS

PALLIATIVE SEDATION

PHYSICIAN-ASSISTED DEATH

3. THE FAMILY'S NEEDS

4. GRIEF, MOURNING, AND BEREAVEMENT

GRIEF

MOURNING

BEREAVEMENT

5. CULTURAL CONSIDERATIONS

6. CONCLUSION

Works Cited

Evidence-Based Practice Recommendations Citations

97500 • Imminent Death and Loss

Education Category. Ethics - Human Rights

Release Date. 11/01/2021

Expiration Date. 10/31/2024

Course Overview

In the last days, the goals of the healthcare team are to ensure a peaceful death for the patient and to support the family during the dying process and throughout grief and mourning. The focus for the patient is management of symptoms and emotional and spiritual ease, and the focus for the family is education to prepare them for the dying process. This course will explore how care providers can best support the patient and family during and after death.

Audience

This course is designed for members of the interprofessional team, including physicians, physician assistants, nurse practitioners, nurses, social workers, marriage and family therapists, and other members seeking to enhance their knowledge of palliative care.

Accreditations & Approvals

In support of improving patient care, NetCE is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. NetCE has been approved by NBCC as an Approved Continuing Education Provider, ACEP No. 6361. Programs that do not qualify for NBCC credit are clearly identified. NetCE is solely responsible for all aspects of the programs. NetCE is approved to offer continuing education through the Florida Board of Nursing Home Administrators, Provider #50-2405. NetCE is approved by the California Nursing Home Administrator Program as a provider of continuing education. Provider number 1622. As a Jointly Accredited Organization, NetCE is approved to offer social work continuing education by the Association of Social Work Boards (ASWB) Approved Continuing Education (ACE) program. Organizations, not individual courses, are approved under this program. Regulatory boards are the final authority on courses accepted for continuing education credit. NetCE is accredited by the International Accreditors for Continuing Education and Training (IACET). NetCE complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, NetCE is authorized to issue the IACET CEU. NetCE is recognized by the New York State Education Department's State Board for Social Work as an approved provider of continuing education for licensed social workers #SW-0033. This course is considered self-study, as defined by the New York State Board for Social Work. NetCE is recognized by the New York State Education Department's State Board for Mental Health Practitioners as an approved provider of continuing education for licensed mental health counselors #MHC-0021. This course is considered self-study by the New York State Board of Mental Health Counseling. Materials that are included in this course may include interventions and modalities that are beyond the authorized practice of licensed master social work and licensed clinical social work in New York. As a licensed professional, you are responsible for reviewing the scope of practice, including activities that are defined in law as beyond the boundaries of practice for an LMSW and LCSW. A licensee who practices beyond the authorized scope of practice could be charged with unprofessional conduct under the Education Law and Regents Rules. NetCE is recognized by the New York State Education Department's State Board for Mental Health Practitioners as an approved provider of continuing education for licensed marriage and family therapists. #MFT-0015.This course is considered self-study by the New York State Board of Marriage and Family Therapy.

Designations of Credit

This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change. NetCE designates this enduring material for a maximum of 1 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. NetCE designates this continuing education activity for 1 ANCC contact hour(s). NetCE designates this continuing education activity for 0.5 pharmacotherapeutic/pharmacology contact hour(s). NetCE designates this continuing education activity for 1.2 hours for Alabama nurses. NetCE designates this continuing education activity for 0.5 NBCC clock hour(s). Social workers participating in this intermediate to advanced course will receive 1 Clinical continuing education clock hours. Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1 MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Completion of this course constitutes permission to share the completion data with ACCME. Successful completion of this CME activity, which includes participation in the evaluation component, enables the learner to earn credit toward the CME and/or Self-Assessment requirements of the American Board of Surgery's Continuous Certification program. It is the CME activity provider's responsibility to submit learner completion information to ACCME for the purpose of granting ABS credit. This activity has been approved for the American Board of Anesthesiology’s® (ABA) requirements for Part II: Lifelong Learning and Self-Assessment of the American Board of Anesthesiology’s (ABA) redesigned Maintenance of Certification in Anesthesiology Program® (MOCA®), known as MOCA 2.0®. Please consult the ABA website, www.theABA.org, for a list of all MOCA 2.0 requirements. Maintenance of Certification in Anesthesiology Program® and MOCA® are registered certification marks of the American Board of Anesthesiology®. MOCA 2.0® is a trademark of the American Board of Anesthesiology®. Successful completion of this CME activity, which includes participation in the activity with individual assessments of the participant and feedback to the participant, enables the participant to earn 1 MOC points in the American Board of Pediatrics' (ABP) Maintenance of Certification (MOC) program. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABP MOC credit. Through an agreement between the Accreditation Council for Continuing Medical Education and the Royal College of Physicians and Surgeons of Canada, medical practitioners participating in the Royal College MOC Program may record completion of accredited activities registered under the ACCME's "CME in Support of MOC" program in Section 3 of the Royal College's MOC Program. This home study course is approved by the Florida Board of Nursing Home Administrators for 1 credit hour(s). This course is approved by the California Nursing Home Administrator Program for 1 hour(s) of continuing education credit - NHAP#1622001-9432/P. California NHAs may only obtain a maximum of 10 hours per course. NetCE is authorized by IACET to offer 0.1 CEU(s) for this program. NetCE designates this continuing education activity for 1 credit(s). AACN Synergy CERP Category A.

Individual State Nursing Approvals

In addition to states that accept ANCC, NetCE is approved as a provider of continuing education in nursing by: Alabama, Provider #ABNP0353, (valid through July 29,2025); Alabama, Provider #ABNP0353, (valid through July 29, 2025); Arkansas, Provider #50-2405; California, BRN Provider #CEP9784; California, LVN Provider #V10662; California, PT Provider #V10842; District of Columbia, Provider #50-2405; Florida, Provider #50-2405; Georgia, Provider #50-2405; Kentucky, Provider #7-0054 through 12/31/2025; South Carolina, Provider #50-2405; South Carolina, Provider #50-2405. West Virginia RN and APRN, Provider #50-2405.

Individual State Behavioral Health Approvals

In addition to states that accept ASWB, NetCE is approved as a provider of continuing education by the following state boards: Alabama State Board of Social Work Examiners, Provider #0515; Florida Board of Clinical Social Work, Marriage and Family Therapy and Mental Health Counseling, CE Broker Provider #50-2405; Illinois Division of Professional Regulation for Social Workers, License #159.001094; Illinois Division of Professional Regulation for Licensed Professional and Clinical Counselors, License #197.000185; Illinois Division of Professional Regulation for Marriage and Family Therapists, License #168.000190;

Special Approvals

This activity is designed to comply with the requirements of California Assembly Bill 1195, Cultural and Linguistic Competency.

Course Objective

The purpose of this course is to bridge the gap in knowledge of palliative care at the time of imminent death and in skills necessary to support patients and families in the moments before death.

Learning Objectives

Upon completion of this course, you should be able to:

1. Develop a strategy for providing care to patients and their families over the last days and hours of life.

2. Support appropriate grief and mourning.

3. Discuss how culture impacts end of life care and death.

Faculty

Lori L. Alexander, MTPW, ELS, MWC, is President of Editorial Rx, Inc., which provides medical writing and editing services on a wide variety of clinical topics and in a range of media. A medical writer and editor for more than 30 years, Ms. Alexander has written for both professional and lay audiences, with a focus on continuing education materials, medical meeting coverage, and educational resources for patients. She is the Editor Emeritus of the American Medical Writers Association (AMWA) Journal, the peer-review journal representing the largest association of medical communicators in the United States. Ms. Alexander earned a Master’s degree in technical and professional writing, with a concentration in medical writing, at Northeastern University, Boston. She has also earned certification as a life sciences editor and as a medical writer.

Alice Yick Flanagan, PhD, MSW, received her Master’s in Social Work from Columbia University, School of Social Work. She has clinical experience in mental health in correctional settings, psychiatric hospitals, and community health centers. In 1997, she received her PhD from UCLA, School of Public Policy and Social Research. Dr. Yick Flanagan completed a year-long post-doctoral fellowship at Hunter College, School of Social Work in 1999. In that year she taught the course Research Methods and Violence Against Women to Masters degree students, as well as conducting qualitative research studies on death and dying in Chinese American families.

Previously acting as a faculty member at Capella University and Northcentral University, Dr. Yick Flanagan is currently a contributing faculty member at Walden University, School of Social Work, and a dissertation chair at Grand Canyon University, College of Doctoral Studies, working with Industrial Organizational Psychology doctoral students. She also serves as a consultant/subject matter expert for the New York City Board of Education and publishing companies for online curriculum development, developing practice MCAT questions in the area of psychology and sociology. Her research focus is on the area of culture and mental health in ethnic minority communities.

Faculty Disclosure

Contributing faculty, Lori L. Alexander, MTPW, ELS, MWC, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Contributing faculty, Alice Yick Flanagan, PhD, MSW, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Division Planners

John M. Leonard, MD

Jane C. Norman, RN, MSN, CNE, PhD

James Trent, PhD

Division Planners Disclosure

The division planners have disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

Implicit Bias in Health Care

The role of implicit biases on healthcare outcomes has become a concern, as there is some evidence that implicit biases contribute to health disparities, professionals' attitudes toward and interactions with patients, quality of care, diagnoses, and treatment decisions. This may produce differences in help-seeking, diagnoses, and ultimately treatments and interventions. Implicit biases may also unwittingly produce professional behaviors, attitudes, and interactions that reduce patients' trust and comfort with their provider, leading to earlier termination of visits and/or reduced adherence and follow-up. Disadvantaged groups are marginalized in the healthcare system and vulnerable on multiple levels; health professionals' implicit biases can further exacerbate these existing disadvantages.

Interventions or strategies designed to reduce implicit bias may be categorized as change-based or control-based. Change-based interventions focus on reducing or changing cognitive associations underlying implicit biases. These interventions might include challenging stereotypes. Conversely, control-based interventions involve reducing the effects of the implicit bias on the individual's behaviors. These strategies include increasing awareness of biased thoughts and responses. The two types of interventions are not mutually exclusive and may be used synergistically.

1. INTRODUCTION

In the last days, the goals of the healthcare team are to ensure a peaceful death for the patient and to support the family during the dying process and throughout grief and mourning. The focus for the patient is management of symptoms and emotional and spiritual ease, and the focus for the family is education to prepare them for the dying process.

2. THE PATIENT'S NEEDS

During the last days, all care should be directed at comfort, and the National Comprehensive Cancer Network (NCCN) has listed several interventions for imminently dying patients (Table 1) [1]. The physician should minimize the number of medications by reassessing the need for each one. The symptoms that occur most commonly during the last days are pain, noisy breathing, dyspnea, and delirium, and medications to manage these symptoms should be maintained or initiated [2]. In addition, medication may be required to reduce the risk of seizures. Medications should be prescribed for the least invasive route of administration (oral or buccal mucosa), but patients may lose the ability to swallow, making a subcutaneous, transdermal, or intravenous route necessary.

Table 1: INTERVENTIONS FOR PATIENTS WHO ARE IMMINENTLY DYING

Intensify ongoing care.

Try to ensure privacy (if not at home, arrange for private room if possible).

Discontinue diagnostic tests.

Reposition for comfort as appropriate.

Avoid unnecessary needle sticks.

Provide mouth care (e.g., hydrogen peroxide/water solution).

Treat for urinary retention and fecal impaction.

Ensure access to medication even when oral route is not available.

Prepare to meet request for organ donation and autopsy.

Allow patient and family uninterrupted time together.

Ensure the patient and family understand the signs and symptoms of imminent death and are supported through the dying process.

Offer anticipatory bereavement support.

Provide support to children and grandchildren.

Encourage visits by children if consistent with family values.

Support culturally meaningful rituals.

Facilitate around-the-clock family presence.

Ensure that caregivers understand and will honor advance directives.

Provide respectful space for families.

Facilitate closure.

Source: [1]

Treatment of pain should continue, and knowledge of opioid pharmacology becomes critical during the last hours of life [2,3]. The metabolites of morphine and some other opioids remain active until they are cleared through the kidneys. If urine output stops, alternative opioids, such as fentanyl or methadone, should be considered, as they have inactive metabolites [4,5].

Anticholinergic medications can eliminate the so-called "death rattle" brought on by the build-up of secretions when the gag reflex is lost or swallowing is difficult. However, it is important to note that results of clinical trials examining various pharmacologic agents for the treatment of death rattle have so far been inconclusive [6]. Despite the lack of clear evidence, pharmacologic therapies continue to be used frequently in clinical practice [3]. Specific drugs used include scopolamine, glycopyrrolate, hyoscyamine, and atropine (Table 2) [2,3,7]. Glycopyrrolate may be preferred because it is less likely to penetrate the central nervous system and with fewer adverse effects than with other antimuscarinic agents, which can worsen delirium [3]. For patients with advanced kidney disease, the dose of glycopyrrolate should be reduced 50% (because evidence indicates that the drug accumulates in renal impairment) and hyoscine butylbromide should not be used (because of a risk of excessive drowsiness or paradoxical agitation) [4]. Some evidence suggests that treatment is more effective when given earlier; however, if the patient is alert, the dryness of the mouth and throat caused by these medications can be distressful. Repositioning the patient to one side or the other or in the semiprone position may reduce the sound. Oropharyngeal suctioning is not only often ineffective but also may disturb the patient or cause further distress for the family. Therefore, it is not recommended.

Table 2: TREATMENT OF EXCESSIVE RESPIRATORY SECRETIONS CAUSING "DEATH RATTLE"

Drug

Dose

Scopolamine (transdermal patch)

One (1.5-mg) patch applied behind the ear and changed every 72 hours

Onset of action may be delayed several hours, so other anticholinergic treatment should be provided until effective.

Glycopyrrolate

0.2–0.4 mg SC, repeat at 30 minutes, then every 4 to 6 hours, as needed; or 0.6–1.2 mg/day CSCI

Hyoscyamine

0.4 mg SC, repeat at 30 minutes, then every 2 to 4 hours, as needed; or 0.6–1.2 mg/day CSCI

Atropine

0.4–0.8 mg SC, repeat every 2 to 4 hours

CSCI = continuous subcutaneous infusion, SC = subcutaneously.

Source: [8]

Terminal delirium occurs before death in 50% to 90% of patients. It is associated with shorter survival and complicates symptom assessment, communication, and decision making. It can be extremely distressing to caregivers and healthcare professionals alike [3]. Safety measures include protecting patients from accidents or self-injury. Reorientation strategies are of little use during the final hours of life. Education and support for families witnessing a loved one's delirium are warranted [3]. There are few randomized controlled trials on the management of terminal delirium. Agents that can be used to manage delirium include haloperidol, which is frequently the first choice for its relatively quick action [3,8]. Other drugs may include olanzapine, chlorpromazine, levomepromazine, and benzodiazepines [3,8]. For terminal delirium associated with agitation, benzodiazepines, including clonazepam, midazolam, diazepam, and lorazepam may be helpful [3,8,9]. Depending on which drug is used, administration may be intravenous, subcutaneous, or rectal, and the dose can be titrated until effective.

Seizures at the end of life may be managed with high doses of benzodiazepines. Other antiepileptics such as phenytoin (administered intravenously), fosphenytoin (administered subcutaneously), or phenobarbital (60–120 mg rectally, intravenously, or intramuscularly every 10 to 20 minutes as needed) may become necessary until control is established.

A calm and peaceful environment should be maintained for the patient. Family and spiritual leaders should be allowed to carry out traditional rites and rituals associated with death.

PALLIATIVE SEDATION

Palliative sedation may be considered when an imminently dying patient is experiencing suffering (physical, psychologic, and/or spiritual) that is refractory to the best palliative care efforts. Terminal restlessness and dyspnea have been the most common indications for palliative sedation, and thiopental and midazolam are the typical sedatives used [1,10,11]. For patients who have advanced kidney disease, midazolam is recommended, but the dose should be reduced because more unbound drug becomes available [1,4]. Before beginning palliative sedation, the clinician should consult with a psychiatrist and pastoral services (if appropriate) and talk to the patient, family members, and other members of the healthcare team about the medical, emotional, and ethical issues surrounding the decision [1,2,9,12,13]. Formal informed consent should be obtained from the patient or from the healthcare proxy.

PHYSICIAN-ASSISTED DEATH

Physician-assisted death, or hastened death, is defined as active euthanasia (direct administration of a lethal agent with a merciful intent) or assisted death (aiding a patient in ending his or her life at the request of the patient) [2]. The following are not considered to be physician-assisted death: carrying out a patient's wishes to refuse treatment, withdrawal of treatment, and the use of high-dose opioids with the intent to relieve pain. The American Medical Association Code of Ethics explicitly states, "Physician-assisted suicide is fundamentally incompatible with the physician's role as healer, would be difficult or impossible to control, and would pose serious societal risks" [14]. Position statements against the use of physician-assisted death have been issued by many other professional organizations, including the National Hospice and Palliative Care Organization and the American Academy of Hospice and Palliative Medicine (AAHPM) [15,16]. The AAHPM states that their position is one of "studied neutrality" [15]. The basis for these declarations is that appropriate hospice care is an effective choice for providing comfort to dying patients.

In 2010, in a first-of-its-kind comprehensive consensus statement, the Heart Rhythm Society in collaboration with the major cardiology, geriatrics, and palliative care societies, emphasized that deactivation of implantable cardioverter-defibrillators is neither euthanasia nor physician-assisted death [17]. The organizations urged clinicians to respect the right of patients to request deactivation.

The NCCN guidelines recommend that physicians explore requests for assisted death and explain to the patient the distinctions among assisted death, treatment withdrawal, and aggressive symptom management [1]. Some states have enacted assisted death statutes. State laws vary, and knowledge of your local statutes is necessary.

3. THE FAMILY'S NEEDS

Ongoing communication with family members is essential to ensure their well-being as their loved one dies. The healthcare team should discuss what will happen over the course of dying so the family can be better prepared for symptoms such as altered breathing patterns and sounds, terminal delirium, and unconsciousness [1,3,18]. The family should be reassured that what they may think the patient is experiencing is not the patient's actual reality.

The altered breathing patterns that are present as death is imminent are distressful for family members, as they believe that the patient is experiencing a sense of suffocation. Also distressful to family is the sound of the death rattle. The healthcare team should assure family that these signs do not indicate that the patient is suffering and explain that additional therapy will not be of benefit.

Families often misinterpret the early signs of terminal delirium as signs of uncontrollable pain. However, if pain has been adequately managed throughout the delivery of palliative care, such pain will not begin during the last hours. As the patient slips in and out of consciousness, family members may become increasingly distressed about not being able to communicate anymore with their loved one. Although it is unknown what a dying patient can hear, other experiences in medicine suggest that awareness may be greater than the ability to respond. Family members should be encouraged to continue talking with their loved one to help them attain a sense of closure.

Despite the best efforts to prepare the family, reactions are unpredictable when death occurs. The clinician should take time to answer questions from family members, including children, and perhaps provide information on the physiologic events associated with death [2]. For family members who were not present during the death, the clinician should describe the event, while reassuring them that the patient died peacefully.

Many experts believe that people can handle grief better if they spend time with a loved one immediately after death. Family members should be allowed to touch, hold, and kiss their loved one as they feel comfortable. The healthcare team should respect the needs of the family to conduct personal, cultural, or religious traditions, rites, and rituals.

4. GRIEF, MOURNING, AND BEREAVEMENT

Evidence Based Practice Recommendation

The National Hospice and Palliative Care Organization recommends that patient and family/caregiver feelings, strengths, goals, and needs related to loss, grief, and bereavement be assessed. Then, interventions should be developed based on the assessment and are incorporated into the interdisciplinary plan of care.

https://www.nhpco.org/regulatory-and-quality/quality

Last Accessed: October 22, 2021

Strength of Recommendation/Level of Evidence: Expert Opinion/Consensus Statement

Palliative care extends beyond the patient's death, with the focus shifting to support of the family during bereavement and mourning. Although the terms "grief," "mourning," and "bereavement" are often used interchangeably, their definitions are different. Grief is a normal reaction to a loss; mourning is the process by which individuals adjust to the loss; and bereavement is the period of time during which grief and mourning occur [2,19]. Psychosocial support of the family is essential throughout the duration of palliative care and can help to decrease the risks of morbidity, substance abuse, and mortality that have been found among spouses and other loved ones of patients who have died [18].

GRIEF

Grief comprises a range of feelings, thoughts, and behaviors that fall in the realm of the physical, emotional, and social domains [2]. Individuals may have trouble sleeping, changes in appetite, or other physical symptoms or illness. Emotions can include sadness, anxiety, guilt, and anger. Return to work, activities with friends, and taking care of family can be beneficial.

Grief counseling for the family and patient should begin when the patient is alive, with a focus on life meaning and the contributions from the patient's family. An understanding of the mediators of the grief response can help physicians and other members of the healthcare team recognize the family members who may be at increased risk for adapting poorly to the loss [20]. These mediators are:

- Nature of attachment (how close and/or dependent the individual was with regard to the patient)

- Mode of death (the suddenness of the death)

- Historical antecedents (how the individual has handled loss in the past)

- Personality variables (factors related to age, gender, ability to express feelings)

- Social factors (availability of social support, involvement in ethnic and religious groups)

- Changes and concurrent stressors (number of other stressors in the individual's life, coping styles)

Clinical assessment should be carried out for individuals at risk of complicated grief. Distinguishing between grief and depression can be challenging, as many signs and symptoms are similar. However, the hallmarks of depression are constant and unremitting feelings of worthlessness, hopelessness, helplessness, anhedonia, and suicidal ideation [8].

MOURNING

Satisfactory adaptation to loss depends on "tasks" of mourning [20]. Previous research referred to "stages" of mourning, but the term "task" is now used because the stages were not clear-cut and were not always followed in the same order. The tasks include:

- Accepting the reality of the loss

- Experiencing the pain of the loss

- Adjusting to the environment in which the deceased is missing (external, internal, and spiritual adjustments)

- Finding a way to remember the deceased while moving forward with life

After the patient's death, members of the palliative care team should encourage the family to talk about the patient, as this promotes acceptance of the death. Explaining that a wide range of emotions is normal during the mourning process can help family members understand that experiencing these emotions is a necessary aspect of grieving. Frequent contact with family members after the loved one's death can ensure that the family is adjusting to the loss. Referrals for psychosocial and spiritual interventions should be made as early as possible to optimize their efficacy.

BEREAVEMENT

Bereavement support should begin immediately with a handwritten condolence note from the clinician. Such notes have been found to provide comfort to the family [21,22]. The physician should emphasize the personal strengths of the family that will help them cope with the loss and should offer help with specific issues. Attendance at the patient's funeral, if possible, is also appropriate.

How bereavement services are provided through a hospice/palliative care program vary. Programs usually involve contacting the family at regular intervals to provide resources on grieving, coping strategies, professional services, and support groups [1,9]. When notes are sent, family members should be invited to contact the physician or other members of the healthcare team with questions. Notes are especially beneficial at the time of the first holidays without the patient, significant days for the family (patient's birthday, spouse's birthday), and the anniversary of the patient's death. Bereavement services should extend for at least one year after the patient's death, but a longer period may be necessary [9,18].

5. CULTURAL CONSIDERATIONS

Cultural sensitivity consists of promoting trust and mutual respect for cultural differences between providers and patients [23]. In end-of-life care, an understanding of cultural differences in beliefs about grieving is necessary. In Western culture, grieving is expected to be time-limited, and extended grieving can be considered pathologic [24]. However, in other cultures, extended periods of grieving are socially sanctioned.

Cultural groups adhere to culturally laden beliefs about death rituals, death symbols, language, gender roles, advanced care planning, end-of-life directives, and bereavement and grief. As a result, a provider's level of cultural competence will influence how he or she interacts with patients and family members during the end of life, ultimately influencing how patients and families perceive the end-of-life experience [25]. In traditional Asian families, for example, the eldest son may be designated to make key health and end-of-life decisions [26]. Various cultural groups will have specific norms about the expression of emotion during funerals. White Protestant individuals, for example, may value stoicism, while the Chinese equate the amount of wailing to the amount of respect paid to the deceased [27]. Crying that involves shaking of the body is considered cathartic and a normal reaction in some cultures [28].

It is also important to consider intersectionality in discussions of cultural competence. Individuals do not belong in one category in terms of their identity. Often, patients have overlapping identities (e.g., sex/gender, socioeconomic status, religion, class, sexual orientation, racial/ethnic minority group). This contributes to discrimination and marginalization, which influences how one experiences death and dying [29]. Some experts assert that the word "competence" in cultural competence is a misnomer, because it implies that providers can obtain a "rational mastery and application of knowledge" [30]. End-of-life care planning is complex, and cultural competence entails being reflective and accessing one's intuition.

6. CONCLUSION

When patients and their families are confronted with a terminal illness and issues of death and dying, it is undoubtedly a time of grief and stress. Although patients and families require support during this period, practitioners may be uncomfortable witnessing grief, as it may raise personal issues about their own mortality. Palliative care eases the burden of suffering experienced by patients approaching life's end and provides for grief counseling and bereavement services for a family adjusting to loss.

Works Cited

1. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Palliative Care. Version 2.2021. Available at https://www.nccn.org/professionals/physician_gls/pdf/palliative.pdf. Last accessed October 19, 2021.

2. Berger AM, O'Neill JF (eds). Principles & Practice of Palliative Care & Supportive Oncology. 5th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2022.

3. National Cancer Institute. Last Days of Life—Health Professional Version. Available at https://www.cancer.gov/about-cancer/advanced-cancer/caregivers/planning/last-days-hp-pdq. Last accessed October 19, 2021.

4. Douglas C, Murtagh FE, Chambers EJ, Howse M, Ellershaw J. Symptom management for the adult patient dying with advanced chronic kidney disease: a review of the literature and development of evidence-based guidelines by a United Kingdom Expert Consensus Group. Palliat Med. 2009;23(2):103-110.

5. Manfredonia J. Prescribing methadone for pain management in end-of-life care. JAOA. 2005;105(3 Suppl):18S-21S.

6. Lokker ME, van Zuylen L, van der Rijt CC, et al. Prevalence, impact, and treatment of death rattle: a systematic review. J Pain Symptom Manage. 2014;47(1):105-122.

7. Wee B, Hillier R. Interventions for noisy breathing in patients near to death. Cochrane Database Syst Rev. 2008;(1):CD005177.

8. Doyle D, Woodruff R. The IAHPC Manual of Palliative Care. 3rd ed. Houston, TX: International Association for Hospice and Palliative Care Press; 2013.

9. Abrahm JL. A Physician's Guide to Pain and Symptom Management in Cancer Patients. 3rd ed. Baltimore, MD: Johns Hopkins University Press; 2014.

10. Elsayem A, Curry E III, Boohene J, et al. Use of palliative sedation for intractable symptoms in the palliative care unit of a comprehensive cancer center. Support Care Cancer. 2009;17(1):53-59.

11. Rietjens JA, van Zuylen L, van Veluw H, van der Wijk L, van der Heide A, van der Rijt CC. Palliative sedation in a specialized unit for acute palliative care in a cancer hospital: comparing patients dying with and without palliative sedation. J Pain Symptom Manage. 2008;36(3):228-234.

12. Lo B, Rubenfeld G. Palliative sedation in dying patients. JAMA. 2005;294:1810-1816.

13. Kirk T, Mahon M. National Hospice and Palliative Care Organization (NHPCO) position statement and commentary on the use of palliative sedation in imminently dying terminally ill patients. J Pain Symptom Manage. 2010;39(5):914-923.

14. American Medical Association. Ethics: Physician-Assisted Suicide. Available at https://www.ama-assn.org/delivering-care/ethics/physician-assisted-suicide. Last accessed October 19, 2021.

15. American Academy of Hospice and Palliative Medicine. Statement on Physician-Assisted Dying. Available at http://aahpm.org/positions/pad. Last accessed October 19, 2021.

16. National Hospice and Palliative Care Organization. Commentary and Resolution on Physician-Assisted Suicide. Available at www.nationalhospiceanalytics.com/library/documents/PAS_resources/NHPCO_PAS_Resolution_Commentary.pdf. Last accessed October 19, 2021.

17. Lampert R, Hayes DL, Annas GJ, et al. HRS expert consensus statement on the management of cardiovascular implantable electronic devices (CIEDs) in patients nearing end of life or requesting withdrawal of therapy. Heart Rhythm. 2010;7(7):1008-1026.

18. National Consensus Project for Quality Palliative Care. Clinical Practice Guidelines for Quality Palliative Care. 4th ed. Richmond, VA: National Coalition for Hospice and Palliative Care; 2018.

19. Stroebe MS, Hansson RO, Schut H, et al. (eds). Handbook of Bereavement Research and Practice: Advances in Theory and Intervention. Washington, DC: American Psychological Association; 2008.

20. Worden JW. Grief Counseling and Grief Therapy. 5th ed. New York, NY: Springer; 2018.

21. Main J. Improving management of bereavement in general practice based on a survey of recently bereaved subjects in a single general practice. Br J Gen Pract. 2000;50:863-866.

22. Bedell S, Cadenhead K, Braboys T. The doctor's letter of condolence: national vital statistics reports final data 1998. N Engl J Med. 2001;344:1161-1162.

23. Ariff KM, Beng KS. Cultural health beliefs in a rural family practice: a Malaysian perspective. Aust J Rural Health. 2006;14(1):2-8.

24. Stroebe M, Gergen M, Gergen K, Stroebe W. Broken hearts or broken bonds: love and death in historical perspective. Am Psychol. 1992;47(10):1205-1212.

25. Martin EM, Barkley TW. Improving cultural competence in end-of-life pain management. Home Healthc Now. 2017;35(2):96-104.

26. Saccomano SJ, Abbatiello GA. Cultural considerations at the end of life. Nurse Pract. 2014;39(2):24-32.

27. Yick AG, Gupta R. Chinese cultural dimensions of death, dying, and bereavement: focus group findings. J Cult Divers. 2002;9(2): 32-42.

28. Hardy-Bougere M. Cultural manifestations of grief and bereavement: a clinical perspective. J Cult Divers. 2008;15(2):66-69.

29. Pirschel C. What oncology nurses need to know about cultural differences during end-of-life care. ONS Voice. 2017;32(11):38-39.

30. Gunaratnam Y. Intercultural palliative care: do we need cultural competence? International Journal of Palliative Nursing. 2007;13:470-477.

Evidence-Based Practice Recommendations Citations

1. National Hospice and Palliative Care Organization. Standards of Practice for Hospice Programs. Alexandria, VA: National Hospice and Palliative Care Organization; 2018. Available at https://www.nhpco.org/regulatory-and-quality/quality. Last accessed October 22, 2021.

91333 • Medical Error Prevention and Root Cause Analysis

Marjorie Conner Allen, BSN, JD

www.netce.com

Copyright © 2019 NetCE, All rights reserved.

The Institute of Medicine's (IOM) 1999 publication To Err is Human: Building a Safer Health System, illuminated the unfortunate reality of medical errors in the healthcare industry. The report reviewed the prevalence of medical errors in the United States and highlighted measures that should be taken to prevent them. Specifically, the authors of the report noted that at least 44,000 and perhaps as many as 98,000 Americans were dying in hospitals each year as a result of medical errors. A 2016 report stated that the average number of annual in-hospital deaths attributable to medical error might actually be much higher, at around 400,000. Certainly, these numbers must be balanced against the millions of admissions to hospitals in the United States, which is in excess of 35 million annually. Healthcare professionals should commit to continuing to pay attention to evaluating current approaches for reducing errors and to building new systems to reduce the incidence of medical errors.

Table of Contents

91333 • Medical Error Prevention and Root Cause Analysis

Course Overview

Audience

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Division Planners

Division Planners Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

1. INTRODUCTION

2. DEFINING "MEDICAL ERROR"

3. ROOT CAUSE ANALYSIS PROCESS

FLORIDA LAW

4. ERROR REDUCTION AND PREVENTION

UNINTENDED RETENTION OF A FOREIGN BODY

WRONG-SITE SURGERY

DELAYS IN TREATMENT

OPERATIVE AND POSTOPERATIVE COMPLICATIONS

PATIENT SUICIDE

PATIENT FALLS

MEDICATION ERRORS

COMMON MISDIAGNOSES

5. OTHER CONSIDERATIONS FOR PATIENT SAFETY

USE OF AN INTERPRETER

6. CONCLUSION

Works Cited

91333 • Medical Error Prevention and Root Cause Analysis

Education Category. Management

Release Date. 09/01/2019

Expiration Date. 08/31/2022

Course Overview

The Institute of Medicine's (IOM) 1999 publication To Err is Human: Building a Safer Health System, illuminated the unfortunate reality of medical errors in the healthcare industry. The report reviewed the prevalence of medical errors in the United States and highlighted measures that should be taken to prevent them. Specifically, the authors of the report noted that at least 44,000 and perhaps as many as 98,000 Americans were dying in hospitals each year as a result of medical errors. A 2016 report stated that the average number of annual in-hospital deaths attributable to medical error might actually be much higher, at around 400,000. Certainly, these numbers must be balanced against the millions of admissions to hospitals in the United States, which is in excess of 35 million annually. Healthcare professionals should commit to continuing to pay attention to evaluating current approaches for reducing errors and to building new systems to reduce the incidence of medical errors.

Audience

This course is designed for all licensed healthcare professionals.

Course Objective

The purpose of this course is to satisfy the requirement of the Florida law and provide all licensed healthcare professionals with information regarding the root cause process, error reduction and prevention, and patient safety.

Learning Objectives

Upon completion of this course, you should be able to:

1. Describe how the Institute of Medicine defines "medical error."

2. Describe the types of sentinel events the Joint Commission has identified.

3. Discuss what factors must be included in a root cause analysis in order for the Joint Commission to consider it "thorough" and "credible."

4. Identify what types of adverse incidents must be reported to the Florida Agency for Healthcare Administration.

5. Identify the most common sentinel events reported to the Joint Commission.

6. Evaluate the most common misdiagnoses, as recognized by the Florida Board of Medicine, and outline the safety needs of special populations, including non-English-proficient patients.

Faculty

Marjorie Conner Allen, BSN, JD, received her Bachelor of Science in Nursing degree from the University of Florida, Gainesville, in 1984. She began her nursing career at Shands Teaching Hospital and Clinics at the University of Florida, Gainesville. While practicing nursing at Shands, she gave continuing education seminars regarding the nursing implications for dealing with adolescents with terminal illness. In 1988, Ms. Allen moved to Atlanta, Georgia where she worked at Egleston Children’s Hospital at Emory University in the bone marrow transplant unit. In the fall of 1989, she began law school at Florida State University. After graduating from law school in 1992, Ms. Allen took a two-year job as law clerk to the Honorable William Terrell Hodges, United States District Judge for the Middle District of Florida. After completing her clerkship, Ms. Allen began her employment with the law firm of Smith, Hulsey & Busey in Jacksonville, Florida where she has worked in the litigation department defending hospitals and nurses in medical malpractice actions. Ms. Allen resides in Jacksonville and is currently in-house counsel to the Mayo Clinic Jacksonville.

Faculty Disclosure

Contributing faculty, Marjorie Conner Allen, BSN, JD, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Division Planners

John M. Leonard, MD

Jane C. Norman, RN, MSN, CNE, PhD

Division Planners Disclosure

The division planners have disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

1. INTRODUCTION

The Institute of Medicine's (IOM) 1999 publicationTo Err is Human: Building a Safer Health System, illuminated the unfortunate reality of medical errors in the healthcare industry. The report reviewed the prevalence of medical errors in the United States and highlighted measures that should be taken to prevent them. Specifically, the authors of the report noted that at least 44,000 and perhaps as many as 98,000 Americans were dying in hospitals each year as a result of medical errors and many more were being seriously injured [1]. They further noted that, even when using the lower estimate of 44,000, deaths in hospitals due to medical errors exceeded the annual deaths attributable to motor vehicle accidents (43,458), breast cancer (42,297), or AIDS (16,516) [1]. A 2016 report stated that the average number of annual in-hospital deaths attributable to medical error might actually be much higher, at around 400,000 [2]. This report places medical errors as the third leading cause of death in the United States. Certainly, these numbers must be balanced against the millions of admissions to hospitals in the United States, which is in excess of 35 million annually [1,3].

It does appear that some progress has been made in the past decade. The Agency for Healthcare Research and Quality found a 17% decline in hospital-acquired conditions between 2010 and 2013, or 1.3 million fewer conditions and 50,000 fewer deaths than if the 2010 rate had remained steady [4]. Though the precise mechanism(s) responsible for this decline is not clear, it occurred following a concerted effort by federal agencies, organizations, and individual providers to curtail medical errors. However, the statistics indicate that medical errors continue to be an issue. Healthcare professionals should commit to continuing to pay greater attention to evaluating approaches for reducing errors and to building new systems to reduce the incidence of medical errors.

Spurred by a commitment to reducing medical error incidents, the Florida Legislature mandates that all healthcare professionals in Florida complete a two-hour course on the topic of prevention of medical errors [5]. This continuing education course is designed to satisfy the requirements of the Florida law and provide all licensed healthcare professionals with information regarding the root cause analysis process, error reduction and prevention, and patient safety, as well as information regarding the five most misdiagnosed conditions as determined by the Florida Board of Medicine.

2. DEFINING "MEDICAL ERROR"

The IOM Committee on Quality of Healthcare in America defines error as "the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim" [1]. It is important to note that medical errors are not defined as intentional acts of wrongdoing and that not all medical errors rise to the level of medical malpractice or negligence. Errors depend on two kinds of failures: either the correct action does not proceed as intended, which is described as an "error of execution," or the original intended action is not correct, which is described as an "error of planning" [1]. A medical error can occur at any stage in the process of providing patient care, from diagnosis to treatment, and even while providing preventative care. Not all errors will result in harm to the patient. Medical errors that do result in injury are sometimes called preventable adverse events or sentinel events—sentinel because they signal the need for immediate investigation and response [6].

Preventable adverse events or sentinel events are defined as those events that cause an injury to a patient as a result of medical intervention or inaction on the part of the healthcare provider whereby the injury cannot reasonably be said to be related to the patient's underlying medical condition. Thus, for example, if a patient has a surgical procedure and dies postoperatively from pneumonia, the patient has suffered an adverse event. But was that adverse event preventable; was it caused by medical intervention or inaction? The specific facts of this case must be analyzed to determine whether the patient acquired the pneumonia as a result of poor handwashing techniques of the medical staff (i.e., an error of execution), which would indicate a preventable adverse event, or whether the patient acquired the pneumonia because of age and comorbidities, which would indicate a nonpreventable adverse event.

Healthcare professionals can learn much by closely scrutinizing and evaluating adverse events that lead to serious injury or death. The evaluation of such events would also enable healthcare professionals to improve the delivery of health care and reduce future mistakes. In addition, healthcare professionals should have a process in place to evaluate those instances in which a medical error occurred and did not cause harm to the patient. By reviewing these processes, healthcare professionals are afforded the unique opportunity to identify system improvements that have the potential to prevent future adverse events. The Joint Commission, recognizing the importance of analyzing both preventable adverse events and near-misses, has established guidelines for recognizing these events and requires healthcare facilities to conduct a root cause analysis to determine the underlying cause of the event [7].

3. ROOT CAUSE ANALYSIS PROCESS

The Joint Commission is a national organization with a mission to improve the quality of care provided at healthcare institutions in the United States. It accomplishes this mission by providing accredited status to healthcare facilities. Accreditors play an important role in encouraging and supporting actions within healthcare organizations by holding them accountable for ensuring a safe environment for patients. Healthcare organizations should actively engage in a cooperative relationship with the Joint Commission through this accreditation process and participate in the process to reduce risk and facilitate desired outcomes of care.

The Joint Commission defines a sentinel event as "an unexpected occurrence involving the death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase 'or the risk thereof' includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome" [6]. Root cause analysis, as defined by the Joint Commission, is "a process for identifying the basic or causal factors that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event" [6].

The following subsets of sentinel events are subject to review by the Joint Commission [6]:

- The event has resulted in an unanticipated death or major permanent loss of function, not related to the natural course of the patient's illness or underlying condition

or

- The event is one of the following (even if the outcome was not death or major permanent loss of function unrelated to the natural course of the patient's illness or underlying condition):

- Suicide of any patient receiving care, treatment, and services in a staffed around-the-clock care setting or within 72 hours of discharge

- Unanticipated death of a full-term infant

- Abduction of any patient receiving care, treatment, and services

- Discharge of an infant to the wrong family

- Rape, assault (leading to death or permanent loss of function), or homicide of any patient receiving care, treatment, and services

- Rape, assault (leading to death or permanent loss of function), or homicide of a staff member, licensed independent practitioner, visitor, or vendor while on site at the healthcare organization

- Hemolytic transfusion reaction involving administration of blood or blood products having major blood group incompatibilities (e.g., ABO, Rh, other blood groups)

- Invasive procedure, including surgery, on the wrong patient or wrong site

- Unintended retention of a foreign object in a patient after surgery or other invasive procedures

- Severe neonatal hyperbilirubinemia (bilirubin >30 mg/dL)

- Prolonged fluoroscopy with cumulative dose >1,500 rads to a single field or any delivery of radiotherapy to the wrong body region or >25% above the planned radiotherapy dose

- Fire, flame, or unanticipated smoke, heat, or flashes occurring during an episode of patient care

- Any intrapartum (related to the birth process) maternal death

- Severe maternal morbidity

Alternatively, the following examples are events that are NOT considered reviewable under the Joint Commission's sentinel event policy [6]:

- Any close call ("near miss")

- Full or expected return of limb or bodily function to the same level as prior to the adverse event by discharge or within two weeks of the initial loss of said function, whichever is the longer period

- Any sentinel event that has not affected a recipient of care (e.g., patient, individual, resident)

- Medication errors that do not result in death or major permanent loss of function

- Suicide other than in an around-the-clock care setting or following elopement from such a setting

- A death or loss of function following a discharge against medical advice

- Unsuccessful suicide attempts unless resulting in major permanent loss of function

- Minor degrees of hemolysis not caused by a major blood group incompatibility and with no clinical sequelae

(For further definition of terms, please refer to the Joint Commission's Sentinel Event Policy and Procedures at https://www.jointcommission.org/sentinel_event_policy_and_procedures.)

As part of the accreditation requirement, the Joint Commission requires that healthcare organizations have a process in place to recognize these sentinel events, conduct thorough and credible root cause analyses that focus on process and system factors, and document a risk-reduction strategy and internal corrective action plan that includes measurement of the effectiveness of process and system improvements to reduce risk [6]. This process must be completed within 45 days of the organization having become aware of the sentinel event.

The Joint Commission will consider a root cause analysis acceptable for accreditation purposes if it focuses primarily on systems and processes, not individual performance [6]. In other words, the healthcare organization should minimize the individual blame or retribution for involvement in a medical error. In addition, the root cause analysis should progress from special causes in clinical processes to common causes in organizational processes, and the analysis should repeatedly dig deeper by asking why, then, when answered, why again, and so on. The analysis should also identify changes that can be made in systems and processes, either through redesign or development of new systems or processes, which would reduce the risk of such events occurring in the future. The Joint Commission requires that the analysis be thorough and credible. To be considered thorough, the root cause analysis must include [6]:

- A determination of the human and other factors most directly associated with the sentinel event and the process(es) and systems related to its occurrence

- Analysis of the underlying systems and processes through a series of "why" questions to determine where redesign might reduce risk

- Inquiry into all areas appropriate to the specific type of event

- Identification of risk points and their potential contributions to this type of event

- A determination of potential improvement in processes or systems that would tend to decrease the likelihood of such events in the future, or a determination, after analysis, that no such improvement opportunities exist

To be considered credible, the root cause analysis must meet the following standards [6]:

- The organization's leadership and the individuals most closely involved in the process and systems under review must participate in the analysis.

- The analysis must be internally consistent; that is, it must not contradict itself or leave obvious questions unanswered.

- The analysis must provide an explanation for all findings of "not applicable" or "no problem."

- The analysis must include consideration of any relevant literature.

Finally, as previously discussed, after conducting this root cause analysis, the organization must prepare an internal corrective action plan. The Joint Commission will accept this action plan if it identifies changes that can be implemented to reduce risk or formulate a rationale for not undertaking such changes, and if, where improvement actions are planned, it identifies who is responsible for implementation, when the action will be implemented, and how the effectiveness of the actions will be evaluated [6].

FLORIDA LAW

Healthcare professionals have an obligation to report adverse events to leadership and ensure that organizations have processes in place to satisfy the Joint Commission requirement. In Florida, certain serious adverse incidents must also be reported to Florida's Agency for Health Care Administration (AHCA). Florida law requires that licensed facilities, such as hospitals, establish an internal risk management program. As part of that program, licensed facilities must develop and implement an incident reporting system, which requires the development of appropriate measures to minimize the risk of adverse incidents to patients, as well as imposes an affirmative duty on all healthcare providers and employees of the facility to report adverse incidents to the risk manager or to his or her designee. The risk manager must receive these incident reports within 3 business days of the incident, and depending on the type of incident, the risk manager may have to report the incident to AHCA within 15 days of receipt of the report.

Florida Statute 395.0197 specifically defines an adverse incident as [8]:

For purposes of reporting to the agency pursuant to this section, the term "adverse incident" means an event over which health care personnel could exercise control and which is associated in whole or in part with medical intervention, rather than the condition for which such intervention occurred, and which:

1. Results in one of the following injuries:

1. Death;

2. Brain or spinal damage;

3. Permanent disfigurement;

4. Fracture or dislocation of bones or joints;

5. A resulting limitation of neurological, physical, or sensory function which continues after discharge from the facility;

6. Any condition that required specialized medical attention or surgical intervention resulting from nonemergency medical intervention, other than an emergency medical condition, to which the patient has not given his or her informed consent; or

7. Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care due to the adverse incident, rather than the patient's condition prior to the adverse incident

2. Was the performance of a surgical procedure on the wrong patient, a wrong surgical procedure, a wrong-site surgical procedure, or a surgical procedure otherwise unrelated to the patient's diagnosis or medical condition;

3. Required the surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage was not a recognized specific risk, as disclosed to the patient and documented through informed-consent process; or

4. Was a procedure to remove unplanned foreign objects remaining from a surgical procedure.

In 2018, the Florida AHCA reported that a total of 131 deaths occurred as a result of hospital error, 20.6% of 636 adverse incidents reported for the year. The next most common incidents during this period were surgical procedure to remove foreign object from a previous surgical procedure (16.5%), transfer of the patient to a unit providing a more acute level of care due to the adverse incident (14.2%), surgical procedures unrelated to the patient's diagnosis or medical needs (10%), and surgical procedure performed on the wrong site (5.3%) [9]. The following adverse incidents must be reported to the AHCA within 15 calendar days after their occurrence [8]:

- The death of a patient

- Brain or spinal damage to a patient

- The performance of a surgical procedure on the wrong patient

- The performance of a wrong-site surgical procedure

- The performance of a wrong surgical procedure

- The performance of a surgical procedure that is medically unnecessary or otherwise unrelated to the patient's diagnosis or medical condition

- The surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage is not a recognized specific risk, as disclosed to the patient and documented through the informed-consent process

- The performance of procedures to remove unplanned foreign objects remaining from a surgical procedure

Each incident will be reviewed by the AHCA, who will then determine the penalty to be imposed upon the responsible party [8]. All Florida healthcare professionals who practice in licensed facilities should familiarize themselves with these requirements and ensure that the facility in which they practice has processes in place to ensure compliance.

Unlike Florida's mandatory reporting of serious adverse incidents, the Joint Commission recommends that healthcare organizations voluntarily report sentinel events, and it encourages the facilities to communicate the results of their root cause analyses and their corrective action plans. As a result of the sentinel events that have been reported, the Joint Commission has compiled Sentinel Event Alerts. These alerts are intended to provide healthcare organizations with important information regarding reported trends and, by doing so, highlight areas of potential concern so an organization may review its own internal processes to maximize error reduction and prevention with regard to a particular issue [7].

4. ERROR REDUCTION AND PREVENTION

Between 2005 and 2018, the Joint Commission reviewed 11,622 sentinel events [11]. Some events, such as fire, impacted multiple patients. Sentinel event reviews during this time period were frequently conducted for unintended retention of a foreign body; wrong-patient, wrong-site, wrong-procedure surgery; delay in treatment; operative and postoperative complications; patient suicide; patient fall; and medication error [11].

UNINTENDED RETENTION OF A FOREIGN BODY

In 2017–2018, the most frequently reported sentinel event reported to the Joint Commission was unintended retained foreign objects [11]. The prevalence of these events has remained relatively stable since 2009, indicating that preventing these errors remains difficult for practitioners and facilities. The most commonly retained items are sponges, followed by catheter guidewires and other (a broad category encompassing a wide variety of items) [10].

In addition to harming patients and contributing to distrust in the medical system, the unintended retention of foreign objects significantly contributes to patient care costs [13]. The average total cost of care related to unintended retained foreign objects is $166,000 to $200,000 [13].

According to the sentinel event data, the most common root causes of unintended retained foreign objects reported to the Joint Commission are [13]:

- The absence of policies and procedures

- Failure to comply with existing policies and procedures

- Problems with hierarchy and intimidation

- Failure in communication with physicians

- Failure of staff to communicate relevant patient information

- Inadequate or incomplete education of staff

WRONG-SITE SURGERY

Operating on the wrong part of a patient's body is an obvious sign that there is a problem in the operating room system. Interestingly, wrong-site surgery occurred more commonly in orthopedic procedures than in all other surgical specialties combined. The American Academy of Orthopaedic Surgeons takes this issue seriously, and it has taken special steps to eliminate the problem. For example, it recommends that a surgeon sign their initials at the correct site of surgery with an indelible pen. Unless the initials are visible, the surgeon should not make an incision [12]. Writing "NO" in large black letters on the side not to be operated on was suggested in the past, but this is discouraged due to possible confusion with the surgeon's initials. In spinal surgery, the Academy recommends that an intraoperative radiograph and radiopaque marker be used to determine the exact vertebral level of spinal surgery [12]. Whatever the mechanism used to prevent and reduce the incidence of this error, it is clear that this is not just the surgeon's problem. All of the operating room personnel, including physicians, nurses, technicians, anesthesiologists, and other preoperative allied health personnel, should monitor procedures to ensure verification procedures are followed, especially for high-risk procedures.

Due to the prevalence of wrong-site, wrong-procedure, and wrong-person surgeries, the Joint Commission, along with more than 50 professional healthcare organizations, convened two summits to help reduce the occurrence of these errors. The first summit, convened in 2003, developed a Universal Protocol that consisted of the following: a preprocedure verification process; marking the operative/procedure site with an indelible marker; taking a "time-out" with all team members immediately before starting the procedure; and adaptation of the requirements to all procedure settings, including bedside procedures. However, the incidence of wrong-site surgeries continued to increase, and in 2007 and 2010, additional summits were organized to pinpoint barriers in compliance and discover new strategies to eliminate these errors [14]. As of 2019, the Universal Protocol has been incorporated into the National Patient Safety Goal chapter of the Joint Commission accreditation manual [15].

DELAYS IN TREATMENT

According to the Joint Commission, more than half of all reported delays in treatment sentinel events in 2010–2014 resulted in patient death [16]. It is important to keep in mind that delays in treatment can occur in any healthcare setting. The most common reason for a delay in treatment is misdiagnosis; however, delays can also result from delayed test results, physician availability, delayed administration of ordered care, incomplete treatment, and even inability to get an initial appointment or follow-up appointment in a timely manner [16]. The main root causes contributing to delays in treatment are inadequate assessments, poor planning, communication failures, and human factors. Recommendations from the Joint Commission include avoiding cognitive shortcuts, improving health information technology, incorporating diagnostic checklists into the electronic record, promoting provider-to-provider communication, engaging leadership in developing solutions, focusing organization attention on the scheduling process and on ordering tests and reporting test results, improving access to care, implementing a standardized communications method, maintaining adequate staffing levels, and increasing patient and family engagement/activation [16].

OPERATIVE AND POSTOPERATIVE COMPLICATIONS

Many of the sentinel events reported to the Joint Commission regarding operative and postoperative complications occurred in relation to nonemergent procedures, such as interventional imaging and/or endoscopy, tube or catheter insertion, open abdominal surgery, head and neck surgery, orthopedic surgery, and thoracic surgery [17]. The majority of the reporting healthcare facilities cited miscommunication as the primary root cause. Other identified causes include failure to follow established procedures, incomplete preoperative assessment, inconsistent postoperative monitoring procedures, and failure to question inappropriate orders. In order to reduce the risk, reporting facilities have identified a number of strategies, including improving staff orientation and training, increasing educational opportunities for physicians, clearly defining expected channels of communication, and monitoring consistency of compliance with procedures. Healthcare facilities should review postoperative patient monitoring procedures to ensure an adequate level appropriate to the needs of the patient, regardless of the setting (e.g., operating room, endoscopy suite, radiology department) [17]. Based upon these findings, it is clear that direct communication among healthcare providers is key to preventing operative and postoperative complications. Healthcare facilities should provide more staff education regarding preventative measures, and healthcare providers can do their part by engaging in a healthy and mutual respect for all of the members of the healthcare team [17].

PATIENT SUICIDE

It is estimated that between 48 and 65 hospital inpatient suicides occur per year in the United States. Most of these cases (31 to 52) occur in psychiatric units or involve psychiatric inpatients. The most common method is hanging [50]. Times of care transition are particularly risky, with a 200% increase in risk in the week after discharge from a psychiatric facility; the elevated risk continues for four years [18]. Other risk factors include previous suicide attempt or self-injury, mental or emotional disorders, history of trauma or loss, serious illness or chronic pain, substance use disorder, social isolation, and access to lethal means.

The most common root cause documented for patient suicide reported between 2010 and 2014 was shortcomings in assessment, most commonly psychiatric assessment [18]. In addition, nearly 25% of behavioral health facilities accredited by the Joint Commission were found noncompliant with the requirement to conduct an adequate suicide risk assessment in 2014.

The Joint Commission has recommended a number of suicide risk reduction strategies, including [18]:

- Review each patient's personal and family medical history for suicide risk factors.

- Screen all patients for suicide ideation, using a brief, standardized, evidence-based screening tool.

- Review screening questionnaires before the patient leaves the appointment or is discharged.

- Establish a collaborative, ongoing, and systematic assessment and treatment process with the patient involving the patient's other providers, family, and friends, as appropriate.

- To improve outcomes for at-risk patients, develop treatment and discharge plans that directly target suicidality.

- Educate all staff in patient care settings about how to identify and respond to patients with suicide ideation.

- Document decisions regarding the care and referral of patients with suicide risk.

A simple review of these measures demonstrates that healthcare providers can avoid the devastating impact of an inpatient suicide by implementing fairly routine preventative strategies, such as removing harmful items and careful screening through the admission and discharge processes.

PATIENT FALLS

Patient falls are a constant challenge in healthcare facilities. Patients who are at highest risk include the elderly, those who have an altered mental status due to chronic mental illness or acute intoxication, and those who have a history of prior falls. It is obvious from these factors that a thorough and complete patient history may be the key to identifying those at risk. The root causes of those patient falls that healthcare facilities identified as sentinel events and reported to the Joint Commission included inadequate assessment, communication failures, lack of adherence to protocols and safety practices, inadequate staff orientation, supervision, staffing levels or skill mix, deficiencies in the physical environment, and lack of leadership [19]. Risk reduction strategies to these root causes are fairly straightforward, although in practice, preventing falls is difficult. The most important are the use of a standardized assessment tool to identify fall and injury risk factors, assessing an individual patient's risks that may not have been captured through the tool, and interventions tailored to an individual patient's identified risks [19].

Because patient falls often result in morbidity, mortality, immobility, and early nursing home placement for patients, it is imperative that healthcare facilities initiate adequate fall prevention programs, which will ultimately reduce injuries. Failure to do so will result in a spiraling increase in the number of falls in healthcare facilities, particularly among the elderly who are at highest risk. As more Americans live beyond 65 years of age, the need to develop mobility protocols and programs to reduce the risk of falls and injuries for the older adult grows more urgent.

MEDICATION ERRORS

Unquestionably, medication errors are one of the most common causes of avoidable harm to patients. These errors may occur at three critical points: when ordered by a physician, dispensed by a pharmacist, or administered by a nurse.

The National Coordinating Council for Medication Error Reporting and Prevention defines a medication error as [20]:

Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems, including prescribing: order communication; product labeling; packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.

A number of medication errors can be linked to the prescriber who continually uses potentially dangerous abbreviations and dose expressions. Despite repeated warnings by the Institute for Safe Medication Practices about the dangers associated with using certain abbreviations when prescribing medications, this practice continues. To eliminate this factor, there are fairly simple steps that can eliminate much confusion. Prescribers should [21]:

- Avoid the use of the symbol "U" or "u" but rather spell "units" when ordering drugs, such as insulin.

- Spell out medication names completely rather than using abbreviations and acronyms.

- Avoid using abbreviations for "daily" (QD), "every other day" (QOD), or "four times daily" (QID), which are easily confused.

- Use leading zeros before a decimal point (e.g., 0.2 mg instead of .2 mg), and do not use trailing zeros (e.g., 2 mg instead of 2.0 mg).

- Write out "morphine sulfate" and "magnesium sulfate" instead of using the abbreviations (MS, MSO_4, MgSO_4).

The Institute for Safe Medication Practices publishes a list of error-prone abbreviations, symbols, and dose designations online at https://www.ismp.org/Tools/errorproneabbreviations.pdf.

Other factors contributing to prescriber errors are illegible or confusing handwriting and, a frequently cited cause of many adverse and sentinel events, the failure of healthcare providers to assess risk and prevent errors. Addressing illegibility may include developing appropriate policies and procedures, tracking and trending patterns, and evaluating results through peer review committees. Improving communication might include developing protocols for the use of verbal orders to assure that those from an onsite practitioner would be limited to an emergency situation only. No verbal orders should be taken for certain medications, such as for chemotherapy, and all verbal orders should be repeated for clarification and, whenever possible, reiterated to a third person. Another method of improving communication might involve reviewing the hospital formulary in collaboration with the Pharmacy and Therapeutics Committee of the medical staff to limit, where appropriate, the number of therapeutically and generically equivalent products [22].

It has been estimated that between 0.2% and 10% of prescriptions are dispensed incorrectly [23]. The most common type of medication error is wrong drug (43.8%), followed by wrong dose (31.5%), failure to consult with prescriber (4.9%), and compounding error (3.7%) [24]. Safe medication dispensing practices may include a number of risk reduction strategies to reduce the incidence of errors that may cause harm to patients [22,25,54]:

- Ensure that appropriate and current drug reference texts and/or online resources are immediately available to pharmacy personnel.

- Ensure that essential patient information, such as allergies, age, weight, current diagnoses, pertinent lab values, and current medication regimen, is available to the pharmacist prior to the dispensing of a new medication order.

- Require clarification of any order that is incomplete, illegible, or otherwise questionable using an established process for resolving questions.

- Whenever possible, dispense dosage units in a ready-to-administer form.

- Dispense single-dose vials and ampoules rather than multidose vials.

- Select oral rather than injectable routes, when possible.

- Require that a pharmacist double-check all mathematical calculations for neonatal and pediatric dilutions, parenteral nutrition solutions, and other compounded pharmaceutical products.

- Create an environment for the dispensing area that minimizes distractions and interruptions, provides appropriate lighting, air conditioning, and air flow, safe noise levels, and includes ergonomic consideration of equipment, fixtures, and technology.

- Require that a second pharmacist double-check the accuracy of order entry and dose calculations for all orders involving antineoplastic agents and other high-risk drugs dispensed by the pharmacy.

- Enhance the awareness of look-alike and sound-alike medications, and use warning signs to help differentiate medications from one another, especially when confusion exists between or among strengths, similar looking labels, or similar sounding names.

- Separate look-alike and sound-alike medications in pharmacy dispensing areas or consider repackaging or using different vendors.

- Follow-up and periodically evaluate the need for continued drug therapy for individual patients.

Once again, communication is likely the key to avoiding dispensing errors. Pharmacists should work closely with their staff to ensure that proper protocols are followed, and most importantly, when questions arise regarding a prescription, the pharmacist should take the time to contact the prescriber directly to obtain clarification.

The healthcare provider who has the responsibility to administer a medication has the final opportunity to avoid a mistake. In most cases, particularly in inpatient settings, this responsibility falls to the nurse. Nurses are often taught in nursing school to review the five "rights" prior to administering any medication: the right patient is given the right drug in the right dose by the right route at the right time [26]. Medication errors generally fall into four categories, which mimic these five "rights." The first is the failure to follow procedural safeguards, such as ensuring that essential patient information, including allergies, age, weight, and current medication regimen, is available. The second is unfamiliarity with a drug. In one case, a jury determined that a nurse was negligent for giving a drug without having reviewed the literature, which stated that the necessary precautions for the administration of the drug required the specialized skill of an anesthesiologist. The third category of drug administration is failure to use the correct mode of administration. A nurse in Delaware was held liable for administering a medication by injection after an order had been written to change the route to oral. The final category involves failure to obtain clarification if an order is incomplete, illegible, or otherwise questionable. In a case tried in Louisiana, a nurse was held liable for administering a medication that a physician ordered, notwithstanding that the dose was excessive. The nurse's administration of the drug led to the patient's death [27].

In addition, healthcare facilities should implement appropriate guidelines, policies, and procedures to ensure safe medication administration practice. These policies should require that staff members who administer medications [25,54]:

- Are knowledgeable about the drug's uses, precautions, contraindications, potential adverse reactions, interactions, and proper method of administration

- Resolve questions prior to medication administration

- Only administer medications that have been properly labeled with medication name, dose to be administered, dosage form, route, and expiration date

- Utilize a standard medication administration time schedule and receive education on how and when to incorporate newly started medication orders safely into the standardized schedule

- Have a second person verify a dosage calculation if a mathematical calculation of a dose is necessary

- Receive adequate education on the operation and use of devices and equipment used for medication administration (for example, patient-controlled anesthesia pumps and other types of infusion pumps)

- Have another person double-check infusion pump settings when critical, high-risk drugs are infused

- Document all medications immediately after administration

Finally, healthcare facilities should have proper quality assurance measures in place to monitor medication administration practices. Included among these would be protocols and guidelines for use with critical and problem-prone medications to help optimize therapies and minimize the possibility of adverse events and to integrate "triggers" to indicate the need for additional clinical monitoring [25].

It is important to note that the pediatric population is especially vulnerable to medication errors. When children are prescribed adult medications, care must be taken to adjust dosage according to weight, requiring the physician to use pediatric-specific calculations. Also, many healthcare settings are not trained to care for the pediatric patient. Intolerance due to physiologic immaturity is also a factor in adverse response to medications, and in many cases, this population cannot communicate their discomfort due to adverse reactions. Risk reduction strategies include standardizing and effectively identifying medications and processes for drug administration, ensuring pharmacy oversight, and using technology, such as medication dispensing programs, infusion pumps, and bar-coding, judiciously [28].

COMMON MISDIAGNOSES

As Florida healthcare professionals, it is important to be aware that in addition to wrong-site/wrong-procedure surgery, several medical conditions also continue to be misdiagnosed. As of 2022, the Florida Board of Medicine has determined the five most misdiagnosed conditions to be [29]:

- Cancer-related conditions

- Neurologic conditions

- Cardiac-related issues

- Missed spinal cord compression

- Gastroenterology-related issues

It is important to be aware of the possibility of misdiagnosis and incorporate this knowledge into practice.

Cancer

The early detection and diagnosis of cancers is crucial for selecting the appropriate treatment approach and to ensure an optimum outcome. However, an estimated 12% of cancer patients are initially misdiagnosed, and the missed or delayed diagnosis of cancers remains a significant cause of medical malpractice claims [30,31]. The causes of missed diagnoses vary widely among cancers in different parts of the body. In many cases, patients who do not fit the typical profile for a specific cancer (e.g., young age) may be underdiagnosed, and it is important that cancer is considered as part of the differential diagnosis in ambiguous cases [31,32,33]. In order to prevent missed or delayed cancer diagnosis, practitioners may take steps to ensure adherence to clinical guidelines for screening and diagnosis, use tools to facilitate communication, and engage strategies to ensure appropriate follow-up [55].

Neurologic/Spinal Cord-Related Conditions

Delayed or missed diagnoses of neurologic conditions may result in serious morbidity and mortality. Headaches are a common presenting condition in acute and primary care, and an estimated 5% of all patients admitted to emergency departments have neurologic symptoms [34]. Acute headache with neurologic symptoms may be misdiagnosed as stroke [35]. In addition, missed spinal fracture diagnoses are one of the leading causes of malpractice claims against radiologists [48].

One of the most common neurologic conditions is headache; however, it has been estimated that 50% of migraine patients remain undiagnosed or misdiagnosed, and only a small number (8% to 10%) of individuals with migraine take migraine-specific medications such as triptans or ergotamines [65,66]. Patients suffering from daily migraines may be misdiagnosed with chronic sinusitis or rhinitis and repeatedly and unsuccessfully treated with broad-spectrum antibiotics [67,68]. The diagnosis of migraine is based solely on a constellation of signs and symptoms, and a comprehensive medical and neurological examination is required to exclude secondary headache [69]. Useful evidence-based clinical guidelines for migraine screening have been developed and are summarized in the mnemonic POUND: pulsatile headache; one-day duration (4 to 72 hours); unilateral location; nausea or vomiting; and disabling intensity [70]. Competence of the clinician and effective communication with the patient play a crucial role in the diagnosis of migraine.

Cardiac-Related Issues

The clinical presentation of chest pain has many possible etiologies, ranging from benign (e.g., panic/anxiety, pneumonia, peptic ulcer, gastroesophageal reflux disease, and pericarditis) to life-threatening (e.g., pulmonary embolism, acute coronary syndrome [ACS], aortic dissection, and pneumothorax). In many cases, it is best to rule out the more urgently threatening possibilities before testing for other causes.

Of the potentially life-threatening causes of chest pain, ACS is the most prevalent. Although a large percentage of individuals with suspected ACS will be seen initially in emergency departments, patients in any healthcare setting, regardless of other diagnoses, may abruptly develop chest pain suspicious for ACS. When a patient presents with clinical signs suspicious for myocardial infarction, immediate medical intervention is directed at confirming a diagnosis and stratifying the person's risk for adverse events such as cardiac arrest and severe/significant damage to the myocardium [41]. It is important to note that while some patients will present with classic ACS-related chest pain (tightness, sensation of pressure, heaviness, crushing, vise-like, aching pain in the substernal or upper left chest), many patients, particularly women and older patients, will present with "atypical" ACS-related chest pain [45,46]. Words commonly used to describe "atypical" chest pain associated with ACS include numbness, tingling, burning, stabbing, or pricking. Atypical chest pain location includes any area other than substernal or left sided, such as the back, area between shoulder blades, upper abdomen, shoulders, elbows, axillae, and ears [43,44,45,46]. Aside from atypical clinical presentation, other possible causes of missed ACS diagnosis include failure of interpretation of the history, failure to correctly interpret the electrocardiogram, failure to perform an electrocardiogram when necessary, and lack of proper use of cardiac enzyme test [47].

Missed Spinal Cord Compression

Epidural compression syndrome is an umbrella term that encompasses spinal cord compression, cauda equina syndrome, and conus medullaris syndrome. While these conditions differ in the level of neurologic deficit at presentation, they are otherwise similar in symptoms, evaluation, and management. Massive herniation of a midline disk, typically at the L4 to L5 disk level, is the most common cause of epidural compression syndrome. Tumor, epidural abscess, spinal canal hematoma, or lumbar spine spondylosis represent other causes [37].

Spinal cord compression is often secondary to herniated disk, vertebral fracture, or space-occupying lesion. Missing this diagnosis, typically by attributing the associated pain to muscle or nerve causes, will miss potentially catastrophic conditions [38,39,40,41]. In a study of 3,786 individuals, the estimated prevalence of asymptomatic spinal cord compression in a healthy population was 24.2%, with a significantly higher prevalence in older populations compared with younger populations and American/European populations compared with Asian populations [42].

In patients with spinal cord compression, neurologic status at diagnosis is the greatest predictor of ultimate neurologic outcome and underscores the importance of early accurate diagnosis. The dominant symptom is back pain with accelerating pain severity. Pain from epidural spinal cord compression is made worse with recumbent positioning, and unilateral or bilateral radiculopathy may develop over time. For many patients, leg pain or neurologic symptoms are more dominant than back pain. Also common at diagnosis is symmetrical lower extremity weakness that may have progressed to gait disturbance or paralysis. Decreased lower extremity reflexes are associated with cauda equina syndrome [37].

Gastroenterology-Related Conditions

Gasteroenterologic conditions may present with nonspecific complaints (e.g., abdominal pain, nausea) common to a variety of illnesses, complicating and delaying diagnosis. In one study of patients with pancreatic cancer, more than 30% were initially misdiagnosed, most commonly with gall bladder disease [71]. Diagnosis and screening for GI disorders may be complicated by a lack of definitive test (e.g., irritable bowel syndrome) or by limits on screening recommendations (e.g., colorectal cancer). However, delayed diagnosis can lead to worsening conditions and poorer prognosis.

In general, gastrointestinal syndromes/symptoms may be classified into three general diagnostic categories: organic, motility, or functional disorders [72,73]. Functional GI disorders are idiopathic disorders of gut-brain interaction and, unlike organic and motility disorders, diagnosis involves identification of symptom clusters. As such, misdiagnosis is more common.

Another important consideration is GI symptom-specific anxiety, an important perpetuating factor that describes threatening interpretation and out-of-proportion behavioral response to GI sensations. This anxiety to real GI symptoms and the frequency of psychiatric comorbidity can lead to functional GI syndromes being dismissed as psychological or psychosomatic in nature.

5. OTHER CONSIDERATIONS FOR PATIENT SAFETY

The most important issue to improving patient safety is being aware of the particular safety hazards that may exist for various patient populations and on particular specialty units. In addition, education of the patient and the family should be a priority.

Infants and young children are not developmentally or cognitively able to participate in care and decision making, thus putting them at higher risk, especially for medication errors. In addition, when a medication error occurs in this population, infants and young children are at higher risk because of their physical immaturity and increased sensitivity to the effects of drugs. The family or guardian of a pediatric patient should be encouraged to ask questions, especially if something seems wrong. In addition, a meta-analysis found that computerized provider order entry with clinical decision support reduced pediatric medication errors by 36% to 87% [51]. As such, the adoption of electronic support systems may help to reduce or eliminate these errors.

An estimated 30% of individuals 65 years of age or older who are living in the community fall each year [52]. Older patients may have poor vision, as a result of cataracts, glaucoma, and/or macular degeneration, and cardiovascular problems, which might result in syncope or postural hypotension. These conditions may affect patients' balance and stability. Bladder dysfunction, such as nocturia, may cause an elderly patient to have to ambulate more during the night in an unfamiliar environment, thereby increasing the risk of a fall. Lower extremity dysfunctions, such as arthritis, muscle weakness, or peripheral neuropathy, may make it more difficult to ambulate at any time. In addition to being at greater risk for falls, the elderly are also more prone to medication errors as their ability to understand instructions or to recognize an unfamiliar medication may be affected by dementia or other cognitive disorders. Interventions that can help prevent falls in the elderly include exercise programs, tai chi, vision improvement (e.g., first cataract surgery), and multifactorial assessment and intervention [52].

There are also unique factors that increase the risk of medical errors on specialty units. For instance, in critical care units, patients may be suffering from environmental psychosis, which could inhibit participation in their care. This is also true of lethargic and comatose patients. These patients are at particular risk because they cannot participate in the identification process. On psychiatric wards, patients may be suicidal or depressed, which may cause them to act out or attempt to harm themselves or others. Patients may also experience orthostatic side effects due to certain psychiatric medications, which may increase the incidence of falls. Obstetric patients are at higher risk for falls because they may have decreased sensation and mobility due to administration of epidural anesthesia, and they may also suffer from excessive blood loss, which could lead to postural hypotension [49]. Again, the key is identifying the unique needs of the particular population.

With regard to education, a number of organizations have developed guidelines to facilitate the role of patients as their own safety advocates. These guidelines are not intended to shift the burden of monitoring medical error to patients. Rather, they encourage patients to share responsibility for their own safety. As healthcare professionals, we should ensure that all of our patients are familiar with these guidelines. The Agency for Healthcare Research and Quality has developed a "Patient Fact Sheet" that outlines 20 tips for patients to help prevent medical errors [53]. Although some of these suggestions may seem extreme, many patients now desire to have a more active role in their care. Some of these items have become routine or are currently required, such as consultations by pharmacists when a patient picks up a prescribed medication.

USE OF AN INTERPRETER

As a result of the evolving racial and immigration demographics in the United States, interaction with patients for whom English is not a native language is inevitable. Because patient education is such a vital aspect of preventing medical errors, it is each practitioner's responsibility to ensure that information and instructions are explained in such a way that allows for patient understanding. When there is an obvious disconnect in the communication process between the practitioner and patient due to the patient's lack of proficiency in the English language, an interpreter is required.

Interpreters are more than passive agents who translate and transmit information back and forth from party to party. They should be professionally trained in ethics, accuracy, completeness, and impartiality. Furthermore, it is the interpreter's role to negotiate cultural differences and promote culturally responsive communication and practice. When they are enlisted and treated as part of the interdisciplinary clinical team, they serve as cultural brokers, who ultimately enhance the clinical encounter. In any case in which information regarding diagnostic procedures, treatment options, or medication/treatment measures is being provided, the use of an interpreter should be considered.

6. CONCLUSION

Although the United States has one of the top 40 healthcare systems in the world, it is apparent that the numbers of medical errors are at unacceptably high levels. The consequences of medical errors are often more severe than the consequences of mistakes in other industries. They may lead to death or to serious and long-term disability, which underscores the need for aggressive action in this area. As a starting point, we should become an active part of the solution. This will only happen if all healthcare professionals voice their concerns when they identify problems in a system or process. In addition, we should actively participate in the root cause analysis process, understanding that the goal is not to assign blame, but rather to identify how we can improve the process to provide the best quality care to our patients. Medical errors are costly, not only because patients may lose their lives or livelihoods, but also because patients lose trust in the system and colleagues lose faith in each other. To preserve the integrity of our system, we must correct this problem, and the solution begins with each of us.

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97922 • Domestic Violence: The Florida Requirement

Marjorie Conner Allen, BSN, JD

Alice Yick Flanagan, PhD, MSW

www.netce.com

Copyright © 2019 NetCE, All rights reserved.

Domestic violence continues to be a prevalent problem in the United States today. Because of the number of individuals affected, it is likely that most healthcare professionals will encounter patients in their practice who are victims. Accordingly, it is essential that healthcare professionals are taught to recognize and accurately interpret behaviors associated with domestic violence. It is incumbent upon the healthcare professional to establish and implement protocols for early identification of domestic violence victims and their abusers. In order to prevent domestic violence and promote the well-being of their patients, healthcare professionals in all settings must take the initiative to properly assess all women for abuse during each visit and, for those women who are or may be victims, to offer education, counseling, and referral information.

Table of Contents

97922 • Domestic Violence: The Florida Requirement

Course Overview

Audience

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Division Planners

Division Planners Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

1. INTRODUCTION

2. DEFINING DOMESTIC VIOLENCE

3. NATIONAL AND STATE STATISTICS AND LEGISLATION

FLORIDA

4. IDENTIFYING GROUPS AT RISK FOR DOMESTIC VIOLENCE

PREGNANT WOMEN

CHILDREN

ELDERLY

MEN

LESBIAN, GAY, BISEXUAL, AND TRANSGENDER VICTIMS

5. CHARACTERISTICS OF PERPETRATORS OF DOMESTIC VIOLENCE

6. SCREENING FOR DOMESTIC VIOLENCE AND ABUSE

7. ASSESSING DOMESTIC VIOLENCE AND ABUSE

CULTURALLY SENSITIVE ASSESSMENT

8. INTERVENTIONS FOR DOMESTIC VIOLENCE AND ABUSE

9. DOCUMENTATION AND FOLLOW-UP

Works Cited

Evidence-Based Practice Recommendations Citations

97922 • Domestic Violence: The Florida Requirement

Education Category. Ethics - Human Rights

Release Date. 08/01/2019

Expiration Date. 07/31/2022

Course Overview

Domestic violence continues to be a prevalent problem in the United States today. Because of the number of individuals affected, it is likely that most healthcare professionals will encounter patients in their practice who are victims. Accordingly, it is essential that healthcare professionals are taught to recognize and accurately interpret behaviors associated with domestic violence. It is incumbent upon the healthcare professional to establish and implement protocols for early identification of domestic violence victims and their abusers. In order to prevent domestic violence and promote the well-being of their patients, healthcare professionals in all settings must take the initiative to properly assess all women for abuse during each visit and, for those women who are or may be victims, to offer education, counseling, and referral information.

Audience

This course is designed for all Florida healthcare professionals required to complete domestic violence education.

Course Objective

The purpose of this course is to enable healthcare professionals in all practice settings to define domestic violence and identify those who are affected by domestic violence in the United States. This course describes how a victim can be accurately diagnosed and identifies the community resources available in the state of Florida for domestic violence victims.

Learning Objectives

Upon completion of this course, you should be able to:

1. Define domestic violence and its impact on health care.

2. Cite the general prevalence of domestic violence on a national and state level and identify state laws pertaining to the issue.

3. Describe how to screen and assess individuals who may be victims or perpetrators of domestic violence, including the importance of conducting a culturally sensitive assessment.

4. Identify community resources presently available for domestic violence victims and their perpetrators throughout Florida concerning legal aid, shelter, victim and batterer counseling, and child protection services.

Faculty

Marjorie Conner Allen, BSN, JD, received her Bachelor of Science in Nursing degree from the University of Florida, Gainesville, in 1984. She began her nursing career at Shands Teaching Hospital and Clinics at the University of Florida, Gainesville. While practicing nursing at Shands, she gave continuing education seminars regarding the nursing implications for dealing with adolescents with terminal illness. In 1988, Ms. Allen moved to Atlanta, Georgia where she worked at Egleston Children’s Hospital at Emory University in the bone marrow transplant unit. In the fall of 1989, she began law school at Florida State University. After graduating from law school in 1992, Ms. Allen took a two-year job as law clerk to the Honorable William Terrell Hodges, United States District Judge for the Middle District of Florida. After completing her clerkship, Ms. Allen began her employment with the law firm of Smith, Hulsey & Busey in Jacksonville, Florida where she has worked in the litigation department defending hospitals and nurses in medical malpractice actions. Ms. Allen resides in Jacksonville and is currently in-house counsel to the Mayo Clinic Jacksonville.

Alice Yick Flanagan, PhD, MSW, received her Master’s in Social Work from Columbia University, School of Social Work. She has clinical experience in mental health in correctional settings, psychiatric hospitals, and community health centers. In 1997, she received her PhD from UCLA, School of Public Policy and Social Research. Dr. Yick Flanagan completed a year-long post-doctoral fellowship at Hunter College, School of Social Work in 1999. In that year she taught the course Research Methods and Violence Against Women to Masters degree students, as well as conducting qualitative research studies on death and dying in Chinese American families.

Previously acting as a faculty member at Capella University and Northcentral University, Dr. Yick Flanagan is currently a contributing faculty member at Walden University, School of Social Work, and a dissertation chair at Grand Canyon University, College of Doctoral Studies, working with Industrial Organizational Psychology doctoral students. She also serves as a consultant/subject matter expert for the New York City Board of Education and publishing companies for online curriculum development, developing practice MCAT questions in the area of psychology and sociology. Her research focus is on the area of culture and mental health in ethnic minority communities.

Faculty Disclosure

Contributing faculty, Marjorie Conner Allen, BSN, JD, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Contributing faculty, Alice Yick Flanagan, PhD, MSW, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Division Planners

Ronald Runciman, MD

Jane C. Norman, RN, MSN, CNE, PhD

Division Planners Disclosure

The division planners have disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

1. INTRODUCTION

Domestic violence continues to be a prevalent problem in the United States today. Because of the number of individuals affected, it is likely that most healthcare professionals will encounter patients in their practice who are victims. Accordingly, it is essential that healthcare professionals are taught to recognize and accurately interpret behaviors associated with domestic violence. It is incumbent upon the healthcare professional to establish and implement protocols for early identification of domestic violence victims and their abusers. In order to prevent domestic violence and promote the well-being of their patients, healthcare professionals in all settings should take the initiative to properly assess all women for abuse during each visit and, for those women who are or may be victims, to offer education, counseling, and referral information.

Victims of domestic violence suffer emotional, psychologic, and physical abuse, all of which can result in both acute and chronic signs and symptoms of physical and mental disease, illness, and injury. Frequently, the injuries sustained require abused victims to seek care from healthcare professionals immediately after their victimization. Subsequently, physicians and nurses are often the first healthcare providers that victims encounter and are in a critical position to identify domestic violence victims in a variety of clinical practice settings where victims receive care. Accordingly, each healthcare professional should educate himself or herself to enhance awareness of the presence of abuse victims in his or her particular practice or clinical setting.

Specifically, healthcare professionals should be aware of the signs and symptoms associated with domestic violence. In addition, when family violence cases are identified, there should be a plan of action that includes providing information on, and referral to, local community resources related to legal aid, sheltering, victim counseling, batterer counseling, advocacy groups, and child protection.

2. DEFINING DOMESTIC VIOLENCE

Domestic violence, which is sometimes also referred to as spousal abuse, battering, or intimate partner violence (IPV), refers to the victimization of an individual with whom the abuser has or has had an intimate or romantic relationship. Researchers in the field of domestic violence have not agreed on a uniform definition of what constitutes violence or an abusive relationship. The Centers for Disease Control and Prevention (CDC) defines IPV as, "violence or aggression that occurs in a close relationship" [1]. According to the Florida Department of Children and Families, domestic violence is "a pattern of behaviors that adults or adolescents use against their intimate partners or former partners to establish power and control. It may include physical abuse, sexual abuse, emotional abuse, and economic abuse. It may also include threats, isolation, pet abuse, using children, and a variety of other behaviors used to maintain fear, intimidation, and power over one's partner" [2]. Florida law defines domestic violence as "any assault, aggravated assault, battery, aggravated battery, sexual assault, sexual battery, stalking, aggravated stalking, kidnapping, false imprisonment, or any criminal offense resulting in physical injury or death of one family or household member by another family or household member" [3]. Family or household members, according to Florida definition, must "be currently residing or have in the past resided together in the same single dwelling unit" [3]. Domestic violence knows no boundaries. It occurs in intimate relationships regardless of race, religion, culture, or socioeconomic status [2].

Whatever the definition, it is important for healthcare professionals to understand that domestic violence, in the form of emotional and psychologic abuse, sexual abuse, and physical violence, is prevalent in our society. Because of the similar nature of the definitions, this course will use the terms "domestic violence" and "IPV" interchangeably.

3. NATIONAL AND STATE STATISTICS AND LEGISLATION

Domestic violence is one of the most serious public health problems in the United States [4]. More than 36.4% of women and 33.6% of men have a lifetime history of IPV [4]. In Florida, the weighted lifetime prevalence of IPV (including rape, physical violence, and/or stalking) is 37.3% among women and 30.9% among men [5]. Although many of these incidents are relatively minor and consist of pushing, grabbing, shoving, slapping, and hitting, IPV resulted in approximately 1,300 deaths in the United States in 2017, with 162 deaths reported in Florida [7,8]. One of the difficulties in addressing the problem is that abuse is prevalent in all demographics, regardless of age, ethnicity, race, religious denomination, education, or socioeconomic status [2].

Victims of abuse often suffer severe physical injuries and will likely seek care at a hospital or clinic. The health and economic consequences of domestic violence are significant. Statistics vary from report to report, and due to the lack of studies on the national cost of domestic violence, the U.S. Congress funded the CDC to conduct a study to determine the cost of domestic violence on the healthcare system [9]. The 2003 CDC report, which relied on data from the National Violence Against Women Survey conducted in 1995, estimated the costs of IPV by measuring how many female victims were nonfatally injured; how many women used medical and mental healthcare services; and how many women lost time from paid work and household chores. The estimated total annual cost of IPV against women in the 1995 survey was more than $5.8 billion [9]. When updated to 2017 dollars, the amount was more than $9.3 billion annually. The costs associated with IPV at this time would be considerably more, but no further studies have been conducted [10]. It should be noted that the costs of any one victimization may continue for years; therefore, these statistics most likely underestimate the actual cost of IPV [9].

The national rate of nonfatal domestic violence against women declined 72% between 1993 and 2011 [11]. The rate of overall violent crime fell by nearly 60% in this same time period [11]. Studies reveal that several factors may have contributed to the reduction in violence, including a decline in the marriage rate and decrease of domesticity, better access to federally funded domestic violence shelters, improvements in women's economic status, and demographic trends, such as the aging of the population [13,14]. Of note, declines in the economy and stress associated with financial hardship and unemployment are significant contributors to IPV in the United States. Following the economic downturn in late 2008, there was a significant increase in the use of the National Domestic Violence Hotline in 2009, with more than half of victims reporting a change in household financial situation in the last year [15].

FLORIDA

In response to troubling domestic violence statistics, Governor Lawton Chiles appointed a Task Force on Domestic Violence on September 28, 1993, to investigate the problems associated with domestic violence in Florida and to compile recommendations as to how the problems should be approached and ultimately resolved. On January 31, 1994, the Task Force issued its first report on domestic violence. This report recommended standards to accurately measure the extent of domestic violence and strategies for increasing public awareness and education. It identified programs and resources that are available to victims in Florida, made legislative and budgetary suggestions for needed changes, provided a methodology for implementing these changes, and identified areas of domestic violence that require further study.

As a result of this report, Florida enacted legislation during the 1995 session implementing various suggestions of the Task Force. Specifically, the Legislature amended Section 455.222 of the Florida Statutes to require that all physicians, osteopaths, nurses, dentists, dental hygienists, midwives, psychologists, and psychotherapists obtain, as part of their biennial continuing education requirements, a one-hour continuing education course on domestic violence [17]. In June of 2006, Governor Jeb Bush signed into law House Bill 699. The bill, which went into effect July 1, 2006, changed the domestic violence continuing education requirement from one hour every renewal period to two hours every third renewal period.

In 1997, at the request of the Governor's Task Force, a workgroup was established by the Florida Department of Law Enforcement (FDLE) to evaluate the feasibility of tracking incidents of domestic violence in the state [18]. This resulted in the creation of the Domestic Violence Data Resource Center (DVDRC). The original mission of the DVDRC was to collect information related to domestic violence and to report and maintain the information in a statewide tracking system [19]. Domestic Violence Fatality Review Teams were established to examine those cases of domestic violence that resulted in a fatality and identify potential changes in policy or procedure that might prevent future deaths. The teams were comprised of representatives from law enforcement, the courts, social services, state attorneys, domestic violence centers, and others who may come into contact with domestic violence victims and perpetrators [20]. In 2000, the creation of Florida Statute 741.316 required the FDLE to annually publish a report based on the data gathered by the Fatality Review Teams [19]. Due to budgetary constraints, responsibility of compiling this data transferred to the Department of Children and Families in 2008 [21].

As part of Governor Jeb Bush's initiative, the "Family Protection Act" was signed into law in 2001. The act requires a 5-day mandatory jail term for any crime of domestic battery in which the perpetrator deliberately injures the victim. The law also makes a second battery crime a felony offense, treating offenders as serious criminals. Additional legislation, signed into law in 2002, includes Senate Bills 716 and 1974. Senate Bill 716 protects domestic violence victims by including dating relationships of six months in the definition of domestic violence laws. Senate Bill 1974 requires judges to inform victims of their rights, including the right to appear, be notified, seek restitution, and make a victim-impact statement. Governor Bush also created the Violence Free Florida campaign to increase public awareness of domestic violence issues [22].

In 2003, Governor Bush signed House Bill 1099, which transferred funding authority of the Florida Domestic Violence Trust Fund from the Department of Children and Families to the Florida Coalition Against Domestic Violence. According to the Domestic Violence in Florida 2010–2011 Annual Report to the Legislature, this has strengthened domestic violence services provided by streamlining the process of allocating funds [23].

In 2007, the Domestic Violence Leave Act was signed into law by Governor Charlie Crist [21]. This law requires employers with 50 or more employees to provide guaranteed leave for domestic violence issues.

In 2017, the FDLE reported 106,979 domestic violence offenses [6]. In general, domestic violence rates have been declining since 1998. An estimated 20.2% of domestic violence incidents involved spouses and 28.4% involved cohabitants; 11.5% of the victims were parents of the offenders. Domestic violence offenses resulted in the death of 162 victims in Florida in 2017, a number that has been decreasing since 2014 [6]. Domestic violence accounted for more than 15% of the state's murders in 2017 [6].

In their 2018 Annual Report, Fatality Review Teams summarized 32 cases of domestic violence fatalities and near fatalities [49]. The most significant findings included the following observations [49]:

- The perpetrators were predominantly male (90%) with female victims (84%) and had prior criminal histories, generally (55%) and for domestic violence specifically (48%).

- In 32% of fatalities, the perpetrators had a known "do not contact" order filed against them, and 32% of perpetrators had a known permanent injunction for protection against them filed by someone other than the victim.

- Substance abuse histories by the perpetrator was identified in 62% of the cases and diagnosed mental health disorders in 30%.

- In most cases, neither the decedent nor perpetrator sought help from the various intervention programs available to them.

To obtain a copy of the Executive Summary of the 2018 Florida Domestic Violence Fatality Review Team Annual Report, please visit https://www.fcadv.org/sites/default/files/FACES%20OF%20FATALITY%20VIII%20web.pdf.

4. IDENTIFYING GROUPS AT RISK FOR DOMESTIC VIOLENCE

Healthcare professionals are in a critical position to identify domestic violence victims in a variety of clinical practice settings. Nurses are often the first healthcare provider a victim of domestic violence will encounter in a healthcare setting and should therefore be prepared to provide care and support for these victims. Although women are most often the victims, domestic violence extends to others in the household as well. For example, domestic violence includes abused men, children abused by their parents or parents abused by their children, elder abuse, and abuse among siblings [3].

Many victims of abuse sustain injuries that lead them to present to hospital emergency departments. Research has found that 49.6% of women seen in emergency departments reported a history of abuse and 44% of women who were ultimately killed by their abuser had sought help in an emergency department in the two years prior to their death [25,50]. Another study of 993 police-identified female victims of IPV found that only 28% of the women were identified in the emergency department as being victims of IPV [26]. These alarming statistics demonstrate that healthcare professionals who work in acute care, such as hospital emergency rooms, should maintain a high index of suspicion for battering of the patients that they see. Healthcare professionals who work in these settings should work with hospital administrators to establish and institute assessment mechanisms to accurately detect these victims.

For every victim of abuse, there is also a perpetrator. Like their victims, perpetrators of domestic violence come from all socioeconomic backgrounds, races, religions, and walks of life [27]. Accordingly, healthcare professionals should likewise be aware that seemingly supportive family members may, in fact, be abusers.

PREGNANT WOMEN

Because a gynecologist or obstetrician is frequently a woman's primary care physician, the American College of Obstetricians and Gynecologists (ACOG) recommends that all women be routinely assessed for signs of IPV (i.e., physical and psychologic abuse, reproductive coercion, and progressive isolation), including during prenatal visits, and providers should offer support and referral information for those being abused [28]. According to the ACOG, IPV affects as many as 324,000 pregnant women each year [25]. A meta-analysis of 92 independent studies found that the average reported prevalence of emotional abuse during pregnancy was 28.4%, physical abuse was 13.8%, and sexual abuse was 8% [51]. As with all domestic violence statistics, these estimates are presumed to be lower than the actual incidence as a result of under-reporting and lack of data on women whose pregnancies ended in fetal or maternal death. This makes IPV more prevalent among pregnant women than some of the health conditions included in prenatal screenings, including pre-eclampsia and gestational diabetes [25]. Because 96% of pregnant women receive prenatal care, this is an optimal time to assess for domestic violence and develop trusting relationships with the women. Possible factors that may predispose pregnant women to IPV include being unmarried, lower socioeconomic status, young maternal age, unintended pregnancy, delayed prenatal care, lack of social support, and use of tobacco, alcohol, or illegal drugs [25,51].

The overarching problem of violence against pregnant women cannot be ignored, especially as both mother and fetus are at risk. At this particularly vulnerable time in a woman's life, an organized clinical construct leading to immediate diagnosis and medical intervention will ensure that therapeutic opportunities are available to the pregnant woman and will reduce the potential negative outcomes [29]. Healthcare professionals should also be aware of the possible psychologic consequences of abuse during pregnancy. There is a higher risk of stress, depression, and addiction to alcohol and drugs in abused women. These conditions may result in damage to the fetus from tobacco, drugs, and alcohol and a loss of interest on the part of the mother in her or her baby's health [16,30]. Possible direct injuries to the fetus may result from maternal trauma [25].

Control of reproductive or sexual health is also a recognized trend in IPV. This type of abuse includes trying to impregnate or become pregnant against a partner's wishes, refusal to use birth control (e.g., condoms, oral contraceptives), or stopping a partner from using birth control [4].

CHILDREN

Children exposed to family violence are at high risk for abuse and for emotional damage that may affect them as they grow older. The Department of Justice estimates that of the 76 million children in the United States, 46 million will be exposed to some type of violence during their childhood [52]. Results of the National Survey of Children's Exposure to Violence indicated that 11% of children were exposed to IPV at home within the last year, and as many as 26% of children were exposed to at least one form of family violence during their lifetimes [31]. Of those children exposed to IPV, 90% were direct eyewitnesses of the violence; the remaining children were exposed by either hearing the violence or seeing or being told about injuries [31]. Of note, according to Florida criminal law, witnessing domestic violence is defined as "violence in the presence of a child if an offender is convicted of a primary offense of domestic violence, and that offense was committed in the presence of a child under age 16 who is a family or household member with the victim or perpetrator" [32].

A number of studies indicate that child witnesses are at increased risk for post-traumatic stress disorder, impaired development, aggressive behavior, anxiety, difficulties with peers, substance abuse, and academic problems than the average child [33,54,55]. Children exposed to violence may also be more prone to dating violence (as a perpetrator or a victim), and the ability to effectively cope with partnerships and parenting later in life may be affected, continuing the cycle of violence into the next generation [34,56].

In addition to witnessing violence, various studies have shown that these children may also become direct victims of violence, and children who both witness and experience violence are at the greatest risk for adverse psychosocial outcomes [53]. Research indicates that between 30% and 60% of husbands who batter their wives also batter their children [35]. Moreover, victims of abuse will often turn on their children; statistics demonstrate that 85% of domestic violence victims abuse or neglect their children. The 2017 Crime in Florida report found that more than 16% of domestic homicide victims were children killed by a parent [6]. Teenage children are also victimized. According to the U.S. Department of Justice, between 1980 and 2008, 17.5% of all homicides against female adolescents 12 to 17 years of age were committed by an intimate partner [36]. Among young women (18 to 24 years of age), the rate is 42.9%. Abused teens often do not report the abuse. Individuals 12 to 19 years of age report only 35.7% of crimes against them, compared with 54% in older age groups [37]. Accordingly, healthcare professionals who see young children and adolescents in their practice (e.g., pediatricians, family physicians, school nurses, pediatric nurse practitioners, community health nurses) should have the tools necessary to detect these "silent victims" of domestic violence and to intervene quickly to protect young children and adolescents from further abuse. Without such critical intervention, the cycle of violence will never end.

ELDERLY

Abused and neglected elders, who may be mistreated by their spouses, partners, children, or other relatives, are among the most isolated of all victims of family violence. In a national study conducted by the National Institute of Justice in 2010, 4.6% of participants (community dwelling adults 60 years of age or older) were victims of emotional abuse in the past year, 1.6% physical abuse, 0.6% sexual abuse, 5.1% potential neglect, and 5.2% current financial abuse by a family member [38]. The estimated annual incidence of all elder abuse types is 2% to 10%, but it is believed to be severely under-measured. According to one study, only 1 in 14 cases of elder abuse are reported to the authorities [39].

The prevalence rate of elder abuse in institutional settings is not clear. However, in a 2019 review of nine studies, 64% of elder care facility staff disclosed to having perpetrated abuse against an elderly resident in the past year [40]. In a random sample survey, 24.3% of respondents reported at least one incident of elder physical abuse perpetrated by a nursing home staff member [57].

As healthcare professionals in Florida, which leads the nation in percentage of older residents, it is important to understand that the needs of older Floridians will increase as will the numbers of elder victims of domestic violence. Because elder abuse can occur in family homes, nursing homes, board and care facilities, and even medical facilities, healthcare professionals should remain keenly aware of the potential for abuse. When abuse occurs between elder partners, it is primarily manifested in one of two ways: either as a long-standing pattern of marital violence or as abuse originating in old age. In the latter case, abuse may be precipitated by issues related to advanced age, including the stress that accompanies disability and changing family relationships [39].

Evidence Based Practice Recommendation

The U.S. Preventive Services Task Force concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening all elderly or vulnerable adults (physically or mentally dysfunctional) for abuse and neglect.

https://annals.org/aim/fullarticle/1558517/screening-intimate-partner-violence-abuse-elderly-vulnerable-adults-u-s

Last Accessed: July 26, 2019

Strength of Recommendation: I (Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.)

It is important to understand that the domestic violence dynamic involves not only a victim but a perpetrator as well. For example, an adult son or daughter who lives in the parents' home and depends on the parents for financial support may be in a position to inflict abuse. This abuse may not always manifest itself as violence, but can lead to an environment in which the elder parent is controlled and isolated. The elder may be hesitant to seek help because the abuser's absence from the home may leave the elder without a caregiver [39]. Because these elderly victims are often isolated, dependent, infirm, or mentally impaired, it is easy for the abuse to remain undetected. Healthcare professionals in all settings should remain aware of the potential for abuse and keep a watchful eye on this particularly vulnerable group.

MEN

Statistics confirm that domestic violence is predominantly perpetrated by men against women; however, there is evidence to suggest that women also exhibit violent behavior against their male partners [4]. Studies demonstrate approximately 5% of murdered men are killed by intimate partners [36]. It is persuasively argued that the impact on the health of female victims of domestic violence is generally much more severe than the impact on the health of male victims [42]. Approximately 512,770 women were raped and/or physically assaulted by an intimate partner in 2008, compared to 101,050 men [58]. In addition, 1 in 4 women has been physically assaulted, raped, and/or stalked by an intimate partner, compared with 1 out of every 10 men [1]. Rape, non-contact unwanted sexual experiences, and stalking against men are primarily perpetrated by other men, while other forms of violence against men were perpetrated mostly by women [5]. Male victims of IPV experienced 3 victimizations per 1,000 boys and men 12 years of age or older in 1994, and this rate decreased by 64%, to 1.1 per 1,000, in 2010 [11]. Of all homicides committed against men between 1980 and 2008, 7.1% were committed by an intimate partner [36]. Although women are more often victims of IPV, healthcare professionals should always keep in mind that men can also be victimized and assess accordingly.

LESBIAN, GAY, BISEXUAL, AND TRANSGENDER VICTIMS

Domestic violence exists in lesbian, gay, bisexual, and transgender (LGBT) communities, and the rates are thought to mirror those of heterosexual women—approximately 25% [43]. However, women living with female intimate partners experience less IPV than women living with men [6]. Conversely, men living with male intimate partners experience more IPV than do men who live with female intimate partners [6]. In addition, 78% of IPV homicide victims reported in 2017 were transgender women or cisgender men [24]. This supports other statistics indicating that IPV is perpetrated primarily by men. A form of abuse specific to the gay community is for an abuser to threaten or to proceed with "outing" a partner to others [41,43].

Transgender individuals appear to be at particular risk for violence. According to a large national report, transgender victims of IPV were 1.9 times more likely to experience physical violence and 3.9 times more likely to experience discrimination than other members of the LGBT community [24].

In 2017, an annual national report recorded 52 incidences of hate violence-related homicides of LGBT+ people, the highest incident number recorded in its 20-year history [24]. This increasing prevalence of anti-LGBT+ violence can exacerbate IPV in LGBT+ communities. For example, a person who loses their job because of anti-trans bias may be more financially reliant on an unhealthy relationship. An abusive partner may also use the violence that an LGBT+ person experiences from their family as a way of isolating that person further [24].

Because of the stigma of being LGBT, victims may be reticent to report abuse and afraid that their sexual orientation or biologic sex will be revealed. In one study, the three major barriers to seeking help were a limited understanding of the problem of LGBT IPV, stigma, and systemic inequities [41]. Many in this community feel that support services (e.g., shelters, support groups, crisis hotlines) are not available to them due to homophobia of the service providers. Unfortunately, this results in the victim feeling isolated and unsupported. Healthcare professionals should strive to be sensitive and supportive when working with homosexual patients.

5. CHARACTERISTICS OF PERPETRATORS OF DOMESTIC VIOLENCE

Abuser characteristics have been studied far less frequently than victim characteristics. Some studies suggest a correlation between the occurrence of abuse and the consumption of alcohol. A man who abuses alcohol is also likely to abuse his mate, although the abuser may not necessarily be inebriated at the time the abuse is inflicted [44]. Domestic violence assessment questionnaires should include questions that explore social drinking habits of both victims and their mates.

Other studies demonstrate that abusive mates are generally possessive and jealous. Another characteristic related to the abuser's dependency and jealousy is extreme suspiciousness. This characteristic may be so extreme as to border on paranoia [12]. Domestic violence victims frequently report that abusers are extremely controlling of the everyday activities of the family. This domination is generally all encompassing and often includes maintaining complete control of finances and activities of the victim (e.g., work, school, social interactions) [12].

In addition, abusers often suffer from low self-esteem and their sense of self and identity is directly connected to their partner [12]. Extreme dependence is common in both abusers and those being abused. Due to low self-esteem and self-worth, emotional dependence often occurs in both partners, but even more so in the abuser. Emotional dependence in the victim stems from both physical and psychologic abuse, which results in a negative self-image and lack of self-worth. Financial dependence is also very common, as the abuser often withholds or controls financial resources to maintain power over the victim [27].

6. SCREENING FOR DOMESTIC VIOLENCE AND ABUSE

Evidence Based Practice Recommendation

The U.S. Preventive Services Task Force recommends that clinicians screen women of childbearing age for intimate partner violence, such as domestic violence, and provide or refer women who screen positive to intervention services. This recommendation applies to women who do not have signs or symptoms of abuse.

https://annals.org/aim/fullarticle/1558517/screening-intimate-partner-violence-abuse-elderly-vulnerable-adults-u-s

Last Accessed: July 26, 2019

Strength of Recommendation: B (There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.)

There is no universal guideline for identifying and responding to domestic violence, but it is universally accepted that a plan for screening, assessing, and referring patients of suspected abuse should be in place at every healthcare facility. Guidelines should review appropriate interview techniques for a given setting and should also include the utilization of assessment tools. Furthermore, protocols within each facility or healthcare setting should include referral, documentation, and follow-up. This section relies heavily on the guidelines outlined in the Family Violence Prevention Fund's National Consensus Guidelines on Identifying and Responding to Domestic Violence Victimization in Health Care Settings; however, protocols should be customized based on individual practice settings and resources available [35]. The CDC has provided a compilation of assessment tools for healthcare workers to assist in recognizing and accurately interpreting behaviors associated with domestic violence and abuse, which may be accessed at https://www.cdc.gov/violenceprevention/pdf/ipv/ipvandsvscreening.pdf [45].

Several barriers to screening for domestic violence have been noted, including a lack of knowledge and training, time constraints, lack of privacy for asking appropriate questions, and the sensitive nature of the subject [35]. Although awareness and assessment for IPV has increased among healthcare providers, many are still hesitant to inquire about abuse [46]. At a minimum, those exhibiting signs of domestic violence should be screened. Although victims of IPV may not display typical signs and symptoms when they present to healthcare providers, there are certain cues that may be attributed to abuse. The obvious cues are physical. Injuries range from bruises, cuts, black eyes, concussions, broken bones, and miscarriages to permanent injuries such as damage to joints, partial loss of hearing or vision, and scars from burns, bites, or knife wounds. Typical injury patterns include contusions or minor lacerations to the head, face, neck, breast, or abdomen and musculoskeletal injuries. These are often distinguishable from accidental injuries, which are more likely to involve the extremities of the body. Abuse victims are also more likely to have multiple injuries than accident victims. When this pattern of injuries is seen, particularly in combination with evidence of old injury, physical abuse should be suspected [44].

In addition to physical signs and symptoms, domestic violence victims also exhibit psychologic cues that resemble an agitated depression. As a result of prolonged stress, various psychosomatic symptoms that generally lack an organic basis often manifest. For example, complaints of backaches, headaches, and digestive problems are common. Often, there are reports of fatigue, restlessness, insomnia, or loss of appetite. Great amounts of anxiety, guilt, and depression or dysphoria are also typical. Women who experienced IPV are also more likely to report asthma, irritable bowel syndrome, and diabetes [4]. Healthcare professionals should look beyond the typical symptoms of a domestic violence victim and work within their respective practice settings to develop appropriate assessment mechanisms to detect victims who exhibit less obvious symptoms.

The unique relationship dynamics of the abuser and abused are not easily detected under the best of circumstances. They may be especially difficult to uncover in circumstances in which the parties are suspicious and frightened, as might be expected when a victim presents to the emergency department. The key to detection, however, is to establish a proper assessment tool that can be utilized in the particular setting and to maintain a keen awareness for the cues described in this course. Screening for IPV should be carried out at the entry points of contact between victims and medical care (e.g., primary care, emergency services, obstetric and gynecologic services, psychiatric services, and pediatric care) [35].

The key to an initial assessment is to obtain an adequate history. Establishing that a patient's injuries are secondary to abuse is the first task. Clearly, there will be times when a victim is injured so severely that treatment of these injuries becomes the first priority. After such treatment is rendered, however, it is important that healthcare professionals not ignore the reasons that brought the victim to the emergency department [35].

7. ASSESSING DOMESTIC VIOLENCE AND ABUSE

Healthcare providers have reported that even if routine screening and inquiry results in a positive identification of IPV, the next steps of assessing and referring are often difficult, and many feel that they are not adequately prepared [46]. According to the Family Violence Prevention Fund, the goals of the assessment are to create a supportive environment, gather information about health problems associated with the abuse, and assess the immediate and long-term health and safety needs for the patient to develop an intervention [35].

Assessment of domestic violence victims should occur immediately after disclosure of abuse and at any follow-up appointments. Assessing immediate safety is priority. Having a list of questions readily available and well-practiced can help alleviate the uncertainty of how to begin to the assessment (Table 1). If the patient is in immediate danger, referral to an advocate, support system, hotline, or shelter is indicated [35].

Table 1: ASSESSMENT OF IMMEDIATE SAFETY FOR DOMESTIC VIOLENCE VICTIMS

Are you in immediate danger?

Is your partner at the health facility now?

Do you want to (or have to) go home with your partner?

Do you have somewhere safe to go?

Have there been threats or direct abuse of the children (if s/he has children)?

Are you afraid your life may be in danger?

Has the violence gotten worse or is it getting scarier? Is it happening more often?

Has your partner used weapons, alcohol or drugs?

Has your partner ever held you or your children against your will?

Does your partner ever watch you closely, follow you or stalk you?

Has your partner ever threatened to kill you, him/herself or your children?

Source: [35]

If the patient is not in immediate danger, the assessment may continue with a focus on the impact of IPV on the patient's mental and physical health and the pattern of history and current abuse [35]. These responses will help formulate an appropriate intervention.

CULTURALLY SENSITIVE ASSESSMENT

During the assessment process, a practitioner should be open and sensitive to the patient's worldview, cultural belief systems and how he/she views the illness [47]. This may reduce the tendency to over-pathologize or minimize health concerns of ethnic minority patients.

Pachter proposed a dynamic model that involves several tiers and transactions [48]. The first component of Pachter's model calls for the practitioner to take responsibility for cultural awareness and knowledge. The professional should be willing to acknowledge that he/she does not possess enough or adequate knowledge in health beliefs and practices among the different ethnic and cultural groups he/she comes in contact with. Reading and becoming familiar with medical anthropology is a good first step.

The second component emphasizes the need for specifically tailored assessment [48]. Pachter advocates the notion that there is tremendous diversity within groups. For example, one cannot automatically assume that a Cuban immigrant adheres to traditional beliefs. Often, there are many variables, such as level of acculturation, age at immigration, educational level, and socioeconomic status, that influence health ideologies. Finally, the third component involves a negotiation process between the patient and the professional [48]. The negotiation consists of a dialogue that involves a genuine respect of beliefs. It is important to remember that these beliefs may affect symptoms or appropriate interventions in the case of domestic violence.

Culturally sensitive assessment involves a dynamic framework whereby the practitioner engages in a continual process of questioning. By incorporating cultural sensitivity into the assessment of individuals with a history of being victims or perpetrators of domestic violence, it may be possible to intervene and offer treatment more effectively.

8. INTERVENTIONS FOR DOMESTIC VIOLENCE AND ABUSE

After the assessment is complete, the patient may or may not want immediate assistance or referral. It is important for healthcare providers to assure patients in a nonjudgmental manner that the decision of what they would like in terms of assistance is their choice and that the provider will help regardless of the decisions they are currently ready to make [35].

If the patient would like to immediately implement a plan of action, information for referral to a local domestic violence shelter to assist the victim and the victim's family should be readily available. The acute situation should be referred immediately to local law enforcement officials. Other resources in an acute situation include crisis hotlines and rape relief centers. After a victim is introduced into the system, counseling and follow-up are generally available by individual counselors who specialize in the care of battered women and their spouses and children. These may include social workers, psychologists, psychiatrists, other mental health workers, and community mental health services. The goals are to make the resources accessible and safe and to enhance support for those who are unsure of their options [35].

In Florida, a 24-hour domestic violence hotline is available for toll-free counseling and information. The number is 800-500-1119. The counselors answering the toll-free line may refer the victim to her or his local domestic violence center. A list of Florida certified domestic violence centers organized by county and city may also be found on the Florida Coalition Against Domestic Violence website at https://www.fcadv.org/local-center-services. As of 2018, Florida had 72 certified domestic violence centers that provide information and referral services, counseling and case management services, a 24-hour hotline, temporary emergency shelter for more than 24 hours, educational services for community awareness relative to domestic violence, assessment and appropriate referral of resident children, and training for law enforcement personnel.

9. DOCUMENTATION AND FOLLOW-UP

It is imperative that healthcare professionals document all findings and recommendations regarding domestic violence in the victim's medical record, including a patient's denial of abuse, if applicable. If domestic violence is disclosed, documentation should include relevant history, results of the physical examination, findings of laboratory and other diagnostic procedures, and results of the assessment, intervention, and referral. The medical record can be an invaluable document in establishing the credibility of the victim's story when seeking legal aid [35].

Healthcare professionals should offer a follow-up appointment if disclosure of past or current abuse is present. Reassurance that assistance is available to the patient at any time is critical in helping to break the cycle of abuse [35].

Works Cited

1. Centers for Disease Control and Prevention. Preventing Intimate Partner Violence. Available at https://www.cdc.gov/ViolencePrevention/intimatepartnerviolence/fastfact.html. Last accessed July 18, 2019.

2. Florida Department of Children and Families. What Is Domestic Violence? Available at https://www.myflfamilies.com/service-programs/domestic-violence/what-is-domestic-violence.shtml. Last accessed July 18, 2019.

3. Florida Statutes. Section 741.28 (2018): Domestic Violence; Definitions. Available at http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&URL=0700-0799/0741/Sections/0741.28.html. Last accessed July 18, 2019.

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5. Smith, SG, Chen, J, Basile, KC, et al. The National Intimate Partner and Sexual Violence Survey (NISVS): 2010–2012 State Report. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2014.

6. Florida Department of Law Enforcement. Crime in Florida, 2017: Florida Uniform Crime Report. Available at https://www.fdle.state.fl.us/FSAC/UCR/2017/CIFAnnual17.aspx. Last accessed July 18, 2019.

7. Federal Bureau of Investigation. Crime in the United States, 2017. Available at https://ucr.fbi.gov/crime-in-the-u.s/2017. Last accessed July 18, 2019.

8. Florida Department of Law Enforcement. Crime in Florida, 2017: Florida Uniform Crime Report. Available at https://www.fdle.state.fl.us/FSAC/UCR/2017/2017SA_CIF.aspx. Last accessed July 18, 2019.

9. National Center for Injury Prevention and Control. Costs of Intimate Partner Violence Against Women in the United States. Atlanta, GA: Centers for Disease Control and Prevention; 2003.

10. Institute for Women's Policy Research. The Economic Cost of Intimate Partner Violence, Sexual Assault, and Stalking. Available at https://iwpr.org/wp-content/uploads/2017/08/B367_Economic-Impacts-of-IPV-08.14.17.pdf. Last accessed July 18, 2019.

11. Catalano S. Intimate Partner Violence: Attributes of Victimization, 1993–2011. Washington, DC: Bureau of Justice Statistics, U.S. Department of Justice; 2013.

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14. Farmer A, Tiefenthaler J. Explaining the recent decline in domestic violence. Contemp Econ Policy. 2003;21(s):158-172.

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24. National Coalition of Anti-Violence Programs. Lesbian, Gay, Bisexual, Transgender, Queer, and HIV-Affected Intimate Partner Violence in 2015. Available at http://avp.org/wp-content/uploads/2019/01/NCAVP-HV-IPV-2017-report.pdf. Last accessed July 18, 2019.

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26. Rhodes KV, Kothari CL, Dichter M, Cerulli C, Wiley J, Marcus S. Intimate partner violence identification and response: time for a change in strategy. J Gen Intern Med. 2011;26(8):894-899.

27. National Center for Victims of Crime. Intimate Partner Violence. Available at http://victimsofcrime.org/docs/default-source/ncvrw2015/2015ncvrw_stats_ipv.pdf?sfvrsn=2. Last accessed July 18, 2019.

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29. Cook J, Bewley S. Acknowledging a persistent truth: domestic violence in pregnancy. J R Soc Med. 2008;101:358-363.

30. Newberger EH, Barkan SE, Lieberman ES, et al. Abuse of pregnant women and adverse birth outcome: current knowledge and implications for practice. JAMA. 1992;267(17):2370-2372.

31. Hamby S, Finkelhor D, Turner H, Ormrod R. Children's Exposure to Intimate Partner Violence and Other Family Violence. Rockville, MD: U.S. Department of Justice Office of Juvenile Justice and Delinquency Prevention; 2011.

32. Child Welfare Information Gateway. Child Witnesses to Domestic Violence. Available at https://www.childwelfare.gov/pubPDFs/witnessdv.pdf. Last accessed July 18, 2019.

33. Kitzman KM, Gaylord NK, Holt AR, Kenny ED. Child witnesses to domestic violence: a meta-analytic review. J Consult Clin Psychol. 2003;71(2):339-352.

34. Finkelhor D, Turner H, Ormrod R, Hamby S, Kracke K. Children's Exposure to Violence: A Comprehensive National Survey. Rockville, MD: U.S. Department of Justice Office of Juvenile Justice and Delinquency Prevention; 2009.

35. Family Violence Prevention Fund. National Consensus Guidelines on Identifying and Responding to Domestic Violence Victimization in Health Care Settings. San Francisco, CA: Family Violence Prevention Fund; 2007.

36. Cooper A, Smith EL. Homicide Trends in the United States, 1980–2008. Washington, DC: Bureau of Justice Statistics; 2011.

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38. Acierno R, Hernandez MA, Amstadter AB, et al. Prevalence and correlates of emotional, physical, sexual, and financial abuse and potential neglect in the United States: the National Elder Mistreatment Study. Am J Public Health. 2010;100(2):292-297.

39. National Council on Aging. Elder Abuse Facts. Available at https://www.ncoa.org/public-policy-action/elder-justice/elder-abuse-facts/. Last accessed July 18, 2019.

40. Yon Y, Ramiro-Gonzalez M, Mikton CR, et al. The prevalence of elder abuse in institutional settings: a systematic review and meta-analysis. Eur J Public Health. 2019;29(1):58-67.

41. Calton JM, Cattaneo LB, Gebhard KT. Barriers to help seeking for lesbian, gay, bisexual, transgender, and queer survivors of intimate partner violence. Trauma Violence Abuse. 2016;17(5):585-600.

42. Compton MT. Clinical Manual of Prevention in Mental Health. 5th ed. Washington, DC: American Psychiatric Publishing; 2010.

43. Ard KL, Makadon HJ. Addressing intimate partner violence in lesbian, gay, bisexual, and transgender patients. J Gen Intern Med. 2011;26(8):930-933.

44. Bhandari M, Dosanjh S, Tornetta P 3rd, Matthews D, Violence Against Women Health Research Collaborative. Musculoskeletal manifestations of physical abuse after intimate partner violence. J Trauma. 2006;61(6):1473-1479.

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46. Sprague S, Madden K, Simunovic N, et al. Barriers to screening for intimate partner violence. Women Health. 2012;52(6):587-605.

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48. Pachter LM. Culture and clinical care: folk illness beliefs and behaviors and their implications for health care delivery. JAMA. 1994;271(9):690-695.

49. Florida Domestic Violence Fatality Review Team. Faces of Fatality, 2018. Available at https://www.fcadv.org/sites/default/files/FACES%20OF%20FATALITY%20VIII%20web.pdf Last accessed July 18, 2019.

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55. Schiff M, Plotnikova M, Dingle K, Williams GM, Najman J, Clavarino A. Does adolescent's exposure to parental intimate partner conflict and violence predict psychological distress and substance use in young adulthood? A longitudinal study. Child Abuse Neglect. 2014;38(12):1945-1954.

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57. Schiamberg LB, Oehmke J, Zhang Z, et al. Physical abuse of older adults in nursing homes: a random sample survey of adults with an elderly family member in a nursing home. J Elder Abuse Negl. 2012;24(1):65-83.

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Evidence-Based Practice Recommendations Citations

1. U.S. Preventive Services Task Force. Screening for intimate partner violence and abuse of elderly and vulnerable adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2013;158(6):478-486. Available at http://annals.org/aim/fullarticle/1558517/screening-intimate-partner-violence-abuse-elderly-vulnerable-adults-u-s. Last accessed July 26, 2019.

31252 • Laws and Rules for Florida Nurses

Jane C. Norman, RN, MSN, CNE, PhD

www.netce.com

Copyright © 2019 NetCE, All rights reserved.

The Florida Nurse Practice Act was legislated to safeguard the public, and the purpose of the Act is to ensure that minimum safety requirements are met by every nurse practicing in the state. This course fulfills the education requirement on the laws and rules that govern the practice of nursing in Florida for all levels of nursing, including registered nurse, licensed practical nurse, clinical nurse specialist, and advanced registered nurse practitioner. While this course will provide an overview of the pertinent sections of the law, all nurses are encouraged to review the Act in its entirety in order to ensure compliance.

Table of Contents

31252 • Laws and Rules for Florida Nurses

Course Overview

Audience

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Division Planner

Division Planner Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

1. INTRODUCTION

2. STANDARDS OF PRACTICE

ADVANCED PRACTICE REGISTERED NURSES

3. CONTINUING LICENSURE IN FLORIDA

4. ETHICAL AND LEGAL ISSUES IN NURSING PRACTICE

5. DISCIPLINARY ACTIONS

6. EXCEPTIONS

7. CONCLUSION

Works Cited

31252 • Laws and Rules for Florida Nurses

Education Category. Management

Release Date. 11/01/2019

Expiration Date. 10/31/2022

Course Overview

The Florida Nurse Practice Act was legislated to safeguard the public, and the purpose of the Act is to ensure that minimum safety requirements are met by every nurse practicing in the state. This course fulfills the education requirement on the laws and rules that govern the practice of nursing in Florida for all levels of nursing, including registered nurse, licensed practical nurse, clinical nurse specialist, and advanced registered nurse practitioner. While this course will provide an overview of the pertinent sections of the law, all nurses are encouraged to review the Act in its entirety in order to ensure compliance.

Audience

This course is designed for all nurses licensed in Florida.

Course Objective

The purpose of this course is to provide basic knowledge of the laws and rules governing the practice of nursing in Florida in order to increase compliance and improve patient care. Florida nurses are legally obligated to be aware of standards that govern professional accountability. Information contained in this course is not intended to be used in lieu of lawful guidelines, but as a learning tool that increases the understanding of some regulations as they apply to nurses who are licensed within the state of Florida.

Learning Objectives

Upon completion of this course, you should be able to:

1. Describe the legislative purpose for the Nurse Practice Act.

2. Identify specific laws and rules related to the practice of nursing and nursing assisting.

3. Outline the pertinent levels of nursing practice in the State and the general scope of practice of each.

4. Discuss the general requirements for continuing licensure in the State.

5. Differentiate between ethical and legal practice.

6. Discuss the process for discipline related to nursing practice.

7. Create a professional plan for career maintenance and development within the limits of the law.

Faculty

Jane C. Norman, RN, MSN, CNE, PhD, received her undergraduate education at the University of Tennessee, Knoxville campus. There she completed a double major in Sociology and English. She completed an Associate of Science in Nursing at the University of Tennessee, Nashville campus and began her nursing career at Vanderbilt University Medical Center. Jane received her Masters in Medical-Surgical Nursing from Vanderbilt University. In 1978, she took her first faculty position and served as program director for an associate degree program. In 1982, she received her PhD in Higher Education Administration from Peabody College of Vanderbilt University. In 1988, Dr. Norman took a position at Tennessee State University. There she has achieved tenure and full professor status. She is a member of Sigma Theta Tau National Nursing Honors Society. In 2005, she began her current position as Director of the Masters of Science in Nursing Program.

Faculty Disclosure

Contributing faculty, Jane C. Norman, RN, MSN, CNE, PhD, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Division Planner

Sharon Cannon, RN, EdD, ANEF

Division Planner Disclosure

The division planner has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

1. INTRODUCTION

Nursing practice acts have a long history in the United States, with the first standards being enacted in the early 1900s. In Florida, a period of major growth and expansion during this period resulted in an increase in the number of hospitals and training schools, which spurred the formation of professional nurses' associations and an interest in establishing standards for the delivery of nursing care [1]. The first practice act passed the Florida Legislature and was signed into law on June 7, 1913 [1].

The Florida Nurse Practice Act was legislated to safeguard the public, and the purpose of the Act is to ensure that minimum safety requirements are met by every nurse practicing in the state. The Nurse Practice Act, Chapter 464 of the Florida Statutes, includes laws governing scope of practice, licensure and certification, and violations and penalties [3]. Chapter 464 established the Florida Board of Nursing as an authority to adopt rules, develop standards for nursing programs, and discipline nurses who violate regulations [2]. Nurses who fall below Florida's required minimum competency or who present a danger to patients, coworkers, or others are prohibited from working in the state.

In addition to Chapter 464, nurses in Florida are regulated by Chapter 456, which includes general provisions for all health professions, and Title 64B9 of the Florida Administrative Code. Together, these laws and rules form the basis for the legal practice of nursing and the regulation of nursing by the state of Florida.

This course fulfills the education requirement on the laws and rules that govern the practice of nursing in Florida for all levels of nursing, including registered nurses (RNs), licensed practical nurses (LPNs), and advanced practice registered nurses (APRNs) [3]. While this course will provide an overview of the pertinent sections of the laws and rules, all nurses are encouraged to review them in their entirety in order to ensure compliance.

2. STANDARDS OF PRACTICE

The basic standards of competent practice directly impact how all nurses in Florida provide care. Not only must a nurse possess the knowledge of lawful and current care standards, but the knowledge must be demonstrated through consistent practice and intervention to prevent unauthorized, inappropriate, erroneous, illegal, contraindicated, or intentional nonperformance of care.

The Nurse Practice Act governs the practice of RNs, LPNs, and APRNs. LPNs are those persons licensed to practice practical nursing, while RNs and APRNs are licensed to practice professional nursing, with various levels of specialization [3]. Both professional and practical nurses are responsible and accountable for making decisions that are based upon their educational preparation and experience in nursing.

According to the Nurse Practice Act, the practice of practical nursing means [3]:

The performance of selected acts, including the administration of treatments and medications, in the care of the ill, injured, or infirm; the promotion of wellness, maintenance of health, and prevention of illness of others under the direction of a registered nurse, a licensed physician, a licensed osteopathic physician, a licensed podiatric physician, or a licensed dentist; and the teaching of general principles of health and wellness to the public and to students other than nursing students. A practical nurse is responsible and accountable for making decisions that are based upon the individual's educational preparation and experience in nursing.

The practice of professional nursing is defined by the Act as "the performance of those acts requiring substantial specialized knowledge, judgment, and nursing skill based upon applied principles of psychological, biological, physical, and social sciences" [3]. The Florida Statutes further define the scope of practice of professional nursing as [3]:

- The observation, assessment, nursing diagnosis, planning, intervention, and evaluation of care; health teaching and counseling of the ill, injured, or infirm; and the promotion of wellness, maintenance of health, and prevention of illness of others

- The administration of medications and treatments as prescribed or authorized by a duly licensed practitioner authorized by the laws of this state to prescribe such medications and treatments

- The supervision and teaching of other personnel in the theory and performance of any of the above acts

ADVANCED PRACTICE REGISTERED NURSES

In addition to the practice of professional nursing, APRNs are certified in advanced or specialized nursing practice. This umbrella term includes certified nurse midwives, certified nurse practitioners, certified registered nurse anesthetists, clinical nurse specialists, and psychiatric nurses [3]. In accordance with the Act, APRNs may perform acts of nursing diagnosis and treatment of alterations of the health status as well as medical diagnosis and treatment, prescription, and operation as authorized within the framework of an established supervisory protocol [3]. Specifically, within the established framework, an APRN may [3]:

- Prescribe, dispense, administer, or order any drug; however, an APRN may prescribe or dispense a controlled substance only if she or he has graduated from a program leading to a Master's or doctoral degree in a clinical nursing specialty area with training in specialized practitioner skills

- Initiate appropriate therapies for certain conditions

- Perform additional functions as may be determined by rule

- Order diagnostic tests and physical and occupational therapy

All APRNs are required to obtain and maintain malpractice insurance or demonstrate proof of financial responsibility prior to licensure, with some exceptions [10]. Proof of compliance with this rule or exemption must be provided to the Board office within 60 days of certification and at each biennial renewal.

Rule 64B9-4.011 states, "APRNs whose protocols permit them to dispense medications…must register with the Board of Nursing by submitting a completed Dispensing Application for Advanced Practice Registered Nurse (APRN), form number DH-MQA 1185" [10]. The APRN dispensing practitioner must comply with all applicable state and federal laws and regulations.

3. CONTINUING LICENSURE IN FLORIDA

The Florida Board of Nursing is responsible for adopting rules establishing the procedure for the biennial renewal of nursing licenses. All Florida nurses are required to renew their licenses and complete mandated continuing education every two years. The Act stipulates that up to 30 hours of continuing education may be required each biennium [3]. Initial licenses that were issued for less than 24 months are required to complete one hour for each month for which the license was valid. As part of this requirement, all licensees must complete an approved two-hour course on the prevention of medical errors and a two-hour course on the laws and rules that govern the practice of nursing in Florida. Starting in 2019, licensees must also complete a two-hour course on human trafficking every renewal period. Beginning with 2018 renewals, a two-hour course on recognition of impairment in the workplace must be completed every other biennium. Every third renewal (or every six years), licensees must successfully complete two hours of continuing education on domestic violence in addition to the 24-hour requirement. A one-hour course on HIV/AIDS must be completed prior to a licensee's first renewal. In addition to these requirements, beginning in 2017, all APRNs must complete at least three hours of continuing education on the safe and effective prescription of controlled substances for each biennial renewal.

Completion of all mandated continuing education must be reported to the Board. Failure to document compliance with the continuing education requirements or furnishing false or misleading information regarding compliance is grounds for disciplinary action.

A nurse may maintain his or her license in inactive status if there is no intent to practice nursing in the upcoming biennium. However, this requires that the licensee apply for inactive status and renew the license as inactive every two years; completion of continuing education is not required for these renewals. A license to practice nursing that is not renewed at the end of the biennium shall automatically revert to delinquent status [10].

In accordance with Rule 64B9-1.013 of the Florida Administrative Code, all licensed nurses must maintain on file with the Board of Nursing the current address at which any notice required by law may be served [10]. If a nurse moves, even out of state, he or she must notify the Board in writing of the new address within 60 days. In addition, all licensed nurses must alert the Board to their current place of practice. Place of practice is defined as one of the following [10]:

- Acute care facility

- Long-term care facility

- Rehabilitation facility

- Clinic

- Physician's office

- Home health care agency

- Educational institution

- Office of independent nursing practice

- Correctional facility

- Mental health facility

- Occupational health facility

- Managed health care organization or insurance company

- Community health facility

- Other

If a nurse wishes to activate an inactive license, he or she may do so by applying to the Department and paying a reactivation fee. As part of the application process, the licensee must disclose convictions or findings of guilt and/or disciplinary action(s) in or out of state [10]. In addition, the nurse must provide proof of completion of all continuing education for all biennial licensure periods for which the individual was inactive.

Completion of a Board-approved nursing refresher course is required to activate a license that has been inactive for more than two consecutive biennial licensure cycles if the licensee has not been practicing nursing in any jurisdiction for the two years immediately preceding the application for reactivation [10]. The refresher course must include at least 80 hours of classroom instruction and 96 hours of clinical experience in medical/surgical nursing and any specialty area of practice of the licensee.

4. ETHICAL AND LEGAL ISSUES IN NURSING PRACTICE

In addition to their legal obligations, nurses have ethical obligations to their patients. The practice of nursing is primarily one of caring, and the ethical theories for nursing are often referred to as "the ethics of caring." Nurses are expected to address both ethical and legal issues in their practice, which can be complex. As medical advancements and new technology progress, these must be incorporated into established ethical standards. The American Nurses Association has established the Code of Ethics for Nurses, which is intended to act as "a guide for nurses to use in ethical analysis and decision-making" [5]. The full text of this Code is available at https://www.nursingworld.org/practice-policy/nursing-excellence/ethics/code-of-ethics-for-nurses. Major ethical issues that may arise in the practice of nursing are related to the provision of patient-centered care, confidentiality, advocacy, delegation, self-care, and supporting colleagues and the profession.

There are also a variety of legal issues that affect the provision of nursing care and maintenance of a nursing license. It is important to note that, although possibly related, the laws governing nursing practice are different from the ethical framework(s) that nurses use to guide decision making. Laws pertaining to documentation, licensure, and standards of care have been established to ensure that nurses practice within a defined scope of practice and are aware of the boundaries of independent nursing action and responsibilities. These laws also act to hold nurses accountable for maintaining an acceptable standard of patient care. However, perhaps the greatest concern for nurses is the threat of negligence or malpractice claims.

According to tort law, four elements must be established for a ruling of malpractice [6]:

- Duty: The nurse owed a duty to meet a particular standard of care.

- Breach of duty: The nurse failed to perform the owed duty.

- Causation: There is a causal connection between the nurse's failure and the patient's injury.

- Damages: An injury occurred for which monetary compensation is adequate relief.

These elements must be shown by a "preponderance of the evidence," defined as more than 50% probability, a lower standard than the "beyond a reasonable doubt" used in criminal law [7,8]. Malpractice cases are decided on the basis of what a "jury is likely to think is fact" rather than actual fact [9].

5. DISCIPLINARY ACTIONS

The Board of Nursing was created to assure protection of the public from nurses who do not meet minimum requirements for safe practice or who pose a danger to the public [3]. Violations of the laws established by the Board to ensure safe nursing practice are punishable by disciplinary action. These penalties are in addition to the results of any legal or civil proceedings that may be brought by the State or by patients or affected parties.

Acts requiring disciplinary or legal action are outlined in sections 464.016, 464.017, and 464.018 of the Nurse Practice Act [3]. According to section 464.016, the following acts are considered felonies in the third degree [3]:

- Practicing advanced or specialized, professional, or practical nursing unless holding an active license or certificate to do so

- Using or attempting to use a license or certificate that has been suspended or revoked

- Knowingly employing unlicensed persons in the practice of nursing

- Obtaining or attempting to obtain a license or certificate by misleading statements or knowing misrepresentation

In addition, the following acts constitute misdemeanors in the first degree [3]:

- Using the name or title "Nurse," "Registered Nurse," "Licensed Practical Nurse," "Clinical Nurse Specialist," "Certified Registered Nurse Anesthetist," "Certified Nurse Practitioner," "Certified Nurse Midwife," "Advanced Practice Registered Nurse," or any other name or title that implies that a person was licensed or certified as same, unless such person is duly licensed or certified

- Knowingly concealing information relating to violations of this part

These actions are punishable by law according to sections 775.082, 775.083, and 775.084 of the Statutes, Constitution, and Laws of Florida [3].

Several actions are also considered grounds for denial of a license or disciplinary action. According to section 464.018, this includes [3]:

- Procuring, attempting to procure, or renewing a license to practice nursing by bribery, by knowing misrepresentations, or through an error of the Department or the Board

- Having a license to practice nursing revoked, suspended, or otherwise acted against, including the denial of licensure, by the licensing authority of another state, territory, or country

- Being convicted or found guilty of, or entering a plea of nolo contendere to, regardless of adjudication, a crime in any jurisdiction that directly relates to the practice of nursing or to the ability to practice nursing

- Being convicted of or found guilty of, or entering a plea of guilty or nolo contendere (no contest) to, regardless of adjudication, any of the following offenses:

- A forcible felony

- Theft, robbery, and related crimes

- Fraudulent practices

- Lewdness and indecent exposure

- Assault, battery, and culpable negligence

- Child abuse, abandonment, and neglect

- Abuse, neglect, and exploitation

- For an applicant for a multistate license or for a multistate license-holder, a felony offense under Florida law or federal criminal law

- Having been found guilty of, regardless of adjudication, or entered a plea of no contest or guilty to, any offense prohibited under Section 435.04 or similar statute of another jurisdiction; or having committed an act which constitutes domestic violence

- Making or filing a false report or record, intentionally or negligently failing to file a report or record required by state or federal law, or willfully impeding or obstructing such filing or inducing another person to do so

- False, misleading, or deceptive advertising

- Unprofessional conduct

- Engaging or attempting to engage in the possession, sale, or distribution of controlled substances for any other than legitimate purposes

- Being unable to practice nursing with reasonable skill and safety to patients by reason of illness or use of alcohol, drugs, narcotics, or chemicals or any other type of material or as a result of any mental or physical condition

- Failing to report to the Department any person who the licensee knows is in violation of this part or of the rules of the Department or the Board

- Knowingly violating any provision of this part, a rule of the Board or the Department, or a lawful order of the Board or Department previously entered in a disciplinary proceeding or failing to comply with a lawfully issued subpoena of the Department

- Failing to meet minimal standards of acceptable and prevailing nursing practice, including engaging in acts for which the licensee is not qualified by training or experience

For a full list of punishable acts, please refer to Chapter 464.018 of the Florida statutes.

Sexual misconduct is considered a breach of mutual trust and can irreparably damage the nurse-patient relationship. According to section 464.017, "Sexual misconduct in the practice of nursing means violation of the nurse-patient relationship through which the nurse uses said relationship to induce or attempt to induce the patient to engage, or to engage or attempt to engage the patient, in sexual activity outside the scope of the practice or the scope of generally accepted examination or treatment of the patient" [3]. Sexual misconduct in the practice of nursing is prohibited and is grounds for disciplinary action.

Disciplinary actions encompass a wide range of possible punishments, and the action chosen will depend on the individual circumstances (e.g., the severity of the violation, the number of past offenses). The Board may take the following actions in response to violations listed above [4]:

- Refusal to certify, or to certify with restrictions, an application for a license

- Suspension or permanent revocation of a license

- Restriction of practice or license

- Imposition of an administrative fine not to exceed $10,000 for each count or separate offense

- Issuance of a reprimand or letter of concern

- Placement of the licensee on probation for a period of time and subject to such conditions as the Board may specify

- Corrective action

- Imposition of an administrative fine for violations regarding patient rights

- Refund of fees billed and collected from the patient or a third party on behalf of the patient

- Requirement that the practitioner undergo remedial education

Nurses who have been found guilty on three separate occasions of violations relating to the use of drugs or narcotics or involving the diversion of drugs or narcotics from patients to personal use or sale are not eligible for reinstatement of licensure [3].

In the annual report of fiscal year 2017–2018, more than 550 nurses licensed in Florida had received disciplinary actions. The most common orders are suspension of the nursing license (36%), limitations/obligations of a nursing license (13%), and voluntary surrender of a nursing license (11%) [11]. In most cases, nurses are also responsible for paying any costs associated with their order (e.g., investigation, court costs).

Certain offences may be resolved by mediation. Rule 64B9-8.012 states that mediation is an acceptable resolution for the first instance of the following violations [10]:

- Issuance of a worthless bank check to the Department or the Board for initial licensure or renewal of license, provided the licensee does not practice on a delinquent license

- Failure to report address changes, provided the failure does not constitute failure to comply with an order of the Board

- Failure to pay fines and investigative costs by the time ordered

- Failure to timely submit documentation of completion of continuing education imposed by Board order

- Failure to update a practitioner profile within 15 days

6. EXCEPTIONS

In addition to the limitations listed in this course, it is important to note that there are exceptions to the Nurse Practice Act. The law expressly states that the Act does not prohibit [3]:

- The care of the sick by friends or members of the family without compensation, the incidental care of the sick by domestic servants, or the incidental care of noninstitutionalized persons by a surrogate family

- Assistance by anyone in the case of an emergency

- The practice of nursing by students enrolled in approved schools of nursing

- The practice of nursing by graduates of prelicensure nursing education programs, pending the result of the first licensing examination for which they are eligible following graduation, provided they practice under direct supervision of a registered professional nurse

- The rendering of services by nursing assistants acting under the direct supervision of a registered professional nurse

- Any nurse practicing in accordance with the practices and principles of the body known as the Church of Christ Scientist

- The practice of any legally qualified nurse or licensed attendant of another state who is employed by the U.S. Government, or any bureau, division, or agency thereof, while in the discharge of official duties

- Any nurse currently licensed in another state or territory of the United States from performing nursing services in this state for a period of 60 days after furnishing to the employer satisfactory evidence of current licensure in another state or territory and having submitted proper application and fees to the Board for licensure prior to employment. If the nurse licensed in another state or territory is relocating to this state pursuant to his or her military-connected spouse's official military orders, this period shall be 120 days after furnishing to the employer satisfactory evidence of current licensure in another state or territory and having submitted proper application and fees to the Board for licensure prior to employment. The Board may extend this time for administrative purposes when necessary.

- The rendering of nursing services on a fee-for-service basis or the reimbursement for nursing services directly to a nurse rendering such services by any government program, commercial insurance company, hospital or medical services plan, or any other third-party payor

- The establishment of an independent practice by one or more nurses for the purpose of rendering to patients nursing services within the scope of the nursing license

- The furnishing of hemodialysis treatments in a patient's home, using an assistant chosen by the patient, provided that the assistant is properly trained (as defined by the Board by rule) and has immediate telephonic access to a registered nurse who is licensed pursuant to this part and who has dialysis training and experience

- The practice of nursing by any legally qualified nurse of another state whose employment requires the nurse to accompany and care for a patient temporarily residing in this state for not more than 30 consecutive days, provided the patient is not in an inpatient setting, the Board is notified prior to arrival of the patient and nurse, the nurse has the standing physician orders and current medical status of the patient available, and prearrangements with the appropriate licensed healthcare providers in this state have been made in case the patient needs placement in an inpatient setting

- The practice of nursing by individuals enrolled in board-approved remedial courses

7. CONCLUSION

It is the responsibility of the Florida Board of Nursing to enforce the laws and rules regulating the practice of nursing as the law is currently stated—not how individuals may wish the law to be. However, as nurses are affected by these rules and regulations, they have the responsibility to keep informed of regulatory changes and provide public comment regarding regulations. Board meetings are held every two months, generally during the first week of every even month, and are open to the public. The full board meetings include disciplinary cases, application review, committee reports, rule discussions, and other necessary Board actions. For more information, please contact the Board at 850-488-0595 or https://floridasnursing.gov/.

Works Cited

1. Florida Nurses' Association. A Brief History of the Beginnings of the Florida Nurses' Association. Available at https://www.floridanurse.org/Resources/documents/HistoryofFloridaNursesAssociation.doc. Last accessed September 19, 2019.

2. Office of Program Policy Analysis and Government Accountability. Florida Nurse Practice Act and Board of Nursing Rules Create No Unreasonable Barriers to Producing New Nurses. Available at http://www.oppaga.state.fl.us/reports/pdf/0704rpt.pdf. Last accessed October 1, 2019.

3. Florida Legislation. 2019 Florida Statutes: Chapter 464 Nursing. Available at http://www.leg.state.fl.us/Statutes/index.cfm?App_mode=Display_Statute&Search_String=&URL=0400-0499/0464/0464PARTIContentsIndex.html. Last accessed October 1, 2019.

4. The 2019 Florida Statutes. 456.072: Grounds for Discipline; Penalties; Enforcement. Available at http://www.leg.state.fl.us/Statutes/index.cfm?App_mode=Display_Statute&Search_String=&URL=0400-0499/0456/Sections/0456.072.html. Last accessed October 1, 2019.

5. American Nurses Association. Code of Ethics for Nursing with Interpretive Statements. Available at https://www.nursingworld.org/practice-policy/nursing-excellence/ethics/code-of-ethics-for-nurses. Last accessed October 1, 2019.

6. Paterick TJ, Carson GV, Allen MC, Paterick TE. Medical informed consent: general considerations for physicians. Mayo Clin Proc. 2008;83(3):313-319.

7. Luce JM. Medical malpractice and the chest physician. Chest. 2008;134(5):1044-1050.

8. Sage WM, Kersh R (eds). Medical Malpractice and the U.S. Health Care System. Cambridge: Cambridge University Press; 2006.

9. Werth B. Damages. New York, NY: Simon and Schuster; 1998.

10. Florida Administrative Code. Division: 64B9. Board of Nursing. Available at https://www.flrules.org/gateway/Division.asp?DivID=332. Last accessed October 1, 2019.

11. Florida Department of Health Division of Medical Quality Assurance. Annual Report and Long-Range Plan, Fiscal Year 2017–2018. Available at http://www.floridahealth.gov/licensing-and-regulation/reports-and-publications/_documents/annual-report-1718.pdf. Last accessed October 1, 2019.

31111 • Recognizing Impairment in the Workplace: The Florida Requirement

Nancy Campbell, RN, BSN, PHN

www.netce.com

Copyright © 2019 NetCE, All rights reserved.

Impairment can place everyone in a workplace at risk of injury. First and foremost is the risk to patients, who trust healthcare professionals to provide safe, reliable, and effective care. This course presents information on recognizing the signs and symptoms of emotional-, mental health-, and substance-related workplace impairment. Strategies for intervention and reporting (e.g., how and to whom impairment should be reported) are also outlined, particularly within the context of the Florida Nurse Practice Act. Treatment of impairment, including treatment programs, employer initiatives for impaired nurses, and returning to work, will be discussed. In the state of Florida, the Intervention Project for Nurses (IPN) is the Department of Health's contracted program to address nurse impairment; this program will be discussed in detail.

Table of Contents

31111 • Recognizing Impairment in the Workplace: The Florida Requirement

Course Overview

Audience

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Division Planner

Division Planner Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

1. INTRODUCTION

2. SCOPE OF THE PROBLEM

3. UNIQUE RISK FACTORS

4. IDENTIFYING IMPAIRMENT IN THE WORKPLACE

DEFINITION OF IMPAIRMENT

SIGNS OF IMPAIRMENT

5. REPORTING COLLEAGUES AND MANDATORY REPORTING LAW

FLORIDA LAW

HOW TO REPORT AN IMPAIRED NURSE

6. TREATMENT PROGRAMS

RETURNING TO WORK

7. PROMOTING SAFETY IN THE WORKPLACE AND PROVIDING ASSISTANCE

Works Cited

31111 • Recognizing Impairment in the Workplace: The Florida Requirement

Education Category. Management

Release Date. 11/01/2019

Expiration Date. 10/31/2022

Course Overview

Impairment can place everyone in a workplace at risk of injury. First and foremost is the risk to patients, who trust healthcare professionals to provide safe, reliable, and effective care. This course presents information on recognizing the signs and symptoms of emotional-, mental health-, and substance-related workplace impairment. Strategies for intervention and reporting (e.g., how and to whom impairment should be reported) are also outlined, particularly within the context of the Florida Nurse Practice Act. Treatment of impairment, including treatment programs, employer initiatives for impaired nurses, and returning to work, will be discussed. In the state of Florida, the Intervention Project for Nurses (IPN) is the Department of Health's contracted program to address nurse impairment; this program will be discussed in detail.

Audience

This course is designed for nurses in Florida who may intervene to prevent or identify impairment in the workplace.

Course Objective

The purpose of this course is to provide nurses with an appreciation of the impact of impairment on the provision of nursing care and on patient health as well as the skills to identify and report instances of workplace impairment.

Learning Objectives

Upon completion of this course, you should be able to:

1. Outline the epidemiology and scope of impairment in the healthcare workplace.

2. Discuss unique risk factors for substance abuse in nurses.

3. Identify the signs of impairment in the nursing workplace.

4. Analyze the process and legal obligations involved in reporting an instance of impairment in the workplace.

5. Describe the treatment programs available for nurses who have been impaired in the workplace.

Faculty

Nancy Campbell, RN, BSN, PHN, received her Bachelor of Science in Nursing degree from California State University, Bakersfield in 1987. She has nursing experience in a variety of clinical settings, including medical/surgical, community health, and preschool health. She was a nurse case manager for a community program supporting teen parents and a public health nurse focusing on communicable disease management. Her primary focus and passion is on direct patient care and patient education. She is presently employed as a registered nurse for the Head Start program in Tulare County, California.

Faculty Disclosure

Contributing faculty, Nancy Campbell, RN, BSN, PHN, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Division Planner

Jane C. Norman, RN, MSN, CNE, PhD

Division Planner Disclosure

The division planner has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

1. INTRODUCTION

Impairment of a healthcare professional can place everyone in a workplace at risk for injury. First and foremost is the risk to patients, who trust healthcare professionals to provide safe, reliable, and effective care. The ethical duty to not harm patients is a cornerstone of nursing, yet impaired healthcare workers injure patients daily. Another concern is the potential for impaired nurses to harm other professionals in the workplace, either directly or indirectly. Direct harm falls on a spectrum ranging from serious, injury-causing accidents to excessive absenteeism, which puts additional strain on staff. Presenteeism (i.e., reporting for work while impaired) places colleagues in the difficult position of having to work harder as a result of another's impairment, working in a potentially dangerous environment, and facing the dilemma of reporting a coworker, colleague, or friend.

Reporting impairment can be a difficult ethical situation for healthcare professionals, who often cover for impaired colleagues out of friendship or loyalty and who fear that reporting may ruin the nurse's career or their own. The truth is that the circumstances causing impairment have already eroded a nurse's professional abilities to some degree, and in most states, including Florida, good-faith reporters (i.e., those with sincere and honest intentions) are protected from retaliation by whistleblower laws. Conversely, not reporting a known impaired nurse is a violation of the Nurse Practice Act that can lead to disciplinary action by the Florida Board of Nursing.

Injury to patients and coworkers is increasingly likely when a worker is impaired, but impairment also gravely affects the individual nurse, whose health, safety, career, and social and financial standing are at risk if interventions are not undertaken. The American Nurses Association (ANA) definition of impairment describes a broad array of conditions that can interfere with workplace functioning, including mental or physical illness, fatigue, substance abuse, and other personal circumstances that adversely affect job performance [2]. Though fatigue and certain personal circumstances may be more easily resolved, these types of impairment still pose a danger. Fatigue, acute physical illness, and personal issues (e.g., stress, relationship problems) are generally dealt with in a different manner than impairment related to chemical dependence, other psychologic disorders, and chronic physical conditions. It should be remembered that alcohol and/or substance abuse is a type of medical and psychologic disorder, and helping the nurse obtain treatment so she or he can get healthy and return to work is the ultimate goal of reporting and intervention. Nearly all states, including Florida, now offer nurses found to be impaired at work an alternative to criminal prosecution, the chance to retain their license, and a return to nursing if they agree to enter and participate in an intervention program.

This course presents information on recognizing the signs and symptoms of emotional-, mental health-, and substance-related workplace impairment. Strategies for intervention and reporting (e.g., how and to whom impairment should be reported) are also outlined, particularly within the context of the Florida Nurse Practice Act. Treatment of impairment, including intervention programs, employer initiatives for impaired nurses, and returning to work, will be discussed. In the state of Florida, the Intervention Project for Nurses (IPN) is the Department of Health's contracted program to address nurse impairment; this program will be discussed in detail.

2. SCOPE OF THE PROBLEM

Historically, the rate of alcohol and drug dependency among healthcare professionals was thought to be much higher than in the general public, due to job stress and easy access to pharmaceutical drugs. However, the rate among nurses and physicians is now estimated to be only slightly higher than or equal to the rate found in the general public (10% to 15%) [3,4,5,6,9]. The ANA has reported that approximately 15% of all nurses abuse substances to the point at which interference with vocational practice can be expected [13]. Based on these data, up to 300,000 of the 3 million nurses in the United States have alcohol and/or drug use disorders, and job performance may be affected in more than 200,000 nurses [6]. Nurses make up the greatest proportion of healthcare workers in the country; therefore, substance-related impairment among nurses is a major healthcare problem, despite similar rates of abuse and dependency among other healthcare professionals [9].

One study found that while the rate of drug dependence was similar among female nurses and women in the general population, the rate of prescription drug abuse was much higher (more than double) among nurses; use of street-type drugs (e.g., cocaine, cannabis) was found to be lower in nurses than in the general population [5]. Reasons cited for the higher rates of prescription drug abuse included easier access, familiarity with dosages and effects, and comfort experimenting with drugs commonly prescribed to patients [6]. This phenomenon, referred to as "pharmacologic optimism," is based on the ingrained belief that pharmaceutical drugs cause profound healing with few to no negative effects, an idea that is established early in some nurses [9]. Aside from alcohol, which is the most commonly abused substance among nurses, one study identified the classes of drugs most often abused, in order of frequency, as amphetamines, opioids, sedatives, tranquilizers, and inhalants. In this study, abuse was defined as prescription drug use without a script, using greater than the prescribed dosage, or using a drug for indications other than those prescribed [9]. In many instances of abuse, drugs were obtained through diversion. Drugs are diverted in several different ways [6,11]:

- A physician writes a prescription for the nurse in the absence of a true indication.

- The nurse steals scripts and falsifies prescriptions for him- or herself.

- A whole dose of an injectable drug ordered for a patient is used by the nurse and replaced with saline, or the nurse retains the correct (drug-filled) syringe and replaces it with another filled with saline.

- Partial doses of medications are administered to patients while the nurse saves or uses the remainder.

- A nurse applies a skin patch to him- or herself before transferring it to the patient.

- A nurse removes syringes or ampules from a sharps waste container to scavenge any remaining drugs.

- The nurse has a colleague who, without actually witnessing the disposal, cosigns a record indicating waste while the nurse actually retains or takes the drug dose.

- The nurse obtains medications for patients who have not asked for them or who refused them.

- The nurse signs out medications for a patient who has been transferred.

All of these examples of diversion techniques have been documented, including cases in which patients have been infected with hepatitis C when a nurse used a syringe of opioid narcotic intended for them before replacing the missing contents with saline and injecting the patient [11]. One study found that 65% of nurses addicted to a pharmaceutical drug were diverting medication from their workplace [19]. Most addicted nurses in this study admitted to treating patients while impaired.

3. UNIQUE RISK FACTORS

In addition to the common risk factors for substance abuse in all individuals, several unique risk factors have been identified for nurses, including [9,15]:

- Positive attitudes toward drugs and drug use (i.e., "pharmacologic optimism")

- Relaxed physician prescribing practices in the facility

- Lack of pharmaceutical controls in a facility

- Little or no education regarding substance use disorders

- Enabling by peers and managers

- Role strain

The prevalence of substance abuse varies by nurse specialty. Critical care, psychiatric, emergency room, and oncology nurses have been found to have the highest rates of substance abuse, but alcohol abuse (five or more drinks per occasion) in particular is a significant problem among oncology nurses [9,19]. Another study found that binge drinking was more common among all nurses than in the general population 35 years of age or older [10].

Gender is another factor for substance abuse in nursing professions. Male nurses are more likely to abuse substances and are over-represented in treatment programs [9]. However, the majority of RNs (90.9%) and LPNs (92.4%) in the United States are women; therefore, the vast majority of nurses with substance use disorders are women [9,12]. Studies have shown that men's addiction runs a more acute course, with less pronounced physical and mental effects; men also tend to seek help sooner for the actual addiction. In contrast, women's addiction tends to be prolonged, with a greater mental and physical toll. Women typically seek help for the manifestations of addiction, such as depression, anxiety, and insomnia, which can delay treatment for the root cause [9].

4. IDENTIFYING IMPAIRMENT IN THE WORKPLACE

It is important that nurses have the ability to recognize signs and symptoms of impaired practice and be able to differentiate a pattern of impairment from isolated incidents that may be caused by job stress. Studies have shown that most nurses are not able to accurately identify impairment in the workplace because they have little education on signs and symptoms of impairment in a professional setting and among other professionals [3,17,18]. This is compounded by the fact that some individuals, particularly experienced healthcare providers, may be able to function at a high level while under chemical influence. Failure to identify impairment or a belief that reporting is unnecessary because an individual is able to function normally despite alcohol/drug abuse may result in a failure to document and report suspected impairment, inadvertently enabling the substance abuse [3]. On the other hand, nurses who have the knowledge and confidence to identify impairment are empowered to confront colleagues and report their peers according to employer protocol.

DEFINITION OF IMPAIRMENT

According to the IPN, "impairment is a condition that results from the use of mind/mood-altering substances, distorted thought processes found in the psychologically impaired, or a physical condition that prevents the nurse from providing safe patient care. Impairment is characterized by the inability to carry out the professional duties and responsibilities in a reasonable manner consistent with nursing standards" [21].

It should be remembered that impaired practice is not strictly related to substance abuse disorders. Common mental health disorders, such as depression and anxiety, have the potential to interfere with nurses' ability to provide adequate patient care [24]. In a meta-analysis of research related to the impact of mental disorders on the work performance of nurses and other healthcare professionals, strong evidence was found to support a relationship between mental disorders and general errors, medication errors, near errors, impaired patient safety, and decreased patient satisfaction [26]. This is a particular concern given the fact that nurses are at greater risk for certain mental health issues (e.g., depression) than the general public [24].

Physical disability may also impede nurses' performance, and steps should be taken to create disability inclusive workplaces [27]. Some nurses may be hesitant to disclose disabilities or known limitations for fear of losing their jobs [28]. Physical limitations are not grounds for dismissal, and failure to disclose poses a greater safety risk than working with healthcare professionals with known disabilities.

SIGNS OF IMPAIRMENT

Signs of impairment related to substance abuse among healthcare professionals fall into three general categories: job performance issues, emotional and mental status, and workplace drug diversion [7]. Impairment specifically related to substance abuse may present differently in nurses than in the general public. Signs of impairment related to job performance include [7,8,22]:

- An excessive number of mistakes at work (e.g., frequent medication errors, errors of judgment in patient care)

- "Job shrinkage" (i.e., the nurse progressively performs the minimal amount of work necessary)

- Increased difficulty meeting deadlines or adhering to schedules

- Frequent or unexplained disappearances

- Implausible and/or elaborate excuses for unusual behavior

- Dishonesty over trivial matters

- Illegible or sloppy charting

- Tremors or shaking

- Extended breaks or lunch hours

- Excessive absence due to alleged illness, particularly following scheduled days off

- Last-minute requests for time off

- Absence without notice

- Smell of alcohol or cannabis

- Excessive use of breath mints, chewing gum, mouthwash, or perfume

Signs of changes in emotional and mental status include [7,8,22]:

- Inappropriate or uncharacteristic responses to criticism (e.g., crying, uncontrolled anger, snapping at or arguing with colleagues)

- Emotional lability (e.g., becoming uncommonly gregarious or quiet, withdrawn, or irritable; has recurrent mood swings and is unpredictable)

- Reduced alertness (e.g., forgetfulness, preoccupation, appearing dazed and confused, slow reaction time)

- Increasing isolation from coworkers (e.g., avoiding informal staff gatherings, eating or taking breaks alone, requesting transfer to another shift)

- Increased and uncharacteristic problem with authority

- Change in dress and/or appearance

Signs that a healthcare professional is diverting drugs for personal use include [7,8,22]:

- Volunteering to work with patients who receive regular or large amounts of pain medication

- Consistently volunteering to be the medication administrator

- Often signing out more controlled drugs than coworkers

- Failing to obtain co-signatures

- Frequently reporting medication spills or other waste

- Reports reflecting excessive use of pain medications on patients

- Discrepancies in end-of-shift medication counts

- Evidence of tampering with vials, other drug containers, or medication counts

- Waiting until alone to open the narcotics box or cabinet, or disappearing after opening it

- An increase in patients' complaints of unrelieved pain

- Defensiveness when questioned about medication errors

- Consistently coming to work early and staying late

Nurse supervisors and managers should maintain an active role in identifying impairment in the workplace by refusing to allow personal manipulation by another nurse or to fear confronting a nurse if patient safety is in jeopardy. It is important to reduce or change a nurse's role or patient assignment and not accept excuses for or ignore poor performance [16]. Several tools have been developed to assess nurses' job performance and fitness for work [24,25]. These measures may be completed by supervisors or individual nurses (i.e., self-report). One such tool is the Common Risky Behaviors Checklist, which assesses five dimensions: absence/tardiness, cognitive impairment, unprofessional communication/boundaries, physical impairment, and drug diversion. A copy of the checklist is available online at https://www.ncsbn.org/ChrisONeil_Checklist.pdf.

5. REPORTING COLLEAGUES AND MANDATORY REPORTING LAW

Florida law requires that a Board-licensed nurse make a good faith report of another individual's known workplace impairment, whether the situation is acute or there is growing suspicion. But, reporting a colleague is a decision with which many nurses struggle [3]. Experienced, older nurses are more likely to report impairment because they have likely witnessed the negative effects in coworkers at some point; younger and less experienced nurses are less likely to report. Many professionals choose to ignore the problem because they think someone else will or is already handling the situation [1,3]. One study identified several factors that contribute to failure to report by coworkers, including feeling like a "tattle-tale," fear of revenge or retaliation, fear the colleague might react in a violent manner, not wanting to be responsible for jeopardizing a colleague's job, not being confident enough in one's own observations or instincts to confront a colleague, not being an expert in chemical dependence, and believing the intervention would be better dealt with by an expert [3]. Although these concerns may be valid, nursing is a profession that holds patient safety and healing as the highest duty—and not one of these concerns seems related to protecting patients. Furthermore, few of the reasons for non-reporting show any regard for helping a coworker to heal. Nursing is about action, and there is no excuse for failing to act.

FLORIDA LAW

Reporting known impairment in Florida is mandatory, not optional. Failure to report an impaired individual who is providing health care can lead to disciplinary action by the Board of Nursing. The Florida Statutes Chapter 464.018 Disciplinary Actions defines nursing impairment and describes the conditions and actions an impaired nurse will face. The section states that the following constitutes grounds for disciplinary action or denial of a license [14]:

Being unable to practice nursing with reasonable skill and safety to patients by reason of illness or use of alcohol, drugs, narcotics, or chemicals or any other type of material or as a result of any mental or physical condition. In enforcing this paragraph, the department shall have, upon a finding of the State Surgeon General or the State Surgeon General's designee that probable cause exists to believe that the licensee is unable to practice nursing because of the reasons stated in this paragraph, the authority to issue an order to compel a licensee to submit to a mental or physical examination by physicians designated by the department. If the nurse refuses to comply with such order, the department's order directing such examination may be enforced by filing a petition for enforcement in the circuit court where the nurse resides or does business. The nurse against whom the petition is filed shall not be named or identified by initials in any public court records or documents, and the proceedings shall be closed to the public…A nurse affected by this paragraph shall at reasonable intervals be afforded an opportunity to demonstrate that she or he can resume the competent practice of nursing with reasonable skill and safety to patients.

The Florida Statutes Chapter 464.018 Disciplinary Actions also contains the mandatory reporting law. The following act constitutes grounds for denial of a license or disciplinary action [14]:

Failing to report to the department any person who the nurse knows is in violation of this part or of the rules of the department or the board. However, a person who the licensee knows is unable to practice nursing with reasonable skill and safety to patients by reason of illness or use of alcohol, drugs, narcotics, chemicals, or any other type of material, or as a result of a mental or physical condition, may be reported to a consultant operating an impaired practitioner program...rather than to the department.

HOW TO REPORT AN IMPAIRED NURSE

Nurses should be familiar with their organization's policies and procedures for reporting employee substance abuse or other impairment and those regarding assistance programs [16]. When aware of the resources available to an impaired nurse, including the process, programs, and benefits of employee assistance programs or alternative-to-discipline programs, nurses are better prepared and more likely to report impairment. In 1983, the Florida legislature established the IPN as a contact point for nursing impairment reporting, as a treatment and rehabilitation facilitator, and as a monitoring program for impaired nurses within the state [20]. Florida nurses are required to report suspected impaired practice to the IPN and/or the Florida Department of Health [21]. Reporting to either of these entities fulfills the mandatory reporting obligation. With the knowledge that recovery, nonpunitive rehabilitation, and returning to work are the goals of such programs, nurses should feel confident that their colleagues will receive the help they need to overcome their impairment [3]. In the long-term, the report will be beneficial to the impaired nurse, and in the short-term, patients are being protected from harm.

Before making a report, documenting changes in the suspected nurses' behavior and work performance is recommended [16]. The signs and symptoms listed in the previous section of this course are a good starting point. Taking note of specific actions or behaviors will help when making the report and/or confronting a colleague or supervisee.

In the past, professional organizations recommended confronting the impaired individual directly, but this strategy was found to be unrealistic and is no longer endorsed [2,3,16,22]. The ANA Code of Ethics no longer recommends confronting colleagues as the initial course of action before notifying a supervisor [3]. The 2015 ANA Code of Ethics states that "the nurse's duty is to take action to protect patients and to ensure that the impaired individual receives assistance. This process begins with consulting supervisory personnel, followed by approaching the individual in a clear and supportive manner and by helping the individual access appropriate resources" [2]. The Code further states that "nurses must follow policies of the employing organization, guidelines outlined by the profession, and relevant laws to assist colleagues whose job performance may be adversely affected by mental or physical illness, fatigue, substance abuse, or personal circumstances" [2]. The Florida Nurse Practice Act clearly states that the IPN or the Department of Health must be notified, but does not specify how an intervention must proceed [21].

Some sources suggest that the best outcomes are achieved when a professional interventionist or personnel trained in intervention confronts the individual [22]. Many facilities have employee assistance or human resources personnel who are trained to intervene. The IPN offers intervention training [23].

The ANA Code of Ethics also provides the following additional advice regarding intervening in cases of suspected workplace impairment [2]:

- The nurse should extend compassion and caring to colleagues throughout the processes of identification, remediation, and recovery.

- Care must also be taken in identifying impairment in one's own practice and in seeking immediate assistance.

- In instances of impaired practice, nurses within all professional relationships should advocate for appropriate assistance, treatment, and access to fair institutional and legal processes. Advocacy includes supporting the return to practice of individuals who have sought assistance and, after recovery, are ready to resume professional duties.

- If impaired practice poses a threat or danger to patients, self, or others, regardless of whether the individual has sought help, a nurse must report the practice to persons authorized to address the problem.

- Nurses who report those whose job performance creates risk should be protected from retaliation or other negative consequences.

- If workplace policies for the protection of impaired nurses do not exist or are inappropriate—that is, they deny the nurse who is reported access to due legal process or they demand resignation—nurses may obtain guidance from professional associations, state peer assistance programs, employee assistance programs, or similar resources.

6. TREATMENT PROGRAMS

When a nurse is reported to either the IPN or the Department of Health, the referral triggers a consultation with the reporter and/or the employer of the impaired nurse [1]. This is followed by an intervention and evaluation. The intervention typically occurs one to three days after a report (whereas a standard disciplinary process typically takes 9 to 12 months to remove a nurse from practice) [1]. If a nurse self-reports to the IPN, the intake and evaluation process begins immediately. In Florida, the IPN is charged with accepting reports, evaluating referrals, determining the proper course of action, monitoring the nurse's progress in treatment, and case managing all individuals returning to work [23]. The IPN program objectives are to [23]:

- Ensure public health and safety through a program that provides close monitoring of nurses who are unsafe to practice due to the use of drugs, including alcohol, and/or psychiatric, psychologic, or physical condition

- Require the nurse to withdraw from practice immediately, and until such time that the IPN is assured that he/she is able to safely return to the practice of nursing

- Facilitate early intervention, thereby decreasing the time between the nurse's acknowledgment of the problem and his/her entry into a recovery program

- Provide a program for affected nurses to be rehabilitated in a therapeutic, non-punitive, and confidential process

- Provide an opportunity for retention of nurses within the nursing profession

- Provide a cost-effective alternative to the traditional disciplinary process

- Develop a statewide resource network for referring nurses to appropriate services

- Provide confidential consultations for nurse managers

Although the IPN assesses referrals to the program to decide the best course of action for the individual, the program does not actually provide treatment for addiction or other diseases/disorders. Rather, the IPN directs individuals to approved treatment programs and providers [1]. Additional services provided by the IPN include advocacy for participants; tracking meeting attendance and discussing recovery progress with group facilitators; comprehensive monitoring of nurses following discharge from treatment; providing random drug screening of participants and detecting relapse; and reporting compliance issues to the proper authority [1,23]. If at any time during the process the nurse refuses to participate in the program or fails to comply with program guidelines, including after returning to work, she or he is referred to the Department of Health for discipline, which entails investigation, hearings, and disciplinary action.

RETURNING TO WORK

Following completion of approved treatment, the IPN determines if nurses in the program are ready to return to practice based on several criteria, including the individual's stability in recovery, cognitive functioning, decision-making/problem-solving ability, use of good judgment, ability to deal with stressful situations, and development of a support system [1]. A signed advocacy contract and completed relapse prevention workbook must also be submitted. Stability in recovery is crucial and is indicated by advocacy contract compliance, consistently negative random urine drug screens, regular attendance at support and monitoring groups, and favorable monitoring reports [1]. Progress reports are generated by treatment providers, nurse support group facilitators, and by the nurses in recovery (i.e., self-reports).

The support system for nurses returning to work includes a weekly support group for ongoing self-care and relapse prevention. A coworker is also established as a workplace monitor to provide feedback to the IPN on the nurse's job performance [1]. If a nurse was referred to the IPN due to pharmaceutical use or diversion, it is recommended that the nurse be assigned a labor exchange colleague assigned to handle patient medication duties. Other restrictions for these individuals may include no overtime or floating; no multiple employers; and no agency, hospice, or home care employment [1].

The Florida Board of Nursing allows nurses two opportunities to return to work after referral for diversion of drugs or narcotics [14]. A nurse will not have their license reinstated after a third violation of drug diversion for sale or personal use.

7. PROMOTING SAFETY IN THE WORKPLACE AND PROVIDING ASSISTANCE

Employers should have clear policies and procedures for fostering and maintaining a drug- and alcohol-free workplace and ensuring that nurses are fit to practice. When system deficiencies are found to exist, these should be remedied. Employees benefit from a sense that policies are enforced equally and without exception; otherwise, uncertainty will exist as to whether poor behavior is overlooked or ignored if an employee is well liked or has perceived seniority. The National Council of State Boards of Nursing (NCSBN) recommends several employer policies to promote safety, including drug testing before employment, testing when there is suspicion of drug use, and conducting regular fitness-to-practice evaluations [9].

All employees should be familiar with and abide by their facility's policies, guidelines, and procedures. The NCSBN recommends that nurses be familiar with procedures (internal and external) related to how to document concerns, how and when to report impairment, return to practice after treatment, and relapse management [9]. Nurses should also be provided with information about employee assistance programs (if applicable), including a clear understanding of the confidentiality of such programs.

Works Cited

1. Smith LL. Alternative to Discipline Programs: The Florida Intervention Project. Available at https://www.ncsbn.org/0113_IRE_LSmith.ppt. Last accessed September 30, 2019.

2. American Nurses Association. Code of Ethics for Nurses with Interpretive Statements. Silver Spring, MD: American Nurses Association; 2015.

3. Bettinardi-Angres K, Bologeorges S. Addressing chemically dependent colleagues. J Nurs Reg. 2011;2(2):10-17.

4. Dunn D. Substance abuse among nurses: defining the issue. AORN J. 2005;82(4):573-582, 585-588, 592-596.

5. Hudspeth R. Survey of advanced practice registered nurses disciplinary action. Online J Issues Nurs. 2007;12(2):7.

6. Copp MAB. Drug Addiction among Nurses: Confronting a Quiet Epidemic. Available at https://web.archive.org/web/20170509104412/http://www.modernmedicine.com/modern-medicine/news/modernmedicine/modern-medicine-feature-articles/drug-addiction-among-nurses-con?page=full. Last accessed September 30, 2019.

7. Intervention Project for Nurses. Employer Information. Available at https://ipnfl.org/employer-information. Last accessed September 30, 2019.

8. American Association of Nurse Anesthetists. Signs and Behaviors of Impaired Colleagues. Available at https://www.aana.com/practice/health-and-wellness-peer-assistance/About-AANA-Peer-Assistance/substance-use-disorder-workplace-resources/signs-and-behavior-of-impaired-colleagues. Last accessed September 30, 2019.

9. National Council of State Boards of Nursing. Substance Use Disorder in Nursing: A Resource Manual and Guidelines for Alternative and Disciplinary Monitoring Programs. Available at https://www.ncsbn.org/SUDN_11.pdf. Last accessed September 30, 2019.

10. Kenna GA, Wood MD. Alcohol use by healthcare professionals. Drug Alcohol Depend. 2004;75(1):107-116.

11. Berge KH, Dillon KR, Sikkink KM, Taylor TK, Lanier WL. Diversion of drugs within health care facilities, a multiple-victim crime: patterns of diversion, scope, consequences, detection, and prevention. Mayo Clin Proc. 2012;87(7):674-682.

12. Minority Nurse. Nursing Statistics. Available at https://minoritynurse.com/nursing-statistics. Last accessed September 30, 2019.

13. Intervention Project for Nurses. IPN Brochure. Available at https://www.ipnfl.org/wp-content/uploads/2019/06/IPN-Brochure-06.24.19.pdf. Last accessed September 30, 2019.

14. Florida Legislature. The 2019 Florida Statutes: Chapter 464.018 Disciplinary Actions. Available at http://www.leg.state.fl.us/Statutes/index.cfm?App_mode=Display_Statute&URL=0400-0499/0464/Sections/0464.018.html. Last accessed September 30, 2019.

15. Clark M. Preventing drug dependency. Part 1: Recognizing risk factors. J Nurs Admin. 1988;18(12):12-15.

16. Thomas CM, Siela D. The Impaired Nurse: Would You Know What To Do If You Suspected Substance Abuse? Available at https://www.americannursetoday.com/the-impaired-nurse-would-you-know-what-to-do-if-you-suspected-substance-abuse. Last accessed September 30, 2019.

17. Lillibridge J, Cox M, Cross W. Uncovering the secret: giving voice to the experiences of nurses who misuse substances. J Adv Nurs. 2002;39(3):219-229.

18. Pullen LM, Green LA. Identification, intervention and education: essential curriculum components for chemical dependency in nurses. J Contin Educ Nurs. 1997;28(5):211-216.

19. Trinkoff AM, Storr CL. Substance use among nurses: differences between specialties. Am J Public Health. 1998;88(4):581-585.

20. Intervention Project for Nurses. IPN History. Available at https://www.ipnfl.org/about. Last accessed September 30, 2019.

21. Intervention Project for Nurses. Frequently Asked Questions. Available at https://www.ipnfl.org/faq. Last accessed September 30, 2019.

22. Angres DH, Bettinardi-Angres K, Cross, W. Nurses with chemical dependence: successful treatment and reentry. J Nurs Reg. 2010;1(1):16-20.

23. Intervention Project for Nurses. IPN Services. Available at https://www.ipnfl.org/informational-videos. Last accessed September 30, 2019.

24. Gärtner FR, Nieuwenhuijsen K, van Dijk FJH, Sluiter JK. Impaired work functioning due to common mental disorders in nurses and allied health professionals: the Nurses Work Functioning Questionnaire. Int Arch Occup Environ Health. 2012;85(2):125-138.

25. Cadiz DM, Truxillo DM, O'Neill C. Common risky behaviours checklist: a tool to assist nurse supervisors to assess unsafe practice. J Nurs Manag. 2015;23(6):794-802.

26. Gärtner FR, Nieuwenhuijsen K, van Dijk FJ, Sluiter JK. The impact of common mental disorders on the work functioning of nurses and allied health professionals: a systematic review. Int J Nurs Stud. 2010;47(8):1047-1061.

27. Matt SB, Fleming SE, Maheady DC. Creating disability inclusive work environments for our aging nursing workforce. J Nurs Adm. 2015;45(6):325-330.

28. Trossman S. A question of disclosure: RNs often struggle with revealing their health conditions to employers. Am Nurse Today. 2007;10(2):39-40.

97110 • Recognizing and Reporting Human Trafficking in Florida

Alice Yick Flanagan, PhD, MSW

www.netce.com

Copyright © 2019 NetCE, All rights reserved.

Today, some label human trafficking as a form of "modern day slavery," and frequently, human trafficking has been linked to sex work and prostitution, although there are other forms of trafficking, such as forced labor and domestic work. Human trafficking can involve women, men, and children. Its victims experience a host of psychologic problems, including post-traumatic stress, helplessness, and depression, due to the physical, sexual, and psychologic abuse they have experienced. This course encompasses a basic overview of human trafficking. The course will attempt to provide practitioners with a glimpse of the realities of human trafficking victims' lives and the physical, psychologic, social, and sexual abuse they experience. Specific interventions and responses are covered, including mental health, social services, educational, prevention, and legal efforts. The course provides an array of resources for victims and practitioners, including organizations/agencies, books, and films/documentaries focusing on the issue of human trafficking.

Table of Contents

97110 • Recognizing and Reporting Human Trafficking in Florida

Course Overview

Audience

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Division Planners

Division Planners Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

1. INTRODUCTION

2. SCOPE OF HUMAN TRAFFICKING

3. DEFINITIONS OF HUMAN TRAFFICKING

4. FORMS OF TRAFFICKING

SEX TRAFFICKING

BONDED LABOR/FORCED LABOR

CHILD LABOR

CHILD CONSCRIPTION

5. FACTORS THAT CONTRIBUTE TO HUMAN TRAFFICKING

GLOBALIZATION

POVERTY

SOCIAL AND FAMILIAL DISORGANIZATION

CORRUPTION

DIGITAL TECHNOLOGY

RACIALIZED SEXUAL STEREOTYPES

CULTURE

6. THE TRAFFICKING EXPERIENCE

TRAFFICKERS: AN OVERVIEW

7. CONSEQUENCES OF HUMAN TRAFFICKING: IMPACT ON VICTIMS

PSYCHOLOGIC AND MENTAL HEALTH CONSEQUENCES

SOCIAL CONSEQUENCES

HEALTH CONSEQUENCES

8. IDENTIFICATION AND ASSESSMENT

POTENTIAL RED FLAGS

SCREENING QUESTIONS

INTERVIEWING TRAFFICKED VICTIMS: BEST PRACTICE GUIDELINES

9. REPORTING

10. INTERVENTIONS AND RESOURCES

EDUCATION AND PREVENTION

MENTAL HEALTH AND SOCIAL SERVICES

ADVOCACY

LAWS AND POLICIES

RESOURCES

11. CONCLUSION

Works Cited

Evidence-Based Practice Recommendations Citations

97110 • Recognizing and Reporting Human Trafficking in Florida

Education Category. Ethics - Human Rights

Release Date. 09/01/2019

Expiration Date. 08/31/2022

Course Overview

Today, some label human trafficking as a form of "modern day slavery," and frequently, human trafficking has been linked to sex work and prostitution, although there are other forms of trafficking, such as forced labor and domestic work. Human trafficking can involve women, men, and children. Its victims experience a host of psychologic problems, including post-traumatic stress, helplessness, and depression, due to the physical, sexual, and psychologic abuse they have experienced. This course encompasses a basic overview of human trafficking. The course will attempt to provide practitioners with a glimpse of the realities of human trafficking victims' lives and the physical, psychologic, social, and sexual abuse they experience. Specific interventions and responses are covered, including mental health, social services, educational, prevention, and legal efforts. The course provides an array of resources for victims and practitioners, including organizations/agencies, books, and films/documentaries focusing on the issue of human trafficking.

Audience

This course is designed for all health and mental health professionals in Florida who may identify and intervene in cases of human trafficking and exploitation.

Course Objective

The purpose of this course is to provide physicians, nurses, and other healthcare professionals an in-depth, practical review of human trafficking, including the definition and scope of the problem, the means of identification and assessment of individuals who may be victims, guidance on reporting of cases, and interventions and resources available to victims.

Learning Objectives

Upon completion of this course, you should be able to:

1. Define human trafficking.

2. Identify the forms of human trafficking.

3. Identify economic, political, social, and cultural factors that contribute to human trafficking.

4. Analyze the trafficking experience, including how traffickers recruit and the financial implications of trafficking.

5. Explain the psychologic, health, and social consequences of human trafficking.

6. Utilize interviewing strategies to assess and identify victims and promote the ethical treatment of trafficking victims

7. Describe the appropriate steps for reporting suspected cases of trafficking.

8. Describe various interventions and resources for human trafficking victims.

Faculty

Alice Yick Flanagan, PhD, MSW, received her Master’s in Social Work from Columbia University, School of Social Work. She has clinical experience in mental health in correctional settings, psychiatric hospitals, and community health centers. In 1997, she received her PhD from UCLA, School of Public Policy and Social Research. Dr. Yick Flanagan completed a year-long post-doctoral fellowship at Hunter College, School of Social Work in 1999. In that year she taught the course Research Methods and Violence Against Women to Masters degree students, as well as conducting qualitative research studies on death and dying in Chinese American families.

Previously acting as a faculty member at Capella University and Northcentral University, Dr. Yick Flanagan is currently a contributing faculty member at Walden University, School of Social Work, and a dissertation chair at Grand Canyon University, College of Doctoral Studies, working with Industrial Organizational Psychology doctoral students. She also serves as a consultant/subject matter expert for the New York City Board of Education and publishing companies for online curriculum development, developing practice MCAT questions in the area of psychology and sociology. Her research focus is on the area of culture and mental health in ethnic minority communities.

Faculty Disclosure

Contributing faculty, Alice Yick Flanagan, PhD, MSW, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Division Planners

John M. Leonard, MD

Jane C. Norman, RN, MSN, CNE, PhD

Abimbola Farinde, PharmD, PhD

James Trent, PhD

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Director of Development and Academic Affairs

Sarah Campbell

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1. INTRODUCTION

Although human trafficking has always existed, it has begun to receive increased attention as a result of awareness and outreach efforts. All social problems compete for attention, and various groups will make compelling claims about social problems using persuasive rhetoric and dramatic statistics [1]. More than just a human rights issue, it has garnered attention from feminists, religious conservatives, labor activists, immigration specialists, and the mental health professions [2]. Furthermore, attention will be drawn from the media, politicians, organizations, and public, all of whom will respond to the gravity of the condition. It is through this process of claims-making and counter claims-making that "conditions" that may not necessarily have initially attracted attention can develop into a recognized social problem [1]. How the problem is described or constructed will influence public opinion, which will then ultimately facilitate action from governmental agencies, social service organizations, and international agencies [3,4,5].

This course will provide a basic overview of human trafficking (e.g., the scope, definitions and frameworks, contributing factors, different forms). The course will attempt to provide practitioners a glimpse of the lives of human trafficking victims, including physical, psychologic, social, and sexual abuse that human trafficking victims experience and the types of control tactics perpetrators use. Specific interventions and responses will be covered, including mental health, social services, educational, prevention, and legal efforts. Finally, for practitioners who do work with human trafficking victims, the emotional toil that it takes upon practitioners as well as the importance of self-care will be discussed. The course will end by offering an array of resources. Practitioners will be encouraged to view films and documentaries about human trafficking, as this is one way to "enter the lives" of human trafficking victims and better understand the dynamics of the complex world of human trafficking.

2. SCOPE OF HUMAN TRAFFICKING

As the issue of human trafficking is so complex, it is difficult to determine the scope of the problem. Many scholars and researchers believe that published estimates are just educated guesses. On a global level, the International Labour Organization has estimated that there are 40.3 million human trafficking victims [6]. The estimates for the United States are not totally clear, but there were approximately 78,000 human trafficking victims reported to the U.S. State Department in 2016; only an estimated 0.2% are rescued [7]. According to Polaris, which founded and runs the National Human Trafficking Hotline, there have been a total of 40,200 cases of human trafficking reported since 2007 [7].

Weitzer's content analysis of websites and publications about human trafficking found that human trafficking is portrayed as an epidemic, growing at alarming rates, with some government reports estimating 40,000 to 50,000 individuals trafficked in the United States each year [8]. Weitzer argues that many of the reports have overestimated the scope of the problem and points out that the estimates fluctuate drastically year to year [9]. Sex trafficking tends to be portrayed more frequently due to its sensationalism. In a study of 50 human trafficking campaigns in Spain between 2004 and 2017, 40 (80%) depicted sex trafficking and exploitation involving women [10]. The U.S. Department of Justice reported 1,045 convictions for human trafficking-related crimes in 2017, including forced labor and sex trafficking of adults and minors. This was an increase of more than 78% over the number reported in 2015 [6]. In 2016, the International Labour Organization stated that there were 4.8 million victims of sex trafficking, and 15.4 million in forced marriages. The majority (62%) of those trafficked are in Asia and Pacific regions [11]. In 2017, it is estimated that there are 24.9 million people around the world who are in forced labor [11].

Florida ranks third in the United States in terms of destinations for trafficked persons [12]. In 2018, the National Human Trafficking Hotline received 1,885 contacts (e.g., phone calls, texts, e-mails) and 767 human trafficking cases reported in Florida. The most common type was sex trafficking (68%), followed by labor trafficking (16.5%) and combined sex/labor trafficking (7.5%) [12]. The majority of victims were female (69%) and adult (55.8%).

3. DEFINITIONS OF HUMAN TRAFFICKING

The United Nations defines human trafficking as [13]:

The recruitment, transportation, transfer, harbouring or receipt of persons, by means of threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability, or of the giving or receiving of payments or benefits to achieve the consent of a person having control over another person, for the purpose of exploitation. Exploitation shall include, at a minimum, the exploitation or the prostitution or other forms of sexual exploitation, forced labour or services, slavery or practices similar to slavery, servitude, or the removal of organs.

In essence, this definition involves three elements: the transport of the person, the force or coercion of the victim, and the abuse and exploitation [14]. The United Nations Office on Drugs and Crime divides the definition of human trafficking into three sections: the act, means, and purpose [15]. The act, or what is done, generally refers to activities such as recruitment, transportation, transfer, harboring, or receipt of persons. The means of trafficking consists of threats or use of force, coercion, abduction, fraud, deception, abuse of power or vulnerability, or giving payments or benefits to a person in control of the victim. Finally, these acts are carried out for the purpose of exploitation, which includes prostitution, sexual exploitation, forced labor, slavery or forced servitude, and the removal of organs [15]. It is important to remember that human trafficking is not human smuggling. Human smuggling involves an individual being brought into a country through illegal means and is voluntary. The individual has provided some remuneration to another individual or party to accomplish this goal [16].

The following video, produced by Free the Slaves, provides a snapshot of modern slavery, including the economics of slavery and the various types of slavery worldwide.

To see this media go to http://www.NetCE.com/activities/ using a browser that supports Adobe Flash.

For more information, visit Free the Slaves at https://www.freetheslaves.net.

The Trafficking Victims Protection Act (TVPA) defines human trafficking to include both sex trafficking and labor trafficking [17]. Sex trafficking is the recruitment, harboring, transportation, provision, obtaining, patronizing, or soliciting of a person for the purposes of a commercial sex act, in which the commercial sex act is induced by force, fraud, or coercion, or in which the person induced to perform such an act has not attained 18 years of age. Labor trafficking is the recruitment, harboring, transportation, provision, or obtaining of a person for labor or services, through the use of force, fraud, or coercion for the purposes of subjection to involuntary servitude, peonage, debt bondage, or slavery. A victim need not be physically transported from one location to another for the crime to fall within this definition.

In many cases, women and children are considered the typical victims of human trafficking. Hart posits that women are more vulnerable to trafficking due to the lack of social safety nets in many developing countries [18]. Coupled with women's subordinate social statuses in many cultures, this leads to the "feminization of poverty." Although the social conditions may make women and children more vulnerable to human trafficking, the reality is that men are also victims of human trafficking.

Overall, the definition of human trafficking is ambiguous because of the many intersections with other issues (e.g., sexual abuse, domestic violence, forced marriage, forced labor) [19]. It occurs both domestically and internationally, but is primarily a hidden problem. This makes research efforts, the prosecution of perpetrators, and policy and community efforts to protect victims even more challenging [19].

4. FORMS OF TRAFFICKING

SEX TRAFFICKING

The TVPA of 2000 is a U.S. federal statute passed by Congress to address the issue of human trafficking and offers protection for human trafficking victims [17]. This statute defines sex trafficking as, "the recruitment, harboring, transportation, provision, or obtaining of a person for the purpose of a commercial sex act" [17]. A commercial sex act is, "any sex act on account of which anything of value is given to or received by any person" [17]. In other words, it usually involves the illegal transport of humans into another country to be exploited in a sexual manner for financial gains [20]. However, it does not always involve the transport of victims from one region to another; such cases are referred to as "internal trafficking" [21]. Victims of sex trafficking could be forced into prostitution, stripping, pornography, escort services, and other sexual services [22]. Victims may be adult women or men or children, although there is a higher prevalence of women and girls. The term "domestic minor sex trafficking" has become a popular term used to connote the buying, selling, and/or trading of children younger than 18 years of age for sexual services within the country, not internationally [22,23]. An element of force, fraud, or coercion is not necessary, as the victims are children and inherently vulnerable [23]. In the United States, the children most vulnerable to domestic minor sex trafficking are those who are homeless, abused, runaways, and/or in child protective services [22].

Although highly controversial, it is said that sex trafficking victims differ from prostitutes in that sex trafficking victims are forced to involuntarily perform sexual services and are often not paid for their "work." Sex trafficking involves the use of force and coercion and can encompass other forms of criminal sexual activities, including forced erotic dancing, "mail-order brides," and pornography [21]. On the other hand, individuals involved in prostitution make a decision to provide sex services for a fee. The decision to enter prostitution does not eliminate the possibility of being a victim of trafficking if one is held against his/her will through physical and/or psychologic abuse [24]. It is also important to remember that this does not necessarily mean prostitution is a choice these individuals would have made if other options were available or that they have a choice in selecting their sexual partners and/or sexual activities [25].

Visit the PBS Frontline website (https://www.pbs.org/wgbh/pages/frontline/slaves/map/indexflash.html) and read the transcripts of interviews with a sex trafficker and five Eastern European female victims who were deceived into sexual slavery.

BONDED LABOR/FORCED LABOR

The United Nations has defined debt bondage as [26]:

The status or condition arising from a pledge by a debtor of his personal services or of those of a person under his control as security for a debt, if the value of those services as reasonably assessed is not applied towards the liquidation of the debt or the length and nature of those services are not respectively limited and defined.

Essentially, because the individual does not have money as collateral for the debt owed, the individual pledges his/her labor or, in some cases, the labor of a child or another individual for an unspecified amount of time [27]. These individuals may be transported or trafficked into another country for the purpose of forced labor.

In many cases of bonded labor, the initial loan may be welcomed by the individual. However, the victims do not realize that with the low wages, unspoken high interest rates and other continually accruing fees, and the perpetrator's manipulation of the "accounts," laborers can never repay the loans. Some estimate that half of all persons in forced labor are bonded laborers. The majority of bonded labor cases occur in India, Bangladesh, and Pakistan [28]. Some families find themselves in a cycle of poverty as the debt cannot be paid off and is passed down from generation to generation [27]. Bonded labor can involve laborers in brick kilns, mines, stone quarries, looming factories, agricultural farms, and other manufacturing factories [27]. In the United States, individuals may be trafficked to work long hours in garment factories, restaurants, and other manufacturing sectors. Frequently, the employer/captor will take away victims' identifications, monitor their movements, socially isolate them, and/or threaten deportation if they do not comply [29]. Migrant workers are at high risk of forced labor [24].

In the United States, forced labor is predominantly found in five sectors [29]:

- Prostitution and sex industry (46%)

- Domestic servitude (27%)

- Agriculture (10%)

- Sweatshops and factories (5%)

- Restaurant and hotel work (4%)

It is speculated that most of the forced labor occurs in California, Florida, New York, and Texas, all major routes for international travel [29].

Domestic servitude refers to a category of domestic workers (usually female) who work as servants, housekeepers, maids, and/or caregivers, often in private homes. In some cases, young women are lured with the promise of a good education and work, and when they arrive in the United States, they are exploited economically, physically, and/or sexually. Their passports or identification papers are taken away, and they are told they have to pay off the debt incurred for their travel, processing fees, and any other bogus expenses. Because they do not speak English, they find they have no other recourse but to endure exploitive working conditions [30]. Unfortunately, as in many sectors of forced labor, there are no regulations to monitor the conditions under which domestic servants operate [29].

The following documentary, A Global Alliance Against Forced Labour, was produced by the International Labour Organization in order to tell the stories of men and women forced to labor and show what is being done globally to combat modern day slavery.

To see this media go to http://www.NetCE.com/activities/ using a browser that supports Adobe Flash.

For more information, visit the International Labour Organization at https://www.ilo.org.

CHILD LABOR

Child labor can be viewed as a specific form of bonded labor or forced labor. However, not all child laborers have been trafficked. Child labor is defined by International Labour Organization (ILO) as economic labor performed by a child younger than 15 years of age or hazardous labor done by a child 18 years of age or younger. Child labor is deeply rooted in poverty and the infrastructure and political stability of the country as well as market forces [31]. The ILO estimates that there are 152 million child laborers in the world [32]. Between 2000 and 2016 there was a nearly 38% decrease in the number of children in child labor. The reduction was greater for girls (43%) than for boys (34%). The largest numbers of child laborers are found in Asia and the Pacific region; however, there is evidence that the number of child laborers in Africa is increasing [32].

The definition of child labor is controversial because the definitions for "work" and "childhood" are ambiguous and often culturally defined [33]. On a conceptual level, work may be beneficial for the socialization and educational processes of children [33,34]. So, it is important to differentiate between child work and child labor. Child work has been defined as activities that are supervised by an adult and that promote the development and growth of the child, while child labor does not benefit the child [31]. Many definitions of child labor create a dichotomy whereby child work is considered not harmful while child labor has negative emotional, intellectual, and social consequences [35]. Work that is exploitive for children has been defined as working long hours at a young age, work that is poorly compensated, and work that produces physical, social, and psychologic stress that will hamper development, access to education, and self-esteem [36]. The ILO adds that child labor is work that interferes, deprives, and interrupts schooling and places children in the position of trying to balance school and long work hours [34].

It is important to remember that child labor occurs in the United States. Runaway and homeless youths are at greatest risk, often lured by promises of work and housing [37]. The Polaris Project found that the top three forms of child labor trafficking in the United States were begging, peddling, and traveling sales crews [37].

CHILD CONSCRIPTION

In some cases of trafficking, children are kidnapped and trafficked to serve as soldiers. Other times, children are coerced by a narrative indicating they will be serving a higher purpose and avenge the deaths of family and friends; this is known as comradeship [38]. Some children are actively recruited and may be promised a small salary to "voluntarily" join. In a study of 132 cases of child conscription in Columbia, 18% of the children were motivated by perceived economic rewards [39]. Many children lack educational opportunities or hope for a better future, perceiving soldiering as the only option [38]. Conscripted girls often cite educational opportunities as a motive [38]. In Nepal, former female soldiers also indicated they were driven to volunteer in the armed groups by a fear that if they stayed with their families they would be married away as children or raped [38].

It is estimated that at any one time 250,000 to 300,000 children younger than 18 years of age are currently serving as child soldiers [40,41]. Traffickers prefer to recruit children to serve as soldiers because they are inexpensive and more easily molded and shaped to comply and obey without question [42]. They are also more likely to kill fearlessly and recklessly. Child soldiers are treated as adults, without any regard to how the physical and psychologic rigors of war will affect them psychologically and developmentally. In Uganda, where children are kidnapped or recruited as child soldiers relatively often, the Lord's Resistance Army has been known to initiate new child soldiers in brutal ritualized killings of others so as to terrorize them into submission and annihilate any moral conscience they may have about killing [42]. In Afghanistan, children have been recruited by the Taliban and have served as suicide bombers [28].

It can be difficult to comprehend the atrocities that these children witness and experience. Bayer, Klasen, and Adam conducted a study involving 169 former Ugandan and Congolese child soldiers who were an average of 15.3 years of age [43]. Almost all (92.9%) reported having witnessed a shooting, 89% witnessed someone wounded, and 84% witnessed someone seriously beaten. A total of 54.4% reported having killed someone, and 27.8% reported that they were forced to engage in sexual activity [43]. In another study, the researchers found that the experience of conscription among children produced significant emotional and psychologic traumas and a host of cognitive and behavioral problems [24]. In this study of 19 child soldiers, 18 had volunteered to join the army and one had been abducted. Although most of the children volunteered into the army, their participation became involuntary. Some tried to run away or disobey, which resulted in beatings and imprisonment. If captured, they were told to commit suicide [24]. The reintegration of child soldiers is not easy. Many are stigmatized when they return to their home villages, as their families and friends fear that these former child soldiers may be violent [41,44].

Listen to a National Public Radio interview with Ishmael Beah, a former child soldier, at https://www.npr.org/templates/story/story.php?storyId=7519542.

5. FACTORS THAT CONTRIBUTE TO HUMAN TRAFFICKING

GLOBALIZATION

Human trafficking has been called one of the "darkest sides of globalization" [45]. Globalization is the term used to describe the interconnectedness of countries and nations, which facilitates easy communication, exchange of ideas, and flow of goods, capital, and services [45]. Crimes such as human trafficking are affected by globalization just as legitimate businesses are [46]. Furthermore, the ideals of Western capitalism may reinforce human trafficking as a business or industry, with its emphasis on the free market and the flow of goods and services across international borders [46].

Globalization has also created the need for cheaper labor [28,47]. A study involving 160 countries examined the effects of globalization and human trafficking trends [48]. Researchers found a positive relationship between globalization and trafficking for forced labor, prostitution, and debt bondage.

POVERTY

Poverty and incessant economic stressors caused by civil wars, natural disasters, and collapses of government systems all contribute to human trafficking [18,23,49]. Families entrenched in deep poverty may feel they have no other recourse but to sell a child or may be more easily lured with promises of money and a better future [49,50,51]. In one study, the odds of being trafficked were nine times greater for those who felt extremely hopeless about upward mobility compared with those with lower levels of hopelessness [49].

SOCIAL AND FAMILIAL DISORGANIZATION

Community factors (such as high social disorganization characterized by violence, unemployment, and high crime) contribute to higher risk of trafficking [23]. In addition, families marked by instability (e.g., domestic violence, child abuse, continual unemployment) are also at higher risk of having a member trafficked [23].

CORRUPTION

Human trafficking cannot occur without the existence of corruption within existing infrastructures. Public officials, police officers, and local leaders in many developing countries have been known to take bribes to provide protection to parties involved in various aspects of human trafficking [45,48,52].

DIGITAL TECHNOLOGY

The rampant use of digital technology, such as the Internet, greatly facilitates sex trafficking. The relative anonymity of online contact can empower traffickers to recruit or sell victims. Graphic images of women and children engaged in sexual acts can be easily disseminated over the Internet [53]. Traffickers may employ the Internet for advertising, marketing to those interested in making pornography [53]. In addition, social media sites such as Facebook, Craigslist, and Instagram have been used as a means of facilitating trafficking (e.g., by connecting and grooming potential victims) [54,55,56]. Newsgroups offer opportunities for those interested in locating women and children for sexual exploitation.

In a qualitative study, smartphones were found to be integral in the business of trafficking [54]. Researchers indicated the phones were used "to maintain contact with each other, in order to facilitate the business 'transactions' and stay in touch with transnational 'partners' and other traffickers who remained in the country of origin" [54,55].

RACIALIZED SEXUAL STEREOTYPES

Race and ethnicity have been inextricably linked to sexual violence and victimization. Myths regarding sexuality in certain cultures or racial fetishization may affect trafficking patterns. For example, there is an over-representation of Asian women on American Internet pornography sites in part due to popular myths sexualizing, eroticizing, and exoticizing Asian women. This has translated into trafficking, as traffickers respond to the demand for young Asian women and girls in part fueled by these stereotypes of exotic, docile, submissive, and eager-to-please Asian women [30]. These stereotypes devalue and dehumanize people, which is the underlying core of human trafficking. This contributes to the acceptability of the exploitation of individuals, particularly members of marginalized groups [57].

These racial stereotypes go beyond simply framing the victims in a particular manner [58]. They raise implicit questions regarding how the powers of state are depicted. In other words, the patriarchal attitudes of certain countries lead to "bad" or "backward" cultural practices or ways of being that then cause trafficking—setting up is a dichotomy of the "West" and "others" [58].

CULTURE

Although many are careful in linking cultural factors to the etiology of human trafficking for fear of imposing judgment on a particular culture, many maintain that cultural ideologies that tolerate sexual trafficking, bonded labor, and child labor may be a stronger factor than poverty in predicting trafficking rates [30,36]. For example, some cultures emphasize collectivism and prioritizing the needs of the family and group first before the needs of the individual. Some children may feel they have to sacrifice themselves for their family when traffickers promise money [30]. Traffickers also know that they can threaten to hurt victims' families to keep them from escaping [30].

Furthermore, in many cultures, boys are more highly valued than girls, and as a result, girls are considered more dispensable [30]. Sons are considered the family's social security, staying with the family while daughters marry into other families. Therefore, girls may be more likely to be sold into slavery than boys.

Child labor is also inextricably tied to cultural factors. In India, for example, child labor is common because it is believed that children in the lower levels of caste system (i.e., the "untouchables") should be socialized early to understand their positions in society [36]. It has been observed that when traditional cultural and societal norms about women's roles were relaxed in some European countries and more women entered the labor force, child labor decreased [36]. Ultimately, it is difficult to unravel the effects of poverty and culture because the pressures of poverty can lead families to use tradition as a justification to sacrifice young men, women, and children [36].

Ultimately, the conversation about human trafficking is complex, and to attempt to isolate the causes is beyond challenging. Multiple factors have been suggested as possibly predicting human trafficking, including macroeconomic factors (e.g., gross domestic product per capita), unemployment rates, female inequality, cultural oppression, and lack of protection of women's rights [59,60]. In one study, ease of land access to the destination country appeared to be a powerful predictor in terms of the number of individuals trafficked [59].

6. THE TRAFFICKING EXPERIENCE

Five stages of the trafficking experience have been identified [61,62,63]:

- Pre-departure stage: The period before the victim becomes involved in the trafficking situation. This may include recruitment and preparing for travel.

- Travel and transit stage: The time after recruitment during which the victim "agrees" or is coerced into the trafficked situation. This phase also includes the journey whereby the trafficker(s) brings the victim(s) to their work destination. It is important to remember that this stage can be very dangerous and can involve numerous transit points.

- Destination stage: This is the period during which the victim arrives at the intended destination. This stage is marked by exploitation, abuse, victimization, and coercion. One way to control the victims is to continually inflate their debt so they have to constantly work to pay it off. Another is to confine and isolate victims.

- Detention, deportation, and criminal evidence stage: If a victim is arrested by the police or immigration authorities, victims are held in legal proceedings and they often fear deportation, and/or retaliation from the trafficker(s).

- Integration and re-integration stage: During this stage, government and nongovernment agencies provide services to victims that involve a long process of attempting to reintegrate the victim back into his/her community.

TRAFFICKERS: AN OVERVIEW

Much attention has been focusing on victims of trafficking; however, it is important to also understand the perpetrators.

Methods of Recruitment

It has been suggested human traffickers employ five general strategies to recruit and traffic victims [64,65,66,67]:

- Kidnapping: Traffickers may kidnap their victims. They may lure them with food or treats or take them by force. Victims with few if any social ties are highly vulnerable, as no one will miss them or report their disappearance.

- Targeting poor families: Traffickers may convince families to sell their children (often daughters). Because many families in developing countries live in abject poverty, traffickers will stress to victims' families how the money will help them to survive. Other traffickers may tell families that selling their daughter will provide her with more promising opportunities.

- Developing a false romantic relationship with victim: A tactic often used with young girls, perpetrators pose as boyfriends by romancing victims, buying gifts, and proclaiming their love. Victims have a difficult time believing that their boyfriends would hurt or deceive them, making them easy targets for trafficking.

- Fake storefronts: Some employment, modeling, or marriage agencies are fronts for illegal trafficking operations. A potential victim might be lured with the promise of employment, a lucrative modeling contract, or an arranged marriage in the United States. After victims have been lured in, traffickers come to assess their "product." Perpetrators may be family members or friends.

- Legal storefronts: Some legal businesses in the tourism, entertainment, and leisure industries integrate trafficking activities into their business structure.

- Recruiting local prostitutes: Traffickers might purchase prostitutes working in local night clubs from brothel owners or simply lure prostitutes by promising them a more affluent future. Women working as prostitutes may later recruit younger victims.

The Financial Profits

Unfortunately, human trafficking can be a lucrative business. According to the ILO, profits from forced labor, trafficking, and modern slavery are estimated to be $150 billion annually [68]. The majority of this total is attributable to commercial sexual exploitation ($99 billion) followed by construction/manufacturing/mining ($34 billion), agriculture ($9 billion), and domestic work ($8 billion) [68].

The receiving country and location of trafficking will affect the profits. For example, if a girl is kidnapped from a village in Nepal and taken to India, she can be sold in India for $1,000 [64]. If she is then trafficked to the United States, she could be sold for $20,000.

Interestingly, the "cost" of a slave has not risen over time. According to Bales, the cost of obtaining a slave to work in the agriculture sector in 2007 was about $100; in 1850, this same slave would cost the equivalent of $40,000 in 2007 currency [69]. In one study, it was approximated that in the United States, a trafficker can make an average of about $300,000 per victim lifetime, which would total $32 billion annually [70]. Income in larger cities (e.g., Atlanta, San Diego, Washington, DC) may be even greater.

7. CONSEQUENCES OF HUMAN TRAFFICKING: IMPACT ON VICTIMS

The social realities of victims of human trafficking are difficult to comprehend, and some may wonder why victims remained silent and complied with their traffickers. The Silence Compliance Model was created to explore the factors that promote victims' seeming willingness to comply to their traffickers' demands [71]. This model has three categories: coercion, collusion, and contrition. Victims are coerced, brutalized, and threatened, and basic necessities of life are withheld from them. Methods of psychologic coercion include isolation, induced exhaustion, threats, degradation, and monopolizing perception [72]. This serves to silence victims and create a sense of helplessness. By isolating and controlling victims' movements and limiting their exposure to the outside world, traffickers have complete monopoly of their attention and perception of reality [72]. Victims are then forced to collude with the traffickers as a result of their relative isolation, fear, false sense of belonging, and complete dependence on the trafficker. Finally, victims feel contrite, ashamed, stigmatized, and remorseful of the things they have been made to do [71].

PSYCHOLOGIC AND MENTAL HEALTH CONSEQUENCES

Victims of trafficking experience a host of psychologic, mental health, and emotional distress. Depression, suicidal ideation, substance use, and anxiety are typically cited mental health problems [23]. Post-traumatic stress disorder (PTSD) is also common given the trauma many victims experience, including physical and/or sexual violence and abuse; victims forced into prostitution experience continual, daily sexual assault [73]. In a study of 192 European women who were trafficked but who managed to escape, the overwhelming majority (95%) disclosed that they experienced physical and sexual violence during the time of their trafficked experience [74]. More than 90% reported sexual abuse, and 76% reported physical abuse.

Trafficked victims experience fear from the start of their capture through the transit phase and after they arrive at their destination. During the transit stage, many victims experience dangerous border crossings, risky types of transports, injury, beatings, and sexual assault [61]. Upon arrival to their destination, many trafficking victims have been socially isolated, held in confinement, and deprived of food [75]. All sense of security is stripped from them—their personal possessions, identity papers, passports, visas, and other documents [61,75]. The continual fear for their personal safety and their families' safety and the perpetual threats of deportation ultimately breed a sense of loss of control and learned helplessness. It is not surprising that depression, anxiety, and PTSD are common symptoms experienced by trafficked victims.

In a study of 164 survivors of human trafficking who returned to Nepal, the authors examined the extent to which they experienced PTSD, depression, and anxiety [76]. All of the survivors experienced some level of these disorders, but the survivors who were trafficked for sex experienced higher levels of depression and PTSD compared to those who were not trafficked for sex. In a study with Moldovan survivors of human trafficking, researchers found that six months after their return, 54% had diagnosable mental health issue. Specifically, 35.8% met the diagnostic criteria for PTSD, 12.5% met the criteria for major depression, and 5.8% were diagnosed with an anxiety disorder [77].

There is also some evidence that trafficked victims may experience complex PTSD, a type of PTSD that involves an acute change of the victims' sense of self, their relationship with others, and their relationship with God or higher being [78]. These persons direct anger inwardly (toward themselves) in addition to toward their perpetrators, which results in a loss of faith in themselves and the world [63,75,78]. Perhaps due to self-directed anger and shame, some will engage in risky sexual behaviors, self-harm, and substance abuse. Some victims also have difficulty managing and expressing how they are feeling, while others experience dissociation [75].

Substance abuse is also common among victims. In interviews, trafficked women discussed how traffickers forced them to use substances like drugs and/or alcohol so they could work longer hours, take on more clients, and/or perform sexual acts that they could not normally [61]. Other victims used substances as a means to cope with their situations. Trafficked individuals who are gender and/or sexual minorities report shame, confusion, and sexual identity issues if forced into heterosexual relationships [63].

Children forced into labor experience grueling hours and are frequently beaten by their captors. According to Clawson and Goldblatt, underage victims of domestic sex trafficking fluctuate through a range of emotions from despair, shame, guilt, hopelessness, anxiety, and fear [79]. Depending upon the level of trauma, some engage in self-destructive behaviors like self-mutilation or suicide attempts. For some, their ambivalence toward the perpetrators may be confusing. On the one hand, they want to escape the abuse, yet simultaneously, they may have a sort of traumatic bond with the perpetrators [79].

Children forced into conscription will also experience a host of psychologic symptoms. In a study comparing former Nepalese child soldiers and children who were never conscripted, former child soldiers experienced higher levels of depression, anxiety, PTSD, psychologic difficulties, and functional impairments [80]. In another study of former children soldiers from the Congo and Uganda, one-third met the criteria for PTSD [43]. The researchers found there was a relationship between greater levels of PTSD symptoms and higher levels of feelings of revenge and lower levels of openness to reconciliation [43]. In-depth narrative interviews of former child soldiers from northern Uganda found that the children spoke of the violence and atrocities they witnessed without any emotion, as if they had removed themselves from their experiences [81]. This speaks to how the victims have to numb themselves psychologically in order to cope. The researchers also found that the children who lost their mothers were more traumatized by this experience than the violence they witnessed as soldiers.

Some have argued that the diagnostic criteria of PTSD may not be easily applied to those from different cultures. As a result, it is important to assess for other psychiatric disorders, such as depression. Japan, for example, never used the PTSD diagnosis prior to 1995, despite the fact that they have a large and intricate mental health system [82]. Ultimately, PTSD cannot be universally applied to every culture and for every humanitarian crisis; therefore, if a human trafficking victim does not necessarily fall within the Diagnostic and Statistical Manual of Mental Disorders criteria for PTSD, one cannot necessarily conclude that they have not experienced trauma or are not traumatized [82].

SOCIAL CONSEQUENCES

When rescued and attempting to reintegrate into their communities, victims of human trafficking often experience stigma, ostracism, and marginalization [80,83]. For example, in Nepal, community members perceived returning child soldiers who had performed acts such as carrying dead bodies or coed sleeping as in violation of Hindu cultural norms [80]. One documentary following former child soldiers living in a refugee camp in northern Uganda found that preconceived notions and myths about children soldiers often led to ridicule and ostracism after they were liberated from the army and returned home.

However, girls who were recruited as soldiers, who were forced to have sex, or who return with children appear to be the most marginalized group [84]. In a qualitative study of former girl soldiers in Sierra Leone, researchers found that, compared to returning boy soldiers, girls were perceived to have violated gender norms and values about sexuality. Although psychologically and developmentally they were still children, the community perceived and treated them as "damaged" or "unclean" women. Their communities were not able to integrate them back in despite the victimization they experienced. These girls lacked voice and experienced shame, marginalization, poverty, and powerlessness upon their return [84]. In a study of former child soldiers in Uganda, the children reported having difficulty finding jobs or getting married when they returned home. Girls who had been raped were stigmatized and made to feel unwelcome in their communities. Others stated that their community perceived them as murderers [44].

HEALTH CONSEQUENCES

In studies of trafficked women, headaches, fatigue, dizziness, back pain, pelvic pain, stomach pain, sexually transmitted infections (STIs), unwanted pregnancies, and gynecologic infections were common, generally the result of continual physical, psychologic, and sexual abuse [23,74]. Victims of labor trafficking also experience health issues related to the type of work, workplace conditions, malnutrition, and violence [85]. It is important to remember that some of these somatic complaints, such as headaches, fatigue, and gastrointestinal problems, may be underlying symptoms of anxiety, depression, and stress [74]. Some cultural groups might not use the terms "depression," "sad," or "anxious," but may use metaphors and somatic symptoms to describe their pain, all of which are embedded within cultural ideologies. The most common culture-based idioms of distress are somatic symptoms. Some groups tend not to psychologize emotional problems; instead, they experience psychologic conflicts as bodily sensations (e.g., headaches, bodily aches, gastrointestinal problems, and dizziness).

Using an in-depth, direct interview survey designed to explore each stage of the trafficking experience, a multi-country European study identified a range of aversive health, sexual, and reproductive consequences common among women and adolescent victims of human trafficking [61]:

- Pre-departure stage: All victims reported having had limited knowledge of the health implications of having sex with strangers, and only 1 in 25 felt well-informed regarding the risks of acquiring HIV or other STIs.

- Travel and transit stage: Half of those interviewed reported having been confined, beaten, and/or raped during the journey.

- Destination stage: A large majority reported having been "intentionally hurt" (as evidenced by contusions, lacerations, loss of consciousness, and signs of head trauma); subjected to solitary confinement and deprived of human contact and adequate food and nutrition; subject to a variety of physical ailments, including headache, fever, undiagnosed pelvic pain, urinary tract infection, STIs, rash/scabies, and oral/dental health issues. All had experienced repeated sexual abuse or coercion, and 1 in 4 reported at least one unintended pregnancy (often involving negative outcomes of abortions performed in unsafe and unhealthy conditions).

Evidence Based Practice Recommendation

The British Association for Sexual Health and HIV has identified trafficked women/commercial sex workers as a group vulnerable to sexual violence. Inquiries about such vulnerabilities will help to identify those in need of additional support and help to facilitate appropriate referrals to mental health services, general practitioners, and support agencies. Access to interpreter and advocacy services may be helpful.

https://www.bashhguidelines.org/media/1079/4450.pdf

Last Accessed: August 15, 2019

Level of Evidence: Expert Opinion/Consensus Statement

In the context of forced prostitution among trafficked victims, safeguards against infection (e.g., regular condom use), early diagnosis, and adequate antimicrobial treatment are inconsistently employed or absent entirely [61]. Consequently, in addition to unwanted pregnancy, the risk for pelvic inflammatory disease and subsequent infertility is relatively high. Moreover, the relationship between forced prostitution and HIV infection is stronger when sexual violence is involved. Women who are forced into prostitution are 11 times more likely to become HIV-infected than women who entered prostitution voluntarily [86]. Sexual violence may increase the transmission risk as a result of open abrasions and injuries to the vagina. Furthermore, sexual violence can negatively impact self-esteem, which could then deter victims from advocating more strongly for condom use [86].

Among child victims of human trafficking, healthy growth and development is especially problematic. Malnourishment and poor hygiene often lead to delayed bone growth, poorly formed teeth, and early dental caries [87]. The intense nature of child labor also has severe negative physical and health consequences. Children working in unsafe conditions without protection, such as in mines or mills, can lead to respiratory problems such as asthma and bronchitis [88]. A study of adult and child laborers on tobacco farms in Kazakhstan found that the workers were unaware that exposure to tobacco and pesticides could affect their health. Protective garments were also rare, with many children not even having gloves [89].

Under normal circumstances, young children are still developing physically; however, such adverse conditions can halt their development. The lungs of adolescent boys typically experience the most rapid growth around 13 to 17 years of age; working in conditions characterized by excessive toxic dust or unclean air makes them more vulnerable to developing silicosis and fibrosis [88]. In the United States, young children participating in agricultural work are at risk of the major traumas associated with farm work, such as injuries caused by tractors or falling from heights, in addition to those injuries associated with repetitive stress and exposure to toxins. Children have thinner layers of epidermis, which make them more vulnerable to the toxicity of pesticides, and this can ultimately increase their risks for certain cancers [88]. Children working in gold mines do intensive digging, lifting, and transporting and mix mercury with the crushed ore, often with their bare hands. Mercury toxicity can lead to neurologic symptoms such as loss of vision, tremors, and memory loss [89].

8. IDENTIFICATION AND ASSESSMENT

Healthcare providers are often the most likely to encounter a victim of human trafficking under circumstances that provide an opportunity to intervene. Yet, many providers lack the training and confidence to identify and assist victims. In a survey of 110 emergency department physicians, nurses, and physician assistants, the majority (76%) reported having a knowledge of human trafficking, but only 13% felt equipped to identify a trafficking victim and only 22% were confident in their ability to provide satisfactory care for such patients [90]. Less than 3% had ever received any training on this topic. In a separate survey of healthcare and social service providers, only 37% had ever received training on identification of trafficking victims [91].

Because human trafficking and exploitation are, by nature, covert processes, the identification and rescue of the victim can be difficult. Traffickers move victims from one area to another to reduce the risk of identification, and one of the main problems with the assessment of such individuals is that practitioners may only have a one-time encounter with the victim [92].

POTENTIAL RED FLAGS

Bruises, scars, and other signs of physical abuse may be missed on examination, as victims are often beaten in areas hidden by clothing (e.g., the lower back) so as not to affect the victim's outer appearance. Physical trauma symptoms may be present, commonly on the torso, breast, and/or genital areas [70]. Burns, broken bones, pelvic pain, and/or STIs (particularly in children) may also be red flags [93]. However, more common physical injuries are also typical with other circumstances, making physical exam of limited value. The entire clinical picture should be considered.

It may also be helpful to assess for tattoos and/or other modifications (e.g., branding, piercings). Some perpetrators use tattoos to identify victims or to signify "ownership" [56].

With regard to episodic clinical encounters, recommendations for providing safe assessments in a culturally sensitive manner are lacking. The Department of Health and Human Services Administration for Children and Families maintains a useful website that addresses practical issues of human trafficking for allied professional groups, known as the Rescue and Restore Campaign [87]. Included are diagnostic and interviewing tips to help healthcare providers recognize, intervene, and refer trafficking victims. Emergency and primary care providers should be cognizant of clues that a patient may be the victim of trafficking and prepared to engage in greater depth of inquiry with special attention to the following indicators [87,93,94,95]:

- Does someone, other than family, who behaves in a controlling manner, accompany the patient? Traffickers attempt to guard and control most every aspect of the victim's life, while maintaining isolation from family, friends, and other common forms of human interaction.

- Are there inconsistencies in answers to basic questions (e.g., name, age, address)?

- Does the patient speak English? If not, has he or she recently been brought to this country, and from where? Many victims of human trafficking have recently been trafficked from other countries. As discussed, common sending countries/regions include Eastern Europe, Asia, Latin America, Africa, India, and Russia.

- If the patient is accompanied by someone other than a family member, who does the talking, and why? Attempt to interview and examine the patient separately and alone, using an interpreter if necessary. Probe in a sensitive manner for detailed information on the situation and relationship.

- Does the patient show signs of psychosocial stress (e.g., appears withdrawn, submissive, fearful, anxious, depressed)? Can the individual account for this?

- Are there visible signs of physical abuse (e.g., bruises, lacerations, scars)? How does the individual explain these?

- Does the patient lack a passport or other immigration and identification documentation (e.g., driver's license, social security number, visa)? If so, what explanation is given? To control victims' movements, traffickers often take away passports and any legal identification documents.

- What is the patient's home and work situation? Basic questions about what they eat, where they live and sleep, who else lives with them, and what work they do can be revealing. For example, "Can you leave your work or job situation if you wish?" or "When you are not working, can you come and go as you please?"

- Is the explanation given for the clinical visit consistent with the patient's presentation and clinical findings?

- Does the victim appear fearful when asked questions about citizenship, country of origin, immigration status, or residence? This may indicate a fear of deportation.

- If the victim is a minor, is s/he in school? Living with parents or relatives? If not, what reasons are given for these circumstances?

SCREENING QUESTIONS

Examples of questions to screen for human trafficking include [96,97,98]:

- Can you tell me about your living situation?

- Has anyone ever threatened you with violence if you attempted to leave?

- Does anyone force/require you to have sexual intercourse for your work?

- Has anyone ever threatened your family if you attempted to leave?

- Does anyone make you feel scared at work?

- Are you free to come and go as you wish?

- Does your home have bars on windows, blocked windows/doors, or security cameras?

- How many hours do you work?

- Have you ever worked without receiving payment you thought you would get?

- Do you owe your employer money?

- Do you have to ask permission to eat, sleep, use the bathroom, or go to the doctor?

The Polaris Project has developed a flow chart for the assessment of potential trafficking victims, available at https://www.traffickingresourcecenter.org/sites/default/files/Assessment%20Tool%20-%20Medical%20Professionals.pdf. If a person is thought to be a victim, one should follow workplace protocols and/or contact the National Human Trafficking Resource Center at (888) 373-7888 for next steps.

INTERVIEWING TRAFFICKED VICTIMS: BEST PRACTICE GUIDELINES

Service providers should repeatedly weigh the risks and benefits of various actions when interviewing human trafficking victims [65,99,100]. The following interviewing recommendations were published by the World Health Organization to encourage service providers to continually and ethically promote human trafficking victims' safety during every phase of the interviewing process [93,101]:

- Each victim and trafficking situation should be treated as unique; there are no standard templates of experiences. Listen carefully to the victim's story. Each story told is unique, and each patient will voice distinctive concerns. Believe each story, no matter how incredible it may seem. As rapport and trust build (perhaps very slowly), accounts may become more extensive.

- Always be safe and assume the victim is at risk of physical, psychologic, social, and legal harm.

- Evaluate the risks and benefits of interviewing before starting the interviewing process. The interviewing process should not invoke more distress. In other words, the interviewing process should not end up re-traumatizing the victim.

- Provide referrals for services where necessary; however, it is necessary to be realistic and not make promises that cannot be kept. Trust is vital because it has been severed on so many levels for trafficking victims.

- Victims' readiness to change will not be based on what societal defines as "ready" or social expectations. Some victims will eagerly grasp new opportunities, while others may be fearful of potential traffickers' threat and be less receptive to help.

- Determine the need for interpreters and if other service providers should be present during the interviewing phase. Ensure that everyone involved is adequately prepared in their knowledge about human trafficking, how perpetrators control their victims, and how to ask questions in a culturally sensitive manner. Keep in mind that often times, traffickers will offer to help with the interpreting. Using interpreters from the same community of the victim should be avoided to prevent breaches in confidentiality.

- All involved should be prepared for an emergency plan. For example, is there a set plan for a victim who indicates he/she is suicidal or in danger of being hurt?

- Always be sure to obtain informed consent. Remember the informed consent process is going to be unfamiliar to many victims. In addition, self-determination and autonomy have been compromised by continual threats and being forced to commit dehumanizing acts. Avoid using legal and technical jargon.

It is important to use a trauma-informed approach when assessing and caring for potential victims, which requires that practitioners understand the impact of trauma on all areas of an individual's life [102]. Physical, emotional, and psychologic safety is at the heart of trauma-informed care. Providers should assume that human trafficking victims are describing their reality to the best of their ability, given the trauma they have experienced. Responses and behaviors (e.g., being guarded, defensive, belligerent) may be coping mechanisms [102].

9. REPORTING

If screening and assessment findings indicate that an individual may be a victim of human trafficking, one should contact the National Human Trafficking Hotline at 1-888-373-7888. A text telephone (TTY) option for people who are deaf, hard of hearing, or speech impaired can be accessed by dialing 711. Reporting by text is available by texting the National Human Trafficking Hotline at 233733. Online chat is also accessible at https://humantraffickinghotline.org.

The National Human Trafficking Hotline collects information about the location of the trafficking case and the name of the suspected trafficker. The hotline will also request non-personally identifying information, such as the city and state of the reporter and how he or she learned of the hotline; reporting can be done anonymously. Reporters and/or victims are only asked to provide information they feel comfortable sharing, and the hotline does not share information with external agencies unless permission is given or when required by law. Hotline calls are managed by anti-trafficking hotline advocates, who are specifically trained. After receiving a report of suspected human trafficking, the National Human Trafficking Hotline will assess each case individually to determine if a case should be reported to a local, state, or federal investigative and/or service agency equipped to investigate the tip and/or respond to the needs of the potential victim.

Under the child abuse laws, practitioners who are mandated reporters and who are suspicious that a minor is being abused should immediately report the abuse. Persons in Florida who know, or have reasonable cause to suspect, that a child is abused, neglected, or abandoned must immediately report such knowledge or suspicion to the Florida Abuse Hotline of the Department of Children and Families at 1-800-96-ABUSE.

10. INTERVENTIONS AND RESOURCES

EDUCATION AND PREVENTION

Education is believed to be a key ingredient in the prevention of human trafficking. Raising awareness through advertisements, campaigns, and other creative vehicles regarding recruitment threats, the various deception techniques employed, the different forms of human trafficking, and the consequences of human trafficking can decrease the incidence [64,103]. Because the general public often believes human trafficking is a problem that only occurs in developing countries, there is a clear need for public education about trafficking and safety for young children and women in and outside the United States [22]. The Campaign to Rescue and Restore Victims of Human Trafficking provides brochures and posters about human trafficking, which are available to be ordered (at no cost) from https://www.acf.hhs.gov/archive/otip/resource/about-rescue-restore [87]. Posting these brochures or posters increases the possibility that a trafficked victim will self-report [100].

Education about human trafficking has become a higher international priority. Innovative and creative approaches are being implemented to disseminate information about human trafficking, particularly how perpetrators recruit high-risk groups (e.g., youths with disabilities, runaways) [67]. For example, groups have used street plays to educate communities about child labor dangers in India [104].

India: Fighting Child Labour with Street Plays was produced by the International Labour Organization to explore the use of street plays to educate communities about child labor in India.

To see this media go to http://www.NetCE.com/activities/ using a browser that supports Adobe Flash.

For more information, visit the International Labour Organization at http://www.ilo.org.

Although the topic of human trafficking has become more common in public discourse, service providers and law enforcement authorities remain under-educated about human trafficking. They are not sure what to look for, what to ask, and what to do if they do identify individuals who are victims of human trafficking [103]. Law enforcement officials require training to identify and assess potential victims at various borders and ports of entry. If a minor is accompanied by an adult who is not the child's parent or legal guardian, this should raise a red flag [103]. Furthermore, to work effectively to identify human trafficking victims, there is a need for service providers to navigate and collaborate with a complex host of government, social service, mental health, and nongovernment legal entities [103].

MENTAL HEALTH AND SOCIAL SERVICES

Care and services provided to victims can be organized into three distinct categories: immediate and concrete services at the time of rescue; services related to recovery; and long-term services pertaining to reintegration [105]. When trafficking victims are rescued, a great deal of counseling services and practical, day-to-day assistance will be required. Housing, transportation, food, clothing, medical care, dental care, financial assistance, educational training, reunification (for those who wish to return to their homeland), and legal aid are some of the concrete services needed [71]. Practitioners should connect, coordinate, and case manage these services as much as possible. During this stage, it is also important to understand victims' needs, their strengths, and their risks and vulnerabilities [75].

Safety planning is also crucial in the immediate rescue stage. Traffickers may be continuing to try to locate some victims; placing victims in safe houses may be necessary [63]. The National Human Trafficking Hotline encourages that safety planning be based on the unique needs and circumstances of the individual.

During the recovery and reintegration stages, as discussed, human trafficking victims experience an array of mental health and psychologic issues. Mental health counseling is vital, but it is important to remember that the concept of counseling or talk therapy may be foreign to victims from non-Western cultures [65]. The expression of emotions may be in opposition to cultural values of emotional restraint, which can be intensified by feelings of shame and guilt resulting from experiences with sexual and physical assault. Beyond the paramount importance of the practitioner gaining the patient's trust, practitioners may educate patients about the counseling process and explore their patients' expectations about counseling, healing, and recovery [106]. As noted, victims' symptoms may not only be a manifestation of the trauma but also coping mechanisms to cope with self-blame, shame, and trauma [56].

Given differing cultural beliefs about healing, it is crucial that practitioners be open to alternative treatment and explore with patients the use of traditional healing methods [65]. There are many indigenous healing interventions victims may be using, including cultural rituals, faith healing, therapeutic touch, herbal remedies, and spiritual practices [107]. These interventions are multi-layered, taking into account the physical, psychologic, communal, and spiritual [107]. These healing methods are historically rooted in specific cultures, and therefore, practitioners should become familiar with traditional healing methods and how they can be integrated with Western counseling techniques [106]. For example, given many cultural groups' beliefs that unmarried girls are defiled if raped, a cultural cleansing ritual may be needed as a first step to help a community accept a returning victim who was sexually assaulted during her trafficking experience [30]. After this ritual is performed, it is possible that both the patient and her family may be more open to counseling and other services.

Other trauma interventions that might be beneficial include cognitive-behavioral therapies, eye movement and desensitization reprocessing therapies, mindfulness techniques, and expressive therapies [56,63].

Physicians, social workers, nurses, therapists, and counselors must be familiar with legal, case management, educational, job and life skills training, and housing services in the community. Human trafficking victims are not only unfamiliar with navigating the social service system, but many are also not proficient in English. Therefore, practitioners will serve as coordinators and advocates, linking necessary services. In one study, the majority of agencies had to rely on collaboration in order to refer clients [108]. Social workers and practitioners relied on word-of-mouth and community meetings to learn about services in order to better meet the needs of human trafficking victims. Furthermore, because many community organizations and agencies are not familiar with human trafficking, practitioners must take a primary role in educating colleagues about the complex dynamics of human trafficking.

It is important to remember that the evidence supporting interventions and therapies for victims of human trafficking is in its infancy [105]. Most efficacy studies of therapies and interventions do not involve experimental designs, which makes it difficult to draw definitive conclusions regarding efficacy. Future work is needed to develop and evaluate interventions that address the multilayered and complex needs of human trafficking survivors.

This informational video on human trafficking and how to identify and assist victims is part of the Rescue & Restore Victims of Human Trafficking public awareness campaign, an initiative of the U.S. Department of Health and Human Services.

To see this media go to http://www.NetCE.com/activities/ using a browser that supports Adobe Flash.

For more information, visit the Office on Trafficking in Persons website at https://www.acf.hhs.gov/otip/partnerships/look-beneath-the-surface.

ADVOCACY

Physicians, social workers, nurses, allied health professionals, counselors, and psychologists will find themselves in multiple roles when working with victims of human trafficking. Advocacy is one of these roles and involves the practitioner being an agent for change. This consists of engaging in activities that alter the social conditions at the individual, family, community, and institutional levels [109]. One way to advocate on behalf of human trafficking victims is by signing petitions or joining credible organizations concerned with changing the circumstances that lead to human trafficking. Many organizations have petitions established on their websites for individuals to persuade policymakers, legislators, and government officials to advocate for the protection of human trafficking victims, create greater awareness of the problem, and prosecute traffickers, including:

- https://www.freetheslaves.net

- https://polarisproject.org

- https://www.stopthetraffik.org

LAWS AND POLICIES

Justice for Victims of Trafficking Act

In 2015, the Justice for Victims of Trafficking Act (JVTA) became law, allowing survivors formal input in federal anti-trafficking policy and providing incentives for states to enact laws to prevent the prosecution of child victims for crimes committed as a direct result of being subjected to trafficking. The JVTA provides additional bases of criminal liability for those who patronize or solicit trafficking victims for commercial sex and creates a new offense prohibiting the advertising of sex trafficking activity. It also clarifies that traffickers in child sex trafficking cases who had a reasonable opportunity to observe the victim can no longer claim ignorance about a victim's age as a defense [24]. Some provisions of this law are scheduled to expire in 2019 and 2020 [110].

Victims of Trafficking and Violence Protection Act

A wide range of laws have been established to protect human trafficking victims and to prosecute perpetrators. A general knowledge of these laws is helpful when caring for victims and seeking appropriate social services. The TVPA was enacted in 2000 and reauthorized in 2003, 2005, 2008, 2013, and 2018 by the Trafficking Victims Protection Reauthorization Acts [24]. It emphasizes the three Ps: prevention, protection, and prosecution [111]. The prevention component consists of training and awareness; the protection dimension gives trafficked victims the ability to receive services using federal funds like other refugees; and the prosecution component focuses on laws and policies for the prosecution of traffickers.

Because victims of trafficking are often viewed as criminals, this law states that victims of severe trafficking should not be penalized for any illegal behaviors or acts they engaged in as a result of being trafficked, including entering the United States with false documents or no documentation or working without appropriate paperwork [64]. This law also allows T Nonimmigrant Status (T visas) to be granted to victims of trafficking so they may remain in the United States with the purpose of collaborating with the federal authorities to prosecute the perpetrators. During this time, victims are offered a range of benefits and services, including access to the Witness Protection Program [64]. After three years, victims can apply for permanent resident status [16].

One of the criticisms of the Act is that it places the burden of demonstrating innocence and coercion on the victim [112]. The Act also fails to recognize the complex dynamics of human trafficking. For example, it focuses more on sex trafficking versus other forms [113]. Many victims have been abused and terrorized by the perpetrators, who they must now provide information and evidence against to stay in the country. Victims are continually fearful that they will be deported [112].

Victims who are of minor age are eligible for Unaccompanied Refugee Minors programs, the Children's Health Insurance program, and Temporary Assistance to Needy Families [103]. Furthermore, victims between 16 and 24 years of age are eligible for work permits and can apply for the Job Corps program [103]. However, it is important to remember that the key to this law is that the victim must have experienced a "severe form" of trafficking and the victim must be willing to assist in the apprehension and prosecution of the perpetrator to receive services [114].

Preventing Sex Trafficking and Strengthening Families Act

The Preventing Sex Trafficking and Strengthening Families Act was signed into law in 2014. In accordance with this law, child welfare agencies are required to monitor and report the number of child sex trafficking victims. Cases of suspected or known child sex trafficking must also be reported to law enforcement [37].

Trafficking Victims Protection Reauthorization Act

The Trafficking Victims Protection Reauthorization Act was introduced and signed into law in 2013. It allocated $5 million in 2009, $7 million in 2010, $7 million in 2011, and $8 million annually through 2017 to provide services to victims and to prevent human trafficking [22,115,116]. It amends the TVPA and assists foreign governments to implement programs to prevent human trafficking. Victims of human trafficking in other countries are also eligible for assistance through organizations that have grants from the U.S. government [115]. Greater monitoring of trafficking trends through databases will also be implemented. The Act also declares that it is not a defense that a defendant is not criminally liable or is subject to reduced criminal liability due to acceptance of the illicit conduct in the foreign jurisdiction.

The Prosecutorial Remedies and Other Tools to End the Exploitation of Children Today Act

The Prosecutorial Remedies and Other Tools to End the Exploitation of Children Today Act was enacted in 2003. This law maintains that all sexual activity with minors, within or outside the United States, is illegal. American citizens who engage in sex with minors in any country and who are caught will be prosecuted in the United States [64].

As of 2017, all 50 states have enacted criminal anti-trafficking laws. In addition, every state has a law on labor trafficking, and all have passed criminal statutes for sex trafficking [117].

SOAR to Health and Wellness Act

The SOAR (Stop, Observe, Ask, and Respond) to Health and Wellness Act was signed into law in 2018. It directs the Department of Health and Human Services to develop a program to train healthcare providers and practitioners to identify possible human trafficking victims, to work with law enforcement agencies, and to refer victims to services [7].

Florida House Bill 369

In 2015, The Florida Legislature passed House Bill 369, which mandates the display of a human trafficking public awareness sign in a wide range of locations, including [118]:

- Every public rest area, turnpike service plaza, weigh station, primary airport, passenger rail station, and welcome center in the state

- Emergency rooms at general acute care hospitals

- Strip clubs or other adult entertainment establishments

- A business or establishment that offers massage or bodywork services for compensation that is not owned by a healthcare professional

The sign must contain text, in both English and Spanish, regarding the steps to take if you or someone you know is the victim of trafficking, exploitation, and/or forced labor.

RESOURCES

For more information and to become involved in advocacy movements, please utilize the following resources. In some cases, the tools provided may be valuable for patient and/or peer training. In particular, the National Human Trafficking Hotline provides free, downloadable awareness materials for victims, first responders, and healthcare and mental health professionals, including a flyer available in 20 languages.

Alliance for Children in Trafficking

https://www.napnappartners.org/provider-public-resources

Coalition to Abolish Slavery & Trafficking

https://castla.org

Coalition Against Trafficking in Women

http://www.catwinternational.org

Futures Without Violence

https://www.futureswithoutviolence.org

HEAL Trafficking

https://healtrafficking.org

Human Rights Watch

https://www.hrw.org

International Justice Mission

https://www.ijm.org

International Labour Organization

https://www.ilo.org

Office of Refugee Resettlement

https://www.acf.hhs.gov/orr

National Human Trafficking Hotline

https://humantraffickinghotline.org

Polaris Project

https://polarisproject.org

Salvation Army

https://www.salvationarmyusa.org

Sex Workers Project

http://sexworkersproject.org

United Nations Office on Drugs and Crime

Human Trafficking Knowledge Portal

https://sherloc.unodc.org/cld/en/v3/htms/index.html

U.S. Department of Health and Human Services

Administration for Children and Families

https://www.acf.hhs.gov

U.S. Department of Health and Human Services

Administration for Children and Families

SOAR to Health and Wellness Training

https://www.acf.hhs.gov/otip/training/soar-to-health-and-wellness-training

Services Available to Victims of Human Trafficking: A Resource Guide for Social Service Providers

https://www.acf.hhs.gov/otip/resource/services-available-to-victims-of-human-trafficking

U.S. Department of Justice

Bureau of Justice Assistance

https://www.bja.gov

U.S. Department of Justice

Office for Victims of Crime

https://ojp.gov/ovc

U.S. Department of Labor

Bureau of International Labor Affairs

https://www.dol.gov/agencies/ilab

U.S. Department of State, Office to Monitor and Combat Trafficking in Persons

https://www.state.gov/bureaus-offices/under-secretary-for-civilian-security-democracy-and-human-rights/office-to-monitor-and-combat-trafficking-in-persons

11. CONCLUSION

Human trafficking is a severe human rights violation. Because the roots of human trafficking are multifaceted, no one solution exists to eliminate this problem. Unfortunately, as the problem grows, practitioners will be confronted with the issue in their patient populations. Practitioners should be committed to the collaboration amongst disciplines to address poverty, racism, discrimination, and oppression in order to reduce the vulnerable positions of human trafficking victims and their families. Because of the social justice component in the codes of ethics of professionals such as physicians, nurses, social workers, psychologists, and counselors, all practitioners can play a key role in the individual, community, and systemic levels to help address this gross abuse of power. One way to begin is to educate oneself and one's respective disciplines about the global nature of human trafficking and the complex dynamics of the problem.

The following video is an excerpt of California Senator Kamala Harris’s keynote address at Examining the Roots of Human Trafficking and Exploitation, the 2014–2015 UCLA School of Law Symposium.

To see this media go to http://www.NetCE.com/activities/ using a browser that supports Adobe Flash.

This recording from the January 2015 University of California Los Angeles Law Review Symposium is provided with permission from the University of California, Los Angeles, School of Law.

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Evidence-Based Practice Recommendations Citations

1. Clinical Effectiveness Group. UK National Guidelines on the Management of Adult and Adolescent Complainants of Sexual Assault, 2011. London: British Association for Sexual Health and HIV; 2012. Available at https://www.bashhguidelines.org/media/1079/4450.pdf. Last accessed August 15, 2019.

91151 • Strategies for Appropriate Opioid Prescribing: The Florida APRN/PA Requirement

Mark Rose, BS, MA, LP

www.netce.com

Copyright © 2019 NetCE, All rights reserved.

Opioid analgesic medications can bring substantial relief to patients suffering from pain. However, the inappropriate use, abuse, and diversion of prescription drugs in America, particularly prescription opioids, has increased dramatically in recent years and has been identified as a national public health epidemic. A set of clinical tools, guidelines, and recommendations are now available for prescribers who treat pain patients with opioids. By implementing these tools, clinicians can effectively address issues related to the clinical management of opioid prescribing, opioid risk management, regulations surrounding the prescribing of opioids, and problematic opioid use by patients. In doing so, healthcare professionals are more likely to achieve a balance between the benefits and risks of opioid prescribing, optimize patient attainment of therapeutic goals, and avoid the risk to patient outcome, public health, and viability of their own practice imposed by deficits in knowledge.

Table of Contents

91151 • Strategies for Appropriate Opioid Prescribing: The Florida APRN/PA Requirement

Course Overview

Audience

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Division Planners

Division Planners Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

1. INTRODUCTION

2. DEFINITIONS

3. EPIDEMIOLOGY OF CHRONIC PAIN AND OPIOID MISUSE

OPIOID MISUSE IN FLORIDA

4. INITIATION AND MANAGEMENT OF THE PATIENT WITH PAIN

ACUTE PAIN

PATIENT EVALUATION AND ASSESSMENT OF ADDICTION RISK

CREATING A TREATMENT PLAN

PERIODIC REVIEW AND MONITORING

CONSULTATION AND REFERRAL

MEDICAL RECORDS

PATIENT EDUCATION ON THE USE AND DISPOSAL OF OPIOIDS

DISCONTINUING OPIOID THERAPY

CONSIDERATIONS FOR NON-ENGLISH-PROFICIENT PATIENTS

5. CRISIS INTERVENTION: MANAGEMENT OF OVERDOSE

OPIOID ANTAGONISTS

6. COMPLIANCE WITH STATE AND FEDERAL LAWS

CONTROLLED SUBSTANCES LAWS/RULES

THE ELECTRONIC FLORIDA ONLINE REPORTING OF CONTROLLED SUBSTANCES EVALUATION PROGRAM

7. IDENTIFICATION OF DRUG DIVERSION/SEEKING BEHAVIORS

8. INTERVENTIONS FOR SUSPECTED OR KNOWN DRUG DIVERSION

9. CASE STUDY

ASSESSMENT

FOLLOW-UP

10. CONCLUSION

Works Cited

Evidence-Based Practice Recommendations Citations

91151 • Strategies for Appropriate Opioid Prescribing: The Florida APRN/PA Requirement

Education Category. Management

Release Date. 09/01/2019

Expiration Date. 08/31/2022

Course Overview

Opioid analgesic medications can bring substantial relief to patients suffering from pain. However, the inappropriate use, abuse, and diversion of prescription drugs in America, particularly prescription opioids, has increased dramatically in recent years and has been identified as a national public health epidemic. A set of clinical tools, guidelines, and recommendations are now available for prescribers who treat pain patients with opioids. By implementing these tools, clinicians can effectively address issues related to the clinical management of opioid prescribing, opioid risk management, regulations surrounding the prescribing of opioids, and problematic opioid use by patients. In doing so, healthcare professionals are more likely to achieve a balance between the benefits and risks of opioid prescribing, optimize patient attainment of therapeutic goals, and avoid the risk to patient outcome, public health, and viability of their own practice imposed by deficits in knowledge.

Audience

This course is designed for all nurses and physician assistants who may alter prescribing practices or intervene to prevent drug diversion and inappropriate opioid use.

Course Objective

The purpose of this course is to provide clinicians who prescribe or distribute opioids with an appreciation for the complexities of opioid prescribing and the dual risks of litigation due to inadequate pain control and drug diversion or misuse in order to provide the best possible patient care and to prevent a growing social problem.

Learning Objectives

Upon completion of this course, you should be able to:

1. Define opioid prescribing and opioid misuse.

2. Apply epidemiologic trends in opioid use and misuse to current practice so at-risk patient populations can be more easily identified, assessed, and treated.

3. Create comprehensive treatment plans for patients with chronic pain that address patient needs as well as drug diversion prevention.

4. Identify state and federal laws governing the proper prescription and monitoring of controlled substances.

5. Evaluate behaviors that may indicate drug seeking or diverting as well as approaches for patients suspected of misusing opioids.

Faculty

Mark Rose, BS, MA, LP, is a licensed psychologist in the State of Minnesota with a private consulting practice and a medical research analyst with a biomedical communications firm. Earlier healthcare technology assessment work led to medical device and pharmaceutical sector experience in new product development involving cancer ablative devices and pain therapeutics. Along with substantial experience in addiction research, Mr. Rose has contributed to the authorship of numerous papers on CNS, oncology, and other medical disorders. He is the lead author of papers published in peer-reviewed addiction, psychiatry, and pain medicine journals and has written books on prescription opioids and alcoholism published by the Hazelden Foundation. He also serves as an Expert Advisor and Expert Witness to law firms that represent disability claimants or criminal defendants on cases related to chronic pain, psychiatric/substance use disorders, and acute pharmacologic/toxicologic effects. Mr. Rose is on the Board of Directors of the Minneapolis-based International Institute of Anti-Aging Medicine and is a member of several professional organizations.

Faculty Disclosure

Contributing faculty, Mark Rose, BS, MA, LP, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Division Planners

John M. Leonard, MD

Jane C. Norman, RN, MSN, CNE, PhD

Division Planners Disclosure

The division planners have disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

1. INTRODUCTION

Pain is the leading reason for seeking medical care, and pain management is a large part of many healthcare professionals' practice. Opioid analgesics are approved by the U.S. Food and Drug Administration (FDA) for moderate and severe pain and are broadly accepted in acute pain, cancer pain, and end-of-life care, but are controversial in chronic noncancer pain. In response to the long-standing neglect of severe pain, indications for opioid analgesic prescribing were expanded in the 1990s, followed by inappropriate prescribing and increasing abuse, addiction, diversion, and overdose through the 2000s. In tandem with the continued under-treatment of pain, these practice patterns led to needless suffering from uncontrolled pain, opioid analgesic addiction, and overdose. Opioid analgesic prescribing and associated overdose peaked in 2010 with both now in multi-year decline, but information on these important trends is largely absent in the medical literature and media reporting.

Patients show substantial opioid response variations in analgesia and tolerability and may exhibit a range of psychologic, emotional, and behavioral responses that reflect inadequate pain control, an emerging opioid use problem, or both. Clinician delivery of best possible care to patients with pain requires appreciation of the complexities of opioid prescribing and the dual risks of inadequate pain control and inappropriate use, drug diversion, or overdose. A foundation for appropriate opioid prescribing is the understanding of factual data that clarify the prevalence, causality, and prevention of serious safety concerns with opioid prescribing.

2. DEFINITIONS

Definitions and use of terms describing opioid analgesic misuse, abuse, and addiction have changed over time, and their current correct use is inconsistent not only among healthcare providers, but also by federal agencies reporting epidemiologic data such as prevalence of opioid analgesic misuse, abuse, or addiction. Misuse and misunderstanding of these concepts and their correct definitions have resulted in misinformation and represent an impediment to proper patient care.

Inappropriate opioid analgesic prescribing for pain is defined as the non-prescribing, inadequate prescribing, excessive prescribing, or continued prescribing despite evidence of ineffectiveness of opioids [1]. Appropriate opioid prescribing is essential to achieve pain control; to minimize patient risk of abuse, addiction, and fatal toxicity; and to minimize societal harms from diversion. The foundation of appropriate opioid prescribing is thorough patient assessment, treatment planning, and follow-up and monitoring. Essential for proper patient assessment and treatment planning is comprehension of the clinical concepts of opioid abuse and addiction, their behavioral manifestations in patients with pain, and how these potentially problematic behavioral responses to opioids both resemble and differ from physical dependence and pseudo-addiction. Prescriber knowledge deficit has been identified as a key obstacle to appropriate opioid prescribing and, along with gaps in policy, treatment, attitudes, and research, contributes to widespread inadequate treatment of pain [2]. For example, a 2013 survey measuring 200 primary care physicians' understanding of opioids and addiction found that [3]:

- 35% admitted knowing little about opioid addiction.

- 66% and 57% viewed low levels of education and income, respectively, as causal or highly contributory to opioid addiction.

- 30% believed opioid addiction "is more of a psychologic problem," akin to poor lifestyle choices rather than a chronic illness or disease.

- 92% associated prescription analgesics with opioid addiction, but only 69% associated heroin with opioid addiction.

- 43% regarded opioid dependence and addiction as synonymous.

This last point is very important because confusion and conflation of the clinical concepts of dependence and addiction has led to accusations of many non-addicted patients with chronic pain of misusing or abusing their prescribed opioid and in the failure to detect treatment-emergent opioid problems [4]. Knowledge gaps concerning opioid analgesics, addiction, and pain are related to attitude gaps, and negative attitudes may interfere with appropriate prescribing of opioid analgesics. For example, when 248 primary care physicians were asked of their prescribing approach in patients with headache pain with either a past or current history of substance abuse, 16% and 42%, respectively, would not prescribe opioids under any circumstance [5]. Possibly contributing to healthcare professionals' knowledge deficit in pain treatment is the extent of educational exposure in school. A 2011 study found that U.S. medical school students received a median seven hours of pain education and Canadian medical students a median 14 hours, in contrast to the median 75 hours received by veterinarian school students in the United States [6]. Additionally, less than 3% of medical schools incorporate pain management into their curriculum, yet chronic pain is the most common reason patients see a provider, accounting for 40% of all visits in primary care [7].

The terms related to addiction are often inconsistent, inaccurate, and confusing, partially reflecting the diverse perspectives of those working in the related fields of health care, law enforcement, regulatory agencies, and reimbursement/payer organizations. Changes over time in the fundamental understanding of addiction have also contributed to the persistent misuse of obsolete terminology [8]. The Diagnostic and Statistical Manual of Mental Disorders (DSM), published by the American Psychiatric Association, is the standard reference for the diagnosis of addiction and all other psychiatric disorders. Prior to the 2013 release of the DSM-5, versions of the DSM eschewed the term "addiction" in favor of "substance dependence," with a separate diagnostic entity of "substance abuse" representing a less severe version of dependence [9]. Also, in earlier DSM versions, physiologic dependence, manifesting as substance tolerance and withdrawal, was considered a diagnostic criterion of substance dependence. The result was the perpetuation of patient and healthcare professional confusion between physical and substance dependence and the belief that tolerance and withdrawal meant addiction. This confusion also enhanced provider and patient fears over addiction developing from opioid analgesics and contributed to the undertreatment of pain. The DSM-5 has eliminated substance dependence and substance abuse by combining them into the single diagnostic entity of substance use disorder. The disorder is measured on a continuum from mild to severe [9].

In 2011, the American Society of Addiction Medicine (ASAM) published their latest revision in defining the disease of addiction. In the abbreviated version, the ASAM states [10]:

Addiction is a primary, chronic disease of brain reward, motivation, memory, and related circuitry. Dysfunction in these circuits leads to characteristic biologic, psychologic, social, and spiritual manifestations. This is reflected in an individual pathologically pursuing reward and/or relief by substance use and other behaviors. Addiction is characterized by inability to consistently abstain, impairment in behavioral control, craving, diminished recognition of significant problems with one's behaviors and interpersonal relationships, and a dysfunctional emotional response. Like other chronic diseases, addiction often involves cycles of relapse and remission. Without treatment or engagement in recovery activities, addiction is progressive and can result in disability or premature death.

According to the ASAM, the five characteristics of addiction are [10]:

- Inability to consistently abstain

- Impairment in behavioral control

- Craving or increased "hunger" for drug or reward experiences

- Diminished recognition of significant problems with one's behaviors and interpersonal relationships

- A dysfunctional emotional response

The ASAM emphatically states this summary of addiction should not be used as diagnostic criteria for addiction because the core symptoms vary substantially among addicted persons, with some features more prominent than others [10].

3. EPIDEMIOLOGY OF CHRONIC PAIN AND OPIOID MISUSE

Chronic pain affects about 100 million American adults—more than the total affected by heart disease, cancer, and diabetes combined [2]. It also costs the nation up to $635 billion each year in medical treatment and lost productivity and is the leading reason for receiving disability insurance [3,11]. The lifetime prevalence of chronic pain ranges from 54% to 80%, and among adults 21 years of age and older, 14% report pain lasting 3 to 12 months and 42% report pain that persists longer than one year [2]. While 5 to 8 million Americans receive long-term opioids for the management of chronic pain, an estimated 41% of patients with chronic pain report their pain is uncontrolled, and 10% of all adults with pain suffer from severe, disabling chronic pain [11].

The increasing prevalence of chronic pain is the result of multiple factors, including the aging population; rising rates of obesity and obesity-related pain conditions, such as joint deterioration; advances in life-saving trauma interventions; poorly managed post-surgical pain; and greater public awareness of pain as a condition warranting medical attention [2]. In addition, many armed forces veterans have been returning from military action in Afghanistan and Iraq with traumatic injuries and chronic pain, and veterans' care clinicians have been reporting the perception that long-term pain management is lacking support in the veteran healthcare infrastructure [12].

There is a widespread misperception that opioid analgesic prescribing and overdose continues to grow, fueling an opioid epidemic [13,14,15,16,17]. Data from a 2018 Centers for Disease Control and Prevention (CDC) surveillance report show that between 2006 and 2017, the annual prescribing rate per 100 persons decreased from 72.4 to 58.5 for all opioids, an overall reduction of 19.2% [18]. (Opioid prescriptions, including codeine, fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, propoxyphene, tapentadol, tramadol, and buprenorphine, were identified using the National Drug Code. Cough and cold formulations containing opioids were not included.) The rate for all opioid prescriptions initially increased annually by 3.0% from 2006 to 2010, but then decreased annually by 1.6% from 2010 to 2014, and continued to decrease annually by 8.2% from 2014 to 2017 [18].

Although the epidemic of drug overdoses that began in the 1990s primarily involved prescription opioids prescribed for analgesia, the rapid increase in overdose deaths in 2010 was primarily attributed to heroin, and in 2013, to synthetic opioids, particularly illicitly manufactured fentanyl [18]. A record number (63,632) of drug overdose deaths occurred in 2016, a rate of 19.8 per 100,000 persons. Although deaths might have involved more than one drug, prescription and/or illicit opioids were involved in 66.4% of these drug overdose fatalities. Among opioid-involved deaths, the most commonly involved drugs were synthetic opioids other than methadone (primarily illicitly manufactured fentanyl [19,413 deaths]), prescription opioids (17,087 deaths), and heroin (15,469 deaths). Prescription opioid deaths included those involving natural and semisynthetic opioids (14,487 deaths) and methadone (3,373 deaths). Cocaine was involved in 10,375 deaths. The increase in overdose deaths in 2016 was attributed to heroin, synthetic opioids other than methadone (mostly illicitly manufactured fentanyl), cocaine, and psychostimulants with abuse potential [18].

There is nearly universal agreement that opioid analgesics were injudiciously overprescribed during the 2000s. Interpretation of the broader trend of increased prescribing from 1990 might be viewed by public health professionals as entirely problematic and by pain medicine professionals as necessary in part, given the past neglect of patients in pain. This reflects the polarized nature of pain care and opioid analgesic prescribing in particular. Efforts to reduce opioid analgesic overprescribing and associated overdose have been successful but have come at a cost to patients who have faced increasing barriers to access, including stigma and abuse in a healthcare system, tapering of opioids without consideration for pain or functional improvements, and difficulty finding a physician [14,19,20].

Worldwide consumption of opioid analgesics increased dramatically over the past few decades, driven primarily by U.S. consumption. For example, the global consumption of oxycodone was 3 tons (2,722 kg) in 1990 and 77 tons (69,853 kg) in 2009, with 62 tons (81%) consumed in the United States [21]. However, in line with a decrease in global manufacture of the drug, global consumption of oxycodone also decreased, from 79.7 tons in 2016 to 62.6 tons in 2017. Consumption remained concentrated in the United States, which consumed 42.4 tons (67.7%) of the world total [22]. In 2017, the United States had 4.3% of the world population but consumed 80% of global opioid supplies and 99.2% of hydrocodone supplies [22]. This is partially because access to opioid analgesics is virtually or entirely non-existent for much of the world's population. An estimated 3.6 billion people (50% of the global population who reside in the poorest countries) receive less than 1% of the distributed opioids [23]. Other countries with adequate opioid access prefer dihydrocodeine or low-dose morphine over hydrocodone for use in moderate or moderately severe pain [24].

Many prescribed opioid analgesic fatalities result from the co-ingestion of central nervous system (CNS)/respiratory depressants (especially benzodiazepines) or prescribed methadone. The National Institute on Drug Abuse reported benzodiazepines contributed to 24% of opioid analgesic fatalities in 2017 (compared with 18.4% in 2004), but this may underestimate the true contribution [25]. A Canadian study evaluated 607,156 adults prescribed opioids for noncancer pain, and of those whose deaths were related to opioids, co-prescribed benzodiazepines were detected in 84.5% [26]. In another study of 2,182,374 North Carolina residents receiving one or more opioid analgesics in 2010, benzodiazepines were present in 61.4% who fatally overdosed [27]. A cross-sectional study of 386,457 ambulatory care visits in the United States from 2003 through 2015 found that the use of benzodiazepines increased substantially from 3.8% to 7.4% of visits, including co-prescribing with other sedating medications [28]. Use for back and chronic pain increased more significantly than use for anxiety and insomnia, which remained relatively unchanged. This increase likely reflects not only a growing number of individuals receiving benzodiazepines, but also an increase in those receiving them on a long-term basis, despite the lack of evidence supporting their use past 8 or 10 weeks [28].

OPIOID MISUSE IN FLORIDA

In Florida, misuse of prescription opioids became a serious problem in the 1990s and 2000s, but efforts to stem the problem appear to be working. The rate of drug overdose deaths increased 58.9% during 2003–2010, and in 2009, one in eight deaths in Florida was attributable to drug overdose [29,30]. As of 2017, 6% of all deaths in Florida were found to have a drug present [31]. Oxycodone-caused deaths accounted for 2.9% of all drug-related deaths (8,646) in 2017 [29]. These trends resulted in the enactment of several measures to address prescribing that was inconsistent with best practices, and partnership with the U.S. Drug Enforcement Administration (DEA) to close and prevent "pill mills" from introducing millions of opioid dose units into illicit markets [32,33]. In May 2017, former Florida Governor Rick Scott signed an executive order declaring the opioid epidemic a public health emergency, providing additional funding and empowering state health professions to take steps to address this pressing issue [33]. As part of this order, the State Health Officer has issued a standing order for opioid antagonists to ensure emergency responders have access [33]. The order has been extended several times and, as of August 2019, is still in place [34].

Drug overdose fatalities in Florida have continued rising from increased use of heroin, synthetic cannabinoids, and novel psychoactive substances such as alpha-PVP ("flakka"). An influx of clandestine fentanyl into Florida in early 2014, and several fentanyl analogs and other novel non-pharmaceutical opioids more recently, has largely driven the increases in opioid overdose fatalities. Several overdose fatalities in Florida were linked to counterfeit alprazolam, oxycodone, and hydrocodone tablets that contained fentanyl [35]. The decrease in prescription opioid fatalities, offset by increasing overdose fatalities from other opioid and non-opioid agents, reflects the intervention focus on the supply side ("pill mill laws") and neglect of treatment funding that would address the demand side of problematic drug use [36].

In Florida, fatalities with benzodiazepines present peaked in 2010 with 6,188, falling to 5,064 in 2017 (37% were alprazolam) [31]. Of the 28,031 deaths investigated by Florida authorities, toxicology results determined that drugs were present at the time of death in 12,439 individuals, with the vast majority revealing more than one drug occurrence [31]. Other primary contributors to opioid analgesic-related fatalities include alcohol and prescribed methadone [37,38].

In addition to the executive order issued in 2017, several new state laws were passed in 2018 to impose additional legal requirements on controlled substance prescribers [39]. These laws will be discussed in detail later in this course.

4. INITIATION AND MANAGEMENT OF THE PATIENT WITH PAIN

In 2016, the CDC issued updated opioid prescribing guidelines for chronic pain that address when to initiate or continue opioids for chronic pain; opioid selection, dosage, duration, follow-up, and discontinuation; and assessing risk and addressing harms of opioid use [40]. Some of the recommendations are standard risk mitigation approaches, but others have been criticized by pain medicine physicians and patient advocates. A common criticism is the sole focus on curtailing prescribing and patient access [41,42,43,44].

It can be difficult to balance the benefits and harms of prescription opioids. This is exacerbated by inadequate education and by opioid prescribing guidelines based on expert opinion instead of scientific evidence. This has resulted in wide variation in clinical practice, inconsistent prescriber guidance, and clinician confusion [45]. For instance, the CDC and other opioid guidelines state that opioids should be considered only after non-opioid therapy fails. However, when pain is severe and patients require powerful analgesic control, there is little choice because no other pain medications are as effective as opioids with lower addiction risk [46].

However, many guidelines do share common recommendations. These represent the current "conventional wisdom" in opioid analgesic prescribing and can inform healthcare professionals of the best clinical practices in opioid prescribing that include approaches to the assessment of pain and function and pain management modalities. Pharmacologic and nonpharmacologic approaches should be used on the basis of current evidence or best clinical practice. Patients with moderate-to-severe chronic pain without adequate pain relief from non-opioid or nonpharmacologic therapy can be considered for a trial of opioid therapy [40,47]. Initial treatment should always be considered individually determined and as a trial of therapy, not a definitive course of treatment [48].

ACUTE PAIN

Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids in a quantity no greater than that needed for the expected duration of severe pain. In most cases, three days or less will be sufficient; more than seven days will rarely be needed [40]. Florida law dictates that, for the treatment of acute pain, a prescription for an opioid drug may not exceed a three-day supply; an exception may be made for a seven-day supply if [49]:

- The prescriber, in his or her professional judgment, believes that more than a three-day supply of such an opioid is medically necessary to treat the patient's pain as an acute medical condition.

- The prescriber indicates "ACUTE PAIN EXCEPTION" on the prescription. (For the treatment of pain other than acute pain, a practitioner must indicate "NONACUTE PAIN" on a prescription.)

- The prescriber adequately documents in the patient's medical records the acute medical condition and lack of alternative treatment options that justify deviation from the three-day supply limit.

With postoperative, acute, or intermittent pain, analgesia often requires frequent titration, and the two- to four-hour analgesic duration with short-acting hydrocodone, morphine, and oxycodone is more effective than extended-release formulations. Short-acting opioids are also recommended in patients who are medically unstable or with highly variable pain intensity [50,51,52].

As part of House Bill 21, passed in 2018, the Florida Board of Medicine and the Board of Osteopathic Medicine are required to establish guidelines for prescribing controlled substances for acute pain; these guidelines are forthcoming [49].

PATIENT EVALUATION AND ASSESSMENT OF ADDICTION RISK

Information obtained by patient history, physical examination, and interview, from family members, a spouse, or state prescription drug monitoring program (PDMP), and from the use of screening and assessment tools can help the clinician to stratify the patient according to level of risk for developing problematic opioid behavioral responses (Table 1). Low-risk patients receive the standard level of monitoring, vigilance, and care. Moderate-risk patients should be considered for an additional level of monitoring and provider contact, and high-risk patients are likely to require intensive and structured monitoring and follow-up contact, additional consultation with psychiatric and addiction medicine specialists, and limited supplies of short-acting opioid formulations [40,53].

Table 1: RISK STRATIFICATION FOR PATIENTS PRESCRIBED OPIOIDS

Low Risk

No past or current personal history of alcohol/substance use disorder (AUD/SUD)

No or minimal co-occurring psychiatric disorders

No family history of alcoholism or substance abuse

Medium Risk

Past history of AUD or SUD

Moderate concomitant psychiatric disorders

Family history of alcoholism or substance abuse/addiction

Patient history of physical, emotional or sexual abuse, especially in childhood

High Risk

Patient actively addicted to or abusing opioids, illicit drugs or alcohol

Untreated or poorly controlled major psychiatric disorder

History of diversion, prescription forgery, selling their prescription drugs

Source: [54,55,56]

Anxiety disorders, major depressive disorder, and intense emotional distress alter pain perception and response. Intensity and perception of reported pain is also influenced by factors such as mood, cultural background, social supports, and financial resources. A biopsychosocial model is required to inform pain assessment in order to address the biologic basis of pain and presence of social and psychologic contributors [46].

Before deciding to prescribe an opioid analgesic, clinicians should perform and document a detailed patient assessment that includes [1]:

- Pain indications for opioid therapy

- Nature and intensity of pain

- Past and current pain treatments and patient response

- Comorbid conditions

- Pain impact on physical and psychologic function

- Social support, housing, and employment

- Home environment (i.e., stressful or supportive)

- Pain impact on sleep, mood, work, relationships, leisure, and substance use

- Patient history of physical, emotional, or sexual abuse

Evidence Based Practice Recommendation

Despite limited evidence for reliability and accuracy, screening for opioid use is recommended by the American Society of Interventional Pain Physicians, as it will identify opioid abusers and reduce opioid abuse.

https://painphysicianjournal.com/2012/july/2012;%2015;S67-S116.pdf

Last Accessed: August 14, 2019

Level of Evidence: Limited (Evidence is insufficient to assess effects on health outcomes because of limited number or power of studies, large and unexplained inconsistency between higher-quality trials, important flaws in trial design or conduct, gaps in the chain of evidence, or lack of information on important health outcomes.)

Depression is perhaps the single most important comorbidity in patients with chronic pain and is vastly underdiagnosed and untreated. Patients with unrecognized and untreated depression are unlikely to respond to opioids and other pain therapies, but successful treatment of depression can promote analgesia [57].

If substance abuse is active, in remission, or in the patient's history, consult an addiction specialist before starting opioids [1]. In active substance abuse, do not prescribe opioids until the patient is engaged in treatment/recovery program or other arrangement made, such as addiction professional co-management and additional monitoring. When considering an opioid analgesic (particularly those that are extended-release or long-acting), one must always weigh the benefits against the risks of overdose, abuse, addiction, physical dependence and tolerance, adverse drug interactions, and accidental exposure by children [40,58].

Screening and assessment tools can help guide patient stratification according to risk level and inform the appropriate degree of structure and monitoring in the treatment plan. It should be noted that despite widespread endorsement of screening tool use to help determine patient risk level, most tools have not been extensively evaluated, validated, or compared to each other, and evidence of their reliability is poor [59].

Opioid Risk Tool (ORT)

The Opioid Risk Tool (ORT) is a five-item assessment to help predict aberrant drug-related behavior. The ORT is also used to establish patient risk level through categorization into low, medium, or high levels of risk for aberrant drug-related behaviors based on responses to questions of previous alcohol/drug abuse, psychologic disorders, and other risk factors [60].

Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R)

The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a patient-administered, 24-item screen with questions addressing history of alcohol/substance use, psychologic status, mood, cravings, and stress. Like the ORT, the SOAPP-R helps assess risk level of aberrant drug-related behaviors and the appropriate extent of monitoring [61].

CAGE and CAGE-AID

The original CAGE (Cut down, Annoyed, Guilty, and Eye-opener) Questionnaire consisted of four questions designed to help clinicians determine the likelihood that a patient was misusing or abusing alcohol. These same four questions were modified to create the CAGE-AID (adapted to include drugs), revised to assess the likelihood of current substance abuse [62,63].

Diagnosis, Intractability, Risk, and Efficacy (DIRE) Tool

The Diagnosis, Intractability, Risk, and Efficacy (DIRE) risk assessment tool is a clinician-rated questionnaire that is used to predict patient compliance with long-term opioid therapy [64,65]. Patients scoring lower on the DIRE tool are poor candidates for long-term opioid analgesia.

Mental Health Screening Tool

The Mental Health Screening Tool is a five-item screen that asks about a patient's feelings of happiness, calmness, peacefulness, nervousness, and depression in the past month [66]. A lower score on this tool is an indicator that the patient should be referred to a specialist for pain management.

CREATING A TREATMENT PLAN

Opioid therapy should be presented as a trial for a pre-defined period (e.g., ≤30 days). The goals of treatment should be established with all patients prior to the initiation of opioid therapy, including reasonable improvements in pain, function, depression, anxiety, and avoidance of unnecessary or excessive medication use [1,40]. The treatment plan should describe therapy selection, measures of progress, and other diagnostic evaluations, consultations, referrals, and therapies. All patients prescribed an opioid for pain related to a traumatic injury (severity score ≥9) should be concurrently prescribed an antagonist (e.g., naloxone) [49].

In opioid-naïve patients, start at the lowest possible dose and titrate to effect. Dosages for opioid-tolerant patients should always be individualized and titrated by efficacy and tolerability [1]. The need for frequent progress and benefit/risk assessments during the trial should be included in patient education. Patients should also have full knowledge of the warning signs and symptoms of respiratory depression.

Prescribers should be knowledgeable of federal and state opioid prescribing regulations. Issues of equianalgesic dosing, close patient monitoring during all dose changes, and incomplete cross-tolerance with opioid conversion should be considered. If necessary, treatment may be augmented, with preference for non-opioid and immediate-release opioids over long-acting/extended-release opioids. Taper opioid dose when no longer needed [58].

Non-Opioid Pain Management Options

Nonpharmacologic Approaches

Several nonpharmacologic approaches are therapeutic complements to pain-relieving medication, lessening the need for higher doses and perhaps minimizing side effects. These interventions can help decrease pain or distress that may be contributing to the pain sensation. Approaches include palliative radiotherapy, complementary/alternative methods, manipulative and body-based methods, and cognitive/behavioral techniques. The choice of a specific nonpharmacologic intervention is based on the patient's preference, which, in turn, is usually based on a successful experience in the past.

Methods to provide distraction from pain come in a wide variety, including reciting poetry, meditating with a calm phrase, watching television or movies, playing cards, visiting with friends, or participating in crafts. Music therapy and art therapy are also becoming more widely used as nonpharmacologic options for pain management.

Non-Opioid Analgesics

Non-opioid analgesics, such as aspirin, acetaminophen (Tylenol), and nonsteroidal anti-inflammatory drugs (NSAIDs), are primarily used for mild pain and may also be helpful as coanalgesics for moderate and severe pain. Acetaminophen is among the safest of analgesic agents, but it has essentially no anti-inflammatory effect. Toxicity is a concern at high doses, and the maximum recommended dose is 3–4 g per day [67]. Acetaminophen should be avoided or given at lower doses in people with a history of alcohol abuse or renal or hepatic insufficiency [67].

NSAIDs are most effective for pain associated with inflammation. Among the commonly used NSAIDs are ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), and indomethacin (Indocin). There are several classes of NSAIDs, and the response differs among patients; trials of drugs for an individual patient may be necessary to determine which drug is most effective [68]. NSAIDs inhibit platelet aggregation, increasing the risk of bleeding, and also can damage the mucosal lining of the stomach, leading to gastrointestinal bleeding. There is a ceiling effect to the non-opioid analgesics; that is, there is a dose beyond which there is no further analgesic effect. In addition, many side effects of non-opioids can be severe and may limit their use or dosing.

Informed Consent and Treatment Agreements

The initial opioid prescription is preceded by a written informed consent or "treatment agreement" [1]. This agreement should address potential side effects, tolerance and/or physical dependence, drug interactions, motor skill impairment, limited evidence of long-term benefit, misuse, dependence, addiction, and overdose. Informed consent documents should include information regarding the risk/benefit profile for the drug(s) being prescribed. The prescribing policies should be clearly delineated, including the number/frequency of refills, early refills, and procedures for lost or stolen medications.

The treatment agreement also outlines joint physician and patient responsibilities. The patient agrees to using medications safely, refraining from "doctor shopping," and consenting to routine urine drug testing (UDT). The prescriber's responsibility is to address unforeseen problems and prescribe scheduled refills. Reasons for opioid therapy change or discontinuation should be listed. Agreements can also include sections related to follow-up visits, monitoring, and safe storage and disposal of unused drugs.

PERIODIC REVIEW AND MONITORING

When implementing a chronic pain treatment plan that involves the use of opioids, the patient should be frequently reassessed for changes in pain origin, health, and function [1]. This can include input from family members and/or the state PDMP. During the initiation phase and during any changes to the dosage or agent used, patient contact should be increased. At every visit, chronic opioid response may be monitored according to the "5 A's" [1]:

- Analgesia

- Activities of daily living

- Adverse or side effects

- Aberrant drug-related behaviors

- Affect (i.e., patient mood)

Signs and symptoms that, if present, may suggest a problematic response to the opioid and interference with the goal of functional improvement include [69]:

- Excessive sleeping or days and nights turned around

- Diminished appetite

- Short attention span or inability to concentrate

- Mood volatility, especially irritability

- Lack of involvement with others

- Impaired functioning due to drug effects

- Use of the opioid to regress instead of re-engaging in life

- Lack of attention to hygiene and appearance

The decision to continue, change, or terminate opioid therapy is based on progress toward treatment objectives and absence of concerning adverse effects and risks of overdose or diversion [1]. Satisfactory therapy is indicated by improvements in pain, function, and quality of life. It is important to remember that for some patients with severe chronic pain, improved function may take longer than pain control. Either pain or function (not both) will improve. In some cases, preventing worsening pain/functional impairment is the best achievable outcome. Brief assessment tools to assess pain and function may be useful, as may UDTs. Treatment plans may include periodic pill counts to confirm adherence and minimize diversion.

Involvement of Family

Family members or the partner of the patient can provide the clinician with valuable information that better informs decision making regarding continuing opioid therapy. Family members can observe whether a patient is losing control of his or her life or becoming less functional or more depressed during the course of opioid therapy. They can also provide input regarding positive or negative changes in patient function, attitude, and level of comfort. The following questions can be asked of family members or a spouse to help clarify whether the patient's response to opioid therapy is favorable or unfavorable [69]:

- Is the person's day centered around taking the opioid medication? Response can help clarify long-term risks and benefits of the medication and identify other treatment options.

- Does the person take pain medication only on occasion, perhaps three or four times per week? If yes, the likelihood of addiction is low.

- Have there been any other substance (alcohol or drug) abuse problems in the person's life? An affirmative response should be taken into consideration when prescribing.

- Does the person in pain spend most of the day resting, avoiding activity, or feeling depressed? If so, this suggests the pain medication is failing to promote rehabilitation. Daily activity is essential, and the patient may be considered for enrollment in a graduated exercise program

- Is the person in pain able to function (e.g., work, do household chores, play) with pain medication in a way that is clearly better than without? If yes, this suggests the pain medication is contributing to wellness.

Assessment Tools

VIGIL

VIGIL is the acronym for a five-step risk management strategy designed to empower clinicians to appropriately prescribe opioids for pain by reducing regulatory concerns and to give pharmacists a framework for resolving ambiguous opioid analgesic prescriptions in a manner that preserves legitimate patient need while potentially deterring diverters. The components of VIGIL are:

- Verification: Is this a responsible opioid user?

- Identification: Is the identity of this patient verifiable?

- Generalization: Do we agree on mutual responsibilities and expectations?

- Interpretation: Do I feel comfortable allowing this person to have controlled substances?

- Legalization: Am I acting legally and responsibly?

The foundation of VIGIL is a collaborative physician/pharmacist relationship [70,71].

Current Opioid Misuse Measure (COMM)

The Current Opioid Misuse Measure (COMM) is a 17-item patient self-report assessment designed to help clinicians identify misuse or abuse in patients with chronic pain. Unlike the ORT and the SOAPP-R, the COMM identifies aberrant behaviors associated with opioid misuse in patients already receiving long-term opioid therapy [53]. Sample questions include: In the past 30 days, how often have you had to take more of your medication than prescribed? In the past 30 days, how much of your time was spent thinking about opioid medications (e.g., having enough, taking them, dosing schedule)?

Pain Assessment and Documentation Tool (PADT)

Guidelines by the Federation of State Medical Boards (FSMB) and the Joint Commission stress the importance of documentation from both a healthcare quality and medicolegal perspective. Research has found widespread deficits in chart notes and progress documentation for patients with chronic pain who are receiving opioid therapy, and the Pain Assessment and Documentation Tool (PADT) was designed to address these shortcomings [72]. The PADT is a clinician-directed interview, with most sections (e.g., analgesia, activities of daily living, adverse events) consisting of questions asked of the patient [73]. However, the potential aberrant drug-related behavior section must be completed by the physician based on his or her observations of the patient.

The Brief Intervention Tool

The Brief Intervention Tool is a 26-item, "yes-no," patient-administered questionnaire used to identify early signs of opioid abuse or addiction. The items assess the extent of problems related to drug use in several areas, including drug use-related functional impairment [66].

Urine Drug Tests

UDTs may be used to monitor adherence to the prescribed treatment plan and to detect unsanctioned drug use. They should be used more often in patients receiving addiction therapy, but clinical judgment is the ultimate guide to testing frequency (Table 2) [74]. The CDC recommends clinicians should use UDT before starting opioid therapy and consider UDT at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs [40]. However, this recommendation was based on low-quality evidence that indicates little confidence in the effect estimate.

Table 2: PATIENT RISK LEVEL AND FREQUENCY OF MONITORING

Monitoring Tool

Patient Risk Level

Low

Medium

High

Urine drug test

Every 1 to 2 years

Every 6 to 12 months

Every 3 to 6 months

State prescription drug monitoring program

Twice per year

3 times per year

4 times per year

Source: [74]

Initially, testing involves the use of class-specific immunoassay drug panels [1]. If necessary, this may be followed with gas chromatography/mass spectrometry for specific drug or metabolite detection. It is important that testing identifies the specific drug rather than the drug class, and the prescribed opioid should be included in the screen. Any abnormalities should be confirmed with a laboratory toxicologist or clinical pathologist. Immunoassay may be used point-of-care for "on-the-spot" therapy changes, but the high error rate prevents its use in major clinical decisions except with liquid chromatography coupled to tandem mass spectrometry confirmation.

Urine test results suggesting opioid misuse should be discussed with the patient using a positive, supportive approach. The test results and the patient discussion should be documented.

CONSULTATION AND REFERRAL

It is important to seek consultation or patient referral when input or care from a pain, psychiatry, addiction, or mental health specialist is necessary. Clinicians who prescribe opioids should become familiar with opioid addiction treatment options (including licensed opioid treatment programs for methadone and office-based opioid treatment for buprenorphine) if referral is needed [1].

Ideally, providers should be able to refer patients with active substance abuse who require pain treatment to an addiction professional or specialized program. In reality, these specialized resources are scarce or non-existent in many areas [1]. Therefore, each provider will need to decide whether the risks of continuing opioid treatment while a patient is using illicit drugs outweigh the benefits to the patient in terms of pain control and improved function [75].

MEDICAL RECORDS

As noted, documentation is a necessary aspect of all patient care, but it is of particular importance when opioid prescribing is involved. All clinicians should maintain accurate, complete, and up-to-date medical records, including all written or telephoned prescription orders for opioid analgesics and other controlled substances, all written instructions to the patient for medication use, and the name, telephone number, and address of the patient's pharmacy [1]. Good medical records demonstrate that a service was provided to the patient and that the service was medically necessary. Regardless of the treatment outcome, thorough medical records protect the prescriber.

PATIENT EDUCATION ON THE USE AND DISPOSAL OF OPIOIDS

Patients and caregivers should be counseled regarding the safe use and disposal of opioids. As part of its mandatory Risk Evaluation and Mitigation Strategy (REMS) for extended-release/long-acting opioids, the FDA has developed a patient counseling document with information on the patient's specific medications, instructions for emergency situations and incomplete pain control, and warnings not to share medications or take them unprescribed [58]. A copy of this form may be accessed online at https://www.fda.gov/media/79776/download.

When prescribing opioids, clinicians should provide patients with the following information [58]:

- Product-specific information

- Taking the opioid as prescribed

- Importance of dosing regimen adherence, managing missed doses, and prescriber contact if pain is not controlled

- Warning and rationale to never break or chew/crush tablets or cut or tear patches prior to use

- Warning and rationale to avoid other central nervous system depressants, such as sedative-hypnotics, anxiolytics, alcohol, or illicit drugs

- Warning not to abruptly halt or reduce the opioid without physician oversight of safe tapering when discontinuing

- The potential of serious side effects or death

- Risk factors, signs, and symptoms of overdose and opioid-induced respiratory depression, gastrointestinal obstruction, and allergic reactions

- The risks of falls, using heavy machinery, and driving

- Warning and rationale to never share an opioid analgesic

- Rationale for secure opioid storage

- Warning to protect opioids from theft

- Instructions for disposal of unneeded opioids, based on product-specific disposal information

There are no universal recommendations for the proper disposal of unused opioids, and patients are rarely advised of what to do with unused or expired medications [76]. According to the Office of National Drug Control Policy, most medications that are no longer necessary or have expired should be removed from their containers, mixed with undesirable substances (e.g., cat litter, used coffee grounds), and put into an impermeable, nondescript container (e.g., disposable container with a lid or a sealed bag) before throwing in the trash [77]. Any personal information should be obscured or destroyed. The FDA recommends that certain medications, including oxycodone/acetaminophen (Percocet), oxycodone (OxyContin tablets), and transdermal fentanyl (Duragesic Transdermal System), be flushed down the toilet instead of thrown in the trash [77]. Patients should be advised to flush prescription drugs down the toilet only if the label or accompanying patient information specifically instructs doing so and no other disposal method is appropriate.

The American College of Preventive Medicine has established best practices to avoid diversion of unused drugs and educate patients regarding drug disposal [76]:

- Consider writing prescriptions in smaller amounts.

- Educate patients about safe storing and disposal practices.

- Give drug-specific information to patients about the temperature at which they should store their medications. Generally, the bathroom is not the best storage place. It is damp and moist, potentially resulting in potency decrements, and accessible to many people, including children and teens, resulting in potential theft or safety issues.

- Ask patients not to advertise that they are taking these types of medications and to keep their medications secure.

- Refer patients to community "take back" services overseen by law enforcement that collect controlled substances, seal them in plastic bags, and store them in a secure location until they can be incinerated. Contact your state law enforcement agency or visit https://www.dea.gov to determine if a program is available in your area.

DISCONTINUING OPIOID THERAPY

The decision to continue or end opioid prescribing should be based on a physician-patient discussion of the anticipated benefits and risks. An opioid should be discontinued with resolution of the pain condition, intolerable side effects, inadequate analgesia, lack of improvement in quality of life despite dose titration, deteriorating function, or significant aberrant medication use [1,40].

Clinicians should provide physically dependent patients with a safely structured tapering protocol. Withdrawal is managed by the prescribing physician or referral to an addiction specialist. Patients should be reassured that opioid discontinuation is not the end of treatment; continuation of pain management will be undertaken with other modalities through direct care or referral.

As a side note, cannabis use by patients with chronic pain receiving opioid therapy has traditionally been viewed as a treatment agreement violation that is grounds for termination of opioid therapy. However, some now argue against cannabis use as a rationale for termination or substantial treatment and monitoring changes, especially considering the increasing legalization of medical use at the state level [75]. Cannabis use for chronic pain in patients receiving opioid therapy continues to receive increased interest and support; however, experts caution that more evidence of improved patient outcomes is needed [78,79,80].

CONSIDERATIONS FOR NON-ENGLISH-PROFICIENT PATIENTS

For patients who are not proficient in English, it is important that information regarding the risks associated with the use of opioids and available resources be provided in their native language, if possible. When there is an obvious disconnect in the communication process between the practitioner and patient due to the patient's lack of proficiency in the English language, an interpreter is required. Interpreters can be a valuable resource to help bridge the communication and cultural gap between patients and practitioners. Interpreters are more than passive agents who translate and transmit information back and forth from party to party. When they are enlisted and treated as part of the interdisciplinary clinical team, they serve as cultural brokers who ultimately enhance the clinical encounter. In any case in which information regarding treatment options and medication/treatment measures are being provided, the use of an interpreter should be considered. Print materials are also available in many languages, and these should be offered whenever necessary.

5. CRISIS INTERVENTION: MANAGEMENT OF OVERDOSE

Individuals who have first contact with persons suspected of experiencing an opioid-related overdose are in the position to intervene to prevent the potentially devastating consequences. In these cases, care begins with crisis intervention directed at immediate survival by reversing the potentially lethal effects of overdose with an opioid antagonist.

Opioid antagonists have obvious therapeutic value in the treatment of opioid overdose. A 2012 study found that wider distribution of naloxone and training in its administration might have prevented numerous deaths from opioid overdoses in the United States [81]. Since the first community-based opioid overdose prevention program began distributing naloxone in 1996, more than 10,000 overdoses have been reversed [81].

In Florida, licensed healthcare providers may prescribe and pharmacists may dispense opioid antagonists (even as a standing order) for at-risk individuals, these individuals' relatives or other caregivers, and emergency responders to be used in their course of duties [82]. Emergency responders include (but are not limited to) law enforcement officers, paramedics, and emergency medical technicians [82]. As noted, there is a statewide standing order for naloxone for all emergency responders in Florida [33].

OPIOID ANTAGONISTS

Relatively minor changes in the structure of an opioid can convert an agonist drug into one with antagonistic actions at one or more opioid receptor types. Opioid antagonists include naloxone, naltrexone, and nalmefene. Interestingly, naloxone also appears to block the analgesic effects of placebo medications and acupuncture. These agents have no abuse potential [83].

In response to acute overdose, the short-acting opioid antagonist naloxone is considered the gold standard, and it remains the most widely used opioid antagonist for the reversal of overdose and opioid-related respiratory depression. It acts by competing with opioids at receptor sites in the brain stem, reversing desensitization to carbon dioxide, and reversing or preventing respiratory failure and coma. There is no evidence that subcutaneous or intramuscular use is inferior to intravenous naloxone. This has prompted some states to pass laws allowing opioid antagonists to be available to the general public for administration outside the healthcare setting to treat acute opioid overdose [84].

When used for opioid overdose, a dose of 0.4–2 mg of naloxone is administered intravenously, intramuscularly, or subcutaneously [85]. If necessary, the dose may be repeated every two to three minutes for full reversal. For ease of use, naloxone is also available in a pre-filled auto-injection device. An intranasal formulation is also available in doses of 2 mg, 4 mg, or 8 mg [85]. It is important that standard Advanced Cardiac Life Support (ACLS) protocols be continued while naloxone is being administered and that medical treatment (at a healthcare facility) be given immediately.

6. COMPLIANCE WITH STATE AND FEDERAL LAWS

In response to the rising incidence in prescription opioid abuse, addiction, diversion, and overdose in the late 1990s and 2000s, the FDA has mandated opioid-specific REMS to reduce the potential negative patient and societal effects of prescribed opioids. Other elements of opioid risk mitigation include FDA partnering with other governmental agencies, state professional licensing boards, and societies of healthcare professionals to help improve prescriber knowledge of appropriate and safe opioid prescribing and safe home storage and disposal of unused medication [69].

Several regulations and programs at the state level have been enacted in an effort to reduce prescription opioid abuse, diversion, and overdose, including [86]:

- Physical examination required prior to prescribing

- Tamper-resistant prescription forms

- Pain clinic regulatory oversight

- Prescription limits

- Prohibition from obtaining controlled substance prescriptions from multiple providers

- Patient identification required before dispensing

- Immunity from prosecution or mitigation at sentencing for individuals seeking assistance during an overdose

CONTROLLED SUBSTANCES LAWS/RULES

The DEA is responsible for formulating federal standards for the handling of controlled substances. In 2011, the DEA began requiring every state to implement electronic databases that track prescribing habits, referred to as PDMPs. Specific policies regarding controlled substances are administered at the state level [87].

According to the DEA, drugs, substances, and certain chemicals used to make drugs are classified into five distinct categories or schedules depending upon the drug's acceptable medical use and the drug's abuse or dependency potential [88]. The abuse rate is a determinate factor in the scheduling of the drug; for example, Schedule I drugs are considered the most dangerous class of drugs with a high potential for abuse and potentially severe psychologic and/or physical dependence.

In Florida, the prescribing, dispensing, and consumption of certain controlled substances are governed by Chapter 893 of the Florida Statutes [89]. This law establishes the standards for controlled substance prescribing, including reporting system requirements, for prescribers and pharmacists in Florida. As of 2019, the Florida schedule of controlled substances aligns with the DEA schedule [39].

THE ELECTRONIC FLORIDA ONLINE REPORTING OF CONTROLLED SUBSTANCES EVALUATION PROGRAM

Emerging trends and patterns of prescription opioid abuse, addiction, and overdose are monitored by several industry and government agencies through data collection from a variety of sources. These include health insurance claims; the Automation of Reports and Consolidated Orders System, a DEA-run program that monitors the flow of controlled substances from manufacturing through distribution to retail sale or dispensing; the Treatment Episode Data Set, which monitors treatment admissions; the National Center for Health Statistics state mortality data; and the Researched Abuse, Diversion, and Addiction-Related Surveillance System, which monitors prescription drug abuse, misuse, and diversion [90].

Almost all states, including Florida, have enacted PDMPs to facilitate the collection, analysis, and reporting of information on controlled substances prescribing and dispensing [1]. All prescribers must consult the Electronic Florida Online Reporting of Controlled Substances Evaluation (E-FORCSE) to review a patient's controlled substance dispensing history before prescribing or dispensing a controlled substance to a patient 16 years of age or older [39,91]. This is mandated even for existing patients and should be done each time a controlled substance is prescribed or dispensed [39]. If the system is nonoperational or cannot be accessed due to a temporary technologic or electrical failure, the prescription may be issued (with documentation of the exception) for up to a maximum three-day supply.

All clinicians who prescribe or dispense controlled substances are required to report the action to E-FORCSE as soon as possible, but no later than the close of the next business day [39]. This should be repeated each time the substance is dispensed. This reporting requirement is waived in certain circumstances, including for [92]:

- The dispensing of a controlled substance in the healthcare system of the Department of Corrections

- The dispensing of a controlled substance to a person younger than 16 years of age

7. IDENTIFICATION OF DRUG DIVERSION/SEEKING BEHAVIORS

Research has more closely defined the location of prescribed opioid diversion into illicit use in the supply chain from the manufacturer to the distributor, retailer, and the end user (the patient with pain). This information carries with it substantial public policy and regulatory implications. The 2016 National Survey on Drug Use and Health asked 11.5 million non-medical users of prescription opioids how they obtained their most recently used drugs [93]. Among persons 12 years of age or older, 53% obtained their prescription opioids from a friend or relative. Of this 53%, 40.4% got the prescription opioids from a friend or relative for free, 8.9% bought them from a friend or relative, and 3.7% took them from a friend or relative without asking; 35.4% got them through a prescription from one doctor (vs. 19.7% in 2012) [93]. Less frequent sources included a drug dealer or other stranger (6%); multiple doctors (1.4%); theft from a doctor's office, clinic, hospital, or pharmacy (0.7%) (vs. 0.8% in 2012); and some other way (3.4%) [93].

As discussed, UDTs can give insight into patients who are misusing opioids. A random sample of UDT results from 800 patients with pain treated at a Veterans Affairs facility found that 25.2% were negative for the prescribed opioid while 19.5% were positive for an illicit drug/unreported opioid [94]. Negative UDT results for the prescribed opioid do not necessarily indicate diversion, but may indicate the patient halted his/her use due to side effects, lack of efficacy, or pain remission. The concern arises over the increasingly stringent climate surrounding clinical decision-making regarding aberrant UDT results and that a negative result for the prescribed opioid or a positive UDT may serve as the pretense to terminate a patient rather than guide him/her into addiction treatment or an alternative pain management program [95].

In addition to aberrant urine screens, there are certain behaviors that are suggestive of an emerging opioid use disorder. The most suggestive behaviors are [75,96,97]:

- Selling medications

- Prescription forgery or alteration

- Injecting medications meant for oral use

- Obtaining medications from nonmedical sources

- Resisting medication change despite worsening function or significant negative effects

- Loss of control over alcohol use

- Using illegal drugs or non-prescribed controlled substances

- Recurrent episodes of:

- Prescription loss or theft

- Obtaining opioids from other providers in violation of a treatment agreement

- Unsanctioned dose escalation

- Running out of medication and requesting early refills

Behaviors with less association with opioid misuse include [75,96,97]:

- Aggressive demands for more drug

- Asking for specific medications

- Stockpiling medications during times when pain is less severe

- Using pain medications to treat other symptoms

- Reluctance to decrease opioid dosing once stable

- In the earlier stages of treatment:

- Increasing medication dosing without provider permission

- Obtaining prescriptions from sources other than the pain provider

- Sharing or borrowing similar medications from friends/family

8. INTERVENTIONS FOR SUSPECTED OR KNOWN DRUG DIVERSION

There are a number of actions that prescribers and dispensers can take to prevent or intervene in cases of drug diversion. These actions can be generally categorized based on the various mechanisms of drug diversion.

Prevention is the best approach to addressing drug diversion. As noted, the most common source of nonmedical use of prescribed opioids is from a family member or friend, through sharing, buying, or stealing. To avoid drug sharing among patients, healthcare professionals should educate patients on the dangers of sharing opioids and stress that "doing prescription drugs" is the same as "using street drugs" [76]. In addition, patients should be aware of the many options available to treat chronic pain aside from opioids. As stated, to prevent theft, patients should be advised to keep medications in a private place and to refrain from telling others about the medications being used.

Communication among providers and pharmacies can help to avoid inappropriate attainment of prescription drugs through "doctor shopping." Prescribers should keep complete and up-to-date records for all controlled substance prescribing. When possible, electronic medical records should be integrated between pharmacies, hospitals, and managed care organizations [76]. It is also best practice to periodically request a report from the E-FORCSE to evaluate the prescribing of opioids to your patients by other providers [76].

When dealing with patients suspected of drug seeking/diversion, first inquire about prescription, over-the-counter, and illicit drug use and perform a thorough examination [76,98]. Pill counting and/or UDT may be necessary to investigate possible drug misuse. Photo identification or other form of identification and social security number may be required prior to dispensing the drug, with proof of identity documented fully. If a patient is displaying suspicious behaviors, consider prescribing for limited quantities [98].

If a patient is found to be abusing prescribed opioids, this is considered a violation of the treatment agreement and the clinician must make the decision whether or not to continue the therapeutic relationship. If the relationship is terminated, it must be done ethically and legally. The most significant issue is the risk of patient abandonment, which is defined as ending a relationship with a patient without consideration of continuity of care and without providing notice to the patient. The American Medical Association Code of Ethics states that "physicians' fiduciary responsibility to patients entails an obligation to support continuity of care for their patients" [99]. While physicians have the option of withdrawing from a case, they cannot do so without giving notice to the patient, the relatives, or responsible friends sufficiently long in advance of withdrawal to permit another medical attendant to be secured or to facilitate the transfer of care, when appropriate [99]. The notice of termination should be sent in writing, should specifically note the cause(s) for the termination, and should give a period of time prior to termination, usually 30 days [100]. Patients may also be given resources and/or recommendations to help them locate a new clinician.

Patients with chronic pain found to have an ongoing substance abuse problem or addiction should be referred to a pain specialist for continued treatment. Theft or loss of controlled substances is reported to the DEA. If drug diversion has occurred, the activity should be documented and a report to law enforcement should be made [101].

9. CASE STUDY

An unemployed man, 64 years of age, is brought to an emergency department by ambulance, after his wife returned from work to find him lying on the couch, difficult to arouse and incoherent. He has a past history of hypertension, diabetes (non-insulin dependent), mild chronic obstructive pulmonary disease, and chronic back and shoulder pain, for which he has been prescribed hydrocodone/acetaminophen for many years. His wife reports that while he seemed his usual self when she left for work that morning, he had, in recent weeks, been more withdrawn socially, less active, and complained of greater discomfort from the back and shoulder pain. She knows little about his actual medication usage and expresses concern that he may have been taking more than the prescribed amount of "pain medicine."

On evaluation, the patient is somnolent and arouses to stimulation but is non-communicative and unable to follow commands. His blood pressure is normal, he is afebrile, and there are no focal neurologic deficits. Oxygen saturation, serum glucose, and routine laboratory studies (blood counts and metabolic profile) are normal except for mild elevation in blood urea nitrogen (BUN) and creatinine; the urine drug screen is negative except for opioids. Additional history from the family indicates that the patient has been admitted to other hospitals twice in the past three years with a similar presentation and recovered rapidly each time "without anything being found."

Following admission, the patient remains stable-to-improved over the next 12 to 18 hours. By the following day, he is awake and conversant and looks comfortable. On direct questioning, he reports recent symptoms of depression but no suicidal ideation. The patient describes an increased preoccupation with his pain syndrome, difficulty sleeping at night, and little physical activity during the day, in part because of physical discomfort. He is vague about his medication regimen and admits to taking "occasional" extra doses of hydrocodone for pain relief.

The family is instructed to bring in all his pill bottles from home, which they do. In addition to the hydrocodone prescribed by his primary care physician, there is a recent refill of a prescription for the medication given to the patient at the time of his last hospital discharge six months earlier.

ASSESSMENT

A full evaluation, including radiographic studies and consultation with psychiatry and physical therapy, is completed. The working diagnosis for the patient's acute illness is toxic encephalopathy caused by the sedative side effects of opioid medication on the CNS. It is explained that the combination of his advancing age and diabetes likely reduced the efficiency of his kidneys in clearing the medication and its metabolites, making him more susceptible to CNS sedation. It is noted that the patient and his wife have little understanding of the rationale, proper use and safeguards, potential side effects, and limited effectiveness of opioid use for chronic pain.

In addition, the patient is diagnosed with poorly controlled chronic pain syndrome secondary to osteoarthritis and degenerative disc disease; exacerbating factors include deconditioning and reactive depression. The use of an opioid analgesic, at least for the near term, is considered appropriate, if dosed properly, monitored closely, and integrated into a comprehensive, multidisciplinary plan that includes treatment of depression and the use of adjunctive, nonpharmacologic modalities of care. In the setting of possible early diabetic nephropathy, the option of utilizing an NSAID, except for very brief periods of break-through pain, is not considered to be a safe option.

At discharge, and in consultation with his primary care physician, a written treatment and management plan addressing all aspects of the patient's care is presented to the patient and his wife for discussion and consent. Among the key issues addressed are:

- Goals: Improvement in subjective pain experience; improved function of daily living manifested by regular walking exercise and improved social interaction with family and friends; relief of depression; and in the long-term, anticipated withdrawal of opioid medication and resumption of part-time work and/or volunteer community activity

- Outpatient physical therapy and back exercise program to increase core muscular strength, improve flexibility, reduce pain, and increase exercise tolerance

- Patient and family counseling regarding the safe use, dosage regulation, side effects, and proper disposal of opioid medication

- Joint patient-physician responsibilities as regards to regular follow-up, monitoring of goals and treatment effectiveness, avoidance of "doctor-shopping," and assent to single provider for prescription medication

FOLLOW-UP

On follow-up six weeks after discharge, the patient is noticeably improved. He reports that he feels stronger and is sleeping better. His affect is brighter, and he is getting out more. He has maintained his physical therapy and exercise routine and is compliant with his medication. Though he still has pain, it is noticeably less and he is coping better. He and his wife are encouraged by his progress, particularly in regard to his improved functional status.

10. CONCLUSION

For patients suffering from pain, prescribed opioid analgesics may substantially lessen pain, distress, and impairment. Inappropriate overprescribing and overdose related to opioid analgesics increased dramatically in the 2000s. These trends are in multi-year reversal, but patient safety and risk mitigation remains no less important, and clinical tools, guidelines, and recommendations are available for use when prescribing opioids to patients with pain. By implementing these tools, the clinician can effectively address issues related to the clinical management of opioid prescribing, opioid risk management, regulations surrounding the prescribing of opioids, and problematic opioid use by patients. In doing so, healthcare professionals are more likely to achieve a balance between the benefits and risks of opioid prescribing, optimize patient attainment of therapeutic goals, and avoid the risk to patient outcome, public health, and viability of their own practice imposed by deficits in knowledge.

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54. Sloan P. Update on extended-release opioids in pain management. Expert Opin Drug Deliv. 2014;11(2):155-158.

55. Federation of State Medical Boards. Model Policy for the Use of Opioid Analgesics in the Treatment of Chronic Pain. Washington, DC: Federation of State Medical Boards; 2013.

56. Cheatle MD, Barker C. Improving opioid prescription practices and reducing patient risk in the primary care setting. J Pain Res. 2014;7:301-311.

57. Nadeau SE. Opioids for chronic noncancer pain. To prescribe or not to prescribe: what is the question? Neurology. 2015;85(7):646-651.

58. U.S. Food and Drug Administration. Guidance: Medication Guides: Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS). Available at https://www.fda.gov/media/79776/download. Last accessed August 6, 2019.

59. Manchikanti L, Abdi S, Atluri S, et al. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: part 2—guidance. Pain Physician. 2012;15(3 Suppl):S67-S116.

60. Webster LR, Webster RM. Predicting aberrant behaviors in opioid-treated patients: preliminary validation of the opioid risk tool. Pain Med. 2005;6(6):432-442.

61. Butler SF, Budman SH, Fernandez KC, Fanciullo GJ, Jamison RN. Cross-validation of a Screener to Predict Opioid Misuse in Chronic Pain Patients (SOAPP-R). J Addict Med. 2009;3(2):66-73.

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64. Fine PG, Finnegan T, Portenoy RK. Protect your patients, protect your practice: practical risk assessment in the structuring of opioid therapy in chronic pain. J Fam Pract. 2010;59(9 Suppl 2):S1-S16.

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66. Katz NP. Opioid Prescribing Toolkit: A Workbook for Clinicians. New York, NY: Oxford University Press; 2010.

67. Dalal S, Bruera E. Assessment and management of pain in the terminally ill. Prim Care Clin Office Pract. 2011;38(2):195-223.

68. Berger AM, Shuster JL, Von Roenn JH (eds). Principles & Practice of Palliative Care & Supportive Oncology. 4th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2013.

69. Strickland JM, Huskey A, Brushwood DB. Pharmacist-physician collaboration in pain management practice. J Opioid Manag. 2007;3(6):295-301.

70. Crespi-Lofton J. VIGIL: answer the question "Is it legitimate?" Pharm Today. 2006;12(1):1.

71. Tanzi MG. VIGIL helps pharmacists screen controlled substances: goal is controlling diversion. Pharm Today. 2012:58.

72. Passik SD, Kirsh KL, Whitcomb L, et al. A new tool to assess and document pain outcomes in chronic pain patients receiving opioid therapy. Clin Ther. 2004;26(4):552-561.

73. Pain Assessment and Documentation Tool. Available at https://www.drugabuse.gov/sites/default/files/files/PainAssessmentDocumentationTool.pdf. Last accessed August 3, 2019.

74. Atluri SL, Akbik H, Sudarshan G. Prevention of opioid abuse in chronic non-cancer pain: an algorithmic, evidence-based approach. Pain Physician. 2012;15(3 Suppl):ES177-ES189.

75. Baxter J. Minimizing the Misuse of Prescription Opioids in Patients with Chronic Nonmalignant Pain. Available at https://www.drugabuse.gov/nidamed/centers-excellence/resources/minimizing-misuse-prescription-opioids-in-patients-chronic-nonmalignant-pain. Last accessed August 6, 2019.

76. American College of Preventive Medicine. Use, Abuse, Misuse and Disposal of Prescription Pain Medication Time Tool. Available at https://c.ymcdn.com/sites/www.acpm.org/resource/resmgr/timetools-files/painmedsclinicalreference.pdf. Last accessed August 6, 2019.

77. Office of National Drug Control Policy. Proper Disposal of Prescription Drugs. Available at https://www.ncjrs.gov/ondcppubs/publications/pdf/prescrip_disposal.pdf. Last accessed August 6, 2019.

78. Campbell G, Hall WD, Peacock A, et al. Effect of cannabis use in people with chronic non-cancer pain prescribed opioids: findings from a 4-year prospective cohort study. Lancet Public Health. 2018;3(7):e341-e350.

79. Merlin JS, Long D, Becker WC, et al. Marijuana use is not associated with changes in opioid prescriptions or pain severity among people living with HIV and chronic pain. J Acquir Immune Defic Syndr. 2019;81(2):231-237.

80. Mucke M, Phillips T, Radbruch L, Petzke F, Hauser W. Cannabis-based medicines for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2018;3:CD012182.

81. Wheeler E, Davidson PJ, Jones TS, Irwin KS. Community-based opioid overdose prevention programs providing naloxone—United States, 2010. MMWR. 2012;61(6):101-105.

82. Florida Legislature. 381.887 Emergency Treatment for Suspected Opioid Overdose. Available at http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&Search_String=&URL=0300-0399/0381/Sections/0381.887.html. Last accessed August 6, 2019.

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84. van den Brink W, Haasen C. Evidence-based treatment of opioid-dependent patients. Can J Psychiatry. 2006;51(10):635-646.

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86. Centers for Disease Control and Prevention. Risk for overdose from methadone used for pain relief—United States, 1999–2010. MMWR. 2012;61(26):493-497.

87. Hannon K. Prescription Drug Abuse Crisis in New York State: Comprehensive Approach - New. Available at https://www.scribd.com/doc/82474334/Prescription-Drug-Abuse-Crisis-in-NYS-Comprehensive-Approach-New. Last accessed August 6, 2019.

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90. Reifler LM, Droz D, Bailey JE, et al. Do prescription monitoring programs impact state trends in opioid abuse/misuse? Pain Med. 2012;13(3):434-442.

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92. Data Submission Dispenser Guide. Florida Department of Health Prescription Drug Monitoring Program: E-FORCSE: 2018. Available at http://rxsentry.net/assets/files/flpdms/2018/FL_Dispenser_Guide_V1.pdf. Last accessed August 5, 2019.

93. Substance Abuse and Mental Health Services Administration. Key Substance Use and Mental Health Indicators in the United States: Results from the 2016 National Survey on Drug Use and Health. Available at https://www.samhsa.gov/data/sites/default/files/NSDUH-FFR1-2016/NSDUH-FFR1-2016.pdf. Last accessed August 5, 2019.

94. Sekhon R, Aminjavahery N, Davis CN Jr, et al. Compliance with opioid treatment guidelines for chronic non-cancer pain (CNCP) in primary care at a Veterans Affairs Medical Center (VAMC). Pain Med. 2013;14(10):1548-1556.

95. Meier B. Increase in Urine Testing Raises Ethical Questions. Available at https://www.nytimes.com/2013/08/02/business/increase-in-urine-testing-raises-ethical-questions.html?_r=0. Last accessed August 6, 2019.

96. Passik SD. Issues in long-term opioid therapy: unmet needs, risks, and solutions. Mayo Clin Proc. 2009;84(7):593-601.

97. Holliday S, Hayes C, Dunlop A. Opioid use in chronic non-cancer pain. Part 2: prescribing issues and alternatives. Australian Fam Physician. 2013;42(3):104-111.

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Evidence-Based Practice Recommendations Citations

1. Manchikanti L, Abdi S, Atluri S, et al. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: part 2—guidance. Pain Physician. 2012;15(3 Suppl):S67-S116. Available at https://painphysicianjournal.com/2012/july/2012;%2015;S67-S116.pdf. Last accessed August 14, 2019.

30830 • Pituitary and Adrenal Disorders

Jane C. Norman, RN, MSN, CNE, PhD

Amanda Perkins, MSN, DNP

www.netce.com

Copyright © 2021 NetCE, All rights reserved.

The pituitary and adrenal glands play a significant role in many functions in the body, and proper functioning is essential for the maintenance of health. Dysfunction in these glands can have detrimental effects and may lead to death if untreated. Although disorders of the pituitary or adrenal glands are not as easy to see or identify as many conditions, they are nonetheless relatively common among many patient populations. This course will provide a brief overview of the anatomy and physiology of the pituitary and adrenal glands, assessment, common disorders, and care of the patient with pituitary/adrenal dysfunction. Nurses have a responsibility and duty to identify the signs and symptoms of these disorders and to care for patients appropriately and fully.

Table of Contents

30830 • Pituitary and Adrenal Disorders

Course Overview

Audience

Accreditations & Approvals

Designations of Credit

Individual State Nursing Approvals

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Division Planner

Division Planner Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

Implicit Bias in Health Care

1. INTRODUCTION

2. ANATOMY AND PHYSIOLOGY

HYPOTHALAMUS

PITUITARY GLAND

ADRENAL GLANDS

HORMONES

3. NURSING ASSESSMENT

PHYSICAL ASSESSMENT

DIAGNOSTIC TESTS

4. NURSING DIAGNOSES

INEFFECTIVE INDIVIDUAL COPING

ALTERATION IN THOUGHT PROCESSES

ALTERATION IN COMFORT

DISTURBANCE IN SELF-CONCEPT

ALTERATION IN NUTRITION AND BOWEL ELIMINATION

ALTERATION IN FLUID VOLUME

5. DIABETES INSIPIDUS

PATHOPHYSIOLOGY

SIGNS AND SYMPTOMS

DIAGNOSIS

TREATMENT

6. SYNDROME OF INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION (SIADH)

PATHOPHYSIOLOGY

SIGNS AND SYMPTOMS

DIAGNOSTIC TESTS

TREATMENT AND NURSING INTERVENTIONS

7. GROWTH HORMONE DEFICIENCY

PATHOPHYSIOLOGY

SIGNS AND SYMPTOMS

DIAGNOSTIC TESTS

TREATMENT AND NURSING INTERVENTIONS

8. DISORDERS OF HYPERSOMATOTROPISM

ACROMEGALY

GIGANTISM

9. ADDISON DISEASE

PATHOPHYSIOLOGY

SIGNS AND SYMPTOMS

DIAGNOSTIC TESTS

TREATMENT AND NURSING INTERVENTIONS

10. CUSHING SYNDROME

PATHOPHYSIOLOGY

SIGNS AND SYMPTOMS

DIAGNOSTIC TESTS

TREATMENT

11. PRIMARY ALDOSTERONISM

SIGNS AND SYMPTOMS

DIAGNOSIS

TREATMENT

12. PHEOCHROMOCYTOMA

SIGNS AND SYMPTOMS

DIAGNOSIS

TREATMENT

13. PSYCHOSOCIAL/LIFESTYLE INFLUENCES AND EFFECTS

SELF-CONCEPT AND SELF-ESTEEM

SEXUAL EXPRESSION AND REPRODUCTION

OCCUPATIONAL AND ECONOMIC FACTORS

DIETARY FACTORS

CULTURAL CONSIDERATIONS

14. CASE STUDIES

ACUTE ADRENAL INSUFFICIENCY (ADDISON DISEASE)

DIABETES INSIPIDUS

SYNDROME OF INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION

15. CONCLUSION

Works Cited

Evidence-Based Practice Recommendations Citations

30830 • Pituitary and Adrenal Disorders

Education Category. Medical / Surgical

Release Date. 08/01/2021

Expiration Date. 07/31/2024

Course Overview

The pituitary and adrenal glands play a significant role in many functions in the body, and proper functioning is essential for the maintenance of health. Dysfunction in these glands can have detrimental effects and may lead to death if untreated. Although disorders of the pituitary or adrenal glands are not as easy to see or identify as many conditions, they are nonetheless relatively common among many patient populations. This course will provide a brief overview of the anatomy and physiology of the pituitary and adrenal glands, assessment, common disorders, and care of the patient with pituitary/adrenal dysfunction. Nurses have a responsibility and duty to identify the signs and symptoms of these disorders and to care for patients appropriately and fully.

Audience

This course is designed for nurses in all practice settings.

Accreditations & Approvals

In support of improving patient care, NetCE is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. NetCE is accredited by the International Accreditors for Continuing Education and Training (IACET). NetCE complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, NetCE is authorized to issue the IACET CEU.

Designations of Credit

This activity was planned by and for the healthcare team, and learners will receive 15 Interprofessional Continuing Education (IPCE) credit(s) for learning and change. NetCE designates this continuing education activity for 15 ANCC contact hour(s). NetCE designates this continuing education activity for 5 pharmacotherapeutic/pharmacology contact hour(s). NetCE designates this continuing education activity for 18 hours for Alabama nurses. NetCE is authorized by IACET to offer 1.5 CEU(s) for this program. AACN Synergy CERP Category A.

Individual State Nursing Approvals

In addition to states that accept ANCC, NetCE is approved as a provider of continuing education in nursing by: Alabama, Provider #ABNP0353, (valid through July 29,2025); Alabama, Provider #ABNP0353, (valid through July 29, 2025); Arkansas, Provider #50-2405; California, BRN Provider #CEP9784; California, LVN Provider #V10662; California, PT Provider #V10842; District of Columbia, Provider #50-2405; Florida, Provider #50-2405; Georgia, Provider #50-2405; Kentucky, Provider #7-0054 through 12/31/2025; South Carolina, Provider #50-2405; South Carolina, Provider #50-2405. West Virginia RN and APRN, Provider #50-2405.

Course Objective

As health care becomes more complex, it is essential that the theoretical concepts of the basis of illness (pathophysiology) be well understood. The purpose of this course is to reinforce the scientific rationales for the interventions nurses perform and the decisions nurses make as patients move through the ever-changing struggle with their pituitary or adrenal illness.

Learning Objectives

Upon completion of this course, you should be able to:

1. Describe the anatomy and physiology of the pituitary and adrenal glands.

2. Outline the action of the hormones excreted by the pituitary and adrenal glands.

3. Describe key aspects of the assessment of patients with pituitary or adrenal disorders, including appropriate diagnostic tools.

4. Discuss the presentation and diagnosis of diabetes insipidus.

5. Outline the options for the treatment of diabetes insipidus.

6. Review the presentation and management of syndrome of inappropriate antidiuretic hormone secretion (SIADH).

7. Evaluate the signs/symptoms, diagnosis, and treatment of growth hormone deficiency.

8. Identify acromegaly and gigantism and appropriate approaches to their treatment.

9. Describe the clinical presentation and diagnosis of Addison disease.

10. Evaluate approaches to the treatment of Addison disease, including identification and management of adrenal crises.

11. Discuss the identification and diagnosis of Cushing syndrome.

12. Evaluate various treatment options for Cushing syndrome, including surgical considerations.

13. Review the signs/symptoms, diagnosis, and treatment of primary aldosteronism.

14. Analyze the clinical presentation, diagnosis, and treatment of pheochromocytoma.

15. Identify psychosocial/lifestyle considerations for patients with pituitary or adrenal disorders.

Faculty

Amanda Perkins, MSN, DNP, is a DNP-prepared registered nurse with a focus in healthcare leadership. Prior to obtaining her DNP, she obtained an MSN with a focus on nursing education. She currently works full-time as an Associate Professor of Nursing at Vermont Tech and per-diem at Gifford Medical Center on the medical-surgical unit and in the long-term care facility. Dr. Perkins also sits on the editorial board, writes, and peer-reviews for the journal Nursing Made Incredibly Easy! She has experience in a variety of settings, including long-term care, residential care, medical-surgical, women and children, intensive care, and inpatient psychiatric units.

Jane C. Norman, RN, MSN, CNE, PhD, received her undergraduate education at the University of Tennessee, Knoxville campus. There she completed a double major in Sociology and English. She completed an Associate of Science in Nursing at the University of Tennessee, Nashville campus and began her nursing career at Vanderbilt University Medical Center. Jane received her Masters in Medical-Surgical Nursing from Vanderbilt University. In 1978, she took her first faculty position and served as program director for an associate degree program. In 1982, she received her PhD in Higher Education Administration from Peabody College of Vanderbilt University. In 1988, Dr. Norman took a position at Tennessee State University. There she has achieved tenure and full professor status. She is a member of Sigma Theta Tau National Nursing Honors Society. In 2005, she began her current position as Director of the Masters of Science in Nursing Program.

Faculty Disclosure

Contributing faculty, Amanda Perkins, MSN, DNP, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Contributing faculty, Jane C. Norman, RN, MSN, CNE, PhD, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Division Planner

Sharon Cannon, RN, EdD, ANEF

Division Planner Disclosure

The division planner has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

Implicit Bias in Health Care

The role of implicit biases on healthcare outcomes has become a concern, as there is some evidence that implicit biases contribute to health disparities, professionals' attitudes toward and interactions with patients, quality of care, diagnoses, and treatment decisions. This may produce differences in help-seeking, diagnoses, and ultimately treatments and interventions. Implicit biases may also unwittingly produce professional behaviors, attitudes, and interactions that reduce patients' trust and comfort with their provider, leading to earlier termination of visits and/or reduced adherence and follow-up. Disadvantaged groups are marginalized in the healthcare system and vulnerable on multiple levels; health professionals' implicit biases can further exacerbate these existing disadvantages.

Interventions or strategies designed to reduce implicit bias may be categorized as change-based or control-based. Change-based interventions focus on reducing or changing cognitive associations underlying implicit biases. These interventions might include challenging stereotypes. Conversely, control-based interventions involve reducing the effects of the implicit bias on the individual's behaviors. These strategies include increasing awareness of biased thoughts and responses. The two types of interventions are not mutually exclusive and may be used synergistically.

1. INTRODUCTION

Body activities, homeostasis, and the response to stress are controlled by two distinct, but interacting systems: the nervous system and the endocrine system. The nervous system creates an immediate but short-lived response, operating on the principles of electricity, through impulse conduction. The endocrine system has a slightly slower onset and a longer duration of action and uses highly specific hormones to control its response chemically.

The endocrine system is composed of many glands scattered throughout the body; these glands secrete unique and potent hormones directly into the bloodstream. Most hormones direct their action to target glands or tissues at distant receptor sites, thereby regulating critical body functions such as urinary output, cellular metabolic rate, and growth and development. Hormonal secretions typically are regulated by negative feedback; information about the hormone level or its effect is fed back to the gland, which then responds accordingly.

Endocrine diseases result from an abnormal increase or decrease in the secretion of hormones. This divergence from normal hormone quantities may be the result of hyperplasia, hypertrophy, or atrophy of an endocrine gland. Changes in gland size that affect the gland's production and secretion of a hormone often result from an insult to the gland, such as infection, radiation, trauma, surgical intervention, or inflammation.

As noted, the principal functional units in the system are the endocrine glands: the pituitary, thyroid, parathyroid, adrenal, and pineal glands; the cells of the islets of Langerhans in the pancreas; the gonads (ovaries and testes); and the thymus. The kidneys also perform an endocrine function. Some of these glands are solely endocrine in function, whereas others form parts of larger organs that may have both endocrine and nonendocrine functions. The pituitary, thyroid, parathyroid, pineal, and adrenal glands have distinct endocrine functions. This course will focus on the pathophysiology of the pituitary and adrenal glands.

Because of the complex actions of the pituitary and adrenal glands, as well as their interaction with each other and with other body systems, their dysfunctions have a variety of causes and clinical manifestations. Pituitary disorders encompass a diverse set of conditions, including diabetes insipidus, SIADH (syndrome of inappropriate antidiuretic hormone secretion), acromegaly, and growth hormone deficiency. Common adrenal disorders include Cushing syndrome, Addison disease, hypoaldosteronism, and hyperaldosteronism. Because the pituitary and adrenal glands work together closely, there is often overlap in the pathophysiology of these disorders.

Dysfunction of the pituitary or adrenal gland is associated with many physical and mental symptoms, with significant impact on patients, families, health services, and society. When caring for patients with these types of disorders, there are key skills necessary to accurately interpret diagnostic testing, identify comorbidities, and effectively manage care.

2. ANATOMY AND PHYSIOLOGY

HYPOTHALAMUS

The hypothalamus plays an important role in the regulation of homeostasis within the body. It is necessary for automatic functions of the nervous system, regulation of the glands of the endocrine system, emotional responses, and behaviors [1]. It may help to think of the hypothalamus as a control center—it monitors information about the body and makes necessary changes based on the information obtained.

The hypothalamus functions as an integral part of both the endocrine and nervous systems. In its neural role, it receives and processes innervations from the thalamus, cerebral cortex, spinal cord, and brainstem. This results in the control of such bodily functions as temperature, respiration, arterial blood pressure and circulation, and metabolism. The hypothalamus also controls certain behavioral functions, including the emotional states of fear, anxiety, anger, rage, pleasure, and pain, as well as the states of sleep, wakefulness, and alertness. The hypothalamus, as it is influenced by the autonomic nervous system, affects all the unconscious actives of the body [2,3]. In its endocrine role, the hypothalamus has two regulatory functions:

- Regulating the anterior pituitary gland by producing and secreting releasing factors

- Producing and secreting two hormones (oxytocin and antidiuretic hormone [ADH]) stored in the posterior pituitary gland

Hypothalamic-releasing factors are proteins that act on the anterior pituitary gland to stimulate or inhibit the release of tropic hormones. Other inhibiting factors and releasing factors have been identified; it is thought, although still unproven, that the hypothalamus may produce both an inhibiting and a releasing factor for each of the anterior pituitary hormones [2,3].

The release or inhibition of these hypothalamic hormones is controlled by various neurotransmitters, such as serotonin, acetylcholine, norepinephrine, and dopamine. The tropic hormones released from the anterior pituitary gland then act upon a target gland or tissues to produce a specific response. In regulating the secretion of these releasing factors, the hypothalamus processes input from both the circulatory and nervous systems [2,3].

PITUITARY GLAND

The pituitary gland (hypophysis) is located in the sella turcica at the base of the skull. It lies just below the hypothalamus and is connected to it by a stalk containing blood vessels and nervous tissue. The pituitary gland is composed of an anterior and posterior lobe (adenohypophysis and neurohypophysis, respectively), each of which performs specific functions, as well as a rudimentary intermediate lobe [4].

In response to the releasing factors from the hypothalamus, the anterior pituitary gland secretes several hormones, some of which control hormonal secretions by other glands. The anterior pituitary hormones secreted include thyroid-stimulating hormone (TSH), adrenocorticotropic hormone (ACTH), growth hormone, luteinizing hormone (also called interstitial cell-stimulating hormone in men), follicle-stimulating hormone, and prolactin. In general, growth hormone, ACTH, and TSH are concerned with metabolic activities, whereas luteinizing hormone, follicle-stimulating hormone, and prolactin are concerned with reproduction. ACTH, TSH, follicle-stimulating hormone, and luteinizing hormone exert their effects on target glands, either increasing their size or their secretions. Prolactin and growth hormone directly affect the metabolism of specific target tissues [5].

Most of the disorders affecting the pituitary gland originate in the anterior lobe. The effects of pathology on the anterior pituitary gland can be broadly summarized as hyperpituitarism and hypopituitarism [6,7].

The most common cause of hyperfunction of the anterior pituitary gland is a neoplastic secreting tumor, usually a benign adenoma. Tumors of the pituitary gland exert their effects through either pressure on structures in the brain, causing visual symptoms and headaches, or excessive secretion of one or more of the anterior pituitary hormones, which results in increased stimulation of one or more target glands.

One of the pathophysiologic manifestations of these tumors is hypersomatotropism, which can result in acromegaly in adults and gigantism in children. Other effects of hypersomatotropism include goiter (from stimulation of the thyroid) and diabetes mellitus (from the diabetogenic effect of growth hormone). Cardiomegaly and hypertension can also occur. Visual impairment and eventual blindness are possible because of compression of tissues by an expanding tumor. Amenorrhea in women and loss of libido and potency in men may occur because compression from the expanding tumor leads to gonadal deficiencies from loss of healthy gonadotropin-producing cells [6,7].

Hyperfunction of the anterior pituitary gland can be secondary to pathology of the anterior pituitary gland or to injury to the hypothalamus resulting in a decrease or absence of hypothalamic-releasing factors. Hypothalamism may be manifested by isolated hormonal deficiencies or by a deficiency of both the anterior and posterior pituitary hormones (panhypopituitarism). The exact hormonal deficit and its etiology are important to understanding patients' symptoms and signs [6,7].

ADRENAL GLANDS

The adrenal glands are paired and located in the retroperitoneal space at the upper pole of the kidney. Because of this position, they may be referred to as the suprarenal glands. Each adrenal gland consists of an outer portion (the cortex) and an inner portion (the medulla), which differ in both anatomic structure and function [8].

The adrenal cortex is composed of three zones, or groups of different cells: the zona glomerulus (the outer layer of cortical cells that secretes the mineralocorticoids), the zona fasciculate (the middle layer of cortical cells that secretes the glucocorticoids), and the zona reticularis (the layer of cortical cells proximal to the medulla that secretes the adrenal sex hormones androgens and estrogen). The adrenal glands receive an abundant blood supply. The medulla of the adrenal gland functions as part of the sympathetic nervous system, whereas the cortex has only minimal nervous system innervation [8].

In response to stimulation by ACTH from the anterior pituitary gland, the adrenal cortex secretes three major types of hormones: glucocorticoids (cortisol), mineralocorticoids (aldosterone), and sex hormones (androgens, estrogen, and progesterone). These hormones affect metabolism, fluid balance, and the development of secondary sex characteristics, respectively. All three types of hormones secreted by the adrenal cortex are structurally similar steroids, which results in some overlapping of their effects [5,9].

The primary causes of hypercortisolism (Cushing syndrome), originating from within the adrenal cortex itself, include neoplastic and bilateral hyperplasia. In iatrogenic hypercortisolism, an exogenous source (e.g., prolonged use of glucocorticoids or ACTH) is responsible for the hypercortisolism. The normal adrenal glandular tissue may be atrophic, and ACTH levels are suppressed [10].

Hyperfunction of the adrenal cortex results in three major disorders: Cushing syndrome, primary aldosteronism, and excessive production of sex hormones characterized by virilizing changes in women, feminizing changes in men, and precocious sexual development in children. These changes often cause serious psychologic issues related to self-esteem and body image.

Hypofunction of the adrenal cortex, or adrenal insufficiency, results in a decreased secretion of glucocorticoids, mineralocorticoids, and sex hormones. The causes of adrenal insufficiency can be grouped into two categories: primary (based on pathology occurring within the gland itself) and secondary (arising from an undersecretion of ACTH due to pathology in the pituitary gland or the hypothalamus). Primary causes may be acute or chronic [11].

Primary adrenal insufficiency (Addison disease) is characterized by a failure of the adrenal cortex to produce sufficient corticosteroids. Acute severe symptoms of Addison disease are referred to as addisonian or acute adrenal crisis.

The adrenal medulla is considered a part of the sympathetic division of the autonomic nervous system, which controls the secretion of its hormones. Because the functions of the sympathetic nervous system and the functions of the hormones of the adrenal medulla are the same, they can compensate for each other. Thus, the medullary hormones are not essential to life but play an important role in the body's response to stress. About 15% of the hormonal secretion by the adrenal medulla is norepinephrine and 75% is epinephrine [5].

Pathophysiology of the adrenal medulla is rare and is usually associated with hyperfunction. The clinical manifestations seen in hyperfunction of the adrenal medulla are related to the excessive secretion of epinephrine and norepinephrine [12]. Pheochromocytoma is the most common cause of adrenal medulla hyperfunction. Other disorders associated with hyperfunction of the adrenal medulla include neurofibromatosis carcinomas (of the thyroid) and hyperparathyroidism [12].

HORMONES

A hormone may be defined as a "chemical substance synthesized by an endocrine gland and secreted into the bloodstream, which carries it to other sites in the body where its actions are exerted" [5]. Hormones may function independently, in conjunction with other hormones, or as a step in a series of related actions. They may influence the action, metabolism, synthesis, and/or transport of another hormone, which is one of the integrative aspects of the endocrine system. Hormones can be differentiated into two major categories: local (with specific local effects) and general (transported by the circulation to distant sites, where they have a physiologic effect) [13].

Only target cells have the capability to respond to a specific hormone in a characteristic way. Their response depends on the presence of specific receptors for a particular hormone. This response is called hormone-target cell specificity, and the process is known as hormone-receptor binding. The initial interaction between a hormone and its target cell receptor initiates a chain of biochemical events that eventually provokes a cellular response. This often involves a hormone-induced change in the activity of a specific enzyme found in the target cell that might change the rate of reactions within the cell, change the growth of the cell, or control the cell's secretion. Because cells are exposed to many hormones, complex hormone-hormone interactions can occur in target cells. These interactions may be inhibitory, synergistic, or permissive (i.e., one hormone, by its presence, potentiates the effect of the second hormone) [13].

Hormones include steroid, polypeptide, amino acid, catecholamine, or iodothyronine structures. The steroidal hormones are aldosterone, cortisol, and the estrogens and androgens. The receptors involved in hormonal-receptor binding differ for steroidal and nonsteroidal hormones. The receptors for most nonsteroidal hormones are located on the outer surface of the plasma membrane of the target cells, whereas the receptors for the steroidal hormones are soluble proteins within the cytoplasm of the target cell. The physiology of hormone receptors is an expanding area of research in endocrinology [13].

Most hormones are not secreted at a constant rate. After secretion into the bloodstream, they circulate in a free form or are bound to proteins. Polypeptide hormones and the catecholamines are essentially unbound in the circulation. These free hormones are directly available to the target tissues, and only they can affect the target cells. The protein-bound forms are thought to represent a hormonal reserve, because the protein binding may prevent excretion of the hormone by the kidney. The amount of circulating free hormone is usually quite small and exists in equilibrium with the bound fractions [13].

There are five major influences of the secretion of hormones by the endocrine glands: the hypothalamus, hypothalamic-releasing factors, anterior pituitary hormones, the autonomic nervous system, and nutrient and ion concentrations in the plasma. The hypothalamus affects hormone secretion by secreting a series of peptides called releasing factors, which stimulate or inhibit the release of hormones by the anterior pituitary gland. The hypothalamus also directly manufactures oxytocin and antidiuretic hormones (ADH or vasopressin). The hypothalamic-releasing factors cause the interior pituitary gland to secrete growth hormone, prolactin, TSH, the gonadotropic hormones follicle-stimulating hormone, luteinizing hormone, and ACTH. The anterior pituitary hormones directly control the release of thyroid hormone (T3 and T4), cortisol, testosterone in men, and estrogen and progesterone in women [13]. In some patients with excessive hormone levels caused by a tumor of the involved endocrine gland, feedback inhibition does not suppress the overproduction of the hormone, and the tumor functions autonomously [14,15].

Diurnal variation is another of the control mechanisms affecting hormonal secretion. A 24-hour cyclical variation in the secretory rates of certain hormones can be seen. For example, growth hormone levels are highest in the first 90 minutes after sleep begins. These circadian rhythms have been found to be different for each hormone. It is evident that the endocrine system affects all aspects of the organism. Through the hormonal secretion of its glands, the system controls and regulates the metabolic processes of anabolism and catabolism, the function of muscles, growth and reproduction, energy production, stress reactions, electrolyte balances, and personality development [14,15].

Antidiuretic Hormone (ADH)

The storage and release of ADH are influenced by such factors as plasma osmolality, blood volume, physiologic and psychological stress, and input from the central nervous system. ADH is produced in the hypothalamus and then transported to the posterior pituitary gland where it is stored. In the posterior pituitary gland, oxytocin and ADH are bound to the protein neurophysin and released into the circulation in response to specific physiological stimuli [3].

ADH plays an important role in the reabsorption of water by the kidneys; decreased ADH leads to diuresis, and increased ADH leads to fluid retention [16]. ADH is typically responsible for osmoregulation, but this changes when a person has a reduction in blood volume, which shifts ADH from osmoregulation to blood volume regulation [17]. ADH induces water reabsorption via vasopressin 2 receptors in the kidneys [18]. The main osmotic stimulus for ADH secretion is increased plasma osmolality and the main non-osmotic stimulus is hypovolemia [18]. The osmotic threshold for ADH is approximately 280–290 mOsm/Kg [17]. As such, ADH levels will significantly decrease when plasma osmolality drops below this level. Plasma osmolality greater than 280–290 mOsm/kg will lead to increased ADH release [17].

Growth Hormone

Growth hormone, also referred to as somatotropin, is produced in the pituitary gland [19]. An estimated 50% of the cells in the anterior pituitary are somatotrophs (cells that secrete growth hormone) [20]. Secretion of growth hormone by the anterior pituitary gland occurs in a pulsatile manner, and the majority (up to 70%) occurs at night during non-REM (typically stage 3) sleep [21,22]. Therefore, the amount and quality of sleep plays an important role in growth and development.

Growth hormone-releasing hormone (GHRH) is secreted from the hypothalamus, so growth hormone levels are primarily under hypothalamic control [22,23]. Growth hormone activates hormone-sensitive lipase (which results in metabolism of fat for energy), affects insulin sensitivity, and stimulates the formation of insulin-like growth factor in the liver [20,24].

Growth hormone can first be detected in the fetus near the end of the first trimester, with levels peaking at 20 weeks and decreasing after birth [21]. It will fall to adult levels until puberty, when levels increase [21]. After puberty, the levels decrease again and remain relatively stable until mid-adulthood, when they undergo another drop [21]. Levels of growth hormone may be increased during fasting or exercising and decreased in those with central obesity [21,23].

In addition to its role in normal development, growth hormone is necessary for the maintenance of bone health. It stimulates osteoblast differentiation and proliferation and increases calcium absorption in the intestines [23]. Further, it plays a role in appetite, cognitive function, energy, memory, mood, neuroprotection, and sleep [25].

Glucocorticoids

The glucocorticoids function in carbohydrate, fat, and protein metabolism and play an important role in the body's response to stress and emotional well-being. The principal glucocorticoid secreted by the adrenal cortex is cortisol, which constitutes 95% of cortical production; corticosterone and cortisone are also produced.

Glucocorticoids act on all cells in the body [26]. Cortisol, the main glucocorticoid, is secreted based on the circadian rhythm and in response to stress; for this reason, it is also known as the stress hormone. When the body is experiencing stress, the pituitary gland secretes ACTH, which stimulates the production and release of cortisol [27]. Cortisol also plays a role in nutrient metabolism, immune response to inflammation, regulation of blood pressure, blood glucose levels, and body fluid homeostasis [28,29].

Mineralocorticoids

The principal and most potent mineralocorticoid secreted by the adrenal cortex is aldosterone. Desoxycorticosterone and corticosterone are also secreted, but their actions are of minor importance. Aldosterone enters the circulation and travels to the kidney, where it binds to a specific receptor in the cytoplasm of the epithelial cells of the distal convoluted tubules. This receptor initiates a series of biochemical events that result in the major physiologic action of aldosterone [5,9].

Aldosterone increases the reabsorption of sodium and the secretion of potassium. This is accomplished as an exchange of sodium ions for potassium or hydrogen ions, which results in the excretion of potassium and hydrogen into the urine and the retention of sodium. As sodium is reabsorbed into the blood, it brings with it water and chlorides, which mechanically increases the blood volume. This action of aldosterone is vital to the maintenance of the extracellular fluid volume. Aldosterone also promotes sodium reabsorption to a lesser degree from the sweat glands, salivary glands, and gastrointestinal (GI) tract [2,3].

Aldosterone is an important factor in the maintenance of circulatory blood volume homeostasis through its effect on the electrolyte balance and its control of blood volume. It is the most potent hormonal regulator of electrolyte excretion. The secretion of aldosterone is regulated by three (or possibly four) major mechanisms: the renin-angiotensin system, ACTH, plasma potassium levels, and perhaps prostaglandins.

Although chiefly affecting the secretion of cortisol, ACTH is also thought to affect aldosterone production for short periods. This appears to be related to crises, during which ACTH causes an increase in the secretion of glucocorticoids and stimulates the production of aldosterone. This effect of ACTH is thought to be minor and secondary to that of the renin-angiotensin system and serum potassium levels [3].

The ratio of serum sodium levels to serum potassium levels is another important regulator of aldosterone secretion. If the serum potassium level rises or the serum sodium level decreases, changing the sodium-potassium ratio, the adrenal cortex will be stimulated to produce aldosterone. Prostaglandins are also thought to be involved in aldosterone secretion through the relation of sodium and water excretion and the release of renin [5,9].

Adrenal Medullary Hormones

The primary hormones secreted by the adrenal medulla are norepinephrine and epinephrine. Norepinephrine increases the contraction of the blood vessels, which increases peripheral resistance and causes the blood pressure to rise. This hormone also dilates the pupils of the eyes, increases the force and rate of myocardial contraction, and inhibits the activity of the GI system. It causes peripheral vasoconstriction, which diverts blood away from less-needed areas (e.g., the GI tract) toward the heart and skeletal muscles in a "fight-or-flight" response. Because of the length of time norepinephrine is retained in the circulation (two to three circulation times), it has an effect ten times larger than that of the sympathetic nervous system [5].

Epinephrine increases body metabolism and, in conjunction with glucagon, elevates the plasma glucose levels by glycogenolysis (the conversion of glycogen to glucose). Epinephrine also inhibits the secretion of insulin and elevates blood lipid levels by promoting lipolysis. These actions provide the body with a plasma glucose source for increased energy expenditure. Epinephrine is also able to constrict the arterioles of the skin selectively (causing pallor) while dilating the blood vessels of the heart and skeletal muscles, again vital to the stress response [5].

It is important to remember the permissive role of the glucocorticoids with respect to catecholamines. In the absence of cortisol, the vasoconstrictive and metabolic responses mediated by norepinephrine and epinephrine will not occur [5,9].

Through innervation from the sympathetic nervous system, the secretion of the adrenal medullary hormones is influenced by emotional stresses (e.g., fear, anxiety) and physiologic stresses (e.g., childbirth, injury, cold, hypoxia, immobilization, physical exercise). The relation between the psychologic-emotional state and the endocrine system is one of the body's major homeostatic mechanisms for protecting the individual from harm and physiologic stresses in a way that preserves integrity [9].

3. NURSING ASSESSMENT

Assessment of pituitary and adrenal issues should begin with a nursing history, followed by a physical examination. Exams should include determination of the patient's signs and symptoms, past medical history, family history, and any medications or supplements that the patient is taking. During the physical assessment, nurses should use the skills of inspection, olfaction, auscultation, percussion, and palpation. Vital signs and the patient's weight should also be obtained during the patient assessment.

PHYSICAL ASSESSMENT

Vital Signs

Patients with suspected pituitary or adrenal disorder should have their height and weight assessed and compared with growth charts. A careful developmental and familial growth history may help in the interpretation of abnormalities. Blood pressure should be measured in both arms initially and in at least two positions (e.g., supine and seated). Apical and radial pulse rates, rhythm, and quality should be evaluated, along with respiratory rate, rhythm, and depth. The patient's temperature should also be recorded [30].

General Appearance

Whether a patient's appearance closely matches his or her chronologic age should be noted. The symmetry and proportionality of the body parts should be assessed. Weight distribution and any abnormal movements of the extremities or face (e.g., spasms or twitching of facial muscles) should be noted. A plethoric (round, erythematous), "moon" face suggests Cushing syndrome [30].

Skin, Hair, and Nails

Pituitary and adrenal dysfunction can affect the temperature and texture of the skin. For example, pheochromocytoma is associated with increased skin temperature with sweating. Ecchymoses often accompany Cushing syndrome, and vitiligo has been seen in patients with adrenal insufficiency. Other possible skin lesions include skin infections (e.g., furuncles, carbuncles), ulcerations, and diabetes-related skin changes (e.g., candidiasis, diabetic dermopathy, diabetic xanthoma) [30]. The texture and distribution of body hair should also be considered.

Eyes

Nurses should pay careful attention to any changes in visual acuity or visual fields defects. Patients whose disorders induce hyperglycemia may display diabetic retinopathy (e.g., retinal edema, microaneurysms, retinal hemorrhages, exudates). Patients with these conditions require immediate referral to an ophthalmologist [30].

Cardiorespiratory System

The patient's heart rate and rhythm should be assessed, with attention to murmurs or extra heart sounds. In pheochromocytoma, hypertension, tachycardia, and atrial fibrillation may be noted. Cushing syndrome often leads to congestive heart failure, as manifested by lethargy, dyspnea on exertion, paroxysmal nocturnal dyspnea, and cough. Hypertension can accompany Cushing syndrome, and hypotension can accompany adrenal insufficiency. Because of the interrelation between cardiac and respiratory systems, cardiac pathology often produces changes in the lungs (e.g., pleural effusions, congestive heart failure). Therefore, the lungs should be assessed for abnormal breath sounds, rales, rhonchi, wheezes, and pleural friction rubs [30].

Abdomen and Genitals

The abdomen should be assessed for any asymmetry that might indicate ascites, enlargement of an organ, or a mass. Auscultation may detect bruits (especially over the renal arteries), and palpation can uncover abdominal pain [30].

Assessment of the genitalia is important in the evaluation of patients with pituitary/adrenal dysfunction, because changes in sexual development and reproductive function often occur. The appearance and any abnormalities of the patient's genitals should be noted. The presence or absence of secondary sex characteristics is recorded, including agreement between the genital, hormonal, and psychologic sex of the patient [30].

Neuromuscular System

Patients should be evaluated for current and past fractures, as may be seen in Cushing syndrome. Other issues may include bone pain, joint pain, and generalized muscle weakness. The neurologic and endocrine systems work closely together to maintain the homeostasis of the internal environment and to help cope with stress. Therefore, pathology in the nervous system often affects endocrine function (e.g., a benign tumor of the pituitary gland can cause hypersecretion of anterior pituitary hormones) and pathology in the endocrine system can be reflected in the nervous system [30].

Nurses should conduct a careful neurologic evaluation, including assessment of mental status, cranial nerves (as dysfunction of cranial nerves I and II is associated with enlargement of the pituitary gland), motor and sensory function, the cerebellum, and deep tendon and superficial reflexes. Ataxia can occur in hypocalcemia and acromegaly. Thoroughness in examination and accuracy in recording findings are essential, and all abnormal findings require additional evaluation [30].

DIAGNOSTIC TESTS

Single measures of endocrine function are rarely sufficient to support a diagnosis but nevertheless should be an integral part of the whole data base. In pituitary and adrenal testing, be aware of the importance of patient preparation and adhere strictly to the testing protocols. Patient and environmental influences that might modify the test results are important nursing considerations [31]. This section will focus on some of the most commonly used tests; general screening tests, such as complete blood count and basic metabolic panel, will not be discussed but are usually part of the workup.

Serum and Urine Osmolality

Serum osmolality testing provides information about the number of particles dissolved in the serum, while urine osmolality provides information about the kidney's ability to concentrate urine [32]. Serum and urine osmolality are controlled by ADH [33]. The release of ADH reduces the amount of fluid output by the kidneys, increasing blood volume and decreasing serum osmolality while simultaneously increasing urine osmolality. Serum osmolality is also increased in patients with hypernatremia and decreased in those with hyponatremia. The opposite is true for urine osmolality—it is increased with hyponatremia and decreased with hypernatremia. Certain medications can affect serum and urine osmolality (Table 1).

Table 1: MEDICATIONS THAT IMPACT SERUM AND URINE OSMOLALITY

Effect

Medications/Drugs

Increased serum osmolality

Corticosteroids

Glycerin

Insulin

Mannitol

Decreased serum osmolality

Carbamazepine

Chlorpromazine

Hydrochlorothiazide

Cyclothiazide

Doxepin

Lorcainide

MDMA/Ecstasy

Increased urine osmolality

Anesthetic drugs

Furosemide

Mannitol

Octreotide

Vincristine

Decreased urine osmolality

Captopril

Demeclocycline

Glyburide

Lithium

Octreotide

Tolazamide

Verapamil

Source: [32]

Cumulatively, serum and urine osmolality will help to estimate the ability of the kidney tubules to concentrate or dilute urine and can be used to aid in the diagnosis of diabetes insipidus and SIADH [33]. The normal range for serum osmolality is 280–300 mOsm/kg, and the normal range for urine osmolality is approximately 250–900 mOsm/kg [32,33]. Normal reference ranges may vary slightly depending on the source or laboratory. Diabetes insipidus is associated with elevated serum osmolality, while decreased values would be indicative of SIADH.

Urine osmolality tests use the first-voided urine specimen, which is thought to represent the maximum concentration ability of the kidneys [34]. Prior to this test, the patient should be asked about recent alcohol use and blood transfusions, as both can interfere with the results [33]. Alcohol should be avoided for at least 12 hours prior to the collection of the serum sample [33].

Water Deprivation Test

A water deprivation test involves withholding water from the patient for 6 to 17 hours while monitoring body weight, vital signs, urine volume, and urine osmolality every 1 to 2 hours [16,35]. Blood samples are also obtained two hours after the start of fluid deprivation and before giving desmopressin [35]. At the end of the test, desmopressin is given and urine osmolality is tested [18]. Water deprivation typically leads to more concentrated urine and increased weight [16]. Extended deprivation results in a urine osmolality level greater than 800 mOsm/kg (considered maximally concentrated) [18]. In patients with complete central diabetes insipidus, urine osmolality will remain less than 300 mOsm/kg during water deprivation but will increase by more than 50% after the administration of desmopressin [18]. With nephrogenic diabetes insipidus, urine osmolality will remain less than 300 mOsm/kg throughout the test and administration of desmopressin will not induce an increase in urine osmolality [18]. Although the test is fairly easy, interpreting the results can be a challenge [35].

If any of the following develop during a water deprivation, the test should be halted [35]:

- Body weight decreased by more than 3%

- Symptoms of orthostatic hypotension, with a heart rate increase of 15% or a mean arterial blood pressure decrease of 15%

- Increase in plasma sodium level to 150 mmol/L or more

Hypertonic Saline Test

The hypertonic saline test can be used to aid in the diagnosis of diabetes insipidus. This procedure involves the administration of a 250-mL bolus of 3% hypertonic saline; the patient is given a 5% glucose infusion and is instructed to drink 30 mL of water per kg of body weight within one hour. Rapid sodium measurements are taken every 30 minutes; plasma osmolality, serum sodium, urea, and glucose are also monitored [18,35]. If the sodium level rises above 147 mmol/L, the infusion should be stopped. If copeptin is being measured, it should be done at this point [18]. With the hypertonic saline test, a plasma copeptin measurement of 4.9 pmol/L or less indicates complete or partial central diabetes insipidus [35].

The advantages of measuring copeptin are that small amounts of serum are needed, the samples collected are stable for one week at room temperature, and results are available within two hours [18,35]. The release of copeptin is triggered by osmotic stimuli and volume depletion [18]. Research has shown that measuring osmotically stimulated copeptin is a useful diagnostic tool [35]. Levels may be measured with a water deprivation or hypertonic saline test, but results are more accurate with hypertonic saline than water deprivation [35]. Baseline copeptin levels should be obtained followed by levels prior to desmopressin [35]. Basal plasma copeptin levels of less than 2.6 pmol/L are indicative of complete central diabetes insipidus [35]. If the ratio of copeptin to plasma sodium is less than 0.02 pmol/L, partial central diabetes insipidus is suggested [35].

Growth Hormone Stimulation Test

As noted, growth hormone is secreted by the anterior pituitary gland periodically throughout the day, with levels highest at night. Due to the episodic nature of growth hormone secretion, random checks are rarely useful [32]. However, to assess for growth hormone deficiency or acromegaly, a growth hormone test is often completed together with a growth hormone suppression test, growth hormone stimulation test, and insulin-like growth factor test [33]. Before testing, the patient should avoid eating, drinking, and exercising for 10 hours [33]. The typical normal value is less than 5 ng/mL in men, less than 10 ng/mL in women, and 0–10 ng/mL in children [33]. Decreased levels are associated with a deficiency, and increased levels are associated with acromegaly.

The growth hormone stimulation typically takes two to five hours to complete and is typically started in the morning with a baseline blood sample [36]. Medication (arginine, glucagon, or insulin) will be given intravenously to stimulate the pituitary gland to release growth hormone [36]. Blood samples may be obtained at baseline and 30, 60, 90, and 120 minutes after administration of the testing agent [33]. Prior to growth hormone stimulation and suppression tests, patients should avoid strenuous activity for at least 12 hours [32]. If the patient has normal values throughout this test, growth hormone deficiency can be ruled out. However, failure of growth hormone levels to increase as expected is an indicator that the patient may have a growth hormone deficiency.

Insulin Tolerance Test

Because hypoglycemia stimulates growth hormone secretion, an insulin tolerance test may also be used to assess growth hormone sufficiency [21]. An insulin tolerance test involves hypoglycemia induced by an intravenous (IV) injection of insulin [37]. With this test, regular insulin is administered intravenously to drop the patient's glucose levels below 40 mg/dL [21]. Within 30 to 60 minutes, growth hormone levels are measured and should reflect a peak. Throughout the course of this test, the patient may experience signs and symptoms of hypoglycemia, including dizziness, anxiety, tremors, sweating, and tachycardia. Seizure and/or loss of consciousness are possible, so close monitoring during the test is necessary [21].

Cortisol Levels

The body typically responds to stress by triggering the pituitary to make ACTH, with a resultant elevation in cortisol [37]. Blood is drawn at the start of the test and every 30 minutes for 2 hours [37]. In patients with Cushing syndrome, cortisol levels are higher than expected [32]. This test is not appropriate for persons taking insulin or on hemodialysis [32]. Patients should be instructed to report signs and symptoms of hypoglycemia.

Growth Hormone Suppression Test

Growth hormone suppression tests are used to aid in the diagnosis of acromegaly. After the baseline blood sample is obtained, the patient is instructed to drink a solution containing glucose within five minutes [38]. Blood samples are then obtained after 60 and 120 minutes [33]. If possible, glucocorticoids should be halted prior to the test [38]. In general, this test is not used for screening—it is only ordered if a patient presents with signs and symptoms of acromegaly [38]. If growth hormone levels stay the same or increase during the test, acromegaly is suggested [38].

Insulin-like growth factor regulates the effects of growth hormone, but it remains stable throughout the day [39]. Testing Insulin-like growth factor levels is indicated for patients with suspected acromegaly or to monitor the effectiveness of growth hormone treatment [39,40]. Elevated levels in the presence of elevated growth hormone levels are indicative of acromegaly [39].

ACTH Stimulation Test

ACTH stimulation testing involves the infusion of cosyntropin (a synthetic form of ACTH) as either intravenous or intramuscular injection [32]. Cortisol levels are collected at baseline, 30 minutes, and (in some cases) 60 minutes after the medication bolus [32]. Normal baseline cortisol levels are greater than 5 mcg/dL; normal levels at 30 to 60 minutes are 18–20 mcg/dL [32]. In response to the cosyntropin infusion, the adrenal cortex should release two to five times the amount of normal plasma cortisol levels within 30 minutes [24]. Prior to undergoing ACTH stimulation testing, patients should abstain from nicotine, alcohol, cortisol-affecting medications, and strenuous activity for at least 12 hours [32]. Some patients may be instructed to remain in bed for one hour prior to the test [32].

Urinary Free-Cortisol Test

For the 24-hour urinary free-cortisol test, urine is collected over 24 hours to measure the amount of unbound cortisol filtered by the urinary system [41]. The accuracy of this test is dependent on the patient's glomerular filtration rate and urinary volume [41]. Normal cortisol levels in a 24-hour urine collection are 450–700 nmol/L [42]. Elevated levels indicate Cushing syndrome, while low levels could indicate Addison disease.

Low-Dose Dexamethasone Suppression Test

The low-dose dexamethasone suppression test (LDDST) is completed by administering low doses of dexamethasone at night, followed by a blood draw in the morning [28]. For this test, the patient is given 1 mg of dexamethasone orally at 11 p.m. and cortisol levels are measured at 8 a.m. [32]. Alternately, dexamethasone may be given every 6 hours for 48 hours, followed by a blood sample 6 hours after the last dose [28]. Cortisol levels are expected to be less than 1.8 mcg/dL when the sample is taken [32]. Administration of dexamethasone decreases cortisol levels, so an elevated finding is indicative of abnormality. This test is used to distinguish between Cushing syndrome and Cushing disease (specifically caused by a pituitary tumor that secretes excessive ACTH) [32]. However, certain medical conditions can affect the results of the test, including severe obesity, pregnancy, dehydration, uncontrolled diabetes, severe weight loss, alcohol withdrawal, severe injury, and stress [33].

Corticotropin-Releasing Hormone Stimulation Test

The corticotropin-releasing hormone stimulation test can help to distinguish between Cushing syndrome and Cushing disease [32]. Corticotropin-releasing hormone is given intravenously and eight cortisol and ACTH levels are collected, one at baseline and the others at 5, 15, 30, 60, 120, and 180 minutes after administration [32]. The expected result in healthy individuals is a peak in cortisol (greater than 20 mcg/dL) and a two- to four-fold increase in ACTH within 30 to 60 minutes [32]. Higher cortisol levels are associated with Cushing disease; cortisol levels that fail to increase may indicate ectopic ACTH secretion [32].

Inferior Petrosal Sinus Sampling

Bilateral inferior petrosal sinus sampling (IPSS) can be used to distinguish Cushing disease from ectopic ACTH secretion [43]. This test is guided by fluoroscopy, typically while the patient is under general anesthesia, and will take 60 to 90 minutes [43,44]. Catheters are inserted through both the left and right femoral veins and advanced to the petrosal sinuses [43]. Samples are drawn simultaneously from the inferior petrosal sinus and the peripheral veins for plasma ACTH five minutes and one minute before administration of 1–100 mcg corticotropin-releasing hormone in a peripheral vein. Samples for plasma ACTH are collected at 2, 5, and 10 minutes after administration. A peripheral sample for plasma cortisol is also taken along with each sample for plasma ACTH.

ACTH should be in higher concentrations when measured from a sample collected close to the gland [43]. Possible complications associated with this test include a groin hematoma and rarely subarachnoid hemorrhage, brainstem injury, brainstem stroke, and infection [43]. Though less accurate, jugular vein sampling is a less-invasive alternative to IPSS [43].

If a tumor is the cause of excess ACTH, this test will help to identify the location [44]. Additionally, comparing results from the right and left sides can help identify the best approach to remove the tumor while maintaining some functional pituitary tissue [44].

Other Tests and Imaging

The late-night salivary cortisol test measures cortisol in the saliva at night, when the levels typically drop; levels will remain elevated in patients with Cushing syndrome [28]. Serum or urinary cortisol, aldosterone, and/or ACTH may also be assessed.

The diagnostic investigation of anterior pituitary dysfunction often involves an x-ray, computed tomography (CT), or most commonly, magnetic resonance imaging (MRI) scan of the skull. A cerebral flow brain scan or echoencephalogram also may be used. In the presence of a pituitary tumor, a widening of the sella turcica (the bony seat of the pituitary gland) may be visualized. To further detect the presence of a brain tumor, a complete neurologic evaluation may be done, including assessment of the patient's visual fields [34].

4. NURSING DIAGNOSES

The nursing diagnosis forms the basis of the plan of care for the patient and provides guidelines for its implementation and evaluation. Because pituitary/adrenal dysfunction has widespread effects, many nursing diagnoses can be used in caring for these patients. Each patient's actual problem is unique, however, and requires a skillful assessment. Recognition of the specific problem and its etiology is integral to a comprehensive, well-executed nursing care plan [46].

INEFFECTIVE INDIVIDUAL COPING

Because of the profound physiologic and psychosocial stresses on the patients with these conditions, it is not unusual for them to be fearful and have difficulty coping. Feelings of anxiety can be directly related to the disorder (as in pheochromocytoma) or exogenous, resulting from feelings of unexplained apprehension about the situation [46].

Pituitary/adrenal disorders often require the patient and family to make major changes in lifestyle. Patients may require lifelong pharmacotherapy and medical/nursing supervision. They also may face the possibility of major surgery and may have some degree of transitory or permanent sensory loss [46].

ALTERATION IN THOUGHT PROCESSES

Central nervous system involvement may produce a variety of problems in patients, ranging from headaches and lethargy (e.g., with pheochromocytoma) to outright psychosis (e.g., Cushing syndrome). Alterations in thought processes and perception pose difficulties not only for patients but for their families and friends as well [47].

ALTERATION IN COMFORT

Some patients with pituitary or adrenal dysfunction will have problems with thermal regulation. For example, patients with pheochromocytoma or hypoglycemia often experience excessive sweating. Those with acromegaly often experience joint pain [46,47].

DISTURBANCE IN SELF-CONCEPT

Changes in the skin and hair occur in patients with pituitary or adrenal dysfunction and can contribute to disturbances in body image. Increases in skin pigmentation may occur in patients with Addison disease. Ecchymosis develops in patients with Cushing syndrome due to changes in the fragility of the capillaries. Facial flushing is often a sign of pheochromocytoma. Hirsutism is a problem for patients with adrenal tumor or hyperplasia and is an especially bothersome body image issue for women [46,47].

Patients with these disorders may have an impaired ability to manage self-care or maintain their home environment. They are at increased risk for injury because of weakness, fatigue, and visual disturbances. For example, weakness of the musculoskeletal system is seen in patients with acromegaly and Cushing syndrome. Patients with Cushing syndrome have an increased incidence of fractures. Fatigue often accompanies adrenal insufficiency, hypoglycemia, and acromegaly. Patients with pituitary tumors may have some level of visual impairment [46,47].

Sexual dysfunction may occur as loss of libido or impotence. Menstrual problems are also relatively common [46,47].

ALTERATION IN NUTRITION AND BOWEL ELIMINATION

Anorexia and weight loss are common in patients with adrenal insufficiency, pheochromocytoma, and hyperkalemia [46,47]. Alteration in bowel elimination, specifically diarrhea, may be seen in patients with Addison disease, while constipation can occur in patients with hypercalcemia and pheochromocytoma [46,47].

ALTERATION IN FLUID VOLUME

Actual or potential fluid volume deficits occur in patients with posterior pituitary disorders. In addition, patients with Cushing syndrome may develop congestive heart failure. Patients with hypercalcemia and hyperaldosteronism may have polydipsia and polyuria [46,47].

5. DIABETES INSIPIDUS

Diabetes insipidus is a rare disorder of the posterior pituitary caused by insufficient production or utilization of ADH and characterized by polyuria, polydipsia, and hypernatremia. It is seen in approximately 1 out of 25,000 people and is more common in adults but can develop in individuals of all ages [45]. Risk factors for the development of diabetes insipidus include tumors, trauma, medications, and alcohol consumption [16].

PATHOPHYSIOLOGY

The underlying cause of diabetes insipidus is generally either pituitary (central) or nephrogenic. More rarely, it may develop during pregnancy or related to a mental disorder.

Central Diabetes Insipidus

Approximately 50% of patients have primary central diabetes insipidus, also known as pituitary or primary diabetes insipidus. This form is associated with familial and congenital factors as well as with subclinical encephalitis. Secondary diabetes insipidus is diabetes insipidus arising from a variety of causes, including hypophysectomy, tumors (e.g., metastatic carcinoma of the breast, craniopharyngiomas), trauma (e.g., basilar skull fractures), vascular lesions (e.g., hemorrhage, aneurysm), infection (e.g., syphilis, encephalitis, meningitis), histiocytosis, and granulomatous disease (e.g., sarcoidosis, tuberculosis) [46,47].

Patients with central diabetes insipidus have an impaired ability to synthesize and secrete vasopressin (ADH) [26]. In most healthy people, ADH is secreted by the pituitary gland when plasma osmolality increases, but this does not occur in those with central diabetes insipidus [48]. Central diabetes insipidus is classified as either complete or partial, depending on the level of ADH present in the body [18].

A variety of factors can lead to central diabetes insipidus, including genetic mutation, medications (e.g., beta-adrenergic agents, ethanol, halothane, phenytoin, opioid antagonists), head (pituitary) trauma, intracranial tumor, infection (e.g., meningitis, encephalitis, tuberculosis), autoimmune disease, disorders of the hypothalamus or pituitary gland, and brain surgery [26,48]. Rarely, central diabetes insipidus may be the result of snakebite. One genetic cause is Wolfram syndrome, an autosomal dominant disorder associated with diabetes mellitus, diabetes insipidus, optic nerve atrophy, and sensorineural hearing loss [48]. The most common causes are trauma and malignancy.

Lesions and autoimmune disorders can lead to the destruction of vasopressin neurons in the hypothalamus, while surgery and trauma can damage or destroy the vasopressin neurons [49]. It is important to note that the body's ability to synthesize vasopressin is greater than the body's needs, so up to 80% to 90% of the vasopressin neurons in the hypothalamus can be destroyed before diabetes insipidus develops [49].

A transient form of polyuria may develop in patients post-trauma or post-surgery, but it usually resolves within four days [49]. In rare cases, these patients may develop a permanent form of diabetes insipidus [49].

Nephrogenic Diabetes Insipidus

In patients with nephrogenic diabetes insipidus, the kidneys do not respond normally to vasopressin [26]. The underlying etiology of this condition may be genetic/congenital, medication-induced kidney damage (e.g., with amphotericin, cisplatin, clozapine, demeclocycline, furosemide, lithium [most common], methicillin), renal or urinary tract infection, or chronic disease processes (e.g., amyloidosis, chronic renal failure, polycystic kidney disease, sickle cell disease, Sjögren syndrome) [18; 26; 50]. Acquired nephrogenic diabetes insipidus is more common than the hereditary form [50].

The genes associated with the hereditary form of nephrogenic diabetes insipidus prevent the kidneys from responding to ADH [50]. Infants with hereditary nephrogenic diabetes insipidus will develop signs and symptoms of the disease within a few months of birth [50].

Gestational Diabetes Insipidus

Gestational diabetes insipidus is a type of transient diabetes insipidus that develops in 2 to 4 of every 100,000 pregnancies [51]. During pregnancy, ADH production is increased and plays a role in the increased blood volume. At the same time, placental vasopressinase, which metabolizes ADH, is increased [51]. This is more commonly seen in pregnancies with multiple fetuses because of the increased placental mass [18,51]. In the majority of cases, the patient will have a normal delivery and healthy newborn [51]. After delivery, vasopressinase levels will decrease by approximately 25% each day, reaching undetectable levels at four to six weeks postpartum and resulting in resolution of the disorder [51].

It is important to note that some patients may have undiagnosed diabetes insipidus prior to pregnancy, with symptoms not becoming apparent until after they become pregnant [51]. If the patient has undiagnosed diabetes insipidus discovered during pregnancy, it is classified as central or nephrogenic, depending on the underlying pathophysiology.

Psychogenic Diabetes Insipidus

In rare cases, patients may develop a psychiatric condition involving the consumption of large amounts of fluids [26]. This is not true diabetes insipidus, but it can be life-threatening and has been associated with increased morbidity and mortality. In psychogenic cases, the function of the pituitary gland and kidneys remain intact, and extracellular fluid dilution develops and inhibits ADH secretion, leading to diuresis [52]. The increased fluid intake leads to functional diabetes insipidus [52].

This condition can be seen in patients with a variety of mental health disorders, including autism, schizophrenia, schizoaffective disorder, and bipolar disorder [53]. Schizophrenia is a common cause, with 11% to 20% of patients with schizophrenia developing psychogenic diabetes insipidus [53].

For some patients, increased fluid intake is a compulsion rather than a response to thirst [53]. Another subset of patients believes that increased water intake is healthy [53]. These individuals typically do not have a mental health disorder but are rather misinformed about the risks of overconsumption of water.

SIGNS AND SYMPTOMS

Patients with diabetes insipidus present with polyuria, nocturia, polydipsia, increased serum osmolality, decreased urine osmolality, and decreased urine specific gravity [16,26]. Many report extreme thirst, even at night, leading to increased fluid intake at all hours [52]. In addition to drinking throughout the day, patients with diabetes insipidus often have a preference for cold or ice water [18]. An intact thirst drive will often prevent severe dehydration and maintain homeostasis in those affected [48]. In some cases, the thirst mechanism is faulty because of damage to osmoreceptors in the hypothalamus, leading to decreased fluid intake and severe dehydration [49].

Patients with diabetes insipidus will have dilute and light-colored urine. Polyuria will develop regardless of normal contributing factors to urine output, such as fluid intake. Patients may urinate as much as 10–20 L/day [26]. In most cases, the urine will be hypotonic and serum osmolality will increase [16,26]. In patients with a serum osmolality of 300–330 mOsm/kg, symptoms may not be apparent [49]. Patients with severe dehydration may develop weakness, postural dizziness, confusion, azotemia, hyperglycemia, secondary hyperaldosteronism with hypokalemia, and coma [49]. Under normal circumstances, an increase in serum osmolality would result in a drop in blood pressure and subsequent secretion of ADH [16]. Additionally, when a patient has increased serum osmolality they will often be very thirsty [16]. Thirst will lead to increased fluid intake, which increases fluid in the vasculature and restores fluid balance. However, in patients with diabetes insipidus, this does not occur, further increasing the risk for dehydration and hypovolemic shock [16].

Serum sodium levels will be normal or increased, with hypernatremia typically developing if the patient does not drink enough water to account for the increased urine output [26]. Patients with hypernatremia may present with altered mental status, myoclonus (muscle jerking), seizures, and focal deficits [26]. If untreated, the patient may progress to an altered level of consciousness or death [16].

Infants with congenital nephrogenic diabetes insipidus present with enuresis, poor intake, poor weight gain, poor growth (failure to thrive), irritability, fevers, diarrhea, and vomiting [50]. If a child with this condition develops dehydration on multiple occasions, it can lead to problems with growth and development [50].

As many as 50% of patients with underlying diabetes insipidus will have increased signs and symptoms during pregnancy [51]. Patients with underlying diabetes insipidus do not have increased levels of ADH during pregnancy, so the symptoms of diabetes insipidus may become apparent [51]. Patients are at increased risk for dehydration and hypernatremia if they experience diabetes insipidus during pregnancy [51]. However, during pregnancy, thirst is triggered at lower serum osmolality levels, which can act as a protective factor [51].

Patients with an exacerbation of a mental illness may also increase their fluid intake; this increase is not related to the regulation or maintenance of homeostasis [53]. Patients with psychogenic diabetes insipidus drink more than 3L of fluids per day [52]. In patients with compulsive fluid intake, drinking fluids calms an acute anxiety and the compulsion can be so strong that they will drink from inappropriate and unhealthy water sources (e.g., toilets) [53]. Individuals who compulsively drink fluids may also have comorbid nicotine, alcohol, and/or eating disorders [53]. Patients with psychogenic diabetes insipidus urinate as often as every 30 minutes, and the urine is dilute, with decreased specific gravity and decreased osmolality [52]. These patients may also report fatigue and constipation [52].

Patients with psychogenic diabetes insipidus typically do not drink fluids at night, which can help differentiate it from true cases of diabetes insipidus [53]. Most patients with diabetes insipidus will develop hypernatremia due to the fluid deficit, but patients with psychogenic diabetes insipidus may develop hyponatremia [53]. If hyponatremia develops in these patients, it is important to determine if it is the result of excessive fluid intake or another cause (e.g., medication) [53]. Patients with schizophrenia and diabetes insipidus typically have lower body weight and increased rates of alcohol consumption and smoking compared with patients without diabetes insipidus [53].

DIAGNOSIS

The diagnosis of diabetes insipidus can be a challenge, and misdiagnosis carries the risk for severe complications [35]. Diabetes insipidus is diagnosed by routine screening tests, such as specific gravity of urine, plasma sodium levels, osmolality tests, and water-deprivation and water-loading tests. If serum osmolality is greater than 300 mOsm/kg and urine osmolality is less than 300 mOsm/kg, the diagnosis is likely diabetes insipidus [48]. Diagnosis is confirmed if a deficiency of ADH is demonstrated and the patient's kidneys are shown to respond normally to ADH. In response to a water-deprivation challenge, patients with diabetes insipidus will demonstrate an inability to increase the specific gravity and osmolality of the urine [54,55]. Differential diagnosis involves other causes of polyuria. A brain scan, skull x-rays, visual field testing, and full neurologic examination may be indicated to rule out the presence of a tumor.

Differentiation between the types of diabetes insipidus can be a challenge but is essential because treatment will vary based on the type identified [18]. Patients with central diabetes insipidus will respond to vasopressin with decreased urine output and increased urine osmolality [48]. If the patient has nephrogenic diabetes insipidus, there will be no response to the vasopressin [48].

A newer diagnostic tool is copeptin, a surrogate marker for ADH [18]. High basal copeptin levels are accurate in diagnosing nephrogenic diabetes insipidus [18]. The copeptin test can also be used during pregnancy, unlike the water deprivation test [51]. In nonpregnant patients, the copeptin test can be combined with the water deprivation test, which increases diagnostic accuracy of both tests [18]. It can also be combined with the administration of hypertonic saline [18].

Diagnosis of psychogenic diabetes insipidus usually requires a multidisciplinary approach [52]. The care team may include primary care, endocrinologists, nephrologists, and psychologists.

TREATMENT

The treatment plan for patients with diabetes insipidus depends on the type and the associated signs and symptoms.

Central Diabetes Insipidus

Evidence Based Practice Recommendation

The Society for Endocrinology recommends that for those patients with central diabetes insipidus and normal serum sodium and who require maintenance intravenous fluid therapy, the type and volume administered should be equivalent to the daily requirements appropriate for other patients without central diabetes insipidus. This should be given together with the agreed, prescribed dose of desmopressin.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6013691

Last Accessed: August 5, 2021

Level of Evidence: Expert Opinion/Consensus Statement

For patients with mild cases of central diabetes insipidus, treatment may be as simple as increasing fluid intake [56]. However, most patients will require ADH replacement therapy. In acute cases, patients are given intravenous or subcutaneous vasopressin [16]. Long-term treatment involves the administration of desmopressin orally, subcutaneously, or intranasally [16]. The most common adverse effect of desmopressin administration is hyponatremia, although fluid retention can also develop [48]. Intranasal desmopressin can result in eye irritation, headaches, dizziness, rhinitis, epistaxis, coughing, and flushing [48]. If diabetes insipidus is caused by pituitary tumor, hypophysectomy may be required [16].

For infants with congenital central diabetes insipidus, the preferred treatment is usually thiazide diuretics [48]. Thiazide diuretics work by inhibiting the amount of sodium lost by the kidneys, which can lead to decreased water loss [57]. However, thiazide diuretics can paradoxically decrease urine flow in some [16]. As such, urine output should be closely monitored in these patients.

Nephrogenic Diabetes Insipidus

Poorly managed nephrogenic diabetes insipidus can cause pain, infection, damage to the genitourinary system, and kidney failure [50]. Appropriate treatment will help to prevent these complications. In many cases, treatment is palliative [57]. A low-sodium diet may be prescribed to help decrease the amount of urine made by the kidneys [56]. As with all types of diabetes insipidus, fluid intake should be increased. Hydrochlorothiazide may be given to help manage symptoms and decrease urine output [56]. Patients may also be prescribed indomethacin, a nonsteroidal anti-inflammatory drug that increases urine concentration [57].

Most of the secondary causes of nephrogenic diabetes insipidus can be reversed [18]. If medications are the cause, their use should be reconsidered. If the underlying cause is lithium, it can take months to years for renal function to recover completely [18].

Infants with nephrogenic diabetes insipidus should intermittently be offered water. Patients unable to take in enough fluid to replace urine output may require a feeding tube [57]. School-aged children should have a plan in place with their school to ensure adequate access to a bathroom and to fluids. The school nurse and teachers should be included in the plan.

Gestational Diabetes Insipidus

Desmopressin is the treatment of choice for gestational diabetes insipidus, with minimal side effects for the patient and fetus [51]. It is important to consider that the dosage should usually be increased as the pregnancy progresses [51]. It is also important to correct any hypernatremia that develops. Patients with diabetes insipidus during pregnancy are at increased risk for recurrence during any future pregnancies [51].

Psychogenic Diabetes Insipidus

For patients with psychogenic diabetes insipidus, behavioral therapy may be beneficial [52]. Medication reconciliation should be done to eliminate agents that impair water excretion, if possible [53]. The treatment of psychogenic diabetes insipidus in children should involve parents/caregivers [52]. In general, adequately addressing the underlying mental health issue will help to resolve the diabetes insipidus. Patients with psychogenic diabetes insipidus due to health misinformation should be given education on appropriate water intake [53].

In some cases, clozapine may be given to help normalize sodium levels and decrease fluid intake [53]. The choice to use this medication should be made carefully, because it is associated with significant side effects [53]. Vasopressin V2 receptor (V2R) antagonists (vaptans) may also be given to normalize serum sodium levels [53]. These medications should be used cautiously and the patient observed closely because they can lead to dehydration and renal damage [53].

Unlike the treatment of other diabetes insipidus types, these patients may be placed on fluid restriction [53]. Weight measurements can help identify patients who will benefit from fluid restriction. If the patient's weight increases, it may be an indicator for fluid restriction. Providing ice chips may also help control fluid intake for patients with psychogenic diabetes insipidus [53].

Surgical Resection

If diabetes insipidus is caused by a pituitary tumor, this must be addressed in order to resolve symptoms. Hypophysectomy can involve the resection of a small tumor or the complete removal of the pituitary gland. The major indications for hypophysectomy are a primary neoplasm of the pituitary gland (adenoma) and the need to halt the growth and spread of other endocrine-dependent malignancies (e.g., breast, ovary, or prostate cancer).

Though historically used, transcranial and transsphenoidal approaches to hypophysectomy are major surgical procedures and have largely been replaced by less invasive options, such as radiation therapy. However, in some cases, surgical resection is required. Because of the risk of damaging the pituitary and the proximity of the optic nerves, optic chiasm, carotid arteries, cavernous sinus, and hypothalamus to the operative area, the surgery involves some risk.

The surgical approach is most commonly transsphenoidal selective tumor resection guided by fluoroscopy [58]. With this type of surgery, the tumor is approached through the sphenoid sinus, avoiding brain tissue. A cut is made along the nasal septum or under the upper lip, near the base of the nose. In addition to the avoidance of brain tissue, this procedure is often associated with fewer side effects and cosmetic effects compared with other surgery types [59]. Drawbacks are that it is more time-consuming and is difficult to perform on large tumors, which often require craniotomy for removal [59]. After a transsphenoidal approach, the patient may report sinus congestion and headaches lasting for one to two weeks postoperatively [59].

Transfrontal craniotomy is indicated when the tumor extends beyond the pituitary fossa and is impinging on the optic chiasm, because this procedure provides the best view of the operative field [60]. With this technique, an opening is made in the skull and the pituitary is accessed through the brain, increasing the risk of brain injury [59]. Complications can include brain damage, stroke, blindness, meningitis, leakage of cerebrospinal fluid, bleeding, diabetes insipidus, and adverse reactions to anesthesia [59].

Transient cerebrospinal fluid leaks can occur following removal of the nasal packings. Most leaks respond to conservative measures aimed at keeping the intracranial pressure low. Lifelong hormonal replacement is necessary if the entire gland is removed [60].

Prior to surgery, patients with diagnosed pituitary tumors should be observed for symptoms and signs of pituitary apoplexy, including severe headache, changes in level of consciousness, diplopia, loss of vision, and shock. Pituitary apoplexy occurs when there is spontaneous hemorrhage into the tumor secondary to rupture of the blood vessels or rapid enlargement of the adenoma with resulting infarction [61].

Postoperative care of patients who have undergone transfrontal craniotomy should also be closely observed for signs/symptoms of [61]:

- Increased intracranial pressure (e.g., hypertension, bradycardia, change in pupil size and reaction to light, changes in level of consciousness, changes in mental or neurologic status)

- Adrenal insufficiency

- Hypothyroidism (which may develop over several weeks)

- Meningitis (e.g., elevated temperature, headache, motor restlessness, photophobia, nuchal rigidity)

- Fluid imbalance (which may indicate transient or permanent diabetes insipidus)

Most patients recover rapidly from transsphenoidal surgery. Patients may report a temporary loss of smell. Oral hygiene is important to keep the oral mucosa moist. Tooth brushing is usually contraindicated because of possible tension on the suture line. Nasal packs are usually removed in 48 to 72 hours [62]. Headache may be a problem in the postoperative period and should be assessed as a possible symptom of meningitis.

A major complication in the postoperative period is hypopituitarism, which may develop into Addisonian crisis and transient or permanent diabetes insipidus. As such, these patients should be watched closely for symptoms and signs of Addisonian crisis (e.g., weakness, lethargy, fever, nausea, hypotension, dizziness) and diabetes insipidus. In the immediate postoperative period, intake and output should be measured and used as a guide to fluid balance; the specific gravity of urine should be checked after each voiding [62].

After total ablation of the pituitary gland, amenorrhea and infertility will result. For men, testosterone may relieve changes in libido and impotence secondary to the surgery. Estrogen may be prescribed for women to relieve atrophy of the vaginal mucosa. Human pituitary gonadotropins have been successful in treating infertility in patients posthypophysectomy, especially women [62].

Postoperative teaching should focus on medications prescribed, including their purpose and side effects, and the importance of regular follow-up care.

Nursing Interventions

When caring for any patient with diabetes insipidus, close monitoring of the patient's fluid balance is necessary. Nurses should also monitor the patient for dehydration, especially if the patient is confused, unconscious, or otherwise unable to communicate (e.g., infants), because these patients are unable to make their needs known regarding fluid intake. This is best done with daily weights and frequent intake and output monitoring. Patients should be assessed for signs and symptoms of fluid deficit, such as poor skin turgor and dry mucous membranes.

Treatment of diabetes insipidus may include the administration of hypotonic intravenous fluids to increase fluid in the vasculature without increasing serum sodium levels [16]. These patients should be closely monitored for fluid overload [16]. Oral fluids should be encouraged for most patients with diabetes insipidus, except those with psychogenic diabetes insipidus. Nurses should also be vigilant for signs of hypovolemic shock, including hypotension and tachycardia. Any of these potential complications should be addressed promptly.

6. SYNDROME OF INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION (SIADH)

Clinically, SIADH is the opposite of diabetes insipidus, with ADH levels increased as opposed to decreased. It is seen more commonly as an individual ages but can develop at any age [17]. A major risk factor for SIADH is hospitalization, and a high number of SIADH cases develop in hospitalized patients older than 30 years of age [24].

PATHOPHYSIOLOGY

The syndrome of inappropriate antidiuretic hormone, or SIADH, is a condition characterized by autonomous release of ADH without regard to plasma osmolality. The body is unable to dilute the urine appropriately, so fluid is retained, which expands the extracellular fluid compartment and leads to hyponatremia. There may also be sodium loss by the kidneys because of a lack of aldosterone [26].

The cause of SIADH is multifactorial and may include genetic, nervous system, malignancy, pulmonary disease, surgery, and medication factors [16]. Hereditary SIDAH is referred to as nephrogenic SIADH and is the result of a functional mutation in the vasopressin 2 receptors in the kidneys that leads to these receptors staying in an active state [17].

Conditions that increase intracranial pressure can lead to the development of SIADH, including head trauma, stroke, meningitis, lesions, hemorrhage, and hydrocephalus [16,24,26]. Vasopressin-secreting tumors of the lung and brain are another potential cause of SIADH; small cell lung cancer is responsible for 70% of the cancer-related causes of SIADH [16,26,63]. Pulmonary disease (e.g., cystic fibrosis, chronic obstructive pulmonary disease) can lead to SIADH, although the exact mechanism is not fully understood [16].

Medications associated with SIADH include carbamazepine, oxcarbazepine, chlorpropamide, cyclophosphamide, selective serotonin reuptake inhibitors (SSRIs), antipsychotics, hormones (i.e., vasopressin, desmopressin, and oxytocin), and antihistamines [16,26]. Of these medications, SSRIs and carbamazepine are the most commonly associated medications [24]. The illicit drug 3,4-methylenedioxy-methamphetamine (MDMA or Ecstasy/E/Molly) induces release of ADH and increases thirst, which causes SIADH and is linked to more severe signs and symptoms [17].

SIGNS AND SYMPTOMS

SIADH is also associated with serum hypo-osmolality, concentrated urine, increased urine specific gravity, decreased urine output, weakness, lethargy, headache, anorexia, nausea, vomiting, mental status changes, seizures, cerebral edema, cerebral hemorrhage, asterixis, myoclonus, pulmonary edema, and coma [26,64]. Hyponatremia and decreased extracellular fluid volume lead to a fluid shift into the cells [17]. The osmotic fluid shifts associated with this condition cause cerebral edema and subsequent increased intracranial pressure [26]. When cerebral edema occurs, there is also a loss of potassium and amino acids from brain cells [24].

In patients with chronic SIADH, solute loss is more prominent than water retention [17]. This can lead to the development of hyponatremia in a euvolemic state. In those with SIADH, ADH is secreted even in instances in which the ADH should be decreased, leading to the reabsorption of water, increased fluid in the bloodstream, dilutional hyponatremia, and an increase in the extracellular fluid volume. Dilutional hyponatremia may be manifested by a bounding pulse, increased or normal blood pressure, muscle weakness, headache, personality changes, nausea, diarrhea, convulsions, and coma [16]. The patient with hyponatremia may also develop gait disturbance, memory and cognition problems, dizziness, and an increased risk for falls.

Hyponatremia can be classified as mild (130–134 mEq/L), moderate (125–129 mEq/L), or profound (less than 125 mEq/L) [64]. In patients with mild-to-moderate hyponatremia, the only signs and symptoms may be nausea and malaise [17]. As hyponatremia worsens, patients will develop additional signs and symptoms, and serum sodium levels less than 120 mEq/L can lead to coma and respiratory arrest [17]. The speed at which the hyponatremia develops is correlated with the neurologic manifestations [26]. If the patient develops acute hyponatremic encephalopathy, the condition may be reversible, but it could also lead to permanent deficits [17]. Vomiting is considered an ominous sign [17].

Hyponatremia that develops quickly can lead to cerebral edema and potential brain herniation [63]. When the body has time to adapt to the cerebral edema, it displaces solutes (e.g., potassium) from the brain and into the extracellular spaces [63]. In those with chronic hyponatremia, the body adapts and the condition can be asymptomatic, even with serum sodium levels less than 120 mEq/L [17]. Although these patients may be asymptomatic, nausea and vomiting are seen in approximately one-third of patients [17]. However, rapid drops in sodium levels can result in delirium, confusion, and seizures, even if the drop is minimal [17].

DIAGNOSTIC TESTS

Evidence Based Practice Recommendation

The European Society of Endocrinology recommends that if clinical assessment indicates that the volume of extracellular fluid is not overtly increased and the urine sodium concentration is >30 mmol/L, other causes of hypotonic hyponatremia should be excluded before implicating SIADH.

https://eje.bioscientifica.com/view/journals/eje/170/3/G1.xml

Last Accessed: August 5, 2021

Level of Evidence: Expert Opinion/Consensus Statement

In all patients with suspected SIADH, hypothyroidism and adrenal insufficiency should be ruled out [17]. Patients should be asked about a history of head injury, chronic pain, smoking, weight loss, respiratory symptoms, drug use, and any new symptoms experienced [17]. The physical exam should include an assessment of the patient's volume status, skin turgor, mucous membranes, neurologic status, and vital signs. There is no specific diagnostic tool or test for SIADH, but the Bartter-Schwartz criteria, developed in 1967, are still used today to aid in diagnosis [17]. The following are the criteria for this tool [17]:

- Serum sodium <135 mEq/L

- Serum osmolality <275 mOsm/Kg

- Urine sodium >40 mEq/L

- Urine osmolality >100 mOsm/kg

- Absence of clinical evidence of volume depletion

- Absence of other causes of hyponatremia

- Correction of hyponatremia with fluid restriction

Selection of appropriate diagnostic tests is vital, because it will affect the successful correction of hyponatremia and patient success rates [65]. Although a variety of tests are used, the three cardinal tests assess urine osmolality, plasma osmolality, and urine sodium [65]. Patients with SIADH will have decreased serum sodium, increased urine sodium, decreased serum osmolality, increased urine osmolality, decreased blood urea nitrogen (BUN), and concentrated urine [16,66]. Urine osmolality will be greater than 50 mOsm/Kg, and often greater than 100 mOsm/kg [64]. Serum ADH will also be increased.

TREATMENT AND NURSING INTERVENTIONS

Treatment of SIADH is directed toward its underlying cause. Approaches will differ for acute and chronic disease [63]. One of the main goals of treatment is the correction of hyponatremia, with a target serum sodium level of more than 130 mEq/L [17]. Even mild cases of hyponatremia are associated with a variety of safety risks, including gait instability, falls, osteoporosis, bone fractures, attention deficit, and increased mortality [67]. Although these risks are known, many patients admitted to the hospital with SIADH are discharged with continued hyponatremia [65].

In elderly patients a common cause of hyponatremia is chronic SIADH, and these patients may have aging-related safety risks exacerbated by low serum sodium levels [67]. Additionally, chronic SIADH is associated with a decreased bone mass, increasing the risk for fractures [63].

It is important to slowly increase sodium levels, because increasing the concentration too quickly can lead to osmotic demyelination syndrome and poor outcomes [17,64]. Osmotic demyelination syndrome, also known as central pontine myelinolysis, is seen more often in those treated with hypertonic saline or tolvaptan [65,68]. Rapid correction of sodium leads to a fluid shift and essentially dehydration of the brain cells, which causes degeneration and demyelination of the myelin [68]. Patients with euvolemic hyponatremia (as opposed to hypervolemic hyponatremia) have an increased risk for rapid sodium correction and the development of osmotic demyelination syndrome [66]. Other risk factors include alcohol use disorder, malnutrition, liver disease, hypokalemia, hyponatremia lasting longer than two days, and decreased serum sodium concentration in conjunction with decreased BUN prior to the start of therapy [66,68]. With this in mind, these laboratory values should be assessed/considered prior to initiating treatment.

The signs and symptoms associated with osmotic demyelination typically arise in two to six days. The first signs and symptoms include changes in level of consciousness and difficulty or inability to speak [68]. Patients may also develop dysarthria, dysphagia, paraparesis, quadriparesis, spastic quadriplegia, confusion, disorientation, obtundation, pseudobulbar palsy, encephalopathy, and coma [68]. These signs and symptoms are the result of noninflammatory demyelination of the pons [68]. In severe cases, a type of locked-in syndrome can develop, whereby the patient is paralyzed and unable to communicate but fully awake [17]. The effects of this condition may be partially reversible, but in many instances, they are permanent. Prevention involves avoidance of sodium increases of more than 8 mEq/L in 24 hours or 0.5–1 mEq/L per hour [17]. Treatment focuses on addressing symptoms and lowering the serum sodium concentration [68].

Patients with mild-to-moderate SIADH may require fluid restriction, which will lead to the release of aldosterone and the conservation of sodium by the kidneys [17,24]. The recommended fluid intake is often 600–800 mL per day, which can be a significant challenge for many patients [24,67]. In fact, the major challenge with fluid restriction is non-compliance, and patient education will play an important role in the patient's plan of care. Fluid restriction should be used cautiously in patients with an increased risk for hypovolemia.

If fluid restriction is unsuccessful or if the patient is acutely ill and symptomatic, hypertonic 3% saline may be administered to help increase serum sodium levels; this is typically reserved for patients with severe hyponatremia [17]. This intervention should be completed cautiously, because when the solution is administered too rapidly the fluid shifts can damage the brain [24]. The initial dose is 100 mL hypertonic 3% saline bolus in the first three to four hours [17]. Serum sodium levels are then checked within two to three hours, and the results will help to guide continued treatment [17]. These patients should be closely monitored for fluid overload. Because of the risks of severe side effects, isotonic saline should only be used in hyponatremic emergencies [65].

In some cases, loop or thiazide diuretics may be ordered to help rid the body of excess fluid. Use of diuretics is often reserved for patients with cardiac symptoms [24]. Patients prescribed diuretics may take oral salt tablets or increase dietary salt intake to decrease the urine concentration [17].

Conivaptan is a vasopressin 2 receptor antagonist that may be ordered for severe cases of hyponatremia [16]. This agent is given intravenously and blocks the action of ADH at the kidney level [16,66].

Tolvaptan is also a vasopressin 2 receptor antagonist, but it is given orally [17]. This medication is hepatotoxic and should be avoided in patients with pre-existing liver disease. Tolvaptan increases sodium levels at a faster rate than other methods, but it can increase the rates too rapidly, leading to osmotic demyelination syndrome [65]. Potential side effects include dry mouth, polydipsia, liver toxicity, and polyuria [63]. It is also important to consider that this medication can be quite costly.

Other medications that may be used in the treatment of this condition are lithium and demeclocycline [17]. Demeclocycline, an antibiotic that blocks the action of ADH at the tubules of the kidney, is administered at a dose of 600–1,200 mg/day in divided doses [24]. Both of these medications are nephrotoxic and associated with undesirable side effects.

If a secreting tumor is the underlying cause of SIADH, the tumor may need to be removed [16]. The removal and additional treatment of the tumor will depend on a variety of factors, including whether the tumor is malignant or benign. If medications are associated with this condition, they should be stopped, if possible.

Patients with SIADH should be monitored for patent airway. For patients without respiratory symptoms, the head of the bed should be kept low (i.e., 10 degrees or less) [24]. Keeping the head of the bed low will enhance venous return and left atrial filling pressure, leading to a decrease in the release of ADH [24].

Other nursing interventions include closely monitoring intake and output, daily weight checks, assisting with hemodynamic monitoring, and neurologic checks. Because the most common indicator of SIADH is decreased serum sodium levels, the patient's laboratory values should be monitored closely [24]. Urinary output may be monitored hourly, with notation of color, clarity, and odor. In most patients with SIADH, urinary output will be decreased and urine will appear concentrated. If the patient on fluid restrictions complains of a dry mouth, hard candies, dry mouth lozenges, or moisturizing mouth swabs may be offered. Patients should also be educated on SIADH and treatment, with an emphasis on the importance of adhering to fluid restriction and increased salt intake.

7. GROWTH HORMONE DEFICIENCY

Growth hormone deficiency is usually the result of genetic mutations or structural defects in the brain and can affect children and adults [69]. Acquired growth hormone deficiency in adults is due to malnutrition, trauma (e.g., traumatic brain injury [TBI], Sheehan syndrome), infection (e.g., meningitis, encephalitis), radiation therapy, brain tumors, or the treatment of acromegaly [69; 70]. In children, malnutrition, neglect, and/or emotional stress can lead to a growth hormone deficiency [16]. Cases in which there is no identifiable cause are classified as idiopathic.

Worldwide, malnutrition is the most common cause of growth hormone deficiency [16]. The prevalence of growth hormone deficiency in children is 1.8 to 2.9 per 10,000 population [71]. Approximately 6,000 new cases of adult-onset growth hormone deficiency are diagnosed each year in the United States [21].

PATHOPHYSIOLOGY

Congenital growth hormone deficiency can be genetic or the result of structural changes in the brain. It appears to have a hereditary factor; approximately 5% to 30% of children with growth hormone deficiency have a first-degree relative with the disorder [20]. These patients have an increased risk for other pituitary hormone abnormalities and anatomic differences of the pituitary gland [20]. Three abnormalities are commonly seen in patients with congenital growth hormone deficiency: interrupted or thin pituitary stalk; absent or ectopic posterior pituitary gland (i.e., the posterior portion of the pituitary gland is in an abnormal position); and anterior hypoplasia or aplasia of the pituitary gland [20].

Genetic causes of growth hormone deficiency include growth hormone deficiency IA, IB, IIB, and III [69]. Growth hormone deficiency IA is an autosomal recessive disorder in which the fetus develops growth retardation in utero [69]. When these children are initially given growth hormone, they respond appropriately, but over time, they create antibodies to the growth hormone [69]. Growth hormone deficiency IB is an autosomal recessive disorder in which the child has some growth hormone and will respond to the administration of growth hormone [69]. Growth hormone IIB is an autosomal dominant disorder, and III is an x-linked disorder [69]. Both of these genetic disorders are similar to growth hormone deficiency IB [69].

Adult-onset growth hormone deficiency is typically caused by a pituitary tumor or brain trauma, but less common causes include surgery, radiation, infection, and hemorrhage [23,69]. These contributing factors cause damage to the pituitary gland, leading to a growth hormone deficiency. Deficiency in adults can also be caused by persistent childhood growth hormone deficiency [23]. It is also important to consider that growth hormone secretion decreases with age [22].

Treatment of acromegaly suppresses growth hormone secretion and reduces insulin-like growth factor levels [22]. An estimated 30% to 75% of patients undergoing radiation therapy for acromegaly develop growth hormone deficiency, with increased risk associated with younger age, high doses of radiotherapy, and extended treatment [22]. This effect will be discussed in greater detail later in this course.

TBI has been associated with growth hormone deficiency; more severe TBI increases this risk [70]. However, growth hormone deficiency after a TBI is not well-known and can be easily missed [70]. The reported prevalence is variable due to a multitude of factors, but an estimated 2% to 30% of patients who have experienced a TBI will develop growth hormone deficiency within one month [25]. Further, an estimated 10% to 63.6% of patients in the chronic phase of TBI will develop growth hormone deficiency [25]. The underlying cause in these patients is ischemic injury to the pituitary gland, particularly the pituitary stalk, which is fragile and prone to injury [25]. In the secondary phase of TBI, ischemic, cytotoxic, and inflammatory changes can increase the risk for the development of a growth hormone deficiency [25].

In some cases, malnutrition, neglect, and/or emotional/environmental stress can lead to delayed growth [71]. This may be related to inflammation that develops due to chronic stress; increased inflammation is associated with decreased levels of insulin-like growth factor and growth hormone resistance [71].

Sheehan Syndrome

Sheehan syndrome is a rare postpartum pituitary dysfunction caused by pituitary necrosis [70]. This condition develops after severe hypotension and shock associated with hemorrhage during delivery [70]. A variety of hormonal deficiencies can develop in the patient with Sheehan syndrome, but growth hormone deficiency is one of the most common [72]. Although relatively rare in the United States, this disorder is still seen frequently in developing countries due to the lack of obstetric care [72].

Sheehan syndrome is characterized by hypopituitarism caused by ischemic pituitary necrosis developing after blood loss associated with childbirth [72]. The pituitary gland is susceptible to injury during and immediately after pregnancy because the anterior pituitary gland enlarges during pregnancy but does not develop an increased blood supply [72].

SIGNS AND SYMPTOMS

The signs and symptoms observed with growth hormone deficiency will vary depending on the age of the individual affected.

Children

Growth hormone deficiency can present in a variety of ways in children. Growth retardation, short stature, and delays in maturation are common signs [69]. Children with this deficiency typically have delays in longitudinal bone growth, and untreated growth hormone deficiency results in an average maximal height of 3–4 feet, although body proportions are normal. These children will also display slowed sexual maturation and, in some cases, cognitive deficits. Excess weight and a younger than expected appearance and voice may also be noted [73].

Children with growth hormone deficiency are typically within normal range for size at birth [69]. However, infants with anatomic changes in the pituitary gland are more likely to be born breech and to have jaundice, hypoxia, and hypoglycemia [20]. As these children grow, they will present with delayed development of the facial bones, slowed tooth eruption, fine hair, poor nail growth, and delayed lengthening of the long bones [69]. If the growth hormone deficiency is associated with malnutrition, changes in the child's weight will often be observed before delayed growth [71]. In infants, the fontanelles may take longer than expected to close [69]. Additional signs and symptoms include poor appetite, decreased strength, decreased muscle development, low energy, poor endurance, sleep difficulties, trouble concentrating, and fatigue [73].

Growth hormone deficiency can impact a child's daily, emotional, and social life [73]. The child may report a decreased ability to play sports or participate in social activities [73]. Short stature may lead to bullying, leaving the child to feel as if he or she is different and socially isolated.

Adults

Adults with a growth hormone deficiency may present with fatigue, weakness, obesity, decreased muscle mass, weakened bones, sexual dysfunction, elevated cholesterol levels, and insulin resistance [16,69]. Decreased bone turnover and decreased bone mass are common, and adults with a growth hormone deficiency have a risk for fracture that is two to three times higher than their counterparts without growth hormone deficiency [23]. Early onset of deficiency (i.e., in childhood) and cigarette smoking can further increase this risk [23].

These patients are at an increased risk for cardiovascular and neurologic disorders. Growth hormone deficiency is associated with increased abdominal subcutaneous tissue, insulin resistance, hypercoagulability, increased total and low-density lipoprotein (LDL) cholesterol levels, decreased high-density lipoprotein (HDL) cholesterol levels, decreased exercise performance, and atherosclerosis [21]. All of these changes can increase the risk for cardiovascular complications.

As with pediatric patients, growth hormone deficiency can decrease adult patients' quality of life, and treatment has been shown to improve satisfaction with life [21,22]. These individuals are more likely to be unemployed, on sick leave, or on disability [21]. Patients who develop a growth hormone deficiency after a TBI are more likely to develop depression and report a decreased quality of life [25].

DIAGNOSTIC TESTS

Evidence Based Practice Recommendation

The Endocrine Society recommends that the insulin tolerance test and the GHRH-arginine test have sufficient sensitivity and specificity to establish the diagnosis of growth hormone deficiency in adults.

https://academic.oup.com/jcem/article/96/6/1587/2833853

Last Accessed: August 5, 2021

Strength of Recommendation/Level of Evidence: 1/⊕⊕⊕⊕ (Strong recommendation based on high-quality evidence)

The diagnosis of congenital causes of growth hormone deficiency is often delayed until slow growth is observed in a child [69]. It is common to see initial diagnosis around 5 years of age, when children start school or when puberty is delayed (10 to 13 years of age for girls, 12 to 16 years of age for boys) [69]. Diagnostic tests for a growth hormone deficiency include serum growth hormone levels, growth hormone stimulation test, pituitary MRI, and bone density tests.

Although growth hormone levels can be measured, these tests can be unreliable because hormones are not secreted in consistent amounts throughout the day. Additionally, a variety of medications can affect growth hormone levels and interfere with diagnostic testing [32]. As such, a medication review should be conducted to determine if any could interfere with testing. Medications that can affect the results include insulin, estrogen, amphetamines, oral contraception, and corticosteroids; the herbal supplement St. John's wort can also impact findings [33].

A more reliable test is the growth hormone stimulation test, which measures the response of growth hormone to hypoglycemia [16]. Medications that may be used in stimulation testing are clonidine, arginine, and glucagon [20]. In the patient with a growth hormone deficiency, growth hormone levels would not elevate as expected.

An MRI is usually completed to assess for tumors, and a bone density test will provide information about bone strength and possible disorders (e.g., osteopenia, osteoporosis). In patients with congenital growth hormone deficiency, an MRI will help to identify abnormal pituitary anatomy rather than for definitive diagnosis. However, conducting an MRI can be challenging for pediatric patients and may require sedation to remain calm and still for approximately 45 minutes.

Diagnosis of a growth hormone deficiency after TBI can be challenging because many of the signs and symptoms associated with each condition overlap [25]. It is important to consider that increases in the severity of TBI likewise increase the risk of growth hormone deficiency [25]. As such, patients with a severe TBI should be evaluated. In these patients, plasma insulin growth factor is not a useful measure, because it lacks sensitivity and accuracy [25]. Instead, an insulin tolerance test, GHRH levels, and/or glucagon stimulation test should be used [25].

The diagnosis of growth hormone deficiency due to Sheehan syndrome is often delayed, in some instances for many years [72]. This is often because it is overlooked by healthcare professionals, and it should be considered as part of the differential diagnosis in women presenting with suggestive signs and symptoms [72].

TREATMENT AND NURSING INTERVENTIONS

The treatment of growth hormone deficiency is most commonly the administration of synthetic human growth hormone. If hormone replacement is initiated during childhood, the patient will usually reach a normal height in adulthood; even those with short stature can catch up [71,74]. The goal is to start hormone replacement before the child drops below the third percentile for height [21].

Growth hormone replacement is also appropriate therapy for adults and can lead to increased bone turnover, expanded remodeling space, decreased fracture risk, and over time, increased bone density [23]. It is interesting to note that some research has shown that the positive effect on bone density is more pronounced in men than women [23].

Somatropin, a recombinant growth hormone, may be used for both children and adults with a growth hormone deficiency. This medication increases skeletal growth in children and increases bone density in adults [75]. Somatropin is administered as a subcutaneous injection, usually in the evening to mimic the body's normal rhythm [21]. The onset of action is typically within three months of the initiation of treatment [75]. Starting treatment early will help prevent delayed growth in children. In most cases, somatropin is administered to children when delayed growth is identified, with doses increased when the child is going through puberty and discontinued when skeletal maturation is reached [69]. However, testing should be completed to determine if the patient should continue treatment, as early cessation can lead to negative consequences in adulthood [69]. Adverse effects of somatropin include edema of the hands and feet, hyperglycemia, hypothyroidism, insulin resistance, pancreatitis, pain at the injection site, lipodystrophy, carpal tunnel syndrome, and arthralgia [21,75]. Lipodystrophy can be prevented by rotating injection sites. Concurrent use of corticosteroids can decrease the effectiveness of somatropin [75].

During somatropin treatment, children should have growth (height and weight) assessed every three to six months [75]. In adolescence, patients' growth and puberty should be monitored every six months [74]. Because this medication has been linked to hypothyroidism, thyroid function should be periodically checked. Somatropin treatment is ineffective in the presence of hypothyroidism, so treatment of the condition is vital [75]. Patients should also be monitored for hyperglycemia, especially patients diagnosed with diabetes. In addition, patients given somatropin after epiphyseal closure should be monitored for signs and symptoms of acromegaly.

Somapacitan, a long-acting human growth hormone analog, was approved for use in adults with growth hormone deficiency in 2020 [76]. This medication is administered as a once-weekly injection [76,77]. The initial dose is 1.5 mg, but the dose can be increased by 0.5–1.5 mg per week (to a maximum 8 mg per week) every two to four weeks based on clinical response and insulin-like growth factor-1 levels. Potential adverse effects include back pain, joint pain, indigestion, sleep disorders, dizziness, tonsillitis, edema of the extremities, vomiting, adrenal insufficiency, hypertension, increased blood creatinine phosphokinase, weight gain, and anemia [76]. The dose should be reduced if needed for adverse reactions or elevated insulin-like growth factor-1 levels. Somapacitan is contraindicated in patients with malignancy, diabetic retinopathy, and acute critical illness [76,77]. Discontinuation of therapy should be considered if no apparent benefits are achieved after 12 to 18 months.

Growth hormone replacement therapy should continue over a prolonged period of time, in some cases for the patient's entire life. Patients receiving this treatment should be taught self-administration techniques.

Due to the length of treatment, adherence can be a challenge. Factors that may affect adherence include cost, length of treatment, and decreased understanding of treatment. Transition to adolescence is an important challenge to adherence [74]. Factors that may negatively affect adherence in adolescence include peer group conflict and loss of a sense of control. This is also a period of increased independence during which adolescents may want to take a more central role in managing their own care.

Poor compliance with or delayed therapy can lead to poor growth in children and to increased weight, changes to bone metabolism and density, and changes to cardiac structure and function (e.g., exercise intolerance, bradycardia, dilated cardiomyopathy) in adults [74]. Cognitive/psychological changes associated with poor compliance may include fatigue, sleep disturbance, decreased motivation, decreased self-esteem, and isolation [74].

With adherence in mind, empowering patients is important. For pediatric patient, parents/caregivers and the patient should be educated, offering choices (whenever possible), rewards, and age-appropriate educational materials [74]. Adolescent patients should be asked how they feel about their treatment and allowed to make decisions so they feel a sense of control. Adult patients should be encouraged to attend regular follow-up appointments and be provided with education on the benefits of treatment. Phone alerts or text or e-mail reminders may be beneficial [74]. Because cigarette smoking can increase the risk for fracture in adults with a growth hormone deficiency, patients should be advised to quit smoking and provided with cessation tools and resources.

8. DISORDERS OF HYPERSOMATOTROPISM

Hypersecretion of somatotropin by the anterior pituitary results in gigantism (before puberty) or acromegaly (after puberty). The crucial factor is the time onset of the disorder. If the hypersecretion of growth hormone occurs during the individual's growth period before the epiphyses of long bones have closed, gigantism will occur. Acromegaly occurs after epiphyseal closure [78,79].

ACROMEGALY

Acromegaly is a rare condition, with approximately 3 to 14 of every 100,000 people diagnosed [80]. It is seen most commonly in adults between 30 and 40 years of age and more frequently in women than men [16,24]. Acromegaly is most commonly caused by pituitary tumors (e.g., adenomas, hypothalamic adenomas), but pituitary hyperplasia and genetic mutation are other possible etiologies.

Pathophysiology

As noted, acromegaly develops when there is excessive growth hormone after the closure of the growth plates [80]. Bones will specifically increase in width rather than length. Subcutaneous connective tissues, organs, and glands may also enlarge [16].

Patients with acromegaly have increased levels of somatotropin and insulin-like growth factor [22]. Insulin-like growth factor alters the metabolism of blood glucose and lipids, increasing the risk for type 2 diabetes, hypertension, and cardiovascular disease [80]. Patients with acromegaly may also have an abnormal production of glucocorticoids, mineralocorticoids, and gonadotropins [24].

The majority of cases of growth hormone hypersecretion (more than 90%) are caused by benign pituitary adenomas [19]. In the United States, it is estimated that about 16% of the population (more than 50 million people) have pituitary tumors, although most are undiagnosed. Approximately 13,000 people are diagnosed with pituitary tumors each year; 25% of these tumors will lead to acromegaly [21]. It is possible for patients to develop a malignant pituitary adenoma that is responsible for acromegaly, but this occurs in less than 1% of cases [24]. The disorder may also be caused by hypothalamic adenomas that increase the amount of GHRH, which, in turn, increases growth hormone levels [19]. Other types of tumors, such as those found in the hypothalamus, pancreas, lungs, chest, or abdomen, can also lead to acromegaly [80]. These tumors can secrete their own growth hormone, although it is more common for them to produce GHRH [80]. Additional possible causes include pituitary hyperplasia and excess GHRH [16].

Acromegaly has been shown to run in families, and several mutated genes have been associated with acromegaly, including AIP, MEN1, CDKN1B, PRKARIA, SDHx, GPR101, and GNAS [81]. The most common genetic cause of acromegaly is familial isolated pituitary adenoma syndrome [81]. Less common causes are Carney complex, multiple endocrine neoplasia, and sporadic acromegaly [81]. The exact mechanisms behind familial isolated pituitary adenoma are not fully understood [81].

Signs and Symptoms

The term acromegaly refers to enlargement of the acral parts—the head, hands, and feet—and these patients often present with enlargement of facial features, excessive growth of the hands and feet, and hypertrophy of soft tissues. The signs and symptoms may develop slowly and not become apparent for years [19].

Patients with acromegaly will have lateral changes to the bones of the face, and the mandible will enlarge and protrude. The space between the patient's teeth may widen and teeth may become displaced, which can lead to problems chewing and eating. The tongue and salivary glands often enlarge, leading to trouble with speaking and eating [16,21]. In addition to the tongue thickening, the lips and nose also enlarge, impeding breathing and possibly causing sleep apnea [80]. The patient's hair and skin may become thick, coarse, and oily [80]. Approximately 70% of patients with acromegaly report oily skin with increased sweating and unpleasant odor [21]. Some patients describe skin tags that become larger and darker [80]. Joint changes are seen in approximately 70% of patients with acromegaly, and joint pain and osteoarthritis often develop [19]. Growth hormone can increase bone resorption and turnover, increasing the risk for fracture [21].

Evidence Based Practice Recommendation

The Endocrine Society suggests evaluating all patients presenting with acromegaly for associated comorbidities, including hypertension, diabetes mellitus, cardiovascular disease, osteoarthritis, and sleep apnea.

https://academic.oup.com/jcem/article/99/11/3933/2836347

Last Accessed: August 5, 2021

Strength of Recommendation/Level of Evidence: 2|⊕⊕○○ (Weak recommendation based on low-quality evidence)

Patients with pituitary enlargement may complain of headaches and visual disturbances (e.g., diplopia) as a result of the adenoma pushing on the brain and cranial nerves III, IV, and VI [16,19,24]. If the tumor presses on other pituitary tissue, it can lead to menstrual changes, erectile dysfunction, thyroid hormone changes, and decreased circulating cortisol [80]. The headaches may be severe and can interfere with the patient's ability to perform daily tasks [21]. If cranial nerve V is involved, the patient may also complain of facial pain [21].

Patients with acromegaly often have a reduced life expectancy because of associated cardiovascular, respiratory, metabolic, and neoplastic conditions [22]. Cardiac disease, including cardiomyopathy, arrhythmias, hypertension, and diastolic overload, is seen in approximately 60% of patients with acromegaly [21]. As many as 50% of patients will develop hypertension [21].

Diagnosis

The slow progression of acromegaly often delays diagnosis and treatment [80]. This is a problem, because associated health conditions can develop and cause significant damage during this period [80]. The first step is in an accurate physical exam and history. Patients should be observed for any enlargement in facial features; it may be helpful to ask the patient to bring in an older photograph for comparison [24]. Patients should also be asked about any changes that they have noticed, such as an increase in ring or shoe size [16]. An oral exam may be significant for an enlarged tongue; if present, respiratory issues may be a concern. Patients should be asked about any problems chewing, eating, or swallowing or with sleep (e.g., snoring and excessive daytime sleepiness, which may be signs of sleep apnea). When speaking with the patient, assess for and note any difficulty speaking. The nurse should ask the patient about skin changes, sweating, increased body odor, changes to body hair, and skin tags, and an assessment of the patient's integumentary system should be conducted. Patients should be asked about a history of headaches or visual changes, either of which would warrant additional investigation.

Appropriate diagnostic tests include serum insulin-like growth factor, growth hormone levels, serum glucose, MRI, CT scan, bone density scans, and x-rays [24]. Insulin-like growth hormone levels are more than five times greater in patients with acromegaly than in those without the disease [24,80]. For patients with moderately elevated insulin-like growth factor, an oral glucose tolerance test may also be ordered. This test consists of the patient drinking a sugary liquid, typically containing 75 mg of glucose, and blood samples taken after one and two hours to measure growth hormone [24,80]. Under normal conditions, growth hormone levels would drop after consumption of glucose, but this will not occur in patients with acromegaly. Theoretically, blood tests of growth hormone levels would also be elevated, but these tests may be unreliable. Elevated blood glucose levels are also common in these patients.

Bone density testing is completed to identify any weakening of the patient's bones, and x-rays are done to identify bone enlargement. An MRI should be conducted to visualize pituitary and any other tumors.

Treatment and Nursing Interventions

The changes associated with acromegaly usually develop over 7 to 10 years, but the best outcomes are associated with early identification and treatment [24]. Left untreated, this condition can result in early mortality and decreased quality of life [80]. However, treatment allows patients with acromegaly a normal life expectancy and quality of life [80].

In most cases, the goal of treatment is to control the size of the underlying tumor, to return growth hormone and insulin-like growth factor levels to normal, and to improve symptoms and manage any associated conditions [80]. It is particularly important to address any cardiovascular complications, as these are the main cause of excess mortality [21].

Surgical Intervention

A common treatment option is the surgical removal of the pituitary adenoma by endoscopic, transnasal, or transsphenoidal route [24]. For 60% of patients, surgery will result in cure, and in many cases, pituitary function may be preserved [24]. However, some may require hypophysectomy, with fluoroscopy-guided removal of the pituitary gland along with any adenoma or other tumors [80].

Possible postoperative complications include bleeding, cerebrospinal fluid leaks, sodium imbalances, fluid imbalances, decreased pituitary hormones, diabetes insipidus, hypopituitarism, and meningitis [24,80]. Postsurgical nursing interventions include [24]:

- Assess neurologic status

- Assess for pain

- Assess for nasal drainage

- Elevate the head of the bed

- Educate about the avoidance of activities that increase intracranial pressure

- Check blood glucose and serum sodium levels

If present, clear nasal drainage should be checked for glucose to ensure that it is not cerebral spinal fluid [24]. The head of the bed should be elevated to promote drainage and to make breathing easier. Patients should be advised to avoid coughing, straining for a bowel movement, or any other activity that can increase intracranial pressure for up to two months following the procedure. Tooth brushing can cause damage to the surgical incision site and should also be avoided. After the removal of pituitary adenoma, hypoglycemia may develop as growth hormone and insulin-like growth factor levels drop [24]. Approximately 20% of patients have associated pituitary damage and may require replacement of glucocorticoids, gonadotropins, and thyroid hormone [24].

Radiation Therapy

Radiation therapy is another treatment option for patients with acromegaly caused by malignancy. It is typically a second-line option if surgery and/or pharmacotherapy are ineffective [80]. It is important to understand that it can take years for this treatment to improve symptoms [80]. Further, this therapy can impair fertility and approximately 50% of patients will require hormone replacement [80].

Pharmacotherapy

Medications used in the treatment of acromegaly include somatostatin analogs, dopamine agonists, and growth hormone-receptor antagonists [80]. These medications are initiated in patients who do not have remission following surgical removal of adenoma or in patients for whom surgery and/or radiation therapy is contraindicated [24].

Somatostatin analogs (e.g., octreotide, lanreotide) work by slowing the release of growth hormone [80]. In some cases, these medications can effectively reduce the size of the pituitary tumor [80]. Octreotide suppresses growth hormone, insulin, and glucagon and helps to normalize growth hormone and insulin-like growth factor levels in patients with acromegaly [75]. Octreotide is available in short- and long-acting forms [24]. The short-acting form is given as a 100-mg subcutaneous injection three times daily; the long-acting form is given as a 10- to 30-mg intramuscular injection once monthly [24]. Lanreotide is a treatment option for patients with acromegaly who are not candidates for or who have not responded to other treatment options [75]. Lanreotide is given as a 60- to 120-mg subcutaneous injection monthly and is intended to be administered by a healthcare professional [75]. Potential side effects of somatostatin analogs include cramps, bradycardia, orthostatic hypotension, gas, diarrhea, gallstones, and hair loss [80]. Octreotide has been linked to dizziness, bradycardia, and orthostatic hypotension, so pulse and blood pressure should be monitored in these patients prior to and periodically throughout treatment. Patients should be advised to move slowly and not operate vehicles or heavy machinery until they know how they respond to the medication. Octreotide can also increase fertility in ovulating patients, so precautions to prevent pregnancy are necessary [75]. GI side effects are common when starting lanreotide but will often decrease with time [75].

Dopamine agonists (e.g., bromocriptine) are a treatment option to inhibit growth hormone production and tumor growth, but they are not as effective as somatostatin analogs [80]. Growth hormone-receptor antagonists (e.g., pegvisomant) decrease growth hormone levels and may be given orally. Potential side effects include GI upset, nausea, vomiting, headache, postural hypotension, dizziness, nasal congestion, and cold-induced vasospasm [21]. Laboratory changes may also be noted, including increased serum BUN, aspartate transaminase (AST), alanine transaminase (ALT), creatine phosphokinase (CPK), alkaline phosphatase, and uric acid levels [75]. Due to the risk of severe hypotension with the first dose, patients should be supervised when treatment is initiated.

Growth hormone antagonists (e.g., pegvisomant) are given to lower insulin-like growth factor levels [24]. Pegvisomant is used for patients with acromegaly who do not respond to other therapies and are not candidates for surgery or radiation [75]. It binds to growth hormone receptor sites and blocks the effects of growth hormone, decreasing the manifestations of acromegaly [75]. Pegvisomant is given as a daily subcutaneous injection and takes two weeks to start working [24,75]. Insulin-like growth factor levels should be checked within four to six weeks of the onset of therapy and every six months thereafter [75]. Side effects include hypertension, peripheral edema, lipohypertrophy, increased glucose tolerance, elevated liver enzymes, increased fertility, dizziness, and back pain [75].

If the therapy regimen includes injectable medications, patients should receive instruction on injection technique and should be able to demonstrate appropriate medication administration. Patients with acromegaly often experience changes to their self-concept [24]. Nurses should inquire about how the condition is affecting their life and help develop a plan of care based on the information obtained from the patient.

GIGANTISM

Gigantism starts in infancy or childhood and is characterized by continuous growth of the body until epiphyseal closure occurs. In adults, it is defined as a height greater than 80 inches; in children, it is defined as three standard deviations above the mean for the child's age as measured on a growth curve. Adults with gigantism may be as tall as 8 feet and weigh more than 300 pounds. Some individuals may develop associated acromegaly features (i.e., very large heads, hands, and feet) in adulthood [79].

Signs and Symptoms

Untreated, patients with gigantism have an increased death rate of approximately twice the normal average for the population. These patients experience progressive debilitation, but treatment can be very effective [78,79]. They generally present with [78,79]:

- Extremely large size

- Enlargement of the heart, liver, spleen, kidneys, pancreas, thyroid, parathyroid, adrenals, soft tissues, and/or peripheral nerves

- Increased metabolic rate

- Incomplete or slow development of secondary sex characteristics

- Glucose intolerance with resulting hyperglycemia and diabetes mellitus

- Possible excess secretion of other anterior pituitary hormones (e.g., prolactin, ACTH)

More advanced signs include extreme muscular weakness and crippling osteoarthritis, which may be associated with a severe kyphosis [78,79].

The symptoms of gigantism are usually attributable to the effects of compression of the adjacent tissues by the pituitary tumor or by metabolic changes. Symptoms include headache, which may be mild to severe and persistent; bitemporal hemianopia and other visual field defects (e.g., changes in color perception, diplopia) due to pressure in the optic chiasm; and seizures and stroke resulting from increased intracranial pressure [78,79].

Treatment

Because the underlying pathophysiology of gigantism is similar to acromegaly (usually pituitary tumor), the approach to treatment is generally the same. However, because most of these patients are children, patient and family education should be adjusted. Patients should be allowed opportunities to discuss their feelings and ask questions about the changes in their physical appearance. Children with gigantism require information about the reasons for the changes in physical appearance and also what might occur in the future. These patients are often coping with major differences in body size and shape as compared with peers, and this can result in bullying and insecurity [55].

9. ADDISON DISEASE

Addison disease, also known as primary adrenal insufficiency, develops when the adrenal glands do not produce enough of the hormones cortisol and aldosterone. In the United States, Addison disease affects approximately 4 out of every 100,000 people and is seen more commonly in women than men [27,37]. This disorder is typically diagnosed among individuals 30 to 50 years of age, but it can develop at any age [37]. Addison disease may be caused by an autoimmune disease, genetics, infections, adrenalectomy, hemorrhage, cancer, amyloidosis, adrenoleukodystrophy (ALD), or medications, or as a side effect of the treatment of Cushing syndrome [45].

PATHOPHYSIOLOGY

As discussed, the adrenal glands are found above each kidney and produce cortisol, a glucocorticoid and aldosterone, a mineralocorticoid. In patients with Addison disease, an abnormality of the adrenal cortex leads to inadequate amounts of circulating cortisol and, in some cases, aldosterone [82].

Autoimmune disease is the most common cause of Addison disease, accounting for approximately 80% to 90% of all cases [37]. Autoimmune Addison disease, also referred to as autoimmune adrenalitis, results in atrophied adrenal glands and an inability to produce hormones in sufficient amounts. Cells destroyed by the inflammatory response are replaced by fibrotic tissue [83]. In these patients, the cells in the adrenal cortex are damaged but the medulla remains intact [83].

Risk for Addison disease is increased in those with a family history of the disease, with heritability accounting for 97% of cases in a Swedish twin study [24]. In addition, other autoimmune conditions have been associated with an increased risk of Addison disease, including vitiligo, type 1 diabetes, and hypothyroidism [45].

Viral, bacterial, or fungal infection or parasitic infestation of the adrenal glands can lead to changes, and childhood infections may predispose a patient to Addison disease [83]. Worldwide, tuberculosis is the most common cause of Addison disease, although this is not routinely seen as a cause in developed countries [45,83]. Many infections that damage the adrenal glands are opportunistic, meaning they develop in immunocompromised individuals [83]. Serious infections (e.g., sepsis) require that the body be able to rapidly activate glucocorticoid production, which can lead to adrenal failure and, in some instances, adrenal crisis [83]. However, it has been hypothesized that infections highlight or exacerbate existing adrenal insufficiency rather than initiating it [83].

Patient who undergo bilateral adrenalectomy, as may occur with Cushing syndrome treatment, require steroid replacement or they will develop adrenal insufficiency and subsequent adrenal crisis. However, unilateral adrenalectomy rarely causes Addison disease unless the patient experiences severe adrenal stress, in which case the reduced adrenal reserve may be depleted [84]. Conditions that increase the risk for adrenal stress include sepsis, cardiopulmonary disturbance, trauma, and postoperative complications [84].

Hemorrhage (usually in response to infection or trauma) or malignant cells in the adrenal glands can cause damage and negatively affect the glands' ability to secrete cortisol and aldosterone [45]. Amyloidosis is a condition whereby the protein amyloid accumulates and causes damage to the adrenal glands, leading to decreased amounts of cortisol in the body [45]. Medications (e.g., antifungals, general anesthesia) can also lead to the development of Addison disease [37,45].

Adrenal crisis is a serious complication of Addison disease that can result in death if not identified and treated appropriately. Anything that increases the cortisol needs of the body can lead to this condition. In the patient with Addison disease, the body is unable to increase the amount of circulating cortisol in the body, leading to a cortisol deficit. The decline in cortisol and aldosterone directly affects the liver, stomach, and kidneys [85].

SIGNS AND SYMPTOMS

Addison disease is associated with vague, gradually developing (insidious) symptoms that can make diagnosis a challenge [37]. Signs and symptoms associated with this disorder are due to hormone deficiency, with the majority being attributable to decreased cortisol levels, although aldosterone plays a role as well [82]. In many cases, signs and symptoms do not develop until approximately 90% of the adrenal cortex is destroyed, and in some patients, symptoms are not recognized until adrenal crisis develops [45,82].

The most common signs and symptoms of Addison disease are chronic fatigue, lethargy, muscle weakness, loss of appetite, weight loss, increased urination, increased thirst, and abdominal pain [37,45]. Other potential signs and symptoms include nausea, vomiting, diarrhea, hypotension, irritability, depression, joint pain, salt cravings, hypoglycemia, dizziness, reduction in underarm and pubic hair, muscular pain, irregular or no menstruation, decreased libido, darkening of the skin, slowed growth in children, neurologic disturbances, depression, impaired concentration, and hypersensitivity to tastes and smells [37,86].

Cortisol plays a significant role in glucose metabolism, and decreases in cortisol levels can lead to hypoglycemia. Aldosterone acts on the kidneys to increase water retention and blood volume, and decreases in aldosterone levels can lead to hypotension, tachycardia, and salt cravings [16,32,82].

Melanodermia, color changes of the skin, is a potential side effect of Addison disease and most often presents in areas of the body most exposed to sunlight, such as the face, neck, knuckles, elbows, knees, and creases of the palms [24,86]. Darkening of scars may also be seen [85]. Pigment changes seen with Addison disease are due to the stimulant effect of excess ACTH on the melanocytes to produce melanin [82].

Electrolyte changes (e.g., hyponatremia, hyperkalemia, hypercalcemia) may occur with Addison disease [86]. As such, these patients should be closely monitored and may require supplementation and/or a modified diet. The patient with this disorder may also develop lymphocytosis and anemia [82].

Late symptoms of adrenal insufficiency are hypotension, dizziness, syncope, nausea, vomiting, diarrhea, abdominal pain, joint pain, back pain, muscle cramps, chronic exhaustion, skin changes, and decreased libido [45]. Signs and symptoms of adrenal crisis are hypotension, hypoglycemia, hyponatremia, hyperkalemia, vomiting, diarrhea, weakness, confusion, severe dehydration, severe pain in the lower back and abdomen, GI pain, and loss of consciousness [37,86]. Patients with later stage Addison disease may present with pale, cold, clammy skin; sweating; rapid, shallow breathing; and severe muscle weakness [45]. Untreated, adrenal crisis can lead to coma and death.

Patients in adrenal crisis lose large amounts of sodium and water, causing a fluid deficit with resulting hypotension and tachycardia [16]. The patient will often present with hyperkalemia, which can lead to cardiac abnormalities. The decreased cortisol levels in Addison disease will cause decreased glucose output by the liver and decreased digestive enzymes [85].

DIAGNOSTIC TESTS

For most patients with Addison disease, diagnosis will be made around 40 years of age, and it is not uncommon for these patients to see multiple physicians before a diagnosis is made [82]. In cases of primary adrenal insufficiency, diagnosis of Addison disease may be delayed up to one year in as many as half of all cases [86]. Misdiagnosis is also common due to the vague signs and symptoms associated with the condition [82].

As discussed, the diagnostic tests that may be used for suspected Addison disease include ACTH stimulation test, serum cortisol levels, insulin tolerance test, antibody testing, and a CT scan or MRI. Aldosterone, serum cortisol, urine cortisol, blood glucose, and electrolyte levels may also be assessed [16,45]. In these patients, cortisol, aldosterone, sodium and glucose levels would all be low in persons with Addison disease; potassium will be elevated [45]. If the patient becomes dehydrated, BUN and hematocrit levels should be checked and will likely both be elevated. A complete blood count may be checked to determine if the patient has lymphocytosis or anemia.

After completion of the ACTH stimulation and insulin tolerance tests, an antibody test may be ordered. If the antibody test is positive, diagnosis of autoimmune Addison disease may be made with no further testing [37]. The CT scan or MRI may be helpful to evaluate the adrenal glands and/or pituitary gland. These imaging studies can determine if the glands are small in size or if they are enlarged due to infection, bleeding, or malignancy [37]. If tuberculosis is suspected, testing to rule out tuberculosis should be conducted.

TREATMENT AND NURSING INTERVENTIONS

When a patient develops Addison disease, glucocorticoids are typically prescribed. Those with autoimmune Addison disease will require lifelong glucocorticoid treatment, and even with steroid replacement, these patients have an increased risk for morbidity, mortality, and decreased quality of life [83].

Hormone replacement should be carefully planned to ensure the best outcome for the patient. Under typical circumstances, two-thirds of the daily dose is given in the morning and one-third in the evening to mimic the natural circadian rhythm of cortisol levels [16]. Increased doses of hormones are required during times of stress, as this will mimic what normally happens in the body; this includes during illness, infection, accident, injury, invasive medical procedures, and strenuous exercise [45]. If the patient is vomiting, IV or intramuscular hydrocortisone may be necessary [27]. Patients should be educated on self-administration of injectable medications.

The most often prescribed corticosteroid for the treatment of Addison disease is hydrocortisone; however, prednisone or dexamethasone may be used [37]. In patients who are deficient in both cortisol and aldosterone, fludrocortisone is the agent of choice [37]. Fludrocortisone aids in the retention of sodium and loss of potassium, and patients taking this medication should be monitored for signs and symptoms of fluid overload. This involves daily weights and assessment of new onset of edema in the lower extremities. Patients who do not make sufficient amounts of aldosterone should be advised to consume high-salt foods, especially if they are craving salt and on hot days.

One side effect of long-term corticosteroid therapy is an increased risk for osteoporosis [37]. As such, calcium and vitamin D supplementation may be necessary, and patients should be educated about incorporating these nutrients into the diet. Corticosteroids can also lead to mood swings and insomnia [45]. Treatment for these side effects is guided by impact on the patient's life and patient preference.

It may also be necessary to restore fluid, electrolyte, and hormone imbalances [24]. The IV fluid typically used for these patients is 5% dextrose in 0.9% sodium chloride to address glucose and sodium imbalances [24]. Electrolyte disturbances are addressed by adding electrolytes to IV fluid, hanging individual bags of specific electrolyte(s), or oral supplementation.

Nursing assessments should include questions about any recent stressors, such as illness, infection, or traumatic events. It is important to inquire regarding the use of steroids or recent surgery, particularly on the adrenal and/or pituitary glands. Identifying associated signs and symptoms (e.g., increased urination, salt cravings) is important. Standard nursing care includes monitoring vital signs, daily weights, intake and output, and laboratory values. Patients who report increased urination should be monitored for dehydration and signs/symptoms of hypovolemia (e.g., hypotension, tachycardia). Understanding that stress can play a role in this disorder, patients should be assessed for coping abilities and educated about stress reduction strategies. It may also be helpful to ask about the patient's support systems. Patients should be encouraged to wear a medical alert bracelet or necklace to help ensure appropriate care, such as the administration of glucocorticoids if the patient is ill or injured and unable to provide a medical history [45].

Adrenal Crisis

When at all possible, it is important to prevent an adrenal crisis. Risk factors for adrenal crisis include GI infection, febrile infection, surgery, strenuous physical activity, discontinuation of glucocorticoids, psychiatric distress, and accidents [86]. If untreated, these patients can go into shock, followed by coma and death [85]. If adrenal crisis is suspected, treatment should be started quickly to restore fluid balance and cortisol levels [16,87]. Replacement fluids should contain glucose. Cortisol levels are restored with the administration of intravenous glucocorticoids. If IV access is not readily available, glucocorticoids can be given intramuscularly [87]. Glucocorticoids are administered either on an around-the-clock schedule or as a continuous infusion [87]. If necessary, electrolytes should be replaced. For children with adrenal crisis, additional challenges include an increased incidence of hypoglycemia, ensuring weight-based dosing for medications, and difficulty attaining IV access [87].

Patient education is essential for the prevention of adrenal crisis. Patients should be aware of the risk factors in addition to associated signs and symptoms. Specific medication orders should be given for sick/stress days, and an emergency hydrocortisone kit should be available at all times [87].

10. CUSHING SYNDROME

As discussed, Cushing syndrome is a disorder of excess cortisol, and the effects of this disorder can be seen in nearly every body system [24]. It is most commonly seen in individuals between 20 and 50 years of age and is three times more common in women than men [88]. Cushing syndrome affects 40 to 70 people per 1 million population in the United States [28]. Nearly 90% of cases are among adults, but children can be affected [24].

PATHOPHYSIOLOGY

Cushing syndrome is further classified as iatrogenic (or exogenous), primary, secondary, or ectopic [24]. Iatrogenic Cushing syndrome is the most common form and is the result of long-term glucocorticoid therapy [21]. Both primary and secondary Cushing syndrome develop as a result of endogenous causes (e.g., adrenal tumor). Primary Cushing syndrome is typically caused by adrenal gland malignancy, while secondary Cushing syndrome (also referred to as Cushing disease) is the result of excessive secretion of ACTH by a pituitary tumor, usually an adenoma [24]. Ectopic Cushing syndrome arises from the endogenous production of ACTH by one of at least 25 different extrapituitary malignancies, including carcinoma of the lung and of several organs in the GI tract. Secondary Cushing syndrome is the most common (66%) endogenous type of the disease. When this condition is seen in infants, it is most commonly caused by an adrenal carcinoma [24].

As noted, Cushing syndrome is most commonly caused by long-term, high-dose glucocorticoid (e.g., prednisolone, dexamethasone) therapy, often used for the treatment of chronic conditions, such as asthma and chronic obstructive pulmonary disease (COPD) [21,28]. Symptoms associated with exogenous Cushing syndrome typically do not develop until the patient has been taking corticosteroids for at least one month [24].

In comparison, endogenous Cushing syndrome is relatively rare, occurring in 2 to 3 out of every 1 million people [41]. Cushing disease (secondary Cushing syndrome) makes up approximately 70% of all endogenous cases [21]. It is important to note that the terms Cushing syndrome and Cushing disease are not synonymous. Cushing syndrome encompasses cortisol changes from a variety of internal (endogenous) or external (exogenous) causes, while Cushing disease is only endogenous disease caused by a pituitary tumor or hyperplasia of the pituitary gland [29,88].

SIGNS AND SYMPTOMS

A variety of signs and symptoms may be observed in patients with Cushing syndrome, including round ("moon") face; flushed face; weight gain above the collarbone and/or on the back of neck ("buffalo hump"); purple striae on the chest, armpits, and abdomen; acne; excessive facial hair; easy bruising; thin skin; rapid central weight gain; thin extremities; hypertension; skin ulcers; headache; muscle weakness; weak bones; menstrual irregularities; decreased libido; erectile dysfunction; hyperglycemia; emotional disturbances; and slowed growth in children [29,88,89]. Visceral fat deposits are one of the most common and often one of the first symptoms [21]. The distribution of fat deposits is different than what is typically seen with obesity [21]. For example, fat deposits are commonly seen on the face and clavicular area, both anterior and posterior; extremities often remain thin unless edema develops [21].

Many of the signs and symptoms associated with this disorder are due to the protein-wasting effect of cortisol [21]. Muscle wasting, thin skin, and striae develop because of the catabolic effect of cortisol on the tissues [16]. Purple/red striae occur then the skin becomes thin and stretched over areas of fat deposits [21]. This sign is most commonly seen on the abdomen, flank, breast, hips, and axillae [21]. The patient's skin may be red and warm to the touch due to inflammatory changes [21]. Patients with Cushing syndrome bruise easily and have fragile skin that is prone to tears. Wound healing is slowed due to the increased cortisol levels and subsequent hyperglycemia [21]. Lower extremity edema may develop and is often due to increased capillary permeability and sodium/fluid retention [21].

Children and adolescents with Cushing syndrome may present with growth delay or arrest (most common), weight gain/obesity, virilism, hirsutism, delay of secondary sexual development, and muscle weakness [90].

Women with Cushing syndrome may display signs of androgen imbalance, including oligomenorrhea or amenorrhea; infertility; excess hair on the face, neck, chest, abdomen, and thighs; thinning of the hair on the scalp; and polycystic ovary syndrome [16,28,90]. In addition to increasing the risk for infertility, Cushing syndrome may also increase the risk for miscarriage, perinatal death, premature birth, intrauterine growth restriction, pre-eclampsia, and eclampsia [21,58]. Men may experience erectile dysfunction and decreased fertility and libido [28].

The symptoms of Cushing syndrome often overlap significantly with metabolic syndrome [41]. These symptoms include obesity, glucose impairment, insulin resistance, dyslipidemia, and hypertension, all of which may persist after diagnosis and treatment of Cushing syndrome [41]. Patients with Cushing syndrome will have an increased risk for heart attack, cardiac failure, and left ventricular hypertrophy [41]. These persisting conditions can lead to a decreased quality of life and an increased risk morbidity and mortality.

Patients with this condition may also present with emotional, behavioral, and cognitive effects, such as mood changes, increased irritability, anxiety, depression, sleep problems, memory problems, and fatigue [29,89]. Anxiety and bipolar disorder are the most common psychiatric disorders associated with Cushing syndrome [41]. In children, obsessive compulsive disorder may be seen, as well as a declining school performance [41].

The catabolic effect of cortisol can cause changes to the patient's bones [16]. Up to 40% of patients with Cushing syndrome will develop osteoporosis and 20% of patients with this disorder will develop compression fractures of the spine [21]. Patients may also have a spontaneous rupture of the Achilles tendon [90]. The patient may also develop kyphosis and decreased height. Individuals with Cushing disease are more prone to opportunistic infections [90].

Many patients with Cushing syndrome report a decreased quality of life. Appropriate diagnosis and treatment can lead to improvements in patient health and well-being.

DIAGNOSTIC TESTS

Diagnosis of Cushing syndrome may be difficult because cortisol levels are variable and will fluctuate throughout the day [89]. Misdiagnosis is common because the disease typically progresses slowly, making symptom identification more difficult [88]. Diagnosis is based on a medical history, physical exam, and laboratory tests. Through the diagnostic process, differential diagnosis is a consideration, as several conditions can mimic the syndrome. Patients should be evaluated for recent use of oral, cream, or inhaled steroids, most commonly hydrocortisone, prednisone, and dexamethasone [88]. Estrogen-containing oral contraceptive pills can increase cortisol and glucose levels, making diagnosis a challenge [21]. When testing for Cushing syndrome, estrogen therapy should be discontinued for six weeks prior to the test, if possible [21].

Diagnosis is especially challenging during pregnancy, because cortisol and glucose levels normally increase during this time [21]. Understanding that pregnancy and oral contraceptives may increase blood glucose and cortisol levels, Cushing syndrome testing should utilize saliva or urine samples in these patients [21].

After Cushing syndrome is diagnosed, it is necessary to determine the underlying cause [41]. This can often be accomplished with a dexamethasone-corticotropin-releasing hormone test [28]. This test can distinguish Cushing syndrome from non-Cushing causes of elevated cortisol. Similarly, bilateral inferior petrosal sinus sampling can be used to differentiate pituitary from ectopic Cushing syndrome [41].

CT or MRI is necessary to identify pituitary or adrenal tumors; MRI is the preferred imaging technique for Cushing syndrome [21]. CT scan can be used, but it is less reliable and may lead to false positive findings [21]. Additional laboratory tests may show neutrophilia and decreased lymphocytes and eosinophils [21].

TREATMENT

Surgery

Evidence Based Practice Recommendation

The Endocrine Society recommends initial resection of primary lesion(s) underlying Cushing disease, unless surgery is not possible or is unlikely to significantly reduce glucocorticoid excess.

https://academic.oup.com/jcem/article/100/8/2807/2836065

Last Accessed: August 5, 2021

Strength of Recommendation/Level of Evidence: 1/⊕⊕⊕⊕ (Strong recommendation based on high-quality evidence)

As noted, the underlying cause of Cushing syndrome will guide the development of a plan of care [58]. If a tumor is the cause, surgery is often necessary. Surgery is effective and is associated with decreased morbidity and mortality [21]. Prior to surgery, hypertension and hyperglycemia should be well-controlled.

An adrenalectomy is the surgical removal or resection of one or both of the adrenal glands. In a subtotal adrenalectomy, only part of an adrenal gland is excised [60]. In most cases, the major goal of adrenalectomy is to reduce hyperfunction secondary to a tumor or hyperplasia of the glands (e.g., pheochromocytoma) or in advanced cases of cancer of the breast and prostate.

Laparoscopic adrenalectomy is the criterion standard for benign adrenal conditions [92]. A number of approaches are appropriate given the location of the adrenal glands, including posterior or lateral retroperitoneal, transthoracic, and lateral transperitoneal. Rarely, an open adrenalectomy may be required for large tumors or complicated cases.

Preoperative nursing care focuses on stabilization of the patient. In a patient with Cushing syndrome, this involves controlling hypertension, hyperglycemia, and hypokalemia. However, it also requires attention to decreased resistance to stress and infection, emotional liability, and edema [61]. The environment should be organized to provide maximum physical and emotional rest for the patient. Hyperadrenocorticism has an impact on the emotions, and patients may require additional support and reassurance. Patients should also be monitored for symptoms or signs of infection [61,92].

Serum electrolytes and urinary glucose and acetone levels will be monitored at regular intervals. Any fluid and electrolyte imbalances should be corrected in the preoperative period, because they may be exacerbated in the postoperative period. Intake, output, and weights should be recorded to assess the degree of fluid retention [54].

In the postoperative period, dietary selections should be centered on controlling hypertension, hyperglycemia, and hypokalemia. If a patient with excessive hyperadrenocorticism has protein depletion (hypoproteinemia), as reflected by a low serum albumin level, he or she may be prescribed a high-protein diet [93].

Corticosteroids are administered preoperatively as well as during surgery to prevent renal insufficiency in the postoperative period. Intravenous fluids are usually started and infused slowly to allow prompt administration of corticosteroids and vasopressors if needed [54].

Patient teaching before adrenalectomy should include [54]:

- What to expect in the immediate postoperative period (i.e., the patient will be in the recovery room or intensive care unit until stable, and vital signs will be monitored regularly)

- The importance of coughing, deep breathing, and early ambulation for prevention of complications

- The nature of the procedure, its indication, and its expected outcome, including the need for lifelong medication and medical supervision

The greatest postoperative concern after adrenalectomy is adrenal insufficiency. Also important are possible hypotension caused by the rapid withdrawal of mineralocorticoids, electrolyte imbalances, and infection resulting from suppression of the immune system. The surgical hazards associated with adrenalectomy include possible injury to the spleen, liver, duodenum, and common bile duct as well as hemorrhage [54].

Postoperative nursing care of the patient following adrenalectomy includes frequent monitoring of the vital signs, including level of consciousness and blood pressure. Blood pressure is monitored every 15 minutes in the immediate postoperative period until it is stabilized. Any unexplained or significant fall in blood pressure should be reported immediately, because it may indicate immediate impending adrenal insufficiency. Complaints of chest pain should also be reported, because they may indicate cardiac involvement or a pulmonary embolism [54].

Patients should also be monitored for signs and symptoms of Addisonian crisis. Early signs of adrenal insufficiency may be subtle, including restlessness, dehydration, and tachycardia. Later signs (preceding overt shock) are increased weakness, hypotension, increased temperature, and vomiting. Addisonian crisis requires prompt intervention with increased corticosteroids, hypertonic saline solution, or both. In rare cases, peripheral vasoconstrictors may be used [54,55].

If the tumor is removed but the gland remains, the gland may start to function again over time [29]. However, the patient may require supplemental cortisol until function returns [29]. Blood hormone levels should be checked at intervals after surgery to assess glandular function. In instances in which the gland is removed along with the tumor, lifelong cortisol replacement will be necessary. Surgery is often paired with radiation therapy and/or chemotherapy.

Pharmacotherapy

Three medication classes may be used in the treatment of Cushing syndrome: somatostatin analogs (central-acting inhibitors of ACTH), adrenal steroidogenesis inhibitors, and antiglucocorticoids [88]. Pasireotide, a somatostatin analog, is used to reduce ACTH to normal levels [88]. It is administered by subcutaneous or intramuscular injection and is effective in approximately 25% of patients; for others, it may decrease but not fully resolve symptoms [88]. It may take up to two months for the full effects of the agent to be seen [88]. Common side effects associated with pasireotide include fatigue, headache, hypertension, edema, alopecia, hyperglycemia, GI upset, anorexia, and injection-site reactions [75]. Ketoconazole, metyrapone, mitotane, and etomidate are adrenal steroidogenesis inhibitors that are used off-label to decrease cortisol levels in patients with Cushing syndrome [88]. For example, when administered at a dose of 400–1,200 mg per day, the antifungal ketoconazole effectively decreases cortisol production [58]. Mifepristone is a antiglucocorticoid commonly used to treat hypertension associated with Cushing syndrome [88]. A variety of side effects are associated with this medication, including but not limited to anxiety, headache, dizziness, fatigue, edema, hypothyroidism, hypocalcemia, GI upset, dry mouth, uterine bleeding, and dyspnea [75].

Radiation Therapy

Treatment of Cushing syndrome may also include targeted radiation therapy, known as stereotactic radiosurgery [88]. Stereotactic radiosurgery involves the application of x-ray beams to destroy the DNA of abnormal tissue [94]. This can reach small and/or difficult to reach areas in the body while decreasing the risk for damage to healthy tissue [94]. Stereotactic radiosurgery is associated with fewer side effects than other types of radiation therapy [94]. When side effects do develop, they may include fatigue, skin irritation at the site of treatment, hair loss at the site of treatment, headache, and GI upset [94].

Nursing Interventions

Standard nursing care for patients being treated for Cushing syndrome includes a medication review, vital signs, intake and output assessment, laboratory test monitoring, and infection prevention. Nurses should inquire about weight gain, paying particular attention to patient reports of the face becoming more "round" or a "hump on their back." Photographic comparison of the patient's previous appearance may be helpful. To assess for skin thinning, examine the skin on the back of the hand for striae, skin color, and skin texture [21]. The patient's muscle strength should be assessed by asking the patient to rise from sitting without using their hands or arms; the muscle wasting that occurs with Cushing syndrome tends to occur in the lower extremities [90]. The nurse should also examine the patient's extremities, noting if they appear thin or atrophied.

Electrolyte monitoring is important because potassium levels are often low and sodium levels are often high, requiring treatment and monitoring [42]. Patients may be encouraged to consume a high-potassium, low-sodium, and high-protein diet [16]. Patient education should include dietary recommendations and the importance of the various nutrients.

Patients with suspected Cushing syndrome should be asked about the use of steroids [90]. If Cushing syndrome is caused by long-term glucocorticoid use, the dose is usually decreased slowly over an extended period of time [28]. The nurse should also provide education to the patient about any medications and/or treatment ordered.

11. PRIMARY ALDOSTERONISM

Primary aldosteronism, also known as Conn syndrome or hyperaldosteronism, is a condition caused by excessive production of aldosterone by the adrenal cortex. It is characterized by hypertension, excessive urinary loss of potassium, and retention of sodium. Primary aldosteronism is thought to be the underlying cause in 1% to 2% of patients with diagnosed hypertension.

Primary aldosteronism originates from one of three sources: single adrenocortical tumor (generally a benign adenoma), bilateral hyperplasia of the adrenal cortices, or tumor of the juxtaglomerular cells of the kidney (which produce renin autonomously). A secondary form of aldosteronism occurs when increased renal secretion of renin leads to the increased production of aldosterone. The increase renin secretion results from other pathologic processes in the body, such as heart failure or cirrhosis. The production of aldosterone it triggers in turn initiates a cycle of pathologic changes, resulting in increased fluid retention, further compromising cardiac and hepatic function [95,96].

SIGNS AND SYMPTOMS

The major clinical manifestations of primary aldosteronism are hypertension, excessive urinary loss of potassium resulting in hypokalemia, and retention of sodium (hypernatremia). The hypertension is usually a moderate elevation in diastolic blood pressure. Patients may complain of headaches, and on physical examination, early hypertensive retinopathy and cardiomegaly may be noted [95,96].

Symptoms of hypokalemia range from mild fatigue to profound weakness. Patients may complain of paresthesia, loss of stamina, muscular weakness, and intermittent periods of paralysis. If hypokalemia alkalosis occurs, resulting in tetany, physical examination may elicit positive Trousseau and Chvostek signs [95,96].

Because of the increased reabsorption of sodium and water, hypernatremia and hypervolemia occur. Generally, edema is not present. The hematocrit may appear abnormally low as a result of the hemodilution. In addition to these major clinical signs, the patient with primary aldosteronism may also have severe polydipsia, polyuria, and nocturia resulting from the renal tubules' inability to respond appropriately to ADH [95,96].

Primary aldosteronism should be suspected in all patients with hypertension, particularly the young. Findings of comorbid hypertension, hypokalemia (potassium level less than 3.5 mEq/L), and excessive mineralocorticoid production (increased serum aldosterone levels) suggest the diagnosis. These findings become more significant if an excessive excretion of urinary potassium is found along with hypernatremia and decreased excretion of urinary sodium [95,96].

DIAGNOSIS

For the diagnosis of primary aldosteronism, a spironolactone test may be used in conjunction with assessment of serum potassium levels. Spironolactone is an aldosterone antagonist and, when given orally for three to four days, will stop the urinary excretion of potassium and restore serum levels to normal. Serum potassium levels have been shown to drop again five to seven days after the drug is halted [95,96].

To identify and localize an aldosterone-producing adenoma, various techniques may be used. Noninvasive procedures such as CT, MRI, and fluorine-18 fluorodeoxyglucose positron emission tomography (FDG-PET)/CT are the most commonly used imaging studies to assess potential adrenal masses. Invasive procedures, such as arteriography and retrograde adrenal venography, are rarely used for this purpose [95,96].

TREATMENT

Evidence Based Practice Recommendation

In patients with primary aldosteronism due to bilateral adrenal disease, the Endocrine Society recommends medical treatment with a mineralocorticoid receptor antagonist (e.g., spironolactone).

https://academic.oup.com/jcem/article/101/5/1889/2804729

Last Accessed: August 5, 2021

Strength of Recommendation/Level of Evidence: 1|⊕⊕○○ (Strong recommendation based on low-quality evidence)

The two main approaches to the treatment of primary aldosteronism are surgery and pharmacotherapy. Surgery is indicated when there is a unilateral aldosterone-producing tumor. In cases of hyperplasia, a subtotal or total adrenalectomy may be performed. Postoperatively, the return of normal aldosterone secretion by the remaining adrenal tissue may take several months. Following resection of the tumor, blood pressure will return to normal in most patients, but in one-third it may be lowered only slightly [97,98].

If surgery is not possible or declined by the patient, mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone) and lifestyle changes may be necessary to help control symptoms [99,100]. Possible side effects of these medications include gynecomastia, hyperkalemia, and hyperglycemia. Lifestyle changes, including weight loss, exercise, and low-sodium diet, and smoking cessation, will also be necessary.

Nursing Interventions

The nursing care of patients with primary aldosteronism should include daily weights and measurement of intake and output to assess the degree of fluid retention and loss, as well as frequent assessment of blood pressure, pulse, and respiratory rate. Symptoms and signs of increased blood pressure (e.g., headaches, changes in visual acuity, hypertensive retinal changes) should also be noted. Patients should also be observed for symptoms and signs of cardiac decompensation and congestive heart failure (e.g., increasing shortness of breath, jugular venous distention, rales at lung bases, orthopnea, and paroxysmal nocturnal dyspnea), and irregularities in heart rate and rhythm [97,98].

Symptoms and signs of hypokalemia, muscle weakness, cramping, fatigue, and skin breakdown should also be noted. Patients should be assessed for paresthesia and tetany. It is vital that these individuals take adequate rest. The recommended diet is low in sodium and high in protein and potassium. Calories may be restricted if weight reduction is desired [97,98].

Patients with primary aldosteronism should receive instruction on the nature of the disorder (e.g., pathophysiology, symptoms and signs, prognosis) and the goals of the treatment plan. If pharmacotherapy is indicated, patients should be familiar with its purpose, action, dosage, administration, and side effects. Patient teaching on diet, physical activity, and regular medical follow-up should also be provided. If surgery is done, patients should be aware of the time frame for resumption of adrenal function, the potential need for postsurgical medication therapy, and signs of surgical complications [97,98].

Patients who are able should take and record their blood pressure and pulse regularly. Nurses can provide instruction on how to interpret the findings and when to report issues. If patients are unable to self-monitor, a caregiver or family member may be engaged in the capacity [97,98].

12. PHEOCHROMOCYTOMA

Pheochromocytomas are tumors that arise from chromaffin cells in the adrenal medulla. While tumors originate in the adrenal medulla, they may rarely develop in the sympathetic ganglia of the abdomen, bladder, or chest; these are referred to as extra-adrenal pheochromocytomas or catecholamine-secreting paragangliomas. Pheochromocytomas characteristically produce both catecholamines (epinephrine and norepinephrine), although some tumors may release only one of the catecholamines. Hypersecretion of epinephrine elevates blood pressure by increasing the strength of contractions of the heart and increasing cardiac output. Norepinephrine causes arteriolar vasoconstriction, increasing peripheral vascular resistance to blood flow. Both of these effects result in marked elevation of both diastolic and systolic blood pressure, which is characteristic of pheochromocytoma [101,102].

Pheochromocytomas are thought to occur more often than clinically recognized and are often diagnosed due to incidental findings when investigating other unrelated issues. Pheochromocytomas are also often asymptomatic or vaguely symptomatic for some time. Tumors that produce primarily epinephrine are typically associated with profuse diaphoresis, palpitations, tremors, anxiety, heat intolerance, and pallor followed by flushing. Tumors that produce primarily norepinephrine are associated with fewer symptoms; when symptoms are present, they are similar to those of essential hypertension [101,102].

Most (70%) pheochromocytomas are benign, unilateral adrenal tumors; however, 10% are benign bilateral or multiple, 10% are extra-adrenal, and 10% are malignant. Men and women are equally affected, and the peak incidence is in the fourth and fifth decades of life, although they can occur at any age. Pheochromocytomas can also be found in association with certain familial neurofibromatosis disorders (e.g., neurofibromatosis, hemangioblastoma), hyperparathyroidism, and thyroid medullary carcinoma [101,102].

SIGNS AND SYMPTOMS

Both epinephrine- and norepinephrine-producing tumors may secrete catecholamines paroxysmally, episodically, or continuously. The most severe symptoms are usually seen in patients with paroxysmally functioning tumors because of the rapid and marked changes in serum catecholamine levels. About 40% of patients with pheochromocytoma have paroxysmal hypertension, whereas the remainder experience either sustained or labile elevations in blood pressure [102].

Paroxysmal attacks vary in frequency, severity, and duration. Both the onset and resolution tend to be abrupt, with the average attack lasting a few minutes to a few hours. In many patients, these attacks may occur without warning, but others may be able to identify a prodrome of dermal paresthesia and increasing anxiety. Paroxysmal attacks may be precipitated by emotional changes (e.g., laughing, sexual activity, pain), postural changes (especially flexion or bending of the body), and/or physical exertion. Attacks may increase in frequency and duration over time and can result in pulmonary edema, cerebral hemorrhage, or ventricular fibrillation [102].

Symptoms of pheochromocytoma include headache, diaphoresis, and intense palpitations. The patient may also complain of extreme anxiety, tinnitus, excessive weakness, tremor, blurred vision, vertigo, dyspnea, and angina. After the attack, the patient may report a feeling of extreme weakness and exhaustion [97,103,104].

Signs of pheochromocytoma include marked elevation of the diastolic and systolic blood pressure (which may rise as high as 200 to 300/150 mm Hg), often with excessive diaphoresis, anxiety, dilation of the pupils, and tachycardia. Orthostatic hypotension and hypertensive retinopathy may occur in patients with persistently functioning tumors. Hyperglycemia and glycosuria are also frequently associated with pheochromocytoma because catecholamines can inhibit insulin production [97,103,104].

DIAGNOSIS

Pheochromocytoma should be suspected in patients with hypertension who have symptoms and signs of sympathetic hyperactivity, although only an estimated 0.2% of hypertension is related to pheochromocytoma. Diagnosis of pheochromocytoma is based on the presence of symptoms, laboratory confirmation, and imaging modalities. Biochemical testing of the serum and/or urine will reflect continuous production of catecholamines and their metabolites (metanephrines) [105]. In the past, pharmacologic tests (e.g., histamine test, phentolamine-blocking test) were used, but these have largely been replaced by more reliable and safer urinary assays [99].

After excessive catecholamine secretion has been determined, imaging studies are done to confirm the diagnosis and localize the tumor [97,104]. PET is the preferred approach, coupled with CT. The American College of Radiology recommends FDG-PET/CT scan to detect metastatic disease [106].

TREATMENT

The definitive treatment of pheochromocytoma is surgical excision of the tumor. In the 10% of patients who are not surgical candidates (because of malignant pheochromocytoma with metastases or serious medical problems), control of symptoms is attempted with cytoreductive techniques, radiopharmaceuticals, chemotherapy, radiotherapy, and experimental therapies.

Surgical resection of a pheochromocytoma is considered high-risk due to the potential impact on heart rate and blood pressure. The Endocrine Society recommends that all patients with hormonally functional pheochromocytoma undergo preoperative blockade to prevent perioperative cardiovascular complications. The recommended preoperative treatment of choice is alpha-adrenergic receptor blockers [107]. This treatment should continue for 7 to 14 days before surgery. During this period, patients should also be instructed to adhere to a high-sodium diet and to increase fluid intake. Adjustments should be made prior to surgery in response to blood pressure, heart rate, and blood glucose level monitoring.

The usual operative approach is minimally invasive (laparoscopic) adrenalectomy. Open resection is reserved for large (i.e., >6 cm) or invasive pheochromocytomas to ensure complete tumor resection, prevent tumor rupture, and avoid local recurrence [107]. Partial adrenalectomy may be appropriate for selected patients.

Evidence Based Practice Recommendation

For patients who have undergone treatment for pheochromocytoma, the Endocrine Society suggests lifelong annual biochemical testing to assess for recurrent or metastatic disease.

https://academic.oup.com/jcem/article/99/6/1915/2537399

Last Accessed: August 5, 2021

Strength of Recommendation/Level of Evidence: 2|⊕⊕○○ (Weak recommendation based on low-quality evidence)

Because of the possibility of extreme fluctuations in the blood pressure in the immediate postoperative period, blood pressure should be monitored every 15 minutes until stabilized; the time to stabilization may be extended in patients with pheochromocytoma. Nurses should be alert for sudden elevation in blood pressure in the early postoperative period, which may reflect a release of epinephrine and norepinephrine from the tumor as it was being excised. An alpha-adrenergic blocking agent may be used intravenously if the blood pressure rises excessively [60].

Severe hypotension may also develop postoperatively and can lead to shock. Metaraminol or norepinephrine, usually administered via IV infusion, may be used to help stabilize the patient. The dosage and flow rate will depend on accurate blood pressure measurements [60]. All patients who have undergone resection of a pheochromocytoma should be advised to change positions slowly to avoid orthostatic hypotension.

Discharge planning should stress the need for lifelong medical supervision. Following successful resection, patients should undergo regular follow-up, including measuring plasma or urine levels of metanephrines, to diagnose persistent (recurrent or metastatic) disease. Pheochromocytomas recur in 10% to 13% of cases [55].

13. PSYCHOSOCIAL/LIFESTYLE INFLUENCES AND EFFECTS

The pituitary and adrenal glands have far-reaching effects on both physiologic and psychological function, and dysfunction can contribute to major developmental and psychosocial crises. To provide comprehensive patient care, nurses should be aware of these potential crises and their manifestations [78,79].

Patients with pituitary and/or adrenal dysfunction may have to face the reality of coping with chronic illness or an acute life-threatening situation. Anger, fear, guilt, and denial are common initial reactions. Individual responses to this challenge vary according to the patient's past experiences, attitudes toward health and illness, coping patterns, and support system strength. It is not unusual to find patients with several years' history of a disease still working through their anger and denial. In pediatric cases, parents' feelings of guilt and denial should also be considered as part of a holistic plan of care [78,79].

In many patients, lifestyle changes are necessary to manage the disease, reduce symptoms, and perform activities of daily living and tolerate stress. However, these changes are often reminders to the patient and family that the illness is serious and that their lives will be affected [78,79].

SELF-CONCEPT AND SELF-ESTEEM

Patients with pituitary or adrenal dysfunction are often confronted with a change in self-concept and a loss of self-esteem arising from changes in body image, decreased functional abilities, sexual dysfunction, loss of autonomy, and limitations in the decision-making processes. Changes in self-concept and loss of self-esteem can interfere with the patient's ability to adhere with the treatment plan and accept the diagnosis and its implications. For example, patients with Cushing syndrome will often require time and support to adjust to the cosmetic implications of the "moon" face, upper back/neck fat deposits, and truncal obesity associated with that disorder. Some conditions will also affect patients' ability to participate in activities as they once had or wish to. Individuals with Addison disease are required to take steps to avoid stressful situations. These pathophysiologic changes affect the patient's ability to function in normal situations, causing further stress and anxiety [78,79].

Certain disorders, including pituitary tumor and dysfunction of the adrenal cortex and medulla, cause emotional liability and personality changes. This presents serious concerns for the patient, who often feels out of control or unrecognizable. The nurse can help both the patient and family to understand the relationship between the physiologic condition problem and the psychological changes [78,79].

SEXUAL EXPRESSION AND REPRODUCTION

Often in disorders affecting the creation of the adrenocortical sex hormones, changes in libido and sexual potency concern patients and their sexual partner. Sensitive intervention by the nurse may relieve anxiety in the couple [79]. Unfortunately, sexual dysfunction is rarely addressed in the treatment plan for these patients. Research indicates that different domains of sexual health are affected by different disease processes, particularly in women. Specifically, hypercortisolism is associated with impaired lubrication, orgasm, sexual arousal, and satisfaction, while hyperprolactinemia and hypoandrogenism are associated with decreased sexual desire and arousal [108]. Treatment of the underlying condition may help, but if sexual dysfunction persists, it should be addressed by pharmacotherapy, adaptive practices, and psychotherapy. It is important to remember that pharmacotherapy cannot address important psychosocial factors of performance anxiety, poor self-confidence, partner sexual dysfunction, relationship conflict or poor communication, sexual factors in the relationship (e.g., sexual scripts, sexual satisfaction), and contextual factors (e.g., life stressors) [109]. Even when sexual dysfunction is primarily physiologic, virtually all patients experience negative psychologic and interpersonal effects. These include interpersonal conflict, depression, performance anxiety, and avoidance of sex.

OCCUPATIONAL AND ECONOMIC FACTORS

Occupational implications of pituitary/adrenal disorders include the possible need to change occupations or limitations in one's ability to work because of a physical disability. Patients with visual loss or changes in mentation often must make significant occupational adjustments. Patients may require adaptive equipment or may move to a different area to be closer to a source of health care or to access a special living environment. Economic factors may include the necessity for lifelong medications and medical supervision along with the increasing costs of diagnostic tests and hospitalizations [101,102].

DIETARY FACTORS

The adjustment to new dietary requirements is a major challenge for patients with pituitary/adrenal disease. Patients who previously gave little thought to nutrition or balanced meals are often introduced into a life of fluid restrictions, special diets, and dietary supplements. These changes add extra strain to an already stressful situation and can also be an economic burden. Nurses should acknowledge the importance of dietary challenges and understand how they affect the patient and family, with particular consideration of how food features in the patient's culture. Patient teaching should include an exploration of dietary customs and how changes will be linked to improved health and quality of life [101,102].

CULTURAL CONSIDERATIONS

As society becomes increasingly diverse, nurses are encountering a wide variety of cultural values and perceptions that influence health behavior in individuals and families. Because culture can have a strong influence on a patient's response to nursing interventions, nurses should be continually aware of these influences.

Cultural competence means being sensitive to differences in the values and beliefs that are shared by the members of an ethnic, cultural, racial, religious, or lifestyle preference of a group. Components of effective transcultural nursing include communication style, use of personal space, eye contact, and understanding of biologic variations. It is important to keep in mind, however, that there can be great variation among individuals within cultures. Therefore, stereotyping and making assumptions about an individual patient's beliefs based solely upon ethnic identification should be avoided.

In most cases, it is not necessary to develop a thorough understanding of each and every culture encountered in diverse healthcare settings. However, a certain degree of cultural competence can and should be developed. The first step in doing this is to recognize that cultural differences do exist. How these variations impact self-management can be explored in the needs assessment. This may include a sensitive exploration of the person's healthcare practices and the role of family members. Other culturally impacted areas may include beliefs about illness, diet, the role of the patient in self-care, gender roles, religious rituals, and communication styles.

Dietary preferences, meal preparation practices, and the symbolism of food represent an especially important area. When giving diet instructions, efforts should be made to consider the food preferences of the cultural group.

Cultural competence includes recognizing that cultural healthcare practices may differ from one's own beliefs about how an illness should be treated. Furthermore, cultural influences may not always be consistent with healthcare recommendations. This may be especially true for diseases that require significant behavioral adaptations. Americanized versions of traditional foods are high in salt, fat, and calories and are not recommended for people with restricted diets. Therefore, patients may experience a conflict between cultural values and those of the mainstream healthcare system.

14. CASE STUDIES

ACUTE ADRENAL INSUFFICIENCY (ADDISON DISEASE)

Present Illness

Patient A, a man 50 years of age, is admitted for diagnosis and initial management of suspected adrenal hypofunction with acute adrenal insufficiency. For the past five years, Patient A has been under considerable stress managing his failing contracting business. Initially, he dismissed his complaints of fatigue and weakness as job-related. Lately, the symptoms have been difficult to ignore and associated with anorexia, nausea, and vomiting. He has lost 30 pounds over the past three months without dieting. He complains of frequently feeling cold and has had two syncopal attacks in the month prior to admission. He reports that although he has spent essentially all this time indoors at the office, his skin has become as dark as his employees who work outdoors.

On the morning of admission, he did not wake at his usual early hour and told his wife that he felt gravely ill. His wife called the family physician, who instructed her to take Patient A to the emergency department. After evaluation in the emergency department, Patient A is admitted to the critical care unit (CCU).

Medical History

A medical history is obtained from Patient A's wife. She states that the patient has no allergies to medications but was very allergic to ragweed when they were first married. During the first 10 years of their marriage, Patient A had frequent asthma attacks requiring treatment with epinephrine injections. The asthma attacks diminished in frequency during his middle years, and his wife cannot remember when he last had an attack.

Patient A also has a history of coccidioidomycosis, which was active for several years late in adolescence and in early adulthood. Mrs. A has no recollection of being told of changes in the patient's routine chest x-rays for some time. Ten years previously, Patient A was diagnosed with hypertension, but his blood pressure has been well-controlled with daily exercise and dietary changes.

Patient A has been married to his wife for 35 years and has three grown children who live out of state. His contracting business had been successful until five years ago, when a decrease in housing starts resulted in a decline in business and increased financial stress.

Assessment and Diagnosis

Upon admittance to the CCU, a full physical exam is conducted (Table 2). A chest x-ray is done and shows normal lung fields and a smaller than expected heart. Several laboratory tests are ordered, with the following results:

- Serum chemistry results:

- Sodium: 125 mEq/L

- Potassium: 6.2 mEq/L

- Chloride: 89 mEq/L

- Carbon dioxide (CO_2): 19 mmol/L

- Blood glucose: 45 mg/dL

- BUN: 37 mg/dL

- Hematocrit: 50%

- White blood count: 3.5 x 10^9/L

Table 2: PATIENT A'S PHYSICAL EXAM RESULTS

Parameter

Findings

General appearance

A thin, well-tanned man who seemed mildly confused

Height: 6 feet 2 inches (188 cm)

Weight: 190 pounds (86 kg)

Head and eyes

Normocephalic

Numerous gray-brown freckles on forehead

Pupils equal (4 mm), round, reactive to light and accommodation

Normal fundoscopic exam

Extraocular muscles full

Nasal turbinates slightly reddened, with clear exudate

Brown freckles on oral mucosa

Pharynx clear

Ears

External ear canals clear

Tympanic membranes clear and retracted

Neck

Supple, without masses or thyromegaly

Nonpalpable cervical lymph nodes

Chest

Symmetrical excursion

Areolas darkly pigmented

Lungs clear to percussion and auscultation

Abdomen

Flat with active bowel sounds in all quadrants

Normally unexposed skin appears tanned

Soft, nontender, and without organomegaly or masses

Extremities

Pulses present, equal, and faint. Normal hair distribution

Genitourinary system

Within normal limits

Neurologic status

Oriented to person, place, and time but very slow to answer questions

Cranial nerves II–XII grossly intact

Deep tendon reflexes 1+ and symmetrical

Bilateral plantar flexor responses

Cardiovascular system

Cardiac rhythm sinus bradycardia without ectopy

Point of maximal impulse at sixth intercostal space 1 inch left of midclavicular line

Heart sounds quiet with normal S1 and S2, without gallops, rubs, or murmurs

Vital Signs

Blood pressure

100/60 mm Hg

Temperature

96.5° F

Heart rate

58 bpm

Respiratory rate

12 breaths per minute

Source: Author

Based on the results of the assessment, Patient A is diagnosed with possible acute adrenal insufficiency and possible Addison disease.

Management

Shortly after arriving in the CCU, Patient A vomits a large amount of bile-colored gastric contents and then develops coma and shock. His blood pressure is 60/10 mm Hg, his heart rate is 50 beats per minute, and his respiratory rate is 8 breaths per minute and gasping. He is quickly resuscitated with rapid IV infusion of normal saline, hydrocortisone sodium succinate (100 mg IV), tracheal intubation, and artificial ventilation. A double lumen nasogastric tube is inserted and connected to low constant suction. An indwelling urinary catheter is inserted and connected to a urine meter. Patient A's condition stabilizes as he becomes alert and orientated, has adequate spontaneous ventilation, and maintains adequate cardiac output and blood pressure. Efforts are made to confirm the diagnosis of Addison disease.

The physician orders diagnostic tests of adrenal, thyroid, and pituitary function. Results of the 24-hour urine collection assessed for 17-ketosteroids and 17-hydroxycorticosteroids indicates that adrenal secretion of cortisol, corticosterone, cortisone, and 11-hydroxycorticosternone is inadequate. The result of the plasma cortisol response to ACTH test confirms the diagnosis of Addison disease. The latest results of tests of thyroid and pituitary function are within normal limits.

Patient A is prescribed fludrocortisone acetate (0.1 mg daily) and hydrocortisone (20 mg daily) as replacement therapy. He responds well and is transferred out of the CCU four days after admission.

Study Questions

Consider the information that has been presented in this course regarding adrenal insufficiency and Addison disease.

1. What fluid and electrolyte imbalances are usually associated with adrenal insufficiency? How does the pathophysiology of adrenal insufficiently create these imbalances?

2. What are the expected results of the plasma cortisol response to ACTH test and 24-hour urine collection in adrenal insufficiency? How are the tests conducted?

3. What risks will subsequent critical illness pose for Patient A?

4. What nursing observation would be important in a critically ill patient with a history of adrenal insufficiency?

5. How might chronic adrenal insufficiency be managed during a critical illness?

6. What are the symptoms and signs of hypoadrenalism?

7. What is the most common type of hypoadrenalism?

8. What are the other causes of hypoadrenalism?

9. How is hypoadrenalism diagnosed?

DIABETES INSIPIDUS

Present Illness

Patient B, a man 26 years of age, is in the hospital recovering from surgical clipping of an aneurysm on the anterior communicating artery. Three days after surgery, he begins voiding large quantiles of very pale urine. His IV intake is 80 mL/hour, and his oral intake is minimal. The specific gravity of the urine is 1.002, and the patient's calculated urine output is more than 200 mL/hour for four consecutive hours. The nurse observes that during the past two hours Patient B's blood pressure has declined from 120/80 mm Hg to 110/70 mm Hg and that his heart rate has increased from 68 beats per minute to 110 beats per minute. The nurse notifies the neurosurgeon of the large unconcentrated urinary output and the changes in vital signs.

Medical History

Patient B has suffered chronic severe headaches, and the diagnosis of cerebral aneurysm led to the cerebrovascular procedure. The surgical procedure went well, and Patient B was recovering as expected.

Assessment and Diagnosis

Upon the onset of diuresis, a full physical exam is conducted (Table 3). Laboratory findings are:

- Plasma osmolality: 289 mOsm/L

- Urine osmolality: 108 mOsm/L

- Serum sodium level: 150 mEq/L

Table 3: PATIENT B'S PHYSICAL EXAM RESULTS

Parameter

Findings

General appearance

A young African American man who appears his stated age and is alert and oriented

Height: 5 feet 11 inches (180.5 cm)

Weight: 190 pounds (86 kg)

Head and eyes

Normocephalic

Dressing dry and intact

No ecchymosis visible

Pupils equal (4 mm), round, reactive to light and accommodation

Normal fundoscopic exam

Extraocular muscles full

Nasal turbinates and oral mucosa pink and moist

Pharynx clear

Ears

External ear canals clear

Tympanic membranes clear

Neck

Supple, without masses or thyromegaly

Chest

Symmetrical excursion

Lungs clear to percussion and auscultation

Abdomen

Flat with active bowel sounds in all quadrants

Soft, nontender, and without organomegaly or masses

Extremities

Pulses present, equal, and moderate

Genitourinary system

Within normal limits

Neurologic status

Oriented to person, place, and time

Cranial nerves II–XII grossly intact

Deep tendon reflexes 1+ to 2+ and symmetrical

Bilateral plantar flexor responses present

Cardiovascular system

Cardiac rhythm normal sinus without ectopy

Point of maximal impulse at fifth intercostal space 2 cm left of midclavicular line

Heart sounds normal S1 and S2, without gallops, rubs, or murmurs

Vital Signs

Blood pressure

110/70 mm Hg

Temperature

98.4° F

Heart rate

69 bpm

Respiratory rate

11 breaths per minute

Source: Author

Based on the findings of the assessment, Patient B is diagnosed with diabetes insipidus secondary to manipulation of the pituitary.

Management

The neurosurgeon orders 2.5 units of aqueous vasopressin to be administered immediately intramuscularly. Following administration, urine output is reduced to 60 mL/hr in 30 minutes. The urine osmolality level two hours later is 760 mOsm/L. Patient B continues to be monitored to determine if the pituitary damage is permanent and if he requires long-term desmopressin therapy.

Study Questions

Consider the information that has been presented in this course regarding diabetes insipidus.

1. What are the key signs and symptoms of diabetes insipidus? How did it present in Patient B?

2. What is the action of vasopressin?

3. What are the main types of diabetes insipidus? What type does Patient B have?

4. What causes central diabetes insipidus? What causes nephrogenic diabetes insipidus?

5. What diagnostic test(s) can reveal whether diabetes insipidus is central or nephrogenic? How are these conditions treated?

SYNDROME OF INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION

Present Illness

Patient C is a Hispanic man, 60 years of age. He is brought to the emergency department by his family because of acute mental confusion and combativeness. His wife and son report that he has been complaining of anorexia, a nonproductive cough, and unusual fatigue and weakness for the past seven months. During this time, he lost 40 pounds. In the past two weeks, Patient C has been unusually irritable and occasionally irrational. The day before admission, the patient's confusion and disorientation became so severe that he tried to hit his wife. Because she could not manage him alone, the patient's wife asked their son to come and stay with them.

The morning of the admission, Patient C has a seizure (with signs consistent with a tonic-clonic seizure), and the family transports the patient to the emergency department for evaluation.

Medical History

Patient C's wife reports that her husband drinks six 12-ounce beers daily and has smoked two to three packs of cigarettes per day for the 35 years of their marriage. She has no knowledge of Patient C's family medical history. In addition, Patient C has only rarely seen a physician for illnesses and has never had a routine physical examination.

Assessment and Diagnosis

Upon presentation to the emergency department, a full physical exam is conducted (Table 4). An electrocardiogram (ECG) is normal with nonspecific ST-T wave changes. Skull imaging is normal, but a chest x-ray visualizes a mass in the lower right lobe. Laboratory studies find:

- Blood chemistry levels:

- Sodium: 115 mEq/L

- Potassium: 3.8 mEq/L

- Chloride: 80 mEq/L

- Calcium: 7.2 mg/dL

- Total protein: 5.8 mg/dL

- CO_2: 25 mmol/L

- BUN: 15 mg/dL

- Blood glucose: 90 mg/dL

- Creatinine: 0.9 mg/dL

- Serum osmolality: 235 mOsm/L

- Urine osmolality: 260 mOsm/L

Table 4: PATIENT C'S PHYSICAL EXAM RESULTS

Parameter

Findings

General appearance

A thin, disoriented, and irritable man who appears older than his stated age and coughs frequently

Height: 5 feet 8 inches (173 cm)

Weight: 149 pounds (68 kg)

Head and eyes

Normocephalic

All structures normal

Ears

External ear canals clear

Tympanic membranes clear

Neck

Supple, without thyromegaly

Firm 2 x 3 cm lymph node in right supraclavicular area

Jugular vein distention to the angle of the jaw while sitting up 45 degrees

Chest

Increased anteroposterior diameter and increased curvature to thoracic spine curvature

Dullness to percussion in right base

Lungs have scattered rhonchi and diminished breath sounds in the right base

Abdomen

Flat with active bowel sounds in all quadrants

Soft with mild tenderness in right upper quadrant

Liver palpable 5 cm below right costal margin

Extremities

Peripheral pulses present, equal, and bounding

Normal hair distribution

Genitourinary system

Within normal limits

Neurologic status

Confused, oriented to self only

Unable to follow instructions for cranial nerve exam

Deep tendon reflexes symmetrically diminished, with bilateral plantar flexion

Cardiovascular system

Heart sounds are normal S1 and S2 with S3 with a soft systolic murmur the base

No pericardial friction rub

Vital Signs

Blood pressure

140/80 mm Hg, supine and standing

Temperature

98.9° F

Heart rate

100 bpm

Respiratory rate

18 breaths per minute

Source: Author

Based on the findings of the assessment, Patient C is diagnosed with severe hyponatremia secondary to water intoxication. A lack of history for excessive water intake suggests SIADH.

Management

The physician suspects that Patient C has SIADH, and further diagnostic studies are planned and carried out. The supraclavicular lymph node is biopsied. The pathology report identifies the node as small-cell lung cancer.

Patient C's serum cortisol is 10 mcg/dL in the morning. A 24-hour urine collection is completed, and 17-ketosteroids excretion is 9 mg per day and sodium excretion is 150 mEq per day. Patient C's fluid intake is restricted, furosemide is administered, and hypertonic saline is carefully infused. As the patient undergoes diuresis, his serum sodium gradually returns to normal and his sensorium improves. His wife is relieved at the return of her normally gentle husband.

Extended management includes assessment of the underlying cause of the SIADH, assumed to be metastatic small-cell lung cancer. The patient is referred to an oncologist for further testing and treatment.

Study Questions

Consider the information that has been presented in this course regarding SIADH.

1. What are the key signs and symptoms of SIADH? What pathophysiology underlies these effects?

2. How do diabetes insipidus and SIADH present differently? How are they similar?

3. What studies assist in confirming the diagnosis of SIADH? What are the nursing responsibilities in conducting these tests?

4. What safety precautions should be implemented for Patient C because he is confused and oriented to self only?

5. What nursing observations and actions are required to compensate for patients who are not alert and/or do not have access to food and water and therefore cannot use normal physiologic mechanisms to achieve fluid and electrolyte balance?

6. What typically causes SIADH?

7. How is SIADH treated?

15. CONCLUSION

The pituitary and adrenal glands play a significant role in many functions in the body, and proper functioning is essential for the maintenance of health. Dysfunction in these glands can have detrimental effects and may lead to death if untreated. Although disorders of the pituitary or adrenal glands are not as easy to see or identify as many conditions, they are nonetheless relatively common among many patient populations.

This course has provided a brief overview of the anatomy and physiology of the pituitary and adrenal glands, assessment, common disorders, and care of the patient with pituitary/adrenal dysfunction. Nurses have a responsibility and duty to identify the signs and symptoms of these disorders and to care for patients appropriately and fully.

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Evidence-Based Practice Recommendations Citations

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4. Katznelson L, Laws ER Jr, Melmed S, et al. Acromegaly: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2014;99(11):3933-3951. Available at https://academic.oup.com/jcem/article/99/11/3933/2836347. Last accessed August 5, 2021.

5. Nieman LK, Biller BMK, Findling JW, et al. Treatment of Cushing's syndrome: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015;100(8):2807-2831. Available at https://academic.oup.com/jcem/article/100/8/2807/2836065. Last accessed August 5, 2021.

6. Funder JW, Carey RM, Mantero F, et al. The management of primary aldosteronism: case detection, diagnosis, and treatment: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2016;101(5):1889-1916. Available at https://academic.oup.com/jcem/article/101/5/1889/2804729. Last accessed August 5, 2021.

7. Lenders JWM, Duh Q-Y, Eisenhofer G, et al. Pheochromocytoma and paraganglioma: an Endocrine Society clinical practice guideline.J Clin Endocrinol Metab. 2014;99(6):1915-1942. Available at https://academic.oup.com/jcem/article/99/6/1915/2537399. Last accessed August 5, 2021.