Study Points

Prescription Opioids: Risk Management and Strategies for Safe Use

Course #91412 - $60 • 15 Hours/Credits

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Study Points

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  1. Define terms associated with opioid therapy and aberrant drug use.
  2. Analyze behavioral responses to prescribed opioids and signs of emerging opioid misuse.
  3. Outline the impact of clinical and professional society attitudes toward opioid prescribing.
  4. Review the role of OxyContin in the rise of prescribed opioids for chronic noncancer pain.
  5. Evaluate the basic epidemiology of prescription opioid use, misuse, and dependence in the United States.
  6. Identify factors that influence opioid prescribing decisions.
  7. Describe the morbidity and mortality associated with the use of prescription opioids.
  8. Discuss characteristics of appropriate and inappropriate opioid prescribing and contributory factors to both.
  9. Compare opioid abuse risk assessment tools and the utility of risk stratification.
  10. Outline the appropriate periodic review and monitoring of patients prescribed opioid analgesics, including the role of urine drug testing.
  11. Describe necessary components of patient/caregiver education for prescribed opioid analgesics, including guidance on the safe use and disposal of medications.
  12. Compare available opioid abuse-deterrent formulations.
  13. Evaluate government and industry efforts to address problems arising from prescription opioid analgesic misuse.
  14. Review the unintended negative consequences of efforts to reduce prescribed opioid analgesic misuse, diversion, and overdose.
  15. Discuss treatment considerations for patients with active or remitted substance use disorder who require prescribed opioid analgesics for chronic pain.
  1. Inappropriate opioid analgesic prescribing is defined as

    DEFINITIONS

    Inappropriate opioid analgesic prescribing for pain is defined as the nonprescribing, inadequate prescribing, excessive prescribing, or continued prescribing despite evidence of ineffectiveness [10]. Appropriate opioid prescribing is essential to achieve pain control, to minimize societal harms from diversion, and to minimize patient risk of abuse, addiction, and fatal toxicity. The foundation of appropriate opioid prescribing is based on 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 pseudodependence. 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 [7]. A 2013 survey measured primary care physician understanding of opioids and addiction. Of the 200 participants, [11]:

    • 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 psychological 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.

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  2. The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) categorizes prescription opioid addiction as

    DEFINITIONS

    The nomenclature related to addiction is 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 [15]. The Diagnostic and Statistical Manual of Mental Disorders (DSM), published by the American Psychiatric Association, is perhaps the most influential reference for the diagnosis of addiction and all other psychiatric disorders. Prior to the 2013 release of the DSM-5, previous versions eschewed the term "addiction" in favor of "substance dependence," with a separate diagnostic entity of "substance abuse" representing a lower-grade, less severe version of substance dependence [16]. Also in earlier DSM versions, physiological 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 psychological dependence and the belief that tolerance and withdrawal meant addiction. This confusion enhanced provider and patient fears over addiction developing from opioid analgesics and contributed to the undertreatment of pain [16]. The DSM-5 has eliminated the categories of 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 [16].

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  3. Which of the following is NOT a characteristic of substance addiction according to the American Society of Addiction Medicine?

    DEFINITIONS

    According to the ASAM, the five characteristics of addiction are [18]:

    • 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

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  4. Which of the following is TRUE regarding aberrant drug use/seeking behaviors?

    BEHAVIORAL RESPONSES TO PRESCRIBED OPIOIDS

    Patients with pain display a continuum of behavioral responses to prescribed opioids. Some develop aberrant behaviors, which are defined as unintended behaviors involving the acquisition or use of prescribed opioids [23]. Depending on the study, researchers have reported that as many as 40% of patients with pain receiving opioid therapy exhibit aberrant behavior; however, in only a minority of these patients does the aberrant behavior reflect an emerging opioid use disorder. It is important to distinguish the underlying basis and the level of risk for opioid use disorder represented in the aberrant behavior. This is accomplished by differential diagnosis (Table 4). To capture the perspective of pain practitioner viewpoints in associating aberrant behaviors and risk of patient opioid problems, 100 pain physicians were instructed to rank a list of 13 aberrant drug-use behaviors from least to most suggestive of emergent opioid use disorder. Selling the prescribed opioid and prescription forgery received highest ranking as most aberrant, and altered route of administration was given the third highest ranking. Lowest ranked were unkempt patient appearance, sporadic unsanctioned dose escalation, and prescribed opioid hoarding [24].

    There are certain behaviors that are suggestive of an emerging opioid use disorder. The most suggestive behaviors are [25,26,27]:

    • 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 a lower level of evidence for their association with opioid misuse include [24,25,26]:

    • 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

    It is essential for clinicians to consider poorly managed pain or poor coping skills as the basis for aberrant behavior. Even aberrant behaviors highly suggesting opioid abuse may reflect a patient's attempt to feel normal or alleviate emotional or physical distress. This is termed chemical coping and refers to the inappropriate use of a prescribed opioid to treat emotional or psychiatric conditions, commonly depression, anxiety, and insomnia. In these cases, the patient is not technically addicted to the opioid, but he or she fears withdrawal from the opioid and losing the ability to function without the drug and, as a result, may abuse opioids, engage in illegal behavior to obtain opioids, or doctor-shop. Aberrant behavior can also be driven by undertreated pain or a failure of treatment management [28]. Importantly, no single behavioral marker clearly identifies addiction in patients with pain who are prescribed opioids, and while all addicts are abusers, not all abusers are opioid-addicted [28].

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  5. Which of the following behaviors is the most suggestive of an emerging opioid use disorder?

    BEHAVIORAL RESPONSES TO PRESCRIBED OPIOIDS

    There are certain behaviors that are suggestive of an emerging opioid use disorder. The most suggestive behaviors are [25,26,27]:

    • 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 a lower level of evidence for their association with opioid misuse include [24,25,26]:

    • 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

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  6. Which of the following has NOT contributed to the historic, widespread pattern of pain undertreatment in the United States?

    CLINICIAN AND PROFESSIONAL SOCIETY ATTITUDES TOWARD OPIOID PRESCRIPTION DRUG USE

    The United States has a long history of pain undertreatment as a standard medical practice. This was a consequence of the long-standing emphasis on treating the underlying primary illness, minimizing the importance of addressing pain, and viewing pain as an endurable consequence [1]. Another primary factor historically responsible for pain undertreatment has been a resistance to prescribing opioids, driven by fears of patient addiction and the threat of prosecution and potential loss of licensure if opioid prescribing was deemed inappropriate by the state medical board. The widespread practice of including non-professional lay members on medical boards intensified physician concerns over prejudicial interpretation by board members, even when legitimate medical necessity merited long-term, high-dose opioid prescribing to patients with severe, chronic noncancer pain [29].

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  7. Which of the following did NOT contribute to broad expansion and indications for opioid prescribing for pain in the 1990s to early 2000s?

    CLINICIAN AND PROFESSIONAL SOCIETY ATTITUDES TOWARD OPIOID PRESCRIPTION DRUG USE

    During the 1990s, the American Pain Foundation endorsed more aggressive treatment of chronic pain, while the American Pain Society (APS) promoted the position that pain should be considered a fifth vital sign. The APS and the American Academy of Pain Medicine (AAPM) published a landmark consensus statement in 1997 that stated long-term opioid analgesic use for chronic noncancer pain posed minimal risk of overdose or addiction [31,41]. The pharmaceutical industry was also instrumental in the movement toward loosening opioid prescribing constraints and broadening the indications for opioid use in managing chronic pain [31,42]. Professional pain societies wrote consensus statements claiming little risk of addiction or overdose in patients with pain and that long-term opioids were easy to discontinue. In 1997, Congress passed SB402, also known as The Pain Patient's Bill of Rights [43]. In 2001, the Joint Commission issued new standards requiring hospitals to make pain assessment routine and pain treatment a priority. The now familiar pain scale was introduced, with patients asked to rate their pain from 1 to 10 and circle a smiling or frowning face, and pain became the fifth vital sign [44]. Immediately following the release of the new standards, concern was raised that the standards would lead to the inappropriate use of opioids. By 2002, pain as a "fifth vital sign" in the standards was changed to "pain used to be considered the fifth vital sign," and by 2004, this phrase no longer appeared in the Joint Commission's Accreditation Standards manual [45]. The standard that pain be assessed in all patients also remained controversial for two reasons: It seemed inappropriate for some patients due to the nature of their medical condition; and no similar standard existed requiring the universal assessment of other symptoms [45]. Thus, in early 2016, the Joint Commission began revising its pain assessment and management standards, with a focus on acute pain in the hospital setting. Draft standards were published in 2017 and implemented in 2018 [46,47].

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  8. Which of the following opioids showed decreased retail purchases from 2010 to 2019?

    CLINICIAN AND PROFESSIONAL SOCIETY ATTITUDES TOWARD OPIOID PRESCRIPTION DRUG USE

    RETAIL PURCHASESa OF PRESCRIPTION OPIOIDS (GRAMS OF DRUG)—UNITED STATES, 2010–2019

    Opioid 2010 2019 Change
    Methadone15,466,040 g15,080,444 g-2.49%
    Oxycodone63,691,987 g35,929,260 g-43.59%
    Fentanyl base528,969 g193,531 g-63.41%
    Hydromorphone1,407,927 g987,221 g-29.88%
    Hydrocodone39,096,895 g20,040,962 g-48.74%
    Morphine22,915,640 g11,966,623 g-47.78%
    Codeine16,141,776 g12,105,985 g-25%
    Meperidine2,333,167 g292,694 g-87.46%
    Total161,582,401 g96,596,720 g-40.22%
    aPurchasers include pharmacies, hospitals, practitioners, teaching institutions, and treatment programs.
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  9. Which of the following is FALSE regarding extended-release opioids before the 1990s?

    CLINICIAN AND PROFESSIONAL SOCIETY ATTITUDES TOWARD OPIOID PRESCRIPTION DRUG USE

    The timing of product launch was fortuitous. Until the 1990s, Schedule II opioids were primarily limited to use in operating rooms and inpatient settings because they required intravenous or intramuscular administration. This posed a serious obstacle to patients with chronic pain who required high-potency opioids. In response to the increasingly permissive climate and by genuine unmet patient need, several high-dose ER formulations of pre-existing opioids were introduced to market. MS Contin, an ER version of morphine sulfate, was introduced in 1985 but was primarily limited to use in cancer pain, partially a result of the stigma surrounding morphine. OxyContin was introduced in late 1995, at the point in time when prescriber attitudes were shifting from fearing iatrogenic addiction to developing a sense of security with prescribing opioid analgesics [44].

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  10. Which of the following has NOT contributed to the increasing prevalence of chronic pain?

    EPIDEMIOLOGY OF CHRONIC PAIN AND OPIOID USE

    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 lifesaving trauma interventions; poorly managed post-surgical pain; and greater public awareness of pain as a condition warranting medical attention [7]. 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 [60].

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  11. Americans consume what percentage of worldwide hydrocodone consumption?

    EPIDEMIOLOGY OF CHRONIC PAIN AND OPIOID USE

    Worldwide consumption of opioid analgesics has increased dramatically in the past few decades, with the United States driving a substantial proportion of this increase. For example, the 1990 global consumption of hydrocodone was 4 tons (3,628 kg), compared with the 2018 consumption of 25.8 tons (23,486 kg); 25.6 tons of this were consumed in the United States. Similarly, 3 tons (2,722 kg) of oxycodone were consumed globally in 1990, versus 65.9 tons (59,856 kg) in 2018, of which 48.8 tons (37,946 kg or 63%) were consumed in the United States [62]. With only 4.25% of the world's population, the United States annually consumes more than 84% of all opioid supplies, including [62]:

    • 99% of all hydrocodone

    • 63% of all oxycodone

    • 40% of all methadone

    • 45% of all hydromorphone

    • 24% of all meperidine

    • 22% of all fentanyl

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  12. Which of the following is TRUE of changes in opioid prescribing between 2014 and 2017?

    EPIDEMIOLOGY OF CHRONIC PAIN AND OPIOID USE

    In 2018, an estimated 15.5 million prescriptions (9% of 169 million opioid analgesic prescriptions) were dispensed for ER/LA opioid analgesics from U.S. retail pharmacies. Five million prescriptions (33%) were for ER morphine; 3 million (20%) were for fentanyl transdermal patch; 3 million (19%) were for single-ingredient ER oxycodone; and 2 million prescriptions (13%) were dispensed for methadone. Similar trends were observed from 2014 through 2017 [64]. The total number of ER oxycodone (e.g., OxyContin and others) prescriptions declined from 4.6 million in 2014 to 3.0 million in 2018 and the total number of ER oxymorphone prescriptions declined from 1 million in 2014 to approximately 353,000 in 2018 [64]. The total number of prescriptions for ER morphine (e.g., Kadian, MS Contin, Avinza) decreased from 6.3 million in 2014 to 5 million in 2018 [64]. ER hydromorphone (e.g., Exalgo), introduced in 2010, was prescribed an estimated 186,000 times in 2014 and 100,000 times in 2018 [64].

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  13. In 2018, primary care providers prescribed the greatest proportion of

    EPIDEMIOLOGY OF CHRONIC PAIN AND OPIOID USE

    In 2018, primary care practitioners (e.g., general practice, family practice, internal medicine) accounted for approximately 41% of total prescriptions dispensed for single-ingredient oxycodone ER from retail pharmacies in the United States. Anesthesiologists and physical medicine and rehabilitation specialists accounted for 19% and 11%, respectively [64].

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  14. Which of the following factors influences the decision to prescribe an opioid analgesic?

    EPIDEMIOLOGY OF CHRONIC PAIN AND OPIOID USE

    A decision to prescribe opioids is based on clinician knowledge and judgment and also on patient preference, availability of non-opioid pain treatment approaches, the complexities and bias in third-party reimbursement, aggressive pharmaceutical marketing, and medico-legal concerns. These and other factors have tended to skew the standard of care toward reliance on opioids for long-term chronic pain management in the past few decades [8].

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  15. Which of the following is NOT true of trends in opioid analgesic misuse/abuse-related emergency department (ED) visits?

    EPIDEMIOLOGY OF CHRONIC PAIN AND OPIOID USE

    In 2011, the overall admission rate for misuse or abuse of opioid analgesics (excluding adverse reactions) was 134.8 per 100,000, an increase of 153% compared with 2004. In the 13 states involved in the legacy DAWN network, the top four opioid analgesics involved in drug-related ED visits for 2011 were various formulations of oxycodone (175,229), hydrocodone (97,183), methadone (75,693), and morphine (38,416). Between 2004 and 2011, ED admissions increased 74% for methadone, 220% for oxycodone, 96% for hydrocodone, and 144% for morphine. Importantly, there was no meaningful change in ED admission rates involving opioid analgesics between 2009 and 2011. If this is also borne out by subsequent data, it strongly suggests a plateau in the misuse and abuse rates of these agents [72].

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  16. In 2018, approximately how many persons engaged in nonmedical use of prescription opioids?

    EPIDEMIOLOGY OF CHRONIC PAIN AND OPIOID USE

    In 2018, 10.3 million people reported nonmedical use of opioid analgesics (i.e., use without a prescription or for the non-analgesic effect) and 3.8 million were first-time nonmedical users that year [74]. An estimated 3.4 million people misused oxycodone products (including OxyContin) in the past year (1.2% of the population) [74]. The most frequent initial (past year) drug used was cannabis (43.5 million), followed by nonmedical use of prescription opioids (9.9 million), nonmedical use of tranquilizers (6.4 million), hallucinogens (5.6 million), cocaine (5.5 million), stimulants (5.1 million), inhalants (2.0 million), methamphetamine (1.9 million), and heroin (808,000) [74].

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  17. In 2018, the most frequent initial illicit drug experience was with

    EPIDEMIOLOGY OF CHRONIC PAIN AND OPIOID USE

    In 2018, 10.3 million people reported nonmedical use of opioid analgesics (i.e., use without a prescription or for the non-analgesic effect) and 3.8 million were first-time nonmedical users that year [74]. An estimated 3.4 million people misused oxycodone products (including OxyContin) in the past year (1.2% of the population) [74]. The most frequent initial (past year) drug used was cannabis (43.5 million), followed by nonmedical use of prescription opioids (9.9 million), nonmedical use of tranquilizers (6.4 million), hallucinogens (5.6 million), cocaine (5.5 million), stimulants (5.1 million), inhalants (2.0 million), methamphetamine (1.9 million), and heroin (808,000) [74].

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  18. In 2018, how many persons in the United States had opioid analgesic abuse or dependence?

    EPIDEMIOLOGY OF CHRONIC PAIN AND OPIOID USE

    In 2018, 2.0 million persons had opioid analgesic abuse or dependence, similar to the number in 2012 (2.1 million). The percentage of people 12 years of age or older in 2018 with an opioid use disorder was similar to the percentages in 2016 and 2017, but it was lower than the percentage in 2015 [74].

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  19. Between 2002 and 2018, the past-year treatment admissions for opioid use disorders

    EPIDEMIOLOGY OF CHRONIC PAIN AND OPIOID USE

    Among persons 12 years of age or older, treatment admissions for prescribed opioid abuse have more than doubled in the last decade. Those whose most recent past-year treatment was for prescription opioids numbered 360,000 persons in 2002; this increased to 3.8 million in 2018 [74].

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  20. Of those who misuse or abuse prescription opioids, what percentage report having obtained their most recently used drugs from a friend or relative for free?

    EPIDEMIOLOGY OF CHRONIC PAIN AND OPIOID USE

    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. This information carries with it substantial public policy and regulatory implications. The 2018 NSDUH data asked nonmedical users of prescription opioids how they obtained their most recently used drugs [74]. Among persons 12 years of age or older, 51.3% obtained their prescription opioids from a friend or relative for free, 34.7% got them through a prescription from one doctor (vs.18.1% in 2010–2011), 9.5% bought them from a friend or relative, and 6.5% bought them from a drug dealer or other stranger. Less frequent sources included stealing from a friend or relative (3.2%); multiple doctors (2.0%); theft from a doctor's office, clinic, hospital, or pharmacy (0.9%) (vs. 0.2% in 2009–2010); and some other way (4.6%) [74].

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  21. Which of the following is NOT a known risk factor for fatal opioid toxicity?

    EPIDEMIOLOGY OF CHRONIC PAIN AND OPIOID USE

    The reasons for opioid analgesic overdose fatalities are multifactorial and include prescriber behaviors, patient contributory factors, nonmedical use patterns, and systemic failures. Risk factors identified for fatal opioid toxicity include [6]:

    • Prescriber error due to knowledge deficits

    • Patient nonadherence to medication regimen

    • Unanticipated medical and mental health comorbidities, including substance use disorders

    • Co-administration of other CNS-depressant drugs, including alcohol, benzodiazepines, and antidepressants

    • Sleep-disordered breathing (e.g., sleep apnea)

    • Body mass index of 30 or greater

    Additional factors specifically contributing to methadone fatality include [94]:

    • Payer policies that encourage or mandate methadone as first-line therapy

    • Methadone prescribing in opioid-naïve patients

    • Lack of prescriber knowledge of methadone pharmacology

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  22. Which of the following statements regarding the escalation in methadone prescribing and fatal toxicity between 1997 and 2007 is FALSE?

    EPIDEMIOLOGY OF CHRONIC PAIN AND OPIOID USE

    Since the mid-2000s, methadone has become disproportionately represented in cases of opioid analgesic fatality. Based on data showing that 70% of fatalities among those prescribed methadone occurred in the first seven days of treatment, the FDA changed the methadone labeling in 2006 to lengthen dosing intervals from every 3 to 4 hours to every 8 to 12 hours; the initial recommended dose of 2.5–10 mg was unchanged [6,100]. In 2008, use of the highest oral dose preparations, 40 mg, was prohibited from use in pain treatment and restricted to addiction therapy [94].

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  23. As reflected by trends in arrestee data, the prescription opioid abuse epidemic is

    EPIDEMIOLOGY OF CHRONIC PAIN AND OPIOID USE

    These results illustrate the uneven geographic distribution of the prescription opioid use epidemic. It is also clear that prevalence rates are stabilizing or declining in all localities. These arrestee data indicate the epidemic has likely peaked and predict the decline in first-time and past-year use and an increase in prescription opioid addiction and treatment-seeking rates. In susceptible persons, progression in severity of a substance use disorder to addiction often occurs over many years. Persons who now meet diagnostic criteria for opioid analgesic addiction, and may be seeking help, probably began their use during an earlier phase of the epidemic.

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  24. Publication of the 2013 FSMB model policy was prompted by findings of additional contributing factors to pain undertreatment and inappropriate opioid prescribing, which include all of the following, EXCEPT:

    MITIGATING RISK IN OPIOID PRESCRIBING PRACTICE

    The 2011 Institute of Medicine report Relieving Pain in America reinforced the importance of framing chronic pain as a unique chronic disease state with complex neurophysiological, emotional, and social components, making its management distinct from that of acute pain [7]. Treating chronic pain differs from acute pain by the duration, multimodal approach, and risk mitigation of the therapy. Clinicians may fear that managing the issues surrounding opioid analgesic prescribing render the practice too difficult or complex [113]. To assist in the dual need of protecting one's clinical practice while reducing opioid abuse, the FSMB released a model policy for opioid analgesic prescribing in 2013. This policy was the result of identification of harmful but remediable factors contributing to pain undertreatment and inappropriate opioid prescribing, including [10]:

    • Knowledge gaps in medical standards, current evidence-based outcomes, guidelines for appropriate pain treatment, and regulatory policies

    • Prescriber concerns that legitimate opioid prescribing will lead to unnecessary scrutiny by regulatory authorities

    • Conflicting information in existing clinical guidelines

    • Prescriber concerns of patient deception to obtain drugs for abuse and fears of precipitating addiction

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  25. Which of the following is NOT a characteristic of appropriate opioid prescribing?

    MITIGATING RISK IN OPIOID PRESCRIBING PRACTICE

    CHARACTERISTICS OF APPROPRIATE AND INAPPROPRIATE OPIOID PRESCRIBING

    Medically Legitimate Pain Management and Prescribing Inappropriate Pain Management and Prescribing
    Based on sound clinical judgment and current best clinical practices
    Appropriately documented
    Demonstrable patient benefit
    Occurs during the usual course of professional practice
    A legitimate physician-patient relationship exists
    Prescribing or administration appropriate to diagnosis
    Careful follow-up monitoring of patient response and safe patient use
    Demonstration of adjustment to therapy, as needed
    Documentation of appropriate referrals, as necessary
    Inadequate attention in initial assessment to clinical indication or patient risk of opioid problems
    Inadequate monitoring
    Inadequate patient education and informed consent
    Unjustified dose escalation without sufficient attention to risks or alternative treatments
    Excessive reliance on opioids, especially high-dose opioids, for chronic pain
    Failure to use risk assessment tools
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  26. The Screener and Opioid Assessment for Patients with Pain–Revised (SOAPP-R)

    MITIGATING RISK IN OPIOID PRESCRIBING PRACTICE

    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 [120].

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  27. A patient prescribed opioids for chronic pain who is 65 years of age and displays high levels of pain acceptance and active coping strategies is considered at what level of risk for developing problematic opioid behavioral responses?

    MITIGATING RISK IN OPIOID PRESCRIBING PRACTICE

    PATIENT RISK STRATIFICATION

    Low Risk
    Definable physical pathology with objective signs and reliable symptoms
    Clinical correlation with diagnostic testing including magnetic resonance imaging, physical examination, and interventional diagnostic techniques
    With or without mild psychological comorbidity
    With or without minor medical comorbidity
    None or well defined and controlled personal or family history of alcoholism or substance abuse
    Age 45 years or older
    High levels of pain acceptance and active coping strategies
    High motivation, willingness to participate in multimodal therapy and attempting to function at normal levels
    Medium Risk
    Significant pain problems with objective signs and symptoms confirmed by radiological evaluation, physical examination, or diagnostic interventions
    Moderate psychological problems, well-controlled by therapy
    Moderate coexisting medical disorders well controlled by medical therapy and which are not affected by chronic opioid therapy such as central sleep apnea
    Those who develop mild tolerance but not hyperalgesia without physical dependence or addiction
    Past history of personal or family history of alcoholism or substance abuse
    Pain involving more than three regions of the body
    Defined pathology with moderate levels of pain acceptance and coping strategies
    Willing to participate in multimodal therapy, attempting to function in their normal daily lives
    High Risk
    Widespread pain without objective signs and symptoms
    Pain involving more than three regions of the body
    Aberrant drug-related behavior
    History of misuse, abuse, addiction, diversion, dependency, tolerance, and hyperalgesia
    History of alcoholism
    Major psychological disorders
    Age younger than 45 years
    HIV related pain
    High levels of pain exacerbation and low levels of coping strategies
    Unwilling to participate in multimodal therapy; not functioning close to a near normal lifestyle
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  28. Which of the following is one of the ten essential steps of opioid prescribing for chronic pain that can help mitigate any potential problems?

    DEVELOPING A SAFE OPIOID TREATMENT PLAN FOR MANAGING CHRONIC PAIN

    All patients with pain have a level of risk that can only be roughly estimated initially and modified over time as more information is obtained. There are ten essential steps of opioid prescribing for chronic pain to help mitigate any potential problems [114]:

    • Diagnosis with an appropriate differential

    • Psychologic assessment, including risk of substance use disorders

    • Informed consent

    • Treatment agreement

    • Pre- and post-treatment assessments of pain level and function

    • Appropriate trial of opioid therapy with or without adjunctive medication

    • Reassessment of patient levels of pain and functioning

    • Regular assessment with the 5 A's (i.e., analgesia, activity, adverse effects, aberrant behaviors, and affect)

    • Periodically review pain diagnosis and comorbid conditions, including substance use disorders

    • Documentation

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  29. Which of the following is NOT one of the 5 A's of monitoring chronic opioid response?

    DEVELOPING A SAFE OPIOID TREATMENT PLAN FOR MANAGING CHRONIC PAIN

    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 [114]. This can include input from family members and/or the state prescription drug monitoring program (PDMP) [114]. 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 [10]:

    • Analgesia

    • Activities of daily living

    • Adverse or side effects

    • Aberrant drug-related behaviors

    • Affect (i.e., patient mood)

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  30. For patients considered at medium risk for misuse of prescription opioids, urine drug testing should be completed every

    DEVELOPING A SAFE OPIOID TREATMENT PLAN FOR MANAGING CHRONIC PAIN

    MONITORING FREQUENCY ACCORDING TO PATIENT RISK

    Monitoring Tool Patient Risk Level
    Low Medium High
    Urine drug testEvery 1 to 2 yearsEvery 6 to 12 monthsEvery 3 to 6 months
    State prescription drug monitoring programTwice per year3 times per year4 times per year
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  31. When using urine drug testing to monitor adherence and compliance, it is important to

    DEVELOPING A SAFE OPIOID TREATMENT PLAN FOR MANAGING CHRONIC PAIN

    Initially, testing involves the use of class-specific immunoassay drug panels [10]. 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 unless liquid chromatography is coupled with 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.

    It is important to appreciate the limitations of UDTs. Healthcare providers are increasingly relying on UDTs as a means to reduce abuse and diversion of prescribed opioids. This has led to a proliferation in diagnostic laboratories that offer urine testing. With this increase have come questions of whether these business interests benefit or hinder patient care, what prescribers should do with the information they obtain, the accuracy of urine screens, and whether some companies and clinicians are financially exploiting the UDT boom [131]. 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 and 19.5% were positive for an illicit drug/unreported opioid [132]. However, a negative UDT result for the prescribed opioid does not necessarily indicate diversion; it may indicate the patient halted its use due to side effects, lack of efficacy, or pain remission. The increasingly stringent climate surrounding clinical decision-making regarding aberrant UDTs is concerning. In many cases, a negative result for the prescribed opioid or a positive UDT serves as the pretense to terminate a patient rather than an impetus to guide him or her into addiction treatment or an alternative pain management program [131].

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  32. The U.S. Food and Drug Administration recommends that unused OxyContin tablets be disposed of by

    DEVELOPING A SAFE OPIOID TREATMENT PLAN FOR MANAGING CHRONIC PAIN

    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 [133]. 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 [134]. 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 [134]. Patients should be advised to flush prescription drugs down the toilet only if the label or accompanying patient information specifically instructs doing so.

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  33. An opioid should be safely discontinued with

    DEVELOPING A SAFE OPIOID TREATMENT PLAN FOR MANAGING CHRONIC PAIN

    The decision to continue or end opioid prescribing should be based on a joint 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 [114].

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  34. Which of the following is an advantage of abuse-deterrent opioid formulations utilizing aversive components?

    ABUSE-DETERRENT OPIOID FORMULATIONS

    ADVANTAGES AND DISADVANTAGES OF ADF STRATEGIES

    ADF Strategy Advantages Disadvantages
    Physical barriers
    Prevents crushing or chewing to block rapid high-dose opioid release into the system
    Prevents accidental crushing or chewing in compliant patients
    No adverse events in compliant patients
    FDA-approved formulation available
    Does not deter abuse of intact tablets
    Only one FDA-approved product available
    Aversive components (e.g., niacin)
    May prevent abuse by chewing or crushing the product
    May limit abuse of intact tablets because taking too much will amplify adverse events
    Potential adverse events in compliant patients taking product as intended
    Adverse events with intact tablets may prevent legitimate dose increase if pain increases or efficacy decreases over time
    Adverse events may not be sufficient to deter a motivated abuser
    No FDA-approved formulations
    Sequestered antagonist (e.g., naloxone, naltrexone)
    Prevents abuse by chewing or crushing opioids
    FDA-approved formulation available
    Does not deter abuse of intact tablets
    Chewing or crushing the tablet may trigger severe withdrawal symptoms
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  35. The introduction of abuse-deterrent OxyContin has resulted in

    ABUSE-DETERRENT OPIOID FORMULATIONS

    Although opioid ADFs have been introduced into widespread clinical use relatively recently, several studies of their efficacy have already been published. These reports have documented significantly reduced abuse rates of ADF opioids after they have fully replaced the original formulations, but no effect on the overall rates of opioid abuse. For example, data were obtained on 140,496 persons assessed for substance abuse treatment, spanning from one year before ADF OxyContin (Oxy ADF) introduction to two years post-Oxy ADF introduction. Abuse of OxyContin was 41% lower with the ADF versus the original formulation, including a 17% decrease in oral abuse and a 66% decrease in abuse through non-oral routes. Meaningful reductions in ER morphine and ER oxymorphone abuse rates were not found. The authors concluded that conversion of OxyContin to an ADF formulation was successful in reducing non-oral administration that requires tampering [143]. Another study found that following OxyContin ADF introduction, poison center exposures for oxycodone ER abuse declined 38% per population and 32% per unique recipients of dispensed drug. Therapeutic error exposures declined 24% per population and 15% per unique recipients of dispensed drug, and diversion reports declined 53% per population and 50% per unique recipients of dispensed drug. The declines were greater than those observed for other prescription opioids in aggregate [144]. However, several published reports have documented the abandonment of opioid analgesics and a migration to heroin use by previous OxyContin abusers following the introduction of ADF OxyContin [145,146].

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  36. The ARCOS system that monitors the flow of controlled substances through the distribution chain is run by the

    OTHER GOVERNMENT AND INDUSTRY EFFORTS

    As noted, 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, including health insurance claims; the Automation of Reports and Consolidated Orders System (ARCOS), 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 (TEDS), which monitors treatment admissions; National Center for Health Statistics state mortality data; and the Researched, Abuse, Diversion and Addiction-Related Surveillance (RADARS) System, which monitors prescription drug abuse, misuse, and diversion [153].

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  37. Which government agency is responsible for formulating federal standards for the handling of controlled substances?

    OTHER GOVERNMENT AND INDUSTRY EFFORTS

    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 [154].

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  38. Patients who require ultra-high-dose opioids to control chronic pain should be restricted from the use of

    UNINTENDED NEGATIVE CONSEQUENCES OF EFFORTS TO REDUCE PRESCRIBED OPIOID MISUSE, DIVERSION, AND OVERDOSE

    Patients with chronic pain who require ultra-high-dose opioids, in some cases more than 2,000 mg/day MED, are likely to be labeled as addicts or abusers by healthcare professionals and family members alike. In general, these patients are profoundly ill, impaired, and/or bed- or house-bound due to severe unremitting pain refractory to analgesic efforts using lower-dose opioids. The reason some patients require ultra-high opioid doses remains unclear, but it is very likely that some, and perhaps the majority, possess a cytochrome P450 polymorphism or other genetic abnormality [162].

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  39. Nonpharmacologic approaches shown to be effective for the treatment of substance use disorder in patients with chronic pain include all of the following, EXCEPT:

    PATIENTS WITH CHRONIC PAIN AND SUBSTANCE USE DISORDER

    The goals of treatment include avoiding harmful use of substances and achieving physical, psychological, and spiritual well-being. In patients with chronic pain with substance abuse disorders, there is a degree of overlap when substance abuse disorder treatment involves a biopsychosocial approach, as it ideally does. Effective approaches for substance abuse disorder include a combination of [176]:

    • Cognitive-behavioral therapy that addresses addiction recovery and chronic pain

    • Deep relaxation/meditation through mindfulness, progressive muscle relaxation, and/or other approaches

    • Working with an addiction counselor to explore substance use issues and to support recovery

    • 12-step program involvement, through Alcoholics Anonymous (AA), Narcotics Anonymous (NA), or Methadone Anonymous (MA), when appropriate. Every 12-step program has sponsors who are support persons successful in their recovery through their respective 12-step program, with a desire to work with new members to help them achieve recovery success. The patient should be encouraged to find a sponsor.

    • Alternatives to 12-step programs for peer support in substance abuse recovery (e.g., Smart Recovery and Rational Recovery)

    • Chronic Pain Anonymous, the peer-support program for those with chronic pain

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  40. Which of the following is NOT an advantage of buprenorphine over methadone treatment of opioid use disorder in patients with chronic pain?

    PATIENTS WITH CHRONIC PAIN AND SUBSTANCE USE DISORDER

    Several pharmacologic aspects of buprenorphine contribute to its safety and effectiveness as therapy for opioid addiction and make it highly suitable for use in primary care [189]. As a partial mu agonist, a ceiling effect exists for its maximal activity—beyond a certain dose, no additional benefit is experienced. In contrast to increases in the dose of pure opioid agonists such as methadone, a greater margin of safety exists from death by respiratory depression. Buprenorphine possesses a short plasma half-life (about four to six hours) and a long duration of action resulting from its high affinity for and slow dissociation from the mu opioid receptor [185]. This slow dissociation likely contributes to a reduction in the severity of withdrawal symptoms during detoxification, and the longer duration of action allows for the potential of alternate-day dosing [190].

    The efficacy literature indicates that higher-dose methadone (>50 mg daily, and 60–100 mg per day in particular) is more effective than lower doses in reducing illicit opioid and possibly cocaine use [191]. Higher-dose methadone is comparable to higher-dose buprenorphine (≥8 mg daily) on measures of treatment retention and reduction of illicit opioid use [191]. Although 30–60 mg per day of methadone may be effective in resolving opioid withdrawal symptoms, some patients require a maintenance dose ≥120 mg per day to eliminate illicit opioid use [191]. Patients requiring high-dose methadone for more severe opioid addiction are unlikely to achieve the same benefit from higher-dose buprenorphine [121]. Methadone has been reported to have higher retention rates, whereas buprenorphine has a lower risk of overdose fatality. These risks should be appropriately weighed by the treating or referring physician [189].

    Sustained stabilization on methadone or buprenorphine can greatly enhance the capacity for normal functioning, including holding a job, avoiding crime, and reducing exposure to infectious disease from injection drug use or risky sexual behavior. Stabilized patients are much more likely to benefit from counseling and group therapy, essential components of recovery [183]. Although patients may experience sedation during the induction phase, tolerance to this effect develops over several weeks, after which the ability to work safely or operate a car or machinery is no longer impaired. Cognitive research has found that, during stabilization, the methadone-maintained patient is just as capable as a healthy, non-addicted person in job performance, assuming education and skill is comparable and abstinence from opioids and other drugs of abuse is ongoing [192]. Unfortunately, serious stigma surrounds methadone treatment, experienced most acutely by patients but also by professionals, which may pose a barrier to treatment support [193].

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