This interactive Mississippi Physician Ebook contains 16 hours of continuing education. To complete click the Complete Your CE button at the top right of the screen.
Mississippi Continuing Medical Education
MISSISSIPPI MEDICAL LICENSURE PROGRAM
MANDATORY CME REQUIRED FOR MISSISSIPPI LICENSE RENEWAL 15 Hours PRESCRIPTION OPIOIDS: RISK MANAGEMENT AND STRATEGIES FOR SAFE USE *+ * Satisfies the DEA's New One-time MATE Requirement + Satisfies five (5) Hours on Prescribing Controlled Substances
In support of improving patient care, TRC Healthcare/ 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.
CME FOR:
AMA PRA CATEGORY 1 CREDITS ™ MIPS MOC STATE LICENSURE
COMPLETE B EFORE: 8/31/2026
AVAILABLE ONLINE AT: MS.CME.EDU
MISSISSIPPI PHYSICIAN
MISSISSIPPI STATE MANDATORY TRAINING REQUIREMENTS
Dear Colleagues,
The InforMed Mississippi Medical Licensure Program is designed to fulfill the mandatory CME requirement for physicians licensed by the state of Mississippi. Completion of this program satisfies eight (8) hours on the DEA’s new one-time MATE requirement and five (5) hours on prescribing controlled substances.
The Mississippi State Board of Medical Licensure requires physicians to complete 40 Category 1 CME hours every two years. For those with a DEA license, the 40 hours must include at least 5 hours on the prescribing of controlled substances.
To complete this program online, visit BOOK.CME.EDU , enter the book code MDMS1526 in the box then click GO .
Thank you for choosing lnforMed as your CME provider. We strive to create a high-quality, streamlined program for our colleagues. Please contact us with any questions, concerns, or suggestions.
Explore our course library to find content that meets your remaining state and national CME requirements.
Best Regards,
The lnforMed CME Team
Mississippi State Department of Health 90 Church St. | Mississippi, NY | (212) 417-4200
We are a nationally accredited CME provider. For all board-related inquiries please contact:
1-800-237-6999
BOOK.CME.EDU
BOOK CODE: MDMS1526
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What’s Inside
01
PRESCRIPTION OPIOIDS: RISK MANAGEMENT AND STRATEGIES FOR SAFE USE 15 CREDIT HOURS SATISIFIES (8) HOURS ON THE DEA’S ONE-TIME MATE REQUIREMENT AND (5) HOURS ON PRESCRIBING CONTROLLED SUBSTANCES The purpose of this course is to provide the information necessary for clinicians to make informed decisions regarding prescribed opioids in order to minimize adverse events, substance abuse, and drug diversion.
FINAL EXAMINATION ANSWER SHEET REQUIRED TO RECEIVE CREDIT
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MOC/MIPS CREDIT INFORMATION
Table 1. MOC Recognition Statements Successful completion of certain enclosed CME activities, which includes participation in the evaluation component, enables the participant to earn up to the amounts and credit types shown in Table 2 below. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit. Board Programs Participants can earn MOC points equivalent to the amount of CME credits claimed for designated activities. InforMed currently reports to the following specialty boards: ABA, ABIM, ABS, ABPath and ABP. To be awarded MOC points, you must obtain a passing score, complete the corresponding activity evaluation, and provide required information necessary for reporting.
American Board of Anesthesiology’s redesigned Maintenance of Certification in Anesthesiology TM (MOCA®) program, known as MOCA 2.0®
ABA
ABIM
American Board of Internal Medicine’s Maintenance of Certification (MOC) program
ABS
American Board of Surgery’s Continuous Certification program
ABPath
American Board of Pathology’s Continuing Certification program
ABP
American Board of Pediatrics’ Maintenance of Certification (MOC) program
Table 2. Credits and Type Awarded
AMA PRA Category 1 Credits T M
Activity Title
ABA ABIM ABS
ABPath
ABP
Prescription Opioids: Risk Management and Strategies for Safe Use
15 Credits LL
15 Credits MK
15 Credits SA + AC
15 Credits LL
15 Credits LL
15 AMA PRA Category 1 Credit(s) TM
Legend: LL = Lifelong Learning, MK = Medical Knowledge, SA = Self-Assessment, LL+SA = Lifelong Learning & Self-Assessment, AC = Accredited CME
DATA REPORTING: Federal, State, and Regulatory Agencies require disclosure of data reporting to all course participants. InforMed abides by each entity’s requirements for data reporting to attest compliance on your behalf. Reported data is governed by each entity’s confidentiality policy. To report compliance on your behalf, it’s mandatory that you must achieve a passing score and accurately fill out the learner information, activity and program evaluation, and the 90-day follow-up survey. Failure to accurately provide this information may result in your data being non-reportable and subject to actions by these entities.
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How to complete
Please read these instructions before proceeding. Read and study the enclosed courses and answer the final examination questions. To receive credit for your courses, you must provide your customer information and complete the mandatory evaluation. We offer two ways for you to complete. Choose an option below to receive credit and your certificate of completion.
ONLINE
FASTEST AND EASIEST!
• Go to BOOK.CME.EDU and enter code MDMS1526 in the book code box, then click GO. • Proceed to your exam. If you already have an account, sign in with your username and password. If you do not have an account, you’ll be able to create one now. • Follow the online instructions to complete your final examination. Complete the purchase process to receive course credit and your certificate of completion. Please remember to complete the online evaluation.
Enter book code
MDMS1526
GO
IF YOU’RE ONLY COMPLETING CERTAIN COURSES IN THIS BOOK: • Go to BOOK.CME.EDU and enter the code that corresponds to the course below, then click GO. Each course will need to be completed individually, and the specified course price will apply.
Complete the answer sheet and evaluation found in the back of this book. Include your payment information and email address. Mail to: InforMed, PO Box 997432, Sacramento, CA 95899
BY MAIL
Mailed completions will be processed within 2 business days of receipt, and certificates emailed to the address provided. Submissions without a valid email address will be mailed to the postal address provided.
Program Options
Price
Option
Code
Credits
ENTIRE PROGRAM: Prescription Opioids: Risk Management and Strategies for Safe Use
$80
MDMS1526 15 Credits
Note: Prices are subject to change
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__________________________________ Prescription Opioids: Risk Management and Strategies for Safe Use
MDMS1526 — 15 CREDITS
R elease D ate : 09/01/23
E xpiration D ate : 08/31/26
Prescription Opioids: Risk Management and Strategies for Safe Use
In addition to receiving AMA PRA Category 1 Credit TM , physicians participating in Maintenance of Certification will receive the following points appropriate to their certifying board: 15 ABIM MOC Points, 15 ABS MOC Points, 15 ABA MOCA Points, 15 ABP MOC Points, 15 ABPath CC Points.
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.
HOW TO RECEIVE CREDIT
Audience This course is designed for physicians, physician assistants, nurses, and pharmacy professionals involved in the care of patients prescribed opioids to treat pain. Course Objective The purpose of this course is to provide the information necessary for clinicians to make informed decisions regard- ing prescribed opioids in order to minimize adverse events, substance abuse, and drug diversion. Learning Objectives Upon completion of this course, you should be able to: 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. • Read the enclosed course. • Complete the final examination questions at the end. A score of 70% is required. • Return your customer information/answer sheet, evaluation, and payment to InforMed by mail or complete online at BOOK.CME.EDU.
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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 addic- tion 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 Mary Franks, MSN, APRN, FNP-C Randall L. Allen, PharmD Senior Director of Development and Academic Affairs Sarah Campbell Division Planners/Director Disclosure The division planners and director have disclosed no relevant financial relationship with any product manufacturer or service provider mentioned. 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.
Designations of Credit NetCE designates this enduring material for a maximum of 15 AMA PRA Category 1 Credit(s) ™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Successful completion of this CME activity, which includes participation in the evaluation component, enables the par- ticipant to earn up to 15 MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equiva- lent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit par- ticipant 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 Self-Assessment requirements of the American Board of Surgery’s Continu- ous 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 Certi- fication 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 Ameri- can 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 15 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. This activity has been designated for 15 Lifelong Learning (Part II) credits for the American Board of Pathology Con- tinuing Certification Program.
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__________________________________ Prescription Opioids: Risk Management and Strategies for Safe Use Disclosure Statement
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 ACC- ME’s “CME in Support of MOC” program in Section 3 of the Royal College’s MOC Program. 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.
It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distrib- uting or providing access to this activity to learners.
Sections marked with this symbol include evidence-based practice recommendations. The level of evidence and/or strength of recommendation, as provided by the evidence-based source, are also included
so you may determine the validity or relevance of the information. These sections may be used in conjunction with the course material for better application to your daily practice.
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and inadequate patient counseling and monitoring, reflecting deficits in knowledge, competence, and performance [6]. Many primary care providers lack sufficient knowledge or training in pain medicine and in appropriate opioid use, and the majority report they do not feel confident managing chronic pain [7; 8]. A clinical skills assessment by the Ameri- can Academy of Family Physicians found significant and widespread knowledge deficits among family practice physicians in the medical skills necessary for providing optimal pain management, managing drug abuse and addiction, and utilizing risk evalu- ation and mitigation strategies when prescribing opioids [9]. The goal of this course is provide clinicians with an understanding of the essential components of appropriate opioid prescribing. This objective will be achieved through discussion of behavioral responses in patients receiving opioids for pain; the anteced- ents, catalysts, manifestations, and consequences of the dramatic and widespread increase in clinical and illicit use of prescription opioids; the assessment and management of pain; patient risk of developing problems with their prescribed opioid analgesic; gov- ernmental, law enforcement, and industry strategies and tactics to reduce prescription opioid abuse; and treatment approaches for patients with comorbid chronic pain and substance use disorders. Among primary care providers, there is great variability in the understanding of opioid use and misuse and in the confidence with which opioids are used for man- agement of chronic pain. Often, there is confusion or difficulty distinguishing physiological tolerance and dependence or uncontrolled pain behaviors from symptoms and signs of opioid use disorder. In addition to substantial differences in patient tolerability and analgesia with opioid analgesics, patients can also exhibit a range of psychological, emotional, and behavioral responses to prescribed opioids, the result of inadequate pain control, an emerging opioid use problem, or both. An apprecia- tion for the complexities of opioid prescribing, and the dual risks of litigation due to inadequate pain control and drug diversion or misuse, is necessary for all clinicians in order to provide the best possible patient care and to prevent a growing social problem.
INTRODUCTION In the United States, the use of prescription opioids for the treatment of pain is challenging and complex. There exists a prevailing tendency to inappropriate patterns of underprescribing (because of fear of adverse effects and addiction) or overprescribing (because of failure to select properly or frustration over a poor therapeutic response). These practice patterns are especially prevalent in the management of patients with chronic noncancer pain and have resulted in or contributed to unnecessary patient suffering from inadequately treated pain and increas- ing rates of opioid abuse, addiction, diversion, and overdose. Morphine was synthesized close to 200 years ago and entered clinical use more than 150 years ago. To this day, morphine and its opioid analogs remain the most powerful analgesics for severe acute pain and effective therapies for many chronic pain condi- tions. Opioid analgesic prescribing for pain control has risen dramatically since the late 1990s, and although opioid analgesic use in moderate-to-severe acute pain, cancer pain, and terminal pain is widely accepted, its use in chronic noncancer pain remains controversial [1]. Opioids can provide effective pain control, but problematic side effects are common, long-term outcomes vary, and escalating rates of addiction, diversion, and fatal overdose involving opioids have occurred in tandem with their increas- ing clinical use for pain control. These negative outcomes from increasingly widespread prescribing have heightened awareness of the need for prescrib- ers to mitigate the inherent risks that come with opioid analgesics in order to minimize their abuse, addiction, diversion, and fatal toxicity [2]. There is a shortage of pain specialist physicians in the United States that is expected to worsen, and this has resulted in most of the medical care for patients with chronic pain being delivered by primary care physicians [3]. The current problems involving pre- scription opioid analgesics are primarily the result of prescriber factors and the undue influence of stake- holders over pain medicine practice [4; 5]. Prescriber factors include inappropriate opioid prescribing
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__________________________________ Prescription Opioids: Risk Management and Strategies for Safe Use There is also considerable evidence that, in the past, major stakeholders have negatively influenced the delivery of safe, effective, and appropriate anal- gesic care to patients with chronic pain. This has occurred, in part, through bias of the information provided to clinicians to guide their practice and prescribing behavior with respect to opioid analge- sics. Effective practice is based on training, clinical judgment, and ongoing study of advances in practice areas. Careful clinicians pay attention to published research and other mediums of knowledge transfer that are relevant to their particular practice, with a trained eye toward the quality of evidence. Unfortu- nately, much of what has been published on chronic pain management, especially as regards opioid drug use, has uncertain validity because of various forms of bias and nonrigorous statistical analysis. This has had an adverse impact on the consistency and quality of care, on clinician confidence in how to render care, and on the public health cost of opioid analgesic care. For these reasons, an Appendix to this course has been included to provide some his- torical perspective on opioid prescribing practices and to address sources of bias in clinical (therapeu- tic) research. 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 behav- ioral 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 treat- ment of pain [7]. A 2013 survey measured primary care physician understanding of opioids and addic- tion. 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. This last point is very important because confu- sion and conflation of the clinical concepts of dependence and addiction has led to accusations of many nonaddicted patients with chronic pain misusing or abusing prescribed opioids and to fail- ure to detect treatment-emergent opioid problems [12]. Knowledge gaps concerning opioid analgesics, addiction, and pain may be related to attitude gaps, and negative attitudes may interfere with appropriate prescribing of opioid analgesics. For example, when 248 primary care physician survey participants were questioned regarding their prescribing approach in patients with headache pain and either a past or
DEFINITIONS Definitions and use of terms describing opioid analgesic misuse, abuse, and addiction have changed over time, and their current correct use is inconsis- tent not only among healthcare providers, but also among federal agencies reporting epidemiological data such as prevalence of opioid analgesic misuse, abuse, or addiction. Misuse and misunderstand- ing of these concepts and their correct definitions has resulted in misinformation and represents an
impediment to proper patient care. OPIOID ABUSE, DEPENDENCE, AND ADDICTION
Inappropriate opioid analgesic prescribing for pain is defined as the nonprescribing, inadequate prescrib- ing, excessive prescribing, or continued prescribing despite evidence of ineffectiveness [10]. Appropri- ate opioid prescribing is essential to achieve pain control, to minimize societal harms from diversion,
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Prescription Opioids: Risk Management and Strategies for Safe Use _ _________________________________ current history of substance abuse, 16% and 42% of physicians, respectively, would not prescribe opioids under any circumstance [13]. Possibly contributing to this knowledge deficit is the extent of educational exposure to concepts central in pain management. A 2018 systematic review evaluated pain medicine curricula in 383 medical schools in Australia, New Zealand, the United States, Canada, the United Kingdom, and Europe [14]. Pain medicine was pri- marily incorporated into anesthesia or pharmacol- ogy courses, rather than offered as a dedicated pain medicine module. Ninety-six percent of medical schools in the United Kingdom and the United States and nearly 80% of medical schools in Europe had no compulsory dedicated pain medicine educa- tion. The median number of hours of pain content in the entire medical school curriculum was 20 in Canada, 20 in Australia and New Zealand, 13 in the United Kingdom, 12 in Europe, and 11 in the United States [14]. 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]. In 2011, the American Society of Addiction Medi- cine (ASAM) published their latest revision in defin- ing the disease of addiction. Since that time, the public understanding and acceptance of addiction as a chronic brain disease and the possibility of remission and recovery have increased. Additionally, there is growing acknowledgment of the roles of prevention and harm reduction along the spectrum of addiction and recovery. Consequently, ASAM updated its definition of addiction and adopted the following revised definition in 2019 [17]:
Addiction is a treatable, chronic medi- cal disease involving complex interactions among brain circuits, genetics, the environ- ment, and an individual’s life experiences. People with addiction use substances or engage in behaviors that become compul- sive and often continue despite harmful consequences. Prevention efforts and treat- ment approaches for addiction are gener- ally as successful as those for other chronic diseases. 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 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 [17].
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 orga- nizations. 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 Psychi- atric 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 psy- chological dependence and the belief that tolerance and withdrawal meant addiction. This confusion enhanced provider and patient fears over addiction
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__________________________________ Prescription Opioids: Risk Management and Strategies for Safe Use Many terms used in discussions of opioid use and misuse may have ambiguous meanings ( Table 1 ). The absence of consensus in the terminology and definitions of substance use, substance use disorders, and addiction has led to considerable confusion and misconceptions ( Table 2 ). These misconcep- tions may be harbored by clinicians, patients, family members, and the public and can negatively impact patient interaction, assessment, treatment, and out- comes. Correction of these erroneous beliefs and attitudes is important, as is the use of nonpejora- tive and nonstigmatizing language when describing opioid analgesics, the patients who need them, and patients who develop aberrant behaviors or addic- tion involving opioids ( Table 3 ). Pejorative termi- nology has a strong negative effect on patients and serves to reinforce their sense of shame and stigma over using opioid analgesics. These terms signal a negative attitude and judgment to patients [15; 19]. BEHAVIORAL RESPONSES TO PRESCRIBED OPIOIDS Patients with pain display a continuum of behavioral responses to prescribed opioids. Some develop aber- rant behaviors, which are defined as unintended behaviors involving the acquisition or use of prescribed opioids [22]. 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 aber- rant 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 sug- gestive of emergent opioid use disorder. Selling the prescribed opioid and prescription forgery received highest ranking as most aberrant, and altered route
OPIOID USE TERMINOLOGY
Term
Definition
Misuse, nonmedical use
Use of the opioid that departs from intended prescribing by the provider
Abuse
A maladaptive pattern of opioid use with the primary intent of achieving euphoria or getting high A primary, chronic, neurobiologic disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. Characterized by behavior including impaired control over drug use, compulsive drug use, continued use despite harm, and drug craving. The expected response to chronic administration of many drug classes such as opioids, anabolic steroids, and beta-blockers, manifesting in neurologic adaptation whereby a drug class-specific withdrawal syndrome is produced by abrupt cessation, rapid dose reduction, decreased blood concentration, or antagonist administration
Addiction
Physical dependence
Tolerance A state of adaptation in which the physiologic changes from drug exposure over time lead to diminished drug effect Pseudoaddiction An iatrogenic condition whereby patients display aberrant drug-seeking behaviors mimicking opioid use disorder but driven by intense need for pain relief. Resolves with adequate pain relief. Diversion Transfer of a controlled substance from authorized to unauthorized possession or distribution Opioid Any compound that binds to an opioid receptor in the CNS, including naturally occurring, synthetic, and semi-synthetic opioid drugs and endogenous opioid peptides Iatrogenic A response, usually unfavorable, to a medical or surgical treatment induced by the treatment itself CNS = central nervous system. Source: [10; 20; 21] Table 1
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COMMON MISCONCEPTIONS OF PAIN THERAPY WITH OPIOID ANALGESICS AND ADDICTION
Misconception or Belief
Correction
The tolerance and withdrawal of opioid dependence equates to opioid addiction.
Tolerance, withdrawal, and physiologic dependence are expected responses to opioids and other controlled substances when given in sufficient doses over time and are not, by themselves, indicative of addiction. Addiction is not an entirely predictable response to reward-producing drugs but may occur in biologically and psychologically susceptible individuals; it is diagnosed over time based on established criteria. Uncontrolled pain or anxiety and other psychiatric illnesses may trigger a relapse to substance use or exacerbate an existing disorder. Treatment should be tailored to patient need and may include alternative treatment modalities, monitored prescriptions, or other measures as needed. Patients with undertreated pain may engage in problematic behaviors that mimic opioid abuse but are driven by intense need for relief and resolve with adequate pain control. Many factors can underlie substance misuse, including varying cultural values, lack of education, misunderstandings, and poor judgment, that do not meet the criteria for a substance use disorder. Misuse does require evaluation for patient education and possible treatment modifications but does not mandate discontinuation of opioids. This has been proven false; the rate of iatrogenic opioid use disorder is low. Addiction is the result of individual susceptibility, and any opioid analgesic can be abused by predisposed individuals. An increase in pain severity can be countered by dose increase, switching to another opioid, or adding a non-opioid analgesic. After an effective dose is reached, many patients with chronic pain are able to maintain analgesia on the same dose. The initial sedation goes away within the first two weeks of initiation. Opioids have conclusively been shown to not hasten death in hospice patients; pain undertreatment is a far greater concern in hastening death.
Addiction can be accurately predicted and diagnosed in the initial assessment of patients with pain.
Medications for pain or anxiety should not be used in patients with a substance use disorder history.
Behaviors such as ‘‘clock-watching,’’ preoccupation with obtaining opioid analgesics, deception, stockpiling unused medication, and illicit substance use indicate addiction. Substance misuse is the same as substance abuse, dependence, or addiction; all require cessation of opioid prescribing.
Opioid therapy always leads to addiction.
Some opioids are worse than others in terms of addiction potential. If morphine is used now, there will not be options when the pain worsens. If I start taking an opioid, I will have to keep increasing the dose to control my pain. Morphine and opioids cause heavy sedation and probably hasten death.
Source: [15; 21]
Table 2
of administration was given the third highest rank- ing. Lowest ranked were unkempt patient appear- ance, sporadic unsanctioned dose escalation, and prescribed opioid hoarding [23]. There are certain behaviors that are suggestive of an emerging opioid use disorder. The most suggestive behaviors are [24; 25; 26]: • 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
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TERMS TO AVOID OR LIMIT THE USE OF
Term
Rationale for not using
Addicted/addiction
Frequently misused by those untrained to make the diagnosis. Not all who abuse are addicted. Patently false when describing a substance. Addiction resides within the person and not in the substance used. Some drugs do have high abuse liability, but most persons do not respond to exposure with addictive behavior. Overused in the literature and by clinicians. Not very helpful, especially if a better treatment or coping strategy is not immediately available. Used when a patient is assumed to lack legitimate need for medication. Should be replaced with relief-seeking, if appropriate.
Addictive
Chemical coping
Drug-seeking
Hooked Slang for addicted. Assumes the absence of medical need for the substance and suggests an off-hand, bad attitude. Inebriated/intoxicated A snap conclusion when a patient suspected of taking medication or other substance displays an altered sensorium. Better to objectively describe observations. Malingering Overcalled and best not expressed unless there is legally valid proof of deception for illicit purposes. Narcotic A term formerly referring to opium, morphine, and heroin and still used in the area of law and misused by media in reference to all opioids. Should never be used in a clinical or education context due to strong emotional association with crime, addiction, and death. Best replaced with opioid.
Painkiller
Negative use by media in reports of opioid addiction and overdose. Best replaced with pain reliever.
Source: [19]
Table 3
CONSIDERATIONS FOR DIFFERENTIAL DIAGNOSES
• 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 man- aged pain or poor coping skills as the basis for aber- rant behavior. Even aberrant behaviors highly sug- gesting opioid abuse may reflect a patient’s attempt to feel normal or alleviate emotional or physical distress. This is termed chemical coping and refers
• Inadequate pain management: – Stable condition but inadequate pain control – Progressive condition/pathology – Tolerance to opioids • Inability to comply with treatment due to:
– Cognitive impairment – Psychiatric condition • Self-medication of mood, anxiety, sleep, post- traumatic stress disorder, etc. • Diversion Source: [19]
Table 4
• 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 [23; 24; 25]:
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Prescription Opioids: Risk Management and Strategies for Safe Use _ _________________________________ 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 [27]. Impor- tantly, 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 [27]. ment 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 inter- pretation by board members, even when legitimate medical necessity merited long-term, high-dose opioid prescribing to patients with severe, chronic noncancer pain [28].
These physician concerns were confirmed by the results of a 1992 survey that captured medical board member perception and opinion of legality and appropriateness in opioid prescribing for different pain conditions. A total of 304 members of 49 state medical boards were surveyed; 85% were physicians (MDs and DOs) and 15% were lay public members [29]. Physician members were asked to rank 12 opi- oids by their order of recommendation for chronic, moderate-to-severe cancer pain. The top selection was codeine with aspirin/acetaminophen (47%), despite codeine being widely accepted as too weak for chronic moderate-to-severe pain. When asked of the general incidence of psychological dependence (as compulsive nonmedical use) from opioid pain treatment, 39% did not know. When asked to define “addiction” by selecting one or more of several com- mon definitions, 85% chose physical dependence, 71% chose psychological dependence, 41% chose tolerance, 21% chose physical dependence alone, 10% chose psychological dependence alone, and 1% chose tolerance alone [29]. Respondents were also asked for their opinion, as state medical board members, of the legality and medical legitimacy of opioid prescribing longer than three months for several patient scenarios. Approximately 10% of board members described opioid prescribing as illegal under medical practice, controlled substances law, or both, and requiring investigation in patients with cancer pain alone, 26% in cancer pain with patient history of opioid abuse, 59% in chronic noncancer pain alone, and more than 90% in patients with chronic noncancer pain and history of opioid abuse [29]. Underscoring the gravity of these findings was that 80% of respon-
For the purposes of this course, the term opioid addiction is used to indicate a severe opioid use problem, consistent with the definition of addiction provided earlier in this course and in place of the now-discarded DSM-IV term of opioid dependence. Opioid use disorder is used to encompass the range of problematic opioid use. CLINICIAN AND PROFESSIONAL SOCIETY ATTITUDES TOWARD OPIOID PRESCRIPTION DRUG USE BACKGROUND Opium and its alkaloids have been used for thou- sands of years as analgesics. From the end of the 19th century into the early 20th century, heroin was sold as a cough suppressant and briefly promoted as more effective and less addictive than morphine. It was legally marketed in pill form and became widely abused for the intense euphoria by crushing the heroin pills into powder for inhalation or injection [1]. Heroin addiction skyrocketed, and Congress banned the drug in 1924. Wariness of prescribing opioids persisted through the 1980s and 1990s [28]. The United States has a long history of pain under- treatment 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 undertreat-
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__________________________________ Prescription Opioids: Risk Management and Strategies for Safe Use dents stated their medical board was the agency most likely to investigate improper controlled substance prescribing in their state [29].
These iatrogenic addiction figures were disseminated through communications to specialists, general practitioners, other providers, administrators, regu- lators, and the lay public. “Less than 1%” became the message that opioids posed little risk of addic- tion in patient with pain without substance abuse histories. Substantial support for compassion-based efforts to broaden opioid use for pain control also came from the 1990 opinion paper by the co-author of the landmark paper describing gate control theory that revolutionized the concept of pain [39]. In 1988, the Federation of State Medical Boards (FSMB) released a policy explicitly reassuring physicians they would not face regulatory action for prescrib- ing even large amounts of opioids, assuming it was medically warranted [30]. Physician awareness of the new FSMB policy was promoted by widely circulated publications. For example, the Joint Commission published a guide, supported by Purdue Pharma, stating, “Some clinicians have inaccurate and exag- gerated concerns about addiction, tolerance, and risk of death,” and “This attitude prevails despite the fact there is no evidence that addiction is a significant issue when persons are given opioids for pain control” [30]. 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 con- sensus statement in 1997 that stated long-term opi- oid analgesic use for chronic noncancer pain posed minimal risk of overdose or addiction [30; 40]. The pharmaceutical industry was also instrumental in the movement toward loosening opioid prescribing con- straints and broadening the indications for opioid use in managing chronic pain [30; 41]. Professional pain societies wrote consensus statements claim- ing 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 [42]. 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
Against this backdrop, some pain physicians began to re-examine and challenge the intense physician reluctance to prescribe opioids. Observing the extent that suffering was relieved by opioids in cancer patients with severe pain and the apparent lack of euphoria that differed from the responses of opioid abusers, it was suggested that opioids could also be used to relieve suffering in many patients with intense, persistent noncancer pain, with little risk of addiction. This was followed by an effort to destigma- tize the use of opioids, with the objective of easing access to opioids by the large number of patients with severe, persistent noncancer pain. While widely viewed as driven by good intentions, this crusade for acceptance of opioid use in noncancer pain was also accompanied by the regular tendency to minimize the inherent potential risks that accompany opioid prescription drug use, despite the absence of valid evidence to support the assumption [30]. Results from a 1986 chart review study of 38 patients with chronic noncancer pain receiving long-term opioid therapy were cited to support the assertion that long-term opioid use in patients with intractable nonmalignant pain was effective and safe with little risk of addiction. Of the 38 patients in the study, the 2 who developed opioid problems had histories of drug abuse [31]. This paper was followed by several other publications on opioids for chronic noncancer pain [32; 33; 34; 35]. Each paper cited the prevalence rates of iatrogenic opioid addiction reported by three earlier pain studies [36; 37; 38]: • Of 11,882 hospitalized patients with a negative substance abuse history who received ≥1 opioid dose, 4 developed addiction. • A national survey of roughly 10,000 patients treated for burn pain found no cases of addiction. • Of 2,369 patients treated at a headache center who had access to opioid analgesics, 3 developed problems with their prescribed opioid.
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Prescription Opioids: Risk Management and Strategies for Safe Use _ _________________________________ rate their pain from 1 to 10 and circle a smiling or frowning face, and pain became the fifth vital sign [43]. 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 [44]. 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 condi- tion; and no similar standard existed requiring the universal assessment of other symptoms [44]. 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, implemented in 2018, and revised in 2019 [45; 46].
2000, when Congress proclaimed 2000–2010 as the Decade of Pain Control and Research [47]. Shift- ing demographics also contributed to the changing attitudes toward opioid prescribing. With painful chronic illness rates increasing with the overall population age, there came growing awareness of the importance in providing effective pain relief [43]. Pharmaceutical companies began introducing new opioid formulations, and existing opioid products became more widely prescribed ( Table 5 ). The theme of minimal abuse liability was widely used in the marketing materials distributed to prescribers and pharmacists [48]. When the escalating rates of addiction, diversion, and fatal overdose involving prescribed opioids became apparent, the same pain specialists and organizations, pain advocacy groups, drug companies, and media reinforced the percep- tion of opioid legitimacy by primarily attributing the growing individual and public health hazard to improper Internet availability, illicit diversion, and the prevalence of societal drug addiction tenden- cies [49]. THE OXYCONTIN STORY: A CASE STUDY The story of extended-release oxycodone, marketed as OxyContin, is informative and unique. Although the United States has experienced several waves of widespread prescription drug abuse over the past 150 years, the rapid ascent of OxyContin from market entry to miracle drug for chronic pain to a demonized substance of abuse and diversion on a vast scale is without precedent. Multiple factors
The financial support supplied to professional soci- eties by drug companies helped influence members to change prescribing practices. Patient advocacy groups, often guided by physicians who felt con- strained by the prohibition of opioid prescribing and pain specialist organization consensus that chronic pain had been previously undertreated, worked to elevate awareness that pain was untreated and unrecognized [28; 40]. During this time, opioid prescribing for chronic noncancer pain dramati- cally increased across the country. The movement for more aggressive pain treatment culminated in
RETAIL PURCHASES a OF PRESCRIPTION OPIOIDS (GRAMS OF DRUG)—UNITED STATES, 2019–2021 Opioid 2019 2021 Change Methadone 15,080,444 g 13,866,600 g -8.01% Oxycodone 35,929,260 g 31,190,066 g -13.2% Fentanyl base 193,531 g 154,574 g -20.1% Hydromorphone 987,221 g 1,013,929 g +2.71% Hydrocodone 20,040,962 g 17,399,719 g -13.2% Morphine 11,966,623 g 9,728,577 g -18.7% Codeine 12,105,985 g 9,942,219 g -17.9% Meperidine 292,694 g 153,171 g -47.7% Total 96,596,720 g 83,448,855 g -13.6% a Purchasers include pharmacies, hospitals, practitioners, teaching institutions, and treatment programs. Source: [50] Table 5
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