This interactive Arizona Physician eBook contains 11 hours of continuing education. To complete click the Complete Your CE button at the top right of the screen.
Arizona Continuing Medical Education
Arizona Medical Licensure Program
Opioids/Substance Abuse/Addiction 3 HOURS SATISFIES OPIOID, SUBSTANCE-USE-DISORDER-, OR ADDICTION-RELATED CME REQUIREMENT DEA REQUIREMENT (NEW) 8 HOURS SATISFIES THE DEA’S NEW ONE-TIME MATE REQUIREMENT Substance Use Disorders
INCLUDES: DEA’s new one-time MATE requirement
CME FOR:
AMA PRA CATEGORY 1 CREDITS ™ MIPS MOC STATE LICENSURE
AZ.CME.EDU
InforMed is Accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
ARIZONA
01 EFFECTIVE MANAGEMENT OF ACUTE AND CHRONIC PAIN WITH OPIOID ANALGESICS COURSE ONE | 3 CREDITS*
30
SUBSTANCE USE DISORDERS: A DEA REQUIREMENT COURSE TWO | 8 CREDITS*+
64
LEARNER RECORDS: ANSWER SHEET & EVALUATION REQUIRED TO RECEIVE CREDIT
*Both courses satisfy the Arizona Boards of Medicine, Osteopathic Examiners and Physician Assistants mandatory requirement of three (3) AMA PRA Category 1 Credits TM or equivalent on Opioids/Substance Abuse/Addiction. +Satisfies the DEA’s new One-time MATE Requirement.
Program Options
Book Option
Price Credits
Code
ENTIRE PROGRAM
$95 11 Credits MDAZ1124
Effective Management of Acute and Chronic Pain with Opioid Analgesics
$50
3 Credits
MDAZ03EM
Substance Use Disorders: A DEA Requirement
$80
8 Credits
MDAZ08SD
CME that counts for MOC Participants can earn MOC points equivalent to the amount of CME credits claimed for designated activities (see page iii for further details). InforMed currently reports to the following specialty boards: the American Board of Internal Medicine (ABIM), the American Board of Anesthesiology (ABA), the American Board of Pediatrics (ABP), the American Board of Otolaryngology–Head and Neck Surgery (ABOHNS), and the American Board of Pathology (ABPath). To be awarded MOC points, you must obtain a passing score, complete the corresponding activity evaluation, and provide required information necessary for reporting.
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.
InforMed has joined the Elite Learning family Two of the nation’s top healthcare education providers have joined forces with one goal in mind: to offer physicians a state-of-the-art learning experience that fulfills your state requirements and empowers you with the knowledge you need to provide the best patient care. Here’s what you can expect from our new partnership: • COURSES: In addition to the mandatory courses you need to renew your state license, you’ll now have access to dozens of hours of elective courses and an expanded content library. • ACCOUNTS: You’ll also have access to a personalized learner account. In your account you can add, organize, and track your ongoing and completed courses. For instructions on how to set up your account, email us at office@elitelearning.com. • BOOK CODES: You may notice a book code on the back cover of the latest InforMed program you’ve received in the mail. When entered on our new site, this code will take you directly to the corresponding self-assessment. See more information below. How to complete Please read these instructions before proceeding.
Read and study the enclosed courses and answer the self-assessment 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. Scan this QR code to complete your CE now !
• Go to BOOK.CME.EDU . Locate the book code MDAZ1124 found on the back of your book and enter it in the box then click GO . • If you already have an account created, sign in to your account with your username and password. If you do not have an account already created, you will need to create one now. • Follow the online instructions to complete your self- assessment. Complete the purchase process to receive course credit and your certificate of completion. Please remember to complete the online evaluation. • To find more elective hours, please visit AZ.CME.EDU ONLINE FASTEST AND EASIEST!
Enter book code
GO
MDAZ1124
If you need help finding your code, Browse Book Code FAQs
• Fill out the answer sheet and evaluation found in the back of this booklet. Please include a check or credit card information and e-mail address. Mail to InforMed, PO Box 2595, Ormond Beach, FL 32175-2595 . • Completions will be processed within 2 business days from the date it is received and certificates will be e-mailed to the address provided. • Submissions without a valid e-mail will be mailed to the address provided. BY MAIL
1-800-237-6999
BOOK.CME.EDU
BOOK CODE: MDAZ1124
i
INFORMED TRACKS WHAT YOU NEED, WHEN YOU NEED IT
Arizona Professional License Requirements
DEA ONE-TIME MATE REQUIREMENT (NEW) Effective June 27, 2023 , renewing DEA-registered practitioners must complete eight (8) hours of one-time training on the treatment and management of patients with opioid or substance use disorders. CONTROLLED SUBSTANCES REQUIREMENT All licensed physicians (MD/DO) and physician assistants (PA) who have an active DEA registration, must complete a minimum of three (3) AMA PRA Category 1 Credits TM or equivalent related to opioids, substance abuse or addiction. Allopathic Physicians (MD ) must complete forty (40) credit hours of continuing medical education during the two calendar years preceding license renewal. All of these credits must be AMA PRA Category 1 Credits TM or equivalent. Currently, for all licensed allopathic physicians (MD) their license will expire at midnight on their birthday in even or odd years. Osteopathic Physicians (DO ) must complete forty (40) credit hours of continuing medical education during the two years preceding license renewal. This must include at least twenty-four (24) credits of AOA Category 1-A and the remaining credit hours may consist of AMA PRA Category 1 Credits TM or equivalent. Currently for all licensed osteopathic physicians (DO) their license will expire on December 31 in even or odd years. Physician Assistants (PA ) must complete forty (40) credits of continuing medical education during their two year licensure period. All of these credits must be AMA PRA Category 1 Credits TM or equivalent. Currently, for all licensed physician assistants (PA) their license will expire at midnight on their birthday in even or odd years.
Arizona Medical Board 1740 W Adams St, Suite 4000 We are a nationally accredited CME provider. For all board-related inquiries please contact:
COMPLETION DEADLINE 3 CREDITS REQUIRED
LICENSE TYPES: MD/DO PA
MD & PA: Midnight on licensee’s date of birth DO: 12/31/2024
Opioids, Substance Abuse or Addiction
Phoenix, AZ 85007 P: (480)-551-2700 F: (480)-551-2702
Disclaimer: The above information is provided by InforMed and is intended to summarize state CE/CME license requirements for informational purposes only. This is not intended as a comprehensive statement of the law on this topic, nor to be relied upon as authoritative. All information should be verified independently.
ii
MOC/MIPS CREDIT INFORMATION
In addition to awarding AMA PRA Category 1 Credits TM , the successful completion of enclosed activities may award the following MOC points and credit types. To be awarded MOC points, you must obtain a passing score and complete the corresponding activity evaluation.
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 ABA American Board of Anesthesiology’s redesigned Maintenance of Certification in Anesthesiology TM (MOCA®) program, known as MOCA 2.0®
ABIM
American Board of Internal Medicine’s Maintenance of Certification (MOC) program
American Board of Otolaryngology – Head and Neck Surgery’s Continuing Certification program (formerly known as MOC)
ABOHNS
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 TM 3 AMA PRA Category 1 Credits TM 8 AMA PRA Category 1 Credits T M
Activity Title
ABA ABIM ABOHNS ABPath
ABP
Effective Management of Acute and Chronic Pain with Opioid Analgesics
3 Credits LL 8 Credits LL
3 Credits MK 8 Credits MK
3 Credits SA 8 Credits SA
3 Credits LL 8 Credits LL
3 Credits LL+SA
Substance Use Disorders: A DEA Requirement 8 Credits LL+SA Legend: LL = Lifelong Learning, MK = Medical Knowledge, SA = Self-Assessment, LL+SA = Lifelong Learning & Self-Assessment, PS = Patient Safety
Table 3. CME for MIPS Statement Completion of each accredited CME activity meets the expectations of an Accredited Safety or Quality Improvement Program (IA PSPA_28) for the Merit-based Incentive Payment Program (MIPS). Participation in this Clinical Practice Improvement Activity (CPIA) is optional for eligible providers.
iii
EFFECTIVE MANAGEMENT OF ACUTE AND CHRONIC PAIN WITH OPIOID ANALGESICS
COURSE DATES:
MAXIMUM CREDITS:
FORMAT:
Release Date:10/2021 Exp. Date: 6/2025
3 AMA PRA Category 1 Credits ™
Enduring Material (Self Study)
TARGET AUDIENCE This course is designed for all physicians and other health care professionals involved in the management of patients with pain. COURSE OBJECTIVE This CME learning activity is designed to increase physician knowledge and skills about guideline-recommended principles of pain management, the range of opioid and non-opioid analgesic treatment options, and specific strategies for minimizing opioid analgesic prescription, diversion, and abuse.
HOW TO RECEIVE CREDIT:
• Read the course materials.
•
Complete the self-assessment questions at the end. A score of 70% is required.
• R eturn your customer information/ answer sheet, evaluation, and payment to InforMed by mail or complete online at BOOK.CME.EDU .
Completion of this course will better enable the course participant to: 1. Identify the range of therapeutic options for managing acute and chronic pain, including non-pharmacologic approaches and pharmacologic therapies. 2. Explain how to integrate opioid analgesics into a function-based pain treatment plan individualized to the needs of the patient, including counseling patients and caregivers about the safe use of opioid analgesics. 3. Discuss recommendations and rationale for incorporating emergency opioid antagonists into prescribing practice for training patients and family members on the use of naloxone. 4. Identify medications currently approved for the treatment of opioid use disorder and the ways these medications differ in terms of mechanisms of action, regulatory requirements, and modes of administration. LEARNING OBJECTIVES IMPLICIT BIAS IN HEALTHCARE Implicit bias significantly affects how healthcare professionals perceive and make treatment decisions, ultimately resulting in disparities in health outcomes. These biases, often unconscious and unintentional, can shape behavior and produce differences in medical care along various lines, including race, ethnicity, gender identity, sexual orientation, age, and socioeconomic status. Healthcare disparities stemming from implicit bias can manifest in several ways. For example, a healthcare provider might unconsciously give less attention to a patient or make assumptions about their medical needs based on race, gender, or age. The unconscious assumptions can lead to delayed or inadequate care, misdiagnoses, or inappropriate treatments, all of which can adversely impact health outcomes. Addressing implicit bias in healthcare is crucial for achieving equity in medical treatment. Strategies to combat these biases involve education and awareness programs for healthcare professionals. These programs help individuals recognize and acknowledge their biases, fostering a more empathetic and unbiased approach to patient care. Additionally, implementing policies and procedures prioritizing equitable treatment for all patients can play a pivotal role in reducing healthcare disparities. Ultimately, confronting implicit bias in healthcare is essential to creating a more just and equitable healthcare system where everyone receives fair and equal treatment regardless of their background or characteristics. ACCREDITATION STATEMENT InforMed is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
1
FACULTY Paul J. Christo, MD, MBA Associate Professor, The Johns Hopkins University School of Medicine Director, Multidisciplinary Pain Fellowship Program (2003-2011) Director, Blaustein Pain Treatment Center (2003-2008) DESIGNATION STATEMENT InforMed designates this enduring material for a maximum of 3 AMA PRA Category 1 Credits ™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
COURSE SATISFIES
Opioids/Substance Abuse/Addiction 3
Division of Pain Medicine Annette Skopura, PHD
SPECIAL DESIGNATION This course satisfies the mandatory CME requirement for three (3) AMA PRA Category 1 Credits TM on opioids, substance abuse or addiction. The Arizona Boards of Medicine, Osteopathic Examiners and Physician Assistants require all licensees with an active DEA registration to complete three (3) AMA PRA Category 1 Credits TM or equivalent related to opioids, substance abuse or addiction.
Medical Writer EnlightenMed
ACTIVITY PLANNER Michael Brooks CME Director InforMed
DISCLOSURE OF INTEREST In accordance with the ACCME Standards for Commercial Support of CME, InforMed implemented mechanisms, prior to the planning and implementation of this CME activity, to identify and resolve conflicts of interest for all individuals in a position to control content of this CME activity. FACULTY/PLANNING COMMITTEE DISCLOSURE
The following faculty and/or planning committee members have indicated they have no relationship(s) with industry to disclose relative to the content of this CME activity: • Annette Skopura, PHD • Michael Brooks
The following faculty and/or planning committee members have indicated they have relationship(s) with industry to disclose: • Paul J. Christo, MD, MBA has received honoraria from GlaxoSmithKline and Eli Lilly.
STAFF AND CONTENT REVIEWERS InforMed staff, input committee and all content validation reviewers involved with this activity have reported no relevant financial relationships with commercial interests. DISCLAIMER *2024. All rights reserved. These materials, except those in the public domain, may not be reproduced without permission from InforMed. This publication is designed to provide general information prepared by professionals in regard to the subject matter covered. It is provided with the understanding that InforMed, Inc is not engaged in rendering legal, medical or other professional services. Although prepared by professionals, this publication should not be utilized as a substitute for professional services in specific situations. If legal advice, medical advice or other expert assistance is required, the service of a professional should be sought.
2
Coupled with rising rates of overdose death are equally dramatic increases in the number of people misusing or abusing opioids. As many as 1 in 4 patients on long-term opioid therapy in a primary care setting are estimated to be struggling with opioid use disorder (OUD), also called opioid addiction. 7-9 In 2016 approximately 11.5 million Americans reported misusing prescription opioids in the previous year. 10 According to the federal Substance Abuse and Mental Health Services Administration (SAMSHA), approximately 80% of heroin users started on their path to addiction after using oral opioid analgesics (either prescribed to them or illicitly). 11 Although the rates of opioid prescriptions have leveled off or declined slightly in recent years, the average days of supply per opioid prescription has continued to rise 10 It is against this background that providers must make daily decisions about how best to treat their patients in pain. Unfortunately, many providers are unfamiliar with the growing evidence base suggesting that opioids are actually not very effective for relieving chronic non-cancer pain in the long-term and, in fact, may be associated with harms such as increased pain, reduced functioning, and physical opioid dependence. 12,13 Providers may also not be aware of the expanding range of both non-opioid medications and non-pharmacological therapies shown to be effective in reducing many common chronic pain conditions. This CME learning activity discusses the management of chronic and acute pain in a variety of patient populations and is structured to conform
to the latest Food and Drug Administration (FDA) Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (2018). It reviews evidence for non-opioid therapies, including non-drug and non-opioid drug options, as well as current evidence regarding opioid efficacy, harms, and overdose prevention with naloxone, and how to slowly and safely taper opioid doses. Key opioid-related terms Opioid: any psychoactive chemical resembling morphine, including opiates, and binding to opioid receptors in the brain. This term describes opioid and opiates. Opiate: “natural” opioids derived from the opium poppy (e.g., opium, morphine, heroin). Semi-synthetic opioids: analgesics containing both natural and manufactured compounds (e.g., oxycodone, hydrocodone, hydromorphone, oxymorphone). Synthetic opioids: fully-human-made compounds (e.g., methadone, tramadol, and fentanyl). Types of Pain Differentiating between nociceptive and neuropathic pain is critical because the two respond differently to pain treatments. Neuropathic pain, for example, may respond poorly to both opioid analgesics and non-steroidal anti-inflammatory (NSAID) agents. 14 Other classes of medications, such as anti-epileptics, antidepressants, or local anesthetics, may provide more effective relief for neuropathic pain. 15
The challenge of pain management Physicians caring for patients in pain face an unusually daunting set of challenges. As with many other chronic conditions, clinicians must carefully balance expected benefits of treatment with the potential for harm from such treatments. Treating pain, however, involves an additional level of complexity because one of the most commonly-used classes of pain medications—opioids—are at the center of national efforts to stem the epidemic of opioid-related abuse, addiction, and overdose. 1 The United States has seen three successive waves of opioid overdose deaths related to both legal and illegal opioids (Figure 1). 2 The first began in the 1990s and was associated with steadily rising rates of prescription opioids. In 2010, deaths from heroin increased sharply, and by 2011 opioid overdose deaths reached “epidemic” levels as described by the Centers for Disease Control and Prevention (CDC). 3 The third wave began in 2013 with a sharp rise in overdose deaths attributed to synthetic opioids, particularly those involving illicitly-manufactured fentanyl. In late 2020, the CDC announced that 81,230 drug overdose deaths occurred in the 12 months ending in May, 2020, which was the highest level of overdose deaths ever reported. 4 The surge was primarily driven by a 34% increase in overdose deaths related to synthetic opioids, primarily fentanyl. 4 Overdose rates appear to have accelerated during the COVID-19 pandemic. 5 Between 1999 and 2019, the CDC estimates that nearly 500,000 people in the United States died from such overdoses. 6
Figure 1. Opioid-related overdose deaths by type in the United States 6
3
Another important dimension of pain is its effects beyond strictly physiological functioning. Pain is currently viewed as a multi-dimensional, multi-level process similar in many ways to other disease processes which may start with a specific injury but which can lead to a cascade of events that can include physical deconditioning, psychological and emotional burdens, and dysfunctional behavior patterns that affect not just the sufferer, but their entire social milieu (illustrated in Figure 2). 16 Although pain is expected after injury or surgery, the patient pain experience can vary markedly. The intensity of pain can be influenced by psychological distress (e.g., depression or anxiety), heightened illness concern, or ineffective coping strategies regarding the ability to control pain and function despite it. 17 It may also be shaped by personality, culture, attitudes, and beliefs.
Assessing the impact of pain on functional status and sleep and screening for mental health conditions potentially related to pain or treatment adherence (e.g., depression, anxiety, and memory issues) may provide useful information for pain management. 19 Depression in older patients, for example, sometimes presents with somatic complaints of pain. Pain complaints may resolve when the underlying depression is treated. Patients can also be screened for known risk factors for OUD (see below). Tools Many tools have been developed to document and assess pain. Initial approaches to assessing pain severity use a numerical rating scale (NRS) rating pain from 0 (no pain) to 10 (worst pain you can imagine) (some scales use a 0 to 100 scale). Such scales are often used in clinical trials of pain therapies, and the minimal clinically important difference using these scales is generally considered a 20%-30% change from baseline (i.e., 2-3 points on a 0-10 scale or 20-30 points on a 0-100 scale). 20 Multidimensional tools, such as those described below, include questions relating to quality of life and participation in daily activities. Such tools can provide a more comprehensive approach to assessing pain and response to treatment. The selection of a pain assessment tool must balance the comprehensiveness of the assessment obtained with the time and energy required to use the tool in a real-world practice setting. Brief pain inventory The Brief Pain Inventory (BPI) is used frequently in clinical trials to assess pain. Specifically developed for patients with chronic pain, the BPI more fully captures the impact of pain on patient function and quality of life than simple VAS scales. 21 By including a pain map, the BPI allows tracking of the location of pain through the course of management. The BPI is self-administered but somewhat time-consuming, which may limit its role in a busy clinical practice. PEG scale The PEG scale (Pain average, interference with Enjoyment of life, and interference with General activity) is a three-item tool based on the BPI and is practical for clinical practice (Figure 3).
Evaluating pain
Take a history The patient’s self-report is the most reliable indicator of pain. 18 Physiological and behavioral signs of pain (e.g., tachycardia, grimacing) are neither sensitive nor specific for pain and should not replace patient self-report unless the patient is unable to communicate. Therefore, talking to patients and asking them about their pain (i.e., obtaining a “pain history”) is integral to pain assessment. The pain history usually is obtained as part of the patient history, which includes the patient’s past medical history, medications, habits (e.g., smoking, alcohol intake), family history, and psychosocial history. Obtaining a comprehensive history provides many potential benefits, including improved management, fewer treatment side effects, improved function and quality of life, and better use of health care resources.
Figure 2. The Biopsychosocial Model of Pain 16
Figure 3: PEG scale 22
What number best describes your pain on average in the past week?
0
1
2
3
4
5
6
7
8
9
10
No pain
Pain as bad as you can imagine
4
Zero-to-10 scales are used to assess pain, enjoyment of life, and general activity. PEG can be self-administered or done by the clinician and is relatively brief. 22 Assessing acute pain Acute pain intensity can be assessed with unidimensional tools such as the VAS and the Wong-Baker FACES Pain Rating Scale (faces depicting increasing levels of pain). While useful for a quick assessment, these scales alone may not appropriately identify patients with pain-related suffering driven by functional limitations, worry, or other factors, and may not detect some patients with clinically significant pain. 23 Although developed for patients with chronic pain, the BPI is also applicable to patients with acute pain. Completed by the patient, the BPI captures ways that pain impacts function and quality of life, although, like most multidimensional
questionnaires, it requires more time (about 10 minutes) and concentration to complete, which may limit its utility in some elderly patients. 21 Pain in patients with dementia Although patients with mild-to-moderate dementia can report their pain and its location, those with severe dementia are often unable to communicate their pain experience or request medication. In these patients, physicians need to observe pain behaviors, including facial expressions, verbal cues, body movements, changes in interpersonal interactions, activity patterns, and mental status. Caregiver observations and reports are critical to appropriate assessment and management of chronic pain conditions. 24
Chronic pain that develops after acute pain A number of factors have been associated with an increased risk for chronic pain following acute pain or surgery including older age, psychological problems, higher levels of pre-procedural pain or pain sensitivity, type and duration of surgery, severity and number of comorbidities, and use of post-procedural radiation or chemotherapy. 25 Some tools have been developed to help clinicians predict the likelihood that a patient will experience chronic pain following acute injury or procedures. The 5-item PICKUP model, for example, showed moderate prognostic performance in a derivation study using data from 2,758 patients with acute low back pain. 26 And Sipila and colleagues developed a 6-item screening instrument for risk factors of persistent pain after breast cancer surgery based on a cohort of 489 women. 27
BEFORE MOVING ONTO THE NEXT SECTION, PLEASE COMPLETE CASE STUDY 1.
Case Study 1
Instructions: Spend 5-10 minutes reviewing the case below and considering the questions that follow.
Maurianne is an 85-year-old woman living in a residence facility for people with Alzheimer disease. Her cognition has deteriorated slowly in the seven years she has lived at the facility and now her speech is often a rambling, incoherent stream-of-consciousness, that she only seldom recognizes as such. Maurianne fell and sustained a right femur fracture requiring internal fixation. On the second day after surgery, the hospital nurse noted that Maurianne had an order for acetaminophen every 6 hours as needed. Although Maurianne was lying still and did not appear to be in distress, the nurse contacted the nursing home nurse who reported that Maurianne rarely lies still. The nursing home nurse explained that they assess pain using the Pain Assessment in Advanced Dementia (PAINAD) tool and emailed a copy to the hospital nurse. A review of the medical chart indicated that Maurianne slept intermittently the previous night, and when she conducted a physical examination, Maurianne seemed rigid and exhibited shallow breathing at a rate of about 20 breaths per minute. The nurse used the PAINAD behavioral tool to assess Maurianne’s pain and the result suggested a positive score for possible pain. The nurse immediately called the surgeon and received an order for 1-2 mg morphine every 8 hours over the next 3 days. After the first dose, Maurianne’s body relaxed, and her breathing became regular at a rate of 14 per minute. Later that evening, Maurianne slept 7 hours.
1. Do you think the initial script for acetaminophen was appropriate for this patient? If now, what would you have prescribed?
2. How might Maurianne’s cognitive impairments affect her pain management plan?
3. What other tools or techniques might be used to characterize Maurianne’s level of pain or her response to prescribed analgesics?
5
Screen for opioid abuse risk factors Screening and monitoring in pain management seeks to identify patients at risk of substance misuse and overdose as well as improve overall patient care. Evaluations of patient physical and psychological history can screen for risk factors and help characterize pain to inform treatment decisions. Screening approaches include efforts to assess for concurrent substance use and mental health disorders that may place patients at higher risk for OUD and overdose. This includes screening for drug and alcohol use and the use of urine drug testing, when clinically indicated. These approaches enable providers to identify high-risk patients so that they can consider whether to prescribe opioids, engage substance misuse and mental health interventions, and education materials to mitigate opioid misuse. 16 Many tools have been developed for the formal assessment of a patient’s risk of having a substance misuse problem, some of which are appropriate for routine clinical use because they are relatively brief and easily implemented. Table 1 lists the tools that appear to have good content and construct validity for assessing patient risks related to chronic opioid therapy, although to date, no single tool has been widely endorsed or thoroughly validated. 28 The Screening, Brief Intervention and Referral to Treatment (SBIRT) is an evidence-based tool used to facilitate screening patients for OUD, which typically takes 5-10 minutes to administer. 29 SBIRT has been endorsed by the Substance Abuse and Mental Health Services Administration (SAMHSA), but should always be paired with referral to treatment. 30 SAMHSA recommends universal screening with oral or writing-based tools because of the high prevalence of substance use disorders in patients visiting primary care settings. In contrast, universal screening with urine, blood, or oral fluid tests are not recommended. 30 In the context of pain care, however, the 2016 CDC guidelines recommend urine drug testing before initiating opioid therapy and probably at least annually when prescribing opioids for chronic pain. 31
Other tools for universal substance abuse screening include: • Single screening question screening tool for drug use • Drug Abuse Screening Test (DAST) 10 • Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) • Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) • the CAGE questionnaire adapted to include drugs (CAGE-AID) Use drug monitoring programs As of March, 2020, all U.S. states (except Missouri) and the District of Columbia have operational prescription drug monitoring programs (PDMPs). 32,33 Information available through PDMPs varies based on reporting requirements and restrictions, but may include DEA schedules reported, timeliness of pharmacy dispensing information, access, and required reviews. Recommendations for using a PDMP include: • Check the PDMP before starting anyone on opioid therapy. • Review the PDMP periodically throughout opioid therapy (at least every 3 months). • Look for prescriptions for other controlled substances, like benzodiazepines, that can increase risk of overdose death. • Review the total MMED (Morphine Milligram Equivalent Dose). Some states have specific requirements for PDMP use, such as requiring review prior to initial prescription or any time a specific prescription is written, such as for hydrocodone ER (Zohydro), therefore clinicians should remain updated about the specific requirements of their state PDMPs. Urine drug testing Urine drug testing (UDT) is recommended before prescribing any opioid and at least annually thereafter. 31 Providers using urine drug screens should be familiar with the metabolites and expected positive results based on the opioid prescribed. For example, a patient taking oxycodone may test positive for both oxycodone and oxymorphone (a metabolite). 34
UDT often involves both presumptive (screen) testing, and definitive (quantitative) testing because many synthetic and semisynthetic opioids cannot be detected by presumptive testing alone. 35,36 If the prescribed opioid is not detected, discuss the finding with the patient and, if diversion is confirmed or suspected, re-evaluate the pain management strategy or taper the opioid. If the patient tests positive for unprescribed drugs, schedule more frequent follow-up visits, consider opioid discontinuation, offer naloxone, or refer for treatment for substance use disorder. Decision tools and help with interpreting urine drug testing results are available at: http://mytopcare.org/udt- calculator/interpret-opiates-test-result. Pain management overview Many pharmacologic and non-pharmacologic approaches to treating pain are available to primary care providers. These options should be employed using the following general principles: • Identify and treat the source of the pain, if possible, although pain treatment can begin before the source of the pain is determined • Select the simplest approach to pain management first. This generally means using non-pharmacologic approaches as much as possible and/or trying medications with the least severe potential side effects, and at the lowest effective doses • Establish a function-based, individualized treatment plan if therapy is expected to be long-term Non-drug approaches Many nonpharmacologic and self-management treatment options have been found to be effective alone or as part of a comprehensive pain management plan, particularly for musculoskeletal pain and chronic pain. 37 Examples include, but are not limited to, psychological, physical rehabilitative and surgical approaches, procedural therapies (e.g., injections, nerve blocks), complementary therapies, and use of approved/cleared medical devices for pain management.
Table 1. Tools for patient risk assessment
Tool
Use
Who Administers?
Length
Current Opioid Misuse Measure (COMM)
Patient self-report
17 items
Monitor for misuse by patients currently on long-term opioid therapy Screen for risk of opioid addiction Screen for risk of opioid addiction
Diagnosis, Intractability, Risk, Efficacy (DIRE)
Clinician
7 items
Opioid Risk Tool (ORT)
Clinician or patient self-report
5 yes/no questions 24 items
Screener and Opioid Assessment for Patients with Pain, Version 1 and Revised (SOAPP, and SOAPP-R)
Screen for risk of opioid addiction
Patient self-report
6
Primary care clinicians should know about the range of treatment options available, the types of pain that may be responsive to those options, and when they should be used as part of a multidisciplinary approach to pain management. 37 Clinicians should also be aware that not all nonpharmacologic options have the same strength of evidence to support their utility in the management of pain, and some may be more applicable for some conditions than others. Movement-based options Movement therapies that may be helpful in patients with chronic pain include muscle- strengthening, stretching, and aerobic exercise (e.g., walking, aquatics). Recommended exercise programs typically occur one to three times a week for a total of 60-180 minutes per week, but any regimen must be carefully tailored to a patient’s existing level of physical conditioning, comorbidities, and cognitive status. 38-40 Additional movement-based options include: • Physical therapy supervised by a licensed physical therapist, which can include resistance, aerobic, balance, and flexibility exercises as well as elements of massage, manipulation, or transcutaneous electrical nerve stimulation. • Tai chi , a mind-body practice that combines controlled movements, meditation, and deep breathing. “Chair tai chi” can be an option for patients with limited mobility. • Yoga , exercises or a series of postures designed to align muscle and bones, and increase strength and flexibility. It can also relax mind and body through breathing exercises and meditation. Gentler forms of yoga that may be more appropriate for older patients include Iyengar, Hatha, or Viniyoga. Although these interventions may cause muscle soreness, increased back pain, or falls, movement- based options are generally considered safe. 40 Weight loss Some pain syndromes, such as knee osteoarthritis, are worsened by obesity. For some patients, pain due to this condition is improved by reducing body weight because of reduced loads and physical stresses on the affected joints. The goal of body weight reduction is a baseline weight loss of 7%-10% by calorie reduction and increased activity using a balanced diet with less than 30% of calories from fat, 15%-20% from protein, and 45%-60% from carbohydrates. 41
Passive options Acupuncture involves the stimulation of specific points on the body, most often involving skin penetration with fine metallic needles manipulated by hand but sometimes also including electrical stimulation or low intensity laser therapy. Potential adverse events include minor bruising and bleeding at needle insertion sites. 42 Massage is the manual manipulation of the body to promote relaxation, reduce stress and improve well-being. Handheld devices may also provide relief for some patients. Some patients may report muscle soreness. 43 Transcutaneous electrical nerve stimulation (TENS) is a machine that generates mild electrical pulses which are applied cutaneously. The electrical stimulation from TENS may block or disrupt pain signals to the brain, reducing pain perception. TENS machines can be used at home or in conjunction with other interventions like physical therapy. Cognitive and behavioral options Cognitive behavioral therapy (CBT) is a structured, time-limited (typically 3-10 weeks) intervention focused on how thoughts, beliefs, attitudes, and emotions influence pain and can help patients use their minds to control and adapt to pain. This therapy includes setting goals, often with recommendations to increase activity to reduce feelings of helplessness. 44 Meditation Mindfulness meditation programs typically include a time-limited (8 weeks; range 3-12 weeks) trainings with group classes and home meditation. The objective is to inculcate a long-term practice that helps patients refocus their minds on the present, increase awareness of self and surroundings, and reframe experiences. 45,46 Non-opioid drug approaches A wide range of medications can be used to
Acetaminophen Lower doses of acetaminophen are recommended to decrease risk of side effects. Patients should not exceed 1000 mg in a single dose. The maximum recommended dose for healthy adults is 4000 mg/day. 47 The most severe potential side effect of acetaminophen is liver toxicity. Acetaminophen is the most common cause of acute liver failure, accounting for 46% of all cases. 48 Patients should stay within recommended doses to help prevent side effects and should only be prescribed one acetaminophen-containing product at a time. NSAIDs Chronic use of NSAIDs may be limited by gastrointestinal (GI) toxicity, including GI bleeding, upper GI symptoms, ulcers, and related complications. For high-risk patients, including the elderly, patients on warfarin or aspirin, and those with coagulopathies, adding a proton pump inhibitor (PPI) may help reduce the risk. 49,50 In addition to GI side effects, NSAIDs have been associated with an increased risk of renal and cardiac complications. Side effects with NSAIDs are typically lower with topical formulations. Some early trials suggested that COX-2 inhibitors, as a class, were associated with higher risks for myocardial infarction and stroke compared to other NSAIDs, and the COX-2 inhibitor rofecoxib (Vioxx) was removed from the market in 2004 because of such concerns. 51 More recent trials and meta-analyses, however, provide strong evidence that the risks of CV events with celecoxib are no greater than those of other NSAIDs, and in 2018 two FDA advisory panels recommended that the FDA change its advice to physicians regarding celecoxib’s safety. 52 Selective serotonin norepinephrine reuptake inhibitors SNRIs such as duloxetine, venlafaxine, and milnacipran are characterized by a mixed action on norepinephrine and serotonin, though their exact mechanism of action for pain reduction is unknown. These agents affect the descending pain pathways to facilitate pain relief. Side effects (e.g., nausea, dizziness, and somnolence) may limit treatment. Monitoring is suggested for blood pressure (duloxetine and venlafaxine), heart rate (venlafaxine), and drug interactions (duloxetine). SNRIs can be very helpful in patients who have central sensitization. TCAs TCAs inhibit reuptake of norepinephrine and serotonin. These agents act on descending pain pathways, but their mechanism of action for pain relief is unknown.
treat pain, including: • Acetaminophen • NSAIDs (oral or topical) • Antidepressants ° serotonin and/or
norepinephrine
reuptake inhibitors
° °
tricyclic antidepressants (TCAs)
selective serotonin reuptake inhibitors (SSRIs)
• Anticonvulsants • Topical lidocaine or capsaicin • Cannabinoid-based therapies • Ketamine
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Examples of TCAs studied for the management of chronic pain include amitriptyline, desipramine, and nortriptyline. Side effects, such as anticholinergic effects (e.g., dry mouth, constipation, dizziness) and QTc prolongation limit the use of TCAs in elderly patients. The majority of side effects occur at the typically higher doses used to treat depression. SSRIs SSRIs, such as citalopram, fluoxetine, and paroxetine, block the reuptake of serotonin in the brain, making more serotonin available in the synapse. The mechanism of SSRIs for pain remains unknown. Compared to SNRIs and TCAs, there is relatively little evidence to support the use of SSRIs in treating chronic pain conditions. 28 Potential side effects of SSRIs include weight gain, sexual dysfunction, and QTc prolongation, especially with citalopram. Anticonvulsants, gabapentin, pregabalin, oxcarbazepine, and carbamazepine, are often prescribed for neuropathic pain and are thought to exert their analgesic effect by inhibiting neuronal calcium channels. Potential side effects include sedation, dizziness, and peripheral edema. Pregabalin and gabapentin have low abuse potential in the general population, are currently classified as Schedule V by the DEA, and prescriptions for these drugs are tracked by some state Prescription Drug Monitoring Programs (PDMPs). Anticonvulsants can be very helpful in patients who have central sensitization and neuropathic pain. Anticonvulsants such as Topical lidocaine and capsaicin Topical lidocaine inhibits the conduction of nociceptive nerve impulses. Irritation at the application site is the most common side effect. The most common products for chronic pain management are lidocaine 5% patches, available by prescription, and lidocaine 4% patches available OTC. Capsaicin is an active component of chili peppers and has moderate analgesic properties at 8% concentrations for neuropathic pain, specifically postherpetic neuralgia and diabetic neuropathic pain of the feet. 53 The most common side effect is a mild-to-severe burning sensation at the application site. Cannabinoid preparations With medical cannabis now legal in 36 states and recreational use legal in at least 10 states and the District of Columbia (as of 2020) 54 , there has been increased interest among patients for the use of cannabis or cannabis derivatives (e.g., cannabidiol [CBD]) for pain relief. The CB1 and CB2 receptors have been shown to mediate the analgesic effects of cannabinoids 55 and some evidence suggests a potential benefit for chronic pain.
A 2017 National Academies of Science report, for example, concluded that “conclusive or substantial evidence” supports a beneficial role for cannabis or cannabinoids for treating chronic pain, 56 and a 2018 Cochrane review of the existing literature evaluating cannabinoids (cannabis, CBD, or combinations) suggests that these agents are moderately effective for neuropathic pain with adverse effects that are less than, or comparable to, existing non-opioid analgesics. 57 But the evidence for a benefit of cannabinoids on acute pain, is extremely limited and mixed. A small double-blind, cross-over study in 18 females and experimentally-induced mild acute pain found no significant analgesic effect of oral cannabis extract. 58 Another randomized, double-blind study with 15 healthy volunteers using smoked cannabis found no analgesic effect with low doses of cannabis, a modest effect with moderate doses, and enhanced pain responses with high doses. 59 The authors of a 2017 review on cannabis and pain conclude that cannabis may have a narrow therapeutic window as a pharmacotherapy for chronic pain but that much more research is needed to inform physician recommendations to patients regarding the analgesic efficacy of cannabis. 60 A systematic review of both randomized trials (47) and observational studies (57) in patients with chronic noncancer pain published through July 2017 found moderate evidence that cannabinoids can exert analgesia. 61 Cannabis preparations, however, may pose both short-term and long-term risks. Short-term effects include impaired memory, motor coordination, and judgment. Paranoid ideation and psychotic symptoms, while rare, may occur with high doses of THC. Possible long-term effects include impaired brain development in young adults, potential for habituation, and increased risk of anxiety or depression. Abrupt cessation of marijuana in long-term users may cause withdrawal symptoms such as anxiety, irritability, craving, dysphoria, and insomnia. There is an increased risk of chronic bronchitis, respiratory infections, and pneumonia with inhaled products. 62 Nonetheless, the use of cannabis may have an opioid-sparing effect at a population level. The use of medical cannabis has been associated with a 25% reduction in opioid overdose mortality in states that legalized medical use. 63 However, a more recent study showed that states legalizing medical cannabis actually experienced a 22.7% increase in opioid overdose deaths. 64 FDA-approved cannabinoids include dronabinol (Marinol), indicated for second-line treatment of chemotherapy-induced nausea and vomiting, and anorexia-associated weight loss in patients with HIV.
Nabilone (Cesamet) is indicated for chemotherapy- induced nausea and vomiting. Common side effects include dizziness/vertigo and euphoria. Dronabinol may cause nausea/vomiting, abdominal pain, and abnormal thinking. Nabilone may cause ataxia and dry mouth. 62,65,66 None of these are indicated for the treatment of pain. When recommending cannabis for patients with chronic pain, clinicians may inform patients that the analgesic properties are due to both the CBD and THC components, which act on different pain pathways. 67 Ketamine Ketamine has been used as a general anesthetic since the 1960s, but its use in subanesthetic concentrations for analgesia has grown rapidly in recent years, due, in part, to efforts to reduce the risks of chronic opioid use. 68 Ketamine has been successfully used to treat such acute pain conditions as sickle cell crises, renal colic, and trauma. 68 Recently the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists released the first joint recommendations for subanesthetic ketamine (including transdermal ketamine) for acute pain. 68 . Ketamine infusions are used for the treatment of complex regional pain syndrome based on placebo- controlled trials, and topical ketamine may also be beneficial for the cutaneous hypersensitivity associated with this condition. 69
Opioids
Mechanism of Action Opioids exert their analgesic effects by acting on the mu, kappa, and delta opioid receptors. Individual agents may be classified as agonists or partial agonists of those receptors: 70 • Agonists (e.g., morphine, codeine, hydromorphone, hydrocodone) stimulate at least one of the opioid receptors and provide continued analgesia with increasing doses. • Partial agonists (e.g., buprenorphine) have high affinity at mu-receptors, have a ceiling for analgesic effect, and are less likely to cause respiratory depression. Opioids are classified by the Drug Enforcement Agency (DEA) according to their presumed abuse and addiction potential, although the evidence base for making these differentiations continues to evolve. Tramadol, for example, is now known to have as much potential for abuse as opioids in more restrictive classes, although its DEA classification has not changed. 71
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Relative effectiveness The analgesic efficacy of opioids for treating acute pain has been known for centuries and they continue to be reliable agents for moderate-to- severe acute pain, although they are not without risks. But the evidence for opioid efficacy for acute pain cannot be extended to chronic pain with a few exceptions that are discussed below. Neuronal and physiologic adaptations to long-term opioid use can result in reduced analgesic effectiveness, or even, paradoxically, increased pain or sensitivity to pain. 72 Opioid-induced hyperalgesia is different pharmacologically from the phenomenon of opioid tolerance, although both can lead to an increased need for opioids and disentangling the two, clinically, can be difficult. 73 For chronic pain, the evidence that opioids reduce pain and improve function more than placebo is relatively weak. A 2018 systematic review and meta-analysis of 96 trials comparing various opioids vs. placebo or non-opioid analgesics in 26,169 patients with chronic noncancer pain found that opioids may slightly reduce pain and increase physical functioning compared to placebo, but not compared to non-opioids. 12 In 76 trials comparing opioids vs. placebo with follow-up ranging from 1 to 6 months, the reduction in pain scores with opioids (on a 10-point scale) was only 0.69 points, which is below the generally-accepted 2-point minimum clinically important difference for pain. Physical function scores (on a 100-point scale) improved with opioids by 2.04 points, which, again, may not be clinically important. The risk of vomiting with opioids, however, was more than 4 times higher than with placebo. 12 The same meta-analysis compared opioids to non-opioid analgesics including NSAIDs, TCAs, anticonvulsants, and synthetic cannabinoids. No significant differences were found in physical functioning scores for any of the comparisons, and no significant differences were found in pain scores for comparisons with NSAIDs, TCAs, or cannabinoids. 12 Exceptions: chronic opioid use in limited patient subsets Sickle cell disease as an example for which chronic opioid therapy may be appropriate in some patients. The risk for opioid death in patients with sickle cell disease comprises a small fraction of the total number of opioid-related deaths. From 1999 through 2013, there were 174,959 documents deaths attributed to opioid use. Of these 174, 959 deaths, 95 were patients with sickle cell disease (0.05%). 74 The pain experienced by patients includes both acute and chronic aspects through multiple mechanisms that are not completely understood. The American Society of Hematology 2020 guidelines endorses the use of
chronic opioid therapy for patients with sickle cell disease with pain that is refractory to multiple other treatments using the lowest effective dose and with regular monitoring. 75,76 Opioid formulations Prescription opioids are available in immediate- release and extended-release/long-acting (ER/ LA) formulations. Immediate-release agents are recommended in opioid-naïve patients and for all acute pain conditions, with ER/LA agents reserved for patients or conditions in which the longer duration of action and smoother pharmacodynamics are preferred. 31 A trial comparing immediate release to an ER/LA opioid did not find evidence that the continuous, time-scheduled use of ER/LA opioids was more effective or safer than intermittent use of the immediate-release opioid. 71 According to the FDA, ER/LA opioids should only be used for patients who tolerate 60 morphine milligram equivalents per day (MMED) for at least one week. 78 Efforts to create formulations with lower risks of abuse have met with limited success. For example, ER Oxymorphone was removed from the market after reports of intravenous abuse of the oral formulation. 79 Abuse-deterrent or tamper- resistant formulations do not prevent patients from developing opioid dependence, opioid use disorder, or simply taking too much of an opioid by mouth. 80,81 BEFORE MOVING ONTO THE NEXT SECTION, PLEASE COMPLETE CASE STUDY 2 ON THE NEXT PAGE. Atypical opoids: tramadol and tapentadol Tramadol and tapentadol are mu receptor agonists and norepinephrine reuptake inhibitors. Their mechanisms of action are unknown, but their analgesic effects are similar to morphine. Patients taking tramadol should be monitored for nausea, vomiting, constipation, and drowsiness, all of which are similar to side effects with opioids. 82 There is potential risk of serotonin syndrome when tramadol is combined with SSRIs, SNRIs, or tricyclic antidepressants. 83 As noted above, tramadol is classified as Schedule IV, which has led some to view it as less potent or safer than other opioids. The 2016 National Survey on Drug Use and Health, however, found that 1.7 million people in the U.S. aged > 12 years reported misusing tramadol products (e.g., Ultram, Ultram ER, Ultracet) in the previous year. 71 In addition, a 2019 cohort study of 88,902 patients with osteoarthritis showed increased risks of death at one year compared to NSAIDs naproxen, diclofenac, and celecoxib. 84
Abrupt cessation of tramadol is associated with opioid withdrawal, restlessness, and drug cravings (similar to those associated with other opioids) as well as hallucinations, paranoia, extreme anxiety, panic attacks, confusion, and numbness/tingling in extremities (which are less typical of other opioids). 85 Tapentadol is FDA-approved for treating neuropathic pain associated with diabetic peripheral neuropathy, although it is also used for musculoskeletal pain. A 2015 Cochrane review of 4 randomized trials with 4,094 patients with osteoarthritis or back pain found modest reductions in pain with tapentadol vs. placebo. 86 Problematic opioid use Although evidence for the long-term effectiveness of opioids for chronic pain is weak, evidence for opioid-related harms is abundant and strong. In a 2007 study assessing behaviors indicative of opioid misuse, many patients in primary care practices reported having engaged in aberrant behaviors with opioids one or more times (Table 2). 9 It is important to recognize and differentiate problematic use from adverse side effects of opioids. For instance, tolerance and opioid withdrawal occur with long term use of prescribed opioids. Clinicians should be able to differentiate this from problematic use. Among adults without a prescription, 41% obtained prescription opioids from friends or relatives for their most recent episodes of misuse. 87 For prescription opioids, long-term therapy is associated with an increased risk in accidental overdose and death. A retrospective study including 9,940 patients who received three or more opioid prescriptions within 90 days for chronic pain between 1997 and 2005 found that annual overdose rates rose significantly as doses exceeded 50 MMED (Figure 4). 88 Combining opioids with sedating drugs such as benzodiazepines or alcohol increases the risk of respiratory depression and overdose death. 34 Benzodiazepines have been linked with overdose fatalities in 50-80% of heroin overdoses, and 40- 80% in methadone-related deaths. 34,89 Patients prescribed benzodiazepines who are being initiated on opioids should have their benzodiazepine tapered and discontinued whenever possible. For patients being co-managed by mental health professionals, coordinate a plan regarding continuing or tapering benzodiazepines in the setting of opioid co-prescribing.
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