This interactive South Carolina Physician Ebook contains 11 hours of continuing education. To complete click the Complete Your CE button at the top right of the screen.
South Carolina Continuing Medical Education
SOUTH CAROLINA MEDICAL LICENSURE PROGRAM
MANDATORY TRAINING REQUIRED FOR SOUTH CAROLINA LICENSE RENEWAL ENCLOSED PROGRAM INCLUDES: • 3 HOURS CONTROLLED SUBSTANCES • 8 HOURS DEA MATE REQUIREMENT
INCLUDES: DEA’s One-time MATE Requirement
InforMed is Accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
CME FOR:
AMA PRA CATEGORY 1 CREDITS ™ MIPS MOC STATE LICENSURE
MD/DO/DPM CME DEADLINE: 6/30/2025 PA CME DEADLINE: 12/31/2025
AVAILABLE ONLINE AT: SC.CME.EDU
SOUTH CAROLINA PHYSICIAN
MANDATORY CME REQUIRED FOR SOUTH CAROLINA LICENSE RENEWAL
Dear Colleagues,
As a condition of biennial license renewal, physicians (MD/DO) must complete two (2) hours of continuing medical education on prescribing and monitoring of controlled substances unless exempt. These hours must be earned in the current renewal cycle and may be counted toward your overall required CME hours.
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.
The InforMed South Carolina Medical Licensure Program is designed to fulfill this mandatory CME requirement for medical professionals in South Carolina. Completion of the program satisfies the two (2) hour requirement on prescribing and monitoring of controlled substances and eight (8) hours on the DEA’s new one-time MATE requirement.
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.
Best Regards,
The lnforMed CME Team
South Carolina State Board of Medical Examiners 110 Centerview Dr | Columbia, SC 29210 | (803) 896-4500
We are a nationally accredited CME provider. For all board-related inquiries please contact:
1-800-237-6999
BOOK CODE: MDSC1125
BOOK.CME.EDU
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What’s Inside
01
RESPONSIBLE AND EFFECTIVE OPIOID PRESCRIBING COURSE ONE | 3 CREDITS SATISFIES 2 CREDITS OF CONTROLLED SUBSTANCES
Opioid analgesic medications can bring substantial relief to patients suffering from pain. However, the inappropriate use, abuse, and diversion of prescription drugs in America, particularly prescription opioids, has increased dramatically in recent years and has been identified as a national public health epidemic. A set of clinical tools, guidelines, and recommendations are now available for prescribers who treat pain patients with opioids. By implementing these tools, clinicians can effectively address issues related to the clinical management of opioid prescribing, opioid risk management, regulations surrounding the prescribing of opioids, and problematic opioid use by patients. In doing so, healthcare professionals are more likely to achieve a balance between the benefits and risks of opioid prescribing, optimize patient attainment of therapeutic goals, and avoid the risk to patient outcome, public health, and viability of their own practice imposed by deficits in knowledge. SUBSTANCE USE DISORDERS AND PAIN MANAGEMENT: MATE ACT TRAINING COURSE TWO | 8 CREDITS SATISFIES THE DEA’S NEW ONE-TIME MATE REQUIREMENT Substance use disorders continue to be an important health issue in the United States and can lead to significant problems in all aspects of a person’s life. For DEA-registered practitioners, fulfill your DEA opioid training requirement and strengthen your expertise on appropriate assessment and management of substance use with this course. In addition, the presence of substance use disorders can complicate the treatment or management of comorbid medical conditions. Given the ongoing prescription and illicit opioid use and overdose epidemic in the United States and the widespread incidence of chronic pain, opioid prescribing and optimum safe pain management is a public health concern. All clinicians should have good knowledge of the available options for substance use disorder treatment and for safe opioid prescribing and dispensing.
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FINAL EXAMINATION ANSWER SHEET REQUIRED TO RECEIVE CREDIT
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MOC/MIPS CREDIT INFORMATION
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.
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
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
3 AMA PRA Category 1 Credits TM
3 Credits LL
3 Credits MK
3 Credits SA + AC
3 Credits LL
3 Credits LL
Responsible and Effective Opioid Prescribing
Substance Use Disorders and Pain Management: MATE Act Training
8 AMA PRA Category 1 Credits TM
8 Credits LL
8 Credits MK
8 Credits SA + AC
8 Credits LL
8 Credits LL+SA
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 MDSC1125 in the book code box, then click GO.
Enter book code
• 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.
MDSC1125
GO
IF YOU’RE ONLY COMPLETING CERTAIN COURSES IN THIS BOOK: • Go to BOOK.CME.EDU and enter 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 • Responsible and Effective Opioid Prescribing • Substance Use Disorders and Pain Management: MATE Act Training
$90
MDSC1125 11 Credits
$21
Responsible and Effective Opioid Prescribing
MDSC03OP 3 Credits
$69
Substance Use Disorders and Pain Management: MATE Act Training
MDSC08SU 8 Credits
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_____________________________________________________ Responsible and Effective Opioid Prescribing MDSC03OP — 3 CREDITS R elease D ate : 05/01/24 E xpiration D ate : 04/30/27
Responsible and Effective Opioid Prescribing
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: 3 ABIM MOC Points, 3 ABS MOC Points, 3 ABA MOCA Points, 3 ABP MOC Points, 3 ABPath CC Points.
Faculty Mark Rose, BS, MA, LP , is a licensed psychologist in the State of Minnesota with a private consulting practice and a medical research analyst with a biomedical communications firm. Earlier healthcare technology assessment work led to medical device and pharmaceutical sector experience in new product development involving cancer ablative devices and pain therapeutics. Along with substantial experience in addiction research, Mr. Rose has contributed to the authorship of numerous papers on CNS, oncology, and other medical disorders. He is the lead author of papers published in peer-reviewed addiction, psychiatry, and pain medicine journals and has written books on prescription opioids and alcoholism published by the Hazelden Foundation. He also serves as an Expert Advisor and Expert Witness to law firms that represent disability claimants or criminal defendants on cases related to chronic pain, psychiatric/substance use disorders, and acute pharmacologic/toxicologic effects. Mr. Rose is on the Board of Directors of the Minneapolis-based International Institute of Anti-Aging Medicine and is a member of several professional organizations. Faculty Disclosure Contributing faculty, Mark Rose, BS, MA, LP, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned. Division Planners John M. Leonard, MD 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.
HOW TO RECEIVE CREDIT
• 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.
Audience This course is designed for all physicians, osteopaths, physician assistants, pharmacy professionals, and nurses who may alter prescribing practices or intervene to prevent drug diversion and inappropriate opioid use. Course Objective The purpose of this course is to provide clinicians who prescribe or distribute opioids with an appreciation for the complexities of opioid prescribing and the dual risks of litigation due to inadequate pain control and drug diversion or misuse in order to provide the best possible patient care and to prevent a growing social problem Learning Outcomes Upon completion of this course, you should be able to: 1. Apply epidemiologic trends in opioid use and misuse to current practice so at-risk patient populations can be more easily identified, assessed, and treated. 2. Create comprehensive treatment plans for patients with pain that address patient needs as well as drug diversion prevention. 3. Evaluate behaviors that may indicate drug seeking or diverting as well as approaches for patients suspected of misusing opioids. 4. Identify state and federal laws governing the proper prescription and monitoring of controlled substances. 5. Describe the available treatment modalities for opioid use disorder.
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Designations of Credit NetCE designates this enduring material for a maximum of 3 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 participant to earn up to 3 MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Completion of this course constitutes permission to share the completion data with ACCME. Successful completion of this CME activity, which includes participation in the evaluation component, enables the learner to earn credit toward the CME and Self-Assessment requirements of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit learner completion information to ACCME for the purpose of granting ABS credit. This activity has been approved for the American Board of Anesthesiology’s ® (ABA) requirements for Part II: Lifelong Learning and Self-Assessment of the American Board of Anesthesiology’s (ABA) redesigned Maintenance of Certification in Anesthesiology Program ® (MOCA ® ), known as MOCA 2.0 ® . Please consult the ABA website, www.theABA.org, for a list of all MOCA 2.0 requirements. Maintenance of Certification in Anesthesiology Program ® and MOCA ® are registered certification marks of the American Board of Anesthesiology ® . MOCA 2.0 ® is a trademark of the American Board of Anesthesiology ® . Successful completion of this CME activity, which includes participation in the activity with individual assessments of the participant and feedback to the participant, enables the participant to earn 3 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 3 Lifelong Learning (Part II) credits for the American Board of Pathology Continuing Certification Program. Through an agreement between the Accreditation Council for Continuing Medical Education and the Royal College of Physicians and Surgeons of Canada, medical practitioners participating in the Royal College MOC Program may record completion of accredited activities registered under the ACCME’s “CME in Support of MOC” program in Section 3 of the Royal College’s MOC Program. About the Sponsor The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare. Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice. Disclosure Statement It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.
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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a prescription opioid such as oxycodone and hydrocodone for chronic pain, and sales of opioid analgesics totaled approximately $7 billion in 2016 [3; 4]. Worldwide consumption of opioid analgesics has increased dramatically in the past few decades, with the United States driving a substantial proportion of this increase. For example, the 1990 global consumption of hydrocodone was 4 tons (3,628 kg), compared with the 2009 consumption of 39 tons (35,380 kg); 99% of this was consumed in the United States. Similarly, 3 tons (2,722 kg) of oxycodone were consumed globally in 1990, versus 77 tons (69,853 kg) in 2009, of which 62 tons (56,245 kg or 81%) were consumed in the United States [5]. With only 4.23% of the world’s population, the United States annually consumes more than 80% of all opioid supplies, including [6; 7]:
INTRODUCTION Pain is the leading reason for seeking medical care, and pain management is a large part of many healthcare professionals’ practice. Opioid analgesics are approved by the U.S. Food and Drug Administration (FDA) for moderate and severe pain and are broadly accepted in acute pain, cancer pain, and end-of-life care, but are controversial in chronic noncancer pain. In response to the long-standing neglect of severe pain, indications for opioid analgesic prescribing were expanded in the 1990s, followed by inappropriate prescribing and increasing abuse, addiction, diversion, and overdose through the 2000s. In tandem with the continued under-treatment of pain, these practice patterns led to needless suffering from uncontrolled pain, opioid analgesic addiction, and overdose. Opioid analgesic prescribing and associated overdose peaked in 2011 with both now in multi-year decline. Patients show substantial opioid response variations in analgesia and tolerability and may exhibit a range of psychologic, emotional, and behavioral responses that reflect inadequate pain control, an emerging opioid use problem, or both. Clinician delivery of best possible care to patients with pain requires appreciation of the complexities of opioid prescribing and the dual risks of inadequate pain control and inappropriate use, drug diversion, or overdose. A foundation for appropriate opioid prescribing is the understanding of factual data that clarify the prevalence, causality, and prevention of serious safety concerns with opioid prescribing. SCOPE OF THE PROBLEM Inappropriate opioid analgesic prescribing for pain is defined as the non-prescribing, inadequate prescribing, excessive prescribing, or continued prescribing despite evidence of ineffectiveness of opioids [1]. Appropriate opioid prescribing is essential to achieve pain control; to minimize patient risk of abuse, addiction, and fatal toxicity; and to minimize societal harms from diversion. The foundation of appropriate opioid prescribing is thorough patient assessment, treatment planning, and follow-up and monitoring. Essential for proper patient assessment and treatment planning is comprehension of the clinical concepts of opioid abuse and addiction, their behavioral manifestations in patients with pain, and how these potentially problematic behavioral responses to opioids both resemble and differ from physical dependence and pseudo- dependence. Prescriber knowledge deficit has been identified as a key obstacle to appropriate opioid prescribing and, along with gaps in policy, treatment, attitudes, and research, contributes to widespread inadequate treatment of pain [2]. The extent of opioid analgesic use in the United States in the 2000s was unprecedented in the country’s history and unparalleled anywhere in the world. Before 1990, physicians in the United States were skeptical of prescribing opioids for chronic noncancer pain. In 2019, 22.1% of adults used
• 99% of all hydrocodone • 68% of all oxycodone • 52% of all methadone • 40% of all hydromorphone • 19% of all fentanyl
This disproportionate rate of opioid consumption reflects sociocultural and economic factors and standards of clinical medicine. Between 1992 and 2003, the U.S. population increased 14%, while persons abusing opioid analgesics increased 94% and first-time non-medical opioid analgesic users 12 to 17 years of age increased 542% [8]. It is interesting to note that while opioid prescribing has increased precipitously among adults in the United States, the rate remained low and steady for children between 1996 and 2012 [9]. A study using data from 2005 to 2015 showed opioid prescribing in 57 million visits from adolescents and young adults, representing a prescribing rate of nearly 15% in emergency departments and nearly 3% in outpatient clinical settings [10]. During the course of the study, emergency department prescribing decreased slightly while outpatient clinical setting prescribing remained the same [10]. To assist in monitoring the public health problem associated with prescribed opioids, numerous governmental, non-profit, and private sector agencies and organizations are involved in collecting, reporting, and analyzing data on the abuse, addiction, fatal overdose, and treatment admissions related to opioid analgesics. Before it was halted in 2011, the Drug Abuse Warning Network (DAWN) provided estimates of the health consequences of nonmedical use of individual drugs, including opioid medications [11]. DAWN indicates that opioid abuse is a growing problem in the United States. In 2005 and 2011, hydrocodone and its combinations accounted for 51,225 and 97,183 emergency department visits, respectively. Oxycodone and its combinations resulted in 42,810 visits to the emergency department in 2005; this number increased to 175,229 visits in 2011 [12; 13]. Visits for nonmedical use of all opioids increased from 217,594 to 420,040 during the six-year period.
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In 2016–2017, there were 127,101 nonmedical opioid emergency department visits [14]. While this number is an improvement from previous years, nonmedical use accounts for 47.6% of all emergency department visits related to opioids [14]. PAIN MANAGEMENT APPROACHES Healthcare professionals should know the best clinical practices in opioid prescribing, including the associated risks of opioids, approaches to the assessment of pain and function, and pain management modalities. Pharmacologic and nonpharmacologic approaches should be used on the basis of current knowledge in the evidence base or best clinical practices. Patients with moderate-to-severe chronic pain who have been assessed and treated, over a period of time, with non-opioid therapy or nonpharmacologic pain therapy without adequate pain relief, are considered to be candidates for a trial of opioid therapy [3; 15]. Initial treatment should always be considered individually determined and as a trial of therapy, not a definitive course of treatment [16]. In 2016, the CDC issued updated guidance on the prescription of opioids for chronic pain [3]. The guideline addresses when to initiate or continue opioids for chronic pain; opioid selection, dosage, duration, follow-up, and discontinuation; and assessing risk and addressing harms of opioid use. In addition, the CDC further updated guidance against the misapplication of this guideline in 2019, noting that some policies and practices attributed to the guideline were inconsistent with the recommendations [17]. While these guidelines were based on the best available evidence at the time, there was some criticism that they were too focused on limiting opioid prescriptions—to the point of patients and prescribers complaining of stigma and reduced access to needed opioid analgesics. In response to this and to the availability of new evidence, the CDC published an updated guideline in 2022 [18]. The updated clinical practice guideline is intended to achieve improved communication between clinicians and patients about the risks and benefits of pain treatment, including opioid therapy for pain; improved safety and effectiveness for pain treatment, resulting in improved function and quality of life for patients experiencing pain; and a reduction in the risks associated with long-term opioid therapy, including opioid use disorder, overdose, and death [18]. It is important to remember that inappropriately limiting necessary opioid medications to address patients’ pain can be damaging and should be avoided. A central tenet of the updated 2022 guideline is that acute, subacute, and chronic pain needs to be appropriately and effectively treated regardless of whether opioids are part of a treatment regimen [18]. ACUTE PAIN Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids
in a quantity no greater than that needed for the expected duration of severe pain. In most cases, three days or less will be sufficient; more than seven days will rarely be needed [3]. Payers and health systems should not use the 2022 guideline to set rigid standards related to dosage or duration of opioid therapy. The guideline is not a replacement for clinical judgment or individualized, patient-centered care [19]. With postoperative, acute, or intermittent pain, analgesia often requires frequent titration, and the two- to four-hour analgesic duration with short-acting hydrocodone, morphine, and oxycodone is more effective than extended-release formulations. Short-acting opioids are also recommended in patients who are medically unstable or with highly variable pain intensity [20; 21; 22]. CHRONIC PAIN Nonpharmacologic therapy and non-opioid pharmacologic therapy are the preferred first-line therapies for chronic pain [18]. Several nonpharmacologic approaches are therapeutic complements to pain-relieving medication, lessening the need for higher doses and perhaps minimizing side effects. These interventions can help decrease pain or distress that may be contributing to the pain sensation. Approaches include palliative radiotherapy, complementary/alternative methods, manipulative and body-based methods, and cognitive/behavioral techniques. The choice of a specific nonpharmacologic intervention is based on the patient’s preference, which, in turn, is usually based on a successful experience in the past. Implantable intrathecal opioid infusion and/or spinal cord stimulation may be options for severe, intractable pain. Both options require that devices or ports be implanted, with associated risks. With intrathecal opioid infusion, the ability to deliver the drug directly into the spine provides pain relief with significantly smaller opioid doses, which can help to minimize side effects (e.g., drowsiness, dizziness, dry mouth, nausea, vomiting, and constipation) that can accompany systemic pain medications that might be delivered orally, transdermally, or through an IV [23]. However, use of opioid infusion has traditionally been limited to cancer pain. With spinal cord stimulation therapy, the most challenging aspect is patient selection. In order for patients to be considered for spinal cord stimulation, other options should have been ineffective or be contraindicated. Spinal cord stimulation is indicated for severe neuropathic pain persisting at least six months. If opioids are used, they should be combined with nonpharmacologic therapy and non-opioid pharmacologic therapy, as appropriate. Clinicians should consider opioid therapy only if expected benefits for pain and function are anticipated to outweigh risks to the patient [18]. Opioid therapy for chronic pain should be presented as a trial for a pre-defined period (e.g., ≤30 days). The goals of treatment should be established with all patients prior to the initiation of opioid therapy, including reasonable improvements in pain,
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function, depression, anxiety, and avoidance of unnecessary or excessive medication use [1; 18]. The treatment plan should describe therapy selection, measures of progress, and other diagnostic evaluations, consultations, referrals, and therapies. Opioid therapy should not be initiated without consideration by the clinician and patient of an exit strategy to be used if opioid therapy is unsuccessful [18]. In patients who are opioid-naïve, start at the lowest possible dose and titrate to effect. Dosages for patients who are opioid- tolerant should always be individualized and titrated by efficacy and tolerability [1; 18]. When starting opioid therapy for chronic pain, clinicians should prescribe short-acting instead of extended-release/long-acting opioid formulations [18]. The need for frequent progress and benefit/risk assessments during the trial should be included in patient education. Patients should also have full knowledge of the warning signs and symptoms of respiratory depression. Prescribers should carefully reassess evidence of benefits and risks when increasing the dosage to ≥50 mg morphine equivalent dose (MED) per day. Decisions to titrate dose to ≥90 mg MED/day should be avoided or carefully justified [17; 18].
The inadequate management of pain is the result of several factors related to both patients and clinicians. In a survey of oncologists, patient reluctance to take opioids or to report pain were two of the most important barriers to effective pain relief [29]. This reluctance is related to a variety of attitudes and beliefs [25; 29]: • Fear of addiction to opioids • Worry that if pain is treated early, there will be no options for treatment of future pain • Anxiety about unpleasant side effects from pain medications • Fear that increasing pain means that the disease is getting worse • Desire to be a “good” patient • Concern about the high cost of medications Education and open communication are the keys to overcoming these barriers. Every member of the healthcare team should reinforce accurate information about pain management with patients and families. The clinician should initiate conversations about pain management, especially regarding the use of opioids, as few patients will raise the issue themselves or even express their concerns unless they are specifically asked [30]. It is important to acknowledge patients’ fears individually and provide information to help them differentiate fact from fiction [26]. For example, when discussing opioids with a patient who fears addiction, the clinician should explain that the risk of addiction is low [25]. It is also helpful to note the difference between addiction and physical dependence. There are several other ways clinicians can allay patients’ fears about pain medication: • Assure patients that the availability of pain relievers cannot be exhausted; there will always be medications if pain becomes more severe. • Acknowledge that side effects may occur but emphasize that they can be managed promptly and safely and that some side effects will abate over time. • Explain that pain and severity of disease are not necessarily related. Encouraging patients to be honest about pain and other symptoms is also vital. Clinicians should ensure that patients understand that pain is multidimensional and emphasize the importance of talking to a member of the healthcare team about possible causes of pain, such as emotional or spiritual distress. The healthcare team and patient should explore psychosocial and cultural factors that may affect self-reporting of pain, such as concern about the cost of medication. Clinicians’ attitudes, beliefs, and experiences also influence pain management, with addiction, tolerance, side effects, and regulations being the most important concerns [25; 27; 29; 31].
The CDC recommends that clinicians should evaluate benefits and risks with patients within one to four weeks of starting opioid therapy for subacute or chronic pain or of dosage escalation. Clinicians should regularly re-evaluate benefits and risks of
continued opioid therapy with patients. (https://www.cdc.gov/mmwr/volumes/71/rr/ rr7103a1. htm. Last accessed April 19, 2024.) Strength of Recommendation/Level of Evidence : A4 (Most patients should receive based on clinical experience and observations, observational studies with important limitations, or randomized clinical trials with several major limitations) Prescribers should be knowledgeable of federal and state opioid prescribing regulations. Issues of equianalgesic dosing, close patient monitoring during all dose changes, and cross- tolerance with opioid conversion should be considered. If necessary, treatment may be augmented, with preference for nonopioids and immediate-release opioids over long-acting/ extended-release opioids. Taper opioid dose when no longer needed [18; 24]. PALLIATIVE CARE AND PAIN AT THE END OF LIFE Unrelieved pain is the greatest fear among people with a life- limiting disease, and the need for an increased understanding of effective pain management is well-documented [25]. Although experts have noted that 75% to 90% of end-of-life pain can be managed effectively, rates of pain are high, even among people receiving palliative care [25; 26; 27; 28].
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A lack of appropriate education and training in the assessment and management of pain has been noted to be a substantial contributor to ineffective pain management [29; 31]. As a result, many clinicians, especially primary care physicians, do not feel confident about their ability to manage pain in their patients [29; 31]. Clinicians require a clear understanding of available medications to relieve pain, including appropriate dosing, safety profiles, and side effects. If necessary, clinicians should consult with pain specialists to develop an effective approach. Strong opioids are used for severe pain at the end of life [26; 27]. Morphine, buprenorphine, oxycodone, hydromorphone, fentanyl, and methadone are the most widely used in the United States [32]. Unlike nonopioids, opioids do not have a ceiling effect, and the dose can be titrated until pain is relieved or side effects become unmanageable. For patients who are opioid-naïve or who have been receiving low doses of a weak opioid, the initial dose should be low, and, if pain persists, the dose may be titrated up daily until pain is controlled. More than one route of opioid administration will be needed by many patients during end-of-life care, but in general, opioids should be given orally, as this route is the most convenient and least expensive. The transdermal route is preferred to the parenteral route, although dosing with a transdermal patch is less flexible and so may not be appropriate for patients with unstable pain [27]. Intramuscular injections should be avoided because injections are painful, drug absorption is unreliable, and the time to peak concentration is long [27]. CREATING A TREATMENT PLAN AND ASSESSMENT OF ADDICTION RISK Information obtained by patient history, physical examination, and interview, from family members, a spouse, or state prescription drug monitoring program (PDMP), and from the use of screening and assessment tools can help the clinician to stratify the patient according to level of risk for developing problematic opioid behavioral responses ( Table 1 ) [33; 34]. Low-risk patients receive the standard level of monitoring, vigilance, and care. Moderate-risk patients should be considered for an additional level of monitoring and provider contact, and high-risk patients are likely to require intensive and structured monitoring and follow-up contact, additional consultation with psychiatric and addiction medicine specialists, and limited supplies of short-acting opioid formulations [18; 35]. Before deciding to prescribe an opioid analgesic, clinicians should perform and document a detailed patient assessment that includes [1]: • Pain indications for opioid therapy • Nature and intensity of pain • Past and current pain treatments and patient response • Comorbid conditions • Pain impact on physical and psychologic function
• Social support, housing, and employment • Home environment (i.e., stressful or supportive) • Pain impact on sleep, mood, work, relationships, leisure, and substance use • Patient history of physical, emotional, or sexual abuse If substance abuse is active, in remission, or in the patient’s history, consult an addiction specialist before starting opioids [1]. In active substance abuse, do not prescribe opioids until the patient is engaged in treatment/recovery program or other arrangement made, such as addiction professional co-management and additional monitoring. When considering an opioid analgesic (particularly those that are extended-release or long-acting), one must always weigh the benefits against the risks of overdose, abuse, addiction, physical dependence and tolerance, adverse drug interactions, and accidental exposure by children [18; 24]. Screening and assessment tools can help guide patient stratification according to risk level and inform the appropriate degree of structure and monitoring in the treatment plan. It should be noted that despite widespread endorsement of screening tools used to help determine patient risk level, most tools have not been extensively evaluated, validated, or compared to each other, and evidence of their reliability is poor [33; 34].
RISK ASSESSMENT TOOLS Opioid Risk Tool (ORT)
The Opioid Risk Tool (ORT) is a five-item, patient- administered assessment to help predict aberrant drug-related behavior. The ORT is also used to establish patient risk level through categorization into low, medium, or high levels of risk for aberrant drug-related behaviors based on responses to questions of previous alcohol/drug abuse, psychologic disorders, and other risk factors [36]. Screener and Opioid Assessment for Patients with Pain- Revised (SOAPP-R) The Screener and Opioid Assessment for Patients with Pain- Revised (SOAPP-R) is a patient-administered, 24-item screen with questions addressing history of alcohol/substance use, psychologic status, mood, cravings, and stress. Like the ORT, the SOAPP-R helps assess risk level of aberrant drug-related behaviors and the appropriate extent of monitoring [36; 37]. Screening Instrument or Substance Abuse Potential (SISAP) The Screening Instrument or Substance Abuse Potential (SISAP) tool is a self-administered, five-item questionnaire addressing history developed used to predict the risk of opioid misuse. The SISAP is used to identify patients with a history of alcohol/substance abuse and improve pain management by facilitating focus on the appropriate use of opioid analgesics and therapeutic outcomes in the majority of patients who are not at risk of opioid abuse, while carefully monitoring those who may be at greater risk [36].
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RISK STRATIFICATION FOR PATIENTS PRESCRIBED OPIOIDS
Low Risk Definable physical pathology with objective signs and reliable symptoms Clinical correlation with diagnostic testing, including MRI, physical examination, and interventional diagnostic techniques With or without mild psychologic comorbidity With or without minor medical comorbidity No or well-defined and controlled personal or family history of alcoholism or substance abuse Age 45 years or older High levels of pain acceptance and active coping strategies High motivation and willingness to participate in multimodal therapy and attempting to function at normal levels Medium Risk Significant pain problems with objective signs and symptoms confirmed by radiologic evaluation, physical examination, or diagnostic interventions Moderate psychologic problems, well controlled by therapy Moderate coexisting medical disorders that are well controlled by medical therapy and are not affected by chronic opioid therapy (e.g., central sleep apnea) Develops mild tolerance but not hyperalgesia without physical dependence or addiction History of personal or family history of alcoholism or substance abuse Pain involving more than three regions of the body Defined pathology with moderate levels of pain acceptance and coping strategies Willing to participate in multimodal therapy, attempting to function in normal daily life High Risk Widespread pain without objective signs and symptoms Pain involving more than three regions of the body Aberrant drug-related behavior History of alcoholism or drug misuse, abuse, addiction, diversion, dependency, tolerance, or hyperalgesia
Major psychologic disorders Age younger than 45 years HIV-related pain High levels of pain exacerbation and low levels of coping strategies Unwilling to participate in multimodal therapy, not functioning close to a near normal lifestyle HIV = human immunodeficiency syndrome, MRI = magnetic resonance imaging. Source: [33; 34]
Table 1
CAGE and CAGE-AID The original CAGE (Cut down, Annoyed, Guilty, and Eye- opener) Questionnaire consisted of four questions designed to help clinicians determine the likelihood that a patient was misusing or abusing alcohol. These same four questions were modified to create the CAGE-AID (adapted to include drugs), revised to assess the likelihood of current substance abuse [38]. Diagnosis, Intractability, Risk, and Efficacy (DIRE) Score The Diagnosis, Intractability, Risk, and Efficacy (DIRE) risk assessment score is a clinician-rated questionnaire that is used to predict patient compliance with long-term opioid therapy [36; 39]. Patients scoring lower on the DIRE tool are poor candidates for long-term opioid analgesia.
and/or physical dependence, drug interactions, motor skill impairment, limited evidence of long-term benefit, misuse, dependence, addiction, and overdose. Informed consent documents should include information regarding the risk/ benefit profile for the drug(s) being prescribed. The prescribing policies should be clearly delineated, including the number/ frequency of refills, early refills, and procedures for lost or stolen medications. The treatment agreement also outlines joint physician and patient responsibilities. The patient agrees to using medications safely, refraining from “doctor shopping,” and consenting to routine urine drug testing (UDT). The prescriber’s responsibility is to address unforeseen problems and prescribe scheduled refills. Reasons for opioid therapy change or discontinuation should be listed. Agreements can also include sections related to follow-up visits, monitoring, and safe storage and disposal of unused drugs.
INFORMED CONSENT AND TREATMENT AGREEMENTS
The initial opioid prescription is preceded by a written informed consent or “treatment agreement” [1]. This agreement should address potential side effects, tolerance
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Responsible and Effective Opioid Prescribing _ ____________________________________________________
PERIODIC REVIEW AND MONITORING When implementing a chronic pain treatment plan that involves the use of opioids, the patient should be frequently reassessed for changes in pain origin, health, and function [1]. This can include input from family members and/or the state PDMP. During the initiation phase and during any changes to the dosage or agent used, patient contact should be increased. At every visit, chronic opioid response may be monitored according to the “5 A’s” [1; 40]: • Analgesia
• Does the person take pain medication only on occasion, perhaps three or four times per week? If yes, the likelihood of addiction is low. • Have there been any other substance (alcohol or drug) abuse problems in the person’s life? An affirmative response should be taken into consideration when prescribing. • Does the person in pain spend most of the day resting, avoiding activity, or feeling depressed? If so, this suggests the pain medication is failing to promote rehabilitation. Daily activity is essential, and the patient may be considered for enrollment in a graduated exercise program • Is the person in pain able to function (e.g., work, do household chores, play) with pain medication in a way that is clearly better than without? If yes, this suggests the pain medication is contributing to wellness.
• Activities of daily living • Adverse or side effects • Aberrant drug-related behaviors • Affect (i.e., patient mood)
Signs and symptoms that, if present, may suggest a problematic response to the opioid and interference with the goal of functional improvement include [41; 42]: • Excessive sleeping or days and nights turned around • Diminished appetite • Short attention span or inability to concentrate • Mood volatility, especially irritability • Lack of involvement with others • Impaired functioning due to drug effects • Use of the opioid to regress instead of re-engaging in life • Lack of attention to hygiene and appearance The decision to continue, change, or terminate opioid therapy is based on progress toward treatment objectives and absence of adverse effects and risks of overdose or diversion [1]. Satisfactory therapy is indicated by improvements in pain, function, and quality of life. Brief assessment tools to assess pain and function may be useful, as may UDTs. Treatment plans may include periodic pill counts to confirm adherence and minimize diversion. Involvement of Family Family members of the patient can provide the clinician with valuable information that better informs decision making regarding continuing opioid therapy. Family members can observe whether a patient is losing control of his or her life or becoming less functional or more depressed during the course of opioid therapy. They can also provide input regarding positive or negative changes in patient function, attitude, and level of comfort. The following questions can be asked of family members or a spouse to help clarify whether the patient’s response to opioid therapy is favorable or unfavorable [41; 42]: • Is the person’s day centered around taking the opioid medication? Response can help clarify long-term risks and benefits of the medication and identify other treatment options.
Assessment Tools VIGIL
VIGIL is the acronym for a five-step risk management strategy designed to empower clinicians to appropriately prescribe opioids for pain by reducing regulatory concerns and to give pharmacists a framework for resolving ambiguous opioid analgesic prescriptions in a manner that preserves legitimate patient need while potentially deterring diverters. The components of VIGIL are: • Verification: Is this a responsible opioid user? • Identification: Is the identity of this patient verifiable? • Generalization: Do we agree on mutual responsibilities and expectations? • Interpretation: Do I feel comfortable allowing this person to have controlled substances? • Legalization: Am I acting legally and responsibly? • The foundation of VIGIL is a collaborative physician/ pharmacist relationship [43]. Current Opioid Misuse Measure (COMM) The Current Opioid Misuse Measure (COMM) is a 17-item patient self-report assessment designed to help clinicians identify misuse or abuse in patients being treated for chronic pain. Unlike the ORT and the SOAPP-R, the COMM identifies aberrant behaviors associated with opioid misuse in patients already receiving long-term opioid therapy [35]. Sample questions include: In the past 30 days, how often have you had to take more of your medication than prescribed? In the past 30 days, how much of your time was spent thinking about opioid medications (e.g., having enough, taking them, dosing schedule)?
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Pain Assessment and Documentation Tool (PADT) Guidelines by the CDC, the Federation of State Medical Boards (FSMB), and the Joint Commission stress the importance of documentation from both a healthcare quality and medicolegal perspective. Research has found widespread deficits in chart notes and progress documentation with patients with chronic pain receiving opioid therapy, and the Pain Assessment and Documentation Tool (PADT) was designed to address these shortcomings [44]. The PADT is a clinician-directed interview, with most sections (e.g., analgesia, activities of daily living, adverse events) consisting of questions asked of the patient. However, the potential aberrant drug-related behavior section must be completed by the physician based on his or her
chromatography coupled to tandem mass spectrometry confirmation. Urine test results suggesting opioid misuse should be discussed with the patient using a positive, supportive approach. The test results and the patient discussion should be documented. CONCURRENT USE OF BENZODIAZEPINES In 2021, nearly 14% of persons who died of an opioid overdose also tested positive for benzodiazepines, a class of sedative medication commonly prescribed for anxiety, insomnia, panic attack, and muscle spasm [47]. Benzodiazepines work by raising the level of the neurotransmitter gamma-aminobutyric acid (GABA) in the brain. Common formulations include diazepam, alprazolam, and clonazepam. Combining benzodiazepines with opioids is unsafe because both classes of drug cause central nervous system depression and sedation and can decrease respiratory drive—the usual cause of overdose fatality. Both classes have the potential for drug dependence and addiction. The CDC recommends that healthcare providers use caution when prescribing benzodiazepines concurrently with opioids whenever possible [18]. If a benzodiazepine is to be discontinued, the clinician should taper the medication gradually, because abrupt withdrawal can lead to rebound anxiety and complications such as hallucinations, seizures, delirium tremens, and, in rare instances, death. The rate of tapering should be individualized [18]. CONSULTATION AND REFERRAL It is important to seek consultation or patient referral when input or care from a pain, psychiatry, addiction, or mental health specialist is necessary. Clinicians who prescribe opioids should become familiar with opioid addiction treatment options (including licensed opioid treatment programs for methadone and office-based opioid treatment for buprenorphine) if referral is needed [1]. Ideally, providers should be able to refer patients with active substance abuse who require pain treatment to an addiction professional or specialized program. In reality, these specialized resources are scarce or non-existent in many areas [1]. Therefore, each provider will need to decide whether the risks of continuing opioid treatment while a patient is using illicit drugs outweigh the benefits to the patient in terms of pain control and improved function [48].
observations of the patient. The Brief Intervention Tool
The Brief Intervention Tool is a 26-item, “yes-no,” patient- administered questionnaire used to identify early signs of opioid abuse or addiction. The items assess the extent of problems related to drug use in several areas, including drug use-related functional impairment [45]. Urine Drug Tests UDTs may be used to monitor adherence to the prescribed treatment plan and to detect unsanctioned drug use. They should be used more often in patients receiving addiction therapy, but clinical judgment is the ultimate guide to testing frequency ( Table 2 ) [46]. The CDC 2016 guideline recommends clinicians should use UDT before starting opioid therapy and consider UDT at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs [3]. However, this recommendation was based on low-quality evidence that indicates little confidence in the effect estimate, and it is not included in the 2022 updated guideline [18]. Initially, testing involves the use of class-specific immunoassay drug panels [1]. If necessary, this may be followed with gas chromatography/mass spectrometry for specific drug or metabolite detection. It is important that testing identifies the specific drug rather than the drug class, and the prescribed opioid should be included in the screen. Any abnormalities should be confirmed with a laboratory toxicologist or clinical pathologist. Immunoassay may be used point-of-care for “on-the-spot” therapy changes, but the high error rate prevents its use in major clinical decisions except with liquid
PATIENT RISK LEVEL AND FREQUENCY OF MONITORING
Monitoring Tool
Patient Risk Level
Low
Medium
High
Urine drug test
Every 1 to 2 years
Every 6 to 12 months Three times per year
Every 3 to 6 months Four times per year
State prescription drug monitoring program
Twice per year
Source: [46]
Table 2
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