Opioid Prescribing Education: Does it Work?

Transcription

1 Opioid Prescribing Education: Does it Work? Opioids in Medicine: Perception and Reality International Conference on Opioids (ICOO) 2018, Boston, MA June 10, 2018 Daniel P. Alford, MD, MPH Professor of Medicine Associate Dean, Continuing Medical Education Director, Clinical Addiction Research and Education (CARE) Unit Director, Safe and Competent Opioid Prescribing Education (SCOPE of Pain) Program Boston University School of Medicine Boston Medical Center Daniel Alford, MD, MPH Disclosures I serve as course director and faculty for safe opioid prescribing CME funded by an unrestricted educational grant awarded to Boston University by the REMS Program Companies as part of the FDA's ER/LA Opioid REMS program I have not received any direct payment from industry for this activity I believe in a balanced approach opioids for chronic pain are not all bad or all good Why educate about safer opioid prescribing if you believe The problem is, there s no evidence that opioids work for chronic pain, according to guidelines released in 2016 by the Centers for Disease Control and Prevention Julia Lurie reporter, Mother Jones, April 27,

2 Meta-Analysis: Opioids vs. Placebo in Chronic Pain FDA requires double-blind placebo-controlled RCTs of at least 3 months 15 RCTs all considered high quality (n=8,749 patients) Opioid efficacy was statistically significant for > 30% and > 50% pain improvement. Standardized mean difference was ( medium effect size ). NSAIDs, APAP, and gabapentin effect sizes ~-0.25 to ( low effect size ) Meske DS et al. J Pain Res. 2018;11: Opioids in Perspective The long-term efficacy of chronic opioid therapy for chronic pain has been inadequately studied Recent RCT found opioids not superior to nonopioids for improving musculoskeletal pain-related function over 12 months (limitation: only 5% (240/4485) enrolled in study)* Risks of opioid misuse can be severe (e.g., addiction, overdose, death) Opioid prescribing needs to be more selective and judicious If opioids can help some patients, providers need to learn how to prescribe them more safely Chou R et al. Ann Intern Med 2015 Dowell D et al. JAMA 2016 Manchikanti L et al. Pain Physician 2011 Reuben DB et al. Ann Intern Med 2015 Volkow ND, McLellan T. N Engl J Med 2016 * Krebs EE et al. JAMA 2018 Education Gap US Medical Schools average of 10 hrs of pain management education with only 30% offering opioid prescribing education 82% of PCPs rated their undergraduate medical education in chronic pain as insufficient, with 55% rating their chronic pain training in residency as insufficient Only 34% of physicians felt comfortable in managing patients with chronic pain and only 1% found doing so satisfying Only 6 board certified pain physicians per 100,000 adult patients with chronic pain Loeser JD, Schatman ME. Postgrad Med Mezei L et al. J Pain 2011 Morely-Forster PK et al. J Pain Res 2013 Upshur CC, et al. J Gen Int Med Watt-Watson J et al. Pain Res Manag 2009 Watt-Watson J et al. Pain 2004 Yanni LM, et al. J Grad Med Educ

3 Institute of Medicine 2011 Curricula for all health professions are full, and advocates of many important causes compete for a greater share of valuable educational time. Yet despite the large role that care of patients with pain will play in their daily practice, many health professionals, appear underprepared for, and uncomfortable with, carrying out this aspect of their work. These professionals need and deserve greater knowledge and skills so they can contribute to the necessary cultural transformation in the treatment of people with pain. Institute of Medicine Relieving Pain in America. Washington DC Pain Medicine Education Acad Med, 2016 States Legislating Pain CME 26 State Medical and Osteopathic Boards require content specifically on pain management 3

4 Does CME Work? 5 systematic reviews concluded: CME improves physician performance and patient health outcomes, and CME has a more reliably positive impact on physician performance than on patient health outcomes 8 systematic reviews concluded: CME activities that are more interactive, use more methods, involve multiple eposures, are longer, and are focused on outcomes that are considered important by physicians lead to more positive outcomes Cervero RM, Gaines JK. The impact of CME on physician performance and patient health outcomes: an updated synthesis of systematic reviews. J Contin Educ Health Prof Cervero RM, Gaines JK. Effectiveness of CME: Updated synthesis of systematic reviews. ACCME 2014 Forsetlund L et al. Cochrane Database Systematic Reviews Measuring Success The Ideal Outcomes Decreases in overdoses Decreases in overdose deaths Decreases in ED visits related to opioids Decreases in opioid addiction Decreases in diversion Improvements in clinician performance (use of evidence-based practices) Improvements in patient health outcomes (decreased pain, improved function and quality of life) More Common Metrics easier to measure Decreases in opioid prescribing (but what is the right amount?? Are changes due to more judicious or fearful prescribing) Improvements in clinicians knowledge, attitudes, confidence Improvement in clinicians self-reported changes in practice 4

5 A National Education Strategy Etended Release/Long Acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) ER/LA Opioid REMS 2012: FDA required a class-wide REMS for all manufacturers of ER/LA Opioid Analgesics Goal: to reduce serious adverse outcomes (addiction, unintentional overdose, death) resulting from inappropriate prescribing, misuse, and abuse of ER/LA opioid analgesics while maintaining patient access to pain medications Manufacturers funding of the education is mandatory Prescriber participation in the education is voluntary A Unique REMS Program Federal Government FDA mandated the class-wide ER/LA Opioid REMS and developed the curricular Blueprint RPC REMS Program Companies representing (currently) 33 manufacturers of ER/LA opioid analgesics provided unrestricted educational grants to accredited CME/CE providers CME/CE Providers BUSM, CO*RE, ACP, and many more who have provided 1000s of activities since 2013 CE Accreditors ACCME, ANCC, ACPE, AOA, AAFP responsible for auditing and capturing and reporting data 5

6 ER/LA REMS Program Grantees Boston University CA Academy FP/CORE ACP/Pri-Med Utah Medical Association Assoc for Hospital Medical Ed University of Washington Temple University Montefiore/Albert Einstein AAPM University of Cincinnati University of Nebraska/FSMB University of North Teas Florida Medical Association Postgrad Institute of Medicine Dannemiller, Inc. Johns Hopkins University Ultimate Medical Academy American Academy of PM&R Global Education Group FDA Blueprint* for Prescriber Education for ER/LA Opioid Analgesics I. Assessing Patients for Treatment with ER/LA Opioid Analgesics II. Initiating Therapy, Modifying Dosing, and Discontinuing Use of ER/LA Opioid Analgesics III. Managing Therapy with ER/LA Opioid Analgesics IV. Counseling Patients and Caregivers about the Safe Use of ER/LA Opioid Analgesics V & VI. General and Specific Drug Information for ER/LA Opioid Analgesic Products * There are no limits or restrictions on what can be included in the ER/LA Opioid REMS training as long as all elements of the FDA Blueprint are covered Measuring Success How does the FDA measure success? Number of qualified completers (clinicians who have prescribed an ER/LA opioid in the last 12 months [estimated to be 320,000]) that have passed a knowledge post-test How does the CME/CE community like to measure success? Improved clinician performance and patient health outcomes 6

7 Challenges to Determining Whether ER/LA Opioid REMS is Successful Inadequate data from participants Limit burden to participants pre- and post-program Limited access to participants for follow-up Difficulties in differentiating effects of the ER/LA Opioid REMS from multitude of concurrent efforts: (overdose education and naloone distribution, epanded OUD treatment, PDMP use, law enforcement closing pill mills, national and state guidelines with dose limits, insurers prior authorizations and dose limits, DEA reduction in opioid quotas) Performance goals (# ER/LA opioid prescribers trained) First training by March 1, % (80,000/320,000) trained by 2/ % (160,000/320,000) trained by 2/ % (192,000/320,000) trained by 2/2017 Participants Completed over 4 Years 3/2013-4/ REMS-compliant activities Group # participants in group % of preceding group Successful completers 208,490 - Successful completers registered to prescribed Schedule II/III drugs 100,521 48% Successful completers registered to prescribe Schedule II/III drugs and who wrote at least one ER/LA opioid prescription in the last year (FDA-defined prescribers) 61,959* 62% *32% of Feb 2017 target of 192,000 ACCME ER/LA Opioid REMS CME Activities in PARS Apr

8 FDA-defined ER/LA Opioid Prescriber Completers (n=61,959) 64% ACCME ER/LA Opioid REMS CME Activities in PARS Apr 2017 SCOPE of Pain, It is not just about ER/LA opioids Case-based (3 2 hrs): new patient on high dose IR opioids for painful diabetic neuropathy and spinal stenosis Assess pain, function and quality of life Assess for opioid misuse risk (substance use, mental illness) Opioid pharmacology (IR and ER/LA), efficacy and safety Multi-modal pain care, rational polypharmacy Assess for appropriateness of opioid analgesics (IR and ER/LA) Counsel patients on opioid risks, safety, and realistic goals (agreement) Monitor for benefits and harms using universal precautions Assessing worrisome behaviors, misuse, use disorder and diversion Risk mitigation strategies (e.g., naloone co-prescribing) Decide on continuing, modifying or d/cing (tapering) opioids; Safely d/c opioids when too little benefit or too much risk and harm Effective communication strategies using risk/benefit framework, documentation 8

9 SCOPE of Pain (3/2013-5/2018) Educational Methodology Registered Completed Total Registered: 150,024 85% Completed: 128, Online Live Meeting Print Monograph Completers by Profession n=128,145 Physician Assistant 10% Nurse 5% Advanced Practice Nurse 13% Physician 65% physician advanced practice nurse physician assistant nurse dentist other podiatrist pharmacist other mental health professionals optometrist psychologist Completers by Specialty n=128,145 Anesthesiology 6% Psychiatry 9% Emergency Medicine 11% Primary Care (Internal Medicine, Family Practice, Adolescent Medicine, Pediatrics) 54% Surgery, Surgical Subspecialties 14% 9

10 Completers Baseline Reported Opioid Prescribing (3/2013-5/2018) 128, ,257 (70%) ,841 (21%) 25,826 (20%) Completers Completers w/dea license Completers who have Completers who have R for >3mo R an ER/LA opioid w/in 1 yr SCOPE of Pain Evaluation Alford DP, Zisblatt L, Ng P et al. Pain Med 2016 Immediate post-program (n=2,850) 87% with intention to change toward guideline-based care 2-month post program (n=476 [17% response rate but no significant differences in demographics to the entire sample]) Significant increase in correct responses to knowledge questions 67% increased confidence in applying safe opioid prescribing care 86% reported implementing practice changes Improvement in alignment of desired attitudes toward safe opioid prescribing Alford DP, Zisblatt L, Ng P et al. Pain Med

11 89 trainers were trained in 9 states 33% of the trainers conducted at least 1 training, with a total of 79 meetings that educated 1,419 participants Trainer-led versus Epert-led participant outcomes Immediate post-training, over 90% of both groups planned to make at least one change toward guideline-based care 2-months post-training, there were no significant differences in improvements in knowledge, confidence, attitudes, and performance Participants of the trainer-led programs were significantly more likely to be practicing in rural settings Zisblatt L, Hayes SM, Lazure P, et al. Subst Abus Misinformation For opioid-makers, the [CE] courses for doctors one of the most important marketing [tactics] that they have, says one pharmacology professor It doesn t look like advertising. It doesn t look like promotion. It looks like education One medical school professor tried to incorporate information into a REMS course about tapering off opioids and using non-pharmacological options, but that was not what we were being paid to do, he told me. Political Response According to a recent investigation, many of the prescriber courses do not conform to the current [CDC guidelines] and do not reflect the most recent treatment of chronic pain or the inherently addictive nature of these drugs. I am concerned that the industry s profit motives may be improperly influencing the education that prescribers receive... 11

12 Does ER/LA Opioid REMS = Marketing? NO! The hallmark of accredited CME is independence from promotion or marketing ACCME standards ensure that accredited CME is relevant, practicebased, and independent of commercial influence or bias Companies providing funding for accredited CME are prohibited from having any influence over faculty or content; cannot pay attendees or faculty for travel, registration, or honoraria; and cannot influence who can attend Currently only 10% of accredited activities receive grant support from drug and device manufacturers Commercial support for CME in general has declined by hundreds of millions of dollars over the past decade Do SCOPE of Pain Participants Detect Commercial Bias? For over 5 years, 99.5% (127,481/128,112) of SCOPE of Pain participants detected NO commercial bias Of the 0.5% who did ~20% erroneously clicked yes and wrote a comment such as there is no bias in this presentation Of those who did detect commercial bias, their comments fell into 3 themes They reported bias because: the topic was about prescribing ER/LA opioids opioids are never appropriate treatment for chronic pain all pharma funded CME is implicitly biased National Trends/Outcomes Associated with the timing of the ER/LA Opioid REMS Programing 12

13 Decreases in Opioid Prescribing IMS Health National Prescription Audit Total # opioid R 2014: 2.2% 2015: 6.8% 2016: 2.9%* *projected Opioids prescribed peaked in 2010 (782 MME/capita) then decreased each year thru 2015 (640 MME) vs 1999 (180 MME) Prescribing rates from : 13.1% Pezalla EJ et al. J Pain Res High dose opioid prescribing (>90 mg MME) declined from Guy GP et al. MMWR Opioid Prescribing Volume Down Retrospective repeated cross-sectional study using longitudinal prescription databases (IMS National Prescription Audit TM and LifeLink TM ) measured prescription volume, projected national estimates Compared ER/LA opioid prescriptions dispensed 2-year pre-rems to 18-month post-rems Post-REMS average quarterly ER/LA opioid prescriptions volume significantly decreased by 4.3% Largest volume decrease in dentists (-48.5%) Emergency medicine specialists (-25.5%) Divino V et al. J Opioid Manag Studies Assessing REMS Effectiveness after 3 years Data sources: Researched Abuse Diversion and Addiction-Related Surveillance (RADARS) and National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) Cepeda MS et al. Pain Med

14 Overdoses by Specific Opioid REMS Shifting Patterns of First Opioid Used Percentage of Heroin-Addicted Treatment Admissions Cicero T et al. JAMA Psychiatry Cicero T et al. Addictive Behaviors s: >80% started with heroin 2000s: >75% started with prescription opioids : Increasing initiation with heroin Opioid Initiation REMS National Academies of Sciences, Engineering, and Medicine Heroin initiation reported in NSDUH Muhuri PK et al. SAMHSA: CBHSQ Data Review

15 Teen Lifetime Prevalence of Prescription Opioid Use Without a Prescription is Decreasing Johnston LD et al. (2018). Monitoring the Future Study Final Thoughts It cannot be limited to training prescribers Safer opioid prescribing is a lot of work Train (and retrain) and utilize other staff (nurses, medical assistants, pharmacist, psychologists, social workers, front desk staff) 15

16 It must be more than knowledge acquisition Opinion Undertreating pain, we are admonished it violates the basic ethical principles of medicine. On the other hand, we are lambasted for overprescribing pain medications creating an epidemic of overdose deaths. For patients with chronic pain, especially those with syndromes that don t fit into neat clinical boes, being judged by doctors to see if they merit medication is humiliating and dispiriting. This type of judgment, with its moral overtones and suspicions, is at odds with the doctor-patient relationship we work to develop. As Mr. W. and I sat there sizing each other up, I could feel our reserves of trust beginning to ebb. I was debating whether his pain was real or if he was trying to snooker me. He was most likely wondering whether I would believe him Danielle Ofri, MD Associate Professor at NYU and a physician at Bellevue Hospital, August 2015 Safer Opioid Prescribing Education Must Address the Comple Realities of Clinical Practice Updated FDA curricular Blueprint (January 2018) 1. Basic Mechanisms of Pain (Definitions, Mechanisms, Pain Assessment) 2. Creating a Pain Treatment Plan a) Nonpharmacologic, Pharmacologic (non-opioid, opioid) b) Managing Patients on Opioids (initiation, ongoing management, identifying OUD, consulting pain specialist, opioid tapering, patient education) c) Addiction Medicine Primer (neurobiology, screening and managing OUD) 16

17 So Is opioid prescribing education effective? If so, should it be mandatory? Thank you! Questions? Thoughts? 17