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Federal Plan for Prescriber Education on Opioids Misses Opportunities

2012; American College of Physicians; Volume: 157; Issue: 3 Linguagem: Inglês

10.7326/0003-4819-156-11-201206050-00448

1539-3704

William C. Becker, David A. Fiellin,

Pharmaceutical industry and healthcare

Ideas and Opinions7 August 2012Federal Plan for Prescriber Education on Opioids Misses OpportunitiesFREEWilliam C. Becker, MD and David A. Fiellin, MDWilliam C. Becker, MDFrom the Yale University School of Medicine, New Haven, Connecticut.Search for more papers by this author and David A. Fiellin, MDFrom the Yale University School of Medicine, New Haven, Connecticut.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-156-11-201206050-00448 SectionsAboutVisual AbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail As deaths from opioid overdose and admissions to treatment facilities for opioid addiction increase (1, 2), policymakers, researchers, and expert clinical societies agree that improved education on safe and appropriate opioid prescribing is a major priority (3). The U.S. Food and Drug Administration (FDA) has heard these calls. Its response includes mandating that pharmaceutical manufacturers develop risk evaluation and management strategies (REMS) for all extended-release and long-acting opioids, including a provision whereby industry will be required to establish goals for the number of prescribers trained and periodically report on reaching those goals (4). The REMS were also a focal point of a White House Office of National Drug Control Policy's call to action, in which it sought to “require drug manufacturers to develop effective educational materials and initiatives to train practitioners on the appropriate use of opioid pain relievers” (5).Most recently, in its Blueprint for Prescriber Continuing Education Program, available for public comment on 4 November 2011, the FDA stated that it expects the training to include some content provided by the pharmaceutical industry; to be free to prescribers; and to be conducted by accredited, independent continuing education providers with costs covered entirely by industry (6). Although the government's move to enlist the pharmaceutical industry in helping address problems to which it has contributed (7) is understandable, this proposal misses opportunities to construct a system that avoids pharmaceutical industry influence, reaches an adequate number of prescribers, and includes competency-based prescribing. Data showing pharmaceutical company influence on physician behavior and a concern that this influence “could compromise clinical decision-making, adversely affecting health care delivery and undermining the reputation of the profession” has led some to call for a reduction of industry support for professional medical association activities to $0 (8). The Institute of Medicine and the American Medical Association have called for developing continuing education systems that are free from commercial influence and support (9, 10).Aside from a substantial reliance on industry for content and funding of opioid prescriber education, the FDA's plan has other weaknesses. For example, the Institute of Medicine recommends that when patterns of adverse events with medications are identified, the FDA should consider restricting the right to prescribe the medication to physicians with special training (11). However, the plan only mandates the creation of educational programming while stipulating that the pharmaceutical industry itself set goals for the number of prescribers trained. In contrast, the Office of National Drug Control Policy stated that it would “work with Congress to amend Federal law to require practitioners ... who request DEA [Drug Enforcement Agency] registration to prescribe controlled substances to be trained on responsible opioid prescribing practices as a precondition of registration.”This move would represent a sea change in the current regulatory environment and would put much-needed teeth behind the FDA's efforts. However, if the current proposal is a preview of how a universal educational program would take shape, we have significant concerns. Namely, the current language used by the FDA is that it is an “expectation”—not a mandate—that training be done by accredited continuing education providers. Furthermore, there is no expectation or requirement that prescribers demonstrate understanding or mastery of content after receiving the training. Finally, although industry has estimated that adequate educational content to improve the safety of opioid prescribing could take up to 30 hours per trainee, the FDA proposed an initial training time of 2 to 3 hours, arguing that basic education for all prescribers was the most feasible goal (4).In contrast to the FDA's proposal, we believe that certain aspects of the Drug Addiction Treatment Act (DATA) of 2000 (12) and the subsequent federal support for training and ongoing prescriber guidance accompanying its implementation provide a useful framework upon which aspects of the REMS educational efforts could be based. This act established an 8-hour training requirement for physicians to prescribe schedule III to V opioids approved for treatment of opioid addiction, a practice previously banned by the Harrison Narcotic Act. To address these training requirements and to respond to mandates within DATA 2000, federal agencies orchestrated the creation of a practice guideline and training material by leading addiction medicine societies and academia (13), independent of industry. In addition, the federal Center for Substance Abuse Treatment subsidized prescriber participation in the trainings. The model, however, did not obligate competency-based prescribing. Since 2004, the Center for Substance Abuse Treatment has funded ongoing education and support for physicians prescribing buprenorphine (2004 to present) and methadone (2008 to 2011), with a new program covering all opioids recently initiated through its clinical support systems (14) (www.pcss-o.org).The essential components of this model—required training before being permitted to prescribe; a federal–medical society collaboration to develop curriculum; and a federal–medical society collaboration to provide training and support systems—are useful but would need substantial additional legislative and fiscal support to meet the goals of the FDA vis-à-vis REMS. Shortcomings of DATA 2000 are also instructive: Training and support services have not resulted in uniform exemplary practices, perhaps due to the absence of competency-based prescribing. Congress should provide federal agencies with the funding and authority to orchestrate a robust prescriber training and ongoing support system created and administered through a government–academia–medical society partnership similar to the one created in the wake of DATA 2000. This would be no small task: There were just over 1 million physicians registered with the DEA in 2009. Thus, training would need to be implemented in a gradual, rolling fashion, perhaps tied to renewal, so that access to needed medications would not be significantly compromised. Training should be of adequate content and scope—at least 8 hours of skills-based, interactive training—with recurring competency-based assessment (15). In addition to the worthwhile content outlined in the Blueprint, the scope should be expanded to include other controlled substances (e.g., short-acting opioids, benzodiazepines, and stimulants) that are often co-prescribed and have contributed to prescription drugs being more commonly abused than all illicit substances except marijuana. This would be entirely in keeping with the FDA's authority to “require a manufacturer to develop a REMS when the FDA finds a REMS is necessary to ensure that the benefits of a drug outweigh its risks” (4).If political will is lacking for the government to fund training entirely, funding could be required of industry, to be pooled and allocated for training developed and implemented by medical societies and academia. In such a scenario, federal agencies would need to ensure the presence of a “firewall” between training development and pharmaceutical industry influence and that accreditation standards for trainings were uniformly upheld, another substantial challenge that will require resources beyond what is currently proposed.Opioid addiction, overdose, and death have reached epidemic levels exacting immeasurable personal tolls (1). The program described here would not guarantee safe and appropriate opioid prescribing in all circumstances, but it would take meaningful and much-needed steps in that direction.References1. Centers for Disease Control and Prevention. Drug overdose deaths—Florida, 2003-2009. MMWR Morb Mortal Wkly Rep. 2011;60:869-72. [PMID: 21734633] MedlineGoogle Scholar2. Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD, et al. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med. 2010;152:85-92. [PMID: 20083827] LinkGoogle Scholar3. McLellan AT, Turner BJ. Chronic noncancer pain management and opioid overdose: time to change prescribing practices [Editorial]. Ann Intern Med. 2010;152:123-4. [PMID: 20083830] LinkGoogle Scholar4. Food and Drug Administration. Draft blueprint for prescriber education for long-acting/extended-release opioid class-wide risk evaluation and mitigation strategy; availability; request for comments. Federal Register. 2011. Accessed at www.gpo.gov/fdsys/pkg/FR-2011-11-07/pdf/2011-28669.pdf on 20 February 2012. Google Scholar5. Office of National Drug Control Policy. Epidemic: responding to America's prescription drug abuse problem. 2011. Accessed at www.whitehouse.gov/sites/default/files/ondcp/policy-and-research/rx_abuse_plan.pdf on 20 February 2012. Google Scholar6. Food and Drug Administration. Blueprint for Prescriber Continuing Education Program. Accessed at www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM277916.pdf on 22 February 2012. Google Scholar7. Meier B. Narcotic maker guilty of deceit over marketing. The New York Times. 11 May 2007. Accessed at www.nytimes.com/2007/05/11/business/11drug.html on 22 January 2012. Google Scholar8. Rothman DJ, McDonald WJ, Berkowitz CD, Chimonas SC, DeAngelis CD, Hale RW, et al. Professional medical associations and their relationships with industry: a proposal for controlling conflict of interest. JAMA. 2009;301:1367-72. [PMID: 19336712] CrossrefMedlineGoogle Scholar9. Institute of Medicine. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: National Academies Pr; 2009. Google Scholar10. American Medical Association. Report 1 of the Council on Ethical and Judicial Affairs (A-11). 2011. Accessed at www.ama-assn.org/resources/doc/ethics/ceja-1a11.pdf on 28 January 2012. Google Scholar11. Institute of Medicine. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: National Academies Pr; 2007. Google Scholar12. Waiver authority for physicians who dispense or prescribe certain narcotic drugs for maintenance treatment or detoxification treatment. H.R. 4365; 2000:122-7. Accessed at buprenorphine.samhsa.gov/fulllaw.html on 22 January 2012. Google Scholar13. Center for Substance Abuse Treatment. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2004. Google Scholar14. Egan JE, Casadonte P, Gartenmann T, Martin J, McCance-Katz EF, Netherland J, et al. The Physician Clinical Support System-Buprenorphine (PCSS-B): a novel project to expand/improve buprenorphine treatment. J Gen Intern Med. 2010;25:936-41. [PMID: 20458550] CrossrefMedlineGoogle Scholar15. Holmboe ES. Assessment of the practicing physician: challenges and opportunities. J Contin Educ Health Prof. 2008;28 Suppl 1 S4-10. [PMID: 19058254] CrossrefMedlineGoogle Scholar Comments0 CommentsSign In to Submit A Comment William C. Becker, MD David A. Fiellin, MDYale University14 September 2012 Author's Response We appreciate the points made by Dr. Webster and agree with the notion that curbing abuse of, addiction to, and overdose deaths from prescription opioids and other controlled substances will require more than provider education. Regarding “pill mills,” a major focus of the Drug Enforcement Administration’s efforts: anonymous tip lines have been established in high prevalence counties, and the expansion of these program should be considered.(1) We have a professional, and, in some states, legally-mandated duty to report unethical or frankly criminal activity.(2) We agree that a national prescription monitoring program makes sense; overcoming logistical barriers to linking each state’s existing system should be a priority. We believe early data failing to show benefit from these programs (3) underscores the need for more research on how these programs can be effectively implemented. Lastly, mandating prescriber education for recertification is exactly the kind of substantive policy the White House’s Office of National Drug Control Policy originally supported but has yet to come to fruition. William C. Becker, MD David A. Fiellin, MD References 1. Palm Beach County Substance Awareness Coalition. New Hotline to Report Pill Mills. http://www.pbcsac.org/new-hotline-report-pill-mills. Accessed September 7, 2012. 2. American Medical Association's Council on Ethical and Judicial Affairs. Reporting Impaired Incompetent or Unethical Colleagues. 1992. http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion9031.page. Accessed September 7, 2012. 3. Paulozzi LJ, Kilbourne EM, Desai HA. Prescription Drug Monitoring Programs and Death Rates from Drug Overdose. Pain Medicine. 2011;12(5):747-54. J. David Haddox, DDS, MD, Paul M. Coplan, DSc, MBA, Laura Pethick, PharmDPurdue Pharma L.P., Purdue Pharma L.P., Sandoz, Inc.2 October 2012 REMS-Compliant Training Will Comply with Accrediting Body Standards To the Editor:Drs. Becker and Fiellin expressed their opinions about how the recently-approved Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting (ER/LA) Opioid Analgesics left some opportunities for prescriber education untapped.1 They referred to language in the White House Office of National Drug Control Policy’s initiatives that could be read as suggesting that manufacturers of pharmaceuticals develop the content of educational materials and directly train practitioners on the appropriate use of opioid analgesics.2 They called for the creation of an industry-funded pool of money to be allocated to medical societies and academia for the purpose of creating and delivering education to prescribers, ensuring that a “firewall” be in place to prevent industry influence and that accreditation standards be upheld.Their article was published online on 8 May 2012. The REMS in question, approved by FDA on 9 July 2012, comports with their express recommendations, in that FDA, not industry, determined the content of and issued the “FDA Blueprint for Prescriber Education,” thus, the firewall was employed.3 FDA further specified that for any prescriber training offered by Continuing Education (CE) providers to be considered “REMS-compliant training,” it must: 1) be offered to licensed prescribers by accredited CE providers, 2) include all the elements of the FDA Blueprint, 3) include a post-course knowledge assessment on all sections of the FDA Blueprint, 4) be conducted in accordance with applicable accreditation body standards (eg, ACCME), and5) be subject to an independent audit to confirm the preceding conditions have been met.While industry is providing educational grants to support REMS-compliant training, it will not dictate, create, or otherwise influence the content of such training.4 If industry were found to have influenced the content of a course, it would be disqualified as REMS-compliant and prescribers who completed it would not be considered to have completed the particular training envisioned by this REMS. As representatives of companies whose products are subject to this REMS, we direct readers interested in learning more about this REMS to FDA’s ER/LA Opioids REMS website5 and the industry site implemented as part of this REMS,6 where links to a list of covered products, their updated full prescribing information, the Request for Applications for CE grants, and other material can be found. Additionally, questions can be directed to the ER/LA Opioid REMS call center at 1-800-503-0784. References: 1. Becker WC, Fiellin DA. Federal plan for prescriber education on opioids misses opportunities [Ideas and Opinion]. Ann Int Med 2012;157(3):205-6. 2. Office of National Drug Control Policy. Epidemic: responding to America's prescription drug abuse problem. 2011:3. Accessed at http://www.whitehouse.gov/sites/default/files/ondcp/policy-and-research/rx_abuse_plan.pdf on 17 September 2012. 3. Food and Drug Administration. Extended-Release (ER) and Long-Acting (LA) Opioid Analgesic REMS Risk Evaluation and Mitigation Strategy (REMS). Revised 8/2012:9-21. Accessed at http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM311290.pdf on 17 September 2012. 4. Food and Drug Administration. Extended-Release (ER) and Long-Acting (LA) Opioid Analgesic REMS Risk Evaluation and Mitigation Strategy (REMS). Revised 8/2012:2. Accessed at http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM311290.pdf on 17 September 2012. 5. Food and Drug Administration. Extended-Release (ER) and Long-Acting (LA) Opioid Analgesic REMS Risk Evaluation and Mitigation Strategy (REMS). Revised 8/2012:9-21. Accessed at http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm on 17 September 2012.6. The ER/LA Opioid Analgesic REMS Companies. Accessed at http://www.er-la-opioidrems.com/IwgUI/rems/home.action on 17 September 2012. Disclosures: All the authors are full-time employees of their respective pharmaceutical companies. No other funding was received in conjunction with this response. Suzanne M. Smith, MD, MPH, MPA, FACP; and Amanda Wilson, MDCleanSlate Centers4 September 2012 Misguided Opiate Strategies TO THE EDITOR: Two articles in the 7 August 2012 Annals highlight difficulties in the clinical use of opioids. Both articles arise from concerns about the alarming increase in opioid addiction and deaths due to opioid overdose (1). Together they underscore the disconnect between national policy and individual practice decisions. Adams uses her experience with one patient to describe the uncertainties inherent in balancing needed pain management with the real potential for dependence or abuse. Opioid use crowded out the patient’s other medical issues.Becker and Fiellin focus on national policy to reduce opioid misuse, particularly prescriber education. To overcome their concerns with potential pharmaceutical manufacturers’ influence on the Prescriber Continuing Education Program formulated by the U.S. Food and Drug Administration, they offer components of the educational program and limited licensure for buprenorphine under the Drug Addiction Treatment Act (DATA) of 2000 (2) as potential opioid prescribing models.We believe that current policies, particularly requirements under DATA, would not be helpful in controlling opioid misuse. A mandatory opioid-prescribing training course, as DATA requires for buprenorphine, might be useful, but it is difficult to imagine how any training course would have been beneficial in the common scenario Adams describes. Adam’s essay illustrates that opioid dependency, especially in the face of chronic pain, requires special expertise and considerable time investment - resources not readily available. A major obstacle for establishing specialty practices where these complex patients can be managed appropriately has been the DATA waiver limit of only 30 patients receiving buprenorphine per physician in the first waiver year. Only 5,820 U. S. physicians have received a waiver to treat 100 patients after one year (3). Mid-level providers can prescribe opioids but not buprenorphine. Ironically, opioid prescribing is not restricted, yet treatment for opioid dependence is tightly controlled. Some insurers restrict access to and treatment duration for buprenorphine, also limiting availability. Where legitimate access to buprenorphine is restricted, illegal street sales of buprenorphine increase (4, 5).Because of prior authorization requirements for opioid prescription refills by some insurers, clinicians have resorted to prescribing large numbers on the first prescription rather than face the potential for patients going without needed pain medication until authorization is approved, leaving excess medication in the hands of many patients.We urge caution in further promulgating any well-intended policies by the government or insurers that translate poorly into clinical practice and actually interfere with appropriate opioid use and treatment for dependency. References 1) Centers for Disease Control and Prevention. Drug overdose deaths – Florida, 2003-2009. MMWR Morb Mort Wkly Rep. 2011;60:869-72. 2) Waiver authority for physicians who dispense or prescribe certain narcotic drugs for maintenance treatment or detoxification treatment. H.R. 4365; 2000: 122-7. Accessed at http://buprenorphine.samsha.gov/fulllaw.html on 1 September 2012. 3) National Public Radio. Meet the drug dealer who helps addicts quit. Broadcast on 26 July 2012. Accessed at http://www.npr.org/blogs/money/2012/07/26/155424108/meet-the-drug-dealer-who-helps-addicts-quit on 1 September 2012. 4) Lofwall MR, Havens JR. Inability to access buprenorphine treatment as a risk factor for using diverted buprenorphine. Drug Alcohol Depend 2012 Jun 13. Accessed at http://www.ncbi.nlm.nih.gov/pubmed/22704124 on 1 September 2012. 5) Bazazi AR, Yokell M, Fu JJ, Rich JD and Zaller ND. Illicit use of buprenorphine/naloxone among injecting and non-injecting opioid users. J Addict Med 2011 Sep;5(3):175-80. Disclosures: Drs. Smith and Wilson are affiliated with CleanSlate addiction treatment centers, where buprenorphine is used for outpatient addiction treatment. James Webster MD, MS, MACPFeinberg School of Medicine of Northwestern University, Department of Medicine20 August 2012 Other Opiod Prescribing Issues The points made by Dr.’s Becker and Fiellin (1) are pitch perfect. However, there are more issues to be addressed if the epidemic of opioid overdose deaths is to be eradicated. Specifically; when there are more “pain clinics” than McDonalds’ franchises in Florida (2) and when 13% of primary care physicians say they would stop prescribing these drugs if they had to take 4-8 hours of Continuing Medical Education (CME) on the topic of prescribing them (3), there are problems. The profession should insist: First; that local and federal law enforcement agencies aggressively shut down the” pill mills” and prosecute the unethical and illegal physicians who are abusing their prescribing privileges for profit. These criminals are directly responsible for many of the deaths (4). The authorities should know that organized medicine will support such efforts. Second; that a national patient data base/prescription monitoring program should be set up to record names with identifying data on users. This is needed to stop “doctor shopping” by addicts or those who would divert the drugs. Many of the “patients” coming to Florida to obtain opioids were/are not residents. Third; that as some states already do (e.g. New Mexico), that physicians must participate in CME on this topic as a condition for maintenance of licensure. With opioid overdoses killing more Americans than automobiles or guns, (4), it will take more than just educational interventions if real progress is to be made. References 1. Becker WC, Fiellin DA. Federal Plan for prescriber education on opioids misses opportunities.Ann. Intern. Med. 2012;157:205-206 2. Michael George. ABC Action News 3/1/11. Accessed 8/11/12 3. Slevin KA, Ashburn MA, Primary care physicians’ opinion survey on FDA opioid risk evaluation and mitigation strategies. J. Opioid Manag. 2011;7:109-115 4. Morbidity and Mortality Weekly Report (MMWR). CDC Grand Rounds: Prescription Drug Overdoses- a U.S. Epidemic. Jan 13,2012/61(01) 10-13 Author, Article, and Disclosure InformationAffiliations: From the Yale University School of Medicine, New Haven, Connecticut.Grant Support: Dr. Fiellin is supported by grants RO1 DA020576 and R01 DA025991 from the National Institute on Drug Abuse and grant U01 AA020795 from the National Institute on Alcohol Abuse and Alcoholism. The funding source had no role in the preparation, review, or approval of the manuscript.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-0251.Corresponding Author: William C. Becker, MD, Yale University School of Medicine, 367 Cedar Street, PO Box 208056, New Haven, CT 06520-8056; e-mail, [email protected].Current Author Addresses: Drs. Becker and Fiellin: Yale University School of Medicine, 367 Cedar Street, PO Box 208056, New Haven, CT 06520-8056.Author Contributions: Conception and design: W.C. Becker, D.A. Fiellin.Analysis and interpretation of the data: W.C. Becker, D.A. Fiellin.Drafting of the article: W.C. Becker, D.A. Fiellin.Critical revision of the article for important intellectual content: W.C. Becker, D.A. Fiellin.Final approval of the article: W.C. Becker, D.A. Fiellin.Administrative, technical, or logistic support: W.C. Becker.This article was published at www.annals.org on 8 May 2012. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoPrescriber Education on Opioids James Webster Prescriber Education on Opioids William C. Becker and David A. 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Learning from the opioid epidemic in the USAA Research Agenda for Enhancing Appropriate Opioid Prescribing in Primary CarePrescriber Education on OpioidsJames Webster, MD, MS 7 August 2012Volume 157, Issue 3Page: 205-206KeywordsAlcoholismComputed axial tomographyDrug policyDrug regulationDrugsOpioid addictionOpioidsSubstance abuse ePublished: 7 August 2012 Issue Published: 7 August 2012 CopyrightCopyright © 2012 by American College of Physicians. All Rights Reserved.PDF DownloadLoading ...