William C. Becker, MD; David A. Fiellin, MD
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.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-0251.
Requests for Single Reprints: William C. Becker, MD, Yale University School of Medicine, 367 Cedar Street, PO Box 208056, New Haven, CT 06520-8056; e-mail, firstname.lastname@example.org.
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.
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James Webster MD, MS, MACP
Feinberg School of Medicine of Northwestern University, Department of Medicine
August 17, 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.
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
Suzanne M. Smith, MD, MPH, MPA, FACP; and Amanda Wilson, MD
September 2, 2012
Conflict of Interest:
Drs. Smith and Wilson are affiliated with CleanSlate addiction treatment centers, where buprenorphine is used for outpatient addiction treatment.
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.
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.
William C. Becker, MD David A. Fiellin, MD
September 14, 2012
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
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, PharmD
Purdue Pharma L.P., Purdue Pharma L.P., Sandoz, Inc.
October 1, 2012
Conflict of Interest:
All the authors are full-time employees of their respective pharmaceutical companies. No other funding was received in conjunction with this response.
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.
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.
Becker WC, Fiellin DA. Federal Plan for Prescriber Education on Opioids Misses Opportunities. Ann Intern Med. 2012;157:205–206. doi: 10.7326/0003-4819-156-11-201206050-00448
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Published: Ann Intern Med. 2012;157(3):205-206.
Education and Training, Healthcare Delivery and Policy, Tobacco, Alcohol, and Other Substance Abuse.
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