It was a privilege to represent AAHPM at the fall meeting of the Council of Medical Specialty Societies in Washington D.C. on November 18 & 19, 2011. This was my first CMSS meeting and I was struck by the energy, collegiality, and nimble structure of this “society of medical societies.” There is no House of Delegates to debate everything like in the AMA – just a Board of Directors, Component Groups (CEO’s, Membership directors, clinical practice guideline developers, etc.) and occasional task forces. They have done a lot, but only taken a stand on 5 public topics – the most recent being support of comparative effectiveness research (in a letter the AAHPM signed).
I spent my time in a day-long seminar on the upcoming REMS – Risk Evaluation and Mitigation Strategy for long acting opioids. Regina Labelle, from the White House Office of National Drug Control Policy certainly got my attention when she explained that in 17 states, deaths from unintended drug overdoses now outnumber deaths from traffic accidents! Understandably Congress and the Administration want something done about this. Theresa Toigo, R.Ph., M.B.A., from the FDA explained that the Food and Drug Administration Amendments Act of 2007 (FDAAA) gave FDA the authority to require manufacturers to develop and implement a REMS when necessary to ensure the benefits of a drug or biological product outweigh its risks.
On April 19, 2011, in conjunction with the Office of National Drug Control Policy (ONDCP) release of the Obama Administration’s Epidemic: Responding to America’s Prescription Drug Abuse Crisis—a comprehensive action plan to address the national prescription drug abuse epidemic, FDA issued letters to application holders (makers and seller of opioids) directing them to submit a REMS within 120 days and describing the elements that needed to be included in the REMS (REMS notification letters).
So what is REMS and why should we care?
After notifying the makers and marketers of long-acting and extended-release (LA/ER) opioid drugs that they were required to submit a risk evaluation and mitigation strategy (REMS), FDA has been working with the sponsors that market these products on the required REMS. The central component of the Opioid REMS is an education program for prescribers (e.g., us) so that LA/ER opioid drugs can be prescribed and used safely. FDA expects the prescriber training to be conducted by accredited, independent continuing education (CE) providers (like AAHPM), without cost to the healthcare professionals, under unrestricted grants to accredited CE providers funded by the sponsors. Kate Regnier, M.A., M.B.A., from ACCME assured us that industry would not be dictating the curriculum so the CME can comply with ACCME standards.
What are they going to be teaching us?
On November 4, 2011, FDA announced the availability for public comment of a draft “Blueprint.” The Blueprint, developed by FDA with advice from other Federal agencies, is a basic outline and the core messages that FDA believes should be conveyed to prescribers in a basic two to three hour educational module. After it is completed and approved as part of the REMS, the Blueprint is posted on the FDA web site for use by CE providers in developing CE courses. The Blueprint for provider education can be found at
http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM277916.pdf
While, in general, I found these tenets reasonable, there isn’t a lot here about effective pain management for seriously ill patients. A few quotes will give you the flavor:
Health care professionals who prescribe extended-release (ER) and long-acting (LA) opioids are in a key position to balance the benefits of prescribing ER/LA opioids to treat pain against the risks of serious adverse outcomes including addiction, unintentional overdose, and death.
Prescribers should caution patients that ER/LA opioids can cause serious side effects that can lead to death.
Prescribers should explain that sharing ER/LA opioids with others may cause serious side effects including death, and that selling or giving away ER/LA opioids is against the law.
Prescribers should ensure that patients adhere to a treatment plan and monitor patients for misuse and abuse by
- Recognizing aberrant behavior
- Utilizing Prescription Drug Monitoring Programs to identify potential abuse where available
- Understanding the role of drug testing and performing drug screens as indicated
- Screening and referring for substance abuse treatment when indicated
- Performing medication reconciliation at each visit
Whether this program will be required to maintain your DEA registration is being discussed. The REMS notification letters stated that although there is no mandatory requirement that prescribers take the course as a precondition to dispensing the medication to patients, application holders will be required to establish goals for the number of prescribers trained, collect the information about the number of prescribers who took the courses, and report the information to FDA as part of periodic required assessments. Although FDA recognizes that additional training modules could be helpful, FDA’s goal is to require basic education for all prescribers of long-acting and extended-release opioids, and at this time, FDA does not intend to develop or approve messages as part of the REMS beyond those approved in the basic core module.
Can we have any input into this?
We have until December 7 to submit comments on the draft Blueprint http://www.regulations.gov.
The AAHPM has been working with a group called CORE to develop a program that meets these criteria. Stay tuned for more about this.