'Dear Prescriber' Letter Describes Opioids REMS, Encourages Physician Participation

AAFP Expects to Have CME Ready by FDA's March 2013 Start Date

August 29, 2012 05:05 pm Matt Brown
[Prescription drug bottle for Exalgo]

Family physicians who received a letter(www.er-la-opioidrems.com) outlining the FDA's recently approved risk evaluation and mitigation strategy (REMS) requirement for extended-release and long-acting (ER/LA) opioids needn't panic, according to Ann Karty, M.D., medical director in the AAFP Continuing Medical Education Division. The AAFP already is moving to develop and accredit appropriate CME opportunities for family physicians who desire more training to prescribe these agents.

The letter, which was sent through the PDR Network, went to more than 4 million DEA registrants in July. Karty said it follows the FDA's blueprint, stating that pharmaceutical companies subject to the REMS have joined together to implement voluntary prescriber education programs for all ER/LA opioid analgesic drug products.

These agents are oral formulations that contain hydromorphone, morphine, oxycodone, oxymorphone, or tapentadol; fentanyl- and buprenorphine-containing transdermal delivery systems; and methadone tablets and solutions that are indicated for use as analgesics.

Part of an ongoing federal initiative aimed at combating misuse and abuse of prescription medications, the REMS requires these manufacturers to fund the development and dissemination of FDA-specified CME/CE on ER/LA opioids. According to the FDA(www.fda.gov), the first of these CME/CE products are expected to be available by March 1, 2013.

story highlights

  • A letter outlining the FDA's recently approved risk evaluation and mitigation strategy (REMS) requirement for extended-release and long-acting (ER/LA) opioids recently went out to 4 million-plus DEA registrants.
  • Part of an ongoing federal initiative aimed at combating misuse and abuse of prescription medications, the REMS requires medication manufacturers to fund the development and dissemination of FDA-specified CME/CE on ER/LA opioids.
  • The AAFP will have appropriate CME products available by the March 2013 start date the FDA has set.

Karty said that the Academy, which is accredited by the Accreditation Council for Continuing Medical Education to provide continuing education for physicians and is a national CME accreditor, will have CME available by the FDA's designated March 2013 start date.

"The AAFP is currently looking at different collaborations and multiple modalities to bring this CME to members," she said. "It will be available in various formats -- live, computer-based or an enduring-read program. The key (from the FDA's viewpoint) is that there is ample participation to meet their metrics … and they want to assure knowledge acquisition."

Karty added that although the letter points out that the FDA strongly recommends physicians and other prescribers begin taking the CME when it becomes available, the FDA alone cannot legally regulate physicians or other clinicians, and it cannot require prescribers to complete education related to opioids or any other drug. Nevertheless, she said, it makes good sense for family physicians to begin taking the courses when they become available.

"The AAFP strongly encourages its members to participate," she said. "While the DEA has not yet required (participation) regarding ability to prescribe, if the numbers (of prescribers participating in the CME) aren't considered adequate from the FDA's perspective, there could be future consequences for all prescribers.

"We don't want family physicians to be limited from being able to prescribe anything that our patients need."


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