The Food and Drug Administration recently announced in the Federal Register that it has released its draft "Blueprint for Prescriber Continuing Education Program.” The blueprint is designed to guide continuing medical education providers as they develop materials to use to train prescribers of long-acting and extended release opioids under these products’ required risk evaluation and mitigation strategy, or .
This blueprint’s impending arrival was a hot topic at this fall’s American Medical Association National Task Force on CME Provider/Industry Collaboration conference due to REMS’ potential to be a new avenue—and new revenue stream—for CME providers. The FDA has said it expects the training would be conducted by accredited, independent CE providers. Instead of requiring healthcare practitioners to pay for it, the FDA also said it expects sponsors will pay for the training through unrestricted grants to accredited CE providers.
The extent of opioid analgesic misuse—more than 35 million Americans age 12 and older have reported nonmedical use of opioid analgesics during 2010—makes nonmedical use of these drugs a major public health problem. The FDA told manufacturers of certain opioid drugs in 2009 that their drugs would need a REMS to ensure that the drugs’ benefits continue to outweigh the risks. After meeting with stakeholders and an advisory committee, this past spring the FDA told the manufacturers to describe what needed to be in the REMS. The most important piece of the opioid REMS program, they said, would be an education program for physicians, nurse practitioners, and physician assistants, and the patients for whom they prescribe the drugs. This requirement for prescriber education is what the blueprint addresses.
The FDA is looking for feedback on the blueprint; comments on the draft version are due by December 7, 2011. Comments can be submitted electronically to Docket No. FDA–2011–D–0771 at www.regulations.gov. Once it has gathered the comments, the FDA will make adjustments, incorporate the revised blueprint into the opioid REMS when it is approved, and post it on the FDA’s Web site for use by CE providers.
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