Will the FDA Mandate Training for Opioid Prescribers?

The federal government has employed a number of strategies to deal with the opioid public health crisis. Recognizing the complexity of trying to keep legal prescription drugs available to the patients who need them, while preventing their abuse by others, the government has adopted a multi-faceted approach. Initiatives at the federal level include increased funding for treatment programs, improved access to drugs with abuse-deterrent qualities and overdose treatment, patient education, support for the CDC Guidelines, and changes to opioid labeling, including additional warnings and safety information.

Health care providers, who are the gatekeepers of access to prescription medications, are a key player in helping to curb the epidemic. In 2012, the FDA developed a “risk evaluation and mitigation strategy” (“REMS”) for addressing the opioid drug use problem. According to the FDA, a “key element of the REMS program is prescriber education.” To that end, the FDA requires manufacturers of opioid drugs to create educational training programs for the healthcare providers who prescribe the opioid analgesics. While manufacturers are required to underwrite this training, the training, like the recently-issued CDC Guidelines, is currently voluntary for the prescribers. In fact, recent reports show that most physicians receive little training, either in medical school or through continuing education as a practitioner, on pain and opioid prescribing. In an interesting irony, federal law requires physicians to complete training in order to prescribe buprenorphine, a medication used in the treatment for addiction, but does not require training for providers who obtain a license to prescribe opioid painkillers.

On May 3 & 4, 2016, a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee convened to review the FDA’s current “risk evaluation and mitigation strategy” for opioid medications. One of the items reviewed was the voluntary prescriber training program. An analysis of the training program revealed that only a fraction of the 80,000 providers the FDA sought to educate on opioid use actually completed the training. At that meeting, the Advisory Committee voted to require mandatory provider training regarding opioid drug use.

Just four years ago, the FDA refused to adopt the same recommendation made by an advisory panel. This time around, however, the result may be different. As public awareness and media coverage of the opioid epidemic has increased, the Obama Administration has also made clear that working on this epidemic is a priority. Last year, in addition to other measures, the White House issued a directive requiring federal healthcare employees and contractors to complete training on appropriate prescription of opioids. And in February of this year, several FDA leaders called for a “far-reaching action plan to reassess the agency’s approach to opioid medications.” In this current political climate, mandated prescriber training could become a reality in the near future.


Further Reading:

FDA Briefing Document, Joint Meeting of the Drug Safety and Risk Management (DSaRM) Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), May 3-4, 2016, available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM497290.pdf.

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