FDA may require physician training to prescribe opioids

Two advisory panels from the Food and Drug Administration will meet Tuesday and Wednesday to discuss the agency's strategy to reduce adverse outcomes of opioid use, including review of its current policy that awards continuing education credits for prescriber training.

The review comes roughly four years after the FDA implemented its Risk Evaluation and Mitigation Strategy for extended-release and long-acting opioids. This strategy required drugmakers to make training available at little or not cost to physicians who prescribe extended-release and long-acting opioids. Physicians were offered continuing education credits to incentivize completion of the voluntary training.

However, just 37,512 providers, or 47 percent, of the targeted 80,000 providers had completed the training as of March 2015, according to guidance briefing documents published by the FDA. The agency found just over half, or 53 percent, of providers who started the opioid training had completed it, and of those who completed the program only 38 percent actually prescribe the medications.

The FDA determined several challenges hinder its training program, including a lack of awareness of the offerings, a program that is not tailored to adult learners with full-time jobs and other competing continuing education activities that dilute its targeted audience.

The FDA said it has long supported linking DEA registration to mandatory prescriber education on opioid use. However, it is aware of burden this would add to patients, prescribers, pharmacies and distributors.

At its meeting this week, the advisory panels will discuss if its Risk Evaluation and Mitigation Strategy should be broadened to include immediate release opioids, and whether training should be required for opioid prescribers, along with other modifications.

 

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