FDA will reconsider whether physicians who prescribe painkillers should undergo specific safety training, according to documents released Friday.
The agency's current risk-management plan for painkillers dates back to 2010, before the recent rise in opioid-related deaths. Under the current program, drugmakers fund voluntary training opportunities for physicians on the best practices for safely prescribing their medications. The program applies only to long-acting painkillers, such as OxyContin, and does not address the most commonly used painkillers, such as Vicodin and Percocet.
CDC: 'Urgent need' for better prescribing practices to fight opioid misuse
Many experts say the current risk-management measures are inadequate, calling instead for mandatory training.
FDA supports mandatory training
In the newly released documents, which appeared in a briefing book for outside safety experts who are advising FDA on its painkiller policies, FDA says its own findings "show mixed results that make it difficult to draw conclusions regarding the success of the program."
The documents say FDA supports adding mandatory training to the criteria that physicians must meet before they can renew their prescribing registration with the Drug Enforcement Administration. But FDA notes that such a requirement would require congressional action.
The outside safety experts will meet next week in an advisory panel to review the risk-management program for opioids and make recommendations (Perrone, AP/Sacramento Bee, 4/29; Meier, New York Times, 5/2).
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