In wake of Opana ER's demise, FDA plans to intensify pharma's opioid-education job

Fierce Pharma ------ Opioid makers may have a new task that’s partly old, partly new: educating prescribers on the proper use and serious risks of their medications. That’s an extension of the agency’s current requirements. The real twist? Requiring that education to include information on rival nonopioid pain therapies and alternative approaches that don’t involve drugs at all. Commissioner Scott Gottlieb said this week that the agency plans new risk-management requirements for companies that make instant-release opioid drugs. The Risk Evaluation and Mitigation Strategy (REMS) plans that apply to extended-release formulas would be extended to the shorter-acting versions. Those training requirements would be handled through continuing education programs, Gottlieb said. Makers of the instant-acting meds would have to provide training for doctors and other prescribers, plus pharmacists, on assessing patients’ pain, managing opioid use and recognizing addiction when it arises. To learn more click on the picture below to read the article.