The Food and Drug Administration intends to update its Risk Evaluation and Mitigation Strategy requirements for extended-release and long-acting opioid analgesics, and extend the same requirements to immediate-release opioid analgesic products, FDA Commissioner Scott Gottlieb, M.D., announced this week. The existing REMS requires companies that manufacture extended-release and long-acting opioid analgesics to make education programs available to prescribers and patients. According to Gottlieb, the new REMS will modify the prescriber education blueprint to include more information on pain management, safe use of opioid analgesics, addiction medicine and opioid use disorders. The REMS also will require manufacturers to make training available to more than physician prescribers, such as nurses and pharmacists involved in pain management. In addition, he said the agency is exploring whether provider education should be mandatory. According to FDA, about 90% of opioid prescriptions in the U.S. are for immediate-release formulations.

Related News Articles

Headline
AHA President and CEO Rick Pollack explains how hospitals have made meaningful progress in patient safety and delivering high-quality care, in a column…
Headline
Boston Medical Center’s Jeff Schneider, M.D., associate chief medical officer, designated institutional official and chair of the Graduate Medical Education…
Headline
A 60-day appeal window has passed for the Food and Drug Administration to appeal a federal court ruling that invalidated its final rule to regulate laboratory-…
Blog
Even before the COVID pandemic, the mental health and wellness of our young people was failing. The pandemic exacerbated the crisis and made it difficult for…
Headline
A new AHA video highlights how Corewell Health is transforming youth behavioral health care access in rural Michigan through school-based clinics and…
Headline
The Departments of Labor, Health and Human Services, and the Treasury May 15 announced that they will not enforce the 2024 mental health parity final rule, a…