FDA to extend REMS requirements to immediate-release opioids

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.