FDA Updates REMS for Opioid Painkillers

As part of the FDA Risk Evaluation and Mitigation Strategy (REMS) program, all manufacturers of extended-release opioid analgesics must provide unrestricted grants to accredited organizations for the development of continuing medical education (CME) related to safe opioid prescribing. Last month, the FDA broadened its opioid analgesic REMS to include immediate-release opioid painkillers.

In addition, the updated REMS requires that the training be made available to all health care professionals involved in the management of patients with pain—not just those who prescribe the medication. Given the larger audience, REMS-compliant education now needs to include more information on both acute and long-term pain management, including information on pharmacological and nonpharmacological alternatives to opioid analgesics.

There is no federal requirement that mandates prescribers or other health care personnel to take these CME modules. However, the agency noted that its Opioid Policy Steering Committee is continuing to assess the landscape of opioid prescribing to see whether there are circumstances when the FDA should require mandatory education. ■