FDA announced that it has approved the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). The plan includes a number of steps to help better communicate the serious risks involved with the use of opioid analgesics to both patients and health care professionals. FDA noted, "This expanded REMS now, for the first time, applies to immediate-release (IR) opioid analgesics intended for use in an outpatient setting. The new REMS also applies to the extended-release and long-acting (ER/LA) opioid analgesics, which have been subject to a REMS since 2012." The REMS program mandates that training be made available to health care providers who are involved in the management of patients with pain, not only to prescribers—so it would include pharmacists and nurses, for example. The REMS also states that the training must cover broader information about appropriate pain management, including alternatives to opioids. FDA said it is approving new product labeling containing information about the health care provider education available through the new REMS. "Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain," said FDA Commissioner Scott Gottlieb, MD. "This includes ensuring that prescriptions are written for only appropriate purposes and durations of use." In addition to expanding the REMS to include IR opioid analgesics intended for outpatient use, FDA has approved the new FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain, which includes updated educational content. FDA noted that its new actions also significantly increase the number of products covered by the REMS, with the ER/LA Opioid Analgesic REMS including 62 products prior to today and the modified Opioid Analgesic REMS now requiring that 347 opioid analgesics intended for outpatient use be subject to these REMS requirements.
FDA approves new safety measures governing the use of IR opioid analgesics
FDA News Release (09/18/18)