REMS for Certain Opioids Approved by FDA

As part of the federal initiative to address the prescription drug abuse, misuse, and overdose epidemic, Food and Drug Administration (FDA) has approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids. The REMS introduces new safety measures designed to reduce risks and improve the safe use of ER and LA opioids, while ensuring access to needed medications for patients in pain. FDA Commissioner Margaret A. Hamburg, MD, stated that the agency’s goal “with this REMS approval is to ensure that health care professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs.” The new REMS will affect more than 20 companies that manufacture these opioid analgesics, indicates FDA in a news release. FDA also indicates that affected companies will be required to make education programs available to prescribers based on an FDA Blueprint and to make available FDA-approved patient education materials on the safe use of these drugs.