FDA announces mail back envelope program for opioids

The FDA announced on April 3 that it will require manufacturers of opioid analgesics dispensed in outpatient settings to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers. The agency’s actions serve as a modification of the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) program – which the FDA uses to ensure medication use behaviors outweigh the risk of using the drug – and are part of the agency’s efforts to provide convenient disposal options for patients as well as reduce opportunities for possible nonmedical use and accidental exposure. Last year, the FDA requested feedback on the proposal and AAOMS submitted comments expressing support for the mail-back program, despite concerns about potential tampering. Manufacturers will have 180 days to submit an updated REMS, and when implemented, outpatient pharmacies and other dispensers will have the option to order prepaid mail-back envelopes from manufacturers and provide them to patients being prescribed opioid analgesics. The REMS modification also requires the same manufacturers to develop educational materials for patients on the safe disposal of opioid analgesics, which outpatient pharmacies and other dispensers may provide to patients.