In an effort to reduce unnecessary exposure to opioids, the Food and Drug Administration (FDA) is considering a mail-back envelope requirement that would provide an additional disposal option for individuals who receive opioid analgesics in an outpatient setting.
The Agency is currently seeking public comment on this potential modification to the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy. The proposed update would require patients who are dispensed a narcotic analgesic in an outpatient setting to receive a nondescript prepaid envelope that would allow them to freely dispose of unused medication.
“As we explore ways to further address this issue more broadly, the mail-back envelope requirement under consideration for these unused medications would complement current disposal programs and provide meaningful and attainable steps to improve the safe use and disposal,” said FDA Commissioner Robert M. Califf, MD.
Current methods of disposable include flushing, commercially available in-home disposal products, collection kiosks, and takeback events. The Agency believes the mail-back envelope would be a safe, convenient, and beneficial addition to these other methods.
“The FDA is committed to addressing the opioid crisis on all fronts, including exploring new approaches that have the potential to decrease unnecessary exposure to opioids and prevent new cases of addiction,” added Califf.
Public comments on the mail-back envelope program will be accepted through June 21, 2022.
FDA considers new approach to improve safe disposal of prescription opioid analgesics, decrease unnecessary exposure to unused medication. News release. Accessed April 20, 2022. https://www.fda.gov/news-events/press-announcements/fda-considers-new-approach-improve-safe-disposal-prescription-opioid-analgesics-decrease-unnecessary