To promote the safe disposal of unused opioid medications, the Food and Drug Administration (FDA) is requiring manufacturers of opioid analgesics dispensed in outpatient settings to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers.
According to the Agency, all manufacturers of opioid analgesics used in outpatient settings will be required to submit the proposed modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy within 180 days of the date of the FDA’s notification letter. This action will help expand the use of mail-back envelopes as an opioid disposal solution in the US; there are currently several programs operating in the country.
Once implemented, outpatient pharmacies and other dispensers will be able to order prepaid mail-back envelopes from opioid analgesic manufacturers and provide them to patients who are prescribed opioid analgesics. The modified REMS will also require manufacturers to develop educational materials for patients on safe disposal of opioid analgesics.
The FDA is also considering whether opioid analgesic manufacturers should be required to make in-home disposal products available to patients. A Federal Register Notice has been issued to obtain information and comments to assist in the agency’s assessment.
“Expanding impactful opioid disposal options, such as mail-back envelopes and in-home disposal, for patients to safely and securely dispose of their unused opioid medications is part of the agency’s comprehensive approach to addressing the overdose crisis,” said FDA Commissioner Robert M. Califf, MD. “We believe these efforts will not only increase convenient disposal options for many Americans, but also reduce unfortunate opportunities for nonmedical use, accidental exposure, overdose and potential new cases of opioid use disorder. We’re pleased to take this first critical step to increase mail-back envelope options in partnership with the US Postal Service.”
FDA moves forward with mail-back envelopes for opioid analgesics dispensed in outpatient settings. News release. US Food and Drug Administration. Accessed April 3, 2023. https://www.prnewswire.com/news-releases/fda-moves-forward-with-mail-back-envelopes-for-opioid-analgesics-dispensed-in-outpatient-settings-301788716.html.