FDA requires prepaid mail-back envelopes for opioid analgesics
pharmafile | April 5, 2023 | News story | Medical Communications |
The FDA has announced that it will require opioid analgesic manufacturers to provide prepaid mail-back envelopes in outpatient pharmacies and dispensers as an additional disposal option for patients.
These manufacturers were notified that they will be required to submit the proposed modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) within 180 days. The modified OA REMS is expected to be approved in 2024, at which point outpatient pharmacies and other dispensers will be able to order the prepaid envelopes from opioid analgesic manufacturers and provide these to patients.
The modification will also require manufacturers to develop educational materials for patients about the safe disposal of opioid analgesics, which the same outpatient pharmacies and dispensers will be able to provide to patients.
Robert M Califf, MD, FDA commissioner, commented: “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. 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.”
Steven Monteith, the US Postal Service’s chief customer and marketing officer and executive vice president, added: “The US Postal Service is proud to partner with the FDA to expand the use of mail-back envelopes as a safe and secure disposal option for prescription opioid analgesics. Serving nearly 165 million addresses each day, with more than 31,000 retail locations across the country, the Postal Service makes it convenient for Americans to dispose of unused prescription drugs to help prevent accidental exposure and overdose.”
Betsy Goodfellow
