FDA Expands OA REMS, Mandates Mail-Back Envelopes for Opioid Analgesics
The FDA has mandated that companies participating in the Opioid Analgesic Risk Evaluation and Mitigation Strategy program provide pre-paid mail-back envelopes for unused or expired opioid medications.
Starting March 31, 2025, companies participating in the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) program must provide pre-paid drug mail-back envelopes to outpatient pharmacies and other dispensers of opioid analgesics upon request, per an approved update to the framework by the FDA.1
US Postal Service mailbox / Tada Images - stock.adobe.com
The update was approved on October 31, 2024, and aims to provide patients and caregivers with a convenient way to safely dispose of any unused or expired opioid analgesics. In partnership with the US Postal Service, mail-back envelopes will be available through outpatient pharmacies or other dispensers of opioid analgesics that order from the OA REMS program.
The OA REMS update will also provide a revised Patient Guide and a new Patient Education Sheet offering additional information about the risks of unused opioids and safe disposal methods. The latter will be included in each mail-back envelope.
“We want to ensure patients have access to opioid analgesics in their pain management regimens and that they are educated about methods available to safely dispose of any leftover medicines, which could pose a real danger to their loved ones and pets,” said Marta Sokolowska, PhD, deputy center director for substance use and behavioral health at the FDA's Center for Drug Evaluation and Research, in a release.1 Unused or expired medications in homes constitute a major safety risk; data from US poison control centers indicate that pain medications were the leading cause of pediatric fatalities between 2015 and 2019.2
“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,” said Steven Monteith, postal service chief customer and marketing officer and executive vice president of the US Postal Service, in a release.3 “Serving nearly 165 million addressees 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.”
READ MORE: FDA Approves Abuse-Deterrent 10 mg Oxycodone Hydrochloride for Severe Pain
The current approval builds on several prior FDA actions to strengthen the OA REMS,1 such as:
- A 2022 public notice seeking input on potential changes
- A 2023 letter to manufacturers of opioid analgesics requiring REMS updates
- Participation in a 2023 workshop on in-home disposal
- An updated FDA OA REMS Education Blueprint for health care providers involved in the treatment and monitoring of patients with pain
- Funding research on commercial in-home disposal products
Further, the OA REMS modification aligns with the FDA’s Overdose Prevention Framework, which aims to “undertake impactful, creative actions to prevent drug overdoses and reduce deaths.”4 It focuses on 4 priorities: supporting primary prevention by eliminating unnecessary prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction; advancing the development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted, or counterfeit drugs.
The approval also underscores a significant shift towards drug disposal strategies aimed at curbing overdose fatalities and the larger opioid epidemic. The Drug Enforcement Administration’s National Prescription Take Back Day, held on the last Saturday of April and October, offers nationwide collection sites for safe medication disposal.5 Additionally, many large pharmacy chains, such as CVS, Walgreens, and Walmart, have installed convenient medication disposal kiosks in their stores across the country.5-7
READ MORE: Pain Management Resource Center
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