FDA Orders Mail-Back Envelopes For Unused Opioids

FDA Orders Mail-Back Envelopes For Unused Opioids

Introduction

The FDA stated that makers of opioid analgesics supplied in outpatient settings must make prepaid mail-back envelopes accessible to outpatient pharmacies and other dispensers as an alternative opioid analgesic disposal option for patients.

The FDA notified all makers of opioid analgesics used in outpatient settings today that they must submit the proposed update to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) within 180 days after receiving the notification letter. The government believes that the updated REMS will be approved in 2024. 

When the programme is fully implemented, outpatient pharmacies and other dispensers will be able to obtain prepaid mail-back envelopes from opioid analgesic manufacturers, which they will subsequently be able to offer to patients who have been prescribed opioid analgesics. The REMS update also mandates manufacturers to create patient education materials on safe opioid analgesic disposal, which outpatient pharmacies and other dispensers may also distribute to patients.

This action follows a Federal Register notice filed in April 2022 seeking public comment on a proposed amendment to the OA REMS requiring the distribution of mail-back envelopes and education on safe disposal with opioid analgesics supplied in an outpatient environment.

After surgical procedures, patients frequently report having unused opioid analgesics, and many people obtain opioids through friends or family who have unused opioids. Studies demonstrate that teaching patients about disposal choices may raise the disposal rate of unneeded opioids and that offering a disposal option in addition to education may boost that rate even more.

There are now many mail-back envelope programs in operation in the United States, and mail-back envelopes are commercially available from a variety of sources. The Drug Enforcement Administration and the United States Postal Service have long-standing regulations and policies in place to ensure that mail-back envelopes are unobtrusive, fit for purpose, and can safely and securely transport unused medicines from the patient's home to the location where they will be destroyed.

The FDA is still looking for new ways to promote the safe disposal of unneeded opioid analgesics. The government is specifically investigating whether opioid analgesic makers should also be compelled to make in-home disposal items available to patients who are given opioid analgesics. In order to further evaluate this potential option, the agency will attend the workshop, Defining and Evaluating In-Home Drug Disposal Systems for Opioid Analgesics, hosted by the National Academies of Sciences, Engineering, and Medicine's (NASEM's) Forum on Drug Discovery, Development, and Translation in June 2023. The FDA has also released a Federal Register Notice seeking public input and opinions to help the agency evaluate in-home disposal techniques.

These collaborative projects are part of the FDA Overdose Prevention Framework implementation, which seeks to prevent drug overdoses and reduce deaths through meaningful and creative actions. The FDA continues to respond to all aspects of substance use, misuse, substance use disorders, overdose, and death in the United States through the framework's four priorities, which include: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing the development of evidence-based treatments for substance use disorders; and protecting the public.