April 03, 2023: “The U.S. FDA announced it is requiring manufacturers of opioid analgesics dispensed in outpatient settings to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients.
“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, M.D.
“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 U.S. Postal Service.”
The FDA issued notice today to all manufacturers of opioid analgesics used in outpatient settings that they are required to submit the proposed modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) within 180 days of the date of the notification letter.
The agency anticipates approval of the modified REMS in 2024. When implemented, outpatient pharmacies and other dispensers will have the option to order prepaid mail-back envelopes from opioid analgesic manufacturers, which they may then provide to patients prescribed opioid analgesics.
The REMS modification also requires manufacturers to develop educational materials for patients on safe disposal of opioid analgesics, which outpatient pharmacies and other dispensers may also provide to patients.
This action follows a Federal Register notice issued in April 2022 that sought public comment on a potential modification of the OA REMS to require that mail-back envelopes be dispensed and education on safe disposal be provided with opioid analgesics dispensed in an outpatient setting.
Patients commonly report having unused opioid analgesics following surgical procedures and many Americans gain access to opioids through friends or relatives who have unused opioids.
Data show educating patients about disposal options may increase the disposal rate of unused opioids and that providing a disposal option along with education could further increase that rate.
Currently, there are multiple mail-back envelope programs operating in the U.S. and mail-back envelopes are commercially available from multiple entities.
There are long-standing regulations and policies, under the Drug Enforcement Administration and United States Postal Service, in place to ensure that mail-back envelopes are nondescript, 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 U.S. 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 Postal Service Chief Customer and Marketing Officer and Executive Vice President Steven Monteith.
“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.”
The FDA continues to consider additional ways to increase safe disposal of unused opioid analgesics. Specifically, the agency is exploring whether manufacturers of opioid analgesic should also be required to make in-home disposal products available to patients who are prescribed opioid analgesics.
In an effort to further evaluate this potential option, the agency will participate in the workshop, Defining and Evaluating In-Home Drug Disposal Systems for Opioid Analgesics External Link Disclaimer, to examine current in-home disposal options 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 issued a Federal Register Notice to seek information and comments from the public to aid the agency’s assessment of in-home disposal methods.
These collective efforts are part of the agency’s implementation of the FDA Overdose Prevention Framework that aims to prevent drug overdoses and reduce deaths through impactful and creative actions.
The FDA remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose and death in the U.S. through the four priorities of the framework, including; supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted or counterfeit drugs presenting overdose risks.”