Recently, the United States Food and Drug Administration (FDA) announced that it will start requiring manufacturers of opioid analgesics to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers, as an additional way for patients to dispose of their opioids.
The requirement would modify the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS). The modification would require not only the mail-back envelopes but also education on safe disposal be provided with opioid analgesics dispensed in an outpatient setting. The FDA believes that this requirement will “reduce the amount of unused opioid analgesics in patients’ homes,” which would in turn reduce opportunities for “nonmedical use, accidental exposures, and overdose,” as well as potentially reduce “the development of new opioid addiction.”
FDA notes that there are currently mail-back envelope programs operating in the United States and that mail-back envelopes are commercially available from several different entities. The mail-back envelopes must be nondescript, fit for purpose, and be able to safely and securely transport unused medicines.
FDA noted in the recent announcement that it is continuing to “consider additional ways to increase safe disposal of unused opioid analgesics,” including whether manfuacturers should be required to make in-home disposal products available to patients who are prescribed opioid analgesics.
The FDA anticipates approval of the modified REMS in 2024.
“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.”
Concerns About the Mail-Back Envelopes Abound
Complicating the matter is that robberies of postal carriers has also increased, with nearly 500 such robberies in 2022, based on data from the United States Postal Inspection Service. “The National Association of Letter Carriers is outraged and angered by the assaults, armed robberies and even murders that America’s letter carriers increasingly face as they deliver the mail. These attacks are completely unacceptable,” said Paul Barner, the union’s executive vice president.