FDA Considers "Return Envelope" Strategy to Improve Safe Opioid Disposal

The US Food and Drug Administration (FDA) announced this week that it is considering a requirement that opioid analgesics prescribed in outpatient settings be accompanied by prepaid mail-back envelopes for unused medication as well as education for patients on other safe disposal options. 

(Not actual mail-back envelope) ©Shane Morris/adobe stock

The agency is seeking public comment on the potential modification to the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy, part of the larger 2018 Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act.  

It is not uncommon for patients to have opioid tablets leftover from prescriptions written after surgical procedures, for example, says the FDA in a news release, creating a dangerous potential for nonmedical use, accidental exposure, including of children, overdose, and igniting new cases of opioid addiction. The Federal Register notice of the agency's request for comments cites a 2017 systematic literature review that found after 7 common surgical procedures, between 67% and 92% of patients had unused opioids.

“Prescribing opioids for durations and doses that do not properly match the clinical needs of the patient not only increases the chances for misuse, abuse and overdose, but it also increases the likelihood of unnecessary exposure to unused medications,” said FDA Commissioner Robert M. Califf, MD, in an FDA news release. "As we explore ways to further address this issue more broadly, the mail-back envelope requirement under consideration…would complement current disposal programs and provide meaningful and attainable steps to improve the safe use and disposal.”

Mail-back a better option

Options currently available to patients for disposal of unused opioids include flushing them down toilets, using commercially available in-home disposal products, and, as the FDA recommends, taking them to specific collection kiosks and to local takeback events.  

Mail-back envelopes, addressed to Drug Enforcement Administration-registered facilities, are an attractive addition to those options for a variety of reasons including patients need not mix the drugs with water or other substances or use other common domestic techniques. Further, the analgesics do not enter the water supply or landfills, the FDA says, but are incinerated.

The agency describes the return envelopes as “nondescript,” postage-paid, and conforming to long-standing regulations that ensure such parcels “are fit for that purpose” and can securely and safely transport the unused medications.

The agency describes the return envelopes as “nondescript,” postage-paid, and conforming to long-standing regulations that ensure such parcels “are fit for that purpose” and can securely and safely transport the unused medications.

The FDA cites data showing that providing patients with education on options for disposing unused medication may increase the volume ultimately discarded and that including a simple disposal option at that time could increase the rate.

These changes support the Department of Health & Human Services Overdose Prevention Strategy, which focuses on primary prevention, harm reduction, evidence-based treatment, and recovery support.

Public comments are being solicited until June 21, 2022, from all interested parties, including patients, patient advocates, health care professionals, academics, researchers, the pharmaceutical industry and other government entities.