After hearing from the public, including patients and health care providers, the FDA has closed the comment period in late June 2022 to consider whether to enact a change that would require opioid analgesics used in outpatient settings to be dispensed with prepaid mail-back envelopes.

The proposed change would also include requiring pharmacists provide patient education on safe disposal of opioids.

A press release1 from the agency issued on April 20, 2022, noted that the proposed change is a modification to the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy. The FDA press release said the modification would provide a "convenient, additional disposal option for patients beyond those already available such as flushing, commercially available in-home disposal products, collection kiosks and takeback events."

Mail-back envelopes do not require patients to mix medications with water, chemicals or other substances nor use other common at-home disposal techniques, the agency release said, thus simplifying the process.

According to the FDA, the nondescript mail-back envelopes would be postage-paid, offering patients a free disposal option. Additionally, there are long-standing regulations and policies in place to ensure that these envelopes would be secure for the trip from patient home to an FDA-registered location where they would be destroyed. The envelopes would take these medications to FDA-registered facilities to be incinerated, and therefore the opioids would not enter the public drinking-water supply and landfills.

In the press release, the FDA commissioner implied that the problem lies with prescribers writing prescriptions for more opioid medication than their patients are likely to need.

"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 the press release.

"As we explore ways to further address this issue more broadly, the mail-back envelope requirement under consideration for these unused medications would complement current disposal programs and provide meaningful and attainable steps to improve the safe use and disposal," Califf said in the press release.

According to the FDA press release, patients often report having unused opioid analgesics left over after surgical procedures. These unused medications, lying around the house, create opportunities for nonmedical use, accidental exposure, overdose and potentially increasing new cases of opioid addiction.

"Since many Americans gain access to opioids for the first time through friends or relatives who have unused opioids, requiring a mail-back envelope be provided with each prescription could reduce the amount of unused opioid analgesics in patients' homes," the press release said.

The education provided by pharmacists could also help patients know how to most safely dispose of any leftover 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," the release said.

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