FDA Explores New Opioid Disposal Strategy

The FDA will be seeking public comment on changes that would require opioid analgesics prescribed in outpatient settings to be disposed of via prepaid mail-back envelopes provided by pharmacists, according to an FDA news release.¹

The changes would modify the current Opioid Analgesic Risk Evaluation and Mitigation strategy and 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.”

It is not uncommon for patients to have unused opioid analgesics on hand after outpatient surgical procedures, creating an environment of opportunity for nonmedical opioid use. Providing a mail-back envelope with these prescriptions can, the FDA said, reduce the quantity of unused medication in patient homes. This effort, coupled with patient education about disposal options, may increase the rate of disposal of unused opioids.

“The FDA is committed to addressing the opioid crisis on all fronts, including exploring new approaches that have the potential to decrease unnecessary exposure to opioids and prevent new cases of addiction,” said Robert M. Califf, MD, FDA Commissioner, in the news release. “Prescribing opioids for durations and doses that do not properly match the clinical needs of the patient not only increases the changes for misuse, abuse, and overdose, but it also increases the likeilihood of unnecessary exposure to unused medications.”

“[T]he mail-back envelope requirement…would complement current disposal programs and provide meaningful and attainable steps to improve the safe use and disposal,” he added.

These changes support the Department of Health & Human Services Overdose Prevention Strategy,² which focuses on primary prevention, harm reduction, evidence-based treatment, and recovery support.

Public comments are being solicited until June 21, 2022.³

References

1. FDA considers new approach to improve safe disposal of prescription opioid analgesics, decrease unnecessary exposure to unused medication. News release. FDA. April 20, 2022. Accessed April 20, 2022. https://www.fda.gov/news-events/press-announcements/fda-considers-new-approach-improve-safe-disposal-prescription-opioid-analgesics-decrease-unnecessary
2. Overdose prevention strategy. Department of Health and Human Services. Accessed April 20, 2022. https://www.hhs.gov/overdose-prevention/
3. Providing mail-back envelopes and education on safe disposal with opioid analgesics dispensed in an outpatient setting. Federal Register. Accessed April 20, 2022. https://www.federalregister.gov/public-inspection/2022-08372/providing-mail-back-envelopes-and-education-on-safe-disposal-with-opioid-analgesics-dispensed-in-an