FDA Considers New Approach to Improve Safe Disposal of Prescription Opioid Analgesics, Decrease Unnecessary Exposure to Unused Medication

Today, the U.S. Food and Drug Administration announced it is seeking public comment on a potential change that would require opioid analgesics used in outpatient settings to be dispensed with prepaid mail-back envelopes and that pharmacists provide patient education on safe disposal of opioids. This potential modification to the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy 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.

“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. 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, M.D. “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.”

Patients commonly report having unused opioid analgesics following surgical procedures, thereby creating unfortunate 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. 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.

Mail-back envelopes have several favorable characteristics. They do not require patients to mix medications with water, chemicals or other substances nor use other common at-home disposal techniques. Opioid analgesics sent back to Drug Enforcement Administration-registered facilities in mail-back envelopes do not enter the water supply and landfills (instead, they are incinerated). The nondescript mail-back envelopes provided would be postage paid, offering patients a free disposal option. Additionally, there are long-standing regulations and policies in place to ensure that mail-back envelopes are fit for that purpose and can safely and securely transport unused medicines from the patient’s home to the location where they will be destroyed.

The change under consideration underscores the agency’s efforts to address the dynamic facets of the opioid crisis and supports the HHS Overdose Prevention Strategy, which focuses on four priority areas — primary prevention, harm reduction, evidence-based treatment and recovery support.

The FDA is accepting public comments from interested parties, including patients, patient advocates, health care professionals, academics, researchers, the pharmaceutical industry and other government entities until June 21, 2022; however, comments are welcome at any time.