FDA Considers New Strategy to Boost Safe Opioid Disposal

FDA 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 pharmacies provide patient education on the safe disposal of opioids.  

The modification to the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy would provide a convenient disposal option for patients beyond those already available, including flushing commercially available in-home disposal products, collection kiosks, and takeback events.  

“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,” FDA Commissioner Robert M. Califf, MD, said in the announcement.  

“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 continued.  

Patients often report having unused opioid analgesics following surgical procedures, creating opportunities for nonmedical use, accidental exposure, overdose, and increasing new cases of opioid addiction.  

A mail-back envelope with each prescription could reduce the unused opioid analgesics in patients’ homes. Data show that educating patients about disposal options could increase the disposal rate of unused opioids, the FDA stated.  

The agency cited many favorable attributes of mail-back envelopes, including that they do not require patients to mix medications with water, chemicals, or other substances, nor use other standard at-home disposal techniques. And opioid analgesics sent back to Drug Enforcement Administration-registered facilities do not enter the water supply and landfills.  

Additionally, there are long-standing regulations and policies to ensure that mail-back envelopes fit this purpose and can safely and securely transport unused medicines from the patient’s home to the location where they will be destroyed.  

The change underscores FDA’s efforts to address the opioid crisis and supports the HHS Overdose Prevention Strategy, which focuses on primary prevention, harm reduction, evidence-based treatment, and recovery support.