The FDA is currently 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.
Patients may commonly have unused opioids following surgery, or when transitioning to other medications. Having opioids accessible creates opportunities for nonmedical use, accidental exposure, misuse, addiction, and overdose. The FDA believes that providing a mail-back envelope 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.
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.