FDA May Require Prepaid Envelopes With Opioid Scripts for Pill Disposal

The FDA is considering a plan that would require prepaid envelopes to be given to outpatients receiving opioid prescriptions following surgical procedures or for other medical reasons so they can return their unused pills, the agency announced on Wednesday.

Under a proposed modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) program, the plan would allow for another option -- along with flushing, pharmacy collection kiosks, take-back events, and others -- for the safe disposal of unused opioids.

FDA cited advantages to the mail-back envelope plan: patients don't need to mix their unused opioids with water or other chemicals, which is typically required with at-home disposal techniques; and the medications would not wind up in landfills or the water supply, as they would be sent to Drug Enforcement Administration-registered facilities in a nondescript postage-paid envelope, and then incinerated.

"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 FDA Commissioner Robert M. Califf, MD, in a statement.

"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," Califf continued. "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."

The agency noted that it is common for patients to wind up with unused opioids after surgery, which can lead to accidental exposures, abuse, and new cases of addiction. For example, one recent study found that 9.7 million kids and adults used prescription pain killers for non-medical purposes in the past year, and nearly 50,000 accidental opioid exposures occurred in young children from 2010 to 2018.

"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 agency noted, adding that patient education about their disposal options for unused medications can increase the disposal rate.

The proposal is open for public comment from patients, healthcare professionals, the pharmaceutical industry, and other stakeholders until June 21.

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