The FDA will require manufacturers of opioid drugs that are dispensed in outpatient settings to provide prepaid mail-back envelopes to outpatient pharmacies and other dispensers, the agency announced Monday.
The move is part of the FDA's comprehensive approach to addressing the overdose crisis, according to FDA Commissioner Robert Califf, MD.
"We believe these efforts will not only increase convenient disposal options for many Americans, but also reduce unfortunate opportunities for nonmedical use, accidental exposure, overdose and potential new cases of opioid use disorder," Califf said in a press release. "We're pleased to take this first critical step to increase mail-back envelope options in partnership with the U.S. Postal Service."
The agency first announced the proposed modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) program in a Federal Register notice a year ago. The plan provides another option -- along with flushing, pharmacy collection kiosks, take-back events, and others -- to safely dispose of unused opioids.
The FDA told all outpatient opioid manufacturers today they are required to submit the potential modification to the Opioid Analgesic REMS within 180 days of the date of the notification letter. The agency anticipates approval of the modified REMS in 2024.
When implemented, outpatient pharmacies and other dispensers will have the option to order prepaid mail-back envelopes from opioid manufacturers which they, in turn, can give to patients. The REMS modification also requires manufacturers to develop materials to educate patients about the safe disposal of opioid analgesics.
The agency indicated that many patients wind up with unused opioids after surgery, and some children and adults use that avenue to gain access to opioids through friends or relatives. A recent study reported that 9.7 million kids and adults used prescription painkillers for non-medical purposes in 2019, and nearly 50,000 accidental opioid exposures occurred from 2010 to 2018.
"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 said.
Multiple mail-back envelope programs currently operate in the U.S. and mail-back envelopes are commercially available. There are long-standing regulations and policies in place under the DEA and U.S. Postal Service to ensure mail-back envelopes are nondescript, fit for this purpose, and can safely and securely transport unused medicines to a location where they will be destroyed, the agency noted.
The FDA also is exploring whether manufacturers of opioid analgesics should be required to make in-home disposal products available to patients. The agency issued a Federal Register Notice today to seek public comments to help the agency assess in-home disposal methods.