FDA Requires Mail-Back Envelops with Opioid Analgesics Dispensation

As a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS), the FDA will now require mail-back envelops with opioid analgesic dispensation in outpatient settings to minimize unfavorable opioid outcomes. After discussing the concept, on April 3, 2023, the organization confirmed they were moving forward with this protocol.

Within six months (180 days) of receiving the notice letter, all manufacturers must provide mail-back envelopes to all outpatient pharmacies. The FDA clarifies that pharmacies and other outpatient facilities dispensing opioids can request and provide mail-back envelopes from manufacturers with every opioid dispensation.

“Expanding impactful opioid disposal options, such as mail-back envelopes and in-home disposal, for patients to safely and securely dispose of their unused opioid medications is part of the agency’s comprehensive approach to addressing the overdose crisis,” said FDA Commissioner Robert M. Califf, MD, in the FDA press release.

The opioid epidemic has proven to be a complex and fatal crisis in the United States. Data from multiple organizations suggests that opioids are the leading cause of overdose deaths. According to the CDC, opioids were involved in 75% of overdoses in 2022.

In addition to overdoses in adult patients, a recent study published in Pediatrics determined that opioids were the most significant contributor to pediatric poisoning deaths. Between 2005 and 2018, there were 731 pediatric fatalities associated with poisoning, overdose, or acute intoxication.

Among the 731 reported cases, 47.3% of deaths were caused by opioids. Of the 46 substances involved in pediatric poisoning deaths, 52.2% were opioids.

“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. We’re pleased to take this first critical step to increase mail-back envelope options in partnership with the US Postal Service,” continued Califf. 

In addition to providing mail-back envelopes, the FDA will require manufacturers to develop educational materials that pharmacies can give patients on proper opioid disposal.