June 22, 2022
ASA Provides Feedback to FDA on Opioid Mail-Back Proposal
On June 14, the American Society of Anesthesiologists (ASA) submitted formal comments to the Food and Drug Administration (FDA) regarding the public docket: Providing Mail-Back Envelopes and Education on Safe Disposal With Opioid Analgesics Dispensed in an Outpatient Setting. ASA commended the exploration of strategies to reduce the amount of unused opioids in patients’ homes, while noting some shortcomings of the proposal.
In the communication, ASA recommended that the FDA require drug manufacturers to provide education on all disposal options as part of the Risk Evaluation and Mitigation Strategies (REMS) program. Drug manufacturers should also supply pharmacies with mail-back envelopes at no cost or burden to patients or pharmacies. ASA believes that emphasizing patient education on various opioid disposal options will increase the disposal rate for unused opioids.
While ASA supports providing patients with multiple safe disposal options, the comments emphasized concern around the mail-back envelope proposal. ASA recommended this disposal program be made available for long-acting opioid prescriptions or for prescriptions of more than 100 MME. The Society also discouraged the utilization of algorithms to target mail-back envelope recipients since using algorithms could result in excluding certain individuals that would benefit from safe disposal educational resources. ASA acknowledged that while mail-back envelopes are a convenient option, they should not be the only method promoted to patients as part of the REMS program.
ASA hopes to continue working with the FDA to provide patients with multiple safe disposal options and increased educational materials to reduce the number of opioids available for nonmedical use and accidental exposure. ASA has significant interest in advocating for patient safety by preventing opioid use disorder (OUD) and has multiple resources on opioid education for patients and clinicians.