Providing Mail-Back Envelopes and Education on Safe Disposal With Opioid Analgesics Dispensed in an Outpatient Setting; Establishment of a Public Docket; Request for Comments

Lauren K. Roth, JD Associate Commissioner for Policy U.S. Food and Drug Administration (FDA) Attn: Dockets Management Staff 5630 Fishers Lane, Room 1061 Rockville, MD 20852 RE: Docket FDA-2022-N-0165 – Providing Mail-Back Envelopes and Education on Safe Disposal with Opioid Analgesics Dispensed in an Outpatient Setting; Establishment of a Public Docket; Request for Comments Dear Associate Commissioner Roth: The American Pharmacists Association (APhA) is pleased to submit our comments to FDA in response to the request for comments regarding the potential application of the Opioid Analgesic (OA) Risk Evaluation and Mitigation Strategy (REMS) to require mail-back envelopes and education on safe disposal with opioid analgesics dispensed in an outpatient setting. APhA agrees that removal of unused opioid analgesics from the home is an important public health intervention and advocates for the importance of safe disposal strategies, systems, and education for opioid analgesics. However, we strongly believe that mail-back envelopes and education on safe disposal should be an option that the pharmacist may offer but should not be required to be dispensed with every opioid prescription. Requiring dispensing of mail-back envelopes would create significant operation and workflow burdens on already understaffed and stretched pharmacy teams that continue to be engaged in the COVID-19 public health response. A new requirement under the OA REMS that requires consultation and risk assessment without appropriate time and/or reimbursement for the pharmacists' services is simply unacceptable. Such an uncompensated mandate will take away valuable time from our nation's already overworked pharmacists that is needed for dispensing, medication counseling, medication management and other services necessary to treat our patients. Furthermore, FDA has failed to demonstrate that "such safe disposal packaging or system may mitigate [the] serious risk [associated with misuse or overdose] and is sufficiently available," as required under the law. The studies cited in the Federal Register notice either evaluated different disposal methods or such methods were not distinguished in the studies. FDA even acknowledged this in the description of the studies. We agree that the studies demonstrate the important role that safe home disposal plays in mitigating the risk, but these studies do not specifically demonstrate that requiring dispensing of mail-back envelopes in the outpatient setting may mitigate the risk. The nexus between the cited studies and demonstrating that this action may mitigate the risk is too broad and insufficient to warrant the significant burden on the pharmacists, pharmacies, and other drug supply chain stakeholders. See, attached .PDF for our full comments and responses to FDA's questions.