FDA to require mail-back envelopes for unused opioids
Drugmakers will soon have to provide patients with postage-paid envelopes to send back unused opioids for safe disposal under a new requirement announced by the US Food and Drug Administration (FDA) as part of its Opioids Analgesic Risk Evaluation and Mitigations Strategy (REMS) program. This plan is scheduled to take effect next year.The action is designed to stem the risk that that unused pills will cause accidental overexposure or addiction. The agency announced on 3 April that “patients commonly report having unused opioid analgesics following surgical procedures and many Americans gain access to opioids through friends or relatives who have unused opioids. 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.”
"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," FDA Commissioner Robert Califf said in a statement. "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.
The mail-back plan was proposed last April 2022. (RELATED: FDA proposes plan to mail back unused opioids, Regulatory Focus 20 April 2022).
FDA said that manufacturers of opioid analgesics used in outpatient settings must submit the proposed modification to the Opioid Analgesics REMS within 180 days of receiving a notification letter. FDA expects to approve the modified REMS in 2024.
When implemented, outpatient pharmacies will be able to order prepaid mail-back envelopes from opioid manufacturers, which will then be provided to patients upon dispensing opioids. The REMS modification also requires manufacturers to develop educational materials for patients on safe disposal of opioid analgesics.
FDA wants input on in-home disposal products
Separately, FDA also wants public input on whether manufacturers of opioids should make in-home disposal products available to patients.
FDA announced in a 3 April Federal Register notice that unused opioid medications “provide opportunities for nonmedical use, accidental exposure, and overdose. Accordingly, FDA’s efforts to address the opioid crisis include a focus on encouraging appropriate disposal of unused opioid analgesics.”
The topic of unused opioids will be the topic of discission at an upcoming workshop sponsored by the National Academies of Sciences, Engineering and Medicine’s (NASEM’s) Forum on Drug Discovery, Development, and Translation on 26 and 27 June 2023.
At the meeting, workshop participants will address various in-home disposal options as well as approaches and methodologies needed to evaluate the safe and correct use of in-home drug disposal options in real-world settings. Participants will consider potential strategies for encouraging and assessing the development and use of in-home drug disposal options.
Both these efforts stem from the agency’s implementation of the FDA Overdose Prevention Framework that aims to prevent drug overdoses and reduce deaths through substance misuse. (RELATED: FDA targets illegal online opioid retailers in new overdose prevention framework, Regulatory Focus 30 August 2022)
The Substance Use Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) signed into law on 24 October 2018, gives FDA new FDA authorities to address the opioid crisis. The law authorized FDA to require through a REMS that a safe disposal packaging or safe disposal system be dispensed to certain patients with opioids or other drugs that pose a serious risk of abuse or overdose.
The deadline for commenting is 28 August 2023.
Announcement on mail-back envelopes
Federal Register notice
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