![]() 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.Īt 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. Accordingly, FDA’s efforts to address the opioid crisis include a focus on encouraging appropriate disposal of unused opioid analgesics.” ![]() Separately, FDA also wants public input on whether manufacturers of opioids should make in-home disposal products available to patients.įDA announced in a 3 April Federal Register notice that unused opioid medications “provide opportunities for nonmedical use, accidental exposure, and overdose. The REMS modification also requires manufacturers to develop educational materials for patients on safe disposal of opioid analgesics.įDA wants input on in-home disposal products 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. FDA expects to approve the modified REMS in 2024. (RELATED: FDA proposes plan to mail back unused opioids, Regulatory Focus 20 April 2022).įDA 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. The mail-back plan was proposed last April 2022. "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. "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. 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 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. The action is designed to stem the risk that that unused pills will cause accidental overexposure or addiction. This plan is scheduled to take effect next year. 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.
0 Comments
Leave a Reply. |