Kelli Boyden JD, Randy C. Hatton Pharm.D., FCCP, Catherine M. Lynch M.D., David B. Brushwood BSPharm, JD
This analysis explores the basis for the US Food and Drug Administration (FDA) requiring a Risk Evaluation and Mitigation Strategy (REMS) for mifepristone for the termination of intrauterine pregnancy. Controversies surround mifepristone and its REMS. The safety and efficacy of mifepristone are briefly reviewed with respect to FDA's actions. It is difficult to justify the continued requirement for a REMS for mifepristone by applying the regulatory framework and considering mifepristone's safety record. Drugs with higher risks are on the US market without an FDA-mandated REMS. Canada removed all restrictions on the use of mifepristone for abortion, which has not resulted in patient safety concerns. All pharmacists should be permitted to dispense mifepristone. The continued requirement for a mifepristone REMS in the US appears to be based more on politics rather than evidence.
本分析探讨了美国食品和药物管理局(FDA)要求米非司酮用于终止宫内妊娠的风险评估和缓解策略(REMS)的依据。围绕米非司酮及其 REMS 存在争议。本文就 FDA 的行动简要回顾了米非司酮的安全性和有效性。通过应用监管框架和考虑米非司酮的安全记录,很难证明继续要求米非司酮实施 REMS 是合理的。美国市场上有风险更高的药物,但没有食品与药物管理局规定的 REMS。加拿大取消了对使用米非司酮进行人工流产的所有限制,这并未导致对患者安全的担忧。应允许所有药剂师配发米非司酮。美国对米非司酮 REMS 的持续要求似乎更多是基于政治而非证据。
{"title":"Restrictions on pharmacist dispensing of mifepristone remain a hard pill to swallow","authors":"Kelli Boyden JD, Randy C. Hatton Pharm.D., FCCP, Catherine M. Lynch M.D., David B. Brushwood BSPharm, JD","doi":"10.1002/jac5.2034","DOIUrl":"https://doi.org/10.1002/jac5.2034","url":null,"abstract":"<p>This analysis explores the basis for the US Food and Drug Administration (FDA) requiring a Risk Evaluation and Mitigation Strategy (REMS) for mifepristone for the termination of intrauterine pregnancy. Controversies surround mifepristone and its REMS. The safety and efficacy of mifepristone are briefly reviewed with respect to FDA's actions. It is difficult to justify the continued requirement for a REMS for mifepristone by applying the regulatory framework and considering mifepristone's safety record. Drugs with higher risks are on the US market without an FDA-mandated REMS. Canada removed all restrictions on the use of mifepristone for abortion, which has not resulted in patient safety concerns. All pharmacists should be permitted to dispense mifepristone. The continued requirement for a mifepristone REMS in the US appears to be based more on politics rather than evidence.</p>","PeriodicalId":73966,"journal":{"name":"Journal of the American College of Clinical Pharmacy : JACCP","volume":"7 11","pages":"1114-1121"},"PeriodicalIF":1.3,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142666103","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}