Ipas, Chapel Hill, NC, USA.
Advancing New Standards in Reproductive Health (ANSIRH), Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, Oakland, CA, USA.
BJOG. 2017 Oct;124(11):1646-1652. doi: 10.1111/1471-0528.14646. Epub 2017 Apr 27.
Given the overall safety profile and increasing availability of medical pregnancy termination drugs, we asked: would the mifepristone-misoprostol regimen for medical termination at ≤10 weeks of gestation meet US Food and Drug Administration regulatory criteria for over-the-counter (OTC) approval, and if not, what are the present research gaps? We conducted a literature review of consumer behaviours necessary for a successful OTC application for medical termination at ≤10 weeks of gestation and identified crucial research gaps. If we were to embark on a development programme for OTC or more generally, self-use of medical termination, the critical elements missing are the label comprehension, self-selection and actual use studies.
Considering medical pregnancy termination through the over-the-counter regulatory lens clarifies critical evidence gaps.
鉴于米非司酮-米索前列醇方案用于≤10 周妊娠的终止具有总体安全性和越来越多的可获得性，我们提出以下问题：米非司酮-米索前列醇方案是否符合美国食品和药物管理局（FDA）关于非处方（OTC）批准的监管标准，若不符合，目前存在哪些研究空白？我们对≤10 周妊娠终止的 OTC 应用所需的消费者行为进行了文献回顾，并确定了关键的研究空白。如果我们要开展 OTC 或更广泛的医疗终止自我使用的开发项目，那么关键缺失的要素是标签理解、自我选择和实际使用研究。
从 OTC 监管角度考虑医疗妊娠终止可明确关键证据空白。
