Razon Na'amah, Wulf Sarah, Perez Citlali, McNeil Sarah, Maldonado Lisa, Fields Alison Byrne, Carvajal Diana, Logan Rachel, Dehlendorf Christine
Department of Family and Community Medicine, University of California, Davis, CA, United States.
Person-Centered Reproductive Health Program, Department of Family and Community Medicine, University of California, San Francisco, CA, United States.
Contraception. 2022 May;109:19-24. doi: 10.1016/j.contraception.2022.01.017. Epub 2022 Feb 4.
In 2000, the United States' Food and Drug Administration (FDA) approved mifepristone for medication abortion. In this article, we explore how the Risk Evaluation and Mitigation Strategy (REMS) criteria for mifepristone specifically impede family physicians' ability to provide medication abortion in primary care settings.
We conducted 56 qualitative interviews with a national sample of family physicians across the US who were not opposed to abortion. We examined how the REMS criteria for mifepristone impact family physicians' ability to provide medication abortion.
Of the 56 interviews conducted, 23 participants (41%) raised the REMS criteria as a barrier to providing medication abortion in primary care. These participants reported the REMS added a layer of bureaucratic complexity that made it difficult for family physicians to navigate, even when trained, to provide abortion care. These family physicians described 2 predominant ways the REMS impede their ability to provide medication abortion: (1) The REMS require substantial involvement of clinic administration, who can be unsupportive; (2) The complexity of navigating the REMS results in physicians and clinic administration in primary care viewing medication abortion as not worth the effort, since it is only a small component of services offered in primary care.
Removing the REMS could simplify integration of medication abortion into primary care, which could meet patient preferences, improve access, and reduce abortion stigma. The FDA's revised REMS criteria may ease administrative burden but will likely maintain key barriers to integrating medication abortion into family physicians' practice.
Our study highlights that the REMS criteria are barriers to family physicians' ability to integrate medication abortion into their primary care practices. The FDA's removal of in person dispensing criteria may provide some impetus for trained family physicians to integrate medication abortion into their scope of practice but the revised REMS criteria maintain key barriers to broader adoption.
2000年，美国食品药品监督管理局（FDA）批准米非司酮用于药物流产。在本文中，我们探讨米非司酮的风险评估与缓解策略（REMS）标准如何具体阻碍家庭医生在初级保健环境中提供药物流产服务的能力。
我们对全美不反对堕胎的家庭医生进行了56次定性访谈。我们研究了米非司酮的REMS标准如何影响家庭医生提供药物流产服务的能力。
在进行的56次访谈中，23名参与者（41%）提出REMS标准是在初级保健中提供药物流产服务的障碍。这些参与者报告称，REMS增加了一层官僚复杂性，使得家庭医生即使经过培训，在提供堕胎护理时也难以应对。这些家庭医生描述了REMS阻碍他们提供药物流产服务能力的两种主要方式：（1）REMS要求诊所管理部门大量参与，而管理部门可能不支持；（2）应对REMS的复杂性导致初级保健中的医生和诊所管理部门认为药物流产不值得付出努力，因为它只是初级保健所提供服务的一小部分。
取消REMS可以简化药物流产融入初级保健的过程，这可以满足患者的偏好，改善可及性，并减少堕胎污名。FDA修订后的REMS标准可能会减轻行政负担，但可能会维持将药物流产融入家庭医生实践的关键障碍。
我们的研究强调，REMS标准是家庭医生将药物流产融入其初级保健实践能力的障碍。FDA取消亲自配药标准可能会为经过培训的家庭医生将药物流产纳入其执业范围提供一些动力，但修订后的REMS标准仍维持着更广泛采用的关键障碍。
