Exploring the impact of mifepristone's risk evaluation and mitigation strategy (REMS) on the integration of medication abortion into US family medicine primary care clinics✰,✰✰.
Exploring the impact of mifepristone's risk evaluation and mitigation strategy (REMS) on the integration of medication abortion into US family medicine primary care clinics✰,✰✰.
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DOI：
10.1016/j.contraception.2022.01.017
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发表时间：
2022-05
期刊：
影响因子：
2.9
通讯作者：
Dehlendorf, Christine
中科院分区：
文献类型：
--
作者：
Razon, Na'amah;Wulf, Sarah;Perez, Citlali;McNeil, Sarah;Maldonado, Lisa;Fields, Alison Byrne;Carvajal, Diana;Logan, Rachel;Dehlendorf, Christine
2000年，美国食品和药物管理局（FDA）批准米非司酮用于药物流产。在这篇文章中，我们探讨了米非司酮的风险评估和缓解策略（REMS）标准如何特别阻碍家庭医生在初级保健环境中提供药物流产的能力。我们对美国全国范围内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的能力。在进行的56次访谈中，23名参与者（41%）提出了REMS标准作为在初级保健中提供药物流产的障碍。这些参与者报告说，REMS增加了一层官僚主义的复杂性，使家庭医生难以导航，即使经过培训，也难以提供堕胎护理。这些家庭医生描述了REMS阻碍其提供药物流产能力的两种主要方式：（1）REMS需要诊所管理人员的大量参与，他们可能不支持;（2）导航REMS的复杂性导致初级保健中的医生和诊所管理人员认为药物流产不值得努力，因为它只是初级保健中提供的服务的一小部分。取消REMS可以简化药物流产与初级保健的整合，这可以满足患者的偏好，改善可及性，并减少堕胎的耻辱感。FDA修订的REMS标准可能会减轻行政负担，但可能会保持将药物流产纳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纳入其初级保健实践的能力的障碍。FDA取消亲自配药标准可能会为训练有素的家庭医生提供一些动力，将药物流产纳入其实践范围，但修订后的REMS标准仍然是更广泛采用的关键障碍。
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.
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DOI：
10.1016/0749-5978(91)90020-t
发表时间：
1991-12-01
影响因子：
4.6
作者：
AJZEN, I
通讯作者：
AJZEN, I
DOI：
10.3122/jabfm.2013.06.120248
发表时间：
2013-11-01
影响因子：
2.9
作者：
Herbitter, Cara;Bennett, Ariana;Gold, Marji
通讯作者：
Gold, Marji
影响因子：
5.8
作者：
Jones RK;Jerman J
通讯作者：
Jerman J
影响因子：
4.4
作者：
Bennett, Ian M.;Baylson, Margaret;Fleischman, Joan
通讯作者：
Fleischman, Joan
影响因子：
4.4
作者：
Munro, Sarah;Guilbert, Edith;Norman, Wendy, V
通讯作者：
Norman, Wendy, V