Department of Family Medicine, University of Chicago, Chicago, IL, United States.
Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, MA, United States; Department of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, MA, United States; Planned Parenthood League of Massachusetts, Boston, MA, United States.
Contraception. 2021 Jul;104(1):24-28. doi: 10.1016/j.contraception.2021.04.002. Epub 2021 Apr 20.
Despite its safety record, mifepristone is subject to a highly restrictive set of regulatory measures through the Risk Evaluation and Mitigation Strategy (REMS) by the US Food and Drug Administration. We argue that these restrictions both reflect and perpetuate a cycle of abortion stigma, creating particular barriers to mifepristone use in primary care settings where communities that historically experience barriers to care can most easily access reproductive health services. Through qualitative interviews with Illinois primary care clinicians, we discovered how the REMS heightens institutional anxiety over implementation of mifepristone use. To address this, we created ExPAND Mifepristone, a learning collaborative targeting institutional anxiety and logistical barriers to mifepristone use. The learning collaborative model holds high potential to mitigate institutional barriers to mifepristone use by increasing providers' self-efficacy to identify, address, and overcome institutional fears. Until the REMS is fully repealed, learning collaboratives constitute a promising tool to combat the practical and psychological barriers to mifepristone use that these restrictions currently pose.
尽管米非司酮安全性记录良好,但它仍受到美国食品和药物管理局风险评估和缓解策略 (REMS) 的高度限制。我们认为,这些限制既反映又延续了堕胎污名的循环,在初级保健环境中使用米非司酮尤其存在障碍,而在这些环境中,历史上面临护理障碍的社区可以最容易地获得生殖健康服务。通过对伊利诺伊州初级保健临床医生的定性访谈,我们发现 REMS 如何加剧了机构对实施米非司酮使用的焦虑。为了解决这个问题,我们创建了 ExPAND Mifepristone,这是一个针对机构对米非司酮使用的焦虑和后勤障碍的学习合作组织。学习合作模式具有很大的潜力,可以通过提高提供者识别、解决和克服机构恐惧的自我效能感来减轻机构对米非司酮使用的障碍。在 REMS 完全废除之前,学习合作组织是一种很有前途的工具,可以克服这些限制目前给米非司酮使用带来的实际和心理障碍。