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邮购药店在现场筛查后提供米非司酮药物流产配药服务。

Mail-Order Pharmacy Dispensing of Mifepristone for Medication Abortion After In-Person Screening.

机构信息

Advancing New Standards in Reproductive Health, Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco, Oakland, California.

Department of Family Medicine, Brown University, Pawtucket, Rhode Island.

出版信息

JAMA Intern Med. 2024 Aug 1;184(8):873-881. doi: 10.1001/jamainternmed.2024.1476.

Abstract

IMPORTANCE

Before 2021, the US Food and Drug Administration required mifepristone to be dispensed in person, limiting access to medication abortion.

OBJECTIVE

To estimate the effectiveness, acceptability, and feasibility of dispensing mifepristone for medication abortion using a mail-order pharmacy.

DESIGN, SETTING, AND PARTICIPANTS: This prospective cohort study was conducted from January 2020 to May 2022 and included 11 clinics in 7 states (5 abortion clinics and 6 primary care sites, 4 of which were new to abortion provision). Eligible participants were seeking medication abortion at 63 or fewer days' gestation, spoke English or Spanish, were age 15 years or older, and were willing to take misoprostol buccally. After assessing eligibility for medication abortion through an in-person screening, mifepristone and misoprostol were prescribed using a mail-order pharmacy. Patients had standard follow-up care with the clinic. Clinical information was collected from medical records. Consenting participants completed online surveys about their experiences 3 and 14 days after enrolling. A total of 540 participants were enrolled; 10 withdrew or did not take medication. Data were analyzed from August 2022 to December 2023.

INTERVENTION

Mifepristone, 200 mg, and misoprostol, 800 µg, prescribed to a mail-order pharmacy and mailed to participants instead of dispensed in person.

MAIN OUTCOMES AND MEASURES

Proportion of patients with a complete abortion with medications only, reporting satisfaction with the medication abortion, and reporting timely delivery of medications.

RESULTS

Clinical outcome information was obtained and analyzed for 510 abortions (96.2%) among 506 participants (median [IQR] age, 27 [23-31] years; 506 [100%] female; 194 [38.3%] Black, 88 [17.4%] Hispanic, 141 [27.9%] White, and 45 [8.9%] multiracial/other individuals). Of these, 436 participants (85.5%; 95% CI, 82.2%-88.4%) received medications within 3 days. Complete abortion occurred after medication use in 499 cases (97.8%; 95% CI, 96.2%-98.9%). There were 24 adverse events (4.7%) for which care was sought for medication abortion symptoms; 3 patients (0.6%; 95% CI, 0.1%-1.7%) experienced serious adverse events requiring hospitalization (1 with blood transfusion); however, no adverse events were associated with mail-order dispensing. Of 477 participants, 431 (90.4%; 95% CI, 87.3%-92.9%) indicated that they would use mail-order dispensing again for abortion care, and 435 participants (91.2%; 95% CI, 88.3%-93.6%) reported satisfaction with the medication abortion. Findings were similar to those of other published studies of medication abortion with in-person dispensing.

CONCLUSIONS AND RELEVANCE

The findings of this cohort study indicate that mail-order pharmacy dispensing of mifepristone for medication abortion was effective, acceptable to patients, and feasible, with a low prevalence of serious adverse events. This care model should be expanded to improve access to medication abortion services.

摘要

重要性

在 2021 年之前,美国食品和药物管理局要求米非司酮必须亲自配药,限制了药物流产的获取途径。

目的

评估通过邮购药房提供米非司酮用于药物流产的效果、可接受性和可行性。

设计、地点和参与者:这是一项前瞻性队列研究,于 2020 年 1 月至 2022 年 5 月进行,包括 7 个州的 11 家诊所(5 家堕胎诊所和 6 家初级保健诊所,其中 4 家是首次提供堕胎服务)。符合条件的参与者在妊娠 63 天或以下时寻求药物流产,会说英语或西班牙语,年龄在 15 岁或以上,愿意经口服用米索前列醇。在通过现场筛查评估药物流产的资格后,使用邮购药房开具米非司酮和米索前列醇处方。患者在诊所接受标准随访护理。临床信息从病历中收集。有意愿的参与者在入组后第 3 天和第 14 天完成在线调查,以报告他们的体验。共有 540 名参与者入组;10 人退出或未服用药物。数据于 2022 年 8 月至 2023 年 12 月进行分析。

干预措施

米非司酮 200mg,米索前列醇 800μg,开给邮购药房,邮寄给参与者,而不是亲自配药。

主要结果和措施

仅用药物完成流产的患者比例、报告对药物流产的满意度以及报告及时收到药物的情况。

结果

获得并分析了 506 名参与者(中位数[IQR]年龄 27[23-31]岁;506 名[100%]女性;194 名[38.3%]黑人、88 名[17.4%]西班牙裔、141 名[27.9%]白人、45 名[8.9%]多种族/其他个体)的 510 例流产的临床结局信息。其中,436 名参与者(85.5%;95%CI,82.2%-88.4%)在 3 天内收到了药物。499 例(97.8%;95%CI,96.2%-98.9%)在使用药物后发生完全流产。有 24 例不良事件(4.7%)因药物流产症状寻求治疗;3 名患者(0.6%;95%CI,0.1%-1.7%)经历了需要住院治疗的严重不良事件(1 例输血);然而,没有不良事件与邮购配药有关。在 477 名参与者中,431 名(90.4%;95%CI,87.3%-92.9%)表示他们将再次使用邮购配药进行堕胎护理,435 名参与者(91.2%;95%CI,88.3%-93.6%)报告对药物流产满意。研究结果与其他已发表的关于亲自配药的药物流产研究结果相似。

结论和相关性

该队列研究的结果表明,通过邮购药房提供米非司酮用于药物流产是有效、可接受和可行的,严重不良事件的发生率较低。这种护理模式应该扩大,以改善药物流产服务的获取。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/447e/11091818/fa57330816e6/jamainternmed-e241476-g001.jpg

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