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BACKGROUND: This qualitative study aims to assess perspectives of clinicians and clinic staff on mail-order pharmacy dispensing for medication abortion. METHODS: Participants included clinicians and staff involved in implementing a mail-order dispensing model for medication abortion at eleven clinics in seven states as part of a prospective cohort study, which began in January 2020 (before the FDA removed the in-person dispensing requirement for mifepristone). From June 2021 to July 2022, we invited participants at the participating clinics, including six primary care and five abortion clinics, to complete a semi-structured video interview about their experiences. We then conducted qualitative thematic analysis of interview data, summarizing themes related to perceived benefits and concerns about the mail-order model, perceived patient interest, and potential barriers to larger-scale implementation. RESULTS: We conducted 24 interviews in total with clinicians (13 physicians and one nurse practitioner) and clinic staff (n = 10). Participants highlighted perceived benefits of the mail-order model, including its potential to expand abortion services into primary care, increase patient autonomy and privacy, and to normalize abortion services. They also highlighted key logistical, clinical, and feasibility concerns about the mail-order model, and specific challenges related to integrating abortion into primary care. CONCLUSION: Clinicians and clinic staff working in primary care and abortion clinics were optimistic that mail-order dispensing of medication abortion can improve the ability of some providers to provide abortion and enable more patients to access services. The feasibility of mail-order pharmacy dispensing of medication abortion following the Supreme Court Dobbs decision is to be determined. TRIAL REGISTRATION: Registry: Clinicaltrials.gov. TRIAL REGISTRATION NUMBER: NCT03913104. Date of registration: first submitted on April 3, 2019 and first posted on April 12, 2019.

ImportanceBefore 2021, the US Food and Drug Administration required mifepristone to be dispensed in person, limiting access to medication abortion.ObjectiveTo estimate the effectiveness, acceptability, and feasibility of dispensing mifepristone for medication abortion using a mail-order pharmacy.Design, setting, and participantsThis 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.InterventionMifepristone, 200 mg, and misoprostol, 800 µg, prescribed to a mail-order pharmacy and mailed to participants instead of dispensed in person.Main outcomes and measuresProportion of patients with a complete abortion with medications only, reporting satisfaction with the medication abortion, and reporting timely delivery of medications.ResultsClinical 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 relevanceThe 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.

On January 30, 2024, over 300 researchers filed an amicus brief in FDA v. Alliance for Hippocratic Medicine, a United States (US) Supreme Court case that could have severely impacted access to mifepristone, one of the two drugs commonly used in medication abortion. The researchers summarize the legal challenges to the US Food and Drug Administration's (FDA's) original approval of mifepristone in 2000 and its 2016 and 2021 decisions modifying mifepristone's Risk Evaluation and Mitigation Strategy (REMS) Program and label, the responses from the FDA and drug manufacturer to the challenges, and the potential implications of the Court's decision on access to mifepristone in the US. The researchers detail how the FDA relied on a robust scientific record analyzing tens of thousands of patient experiences that conclusively demonstrated the safety and effectiveness of the changes to the mifepristone REMS Program and label and urge the Supreme Court to rely on the clear scientific record and preserve access to mifepristone without reimposing restrictions. What follows is a reprint of this brief., (© 2024 University of Ottawa.)