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

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.

Induced Abortion and the Risk of Rh Sensitization.

Importance: While population-level data suggest Rh immunoglobulin is unnecessary before 12 weeks' gestation, clinical evidence is limited. Thus, guidelines vary, creating confusion surrounding risks and benefits of Rh testing and treatment. As abortion care in traditional clinical settings becomes harder to access, many people are choosing to self-manage and need to know if ancillary blood type testing is necessary. Objective: To determine how frequently maternal exposure to fetal red blood cells (fRBCs) exceeds the most conservative published threshold for Rh sensitization in induced first-trimester abortion. Design, Setting, and Participants: Multicenter, observational, prospective cohort study using high-throughput flow cytometry to detect circulating fRBCs in paired maternal blood samples before and after induced first-trimester abortion (medication or procedural). Individuals undergoing induced first-trimester abortion before 12 weeks 0 days' gestation were included. Paired blood samples were available from 506 participants who underwent either medical (n = 319 [63.0%]) or procedural (n = 187 [37.0%]) abortion. Exposure: Induced first-trimester abortion. Main Outcomes and Measures: The primary outcome was the proportion of participants with fRBC counts above the sensitization threshold (125 fRBCs/5 million total RBCs) after induced first-trimester abortion. Results: Among the 506 participants, the mean (SD) age was 27.4 (5.5) years, 313 (61.9%) were Black, and 123 (24.3%) were White. Three of the 506 participants had elevated fRBC counts at baseline; 1 of these patients had an elevated fRBC count following the abortion (0.2% [95% CI, 0%-0.93%]). No other participants had elevated fRBC counts above the sensitization threshold after induced first-trimester abortion. The median change from baseline was 0 fRBCs, with upper 95th and 99th percentiles of 24 and 35.6 fRBCs, respectively. Although there was a strong association between the preabortion and postabortion fRBC counts, no other baseline characteristic was significantly associated with postabortion fRBC count. Conclusions and Relevance: Induced first-trimester abortion is not a risk factor for Rh sensitization, indicating that Rh testing and treatment are unnecessary before 12 weeks' gestation. This evidence may be used to inform international guidelines for Rh immunoglobulin administration following first-trimester induced abortion.

Mail-order pharmacy dispensing of mifepristone for medication abortion after in-person clinical assessment.

OBJECTIVE(S): To estimate the effectiveness, acceptability, and feasibility of medication abortion with mifepristone dispensed by a mail-order pharmacy after in-person clinical assessment. STUDY DESIGN: This is an interim analysis of an ongoing prospective cohort study conducted at five sites. Clinicians assessed patients in clinic and, if they were eligible for medication abortion and ≤ 63 days' gestation, electronically sent prescriptions for mifepristone 200 mg orally and misoprostol 800 mcg buccally to a mail-order pharmacy, which shipped medications for next-day delivery. Participants completed surveys three and 14 days after enrollment, and we abstracted medical chart data. RESULTS: Between January 2020 and April 2021 we enrolled 240 participants and obtained clinical outcome information for 227 (94.6%); 3 reported not taking either medication. Of those with abortion outcome information (N = 224), 216 (96.4%) completed day-3 and 212 (94.6%) day-14 surveys. Of the 224 that took medications, none reported taking past 70 days' gestation, and complete medication abortion occurred for 217 participants (96.9%, 95% CI 93.7%-98.7%). Most received medications within three days (82.1%, 95% CI 76.5%-86.9%). In the day-3 survey, 95.4% (95% CI 91.7%-97.8%) reported being very (88.4%) or somewhat (6.9%) satisfied with receiving medications by mail. In the day-14 survey, 89.6% (95% CI 84.7%-93.4%) said they would use the mail-order service again if needed. Eleven (4.9%, 95% CI 2.5%-8.6%) experienced adverse events; two were serious (one blood transfusion, one hospitalization), and none were related to mail-order pharmacy dispensing. CONCLUSIONS: Medication abortion with mail-order pharmacy dispensing of mifepristone appears effective, feasible, and acceptable to patients. IMPLICATIONS: The in-person dispensing requirement for mifepristone, codified in the drug's Risk Evaluation and Mitigation Strategy, should be removed.

A non-inferiority study of outpatient mifepristone-misoprostol medical abortion at 64-70 days and 71-77 days of gestation.

OBJECTIVES: This open-label non-inferiority study assessed efficacy of a common outpatient medical abortion regimen among people with pregnancies 64-70 days and 71-77 days of gestation. STUDY DESIGN: We defined non-inferiority by a 6% margin of method success. People with intrauterine pregnancies 64-77 days' gestational age by abdominal ultrasound seeking medical abortion at one of eight clinics and met eligibility criteria were offered participation. Consenting participants took mifepristone 200 mg followed 24-48 h later by misoprostol 800 mcg buccally, and returned after one week for provider evaluation and abdominal ultrasound to determine abortion status. Participants recorded medication use, pregnancy expulsion, daily bleeding and pain scores until the one-week follow up. Clinic staff interviewed participants prior to study discharge to assess acceptability. RESULTS: Seven hundred and nineteen participants were enrolled, 393 and 326 in the respective groups. Successful expulsion without surgical intervention was achieved in 92.3% of the earlier gestational age group and 86.7% of the later group (difference in proportions 5.6%, 1-sided 95% CI 9.6). Ongoing pregnancy accounted for 3.6% and 8.7% (p = 0.007) of outcomes, respectively. Participants in the 71-77 day group reported nausea and weakness more frequently. Pain, bleeding and acceptability measures between groups were similar. CONCLUSION: Although the success rate at 71-77 days of gestation was within the non-inferiority margin, we cannot rule out that it is statistically worse than in the previous gestational week. Significantly more ongoing pregnancies in the later group raise concerns about using the regimen at 71-77 days.

Self-assessment of medical abortion outcome using symptoms and home pregnancy testing.

OBJECTIVES: We aimed to evaluate compliance with a strategy to enable medical abortion patients to assess treatment outcome on their own and decide whether to seek clinical follow-up. STUDY DESIGN: We enrolled women undergoing medical abortion with mifepristone and misoprostol at three clinics in the United States. Each participant was instructed to perform a multilevel pregnancy test (MLPT) 7 days after mifepristone ingestion and to contact the clinic immediately if the test indicated a possible ongoing pregnancy or if specified symptoms occurred. A telephone call was scheduled 14 days after mifepristone ingestion to evaluate participants who had not contacted the clinic earlier. RESULTS: Of the 343 enrolled participants, 90 (26%) did not provide sufficient follow-up information for analysis of compliance with instructions. Of the 253 (74%) who did, 218 (86%) implemented the self-assessment strategy as instructed, 20 (7.9%) failed to report a non-reassuring MLPT result, 4 (1.6%) failed to promptly report symptoms that the study clinician subsequently judged to require evaluation, and 11 (4.3%) did not perform the MLPT. We ascertained abortion outcomes for 239 (70%) of the enrolled women, of whom three were diagnosed with ongoing pregnancies. One other participant was hospitalized for bleeding. All four women had implemented the strategy correctly. Of the 219 enrolled participants (64%) who provided opinions, 170 (78%) indicated that most could use the MLPT to decide whether they are "OK" after an abortion. We did not ascertain opinions from 124 enrolled participants (36%). CONCLUSIONS: At least two thirds of enrolled participants correctly implemented a strategy using symptom evaluation and a MLPT to assess their own medical abortion outcomes. No ongoing pregnancies occurred in women documented not to have implemented the strategy as intended. Perceived feasibility of the self-assessment approach was high. Implications Statement The common practice of scheduling a clinical contact after every medical abortion may not be necessary to ensure safety; enabling patients to determine for themselves whether or not a contact is needed can be a reasonable approach.

Mixed-methods investigation of women's experiences with second-trimester abortion care in the Midwest and Northeast United States.

OBJECTIVE(S): We studied women's experiences seeking and receiving second-trimester abortion care in two geographically and legislatively different settings to inform ways to improve abortion care access and services. STUDY DESIGN: We conducted in-depth interviews with women who obtained second-trimester abortion care. Themes from the interviews were then used to inform a self-administered survey, which was completed by 108 women who received second-trimester abortion care in the Northeast and Midwest. We calculated descriptive statistics and used chi-squared and t-tests to compare responses. RESULTS: We interviewed eight women and surveyed 108 women. Most interviewees and 65.2% of survey respondents reported difficulties accessing care. Although most interview and survey respondents had insurance, a slight majority reported difficulty funding care. All interviewees and 57.9% of survey respondents reported positive experiences with providers, with many interviewees and 62.0% of survey respondents saying their abortion care was better than their usual health care. Most interviewees and 75.8% of survey respondents reported pain as low to moderate, and the majority of participants reported it was the same or less than expected. Knowledge about abortion restrictions was low. Most interviewees and 68.4% survey respondents disagreed with restrictions on insurance coverage of abortion. Common recommendations to improve experiences were to ensure travel and financial support and to decrease wait times at clinics. There were few regional differences among outcomes. CONCLUSION(S): Women seeking second-trimester abortion in these locations reported positive abortion experiences. However, they had to overcome significant obstacles to obtain care. IMPLICATIONS: This is the first study to systematically research women's second-trimester care experiences in two different regions of the United States. Regardless of location, women experienced barriers due to policies that impose gestational age restrictions, limit provider availability (consequently increasing wait times), and increase costs. Policy change to reduce these barriers is critical to improve access to and experiences with second trimester abortion care.