Advancing Reproductive Health through Policy-Engaged Research in Abortion Care.

Mifepristone medication abortion was first approved in China and France more than 30 years ago and is now used in more than 60 countries worldwide. It is a highly safe and effective method that has the potential to increase population access to abortion in early pregnancy, closer to home. In both Canada and the United States, the initial regulations for distribution, prescribing, and dispensing of mifepristone were highly restricted. However, in Canada, where mifepristone was made available in 2017, most restrictions on the medication were removed in the first year of its availability. The Canadian regulation of mifepristone as a normal prescription makes access possible in community primary care through a physician or nurse practitioner prescription, which any pharmacist can dispense. In this approach, people decide when and where to take their medication. We explore how policy-maker-engaged research advanced reproductive health policy and facilitated this rapid change in Canada. We discuss the implications of these policy advances for self-management of abortion and demonstrate how in Canada patients "self-manage" components of the abortion process within a supportive health care system.

Mifepristone (RU-486®) as a Schedule IV Controlled Drug-Implications for a Misleading Drug Policy on Women's Health Care.

BACKGROUND: Mifepristone (RU-486) has been approved for abortion in Taiwan since 2000. Mifepristone was the first non-addictive medicine to be classified as a schedule IV controlled drug. As a case of the "misuse" of "misuse of drugs laws," the policy and consequences of mifepristone-assisted abortion for pregnant women could be compared with those of illicit drug use for drug addicts. METHODS: The rule-making process of mifepristone regulation was analyzed from various aspects of legitimacy, social stigma, women's human rights, and access to health care. RESULTS AND DISCUSSION: The restriction policy on mifepristone regulation in Taiwan has raised concerns over the legitimacy of listing a non-addictive substance as a controlled drug, which may produce stigma and negatively affect women's reproductive and privacy rights. Such a restriction policy and social stigma may lead to the unwillingness of pregnant women to utilize safe abortion services. Under the threat of the COVID-19 pandemic, the US FDA's action on mifepristone prescription and dispensing reminds us it is time to consider a change of policy. CONCLUSIONS: Listing mifepristone as a controlled drug could impede the acceptability and accessibility of safe mifepristone use and violates women's right to health care.

Adherence to treatment and prevalence of side effects when medical abortion is delivered via telemedicine: a prospective observational cohort study during COVID-19.

BACKGROUND: The Scottish government introduced legislation during the COVID-19 outbreak to permit medical abortion at home with telemedicine. All women received an initial telephone consultation. For those choosing medical abortion, we provided self-administered medications to eligible women with pregnancies under 12 weeks' gestation. AIMS: To assess adherence to the recommended abortion drug regimen, with particular focus on the number of misoprostol doses used and the interval between mifepristone and misoprostol administration and the induction-expulsion interval. Additionally, to evaluate use of analgesia, antiemetics and antibiotics, and the side effects, pain and bleeding profile of medical abortion at home. METHODS: We conducted a prospective cohort study of 663 women choosing medical abortion at home via telemedicine at an NHS abortion service in Edinburgh, Scotland between 1 April and 9 July 2020. Interviewer-administered questionnaires were completed at telephone follow-up 4 and 14 days following treatment. Outcome measures were self-reported and included use of mifepristone and misoprostol, induction-expulsion interval (time from misoprostol administration until expulsion of pregnancy), antiemetics, antibiotics, analgesia use, pain scores, rates of side effects, bleeding and preparedness for treatment. RESULTS: Among the respondents, 652/663 women (98%) answered at least one questionnaire, and 594/663 (89.6%) used both abortion medications as directed (24-72 hours between medications). The mean (SD) induction-expulsion interval was 4.3 (4.3) hours. Antiemetics were used by 611/663 (92%), 383/599 (64%) completed the course of prophylactic antibiotics, and 616/663 (93%) used analgesia, with mean (SD) worst-pain scores of 6.7 (2.2) out of 10. Regarding side effects, 510/663 (77%) experienced either nausea, vomiting, diarrhoea or headache, 101/663 (15%) experienced headache and 510/663 (77%) experienced bleeding that was heavier than a period; 554/663, (84%) felt prepared for their treatment by teleconsultation. CONCLUSION: Patients are able to correctly self-administer abortion medications following a telemedicine consultation. Further research is required to optimise pain management and gastrointestinal side effects during medical abortion.

Should COVID-specific arrangements for abortion continue? The views of women experiencing abortion in Britain during the pandemic.

BACKGROUND: During the COVID-19 pandemic, the British governments issued temporary approvals enabling the use of both medical abortion pills, mifepristone and misoprostol, at home. This permitted the introduction of a fully telemedical model of abortion care with consultations taking place via telephone or video call and medications delivered to women's homes. The decision was taken by the governments in England and Wales to continue this model of care beyond the original end date of April 2022, while at time of writing the approval in Scotland remains under consultation. METHODS: We interviewed 30 women who had undergone an abortion in England, Scotland or Wales between August and December 2021. We explored their views on the changes in abortion service configuration during the pandemic and whether abortion via telemedicine and use of abortion medications at home should continue. RESULTS: Support for continuation of the permission to use mifepristone and misoprostol at home was overwhelmingly positive. Reasons cited included convenience, comfort, reduced stigma, privacy and respect for autonomy. A telemedical model was also highly regarded for similar reasons, but for some its necessity was linked to safety measures during the pandemic, and an option to have an in-person interaction with a health professional at some point in the care pathway was endorsed. CONCLUSIONS: The approval to use abortion pills at home via telemedicine is supported by women having abortions in Britain. The voices of patients are essential to shaping acceptable and appropriate abortion service provision.

Outcomes and Safety of History-Based Screening for Medication Abortion: A Retrospective Multicenter Cohort Study.

Importance: Screening for medication abortion eligibility typically includes ultrasonography or pelvic examination. To reduce physical contact during the COVID-19 pandemic, many clinicians stopped requiring tests before medication abortion and instead screened patients for pregnancy duration and ectopic pregnancy risk by history alone. However, few US-based studies have been conducted on the outcomes and safety of this novel model of care. Objective: To evaluate the outcomes and safety of a history-based screening, no-test approach to medication abortion care. Design, Setting, and Participants: This retrospective cohort study included patients obtaining a medication abortion without preabortion ultrasonography or pelvic examination between February 1, 2020, and January 31, 2021, at 14 independent, Planned Parenthood, academic-affiliated, and online-only clinics throughout the US. Exposures: Medications for abortion provided without preabortion ultrasonography or pelvic examination and dispensed to patients in person or by mail. Main Outcomes and Measures: Effectiveness, defined as complete abortion after 200 µg of mifepristone and up to 1600 µg of misoprostol without additional intervention, and major abortion-related adverse events, defined as hospital admission, major surgery, or blood transfusion. Results: The study included data on 3779 patients with eligible abortions. The study participants were racially and ethnically diverse and included 870 (23.0%) Black patients, 533 (14.1%) Latinx/Hispanic patients, 1623 (42.9%) White patients, and 327 (8.7%) who identified as multiracial or with other racial or ethnic groups. For most (2626 [69.5%]), it was their first medication abortion. Patients lived in 34 states, and 2785 (73.7%) lived in urban areas. In 2511 (66.4%) abortions, the medications were dispensed in person; in the other 1268 (33.6%), they were mailed to the patient. Follow-up data were obtained for 2825 abortions (74.8%), and multiple imputation was used to account for missing data. Across the sample, 12 abortions (0.54%; 95% CI, 0.18%-0.90%) were followed by major abortion-related adverse events, and 4 patients (0.22%; 95% CI, 0.00%-0.45%) were treated for ectopic pregnancies. Follow-up identified 9 (0.40%; 95% CI, 0.00%-0.84%) patients who had pregnancy durations of greater than 70 days on the date the mifepristone was dispensed that were not identified at screening. The adjusted effectiveness rate was 94.8% (95% CI, 93.6%-95.9%). Effectiveness was similar when medications were dispensed in person (95.4%; 95% CI, 94.1%-96.7%) or mailed (93.3%; 95% CI, 90.7%-95.9%). Conclusions and Relevance: In this cohort study, screening for medication abortion eligibility by history alone was effective and safe with either in-person dispensing or mailing of medications, resulting in outcomes similar to published rates of models involving ultrasonography or pelvic examination. This approach may facilitate more equitable access to this essential service by increasing the types of clinicians and locations offering abortion care.

Accuracy of self-assessment of gestational duration among people seeking abortion.

BACKGROUND: Mifepristone, used together with misoprostol, is approved by the United States Food and Drug Administration for medication abortion through 10 weeks' gestation. Although in-person ultrasound is frequently used to establish medication abortion eligibility, previous research demonstrates that people seeking abortion early in pregnancy can accurately self-assess gestational duration using the date of their last menstrual period. OBJECTIVE: In this study, we establish the screening performance of a broader set of questions for self-assessment of gestational duration among a sample of people seeking abortion at a wide range of gestations. STUDY DESIGN: We surveyed patients seeking abortion at 7 facilities before ultrasound and compared self-assessments of gestational duration using 11 pregnancy dating questions with measurements on ultrasound. For individual pregnancy dating questions and combined questions, we established screening performance focusing on metrics of diagnostic accuracy, defined as the area under the receiver operating characteristic curve, sensitivity (or the proportion of ineligible participants who correctly screened as ineligible for medication abortion), and proportion of false negatives (ie, the proportion of all participants who erroneously screened as eligible for medication abortion). We tested for differences in sensitivity across individual and combined questions using McNemar's test, and for differences in accuracy using the area under the receiver operating curve and Sidak adjusted P values. RESULTS: One-quarter (25%) of 1089 participants had a gestational duration of >70 days on ultrasound. Using the date of last menstrual period alone demonstrated 83.5% sensitivity (95% confidence interval, 78.4-87.9) in identifying participants with gestational durations of >70 days on ultrasound, with an area under the receiver operating characteristic curve of 0.82 (95% confidence interval, 0.79-0.85) and a proportion of false negatives of 4.0%. A composite measure of responses to questions on number of weeks pregnant, date of last menstrual period, and date they got pregnant demonstrated 89.1% sensitivity (95% confidence interval, 84.7-92.6) and an area under the receiver operating curve of 0.86 (95% confidence interval, 0.83-0.88), with 2.7% of false negatives. A simpler question set focused on being >10 weeks or >2 months pregnant or having missed 2 or more periods had comparable sensitivity (90.7%; 95% confidence interval, 86.6-93.9) and proportion of false negatives (2.3%), but with a slightly lower area under the receiver operating curve (0.82; 95% confidence interval, 0.79-0.84). CONCLUSION: In a sample representative of people seeking abortion nationally, broadening the screening questions for assessing gestational duration beyond the date of the last menstrual period resulted in improved accuracy and sensitivity of self-assessment at the 70-day threshold for medication abortion. Ultrasound assessment for medication abortion may not be necessary, especially when requiring ultrasound could increase COVID-19 risk or healthcare costs, restrict access, or limit patient choice.

The future of abortion is now: Mifepristone by mail and in-clinic abortion access in the United States.

The COVID-19 pandemic disrupted health care delivery in all aspects of medicine, including abortion care. For 6 months, the mifepristone Risk Evaluation and Mitigation Strategy (REMS) was temporarily blocked, allowing for the remote provision of medication abortion. Remote medication abortion may become a dominant model of care in the future, either through the formal health system or through self-sourced, self-managed abortion. Clinics already face pressure from falling abortion rates and excessive regulation and with a transition to remote abortion, may not be able to sustain services. Although remote medication abortion improves access for many, those who need or want in-clinic care such as people later in pregnancy, people for whom abortion at home is not safe or feasible, or people who are not eligible for medication abortion, will need comprehensive support to access safe and appropriate care. To understand how we may adapt to remote abortion without leaving people behind, we can look outside of the U.S. to become familiar with emerging and alternative models of abortion care.

Expansion of a direct-to-patient telemedicine abortion service in the United States and experience during the COVID-19 pandemic.

OBJECTIVE: To present updated evidence on the safety, efficacy and acceptability of a direct-to-patient telemedicine abortion service and describe how the service functioned during the COVID-19 pandemic. STUDY DESIGN: We offered the study at 10 sites that provided the service in 13 states and Washington DC. Interested individuals obtained any needed preabortion tests locally and had a videoconference with a study clinician. Sites sent study packages containing mifepristone and misoprostol by mail and had remote follow-up consultations within one month by telephone (or by online survey, if the participant could not be reached) to evaluate abortion completeness. The analysis was descriptive. RESULTS: We mailed 1390 packages between May 2016 and September 2020. Of the 83% (1157/1390) of abortions for which we obtained outcome information, 95% (1103/1157) were completed without a procedure. Participants made 70 unplanned visits to emergency rooms or urgent care centers for reasons related to the abortion (6%), and 10 serious adverse events occurred, including 5 transfusions (0.4%). Enrollment increased substantially with the onset of COVID-19. Although a screening ultrasound was required, sites determined in 52% (346/669) of abortions that occurred during COVID that those participants should not get the test to protect their health. Use of urine pregnancy test to confirm abortion completion increased from 67% (144/214) in the 6 months prior to COVID to 90% (602/669) in the 6 months during COVID. Nearly all satisfaction questionnaires (99%, 1013/1022) recorded that participants were satisfied with the service. CONCLUSIONS: This direct-to-patient telemedicine service was safe, effective, and acceptable, and supports the claim that there is no medical reason for mifepristone to be dispensed in clinics as required by the Food and Drug Administration. In some cases, participants did not need to visit any facilities to obtain the service, which was critical to protecting patient safety during the COVID-19 pandemic. IMPLICATIONS: Medical abortion using telemedicine and mail is effective and can be safely provided without a pretreatment ultrasound. This method of service delivery has the potential to greatly improve access to abortion care in the United States.