Early in the COVID-19 pandemic, medication abortion, which typically includes mifepristone (ie, progesterone receptor antagonist) and misoprostol (ie, prostaglandin), gained prominence because it can be provided without physical contact. The American College of Obstetricians and Gynecologists and other professional organizations quickly endorsed telehealth and no-test abortion care.1 These protocols omit Rh testing2 and use patient history, rather than routine ultrasonography, to assess pregnancy duration and screen for ectopic pregnancy risks.3,4
To mitigate potential risk of complications, US Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) require that mifepristone be dispensed in a medical office, clinic, or hospital, prohibiting dispensing from pharmacies. Between a federal judge’s ruling that suspended enforcement of this requirement in July 2020 and a reversal by the Supreme Court in January 2021, clinicians could offer medication abortion via telehealth and dispense from mail-order pharmacies where not prohibited by state law. During this period, a virtual clinic called Choix began providing medication abortions in California. We assessed safety and efficacy outcomes of a telehealth medication abortion model, which could inform the FDA’s decision regarding removal of the REMS.
This retrospective cohort study was approved by the institutional review board at the University of California, San Francisco, and informed consent was waived because the research presented no more than minimal risk. We followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline for cohort studies.
We examined the safety and efficacy of fully remote, asynchronous medication abortion care using a published protocol.3 Eligibility criteria, assessed using an online form, included pregnancy duration of less than 70 days (by history, including date of last menstrual period, or by ultrasonography) and no contraindications to mifepristone or misoprostol. Nurse practitioners reviewed the form within 24 hours and referred patients with unknown last menstrual period date or ectopic pregnancy risk factors for ultrasonography to confirm eligibility. A mail-order pharmacy delivered medications to eligible patients. The protocol involved 3 follow-up contacts: confirmation of medication administration, a 3-day assessment of expulsion and pregnancy symptoms, and a 4-week home pregnancy test. Follow-up interactions were conducted by text, secure messaging, or telephone. At each scheduled follow-up, clinicians made up to 4 attempts to contact patients.
The service provided abortion care for 141 patients between October 2020 and January 2021. Mean (SD) participant age was 29 (7) years, 81 (57%) had pregnancy durations 42 days or less, and 24 (17%) had screening ultrasonography (Table 1). At least 1 follow-up contact was made for 128 patients (91%), and abortion outcomes were collected for 110 patients (86%). Among the 110 patients with outcome data, 105 (95%) had a complete abortion without intervention. Five patients (5%) required medical care to complete the abortion, 2 of whom were treated in emergency departments. No patients reported any major adverse events (Table 2).
These results represent some of the earliest data on new telehealth abortion clinics in the US. This 95% efficacy rate is similar to in-person provision5 and recent international studies of telehealth for medication abortion.6
In April 2021, the FDA paused enforcement of the REMS for the duration of the COVID-19 pandemic, allowing clinics and pharmacies to mail mifepristone once again. The FDA is now considering permanently removing the REMS. This study is small with some loss to follow-up, and thus some adverse events and ongoing pregnancies may have been undetected. However, it reflects real-world data, which increases generalizability. This study provides preliminary evidence that suggests medication abortion care, administered by telehealth and delivered via mail, is feasible, safe, and efficacious.
Accepted for Publication: June 20, 2021.
Published: August 24, 2021. doi:10.1001/jamanetworkopen.2021.22320
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Upadhyay UD et al. JAMA Network Open.
Corresponding Author: Ushma D. Upadhyay, PhD, MPH, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, 1330 Broadway, Ste 1100, Oakland, CA 94612 (firstname.lastname@example.org).
Author Contributions: Dr Upadhyay had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: All authors.
Acquisition, analysis, or interpretation of data: Upadhyay, Koenig.
Drafting of the manuscript: Upadhyay, Koenig.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Koenig.
Obtained funding: Upadhyay.
Administrative, technical, or material support: Upadhyay, Meckstroth.
Conflict of Interest Disclosures: Dr Meckstroth reported receiving personal fees from Danco, Inc, a distributor of mifepristone, for staffing a US Food and Drug Administration–mandated expert hotline. The mifepristone used in this care was purchased from GenBioPro, not Danco. No other disclosures were reported.
Funding/Support: Dr Upadhyay and Ms Koenig were supported by grants from Jess Jacobs, the BaSe Family Fund, the Kahle/Austin Foundation, and the Preston-Werner Foundation.
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: We thank Cindy Adam, NP, (Choix), for support with data acquisition, and Elizabeth Raymond, MD, MPH, (Gynuity Health Projects), for her contributions to conceptualization and study design. Neither of these contributors were compensated for their work in this study.
J. Effectiveness, safety and acceptability of no-test medical abortion (termination of pregnancy) provided via telemedicine: a national cohort study. BJOG
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