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SRF025: Expanding Access to Medication Abortion through Pharmacy Dispensing of Mifepristone: Primary Care Perspectives from Illinois

Kayla Rasmussen, BS; Debra Stulberg, MD; Alischer Cottrill, BA; Elizabeth Janiak, ScD

Abstract

Context: Medication abortion, using mifepristone and misoprostol, is a safe, effective, and increasingly popular method of pregnancy termination that has potential to expand abortion access via provision in primary care. However, mifepristone is regulated by the Food and Drug Administration through a strict Risk Evaluation and Mitigation Strategy (REMS) that prohibits pharmacy dispensing, requiring patients to access mifepristone from a medical provider. A current legal ruling allows mail dispensing during the COVID19 pandemic, but pharmacy dispensing is still not permitted. While there is no evidence that the REMS improves the safety of mifepristone, it does impose burdens on availability and accessibility. Given the ability of primary care providers (PCPs) to expand medication abortion access, especially in underserved areas, it is important to understand how the REMS affects their ability to provide. Objective: Assess PCP perspectives on how lifting the REMS to allow pharmacy dispensing of mifepristone would affect the provision of medication abortion in primary care. Human Subjects Review: Approved by the University of Chicago IRB. Design: Data were collected as part of a larger qualitative study on medication abortion in primary care. PCPs with experience or interest in providing medication abortion and their administrative colleagues were recruited through known professional contacts and snowball sampling. The final sample (n=19) consisted of 7 family medicine physicians, 7 APCs, and 5 administrative colleagues. Interviews were conducted by telephone using a semi-structured guide. Participants were asked how, if at all, removing the REMS to allow pharmacy dispensing of mifepristone would affect their ability to provide medication abortion. Interviews were recorded, transcribed, and dual-coded using ATLAS.ti. Discussions of pharmacy dispensing were analyzed to identify major themes. Setting: Illinois primary care. Results: PCPs expressed support for pharmacy dispensing due to its ability to help normalize medication abortion, reduce implementation barriers in primary care, and expand abortion access. Further challenges to address if the REMS restrictions are lifted include federal funding restrictions on abortion, concerns about unsupervised mifepristone use, and pharmacy cooperation. Conclusion: Removing the mifepristone REMS to allow pharmacy dispensing could facilitate provision in primary care and address disparities in abortion access.
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Debra Stulberg
11/21/2020

Great job, Kayla!

Kayla Rasmussen
11/22/2020

Thank you, Debbie!

Jack
jwestfall@aafp.org 11/21/2020

great study. thanks for the work you are doing to assure women have access to full reproductive healthcare. great job

Kayla Rasmussen
11/22/2020

Thank you so much!

Tyler Barreto
11/22/2020

Nice job! This is important work - thank you for sharing! Two questions: 1) It seems PCPs agree with increasing access to mifepristone. Are there any studies on what patients think? Do patients want to get abortion care from their PCP? My very biased opinion is - "of course they do! We're the best!!" :) Is there a more evidence based answer? 2) Do you have any thoughts on self-managed abortion and how lifting the REMS label might impact that?

Kayla Rasmussen
kayla.rasmussen@uchospitals.edu 11/24/2020

Thank you for your interest in the study and your thoughtful reflections! These are two excellent questions! 1) Yes, there is evidence that patients would like to receive abortion care from their PCP. Studies have demonstrated high satisfaction rates in patients who receive abortion care in primary care, with patients citing familiarity with the clinic and provider, convenience, privacy, and continuity of care as reasons for choosing a primary care site [1,2]. While other patients may prefer to seek abortion care in specialty clinics, it is important to expand access to these various options in order to expand access and provide patients with the ability to choose the setting they are most comfortable with. [1] Summit, Aleza K, Lauren M J Casey, Ariana H Bennett, Alison Karasz, and Marji Gold. “‘I Don’t Want to Go Anywhere Else’: Patient Experiences of Abortion in Family Medicine.” FAMILY MEDICINE, n.d., 5. [2] Wu, Justine P, Emily M Godfrey, Linda Prine, Kathryn L Andersen, Honor MacNaughton, and Marji Gold. “Women’s Satisfaction With Abortion Care in Academic Family Medicine Centers.” FAMILY MEDICINE, n.d., 9. 2) Along these lines, I think our goal as providers is to expand access to safe, effective, and equitable reproductive healthcare. Our study suggests that lifting the mifepristone REMS would promote this goal by synergistically expanding abortion access via primary care integration, telemedicine provision, and pharmacy distribution. However, self-managed abortion would require further steps and considerations in order to effectively integrate it into the U.S. abortion care landscape. For example, mifepristone and misoprostol would have to obtain over-the-counter status and patients who choose to self-manage their abortion would need access to adequate information and support. Thus, while I personally think self-managed abortion has great potential to expand reproductive health equity and personal autonomy, further barriers will need to be addressed in order to ensure successful integration of this strategy.

Hunter Holt
hunter.holt@ucsf.edu 11/23/2020

Wonderful work and really highlights an important issue. Especially considering that mife can be mailed during COVID it should be able to be RX at pharmacies.

Kayla Rasmussen
kayla.rasmussen@uchospitals.edu 11/24/2020

Thank you so much! I agree, the COVID-19 pandemic and legal injunction have highlighted the need to reevaluate the REMS restrictions

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