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Mifepristone restrictions and primary care: Breaking the cycle of stigma through a learning collaborative model in the United States

      Abstract

      Despite its safety record, mifepristone is subject to a highly restrictive set of regulatory measures through the Risk Evaluation and Mitigation Strategy (REMS) by the US Food and Drug Administration. We argue that these restrictions both reflect and perpetuate a cycle of abortion stigma, creating particular barriers to mifepristone use in primary care settings where communities that historically experience barriers to care can most easily access reproductive health services. Through qualitative interviews with Illinois primary care clinicians, we discovered how the REMS heightens institutional anxiety over implementation of mifepristone use. To address this, we created ExPAND Mifepristone, a learning collaborative targeting institutional anxiety and logistical barriers to mifepristone use. The learning collaborative model holds high potential to mitigate institutional barriers to mifepristone use by increasing providers’ self-efficacy to identify, address, and overcome institutional fears. Until the REMS is fully repealed, learning collaboratives constitute a promising tool to combat the practical and psychological barriers to mifepristone use that these restrictions currently pose.

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      References

        • Gatter M
        • Cleland K
        • Nucatola DL.
        Efficacy and safety of medical abortion using mifepristone and buccal misoprostol through 63 days.
        Contraception. 2015; 91: 269-273
        • Fjerstad M
        • Sivin I
        • Lichtenberg ES
        • Trussell J
        • Cleland K
        • Cullins V
        Effectiveness of medical abortion with mifepristone and buccal misoprostol through 59 gestational days.
        Contraception. 2009; 80: 282-286
        • Schaff EA
        • Fielding SL
        • Eisinger SH
        • Stadalius LS
        • Fuller L.
        Low-dose mifepristone followed by vaginal misoprostol at 48 hours for abortion up to 63 days.
        Contraception. 2000; 61: 41-46
        • Dzuba IG
        • Chong E
        • Hannum C
        • Lichtenberg ES
        • Lugo Hernández EM
        • Ngoc NTN
        • et al.
        A non-inferiority study of outpatient mifepristone-misoprostol medical abortion at 64-70 days and 71-77 days of gestation.
        Contraception. 2020; 101: 302-308
      1. Reproductive Decisions, Promoting access to medication and first trimester aspiration terminations by supporting skilled providers [Internet]. AAFP Home, 2019. Accessed January 5, 2021. Available at: https://www.aafp.org/about/policies/all/reproductive-decisions-promoting-access.html

        • Beaman J
        • Schillinger D.
        Responding to evolving abortion regulations—the critical role of primary care.
        N Engl J Med. 2019; 380: e30
        • Prine LW
        • Lesnewski R.
        Medication abortion and family physicians' scope of practice.
        J Am Board Fam Pract. 2005; 18: 304-306
        • Beaman J
        • Prifti C
        • Schwarz EB
        • Sobota M.
        Medication to manage abortion and miscarriage.
        J Gen Intern Med. 2020; 35: 2398-2405
        • Stulberg DB
        • Monast K
        • Dahlquist IH
        • Palmer K.
        Provision of abortion and other reproductive health services among former Midwest Access Project trainees.
        Contraception. 2018; 97: 341-345
        • Srinivasulu S
        • Maldonado L
        • Prine L
        • Rubin SE.
        Intention to provide abortion upon completing family medicine residency and subsequent abortion provision: a 5-year follow-up survey.
        Contraception. 2019; 100: 188-192
        • Jones RK
        • Jerman J.
        Abortion incidence and service availability in the United States, 2014.
        Perspect Sex Reprod Health. 2017; 49: 17-27
        • Schreiber CA
        • Creinin MD
        • Atrio J
        • Sonalkar S
        • Ratcliffe SJ
        • Barnhart KT.
        Mifepristone pretreatment for the medical management of early pregnancy loss.
        N Engl J Med. 2018; 378: 2161-2170
        • Chu JJ
        • Devall AJ
        • Beeson LE
        • Hardy P
        • Cheed V
        • Sun Y
        • et al.
        Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial.
        Lancet. 2020; 396: 770-778
        • Shaw KA
        • Lerma K
        • Shaw JG
        • Scrivner KJ
        • Hugin M
        • Hopkins FW
        • et al.
        Preoperative effects of mifepristone for dilation and evacuation after 19 weeks of gestation: a randomised controlled trial.
        BJOG. 2017; 124: 1973-1981
      2. Center for Drug Evaluation and Research. FAQs about REMS [Internet]. U.S. Food and Drug Administration, 2018. Accessed January 5, 2021. Available at: https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/frequently-asked-questions-faqs-about-rems

        • Henderson JT
        • Hwang AC
        • Harper CC
        • Stewart FH.
        Safety of mifepristone abortions in clinical use.
        Contraception. 2005; 72: 175-178
        • Yalahow A
        • Doctoroff J
        • Mark A
        • Foster AM.
        Trends in medication abortion provision before and after the introduction of mifepristone: a study of the National Abortion Federation's Canadian member services.
        Contraception. 2020; 102: 119-121
      3. Government of Canada HC. Health Canada approves updates to Mifegymiso prescribing information: ultrasound no longer mandatory [Internet]. Recalls and Safety Alerts, 2019. Accessed January 5, 2021. Available at: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/69620a-eng.php

        • Aiken ARA
        • Starling JE
        • Gomperts R
        • Scott JG
        • Aiken CE.
        Demand for self-managed online telemedicine abortion in eight European countries during the COVID-19 pandemic: a regression discontinuity analysis.
        BMJ Sex Reprod Health. 2021; https://doi.org/10.1136/bmjsrh-2020-200880
      4. Online ahead of print.
        • Rasmussen K
        • Janiak E
        • Cottrill A
        • Stulberg D.
        Expanding access expanding access to medication abortion through pharmacy dispensing of mifepristone: primary care perspective through Illinois [Internet].
        National American Primary Care Research Group, 2020 (Accessed February 4, 2021Available at:)
        • Kumar A
        • Hessini L
        • Mitchell EM.
        Conceptualising abortion stigma.
        Cult Health Sex. 2009; 11: 625-639
        • Harris LH
        • Debbink M
        • Martin L
        • Hassinger J.
        Dynamics of stigma in abortion work: findings from a pilot study of the Providers Share Workshop.
        Soc Sci Med. 2011; 73: 1062-1070
        • O'Donnell J
        • Weitz TA
        • Freedman LR.
        Resistance and vulnerability to stigmatization in abortion work.
        Soc Sci Med. 2011; 73: 1357-1364
        • Institute for Healthcare Improvement
        The breakthrough series: IHI's collaborative model for achieving breakthrough improvement.
        Diabetes Spectr. 2004; 17: 97-101
        • Lang JM
        • Franks RP
        • Epstein C
        • Stover C
        • Olver JA.
        Statewide dissemination of an evidence-based practice using Breakthrough Series Collaboratives.
        Children Youth Serv Rev. 2015; 55: 201-209
        • Ebert L
        • Malte C
        • Hamlett-Berry K
        • Beckham J
        • McFall M
        • Saxon A.
        Use of a learning collaborative to support implementation of integrated care for smoking cessation for veterans with posttraumatic stress disorder.
        Am J Public Health. 2014; 104: 1935-1942
        • Morton C.H.
        • Peterson
        Improving outcomes of preeclampsia in California: from review of maternal death to quality care collaboratives.
        J Obstetr Gynecol Neonatal Nurs. 2014; 43: S74-S75
        • Shellhaas C
        • Conrey E
        • Crane D
        • Lorenz A
        • Wapner A
        • Oza-Frank R
        • et al.
        The Ohio Gestational Diabetes Postpartum Care Learning Collaborative: development of a quality improvement initiative to improve systems of care for women.
        Matern Child Health J. 2016; 20: 71-80
        • Raymond EG
        • Grossman D
        • Mark A
        • Upadhyay UD
        • Dean G
        • Creinin MD
        • et al.
        Commentary: no-test medication abortion: a sample protocol for increasing access during a pandemic and beyond.
        Contraception. 2020; 101: 361-366
      5. State funding of abortion under Medicaid Guttmacher Institute [Internet.]. Guttmacher Institute, 2021. Accessed January 19, 2021. Available at: https://www.guttmacher.org/state-policy/explore/state-funding-abortion-under-medicaid

      6. Regulating insurance coverage of abortion Guttmacher Institute [Internet.]. Guttmacher Institute, 2021. Accessed January 19, 2021. Available at: https://www.guttmacher.org/state-policy/explore/regulating-insurance-coverage-abortion

        • Norris A
        • Bessett D
        • Steinberg JR
        • Kavanaugh ML
        • De Zordo S
        • Becker D.
        Abortion stigma: a reconceptualization of constituents, causes, and consequences.
        Womens Health Issues. 2011; 21: S49-S54
        • Hanschmidt F
        • Linde K
        • Hilbert A
        • Riedel-Heller SG
        • Kersting A.
        Abortion stigma: a systematic review.
        Perspect Sex Reprod Health. 2016; 48: 169-177
        • Janiak E
        • Goldberg AB.
        Eliminating the phrase "elective abortion": why language matters.
        Contraception. 2016; 93: 89-92
        • Kumar A.
        Disgust, stigma, and the politics of abortion.
        Fem Psychol. 2018; 28: 530-538
        • Summit AK
        • Gold M.
        The effects of abortion training on family medicine residents' clinical experience.
        Fam Med. 2017; 49: 22-27
      7. Training in early abortion for comprehensive healthcare Guttmacher Institute [Internet.]. TEACH. Accessed February 4, 2021. Available at: https://www.teachtraining.org/