Contraception Special Issue on the mifepristone Risk Evaluation and Mitigation Strategy (REMS)

Cleland, Kelly; Foster, Angel M.; Gómez, Anu Manchikanti; Raymond, Elizabeth G.; Westhoff, Carolyn

doi:10.1016/j.contraception.2021.05.012

Cited by 6 publications

(7 citation statements)

References 25 publications

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“…The abortion-providing community hopes that a sufficient body of evidence will be established that demonstrates how the temporary suspension of these REMS restrictions improved abortion access 23 and which may ultimately support making this suspension permanent.…”

Section: Discussionmentioning

confidence: 99%

COVID‐19, health care, and abortion exceptionalism in the United States

Joffe

Schroeder

2021

Perspect Sexual Reproductive

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Context: Few qualitative findings have been published that explore and identify the challenges experienced by independent abortion providers during the COVID-19 pandemic in the United States (US). In this paper, we explore these themes while expanding the concept of "abortion exceptionalism" beyond its original legal meaning to address the impact of abortion stigma.Methods: Twenty abortion providers from independent abortion clinics throughout the US South and Midwest participated in semi-structured interviews in June and July 2020. Interviews explored the challenges of providing abortion care in the wake of the COVID-19 pandemic and sought to identify how clinics strategized and amended their clinical practices to continue providing abortion care during this time.Results: All providers we spoke to noted significant challenges to providing abortion care in the early days of COVID-19. In addition to experiencing the same concerns as other health care institutions, abortion clinics also faced additional, unique burdens that can only be attributed to the politics of abortion exceptionalism. Examples of this abortion exceptionalism include abrupt orders to close clinics, the need to rely on traveling physicians, legislature-imposed limits on telemedicine, heightened activities of protesters, and non-evidence-based regulation of medication abortion. Conclusion:Despite major challenges and differential treatment, independent abortion clinics in the US persevered to continue to provide abortion care throughout the COVID-19 pandemic. SETTING THE CONTEXTCOVID-19 has brought significant challenges to virtually all health care services in the United States (US). Patients' needs for in-person clinical services have had to be weighed against the need to protect both patients and health care providers from contracting or spreading the virus. Health care institutions have made numerous changes to their practices to minimize the threat of infection by both patients and staff. Facilities that provide abortion not only experienced these same challenges but also faced additional and unique challenges. In what follows, we outline the impacts of "abortion exceptionalism," that is the idea that abortion is regulated both differently and more stringently than other medical procedures that are comparable to abortion in complexity and safety. [1][2][3][4] This exceptionalism has affected nearly every aspect of abortion care during the pandemic and has placed additional burdens on patients and clinic staff alike.While the concept of "abortion exceptionalism" was originally used by legal theorists to describe regulatory issues relating to abortion, in this paper, we extend the meaning of the concept to also encompass the highly politicized and stigmatized status of abortion in American society. We argue that this status has significantly impacted

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Section: Discussionmentioning

confidence: 99%

COVID‐19, health care, and abortion exceptionalism in the United States

Joffe

Schroeder

2021

Perspect Sexual Reproductive

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“…The study concluded that this "efficacy rate is similar to in-person provision, suggesting that abortion provided via telehealth is feasible and safe" (Upadhyay et al 2021). In July of 2021, the journal Contraception published a special issue on the mifepristone REMS (Cleland et al 2021). Articles included in the issue described the REMS as "needless and unlawful barriers to care," noting the disproportionate burdens of the REMS on vulnerable populations and several advocating for removing the in-person dispensing requirement (Kaye, Reeves, and Chaiten 2021).…”

Section: R I P Tmentioning

confidence: 97%

History and Politics of Medication Abortion in the United States and the Rise of Telemedicine and Self-Managed Abortion

Baker

2023

Journal of Health Politics, Policy and Law

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This article examines the decades-long campaign to increase access to abortion pills in the United States, including advocates’ work to win U.S. Food and Drug Administration approval of mifepristone and misoprostol for abortion, the continuing restrictions on mifepristone and the multiple strategies advocates have pursued to challenge these restrictions, including lobbying the FDA to remove the restrictions, obtaining a limited research exemption from FDA restrictions and suing the FDA during the COVID pandemic. The article pays particular attention to influence of research conducted on the safety and efficacy of medication abortion as well as research on the impact of increased availability of abortion pills through telemedicine during the pandemic. The article also addresses self-managed abortion, where people obtain and use mifepristone and/or misoprostol outside of the formal healthcare system, and documents the growing network of organizations providing logistical, medical and legal support for people self-managing abortion. The article concludes with reflections on the role abortion pills might play in the post-Roe era amid increasingly divergent abortion access trends across different regions of the United States.

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“…85 The REMS restriction involves "Elements to Assure Safe Use," which include (1) in-person dispensing, or that patients must obtain the pill at a clinic, medical office, or hospital, (2) the distributing clinician must be a registered prescriber, and (3) patients must sign a special "patient agreement" form provided by the manufacturer. 83 Although the COVID-19 pandemic brought a temporary lift of the in-person dispensing requirement, 86 and early 2023 showed promise in permanent removal of this requirement with new hope of a pharmacy certification process, 87 the Alliance for Hippocratic Medicine versus FDA's court case in 2023 challenged the decade-old drug approval of mifepristone putting an immediate pause on any pharmacy dispensing process. 4 At the time of this publication, the Supreme Court had granted the FDA continued approval of the medication, whereas litigation continues in lower courts.…”

Section: Legislative Initiatives To Restrict Abortionmentioning

confidence: 99%

Medication Abortion: A Comprehensive Review

Fleurant,

McCloskey

2023

Clinical Obstetrics &Amp; Gynecology

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This chapter provides an overview of evidence-based guidelines for medication abortion in the first trimester. We discuss regimens, both FDA-approved and other clinical-based protocols, and will briefly discuss novel self-managed abortion techniques taking place outside the formal health care system. Overview of patient counseling and pain management are presented with care to include guidance on “no touch” regimens that have proven both feasible and effective. We hope that this comprehensive review helps the health care community make strides to increase access to abortion in a time when reproductive health care is continuously restricted.

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Contraception Special Issue on the mifepristone Risk Evaluation and Mitigation Strategy (REMS)

Cited by 6 publications

References 25 publications

COVID‐19, health care, and abortion exceptionalism in the United States

COVID‐19, health care, and abortion exceptionalism in the United States

History and Politics of Medication Abortion in the United States and the Rise of Telemedicine and Self-Managed Abortion

Medication Abortion: A Comprehensive Review

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