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In the United States (US), mifepristone used together with misoprostol is registered by the Food and Drug Administration (FDA) for termination of intrauterine pregnancy up to 70 days’ gestation.1 While medication abortion is safe and effective,1 current FDA requirements delineated in the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone mandate that it be dispensed in a clinic, medical office or hospital.2 Patients then complete the medication regimen outside of the facility. Post-treatment assessment is recommended to ensure the pregnancy is not ongoing, which can take place in person or remotely.3 While there is little evidence demonstrating that the mandated dispensing requirement improves patient safety, it may pose an insurmountable barrier for people unable to travel to an abortion facility.4 In addition, hostile policy environments have made abortion nearly unattainable in some US states, a situation that may worsen in the near future as the US Supreme Court considers a case challenging Roe v Wade.5 The recent passage of Texas Senate Bill 8 (SB 8) bans most abortions after 6 weeks’ gestation.6 While it is still being challenged in court, this law effectively forces people to travel out of state to access care, increasing the travel distance and cost to reach a clinic. These barriers will create delays in accessing care, pushing some patients later in pregnancy before they can obtain the service and preventing others from obtaining a wanted abortion entirely.
Since April 2021 and for the duration of the COVID-19 public health emergency, the FDA is exercising enforcement discretion regarding the in-person dispensing requirement for mifepristone, which allows providers to mail mifepristone to patients or use a mail order pharmacy.7 Reducing the need for in-person clinical encounters using telehealth and other strategies can improve the patient experience and increase …
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Correction notice This paper has been updated since it was first published. The funder name has been corrected.
Funding This study was funded by Fidelity Charitable.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.