Clinical researchers at the University of Minnesota Medical School partnered with the university health system's compliance department to create standard processes for ordering and documenting mifepristone administration, which adhere to the Risk Evaluation and Mitigation Strategy (REMS) requirements. They established a single prescriber account to represent all system prescribers who met REMS requirements, allowing for centralized ordering and distribution by the pharmacy purchasing team. This process mirrors other standard operating procedures used by the health system to purchase other medications. Establishing processes for mifepristone for early pregnancy loss accelerated integration of its use for medical abortion. As the barriers to mifepristone use are similar, regardless of indication, the new process reduced barriers to providing abortion care at a time when access has become limited throughout the Midwest.
What We Know: Mifepristone and misoprostol taken together remain the standard for medical management of early pregnancy loss (EPL) and first-trimester abortion. While misoprostol is readily available, distribution of mifepristone has been restricted, regardless of reason for its use. Despite its documented safety, mifepristone is regulated by a Risk Evaluation and Mitigation Strategy (REMS) program—a barrier for both labeled and off-label use.
What This Study Adds: Study authors created standard processes for ordering and documenting mifepristone administration that were in compliance with the new regulations restricting use of this medication. This process reduced barriers to providing both management of early pregnancy loss and first-trimester abortion care.
Streamlining the Use of Mifepristone for Early Pregnancy Loss Across a Large Health Care System Sets the Stage for Rapid Expansion of Medication Abortion Access in a Post-Roe Environment
Nicole Chaisson, MD, MPH, University of Minnesota Medical Center Residency Program, Department of Family Medicine and Community Health, University of Minnesota Medical School, St. Paul, Minnesota, and Katherine Montag Schafer, PharmD, St. John's Hospital Family Medicine Residency Program, Department of Family Medicine and Community Health, University of Minnesota Medical School, St. Paul, Minnesota
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