Background: The Mifeprex® Risk Evaluation and Mitigation Strategy (REMS) requires that the drug be dispensed only in a clinic, office, or hospital, despite the lack of evidence that this improves safety. In a recent survey of obstetrician-gynecologists (Ob-Gyns), we found that only 14% provided medication abortion, but an additional 15% said they would provide it if they could write a prescription for mifepristone.
Methods: We propose to perform a prospective cohort study of patients obtaining medication abortion with mifepristone (Mifeprex®) dispensed from a mail-order pharmacy. The study will be conducted under an Investigational New Drug application to the Food and Drug Administration. First we will pilot test our study protocol with approximately 25 patients at one existing medication abortion site. We will then identify 15 to 20 sites that are interested but do not currently provide medication abortion to participate in the main study, where we will train new Ob-Gyn, family medicine, and internal medicine physicians to provide medication abortion with the medications dispensed via mail-order pharmacy; approximately 400 patients will be recruited for the main study from these sites.
Proposed analysis: The primary outcomes will be acceptability (patient satisfaction) and feasibility (timeliness of receipt of medications, maintenance of patient confidentiality); secondary outcomes include medication abortion effectiveness and safety. The purpose of the study is to create evidence that will be useful to advocate for the removal of the Mifeprex® REMS and to document the feasibility and acceptability of dispensing mifepristone by mail-order pharmacy. The study will improve access to medication abortion by building the capacity of new providers who are currently unable or unwilling to stock mifepristone in their facilities, to now prescribe medication abortion to their patients.