Medication Management of Early Pregnancy Loss: The Impact of the U.S. Food and Drug Administration Risk Evaluation and Mitigation Strategy [A289

Abstract

INTRODUCTION: Early pregnancy loss (EPL) occurs in 1 million U.S. patients annually. Mifepristone pretreatment for medication management increases efficacy but requires compliance with the U.S. Food and Drug Administration Risk Evaluation and Mitigation Strategy (REMS) program. This study examined how REMS influences mifepristone use for EPL among obstetrician–gynecologists (ob-gyns) in Massachusetts. METHODS: This mixed methods study included in-depth qualitative interviews focused on EPL management analyzed under a thematic analysis framework using multiple coders and a consensus method. Qualitative data informed development of a survey fielded among all ob-gyns in Massachusetts identified through the American Medical Association Physician Masterfile. The Partners IRB deemed this study exempt. RESULTS: Nearly all interviewees (17 of 19, 89%) listed the REMS as a barrier to mifepristone use. Barriers included belief that the REMS indicated mifepristone was not available to general ob-gyns, lack of pharmacy dispensing, and concerns about signing the required prescriber agreement. The REMS sometimes gave hospital or pharmacy leadership the impression that mifepristone is dangerous, prolonging protocol development and implementation. A total of 197 physicians responded to a subsequent survey. Of those, 37% did not offer mifepristone for EPL, and 40% were not or only somewhat familiar with mifepristone's REMS program. Among those who reported on barriers to mifepristone use (n=57), the most common was uncertainty with how to comply with the REMS (53%); 73% reported that removing these regulations would help them use mifepristone for EPL. CONCLUSION: The FDA REMS program for mifepristone impedes evidence-based medication management of EPL. Removing the REMS would improve access to this best practice.