Effect of Removal of Pregnancy Category on Prescribing in Pregnancy: A Randomized [5OP

Abstract

INTRODUCTION: To assess the degree to which the removal of pregnancy drug categories (A, B, C, and D) from labeling information affects the likelihood that providers will prescribe medications. METHODS: From October 2015 through October 2016, a convenience sample of providers was recruited into a randomized, survey-based, study. The survey instrument described four clinical vignettes, one each for pregnancy categories A, B, C, and D. Each vignette described a pregnant woman with an indication for the drug in question, and provided detailed drug information. Two forms of the survey were randomly distributed; one presented the clinical vignette, drug information along, and the pregnancy category. The other presented the identical vignette and drug information but did the pregnancy category. Using a 5-point Likert scale the respondents were asked to estimate their likelihood of prescribing the drug. RESULTS: One hundred and sixty-two surveys were included in the analysis. In the model without covariates there was a significant form type (with or without letter categories) by drug category interaction (P=.003); simple effects analysis showed that provision of a letter significantly affected the decision to prescribe the category B (P<.001) and C drugs (P=.008) but not the A or D. Participants were significantly less likely to prescribe the B and C drugs when the letters were not available for review. After adding covariates (eg, age, gender, specialization, years of experience) to the model the interaction persisted (P<.001). CONCLUSION: Without the pregnancy category physicians are less likely to use category B and C drugs, the most common medications prescribed in pregnancy. Therefore, it is possible that in the absence of a letter, pregnant women's access to medications may become more restrictive, and further research is needed to address that concern and monitor for trends as the new system is well-established.