Abstract
Objective: This study aimed to assess and evaluate knowledge and application of the Food and Drug Administration (FDA) Pregnancy and Lactation Labeling Rule (PLLR) among pharmacists and physicians.
Design, Setting, and Participants: A cross-sectional study was conducted to evaluate the knowledge of and attitudes toward the new FDA PLLR among pharmacists and physicians. The primary outcome for this study was knowledge of the FDA PLLR. Descriptive statistical analysis was conducted for all study variables, and linear regression analyses were conducted to assess predictive factors of knowledge of the FDA PLLR. SPSS version 25 was used, and all analyses were conducted at an alpha value of 0.05.
Results: In a cross-sectional study that included 167 pharmacists and physicians, majority were pharmacists (78.4%), and the rest were physicians (21.6%). The overall knowledge score was low with the average number of items answered correctly being 3.03 out of 7. Of all explored predictors, only gender (P < 0.01) and pregnancy letter category knowledge score (P < 0.05) were significant predictors of PLLR knowledge, adjusting for the other factors.
Conclusion: The study's findings showed several gaps in the knowledge of the new PLLR among physicians and pharmacists, thus demonstrating a need to have concerted continuing pharmacy and medical education efforts. Increasing knowledge in this area will lead to better risk communication and quality of care for expectant and nonexpectant women of reproductive age. (C) 2022 Published by Elsevier Inc. on behalf of the American Pharmacists Association.