Suitability of Japanese Medical Databases for Studies on Infant Outcomes After Maternal Drug Exposure: An Evaluation Based on Core Data Elements

Purpose Pharmacotherapy during pregnancy should be approached with caution due to the potential risk of adverse effects, including birth defects, in the fetus. Appropriate post‐marketing surveillance and perinatal pharmacoepidemiology are essential to ensure the safety of pharmacotherapy during pregnancy. However, due to limited research infrastructure in pharmacoepidemiology, collecting reliable data on drug safety in pregnant women and infants remains a challenge in Japan. Thus, we examined the suitability (fitness for purpose) of Japanese medical databases for perinatal studies to establish infrastructure in this field. Methods We assessed seven available databases in Japan: the DeSC database, EBM provider, Japanese Adverse Drug Event Report database, JMDC claims database, MDV analyzer, the National Database of Health Insurance Claims, and Tohoku Medical Megabank Project Birth and Three‐Generation Cohort Study (TMM BirThree Cohort Study). To assess the quality of databases for maternal studies, we evaluated the content of each mother‐infant linkable database based on the core data elements recommended for perinatal pharmacoepidemiology. Results Three of the databases were found to be mother‐infant linkable: the DeSC database, JMDC claims database, and the TMM BirThree Cohort Study. The coverage of core data elements in perinatal pharmacoepidemiology was 73.5% in the DeSC and JMDC claims databases and 92.9% in the TMM BirThree Cohort Study. Conclusion Some representative medical databases in Japan are well suited for use in perinatal pharmacoepidemiologic research on infant outcomes.