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

ABSTRACT:

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

SUBMITTER: Hatakeyama S 

PROVIDER: S-EPMC12611501 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature