Related Experiment Video
Updated: Jan 11, 2026

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale
Published on: August 25, 2014
Suitability of Japanese Medical Databases for Studies on Infant Outcomes After Maternal Drug Exposure: An Evaluation
Shiro Hatakeyama1,2, Takamasa Sakai3, Masami Tsuchiya4
1Department of Pharmacy, Tohoku Medical and Pharmaceutical University Hospital, Sendai, Miyagi, Japan.
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.
More Related Videos
06:55Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index
Published on: January 8, 2020
09:20Cloud-Based Phrase Mining and Analysis of User-Defined Phrase-Category Association in Biomedical Publications
Published on: February 23, 2019
Related Concept Videos
Drug Dosing: Infants and Children
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Teratogenicity
Factors Affecting Drug Response: Overview
Bioavailability Study Design: Healthy Subjects Versus Patients
Analysis of Population Pharmacokinetic Data