ArticleDrug safety2025
Evaluation of Data Quality and Utility of the Japan Drug Information Institute in Pregnancy (JDIIP) Consultation Case Database for Pregnancy Pharmacovigilance.
Article in Drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Who cites it
1 citing paper in PubMed.
- Suitability of Japanese Medical Databases for Studies on Infant Outcomes After Maternal Drug Exposure: An Evaluation Based on Core Data Elements.Pharmacoepidemiology and drug safety · 2025Article
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14 authors.
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Abstract
introductionEnsuring medication safety during pregnancy is crucial for protecting maternal and fetal health. However, fragmented data sources and the lack of comprehensive databases present substantial barriers to effective pharmacovigilance. The Japan Drug Information Institute in Pregnancy (JDIIP) database, which contains data on drug treatment counseling for pregnant women, is expected to help address the lack of comprehensive databases for pregnancy pharmacovigilance (PregPV).
objectiveWe evaluated the quality and utility of the JDIIP database for PregPV activities, particularly its ability to consolidate and utilize drug-exposure data among pregnant women in Japan.
methodsTo assess the quality and utility of the JDIIP database for PregPV, we examined its alignment with 48 core data elements (CDEs) considered critical for PregPV, as recently proposed by a European Union consortium through the ConcePTION Project. We performed a detailed mapping of each CDE definition-including maternal lifestyle factors, drug exposure, and pregnancy outcomes-against the corresponding data elements captured in the JDIIP database.
resultsThe JDIIP database either directly collected or could derive 38 of the 48 specific items (79%) recommended by the ConcePTION Project. At the category level, the JDIIP database aligned closely with the CDE requirements for database management details, pregnancy details, maternal medical history, pregnancy medication exposure, live/stillborn birth outcomes, and malformation details, achieving coverage of over 80% of the necessary variables in each category. Some categories, such as maternal medical conditions arising during pregnancy and infant complications within the first year of life, showed less alignment, with coverage rates below 50%. Although the JDIIP database provides comprehensive coverage of critical pharmacovigilance elements, data collection for specific variables and categories that better align with the CDE framework can be enhanced to improve alignment with the CDE framework and strengthen pharmacovigilance capabilities.
conclusionsOur findings highlight the potential of the JDIIP database as a valuable resource for advancing PregPV research. Although the collection of certain maternal and infant data elements could be improved, the substantial alignment of the database with established CDEs positions it as a promising tool for advancing PregPV initiatives in Japan.
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