| アブストラクト | 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. |
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| 投稿者 | Hatakeyama, Shiro; Sakai, Takamasa; Tsuchiya, Masami; Kikuchi, Daisuke; Sato, Yuri; Kondo, Yuki; Sato, Izumi; Okada, Yuko; Obara, Taku |
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| 組織名 | Department of Pharmacy, Tohoku Medical and Pharmaceutical University Hospital,;Sendai, Miyagi, Japan.;Department of Pharmacy, Yamagata University Hospital, Yamagata, Japan.;Drug Informatics, Faculty of Pharmacy, Meijo University, Nagoya, Aichi, Japan.;Division of Drug Informatics, Keio University Faculty of Pharmacy, Tokyo, Japan.;Division of Community Medicine and Pharmacy, Faculty of Pharmaceutical Sciences,;Tohoku Medical and Pharmaceutical University, Sendai, Miyagi, Japan.;KTS Plan Inc., Sendai, Miyagi, Japan.;Department of Clinical Chemistry and Informatics, Graduate School of;Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.;Department of Clinical Epidemiology, Graduate School of Biomedical Sciences,;Nagasaki University, Nagasaki, Japan.;Faculty of Pharmacy, Takasaki University of Health and Welfare, Takasaki, Gunma,;Japan.;Department of Pharmaceutical Sciences, Tohoku University Hospital, Sendai,;Miyagi, Japan. |
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