Use of National Database of Health Insurance Claims and Specific Health Checkups for examining practical utilization and safety signal of a drug to support regulatory assessment on postmarketing drug safety in Japan

Frontiers in Medicine

Medicine

Haruka Shida¹  Kazuhiro Kajiyama¹  Sono Sawada¹  Chieko Ishiguro¹  Yoshiaki Uyama¹  Yukio Oniyama²  Mikiko Kubo²  Ryota Kimura²  Mai Hirano³  Toyotaka Iguchi³  Noriyuki Komiyama³ 

[1] Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan;Office of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan;Office of Pharmacovigilance II, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan;

关键词: real-world data;    pharmacoepidemiology;    national claims database;    drug safety;    regulatory decision-making;   

DOI  :  10.3389/fmed.2023.1096992

 received in 2022-11-13, accepted in 2023-02-07,  发布年份 2023

来源: Frontiers

【 摘 要 】

The Pharmaceuticals and Medical Devices Agency (PMDA) has conducted many pharmacoepidemiological studies for postmarketing drug safety assessments based on real-world data from medical information databases. One of these databases is the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB), containing health insurance claims of almost all Japanese individuals (over 100 million) since April 2009. This article describes the PMDA’s regulatory experiences in utilizing the NDB for postmarketing drug safety assessment, especially focusing on the recent cases of use of the NDB to examine the practical utilization and safety signal of a drug. The studies helped support regulatory decision-making for postmarketing drug safety, such as considering a revision of prescribing information of a drug, confirming the appropriateness of safety measures, and checking safety signals in real-world situations. Different characteristics between the NDB and the MID-NET® (another database in Japan) were also discussed for appropriate selection of data source for drug safety assessment. Accumulated experiences of pharmacoepidemiological studies based on real-world data for postmarketing drug safety assessment will contribute to evolving regulatory decision-making based on real-world data in Japan.

【 授权许可】

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Copyright © 2023 Shida, Kajiyama, Sawada, Ishiguro, Kubo, Kimura, Hirano, Komiyama, Iguchi, Oniyama and Uyama.