Creating a Checklist and a Survey on Research That Used the Japanese Adverse Drug Event Report Database

Takamasa Sakai; Yukito Wada; Akira Kokan; Kouichi Tanabe; Nobuyuki Goto; Fumiko Ohtsu

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Creating a Checklist and a Survey on Research That Used the Japanese Adverse Drug Event Report Database

VernacularTitle:日本の有害事象自発報告データベース（JADER）を用いた研究におけるチェックリストの作成と実態調査
Author: Takamasa SAKAI ¹ ; Yukito WADA ¹ ; Akira KOKAN ² ; Kouichi TANABE ¹ ; Nobuyuki GOTO ³ ; Fumiko OHTSU ¹
Author Information

1. Drug Informatics, Faculty of Pharmacy, Meijo University
2. Pharmaceutical and Medical Device Regulatory Science Society of Japan
3. Department of Pharmacy, University of Fukui Hospital
Keywords: Japanese Adverse Drug Event Report database; spontaneous reporting system; signal detection
From:Japanese Journal of Drug Informatics 2020;22(1):7-16
CountryJapan
Language:Japanese
Abstract: Objective: The purpose of this study was to create a checklist that summarizes checkpoints that should be noted when using the Japanese Adverse Drug Event Report database (JADER). After we created the checklist, we then used it to survey published academic papers that used JADER.Method: First, we created a draft checklist for research that uses JADER by citing the report of CIOMS working group VIII “Practical Aspects of Signal Detection in Pharmacovigilance”. Then, we conducted a pilot test and revised the draft checklist. Finally, the checklist was completed after the review by a pharmacoepidemiology expert. The checklist was applied to published academic papers that used JADER, and the fulfill rate of each checkpoints was calculated.Results: A “checklist of important points to be noted during research that uses the data mining method in JADER (mainly signal detection by disproportionality analysis)” was created. We also revealed problems with published academic papers that used JADER. For example, some researchers were thought to be inappropriately using JADER as a source of their research while others used an inappropriate version of MedDRA.Conclusion: The checklist created in this study summarizes key points that could be noted in research that uses JADER and is thought to contribute to an improvement in quality of research that uses JADER. Additionally, in our investigation of published academic papers that used JADER, we found the possibility that both the role of signal detection and the impact on analysis of JADER using the updated MedDRA version are not well understood.