著者
関山 英孝 寒水 孝司
出版者
日本計量生物学会
雑誌
計量生物学 (ISSN:09184430)
巻号頁・発行日
vol.37, no.2, pp.89-100, 2016-12-31 (Released:2017-05-16)
参考文献数
11
被引用文献数
2 3

The Japanese Adverse Drug Event Report (JADER) database of the Pharmaceutical and Medical Devices Agency (PMDA) has been available to the public since 2012. The database includes reports on drug-related adverse events from pharmaceutical companies or medical institutions. It is expected to improve the proper use of pharmaceutical products through pharmacoepidemiological studies using the JADER. However, wrong results and interpretations would be derived unless the features of JADER are carefully considered before the study. However, no study has investigated JADER from the viewpoint of data cleaning.Herein, we summarized the features and precautions for use of JADER (downloaded on June 2015). For example, we found many misspellings and drug names input in various forms because of incorrect Japanese Kanji, voiced and semi-voiced dots, and half-width and full-width forms. We also found that the number of adverse events tends to increase throughout the year, with the highest number reported in the third quarter (October-December). Finally, emergency or rapid safety information (i.e., yellow letter and blue letter) and results of drug use surveys generally increase the number of adverse events reported in JADER.

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Twitter (4 users, 5 posts, 1 favorites)

@Fizz_DI @syuichiao89 ブルーレターやイエローレターがでると有害事象(の報告数)が増えるみたいですね JADER https://t.co/WVnIOnGUqB
@fukujyu4 「症例報告書では解析に用いられるデータのみ収集」とあること、「承認年度の翌年度の副作用報告数が 極端に大きい」ことなどが原因です
医薬品副作用データベースの要約と副作用報告数に影響する要因の検討 https://t.co/JKIZjbvUpf
関山英孝・寒水孝司(2016). 医薬品副作用データベースの要約と副作用報告数に影響する要因の検討 37, 89-100. https://t.co/v886ypXC6v

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