計量生物学
Online ISSN : 2185-6494
Print ISSN : 0918-4430
研究速報
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
関山 英孝寒水 孝司
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ジャーナル フリー

2016 年 37 巻 2 号 p. 89-100

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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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