Identify the method to compensate for the weaknesses of the spontaneous adverse event reporting system database

2016 Fiscal Year Final Research Report

• Project/Area Number: 25460209
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Medical pharmacy
• Research Institution: Osaka University of Pharmaceutical Sciences (2016); Kyoto University (2013-2015)
• Principal Investigator: Kadoyama Kaori 大阪薬科大学, 薬学部, 准教授(移行) (10571391)
• Project Period (FY): 2013-04-01 – 2017-03-31
• Keywords: 有害事象自発報告 / FAERS / JADER / シグナル検出 / データベース / 発現時期 / 層別解析

Outline of Final Research Achievements

The purpose of this study was to identify the method to compensate for the weaknesses of the spontaneous adverse event reporting system database. Associations with adverse events were analyzed for various drugs, using PRR, ROR, IC, and EBGM. These results were suggested that the ROR method was more appropriate for pharmacovigilance and the EBGM method was more suitable for pharmacoepidemiological studies. In addition, these results became clear that it is necessary to perform stratified analysis by age and gender according to the actual clinically adapted patient layer of the drug to be analyzed. Furthermore, these results were shown that the number of adverse events registered in JADER was affected by the marketed order of drugs and the seriousness of adverse events among the same drug efficacy. By considering these points, it was suggested that analysis by signal detection method and interpretation of the results can be appropriately implemented.

Free Research Field

医療薬学