Proposed Procedure for Pharmacovigilance Activities Carried out by Pharmaceutical Companies―An Example of Adverse Drug Reaction Signal Detection Method using JADER―

DOI
  • Umeyama M
    Graduate School of Public Health, Teikyo University
  • Suzuki A
    Graduate School of Public Health, Teikyo University

Bibliographic Information

Other Title
  • 製薬企業が行う自社製品に関する安全性監視活動の手順の提案―JADERを用いた副作用シグナル検出の実施例―

Abstract

<p>　Although many previous studies on the signal detection of adverse drug reaction using data mining methods in JADER, a domestic spontaneous reporting database, have been reported, standardized procedures for pharmaceutical companies to detect signals in their products have not yet been presented. In this study, we retrospectively examined whether signals could be detected earlier by using data-mining methods in adverse drug reactions (interstitial pneumonia under DOAC use) that were added in a revised package insert after launch, with the aim of providing useful practices for company practice. The results showed that early detection was achieved for two of the four targeted DOACs. Although early detection was not achieved for the remaining two products, important considerations for the application of the method could be discussed. The results of this study are expected to enhance the detection of adverse drug reaction signals through the introduction of data mining methods using JADER in the safety surveillance activities of companies.</p>

Journal

Keywords

Details 詳細情報について

  • CRID
    1390861317116410752
  • DOI
    10.14948/jami.42.95
  • ISSN
    21888469
    02898055
  • Text Lang
    ja
  • Data Source
    • JaLC
  • Abstract License Flag
    Disallowed

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