著者
藤田 利治
出版者
一般社団法人 日本薬剤疫学会
雑誌
薬剤疫学 (ISSN:13420445)
巻号頁・発行日
vol.14, no.1, pp.27-36, 2009 (Released:2009-09-30)
参考文献数
11
被引用文献数
23 30

During the post-approval period, hypotheses about potentially new adverse drug reactions (ADR) have traditionally emerged from passive surveillance systems that collect large volumes of spontaneous case reports of suspected adverse drug reactions. With signal detection by traditional (or conventional, or manual) methods, quantitative (or statistical, or automated) methods for spontaneous reporting system (SRS) databases were introduced in the late 1990’s in order to detect serious ADR as early as possible. Most quantitative methods rely on comparisons of relative reporting frequencies, also known as disproportionality analyses. In FY 2009, the Pharmaceuticals and Medical Device Agency (PMDA) plans to introduce the quantitative methods (data mining method) used on Japanese SRS database. This paper introduces the recent situation on signal detection and signal management of adverse drug reactions.

言及状況

外部データベース (DOI)

はてなブックマーク (1 users, 1 posts)

Twitter (2 users, 5 posts, 0 favorites)

受動的サーベイランスの短所(続き) https://t.co/CCXkt27RYE より ・遅発性の有害作用の検出を見逃す可能性 ・背景での発生率が低いとはいえない疾患を見逃す可能性(例:高齢者での虚血性心疾患,悪性新生物など)
受動的サーベイランスの短所 https://t.co/CCXkt27RYE より ・過少報告 ・不安定な報告割合 ・詳細な臨床情報の不足 ・発生頻度の分母となる直接的な情報の欠如のため,発生頻度の算出が困難 続く

収集済み URL リスト