後発医薬品会社における個別症例安全性報告の因果関係評価基準

概要

論文の詳細を見る
The purpose of this study was to determine the items necessary for causality assessment in order to improve the usefulness of the individual case safety report (ICSR) from medical institutions as adverse drug reaction (ADR) information. Thus, we evaluated the standard items for causality assessment by surveying the items used in pharmaceutical manufacturers of generic drugs. The number of respondents was 35, which was 89.7% of the member companies of Japan Generic Pharmaceutical Manufacturers Association. The use of algorithms for causality assessment, terms for causal relation, and criteria for assessing whether or not ADR were varied among the companies. These findings were similar to the previous results in a survey of pharmaceutical companies of original drug. The variety of assessment criteria is inconvenient for reporters to judge and also lowers the validity of judgment. Additionally, it will be inappropriate to assess ADR information all together. And these variations may cause wide differences in the frequency measurement of ADR. Therefore, it is crucial to immediately derive consensus on international assessment criteria for causality assessment.
日本臨床薬理学会 = The Japanese Society of Clinical Pharmacology and Therapeuticsの論文
2008-09-30