著者

高月 公博 古川 裕之 宮本 謙一

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.39, no.5, pp.173-179, 2008 (Released:2009-02-05)

参考文献数

18

被引用文献数

1 1

---

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.

著者

高月 公博 古川 裕之 宮本 謙一

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.34, no.9, pp.838-846, 2008 (Released:2010-02-07)

参考文献数

14

被引用文献数

2 1

---

The purpose of this study was to clarify the causality assessment information items necessary to improve the usefulness of individual case safety reports (ICSRs) from medical facilities as adverse drug reaction (ADR) information.To do this,we investigated standard causality assessment items used by pharmaceutical companies.The number of the companies responding was 76,93.8% of all Japan Pharmaceutical Manufacturers Association (JPMA) member companies.We found that the use of algorithms for causality assessment,the grades and expressions used to describe causality,and criteria for determining whether reactions were ADRs or not varied among the companies as well as their divisions (whether they conducted clinical trials or post-marketing surveillance).Having such a variety of assessment criteria is inconvenient for the reporters who have to judge it and also lowers the validity of judgments.It also hampers the overall assessment of ADR information and may cause great differences in ADR frequencies.We therefore feel that it is desirable to agree on international criteria for causality assessment as soon as possible.