医療機関における医薬品の市販後安全性情報の管理 : 臨床試験および市販直後調査における情報について

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While the management of safety information obtained from investigational drugs has been much studied up till now, few studies have been done on the management of safety information obtained from post marketing drugs. Through collecting adverse event information from post marketing clinical trials and those for additional indications carried out at our institution, we investigated the situation of adverse event information available after the marketing of drugs, the management of such information and its submission to the IRB. Though there was no appreciable change in the amount of post-marketing information for cancer drugs over a three-year period beginning in April, 2001, for other categories of drugs, a major increase in the amount of information in the last year of our study was noted. Regarding the predictability and seriousness of adverse event information, it was noted that "unexpected non-serious events" were included in the reporting system (3.2% of post-marketing information) and that information on "expected serious events" accounted for 72.2% of post-marketing information. In 2002, the year that Early Post-marketing Phase Vigilance was introduced on a full scale, major differences in the handling of safety information among individual pharmaceutical companies began to be observed. Through the present study, we were able to determine the current status of the reporting of post-marketing information to medical institutions. In the future, it will be necessary to evaluate the quality of the adverse event information.
日本医療薬学会の論文
2004-11-10

医療機関における医薬品の市販後安全性情報の管理 : 臨床試験および市販直後調査における情報について

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