<b>1. Practical Use of the Open Japanese Adverse Drug Event Report Database (JADER)</b> / 薬剤疫学

ABSTRACT

As for spontaneous case reports of suspected adverse drug reactions, the following problems are known, a part of phenomenon actually recognized to be side effects in clinical site is reported, moreover, the thing which report bias which fluctuate produces by a factor with the various rates exists, since an appearance ratio is incalculable, it cannot be adapted in the analysis technique for common side-effects data. Therefore, the search algorithm analyzing method of signal detection has been established. Japanese Adverse Drug Event Report database (abbreviation; JADER) is exhibited from Pharmaceuticals and Medical Devices Agency (abbreviation; PMDA) to April 2012, and can use anyone now without restrictions. It is expected that the quality of research of pharmacoepidemiology will improve by practical use of JADER. However, as for the present condition, there are few reports of the practical use example in a pharmaceutical company as a subject which tends to attract attention from “signal detection” as the practical use method, consequently regulatory agency should cope with. Although the pharmacoepidemiology group of the author Japanese Society for Biopharmaceutical Statistics is not comprehensive before public presentation of JADER, the list obtained by “case report line list search with which side effects are suspected” which PMDA offers was collected and put in a database, and practical use in a pharmaceutical company has been tried by referring to the examination method of pharmacoepidemiology. This paper explains the processing method of the JADER data for enabling signal detection. Using this method, application to the subject of much pharmacoepidemiology is performed actively, and it expects to contribute to improvement in the quality of research of pharmacoepidemiology.