Development of an Application for Using the Pharmaceuticals and Medical Devices Agency Side Effect Dataset More Effectively
10.11256/jjdi.16.81
- VernacularTitle:独立行政法人医薬品医療機器総合機構の医薬品副作用 データベースを簡便に利用するためのアプリケーションの開発
- Author:
Hiroshi Sakata
;
Yukari Inagaki
;
Mizuki Nakazaki
;
Fumiko Otsu
;
Nobuyuki Goto
- Publication Type:Journal Article
- Keywords:
PMDA;
side effects;
risk management plan;
JADER
- From:Japanese Journal of Drug Informatics
2014;16(2):81-89
- CountryJapan
- Language:English
-
Abstract:
Objective: The Pharmaceuticals and Medical Devices Agency (PMDA) discloses reports with accumulated side effect information in comma-separated value (CSV) format. It is difficult to use the information in this type of text file because the amount of data is large and composed of multiple fields. Therefore, we developed an application that presents the data in a way that is easier to read and understand.
Methods: The application can display the whole dataset, or the search results of certain medicines and side effects within the database in Microsoft Access 2013. It exports data from search results into an Excel spreadsheet organized by medicine and side effect.
Results: This application makes it possible to understand statistics contained in the side effect dataset, such as the number of cases, the medicines, and the side effects themselves. Moreover, the application allows the totaled search results for the medicines and the side effects to be graphed. It also makes it possible to understand the sex and age distribution of patients, as well as the days elapsed before developing a side effect.
Conclusions: Recently, the importance of information concerning the safety of medicine has increased. This system could facilitate the effective use of side effect information and the creation of medicine risk management plans in medical institutions.
