3．For a Change of Pharmacovigilance Activities, from a Viewpoint of a Pharmaceutical Company
10.3820/jjpe.20.17
- VernacularTitle:3．安全性監視活動の変化に向けて：企業の立場から
- Author:
Makoto MIYAZAKI
;
Minoru SHIMODERA
- Publication Type:Journal Article
- Keywords:
database study;
drug use result survey;
pharmacovigilance activity;
research question;
study design
- From:Japanese Journal of Pharmacoepidemiology
2015;20(1):17-25
- CountryJapan
- Language:Japanese
-
Abstract:
This article describes findings about effective utilization of electronic medical databases from a viewpoint of a pharmaceutical company, with a progress of MIHARI Project in mind. Purposes of this article are (1) to understand merits to perform a database study and a drug use result survey as an additional pharmacovigilance activity for each risk in a risk management plan, and (2) to find points to be considered when their activities are to be selected. A database study has advantages as follows: a comparison group can be set easily; a power is high as a database has many cases; and no need to consider some points such as reporting bias and recall bias. On the other hand, some issues of a technical point (e.g. understanding characteristics of each database) and a regulatory system (e.g. clarifying association to the drug reexamination system) should be considered. A drug use result survey has advantages as follows: data can be collected, even the data that databases do not have; and a drug use result survey in a specific condition can be useful. As a usual design of drug use result surveys however is hard to answer a research question on each risk, more various designs should be considered. Each pharmacovigilance activity has different points to be considered. Therefore, we have to clearly understand the purpose to perform an additional activity and select the most appropriate activity to maximize the benefit of medication users.
