<b>Expectation for Development of Pharmacoepidemiology Studies in Japan with SS-MIX Standardized Storage </b> / 薬剤疫学

ABSTRACT

Resources for legitimate pharmacoepidemiology studies have been poor in Japan. One of the pivotal elements which may lead to the development of the infrastructure for legitimate pharmacoepidemiology studies in Japan is to make post-authorization studies conducted by drug companies employ more scientific pharmacoepidemiology principles. In 2012, a notice on risk management plan (RMP) was issued to require the implementation of pharmacovigilance plan (PVP)given in the ICH's E2E guidelines as well as the risk minimization action plan. The ICH's E2E guidelines require the use of pharmacoepidemiology principles in the post-authorization studies. In this article, the registry-type post-authorization study using the SS-MIX standardized storage is compared with the old Drug Utilization Investigation (DUI) conducted for several decades in Japan. A DUI has a potential to become a promotional study as the prescription of the medicine is not separated from the decision to include the patient in the study which can be avoided by the identification of study subjects by using the SS-MIX standardized storage. In addition, the standardized storage will be powerful in identifying new users of two drugs to be compared. The database study may become a component of the post-authorization studies in the future, but mainly due to the difficulty of the record linkage, the registry-type study will remain important to complement the database studies for the time being. The promotion of both of the registry-type studies and database studies using the SS-MIX standardized storage will facilitate the development of the infrastructure needed to conduct legitimate pharmacoepidemiology studies. (Jpn J Pharmacoepidemiol 2013;18(1)41-48)