わが国の市販後の安全性監視の現状と今後のあるべき姿

抄録

Current pharmacovigilance activities may be captured by two important concepts, pharmacovigilance planning (PVP) and risk minimization action plan (risk MAP). PVP was advocated in E2E guideline of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in 2004. Risk MAP was proposed in 2005 in FDA's guidance as well as in EU risk management plan (EU-RMP). PVP requires a scientific approach where important safety issues unique to each product are specified and the conduct of the study with a design best for the specified problems. Similarly, risk MAP requires developing the best strategy to mitigate the specified problems. In Japan, drug use investigation (DUI) (shi-yo-sei-seki-cho-sa) was developed as early as in 1970s and became mandatory after the re-examination system for newly approved drugs was introduced in 1979. DUI is a stereotyped survey without control group where thousands of patients prescribed a new drug are followed typically for 3 to 6 months. Within 2012 risk management plan guidance will be implemented in Japan. This may promote a better practice of risk MAP. On the other hand, the real implementation of PVP is challenging because it requires various resources which do not currently exist in Japan. For example, it is important to establish the education system which can produce people who is capable of planning and conducting a good study. In addition, the system to achieve transparency, independence and standard like European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) may be established.