Novel Trend of Pharmacovigilance and Risk Management by the Regulatory Body

NOVEL TREND OF PHARMACOVIGILANCE AND RISK MANAGEMENT BY THE  REGULATORY BODY

Another change occurring in Japan are the activities conducted by the regulatory body itself, which are distinct from the regulation for the drug companies. Traditionally, the contribution of the regulatory body to drug safety has mainly been achieved through regu-lating the drug company, though there have been some exceptions including collecting spontaneous reports directly from health professionals. Many of the new activities still remain in the planning stage but the enterprises encompass a wide range of areas, includ-ing risk management planning. First, the research on the methodology and logistics for the data mining technique employed by several foreign regulatory bodies (e.g., the procedures using proportional report-ing ratio (PRR) in the UK Medicines and Healthcare products Regulatory Agency (MHRA) and Bayesian Confidence Propagation Neural Network (BCPNN) in WHO Uppsala Monitoring Center) has been initi-ated inside PMDA (PMDA, 2005). The research in the PMDA aims to develop the procedures that can be used in the daily regulatory activity by the end of 2008. Second, a network of sentinel monitoring centers, consisting of a couple of hospitals, is being formed to provide the regulatory body with infor-mation associated with drug safety and other issues. According to the PMDA, the PMDA has already operated this system for recently approved concomi-tant anti-cancer drugs. Third, the information center for pregnancy and drug use will be made in the National Center for Child Health and Development (NCCHD) (MHLW, 2005a). In this network, the NCCHD functions as a centre for consultation with pregnant women who became anxious about the effect of a drug taken during pregnancy. The scheme will be run in collaboration with the hospital for sick chil-dren in Toronto, Canada. Similar to the Canadian ‘Motherisk program,’ the NCCHD collects informa-tion on the outcome of the pregnancy. The informa-tion obtained in the follow-up will be used in the regulation, including updates to the package insert. Fourth, the 4-year enterprise for compiling the ‘ADR manuals’ has been started in 2005 to provide the information related to the serious ADRs to health professionals (MHLW, 2005b). The information may include a description of the clinical course of typi-cal cases, diagnosis, laboratory data, risk factors and treatment for the ADRs. Fifth, the information to facil-itate the patient’s prognostic and preventive measures in the early stage of serious ADRs is being collected and will be distributed through the website and other media. Sixth, the medication guides for patients regarding the drugs which need special attention are being developed under the leadership of the regula-tory body. This may again promote the appropriate use of drugs by the patients to minimize the chance of serious events and maximize the chance of their early detection.