Promotion of Commitment of Clinicians in Pharmacovigilance in Japan / 薬剤疫学

ABSTRACT

Although the two regulatory bodies, Pharmaceutical and Medical Devices Agency (PMDA) and Ministry of Health, Labour & Welfare (MHLW) cooperate in pharmacovigilance in Japan, presence of clinicians in the two bodies is surprisingly limited with only about twenty medical doctors compared more than 300 in CDER/CBER. The lack of doctors in PMDA, resulting from several factors including low social status and hard work, make them to review drugs and devices in which they are not expertised at all. For example, a paediatric cardiologist is obliged to review a drug for overactive bladder because no urologist is available for drug review in PMDA. Such a case would make the reviewer guilty of professional negligence. These critical issues make a PMDA reviewer rather dangerous than unexciting job. On the other hand, most Japanese doctors, heavily dependent on PMDA and pharmaceutical companies for drug information, would not commit in the drug review or pharmacovigilance. To make Japanese doctors more committed in pharmacovigilance, there are several measures to be implemented. First, better benefit, i.e. income, working hours, holidays. Second, escape clause for the reviewers. Third, more doctors to the Office of Safety rather than the Offices of New Drug. People outside PMDA can also contribute to pharmacovigilance with better media literacy and better understanding of PMDA.