２．市場撤退薬の諸相

抄録

The burden of adverse drug reaction (ADR) is not limited to morbidity and mortality. It also causes healthcare burden as measured by direct cost of hospitalization, etc. as well as economic burden including indirect cost of labor loss and the withdrawal of drugs from the market. It inflicts additional burden on healthcare resources because of litigations that often ensue in cases of serious ADR. Drug withdrawal can be very costly for the companies involved. Since the 2000s, pharmacogenetics has attracted attention as a means of preventing ADRs. The Council for International Organizations of Medical Sciences (CIOMS) published a report on pharmacogenetics in 2005. The Committee to review cases of “Yakugai” hepatitis in Japan and the regulation aimed at preventing its recurrence was established in association with Ministry of Health, Labor and Welfare (MHLW) in May 2008. This paper reviewed the various research on drug withdrawal conducted in the UK and the rest of the world, the US, and Japan. Several litigation cases were introduced. Four preventive measures were discussed, i.e. 1)use of pharmacogenetics in preventing ADRs, 2)use of economic Darwinism by providing longer exclusivity periods to those drugs proven to be safe through long-term clinical trials, etc., 3)use of private or foreign drug review agency as well as margin and insurance systems, and 4)voluntary marketing suspension of drugs with questionable safety profile initiated by pharmaceutical companies.