2. Various Aspects of Drug Withdrawal

DOI 4 Citations 2 References
  • TSUTANI Kiichiro
    Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences,The University of Tokyo

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Other Title
  • 市販後に分かる薬の安全性と最近の撤退薬　　２．市場撤退薬の諸相

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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.

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Details 詳細情報について

  • CRID
    1390282680345647616
  • NII Article ID
    130004541283
  • DOI
    10.3999/jscpt.40.7
  • ISSN
    18828272
    03881601
  • Text Lang
    ja
  • Data Source
    • JaLC
    • Crossref
    • CiNii Articles
  • Abstract License Flag
    Disallowed

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