A Systematic Review of Decided Litigated Cases on Adverse Drug Events in Japan: Classification of Decided Cases Appearing in Law Reports

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  • Eguchi Rika
    Fukuoka City Pharmaceutical Association Pharmacy Nanakuma Branch Department of Health Care Administration and Management, Graduate School of Medical Sciences, Kyushu University
  • Kato Masahisa
    Fukuoka City Pharmaceutical Association Pharmacy Nanakuma Branch
  • Kaneko Erina
    Fukuoka City Pharmaceutical Association Pharmacy Nanakuma Branch
  • Kusaba Kenji
    Fukuoka City Pharmaceutical Association Pharmacy Nanakuma Branch
  • Yoshikawa Manabu
    Fukuoka City Pharmaceutical Association Pharmacy Nanakuma Branch
  • Yamano Toru
    Fukuoka City Pharmaceutical Association
  • Seo Takashi
    Fukuoka City Pharmaceutical Association
  • Hagihara Akihito
    Department of Health Care Administration and Management, Graduate School of Medical Sciences, Kyushu University

Bibliographic Information

Other Title
  • わが国における薬剤による有害事象に関する判例の検討：判例誌掲載例の分類
  • ワガクニ ニ オケル ヤクザイ ニ ヨル ユウガイ ジショウ ニ カンスル ハンレイ ノ ケントウ : ハンレイシ ケイサイレイ ノ ブンルイ

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Abstract

  Much of the damage to health caused by drugs could be prevented by appropriate care. A well-defined duty of care and further information are required for healthcare professionals. Although there are many litigation cases to use as references, neither the extent of the duty of care nor the obligation to explain medication according to the type of drug prescribed has yet been fully established. Thus, we systematically collected decided cases of adverse drug events, and assessed the degree of the duties of care and information. Specifically, we collected decided cases in which physicians, dentists, pharmacists, nurses, or hospitals had been sued. Data were derived from Bessatsu Jurist Iryo-kago Hanrei Hyakusen, Hanrei Jihou, and Hanrei Times from 1989 to November 2013, and information on precedents in the records of the Supreme Court of Japan from 2001 to November 2013. We analyzed the cases, and assessed the following according to the type of drug: (1) standards and explanations when dealing with drugs that were critical issues in litigation, and (2) the degree of the physician's or pharmacist's duties of care and information. In total, 126 cases were collected. The number of drug categories classified was 27, and 9 were considered of practical importance. After this systematic review, we found a trend in the degree of the required level of care and information on several drugs. With respect to duties of care and information, the gap between the required level and actual practice suggests that healthcare professionals must improve their care and explanations.<br>

Journal

  • YAKUGAKU ZASSHI

    YAKUGAKU ZASSHI 135 (3), 501-506, 2015-03-01

    The Pharmaceutical Society of Japan

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