医薬品の適正使用について ―未承認薬・適応外薬の使用にあたって―  [in Japanese] Appropriate Drug Use for Children: What a Medical Doctor Must Know When Using an Unapproved or Off-label Drug  [in Japanese]

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Abstract

禁忌とされる医薬品が使用され社会問題にまで発展したことを受け,医薬品の適正使用と医師の裁量に基づく未承認薬や適応外薬の使用に対する考え方について述べた.<br> 医療の場において,他に治療法がない場合には医師は裁量により薬事法や保険診療上認められていない医療行為であっても行うことがある.未承認や適応外の医薬品等の使用もその一つである.この場合,倫理委員会の承認とともに患者の同意や承諾を得たとしても,医療水準を基準にして事後的に注意義務違反が存在し,それに伴い患者の生命・身体に重大な損害が生じれば,医師の裁量権の逸脱として違法行為となると考えられる.医薬品の添付文書は薬事法で定められた唯一法的根拠に基づいた公的文書であり,医療の基準となっている.添付文書に禁忌とされた医薬品の使用法は健康被害のリスクが高いため避けられねばならない.医師は医薬品の使用にあたって,必ず添付文書に目を通しておくべきである.

Information is provided that a medical doctor must know when using an unapproved or off-label drug.<br>News of the death of an infant sedated with propofol, a contraindicated drug for patients under mechanical ventilation in the intensive care unit, has developed into a serious social problem. Although, as a general rule, unapproved or off-label and contraindicated drugs should not be used, they are indispensably used at the discretion of medical doctors, especially when no other treatment has been established. However, this discretion does not legally protect doctors from medical law suits if such unapproved or off-label drugs have harmful effects, even if they obtained the approval of the ethical committee and informed consent from the patients. This is because discretion is considered a legal concept that guides the decision to violate a medical standard, and a serious harmful effect caused by an unapproved or off-label drug would suggest that the violation was a deviation from the discretion of a medical doctor. The drug information sheet is the only official document provided by the Pharmaceutical Affairs Law, and therefore, the standard of medical treatment depends on it. It goes without saying that we must avoid using drugs in contraindicated ways, since previous evidence has demonstrated them unsafe and risky.<br>Medical doctors should read the drug information sheet before using medicines for the first time.

Journal

  • Pediatric Cardiology and Cardiac Surgery

    Pediatric Cardiology and Cardiac Surgery 30(5), 498-502, 2014

    Japanese Society of Pediatric Cardiology and Cardiac Surgery

Codes

  • NII Article ID (NAID)
    130004700072
  • Text Lang
    JPN
  • ISSN
    0911-1794
  • Data Source
    J-STAGE 
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