Appropriate Drug Use for Children: What a Medical Doctor Must Know When Using an Unapproved or Off-label Drug

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  • Nakagawa Masao
    Department of Pediatrics, Kyoto Kizugawa Hospital, Kyoto, Japan

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  • 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―

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Abstract

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.

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