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KMID : 1011120230160020073
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Bioethics Policy Studies
2023 Volume.16 No. 2 p.73 ~ p.87
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A Study on the Improvement of Off-Label Drug Use Management System
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Kim Ji-Hye
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Abstract
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When a drug has been approved by the regulatory authorities for indications, ages, doses, and routes of administration, but any of them is used for purposes not listed in the permit, it is referred to as off-label drug use. The off-label drug use is often used for patients in vulnerable situations, such as children, the elderly, and cancer patients, who have difficulty in clinical trials for indication and dose determination.
Appropriate off-label drug use can lead to the expansion of patients’ right to treatment, and systematic monitoring can help identify the current status of drugs used outside the license and ensure the stability of drug use. However, criticism cannot be avoided that there is no consistent and systematic safety management for off-label drug use in Korea because the procedures for off-label drug use of benefits and non-benefit drugs, general drugs and anticancer drugs are different.
Therefore, after reviewing the concept and characteristics of off-label drug use, and the current status and problems of the domestic management system, I would like to argue the necessity of preparing decision-making procedures for expert groups and protecting patients’ right to self-determination.
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KEYWORD
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off-label drug use, medication management
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