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KMID : 1011320100030010001
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Journal of Pharmacoepidemiology and Risk Management
2010 Volume.3 No. 1 p.1 ~ p.6
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Off-label Drug Use and Its Implications for Evidence-based Decision Making
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Shin Ju-Young
Jung Sun-Young
Park Byung-Joo
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Abstract
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Off-label prescribing refers to the use of a drug for an indication which is not included in the approved labeling of the drug from regulatory agency such as FDA. Off-label prescribing is legal and common in clinical settings. Although this practice provides a pathway to innovation in clincal practice, it raises key concerns about risk to patients. Therefore, it has long been controversial in several aspects. This paper addresses the issues concerning risks and benefits of off-label drug use and overview the studies related to the off-label use in other countries. Ultimately, we will suggest the possible solutions for evidence-based decision-making in clinical setting.
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KEYWORD
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Off-label, Unlicensed drug, Risk-benefit, Drug safety, Evidence-based decision making, Pharmacoepidemiology
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