藥品仿單標示外使用(Off-Label Use)

The package inserts (label) accompanying with prescription drug packages outline the drug's efficacy and safety informations, which have been reviewed and confirmed by the Department of Health. Off-label use refers to the prescription of a registered drug for a use that is not included or disclaimed in the package insert. Examples include use in a different indication, dose, patient population, route, or dosage form that is not approved by regulatory authorities. Prescribing drugs off-label is common in the medical community and some reasons can be attributed to the popularity of off-label uses. First package inserts usually do not show complete information of drug uses; second, drug manufacturers are not willing to obtain approval for off-label uses; and the last is off-label uses are essential for optimal patient care. It is admitted that off-label uses are necessary for clinical treatments, but several doubts also arise from that. Off-label drug uses create special risks, which do not arise when drugs are used in manners that are approved by Department of Health. Which measures should be taken to control the risks? The issues mentioned above need further discussion.