The use of off-label drugs in medicine: ethical and legal issues.
Keywords:off-label drug use, pharmaceuticals, prescribing
The term off-label drug describes the use of a particular drug outside its approved indication, dose, frequency and route of administration of that patient group for which it is registered. Despite the stated definition indicating a certain risk for their application, off-label application is part of everyday medical practice and is often the only treatment option for patients when no suitable approved drug is available. Possible legal-ethical-medical problems for a physician may arise if after such a therapy an adverse outcome occurs, not necessarily due to a given therapy. Drug Commission and Clinical Pharmacologists from the physician's institution could be the first instance to which a doctor might address if his intended treatment includes off-label medication.
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