Off-label prescription refers to the use of a medication beyond what it is established in the respective Marketing Authorization Application (MA). This broad definition encompasses situations in which the drug was used for a therapeutic indication not authorized in the MA; with a different dosage or with a different frequency than those mentioned in the MA; introduced in the patient’s body by a different procedure, not stated in the MA; or to a group of patients not specified in the MA.The freedom of prescription is a defining note of the medical profession; therefore, the doctor has the power to choose which drug to use, even disregarding the content of the MA, provided it complies with the medical leges artis. However, when a drug is prescribed off-label this means that it is being used in a medical scenario for which it has not been specifically authorized (i.e., the drug was not submitted to clinical trials concerning that particular medical situation). Because of the lack of scientific evidences regarding the efficiency and safety of the drug the patient can suffer serious injuries and, consequently, the doctor and the pharmaceutical company are more susceptible to lawsuits. This is the reason why it is of outmost importance to provide proper legal protection to patients’ rights (namely, the right to inform consent) and to guarantee that either the pharmaceutical company either the doctor act for the benefit of patient’s safety.
Vera Lúcia C. Raposo, University of Macau, China
Stream: Law 10. Laws of Health and Medicine
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