Legal Aspects Of The Prescription Of Drags For Off-label-use

E.A. Volskaya

Legal aspects of the prescription of drags for off-label-use
The article is dedicated to the problem of drugs administration out of the instructions for use (off-label-use). It is emphasized that the off-label-use of drugs applies not only for indications but also for others formal parameters, such as dosage form, dosage, mode of administration, etc. We discuss the practice of off-label-use in foreign countries, particularly in Germany. In Russia, there is no normative document giving guidance for action if off-label-use of drug required. Today, however, the legal practice of off-label-use may occur as individual therapy for health reasons when performing the necessary requirements for scientific substantiation of the potential benefit to the patient, decision-making by council of physicians, adequate informing the patient (or his representative) and patient voluntary informed consent.

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