Русский
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.
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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