Marta Bilska, Grzegorz Grześk

Zastosowanie leku poza wskazaniami, ale zgodnie z aktualną wiedzą medyczną

Off label use of drugs, but according to current medical knowledge

Off label treatment occurs in case of the conflict between prescription and information contained in the Summaries of Product Characteristics (SPC). It includes the application of drugs beyond approved indications, for unapproved age group, with different dosage regimens or different administration route.

Off label drug use frequently occurs in medical practice because knowledge of the effectiveness of drugs is constantly evolving. The choice of therapeutic method should be consistent with the recent scientific evidence. Medical professionals regard ordination of drugs should depend on active pharmaceutical ingredient and evidence of efficacy. It is necessary to establish a registry for off label drug use.

Keywords: off label use of drugs, indications of drugs, Summary of Product Characteristics.

© Farm Pol, 2017, 73 (5): 322–327