Janusz Jaroszyński, Marta Roszkowska, Zofia Specht-Szwoch

Prawno-medyczne aspekty stosowania produktów leczniczych poza wskazaniami rejestracyjnymi (off label use). Część 3

Legal and medical aspects of off-label use of medicinal products. Part 3

Off-label use of medicinal products raises a lot of questions regarding the interpretation not only among physicians but also pharmacists and lawyers. The use of drugs in a manner other than that specified in the Summary of Product Characteristics is not regulated in the Polish law. The author’s goal is to present the topic not only in theoretical terms but mainly from the practical perspective, indicating specific examples and system solutions which are extremely important in the functioning of the entire health care system. Currently, the question of doctor and pharmacist’s responsibility is becoming increasingly important, especially in the context of concluding contractual agreements. The publication indicates a narrow line between the medical experiment and acting in accordance with current medical knowledge.

Keywords: off label use, medical benefits, charge, patient

© Farm Pol, 2015, 71(5): 321-327