Agnieszka Zimmermann, Rafał Zimmermann

Stosowanie leku off-label - aspekt prawny

Off label use of medicines - legal aspect. Off label use of medicines described in the Summary of Medicinal Product Characteristics (SPC) raise the pharmacists and physicians doubts. This is a problem of legal, ethical and economical nature - connected with the possibility to refund cost of the therapy with an off-label medicinal product. It mainly refers to the application of medicinal products which do not include recommendations of pediatrics but are used in the treatment of children as well as to the oncological preparation used in chemotherapy schemes other than those resulting from the registration indications or in the treatment of rare types of tumours.