Causes and legal aspects of the off label drugs emergence: literature review

Abstract

“Off label use” is the use of a medicinal product “beyond the label”. The term has a broader meaning: use according to an indication, in a dosage form, dose, or scheme, in a population of patients, information about which is not contained in the approved instructions for the medical use of the drug. Today, in off-label therapy, an important unresolved legal issue remains professional responsibility for the selection and prescription of off-label drugs, since the situation in each country for off-label prescription of drugs is different. The work aimed to analyze the reasons and legal aspects of the appearance of off-label drugs worldwide.