Physician's knowledge and experience with the off-label use of medicines

Abstract

The off-label use of medicines is neither prohibited nor explicitly allowed, according to the current European Union (EU) pharmaceutical legislation. This can cause confusion in physicians’ practice as well as lead to patients’ dissatisfaction. The purpose of this survey is to assess the knowledge and experience of Bulgarian physicians with the off-label use of medicines. The survey was performed at the beginning of 2020 in the biggest private hospital in South-Central Bulgaria. Ninety-six physicians from the inpatient and outpatient medical care participated in the survey and answered 10 questions. The data analysis was performed using the statistical program SPSS v19.0. The results are described as numbers and percentages for the qualitative variables and mean value (median due to their distribution) and a variance measure (range) for the quantitative ones. The distribution of the variables was tested with the Kolmogorov–Smirnov test. The evaluation of the relationships between the qualitative variables was performed using the χ 2 test or the Fisher's exact test, where applicable. The results showed that most of the participants (81%) have never prescribed medicines off-label and believe it is not allowed to use medicines off-label (73%). Physicians strongly support the introduction of clear rules for the off-label use (88%). In conclusion, physicians practicing outside of the capital city demonstrated good level of knowledge, but relatively low awareness and little experience with the off-label use of medicines. They feel also, uncertainty in their prescribing activities when they use medicines off-label and strongly support introduction of clear rules for the off-label use.