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.

摘要

根据现行的欧盟（EU）药品法规，既不禁止也不明确允许非标签使用药物。这可能会导致医师执业混乱，并导致患者不满。这项调查的目的是评估保加利亚医生在非标签使用药物方面的知识和经验。该调查于2020年初在保加利亚中南部最大的私立医院进行。来自住院和门诊医疗服务的96位医生参加了调查，并回答了10个问题。使用统计程序SPSS v19.0进行数据分析。结果描述为定性变量的数量和百分比，平均值（由于其分布而中位数）和定量变量的方差度量（范围）。变量的分布通过Kolmogorov–Smirnov检验进行了检验。定性变量之间的关系的评估是使用χ ²检验或Fisher精确检验，如适用。结果显示，大多数参与者（81％）从未处方过处方药，并认为不允许使用处方外药品（73％）。医师强烈支持为标签外使用制定明确的规则（88％）。总之，在首都以外地区执业的医生表现出较高的知识水平，但认知水平相对较低，并且在标签外使用药物的经验很少。他们还感到，在使用非标签药品时，他们的处方活动存在不确定性，并强烈支持为非标签药品的使用制定明确的规则。