The off-label use of medicines in pediatric outpatients in Bulgaria based on an analysis of their prescription data

Background The off-label use of medicines is a common practice that occurs over a wide range of therapeutic areas in both adults and children, but occurs much more frequently in pediatric population. So far, the extent of off-label use among children in Bulgaria has not been studied. Objective The aim of this nested, retrospective, non-interventional, single-center study is to provide data on the frequency, type, and the most common situations in which off-label medicines are prescribed in daily pediatric practice in Bulgaria. Methods The data on prescriptions of 360 pediatric outpatients, treated during a 1-year period, were recorded and provided for analysis. The summaries of product characteristics (SmPC) were used as reference documents for the assessment of prescriptions. Descriptive statistics, with absolute frequencies, means, and standard deviation, were used to analyze the processed data. Results The results from this study show that most pediatric patients (78%) were exposed to off-label use. Half of the medicines prescribed off-label were used for a therapeutic indication other than the one listed in the SmPC. We found that certain medicines were used 100% off-label, and certain diseases were also 100% treated with off-label medications. Conclusion Although the study was limited to one center, it deserves attention as it reveals many different aspects of the off-label use of medications in pediatric patients in Bulgaria. Further studies involving a larger number of medical centers are needed to establish more accurate data on off-label prescribing in pediatric patients at a national level.