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

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Abstract

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.

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Authors and Affiliations

  1. Faculty of Pharmacy, Medical University Sofia, 2 Dunav Str., 1000, Sofia, Bulgaria

    Maria Drenska, S. Elitova & I. Getov

  2. Acibadem City Clinic Cancer Center, Sofia, Bulgaria

    V. Grigorova

  3. Faculty of Public Health, Medical University Sofia, Sofia, Bulgaria

    E. Naseva

Authors
  1. Maria Drenska
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  2. V. Grigorova
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  3. S. Elitova
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  4. E. Naseva
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  5. I. Getov
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Corresponding author

Correspondence to Maria Drenska.

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Conflict of interest

M. Drenska, V. Grigorova, S. Elitova, E. Naseva, I. Getov have no conflicts of interest that are directly relevant to the content of this article.

Funding

No sources of funding were used to conduct this study or prepare this manuscript.

Ethical approval

This retrospective study is based on recorded data and approval from owners of the data was received.

Data confidentiality

Data confidentiality of all prescription records were respected at all time. Information about the identity of the patients was not collected.

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Drenska, M., Grigorova, V., Elitova, S. et al. The off-label use of medicines in pediatric outpatients in Bulgaria based on an analysis of their prescription data. Drugs Ther Perspect 35, 391–395 (2019). https://doi.org/10.1007/s40267-019-00638-4

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  • DOI: https://doi.org/10.1007/s40267-019-00638-4

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