Across European nations, the availability of first-line medicines for treating drug-susceptible tuberculosis (DS-TB) varies significantly, raising concerns, especially in the realm of child-friendly medications. Instances have been reported where physicians were compelled to modify or combine formulations designed for adults to treat pediatric TB cases. This reliance on suboptimal treatment options poses potential challenges such as decreased compliance, uncertain effects on treatment outcomes, and unpredictable toxicity. Moreover, the use of these alternatives may elevate the risk of developing drug-resistant TB.
This study meticulously examined the availability and utilization of TB medicines within the European Union (EU) and European Economic Area (EEA), with a specific emphasis on formulations suitable for children. The approach involved a comprehensive survey conducted through the EU regulatory network. Countries were queried about the marketing status of anti DS-TB medicines, strategies employed to address their absence, and the overall challenges encountered in treating pediatric TB.
The findings underscored that rifampicin suspension stands as the lone child-friendly formulation available in Europe, endorsed in merely ten Member States. Notably, 24 out of 30 countries acknowledged the deficiency of adequate DS-TB medicines as an unmet medical requirement. To cope with this shortfall, countries confirmed resorting to importation or utilizing adapted formulations.
Addressing this critical gap necessitates collaborative efforts from European institutions and the pharmaceutical industry. Their joint endeavors are pivotal for the development of pediatric formulations, ensuring improved compliance and enhanced health outcomes in the battle against tuberculosis.
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References
- Cherchi, A., Vaz, A., Coelho, A. C., Fregonese, L., & Thirstrup, S. (2023). Tuberculosis medicines for children in Europe: an unmet medical need. ERJ Open Research, 9(4), 00730–02022. https://doi.org/10.1183/23120541.00730-2022
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