Abstract
The availability of first-line medicines for the treatment of drug susceptible tuberculosis (DS-TB) is inconsistent across European countries. This is particularly worrisome for child-friendly medicines. There were reported examples of physicians being forced to adapt and/or combine formulations intended for adults to treat children with TB. Reduced compliance, unknown effects on treatment outcomes and unpredictable toxicity are potential consequences of resorting to these sub-optimal treatment options. Furthermore, the use of these alternatives may increase the risk of drug resistant TB. This study analyzed the availability and use of TB medicines in the European Union (EU)/ European Economic Area (EEA), with a particular focus on child-friendly formulations. We sought to carry out a full review of the situation by means of a survey involving the EU regulatory network. Countries were asked to confirm marketing status of anti DS-TB medicines, ways used to overcome their absence in their territory and the general difficulties they face to treat children with TB. Results confirmed that rifampicin suspension is the only child-friendly formulation available in Europe, approved in just ten Member States. Overall, 24 countries out of 30 considered the lack of adequate DS-TB medicines an unmet medical need. To overcome this, countries confirmed that they resort to importation or use adapted formulations. The joint forces of European institutions and pharmaceutical industry are crucial for the development of pediatric formulations and contribute to better compliance and health outcomes.
Footnotes
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- Received December 21, 2022.
- Accepted May 25, 2023.
- Copyright ©The authors 2023
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