Pediatria pre prax 5/2011

Does the EU`s legislation serve the rational use of medicinal products in paediatric population?

Paediatric practitioners routinely use medicines unlicensed for use in children, which is referred to as the off-label use. The paper deals with the critical problems of the unsatisfactory availability of medicines for paediatric patients such as inappropriate drug formulations, lack of medicines with suitable dosing for children, and problems with performing clinical trials in children. Furthermore, it describes in detail the European legislation which entered into force at the beginning of 2007 and which is summarized in the Regulation (EC) No. 1901/2006 of the European Parliament and of the Council on paediatric medicines. The main goals of the legislation, i.e. the ways of motivating pharmaceutical producers to increase the availability of medicines for children and thus contribute to health improvement of children in Europe, are described. The paper lists medicinal products the research of which is crucial for paediatric population. It concludes with presenting the situation of off-label use of medicines in the Slovak Republic.

Keywords: children, paediatric regulation, off-label prescribing, paediatric investigation plan.