thesis
Use and Safety of Respiratory Medicines in Children
- Publication date
- 9 February 2011
- Publisher
- The lack of appropriately authorised and formulated medicines for use in the pediatric population
is a longstanding problem and cause for concern. As a result, most medicines are prescribed
to children on an off -label or an unlicensed
basis. Dosing regimens approved for adults are extrapolated to pediatric age
groups, for example on the basis of proportionality of weight, without pediatric pharmacokinetic
or pharmacodynamic data. Safety and effi cacy are presumed to be the same as in
adults, but this may not be the case. Evidence-based information in children is often not readily
available, and prescribing decisions may have to be based on accepted practice presented in
formularies.
On January 26, 2007, the new regulation of the European Union (EU) on medicinal products
for pediatric use came into force. The overall aim of the regulation is to improve the health
of children in the EU. More specifi cally the objectives include: increasing the development of
medicines for use in children; ensuring that medicines used to treat chil
