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Barriers that impede the safety of medicinal products for children.

The European Paediatric Regulation 2007 was introduced to improve development of high quality medicines for children. A lack of appropriate medicines for this client group is an extensive and well-documented problem and the use of off-label and unlicensed medication is a widespread practice. Ernest et al ( 2007 ) state that most drugs are not labelled, or are inadequately labelled, for use in child patients. Critical safety and efficacy information is lacking and poses significant risks to this vulnerable population.