Legal Aspects of Children’s Treatment With Medicines
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Abstract
The paper discusses the present-day practical and legal situation in children’s treatment with medicines, highlights the historical preconditions of treating children with drugs which have not been clinically tried by pediatric population are highlighted, and reviews the legal acts that regulate the development of medicines for children’s treatment. Most drugs being developed are only tried on adults before they are approved, both because of practical and technical difficulties in doing research on children as well as ethical considerations on inclusion of children in the trial of new drugs. Recently more attention has been drawn to the fact that pharmacotherapy in children does not have the same evidence-based platform as in adults: pediatricians are forced to prescribe medications off-label with uncertain efficacy and safety. In US, approximately 75% of all medications on the market do not have approved pediatric labeling. Children have been described as “therapeutic orphans” because of the deficit of appropriate studies in their age group.
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Section
Articles
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Authors retain copyright of their work, with first publication rights granted to the Association for Learning Technology.
Please see Copyright and Licence Agreement for further details.
