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Off-Label Drug Use in Paediatrics: A World-Wide Problem

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Since more than 35 years, the international medical scientific community tries to solve the problem of the offlabel use of paediatric drugs. The aim is simple, but ambitious: to supply children and adolescents with effective drugs, as safe as possible, with known and well-documented side effects, and with accurate and up-to-date information on dosage and administration form. However, despite the significant efforts of paediatricians, researchers and international health politics, a number of severe obstacles for the optimal supply of children and adolescents with safe drugs remain. The detailed analysis of the problem shows not only a still remaining lack of medical knowledge, but also persistent weaknesses in the ethical, legal, medical, pharmacological, and political practices that surround the phenomenon of off-label use in paediatrics. The article gives an overview about the remaining difficulties in the field of paediatric off-label medication with special consideration to ethical and regulatory questions.
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Keywords: Ethical and legal regulation; Pediatric Rule; adolescents; children; dosage; effective drugs; off-label use; paediatrics; quality and safety; unlicensed drug

Document Type: Research Article

Affiliations: Institutional Review Board, Ulm University, Institute for History, Theory & Ethics of Medicine, Frauensteige 6, D-89075 Ulm, Germany.

Publication date: 2012-06-01

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  • Current Drug Targets aims to cover the latest and most outstanding developments on the medicinal chemistry and pharmacology of molecular drug targets e.g. disease specific proteins, receptors, enzymes, genes. Each issue of the journal will be devoted to a single timely topic, with series of in-depth reviews, written by leaders in the field, covering a range of current topics on drug targets. These issues will be organized and led by a guest editor who is a recognized expert in the overall topic. As the discovery, identification, characterisation and validation of novel human drug targets for drug discovery continues to grow; this journal will be essential reading for all pharmaceutical scientists involved in drug discovery and development.
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