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Current Drug Targets


ISSN (Print): 1389-4501
ISSN (Online): 1873-5592

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

Author(s): Christian Lenk

Volume 13, Issue 7, 2012

Page: [878 - 884] Pages: 7

DOI: 10.2174/138945012800675759

Price: $65


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.

Keywords: Ethical and legal regulation, off-label use, paediatrics, effective drugs, dosage, children, adolescents, unlicensed drug, Pediatric Rule, quality and safety

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