Curr Drug Targets. 2012 Apr 18. [Epub ahead of print]
Off-label drug use in paediatrics: a world-wide problem.
Source
Institutional Review Board, Ulm University, Institute for History, Theory & Ethics of Medicine, Frauensteige 6, D-89075 Ulm. christian.lenk@uni-ulm.de.
Abstract
Since more than 35 years, the international medical scientific community tries to solve the problem of the off-label 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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