title: Off-label drug use in paediatrics: a world-wide problem.
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.
authors.affiliation: Institutional Review Board, Ulm University, Institute for History, Theory & Ethics of Medicine, Frauensteige 6, D-89075 Ulm, Germany. christian.lenk@uni-ulm.de
authors.forename: Christian
authors.initials: C
authors.lastname: Lenk
mesh_terms: D000293:Adolescent; D002648:Child; D003906:Developing Countries; D004989:Ethics; D005062:European Union; D014943:Global Health; D006801:Humans; D056687:Off-Label Use / Q000941:ethics / Q000331:legislation & jurisprudence; D010372:Pediatrics