title: [Off-label use of drugs in paediatrics causes uncertainty].
abstract: The off-label use of drugs in paediatrics is a common practice casting doubts on the adequate safety of drug therapy. Regulatory initiatives of European and national legislators aim to address this paucity of clinical drug trials in paediatrics through clarifying regulations and incentives in pharmaceutical law, thereby promoting an increase in the approval of paediatric drugs, the improvement of drug and thus treatment safety. This paper describes the present situation in paediatrics and the legal status of off-label use in pharmaceutical law, medical malpractice law and statutory health insurance law.
authors.affiliation: Institut für Gesundheits- und Medizinrecht, Fachbereich Rechtswissenschaft, Universität Bremen. hart@uni-bremen.de
authors.forename: Dieter
authors.initials: D
authors.lastname: Hart
authors.forename: Bernd
authors.initials: B
authors.lastname: Mühlbauer
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic; D004348:Drug Labeling / Q000592:standards*; D005858:Germany; D006801:Humans; D007880:Legislation, Drug / Q000592:standards*; D010372:Pediatrics / Q000592:standards*; D035501:Uncertainty