Abstract
BackgroundPopulation-based self-reported data on off-label medicine use independent from health care provisions are lacking. The purpose of this study is to investigate off-label medicine use in children and adolescents in Germany in a non-clinical setting and to identify prevalence, determinants and spectrum of off-label medicine use.MethodsData were obtained from the German Health Interview and Examination Survey for Children and Adolescents (KiGGS) conducted by the Robert Koch Institute (2003–2006). 17,450 randomly selected children aged 0–17 years took part in the drug interviews. Of those, 8,899 took at least one medicine during the 7 days preceding the interview. Off-label medicine use was defined as the discrepancy between actual use and the intended use described in the summary of product characteristics. Off-label medicine use was stratified into off-label indication, off-label age, off-label over-dosing, and off-label under-dosing.ResultsThe prevalence rate of off-label medicine use among those who used medicines amount of is 40.2%. The prevalence rate is significantly higher in boys (41.4%), in children aged 3 to 6 years (48.7%), without migration background (40.9%), with high social status (42.5%), living in small (42.0%) and medium sized cities (41.6%), and with a poor parents rated health status (41.7%). 12,667 preparations (attributable in respect to off-label use) were taken by 8,899 children. 30% of the medicines have been used off-label. Off-label medicine use was highest in preparations of the ATC-class “C00 Cardiovascular System”. In all origins of medicine, all age groups and all ATC-classes under-dosing was the most frequent reason for off-label medicine use.ConclusionsThere is a considerable level of self-reported off-label medicines use in the general paediatric population. Further investigations are needed to examine in how far off-label medicine use is based on lack of knowledge or on empiricism in paediatric pharmacotherapy. Attention also needs to be paid to under-dosing which potentially exposes drug users to risks of side effects without the benefit of a therapeutic effect. Clinical trials for licensing of paediatric medicines, education of health care professionals, but also of parents and carers are needed to ensure the rational use of medicines.
Highlights
Population-based self-reported data on off-label medicine use independent from health care provisions are lacking
Among medicines which were newly licensed by the European Medicine Agency (EMA) between 1995 and 2005 only one third was licensed for children [2]
There is hope that this situation will improve with the Paediatric Regulation [3] which came into force in 2007 and which requires companies to develop a paediatric investigation plan (PIP), while granting incentives once a license for paediatric use has been obtained
Summary
Population-based self-reported data on off-label medicine use independent from health care provisions are lacking. Off-label medicine use among children and adolescents constitutes an important public health issue as the effects and potential health risks may be unpredictable. Pioneering work in this area was conducted already in the year 1953 by the paediatrician F. National and international studies report a wide range of prevalence rates of off-label medicine use in children and adolescents, reaching from 3.2% to 80% [4,5,6,7,8,9,10,11,12,13,14,15,16,17,18]
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