Off-label medicine use in children and adolescents: results of a population-based study in Germany

BMC Public Health

Research Article

Wanli Zhuang¹  Ingrid-Katharina Wolf¹  Hildtraud Knopf¹  Antje Neubert²  Wolfgang Rascher²  Giselle Sarganas³ 

[1] Department of Epidemiology and Health Monitoring, Robert Koch Institute, General-Pape-Str. 62-66, 12101, Berlin, Germany;Department of Paediatrics and Adolescent Medicine, Paediatric Clinical Study Center, University Hospital Erlangen, Loschgestr. 15, 91054, Erlangen, Germany;Institute of Clinical Pharmacology and Toxicology, Charité Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany;

关键词: Off-label;    Children;    Paediatric;    KiGGS study;    Under-dosing;   

DOI  :  10.1186/1471-2458-13-631

 received in 2013-02-21, accepted in 2013-06-26,  发布年份 2013

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© Knopf et al.; licensee BioMed Central Ltd. 2013