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Acta Paediatr. 2011 Sep;100(9):1272-5. doi: 10.1111/j.1651-2227.2011.02287.x. Epub 2011 May 11.

Paediatric drug use with focus on off-label prescriptions in Swedish outpatient care--a nationwide study.

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  • 1Department of Pharmacovigilance, Medical Products Agency, Uppsala, Sweden.



To determine drug prescription and proportion of off-label dispensing in the Swedish paediatric outpatient population.


All dispensed outpatient prescriptions to children aged 0 < 18 years as well as the proportion of off-label drug use during 2007 were analysed using data from the Swedish Prescribed Drug Register.


In total, 2.19 million drug prescriptions of 898 different drug substances were dispensed to paediatric patients, and of those substances, 64% had been dispensed off-label at least once. The overall off-label rate of all prescriptions was 13.5%, among which topical drugs as well as sex hormones were the most commonly prescribed off-label drugs. More than half of all children in Sweden had received at least one prescribed drug in 2007.


There is a high prescribing of medicines to children in outpatient care in Sweden with a considerable amount of off-label prescriptions. Topically administered drugs, sex hormones, antidepressants, hypnotics, cardiovascular drugs and nonsteroidal anti-inflammatory drugs were commonly prescribed off-label.

© 2011 The Author(s)/Acta Paediatrica © 2011 Foundation Acta Paediatrica.

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