Prescribing of medicines in the Danish paediatric population outwith the licensed age group: characteristics of adverse drug reactions.
OBJECTIVE
To identify adverse drug reactions (ADRs) associated with off-label prescribing of medicines in a paediatric population.


METHODS
We analysed spontaneous ADR reports for children from ages 0 to 17 years submitted to the Danish national ADR database from 1998 to 2007. We defined off-label prescribing as prescriptions outside the licensed age group. Off-label ADRs were categorized by therapeutic group, age of child, type and severity. The unit of analysis was one ADR.


RESULTS
We analysed 4388 ADRs for children reported in the national database. Approximately 17% of reported ADRs were associated with off-label use, 60% of them serious. More than one half of off-label ADRs were reported in adolescents. Serious ADRs due to off-label prescribing are more likely to be reported for hormonal contraceptives (ATC group G), anti-acne preparations (ATC group D) and allergens (ATC group V).


CONCLUSIONS
One-fifth of all ADRs reported over a decade in Danish children was associated with off-label prescribing, and serious ADRs due to off-label prescribing were primarily present in three therapeutic groups: sex hormones, dermatologicals and allergens. There is a need for more research into the prescribing of these medicines in the teenage population, as well as tighter reporting and monitoring of ADRs for medicines prescribed off-label in the paediatric population.
Department of Pharmacology and Pharmacotherapy, Section for Social Pharmacy, Faculty of Pharmaceutical Sciences, University of Copenhagen, FKL-Research Centre for Quality in Medicine Use, Copenhagen, Denmark. laa@farma.ku.dk
Lise
L
Aagaard
Ebba Holme
EH
Hansen
D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D017677:Age Distribution; D002648:Child; D002675:Child, Preschool; D003718:Denmark / Q000453:epidemiology; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000209:etiology; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D056687:Off-Label Use / Q000706:statistics & numerical data*; D012189:Retrospective Studies; D012720:Severity of Illness Index; D055815:Young Adult
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