Reported adverse drug reactions and their determinants in Dutch children outside the hospital.
OBJECTIVE
The interpretation of the available studies on adverse drug reactions (ADRs) in children outside the hospital is hampered because none of these studies used a control group. The aim of this study was to describe ADRs in children outside the hospital, controlled for drug use in the paediatric background population.


METHODS
Using a case-control design, we compared drugs on which a suspected ADR was reported to the Netherlands Pharmacovigilance Centre LAREB, and drugs used in the general paediatric population from the InterAction pharmacy database, both in the year 2001, for children aged 0-16 years.


RESULTS
The main findings are that ADRs were disproportionately more often reported on systemic drugs (OR 3.0; [95%CI: 1.9-4.8]), new drugs (2.4; [1.6-2.7]), anti-infective drugs (1.7; [1.1-2.7]) and nervous system drugs (2.1; [1.3-3.5]), whereas unlicensed drugs (0.1; [0.0-0.4]), frequently used drugs (0.3; [0.2-0.5]) and dermatologicals (0.1; [0.0-0.4]) were less likely to be associated with a reported ADR. Overall, the proportion of off-label prescriptions did not differ between drugs suspected of an ADR and drugs used by children in a general population.


CONCLUSIONS
The pattern of drugs associated with a reported ADR could not be solely explained on the basis of drug utilisation patterns in the general population.
Schirm
Eric
E
Groningen University Institute for Drug Exploration, University of Groningen, Department of Social Pharmacy, Pharmacoepidemiology and Pharmacotherapy, Groningen, The Netherlands.
Tobi
Hilde
H
van Puijenbroek
Eugène P
EP
Monster-Simons
Margje H
MH
de Jong-van den Berg
Lolkje T W
LT
D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000145:classification / Q000627:therapeutic use; D016022:Case-Control Studies; D002648:Child; D002675:Child, Preschool; D016303:Clinical Pharmacy Information Systems; D011307:Drug Prescriptions / Q000145:classification / Q000706:statistics & numerical data; D017723:Drug Utilization Review; D006801:Humans; D007223:Infant; D009426:Netherlands / Q000453:epidemiology; D010818:Practice Patterns, Physicians'; D013997:Time Factors
D000890:Anti-Infective Agents