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Reported adverse drug reactions and their determinants in Dutch children outside the hospital
Author(s) -
Schirm Eric,
Tobi Hilde,
van Puijenbroek Eugène P.,
MonsterSimons Margje H.,
de Jongvan den Berg Lolkje T. W.
Publication year - 2004
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.843
Subject(s) - medicine , pharmacoepidemiology , drug , drug reaction , pediatrics , adverse effect , adverse drug reaction , emergency medicine , intensive care medicine , medical emergency , pharmacology , medical prescription
Purpose 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. Copyright © 2003 John Wiley & Sons, Ltd.