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PEDIATRICS Vol. 110 No. 2 August 2002, pp. 254-257

Survey of Adverse Drug Reactions on a Pediatric Ward: A Strategy for Early and Detailed Detection

Jutta Weiss, MD^*, Sabine Krebs, RPh, Claudia Hoffmann, MD, Ulrike Werner, RPh, Antje Neubert, RPh, Kay Brune, MD and Wolfgang Rascher, MD^*

^* Department of Pediatrics, University of Erlangen-Nürnberg, Erlangen, Germany
Department of Experimental and Clinical Pharmacology and Toxicology, Erlangen, Germany

Objective. Adverse drug reactions (ADRs) occur frequently in children. However, the exact incidence of ADRs is unknown. Therefore, we studied ADRs in 1 ward and assessed whether a general approach, eg, by a computerized monitoring system, to detect ADRs in children is feasible and likely to yield a higher rate of early detected ADRs. The aim was to assess the usefulness of a computerized monitoring system before implementing costly adaptations.

Methods. An 8-month prospective study was conducted at a 10-bed pediatric isolation ward of the University Hospital. Charts were reviewed once weekly by a pharmacoepidemiological team. Clinical signs as well as laboratory changes were documented and assessed. Algorithms were used to assess the probability and severity of each detected event.

Results. All 214 patients admitted were enrolled in the study. A total of 68 ADRs were detected in 46 of 214 patients by the pharmacoepidemiological team. Thirty-four ADRs (50%) were detected by the staff physician, and 27 (40%) were detected primarily by analyzing laboratory parameters. Antibiotics-associated ADRs (50%) predominated, followed by glucocorticoids (16%), tuberculostatic (4%), and immunosuppressive agents (4%). In 5 cases, an ADR was responsible for the prolongation of hospital stay, and in 4 children, the ADR was responsible for hospitalization.

Conclusions. The detection rate of ADRs would almost be doubled by a computerized monitoring system analyzing laboratory data. Implementation of a computer monitor system that automatically generates laboratory signals may help to identify ADRs in children, and to reduce morbidity and hospital stay, as well as costs.

Key Words: children • adverse drug reaction • hospital pharmacoepidemiology • computer monitoring • off-label • unlicensed

Abbreviations: ADR, adverse drug reaction • WHO, World Health Organization • ADE, adverse drug event

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Received for publication Aug 14, 2001; Accepted Feb 26, 2002.

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