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Pediatrics. 2002 Aug;110(2 Pt 1):254-7.

Survey of adverse drug reactions on a pediatric ward: a strategy for early and detailed detection.

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  • 1Department of Pediatrics, University of Erlangen-N├╝rnberg, Erlangen, Germany.

Abstract

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.

PMID:
12165575
[PubMed - indexed for MEDLINE]
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