Survey of adverse drug reactions on a pediatric ward: a strategy for early and detailed detection.
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.
Weiss
Jutta
J
Department of Pediatrics, University of Erlangen-Nürnberg, Erlangen, Germany.
Krebs
Sabine
S
Hoffmann
Claudia
C
Werner
Ulrike
U
Neubert
Antje
A
Brune
Kay
K
Rascher
Wolfgang
W
D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D000465:Algorithms; D002648:Child; D002675:Child, Preschool; D003141:Communicable Diseases / Q000188:drug therapy; D003625:Data Collection; D064420:Drug-Related Side Effects and Adverse Reactions; D006743:Hospital Bed Capacity, under 100; D006757:Hospital Units / Q000706:statistics & numerical data*; D006785:Hospitals, University / Q000706:statistics & numerical data; D006801:Humans; D007223:Infant; D010356:Patient Isolation; D010372:Pediatrics / Q000706:statistics & numerical data*; D011336:Probability; D011446:Prospective Studies