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American Journal of Epidemiology Vol. 110, No. 2: 196-204
Copyright © 1979 by The Johns Hopkins University School of Hygiene and Public Health


research-article

DRUG UTILIZATION AND REPORTED ADVERSE REACTIONS IN HOSPITALIZED CHILDREN

ALLEN A. MITCHELL1,2,, PETER GOLDMAN1, SAMUEL SHAPIRO2 and DENNIS SLONE2

1 Clinical Pharmacology Unit, Children's Hospital Medical Center, the Departments of Pediatrics and Pharmacology, Harvard Medical School, the Center for the Analysis of Health Practices, Harvard School of Public Health
2 The Drug Epidemiology Unit, Boston University Medical Center Boston, MA

Reprint requests to Dr. Mitchell, Children's Hospital Medical Center, 300 Longwood Ave., Boston, MA 02115

An intensive drug surveillance program has been developed to study the clinical effects of drugs in hospitalized children. This program collects information on drug exposures and the occurrence of adverse clinical events. The 1669 children monitored to date received an average of 7.6 drugs during an average hospital stay of 8.4 days. A group of specified adverse clinical events, whether or not drug attributed, occurred in 45.7% of the patients; drug-attributed events (adverse drug reactions) occurred in 16.8%. Both drug use and reported adverse reactions tended to increase with age, except that newborns received many drugs but had the lowest reported adverse reaction rates. Newborns, however, had the highest rate of adverse events not attributed to drugs, suggesting that perhaps some of these latter events include presently unrecognized adverse drug reactions.

drug evaluation; drug utilization; pediatrics


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