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Drug utilization and reported adverse reactions in hospitalized children
Insights
A drug surveillance program monitored 1669 children, finding adverse drug reactions in 16.8%. While drug use and reactions increase with age, newborns had few reactions but high unclassified adverse events, possibly unrecognized drug reactions.
Area of Science:
- Pediatric Pharmacology
- Clinical Drug Surveillance
- Patient Safety
Background:
- Hospitalized children often receive multiple medications.
- Understanding drug effects and adverse events in pediatric populations is crucial.
- Existing surveillance methods may not fully capture pediatric drug-related morbidities.
Purpose of the Study:
- To implement and evaluate an intensive drug surveillance program for hospitalized children.
- To collect data on drug exposures and clinical events.
- To determine the incidence of adverse drug reactions in this population.
Main Methods:
- Established a drug surveillance program in a pediatric setting.
- Monitored 1669 children during their hospital stay.
- Collected data on all drugs administered and occurrence of adverse clinical events, differentiating between drug-attributed and non-attributed events.
Main Results:
- Patients received an average of 7.6 drugs during an 8.4-day hospital stay.
- 45.7% of patients experienced specified adverse clinical events.
- Drug-attributed adverse reactions occurred in 16.8% of patients.
- Adverse drug reactions and drug use increased with age.
- Newborns had the lowest reported adverse reaction rates but the highest rate of unclassified adverse events.
Conclusions:
- The intensive drug surveillance program effectively identified drug exposures and adverse events in hospitalized children.
- Adverse drug reactions are a significant concern in pediatric inpatients, increasing with age.
- Newborns may experience unrecognized adverse drug reactions presenting as unclassified adverse events, warranting further investigation.
Abstract:
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.