Reevaluating the safety profile of pediatrics: a comparison of computerized adverse drug event surveillance and voluntary reporting in the pediatric environment.

OBJECTIVES: Children are at exceptionally high risk for adverse drug events. At Duke University Hospital, computerized adverse drug event surveillance and voluntary safety reporting systems work synergistically to identify adverse drug events. Here we identify the most deleterious drug classes to pediatric inpatients and determine which detection methodology provides the greatest opportunity to reduce harm.

PATIENTS AND METHODS: We evaluated all of the medication-related events detected by our computerized surveillance and safety reporting systems over a 1-year period for Duke University Hospital pediatric inpatients. Events from both systems were scored for severity and assigned a drug event category. Surveillance events were additionally scored for causality.

RESULTS: A total of 849 medication-related reports were entered into the safety reporting system, and 93 caused patient harm, resulting in an adverse drug event rate of 1.8 events per 1000 pediatric patient-days. Seventy eight of the 1537 medication-related events detected by surveillance resulted in patient harm, giving a rate of 1.6 events per 1000 patient-days. The most common events identified by the safety reporting system were failures in the medication use process (26.9%), drug omissions (16.1%), and dose- or rate-related events (12.9%). The most frequent adverse drug event surveillance categories were nephrotoxins (20.7%), narcotics and benzodiazepines (19.3%), and hypoglycemia (11.5%). Most voluntarily reported events originated in ICUs (72.0%), whereas surveillance events were split evenly across intensive and general care. There was little overlap between methodologies.

CONCLUSIONS: The epidemiology of pediatric adverse drug events is best addressed by using voluntary reporting in tandem with other strategies, such as computerized surveillance and targeted chart review. Although voluntary reporting excels at identifying administration errors, surveillance excels at detecting adverse drug events caused by high-risk medications and identifies evolving conditions that may provoke imminent patient harm. Surveillance underperformed in pediatrics when compared with adult detection rates, suggesting that tailored rules may be necessary for a robust pediatric adverse drug event surveillance system.