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ARTICLE |
a Division of General Pediatrics, Department of Pediatrics, University of Southern California School of Medicine, Los Angeles, California
b Patient Safety Program, Children's Hospital Los Angeles, Los Angeles, California
c Division of Infectious Diseases, Department of Pediatrics, University of Southern California School of Medicine, Los Angeles, California
d Quality Management Program, Children's Hospital Los Angeles, Los Angeles, California
e Department of Pharmacy, Childrens Hospital Los Angeles, Los Angeles, California
f Performance Improvement Division, Child Health Corporation of America, Shawnee Mission, Kansas
g Division of General Pediatrics, Department of Pediatrics, Stanford University School of Medicine, and Department of Quality Management, Lucile Packard Children's Hospital, Palo Alto, California
OBJECTIVES. The purposes of this study were to develop a pediatric-focused tool for adverse drug event detection and describe the incidence and characteristics of adverse drug events in children's hospitals identified by this tool.
METHODS. A pediatric-specific trigger tool for adverse drug event detection was developed and tested. Eighty patients from each site were randomly selected for retrospective chart review. All adverse drug events identified using the trigger tool were evaluated for severity, preventability, ability to mitigate, ability to identify the event earlier, and presence of associated occurrence report. Each trigger and the entire tool were evaluated for positive predictive value.
RESULTS. Review of 960 randomly selected charts from 12 children's hospitals revealed 2388 triggers (2.49 per patient) and 107 unique adverse drug events. Mean adverse drug event rates were 11.1 per 100 patients, 15.7 per 1000 patient-days, and 1.23 per 1000 medication doses. The positive predictive value of the trigger tool was 3.7%. Twenty-two percent of all adverse drug events were deemed preventable, 17.8% could have been identified earlier, and 16.8% could have been mitigated more effectively. Ninety-seven percent of the identified adverse drug events resulted in mild, temporary harm. Only 3.7% of adverse drug events were identified in existing hospital-based occurrence reports. The most common adverse drug events identified were pruritis and nausea, the most common medication classes causing adverse drug events were opioid analgesics and antibiotics, and the most common stages of the medication management process associated with preventable adverse drug events were monitoring and prescribing/ordering.
CONCLUSIONS. Adverse drug event rates in hospitalized children are substantially higher than previously described. Most adverse drug events resulted in temporary harm, and 22% were classified as preventable. Only 3.7% were identified by using traditional voluntary reporting methods. Our pediatric-focused trigger tool is effective at identifying adverse drug events in inpatient pediatric populations.
Key Words: adverse drug event • trigger tool • pediatrics • harm • patient safety
Abbreviations: AE—adverse event • ADE—adverse drug event • MAR—medication administration record • IHI—Institute for Healthcare Improvement • CHCA—Child Health Corporation of America • PPV—positive predictive value • CI—confidence interval
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