PALO ALTO, Calif-- Hospitalized children experience medication-related harm nearly five times more frequently than previously believed, according to a new study led by a researcher at Lucile Packard Children’s Hospital and Stanford University School of Medicine.
 
The researchers used a “trigger tool” method, scrutinizing medical charts to ferret out previously unidentified episodes of harm, or adverse drug events.
 
“A trigger is basically a red flag that a harmful event may have occurred,” said Packard Children’s chief clinical patient safety officer Paul Sharek, MD, MPH, the senior author on the study. “When we identify a trigger, we take a closer look at the events surrounding it in that patient’s chart.” Sharek is assistant professor of pediatrics at the medical school.

The study is the first large-scale national study using this method of chart review to investigate patterns of medication-related harm in children. Previous efforts to identify the frequency of adverse drug events in pediatric institutions relied mostly on either comprehensive unfocused reviews of randomly selected medical records, administrative databases, or voluntary reporting methods.
 
Targeted, or triggered, chart review is somewhat like scanning a page of text for a person’s name. Rather than reading every word, most people skim for give-aways like capital letters within a sentence to help them zero in on their target. Triggers for adverse drug events included the use of antidotes to combat dosing errors, severely abnormal laboratory test results, or the sudden cessation of drug treatment.
 
Although medication errors can lead to adverse drug events, the two are not identical. A child can experience an adverse side event like a rash even when appropriately medicated. Identifying these occurrences, however, can help pinpoint those that are particularly prevalent or troublesome and focus future efforts on preventing them. For example, Packard Children’s has since instituted evidence-based medication order sets  using “corollary orders,” in which a drug like a stool softener or anti-emetic is automatically prescribed when children are started on medications likely to cause side-effects like constipation or nausea.  
 
The researchers performed targeted chart review on 960 charts from 12 children’s hospitals across the country. They found 107 unique adverse drug events, or 11.1 per 100 patients and 15.7 per 1000 patient days. Previous studies had estimated a frequency of about 2.3 per 100 patients. Fewer than four percent of these harmful events had been detected by hospital incidence reports. Adverse drug events were most commonly associated with the use of analgesics, opioids or antibiotics. The most common events included itching and nausea, although some were more serious. The overwhelming majority, or 97 percent of the adverse drug events, resulted only in temporary, mild harm.
 
Although the study was published in the April issue of Pediatrics, the data were first gathered and analyzed in 2002. The interval allowed Packard Children’s and other participating hospitals time to craft specific interventions to address their individual weak spots. For example, in 2003 Packard Children’s instituted preprinted orders—a kind of medication menu for doctors that reduces errors by providing standardized doses and  eliminating sloppy writing, unclear abbreviations, and potentially confusing brand names. More recently, the hospital has begun implementing computerized provider order entry, which automatically flags dosage errors and dangerous drug interactions as soon as medications are ordered.

Packard Children’s has won national recognition for its success in reducing adverse drug events, in part stemming from the knowledge obtained from using the trigger tool methodology locally. In 2005, the hospital received the 2005 Race for Results Award from the Child Health Corporation of America. The hospital won the award—the fourth in a 12-month period for ongoing improvements in patient safety—for significantly reducing the already low number of adverse drug events at the hospital over the previous two years.
 
“We wanted to understand and establish the epidemiology of harm,” said Sharek, “to determine what our biggest medication safety issues are. In the future we will explore ways to identify harmful events in real time and even to predict and prevent them.”
 
Sharek’s co-authors on the study include colleagues from the University of Southern California’s School of Medicine, Childrens Hospital Los Angeles, and the Child Health Corporation of America.
 
About Lucile Packard Children's Hospital
Ranked as one of the nation's top 10 pediatric hospitals by U.S. News & World Report, Lucile Packard Children's Hospital at Stanford is a 272-bed hospital devoted to the care of children and expectant mothers. Providing pediatric and obstetric medical and surgical services and associated with the Stanford University School of Medicine, Packard Children's offers patients locally, regionally and nationally the full range of health care programs and services, from preventive and routine care to the diagnosis and treatment of serious illness and injury. For more information, visit www.lpch.org.