Adverse drug event surveillance tailored to hospitalized children
Research Activities, April 2011, No. 368
Hospitalized children are at high risk for adverse drug events (ADEs). Novel detection strategies, such as computerized surveillance, are underexplored in this fragile population. In addition, trigger rules to detect ADEs have primarily been developed for adults. A new study looked at how to tailor trigger rules to identify pediatric ADEs at one hospital.
Trigger rules are clinical indicators that an ADE such as hypoglycemia (low blood sugar) has occurred. For example, for adults, administration of 50 percent dextrose solution, typically used to treat hypoglycemia, would be a trigger to look at a patient's chart for hypoglycemia as an ADE.
The study hospital employed two ADE detection systems: a voluntary safety reporting system (SRS) and computerized ADE surveillance (ADE-S). Initially, the researchers identified problem areas by reviewing 5 years of incident reports from the SRS. They found that electrolyte preparations and total parenteral nutrition/lipids were primary causes of pediatric ADEs. For example, in one case, the administration of intravenous potassium was not halted in time and resulted in excessive potassium levels. To pinpoint critical threshold values for trigger logic, the researchers gathered and analyzed the distribution of historical pediatric lab results for the electrolytes ionized calcium, chloride, magnesium, potassium, and sodium, as well as triglycerides.
Based on these findings, typically the upper and lower 0.5 percent of the values were chosen as critical values that would indicate an ADE. Over the 3-month study period, however, the lab value triggers did not identify any ADEs, since no objective evidence of patient harm was documented. In contrast, application of the pediatric hypoglycemia trigger rule, which alerted for insulin administration, as opposed to dextrose 50%, in the setting of low blood glucose (since dextrose 50% is not regularly used to treat pediatric hypoglycemia) produced 23 alerts in 103 pediatric patients, which uncovered 14 ADEs. Compared with the older adult-focused hypoglycemia rule that found only 4 ADEs, the new tailored trigger rule increased the pediatric event detection rate from 0.43 to 1.51 events per 1,000 patient days. This study was supported by a grant from the Agency for Healthcare Research and Quality (HS14882).
See "Tailoring adverse drug event surveillance to the pediatric in patient," by Andrea L. Long, Pharm.D., Monica M. Horvath, Ph.D., Heidi Cozart, R.Ph., and others in Quality and Safety in Health Care 19(e40), pp. 1-5, 2010.