Tailoring adverse drug event surveillance to the paediatric inpatient

Abstract

Introduction: Although paediatric patients have an increased risk for adverse drug events, few detection methodologies target this population. To utilise computerised adverse event surveillance, specialised trigger rules are required to accommodate the unique needs of children. The aim was to develop new, tailored rules sustainable for review and robust enough to support aggregate event rate monitoring.

Methods: The authors utilised a voluntary staff incident-reporting system, lab values and physician insight to design trigger rules. During Phase 1, problem areas were identified by reviewing 5 years of paediatric voluntary incident reports. Based on these findings, historical lab electrolyte values were analysed to devise critical value thresholds. This evidence informed Phase 2 rule development. For 3 months, surveillance alerts were evaluated for occurrence of adverse drug events.

Results: In Phase 1, replacement preparations and total parenteral nutrition comprised the majority (36.6%) of adverse drug events in 353 paediatric patients. During Phase 2, nine new trigger rules produced 225 alerts in 103 paediatric inpatients. Of these, 14 adverse drug events were found by the paediatric hypoglycaemia rule, but all other electrolyte trigger rules were ineffective. Compared with the adult-focused hypoglycaemia rule, the new, tailored version increased the paediatric event detection rate from 0.43 to 1.51 events per 1000 patient days.

Conclusions: Relying solely on absolute lab values to detect electrolyte-related adverse drug events did not meet our goals. Use of compound rule logic improved detection of hypoglycaemia. More success may be found in designing real-time rules that leverage lab trends and additional clinical information.

Figure 1

Histograms showing the distribution of paediatric lab test results. The distributions of paediatric lab test values for (a) potassium, (b) ionised calcium, (c) chloride and (d) magnesium were examined over a 2-year time period. Chloride, triglycerides and total bilirubin were examined but are not shown. In each graph, the vertical axis comprises the counts of lab results. The arrows represent the thresholds for the upper or lower 0.5% of all test results (upper 2.5% for calcium, B). These values were considered extreme outliers and guided trigger rule logic. Accepted reference values for each test were dependent on age, but the most common ranges are shown.