Developing and validating a Global Trigger Tool for assessing frequency, level of harm, and preventability of adverse drug events in pediatric inpatients units.

Background: Medications are a major cause of harm to patients in hospitals, and several studies have found that they cause approximately 20% of injuries that occur in medical institutions. It was found that the rate of adverse drug events (ADEs) in pediatric hospitalizations ranges from 11 to 40 events per 100 hospitalizations and 1% of cases caused death.

Objectives: This is a comparative and retrospective study. The overarching objective is to adapt the Pediatric Trigger Tool (PTT) of the "Child Health Corporation of America" to pediatric wards in Israel, with the intention of using it to assess the rate of adverse events that occur during medication given in pediatric wards. The study characterized ADEs and examined the ability of the PTT to identify ADEs in relation to those that were voluntarily reported by the staff.

Method: This study included internal and surgical pediatric wards at an academic pediatric medical center. The PTT was validated on medical record data from 700 hospitalizations between the years 2015 and 2017. The study also determined, among other things: the stage of drug administration at which the events occurred, the percentage of all events that could have been prevented, the degrees of damage the ADE caused and more.

Results: The Positive Predictive Value of the customized tool stands at 16.91%. The study found 108 ADEs in 78 hospitalizations. The ADE rate per 100 hospitalizations was 15.4, the ADE rate per 1000 drug doses was 3.9, and the ADE rate per 1000 hospitalization days was 22.8, of which 18.5% were preventable. The category of drugs that led to the highest number of ADEs was painkillers. Those ADEs led to a large number of adverse clinical effects: constipation, hypokalemia, vomiting, and rash. The most common reason for coming to the hospital was suspicion or treatment of a hematologic disease, followed by hospitalization due to a burn. The customized tool found 10.8 times more ADEs than those reported voluntarily-subjectively by the clinical staff.

Conclusions: The study found that, properly adapted, the PTT tool can be used to detect ADEs in internal and surgical pediatric wards.