Adverse Drug Event Detection in Pediatric Oncology and Hematology Patients: Using Medication Triggers to Identify Patient Harm in a Specialized Pediatric Patient Population

Abstract

Objective To investigate the use of a trigger tool for adverse drug event (ADE) detection in a pediatric hospital specializing in oncology, hematology, and other catastrophic diseases. Study design A medication-based trigger tool package analyzed electronic health records from February 2009 to February 2013. Chart review determined whether an ADE precipitated the trigger. Severity was assigned to ADEs, and preventability was assessed. Preventable ADEs were compared with the hospital’s electronic voluntary event reporting system to identify whether these ADEs had been previously identified. The positive predictive values (PPVs) of the entire trigger tool and individual triggers were calculated to assess their accuracy to detect ADEs. Results Trigger occurrences (n=706) were detected in 390 patients from six medication triggers, 33 of which were ADEs (overall PPV = 16%). Hyaluronidase had the highest PPV (60%). Most ADEs were category E harm (temporary harm) per the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) index. One event was category H harm (intervention to sustain life). Naloxone was associated with the most grade 4 ADEs per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Twenty-one (64%) ADEs were preventable; 3 of which were submitted via the voluntary reporting system. Conclusion Most of the medication-based triggers yielded low PPVs. Refining the triggers based on patients’ characteristics and medication usage patterns could increase the PPVs and make them more useful for quality improvement. To efficiently detect ADEs, triggers must be revised to reflect specialized pediatric patient populations such as hematology and oncology patients.

Evaluating iatrogenic prescribing: Development of an oncology-focused trigger tool

“…For each of three ADEs (Vitamin K antagonist (VKA) overdose, unavoided anticipated allergic reaction, poor/delayed management of opiate-induced constipation), we tested two triggers in order to identify the better method of ADE detection and kept the one with the better PPV. A laboratory measurement or clinical condition proves to be a better trigger of an ADE than the actual drug, as stated recently by Call et al [35]. The final OTT was made up of 22 triggers and targeted either the ADE once it had occurred (e.g.…”

“…Harm assessment is customarily greatly dependent on experience and interpretation of reviewers. Therefore it is a source of high variability [34,35]. This may be explained by our use of the standard NCI CTCAE grading scale for adverse events (AEs)/ADEs in oncology, which has no equivalent in other disciplines, rather than use of, for instance, NCC MERP index criteria and AHRQ Common Format Harm Scales [31,35].…”

“…Therefore it is a source of high variability [34,35]. This may be explained by our use of the standard NCI CTCAE grading scale for adverse events (AEs)/ADEs in oncology, which has no equivalent in other disciplines, rather than use of, for instance, NCC MERP index criteria and AHRQ Common Format Harm Scales [31,35]. The combination of flowchart construction and NCI CTCAE grading scale use probably contributed greatly towards standardised assessment of iatrogenic effects.…”

Medication reconciliation as a strategy for preventing medication errors

“…Since 1990s, many publications contributed to the knowledge and awareness of the importance of medication errors (Hartwig et al, 1991;Leape et al, 1991;Kohn et al, 2001;Otero et al, 2002;Rosa, Perini, 2003;WHO, 2007;Smith et al, 2014;Call et al, 2014). From then on, researchers in the health field focused their attention to this problem, previously unnoticed in everyday of health professionals that deal with medicine use.…”

Electronic ordering and the management of treatment interdependencies: a qualitative study of paediatric chemotherapy

“…The literature suggests that design of CPOE for chemotherapy is 'confronted with problems' (21) and that CPOE alone is not su cient to eliminate chemotherapy errors. Other safety strategies generally co-exist, including error surveillance systems (22,23), checking of patient regimens against standard protocols (22,24), and interventions to improve situational awareness (12,22). The literature remains unclear on how CPOE relates to such strategies, especially with regard to management of interdependencies.…”