Iatrigger Project: Development and Validation of a Tool to Evaluate Adverse Drugs Events in Oncology Patients

ABSTRACT Objective Adverse events related to drugs occur frequently and many of them are preventable. Despite cancer treatment are known to involve hazardous drugs, there are few practical methods to identify adverse drug events (ADEs) and measure harm to the patient. The purpose of this work was to develop a tool for adverse event detection in oncology patients. Methods The Trigger Tool approach has been developed and tested in oncology. First, 27 triggers were identified and flowcharts were constructed, based on international, national or local recommendations. Second, 11 clinical experts have validated the content of each trigger on three criteria: the criticality of the adverse event, the educational value of feedback, and the clinical relevance of the analysis. For each trigger, severity has been graded according to the NCI CTCAE 4.03. Third, the feasibility of the analysis based on a random sample of 130 patient records has been assessed through the time of analysis for each patient record, and the number of trigger and ADE observed. Results Experts evaluated the criticality of the 27 triggers from 5.1 to 10.9/25 and their educational value from 4.5 to 7.7/10. Regarding the feasibility analysis, 1157 hospital-bed days were reviewed from October 2010 to March 2011.It revealed 387 positive triggers, 80 of which are adverse events and 46 were drug related (ADE). The study counted 0.6 ADE/patient, including 1 grade 3 or more ADE for 11.8 patients. The most frequently observed ADE were constipation (7 ADE), fall (5 ADE), hypo/hyperglycemia (4 ADE), hypo/hyperkaliemia (3 ADE). The average time of analysis was established at 26min35s by patient record. Based on these results, 22 triggers have been preserved, composing the Iatrigger tool. Conclusion ADE detection is an important priority in patient safety research. The use of a ADE detection method requires some resource commitments. However, a validated tool like the Iatrigger tool can be applied in different hospital settings, allowing a precise follow-up of this particularly frail population. Disclosure All authors have declared no conflicts of interest.