The application of Global Trigger Tool in monitoring antineoplastic adverse drug events: a retrospective study

TL;DR

This study adapted a tool to detect adverse drug events in cancer patients receiving antineoplastic drugs and found key risk factors and drug types associated with these events.

Contribution

The study developed and validated a modified Global Trigger Tool for monitoring antineoplastic drug adverse events in a Chinese hospital setting.

Findings

The trigger tool detected ADEs in 63% of patients with a high sensitivity rate of 91.8%.

Antimetabolic drugs, plant sources, and platinum drugs were most associated with ADEs, primarily affecting the hematologic system.

Multidrug use and prior adverse drug reactions were significant risk factors for ADEs.

Abstract

This study aimed to establish an antineoplastic drugs trigger tool based on Global Trigger Tool (GTT), to examine the performance by detecting adverse drug events (ADEs) in patients with cancer in a Chinese hospital (a retrospective review), and to investigate the factors associating with the occurrence of antineoplastic ADEs.

Based on the triggers recommended by the GTT and those used in domestic and foreign studies and taking into account the scope of biochemical indexes in our hospital, some of them were adjusted. A total of 37 triggers were finally developed. Five hundred medical records of oncology patients discharged in our hospital from 1 June 2020 to 31 May 2021 were randomly selected according to the inclusion and exclusion criteria. These records were reviewed retrospectively by antineoplastic drugs trigger tool. The sensitivity and specificity of the triggers were analyzed, as well as the characteristics and risk factors for the occurrence of ADEs.

Thirty-three of the 37 triggers had positive trigger, and the sensitivity rate was 91.8% (459/500). For the specificity, the positive predictive value of overall ADEs was 46.0% (715/1556), the detection rate of ADEs was 63.0% (315/500), the rate of ADEs per 100 admissions was 136.0 (95% CI, 124.1–147.9), and the rate of ADEs per 1,000 patient days was 208.33 (95% CI, 201.2–215.5). The top three antineoplastic drugs related to ADEs were antimetabolic drugs (29.1%), plant sources and derivatives (27.1%), and metal platinum drugs (26.3%). The hematologic system was most frequently involved (507 cases, 74.6%), followed by gastrointestinal system (89 cases, 13.1%). Multivariate logistic regression analysis showed that the number of combined drugs (OR = 1.14; 95% CI, 1.07–1.22; P < 0.001) and the previous history of adverse drug reaction (ADR) (OR = 0.38; 95% CI, 0.23–0.60; P < 0.001) were the risk factors for ADEs. The length of hospital stay (OR = 0.40; 95% CI, 0.14–1.12; P < 0.05) and the previous history of ADR (OR = 2.18; 95% CI, 1.07–4.45; P < 0.05) were the risk factors for serious adverse drug events (SAE).

The established trigger tool could be used to monitor antineoplastic drugs adverse events in patients with tumor effectively but still needs to be optimized. This study may provide some references for further research in order to improve the rationality and safety of antineoplastic medications.