Use of Run Charts and Statistical Process Control Charts to Monitor Quality Indicators in Adverse Drug Reactions Reporting: An Australian Health Service Network Experience During the COVID-19 Pandemic

Purpose: The utility of run charts and statistical process control (SPC) charts in monitoring adverse drug reaction (ADR) management processes has not been well-described. In this retrospective observational cohort study, we explored the use of these tools to evaluate process variations over time in the quantity and quality of ADR reporting at a quaternary health institution, amidst the national Coronavirus-19 (COVID-19) vaccination program roll-out. Methods All submitted ADR reports to the institutional review committee between 1st January and 31st December 2021 were evaluated with regards to the total number of reports, reporter characteristics and quality, using locally validated ADR Reports Quality Algorithm (AQUA-12). Results Of 271 reports submitted, 187(69%) were by hospital pharmacists and > 30% concerned severe reactions. The median AQUA-12 score was 10 (IQR: 9–12), and 26.6% of the reports were of low-quality. Using run charts, significant increases in the number of ADR reports submitted were detected during March and June 2021 periods, corresponding to the roll-out of Phases 1 and 2a of the COVID-19 vaccination program. These signals of change were driven mainly by COVID-19 vaccine-related reports. Using SPC charts, corresponding increase in the proportion of ADR reports submitted by nurses, with an inverse decrease in that submitted by pharmacists, was detected for the same periods. Despite these variations, SPC charts indicated that the proportion of ADR reports of severe nature and the quality of reports remained stable. Conclusions This study demonstrated that the overall state of ADR reporting processes in hospitals can be monitored using suitable quality indicators and tools.