Improving the reporting of adverse drug reactions by healthcare professionals in Australia: a mixed methods study

Abstract

Introduction. Under-reporting adverse drug reactions (ADRs) is a significant healthcare problem as it delays identifying safety issues. Various strategies have been implemented to improve ADR reporting, however these have only been temporarily effective. Therefore, there is a need to create an effective intervention.

Methods A mixed methods study was used for this research. In phase one, a retrospective analysis of hospital records identified whether ADR related admissions were reported. An analysis of a regulatory intervention to improve ADR reporting utilised a time series analysis to assess any improvement in this area. In phase 2, a survey was deployed to identify the barriers and enablers of ADR reporting, which were mapped to the Theoretical Domains Framework (TDF). In phase 3, the evidence was integrated to create a proposed intervention to improve ADR reporting.

Results A total of 9% of admissions were considered ADR related. Up to 99% of all known ADRs were not reported. The impact of a regulatory intervention on ADR reporting showed that there was an increase of 0.41 reports per medicine (95%CI 0.02 – 0.80) and an almost 3-fold improvement in the quality of reporting. The survey was completed by 133 HCPs and knowing how to report ADRs (OR 3.58, 95%CI 1.05 – 12.2) and encountering ADRs (OR 18.6, 95%CI 5.52 – 62.5) were predictors of reporting. Content analysis identified three categories: modifying the reporting process, enabling clinicians to report ADRs, and creating a positive reporting culture. These were mapped to 3 domains: knowledge, environmental context/resources, and beliefs about consequences.

Conclusion The findings from this mixed methods research suggest that a multifaceted approach targeting the three TDF behavioural domains would be required to improve the quantity and quality of reporting.