Project Summary

Medicines have many benefits but can also cause harm; these harms are called adverse drug events (ADEs). ADEs are common and often lead to patient harm. In Australia, we estimate that 1.2 million people experienced an ADE within a six-month period. Currently pharmacovigilance processes require voluntary ADE reports to regulatory authorities. These reports are then investigated to identify new medical safety issues. Despite the need, there is no proactive system in Australia that helps to enable consumers and health professionals to detect and manage ADEs, nor a mechanism for consumers to report ADEs that is easy-to-use, intuitive and engages them. This project aims to co-design a digital health platform to enable consumers and health professionals to actively detect medicine harms, and for consumers to report the harms to the medicine regulatory authority in Australia.  

Project Date

Jun 2022 - Dec 2025


Project Lead


Dr Christopher Thornton - University of South Australia

Dr Andre Andrade - University of South Australia

A/Prof Lisa Kalisch Ellett - University of South Australia

Tracey-Lea Laba - University of South Australia

Prof Nicole Pratt - University of South Australia

Prof Libby Roughead - University of South Australia

Dr Sieta de Vries - University Medical Centre Groningen

Dr Myra Thiessen - Monash University

Dr Oliver Frank - University of Adelaide

Prof Phaik Yeong Cheah - University of Oxford

Prof Kim-Kwang Raymond Choo - University of Texas at San Antonio

Ms Ximena Camacho - UNSW Sydney

Research Question

1) Can we better detect and manage ADEs in the community to prevent more serious harms such as ADE-related hospital admissions? 
2) Can we increase the number and quality of ADE reporting by consumers to the TGA to help accelerate safety signal detection?

Data Sources

We have conducted a pilot study where we developed a platform (as an app and a website) for consumers to report any medicine side effects they experienced, and a systematic review of existing tools to identify ADEs. The proposed project will leverage findings from our pilot project and systematic review.

Policy Implications

By proactively detecting and managing ADEs, our digital health platform has significant potential to reduce ADE-related emergency department visits and hospital admissions, thereby reducing pressure on an already overstretched healthcare system. By streamlining the ADE reporting process, our platform has the potential to contribute to more timely detection and verification of potential medicines safety signals.

End Users

  • Consumers
  • Health Professionals
  • Regulatory Authority


Stay tuned

This section will be updated throughout the project. Please return in the future to see the impact from this project.