Abstract
BACKGROUND: Adverse medicine events (AMEs) are unintended effects that occur following administration of medicines. Up to 70% of AMEs are not reported to, and hence remain undetected by, health care professionals and only 6% of AMEs are reported to regulators. Increased reporting by consumers, health care professionals, and pharmaceutical companies to medicine regulatory authorities is needed to increase the safety of medicines. OBJECTIVE: We describe a project that aims to co-design a digital reporting platform to improve detection and management of AMEs by consumers and health care professionals and improve reporting to regulators. METHODS: The project will be conducted in 3 phases and uses a co-design methodology that prioritizes equity in designing with stakeholders. Our project is guided by the Consolidated Framework for Implementation Research. In phase 1, we will engage with 3 stakeholder groups-consumers, health care professionals, and regulators-to define digital platform development standards. We will conduct a series of individual interviews, focus group discussions, and co-design workshops with the stakeholder groups. In phase 2, we will work with a software developer and user interaction design experts to prototype, test, and develop the digital reporting platform based on findings from phase 1. In phase 3, we will implement and trial the digital reporting platform in South Australia through general practices and pharmacies. Consumers who have recently started using medicines new to them will be recruited to use the digital reporting platform to report any apparent, suspected, or possible AMEs since starting the new medicine. Process and outcome evaluations will be conducted to assess the implementation process and to determine whether the new platform has increased AME detection and reporting. RESULTS: This project, initiated in 2023, will run until 2026. Phase 1 will result in persona profiles and user journey maps that define the standards for the user-friendly platform and interactive data visualization tool or dashboard that will be developed and further improved in phase 2. Finally, phase 3 will provide insights of the implemented platform regarding its impact on AME detection, management, and reporting. Findings will be published progressively as we complete the different phases of the project. CONCLUSIONS: This project adopts a co-design methodology to develop a new digital reporting platform for AME detection and reporting, considering the perspectives and lived experience of stakeholders and addressing their requirements throughout the entire process. The overarching goal of the project is to leverage the potential of both consumers and technology to address the existing challenges of underdetection and underreporting of AMEs to health care professionals and regulators. The project potentially will improve individual patient safety and generate new data for regulatory purposes related to medicine safety and effectiveness. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/60084.