Co-designing a consumer-focused digital reporting health platform to improve adverse medicine event reporting: Protocol for a multi-method research project (the ReMedi project) (Preprint)

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, healthcare professionals and only 6% of AMEs are reported to regulators. Increased reporting by consumers, healthcare 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 healthcare professionals and improve reporting to regulators. METHODS The project will be conducted in three phases and employs a co-design methodology that prioritises equity in designing with stakeholders. Our project is guided by the Consolidated Framework for Implementation Research. In Phase 1, we will engage with three stakeholder groups: consumers, healthcare 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 is currently underway, and we will publish findings progressively as we complete our analyses. 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 under-detection and under-reporting of AMEs to healthcare professionals and regulators. The project potentially will improve individual patient safety and generate new data for regulatory purposes related to medicine safety and effectiveness.