(352) Views on The Development and Use of a New Digital Health Platform to Improve Adverse Drug Event Detection, Management and Reporting in Australia: A Qualitative Study

Background: Early detection and management of adverse drug events (ADEs) is crucial to prevent further harm in individuals and spontaneous reporting of ADEs to regulatory authorities is important for medicine safety surveillance. The ReMeDi project has been initiated to “Co-design a consumer-focused digital health reporting platform to improve ADE detection, management and reporting”.

Objectives: As part of the ongoing project, this first study explored views on the development and use of a new platform designed for ADE detection and management in clinical practice and reporting to the regulatory authority in Australia, i.e. the Therapeutic Goods Administration.

Methods: A qualitative study was conducted using semi-structured interviews, focus groups, and co-design workshops with relevant stakeholders comprising of medicine consumers, healthcare professionals, and regulators in Australia. The audio and/or video-recorded data were transcribed verbatim, manually checked for accuracy, coded, and analysed thematically. Regarding the thematic analyses, an inductive approach was used to map the arising themes to the Capability, Opportunity, Motivation, Behaviour (COM-B) model, a frequently employed framework for recognising and addressing behaviours.

Results: Twenty-two people participated in the interviews of whom half were consumers, one a regulator, and the other ten were healthcare professionals. Most of these participants next participated in one of two focus groups and three co-design workshops. Views related to ADE reporting in general as well as specifically to a new digital health platform were uncovered. For ADE reporting in general, the following themes were identified: being able to identify ADEs and health literacy aspects e.g. remembering the name of a medicine (Capability), awareness of the possibility to report and perspectives regarding direct-reporting by patients (Opportunity), and reasons for reporting, e.g., for the common good, benefits for the reporter, and what ADEs to report (Motivation). The following themes were identified that might be considered in the development of a new digital health platform: influence of health states, e.g. poor eyesight (Capability), features that influence intuitive use, user experiences, and convenience and accessibility (Opportunity), and privacy and confidentiality and feedback (Motivation).

Conclusions: The uncovered views inform future phases of the project including the development of the digital health platform and its implementation and evaluation.