Linking Activity Theory Within User-Centered Design: Novel Framework to Inform Design and Evaluation of Adverse Drug Reaction Reporting Systems in Pharmacy

Abstract

Background Adverse drug reactions (ADRs) may cause serious injuries including death. Timely reporting of ADRs may play a significant role in patient safety; however, underreporting exists. Enhancing the electronic communication of ADR information to regulators and between health care providers has the potential to reduce recurrent ADRs and improve patient safety. Objective The main objectives were to explore the low rate of ADR reporting by community pharmacists (CPs) in Australia, evaluate the usability of an existing reporting system, and how this knowledge may influence the design of subsequent electronic ADR reporting systems. Methods The study was carried out in 2 stages. Stage 1 involved qualitative semistructured interviews to identify CPs’ perceived barriers and facilitators to ADR reporting. Data were analyzed by thematic analysis, and identified themes were subsequently aligned to the task-technology fit (TTF) framework. The second stage involved a usability evaluation of a commercial web-based ADR reporting system. A structured interview protocol that combined virtual observation, think-aloud moderating techniques, retrospective questioning of the overall user experience, and a System Usability Scale (SUS). The field notes from the interviews were subjected to thematic analysis. Results In total, 12 CPs were interviewed in stage 1, and 7 CPs participated in stage 2. The interview findings show that CPs are willing to report ADRs but face barriers from environmental, organizational, and IT infrastructures. Increasing ADR awareness, improving workplace practices, and implementing user-focused electronic reporting systems were seen as facilitators of ADR reporting. User testing of an existing system resulted in above average usability (SUS 68.57); however, functional and user interpretation issues were identified. Design elements such as a drop-down menu, free-text entry, checkbox, and prefilled data fields were perceived to be extremely useful for navigating the system and facilitating ADR reporting. Conclusions Existing reporting systems are not suited to report ADRs, or adapted to workflow, and are rarely used by CPs. Our study uncovered important contextual information for the design of future ADR reporting interventions. Based on our study, a multifaceted, theory-guided, user-centered, and best practice approach to design, implementation, and evaluation may be critical for the successful adoption of ADR reporting electronic interventions and patient safety. Future studies are needed to evaluate the effectiveness of theory-driven frameworks used in the design and implementation of ADR reporting systems.

A Web-Based Tool to Report Adverse Drug Reactions by Community Pharmacists in Australia: Usability Testing Study

“…Our results are timely as health systems introduce new electronic infrastructure to improve health information sharing, such as through e-prescribing or drug information gathering [ 40 ]. If CPs are to increase their reporting of ADRs and provide high-quality information that regulators seek to capture, we must prioritize the design of reporting systems [ 33 ]. This can enable CPs to meet their care delivery goals while preventing adverse drug exposure by providing timely patient safety data.…”

“…This study forms part of a larger study focused on assessing the impact of IT on facilitating the reporting of ADRs by CPs in Australia [ 10 , 19 , 28 , 33 ]. A qualitative study with semistructured interviews was conducted with 7 CPs working in community pharmacies across Victoria, Australia, between June 2022 and August 2022.…”

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)

“…While the initial year saw a notable increase in AME reporting rates to the TGA, the subsequent year saw a decline, hinting at challenges in maintaining sustained adoption. 34 Factors influencing the adoption and ongoing use of digital health technologies include cost, simplicity of language, ease of use, design, scientific evidence base, motivation and perceived value by end-users. [22][23][24] To effectively tackle the challenges related to fulfilling the requirements of stakeholders and overcoming low adoption rates, our project takes a unique approach by grounding it in a multidisciplinary ideology from its outset.…”