Background Medication use can result in adverse drug reactions (ADRs) that cause increased morbidity and health care consumption for patients and could potentially be fatal. Timely reporting of ADRs to regulators may contribute to patient safety by facilitating information gathering on drug safety data. Currently, little is known about how community pharmacists (CPs) monitor, handle, and report ADRs in Australia. Objective This study aimed to identify perceived barriers to and facilitators of ADR reporting by CPs in Australia and suggest digital interventions. Methods A qualitative study with individual interviews was conducted with CPs working across Victoria, Australia, between April 2022 and May 2022. A semistructured interview guide was used to identify perceived barriers to and facilitators of ADR reporting among CPs. The data were analyzed using thematic analysis. We constructed themes from the CP-reported barriers and facilitators. The themes were subsequently aligned with the Task-Technology Fit framework. Results A total of 12 CPs were interviewed. Identified barriers were lack of knowledge of both the ADR reporting process and ADR reporting systems, time constraints, lack of financial incentives, lack of organizational support for ADR reporting, inadequate IT systems, and preference to refer consumers to physicians. The proposed facilitators of ADR reporting included enhancing CPs knowledge and awareness of ADRs, financial incentives for ADR reporting, workflow-integrated ADR reporting technology systems, feedback provision to CPs on the reported ADRs, and promoting consumer ADR reporting. Conclusions Barriers to and facilitators of ADR reporting spanned both the task and technology aspects of the Task-Technology Fit model. Addressing the identified barriers to ADR reporting and providing workplace technologies that support ADR reporting may improve ADR reporting by CPs. Further investigations to observe ADR handling and reporting within community pharmacies can enhance patient safety by increasing ADR reporting by CPs.

Background Adverse drug reactions (ADRs) are unintended consequences of medication use and may result in hospitalizations or deaths. Timely reporting of ADRs to regulators is essential for drug monitoring, research, and maintaining patient safety, but it has not been standardized in Australia. Objective We sought to explore the ways that ADRs are monitored or reported in Australia. We reviewed how consumers and health care professionals participate in ADR monitoring and reporting. Methods The Arksey and O’Malley framework provided a methodology to sort the data according to key themes and issues. Web of Science, Scopus, Embase, PubMed, CINAHL, and Computer & Applied Sciences Complete databases were used to extract articles published from 2010 to 2021. Two reviewers screened the papers for eligibility, extracted key data, and provided descriptive analysis of the data. Results Seven articles met the inclusion criteria. The Adverse Medicine Events Line (telephone reporting service) was introduced in 2003 to support consumer reporting of ADRs; however, only 10.4% of consumers were aware of ADR reporting schemes. Consumers who experience side effects were more likely to report ADRs to their doctors or pharmacists than to the drug manufacturer. The documentation of ADR reports in hospital electronic health records showed that nurses and pharmacists were significantly less likely than doctors to omit the description of the drug reaction, and pharmacists were significantly more likely to enter the correct classification of the drug reaction than doctors. Review and analysis of all ADR reports submitted to the Therapeutic Goods Administration highlighted a decline in physician contribution from 28% of ADR reporting in 2003 to 4% in 2016; however, within this same time period, hospital and community pharmacists were a major source of ADR reporting (ie, 16%). In 2014, there was an increase in ADR reporting by community pharmacists following the introduction of the GuildLink ADR web-based reporting system; however, a year later, the reporting levels dropped. In 2018, the Therapeutic Goods Administration introduced a black triangle scheme on the packaging of newly approved medicines, to remind and encourage ADR reporting on new medicines, but this was only marginally successful at increasing the quantity of ADR reports. Conclusions Despite the existence of national and international guidelines for ADR reporting and management, there is substantial interinstitutional variability in the standards of ADR reporting among individual health care facilities. There is room for increased ADR reporting rates among consumers and health care professionals. A thorough assessment of the barriers and enablers to ADR reporting at the primary health care institutional levels is essential. Interventions to increase ADR reporting, for example, the black triangle scheme (alert or awareness) or GuildLink (digital health), have only had marginal effects and may benefit from further improvement revisions and awareness programs.

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.

BACKGROUND 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. Improving the electronic communication of ADR information to regulators and between healthcare providers has the potential to reduce recurrent ADRs and improve patient safety. OBJECTIVE Objectives: 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 Methods: The study was carried out in two stages, stage one involved qualitative semi-structured interviews to identify CPs perceived barriers and facilitators to ADR reporting. Data was analysed 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 online 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 Results: 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, organisational and IT infrastructures. Increasing ADR awareness, improving workplace-practices and implementing user focused electronic reporting systems were seen as facilitators to ADR reporting. User testing of an existing system resulted in an 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 pre-filled data fields were perceived to be extremely useful for navigating the system and facilitate ADR reporting. CONCLUSIONS Conclusions: Existing reporting systems are not suited to report ADRs, adapted to workflow and are rarely used by CPs. Our study uncovered important contextual information for design of future ADR reporting interventions. Based on our study, a multifaceted, theory‐guided, user-centered and best practice approach to design, implementations and evaluation may be critical for 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.

BACKGROUND Medications aim to relieve suffering & ailment, but they can be associated with adverse side effects or adverse drug reactions (ADRs). ADRs are a major cause of hospital admissions and cause a significant strain on healthcare funding in Australia and Globally. There is little integrative and collective knowledge on ADR reporting and monitoring in the Australian healthcare system. OBJECTIVE This review aims to investigate the current trends in ADR reporting, monitoring, and handling in the Australian healthcare system and describe related interventions. METHODS A comprehensive search of appropriate keywords, regarding ADRs was used to search 6 electronic databases to retrieve peer-reviewed scientific articles published from 2010 to 2021. Only articles with a precise focus on ADRs in the Australian medicine’s management context were included. RESULTS Seven articles met the inclusion criteria. The findings offer a comprehensive picture of ADR reporting and monitoring in the Australian healthcare system. The current ADR systems were compiled with the involvement of both consumer/ patients and healthcare providers to record or report all types of ADRs of various severities and aimed at improving ADR monitoring and reporting. The major barrier to consumer/patients’ participation is awareness to reporting mechanisms. Consumers are also more likely to report ADRs to their doctor or pharmacists. Documentation of opioid and penicillin ADR reports in hospital electronic health records shows nurses and pharmacists to be significantly less likely than doctors to omit the reaction description and pharmacists significantly more likely to enter the correct classification than doctors. CONCLUSIONS There is a need to (1) improve the current initiatives on public awareness to ADR reporting and the provision of report feedback to enhance interdisciplinary collaboration; (2) implement digital solutions to support consumer/patients reporting and empower healthcare providers to electronically capture and report ADRs within their clinical workflow; (3) undertake studies to understand ADR management at the primary healthcare institutional level; (4) develop and validate frameworks to evaluate novel technological solutions designed to facilitate pharmacovigilance and improve the safety of medicines management in Australia.