The Arksey and O’Malley methodology framework was adopted for conducting this scoping review [23,24]. This framework uses a rigorous process of transparency that enables the replication of the search strategy, which increases the reliability of the study findings. The framework has six stages as follows.

The focus of this scoping review was to explore ADR reporting in the Australian health care system and the extent of participation by consumers or HCPs and to describe the different reporting systems. The core questions are (1) How are ADRs monitored, reported, and handled in the Australian health care system? and (2) What is the extent of participation by consumers or HCPs?

The search strategy was developed by authors JFT and RAY. Six scientific databases were searched (Web of Science; Scopus; Embase; PubMed, including MEDLINE; CINAHL; and Computer & Applied Science Complete) for research articles published in English between 2010 to 2021. Furthermore, a reference list search (ie, backward reference search) and a cited reference search (ie, forward reference search) were carried out based on the full-text papers that met the study selection criteria. The reference search was repeated on newly identified papers until no additional relevant papers could be found. Multimedia Appendix 1 presents the full search strategy for each database.

The inclusion and exclusion criteria are presented in Textbox 1.

Five authors (JFT, RAY, THD, RM, and NW) independently screened the titles and abstracts of the studies to identify the ones for potential inclusion. Disagreements about exclusions were discussed until a consensus was reached. The full texts of the articles were then independently reviewed by 2 authors (JFT and RAY), who decided whether or not they met the selection criteria. In the case of disagreement, a third author (NW) made the final decision.

Two reviewers (JFT and RAY) identified characteristic data sets to describe the articles, which included the author(s), year of publication, setting (where the study was conducted, eg, hospital and community pharmacy), study population (eg, physicians), gender, age, intervention, and reporting rates. The data were represented in a logical and descriptive manner in line with the objectives of this review. As per guidelines, scoping reviews do not exclude research based on the research quality but rather identify areas that are lacking in research [23,24]. Therefore, methodological quality or risk of bias of the included articles were not needed [23,24].

The information extracted were summarized, organized, and discussed. A PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) flow chart was developed to summarize the identified literature and study selection steps. The narrative and a numerical summary of the characteristics of the included studies were tabulated. In the conceptual analysis, the study aimed to describe 2 main themes: (1) how ADRs are monitored, handled, or reported in the Australian health care system and (2) the extent of participation by stakeholders. The results of the first theme are presented in Multimedia Appendix 2 as the type of reporting or intervention, PV system used, and the focus of the surveillance. The results of the second theme are presented by the study population, setting, and reporting rates.

The last stage was to engage in a consultation exercise with stakeholders to discuss, inform, and validate the results of the study [23,24]. This scoping review was interdisciplinary [23,24]; the overall expertise covered medicine, clinical pharmacy, PV, epidemiology, public health, health informatics, and statistics. The participation of all the authors throughout the research process served the purpose of constant consultation and provided the rigor and strength to the study findings and conclusions.

Figure 1 (PRISMA flow chart) depicts the full review process and shows the number of citations excluded at each step. A total of 3538 citations were retrieved from the scientific electronic databases after duplicates (n=878) were removed. We screened the titles, abstracts, and full texts using the exclusion criteria and resulted with 6 citations to be included. The reference lists of the selected studies were also manually searched, and 1 article was identified; in total, 7 citations were relevant to the research question and included in the flow chart (stage 3). Multimedia Appendix 3 presents a list of the included studies.

The selected studies were published between 2013 and 2021. Among the studies, 2 focused on consumers and patients, 2 on health care providers, and 3 on information systems. In all, 5 of the 7 studies were in the hospital settings, and the rest were in the community. The findings of the selected studies are presented in 2 themes that relates back to the research questions, “ADR reporting, monitoring, and handling in the Australian health care context” and “participation.” The characteristics of the studies’ findings are summarized in Multimedia Appendix 2.

The results of our review indicates that consumer reporting is low, as reported in other studies [27]; despite this, consumers who are aware of reporting schemes may be willing to report. The studies showed that consumers were generally more likely to report ADRs to doctors (physicians) or pharmacists [27,28]. The findings are consistent with a recent study reporting that community pharmacists are usually the first point of contact regarding medication-related issues as the most frequently visited HCPs in Australia [10]. Introducing measures to facilitate ADR reporting for both consumer and patients and HCPs can be beneficial. A 2020 systematic review of interventions to improve ADR reporting also concluded that there was scope to include community pharmacies to improve ADR reporting [22]. These findings were also reported in other reviews [20,21]. Robertson and Newby [27] published in 2013 that only 10.14% of consumers (respondents) were aware of ADR reporting schemes. In 2020, Li et al [31] reported the findings of a black triangle scheme (ADR awareness) introduced by the TGA in 2018 to increase awareness and promote the reporting of ADRs by consumers and HCPs [31]. The effect of the black triangle scheme was only marginally successful at increasing ADR reports, that is, there was an improvement in the overall quality of ADR reports submitted but no meaningful increase in the quantity of reports [31]. The study concluded that additional strategies were required to enhance the overall PV system in Australia [28,31]. Considering that there has only been a marginal change in ADR reporting since 2013 [27], it suggests that there is opportunity for regulators to provide more awareness, such as education and further research. The provision of feedback to consumers about their ADR reports and involving consumers in the ADR management process, for example, the provision of ADR Warning cards, resulted in a high level of patient satisfaction and may have positively contributed to patient awareness [25]. In addition, feedback to health care providers on their submitted ADR reports may also encourage further reporting [28].

Consumers who experienced a side effect reported the event to an HCP, most often a GP (physician) [27]. However, the review and analysis of all ADR reports submitted to the TGA highlighted a decline in GPs’ contribution, from 28% of ADR reporting in 2003 to 4% in 2016 [26,27]. Therefore, understanding the barriers to and facilitators of ADR reporting among GPs in Australia may inform future interventions. Furthermore, in 2016, the TGA data also highlighted that hospital pharmacists and community pharmacists were a major source of ADR reporting, at a much higher rate than doctors (16% from pharmacists vs 4% from GPs) [26]. A Canadian study exploring why clinicians do not report ADRs posited that previous studies had focused predominantly on the knowledge and attitudes of HCPs and framed underreporting as a failure of individual clinicians without investigating workplace structures or practices that may have influenced reporting [18]. The discrepancies in reporting between GPs and pharmacists are vital and may warrant further investigation into organization and workplace structures. This is particularly important given our results in the documentation of opioid and penicillin ADR reports in a hospital electronic health records that showed that nurses and pharmacists were significantly less likely than doctors to omit the reaction description and that pharmacists were significantly more likely to enter the correct classification than doctors [29,30]. It is important to note that the study did not mention the reasons for reporting differences, leaving room for further investigations. Conversely, despite nurses being less likely to omit the reaction description, their perspective and reporting rate were not discussed and would benefit from further exploration. Nevertheless, although new technologies, for example, “electronic health records,” present as an opportunity to facilitate ADR reporting [21], it has been noted that in practice, these electronic systems can cause unexpected errors, desensitize clinicians to alerts, and increase the documentation burden [19]. This is evident in our findings, where in June 2014, a pharmacy software vendor, GuildLink, created a web-based Adverse Events Recording module that integrated directly into the TGA ADR web service [28]. This allowed community pharmacists to report ADRs directly to the TGA from their professional service program instead of having to manually complete a separate ADR reporting form [28]. In the follow-up from the GuildLink intervention, the quantity of reports received by the TGA was nearly as high as that of the previous year (2013); however, despite the positive start, the numbers declined again in 2015 [28]. The factors that may have influenced a sustained adoption of the GuildLink system were not mentioned or discussed. As new digital technologies emerge and continue to transform health care management [32], exploring existing technology and their shortcomings, for example, GuildLink, and evaluating their health impact present areas of opportunity for improving health quality and patient safety.

Repeated calls for mandated ADR reporting for HCPs have been made, and as discussed above, patients are more likely to discuss or report issues with their medications to the HCPs who initially dispensed or prescribed them (GPs or pharmacists). The Consumers Health Forum in their 2015 submission argued for mandatory requirements for doctors and pharmacists to report ADRs [23,28]. However, the Royal Australasian College of Physicians also expressed the need for Australian physicians to receive payment for completing ADR reports [27]. Furthermore, one of the studies in our results suggested financial incentives for ADR reporting was also highly regarded as a measure to improve reporting by pharmacist [28]. Considering these points, none of the studies in our results explored or noted the impact of mandatory reporting or incentives, for example, financial, on ADR reporting. Furthermore, the finding of the review also showed that despite national and international guidelines for ADR reporting and management, there is no established gold standard systems (policy or guideline) at the individual health care facility level in Australia [26]. Therefore, there exists substantial interinstitutional variability with respect to the timing and nature of reporting ADRs [26]. It was also not possible to pinpoint the net effect of interinstitutional variability in ADR reporting to the TGA, which requires further investigation.

The strength of this scoping review is that it is the first review to attempt an integration and synthesis of the available literature on ADR reporting, monitoring, and handling in the Australian health care context; the extent of participation; and ADR reporting systems. Notwithstanding the value of this research, some limitations must be acknowledged. This review was limited to papers published in English; it is possible that other potentially relevant literature in other languages were omitted. Although this review was performed using multiple major databases, searching other databases may have yielded other relevant published papers. A quality assessment of the studies included in the review was not undertaken; however, it was not relevant for the aim and not always necessary for scoping reviews [23,24]. There was limited data from the included studies in regard to the variabilities in participants’ age, gender, or educational status. The majority of the studies were undertaken in the hospital setting and predominately focused on pharmacists and physicians; therefore, applying these results to the entire Australian health care system may require additional considerations, for example, the impact of age, gender, task, or work setting. Different states, regions, and countries may differ in their infrastructures, capacities, general workplace culture, medical education programs, and economic status, which limits the generalizability of the findings of this review.

The exploratory nature of the scoping review helped to integrate and synthesize the literature to give us a broad overview of the PV and ADR-reporting landscape in Australia. This review is beneficial for identifying research gaps and serves as a vital step to identify key areas for digital interventions and quality improvement in ADR reporting. It is also hoped that the results of this scoping review send a message to regulators (eg, the TGA), software vendors, or policy makers concerning the work that is needed to develop a robust and standardized PV system in Australia. This review did not find a generally accepted “gold standard” protocol or framework for ADR reporting among individual health care facilities, and there is substantial interinstitutional variability with respect to the timing and nature of ADR reporting in Australia.

Despite the marginal effects from previous interventions aiming to enhance ADR reporting, for example, ADR awareness (black triangle scheme) or digital health interventions (GuildLink), there is opportunity to improve patient safety in relation to ADRs. Further evidence-based research is needed to guide ADR interventions design and implementation. To support these interventions, knowledge of the barriers and enablers to ADR reporting among consumers, pharmacists, physicians, and nurses at a primary health care institutional level is warranted.