| Summary: | <p>Undertaking effective drug safety monitoring can be particularly challenging in Low-Resource Settings (LRSs) due to a lack of infrastructure, weak regulatory systems and poor access to training and education. Having identified that more could be done to provide or draw together existing free or low-cost resources, Global Pharmacovigilance (GPV), an online platform dedicated to pharmacovigilance activities in LRSs was launched on The Global Health Network (TGHN) in mid-2016.</p>
<p>This action research project sought to investigate whether GPV’s membership could be harnessed to work together in a Community of Practice (CoP) on specific challenges facing pharmacovigilance in LRSs, and to assess the impact of the CoP outcomes on the work of those engaged in pharmacovigilance activities in LRSs. Participants were invited to work together to develop relevant training, guidance, tools and/or resources to address the challenges identified, using the online environment as the workspace for discussions, networking and dissemination of outputs.</p>
<p>Following the emergence of the COVID-19 pandemic during the course of this research, and given its significant impact upon health systems globally, it was deemed essential to ensure that pharmacovigilance stakeholders in LRSs had the capacity to address both the exacerbated pre-existing and novel challenges that they were facing. The focus of the research was accordingly contextualised to focus on the greatest challenges facing pharmacovigilance in LRSs during the COVID-19 pandemic.</p>
<p>Adopting an action research mixed methods approach, this project built upon on a rapid consensus-gathering methodology developed by TGHN, which had been implemented successfully to address wider COVID-19 research priorities and iteratively drive the improvement of knowledge, skills and methods gaps in the field of Global Health.</p>
<p>This began with a novel, hybrid knowledge synthesis strategy to identify published literature and existing training and education resources relevant to pharmacovigilance in LRSs. Consensus-gathering activities began with an online survey of GPV members, to identify highly-ranked areas for pharmacovigilance improvement in LRSs during the pandemic. Survey development included the implementation and assessment of a novel, hybrid validity testing methodology. A virtual open workshop was then hosted to share the survey findings with the CoP, invite further discussion on the results, and to reach consensus on the highest priorities at that time. Two international virtual working groups were then formed, each focussing on one of the highest priorities identified in the consensus-gathering activities. These working group were supported by GPV to work together to facilitate the development of (or provision of, if already available elsewhere) pharmacovigilance resources to address the priorities identified.</p>
<p>A significant number of challenges to the conduct of pharmacovigilance in LRSs were identified. The highest priorities for pharmacovigilance in LRSs during the COVID-19 pandemic included ensuring the safe use of medical interventions in vulnerable populations (particularly children and pregnant women), improving communication between pharmacovigilance stakeholders, and increasing local agency of local pharmacovigilance data.</p>
<p>The CoP model represented an effective strategy for fostering collaboration and enabling knowledge exchange and generation amongst pharmacovigilance stakeholders in LRSs. In addition, the CoP approach facilitated the successful identification of the highest priorities for pharmacovigilance in LRSs during the COVID-19 pandemic, where tools, education and guidance were needed. Whilst the implementation and impact of resources to address these challenges was not assessed, the CoP model was shown to provide an effective platform for the collaborative, community-led development of such resources through the conception of clear and ambitious intervention proposals by highly-engaged working group members.</p>
<p>A knowledge community approach was found to offers an effective strategy for guiding improvements to pharmacovigilance activities in LRSs. The democratic, participant-led methodology provides direct solutions to many of the challenges facing pharmacovigilance in these regions, through the creation of inter-organisational and international networks, the holistic approach to participant contribution, and the collaborative approach to resource sharing and development. The adoption of a knowledge community approach either as the core element of pharmacovigilance capacity building initiatives, or as supporting element to guide such initiatives, has the potential to greatly improve pharmacovigilance capacity in LRSs, and reduce the inequities amongst pharmacovigilance stakeholders around the globe.</p>
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