Factors influencing the institutionalization of digital pharmacovigilance tools in LMICs: a scoping review using the non-adoption, abandonment, scale-up, spread, and sustainability framework

BACKGROUND: Digital tools for pharmacovigilance (PV) have been widely promoted to strengthen adverse drug reaction (ADR) reporting in low- and middle-income countries (LMICs). Despite growing evidence on the implementation of digital pharmacovigilance tools, limited evidence has examined the factors influencing their institutionalization in LMICs. This scoping review examines the institutionalization of digital PV tools in LMICs and identifies factors shaping their long-term integration. METHODS: A scoping review was conducted following PRISMA-ScR guidelines. 2 reviewers independently screened studies identified through MEDLINE, Embase, Web of Science, Google Scholar, and selected grey literature. Eligible studies examined digital PV tools implemented in LMICs and reported implementation-related findings. Data were synthesized using an inductive-deductive thematic approach informed by the Non-adoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework. RESULTS: 21 studies from 14 LMICs were included of which the majority are in sub-Saharan Africa, with fewer studies from South/Southeast Asia, the Middle East, and none from Latin America. Evidence was heavily concentrated on technological features, user adoption, and short-term organizational readiness. Key facilitators included simplified reporting interfaces, offline functionalities, training, and alignment with WHO PV standards. However, persistent barriers were identified at organizational and system levels, including weak or absence of governance, limited feedback mechanisms, fear of blame, fragmented workflows, and heavy reliance on external donor funding. Evidence related to long-term embedding, such as routinization, domestic and sustainable financing, and institutional ownership, was sparse. 16 of 21 included studies (76%) examined tools at the implementation stage (pilot/trial/early routine use), 4 (19%) at the pre-implementation stage, and only 1 (5%) at post-implementation/sustained use. CONCLUSIONS: Digital PV in LMICs is frequently treated as a technical intervention rather than a complex socio-technical and institutional change. Strengthening the long-term integration of digital PV may require greater attention to legal mandates, sustainable financing, organizational and professional capacities, and political commitment.