Global Inequalities In Pharmacovigilance: A Critical Review And Methodological Framework For Inclusive Pharmacoepidemiology

Abstract

Post-marketing drug safety surveillance relies overwhelmingly on data from high-income countries (HICs), creating a critical evidentiary blind spot for global health. Although lowand middle-income countries (LMICs) represent over 80% of the world’s population, they contribute less than 1% of individual case safety reports to global databases such as WHO VigiBase. Current pharmacovigilance paradigms depend heavily on electronic health records, specialist clinician verification, and standardised diagnostic coding infrastructure rarely present in low-resource settings. Consequently, non-clinical harms, context-specific drug-drug interactions, and adverse events in underrepresented populations are routinely missed or dismissed as statistical noise. This paper critically reviews the structural, technical, and governance disparities inherent in modern post-marketing surveillance and introduces the Inclusive Pharmacoepidemiology Framework (IPF). The IPF re-engineers the evidence pipeline across seven core dimensions: incorporating non-traditional data sources (e.g., community health worker logs, mobile reporting), expanding outcomes to include socio-economic harms, applying socio-structurally disaggregated Bayesian signal detection, embedding participatory co-design, mandating reflexive data governance, establishing rapid reciprocal data feedback, and integrating reflexive data feedback, and integrating non-standard real-world evidence into regulatory decision making. By shifting from HIC-centric administrative expansion to methodological reorientation, the IPF transforms global drug safety surveillance into a proactive, equitable instrument for global health justice.