Empowering citizens to spontaneously report suspected adverse drug reaction: Systematic literature review of interventions and their impact

This systematic literature review aimed to identify and characterize existing interventions designed to empower citizens to spontaneously report adverse drug reactions (ADRs) and to determine which interventions have been shown to be the most effective internationally. The research question was structured using the PICO framework. Searches were conducted in three databases, following PRISMA guidelines, with protocol registered in PROSPERO(2025CRD42025645431). From 3.843 studies initially identified, 15 met the inclusion criteria and were analysed. These studies described and evaluated interventions implemented to empower citizens to report ADRs spontaneously. Most interventions (digital tools, media campaigns, interviews, educational materials, telephone-based interventions, pharmacist- and physician-led education) targeted the general public(n = 7)-including patients, parents, teachers and citizens-while others involved users supported by pharmacists(n = 5) or by physicians(n = 3). Approximately 80%(n = 12) of the studies reported an increase in ADR notifications following the intervention, and three studies demonstrated improvements in participants' knowledge, attitudes and perceptions regarding pharmacovigilance. Interventions led by pharmacists and physicians that offered practical education to citizens were particularly effective, emphasizing the central role of education in promoting active participation in drug safety monitoring. However, heterogeneity in study design, outcome measures and evaluation metrics limited direct comparison of effectiveness across studies. Overall, this review shows that professional-led, multi-component interventions are the most consistently effective for empowering citizens to report ADRs, whereas digital and awareness-based strategies yield more variable results, highlighting the importance of structured education to support active pharmacovigilance and inform practice and policy. To our knowledge, this is the first systematic review focused exclusively on empowering the public.