Trigger tool methodologies in hospital settings: reappraising their role in pharmacovigilance and digital safety surveillance

INTRODUCTION: Trigger tool methodologies have become important approaches for detecting adverse events in hospital care because they identify more harm than conventional incident reporting systems. Their role is particularly relevant for medication-related harm, which is often under-recognized or insufficiently documented in routine clinical practice. AREAS COVERED: This structured narrative review examines the development, methodological foundations, performance, and clinical applications of trigger tools in hospital settings, with emphasis on their use in detecting adverse drug events. It also discusses population-specific adaptations, methodological variability, and recent advances in electronic health record-based, automated, and artificial intelligence-assisted trigger approaches. The literature search was conducted using PubMed and Google Scholar, with additional studies identified through manual screening of reference lists. EXPERT OPINION: Trigger tools should be viewed not only as methods for retrospective harm detection, but also as potential links between hospital patient safety monitoring and pharmacovigilance. Their future value will likely depend on greater standardization and on the development of hybrid, clinically validated systems that combine relevant triggers, electronic health record data, and clinician review. Importantly, trigger tool findings should be incorporated into closed-loop workflows that support pharmacovigilance reporting, clinician feedback, quality improvement, and measurable reduction of preventable medication-related harm.