Digital Pharmacovigilance: A Review of Emerging Technologies for Adverse Drug Raction Reporting and Drug Safety Monitoring

Abstract

Digital pharmacovigilance is transforming the collection, processing, evaluation, and monitoring of adverse drug reactions (ADRs) through the integration of emerging digital technologies into drug-safety systems. Conventional pharmacovigilance relies substantially on spontaneous reporting, manual case processing, and periodic safety evaluations, which may be limited by underreporting, delayed submissions, incomplete information, and increasing volumes of safety data. Digital technologies, including artificial intelligence (AI), machine learning (ML), natural language processing (NLP), electronic health records (EHRs), mobile health applications, social media monitoring, cloud computing, and real-world data analytics, offer opportunities to strengthen the efficiency and responsiveness of drug-safety surveillance. This review examines the applications of these technologies in ADR identification, electronic reporting, case processing, safety-signal detection, and post-marketing surveillance. AI-assisted systems can support duplicate detection, adverse-event extraction, report prioritization, and the identification of potential safety signals across heterogeneous data sources. EHRs and real-world databases facilitate active surveillance, while mobile applications and patient-centered digital platforms may improve accessibility and timeliness of ADR reporting. Social media and online health communities provide supplementary information about patient experiences, although the reliability and clinical interpretation of these data require careful evaluation. Despite these advances, important challenges remain, including data quality, interoperability, algorithmic bias, privacy protection, cybersecurity, regulatory compliance, and limited external validation of computational models. Digital systems may also generate false-positive signals and cannot independently establish causality between drug exposure and an adverse event. Effective implementation therefore requires human oversight, standardized reporting procedures, transparent algorithms, and collaboration among healthcare professionals, regulatory authorities, technology developers, and patients. Digital pharmacovigilance should complement established safety-monitoring practices through responsible technology adoption, evidence-based evaluation, and continuous performance assessment. Integrating digital tools into pharmacovigilance workflows may support earlier signal identification, improved reporting efficiency, and more proactive, patient-centered drug-safety monitoring.