Pharmacovigilance: Overview of Italian and European regulations, tools, and perspectives.
Journal:
The International journal of risk & safety in medicine
Published Date:
Aug 7, 2025
Abstract
BackgroundThis study provides a concise overview of the Italian and European pharmacovigilance (PV) systems.ObjectiveTo evaluate the regulatory frameworks of above mentioned systems, operational tools, and recent trends in adverse drug reaction (ADR) reporting. The primary objective is to highlight the strengths and critical issues of the current system in improving drug safety and protecting public health.MethodsOur analysis confirms a progressive increase in ADR reporting in Italy over the past decade, with a peak in 2021 during the COVID-19 vaccination campaign, followed by a subsequent decline.ResultsHospital physicians and pharmacists remain the primary reporters, while patient reports account for around 10%. The causality assessment process continues to rely heavily on tools such as the Naranjo algorithm and the WHO-UMC criteria, although no single gold standard exists. Despite regulatory improvements and digital infrastructure development, key limitations persist, notably underreporting, inconsistent report quality, and lack of population exposure data.ConclusionWhile Italy's PV system has evolved considerably, a more integrated, proactive, and technology-enhanced approach is required to improve the sensitivity and timeliness of signal detection. Future directions should include the use of artificial intelligence, electronic health records, and real-world evidence to enhance pharmacovigilance performance.
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