Pharmacovigilance plays a crucial role in ensuring drug safety and promoting patient well-being throughout the life cycle of medicinal products. However, this field faces several challenges, including underreporting adverse events, data quality issues, complexity signal detection large datasets. To address these challenges enhance monitoring, there is growing interest harnessing potential gener...

Spontaneous reporting systems for suspected adverse drug reactions (ADRs) remain a cornerstone of pharmacovigilance. In The Netherlands ‘the Netherlands Pharmacovigilance Foundation Lareb’ maintains such a system. A primary aim in pharmacovigilance is the timely detection of either new ADRs or a change of the frequency of ADRs that are already known to be associated with the drugs involved, i.e...

Background: Adverse Drug Reactions (ADRs) underreporting is a serious drawback of the pharmacovigilance system. Spontaneous reporting of ADRs is a valid instrument to enhance pharmacovigilance. Objectives: To avoid prescribing again to patients the drug that caused them the ADRs, to evaluate spontaneous reporting of ADRs by patients to their General Practitioner (GP); to investigate the most in...

INTRODUCTION Patient reporting in pharmacovigilance is important and contributes to signal detection. However, descriptions of methodologies for using patient reports in signal detection are scarce, and published experiences of how patient reports are used in pharmacovigilance are limited to a few individual countries. OBJECTIVE Our objective was to explore the contribution of patient reports...

Purpose: This study aims to investigate preventability criteria of adverse drug reactions (ADRs) involving non-steroidal anti-inflammatory drugs (NSAIDs) by analyzing individual case safety reports (ICSRs) sent through Campania region (Italy) spontaneous reporting system from July 2012 to October 2016. Methods: For all the ICSRs that reported NSAIDs as suspected drug, a trained multidisciplinar...