Pharmacovigilance: Assessing the Effectiveness of Adverse Drug Reaction Reporting Systems

Abstract

Pharmacovigilance plays a crucial role in ensuring drug safety by systematically detecting, assessing, and preventing adverse drug reactions (ADRs). Effective ADR reporting systems are essential for identifying potential risks associated with medications, thereby safeguarding public health. This paper examines the effectiveness of ADR reporting systems worldwide, focusing on their structure, data collection, and reporting mechanisms. Through analysis of various regional and national systems, including spontaneous reporting systems (SRS) and electronic health record (EHR)-linked reporting, this study highlights challenges such as underreporting, data quality, and timeliness. Additionally, it assesses the integration of advanced technologies like artificial intelligence (AI) and machine learning (ML) in enhancing signal detection and risk evaluation. The findings suggest that while ADR reporting systems are pivotal for drug safety, improvements in reporting rates, standardization, and technological support are needed to optimize pharmacovigilance practices. Recommendations for policy changes, training, and public awareness campaigns are provided to strengthen ADR reporting and improve the overall effectiveness of pharmacovigilance systems..