Monitoring and Reporting of Adverse Drug Reactions in recent years (2021-2025)

Abstract

Adverse drug reactions (ADRs) represent a persistent challenge to patient safety and healthcare systems worldwide, underscoring the importance of effective pharmacovigilance. This study aimed to evaluate trends in ADR monitoring and reporting between 2021 and 2025 across regional, national, and international pharmacovigilance systems. A retrospective descriptive approach was adopted, utilizing aggregate data obtained from publicly available pharmacovigilance databases and institutional safety reports. Year-wise reporting patterns were examined, and a five-year mean of ADR reports was calculated using a consistent national dataset to enable standardized comparison. The findings indicate variability in reporting trends across systems, with an overall increase in ADR submissions observed toward the later years of the study period. In the selected national dataset, reporting declined from 2021 to 2023, followed by a marked rise in 2024 and 2025. The calculated five-year mean of ADR reports was 835.8 per year. This upward trend coincided with the implementation of targeted awareness programs, enhanced regulatory focus, and the adoption of digital and QR-code–based reporting mechanisms, which simplified reporting processes and improved healthcare professional participation. The study highlights persistent challenges such as underreporting and inconsistencies across reporting frameworks while emphasizing the positive impact of technological integration and structured pharmacovigilance initiatives. Strengthening awareness, standardizing reporting systems, and expanding digital infrastructure are essential for improving ADR surveillance. Continuous monitoring of reporting trends can support early signal detection and contribute to safer medication use and better patient outcomes.