Abstract

Bharti Patel, Shailesh Jain, Sajal Raghuvanshi

ABSTRACT

Pharmacovigilance systems play a crucial role in ensuring medication safety through systematic monitoring and assessment of adverse drug reactions (ADRs). This comprehensive review examines the current state, challenges, and future directions of pharmacovigilance systems, with particular emphasis on ADR reporting mechanisms and emerging technological solutions. Despite significant advances in pharmacovigilance practices, substantial challenges persist, including widespread underreporting of ADRs, varying report quality, and healthcare provider barriers. The review analyzes how these challenges are particularly pronounced in developing countries, where resource limitations and infrastructure constraints impact effective safety monitoring. Special attention is given to the complexities of detecting and validating rare adverse reactions and addressing population-specific reporting issues. The integration of digital technologies has transformed traditional pharmacovigilance practices. Electronic health records, mobile applications, artificial intelligence, and big data analytics have enhanced the capability to detect and analyze safety signals more efficiently. These technological advances have enabled more proactive approaches to safety monitoring and improved the timeliness of regulatory responses to emerging safety concerns. The review highlights successful solutions and best practices, including targeted educational initiatives, standardization of reporting processes, and innovative incentive mechanisms. International collaboration emerges as a critical factor in strengthening global pharmacovigilance capabilities, particularly through shared resources and harmonized approaches to safety monitoring. Looking ahead, emerging technologies such as blockchain, advanced biosensors, and quantum computing show promise in further revolutionizing ADR detection and assessment. The review concludes by identifying key research priorities and policy recommendations necessary to advance pharmacovigilance science while ensuring patient safety in an increasingly complex therapeutic landscape.