Abstract

THE ROLE OF PHARMACOVIGILENCE IN PREVENTING ADVERSE DRUG REACTION: METHODS AND TECHNIQUES FOR EARLY DETECTION OF DRUG SAFETY ISSUES

*Jyothsna Kommula, Dr. A. Prameela Rani, Sadapu Yamini, Sakila Chandrika, Kanaparthy Meghana

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Abstract

As the global pharmaceutical business has grown, so too has the complexity of medicine therapy, making strong pharmacovigilance (PV) systems necessary to guarantee drug safety and effectiveness. The many goals of pharmacovigilance are examined in this article, with a focus on how important it is for tracking adverse drug reactions improving risk management, and encouraging international cooperation. It emphasises how crucial it is to guarantee medication safety for a range of demographics, to identify adverse drug reactions (ADRs) and drug-drug interactions early, and modify PV systems to accommodate novel drug classes and emerging therapies. The difficulties in pharmacovigilance, such as the underreporting of adverse drug reactions, problems with data quality and the requirement for efficient causality assessment are also covered in the paper. By looking at the pharmacovigilance methods used, including patient reporting systems, spontaneous reporting systems and sophisticated statistical methods and safety. The importance, advantages, difficulties and prospects of patient reporting systems and PROs in pharmacovigilance are examined in this article. Adverse drug reactions and other drug-related problems can be reported directly to pharmaceutical companies, healthcare organizations.

Keywords: Adverse drug reactions (ADR), Aims of pharmacovilance, Drug safety monitoring (DSM), challenges of adverse drug reactions, Spontaneous reporting system.