PHARMACOVIGILANCE AND DRUG SAFETY

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Authors: Dr.Padige Sri Varsha*, Padakanti Naga Harshitha, Banda Jashwanth, Vaddera Prashanthi
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Abstract

Through the identification, evaluation, comprehension, and prevention of adverse drug reactions (ADRs) throughout a medication's lifecycle, pharmacovigilance plays a crucial role in guaranteeing drug safety. Strong pharmacovigilance systems are essential because, despite thorough pre-marketing clinical trials, uncommon, long-term, and population-specific side effects frequently only manifest during post-marketing use. The purpose of this study is to assess how pharmacovigilance can enhance drug safety outcomes, with a focus on risk minimization techniques, signal detection, and reporting adverse drug reactions. A thorough analysis of active surveillance databases, pharmaco-epidemiological studies, and spontaneous reporting systems was carried out. To evaluate patterns of ADR reporting, causality assessment, and regulatory actions taken in response to identified safety signals, data from national and international pharmacovigilance programs were analysed. The results show that early signal detection and prompt regulatory interventions, such as label modifications, risk communication, and, in certain situations, drug withdrawal, are greatly aided by efficient pharmacovigilance systems. ADR underreporting is still a significant issue, especially in low- and middle-income nations. Signal detection capabilities have been improved through the integration of real-world evidence, electronic health records, and sophisticated analytical techniques. In order to protect public health and maximize the benefit-risk profile of pharmaceuticals, pharmacovigilance is crucial. To advance drug safety surveillance worldwide, it is imperative to adopt innovative technologies, improve data quality, and strengthen the culture of ADR reporting. Keywords: Pharmacovigilance, Drug Safety, Adverse Drug Reactions, Signal Detection, Post-Marketing Surveillance. Phytochemical studies; Herbal face serum.

Fields of Study & Subjects

Pharmacovigilance and Adverse Drug Reactions Pharmaceutical Quality and Counterfeiting Computational Drug Discovery Methods

Publication details

Journal / source
Zenodo (CERN European Organization for Nuclear Research)
Publication date
5 January 2026