Chapter 7: Information Resources in Pharmacovigilance

Chapter 7: Information Resources in Pharmacovigilance

Author: Mr. Ashutosh Jain
Volume: 01
First Online: 31 August 2024
Pages: 79-86
DOI:

Abstract

Information resources in pharmacovigilance are crucial for the effective monitoring, assessment, and prevention of adverse drug reactions (ADRs) and other drug-related problems. These resources include a wide range of databases, guidelines, and tools designed to support healthcare professionals, regulatory authorities, and pharmaceutical companies in ensuring drug safety. Key resources include the World Health Organization’s Global Individual Case Safety Reports (ICSRs) database (VigiBase), the European Medicines Agency’s EudraVigilance system, and the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS). Additionally, standardized terminologies and dictionaries like MedDRA (Medical Dictionary for Regulatory Activities) and the WHO Drug Dictionary provide consistent language and coding for adverse events and medications. Pharmacovigilance guidelines from organizations such as the International Council for Harmonisation (ICH) and the World Health Organization (WHO) offer frameworks for best practices in drug safety monitoring. These resources collectively enhance the ability to detect, analyze, and respond to potential drug safety issues, ultimately contributing to the protection of public health on a global scale.

Keywords: Pharmacovigilance, Information Resources, Adverse Drug Reactions (ADRs), VigiBase, EudraVigilance, FAERS, MedDRA