Chapter 7: Fundamentals of Pharmacovigilance

Author

Mrs. Tanuja Methra,

Assistant Professor, Department of Pharmacology, Pydah College of Pharmacy, Patavala, Kakinada, Andhra Pradesh, India

Abstract

Pharmacovigilance is the foundational science of drug safety, built upon a precise lexicon that distinguishes between coincidental medical occurrences and true drug-induced harm. The discipline begins with the critical distinction between an Adverse Event (AE), which is simply a temporal association between a drug and a negative outcome, and an Adverse Drug Reaction (ADR), which implies a suspected causal link. The regulatory machinery of reporting is triggered by specific filters, the most important being the Seriousness Criteria. Six specific outcomes death, life-threatening conditions, inpatient hospitalization, persistent disability, congenital anomaly, and medically significant events elevate an event to the status of a Serious Adverse Event (SAE), mandating expedited reporting to health authorities. The intellectual process of Causality Assessment is essential for determining the likelihood of drug attribution, utilizing structured tools like the Naranjo Probability Scale and the WHO-UMC system to evaluate dechallenge and rechallenge data. Finally, the concept of Expectedness acts as the regulatory gatekeeper. The Reference Safety Information, such as the Investigator's Brochure in trials or the Summary of Product Characteristics in post-marketing, serves as the legal baseline for determining whether a serious reaction is "unexpected" and thus qualifies as a Suspected Unexpected Serious Adverse Reaction (SUSAR) requiring immediate, expedited notification to global health authorities.

Keywords: Adverse Drug Reaction (ADR), Seriousness Criteria, Causality Assessment, Expectedness, SUSAR

VIEW PDF