Abstract

Establishing a relationship of causality between the medications received and the events occurred utilizing causality assessment scale is much needed to reduce the occurrence of Adverse Drug Reactions (ADRs) and to prevent exposure of patients towards additional drug hazards. Causality assessment can be defined as the determination of chance, whether a selected intervention is the root cause of the adverse event observed. The causality assessment is the responsibility of either a single expert or an established committee. As it is a common phenomenon of variable perception of knowledge and experience by each expert, there is a high possibility of disagreement and inter-individual variability on assessment. Many of the causality assessment methods have their advantages and disadvantages. However, no single scale has been adopted as standardized and considered for uniform acceptance.

Highlights

  • Pharmacovigilance is an integral branch of the science which is related to collection, detection, assessment, understanding, and prevention of adverse effects or any other problems related to drug use [1]

  • World Health Organization (WHO) defined the Adverse Drug Reactions (ADRs) as “response to a drug, which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function [2]

  • Establishing or evaluating likelihood between the adverse event and the drug through causality assessment is much needed to reduce the occurrence of ADRs and to prevent exposure of patients towards additional drug hazards [11]

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Summary

INTRODUCTION

Pharmacovigilance is an integral branch of the science which is related to collection, detection, assessment, understanding, and prevention of adverse effects or any other problems related to drug use [1]. World Health Organization (WHO) defined the ADR as “response to a drug, which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function [2]. Establishing or evaluating likelihood between the adverse event and the drug through causality assessment is much needed to reduce the occurrence of ADRs and to prevent exposure of patients towards additional drug hazards [11]. It is a key element of Pharmacovigilance and contributes to evaluate risk-benefit profiles and identify signals, thereby assisting in regulatory decision making [13]. The current review article focuses on the merits and demerits of different assessment scales and briefs the use of a specific scale for a given clinical practice setup

Methods of causality assessment
Limitations
Findings
CONCLUSION
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