Pharmacovigilance is the science and activities relating to the collection, detection, assessment, monitoring, understanding and prevention of unintended effects, Adverse Drug Reactions (ADRs) or any other possible Medication related problems caused by Pharmaceutical product. Adverse Drug Reactions (ADR) is any response to a drug which is noxious and unintended, and which occurs at doses normally used in men for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function
The following notes include- aims; scope, objectives and functions of pharmacovigilance; ADR- need to monitor ADR; classification of ADR- Traditional classification & Newer classification; Predisposing factors for ADR; ADR severity assessment scale; Mechanisms of ADR; causality assessment- Naranjo's scale, WHO probability scale; Detection of ADR, ADR reporting- Spontaneous reporting, cohort event monitoring, record linkage; Management of ADR; risk factors & monitoring of ADR; over reporting, under reporting.
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