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Pharmacovigilance (abbreviated PV or PhV) is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines.[1] Generally speaking, pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medicationsbiologicalsherbalism and traditional medicineswith a view to:

  • Identifying new information about hazards associated with medicines
  • Preventing harm to the patients.

Pharmacovigilance starts from the clinical stage and continues throughout the product life cycle of the drug, mainly divided as pharmacovigilance during pre-marketing (that is clinical phase) and post-marketing. The process of collection of such information about a drug begins in phase I of the clinical trial, before approval of the drug, and continues even after approval; several post-market safety studies are conducted, with many made mandatory by drug regulatory agencies around the world.
The etymological roots are: pharmakon (Greek), “drug;” and vigilare (Latin), “to keep awake or alert, to keep watch.” Pharmacovigilance is particularly concerned with adverse drug reactions, or ADRs, which are officially described as "A response to a drug which is noxious and unintended including lack of efficacy of drug and which occurs at doses normally used… for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function. It also includes overdose, misuse and abuse of drug.[2]

Pharmacovigilance is gaining importance for doctors and scientists as the number of stories in the mass media of drug recalls increases.[citation needed]


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