Pharmacovigilance is the pharmacological science relating to the detection, assessment of adverse reactions related to the safe use of medicinal products. The success of the system depends on the quality and accuracy of the information reported on the advberse recation by health care professional.
Adverse reactions are undesirable reactions to health products. Health products include drugs, medical devices and natural health products. Drugs include both prescription and nonprescription pharmaceuticals; biologicaly-derrived products such as vaccines, serums, and blood derived products; cells, tissues and organs; disinfectants; and radiopharmaceuticals.
Reactions may occur under normal use conditions of the product. Reactions may be evident within minutes or years after exposure to the product and may range from minor reactions like a skin rash to serious and life-threatening events such as a heart attack or liver damage.
A noxious and unintended response to a drug, which occurs at any dose and requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistant or significant disability or incapacity, is life-threatening or results in death.
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