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Pharmacovigilance
is the science of collecting, monitoring, researching, assessing, and
evaluating of current safety drug information from healthcare providers
(primarily from spontaneous reporting), aiming the early identification of
drug safety problems, their quantitative (frequency) and qualitative
characterization (seriousness, severity, reversibility, mechanism and public
health implications) and prevention of harm to patients (through the
identification of risk factors and groups of risk and the implementation of
regulatory actions toward risk management). Effective and open communication
of safety information, supporting health education, is the final and
challenge goal of Pharmacovigilance. |