Pharmacovigilence
The role of pharmacovigilance is to assess and the safety of the drug after market authorization.
But why is this necessary and why do we do this?
Before a drug is granted market authorization it must prove to be effective and safe for use. However, post marketing surveillance is needed to determine:
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Long term effects
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Large scale effects on a larger population than the phase 3 of the clinical trials
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Trace uncommon side effects
The specific aims of pharmacovigilance are to10:
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Improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions
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Improve public health and safety in relation to the use of medicines
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Contribute to the assessment of benefit, harm, effectiveness and risk of medicines
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Encouraging the safe, rational and more effective (including cost-effectiveness) use of medicines
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Promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public
Selected videos on pharmacovigilence:
Understanding Pharmacovigilance
How does Pharmacovigilence work?
Illustration:
https://www.ema.europa.eu/en/human-regulatory/overview/pharmacovigilance-overview
