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Pharmacovigilance

What is Pharmacovigilance?

According to the World Health Organization, Pharmacovigilance is the science and practice of detecting, assessing, analyzing, and preventing adverse effects or any other drug-related problems.

What Is an Adverse Drug Reaction/Effect?

An adverse reaction, or ADR, is an unpleasant and unanticipated response to medicine that occurs at dosages routinely employed in man for disease prevention, diagnosis, therapy, or modifying physiological function.

What Is the Importance of Pharmacovigilance?

ADR must be collected to estimate the risk and benefit of medication to promote its responsible and safe usage. Good pharmacovigilance detects drug-related risks as soon as possible to minimize or avoid any potential drug-related harm.

What Is the Minimum Amount of Information Needed for a Report?

An identified reporter, an identifiable patient, an adverse reaction, and a suspected product are the minimum requirements for reporting.

Adverse Event Reporting

Adverse Reaction Information

Check appropriate:

Suspected drug causing Adverse Drug Reaction:

Did the adverse reaction stop after stopping the drug?

Concomitant drugs and history

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