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What is pharmacovigilance?

Pharmacovigilance is the monitoring of a drug’s effects after it has been licensed for use, especially to identify, evaluate, understand, and prevent previously unknown adverse reactions or any other problems related to the medicine.

Pharmacovigilance is a crucial element of post-market surveillance and the continual reevaluation of a medication’s safety. It allows manufacturers to see which adverse events occur and what new information this provides about the medication. For example, pharmacovigilance may reveal a certain disease population who should not use the drug, or that it is not safe to use for longer than a certain amount of time.

As a part of pharmacovigilance, new adverse events are analyzed and addressed to ensure that the drug’s benefits continue to outweigh its possible risks.

Why is pharmacovigilance important for healthcare?

All drugs are required to undergo rigorous safety and efficacy testing through clinical trials before they can be authorized for use. However, clinical trials generally study these products in a small number of selected individuals for a short time. As such, some side effects may not arise in the clinical trial but emerge when used by a heterogeneous population. For example, those with other concurrent diseases may see side effects that the clinical trial population did not.

Pharmacovigilance ensures that a drug’s safety information is continually updated to avoid additional adverse events.