In Part 1, we discussed what pharmacovigilance is and why it is important. Now let’s understand how it actually works.
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Drug safety monitoring begins during clinical trials. In Phase I, II, and III trials, researchers closely observe participants for any adverse effects. All reactions are recorded and analyzed before approval.
However, pharmacovigilance becomes even more important after the drug is approved and released to the public. This stage is called post-marketing surveillance (Phase IV).
At this stage, adverse drug reactions are reported by doctors, pharmacists, healthcare professionals, and sometimes even patients. These reports are collected, assessed for causality, documented, and submitted to regulatory authorities.
If serious safety issues are identified, warnings may be updated, usage may be restricted, or in rare cases, the drug may be withdrawn from the market.
Pharmacovigilance is a continuous global effort to protect public health.
MBH/AB