All the answers I asked you related to pharmacovigilience give me an answer in short
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What is the pharmacovigilence
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
Key points:
- Defined by the WHO as monitoring drug safety after they reach the market
- Also called post-marketing surveillance
- Covers all medicines: prescription drugs, OTC, biologics, vaccines, herbal products
- Main goal: ensure drugs are safe and effective in real-world use
Core activities include:
- Collecting adverse drug reaction (ADR) reports
- Signal detection (identifying new safety concerns)
- Risk-benefit assessment
- Regulatory action (label changes, withdrawals)
Why it matters: Clinical trials only test drugs on a limited population for a short time. Rare or long-term side effects only emerge after millions of people use the drug - that's where pharmacovigilance steps in.
Key term: An Adverse Drug Reaction (ADR) is a harmful, unintended response to a medicine at normal doses - this is the core unit of pharmacovigilance reporting.
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