Pharmacovigilance (PV) plays a vital role in healthcare by monitoring the safety of medicines and ensuring that their benefits outweigh any potential risks. It is a scientific discipline that involves the collection, detection, assessment, and prevention of adverse drug reactions (ADRs) and other drug-related problems. The goal of pharmacovigilance is to enhance patient safety by identifying and minimizing risks associated with pharmaceutical products.
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Why is Pharmacovigilance Important?
1. Early Detection of Adverse Drug Reactions (ADRs): Many medications can have unintended side effects, some of which may be severe. Pharmacovigilance helps in identifying these adverse reactions early.
2. Ensuring Patient Safety: By continuously monitoring drugs post-marketing, regulatory agencies and pharmaceutical companies can take necessary actions to prevent harmful effects.
3. Regulatory Compliance: National and international regulatory bodies, such as the FDA (USA), EMA (Europe), and CDSCO (India), require strict pharmacovigilance reporting to ensure drug safety.
4. Improvement of Drug Formulations: If certain drugs show frequent side effects, pharmaceutical companies can reformulate them to enhance safety and efficacy.
5. Public Health Protection: Pharmacovigilance contributes to public health by preventing widespread medication-related harm and ensuring that only safe drugs remain in circulation.
Who is Responsible for Pharmacovigilance?
Pharmacovigilance is a shared responsibility involving multiple stakeholders, including:
Healthcare Professionals (Doctors, Pharmacists, Nurses) – They report ADRs and educate patients.
Pharmaceutical Companies – They conduct clinical trials and post-marketing surveillance.
Regulatory Agencies – They enforce drug safety regulations and monitor reported ADRs.
Patients – They play a key role by reporting side effects and ensuring medication adherence.
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