Definition and scope of pharmacovigilance

 Definition:

Pharmacovigilance, often abbreviated as PV, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It encompasses the monitoring of drugs, biologics, herbal remedies, and vaccines once they are on the market to ensure their safety and efficacy in real-world settings. Pharmacovigilance aims to improve patient care and safety by identifying and evaluating potential risks associated with pharmaceutical products.

Scope:

1. Adverse Drug Reaction (ADR) Reporting and Monitoring: One of the primary functions of pharmacovigilance is the collection, assessment, and monitoring of adverse drug reactions (ADRs). This involves the systematic gathering of information from healthcare professionals, patients, and regulatory authorities regarding any unexpected or harmful effects associated with medications.

2. Signal Detection: Pharmacovigilance activities involve the identification of signals that may indicate potential safety concerns or previously unrecognized hazards associated with medications. This process involves analyzing data from various sources, including spontaneous reporting systems, clinical trials, epidemiological studies, and scientific literature.

3. Risk Assessment and Management: Pharmacovigilance professionals assess the risks associated with specific drugs or classes of drugs and develop strategies to mitigate these risks. This may involve updating product labeling, implementing risk minimization measures, or even withdrawing a product from the market if the risks outweigh the benefits.

4. Post-Marketing Surveillance: Pharmacovigilance extends beyond pre-market clinical trials to monitor the safety and effectiveness of drugs once they are available to the general population. Post-marketing surveillance involves ongoing monitoring of adverse events, product quality issues, and other drug-related problems to ensure patient safety.

5. Pharmacovigilance in Special Populations: Pharmacovigilance activities also focus on specific populations, such as pregnant women, children, elderly individuals, and patients with comorbidities. These groups may be more vulnerable to adverse drug reactions or may require special considerations in terms of dosing and monitoring.

6. Regulatory Compliance: Pharmacovigilance plays a crucial role in ensuring regulatory compliance with national and international drug safety regulations. Regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require pharmaceutical companies to conduct pharmacovigilance activities as part of their post-market obligations.

7. Global Collaboration: Given the global nature of the pharmaceutical industry, pharmacovigilance involves collaboration among multiple stakeholders, including regulatory agencies, pharmaceutical companies, healthcare professionals, and patient advocacy groups. International initiatives, such as the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring, facilitate the exchange of pharmacovigilance information and promote global patient safety.