JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD B.Pharmacy IV PHARMACOVIGILANCE Previous Question Paper (September-2021 - R17)

The Pharmacovigilance Program of India (PvPI) was launched in 2010 by the Ministry of Health and Family Welfare, Government of India, with the All India Institute of Medical Sciences (AIIMS), New Delhi, as the National Coordination Centre (NCC). It is currently coordinated by the Indian Pharmacopoeia Commission (IPC), Ghaziabad.

The primary objectives of PvPI include:

• Monitoring the safety of medicines in the Indian population to identify signals of adverse drug reactions (ADRs).
• Generating evidence-based data to support regulatory decisions regarding the safety of pharmaceutical products.
• Communicating safety information to healthcare professionals and the public to minimize risks.
• Collaborating with international pharmacovigilance centers, such as the WHO Uppsala Monitoring Centre (UMC).

The program operates through a network of Adverse Drug Reaction Monitoring Centres (AMCs) located in medical colleges and hospitals across the country. These centers collect ADR reports from healthcare professionals, validate them, and upload the data into the Vigiflow software, which is then transmitted to the global database, Vigibase. PvPI also conducts training programs and awareness campaigns to promote a culture of spontaneous reporting among healthcare providers.

Predisposing factors for Adverse Drug Reactions (ADRs) are characteristics that increase an individual's susceptibility to experiencing an unintended or harmful effect from a medication. These factors are categorized as follows:

• Patient-related factors: Age is a significant factor, as neonates and the elderly often have altered drug metabolism and excretion. Gender, genetic polymorphisms (e.g., variations in cytochrome P450 enzymes), and underlying disease states like renal or hepatic impairment significantly influence drug handling.
• Drug-related factors: The chemical properties of the drug, its therapeutic index, dosage, route of administration, and the duration of therapy are critical. Polypharmacy, or the concurrent use of multiple medications, increases the risk of drug-drug interactions.
• Environmental and lifestyle factors: Dietary habits, alcohol consumption, smoking, and exposure to environmental toxins can induce or inhibit drug-metabolizing enzymes, thereby altering the pharmacokinetics of the administered drug.
• Clinical factors: Previous history of allergies or prior ADRs is a strong predictor of future reactions. Additionally, the nature of the disease being treated can alter the patient's physiological response to the drug.