Podcast
Questions and Answers
What is the primary goal of the Indian Pharmacopoeia Commission?
What is the primary goal of the Indian Pharmacopoeia Commission?
Promoting safe use of medicines
How many adverse drug reaction (ADR) monitoring centers report ADRs to the NCC?
How many adverse drug reaction (ADR) monitoring centers report ADRs to the NCC?
179
What was the completeness score of India's contribution to the global safety database?
What was the completeness score of India's contribution to the global safety database?
The Nationwide Pharmacovigilance Programme of India (PvPI) was launched in 2005.
The Nationwide Pharmacovigilance Programme of India (PvPI) was launched in 2005.
Signup and view all the answers
What measures are being taken by the NCC to enhance patient safety?
What measures are being taken by the NCC to enhance patient safety?
Signup and view all the answers
What significant safety label changes were notified by the Central Drugs Standard Control Organization in 2015?
What significant safety label changes were notified by the Central Drugs Standard Control Organization in 2015?
Signup and view all the answers
What percentage of hospital admissions in the USA is attributed to ADRs?
What percentage of hospital admissions in the USA is attributed to ADRs?
Signup and view all the answers
Study Notes
Overview of Pharmacovigilance Programme of India (PvPI)
- Indian Pharmacopoeia Commission (IPC) serves as the National Coordination Center (NCC) for PvPI.
- PvPI aims to promote the safe use of medicines in India.
Current Monitoring and Contributions
- One hundred seventy-nine monitoring centers report Adverse Drug Reactions (ADRs) to NCC.
- India contributes 3% to the global safety database with a completeness score of 0.93 out of 1.
Measures to Enhance Patient Safety
- NCC implements capacity-building initiatives for better monitoring and surveillance of ADRs.
- Collaboration with national health programs and organizations aims to boost ADR reporting.
- PvPI functions as a knowledge database for Indian regulators.
Regulatory Actions and Drug Safety
- The Central Drugs Standard Control Organization (CDSCO) implemented important safety label changes for drugs like carbamazepine and piperacillin + tazobactam in 2015.
- Ongoing monitoring of other drugs to determine if further regulatory interventions are necessary.
Global Context and Impact of ADRs
- ADRs are a significant concern worldwide, causing substantial morbidity and mortality.
- ADRs account for 0.9% of hospital admissions in England (1999-2008) and 1% in the Australian healthcare system.
- In the USA, ADRs contribute to 3.4%–7% of hospital admissions, highlighting the global health impact of ADRs.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Description
This quiz explores the Pharmacovigilance Programme of India (PvPI), focusing on its objectives, monitoring centers, and regulatory actions. Learn about the initiatives implemented to enhance patient safety and the role of the Indian Pharmacopoeia Commission in improving drug safety in India.
