Podcast
Questions and Answers
What is the primary priority of the Indian Pharmacopoeia Commission?
What is the primary priority of the Indian Pharmacopoeia Commission?
Promoting safe use of medicines
How many adverse drug reactions (ADRs) monitoring centers currently report to the NCC?
How many adverse drug reactions (ADRs) monitoring centers currently report to the NCC?
- 200
- 100
- 150
- 179 (correct)
What percentage does India's contribution to the global safety database reach?
What percentage does India's contribution to the global safety database reach?
3%
The completeness score of India's ADR reporting is 0.93 out of 1.
The completeness score of India's ADR reporting is 0.93 out of 1.
What was launched in 2010 to inspire confidence in medicine safety?
What was launched in 2010 to inspire confidence in medicine safety?
Which organization notified important safety label changes on drugs such as carbamazepine and piperacillin + tazobactam in 2015?
Which organization notified important safety label changes on drugs such as carbamazepine and piperacillin + tazobactam in 2015?
ADRs account for less than 1% of hospital admissions in the USA.
ADRs account for less than 1% of hospital admissions in the USA.
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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.
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