National Programmes related to Pharmacovigilance Pharmacovigilance in India scope of pharmacovigilance in India ADR and Vigi flow

1. National Programmes Related to
Pharmacovigilance
Naveen K L
M Pharma (2nd Sem)
Dept. of Pharmacology
Srinivas College of Pharmacy
Valachil, Mangaluru
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2. Pharmaco – Vigilance
 Pharmakon = Medicine
 Vigilance = To keep watch
- Alert of watchfulness
- In respect of danger; care; caution
Introduction:
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3. What is Pharmacovigilance ?
• Pharmacovigilance is a system to monitor the safety and
effectiveness of medicines and other Pharmaceutical
products.
• As per WHO:
Pharmacovigilance as ‘’science and activities relating to the
detection, assessment, understanding, reporting and
prevention of adverse effects or any other possible drug-
related problems’’.
Detection
Assessment
Understanding
Reporting
Prevention
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4. Why Pharmacovigilance?
• Incomplete information collected during the pre-marketing phase of
drug.
• ADRs are leading cause of morbidity and mortality in both developing
and developed world.
• 4th leading cause of death in USA.
• 30-70% of all ADRs are Preventable.
• They increase cost of patient care and loss of patient confidence in
health care system.
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5. Methods in Pharmacovigilance….
• Passive surveillance
Spontaneous reporting
Case series
• Stimulated reporting
• Active surveillance
• Comparative observational studies
Cross sectional, case control and cohort studies
• Targeted clinical investigations
• Descriptive studies
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6. Spontaneous reporting
• Health care professional describes his/her own clinical observation of a
suspected ADR with marketed drug.
• USA Med watch program
• UK yellow card system
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7. Impact of yellow card scheme
Year Medicine Adverse reaction
2014 Voriconazole Liver and photo toxicity, squamous
cell carcinoma
2014 TNF alpha inhibitor Risk of TB
2013 Risperidone and paliperidone Intraoperative floppy iris syndrome
during cataract surgery
2012 Statins Hyperglycaemia and diabetes
2011 Citalopram and escitilopram QT interval prolongation
2009 Finasteride Potential risk of male breast cancer
2003 Aspirin Reyes syndrome in children's under
16 years
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8. Why do we need Pharmacovigilance in India ?
• India is a vast country with a population of over 1.2 billion with
 Vast ethnic variability
Different disease prevalence patterns
Practice of different systems of medicines
Different socioeconomic status
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9. Pharmacovigilance in India
• 1986 – Started the ADR monitoring centre with 12 regional centres
• 1997 – India joined WHO-ADR monitoring program
• 2004 – National Pharmacovigilance programme
• 2010 – Pharmacovigilance Programme of India
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10. Pharmacovigilance Programme Of India (PvPI)
• Initiated by the Central Drugs Standard Control Organisation (CDSCO)
and initially coordinated by the AIMS New Delhi.
Then in 2011 it was shifted to
• National Coordinating Centre (NCC)
- Indian Pharmacopeia Commission, Ghaziabad
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11. Mission
• To ensure that the
 Benefits of use of medicine outweighs the risk
and
 Safeguard the health of the Indian population
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12. Objectives
• To monitor adverse drug reactions (ADRs) in Indian populations
• To create awareness amongst health care professionals about the
importance of ADR reporting in India
• To monitor the benefits risk profile of medicine
• Generate independent, evidence based recommendations on the
safety of medicines
• Support the CDSCO for formulating safety related regulatory decisions
for medicine
• Communicate findings with all key stakeholders
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13. Goals
Short term Goals
• To develop and implement Pharmacovigilance system in india
• To enrol, initially, all MCI approved medical colleges in the program covering
north, south, east and west of india
• To encourage healthcare professionals in reporting of adverse reaction to
drugs, vaccines, medical devices and biological product
• Collection of case report and data
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14. Long term Goals
• To expand Pharmacovigilance Programme to all hospitals (govt & private)
and centres of public health programs located across India
• To develop and implement electronic reporting system (e- reporting)
• To develop reporting culture amongst healthcare professionals
• To make ADR reporting mandatory for all healthcare professionals
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16. Working Pattern of
Pharmacovigilance Programmes Of
India
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17. Health Professionals
ADRs Monitoring Centre / National Coordinate Centre
Data’s entered in Vigiflow
National Coordinated Centre
WHO Uppsala Monitoring Centre, Sweden
To fill the suspected ADRs Form
Causality Assessment & check the completeness of the data
Forwarded to
Analysed CDSCO for Regulatory Intervention
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18. ADR Monitoring Centre In Medical College
• Collection of ADR reports
• Perform follow up with the complaints to check completeness as per
SOPs
• Data entry into Vigiflow
• Postgraduate / undergraduate training in Pharmacovigilance
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19. ADR Monitoring Centre other than Medical College
• Collection of ADR reports
• Perform follow up with the complaints to check completeness as per
SOPs
• Report the to CDSCO HQ
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20. National Coordinating Centre
• Preparation of SOPs, guidance documents & training manuals
• Cross check completeness, causality assessment as per SOPs
• Reporting to CDSCO headquarters
• Conduct training workshops of all enrolled centers
• Publications of medicine safety newsletters
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21. CDSCO
• Take appropriate regulatory decision and actions on the basis of
recommendations of NCC
• Propagation of medicine safety related decision to satkeholders
• Collabarations with WHO- Uppsala Monitoring Center
• Provide for budgetary provision and administrative support to run
PvPI
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22. Regional Centres under PvPI
• These regional centers are recognized as regional Resource Centre.
• Eastern Region: IPGMER, Kolkata
• Western Region:KEM Hospital, Mumbai
• Northern Region:PGIMER, Chandigarh
• Southern Region: JSS Hospital, Mysore
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23. Whom to Report ?
• Use the ‘’ Suspected Adverse Drug Reaction Reporting Form’’ to
report any ADRs.
• Form is available in all AMCs or downloaded from www.ipc.gov.in or
www.cdsco.gov.in
• The filled reporting form can be submitted to the AMC or directly to
the NCC
• A reporter can also mail the form at pvpi.ipcindia@gmail.com
• Toll free number 1800-180-3024 for reorting ADR
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25. Reference:
• Management science for health USA, chapter 35 Pharmacovigilance
by Christopher olsan.
• Kumar, D.A., Reddenna, L. and Basha, S.A., 2015. Pharmacovigilance
programme of India.
• https://www.slideshare.net/JamshedAhmad2/pharmacovigilance-
47232014
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