Ppt On National Programmes Related to Pharmacovigilance

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 (2 nd S em) Dept. of Pharmacology Srinivas College of Pharmacy Valachil, Mangaluru 1

2. Pharmaco – Vigilance Pharmakon = Medicine Vigilance = To keep watch Alert of watchfulness In respect of danger; care; caution Introduction: 2

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 3

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. 4 th 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. 4

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 5

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 6

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 an d 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 7

8. Why do we need Pharmacovigilance in I ndia ? 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 8

9. Pharmacovigilance in I ndia 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 I ndia 9

10. Pharmacovigilance Programme Of India (PvPI) Initiated by the C entral 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 10

11. Mission To ensure that the Benefits of use of medicine outweighs the risk and Safeguard the health of the Indian population 11

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 12

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 13

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 14

15. 15

16. Working Pattern of Pharmacovigilance Programmes Of India 16

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 17

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 18

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 19

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 20

21. CDSCO Take appropriate regulatory decision and actions on the basis of recommendations of NCC P ropagation of medicine safety related decision to satkeholders Collabarations with WHO- Uppsala Monitoring Center Provide for budgetary provision and administrative support to run PvPI 21

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 22

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 [email protected] Toll free number 1800-180-3024 for reorting ADR 23

24. 24

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 25

26. 26