Pharmacovigilance - Defination, Aim, Need ,Importance ,history, workflow, conclusion of pharmacovigilance.

pharmacovigilance(PV)

Defination of pharmacovigilance

Aims of pharmacovigilance

Origin of pharmacovigilance

History of pharmacovigilance

Importance of pharmacovigilance

Work flow of Pharmacovigilance

Conclusion

1. Presented By - Madhav Jajnure Class - M.Pharm.II Year ( Pharmacology) Sinhgad College Of Pharmacy, Vadgaon , Pune 411041 Importance Of Pharmacovigilance : A Case Study

2. Contents : Defination Aims Origin of pharmacovigilance History of pharmacovigilance Importance of pharmacovigilance Work flow of Pharmacovigilance Conclusion References

3. Pharmacovigilance : “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”. Pharmacon - Drug Vigilance-To Keep Watch Pharmacovigilane Detection – Detection of adverse event( Vomitting , nausea, accident etc..) Assesment - Asses all adverse events whether which are caused by drug or not. if it is caused by drug divide-1) mild 2) moderate 3) severe Naranjo scale ( for causality assesment )and modified Hartwig scale ( severity grading ) Understanding - Study of pharmacology -mechanism behind adverse events. Prevention – Precautions , advice,directions

4. Aims: To improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions. To improve public health and safety in relation to the use of medicines. To detect problems related to the use of medicines and communicate the findings in a timely manner. To encourage the safe, rational and more effective (including cost effective) use of medicines. Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, leading to the prevention of harm and maximization of benefit.

5. Origin Of Pharmacovigilance Thalidomide - 1950s (1957) as a sedative. In early 1961- Dr William McBride- he described- the drug thalidomide- increase in birth defects. drug was quickly banned or withdrawn from the market in one country after another.(Germany) Thalidomide was the biggest man‐made medical disaster ever. More than 10,000 children were born with a range of severe and debilitating malformations, along with an unknown number of fetal deaths. 1

6. The Thalidomide scandal led to the beginning of both national and international collection of ICSRs to further benefit patients and improve medicines safety and decision-making among healthcare professionals. In 1963, the UK - Yellow Card Scheme In 1968 , the WHO established its Programme for International Drug Monitoring (PIDM). Mandating proof of the efficacy of a drug and its safety - regulatory agencies( USFDA, MHRA) Continue…

7. Two decades later, 1982 – benoxaprofen - For arthritis as anti-inflammatory agent 2 After two years cholestatic jaundice fatal liver toxicity ICH Guidelines on Pharmacokinetic studies in drug development. Development of guidelines on drug interactions- In European union (1997) In US(1999). WHY PV IMPORTANT : To reduce further such disasters pharmacovigilance is important.

8. History of pharmacovigilance in india ADR monitoring system proposed Joined with WHO-ADR (AIIMS,KEM,&AMU) NPP by central health minister at new dehli NPP by CDSCO ,2 zonal ,5 regional, 24 peripheral PvPI initiated (AIIMS as NCC ) NCC shifted to Gaziabad 1986 1997 2004 2005 2010 2011 VISION : To improve patient safety & welfare in the Indian population by monitoring the drug safety & thereby reducing the risk associated with use of medicine. Current Affairs : CDSCO: New Dehli

9. Importance of pharmacovigilance To identify : Risks and benefits of medicines to improve their safe use. Changes in the patterns of adverse effects ( frequency, severity). Early detection of hitherto unknown adverse reactions and interactions. Detection of increases in frequency of (known) adverse reactions. Identification of risk factors and possible mechanism underlying adverse reactions. Complete safety data cannot be captured through clinical trials – limited volunteers,not taking any other medications,they don’t have concomitant disease.

10. Work flow of pharmacovigilance Data entry in data base Case processing (AMC) Data collection (ICSR) Review Panel(NCC) Causality Assesment Signal Detection Aggregate Reporting (PSUR) UMC, Sweden Regulatory Authoritis (CDSCO ) Action

11. The impact of various disasters was significant , as it revolutionised the regulatory approach towards the safe use of medicines. At the time of marketing ,the safety profile is not completely ascertained. Across india HCPs should start reporting ADR and participate in PvPI to ensure that people in india receives safe drugs, with the coordination of stakeholders, a world class pharmacovigilance in india can be build up . Conclusion

12. Campbell, J.E., Gossell -Williams, M. and Lee, M.G., 2014. A review of pharmacovigilance. The West Indian Medical Journal, 63(7), p.771. https://cdsco.gov.in/opencms/opencms/en/About-us/Introduction / Introduction to pharmacovigilance - (who-umc.org) https://www.researchgate.net/publication/348035252 : Review on pharmacovigilane https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance Rohilla , A., Singh, N., Kumar, V., Kumar, M., Sharma, A.D. and Kushnoor , A., 2012. Pharmacovigilance: Needs and objectives. Journal of Advanced Pharmacy Education & Research Oct-Dec, 2(4). References :

13. Thank You