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 drug was quickly banned or withdrawn from the market in one country after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 :
Drug Controller General
Of India(DCGI)
(Dr.V.G.Somani)
Sub-zonal
Offices (7)
Zonal
Offices(6)
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