Small Group Discussion (SGD) CBME based curriculum

1. Pharmacovigilance
By Nishant Raj

2. Introduction
 Emergence of newer discipline that widens the area of drug safety

3. According To WHO 2002, Pharmacovigilance is the science
and activities related to :
• Detection
• Assessment
• Understanding
• Prevention of Adverse effects or any other
possible drug related problem..

4. What’stheNeed..

5. • Dying from a disease may be inevitable , dying from a
medicine is unacceptable
• Insufficient evidence of safety
 Animal experiments
 Clinical trials prior to marketing ( however , some adverse
reactions (ADRs) are often detected ONLY after marketing
• ADRs are expensive/ can be life threatening

6. PRE Authorization : Analysis of safety information ( usually
obtained from preclinical and clinical studies ) collected
before the marketing authorization of the drug
• Preclinical phase
• Phase I,II,III
POST Authorization : Analysis of safety information (usually
obtained from spontaneous case reports , literature
publications, safety studies ) collected after the marketing
authorization of the drug
• Phase IV
PRE AUTHORTISATION AND POST
AUTHOISATION PHARMACOVIGILANCE

7. ALessonfromHistory…….

8. AIM OF PHARMACOVIGILANCE
1.
• To improve public health and safety in relation to
medicines , cosmetics , herbal products ,etc.
2.
• Early detection of unknown adverse effects and
interactions
3.
• Identification of risk factors and possible mechanism
underlying adverse reaction
• Estimation of quantitative aspects of benefit /risk analysis of
information needed to improve drug prescribing and
regulation

9. FrameworkofPharmacovigilance

10. FunctionsofPharmacovigilance
1.
• Collects reports , data , ADRs
2.
• Analyses and assesses the reports
• Promote the safe use of drugs
3.
• Identifying new information about hazards associated with
medicines
• Preventing harm to the patients

11. CausalityAssessment
• It is the assessment of relationship between a drug
treatment and the occurrence of an Adverse event
• Basically the practical tool for assessment of case
reports
Grading –
• Definite : clearly caused by the exposure
• Probable : likely to be related to the exposure
• Possible : may be relate to exposure
• Unlikely : doubtfully related to the exposure
• Unrelated : clearly not related to the exposure

12. ORGANISATIONSINVOLVED
• WHO – collaborating center for international drug
monitoring is Uppsala monitoring center
,sweden,1978, provides activities and events
• CIOMS(council for international organizations of
medical sciences) – ensuring the communication
between regulators and industries
• ICH( International conference on harmonization )

13. • India joined WHO programme of internationaldrug monitoringin
1997
• It started as the National pharmacovigilance programme (NCC)
officially in 2004
• The Pharmacovigilance programme was initiated in the year
2010, by the governmentof India at AIIMS as National
Coordinatingcenter (NCC) but shifted toIndian Pharmacopoeia
commission(IPC), Ghaziabad(U.P) in the year 2011
• Pharmacovigilance is conducted by CDSCO ( center for drug
standard and control organisation,Delhi and coordinatingby IPC

14. KeystockholdersinPharmacovigilance…..

15. Who can?
Physician
Surgeon
Interns
Dentist
Pharmacist , Nurse ,
physiotherapist
Patient attendants
What
should?
For newer drugs
report all suspected
reaction including
minor ones
For established or
well known drugs
all serious or
unexpected
Where to ?
In ADR Monitoring
centers(AMC)
MCI approved
medical colleges and
hospitals
Private hospitals
Autonomous
institutes (ICMR )
REPORT

16. ADRMonitoringCenters
• Report ADR at AMCs or NCC
• Toll free number. 1800-180-3024 ( 9 am to 5.30 pm )
Monday to Friday
• Email at: pvpi@ipcindia.net or pvpi.ipcindia@gmail.com
• ADR mobile app
• As of today , in India there are more than 300 AMCs (
March ,2021)

17. our college has obtained recognition as AMC center in 2017 JUNE by
Ministry of Health and family welfare , GovernmentOf India under
pharmacovigilance programme of India
SHKM GMC , NALHAR ,NUH
HARYANA

18. MobileApplicatione-PvPI

19. Procedure for Reporting ADR
Medical colleges / hospitals
ADR Monitoring
Forward ADR report to NCC by a software
VIGIFLOW

20. NCC Ghaziabad
Conclusive ADR report
CDSCO informs to

21. International center of pharmacovigilance ,
Sweden (UPPSALA MONITORING CENTER )
Patients
(no to take drug)
Doctors
(not to prescribe
drug)
Drug companies
(to withdraw drug
from market )

22. Somewithdrawndrugs….
• Rofecoxib
• Rosiglitazone
• Phenylpropanolamine
• Astemizole
• Terfenadine
• Thalidomide
• Gatifloxacin
• Trovafloxacin
• Nimesulide

23. …Thank You…