Pharmacovigilance is the science of detecting, assessing, understanding, and preventing adverse effects or any drug-related problems. It is important because some adverse drug reactions are only detected after a drug is approved and used by many patients. The goal of pharmacovigilance is to improve public health and safety in relation to medicines by facilitating early detection of unknown adverse effects and interactions. Key organizations involved in pharmacovigilance include the WHO, ICH, and national regulatory authorities. In India, pharmacovigilance activities are coordinated by the Indian Pharmacopoeia Commission and adverse drug reactions can be reported to over 300 Adverse Drug Reaction Monitoring Centers across the country.

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…