This document provides an overview of pharmacovigilance, including its history, objectives, and importance. Pharmacovigilance is defined as the science of detecting, assessing, understanding, and preventing adverse effects of medicines. It emerged due to limitations of clinical trials in assessing safety and high-profile drug disasters in the 1930s-1960s. The key objectives of pharmacovigilance are to improve patient safety, promote rational drug use, and ensure public confidence in medicines. It plays an important humanitarian and ethical role in monitoring drug safety worldwide.

1. Pharmacovigilance
Aamir Y. Khan
M.Pharm (Pharmacology and Toxicology)

2. Outline of Presentation
 Introduction to Pharmacovigilance
 History of Pharmacovigilance
 Why this Pharmacovigilance evolved
 Need of Pharmacovigilance

3. • WHY WE ALL USE MEDICINE ?

4. • How to minimize the adverse effect related to
a medicinal product? .........
PHARMACOVIGILANCE (Drug Safety )
• Pharmakon (Greek) = Medicinal Product
• Vigilance (Latin) = To keep Watch

5. • Pharmacovigilance is the science
and activities relating to the
detection, assessment,
understanding and prevention of
adverse effects or any other
medicine/vaccine related
problem.
• pharmacovigilance
mainly focuses on
adverse drug reactions.
detection,
assessment
Understanding
prevention
of adverse
effects

6. Objective of Pharmacovigilance
 Improve Pateint care and safety
 Imporove public health and safety
 Promote education and Clinical training
 Early detection of unknown safety problem
 Detection of increase in frequency of (known )ADR

7. History of Pharmacovigilance
• Sulfanilamide Disaster of 1937- Ethylene glycol

9. Thalidomide Disaster of 1962

11. Why do we need
PHARMACOVIGILANCE

12. Reason1:
Humanitarianconcern
Insufficient evidenceofsafety from
clinicaltrials,Animal experiments&
Phase1–3 studiesprior to marketing
authorization

14. Limitationsof clinicaltrials
•Small number of patients
studied
•Restricted populations (age,
sex, ethnicity)
•Narrow indications
•Short duration ofdrug
exposure

15. Reason2:
Medicinesare supposedto
savelives
Dying from adiseaseis
sometimes unavoidable;
dying from amedicineis
unacceptable.
Lepakhin V
.Geneva2005

16. • ADRswere 4th-6th
commonest causeof death
in the USin1994
Lazarouet al,1998
USA
• It hasbeen suggestedthat
ADRsmay cause5700
deaths per year inUK.
Pirmohamed et al,2004
UK

17. Reason3:
Promoting rational use of
medicines andadherence
Reason6:
Ensuring public confidence
Reason7:
Ethics T
o know of something
that is harmful to another
person who does not know, and
not telling, isunethical

19. Whoprogram for international drug
monitoring
• Started 1968
• Located in Uppsala,
Sweden
• Collaborating centre for
maintaining global ADR
database - Vigibase

20. Rolesof WHOCollaboratingCentre
• Identify early warning
signals of seriousadverse
reactions to medicines
• Evaluatethe hazard
• Undertake research into
the mechanisms of action
to aid the developmentof
safer and more effective
medicines

22. Thank you