2. Outline of Presentation
Introduction to Pharmacovigilance
History of Pharmacovigilance
Why this Pharmacovigilance evolved
Need of Pharmacovigilance
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
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
18.
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
