Professional Documents
Culture Documents
manjunath
Associate professor
SSMC
Tumkur
History
• 1961 - thalidomide disaster
• 1968 – WHO pilot research project for
international drug monitoring
• 1971 – WHO meeting
1.to advocate establishment of national
centers for drug monitoring
2.to provide guidelines
3.to identify the contribution that national
centers might take to the international
system
Contd.
• 1984 – international society of
pharmacoepidemiology
• 1992 – european society of
pharmacovigilance
• 2002 – WHO pharmacovigilance
• 2004 – national pharmacovigilance
advisory committee (NHAC) with DGHS as
chairman and drug controller general of
india as member secretary
• 24 peripheral centers, 6 regional centers
and 2 zonal centers
Widening horizons
• Illegal sale of medicines and drugs of
abuse over internet
• Increasing self medication practices
• Widespread manufacture and sale of
counterfeit and substandard medicines
• Increasing use of traditional medicines
outside the confines of traditional culture
of use
• Increasing use medicines of different
systems with potential for drug
interactions
Post marketing surveillance
• Monitoring of drug safety after
introducing into the market through
various systems
• Need
1.To assess risk benefit ratio
2.To confirm safety and efficacy
3.To detect less common adverse
effects
Methods of surveillance
• Anecdotal reporting
• Voluntary reporting
• Intensive event reporting
• Cohort studies (prospective)
• Case control studies (retrospective)
• Population statistics
• Meta-analysis
Organizations involved
• WHO – collaborating center for international drug
monitoring is Uppsala monitoring centre provides
activities and events in PV
• CIOMS – council for international organizations of
medical sciences-safety information
communication between regulators and
industries.
• ICH – international conference on harmonization
discusses scientific and technical aspects of
product registration.
• WHO-ART – WHO adverse reaction terminology
for coding clinical information to drug therapy.
Frequency of ADR
• Very common>=1/10
• Common >=1/100 and <1/10
• Uncommon >=1/1000 and <1/100
• Rare >=1/10000 and <1/1000
• Very rare <1/10000
Causality assessment
• Certain : proven on dechallenge and
rechallenge
• Probable : dechallenge confirms.cannot
rechallenge
• Possible : can be explained by concurrent
disease or other drugs
• Unlikely : not documented in literature
• Unclassified : additional data is awaited so
not documented
• Unclassifiable : additional data has come
but not fit into any categories
Methods of causality
assessment
• WHO assessment scale
• Naranjo’s scale
• European ABO system
• Karch and Lasagna’s scale
• Kramer scale
• Bayesian network
• Yale logarithm
• Spanish imputation system
question Yes No Don’t
know
1 Are there previous conclusion reports on this +1 0 0
reaction?
2 Did the adverse event appear after the suspect drug +2 -1 0
was administered?
3 Did the AR improve when the drug was discontinued +1 0 0
or a specific antagonist was administered?
4 Did the AR reappear when drug was readministered? +2 -1 0