2008 EMEA / IFAH–Europe Info Day
« Balancing the benefits and risks
of
Veterinary Medicinal Products »
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Update on Pharmacovigilance
Perspective of the veterinary practitioner
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FVE is a Federation of
42 veterinary organisations
in 37 European countries
Through its members, FVE represents
approximately 200 000 veterinarians
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FVE’s objective
Representing the Veterinary Profession at the
European level in order to:
• Promote veterinary medicine
• Support veterinarians in delivering their
services and their responsibilities towards our
societies
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Animals
Science
Knowledge / Skills
Ethics / Attitude
Society
v
Objective
Independent
Impartial
Owners /
Keepers
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• benefits / risk of vmps
• cost / benefits of monitoring system
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VMPs are very important tools in the prevention
and control of animal diseases
Veterinary practitioners would like to have
• broad range of products for all species and
indications (incl MUMS)
• that are reliable i.e. have a good and
predictable efficacy and safety
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Veterinarians believe that current
• product safety and efficacy evaluations required
for obtaining a marketing authorisation
• and batch tests
are solid
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Veterinary practitioners see the need for
continuous monitoring of vmps under field
conditions !
• To have a better understanding of the product
• To be re-assured that a product is efficacious
and safe
• To be alerted in case something goes wrong or
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Adverse effects are unwanted,
especially in case
•
•
•
•
they were not foreseen
they are serious and / or long-lasting
where groups of animals are involved
where the owner is worried
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Reasons for veterinary practitioners
to report (suspected) product failure
• Ethical and legal obligation
• Prevention of future cases (general
interest)
• For compensation of damage (per case)
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Veterinarians are more
motivated to report adverse effects, when they
see an added value:
– when they encounter something new
– when it is considered a serious case
– when it does not cause too much extra work
– preferably on-line reporting
– when they get feedback on the report
– when the owner of the animal complains
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Balancing risk / benefits of vmps
• Normal authorisation procedure
• By CA for immunologicals in the event of
serious epizootic diseases
• Post marketing surveillance /
Pharmacovigilance
• By veterinary practitioner case by case
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Balancing the monitoring system
Veterinary practitioners wish to
• have limited administrative procedures (simple as
possible)
• get feedback on indivisual cases
• get feedback on the system / trends (make it visible)
• avoid disproportionate concerns about possible
adverse reactions
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How far do we want to go?
What are the priorities?
What is proportionate?
– In relation to the effect as such
– In relation to other Community animal health
and welfare policies
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Recommendation: a more intelligent
use of the expertise available
through the veterinary practitioners
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“Hominum Animaliumque Saluti”
Thank you for your attention!
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For Further information:
Tel (+ 32) 2 533 70 20
[email protected]
www.fve.org
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