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Vet Pharmacovigilance : Experiences in Horses
EMA London FVE Nov 2016
+ Vet Pharmacovigilance : Experiences in Horses EMA London FVE - - PowerPoint PPT Presentation
+ Vet Pharmacovigilance : Experiences in Horses EMA London FVE - - PowerPoint PPT Presentation
+ Vet Pharmacovigilance : Experiences in Horses EMA London FVE Nov 2016 + The Horse : center of a unique world + Working animal Transportation Field work Money maker Equine industry High level sport Gambling The
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The Horse : a unique animal
Working animal Transportation Field work Money maker Equine industry High level sport Gambling Leisure God Food producer MANY DESTINATIONS
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The Horse : a unique animal
Food animal Meat producer Breeders, slaughters, butchers,
consumers…, Vets
Specialized but Opened industry Origin traceability Minor species FOOD ANIMAL
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The Horse : a unique animal
Drug availability Market authorizations European / International market Medical knowledge Vet Responsability Medical challenge Vet competition Horses value Legislation LMR Cascade Antibiotics EL Exclusion ‘Science’ Clients Dreams MINOR SPECIES VET CHALLENGES
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Equine pharmacovigilance : FVE, Europe
3545 vet answers 668 France Horses 5% Side effects Lack of efficacy
2015 2015
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Equine pharmacovigilance : ANMV, France
3190 declarations side effects 90% by vets 83% small animals Horses <3% 3857 declarations – 98/horses SA 81%>BV 9%>Horses 2,5% Species #2 (#1=cats) 1 declaration /8000 horses
2013 2015
0.1 0.2 0.3 0.4 0.5
ANMV 2015 declarations
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Equine pharmacovigilance : ANMV, France
98 declarations side effects 44 important 22 deaths 657 declarations 1051 horses 349 imp 209 deaths
2015 10 years : 2005 - 2015
10 20 30 40 50 60 70
Equine side effects reported %
50 100 150 200 250
Imp equine reports/category
Imp Non imp
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Equine pharmacovigilance : ANMV, France
133 drugs 5 ‘top categories’ 214 drugs 5 ‘top categories’
2015 10 years : 2005 - 2015
Vaccines 33% Anesth /NS 31% AI 9% AB 8% Dewormers 8% Others 11%
Drug category 2015
Vaccines 27% Anesth /NS 18% AI 10% AB 15% Dewormers 16% Others 14%
Drug category 2005-2015
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Equine pharmacovigilance : ANMV, France
133 drugs 5 ‘top categories’ 214 drugs 5 ‘top categories’
2015 10 years : 2005 - 2015
10 20 30 40 50 60 Vaccines Anesth /NS AI AB Dewormers Others 2015 2005-2015
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Equine pharmacovigilance : AVEF, France
73 vets / 24h 69% = pure equine practice Time in practice From 2 to >30 years
Nov 2016 Nov 2016
69% 8% 10% 8% 5%
Equine practice %
100% 75-90% 50-75% 25-50% <20% 2--5 6--10 11--15 15--20 21--25 26--30 >30 10 20 11 10 8 6 8
Years of experience
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Equine pharmacovigilance : AVEF, France
What for ? Side effects 70% Mortality 31% Lack of efficacy 23% Where to declare ? Industry 43% ANMV 28%
Nov 2016 Nov 2016
Mortality 31% Lack of efficacy 23% Availability 4% Side effects 36% Price report 1% Sales practices 5%
Pharmacovigilance
10 20 30 40 50 Industry Centrale DGAL ANMV AVEF SNGTV CNITV Ordre
Where to declare
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Equine pharmacovigilance : AVEF, France
Experience of drug problem Yes = 64% Nb of declarations Yes = 57%
Nov 2016 Nov 2016
YES 89% NO 11%
Drug problem
no, never 41% yes, 1 time 28% yes, 2 - 5 times 27% yes, >5 times 4%
Nb of declarations
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Equine pharmacovigilance : AVEF, France
Drugs categories AB = 35% Vaccines = 19% AI = 14% Anesthetics = 9%
Nov 2016 Nov 2016
5 10 15 20 25 30 35
Drug category
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Equine pharmacovigilance : AVEF, France
60 molecules reported Top 6 drugs Penicillin
10/60
Critical AB
7/60
Biphosphonates
7/60
Anesthetics
6/60
Herpes vaccines
5/60
Imidocarbe
4/60 Nov 2016 Nov 2016
Peni 26% Critical AB 18% Biphosphonates 18% Anesth 15% Herpes vaccine 13% Imidocarbe 10%
Top 6 drugs
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Equine pharmacovigilance : AVEF, France
Comments by vets Lack of answer back Too much time to report
Nov 2016 Nov 2016
YES 41% NO 59%
Answer back
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Pharmacovigilance in Horses
In Practice NOW
More reports by vets
Help by tecnical associations? Scientific papers Save + more drugs / horses
FUTURE
Reports by vets
Time to report Increasing interest Responsability Out of label drug uses …
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Equine Pharmacovigilance
Horse’s welfare Vet position Public health
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THANK YOU
Treat better !
Claire Scicluna