+ 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 Horse : a Leisure unique animal God Food producer MANY DESTINATIONS
+ Food animal Meat producer Breeders, slaughters, butchers, consumers…, Vets Specialized but Opened industry Origin traceability The Horse : a unique animal FOOD ANIMAL Minor species
+ Drug availability Market authorizations European / International market Medical knowledge Vet Responsability Medical challenge Vet competition The Horse : a Horses value unique animal Legislation LMR Cascade MINOR SPECIES Antibiotics VET CHALLENGES EL Exclusion ‘Science’ Clients Dreams
+ Equine pharmacovigilance : FVE, Europe 2015 2015 3545 vet answers Side effects 668 France Horses 5% Lack of efficacy
+ Equine pharmacovigilance : ANMV, France 2013 2015 3190 declarations 3857 declarations – 98/horses side effects SA 81% >BV 9% >Horses 2,5% 90% by vets Species #2 (#1=cats) 83% small animals 1 declaration /8000 horses ANMV 2015 declarations Horses 0.5 <3% 0.4 0.3 0.2 0.1 0
+ Equine pharmacovigilance : ANMV, France 2015 10 years : 2005 - 2015 98 declarations 657 declarations side effects 1051 horses 44 important 349 imp 22 deaths 209 deaths Equine side effects reported % Imp equine reports/category 70 250 60 50 200 40 150 30 20 100 10 50 Imp 0 0 Non imp
+ Equine pharmacovigilance : ANMV, France 2015 10 years : 2005 - 2015 133 drugs 214 drugs 5 ‘top categories’ 5 ‘top categories’ Drug category 2015 Drug category 2005-2015 Others Others Dewormers 11% 14% 8% Dewormers Vaccines Vaccines AB 16% 27% 33% 8% Anesth /NS AB 18% Anesth /NS 15% AI AI 31% 10% 9%
+ Equine pharmacovigilance : ANMV, France 2015 10 years : 2005 - 2015 133 drugs 214 drugs 5 ‘top categories’ 5 ‘top categories’ 60 50 40 2015 30 2005-2015 20 10 0 Vaccines Anesth /NS AI AB Dewormers Others
+ Equine pharmacovigilance : AVEF, France Nov 2016 Nov 2016 73 vets / 24h Time in practice 69% = pure equine practice From 2 to >30 years Equine practice % Years of experience 100% 75-90% 50-75% 25-50% <20% 8 >30 5% 6 26--30 8% 8 21--25 10% 10 15--20 11 11--15 8% 20 6--10 69% 10 2--5
+ Equine pharmacovigilance : AVEF, France Nov 2016 Nov 2016 What for ? Where to declare ? Side effects 70% Industry 43% Mortality 31% ANMV 28% Lack of efficacy 23% Where to declare Pharmacovigilance Sales practices Price report 5% Ordre 1% CNITV Mortality SNGTV 31% AVEF Side effects 36% ANMV DGAL Lack of efficacy Centrale 23% Industry Availability 4% 0 10 20 30 40 50
+ Equine pharmacovigilance : AVEF, France Nov 2016 Nov 2016 Experience of drug problem Nb of declarations Yes = 64% Yes = 57% Drug problem Nb of declarations yes, >5 times NO 4% 11% yes, 2 - 5 times no, never 27% 41% YES 89% yes, 1 time 28%
+ Equine pharmacovigilance : AVEF, France Nov 2016 Nov 2016 Drugs categories AB = 35% Vaccines = 19% Drug category AI = 14% 35 Anesthetics = 9% 30 25 20 15 10 5 0
+ Equine pharmacovigilance : AVEF, France Nov 2016 Nov 2016 60 molecules reported Top 6 drugs Penicillin 10/60 Top 6 drugs Critical AB 7/60 Biphosphonates 7/60 Imidocarbe Peni Anesthetics 6/60 10% 26% Herpes vaccine 13% Herpes vaccines 5/60 Imidocarbe 4/60 Anesth 15% Critical AB 18% Biphosphonates 18%
+ Equine pharmacovigilance : AVEF, France Nov 2016 Nov 2016 Comments by vets Lack of answer back Too much time to report Answer back YES 41% NO 59%
+ Pharmacovigilance in Horses In Practice NOW FUTURE Reports by vets More reports by vets Time to report Help by tecnical associations? Increasing interest Scientific papers Responsability Save + more drugs / horses Out of label drug uses …
+ Equine Pharmacovigilance Horse’s welfare Vet position Public health
+ THANK YOU Treat better ! Claire Scicluna
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