1. The Role of the Private Vet
Pharmacovigilance:
The Role of the Private Vet
Istanbul
April 2011
Dr Joe Collins MVB PhD CBiol FSB MRCVS CertEP CertVR

2. Who Participates in Pharmacovigilance?

3. WHAT IS PHARMACOVIGILANCE?
Evaluating quality, safety and efficacy of veterinary medicines in practical use situations
Using these findings in product availability and literature in order to
Maximise animal health, welfare and public health
The combined efforts of:
Authorities
Industry
Animal owners/keepers
Private Veterinary Practice
Vets
Vet nurses
Staff

9. Working Dogs!
Fat Dogs!
Fat Dogs!
Old Dogs!
Pre-Disposed Breeds!

11. Private Vet Pharmacovigilance System- Initial Recognition
Regulatory Authority
Private Vet
End user
Pharma Sales Force
Pharma Veterinary Services

12. Adverse Drug Reaction
A 'reaction in human or animal to a VMP which is noxious and unintended and which occurs after the use of, or exposure to, a veterinary medicinal product, whether on or off-label'.

13. WHY DO WE NEED PHARMACOVIGILANCE?
Limitations of pre-marketing drug trials:
Many are non-clinical studies
Tight focus:
Short Duration
Narrow Population
Narrow set of indications
Small size
Trials seldom detect or define the frequency of all important adverse reactions

14. Limitations of Reported Pharmacovigilance
Length of time product has been on the market – newness
-increased reporting rate in the first 2 years
Temporal reporting biases –recently treated
-reactions within 4 weeks of treatment
Reporting environment - topical
-media coverage
Individual biases - subjective
-reporter is ‘convinced’ product is responsible or not effective

15. LIMITATIONS OF PHARMACOVIGILANCE

16. Report Types
Suspect Adverse Drug Reaction (Human and Animal)–SSADR & SADR
Suspect Lack of Expected Efficacy – SLEE
MRL violations
Environmental issues

17. Accidental Self-Administration

18. Palatability

19. Injection - Drench - Pour-On

20. PVP Issues with PV Reporting
Funding of diagnostic tests / referral examinations
Return product analysis
Company Veterinary opinion
Complaint resolution
Communication with owner, industry, RA

21. Essentials of a PV Report
REPORTER IDENTIFICATION
ANIMAL DATA
PRODUCT DATA
SUSPECTED ADVERSE REACTION

22. THANNKS FOR YOUR ATTENTION