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Istanbul April 2011

Pharmacovigilance: The Role of the Private Vet. Istanbul April 2011. Dr Joe Collins MVB PhD CBiol FSB MRCVS CertEP CertVR. Who Participates in Pharmacovigilance?. WHAT IS PHARMACOVIGILANCE?. Evaluating quality, safety and efficacy of veterinary medicines in practical use situations

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Istanbul April 2011

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  1. 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 Maximiseanimal health, welfare and public health The combined efforts of: Authorities Industry Animal owners/keepers Private Veterinary Practice Vets Vet nurses Staff

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

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

  6. 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'.

  7. 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

  8. 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

  9. LIMITATIONS OF PHARMACOVIGILANCE

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

  11. Accidental Self-Administration

  12. Palatability

  13. Injection - Drench - Pour-On

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

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

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