#34 Veterinary pharmacovigilance, Part I – James Mount

Drug Safety Matters

Human and veterinary pharmacovigilance (PV) share many goals, challenges and approaches. But there are also significant differences, such as the numerous species and breeds that veterinary PV needs to take into account. In this two-part episode of Drug Safety Matters, James Mount, Veterinary Pharmacovigilance assessor at the Swedish Medical Products Agency, and EU elected chair of the Pharmacovigilance Working Party for veterinary medicinal products, joins the show to talk about veterinary PV practice and its differences and similarities to human PV.

Tune in to find out:

• What are the similarities and differences between veterinary and human pharmacovigilance?
• How is animal health connected to public health?
• What types of adverse events are reported on the veterinary side compared with the human side?
• What can be found in the EU veterinary pharmacovigilance database?

Want to know more?

• The new veterinary medicines regulation (Regulation (EU) 2019/6) can be found here.
• The public portal of the European Union Veterinary Pharmacovigilance Database.
• WHO's information page on One Health, an integrated approach to the well-being of people, animals and the environment.
• A survey of veterinary professionals in Sweden, about current practices and attitudes in relation to adverse events reporting and the accessibility of product safety information.
• A review of adverse events in animals and children after secondary exposure to transdermal hormone-containing medicinal.
• A study looking at suspected adverse drug reaction reporting in veterinary free‐text clinical narratives.
• The EMA Big Data strategy for veterinary medicines in the EU.
• Data quality framework for medicines regulation | European Medicines Agency (EMA)
• Small Animal Veterinary Surveillance Network (SAVSNET) - University of Liverpool
• VetCompass - Royal Veterinary College, RVC
• Reflection paper on the use of artificial intelligence in the lifecycle of medicines | European Medicines Agency (EMA)
• The Swedish Medical Products Agency's online reporting form for suspected adverse drug reactions in animals (In Swedish).

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Kapitel

1. #34 Veterinary pharmacovigilance, Part I – James Mount (00:00:00)

2. Intro (00:00:15)

3. How similar is veterinary pharmacovigilance to human pharmacovigliance? (00:01:36)

4. The connection between animal and public health (00:06:31)

5. Side effects in animals, detection and (under-) reporting (00:10:00)

6. Proportion of ADR reports from pet owners vs professionals (00:14:20)

7. Detection and reporting of side effects in production animals (00:14:56)

8. Initiatives and innovations to stimulate more reporting on the veterinary side (00:16:31)

9. Are we tolerating more side effects from veterinary medicinal products? (00:25:23)

10. Are animal protection regulations reflected in national veterinary PV practices? (00:27:34)

11. Why, and how, are veterinarians using both human and veterinary medicinal products in their practice? (00:29:38)

12. The EU database for veterinary suspected adverse drug reactions (00:36:20)

13. Differences in ADR reporting of individuals (pets) vs masses (production animals)s (00:40:08)

14. More on veterinary pharmacovigilance databases, VeDDRA, etc. (00:42:52)

15. Thanks and goodbye (00:45:12)