Workshop on EU Legislation for Veterinary Medicinal products Istanbul Turkey, 18 – 19 April 2011 The Veterinary position on Responsible Use of Medicines (FVE and WVA) Peter Jones, Member of the FVE Medicines Group © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES

Who am I ?! © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

Not a bad place to live! © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

What am I? I am a veterinarian who graduated from the Faculty of Veterinary Science at the University of Liverpool in the United kingdom in 1971 © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

There are veterinarians (and farmers) in many parts of Europe today that may not be using medicines in a careful and responsible manner True or False? © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

Responsible Use What is it? Why do we need it? Who’s involved? What medicines? What animals? © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

Let’s first agree some assumptions Good health is essential for welfare and for optimal performance of animals Disease control is therefore an essential part of any successful management programme. In turn, healthy animals are the source of safe food for human consumption. Effective disease control is part of high quality food production. One World - One Health underpins this convergence of human and animal health Farmers should regularly monitor the health and welfare of their animals: Farm Health Planning is key Appropriate professional veterinary advice should always be provided on the effective prevention, diagnosis and treatment of disease. This is the basis for the appropriate use of medicines which must never be used as a default for poor management © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

Good management is a must © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

Animal Health Planning Bio-security > Farmer Good animal husbandry > Farmer Good hygiene practices > Farmer / Veterinarian Medicines > Farmer and Veterinarian © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

Decision made to medicate/vaccinate © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

Responsible Use ~ What is it? A coordinated and integrated approach to best practice in use of animal medicines Complying with our professional obligations to safeguard the health and welfare of animals under our control Taking joint responsibility with producers to use medicines properly To follow the Summary of Product Characteristics (SPC) to the letter To keep updated on guidelines on use of medicines Maximizing the benefits of farm health planning © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

© JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

Responsible Use ~ Why do we need it? Food safety and the concerns of consumers are very much in the spotlight Reports of misuse leads to criticism & limits on use Farmer’s priorities are often different to the vet’s Vets under pressure: our response is critical The opportunities for improper use are many Vet medicines are complex; their safe use is key © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

Responsible Use-Who’s involved? © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

Can it work? ~ YES! – if: VETS FARMERS INDUSTRY MEDICS? GOVERNMENT REGULATORS © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

How can it happen? © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

Practically – Can it work? © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

-And at European level? © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

What is EPRUMA EPRUMA is a multi-stakeholder platform linking best practice with animal health and public health, which to ensure best practice through responsible use of medicines in the prevention and control of animal diseases. EPRUMA pursues its goal by facilitating and promoting a co-ordinated and integrated approach, involving all stakeholders including veterinarians, farmers, manufacturers of animal medicines, feed manufacturers, and professionals working in animal health They develop framework documents on how to best use veterinary medicines and vaccines. In other words, EPRUMA works on broad principles at EU level, which in turn can be tailored nationally to reflect local specificities at EU Member States. An example of this is the "Best practice framework for the use of antimicrobials in food-producing animals", which EPRUMA launched in 2008, and is available in various European languages .EPRUMA partners are committed to work together to ensure safe use of veterinary medicines and to minimise the development of resistance. © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

© JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

Responsible Use ~ What Medicines Applies to all medicinal products Prime focus on: - Antimicrobials - Antiparasitics - Vaccines © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

© JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

© JONES P CONSULTING LTD: GLOBAL ADVICE O Oct 2009

© JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

And Vaccines? ALWAYS READ THE SUMMARY OF PRODUCT CHARACTERISTICS (SPC) - This includes vaccines regularly used in the flock/herd as SPCs change. Storage Operator safety Target Animal Safety Vaccine Courses and Booster Vaccination © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

And Vaccines continued: Preparing the Vaccine - FOLLOW THE ADVICE ON THE SPC (DATA SHEET) Check the dose, dilution rate, route of administration and all precautions. Ensure all equipment is clean and suitable for purpose. Ensure all vaccines for injection remain sterile. Ensure if injecting, that needles remain clean, sharp and are regularly changed. Ensure during vaccination that the vaccine does not come into contact with anything that inactivates it © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

And Vaccines Continued Vaccinating the animal Recording Vaccination Disposal of Vaccines and Containers Appropriate herd/flock health plans should be drawn up, observed and regularly reviewed in association with the attending veterinary surgeon or other adviser. This plan should outline routine preventive treatments and management including vaccination. Vaccine usage should be based on a risk assessment but some should be used as a routine. Vaccines are complimentary to good management. © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009

Finally One Health means the convergence of animal and human health Healthy animals mean healthy food Good management is paramount Medicines are to be used to assist good management but not as an alternative When used they must be used responsibly Thank you © JONES P CONSULTING LTD: GLOBAL ADVICE ON VETERINARY MEDICINES: TAIEX Oct 2009