How can we treat animals when no authorised medicines are available?

*This is a guest article by Nancy De Briyne , Executive Director at FVE - Federation of Veterinarians of Europe

Human medicines are for one species: humans. Veterinary medicines, however, are for a multitude of species – ranging from cold-blooded reptiles to farm animals, to dogs and cats who are family members, to farmed fish and even to wildlife. Each of these species has unique diseases, pharmaceutical needs, and preferred methods of administration - anyone who has tried giving a pill to a cat can attest to this challenge!

Why Veterinarians Need the “Cascade”

The consequence is that veterinarians often face difficulties when there is no veterinary medicine authorised for a particular animal or disease indication.

This is especially common for:

·?????? Rare diseases, which occur infrequently or only in certain countries or regions.

·?????? Minor species that include animals outside the "main" species groups of cattle, sheep for meat production, pigs, chickens, dogs or cats.

For such "limited markets", it is often not commercially viable for pharmaceutical companies to develop and market veterinary medicines.

Thankfully, regulators have created a safety net Articles 112-114 of Regulation (EU) 2019/6, commonly known as the “Cascade”.

What Is the “Cascade”?

The “Cascade” is a set of rules guiding veterinarians on how to use medicines when no authorised veterinary product is available. These rules balance effectiveness, safety, and animal welfare while maintaining public health standards. The veterinarian may apply the “Cascade”, exceptionally, under their own responsibility and to avoid unacceptable suffering.

The ”Cascade” also restricts use of some antibiotics in animals, requiring prior pathogen identification and susceptibility testing. Such special precautions apply to antimicrobials to prevent the development of antimicrobial resistance – a global health threat.

Want to learn more or ask questions? Attend our special EMA/FVE Webinar

Veterinarians have more flexibility but also greater complexity when prescribing treatments under the “Cascade”. Navigating these rules can be challenging – this is why we organise a joint EMA/FVE Webinar!

What we’ll cover:

This interactive webinar will address practical scenarios and provide clarity on questions such as:

·?????? Can I use the “Cascade” for shortages of authorised products?

·?????? When do these new rules apply?

·?????? Can I use the “Cascade” to ensure prudent use of antimicrobials?

·?????? How should I manage adverse events with “cascade”-prescribed products?

·?????? What are the best practices for recording “cascade” use?

Webinar Details

??? Date: Thursday, 16 January 2025 ? Time: 2 PM CET ?? Topic: Use of veterinary medicines using the cascade including specific precautions to take for using antimicrobials.

?? Don’t miss this opportunity to ask your questions about veterinary medicine’s most critical regulations.

?? Register now and join us for an insightful discussion!