off label use/cascade

Question 1

What is the reason for the off label cascade?

Answer 1

vets are permitted to use their clinical judgement to treat animals under their care in accordance with the cascade where there is no suitable veterinary medicine authorised for the condition being treated

Question 2

What are the steps of the off label cascade in the UK?

Answer 2

Step 1 - Veterinary medicine with a Marketing Authorisation for the indicated species and condition
Step 2 - Veterinary medicine with a Medicine Authorisation valid in NI for indicated species and condition
Step 3 - Veterinary medicine with a Marketing Authorisation for a different species or condition
Step 4 - Human medicine with a Marketing Authorisation
Step 5 - extemporaneous preparation by a vet, pharmacist or person with a Manufacturers Authorisation
Exception - in exceptional circumstances, human medicine from outside the UK can be imported

Question 3

What is needed for medicines not authorised GB or UK wide to be used in the UK?

Answer 3

Special import certificate from the VMD

Question 4

What are the conditions that must apply when prescribing a product for use in a food-producing species?

Answer 4

pharmacologically active substances must have an MRL
vet must specify a withdrawal time
vet must keep specified records

Question 5

What are the minimum statutory withdrawal periods for medicine used in food-producing animals?

Answer 5

Eggs + milk: 7 days
Meat: 28 days
Fish meat: 500/temp of water (degree days)

Question 6

When do horses need to be treated as non-food producing?

Answer 6

if they are signed out of the food chain in their passport