PHARMACOLOGY - The Cascade Flashcards
What does veterinary drug authorisation entail?
Drug authorisation requires assessment of drug quality, safety and efficacy as well as considers potential risks to animals, to the environment, to operaters and consumers. This information is them gathered into a Summary of Product characteristics (SPC)
What are the three main problems associated with unauthorised drugs?
May not be of consistent quality
May not be safe and effective in that species
May pose a risk to consumers
What are the four excemptions that allow you to use unauthorised drugs?
Drugs administered for research
Exceptional circumstances e.g a disease outbreak
Immunological drugs for imported or exported animals
Use of the Cascade
What is the Cascade?
The cascade allows veterinarians to legally prescribe drugs that are not authorised for the relevant clinical case or for the relevant species being treated, when there is no authorised veterinary drug available
What should you do before prescribing an unauthorised drug?
When prescribing an unauthorised drug, you should seek written informed consent from the client, making them aware of the intended use of the drug and any potential side effects
Who can prescribe a drug using the Cascade?
Only the Veterinary surgeon
Who can dispense a drug under the Cascade?
A pharmacist or suitably qualified person (SQP) may dispense a drug under the cascade
What are the four extra regulations you must follow when prescribing unauthorised drugs to food producing animals?
Active substance in the drug must have a maximum residue limit (MRL)
Any imported drugs must be authorised in a food producing species in the country of origin
Veterinarians must specify the withdrawal period for that drug
Veterinarians must keep additional records
What is the maximum residue limit (MRL)?
The maximum residue limit (MRL) is the maximum concentration of drug or drug metabolite residue that is legally permitted and recognised as acceptable in food following the use of a veterinary medicine
What can you use to determine if a drug has a maximum residue limit (MRL) and then thus can be used in a food producing animal?
If the drug is in the allowed substance list on the Great Britain maximum residue limit (MRL) register, or Table 1: Allowed substances for Northern Ireland
What is the withdrawal period?
The withdrawal period is a period of time, following the treatment of an animal with a veterinary medicine, in which meat, milk, eggs or honey from the treated animal must not enter the food chain due to the possible presence of residues
Who is responsible for setting a withdrawal period?
Veterinary surgeon
How do you set a withdrawal period for a veterinary authorised drug?
If you have used the drug in accordance with the summary of product characteristics (SPC), you can use the authorised withdrawal period in the SPC for that drug. However, if you have not used the drug in accordance with the SPC, you should set at least the minimum statutory withdrawal period
What is the minimum statutory withdrawal period for eggs?
14 days
What is the minimum statutory withdrawal period for milk?
7 days