PHARMACOLOGY - The Cascade Flashcards
(32 cards)
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 then 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 additional regulations you must follow when prescribing drugs to food producing animals under the cascade?
- Maximum residue limit (MRL)
- Imported drugs must be authorised in a food producing species in the country of origin
- Apply minimum statutory withdrawal period
- Veterinarians must keep additional records for 3 years
- Applies to a single holding (can only be used on the premesis where it has be presribed for)
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 milk?
1.5 times the milk withdrawal period in the summary of product characteristics (SPC) for use in the authorised species. If the drug is not authorised in a milk producing species, then a minimum of 7 days is required
What is the minimum statutory withdrawal period for eggs?
1.5 times the egg withdrawal period in the summary of product characteristics (SPC) for use in the authorised species. If the drug is not authorised in an egg producing species, then a minimum of 14 days is required
What is the minimum statutory withdrawal period for meat/offal?
1.5 times the meat/offal withdrawal period in the summary of product characteristics (SPC) for use in the authorised species. If the drug is not authorised in a meat/offal producing species, then a minimum of 28 days is required
How long should you keep the additional records required to prescribe an unauthorised drug for a food producing animals?
Minimum of 5 years
What is the first step of the Cascade?
Choose a veterinary medicine authorised in Great Britain or UK wide for use in the indicated species and condition in accordance with the summary of product characteristics (SPC)
What is the second step of the Cascade?
If step one is not possible, choose a veterinary medicine authorised in Northern Ireland for the indicated species and condition, in accordance with the summary of product characteristics (SPC)
What is required to use veterinary medicines authorised in Northern Ireland?
Special Import Certificate (SIC) from the VMD
What is the third step of the Cascade?
If step two is not possible, use a veterinary medicine authorised in Great Britain, Northern Ireland or UK wide for use in a different species for the same condition or for another condition in the same species
Need an SIC for Northern Ireland
What is step four of the Cascade?
If step three is not possibe, use a human medicinal product authorised in Great Britain, Northern Ireland or the UK, or, use an authorised veterinary medicine from outside the UK (will require an SIC)
What is step five of the Cascade?
If step four is not possible, use an extemporaneous preparation prepared by a vet, pharmacist or person holding a Manufacturer’s authorisation in the UK
What should you check to ensure a horse has been signed out of the food chain?
Check section IX: Admnistration of Veterinary Medicinal products, Part II of the horse passport to ensure the horse is not intended for human consumption
