Lecture 8 Flashcards
What is the legislation regarding veterinary medicines
Veterinary medicines regulations act 2013
What are veterinary medicines
Medicines used to treat/ prevent diseases in all animals other than humans
What is the regulatory body regarding veterinary medicines
Veterinary Medicines directorate VMD which is a part of DEFRA ( department of environmental, food and rural affairs)
What is the role DEFRA
- Enforce regulations on VMD
- pharmacovigilance, monitor and act upon veterinary medicines
- testing vet. Meds in animals and animal products
- licensing vet medicines
-inspect premises involved in the supply chain of vet. Meds.
Hope many classes of vet meds are there
4
What’s are the different classes of vet. Meds.
- POM V
- POM VPS
- NFA VPS
- AVM GSL
What is a POM V
A POM med that can only be prescribed by a vet. Surgeon and supplied by a vet surgeon or a pharmacist with a prescription.
Clinical assessment is needed
What is a POM VPS
A POM med. that can only be presribed and supplied by a vet. Surgeon a pharmacist or a suitibaly qualifies person (SQP) using an oral or written prescription.
however a prescription is only needed if the supplier is not the prescriber.
What is a NFA VPS
Medicines for non food animals (animals that aren’t ate) that can be supplied by vet. Surgeon, pharmacist and a suitably qualified person however the supply requires a pharmacist present
What is AVN GSL
Authorised vetinary medicines and these are available as a GSL so don’t need a prescription or a pharmacist present
Which types of vet. Meds. Need prescriptions
POM V and POM VPS
Which type of vet. Meds. Need a pharmacist present
POM V, POM VPS and NFA VPS
What are exempt medicines under schedule 6 of the VMR
These are unlicensed meds. That don’t require an MA for the use in small animals and pets that don’t enter the food chain
SAES- small animal exception scheme
What administration routed are exempt medicines restricted to
Oral or topical routes of admin.
What are unauthorised vet medicines.
These are meds that don’t have an MA and aren’t eligible for use in SAES, these can only be prescribed by veterinary surgeons under the cascade.
Includes human meds for veterinary use.
What prescriber information is required to be on a veterinary prescription
The prescribers:
- name
- address
- qualification
- tel. Number
- signature
In the case of a schedule 2/3 drug, must contain the RCVS ( royal college of veterinary surgeon) number
What must be included in a veterinary prescription
-prescribers info
- the name and address of owner
- the name and type of dog
- the date
- the med. name, strength, form and quantity
- directions for use, cannot have as directed, must be clearer cut instructions
- necessary warning periods and withdrawal effects
- if necessary, stating that it is under the cascade effect
- how many times it should be repeated if repeatable
How long does a veterinary prescription have to be dispensed
6 months from the date on the prescription
How long do schedule 2,3,4 drugs have to be dispensed from a veterinary prescription
28 days
What must a veterinary prescription have if a schedule 2,3
Must state the med is prescribed for an animal by a veterinary surgeon
Do vet. Prescriptions need to be standardised
No they can all be written on different prescription forms
How long do vet prescriptions get held for
5 years
Do vet. Prescriptions need to be submitted to the NHS
No
How long should CDs be used for the treatment of animal
28 days however in certain circumstances it may be for more time.
What is medicines prescribed ‘under cascade’
Due to a lack of UK MA vet. Medicines, human medicines can be prescribed to animal under the cascade by a vet.
What are the stages under the cascade
- supply a vet medicine with a UK/BG MA
- if not possible, a vet. Med. with a NI MA can be used
- A vet. Med. from NI,UK or BG can be for another species of condition can be used.
- if not possible use a NI, UK or GB MA human medicine or a vet. Med. with an MA in another country
- if still not possible an exempted/ specifically made medicine can be used.
Can GLS,P or POM medicines be supplied for animal use outside the cascade
No only under cascade can any type of medicinal rod cut be prescribed
What needs to be on the vet. Prescription
- Name of vet. Surgeon
- name and address of the owner
- name and address of pharmacy
- name and the species of the animal
-date of supply - expiry date of the med.
- dosage and administration instruction
- name and description of the productD
Do VMPs need labelling
No because they VMP have lots of information on them
What records of POM V and POM VPS must be kept
Name of medicine,
Date of receipt
Batch number
Name and address of supplier and recipient
The name and address of the prescriber and a copy of the prescription
Must be kept for 5 years
Who can supply vet. Meds. To retailers
Only the manufacturer of a wholesale vet meds can and they need to have WDA
In what scenario can a vet. Med. be supplied without a WDA
In the event of a supply shortage, a retailer can supply another retailer with a vet. Med. without a WDA as the VMR try to reduce vet. Med. shortages
The supply of a human medicines to a vet requires a WDA (h) authorised by the MHRA.
3 offences relates to vet. Meds
- marketing human meds for animal supply
- supplying an out of date med
- having an unauthorised medicine not in cascade
