W13 Vetinary Medicines (AT)

Question 1

What is the Veterinary Medicines Regulations 2013? (VMR)
What is the Veterinary Medicines Directorate (VMD)?
What is the Vetinary Products Comittee (VPC)

Answer 1

VMR
•Legal controls on the production, distribution, possession, dispensing and administration of veterinary medicines

•Veterinary Medicines Directorate (VMD)
•Executive agency of the Department for Environment, Food & Rural Affairs (DEFRA)
•Licenses veterinary medicines and inspects

•Veterinary Products Committee (VPC)
•Scientific advice on any aspect of veterinary medicines requested by the VMD

Question 2

What does the Veterinary Products Committee (VPC) provide?

Answer 2

Scientific advice on any aspect of veterinary medicines requested by the VMD

Question 3

What does the category NFA-VPS stand for?

Answer 3

Non-food animals that can be supplied by a veterinary surgeon, a pharmacist or a suitably qualified person without a written prescription. These medicines should not be accessed by the public in a pharmacy .

Question 4

What are POM-V medicines?

Answer 4

Prescription-only medicines that can only be prescribed by a veterinary surgeon and supplied by a veterinary surgeon or a pharmacist with a written prescription

Question 5

What distinguishes POM-VPS from POM-V?

Answer 5

POM-VPS can be prescribed and supplied by a veterinary surgeon, a pharmacist, or a suitably qualified person on an oral or written prescription

Question 6

What is an AVM-GSL?

Answer 6

An authorised veterinary medicine that is available on general sale

Question 7

What are SAES in the context of veterinary medicines?

Answer 7

Exempt medicines under Schedule 6 of the veterinary medicines regulations for small pet animals

An unlicensed veterinary medicine that does not require a marketing authorisation because it meets criteria laid out in Schedule 6 of the Veterinary Medicines Regulations - Exemptions for small pet animals

Question 8

What is an unauthorized veterinary medicine?

Answer 8

An unlicensed medicine that does not have a marketing authorization and is not eligible for exemption through the SAES

Question 9

What information is required on a prescription for POM-V and POM-VPS?

Answer 9

Name, address, telephone number, qualification and signature of the prescriber
Name and address of the owner
Identification and species of the animal
Date ( Prescriptions are valid for six months or shorter if indicated by the prescriber)
Name, quantity, dose and administration instructions
(as directed” is not an acceptable administration instruction.)
Any necessary warnings and if relevant the withdrawal period
Statement highlighting that the medicine is prescribed under the veterinary Cascade
If repeatable, the number of times it can be repeated

Question 10

True or False: Prescriptions for POM-V and POM-VPS are valid for six months.

Answer 10

True

Question 11

What is the recommended duration for prescribing controlled drugs (CDs) on veterinary prescriptions?

Answer 11

Good practise for Only 28 days worth of treatment unless in situations of long-term ongoing medication (e.g. when treating epilepsy in dogs).

Question 12

What must be included in veterinary prescriptions for Schedule 2 and 3 CDs?

Answer 12

• Standardised forms are not required
  •Statement that the medicines are ‘prescribed for the treatment of an animal or herd under my care’ is required for Schedule 2 and 3 CDs
• The Royal College of Veterinary Surgeons (RCVS) registration number of the prescriber

Question 13

What details must appear on the dispensing label when a medicine is supplied under the Cascade?

Answer 13

Name of the prescribing veterinary surgeon
Name and address of the animal owner
Name and address of the pharmacy
Identification and species of the animal
Date of supply
Name or description of the product
Dosage and administration instructions
Special storage instructions (if appropriate)
Any necessary warnings
Applicable withdrawal period (i.e. the time between when an animal receives a medicine and when it can safely be used for food)
The words: ‘For animal treatment only’
The words: ‘Keep out of reach of children’

Question 14

What is the record-keeping requirement for POM-V and POM-VPS?

Answer 14

Records must be kept for at least five years

•It is a requirement to keep records of receipt and supply of POM-V and POM-VPS
•Records can be kept in their private prescription book
•Can be kept electronically
•Entry showing:
•Name of the medicine
•Date of the receipt or supply
•Batch number
•Quantity
•Name and address of the supplier or recipient

•If there is a written prescription, record the name and address of the prescriber and keep a copy of the prescription

Question 15

What are suspect adverse drug reactions (SADRs) often associated with?

Answer 15

A failure to read and/or adequately follow product guidance information
Examples include animal sprays and ‘spot-ons’ onto human skin.

Question 16

What is the equivalent of the ‘yellow card’ scheme for human medicines in veterinary medicines?

Answer 16

The adverse reaction scheme for veterinary medicines

Question 17

Who may routinely supply authorized retailers with veterinary medicines?

Answer 17

Only the manufacturer of a veterinary medicine or a holder of a wholesale dealer’s authorisation (WDA)

An authorised retailer of veterinary medicines may supply products they are qualified to supply to another authorised retailer to relieve a temporary supply shortage, without a WDA. This exemption from the VMR is intended to prevent shortages of available medicines causing animal welfare problems. It is not intended to exempt wholesale supply from the need for a WDA.’

Question 18

Fill in the blank: Veterinary prescriptions for POM-V and POM-VPS for sch 2 and 3 cds must include the _______ of the prescriber.

Answer 18

Royal College of Veterinary Surgeons (RCVS) registration number

Question 19

What should be done to prevent shortages of available medicines causing animal welfare problems?

Answer 19

An authorised retailer may supply products they are qualified to supply to another authorized retailer without a WDA