Veterinary medicines

What is the main legislation for veterinary medicines called?

Veterinary Medicines Regulations 2013

What is the legal definition of veterinary medicines?

all products or substances that give the impression of treating/preventing disease or restore, corrects, modifies physiological functions by exerting a pharmacological, immunological or metabolic action in animals other than humans

What is the organisation in charge of veterinary medicines?

the veterinary medicines directorate (part of the department for environment, food and rural affairs)

What are the key role and responsibilities of the veterinary medicines directorate?

• pharmacovigilance, monitor and act upon any adverse effects

• testing veterinary medicines in animals and animal products

• licencing veterinary medicines (MAs)

• assess and authorise companies to sell veterinary medicines

• control how veterinary medicines are made and distributed

• inspects premises involved in the supply chain

• advises government ministers

What is a POM-V medicine?

prescription only medicines that can only be prescribed by a veterinary surgeon and supplied by a veterinary surgeon or a pharmacist with the prescription, a clinical assessment is required (the vet must see the animal recently before the prescription)(must be under the vet’s care)(the vet must keep records)

What is a POM-VPS medicine?

prescription only medicines that are prescribed or supplied by a veterinary surgeon, pharmacist or a suitably qualified person on an oral or written prescription. The written prescription is only required if the prescriber is not the supplier

What is a NFA-VPS?

medicines for non-food animals that is supplied by a veterinary surgeon, pharmacist or suitably qualified person, no written prescription is required

What is a AVM-GSL?

an authorised veterinary medicine available on general sale

What is a suitably qualified person?

a person who is trained and registered (with the VMD) to sell a limited range of veterinary medicines

What is a medicine that is exempt?(SAES)

an unlicenced veterinary medicine that does not require a MA due to exemptions under the VMR - Exemptions for small pet animals, there are no restrictions on the retail supply of these medicines. Topical and oral only. Must follow manufacturing requirements. Pharmacovigilance still applies.

What are unauthorised veterinary medicines?

an unlicenced medicine without a MA and is not exempt through SAES, can only be prescribed by a veterinary surgeon under cascade, includes any human medicines used for animals

What is required on any veterinary prescription?

• prescriber name, address, telephone number, qualification and signature

• owner’s name and address

• identification, species and address of animal (if different from owner)

• date

• name, quantity, dose and administration instructions of the required medicine

• any warnings or withdrawal period (if needed)

• if needed a statement saying that the medicine has been prescribed under veterinary cascade

• if repeatable the number of times it can be repeated

What is the withdrawal period with animals?

the time that must elapse between when an animal receives a medicine and when the animal can be used for food

What are the additional prescription requirements if the medicine is a Sch 2 or 3 CD?

• the registration number (RCVS) of the prescriber

• a declaration that ‘the item has been prescribed for an animal or herd under the care of the veterinarian

How long are veterinary prescription valid for?

• 6 months or shorter if indicated by the prescriber

• Sch 2,3 and 4 CDs are valid for 28 days

How long should veterinary prescriptions for controlled drugs be retained for?

5 years

What is the required form for a veterinary prescription?

no required form

For good practice how much supply of CD should you provide?

maximum 30 days unless long term ongoing medication needed or justifiable reasons

What are the legal requirements for pharmacists who supply NFA-VPS medicines or prescribe POM_VPS medicines?

• advise on how to use the product safely

• advise on any applicable warnings and contraindications on the packaging label

• be satisfied that the recipient intends to use the medicine correctly and is competent to do so

When could there be additional controls and considerations for?

food producing animals, horses and certain veterinary medicines

Under the VMR……….

………..only authorised veterinary medicines may be prescribed or administered to animals (unless a prescription under the cascade)

What is the steps of the cascade?

1. an authorised medicine for the condition and species

2. a medicine authorised in Northern Ireland for the condition and species

3. an authorised medicine for the condition but a different species

4. an authorised human medicine or medicine authorised outside the UK

5. a specially prepared product

If you prescribe a medicine using the cascade what must you do?

write for administration under cascade (or something similar)

What are the laws around selling human medicines for animal use?

it is unlawful to sell or supply human medicines including GSL or P medicines for animal use unless it is under the cascade

What does the supply of POM-V, POM-VPS and NFA-VPS medicines require?

the physical presence of a pharmacist unless the transaction had been individually authorised in advance by a pharmacist and the person handing out the prescription is judged to be competent

What must be on the label if the medicine is prescribed under the cascade?

• name of the prescribing veterinary surgeon

• name, address of animal owner

• name, address of Pharmacy

• identification and species of animal

• date of supply

• expiry date

• dose and administration

• name/description of product/active ingredients and content quality

• special storage instructions

• warnings

• withdrawal period

• ‘For animal treatment only’

• ‘Keep out the reach of children’

What is the legal requirements of labelling authorised VMPs?

none, if they are in their authorised packaging

What should be on the label of a VMP for good practice?

• RCVS requirements

• name and address of owner

• name and address of vet practice

• date of supply

• name, strength and quantity of product

• dosage

• directions for use

• ‘For animal treatment only’

What classes of veterinary medicines do you need to keep records of receipts and supply for?

POM-V, POM-VPS

What must records for veterinary medicines contain?

• medicine name

• date of receipt or supply

• batch number

• quantity

• name and address of the supplier or recipient

• name and address of prescriber and prescription if their is a written one

How long must veterinary medicine records be kept for?

5 years

What are the special requirements that pharmacies that supply POM-Vs and POM-VPSs must do?

annual audit

What are the rules around the wholesale supply of human medicines?

the same as for humans

What do you need to be apply to supply medicines for veterinary use under the cascade?

a WDA(H) issued by MHRA