2. Content
• Background legislative documents and bodies
• The Cascade
• Withdrawal periods
• Legal categories
• RQPs
• Controlled Drugs
• Prescriptions/Labels
• Record keeping
• Adverse reactions
• Veterinary Pharmacy bodies/courses
3. The Veterinary Medicines
Regulations
• Until October 2005 Veterinary Medicines regulated under the
Medicines Act
• New legislation came into force on 30th
October 2005 called The
Veterinary Medicines regulations
• Replaces all pre-existing legislation including the Medicines Act
1968 (except controlled drug legislation)
• Aim to have all legislation covered under one document
• Reviewed on an annual basis (October each year)
4. Veterinary Medicines Regulations
2009
Controls all aspects pertaining to veterinary
medicinal products including….
• Manufacture
• Marketing
• Advertising
• Classification
• Supply and
possession
• Administration
• Record keeping
• Disposal
• Importation
• Prescriptions
5. Veterinary Medicines Directorate
(VMD)
• Veterinary Medicines Directorate
– Executive agency of DEFRA (Department for Environment, Food and
Rural Affairs)
– Operate the licensing system for animal medicines
– Safe guard public health, animal health and the environment
• Ensure the safety, quality and efficacy of medicines within the UK
• Veterinary Products Committee
– Committee of experts advising the VMD on new and renewal of
marketing authorisations
• SARSS
– Suspected Adverse Reaction Surveillance Scheme
• MAVIS
– Medicines Act Veterinary Information Service
• Veterinary Residues Committee
– Committee of experts advising the VMD and Food Standards Agency on
residue surveillance programmes etc
6. Overview of control
VMD (agency of DEFRA)
Legislation
RCVS
Additional guidelines,
filling in the gaps
Interpretation
BVA
Interpretation and the
provision of guides
Interpretation
Guidelines for
Pharmacists
RPSGB/GPhC
7. Cascade for selecting drugs – Non
food animal
If there is no medicine authorised in the UK for a condition affecting a non
food-producing species, the veterinary surgeon responsible for treating the
animal(s) may, in particular to avoid unacceptable suffering, treat the
animal(s) in accordance with the following sequence:
(a) a veterinary medicine authorised in the UK for use in another animal species or
for a different condition in the same species; or, if there is no such product:
(b) either:
(i) a medicine authorised in the UK for human use; or
(ii) in accordance with an import certificate, a medicine authorised for veterinary
use in another Member State; or, if there is no such product:
(c) a medicine prepared extemporaneously, by a veterinary surgeon, a pharmacist
or a person holding an appropriate manufacturer’s authorisation, as prescribed
by the veterinary surgeon responsible for treating the animal.
8. Cascade for food producing species
If there is no medicine authorised in the UK for a condition affecting a food
producing species, the veterinary surgeon responsible for treating the
animal(s) may use the cascade as for non-food animals except that:
• the treatment in any particular case is restricted to animals on a single holding;
• any medicine imported from another Member State (option b(ii)) must be
authorised for use in a food-producing species in the other Member State;
• the pharmacologically active substances contained in the medicine must be
listed in Annex I, II or III to Regulation (EEC) No. 2377/90;
• the veterinary surgeon responsible for prescribing the medicine must specify an
appropriate withdrawal period;
• the veterinary surgeon responsible for prescribing the medicine must keep
specified records.
9. Withdrawal Periods
• Withdrawal periods are set for food-producing animals to
protect consumers.
• Time before which meat or animal products from that
animal may not be used in the food chain
• If withdrawal period not specified
• Not less than 7 days for eggs and milk
• Not less than 28 days for meat
• Not less than 500 degree days for meat from fish
10. Veterinary Medicines – Legal
categories
• All Veterinary Medicinal Products require a product licence
• Legally classified into four different categories
– Prescription Only Medicine – Veterinarian (POM-V)
– Prescription Only Medicine – Veterinarian, Pharmacist, SQP (POM-
VPS)
– Non-Food Animal – Veterinarian, Pharmacist, SQP (NFA – VPS)
– Authorised Veterinary Medicine – General Sales List (AVM-GSL)
11. “Animals under his/her care”
• For prescribing POM-V medicines
• RCVS definition:
– Vet has responsibility for the animal(s)
– Real and not nominal
– Seen at prescribing or recently or often enough
– Vet must keep the clinical records of this animal or group of animals
12. What is a RQP?
• POM-VPS and NFA-VPS products can be prescribed by a RQP
which may be a
– Vet
– Registered pharmacist
– SQP –
• In some cases this may be a veterinary nurse
• May be an animal feed merchant
• Trained by Animal Medication Training Regulatory Authority
(AMTRA)
• Registered with the VMD for some or all classes of POM-VPS and
NFA-VPS
13. Controlled Drugs
• Veterinary controlled drugs legislated under the Misuse of Drugs
Regulations
• Legal requirements the same as for human drugs except no
requirement for private prescriptions to be on a standardised form
14. Written prescriptions- legal
requirements
• the name, address and telephone number of the person prescribing the product;
• the qualifications enabling the person to prescribe the product. It is good practice to
cite MRCVS or the SQP registration number. This is a legal requirement when
prescribing controlled drugs;
• the name and address of the owner or keeper;
• identity (including the species) of the animal or group of animals;
• the premises at which the animals are kept if this is different from the address of the
owner or keeper;
• the date of the prescription;
• the signature or other authentication of the person prescribing the product;
• the name and amount of the product prescribed;
• the dosage and administration instructions;
• any necessary warnings;
• the withdrawal period, if relevant;
• if it is prescribed under the cascade, a statement to that effect.
Extra requirements for CDs the same as for human prescriptions
15. Labelling
• the name and address of the pharmacy, veterinary surgery or approved premises
supplying the veterinary medicinal product;
• the name of the veterinary surgeon who has prescribed the product;
• the name and address of the animal owner;
• the identification (including the species) of the animal or group of animals;
• the date of supply;
• the expiry date of the product, if applicable;
• the name or description of the product, which should include at least
• the name and quantity of active ingredients;
• dosage and administration instructions;
• any special storage precautions;
• any necessary warnings for the user, target species, administration or disposal of the
product;
• the withdrawal period, if relevant; and
• the words “Keep out of reach of children” and “For animal treatment only”
16. Record Keeping
• Records must be kept for receipts and supplies of POM-V and POM-VPS
products.
• In addition to the record you would make when supplying against a private
prescription for a human you must record the Batch number (if for a non-
food-producing animal, you only need to make a record of this either on the
date you received it from your supplier or the date when you first supplied
the product).
• The pharmacist can either keep all documents that show all the required
information or make a record in their private prescription book.
• Records can be kept electronically.
• Records and documents must be kept for at least 5 years.
• Pharmacies which stock veterinary medicines must undertake an annual
stock audit of their veterinary medicines.
17. Adverse reactions
• Should be reported to the Veterinary Medicines Directorate (VMD)
under the Suspected Adverse Reaction Surveillance Scheme
(SARSS)
• Also report adverse effects on humans administering the product
and reactions to human products prescribed under the cascade
• Use yellow card from back of NOAH compendium (form MLA 252A)
or on VMD website
• VPC advises on problems identified by VMD
18. Veterinary Pharmacy Courses
• The Veterinary Pharmacy Education Programme, in conjunction
with Harper Adams College run a number of courses
– Professional Certificate in Companion Animal & Equine Health Care
– Professional Certificate in Large Animal Health Care
– HAUC University College Diploma in Veterinary Pharmacy (UCDip)
– HAUC Postgraduate Diploma in Veterinary Pharmacy (PgD)
– HAUC Masters in Veterinary Pharmacy (MSc)
19. The Veterinary Pharmacists Group
• Scope:
• “The Veterinary Pharmacists Group is open to all pharmacists interested or
involved in the supply of veterinary medicines to pet owners and the
keepers of livestock. The group promotes the practice of veterinary
pharmacy and plans to hold an annual conference and convene periodic
webinars.”
• Aims and objectives:
• “to advise and represent the Society on professional interests of
pharmacists involved in the supply of veterinary medicines,
• to act as a source of information and education (including CPD)
• to represent the profession with external stakeholders including VMD, BVA,
RCVS, NOAH, AMTRA, AHDA, RUMA, PHC and others”
20. Publications
• Pharmacists can apply to get the Vet Times and Veterinary Record
• Other reference sources:
– Veterinary Pharmacy (Pharmaceutical Press)
– BSAVA Small Animal Formulary (BSAVA)
– Veterinary Formulary (Pharmaceutical Press)
