Veterinary medicines

Question 1

Define: Veterinary Medicinal Product

Answer 1

any substance or combination of substances presented as having properties for treating or preventing disease in animals

Question 2

what does Veterinary Surgeons Act 1966 define?

Answer 2

1) Defines who can diagnose and treat animals.

2) Defines veterinary terms

Question 3

name the regulatory bodies for veterinary medicines

Answer 3

1) Royal College of Veterinary Surgeons (RCVS)
- Statutory regulator, Maintains a register of veterinary surgeons, Set standards for veterinary education, professional conduct
2) Animal Medicines Training Regulatory Authority
- Independent regulatory body, appointed by the Secretary of State to keep a register of Suitably Qualified Persons (SQP).
- Professionally qualified persons entitled to prescribe and/or supply certain veterinary medicines in the UK

Question 4

outline the Veterinary Medicines Legislation

Answer 4

1) Medicines Act 1968: all medicines, including POMs could previously only be supplied or prescribed by veterinary surgeons for animals under their care.
2) Currently working on Veterinary Medicines Regulation 2014
3) Veterinary Medicines Regulations 2005: reclassified veterinary medicines, updated rules on record keeping, updated annually since implementation.

Question 5

what is the role of the Veterinary Medicines Directorate

Answer 5

1) The Veterinary Medicines Directorate (VMD) has primary responsibility for the licensing, monitoring and control for veterinary medicines and their supply in the UK, among others.

Question 6

what is the role of the Veterinary Products Committee

Answer 6

1) set up in 1970: To give scientific advice to the Secretary of State on any aspect of veterinary medicinal products and specified feed additives
2) Hear representations on decisions relating to MA
3) To promote the collection and investigation of information relating to suspected adverse reactions to veterinary medicines

Question 7

describe the different Categories of veterinary medicines

Answer 7

1) Prescription only medicines – veterinarian (POM-V)
2) Prescription only medicines – vet, pharmacist, suitably qualified person (POM-VPS)
3) Non-food producing animal – vet, pharmacist, suitably qualified person (NFA-VPS)
4) Authorised veterinary medicine – general sales list (AVM-GSL)
5) Exempt medicines under the Small Animal Exemption Scheme (SAES)
6) Unauthorised Veterinary medicine (cascade)

Question 8

what is a POM-V medication?

Answer 8

1) Prescription-only medicines that can only be prescribed by a veterinary surgeon
2) Supplied by a veterinary surgeon or a pharmacist with a written prescription.
3) If for CDs, must carry a declaration by the vet stating that the medicine is prescribed for an animal or herd under his/her care.
4) May only be sold or supplied in accordance with a prescription given by a vet.

Question 9

what is a POM-VPS medication?

Answer 9

1) Prescription-only medicines that can be prescribed and supplied by a vet, a pharmacist or a suitably qualified person.
2) Prescriber may give oral or written prescription before supplying the product.
3) a veterinary prescription is only required if the supplier is not the prescriber.

Question 10

what is a NFA-VPS medication?

Answer 10

1) Medicines for non-food animals that can be supplied by a vet, pharmacist or SQP.
2) A written prescription is NOT required
3) Good practice requirement to keep records of medicines received or supplied.

Question 11

outline the Legal requirement for a pharmacists supplying a NFA-VPS medicine or prescribing a POM-VPS

Answer 11

1) advise on the safe use of the product
2) advise on any warnings or contra-indications
3) be satisfied that the person using it is competent to use it and intends to use it for an authorised use
4) not supply more than the minimum amount needed for treatment.

Question 12

Does the pharmacist need to be physically present when handing out a POM V, POM-VPS and NFA-VPS?

Answer 12

1) Pharmacist must be present when handing out medicines
2) Unless the transaction has been individually authorised in advance by a pharmacist and the person handing out the medicine is judged to be competent.
3) Supply the product from registered pharmacy premises or premises which are registered under the latest Veterinary Medicines Regulations.

Question 13

what is a AVM-GSL medication?

Answer 13

May be supplied by any retailer without any restrictions, or provision of advice e.g. in pet shops, supermarkets.

Question 14

outline the Exempt Medicines under the Small Animal Exemption Scheme (SAES)

Answer 14

1) Medicines for sole use in small, non-food producing animals (e.g. cage birds, aquarium animals, small rodents)
2) Not authorised so not assessed for safety, quality or efficacy but may still be marketed legally and administered according to instructions on the label.

Question 15

What happens when there is no suitable licensed veterinary medicine on the market?

Answer 15

1) Prescribe using the veterinary cascade.
2) Can only be prescribed by a veterinary surgeon
- Unauthorised Veterinary Medicine

Question 16

describe the The Veterinary Cascade

Answer 16

1) where available it is a legal requirement to : supply a veterinary medicine
2) only when the above is not possible: an existing licensed veterinary medicines for another species or different condition can be considered
3) only when the above is not possible: a licensed human medicine or an EU licensed veterinary medicine can be considered
4) only when the above is not possible: extemporaneous or specially manufactured medicines can be considered

Question 17

when is it legal to supply a human medicine for a animal? eg is a costumer wants some piriton for a cat

Answer 17

1) must be prescribed by a vet

2) state “for administration under the cascade”

Question 18

outline the Prescription requirements for a veterinary medication:For POM-V, POM-VPS and medicines supplied under the veterinary cascade

Answer 18

1) Name, address, telephone number; qualification and signature of the prescriber. write in a clearer way
2) Name and address of the owner.
3) Identification and species of the animal and its address (if different from the owner’s address).
4) Date: Rx valid for 6 months or shorter if indicated by prescriber.
5) Name, quantity, dose and administration instructions of the required medicine.
6) Any necessary warnings and if relevant the withdrawal period.
8) Where appropriate, a statement highlighting that the medicine is prescribed under the veterinary cascade
9) Where schedule 2 or 3 controlled drugs have been prescribed, a declaration that “the item has been prescribed for an animal or herd under the care of the veterinarian” – usual CD prescription requirements apply.
10) If the prescription is repeatable, the number of times it can be repeated.

Question 19

outline the prescription requirements for CDs

Answer 19

1) Standardised forms are not required for veterinary prescriptions
2) Retain veterinary prescriptions for 5 years
3) No requirement to submit CD prescriptions to the relevant NHS agency.
4) For all CDs, good practice to prescribe for only 28 days’ worth of treatment unless in situations of long term ongoing medication

Question 20

outline the labelling requirements for veterinary medicines when supplied by a pharmacy for use under the cascade

Answer 20

1) Name of the prescribing veterinary surgeon
2) Name and address of the animal owner
3) Name and address of the pharmacy
4) Identification and species of the animal
5) Date of supply
6) Expiry date of the product
7) The name or description of the product or its active ingredients and content quantity
8) Dosage and administration instructions
9) If appropriate, special storage instructions
10) Any necessary warnings for the user (e.g. relating to administration, disposal, target species, etc)
11) Any applicable withdrawal period
12) The words: “For animal treatment only”
13) The words: “keep out of the reach of children”

Question 21

outline what the records for For a POM-V and POM-VPS should contain (NFA-VPS not legal but good practice).

Answer 21

.
Records must be kept for receipts and supplies:
1) Name of the medicine
2) Date of the receipt or supply
3) Batch number
4) Quantity
5) Name and address of the supplier or recipient
6) If there is a written prescription, record
- Name and address of prescriber and keep a copy of the prescription
7) Either keep all documents showing required information or record in private prescription book
8) Electronic records acceptable
9) Entry must be made on the same day that the sale or supply takes place
10) Records and documents kept for at least 5 years

Question 22

is a stock audit a legal requirement and how often does it occur?

Answer 22

1) Once a year
2) Legal requirement!
3) For POM-V and POM-VPS
- NFA – VPS not mandatory
- No requirement for AVM-GSL

Question 23

what do you do if there is an adverse reaction to a veterinary medicine?

Answer 23

Report both animal and human adverse reactions to veterinary medicine Directorate (see VMD website for details of scheme and reporting forms

Question 24

how do you treat fleas OTC?

Answer 24

1) products containing fipronil (brand include Frontline Spot-on)
2) For cats and dogs

Question 25

how do you treat worms OTC?

Answer 25

1) products containing fipronil (brand include Frontline Spot-on)
2) For cats and dogs
25
how do you treat worms OTC?