Veterinary Medicines 3.5 Flashcards
Background
Pharmacists allowed to supply vet meds for animal use in certain circumstances and are responsible for the supply. Pharmacists cant diagnose animals and should, refer to vet.
CLASSES OF VET MEDICINES:
NFA-VPS = non-food animals, No prescription needed but not accessible by the public in a pharmacy. Supplied by a veterinary surgeon, a pharmacist or a suitably qualified person
POM-V = only be prescribed by a veterinary surgeon. Supplied by a veterinary surgeon or pharmacist
POM-VPS= POM that can be supplied prescribed and supplied by veterinary surgeon, a pharmacist or a suitably qualified person on an oral or written prescription. A written prescription is only required if the supplier is not the prescriber.
AVM-GSL = authorised veterinary medicine, available on general sale.
Exempt medicines under Schedule 6 of the vet medicines regulations – exemptions for small pet animals (SAES - small animal exemption scheme) = unlicensed vet medicine that doesn’t require a marketing authorisation because it meets criteria laid out in Schedule 6 of the Vet Medicines Regulations - Exemptions for small pet animals.
Unauthorised veterinary medicine = Unlicensed medicine that doesn’t have a marketing authorisation and isn’t eligible for exemption through the SAES. It can only be prescribed by a vet surgeon under the Cascade. INC. human medicine used for animals.
Oral prescription only counts if prescriber is also supplier. If not has to be written.
Prescription requirements for POM-V, POM-VPS and medicines supplied under the veterinary Cascade 3.5.1
Prescription requirements:(5/8)
1. Name, address, telephone number, qualification and signature of the prescriber. IF giving CD 2, 3 RCVS registration number needed.
2. Name and address of owner.
3. Identification and species of animal and its address.
4. Date. - valid for 6 months or less if said by prescriber (same for repeats). CD 2, 3, 4 - 28 days.
5. Medicine - name, quantity, dose and administration instructions. As directed not allowed.
6. Any necessary warnings and if relevant the withdrawal period.
7. Where needed statement saying its been supplied under veterinary cascade.
8. If repeat - the number of repeats
For CD 2, 3 NEED TO SAY ‘the item has been prescribed for an animal or herd under the care of the veterinarian’
EXAMPLE IN MEP
Similarities/differences between veterinary and human CD prescriptions:
Differences:
* Vet prescription dont need standardised form but need to say: ‘prescribed for the treatment of an animal or herd under my care’ is required for CD 2, 3.
* Standardised forms are required for human private prescriptions for CD 2,3s.
* Vet prescription kept for 5 years and dont need to be submitted to NHS agency. Human private prescription for CD2,3 need to be submitted to NHS agency.
* FOR ALL VET CDs only 28 days supply max. for HUMANS only CD 2,3,4 is max 30 days supply.
* CD 2,3 vet prescriptions need RCVS registration number. human CD 2,3 need prescriber identification number.
Similarities:
* BOTH valid for 28 days
* Usual CD prescription content requirements apply to both.
The veterinary Cascade 3.5.2
Unlawful to supply human medicines with vet prescription unless prescribed by vet surgeon and specifically states that it is ‘for administration under the Cascade’, or similar wording.
Cascade is an exemption within the VMR and says that other medicines can be used in strict order preference if licensed vet product isn’t available.
Veterinary Cascade:
1. Supply a vet medicine with a GB or UK wide marketing authorisation for the species and condition indicated. NOT POSSIBLE THEN
2. A vet medicine with NI* marketing authorisation for the species and condition indicated. NOT POSSIBLE THEN
3. GB, NI, or UK wide vet medicine licensed for for anther species or condition can be considered. NOT POSSIBLE THEN
4. A) GB, NI, or UK wide licensed human medicine.
OR
B) Vet medicine authorised outside the UK can be considered. NOT POSSIBLE THEN
5. Extemporaneous or a specifically manufactured medicine can be considered.
*For products not authorised in GB or UK-wide (including those licensed in NI only) a Special Import Certificate is required.
Vet meds licensed for another species or another condition in the same species, extemporaneously prepared medicines or human medicines cannot be supplied against a veterinary prescription unless the prescription specifically states that it is ‘for administration under the Cascade’, or other similar wording.
SALE OF UNAUTHORISED VETERINARY MEDICINES
Unlawful to sell or supply unauthorised vet meds including human medicines such as GSL and P medicines, for an animal unless this takes place under the veterinary Cascade. This applies even if a veterinary surgeon asks the animal owner verbally to purchase an OTC human product from a pharmacy.
SALE OF NFA-VPS AND POM-VPS MEDICINES
Legal requirement for pharmacists who supply NFA-VPS medicines or prescribe POM-VPS medicines to:
* Advise on how to use the product safely
* Advise on any applicable warnings and contraindications on the packaging or label
* Be satisfied that the recipient intends to use the medicine correctly and is competent.
* Prescribe or supply the minimum quantity required for treatment.
** PHYSICAL PRESENCE OF A PHARMACIST**
Unless a transaction has been individually authorised in advance by a pharmacist and the person handing out the medicine is judged to be competent, the physical presence of the pharmacist is required for POM-V, POM-VPS and NFA-VPS medicines to be supplied.
Labelling of dispensed veterinary medicines 3.5.3
For medicine supplied by pharmacy under cascade - Following details must appear on the dispensing label unless they already appear on the packaging and are not covered by the dispensing label: (13)
1. Name of the prescribing veterinary surgeon
2. Name and address of the pharmacy
3. Name and address of the animal owner
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 (i.e. the time between when an animal receives a medicine and when it can safely be used for food)
12. The words: ‘For animal treatment only’
13. The words: ‘Keep out of reach of children’.
if medicine NOT given under cascade dispensing label NOT needed if medicine is given in original package.
BUT RPS recommends to make label for all.
Make sure label dont cover info on the package
Record keeping 3.5.4
Requirement to keep records of receipt and supply of POM-V and POM-VPS products showing:
* Name of medicine
* Date of the receipt/supply
* Batch number
* Quantity
* Name & 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
- Pharmacists can either keep all documents that show the required information or can make appropriate records in their private prescription book
- Records can be kept electronically
- Records and documents must be kept for at least 5 years
- Pharmacies that supply POM-V and POM-VPS medicines must undertake an annual audit.
ADVERSE REACTIONS TO VETERINARY MEDICINES
Suspect adverse drug reactions (SADRs) happen when ppl fail to read and/or follow product guidance properly.
EG = animal sprays and spot ins on to human skin.
Animal ADR scheme is similar to human yellow card scheme.
Reaction to animal and human should be reported.
And report suspected issues with microchip.
Wholesaling veterinary medicines and temporary supply shortages 3.5.5
Vet medicines guidance:
‘Only the manufacturer of a vet medicine or a holder of a WDA can routinely supply authorised retailers with vet medicines’.
‘An authorised retailer of vet medicines can 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 meds causing animal welfare problems. It is not intended to exempt wholesale supply from the need for a WDA. If you wish to supply human medicines for veterinary use under the cascade, you must hold a WDA(H) issued by the MHRA.’
Selling veterinary medicines on the internet 3.5.6
Guidance on the legal requirement for selling vet medicines over the internet see the VMD
website. The VMD accredits UK -based retailers of veterinary medicines who meet the Accredited Internet Retailer Scheme (AIRS).
https://www.gov.uk/guidance/sell-veterinary-medicines-on-the-internet
