Pharmacy practice Flashcards
What are the 2 visions of the veterinary medicines directorate?
- To ensure the responsible, safe and effective use of VMPs
- To protect public health, animal health, the environment and promote animal welfare by assuring the safety, quality and efficacy of veterinary medicines
What are the 4 responsibilities of the veterinary medicines directorate?
- To authorise veterinary medicines (equivalent to MA)
- To monitor safety and efficacy following authorisation
- To develop, update and enforce legislation controlling
- To monitor foodstuffs derived from animals for residues
What is a veterinary medicinal product?
Any substance presented as having properties that may be used to restore, correct or modify physiological functions of animals
What are the 4 different legal classifications of VMPs?
POM-V (POM-Veterinarian)
POM-VPS (Vet, Pharmacist & Suitably Qualified Person - SQP)
NFA-VPS for Non Food-producing Animals
AVM-GSL (Authorised Veterinary Medicine-General Sales List)
What are POM-Vs?
Must be prescribed by a vet after a clinical assessment of an animal under their care
If not supplied by the prescribing vet, a written Rx is required
Record of receipt and supply must be kept for 5 years (including batch numbers)
What are the 4 reasons why medicines are categorised as POM-V?
- Contains narcotic or psychotropic substances
- Diagnosis and clinical assessment is required by a vet before use
- Requires a strict limitation on its use for safety reasons
- Has a narrow safety margin requiring above average care in its use
What are POM-VPSs?
- May be prescribed by any Registered Qualified Person
- Clinical assessment not required
- Client may request written Rx
- RQP may supply a POM-VPS medicine against Rx from another RQP
- Record of supply kept for 5 years (including batch numbers)
What are the 3 reasons why medicines are classified as POM-VPS?
- It is used to prevent routine disease in herds, flocks or individual animals
- Use implies risks for user, animal, consumer safety or the environment but users can be made aware of precautions to take
- Professional user can be given adequate training in its safe use
What are NFA-VPSs?
Non food-producing animal
- May be supplied without a prescription
- Indicated for use only in non food-producing animals
- Used routinely to prevent or limit effects of disease
- Supplied by RPQ
What are AVM-GSLs?
Authorised Vet Med - GSL
- No restrictions apply
- Its use has a wide margin of safety
- It is used to alleviate or prevent the signs of disease or support the treatment of common ailments
- Special advice is not required to permit safe/effective use
What are schedule 6 products?
Exemptions for small animals
Schedule 6 permits certain medicines to be marketed without an MA
Vet medicines labelled exclusively for use in specified animals
May be sold by any retailer
Which 5 legislations are Vet CDs still required to adhere to?
- Prescriptions
- Supply
- Record keeping (CD Register (schedule 2) + Vet Record (all))
- Storage requirements (most Sch 2 and some 3)
- Destruction and disposal (witnessed for Schedule 2)
How does the cascade of a VMP outside of its MA work?
The first treatment choice considered by a vet must always be a UK AVM, for that condition in that species.
If there is no such product, the vet surgeon responsible for that animal may, in particular to avoid unacceptable suffering, treat the animal with the following ‘the cascade’ in the following order:
- The same condition in a different species or
- A different condition in the same species
If no veterinary licensed product available, the vet may consider a product licensed for:
- Humans in the UK and then…
- Vet product licensed in EU (SIC needed)
What is required of a vet prescription?
May be oral or written
A written prescription is required when the product is to be supplied elsewhere
Name, address & telephone number of prescriber
Qualifications of prescriber - MRVCS or SQP (only legal if a CD)
Name & address of owner
Species of animal, identification & number of animals
Premises where kept if different from owner’s address
Date of the Rx
Signature of prescriber
Name & quantity of product
Explicit osage & administration instructions
Necessary warnings
Withdrawal period if relevant
If prescribed under the cascade, a statement to that effect
Number of repeats, if necessary
Validity remains the same as human Rx
What must also be included in a vet prescription if sc2,3,4?
Address of prescriber (must be in UK)
RCVS Registration number
Form of the preparation
Strength where more than one available
Total quantity in words and figures
Declaration that the CD is prescribed for an animal or herd under the vet’s care
Name & address of the person to whom the CD is to be delivered
If to be dispensed in instalments – amount of instalment and intervals of supply
S1 to 4 CD Rx are valid for 28 days
Repeats of S2 and 3 CDs not allowed
Repeats are allowed for S4 but all repeats must be supplied within the 28 days
What are the 4 laws surrounding retail supply for vet meds?
- May only be from a Registered premises
- Supply only to the final user (except emergency)
- Pharmacists must supply a licensed vet product if one is available
- Is offence to supply a medicine licensed for humans for administration to animals unless it is in accordance with a prescription from a vet for administration under the ‘cascade’
What are the pharmacist requirements for supply of vet meds?
A pharmacist may only supply a veterinary medicinal product classified as POM-V, POM-VPS or NFA-VPS from
- premises registered as a pharmacy with the GPhC or with the PSNI;
- premises from which a veterinary surgeon supplies veterinary medicinal products; or
- premises from which a suitably qualified person supplies veterinary medicinal products
A pharmacist supplying a veterinary medicinal product (other than AVM-GSL) must be present when it is handed over unless the pharmacist
- authorises each transaction individually before the product is supplied; and
- is satisfied that the person handing it over is competent to do so.
What are the duties of a pharmacist during supply of vet meds?
- Must be satisfied that the person who will use the product is competent to do so safely
- Must advise on safe administration and on any warnings or contra-indications on the label or package leaflet
- Must not supply more than the minimum amount required for treatment as far as possible
What are the 4 laws surrounding advertisement of vet meds?
A VMP may be advertised provided that the advertisement is not misleading
Any advertising for POM-V and POM-VPS medicines must be aimed at ‘professionals’
Antimicrobials must not be advertised to professional keepers of animals
It is an offence to advertise to public
- POM-V and POM-VPS medicines
- Any human medicine for administration to an animal
- Any ‘off-label’ use of a product
Who is in control of medics?
GMC
Consists of :
i) 6 appointed medical members
ii) 6 lay members