Labelling And vetinary Medicines Flashcards
In terms of the drug, what must be on your label?
Name of product, matching the Rx
Form of product
Strength
QUANTITY
What must always be on your label? (ie what is Pre-printed by system)
Keep out of reach of children (Pre-printed)
Name and address of pharmacy are legally required
Patients Name and DATE are legally required
When writing directions on the label, what is preferred for children? And animals?
GIVE is preferred to Take
If you’ve made a POM entry, what should be included on your label?
A reference number
POM entries made for private prescriptions and emergency supplies
If the medicine is an emergency supply at request of a PATIENT, what should be included on Label? What about are request of a doctor?
At request of patient: emergency supply to be written on label
At request of doctor: does not need emergency supply written
What additional label should be added to Liquid emulsions, suspensions and aerosol formations?
Shake well before use
shake gently before use proffered for some preps
For products applied to the skin or scalp, what extra label is needed?
for external use only
May include the label ‘Spread thinly on the affected skin only’ for eg Betnovate RD cream
On labels for EYE, EAR, NASAL, VAGINAL and RECTAL products, what caution should be included?
Not to be taken by mouth
What extra labels are requires for vaginal suppositories? Eg Diclofenac 50mg suppositories
Not to be taken by mouth
Store in a cool place
What extra labels would be needed for Pilocarpine 1% eye drops?
Not to be taken by mouth
Discard four weeks after opening
The discard four weeks after opening label must be included on labels for all eye preparations.
Some granules and powders for reconstitution have a short shelf life once reconstituted (made up into suspension). What additional info on the label should be present?
Specific expiry date after which they shouldn’t be used,
Eg discard after dd/mm/yy
What should be on the label of extemporaneously manufactured products?
Should have specific expiry date
Should have Batch Number of product both on label
In terms vetinary medicinal products and human medicinal products, which can be interchanged?
Medicinal products for human use can be used to treat animals under certain circumstances, under the Vetinary Cascade
But vetinary medicines can NEVER be used to treat Humans!!
Are vetinary medicines under the Medicines act?
No, not anymore since 2005.
Vetinary Medicines Directorate (VMD) was established, this issues new Vet Medicines Regulations each year.
What animals does the vetinary medicines regulations cover?
Medicines supplied for most animals
Including birds, reptiles, fish, molluscs, crutacea and bees
Do vetinary medicines need Marketing authorisations, if they’re not under the control of the MHRA?
Yes, they need something similar to a marketing authorisation, issued by the veterinary medicines directorate.
Who can provide advice to the vetinary medicines directorate?
The Independent vetinary products committee
They offer advice on behalf of the Minister of Agriculture
They consider appeals
What does POM-V mean?
POM- Veterinarian
What does POM-VPS mean?
Vet, pharmacist and suitably qualified person
Suitably qualified person must be registered with animal medicines training regulatory agency
NFS-VPS, what’s this for?
For non food producing animals
AVM-GSL, what does AVM stand for?
Authorised veterinary medicine
When can POM-V medicines be supplied?
Only If prescribed by a vet after clinical assessment of the animal
Can be supplied by a vet or a pharmacist
How long must records of POM-Vs be kept?
5 years
When can POM-VPS been prescribed? Does the animal need to be clinically assessed?
Can be prescribed by any registered Qualified person
(vet, pharmacist or SQP)
Clinical assessment of animal is NOT needed
Pharmacist or SQP can supply against prescription from a Vet, OR vice versa.
Again record of supply should be kept for 5 years
Can NFA-VPS (for non food producing animals) be supplied without a prescription?
Yes
They’re used to prevent or limit the effects of disease in NFAs
NFAs: horses, cats, dogs?
Do any restrictions apply with AVM-GSLs?
No, no restrictions
They have wide margins of safety
Used to alleviate the signs of disease, or to treat common ailments
Eg may be flea-killing products, that you can buy in pet stores
What does the small animals exemptions scheme involve?
Permits certain medicines to be marketed without a marketing authorisation, subject to certain conditions, for vet MPs exclusively for use in specified animals, that aren’t intended for human consumption.
Eg for fish, caged birds, small rodents
Controlled drugs (VMGN 20) Schedule 2 and 3 are classified as \_\_\_\_\_\_ under the Vet regulations. They're subject to both Vet regs and \_\_\_\_\_\_\_ for prescriptions, supply and record keeping, storage and disposal.
Classified as POM-V
Subject to both Vet regs and MDA regs
What is the code for vetinary Prescritpions?
VMGN3
Prescriptions can be oral or written
What must a Vetinary prescription include?
Name, address, and TELEPHONE number of prescriber
Qualification of Prescriber (Vet)
Name and address of OWNER of the animal
SPECIES of animal
ANIMALS NAME
NUMBER of animals
(premises where it’s kept if different to owners address)
Date
Signature
Name, strength, quantity
Dosage and administration instruction (as directed is NOT allowed)
Warnings
Withdrawal period possibly
If its been prescribed under the CASCADE (ie it’s a medicine for human use but is being given to the animal) then a statement needs to be on there saying this
If prescriptions repeatable, the number of REPEATS
Can you alter Vetinary prescriptions if you notice something wrong?
No, this is against the law
Unless you are authorised by the person who signed the Rx
How long are vetinary prescriptions valid for?
6 months after appropriate date
Unless for CD schedules 1-4 (28 days)
What is an important statement that must be on CD Prescritpions for Animals?
Declaration that the CD is prescribed for an animal under the VETS CARE
With vetinary CD prescriptions, when aren’t Repeats allowed?
Repeats of Sch2 and 3 drugs aren’t allowed
It’s an offence to supply a medicine licensed for humans for administration to animals, unless it’s _____
Under the CASCADE
A pharmacist supplying a vetinary medicinal product must be present when it’s handed to the owner UNLESS:?
They have authorised each transaction individually before the product is supplied
And only if they’re satisfied that the person handing it over is competent to do so.
If a vetinary Medicinal Product is in the manufacturers original packaging and is NOT prescribed under the Cascade, then what are the requirements on labelling?
There is NO LEGAL requirement to label!
But it’s good practice to do so with name and address of pharmacy, name and address of owner, and the date of the supply.
With veterinary medicines prescribed under the cascade, ie the medicine is for use in humans, what additional things need to be on the label?!
Should say GIVE not take Name of animal and it's species (eg Jack the Dog) Name and address of OWNER Name of prescriber For animal treatment only Expiry date (potentially) reference number from POM BOOK Keep out of reach of children Name and address of pharmacy DATE
What must be written in a POM book entry for POM-V and POM-VPS (if under the cascade)?
"Jack the Dog" Owners name and address Drug, strength, quantity Directions Batch number vet name, vet address, vet TELEPHONE No Date on Rx: date supplied: For animal under vets care For administration under the veterinary prescribing cascade
Sheep dips: a liquid formulation of insecticide or fungicide
Supply must only be to a person qualified to use it
They must have a certificate
You must keep a record of the certificate number for 3 years
If the sheep dip also contains an organophosphorous compound, you must also supply;
a4 laminate instruction sheet
2 pairs of protective gloves
What vetinary products is it an offence to advertise?
Any POM-V or POM-VPS
Any human medicine for administration to an animal
Any “off label” use of a product
What are most often supplied from pharmacies in terms of vetinary medicines?
Prophylactic medicines for fleas and worms for pets that do not require diagnosis
What kinds of Vet medicines can pharmacists prescribe?
POM-VPS
NFA-VPS
NOT POM-Vs! These can only be prescribed by a Vet after clinical assessment
Pharmacists can only supply human medicines for animal use against a _____ from a vet, pharmacists cannot prescribe these themselves. These are POMs, GSLs and Ps that are all used I’m humans.
Against a WRITTEN prescription from a vet (oral not good enough)
This includes GSL and P medicines
