7) Veterinary Medicines Flashcards
What were earlier veterinary medicines regulations previously covered by?
They were covered within the Medicines Act 1968
What has the Medicines Act 1968 been replaced by now?
The Annual Veterinary
Regulations. The Department of Environment, Food and Rural Affairs otherwise known as
DEFRA, proposed to update these regulations annually, and the veterinary products
committee provides scientific advice on veterinary medicines requested by Secretary of
State, or DEFRA. And they’ll have functions specified in the regulations around this.
What do the annual veterinary regulations specify?
- That a veterinary medicinal product, is
any substance presented as having properties for treating and preventing disease in animals. - Or they can be considered any combination of
substances, which may be used or administered to animals with a view to restore, correct,
modify, physiological functions by exerting a pharmacological, immunological or metabolic action, all by making a medical diagnosis. - The
regulations also stipulate what an animal means. So, an animal is something other than a man, and it includes birds, reptiles, fish, mollusks, crustacean and bees.
There are specific offences against the regulations. So, the offences include:
- placing a vet medicinal product upon the market, if it doesn’t have a marketing
authorisation granted by Secretary of State. - Another offence is to administer a veterinary medicinal product to an animal, unless the product has a marketing authorisation that authorises it for administration in the
UK. - It also has to be administered in accordance with the regulations, so specific
requirements that have to be met. - It’s also an offence to supply a veterinary medicinal product that’s past its expiry
date. - And it’s an offence to supply a medicinal product authorised for human use, for
administration to an animal, other than in accordance with a prescription given via a veterinary surgeon for administration under the cascade. So, you can only supply a
medicinal product for animal use, if it has a marketing authorisation. And, you cannot supply a human medicinal product, unless it’s under the cascade as written by a veterinary surgeon.
Classes of veterinary medicines?
- POM-V, they are prescription only medicines that can only be prescribed by a veterinary surgeon. They can be supplied by a veterinary surgeon or pharmacist
with a prescription. - POM-VPS: that’s a prescription only medicine that can be prescribed and
supplied by veterinary surgeon, a pharmacist or a suitably qualified person, with
an oral or written prescription. A written prescription is only required if the
supplier is not the prescriber. - NFA-VPS: that’s a category of medicine for nonfood animals, that can be supplied
by a veterinary surgeon, a pharmacist or a suitably qualified person. And a
written prescription is not required. - AVM-GSL: that’s an authorised veterinary medicine that is available for GSL, for
general sales list. - Exempt medicines under the small animal exemption scheme (SAES). That’s
where there is an unlicensed veterinary medicine that doesn’t require a
marketing authorisation, because it meets criteria laid out in this particular
scheme. - Unauthorised veterinary medicine. These are unlicensed medicines. They don’t
have a marketing authorisation, and they’re not eligible for exemption under the
SAES. They can only be prescribed by a veterinary surgeon under the cascade,
and they can include human medicines that can be used for animals.
Who can supply veterinary medicinal products by
wholesale, or be in possession of it for that purpose?
Only holders of a marketing authorisation or a holder of a manufacturing authorisation, or
the holder of a wholesale authorisation. wholesale, or be in possession of it for that purpose.
So those specific authorisations are required for supply of veterinary medicinal products.
Who can veterinary medicinal products only be supplied to?
To a person who may supply veterinary
medicinal products, either by wholesale or by retail. If the supply is made by a suitably
qualified person, then the supply must be made to them on that person’s approved
premises. That needs to be a requirement.
A wholesale dealer can break open any package, other than the immediate package of a
veterinary medicinal product.
Remember that!!
There are prescription requirements for POM-V’s.
- now initially a veterinary surgeon prescribing a veterinary product, must carry out a
clinical assessment of the animal, and the animal must be under their care. If they
don’t carry out this initial procedure, then it’s actually an offence. It’s also an offence
to prescribe more than the minimum amount of the product required for the
treatment. - Now the prescription that they (veterinary surgeons) issue, it can be oral, or it can be
written. - So, the person supplying the product can only supply the product specified on the
prescription. - They must ensure the supply is only made to the person named on the prescription.
And they must take reasonable steps to ensure that the prescription has been
written and signed by the person who’s entitled to prescribe it. - So, looking at the actual form, the actual prescription, what needs to be on there.
You will see similarities to the human private prescriptions.
o the name, address, telephone number, qualification and signature of the
prescriber.
o the name and address of the owner of the animal,
o identification and species of the animal, and its address. If it’s different to the
owners,
o date. Now the validity of these prescriptions is for six months, or it can be
shorter if indicated by the prescriber.
o If the prescription is repeatable, all supplies must be made within six months
or shorter if indicated.
o Now, if this prescription’s for controlled drug it is only valid for 28 days.
o For the medicine, you need to have the name of the medicine, the quantity,
the dose and administration instructions, as directed in this case is not
acceptable. It needs to be very specific.
o It needs to have any necessary warnings, and if relevant, the withdrawal
period. Which means anytime that must lapse before the medicine is used,
and when the animal can be used as a food itself (i.e. consumed).
o Where appropriate, a statement highlighting that the medicine is prescribed
on the veterinary cascade, needs to be on the prescription.
o If the medicine is a schedule two, or a schedule three controlled drug, then
the declaration on the prescription needs to include, ‘the item has been
prescribed for an animal or herd, under the care of the veterinarian’. And the
usual controlled drug prescription requirements apply. So, the name and the
quantity of the medication, in words and figures. If the prescription is
repeatable, then the number of times that it can be repeated also needs to
be on the prescription.
The veterinary cascade:
This has been mentioned a few times. It is a process under which a prescriber can prescribe
medicines, that don’t necessarily have a marketing authorisation for use in animals. So, for
veterinary medicine, it should have a UK marketing authorisation, to allow it to be
prescribed and supplied. And it allows the medicine to be clinically appropriate for use in
the animal. Now, cascade exemption allows medicines not licensed for animals to be
supplied. So, it’s unlawful to supply a human medicine against the veterinary prescription,
unless it’s prescribed by a veterinary surgeon and they specifically state on the prescription,
that it’s ‘for administration under the cascade’. to prescribe more than the minimum amount of the product required for the
treatment. - Now the prescription that they (veterinary surgeons) issue, it can be oral, or it can be
written. - So, the person supplying the product can only supply the product specified on the
prescription. - They must ensure the supply is only made to the person named on the prescription.
And they must take reasonable steps to ensure that the prescription has been
written and signed by the person who’s entitled to prescribe it. - So, looking at the actual form, the actual prescription, what needs to be on there.
You will see similarities to the human private prescriptions.
o the name, address, telephone number, qualification and signature of the
prescriber.
o the name and address of the owner of the animal,
o identification and species of the animal, and its address. If it’s different to the
owners,
o date. Now the validity of these prescriptions is for six months, or it can be
shorter if indicated by the prescriber.
o If the prescription is repeatable, all supplies must be made within six months
or shorter if indicated.
o Now, if this prescription’s for controlled drug it is only valid for 28 days.
o For the medicine, you need to have the name of the medicine, the quantity,
the dose and administration instructions, as directed in this case is not
acceptable. It needs to be very specific.
o It needs to have any necessary warnings, and if relevant, the withdrawal
period. Which means anytime that must lapse before the medicine is used,
and when the animal can be used as a food itself (i.e. consumed).
o Where appropriate, a statement highlighting that the medicine is prescribed
on the veterinary cascade, needs to be on the prescription.
o If the medicine is a schedule two, or a schedule three controlled drug, then
the declaration on the prescription needs to include, ‘the item has been
prescribed for an animal or herd, under the care of the veterinarian’. And the
usual controlled drug prescription requirements apply. So, the name and the
quantity of the medication, in words and figures. If the prescription is
repeatable, then the number of times that it can be repeated also needs to
be on the prescription.
What is the veterinary cascade?
It is a process under which a prescriber can prescribe medicines, that don’t necessarily have a marketing authorisation for use in animals. So, for
veterinary medicine, it should have a UK marketing authorisation, to allow it to be
prescribed and supplied. And it allows the medicine to be clinically appropriate for use in
the animal. Now, cascade exemption allows medicines not licensed for animals to be
supplied. So, it’s unlawful to supply a human medicine against the veterinary prescription,
unless it’s prescribed by a veterinary surgeon and they specifically state on the prescription,
that it’s ‘for administration under the cascade’.
Cascade?
- Now how that works, where a licenced veterinary medicine exists, then that should
be the first medicine that is seen as appropriate for use in the animal. - Where that isn’t possible, a veterinary medicine that has a license for another
species or different condition can be considered. - Where that condition isn’t possible, then a lisenced human medicine or EU licence
veterinary medicine can be considered. - And where those conditions cannot be met, then an extemporaneous or specially
manufactured medicine could be considered for the animal.
What is a suitably qualified person?
This is a person who has passed an exam approved by a body and is registered with such a
body by the Secretary of State.
Now this specific body, is the Animal Medicines Training Regulatory Authority (AMTRA).
Now, as Secretary of State have issued a code of practice for that suitably qualified person,
and AMTRA (Animal Medicines Training Regulatory Authority) has the duty to ensure that
it’s complied with.
- They also supplement the principal
legal requirements with other provisions related to personnel, sales, storage arrangement,
and standards of premises.
What is record keeping?
A legal requirement where any veterinary surgeon, pharmacist or suitably
qualified person sells or receives any medicinal products intended for the administration to
animals, and whose animal products are intended for human consumption. And that’s really to have an auditable trail of what that animal has been exposed to, before it reaches human consumption.
Specific requirements for record keeping?
- identity of the product or the medicinal product,
- the date of receipt or supply,
- the batch number,
- the quantity,
- the name and address of the supplier, and/or recipient.
- If there’s a written prescription, you need to record the name and address of the
prescriber and keep a record of the prescription. You can keep all of the documents
with the required information or make a record in a private prescription book.
Records can also be kept electronically, if that’s preferable. - You must keep the records for at least five years and pharmacies supplying VPS,
must undertake an annual audit. - Now that annual audit, as it sounds, must be carried out at least once a year, by
every person who is entitled to supply veterinary products on prescription. Incoming
and outgoing products must be reconciled with products currently held in stock, and
any discrepancies should be recorded. So, a robust system should be in place.
If these details are not on the packaging, what needs to be in the dispensing label
- the name of the prescriber,
- the name and address of the owner,
- the name and address of the pharmacy,
- the identification of species of the animal,
- the date of supply,
- the expiry date of the product, dosage and administration instructions.
- If appropriate, you should have the storage instructions, and also any warnings for
the user. - If there’s a specific withdrawal period, that should be included.
- And there’s two statements that should be on there. That’s ‘for animal treatment
only’ and ‘keep out of reach of children’.
