Veterinary pharmacy
Differences in diagnosis, treatment, prescribing and supply of medicines between animals and humans
Legislation and legal definitions that apply when dealing with medicines for animals
Prescribing and the supply cascade
Introduction
Veterinary medicines are not dealt with by every pharmacist on a day-to-day basis and some pharmacists may never supply a veterinary medicine during their whole career.
Some pharmacists however, choose to work more exclusively with animals and may undertake further training (e.g. a postgraduate diploma in veterinary pharmacy). Such pharmacists will often work in more rural areas and with food-producing animals (see Ch. 14).
The regulations relating to veterinary medicines are very different from those for human medicines and it is important that pharmacists understand the differences and where to access up-to-date information.
Animals, disease and medicines
It is unsafe to assume that the way a drug works in one animal species will be the same as the way it works in a human. This is also the case between different species of animals, and so in order to have a complete set of drugs available for every species of animal, very large sums of money would need to be invested in research and development. This does not happen and so anyone involved in treating animals may have to potentially prescribe medicines that have not been tested on that particular animal species. The other big difference between treating humans and animals is that humans are often in a position to describe symptoms, progression of symptoms and any contributing factors. When treating animals, a veterinary surgeon has to rely on physical examination and the owner’s observation of the animal, thus making diagnosis more difficult.
It is also important to recognize that some animals are food-producing, either because some produce food, e.g. eggs, milk, or are eaten as meat. If they have been taking medicines in the period of time before they or their products enter the human food chain, then it is likely that humans could be consuming quantities of the medicine. These medicines may not have been tested in humans and so may cause adverse drugs reactions or interactions with other prescribed medications within the human. Pharmacists involved in supplying veterinary medicines need to be aware of these issues, as they influence the medicines supplied, records made and advice given.
Definitions
There are three additional definitions used when working with medicines and animals:
1. Classification of a veterinary medicine
o. For treating or preventing disease in animals, or for making a medical diagnosis, or to restore, correct or modify physiological functions
2. Classification of an ‘animal’
o. ‘Animal’ means all animals other than man and includes birds, reptiles, fish, molluscs, crustacea and bees
3. Suitably qualified person (SQP)
o. This may include veterinary nurses, agricultural merchants, internet retailers and pet-shop staff. The list of SQPs is maintained by the Animal Medicines Training Regulatory Authority (AMTRA) and an individual can enter the list if they have undertaken an accredited training programme, have met the registration criteria and keep up-to-date. Registration allows the individual to supply certain legal classes of veterinary medicines.
Veterinary medicines directorate (VMD)
The VMD is the regulatory body for veterinary medicines. The vision of the VMD is the responsible, safe and effective use of veterinary medicinal products and in working towards this vision, the VMD aims to protect public health, animal health, the environment and promote animal welfare by assuring the safety, quality and efficacy of veterinary medicines.
Legal classifications
Each year, the VMD issues a new set of Veterinary Medicines Regulations (VMR), which are legally binding in the UK. These regulations displaced the Medicines Act in Great Britain and Northern Ireland. Other countries have similar regulations and there are also some European regulations.
There are four main legal classes of medicine and within these categories, there are also further classifications for controlled drugs (CDs).
POM-V (prescription only medicine – veterinarian)
May be sold or supplied by a pharmacist or a veterinary surgeon against a prescription which must be issued by a veterinary surgeon.
The prescription can be oral, i.e. not written down, unless it is being supplied elsewhere.
POM-VPS (prescription only medicine – veterinarian, pharmacist or SQP)
Must be both prescribed and supplied by a veterinary surgeon, pharmacist or SQP. The medicine must be supplied from registered premises.
The owner may request a written prescription if they do not want the prescriber to supply the medicine.
A clinical assessment of the animal is not required when prescribing this category of veterinary medicine.
NFA-VPS (non-food animal medicine – veterinarian, pharmacist, SQP)
Medicines in the NFA-VPS category are for companion animals (excluding horses). They must be supplied by a veterinary surgeon, pharmacist or SQP from registered premises.
A clinical assessment of the animal is not required for supply of this category of veterinary medicine.
AVM-GSL (authorized veterinary medicine – general sales list)
Medicines in the AVM-GSL category may be legally supplied by any retailer, to anyone, without restriction.
However, veterinary surgeons should take account of their professional duties in deciding when to supply all medicines, regardless of classification.
Prescribing and supply cascade
In-line with human medicines legislation, veterinary medicines regulations start from the principle that veterinary medicines must be authorized to protect the animal, user and the environment from untested or poor quality products. However, it is recognized that in some circumstances the benefits of supplying an unauthorized medicine will outweigh the risks and so veterinary surgeons have been given an exemption from the general rule under certain circumstances and this is known as the cascade.
The cascade tries to provide the balance between the need to use authorized products when available and the need for prescriber freedom when they are not. It is a way of increasing the range of products available to compensate for the lack of licensed products available for every condition in every animal species.
Any decision to supply a product under the cascade must take into account the following:
The veterinary surgeon remains responsible for the treatment of the animal under their care and so should use clear clinical evidence to support their decision-making process
If using a human medicine, the dose may seem appropriate but the formulation may mean it is not
Safety information about human medicines cannot be assumed to be relevant to their use in animals
Generic human medicines cannot be prescribed when a licensed veterinary product is available.
If there is no medicine authorized in the UK for a specific condition, the veterinary surgeon responsible for treating the animal(s) may, in order to avoid unacceptable suffering, treat the animal(s) in accordance with the following sequence:
1. A veterinary medicine authorized in the UK for use in another animal species or for a different condition in the same species
2. If there is no such medicine, use either a medicine authorized in the UK for human use or a veterinary medicine from another country
3. If there is no such medicine, a medicine prepared extemporaneously by a veterinary surgeon, pharmacist or a person holding an appropriate manufacturer’s authorization.
After the decision to supply has been made, then a prescription will be produced. There are legal requirements about what needs to be on this prescription (see Box 28.1).
Box 28.1 Prescription requirements
The name, address and telephone number of the person prescribing the product. It is considered good practice to include the registration number of the veterinary surgeon (MRCVS) or SQP writing the prescription
The qualifications of the person writing the prescription
The name and address of the owner or keeper of the animal
The identification (including the species) of the animal or group of animals to be treated
The premises at which the animal(s) is kept if this differs from the address of the owner or keeper
The date that the prescription is written
The signature of the person writing the prescription
The name and amount of the medicine prescribed
Additional requirements for CD prescriptions – Schedule 2 or 3 (excluding temazepam):
The address of the prescriber must be in the UK
The total quantity of the drug must be written in words and numbers
The form of the drug (e.g. injection, tablet) must be given
The prescription must include a declaration that the animal(s) being treated is under the veterinary surgeon’s care. It is a legal requirement to include the MRCVS registration number of the veterinary surgeon writing the prescription. The strength of the drug must also be included in the prescription if more than one is available
The prescription no longer needs to be handwritten
It is recommended that prescriptions should not be written for more than 30 days’ supply
Repeat prescriptions are not allowed for Schedule 2 or 3 drugs
CD prescriptions for Schedule 2, 3 or 4 drugs are only valid for 28 days.
Supply under the cascade
Medicines prescribed by a veterinary surgeon in accordance with the cascade may be supplied against a written prescription by another veterinary surgeon, a pharmacist or a SQP, provided the medicine is of a classification and for a species for which the supplier would normally be permitted to supply it. For instance, a POM-VPS medicine authorized for dogs and horses, but prescribed under the cascade for cats could be prescribed by a veterinary surgeon and supplied against a written prescription by a SQP, but only if that SQP was qualified to supply companion animal medicines. Only veterinary surgeons and pharmacists may supply POM-V medicines.
The other conditions of supply must still be met. Other considerations when using the cascade:
The legislation does not allow the cost of the medicine to be taken into account when deciding which medicine to use. For example, it is not permissible to use a human medicine because it is cheaper
However, the cascade may be invoked in other appropriate circumstances, such as where microbiological tests show that a particular strain of an organism has developed resistance to all medicines whose labels contain indications against it.
Use of the cascade in food-producing animals
In food-producing animals, only authorized products may be administered or dispensed.
Food-producing animals also have a specified minimum withdrawal period, i.e. the minimum amount of time after administration of the medicine before food products can enter the human food chain. The withdrawal period is species specific:
28 days for meat from poultry and mammals, including fat and offal
500-degree days for fish. The number of days of the withdrawal period is calculated by dividing 500 by the mean temperature of the water in degrees Celsius.
When the veterinary medicine is dispensed, there are requirements about the labelling of the product and these are listed in Box 28.2.
Box 28.2 Labelling requirements for dispensed medicines
The name and address of the pharmacy, veterinary surgery or approved premises supplying the veterinary medicine
The name of the veterinary surgeon who has prescribed the medicine
The name and address of the animal’s owner
The identification (including the species) of the animal or group of animals
The expiry date of the medicine (if applicable)
The name or description of the medicine, which should include at least the name and quantity of the active ingredient(s)
The dosage and administration instructions
Any special storage precautions
Any necessary warnings with reference to the user, target species, administration or disposal of the product
The words ‘Keep out of reach of children’ and ‘For animal treatment only’. Also the words ‘For external use only’ for topical preparations.
Pharmacists need to also be aware of the requirements for record-keeping when involved in the supply of veterinary medicines and these are listed in Box 28.3.
When supplying veterinary medicines (except AVM-GSL where record-keeping is good practice rather than a legal requirement), the following records should be kept:
Date and nature of transaction
Name of the veterinary medicine
The batch number (in the case of a medicinal product for a non-food-producing animal, this need only be recorded either on the date the batch was received or the date the batch was first used or supplied)
Name and address of the supplier or recipient
If there is a written prescription, the name and address of the person who wrote the prescription and a copy of the prescription.
Pharmacist advice-giving
If a pharmacist is involved in supplying a veterinary medicine from the following legal classes: POM-V, POM-VPS or NFA-VPS, then they must ensure that they:
provide advice on how to safely administer the product
provide advice about the warnings or contraindications that appear on the label or package leaflet
be satisfied that the person receiving the product is competent to use it safely and intends to use it for authorized use.
When giving advice, it is also important to be aware of the requirements about advice and diagnosis in the Veterinary Surgeons Act 1966:
Retail sale
There are some opportunities for the retail sale of veterinary products to treat tick and flea infestations in cats and dogs. This is potentially a large market with the estimated numbers of 6 million dogs and 8 million cats living as domestic pets in the UK.
There are licensed products available as NFA-VPS containing the insecticide fipronil and these products can be sold by a pharmacist if the owner has diagnosed the condition or for prophylaxis.
Before a pharmacist begins selling these products, they should ensure they are competent by completing training that will enable the products to be sold appropriately with the correct advice and to ensure that the products are then used correctly, as they can be toxic to other species, especially fish.
Conclusion
While many pharmacists may never be involved in supplying veterinary medicines, all pharmacists should be aware that there are additional restrictions on the prescribing and supply of medicines to treat animals.
Pharmacists should be particularly aware of the restrictions placed on pharmacists that relate to them diagnosing animals and giving advice about veterinary medicines.
Treating animals with drugs can be more complex that treating humans, as there are fewer species-specific products available.
Key Points
Some pharmacists will specialize in veterinary medicines
There are additional regulations that apply to the prescribing and supply of medicines for animals
Animals are unable to describe their symptoms, so diagnosis is based on examination and observation only
Medicines prescribed to animals that are food producing have additional safeguards to prevent these medicines entering the human food chain
Medicines must be prescribed and supplied under a cascade system to ensure that the most appropriate product is supplied for a particular type of animal, to minimize harm
Legal requirements for prescriptions, labelling and record-keeping for veterinary medicines
Pharmacists are restricted in the advice they can give about animal health and veterinary medicines