PSS training and resources

This would count as a veterinary prescription, even where the human-licensed medicine is not itself prescription-only.

Human-licensed medication could be prescribed under step (c)(i) (in Great Britain) or (b)(i) (in Northern Ireland) of the prescribing cascade. However, the justification in this case would also need to account for why a veterinary medicine (authorised for that species and condition, or for another species or condition) could not be used.

For specific information about prescribing human-licensed paracetamol, see our 2020 news article on the subject.

Additionally, the VMD has provided the following guidance on the use of medicines commonly found around the home:

In exceptional emergency circumstances, you may judge there is a need to alleviate a pet’s discomfort until a home visit can be made or the animal brought to the surgery. You could recommend that an animal owner use a human medicine that they already have in their possession, such as antihistamine tablets. This does not mean a pet owner should be encouraged to go into a pharmacy and ask for a human medicine for their pet.

Prescription validity refers to the time in which the medicine must be dispensed, otherwise the prescription will no longer be valid.

A written prescription for a POM-V is valid for six months (unless a shorter period is stated).

A written prescription for a schedule 2 or 3 controlled drug has a validity of 28 days (unless a shorter period is stated) and is not repeatable.

There is nothing to prevent more than one medication (or animal) being included on a written prescription. However, where multiple medicines and animals are noted on one prescription it must be explicit which medicine is for which animal. Veterinary surgeons are free to exercise professional judgement in this regard.

Out-of-date stock

Destruction - The legal requirements to witness the destruction of Schedule 2 CDs apply to stock. This refers to CDs that have not been issued or dispensed to a patient.

However, any leftover medicines, for example liquids, which are still required for use, are considered as stock. A witness is required if these are to be destroyed on expiry or for other reasons.

The following are examples of out-of-date stock:

• The remains of bottles of Ketamine, Methadone, or Fentanyl 28 days after broaching.
• Any other Schedule 2 CDs that have passed their expiry date.

There are commercially available denaturing kits, and these can be used to destroy out-of-date stock CDs and returned CDs. Veterinary surgeons should follow the instructions for use and disposal specific to the kit, as these may differ depending on the kit used.

Recording - The VMD advise that a record must be made of the date of destruction and the quantity destroyed, which the witness must sign. The witness, if an independent veterinary surgeon, should record their RCVS number and confirm their independence in writing in the CD register. The VMD also say that the following information should be recorded: name of the CD, form, strength and quantity, and the signature of the professional destroying the drug.

Expired stock should not be marked out of the running balance in the CDR until it is destroyed.

Returned drugs

Destruction – Any CDs returned to the practice by clients should not be re-used and should be destroyed as soon as possible. The VMD advises that the CD must be clearly labelled as a return and stored in the CD cabinet – but separated from practice stock CDs to avoid potential dispensing errors or re-use.

Recording - The VMD advise that the requirements to witness and record the destruction of CDs do not apply to returned CDs. However, they advise that it would be good practice for veterinary surgeons should consider making a record of any CD that is returned and having the destruction witness by another member of staff and signed against. This can be recorded in a separate book or sheets designed for that purpose.

Where an animal has died part way through treatment, the VMD recommends that the prescribing veterinary surgeon should consider making every effort to recover and destroy any remaining product.

Residual or waste drugs

Destruction - There is no legal requirement to have the disposal of waste product witnessed. Residual CDs are not usually denatured using kits because, as their destruction is required daily, this would prove too costly. Instead, residual drugs can be rendered irretrievable by collection into cat litter. Periodically, this cat litter is then sent as pharmaceutical waste through the waste contractor.

Recording - Any medicine left over in an ampoule, vial, or injected into fluids to make a constant rate infusion, which is considered unusable, is considered waste product (as opposed to practice stock). Both the amount administered, and the amount denatured should be recorded on the same line of the CDR to ensure that the running balance tallies – e.g. if 10mg morphine is dispensed to a patient but only 5mg is administered the record should show that 5mg was given and 5mg was wasted. Doing so ensures that the whole vial or ampoule is accounted for in the CDR. It is good practice for the entry in the CDR to be double signed.

In order to be an independent witness, a veterinary surgeon must be independent of a practice where the destruction takes place, and they must not have personal, professional, or a financial interest in the veterinary practice where the drug is being destroyed.

*This is under review by the VMD, it will be updated in due course.

One practice may supply to another practice to relieve a temporary supply shortage, without a Wholesale Dealers Authorisation. This exemption from the VMR is intended to prevent shortages of available medicines causing animal welfare problems and should not be a regular occurrence.

Veterinary surgeons are required to store CDs securely and appropriately in a suitable cabinet to prevent unauthorised access. The following CDs are legally required to be stored in a locked container which is compliant with the Misuse of Drugs (Safe Custody) Regulations 1973:

• All CDs in Schedule 2 (with the exception of quinalbarbitone)
• CDs in Schedule 3 containing buprenorphine, diethylpropion, flunitrazepam and temazepam

The RCVS considers it advisable for all CDs in Schedule 3 to be stored in the CD cabinet. The Safe Custody Regulations describe the requirements for CD cabinets, safes and rooms and the standards to which they must be manufactured or built.

A T28 exemption certificate is what practices need in order to be able to denature controlled drugs for disposal in compliance with the Misuse of Drugs Regulations 2001. Practices can register for the exemption online through the Environment Agency here. Some corporate bodies will register all their practices, and other practices will need to do so on an individual basis. The registration process is free of charge and lasts for 3 years.

Having a T28 certificate does not change the requirements for witnessed destruction.

Once a veterinary surgeon has met their ‘under care’ obligations pursuant to the Veterinary Medicines Regulations 2013, and Chapter 4 of the supporting guidance to the Code of Conduct, they may delegate the dispensing/supply of those POM-Vs to a team member.  They must be satisfied that the person handing it over to the client, is competent to do so. For the veterinary surgeon  to be satisfied the person dispensing must have knowledge of practice protocols (i.e. trained) and there must an SOP in place.

The prescribing and delegating veterinary surgeon will remain ultimately responsible, and their responsibilities associated with the prescription and supply of POM-Vs, is set out at paragraphs 4.24-4.26 of Chapter 4, as follows:

4.24  A veterinary surgeon or SQP who prescribes POM-VPS veterinary medicinal product, or supplies a NFA-VPS veterinary medicinal product, and a veterinary surgeon who prescribes a POM-V veterinary medicinal product must:

1. before s/he does so, be satisfied that the person who will use the product is competent to use it safely and intends to use it for a use for which it is authorised;
2. when s/he does so, advise on the safe administration of the veterinary medicinal product;
3. when s/he does so, advise as necessary on any warnings or contra-indications on the label or package leaflet; and
4. not prescribe (or in the case of a NFA-VPS product, supply) more than the minimum quantity required for the treatment.

4.25  The Veterinary Medicines Regulations do not define 'minimum amount' and the RCVS considers this must be a matter for the professional judgement of the veterinary surgeon in the individual case.4.26  Veterinary medicinal products must be supplied in appropriate containers and with appropriate labelling.

Having prescribed POM-V medicines, if the veterinary surgeon is not present when there is a request for the medicine to be repeated, the veterinary surgeon must:

• Authorise each transaction individually before the medicine is supplied; and 
• Be satisfied that the person handing it over is competent to do so.

A veterinary surgeon could meet the requirement to authorise each transaction by:

• Handing over a medicine personally following a consultation, or instructing a fellow team member to dispense/supply the medicine;
• Making a note on a client’s record that repeat prescriptions could be supplied to the client;
• A team member taking a call from a client and putting a medicine aside for the veterinary surgeon to authorise before being supplied;
• In the case of a client unexpectedly coming into the practice, by a phone call to the veterinary surgeon, to authorise the supply.

Whichever method is used there must be an audit trail to show that the medicines has been prescribed by a veterinary surgeon.

Note: A Suitably Qualified Person (SQP) under the Veterinary Medicines Regulations 2013, is under similar requirements for the prescription and supply of POM-VPS medicines.

As per the RCVS Controlled Drugs Guidance, discrepancies between the amounts recorded as used, the volume of the product left in the vial, and the total stated volume must be avoided.  The Veterinary Medicines Directorate (‘VMD’) advise that pharmaceutical companies try to ensure that every bottle of medicine is precisely filled but some small variability may occur.  This may result in discrepancies regarding the amount of Controlled Drugs used when taking into consideration the volume remaining in the container.  There may also be some wastage within the needle and hub of the syringe each time the product is withdrawn, known as ‘deadspace’.  The Home Office has advised the VMD that discrepancies of up to 10% should not cause undue concern.  Reconciliation at the end of each bottle is recommended to avoid consolidation of errors.  Obviously, a balance of LESS than expected should be treated with greater concern.  While efforts should always be made to minimise wastage, the Home Office, the VMD, and RCVS Practice Standards Inspectors are all aware that some wastage due to deadspace will be unavoidable and these small discrepancies should always be recorded.

A Standard Operating Procedure (‘SOP’) should be in place, detailing what to do in the event of a discrepancy. The BSAVA state that one way of accounting for deadspace volume is to add this to each dose dispensed, but the volume is likely to vary, depending on the manufacturer of the needle and syringe, and the size of the syringe used - typically this is 0.05mls.

In reconciling, the RCVS recommends estimating by eye, making a scale on an empty bottle (for example), and then measuring a full bottle against it, or for more accuracy, weighing the bottles and recording weights.  Physically withdrawing remaining volume from a multi-dose bottle to allow for it to be accurately measured via needle/syringe, before returning the drug to the bottle, is not recommended, due to a health & safety risk of repeatedly drawing out volumes of controlled drugs, increasing the risk of them blowing back into someone’s face, and of course, increased wastage.

The VMD advise that for all CDs, a veterinary surgeon should consider prescribing only 28 days’ worth of treatment unless in situations of long-term ongoing medication (e.g. when treating epilepsy in dogs).

If more than 28 days’ worth of treatment is prescribed, it must be ensured that the owner is competent to use the medicine safely.

When prescribing under the Cascade, veterinary surgeons should ensure they obtain written consent* for use of that medicine from the client. A consent form template is available from the VDS (which has been reproduced in the RCVS PSS Small Animal module).

It should be noted it is generally unacceptable for veterinary surgeons to use an all embracing “general” lifelong consent for any and all products provided under the Cascade that might be given to any animal.  Practically, this means specific consent needs to be obtained from a client for each unauthorised medicine used. 

However, it is acceptable for a lifelong consent form to be used for a specific ongoing condition requiring unauthorised medicine for that particular medicine in that particular animal.  It is also acceptable to use lifetime consent in the case of exotics where there are no licenced products available.

*Subject to Covid-19 restrictions.

All such medicines supplied by a veterinary practice must be labelled in accordance with the Veterinary Medicines Regulations ‘VMRs’.  For products supplied under the Cascade, the following information must be always included:

1. The name and address of the pharmacy, veterinary surgery or approved premises supplying the veterinary medicinal product
2. The name of the veterinary surgeon who has prescribed the product
3. The name and address of the animal owner
4. The identification (including the species) of the animal or group of animals
5. The date of supply
6. The expiry date of the product, if applicable
7. The name or description of the product, which should include at least the name and quantity of active ingredients
8. Dosage and administration instructions
9. Any special storage precautions
10. Any necessary warnings for the user, target species, administration or disposal of the product
11. The withdrawal period, if relevant
12. The words ‘Keep out of reach of children’ and ‘For animal treatment only’.

For a Veterinary Medicine Product supplied in a container other than that specified in the marketing authorisation (e.g. tablets dispensed into smaller containers) the person supplying the product must ensure that the container is ‘suitably labelled’ and must supply sufficient written information for the medicine to be used safely. This legal requirement may be met by:

• Labelling the product in accordance with the PSS’s requirements (see below) and providing a copy of the package insert or the SPC to the client.
• Providing the NOAH data sheet, or a link to the data sheet online.
• Using a dispensing envelope supplied by the drug company, or that includes that practices own written information.

RCVS PSS requirements for labelling VMPs:

All POM-V medicines supplied by the practice must be legibly and indelibly labelled with:

• Name and address of the animal owner
• Name and address of the veterinary practice supplying the medicine
• Date of supply
• Name, strength and quantity of product
• Dosage and directions for use
• ‘For animal treatment only’
• For topical preparations ‘For external use only’.

In 47% of PSS assessments, assessors found that there was lack of evidence of temperature monitoring for medicines.

Medicines need to be stored at the correct temperature in accordance with the Summary of Product Characteristics.

Where medicines are to be stored at ambient room temperature, the temperature should be kept between 8°C and 25°C and should be monitored. This is especially important where the outside temperature is particularly high or low.

Medicines such as vaccines and insulin need to be refrigerated between 2°C and 8°C. They should only be removed from the refrigerator for immediate use.

Fridge temperatures should be monitored daily, ideally by the same person, and the results logged, or if monitored by using an electronic data logger these should be alarmed, the alarm checked daily to make sure it has stayed within range and the data downloaded weekly.

A written standard operating procedure should be in place, detailing the actions to be taken should the temperatures fluctuate outside the recommended limits.

It is an offence under the VMR to supply or administer an out of date or expired medicine. This applies to all veterinary medicinal products, including CDs.

All multi-dose injectables will have an “in use shelf-life” that tells the user how long the vial can be used for, after it has first been broached. It is an offence under the VMR to use a medicine for longer than this period.

Multi-dose vials should be marked with the date of first opening, or the date of expiry, and any medicine left in the vial after the specified time must be discarded/denatured. If the medicine is a Schedule 2 CD, denaturing must be independently witnessed.