Part 1D of the Royal College of Veterinary Surgeons (RCVS) Guide to Professional Conduct states that:

• ‘You should obtain the client’s informed consent to treatment unless delay would adversely affect the animal’s welfare (to give informed consent, clients must be aware of the risks).’

Who can give consent?

• The veterinary surgeon should be satisfied that the person being dealt with is the owner registered in the clinical records.
• If not the owner, the veterinary surgeon should be satisfied that the person has the authority to give consent.
• If the animal is presented by one half of a couple (i.e. joint owners), the veterinary surgeon should be sure that the wishes of the presenting owner are also those of the one who is not present.
• If the animal is presented by the owner of a boarding kennel in the owner’s absence, there should be a satisfactory agreement between them which delegates authority to the kennel or cattery owner.
• If the animal is presented by a young person, the veterinary surgeon should be sure that they are legally competent to give consent. Unfortunately, there is no clear legal ruling on this point. Whilst a minor is defined as someone under 16, and an 18-year-old can be considered an adult, there is a grey area between the two. In such cases it is up to the veterinary surgeon to make a decision, based on their judgement, as to the capability of the client to understand both what they are proposing to do, and the consequences.
• If the animal is presented on behalf of an owner by a carer, the veterinary surgeon must be sure that the carer has the owner’s authority to authorize treatment.

What is consent?

• Consent is the owner’s formal agreement to the medical or surgical course of action proposed, which should ideally also include acknowledgement of an estimate of the associated costs.
• Consent does not have to be written, although it is useful to be able to produce a signed consent form in the event of a dispute.
• If a person who is not the registered owner gives written consent, they should sign the consent form as ‘Owner’s agent’ and state their relationship to the owner.
• Consent must be ‘informed’. The owner must understand the nature of the procedure to be undertaken, and the risks and possible side-effects which may ensue.
• Owners must understand what they are signing.
• It is no longer enough to add the catch-all phrase, ‘and all other procedures which may be considered necessary’, without some explanation as to what they might be. ‘Such procedures’ will involve additional cost, and possibly additional risk, and the various options should be explained beforehand.
• Consent may include reference to the use of unauthorized drugs. Owners should understand why it is sometimes necessary to use a medication ‘off-label’ and give consent for their animal to receive such treatment.

The cascade and ‘off-label’ use
The RCVS considers that there is now a requirement for veterinary surgeons to obtain consent from owners if they intend to use drugs ‘off-label’. The RCVS Practice Standards Scheme (PSS) inspectors will ask to see examples of signed ‘off-label’ consent forms, in order to ensure that this message has got through.

‘Off-label’ use

• Datasheets are not legally binding and do not override clinical judgement.
• If a veterinary surgeon decides to use an unauthorized medicine they may do so in accordance with the cascade.
• However, the veterinary surgeon must have a good clinical reason for the decision; a theoretical whim is not enough. If challenged by either a client’s solicitor or the Veterinary Medicines Directorate (VMD) inspectorate, they should be able to cite some scientific justification for the action.
• The prospect of explaining the obligations of the cascade to an owner is a daunting one. On hearing the explanation, the vast majority of pet owners immediately jump to the conclusion that some sort of experimentation is going on, and are sensitized to the possibility of something going wrong. When it does, they may conclude that it was the use of an unauthorized drug(s) which caused the problem. Therefore, it is very important that the right message should be given. Practices may even consider creating a generic information sheet on the subject, which owners can read at their leisure.

Information sheet
An information sheet could include the following points:

• The drugs which the practice may wish to use have been in general veterinary use for years, e.g. those found in the emergency box in most operating theatres (adrenaline, atropine, potassium chloride)
• The names of the drugs themselves can usefully be inserted, as this increases the degree of the owner’s informed consent. Many are related to anaesthesia and analgesia (e.g. morphine, methadone, diazepam). In other words, the practice is not seeking permission to do an experiment. The sight of such familiar names will go a long way to quell any lingering feeling among owners that some sort of sinister experimentation is going to take place
• The reason why these drugs do not have a UK marketing authorization, which in some cases is purely due to the prohibitive cost of obtaining the authorization, which would never be recovered through sales.

Consent forms
As has already been emphasized, it is not the signature on the form, but the fact that the owner understands the reason for signing it, which is paramount.

Single-use consent form
As the wording implies, this is used in a situation where a specific medication is required, but which does not carry a veterinary marketing authorization. For example, this would be in a case where the veterinary surgeon wishes to use a cytotoxic drug to treat a specific type of neoplasia.

Multiple-use consent form
This is used in situations where there are no authorized medications for use in the species concerned. An increasing variety of species are now kept as pets and their owners are usually able to appreciate the reason why the veterinary surgeon needs to prescribe medicines in accordance with the cascade. A single consent form can be signed by an owner on registering with the practice, or at the start of treatment, but the giving of ‘blanket consent’ does not remove the obligation on the veterinary surgeon to ensure that it is informed consent.

Consent for general anaesthesia
If unauthorized drugs are going to be used as part of the anaesthetic routine, or to provide peri- and postoperative analgesia, then the consent form should contain some reference to this fact. For example, by adding the phrase ‘…which will/may include the use of drugs unauthorised for use in…(insert species)…’

The fact that the use of these drugs is associated with general anaesthesia can often raise the owner’s level of apprehension unnecessarily. Providing a written explanation for owners to take away with them is helpful, as they will often fail to comprehend information conveyed to them verbally when they are stressed or upset.

Further information

RCVS – consent forms

Veterinary Defence Society - www.veterinarydefencesociety.co.uk
Consent form for ‘off-label’ single use
Consent form for ‘off-label’ lifetime use