4. Veterinary medicines

Introduction

4.1  The responsible use of veterinary medicines for therapeutic and prophylactic purposes is one of the major skills of a veterinary surgeon and crucial to animal welfare and the maintenance of public health.

4.2  The Veterinary Medicines Regulations 2013 (as amended) (VMRs) are the main piece of legislation that applies in this area. The original Veterinary Medicines Regulations 2013 apply to all the United Kingdom (UK) – i.e., England, Wales, Scotland, and Northern Ireland. However, the amendments that came into effect in 2024 only apply in Great Britain (i.e., England, Wales, and Scotland). As such, the amended VMRs provide, in effect, two sets of Regulations having effect in GB and Northern Ireland, respectively.

4.3  Notwithstanding this, the RCVS Practice Standards Scheme’s (PSS) Core Standards reflect many of the provisions contained within the amended VMRs. It is an RCVS Code of Conduct obligation that all veterinary surgeons and veterinary nurses maintain standards equivalent to the Core Standards in the practices where they work. This obligation applies regardless of where in the UK the practice is based or whether it is part of PSS. 

4.4  The requirements and obligations in this chapter, and in PSS Core Standards, therefore, apply to all veterinary surgeons and veterinary nurses (including those in Northern Ireland) unless specifically stated otherwise. More information on Core Standards can be found in the relevant PSS Modules and Awards, as follows:

• PSS Small Animal Modules and Awards
• PSS Farm Animal Modules and Awards
• PSS Equine Modules and Awards

Classification of veterinary medicines

4.5  The main authorised veterinary medicines are:

a.  Prescription-only Medicine – Veterinarian; abbreviated to POM-V;

b.  Prescription-only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person (SQP); abbreviated to POM-VPS;

c.  Non-Food Animal – Veterinarian, Pharmacist, Suitably Qualified Person; abbreviated to NFA-VPS; and,

d.  Authorised Veterinary Medicine – General Sales List; abbreviated to AVM-GSL.

Prescription and supply of veterinary medicines

4.6  Veterinary surgeons and those veterinary nurses who are also SQPs should prescribe responsibly and with due regard to the health and welfare of the animal.

4.7  POM-V medicines must be prescribed by a veterinary surgeon, who must first carry out a clinical assessment of the animal under their care. (see below for RCVS interpretations.)

4.8  POM-VPS medicines may be prescribed in circumstances where a veterinary surgeon has carried out a clinical assessment and has the animals under their care. However, the Veterinary Medicines Regulations provide that POM-VPS may be prescribed in circumstances where the veterinary surgeon, pharmacist or SQP has made no clinical assessment of the animals and the animals are not under the prescriber’s care. 

4.9  NFA-VPS medicines may be supplied in circumstances where the veterinary surgeon or SQP is satisfied that the person who will use the product is competent to do so safely, and intends to use it for the purpose for which it is authorised.

4.10  Veterinary surgeons have additional responsibilities with the prescription or supply of POM-V and POM-VPS and the supply of AVM-GSL medicines.

4.11  There are five schedules of controlled drugs under the Misuse of Drugs Regulations 2001, each subject to a variety of different controls, including, for example: schedule 1 - possession requires a Home Office licence; schedule 2 - drugs obtained and supplied must be recorded in a register for each drug; schedule 2 and 3 - prescriptions are subject to additional requirements; and Schedule 4 and 5 - drugs are subject to fewer controls. Veterinary surgeons should take extra care when prescribing controlled drugs, to ensure that the medicines are used only for the animals under treatment.

Under care

Prescribing POM-Vs and veterinary medicinal products under the cascade

This section provides guidance on what it means to have an animal under your care and what is required when carrying out a clinical assessment before prescribing POM-Vs and veterinary medicinal products under the cascade. This section also includes a requirement for veterinary surgeons to be able, on a 24/7 basis, to physically examine animals under their care, or attend the premises in the case of production animals, equines, farmed aquatic animals and game, should it become necessary.

4.12  To prescribe POM-Vs or veterinary medicinal products under the cascade a veterinary surgeon is required to carry out a clinical assessment of the animal and the animal must be under their care. The terms 'clinical assessment' and 'under…care' are not defined by the VMRs, however the RCVS has interpreted them in the following way.

4.13  An animal is under a veterinary surgeon’s care when the veterinary surgeon is given, and accepts, responsibility for the health of an animal (or a herd, flock or group of animals) whether generally, or by undertaking a specific procedure or test, or by prescribing a course of treatment. Responsibility for an animal may be given by the owner, client or keeper, statute or other authority. A veterinary surgeon who has an animal under their care must be able, on a 24/7 basis, to physically examine the animal, or visit the premises in the case of production animals, equines, farmed aquatic animals and game. Veterinary surgeons should also be prepared to carry out any necessary investigation in the event that animals taken under their care do not improve, suffer an adverse reaction or deteriorate. Veterinary surgeons should provide this service within an appropriate timeframe depending on the circumstances, which could be immediately.

4.14  Where a veterinary surgeon is not able to provide the service set out in paragraph 4.13 themselves, another veterinary service provider may do so on their behalf. It is the veterinary surgeon’s responsibility to make these arrangements and it is not sufficient for the client to be registered at another practice. This arrangement should be in line with paragraphs 3.4 -3.6 of Chapter 3: 24-hour emergency first-aid and pain relief, made in advance before veterinary services are offered and confirmed in writing as part of the conditions of service agreed by the client. Veterinary surgeons should provide clients with full details of this arrangement and make this information publicly available, including relevant telephone numbers, location details, when the service is available, and the nature of service provided.

4.15  Where an animal is under the care of more than one veterinary surgeon, those veterinary surgeons should keep each other informed of any relevant clinical information (see Chapter 5: Communication between professional colleagues for further guidance on mutual clients).

4.16  A clinical assessment is any assessment which provides the veterinary surgeon with enough information to diagnose and prescribe safely and effectively. A clinical assessment may include a physical examination; however, this may not be necessary in every case.

4.17  Whether a physical examination is necessary for the prescription of POM-Vs or veterinary medicinal products under the cascade is a matter for the veterinary surgeon’s judgement depending on the circumstances of each individual case (please note that the Animals (Scientific Procedures) Act 1986 should be followed where it applies). When deciding whether a physical examination is required, the following factors are relevant, however veterinary surgeons should note this list is not exhaustive:

a.  The health condition(s), or potential health condition(s), being treated and any associated risks (see further guidance below at paragraph 4.18 and 4.19)

b.  The nature of the medication being prescribed, including any possible risks and side effects (see further guidance below at paragraphs 4.20 and 4.21)

c.  Whether the medication is being prescribed under the cascade (see further guidance below at paragraph 4.24)

d.  When the animal was last physically examined by a veterinary surgeon, or premises physically inspected in the case of production animals, farmed aquatic animals or game

e.  Whether there is access to the animal’s previous clinical history or, in the case of production animals, farmed aquatic animals and game, knowledge of the health status at the premises

f.  The understanding and knowledge of the owner/keeper in relation both to animal health and welfare, and the importance of open and honest communication with the veterinary team

g.  Whether the individual animal, herd, flock or group of animals is/are known to the veterinary surgeon and/or whether there is an existing relationship with the client or animal owner/keeper

h.  The practicality of a physical examination for individual animals

i.  The health status of the herd, flock or group of animals

j.  The overall state of the animal’s health

k.  The impact of any prescription made without physical exam on the ability to gather subsequent diagnostic information

4.18  The more complex or unusual the health needs of the animal, or where a differential diagnosis includes serious conditions not yet ruled out, the more likely a physical examination will be necessary.

4.19  In respect of paragraph 4.17 (a) above, a physical examination is required where a notifiable disease is suspected or part of a differential diagnosis.

4.20  In respect of paragraph 4.17 (b) above, and given the importance of minimising the development of resistance to antimicrobials and anthelmintics, and minimising the potential negative environmental impact of antimicrobials and antiparasitics:

a.  A physical examination is required at the time of prescription in all but exceptional circumstances where a veterinary surgeon prescribes antibiotics, antifungals, antiparasitics or antivirals for an individual animal or group of animals that are not production animals, farmed aquatic animals or game. Veterinary surgeons should be prepared to justify their decision in cases where antimicrobials are prescribed without a physical examination and record this justification in the clinical notes.

b.  When prescribing antibiotics, antifungals, antiparasitics or antivirals for production animals, farmed aquatic animals and game, veterinary surgeons should ensure they have an in-depth knowledge of the premises, including its production systems, the environment, disease challenges and the general health status of the herd, flock or group. Veterinary surgeons should have attended and inspected the premises and physically examined at least one representative animal prior to prescribing, or recently enough to ensure they have adequate current information and knowledge to prescribe responsibly and effectively, taking into account any available production data and diagnostic laboratory results. In exceptional cases where this is not possible, or in sectors such as large-scale commercial poultry and fish enterprises, and antimicrobials are prescribed without conducting a physical examination, veterinary surgeons should be prepared to justify their decision and to record this justification in the clinical notes. For the factors relevant to whether a physical examination is required, please see paragraph 4.17, above.

c.  Where samples are obtained for the purpose of testing following a physical examination (or, in the case of production animals, farmed aquatic animals and game, following a physical examination which was carried out 'recently enough'), it is acceptable for a veterinary surgeon to prescribe antibiotics, antifungals, antiparasitics and antivirals based on the results of those contemporaneous tests without the need for a further physical examination.

Note: For more information about responsible prescribing to minimise antimicrobial resistance, please see paragraphs 4.35 to 4.36 and 4.43 to 4.46 below.

4.21  In respect of 4.17 (b) above, when prescribing a controlled drug to an animal, veterinary surgeons should in the first instance carry out a physical examination in all but exceptional circumstances and be prepared to justify their decision where no physical examination has taken place. This justification should be recorded in the clinical notes. It is acceptable to issue a further prescription for that controlled drug without a physical examination, however veterinary surgeons should carry out a further clinical assessment to ensure they have enough information to do so safely and effectively (see RCVS Controlled Drugs Guidance - A to Z for further guidance on controlled drugs).

4.22  Veterinary surgeons must maintain clinical records of animals, herds, flocks or other groups of animals under their care.

Diagnosis

4.23  Diagnosis for the purpose of prescription should be based on professional judgement following clinical examination and/or post mortem findings supported, if necessary, by laboratory or other diagnostic tests.

Choice of medicinal products

4.24  In the first instance a veterinary surgeon should prescribe a medicine authorised in the jurisdiction where they are practising, for use in the target species, for the condition being treated, and used at the manufacturer's recommended dosage. Where there is no suitable authorised medicine available, the veterinary surgeon responsible for treating the animal(s) may, in particular to avoid unacceptable suffering, treat the animal(s) in accordance with the cascade. Guidance on how to apply the cascade in Great Britain (i.e., England, Wales, and Scotland) and in Northern Ireland, can be found below at paragraphs 4.32 and 4.33.

4.25  A decision to use a medicine which is not authorised for the condition in the species being treated where one is available should not be taken lightly or without justification. It is an RCVS requirement that veterinary surgeons and veterinary nurses do not promote or facilitate any purported use of the cascade which is not in accordance with the VMRs. In England, Wales and Scotland, it is an offence under the amended VMRs for any person to do so.

4.26  Where a veterinary surgeon considers it necessary to prescribe under the cascade, clients should be made aware of the intended use of unauthorised medicines and given a clear indication of potential side effects. Their consent should be obtained in writing. In the case of exotic species, most of the medicines used are unlikely to be authorised for use in the UK and owners should be made aware of and consent to this from the outset. 

4.27  When it is necessary to have a product prepared as an extemporaneous preparation, in the first instance it is recommended that the veterinary surgeon contacts a manufacturer holding an authorisation that permits them to manufacture such products (commonly referred to as Specials Manufacturers (ManSA). See the list of Specials Manufacturers held by the Medicines and Healthcare products Regulatory Agency and by the VMD for veterinary-only ManSA).

4.28  Specials Manufacturers may already have experience of preparing the product in question and will have the necessary equipment to prepare and check the quality of the product.

4.29  Horses declared ‘not for human consumption’ under the horse passport scheme are regarded as non-food-producing animals for the purposes of these provisions. 

4.30  Autogenous vaccines should only be administered to animals in exceptional circumstances where no suitable immunological veterinary medicinal product has been authorised in relation to the target species and indication and is to be done in accordance with a prescription under the cascade.

4.31  Explanations of the terms used in the below guidance on the application of the cascade across the UK are as follows:

a.  GB: a medicine only authorised in England, Wales, and Scotland*.

b.  NI: a medicine only authorised in Northern Ireland*.

c.  UK-wide: a medicine authorised in all jurisdictions of the United Kingdom, i.e. England. Wales, Scotland, and Northern Ireland*.

d.  EU Member State: a medicine authorised by a member of the EU – this does not include the UK.

[*All veterinary medicines granted authorisation before 31 December 2020 are categorised as UK-wide. Since 1 January 2021, a pharmaceutical company has been able to apply for UK-wide, GB, or NI only authorisation, thus creating these two new categories of authorised veterinary medicines.]

Cascade - England/Wales/Scotland, i.e. GB

4.32  If there is no medicine authorised in GB or UK-wide for a condition affecting a non-food-producing species, the veterinary surgeon responsible for treating the animal(s) may, in particular to avoid unacceptable suffering, treat the animal(s) in accordance with the following sequence, in descending order:

a.  a veterinary medicine authorised in NI for target species or condition**

b.  a veterinary medicine authorised in GB, NI**, or UK-wide for use in another animal species or for a different condition in the same species; or, if there is no such product:

c.  either:

i.  a human medicine authorised in GB, NI**, or UK-wide; OR

ii.  a veterinary medicine authorised outside of the UK**

d.  a medicine prescribed by the veterinary surgeon responsible for treating the animal and prepared extemporaneously by a veterinary surgeon, a pharmacist or a person holding an appropriate manufacturer’s authorisation, located in the UK; or, if there is no such product:

e.  a human medicine imported from outside of the UK**, in exceptional circumstances.

[**For products not authorised in GB or UK-wide, a Special Import Certificate will be required.]

Cascade - Northern Ireland

4.33  If there is no medicine authorised in NI or UK-wide for a condition affecting a non-food-producing species, the veterinary surgeon responsible for treating the animal(s) may, in particular to avoid unacceptable suffering, treat the animal(s) in accordance with the following sequence, in descending order: 

a.  a veterinary medicine authorised in NI, or UK-wide for use in another animal species or for a different condition in the same species; or, if there is no such product:

b.  either:

i.  a human medicine authorised in NI, or UK-wide; OR

ii.  a veterinary medicine authorised for use in an EU Member State***; or, if there is no such product:

c.  a medicine prescribed by the veterinary surgeon responsible for treating the animal and prepared extemporaneously by a veterinary surgeon, a pharmacist or a person holding an appropriate manufacturer’s authorisation, located in the UK; or, if there is no such product:

d.  a veterinary medicine with authorisation outside*** of Northern Ireland or UK-wide, or a human medicine from outside of Northern Ireland may be imported in exceptional circumstances.

[***For products not authorised in Northern Ireland or UK-wide, a Special Import Certificate will be required]

The prescribing cascade – food-producing animals

4.34  If there is no medicine authorised in the UK for a condition affecting a food-producing species, the veterinary surgeon responsible for treating the animal(s) may use the cascade options as set out in paragraphs 4.32 and 4.33 above, except that the following additional conditions apply:

a. the treatment in any particular case is restricted to animals on a single holding;

b. any medicine imported from another country must be authorised for use in a food-producing species in that country;

c. for use in Northern Ireland - the pharmacologically active substances contained in the medicine must have a Maximum Residue Limit (MRL), but not necessarily in the species for which it is intended to be used:

i.  veterinary surgeons should consider the ‘other provisions’ listed with the MRL, for example, some substances are not allowed for use in animals producing eggs or milk for human consumption;

ii. allowed substances are listed in table 1 in the Annex to Regulation (EU) No. 37/2010;

d. for use in Great Britian, (i.e., England, Scotland, and Wales) - all substances contained in the medicine must have a MRL, but not necessarily in the species for which it is intended to be used, or do not fall within the scope of assimilated Regulation (EC) No 470/200:

i. veterinary surgeons should consider the ‘other provisions’ listed with the MRL, for example, some substances are not allowed for use in animals producing eggs or milk for human consumption;

ii. substances with a MRL are listed in the GB MRL Register as established under Article 14A of assimilated Regulation (EC) No 470/2009

e. the veterinary surgeon responsible for prescribing the medicine must specify an appropriate withdrawal period; 

f. the veterinary surgeon responsible for prescribing the medicine must keep specified records.

Antimicrobial and anthelmintic resistance

4.35 The development and spread of antimicrobial resistance is a global public health problem that is affected by use of these medicinal products in both humans and animals. Veterinary surgeons must be seen to ensure that when using antimicrobials, they do so responsibly, and be accountable for the choices made in such use. Resistance to anthelmintics in grazing animals is serious and on the increase; veterinary surgeons must use these products responsibly to minimise resistance development.

4.36 There are a number of publications and sources of advice available to help veterinary surgeons make informed and professional decisions about prescribing antimicrobials. Some examples include:

• British Veterinary Association (BVA) information on responsible use of antimicrobials, including plans for veterinary practices, resources for animal keepers (farmers and pet owners), posters for practice waiting rooms (British Veterinary Association website and specialist divisions websites)
• British Small Animal Veterinary Association (BSAVA) information to support practices in discussing and drawing up practice guidelines on responsible antibacterial use, including the PROTECT poster and associated guidance
• British Equine Veterinary Association (BEVA) information on antimicrobial resistance, including the ProtectME toolkit and associated leaflets 
• Responsible Use of Medicines in Agriculture (RUMA) Alliance Guidelines on responsible use 
• National Office of Animal Health (NOAH) advice on antibiotic resistance
• Control of Worms Sustainably (COWS) advice on best practice 
• Sustainable Control of Parasites in Sheep (SCOPS) advice on best practice 
• Moredun Research Institute advice on Parasite Control in Horses
• EU Action Plans on Antimicrobial Resistance  
• UK Department of Health and Defra Five Year Antimicrobial Resistance Strategy 2013 to 2018 
• Veterinary Medicines Directorate (VMD) information leaflet for veterinary surgeons on Antimicrobial Resistance and Responsible Use of Antimicrobials 
• The World Health Organization advice on antimicrobial resistance

Responsibilities associated with the prescription and supply of medicines

4.37  A veterinary surgeon or veterinary nurse who is also an SQP who prescribes a POM-VPS veterinary medicinal product, or supplies a NFA-VPS veterinary medicinal product, and a veterinary surgeon who prescribes a POM-V or a veterinary medicinal product under the cascade is required:

a.  before they do so, to 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;

b.  when they do so, to advise on the safe administration of the veterinary medicinal product;

c.  when they do so, to advise as necessary on any warnings or contra-indications on the label or package leaflet;

d.  to not prescribe (or in the case of a NFA-VPS product, supply) more than the minimum amount required for the treatment

4.38  The VMRs 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.

4.39  The prescribing veterinary surgeon or SQP is required to be present when POM-Vs, POM-VPS, or NAF-VPS are handed over unless they have authorised each transaction individually before the product is supplied and is satisfied that the person handing it over is competent to do so.

4.40  Veterinary medicinal products must be supplied in appropriate containers and with appropriate labelling.

4.41  It is illegal under the VMRs to use or supply a veterinary medicinal product that has passed its expiry date.

4.42  Internet retailers and online suppliers of POM-V, POM-VPS, and NFA-VPS medicines in England, Wales, and Scotland must be registered with the Veterinary Medicines Directorate and have an address in Great Britian. In addition, they must include on their websites contact details of the secretary of state, a link to the published register, and the following statement, ‘registered internet retailer or veterinary medicines’. These details should be included on each part of the website where products are offered.

Additional responsibilities when prescribing antimicrobials/antibiotics

4.43  Antimicrobials must only be prescribed for the most limited period that is consistent with the risk to be addressed. The VMRs define ‘antimicrobials’ as ‘any substance with a direct action on micro-organisms that is used for treatment or prevention of infections or infectious diseases and includes antibiotics, antivirals, antifungals and antiprotozoals’.

4.44  Veterinary surgeons must not prescribe antibiotics to be used:

a.  routinely,

b.  to compensate for poor hygiene, inadequate animal husbandry, or poor farm management practices, or

c.  to promote growth or increase yield.

4.45  Veterinary surgeons must not prescribe an antibiotic for prophylactic purposes, unless it is an exceptional circumstance where the risk of an infection or of an infectious disease is very high and where the consequences of not prescribing the antibiotic are likely to be severe. Where an antibiotic is prescribed for administration to a group of animals for prophylactic purposes, the veterinary surgeon must:

a. clearly record the rationale for prescribing the product (this record must outline how the relevant conditions have been satisfied and be kept for five years), and

b. carry out a management review when the antibiotic is administered, or as soon as reasonably practicable afterwards, to identify factors and implement measures to eliminate the need for future administration due to the same circumstances.

4.46  In England, Wales and Scotland, veterinary surgeons must provide information relating to the sales and usage of antibiotics if the secretary of state services a notice on them to do so.

Administration

4.47  A medicine prescribed in accordance with the cascade may be administered by the prescribing veterinary surgeon or by a person acting under their direction. Responsibility for the prescription and use of the medicine remains with the prescribing veterinary surgeon.

Registration of practice premises

4.48  Under the VMRs, practice premises from which veterinary surgeons supply veterinary medicinal products (except AVM-GSL medicines) must be registered with the RCVS as a ‘veterinary practice premises’. It should be noted that in England, Wales, and Scotland, wholesale supply of veterinary medicinal products may only be delivered to a registered veterinary practice premises (RVPP).

4.49 Premises likely to be considered as ‘veterinary practice premises’ are those:

a.  from which the veterinary surgeons of a practice provide veterinary services; and/or,

b.  advertised or promoted as premises of a veterinary practice; and/or,

c.  open to members of the public to bring animals for veterinary treatment and care; and/or,

d.  not open to the public, but which are the base from which a veterinary surgeon practises or provides veterinary services to more than one client; and/or,

e.  to which medicines are delivered wholesale, on the authority of one or more veterinary surgeons in practice.

4.50  Main and branch practice premises from which medicines are supplied are veterinary practice premises and must be registered with the RCVS.

Storage of medicines

4.51  All medicines, including during transport, should be stored in accordance with the terms of any instructions on the label and in accordance with the relevant summary of product characteristics. If it is stipulated that a medicine be used within a specific time period, it must be labelled with the opening date, once broached.

4.52  Drugs controlled under the Misuse of Drugs Act and the 2001 Regulations, as amended, must be stored properly, so that there is no unauthorised access. There should be no direct access by members of the public (including family and friends); and staff and contractors employed by the practice should be allowed access only as appropriate. Veterinary surgeons should take steps to ensure that members of staff with access to controlled drugs are not a danger to themselves or others when they join the practice and at times when they may be vulnerable.

4.53  Schedule 2 controlled drugs, such as methadone, fentanyl, and ketamine, are subject to safe custody requirements and legally must be kept in a secure cabinet to prevent unauthorised access. Although quinalbarbitone is not legally subject to the same safe custody requirements, it is an RCVS requirement that ALL Schedule 2 drugs are locked away equivalent to safe custody.

4.54  Although not all Schedule 3 controlled drugs are subject to the same legal safe custody requirements, it is an RCVS requirement that ALL Schedule 3 controlled drugs, for example tramadol, buprenorphine, pentazocine, the barbiturates, gabapentin and pregabalin (this list is not exhaustive), be securely locked away.

4.55  Veterinary surgeons should keep a record of premises and other places where they store or keep medicinal products, for example, practice vehicles and homes where medicinal products are kept for on-call purposes. The record should be held at the practice’s main ‘veterinary practice premises’ in accessible form.

Associations with other suppliers of medicines

4.56  A veterinary surgeon who is associated with retail supplies of POM-VPS, NFA-VPS, or AVM-GSL veterinary medicinal products (or makes such supplies), should ensure that those to whom the medicines are supplied, or may be supplied, are informed of:

a.  the name and qualification (veterinary surgeon, pharmacist or SQP) of any prescriber;

b.  the name and qualification (veterinary surgeon, pharmacist or SQP) of the supplier; and,

c.  the nature of the duty of care for the animals.

4.57  Similar safeguards should be put in place by a veterinary surgeon who is associated with retail supplies of POM-V veterinary medicinal products by pharmacists.

Ketamine

4.58  As of 30 November 2015, Ketamine is rescheduled as a Schedule 2 controlled drug (previously Schedule 4). It is therefore subject to the strict storage, prescription, dispensing, destruction and record keeping requirements that apply to all CDs in this Schedule. For further details on these requirements please see the VMD veterinary medicines guidance on CDs.

Obtaining medicines

4.59  Veterinary surgeons should ensure that medicines they supply are obtained from reputable sources and in accordance with the legislation, particularly where medicines are imported or manufactured overseas.

RCVS Practice Standards Scheme and additional information

4.60  The RCVS Practice Standards Scheme manual and the Veterinary Medicines Guidance provide additional information on medicines, as well as the British Veterinary Association’s Good Practice Guide on Veterinary Medicines on responsible use of medicines, and the British Small Animal Veterinary Association’s Guide to the Use of Veterinary Medicines.

Cytotoxic drugs and COSSH Regulations

4.61  Cytotoxic drugs are used in therapies such as cancer treatment. They are medicines which are toxic to cells, preventing their replication or growth. Given their properties, these drugs can be harmful to those involved in preparing and administering them, and those looking after animals treated with them. Cytotoxic drugs are hazardous substances, as defined by the Control of Substances Hazardous to Health Regulations (COSHH).

4.62  Therapies involving cytotoxic drugs are high-risk areas of veterinary practice and it is important for veterinary surgeons to comply fully and properly with the associated health and safety legislation. This may be difficult in some small animal practices which do not have the resources necessary and veterinary surgeons should consider their resources and abilities before committing to providing therapies using cytotoxic drugs. For some veterinary surgeons and practices, it may be advisable to refer a case to a specialist centre.

4.63  Veterinary surgeons need to be aware of the hazards associated with cytotoxic drugs and precautions must be taken. Under health and safety legislation, employers have a legal duty to protect the health of their employees and anyone else (e.g. animal owners) who may be affected by their work. Likewise, employees have a legal duty to take care of their own health and safety and that of others affected by their actions. Employers must have a health and safety policy and employees must be informed of that policy and comply fully and properly with measures put in place by their employer.

4.64  Under the COSHH Regulations, employers have a legal duty to assess the risks to employees and others from handling cytotoxic drugs and to take suitable precautions to protect their health. In conducting this risk assessment, the Health and Safety Executive (HSE) advise generally that the employer should:

• Identify the hazards – what are the potential adverse effects on health of the drugs used?
• Decide who might be harmed and how – this will include the animal receiving treatment, the owner of the animal and the veterinary staff involved in the case.
• Evaluate the risk – what is the frequency and scale of contact with cytotoxic drugs and how effective are the control measures?
• Record the findings
• Review the risk assessment – even in the absence of changes or incidents, it is good practice to review the assessment from time to time to ensure that precautions are still working effectively.

4.65  The HSE advise that employers must appoint a ‘competent person’ to help them meet their health and safety duties (see Health and Safety Executive web page on 'What is competence?'.) A competent person is someone who has the necessary skills, experience and knowledge to manage health and safety. Even senior and experienced veterinary surgeons should consider whether they are suitably competent in respect of health and safety and the performance of risk assessments.

4.66  The key for those working with cytotoxic drugs is to prevent and control exposure. Veterinary surgeons should think about ways in which work can be organised to reduce the risks, for example, having a designated area for preparation, and restricting access to authorised staff. Matters including safe handling, storage, disposal of hazardous waste and dealing with spillages and patient excreta/body fluids should be considered, and all staff involved should receive appropriate training on these areas, as well as training on any personal protective equipment that may be issued.

4.67  Veterinary surgeons should also assess any risk to clients from their pets undergoing therapies which use cytotoxic drugs – both the risk from handling and administering medicines, and the risk from animal excreta/body fluids. All owners of patients undergoing such therapies should be informed of the risks and educated in safe handling of the drugs and in matters relating to hazardous waste management. It is advisable for this information to be provided in writing. (See also paragraph 4.26 above regarding written consent for off-licence use and responsibilities associated with the supply of medicines.)

4.68  It should be borne in mind that there are different ways in which cytotoxic drugs are administered, and in some cases additional manipulation of the drug may be required before administration, with associated risks – aerosolisation for example. If a veterinary surgeon is not able to adequately manage these risks and comply with the health and safety legislation, bearing in mind the work involved, they should consider purchasing drugs prepared commercially or by another veterinary practice or pharmacy. A client should never be asked to crush or split tablets or capsules and an explicit warning should be included on any medicines dispensed.

4.69  Veterinary surgeons should continue to ensure the adequacy of the control measures put in place. The efficiency of any equipment should be monitored by way of examination and testing, if appropriate and available. Safety equipment should be subject to routine maintenance according to HSE guidelines. It is important to keep suitable records in this regard.

4.70  Veterinary surgeons should be aware of the need to report certain incidents and dangerous occurrences to the relevant enforcing authority. See Health and Safety Executive web page on 'Dangerous occurrences'  

4.71  Further detailed information on the safe handling of cytotoxic drugs can be found on the HSE website, including links to additional sources of information - Health and Safety Executive web page on 'Safe handling of cytotoxic drugs in the workplace'

Reporting adverse events (including suspected adverse reactions) following use of veterinary medicines

4.72  The VMD’s Pharmacovigilance Unit closely monitors all reports of adverse events, including suspected adverse events, serious adverse events, adverse environmental events, human adverse events, and lack of efficacy, following use of veterinary medicines.

4.73  An adverse event is defined by the VMD as any observation in animals that occurs after any use of a veterinary medicinal product, whether or not considered to be product-related, that is unfavourable and unintended.

4.74  A serious adverse event is defined by the VMD as an adverse reaction that results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly or birth defect, or that results in permanent or prolonged signs in the animals treated.

4.75  An adverse environmental event is defined by the VMD as an event where a non-target organism, population or ecosystem is adversely affected as a result of exposure to a veterinary medicinal product, its active substances or its metabolites present in soil, water or animal remains.

4.76  A human adverse event is defined by the VMD as a reaction that is noxious and unintended and that occurs in a human being following exposure to a veterinary medicinal product.

4.77  Lack of efficacy is defined by the VMD as the apparent inability of an authorised veterinary medicinal product to have the expected efficacy in an animal, whether or not the product was used in accordance with the summary of product characteristics.

4.78  If, following administration of an authorised medicine in the UK, you become aware of any adverse events including adverse reactions involving an animal, a human, or the environment, you should record what happened in as much detail as possible and make a report to the VMD and/or the company who market the product, who are legally obliged to forward such reports to the VMD. Further information is available by searching for VMD on gov.uk or you can phone the VMD’s Pharmacovigilance Unit on 01932 338427.

Reporting prescription misuse

4.79  It is illegal for any person to submit a written prescription to a retailer on more than one occasion where the prescription is not repeatable. In England, Wales, and Scotland, this is a specific offence under the VMRs and in Northern Ireland it would fall under the Fraud Act 2006.

4.80  Suspected prescription misuse (which could include an alteration to an existing prescription or prescription fraud) can be reported to the VMD via its dedicated prescriptions misuse page. Making such a report will, in most cases, require a veterinary surgeon to release confidential information about their client to the VMD. The RCVS considers that reporting cases of prescription misuse is in the public interest and in most cases a report to the VMD will be a justified breach of client confidentiality. In addition, it is considered that such a report would be within the scope of the GDPR as this allows personal data to be processed where it is necessary for the purposes of a legitimate interest, and in most cases, it seems unlikely that this would be overridden by the interests or fundamental rights and freedoms of the relevant individual. However, this should be considered in each case. For advice on client confidentiality on a case-by-case basis please contact the RCVS Professional Conduct Department on 020 7202 0789.