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4. Veterinary medicines
Updated 1 April 2016
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.
Classification of veterinary medicines
4.2 The main authorised veterinary medicines are
- Prescription-only Medicine – Veterinarian; abbreviated to POM-V;
- Prescription-only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person (SQP); abbreviated to POM-VPS;
- Non-Food Animal – Veterinarian, Pharmacist, Suitably Qualified Person; abbreviated to NFA-VPS; and,
- Authorised Veterinary Medicine – General Sales List; abbreviated to AVM-GSL.
Prescription of veterinary medicines
4.3 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.
4.4 POM-V medicines must be prescribed by a veterinary surgeon, who must first carry out a clinical assessment of the animal under his or her care. (See below for RCVS interpretations)
4.5 POM-VPS medicines may be prescribed in circumstances where a veterinary surgeon has carried out a clinical assessment and has the animals under his or her 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.
4.6 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.
4.7 Veterinary surgeons have additional responsibilities with the prescription or supply of POM-V and POM-VPS and the supply of AVM-GSL medicines.
4.8 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 his care
4.9 The Veterinary Medicines Regulations do not define the phrase 'under his care' and the RCVS has interpreted it as meaning that:
- the veterinary surgeon must have been given the responsibility for the health of the animal or herd by the owner or the owner's agent
- that responsibility must be real and not nominal
- the animal or herd must have been seen immediately before prescription or,
- recently enough or often enough for the veterinary surgeon to have personal knowledge of the condition of the animal or current health status of the herd or flock to make a diagnosis and prescribe
- the veterinary surgeon must maintain clinical records of that herd/flock/individual
4.10 What amounts to 'recent enough' must be a matter for the professional judgement of the veterinary surgeon in the individual case.
4.11 A veterinary surgeon cannot usually have an animal under his or her care if there has been no physical examination; consequently a veterinary surgeon should not treat an animal or prescribe POM-V medicines via the Internet alone.
4.12 The Veterinary Medicines Regulations do not define ’clinical assessment‘, and the RCVS has interpreted this as meaning an assessment of relevant clinical information, which may include an examination of the animal under the veterinary surgeon's care.
4.13 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
4.14 The selected product should be authorised for use in the UK in the target species for the condition being treated and used at the manufacturer's recommended dosage.
4.15 If there is no suitable authorised veterinary medicinal product in the UK for a condition in a particular species, a veterinary surgeon may, in particular to avoid unacceptable suffering, treat the animal in accordance with the 'Cascade'.
4.16 If there is no medicine authorised in the UK 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:
- a veterinary medicine authorised in the UK for use in another animal species or for a different condition in the same species; or, if there is no such product:
- a medicine authorised in the UK for human use; or
- in accordance with an import certificate (see the Veterinary Medicines Guidance issued by the Veterinary Medicines Directorate), a medicine authorised for veterinary use in another Member State; or, if there is no such product:
- a medicine prepared extemporaneously by a veterinary surgeon, a pharmacist or a person holding an appropriate manufacturer’s authorisation, as prescribed by the veterinary surgeon responsible for treating the animal.
4.17 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. In such cases 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.
4.18 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).
4.19 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.
4.20 Horses declared ‘not for human consumption’ under the horse passport scheme are regarded as non-food-producing animals for the purposes of these provisions.
The prescribing cascade – food-producing animals
4.21 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 4.16 above, except that the following additional conditions apply:
- the treatment in any particular case is restricted to animals on a single holding;
- any medicine imported from another Member State (option b(ii)) must be authorised for use in a food-producing species in the other Member State;
- the pharmacologically active substances contained in the medicine must be listed in the table in the Annex to Regulation (EU) No. 37/2010 (this table replaces Annexes I, II or III of Council Regulation (EEC) 2377/90);
- the veterinary surgeon responsible for prescribing the medicine must specify an appropriate withdrawal period;
- the veterinary surgeon responsible for prescribing the medicine must keep specified records.
Antimicrobial and anthelmintic resistance
4.22 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.
4.23 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 (www.bva.co.uk 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 (http://www.bsava.com/Resources/PROTECT.aspx)
- British Equine Veterinary Association (BEVA) information on antimicrobial resistance, including the ProtectME toolkit and associated leaflets (http://www.beva.org.uk/useful-info/Vets/Guidance/AMR)
- Responsible Use of Medicines in Agriculture (RUMA) Alliance Guidelines on responsible use (www.ruma.org.uk)
- National Office of Animal Health (NOAH) Advice on Antibiotic Resistance (www.noah.co.uk)
- Control of Worms Sustainably (COWS) advice on best practice (www.cattleparasites.org.uk)
- Sustainable Control of Parasites in Sheep (SCOPS) advice on best practice (www.nationalsheep.org.uk)
- Moredun Research Institute advice on Parasite Control in Horses (www.moredun.org.uk/equine-worms)
- EU Action Plans on Antimicrobial Resistance – http://europa.eu/rapid/press-release_IP-11-1359_en.htm
- UK Department of Health and Defra Five Year Antimicrobial Resistance Strategy 2013 to 2018 (http://www.gov.uk/government/publications/uk-antimicrobial-resistance-strategy-and-action-plan-engagement-exercise)
- Veterinary Medicines Directorate (VMD) information leaflet for veterinary surgeons on Antimicrobial Resistance and Responsible Use of Antimicrobials (https://www.vmd.defra.gov.uk/pdf/leaflet_antimicrobials.pdf)
- The World Health Organization advice on antimicrobial resistance (http://www.who.int/mediacentre/factsheets/fs194/en/)
Responsibilities associated with the prescription and supply of medicines
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:
- 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;
- when s/he does so, advise on the safe administration of the veterinary medicinal product;
- when s/he does so, advise as necessary on any warnings or contra-indications on the label or package leaflet; and
- 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 judgment of the veterinary surgeon in the individual case.
4.26 Veterinary medicinal products must be supplied in appropriate containers and with appropriate labelling.
4.27 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
4.28 Practice premises from which veterinary surgeons supply veterinary medicinal products (except AVM-GSL medicines) must be registered with the RCVS as ‘veterinary practice premises’, in accordance with the Veterinary Medicines Regulations (Paragraph 8 of Schedule 3).
4.29 Premises likely to be considered as ‘veterinary practice premises’ are those:
- from which the veterinary surgeons of a practice provide veterinary services; and/or,
- advertised or promoted as premises of a veterinary practice; and/or,
- open to members of the public to bring animals for veterinary treatment and care; and/or,
- 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,
- to which medicines are delivered wholesale, on the authority of one or more veterinary surgeons in practice.
4.30 Main and branch practice premises from which medicines are supplied are veterinary practice premises and must be registered with the RCVS.
Storage of medicines
4.31 All medicines should be stored in accordance with manufacturers’ recommendations whether in the practice or in a vehicle. If it is stipulated that a medicine be used within a specific time period, it must be labelled with the opening date, once broached.
4.32 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.
4.33 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
4.34 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:
- the name and qualification (veterinary surgeon, pharmacist or SQP) of any prescriber;
- the name and qualification (veterinary surgeon, pharmacist or SQP) of the supplier; and,
- the nature of the duty of care for the animals.
4.35 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.
4.36 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: www.gov.uk/controlled-drugs-veterinary-medicines
4.37 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
4.38 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
4.39 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).
4.40 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.
4.41 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.
4.42 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.
4.43 The HSE advise that employers must appoint a ‘competent person’ to help them meet their health and safety duties (see http://www.hse.gov.uk/competence/what-is-competence.htm.) 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.
4.44 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.
4.45 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 4.17 regarding written consent for off-licence use and responsibilities associated with the supply of medicines.)
4.46 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.
4.47 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.
4.48 Veterinary surgeons should be aware of the need to report certain incidents and dangerous occurrences to the relevant enforcing authority. See http://www.hse.gov.uk/riddor/dangerous-occurences.htm
4.49 Further detailed information on the safe handling of cytotoxic drugs can be found on the HSE website, including links to additional sources of information - http://www.hse.gov.uk/healthservices/safe-use-cytotoxic-drugs.htm
Reporting suspected adverse events following use of veterinary medicines
4.50 The VMD’s Pharmacovigilance Unit closely monitors all reports of suspected adverse reactions (in animals or humans) and lack of efficacy following use of veterinary medicines. All suspected adverse events should be reported to either the VMD or the company who market the product, who are legally obliged to forward these to the VMD. Reports can be submitted online to the VMD. Alternatively, paper copies of the yellow form can be downloaded from the same page and returned using the freepost address or fax number provided on the form. Further information is available from the VMD’s Pharmacovigilance Unit on 01932 338427.
Reporting prescription misuse
4.51 Suspected prescription misuse (which could include an alteration to an existing prescription or prescription fraud) can be reported to the Veterinary Medicines Directorate (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. For advice on client confidentiality on a case by case basis please contact the RCVS Professional Conduct Department on 020 7202 0789.