Law, Ethics And Proffesional Practice Flashcards
Who oversees UK veterinary medicine legislation?
The Veterinary Medicines Directorate (VMD), which is an executive agency, sponsored by the Department for Environment, Food & Rural Affairs.
The Veterinary Medicines Directorate (VMD) is responsible for;
monitoring and taking action on reports of adverse events from veterinary medicines
testing for residues of veterinary medicines or illegal substances in animals and animal products
assessing applications for and authorising companies to sell veterinary medicines
controlling how veterinary medicines are made and distributed
advising government ministers on developing veterinary medicines policy and putting it into action
making, updating and enforcing UK legislation on veterinary medicines
list the UK veterinary medicines categories
Prescription-only Medicine – Veterinarian; POM-V- antibiotics, analgesic, steroids
Prescription-only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person (SQP); POM-VPS- horse wormers, some sheep vaccines, ectoparasitisides
Non-Food Animal – Veterinarian, Pharmacist, Suitably Qualified Person; NFA-VPS- flea spot on
Authorised Veterinary Medicine – General Sales List; AVM-GSL- fly sprays, antiseptics, sweet itch treatment, sheep vitamin tablets
anything else cannot be sold as vet medicine
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.
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.
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.
What does ‘Under his/her care’ mean?
RCVS interpretation:
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
‘Recent enough’ is decided by the VS in each case.
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.
what is an SQP
A Suitably Qualified Person (SQP) is a legal category of professionally qualified persons who, under the Veterinary Medicines Regulations, are entitled to prescribe and/or supply certain veterinary medicines (POM-VPS and NFA-VPS) for companion animals, equines, farm animals and birds
Pharmacovigilance
Alternatively known as ‘drug safety’
Defined as the pharmaceutical science relating to the “collection, detection, assessment, monitoring, and prevention” of adverse effects with pharmaceutical products
In the UK, responsibility lies with VMD’s Pharmacovigilance Unit
Unit monitors all reports of adverse events, including suspected adverse reactions (in animals or humans), lack of efficacy following use of veterinary medicines, environmental reports and residues cases.
Your responsibility as a VS?
If you become aware of any adverse events including adverse reactions involving an animal, you should record what happened in as much detail as possible and make a report to the VMD or the company who market the product
Company is legally obliged to forward such reports to the VMD
Search for VMD on gov.uk or you can phone the VMD’s Pharmacovigilance Unit on 01932 338427
adverse reactions
An adverse reaction is defined by the VMD as a reaction to a veterinary medicine which is harmful and unintended when products are used in animals for the prophylaxis, diagnosis or treatment of disease or to restore, correct or modify a physiological function.
Adverse event
any observation in animals, whether or not considered to be product-related, that is unfavourable and unintended and that occurs after any use of a veterinary medicine (off-label and on-label uses).
Included are events related to a lack of expected efficacy, noxious reactions in humans/animals after being exposed to a veterinary medicine, environmental reports and residue cases.
What is the cascade?
The cascade is a risk-based decision tree to aid prescribing on a case-by-case basis.
Initially a VS 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.
If no such product exists, follow the cascade.
Nb. There is separate guidance on the Cascade for veterinary surgeons practising in England/Wales/Scotland, and for those in Northern Ireland. Please refer to VMD website
what are the steps in the cascade
Step 1 Veterinary medicine with a Marketing Authorisation valid in GB or UK wide for indicated species and condition
Step 2 Veterinary medicine with a Marketing Authorisation valid in NI for indicated species and condition, in accordance with a Special Import Certificate from the VMD is required
Step 3 Veterinary medicine with a Marketing Authorisation valid in GB, NI or UK wide for a different species or condition. For products not authorised in GB or UK wide a Special Import Certificate from the VMD is required
Step 4 Human medicine with a Marketing Authorisation valid in GB, NI or UK wide OR an authorised veterinary medicine from outside of the UK. For products not authorised in GB or UK wide a Special Import Certificate from the VMD is required; in the case of a food-producing animal the medicine must be authorised in a food-producing species
Step 5 Extemporaneous preparation prepared by a vet, pharmacist or person holding an appropriate Manufacturer’s Authorisation, located in the UK
Exception In exceptional circumstances, a human medicine may be imported from outside of the UK. For products not authorised in GB or UK wide a Special Import Certificate from the VMD is required
step 1 of the cascade
Veterinary medicine with a Marketing Authorisation valid in GB or UK wide for indicated species and condition
step 2 of the cascade
Veterinary medicine with a Marketing Authorisation valid in NI for indicated species and condition, in accordance with a Special Import Certificate from the VMD is required
step 3 of the cascade
Veterinary medicine with a Marketing Authorisation valid in GB, NI or UK wide for a different species or condition. For products not authorised in GB or UK wide a Special Import Certificate from the VMD is required
step 4 of the cascade
Human medicine with a Marketing Authorisation valid in GB, NI or UK wide OR an authorised veterinary medicine from outside of the UK. For products not authorised in GB or UK wide a Special Import Certificate from the VMD is required; in the case of a food-producing animal the medicine must be authorised in a food-producing species
step 5 of the cascade
Extemporaneous preparation prepared by a vet, pharmacist or person holding an appropriate Manufacturer’s Authorisation, located in the UK
what are the aditional considerations for food animals in the cascade
The treatment in any particular case is restricted to animals on a single holding
Any medicine imported from another country must be authorised for use in a food-producing species in that country
The pharmacologically active substances contained in the medicine must be listed either
for use in NI – in table 1 of the Annex to Regulation (EU) No. 37/2010 (this table replaces Annexes I, II or III of Council Regulation (EEC) 2377/90);
for use in GB – in the GB MRL Register as part of the VMD’s Product Information Database.
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
Food-producing animals can ONLY be given drugs which have a withdrawal period associated with them and are listed in the GB MRL list;
medication on the cascade for horses
technically food producing animals
There is a list of substances considered essential for the treatment of horses if they enter the food chain. These substances can only be used with a withdrawal period of six months.
The animal or its products must not be consumed until the withdrawal period has ended.
If any substance which is not on this list or is not listed in Table 1 of 37/2010, (e.g.phenylbutazone) is administered, that horse must be permanently excluded from the food chain and the declaration ‘not for human consumption’ entered in the passport signed by either the horse owner, its keeper or the vet.
What are controlled drugs(CDs)?
Controlled drugs (CDs) are listed in Schedules 1 to 5 of the Misuse of Drugs Regulations 2001
Veterinary medicines only contain CDs in Schedules 2, 3, 4 and 5
Schedule 1 drugs
include drugs such as cannabis or LSD – highly addictive, no therapeutic value
Schedule 2 CDs h
have therapeutic value but are highly addictive
Licenced examples;
Methadone
Fentanyl
Pethidine
Ketamine
written prescription must be signed by the person issuing it which may be hand-written, typed in a computerised form or computer generated.
This prescription is only valid for 28 days.
Repeat dispenses on the same prescription are not allowed with schedule 2 or 3 drugs
Recommended that you keep a copy of a CD requisition to assist in complying with the law on wholesale supply
Complete records of Schedule 2 CDs must be kept in a Controlled Drugs Register (CDR)
Schedule 3 CD
includes buprenorphine, barbiturates and some benzodiazepines which are also subject to special prescription writing requirements. Some are also subject to special storage requirements
written prescription must be signed by the person issuing it which may be hand-written, typed in a computerised form or computer generated.
This prescription is only valid for 28 days.
Repeat dispenses on the same prescription are not allowed with schedule 2 or 3 drugs
Recommended that you keep a copy of a CD requisition to assist in complying with the law on wholesale supply
Schedule 4 and schedule 5 drugs
have no additional special controls
Ketamine WAS Schedule 4
Since November 2015 reclassified as Schedule 2
Now subject to full schedule 2 legal requirements
Following guidance is for Schedule 2 CDs
Obtaining CDs
Obtained from wholesalers providing a signed prescription has been issued by the requesting veterinary surgeon
Must keep requisition records for at least 2 years
Schedule 2 or 3 CDs ; written prescription must be signed by the person issuing it which may be hand-written, typed in a computerised form or computer generated.
This prescription is only valid for 28 days.
Repeat dispenses on the same prescription are not allowed with schedule 2 or 3 drugs
Recommended that you keep a copy of a CD requisition to assist in complying with the law on wholesale supply
records for controlled drugs (CDR)
Complete records of Schedule 2 CDs must be kept in a Controlled Drugs Register (CDR)
CDR = either a computerised system or a bound book separated into each class of drug with a separate page for each strength and form of that drug at the top of each page.
Loose leaf registers or card index systems are not allowed
CDR entries must be
In chronological order, made in ink or in a computerised form in which every entry can be audited, and made on the day of the transaction
The book must be kept at the premises to which it relates and be available for inspection at any time
It must be kept for a minimum of two years after the date of the last entry
The CDR must record for all CD purchased and supplied
The date supply received, name and address of supplier and quantity received
The CDR must record for all CDs administered or supplied
The date supplied, name and address of person supplied, details of the authority to possess (prescriber or licence holder’s details) and the quantity supplied
Storage of CDs
Schedule 2 and Schedule 3 CDs containing buprenorphine must be kept in a locked container which is constructed and maintained to prevent unauthorised access to the drugs and can only be opened by a veterinary surgeon or other authorised person
The room housing this container should be lockable and tidy to avoid drugs being misplaced
CD container keys should not be kept with keys to other parts of the building
The room should not normally be accessible to clients
Any returned CDs should not be re-used and should be destroyed according to regulations.
conditions where a Veterinary nurses is administering CDs
RCVS considers that a veterinary nurse may draw up and administer a CD
Provided the veterinary surgeon
Prescribed the drug to a specific animal
Decided on the dose
Authorised that it be drawn up and is confident that the veterinary nurse is competent to draw up and administer the prescribed dose
A veterinary surgeon does not need to be present when the drugs are drawn up or administered
but the legal responsibility for the supply of the CDs remains with the veterinary surgeon
Recommended to have a standard operating procedure
SOP sets out
Procedure for accessing CDs
Protocol for recording their use
Suggested access to the CD cabinet limited to authorised individuals within the practice
Perhaps 2 ‘responsible persons’ at a time
Veterinary nurses may administer CDs out of hours when there is no vet on the premises
RCVS advise the veterinary surgeon must prescribe the drug and dose
Also consider, before going off duty, drawing up the correct dose, labelling it and leaving it with instructions as to what time it is to be given to a particular patient
A veterinary nurse is not able to decide to give a CD or change the dose (i.e. make prescribing decisions) without the instructions of a veterinary surgeon
See also the RCVS supporting guidance on delegation to veterinary nurses
RCVS Regulation of the Veterinary Profession
The RCVS regulate the profession in accordance with The Veterinary Surgeons Act 1966. Under the provisions of the Act, the RCVS will:
Keep the Register of Veterinary Surgeons
Supervise undergraduate veterinary surgeon training in the UK
Recognise certain qualifications awarded outside the EU
Supervise the professional conduct of veterinary surgeons
Each of the above areas will be discussed in more detail later in this presentation.
The RCVS are the statutory regulator for veterinary surgeons. It is written into the Veterinary Surgeons Act 1966 that the RCVS is responsible for keeping the Register of Veterinary Surgeons eligible to practise in the UK, setting standards for veterinary education and regulating the professional conduct of veterinary surgeons.
Under this Act, it is illegal for anyone to call themselves, or practise as a veterinary surgeon in the UK if their name is not held on the RCVS register.
Schedule 3 of the Veterinary Surgeons Act 1966 and why it is relevant to you
The Veterinary Surgeons Act 1966 (Schedule 3 Amendment) Order 2002 provides that veterinary surgeons may direct registered or student veterinary nurses who they employ, to carry out limited veterinary surgery.
Under this Schedule 3 exemption, the privilege of giving any medical treatment or carrying out minor surgery, not involving entry into a body cavity, is given to:
Registered veterinary nurses under the direction of their veterinary surgeon employer to animals under their employer’s care. The directing veterinary surgeon must be satisfied that the veterinary nurse is qualified to carry out the medical treatment or minor surgery.
Student veterinary nurses under the direction of their veterinary surgeon employer to animals under their employer’s care. In addition, medical treatment or minor surgery must be supervised by a veterinary surgeon or registered veterinary nurse and, in the case of minor surgery, the supervision must be direct, continuous and personal. The medical treatment or minor surgery must be carried out in the course of the student veterinary nurse’s training
RCVS Regulatory Role: Education
Requirements for gaining RCVS accreditation for course provision and/or Awarding Body.
Monitoring of accredited course providers and EMS/clinical placement
Requirements for EMS and clinical rotations
Setting of the Day One Competences (DOC)
Minimum requirements for becoming a Member of the Royal College of Veterinary Surgeons, (MRCVS). This also includes vets from overseas who want to work in the UK.
Day One Competences
Day One Competences’ are the minimum standards required for registration as a veterinary surgeon with the RCVS.
Assessment of the Day One Competences is built into your degree via assignments, examinations, etc.
summerise Animal Welfare Act (2006)
Owners and keepers have a duty of care to their animals and must make sure they meet their needs:
for a suitable environment and place to live for a suitable diet to exhibit normal behaviour patterns to be housed with, or apart from, other animals (if applicable) to be protected from pain, injury, suffering and disease
Anyone who does not provide for an animal’s welfare needs may:
be banned from owning animals face an unlimited fine be sent to prison for up to 6 months
The 2006 Act also sets out offences relating to cruelty and animal fighting. The maximum sentence for these offences is 5 years imprisonment and/or an unlimited fine.
Animal cruelty includes:
causing unnecessary suffering to an animal mutilation docking the tail of a dog except where permitted poisoning an animal
The 2006 Act applies to all vertebrate animals
1)If an inspector or a constable reasonably believes that a protected animal is suffering, he may take, or arrange for the taking of, such steps as appear to him to be immediately necessary to alleviate the animal’s suffering.
(2)Subsection (1) does not authorise destruction of an animal.
(3)If a veterinary surgeon certifies that the condition of a protected animal is such that it should in its own interests be destroyed, an inspector or a constable may—
(a)destroy the animal where it is or take it to another place and destroy it there, or
(b)arrange for the doing of any of the things mentioned in paragraph (a).
(4)An inspector or a constable may act under subsection (3) without the certificate of a veterinary surgeon if it appears to him—
(a)that the condition of the animal is such that there is no reasonable alternative to destroying it, and
(b)that the need for action is such that it is not reasonably practicable to wait for a veterinary surgeon.
(5)An inspector or a constable may take a protected animal into possession if a veterinary surgeon certifies—
(a)that it is suffering, or
(b)that it is likely to suffer if its circumstances do not change.
(6)An inspector or a constable may act under subsection (5) without the certificate of a veterinary surgeon if it appears to him—
(a)that the animal is suffering or that it is likely to do so if its circumstances do not change, and
(b)that the need for action is such that it is not reasonably practicable to wait for a veterinary surgeon.
The Animal Welfare (Licensing of Activities Involving Animals) (England) Regulations 2018 (part of the Animal Welfare Act).
The five licensable activities covered by the Animal Welfare (Licensing of Activities Involving Animals) (England)
Regulations 2018 include:
• Selling animals as pets;
• Providing for or arranging for the provision of boarding for cats and dogs (includes boarding in kennels or
catteries, home boarding for dogs and day care for dogs);
• Hiring out horses (for riding or instruction in riding);
• Dog breeding (A breeding licence will be required for anyone breeding three or more litters and selling at
least one puppy in a 12-month period, and , and for anyone that places an advertisement for a puppy if
they meet the business test of an income of over £1000 within a year and fail to provide documented
evidence that no profit has been made); and
• Keeping or training animals for exhibition (for people attending in person or recording of images for
display. Military, policy and sporting animals are not included. Licences are not required for activities
already licenced under the Welfare of Wild Animals in Travelling Circuses (England) Regulations 2012 or
the Zoo Licensing Act 1981).
The General Conditions that businesses must meet in order to obtain an animal activity licence centre around the
five welfare needs as set out in the Animal Welfare Act (2006).
These are:
a) its need for a suitable environment;
b) its need for a suitable diet
c) its need to be able to exhibit normal behaviour patterns;
d) any need it has to be housed with, or apart from, other animals; and
e) its need to be protected from pain, suffering, injury and disease.
Licences are issued through a risk-based system which determines a risk scoring for each operator and indicates
the licence length and star rating that a business should be awarded. The maximum licence length for a low risk,
5-star establishment is a 3-year licence with a minimum of 1 unannounced visit within a 36-month period
For the activity of “Keeping or Training Animals for Exhibition”, all licences are for three years on the
basis that these activities have hitherto been subject to a simple registration system. There is no risk
assessment applied to such activities.
• For all other activities, if a new applicant (someone who has no compliance history with a local authority
or UKAS) is successful, they will automatically be considered as high risk due to a lack of history.
• Such operators will have the length of their licence determined by their risk rating (automatically high risk)
and whether the operator is already meeting the specified higher standards of animal welfare rather than
the minimum required by the licence conditions.
• If an existing operator is applying for the renewal of a licence, then the length of time the licence is
granted for will be determined by their risk rating and the licence length can be up to three years. Those
with longer licences will receive fewer inspections because inspections tend to be on renewal, and
therefore they will pay less for inspection fees as a result.
Criteria considered within the risk scoring matrix includes:
• History of meeting licensing conditions;
• History of complaints received;
• Understanding of relevant environmental enrichment;
• Understanding of potential risks/hazards and role under relevant legislation; and
• Welfare management procedures (written procedures; supervision of staff; record keeping; training of
staff).
Upon application to a local authority for an animal activity licence, the business will be inspected. The licence
will be issued or denied based upon a report issued by a suitably qualified inspector assessing whether the
business is likely to meet the general and specific licence conditions as set out for the licensable activity in
question in The Animal Welfare (Licensing of Activities Involving Animals) (England) Regulations 2018
Local authorities must carry out an inspection with a suitably qualified inspector before renewing the licence.
A suitably qualified inspector is defined as:
a) Any person holding a Level 3 certificate granted by a body, recognised and regulated by the Office of
Qualifications and Examinations Regulation which oversees the training and assessment of persons in
inspecting and licensing animal activities businesses, confirming the passing of an independent
examination. A person is only considered to be qualified to inspect a particular type of activity if their
certificate applies to that activity. Or;
b) Any person holding a formal veterinary qualification, as recognised by the Royal College of Veterinary
Surgeons (“RCVS”), together with a relevant RCVS continuing professional development record;
c) Until October 2021, any person that can show evidence of at least one year of experience in licensing
and inspecting animal activities businesses
The role of veterinary inspectors
Under these regulations, local authorities may request a veterinary inspector to:
• Conduct the initial or renewal inspection of a dog breeding establishment.
• Conduct an initial, renewal and annual inspection of horse-riding establishments. NB this only applies to
veterinarians who are listed on the RCVS approved riding establishment inspectors list.
• Provide advice to suitably qualified inspectors.
• For the purposes of ensuring the licence conditions are being complied with, take samples for laboratory
testing from any animals on premises occupied by an operator.
• Produce an inspector’s report following an inspection stating whether it is expected that the business will
be able to meet the licence conditions (both the general and specific conditions)
s part of the General Conditions of the regulations it is stipulated that:
The licence holder must register with a veterinarian with an appropriate level of experience in the health and
welfare requirements of any animals specified in the licence and the contact details of that veterinarian must be
readily available to all staff on the premises on which the licensable activity is carried on
The Pet Animals Act 1951 (as amended in 1983)
No person shall keep a pet shop except under the authority of a licence granted in accordance with the provisions of this Act
Every local authority may, on application being made to them for that purpose by a person who is not for the time being disqualified from keeping a pet shop, and on payment of such fee as may be determined by the local authority, grant a licence to that person to keep a pet shop at such premises in their area as may be specified in the application and subject to compliance with such conditions as may be specified in the licence.
Where a person is for the time being disqualified under section 28F(1) and (2) of the Animal Health Act 1981 (c. 22), or section 40(1) and (2) of the Animal Health and Welfare (Scotland) Act 2006 (asp 11), notwithstanding subsection (2), a local authority shall not grant a licence to keep a pet shop to that person
n determining whether to grant a licence for the keeping of a pet shop [F7in Wales] by any person at any premises, a local authority [F7in Wales] shall in particular (but without prejudice to their discretion to withhold a licence on other grounds) have regard to the need for securing—
(a)that animals will at all times be kept in accommodation suitable as respects size, temperature, lighting, ventilation and cleanliness;
(b)that animals will be adequately supplied with suitable food and drink and (so far as necessary) visited at suitable intervals;
(c)that animals, being mammals, will not be sold at too early an age;
(d)that all reasonable precautions will be taken to prevent the spread among animals of infectious diseases;
(e)that appropriate steps will be taken in case of fire or other emergency;
Pets not to be sold in streets
A local authority [F1in Wales] may authorise in writing any of its officers or any veterinary surgeon or veterinary practitioner to inspect (subject to compliance with such precautions as the authority may specify to prevent the spread among animals of infectious diseases) any premises in their area as respects which a licence granted in accordance with the provisions of this Act is for the time being in force, and any person authorised under this section may, on producing his authority if so required, enter any such premises at all reasonable times and inspect them and any animals found thereon or any thing therein, for the purpose of ascertaining whether an offence has been or is being committed against this Act
Animal Boarding Establishments Act 1963
he 1963 Animal Boarding Establishments Act deals with places where the boarding of animals is being carried on as a business. This act requires such establishments to be licensed by the local authority. The act defines “boarding establishments” as those premises, including private dwellings, where the business consists of providing accommodation for other people’s cats and dogs. When deciding to issue a license, the local authority shall consider the suitability of the conditions (e.g., size of quarters, lighting, food, water, disease control, etc.) present at the boarding establishment.
(a) that animals will at all times be kept in accommodation suitable as respects construction, size of quarters, number of occupants, exercising facilities, temperature, lighting, ventilation and cleanliness;
(b) that animals will be adequately supplied with suitable food, drink and bedding material, adequately exercised, and (so far as necessary) visited at suitable intervals;
(c) that all reasonable precautions will be taken to prevent and control the spread among animals of infectious or contagious diseases, including the provision of adequate isolation facilities;
(d) that appropriate steps will be taken for the protection of the animals in case of fire or other emergency;
(e) that a register be kept containing a description of any animals received into the establishment, date of arrival and departure, and the name and address of the owner, such register to be available for inspection at all times by an officer of the local authority, veterinary surgeon or veterinary practitioner authorised under section 2(1) of this Act
A local authority may authorise in writing any of its officers or any veterinary surgeon or veterinary practitioner to inspect (subject to compliance with such precautions as the authority may specify to prevent the spread among animals of infectious or contagious diseases) any premises in their area as respects which a licence granted in accordance with the provisions of this Act is for the time being in force, and any person authorised under this section may, on producing his authority if so required, enter any such premises at all reasonable times and inspect them and any animals found thereon or any thing therein, for the purpose of ascertaining whether an offence has been or is being committed against this Act.
(2) Any person who wilfully obstructs or delays any person in the exercise of his powers of entry or inspection under this section shall be guilty of an offence.
