Law, Ethics And Proffesional Practice Flashcards
(94 cards)
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