Flashcards in Veterinary Medicines Deck (24)
What is the definition of veterinary medicinal product?
Any substance or a combination of substances presented as having properties for treating or preventing disease in animals
What is the veterinary surgeons act of 1966?
- Defines who can diagnose and treat animals
- Defines veterinary terms
What are the regulatory bodies for veterinary medicines and what do they do?
1. Royal college of veterinary surgeons (RCVS)
- Maintains a register of veterinary surgeons that are eligible to practice in the UK as set out in the 1966 act
2. Animals Medicines Training Regulatory Authority (AMTRA)
- Independent body, professional regulator for suitably qualified persons
- They have to keep a register of the Suitably Qualified Persons (SQP)
3. They all have the role to prescribe and/or supply certain veterinary medicines in the UK under the vet med regulation.
- Almost 5700 SQPs, 700 in veterinary practises, registered pet shops, suppliers of equine products and those working in agricultural merchants and country stores.
What is the veterinary medicines legislation?
1. Medicines Act 1968, all medicines including POMS could previously only be supplied or prescribed by veterinary surgeons for animals under their care.
2. Vet Meds Regulation 2014 coming out soon
3. Record keeping has to occur annually due to implementation of 2005 rule
What is the veterinary medicines directorate?
The veterinary medicines directorate (VMD) has primary responsibility for the supply for veterinary medicines and their supply in the UK, among others
What is the veterinary products committee?
- Set up in 1970 to give scientific advice to the secretary of state on any aspect of veterinary medicinal products
- Hear representations on decisions relating to MA
- To promote the collection and investigation of information relating to suspected ADR reactions to vet medicines
What are the categories of veterinary medicines?
- Prescription only medicines- veterinarian (POM-V)
- Prescription only medicines- Vet, pharmacist, suitably qualified person (POM-VPS)
- Non-food producing animal (dog) - vet pharmacist suitably qualified person
- Authorised veterinary medicine- GSL- (AVM-GSL)
- Exempt medicines under the Small Animal Exemption Scheme (SAES)
- Unauthorised Veterinary medicine (see Cascade)
Describe a POM-V?
- POMs that can only be prescribed by veterinary surgeon
- Supplied by a veterinary surgeon or pharmacist with a written prescription
- If it's CD, must carry out a declaration by the vet stating that the medicine is prescribed for an animal or herd under his/her care
- May only be sold or supplied in accordance of the prescription given by the vet
Describe a POM VPS?
- POM medicines that can be prescribed and supplied by a vet, pharmacist or suitably qualified person
- Prescriber may have to give oral or written prescription before supplying the product
- POM VPS prescription only needed if the supplier is not the prescriber
Describe a NFA-VPS? (Non food producing animal)
- Medicines for non food animals (dog etc) that can be supplied by a vet, pharmacist or SQP
- Written prescription NOT required
- Good practice requirement to keep records of medicines received or supplied
What are the legal requirements for the sale of NFA-VPS and POM-VPS?
1. Advise on the safe use of the product
2. Advise on any warnings or contra-indications
3. Be satisfied that the person using it is competent to use it and intends to use it for authorised use
4. Not supply more than the minimum amount for treatment
What is the physical presence of the pharmacist in relation to V meds?
1. Pharmacist must always be present when handing out medication
2. Except when the transaction has been individually authorised and the person handing it is competent
3. Product is supplied from registered pharmacy premise which is registered under the latest veterinary medicines regulation
Describe what an AVM-GSL is?
1. Authorised Veterinary medicine
2. No Rx required, just a normal GSL
3. May be supplied by any retailer without any restrictions or provision of advice (pet shops, supermarkets)
What are the rules for the exempt medications under the SAES?
1. Medicines for sole use in small, non food producing animals (cage birds, aquarium animals, small rodents)
2. Not authorised so not assessed for safety, quality or efficacy but can still be marketed legally and administered according to instructions on label
What is unauthorised veterinary medicines?
- When a prescription is made by a veterinary surgeon using the veterinary cascade
- This is only done if there's no suitable licensed V med on the market
What are the steps in the veterinary cascade?
1. Legal requirement to supply a licensed veterinary medicine
2. Can consider an existing licensed V med for another species or conditions when above requirement not met
3. Licensed human medicine or EU licensed V med can be considered only when above requirement not met
4. Extemporaneous or specially manufactured medicines can be considered when above requirement not met
What does the veterinary cascade mean and what must be written on it?
1. When it's unlawful to supply a human medicine against a vet prescription unless it's prescribed by a vet (must have the prescription Rx)
2. For administration under the cascade
What must be written on a V prescription for it to be valid?
1. Name, address, telephone number; qualification and signature of the prescriber. write in a clearer way
2. Name and address of the owner.
3. Identification and species of the animal and its address (if different from the owner’s address).
4. Date: Rx valid for 6 months or shorter if indicated by prescriber
5. Name, quantity, dose and administration instructions of the required medicine.
6. Any necessary warnings and if relevant the withdrawal period.
7. Where appropriate, a statement highlighting that the medicine is prescribed under the veterinary cascade (e.g. prescribed under the cascade or other wording to the same effect)
8. Where schedule 2 or 3 controlled drugs have been prescribed, a declaration that “the item has been prescribed for an animal or herd under the care of the veterinarian” – usual CD prescription requirements apply.
9. If the prescription is repeatable, the number of times it can be repeated is 7
(Also CD's valid for 28 days)
What procedure must you follow for CD prescriptions?
1. Standardised forms are not required for V prescriptions
2. Retain veterinary prescriptions for 5 years
3. No requirement to submit CD prescriptions to the relevant NHS agency
4. For all CDs, good practice to prescribe for only 28 days worth of treatment (no legal requirement though), unless ongoing term medication
How do you label a veterinary medicine?
Name of the prescribing veterinary surgeon
Name and address of the animal owner
Name and address of the pharmacy
Identification and species of the animal
Date of supply (this isn't in normal human Rx)
Expiry date of the product
The name or description of the product or its active ingredients and content quantity
Dosage and administration instructions
If appropriate, special storage instructions (fridge)
Any necessary warnings for the user (e.g. relating to administration, disposal, target species, etc)
Any applicable withdrawal period
The words: “For animal treatment only”
The words: “______________________”
What are the requirements when record keeping a veterinary medicine?
- Name of the medicine
- Date of the receipt or supply
- Batch number
- Name and address of the supplier or recipient
If there is a written prescription, record
- Name and address of prescriber and keep a copy of the prescription
- Either keep all documents showing required information or record in private prescription book
- Electronic records acceptable
- Entry must be made on the same day that the sale or supply takes place
- Records and documents kept for at least 5 years
What are the requirements for a stock audit?
Once a year
For POM-V and POM-VPS
NFA – VPS not mandatory
No requirement for AVM-GSL
What should you do if you come across an ADR?
Report both animal and human adverse reactions to veterinary medicine (see VMD website for details of scheme and reporting forms