Pharmacy and medications Flashcards
Give a definition of ‘Veterinary medicines’
Any substance or combination of substances presented as having properties for preventing disease in animals.
Who regulates Veterinary Medicines?
EU directives
What are the 6 responsibilities of the veterinary medicines directorate? - exclusive agency of DEFRA
- monitoring and acting on reports of adverse effects
- residue monitoring
- authorising companies to sell veterinary medicines in the UK and EU
- controlling how veterinary medicines are made and distributed
- advising government of developing veterinary medicines policy
- Making, updating and enforcing EU legislation
Who can authorise veterinary medicinal products? (2 answers)
- Veterinary medicines directorate (UK)
- European medicines agency (EU)
Which 3 criteria need to be met to receive market authorisation?
- Quality
- Safety
- Efficacy
What are the 4 main classifications of veterinary medicinal products?
- POM-V
- POM-VPS
- NFA-VPS
- AVM-GSL
Who comes under the term ‘Registered qualified person’?
- Vet
- Pharmacist
- SQP
Which category of medicinal product is being described:
- No prescription
- Supplied by RQP
- Non-food animal only
NFA-VPS
What does AVM-GSL stand for and describe this category of medicinal product
Authorised vet medicine - General sales list
- Doesn’t require a prescription
- Can be supplied by anyone
Which category of medicinal product is being described:
- prescribed by a vet only
- supplied by a vet or pharmacist
- requires a clinical assessment of an animal which is under their care
POM-V
What is a clinical assessment defined by the RCVS as meaning?
- Assessment of relevant clinical information
- May include an examination of the animal
What is ‘under their care’ defined by the RCVS as meaning?
The veterinary surgeon must have been given the responsibility for the health of the animal/herd by the owner or the owners agent.
- the veterinary surgeon must maintain clinical records of that herd/flock/individual
- the animal/herd must have been seen immediately before prescription or recently/often enough for the veterinary surgeon to have personal knowledge of the health of the animal
Define an what makes a person an SQP
- A legal category of a professionally qualified person who are qualified to prescribe and supply certain veterinary medicines
- RVNs not automatically an SQP
- Registered with AMTRA, vet skill or vetpol
Which legislation act controls controlled drugs?
Misuse of drugs act 1971
What are controlled drugs scheduled according to?
- Therapeutic usefulness
- Need for legitimate access
- Potential for misuse and harm caused by that misuse
Define schedules 1-5 listed in the Misuse of drugs regulations 2001
- Little or no therapeutic value, high potential for misuse
- Therapeutic value but are highly addictive
- Therapeutic value with less potential for abuse
- Reduced potential for abuse
- Preparations of codeine, morphine etc. in v low doses
Veterinary medicines contain controlled drugs in schedules?
2-5
An order form for controlled drugs must contain?
- Name, address and profession of recipient
- Purpose for which drug is required
- Total quantity required
- Signature of recipient in ink
- RCVS registration number
Which schedule requires an independent witness for destruction?
Schedule 2
Which schedule has a prescription valid for 6 months? (the rest are 28days)
Schedule 5
Which schedules are required/recommended to be kept in safe custody?
Required = 2 Recommended = 3
Describe ‘safe custody’ of storing veterinary medicines
- Kept in a locked cabinet attached to the fabric of the building
- Only accessed by a veterinary surgeon or person authorised by the vet
- Key kept by one person or a combination key box
- No indication that the cabinet contains CDs
- Clients not allowing in the room with the cabinet without supervision
Describe the cascade/drug selection sequence for when there is no authorised product that exists for a condition
- Veterinary medicine authorised for use in another species or for a different condition in the same species
- Medicine authorised in the UK for human use or medicines authorised in animals in another EU member state
- Medicine made up at the time on a one-off basis by a veterinary surgeon or a properly authorised person
How does the cascade differ in food producing animals? What are the conditions?
- Medicines imported from an EU member state must be authorised for use in a food producing species
- The vet must specify an appropriate withdrawal period
- The vet must keep appropriate records
What are some prescribing responsibilities of the vet or SQP?
- Be satisfied that the person who will use the product is competent to do so safely and intends to use it for the use it is authorised for
- Advise on safe administration of the VMP
- Advise on any warnings/contradictions on the label or packaging
- Not prescribe more than the minimum quantity required
- Supply products in appropriate containers with appropriate labelling
How long is a written prescription valid for?
6 months
28 days for controlled drugs
For which schedules of controlled drugs can repeat prescriptions not be issued?
2 and 3
What must a premises do to be able to supply veterinary medicines?
Must be registered with the RCVS as a Veterinary practice premises
What is considered as a prescribing premises?
- Place from which veterinary surgeons provide veterinary services
- Advertised as a premises of a veterinary practice
- Open for members of the public to bring animals for veterinary treatment
- Medicines are delivered wholesale to the premises on the authority of a veterinary surgeon
How long should vet records be kept for?
5 years
Give examples of what should be kept on all vet records?
- Date
- Quantity of drug
- Withdrawal period
- Name and address of recipient
- Product identity and batch numbers
- Name of veterinary surgeon
What needs to be included in a standard operating procedure (SOP)?
- Drug categories
- Storage
- Records to be kept
- Ordering protocols
- Handling of medications
- Dispensing
- Disposal
What is meant by maximum residue limits (MRL)?
Maximum concentration of residue allowed in an animal food product
How are maximum residue limits established and set?
- No observed effect level established for a drug
- Divided by a safety factor of 100-1000 in order to establish an Acceptable Daily Intake
- MRLs are set at a level for each animal tissue
What are withdrawal periods calculated using?
MRL and pharmacokinetic data
What are the 7 points of the BVA 7 point plan?
- Work with clients to avoid need for antimicrobials
- Avoid inappropriate use
- Choose the right drug for the right bug
- Monitor antimicrobial safety
- Minimise use
- Record and justify deviations from protocols
- Report suspected treatment failures to the VMD
