Pharmacy Legislation and Management Flashcards
What is the role of the Veterinary Medicine Directorate?
• Ensure the safety and efficacy of veterinary medicines
• Set the legislation
• Inspect practices that are not part of the practice standards scheme
What are The Veterinary Medicines Regulations 2024?
• Regulations set by the VMD relating to the supply of animal medicine that are updated every 18-24 months
• The VMD grant the licence, determine its legal category and issue a Marketing Authorisation number
What is quality in relation to VMD medicine testing? How is this translated on the label?
• What is in the drug, how it is made and how stable it is
• Label - Declared strength, storage requirements and expiry date
What is safety in relation to VMD medicine testing? How is this translated on the label?
• Toxicity studies, absorption, distribution, metabolism, excretion, residue studies and a risk assessment
• Label - Warnings to protect the user, animal and consumers if a farmed animal
What is the withdrawal period?
• The length of time taken for a product to leave the meat, milk or eggs in a food producing animal
• The food should not be eaten during this
What is ecotoxicity in relation to VMD medicine testing?
Consideration to the environment including safe disposal of medicine and reducing potential risk
What is efficacy in relation to VMD medicine testing?
How well the product works including advice such as dose, dose interval, treatment length precautions and side effects
What are the 4 stages of the prescribing cascade?
• Use a product authorised for the species and condition
• Use a product licensed for the same condition but a different species or vice versa
• Use a product UK authorised for human use or a veterinary product authorised in another country
• Use a product made up on a one-off basis by an authorised person
What is required for off label use?
A discussion and informed consent from the client with details of all the potential problems of the unauthorised medicine given
What are the 4 legal catagories for veterinary medicine?
• POM-V
• POM-VPS
• NFA-VPS (non food animal)
• AVM-GSL (general sales list)
Define ‘diagnose’
A vet deciding upon the cause of a problem in an animal
Define ‘prescribe’
Authorise the use of a particular medicine for an animal
Define ‘supply’
Stock and sell products in accordance with legislation
Define ‘dispense’
Hand over medicines to clients with instructions for safe use
What must an SQP consider to ensure the medicine is appropriate for the animal?
Species, no. of animals being treated, weight, age, pregnancy/lactation, overall health and other medication being taken
What are the 3 responsibilities of an SQP when supplying medicine to clients?
• The client knows how to use the product safely and intends to use it for the authorised purpose
• The medicine is correctly labelled
• No more than the minimum amount required for treatment is given
When can an SQP delegate handing over medicine to a non-SQP?
When they have prescribed or supplied the medicine, checked it has been correctly picked from stock, set it aside for the client and are satisfied the non-SQP is competent
What registration and CPD is required for an SQP?
• SQP’s need to be registered with AMTRA or VetSkill and an annual retention fee must be paid
• CPD is required depending on the class of SQP e.g. C-SQP requires 15 hours over 3 years
What are the limitations to the SQP role?
• Cannot diagnose
• Cannot prescribe POM-V
• Can only prescribe as per the product licence
What is the difference between the VN role and the SQP role?
Veterinary nurses (who are not SQPs) cannot prescribe or supply veterinary medicine but they can dispense them under the veterinary surgeons direction.
Who can inspect a practice’s pharmacy to ensure it fulfils certain requirements?
• RCVS (as part of the Practice Standards Scheme)
• VMD (Inspections and Investigations team)
What 2 pieces of Health and Safety legislation cover the pharmacy?
• The Health and Safety at Work Act 1974
• The Control of Substances Hazardous to Health (COSHH) Regulations 2002
What 7 points does stock control include?
• Having low stock levels for accurate stocking
• Named person responsible
• Logical storage system
• Stock rotation
• Expiry date monitoring system
• Usage date noted on injectables
• No returned goods should be offered for resale
How and why is it important that medicines are correctly stored?
• Maintains efficacy for health and safety and complies with legislation
• Protected from light (no windows, amber bottles)
• Protect from moisture (away from autoclave/laundry room)
• Store at correct temperature (thermostats, fridge
• Cytotoxic drugs should be labelled
• Certain drugs must be stored away from public access or in a DD cupboard
