Drugs and law 1 Flashcards
What is the role of the VMR?
The veterinary medicines regulations came into force 2013.
- Controls risks to human health, animal health and the environment by safe use of vet drugs. (professional advice/ controlled supply/ controlled manufacture/ surveillance)
- Provide assurance on efficacy
- Provide reliable information to users
What processes are used to achieve regulation for a veterinary licensed medicinal product?
- Data assessment/ authorisation
- Certification / qualification
- Prescribing, dispensing and supply
- Testing, inspection and investigation
- Post authorisation
What are the different drug distribution categories?
- POM-V (vet only)
- POM VPS (Vet, pharmacist, SQP)
- NFA-VPS (Non food animal- Vet, Pharmacist, SQP)
- AVM-GSL (general sales)
- Schedule 6 exemption products
Describe POM-V classification
- ONLY prescribed by a vet surgeon AFTER a clinical assessment
- The vet may then either dispense the drug or in accordance with written prescription another vet or pharmacist may do it
- Must be supplied by a registered premises
- Drug requires strict limitation on use due to safety reasons
- Requires specialist knowledge for use/ application and has a narrow safety margin
Describe POM-VPS classification
- Must be prescribed by a vet, pharmacist or SQP
- Supplied by a registered premises
- Client can have written prescription
- Clinical assessment NOT required
- Prescriber MUST be happy the client knows how to apply it safely and it will be used for intended purpose
- must ADVISE on safe administration
- These drugs are used to reduce/ prevent effects of endemic disease in herds, flocks or individuals
- Use implies risk for user, animal, consumer safety or environment
Describe NFA-VPS classification
- ONLY for companion animals (excl horses)
- Supplied from registered premises
- Vet, pharmacist, SQP only
- Clinical assessment NOT needed
- Advise of safe administration and ensure the client is competent
- Supply no more than minimum needed for treatment
- These drugs used to prevent endemic disease in NFA
What is the small animal exemption scheme? (SAES)
-Covers medicines used in certain species:
aquarium fish, cage birds, ferrets, homing pigeons, rabbits, small rodents
- These drugs are exempt from requirement for a marketing authorisation: not required to prove safety, quality, efficacy.
-Must be manufactured to same standards as authorised drugs
-Considered equivalent to AVM-GSL
Describe the rules of medicine distribution by a vet
- Vet can dispense against another vet’s prescription
- Vet may supply to animals not under his/ her care (not POM-V drugs)
- Internet/ postal supply allowed so long as supplier applies controls
What is specified feed additive?
They are authorised under Reg EU 1831/ 2003 belonging to funcitonal groups; coccidiostats, histomonostats and other zootechnical additives)
What should be taken into account when prescribing?
- Circumstances of animals being treated
- Available authorised vet medicinal products
- Need for responsible use (of meds and minimum amount needed for treatment)
- Competence of client
What is meant be a registered premises?
- All premises where vet medicinal products (VMPs) are stored/ supplied are required to be listed on a register as a veterinary practice premises (VPP)
- Must be in a permanent/ secure building. That doesn’t allow entrance of birds/ vermin
- Medicine storage area designed so drugs stored at correct temp,a way from excessive light/ and or moisture
- Toilets and hand washing facilities away from drug storage areas.
Who inspects VPPs?
Maintained by the RCVS on behalf of the VMD
- VMD can inspect wholesalers whos supply VPPs
- VPPs themselves inspected by RCVS practice standards scheme
Describe supply of POM-V and POM-VPS without a vet present
- Must be authoriseed by a vet
- Vet could write on clients notes tht repeat prescriptions can be supplied to the client, phone call can be used to get authority from vet if client suddenly appears in practice.
- Vet must be satisfied client is competent and drug will be used as intended
- Minimum amount needed only
What is a SOP?
Standard Operating Procedure
What does SIC and STC stand for?
Special import certificate
Special treatment certificate
