All premises where veterinary medicinal products (VMPs) are stored or supplied are required to be listed on a register as Veterinary Practice Premises (VPPs). This register is maintained by the Royal College of Veterinary Surgeons (RCVS) on behalf of the Veterinary Medicines Directorate (VMD). VMPs can be supplied by a wholesaler to a veterinary surgeon at non-registered premises, but the veterinary surgeon can only supply the VMPs from a VPP. The VMD will be able to inspect these premises.
Those practices that are members of the RCVS Practice Standards Scheme (PSS) will not currently be inspected by the VMD inspectors, as their pharmacies will be inspected as part of the PSS. Both inspections by the VMD and under the RCVS PSS will include a check on the RCVS registration of veterinary surgeons and premises, as well as the registration and qualifications of any suitably qualified persons (SQPs).
Premises
Premises will be inspected to ensure that:
- They are housed in a permanent and secure building, which does not allow the entrance of birds or vermin
- The medicines storage areas are designed to allow drugs to be stored at the correct temperature. This needs to be monitored by the use of maximum and minimum thermometers to check that temperatures do not fluctuate from the manufacturers’ recommended range. Medicines should be stored in areas away from excessive light and/or moisture
- There are appropriate staff amenities, toilets and hand washing facilities, and that these are separate from the drug storage areas.
Supply of medicines
The supply of medicines will be checked to ensure that:
- There is no self-service of medicines, except for those in the AVM-GSL category
- There is an effective stock control system in operation and that out-of-date, damaged or returned medicines are disposed of correctly
- Out-of-date medicines are not used or supplied to clients
- All medicines are supplied and labelled correctly
- For all POM-VPS medicines there is evidence that each act of prescribing and supplying has been authorized by a veterinary surgeon, pharmacist or SQP
- For all POM-V medicines there is evidence that each act of prescribing has been authorized by a veterinary surgeon, and that each act of supplying has been authorized by a veterinary surgeon or pharmacist
- For all NFA-VPS and POM-VPS medicines there is evidence that before the medicine is supplied, a veterinary surgeon, pharmacist or SQP has checked that the person who will be administering the medicine is competent to do so safely, and intends to use it for a purpose for which it is authorized. They must also advise on the safe administration of the medicine and on any warnings/contraindications stated on the label or package leaflet
- Staff ‘handing over’ medicines to clients have been trained to do so (e.g. have knowledge of practice protocols and standard operating procedures)
- All veterinary medicines, including medicines prescribed in accordance with the cascade, are labelled correctly
- Written prescriptions include all the information required under the Veterinary Medicines Regulations (VMR).
Records
Records will be checked to ensure that all the following information is recorded and kept for at least 5 years:
- Receipt and supply of prescription medicines
- The date of supply/receipt
- Name of medicine
- Batch number (for non-food animals, batch numbers need only be recorded at intake and when batch first started; but it is good practice to record all vaccine batch numbers)
- Quantity of medicine
- Name and address of supplier or recipient
- Copies of all written prescriptions
- Record of the most recent drug audit
- All imported medicines have the correct relevant paperwork (special import certificates (SICs) and special treatment certificates (STCs).
Inspectors will also check that medicines prescribed and supplied in accordance with the cascade are only done so to avoid unacceptable suffering, and that the practice is aware of the Suspected Adverse Reaction Surveillance Scheme (SARSS) and is reporting adverse reactions or lack of efficacy.
Controlled Drugs
The storage and use of Controlled Drugs will be inspected to ensure that:
- Schedule 2 Controlled Drugs are kept in a secure lockable and immoveable container, which can only be opened by a veterinary surgeon or a person authorized by them
- A Register is kept of the receipt, use and supply of specified categories of Controlled Drugs. This Register may be computerized but if so the system must be secure
- An informal Register of ketamine use is kept. Again, this can be computerized if secure
- The inspector will ask to see a full audit and reconciliation of all Schedule 2 Controlled Drugs (i.e. the Register and the balance of drugs in stock).
Advertising
Advertising will be checked to ensure that:
- POM-V and POM-VPS medicines are only advertised to permitted persons (but veterinary practices are allowed to display price lists of these VMPs to the public).