Registration and inspection of veterinary practices
Since 1 April 2009, veterinary surgeons have only been permitted to supply veterinary medicines from veterinary practice premises (VPPs) registered with the Royal College of Veterinary Surgeons (RCVS).
The VMD agreed with the RCVS that those VPPs registered with the RCVS under its Practice Standards Scheme (PSS) would be inspected by PSS Inspectors. The VMD would inspect those outside the PSS (non-PSS VPPs). This was to avoid some practices being inspected by two bodies.
Guidance and a Frequently Asked Questions (FAQ) document for veterinary surgeons about registering a VPP have been produced with the involvement of the VMD and are published on the RCVS's website.
Registration & inspection fees:
For VPPs that come within the VMD's inspection programme, there are two fees:
- a £34 registration fee payable to the RCVS on first application and then annually in April. This fee is to cover the administrative costs incurred in maintaining the database
- a £350 inspection fee payable to the VMD. This is invoiced after the inspection.
How the inspection system works
Notifying you of an inspection
Before you are inspected, we will send you a letter about two weeks in advance. This letter will give you some information on what we will be looking for by pointing you to the inspection criteria in Annex B of our Veterinary Medicines Guidance Note No 3 - Guidance for Retailers. It and will also inform you of the inspection fee.
After receiving our notification letter, if you tell us that you've applied to join the RCVS's PSS and provide documentary evidence, we will cancel our inspection. However, if your premises don't appear on the RCVS's register of PSS practices within three months, we will carry out an inspection.
The inspector will introduce themselves when they arrive and give you an overview of what the inspection will involve. They will look for evidence of compliance with the requirements laid out in Annex B of Veterinary Medicines Guidance Note 3 (VMGN 3). At the end, the inspector will summarise their findings, explaining where the practice complies and any deficiencies. You will have a chance to ask any questions for clarification.
After the inspection
Within 30 days, we will send you a written report. We prefer to send this by secure email. But if you prefer, you may have a paper copy. The report will confirm the inspector's findings, that were discussed at the end of the inspection, and detail where you are compliant and the areas where you are not. It will also lay out the actions we wish you to take and give you an estimate of your next inspection date.
Most practices have been inspected once
We are coming to the end of the first round of inspections.
Once we have inspected all of the non-PSS practices, we will aim to inspect generally compliant VPPs every four years. But we will inspect less compliant VPPs more frequently, depending on the perceived 'risks'.
Review of the inspections system
Having inspected most of the non-PSS practices, we are reviewing the inspection process. One area we are looking at is the regulation of small practices, such as:
- branches with limited opening hours that are attached to a main practice; and
- 'home vets' - these are often retired vets who keep a few medicines for treating family and friends' animals.
We would welcome feedback on how controls on the storage and supply of veterinary medicines from such VPPs can be maintained. In particular we would like views on regulating the storage and use of controlled drugs (CDs). You can send your views to email@example.com
Findings and deficiencies (non-compliances)
We found most practices are working to a good standard This is not to say that practices did not have some deficiencies, but they were generally issues that we consider would be corrected through advice.
How can I avoid the main pitfalls?
- Store medicines within the temperature range specified in the Summary of Product Characteristics (SPC) - Vaccines and some other products must be kept between 2 and 8°C. Some must not be allowed to freeze. We will expect to see the maximum and minimum temperatures monitored and recorded every day.
Most other medicines need to be stored below 25°C. So if either the practice or vehicle where you store medicines may exceed this, the maximum and minimum temperatures should be monitored and recorded. If this shows the temperature does exceed the requirement in SPCs you should take steps to rectify this.
- Labelling of medicines dispensed into smaller containers - if you supply a medicine in a different container to its authorised one, you have to supply enough written information to enable your client to use it safely. This could include giving your client a copy of the product's authorised package insert or leaflet, or providing your own written advice.
- Controlled Drugs - Most Schedule 2 CDs, such as morphine, and some schedule 3 CDs are subject to secure storage requirements. This includes when they are being stored in vehicles. Being in a locked container in the vehicle is not enough; the locked container must be secured to the vehicle. Storage in a locked glove box is sufficient.
If you have Schedule 2 CDs, you must have a register in each place where they are stored, including vehicles. The Misuse of Drugs Regulations 2001 specifies a strict format for the register. There must be no crossings out or overwriting figures. You can find further information about recording CDs on our Controlled Drug Information page.
Ketamine is a Schedule 4 CD. As such it would not normally be subject to safe custody and recording in a CD register. However, as it is a drug of abuse, the VMD and the RCVS recommend that it is stored securely and recorded in an informal register in the same way as for Schedule 2 CDs. You can find more details in Veterinary Medicines Guidance Note No 20 on Controlled Drugs
- Medicines records - You must have a record of the batch numbers of all prescription medicines (POM-V and POM-VPS). These must be available for us to inspect.
For cats, dogs and other pets, it is sufficient that you have a record of either when the batch was delivered to your practice or when you first used it. If the details are on the Tote sheets you receive from the wholesaler, just keep those. If your wholesaler keeps the details for you, that's acceptable, providing you are able to log onto their site and allow us to see them.
Food-producing species, you must record the batch number each time you supply (including administer) a prescription medicine to a food-producing animal. You must also record any withdrawal period. If you're a small animal practice, you may sometimes treat chickens. While your clients may consider their hens to be pets, if they're eating the eggs then those birds are 'food-producing animals' and you must keep appropriate records.
- Broach dates - many products have a use-by time after the first withdrawal of a dose. This is often 28 days but does vary. Use after the specified broach time is not permitted. To demonstrate that use outside the broach time has not occurred, vets should record the opening or use-by dates on broached products. However, ensure that you have a single branch policy.
- Prescriptions - there are legal requirements for what must be included on prescriptions. You can find details of what must be included on a prescription in VMGN 3.
- Disposals - we recommend that practices set up a dummy client called 'Disposal' on their practice management system and record all medicines that are unusable. This can help the practice identify where medicines are being wasted and also help with reconciling stock during audits.
- Cytotoxic, cytostatic and certain hormonal medicines require special handling and disposal procedures. Products include:
- Cancer chemotherapeutics - which include products such as vincristine, pharmarubicin, methotrexate, and all similar classes of tumour toxic medicines.
- Antiviral medicines - including aciclovir ophthalmic ointment
- Ciclosporin medicines in any form
- Certain hormonal preparations: including prostaglandins and androgens
- Spill kit. It is considered good practice to have a spill kit and appropriate protective equipment readily available to deal with spillages/leakages of all medicines. Particular attention should be given to dealing with spillages of CDs and products referred to in 8 above.
Where can I get more information?
The VMD website has a number of useful features for vets:
- Online reporting of suspected adverse events - we encourage all reporting of possible adverse events, including if you suspect a medicine has not worked as you thought it should (suspected lack of expected efficacy).
- Product information database - on our website there is a database where you can search on: species, product name, active ingredient etc for all of the authorised veterinary medicines in the UK. You will also be able to download their Summaries of Product Characteristics.
- Prescription misuse reporting - with the growth of on-line medicines sales, the issue of prescription misuse has grown. In this section, there is guidance on what information must be on a prescription, the types of misuse we have seen and how you can report any concerns you have on-line.
- Special imports section - you may find that there is no suitable product available in the UK, but there may be one available in another country. Under the 'cascade' you can apply on-line for a Special Import Certificate or Special Treatment Certificate to allow you to import the medicine. There is no charge for online applications for these certificates.
There are some obligations on you if you use import certificates. These are laid out in Veterinary medicines Guidance Note No 5.