Veterinary Practice Premises
The requirement to register practice premises came into force on 1 April 2009. Applications to register are dealt with by the Royal College of Veterinary Surgeons.
Guidance and a Frequently Asked Questions (FAQ) document for veterinary surgeons on how to register have been produced with the involvement of VMD and are published on the RCVS website
Observations of a year of Veterinary Practice Premises Inspections.
Since 1 April 2009, veterinary surgeons have only been permitted to supply veterinary medicinal products (VMPs) from veterinary practice premises (VPPs) registered with the RCVS. In accordance with the principles of the Hampton review to minimise administrative burdens to businesses in the UK, we have agreed with the RCVS that those VPPs that are registered with RCVS's Practice Standards Scheme (PSS) are inspected by PSS Inspectors, whilst all others are inspected by VMD inspectors within a four year timescale.
Thereafter, compliant VPPs will continue to be inspected every four years, with non-compliant VPPs inspected more frequently, depending on the perceived 'risks'.
VMD has completed over 200 VPP inspections in the past year and found most to be working to a good standard. This article sets out the most common issues that have arisen from those inspections to help practices to prepare for an inspection.
Registration & inspection fees:
There appears to be some confusion over the registration and inspection fees for VPPs inspected by VMD. VPPs are currently required to pay an annual £40 registration fee to the RCVS to cover the administrative costs incurred in maintaining their database, in addition to a separate inspection fee of £250 charged by VMD following an inspection. This is clearly stated in the inspection notification letters which are sent out at least 2 weeks in advance of the visit. Following notification, if practices subsequently notify the VMD that they intend to join the PSS they are not inspected by the VMD, but by the RCVS as part of the application process for the PSS. If no application has been received by the RCVS after 3 months, the VMD may decide to carry out an inspection as originally planned.
Inspection of Premises:
A number of vets who work from home have queried the need for them to be registered and inspected. Examples include semi-retired vets who only treat animals belonging to family and friends, small dedicated referral practices, and vets who undertake locum or consultancy work. These categories of vets often cited their 'practice' as consisting of a small cabinet or a locked 'drug case' kept at their homes. Such premises would fall within the criteria considered a 'veterinary practice premises' by the RCVS and VMD and, therefore, require an inspection. The VMD would welcome feedback on how controls on the storage and supply of VMPs from such VPPs can be maintained and assured, in particular regarding compliance with the Misuse of Drugs Regulations, whilst minimising the financial impact on small businesses.
One possible solution is for all premises to be registered with the RCVS but have criteria for exempting certain VPPs from inspection. VMD is also interested to hear if vets working from home have any concerns on their details being provided on a published register.
Several veterinary businesses with multiple branches asked whether all of their premises have to be inspected if they all adhere to the same standards. VMD considers that they should all be inspected, as with other registered businesses, but would welcome any comments on this issue.
Storage of VMPs:
Inspectors have observed products, particularly temperature sensitive products such as vaccines, being stored outside the specific requirements of their SPC. Whilst vets may have anecdotal experience of products continuing to work even when stored outside their specified requirements, VMD considers it a breach of a product's marketing authorisation if that product is not stored in accordance with its specific storage requirements. Medicines should be stored at the temperature specified on their SPCs, usually under 25°C (ambient room temperature) or between 2°C and 8°C in a fridge. Fridges should be checked daily and the min/max temperatures recorded. Any excursions outside the specified temperature range should be investigated and a record made of any actions taken, for example, information provided by the manufacturers on the likely effects of the excursion on the products. The ambient temperatures of storage areas which are likely to exceed 25°C or to fall below freezing should also be monitored and recorded. Appropriate measures to ensure and demonstrate that VMPs are stored correctly in vehicles should also be implemented.
Supply, labelling & usage of VMPs:
Inspectors have observed non-compliances relating to the supply, labelling and usage of VMPs. The VMR require that where a VMP is supplied in a container other than that specified in the marketing authorisation, the person supplying the VMP must ensure that the container is suitably labelled and must supply sufficient written information (which may include a copy of the SPC or package leaflet to enable the product to be used safely). A number of veterinary surgeons have queried whether a dispensing label meets the requirements of 'sufficient written information'. VMD is satisfied that provided the dispensing label includes adequate information to enable the product to be used safely in the animal prescribed the product and for the owner administering the product, then this requirement is being met.
In the case of dispensed cascade products, there are specific labelling requirements. The two most common non-compliances noted are the failure to add the name of the veterinary surgeon on the dispensing label, which is required in addition to the Practice name and address (VMD will accept initials if these enable the prescribing/dispensing vet to be identified); and the failure to add the species of animal, which is required in addition to the identification of the animal or group of animals. Any necessary warnings for the user, target species, administration or disposal of the product should also be included on the label.
Inspectors noted instances of vets not recording opening or "use by" dates on broached products, and several vets have queried whether they can continue to use VMPs after the 'use by' date if they 'risk-assess' the product. VMD has discussed this issue with the European Medicines Agency (EMA) and the National Office of Animal Health (NOAH), and agreed that the requirement to use a product within a specified period once broached reflects data showing that the products remain stable and effective up to the usage date. As such, the VMD considers that vets should record opening or use by dates on broached products if the SPC so requires, and dispose of products whose usage date has expired as they are no longer within the terms of their marketing authorisation and may not be administered.
Controlled Drugs issues:
The main non-compliances noted relate to Register requirements and destruction of controlled drugs. Schedule 2 CDs and certain Schedule 3 CDs e.g those containing Buprenorphine, must be securely stored in a locked receptacle to which only authorised persons have access. VMD and RCVS also consider it good practice for Ketamine containing products to be similarly stored. Whilst nearly all VPPs inspected had locked receptacles for Schedule 2 (and other) CDs, many were accessible to all staff rather than specifically authorised personnel.
The Misuse of Drugs Regulations 2001 also requires any person who purchases or supplies any product containing a controlled drug specified in Schedule 2 to maintain a Controlled Drug Register. This is in addition to the existing record keeping for veterinary medicinal products. There are very specific requirements for the format of a CD Register, which must either be a bound book or computerised record. Whichever is used, it should not be possible to make any alterations or amendments. The main issues noted include the failure to separate the Register into each class of drug, and to have a separate headed page for each strength and form of a drug. A separate Register must be kept for each set of premises.
VMD also consider it good practice (and it is a requirement under the RCVS Practice Standards Scheme) for a running balance to be kept for each drug inthe Register and for a weekly stock check to be carried out. A similar, but informal, Register should be kept for Ketamine containing products.
Vets must keep intake records with batch numbers for all POM products and these records must be available at VPPs. Some vets have relied on their Wholesale Dealer to keep the batch numbers of VMPs supplied, but VMD considers that this is not acceptable unless the vet has direct access to those records e.g. via a login procedure.
There is a requirement for vets to carry out an annual VMP audit but many vets have highlighted the difficulty in undertaking such a full stock reconciliation exercise. VMD has noted this problem and considers that, provided vets carry out a physical stock check at least annually and have adequate means of tracing VMPs, the audit requirements are being met.