Veterinary Medicines Directorate
Vets, pharmacists and anyone involved in prescribing, supplying, keeping records of, storing, disposing or destroying veterinary medicines that contain controlled drugs (CDs) must comply with the law on the misuse of drugs and veterinary medicines.
There are general requirements for working with CDs in addition to those in the Veterinary Medicines Regulations (VMR), these requirements are different in Northern Ireland.
List of , their relevant schedule under the Misuse of Drugs Regulations and whether they are subject to the safe custody requirements.
Schedule 2 Controlled Drugs Register
Any person who purchases or supplies any product containing a CD specified in Schedule 2 must maintain a Controlled Drugs Register (CDR). The prescribing vet may delegate the task of completing the register; however, they remain responsible for supplying the CD.
The register must:
- be either a computerised system or a bound book (which does not include any form of loose leaf register or card index)
- be separated into each class of drug
- have a separate page for each strength and form of that drug, with this recorded at the top of each page
- have the entries in chronological order and made on the day of the transaction or, if not reasonably practical, the next day
- have the entries made in ink or in a computerised form in which every entry can be audited
- not have cancellations or alterations
- ensure any corrections are made by a signed and dated entry in the margin or at the bottom of the page
- be kept at the premises to which it relates (for example separate registers for each set of premises) and be available for inspection at any time
- not be used for any other purpose
- be kept for a minimum of two years after the date of the last entry
The following must be recorded in the register when Schedule 2 CDs are purchased:
- date supply received
- name and address of supplier (e.g. wholesaler, pharmacy)
- quantity received
The following must be recorded in the register when Schedule 2 CDs are supplied (which includes by way of administration):
- date supplied
- name and address of person or company supplied
- details of the authority to possess (prescriber or licence holders details)
- quantity supplied
- person collecting a Schedule 2 CD (animal owner or animal owners representative, or healthcare professional) and if a healthcare professional, their name and address
- whether proof of identity was requested of animal owner or animal owners representative (yes or no)
- whether proof of identity of person collecting was provided (yes or no)
In addition to the above, we recommend keeping a running balance of stock in the register.
The aim of maintaining a running balance in the register is to ensure irregularities are identified as quickly as possible. The running balance of drugs remaining should be calculated and recorded after each transaction and balances should be checked with the physical amount of stock at regular intervals.
Pharmaceutical companies try to ensure that every bottle of medicine is precisely filled but some small variability may occur. This may result in discrepancies regarding the amount of CD used when taking into consideration the volume remaining in the container.
You should consider recording the total use of the product, even if the reconciliation of the quantity used exceeds the nominal volume on the product stated on the label. This will help to ensure accurate record keeping of the use of the CD.
Recording use and wastage of multi-dose preparations
You must avoid having discrepancies between the amounts recorded as used, the volume of product left in the vial and the total stated volume.
The filling volume of a product is set and checked to ensure that it is as stated on the label on the vial. There is minimal variation in fill volume of the product.
There will be some wastage within the needle and hub of the syringe each time the product is withdrawn. If numerous doses are withdrawn, there will be considerably more product lost to this dead space than if fewer doses are given. It is not possible to quantify exactly how much product might be wasted in the syringe hub and needle. There are international manufacturing standards which specify the maximum amount of dead space that is permitted in needles and syringes of different sizes and gauges. You can obtain this information from manufacturers or wholesalers. In general, the smaller the gauge of needle or size of syringe, the less wastage occurs.
Some vets use insulin syringes to minimise wastage. This is acceptable although it is important to ensure that the syringe allows accurate measurement of the dose in millilitres.
Other potential factors that may increase wastage are:
- the use of a separate, larger bore needle to withdraw the product from the vial before changing to a smaller needle to administer the product
- the process of expelling air from the syringe prior to injection
Minimise wastage and recording it
You must carefully select the injection equipment and use good technique to reduce wastage due to dead space in syringes. You must record the volume (dose) withdrawn on each occasion and write off the vial as unusable (destroyed) in the register once there is no useable volume remaining.
Inspectors from the VMD or Royal College of Veterinary Surgeons (RCVS) who inspect veterinary premises are aware that some wastage will be unavoidable even after all steps are taken to minimise this. The recording of small discrepancies that can be explained by wastage due to dead space is not considered a breach of the legislation; provided that inspectors are satisfied appropriate measures are in place to comply with the requirements of the Misuse of Drugs Regulations.
Example CD register
The following example CD register has been put together as a guide.
Disposal of Controlled Drugs
Destruction and disposal
Schedule 2 CDs must be destroyed in the presence of and as directed by, any of the following:
- an inspector appointed under the VMR
- a vet, independent of the practice where the destruction takes place
- a person legally authorised to witness the destruction of CD such as a Police CD Liaison Officer (CDLO)
It is important to note that vets in Northern Ireland are not approved to witness Schedule 2 CD disposal in any veterinary practice. In Northern Ireland, destruction of out of date Schedule 2 CDs can only be carried out in the presence of a person legally authorised by the Northern Ireland Department of Health, which includes the Northern Ireland Veterinary Inspectors.
The above also applies to schedules 3 and 4 CD that have been prepared extemporaneously for use under the Cascade.
The date of destruction and the quantity destroyed must be recorded in the register and signed by the witness.
CDs should be rendered irretrievable before disposal, e.g. by using a denaturing kit. These are plastic boxes containing absorbent material which can be passed on to an authorised waste contractor. Alternatively, an injectable solution may be placed into sawdust or cat litter and tablets may be crushed and mixed with soapy water.
Controlled drug liaison officers (CDLOs)
All police forces in England, Wales and Scotland have CDLOs who offer advice on safe storage, auditing, destruction, suspicious activity, internal thefts, forged or stolen prescriptions, as well as current crime trends. Contact details for officers in your area can be obtained from the Association of Police Controlled Drugs Liaison Officers.
Independent veterinary surgeons
In order to be considered independent of the practice, another vet:
- must have no personal, professional or financial interest in the veterinary practice where the drug is being destroyed (this includes temporary staff (locums) and family members)
- must not demand or accept any form of payment, beyond that reasonable to