As a vet or pharmacist, you must follow legal requirements when working with controlled drugs in veterinary medicine.
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.
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. 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, for example, 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 holder’s details)
- quantity supplied
- person collecting a Schedule 2 CD (animal owner or animal owner’s representative, or healthcare professional) and if a healthcare professional, their name and address
- whether proof of identity was requested of animal owner or animal owner’s 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
In Great Britain, Schedule 2 Controlled Drugs (CDs) must be destroyed in the presence of and as directed by, any of the following witnesses:
- 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 CDs such as a Police CD Liaison Officer (CDLO)
In Northern Ireland, it is important to note that vets are not approved to witness Schedule 2 CD disposal in any veterinary practice. In Northern Ireland, destruction of 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 two paragraphs also apply to schedules 3 and 4 CDs that have been prepared extemporaneously for use under the Cascade.
The date of destruction and the quantity destroyed must be recorded in the CD register and signed by the witness. This should be compared to the expected amount of medication that should be remaining (documented in the stock list and CD register). Any differences should be accounted for and documented by the holding practice and responsible vet. The weekly stock check should highlight any discrepancies with the amount held in stock and the amount to be destroyed.
CDs should be rendered irretrievable before disposal, for example, by using a denaturing kit. These are plastic boxes containing absorbent material which can then be passed on to an authorised waste contractor. Alternatively, an injectable solution may be placed into sawdust or appropriately absorbent cat litter and tablets may be crushed and mixed with soapy water.
Some absorbent materials can have their limitations and may not be suitable – it is important to ensure that CDs cannot be reconstituted or reused at any time during the disposal process.
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 veterinary practice where CDs need to be destroyed, a vet:
- may not demand or accept any form of payment, beyond that reasonable to cover travel costs
- should record their RCVS number and confirm their independence in the CD register
- must have no personal, professional or financial interest in or relationship with the veterinary practice where the drug is being destroyed (for example, temporary staff and family members of staff are not considered to be independent; ‘family member’ refers to spouse, partners, parents, siblings, children or other relatives)
- must not share stock with or provide services (with exception of the function as a witness to the destruction of CDs) to the practice where the drugs are being destroyed
- may work for the same franchise or corporate group provided the practices have a different owner and are separate legal entities
In order to maintain independence, vets should not rely on the same vet to repeatedly witness destruction of CDs at their practice.
Examples of where a vet would be considered “independent” provided the above conditions are met:
- A vet who works in an independent practice in a single practice premises
- A vet who works in a practice that shares a premises with the practice requiring witnessed CD destruction, for example providing out-of-hours services from the same premises, but the two practices do not belong to the same owner and are separate legal entities
- A vet who works for a practice operating under the same franchising or branding (corporate group) as the practice requiring witnessed CD destruction, but the two practices do not belong to the same owner and are separate legal entities
Suggested procedure for independent vets witnessing destruction and disposal of CDs
- In the presence of the witness, the vet of the practice where CDs are being disposed of should render the CDs irretrievable by one of the suggested means above.
- The date of destruction and the quantity destroyed should be recorded against the appropriate entry of the controlled drugs register
- The witness shall sign and date the entry; including a statement to confirm their independence and RCVS number: for example “I am an independent vet RCVS No: XXXXX
- Once the register has been completed the drugs that have been rendered irretrievable should be disposed of appropriately and in accordance with the Summary of Product Characteristics (SPC) and any local requirements.
Witnessing disposal of waste product
The legal requirements to witness the destruction of Schedule 2 CDs apply to stock. This refers to CDs that have not been issued or dispensed to a patient. This includes medicines that are left over in quantities that could still be used, even if the product is out of date.
Any medicine left over of an unusable quantity is considered waste. Medicine is also considered ‘waste’ if it has been prepared for administration but not actually used. For example a quantity of medicine which has been ‘drawn up’ into a syringe from its original container, but not all of it was used. Such waste must still be recorded and the medicine denatured prior to disposal; however, this disposal does not need to be formally witnessed.
Examples of Stock vs. Waste
1 ml single use vial – 0.6 ml drawn up and used leaving 0.4 ml remaining – this is considered waste and does not require formal witnessing of disposal.
10 ml vial – 2 ml drawn up and used leaving 8 ml remaining (beyond 28 day broached life). Due to the ‘useable’ quantity this is considered stock and formal witnessing of disposal is required.
Waste Management Exemptions
The destruction and disposal of CDs are subject to restrictions on waste management licensing. Further guidance is available for each region:
Further guidance is available on the Controlled Drugs: veterinary medicines page.