Controlled Drugs Guidance – A to Z

It is an RCVS Core Standard requirement that practices carry out a full audit and reconciliation of all Schedule 2 CDs (i.e., the Controlled Drugs Register (‘CDR’) and the balance of drugs in stock). It is expected that all CDs are audited regularly, at least weekly.

Audit and reconciliation can be achieved by recording supply, use and wastage, keeping a running total in the CDR, and having a system of reconciling the balance in the CDR with the stock in the CD cabinet. Any discrepancies should be recorded and, where necessary, investigated.

The CDR can be maintained by a suitably-trained and authorised person, e.g., a veterinary nurse, however, ultimate responsibility lies with the prescribing veterinary surgeon. It is recommended that once tallied, the balance should be marked as checked and countersigned – this can be done by someone responsible for the CDR, not necessarily a veterinary surgeon. If this is carried out daily (or at least weekly), discrepancies are much easier to trace.

Buprenorphine is a Schedule 3 CD. Its use does not need to be recorded in a CDR; however, it is an RCVS requirement that it is securely locked away. Schedule 3 CDs are also subject to extra prescription-writing requirements (see: Prescriptions and prescribing).

If dispensing transmucosal buprenorphine, written informed consent should be obtained from the client, as this is off-licence use in accordance with the prescribing Cascade (see: RCVS Guidance Chapter 4).

Transmucosal buprenorphine is sometimes used for cats as a short-term analgesic treatment and in some circumstances may be supplied to clients to administer to their cats at home. Where this is the case, veterinary surgeons should:

• Have a genuine clinical reason for prescribing the medicine under the cascade.
• Personally discuss this treatment with the client and be satisfied that the client is able to administer the medication responsibly.
• Obtain written informed consent from the client.
• Emphasise that this drug is a CD and that it should be treated with extreme caution (e.g. keep out of reach and sight of children; skin splashes should be washed off immediately).
• Demonstrate correct handling of the medication during administration.
• Only supply a limited amount of buprenorphine, preloaded into appropriate syringes that are capped with a syringe bung and dispensed in appropriate packaging.
• Request that the client return all used and any unused syringes to the practice for disposal.
• Provide all this information in written format for the client and record all pertinent information within the client record.

Veterinary surgeons should use their professional judgement when storing CDs in vehicles and they must take reasonable steps to minimise unauthorised access. This might require them to consider particular risk factors, such as whether practice vehicles are easily identifiable or have been targeted in the past, and where vehicles are parked.

When transporting Schedule 2 and 3 CDs, Veterinary surgeons should ensure that Schedule 2 and 3 CDs in practice vehicles are kept in a locked receptacle which is fixed within the vehicle. If the vehicle cannot be modified in such a way, it may be reasonable to secure the receptacle to a structure in the vehicle, for example, using a metal cable tethered to an anchor point, such as the seat runners or seatbelt post, or bolting the lockable receptacle to the floor of the vehicle. In any case, the receptacle should be kept out of sight. The secure container would ideally be fixed to the frame of the vehicle, but using a secure, lockable glove compartment or a secure container chained to the inside of the vehicle (e.g. passenger seat) would also be acceptable. Examples of secure containers include car safes, laptop safes and lockable cash tins.

When on duty, veterinary surgeons should avoid leaving the secure container/locked receptacle unattended. However, where this is unavoidable, the vehicle and container should remain locked and the time unattended kept to a minimum. When off duty, controlled drugs should be returned to the controlled drugs cabinet at the practice for storage overnight wherever practicable. Where this is not practicable, controlled drugs may be stored in a locked vehicle, but they should be inside the locked receptacle secured to the structure of the vehicle and kept out of sight.

Veterinary surgeons who store CDs in their vehicle must keep a separate controlled drugs register (CDR). This requirement applies to veterinary surgeons who store CDs in their vehicle for any period, except in cases where CDs recorded on the practice’s CDR are briefly removed from the premises.

For further guidance, please see:

• The Practice Standards Scheme Core Standards (Small Animal 10.1.2, Farm Animal 8.1.2, Equine 9.1.2)
• Chapter 4 of the supporting guidance to the Code of Professional Conduct: Veterinary Medicines

Some police forces in the UK have Controlled Drugs Liaison Officers (CDLOs) who offer advice on all aspects of CD use within veterinary practice, including safe storage, auditing, destruction, suspicious activity, internal theft, forged or stolen prescriptions, and ‘current crime trends’. Contact details for local officers can be obtained from the Association of Police Controlled Drugs Liaison Officers.

The balances in the CDR should always tally with the amounts of CDs in the cabinet. If they do not, the discrepancy must be reported to the appointed senior veterinary surgeon, and steps taken to investigate and resolve the matter.

Discrepancies are inevitable when using multi-dose CDs due to needle-hub and syringe deadspace. Multi-dose vials of CDs increase the potential for abuse, and running balances are difficult to keep due to deadspace volumes. One way of accounting for deadspace volume is to add this to each dose dispensed, although the volume is likely to vary, depending on the manufacturer of the needle and syringe, and the size of the syringe used.

A standard operating procedure should be in place detailing what to do in the event of a discrepancy, this should detail the arrangements for investigating and reporting them. Such arrangements might include:

• Informing the appointed senior veterinary surgeon immediately;
• Ensuring the following information is carefully checked:
  • All CDs received from the wholesaler have been entered into the correct page of the CDR.
  • All CDs administered have been entered into the correct CDR.
  • Items have not been accidentally put in the wrong place in the CD cabinet or left out. Practice vehicles and bags should be checked where applicable.
  • Arithmetic to ensure that balances have been calculated correctly (i.e., two members of staff to check the balance to confirm calculations).
  • Check running totals and discrepancies at the end of each bottle; a weekly stock check against the CDR will minimise this.
  • Check that bottles been entered as the correct volumes.
  • Check that all entries are supported by clinical records.
  • Check volumes of any product awaiting disposal to establish if they have been used instead of the usable stock.
• If the error or omission is traced, the appointed senior veterinary surgeon should make an entry in the CDR clearly stating the reason for the discrepancy and the corrected balance. This entry should be witnessed by another veterinary surgeon or a veterinary nurse and both should sign the CDR.
• If no errors or omissions are detected, steps should be taken to investigate the discrepancy.
• Practice clinical records for the CD use should be checked to ensure that all uses have been recorded.
• Interviews with relevant staff members may be required and, if so, the details recorded.
• The practice may wish to consider reporting the discrepancy to the local police or CDLO in line with the practice’s policy for reporting incidents (CDLOs may be able to offer advice on this).
• Security arrangements and procedures should be reviewed as soon as possible and, where applicable, codes to the CD cabinet or key safe changed.
• If there are concerns that a veterinary surgeon or veterinary nurse is involved in suspected theft, consideration should be given about whether or not to report it to the police.
• If a veterinary surgeon or veterinary nurse receives a caution of conviction in relation to theft, consideration should be given about whether or not to report it to the RCVS.

It is an offence to supply Schedule 2 or 3 CDs against an electronic or faxed prescription; the original prescription must be obtained before the CD is dispensed and retained for at least five years.

In practical terms, this means that a client could request a CD with an electronic prescription and the pharmacy could prepare this medication, but until the pharmacy receives the original copy of the prescription, it must not be dispensed.

The dispensing veterinary surgeon should undertake checks to ensure the prescription is genuine.

See also: VMD guidance on retail of veterinary medicines, which includes advice for online retailers.

It is an offence for one veterinary practice to supply another with CDs unless they have wholesale dealer’s authorisation from the VMD.

It may be possible to justify a one-off emergency supply if the welfare of a patient is at risk (e.g., if a practice runs out of methadone and needs to treat an animal in pain). The transaction should be clearly recorded in both the supplier’s and the recipient’s CDR.

Fentanyl is a Schedule 2 CD. It is therefore subject to safe custody requirements and must be recorded in the CDR. There is only one veterinary authorised fentanyl product, which is a POM-V Schedule 2 CD. It is an injectable solution authorised for use in dogs, for the control of significant post-operative pain and intra-operative analgesia.

The licensed product may not be suitable for a particular case and recourse may be had to fentanyl patches prescribed under the cascade. Fentanyl patches can provide highly effective pain relief after orthopaedic operations; however, their use also carries significant risks, including respiratory depression (particularly in small children) and risks to the patient and other household pets should they lick or ingest the patch.

Good practice guidance is as follows:

• Ideally, fentanyl patches should not be used if there are small children in the household.
• Veterinary surgeons should be mindful of the risks of ingestion by other animals.
• It is vital to get the client’s informed consent, which must include an explanation of the risks.
• The client must be told what to do if a fentanyl patch comes off and how to safely dispose of it.
• This information should be provided in writing and recorded on the client record.

Further information about the risks and best practice can be found in the BSAVA Client Information Leaflets (Membership required).

The import and export of CD raw materials and medicines (packaged for use) under Schedules 2, 3, and 4 Part I is licensed by the Home Office.

Schedule 4 Part II drugs must be carried on the patient (or pet owner), or in their luggage, through UK ports. Importation or exportation using postal or courier services is not permitted.

When in a medicinal form for personal use (i.e., already dispensed for a named animal or animals) these and Schedule 5 CDs do not need a personal import or export licence to enter or leave the UK.

Ketamine is a Schedule 2 CD and is subject to the strict storage, prescription, dispensing, destruction, and record keeping requirements that apply to all CDs in this schedule.

See also: The VMD’s Veterinary Medicines Guidance on CDs

• Misuse of Drugs Act 1971 (‘misuse of drugs’)
• Misuse of Drugs Regulations 2001 (‘misuse of drugs’)
• Misuse of Drugs Regulations (Northern Ireland) 2002 (‘misuse of drugs’)
• Misuse of Drugs (Safe Custody) Regulations 1973 (‘Safe Custody Regulations’)
• Misuse of Drugs (Safe Custody) Regulations (Northern Ireland) 1973 (‘Safe Custody Regulations’)
• The Controlled Drugs (Supervision of Management and Use) Regulations 2013
• Veterinary Medicines Regulations 2013 (as amended) (‘VMRs’)

All CDs are listed in Schedules 1 to 5 of the Misuse of Drugs Regulations 2001. These are numbered in decreasing order of severity of control. The Schedules relate to the drugs’ therapeutic usefulness, the need for legitimate access, and the potential harm caused by their misuse. In short, Schedule 1 CDs are subject to the most restrictions and Schedule 5 CDs are subject to the least.

Veterinary medicines include CDs in Schedules 2, 3, 4 and 5. Legal possession and supply of Schedule 1 CDs requires a Home Office license. This means that veterinary surgeons have authority to supply all but Schedule 1 CDs. CDs in Schedules 2-5 are categorised as follows:

• Schedule 2 CDs have therapeutic value, are highly addictive, and may be subject to abuse. Their use is strictly controlled, including special prescription, storage, destruction, and record keeping requirements.
• Schedule 3 CDs include barbiturates and some benzodiazepines. While less rigorously controlled than Schedule 2 CDs, they are subject to special prescription requirements. While not all Schedule 3 CDs are subject to the same legal safe custody requirements, it is an RCVS Core Standard requirement that all Schedule 3 CDs are securely locked away.
• Schedule 4 CDs are divided into 2 parts. Part 1 contains most of the benzodiazepines and Part 2 contains the anabolic and androgenic steroids. There are no additional special controls for Schedule 4 CDs.
• Schedule 5 CDs include preparations containing substances such as codeine or morphine, which are used in such low strength that they present little or no risk of misuse. There are no additional special controls for Schedule 5 CDs.

It is illegal to use or supply out of date or expired veterinary medicinal products, including CDs and so they must be disposed of. This includes part-used medicines that have been open for more than the designated number of days after being broached.

Out of date/expired CDs should be clearly labelled as such and stored in the CD cabinet until destruction but kept separate from in-date practice stock to avoid potential dispensing errors or re-use.

Whilst the Veterinary Medicines Regulations 2013 (as amended), do not prohibit veterinary surgeons from prescribing to their own animals, veterinary surgeons should not prescribe or dispense CDs to their own animals due to the increased risk of a real or perceived conflict of interest, and the possibility that their integrity could be questioned.

RCVS Code of Professional Conduct for Veterinary Surgeons:

1.5 Veterinary surgeons who prescribe, supply, and administer medicines must do so responsibly.

2.4 Veterinary surgeons must communicate effectively with clients, including in written and spoken English, and ensure informed consent is obtained before treatments or procedures are carried out.

4.3 Veterinary surgeons must maintain minimum practice standards equivalent to the Core Standards of the RCVS Practice Standards Scheme.

6.4 Veterinary surgeons must comply with legislation relevant to the provision of veterinary services.

Please see relevant chapters of RCVS Supporting Guidance and Practice Standards Scheme Modules and Awards for relevant guidance in relation to these Code of Conduct obligations, as set out in key guidance above

Any person who purchases or supplies any product containing a Schedule 2 CD must maintain a controlled drugs register (CDR).

CDRs must:

• Be a computerised system (not including a practice management system) or a bound book (which do 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 drug, with this information included at the head 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, obliterations, or alterations.
• Corrections must be made by a signed and dated entry in the margin or at the bottom of the page. This author should bracket the mistake and make a footnote detailing the mistake. The running balance should then be corrected as necessary.
• Be kept at the premises to which they relate and be available for inspection at any time. A separate register must be kept for each set of premises, and for each cabinet within those premises.
• Not be used for any other purpose.
• Be kept for a minimum of two years after the date of the last entry.

A computerised register must not be alterable, must be auditable, printable, and an appropriate back-up must be kept. A practice management system is not considered a sufficient computerised CDR unless it complies with the characteristics of a computerised CD register.

A separate register should be kept for CDs kept in cars for any length of time. If CDs are moved back to the practice after each visit, then it may be acceptable to have just one register in which the CD is signed out on departure and signed back in again on return.

CDs in Schedules 3, 4, and 5 do not need to be recorded in the CDR but invoices and usage records must be retained for 5 years.

The CDR must record the following information for all Schedule 2 CDs purchased and supplied:

• date supply received;
• name and address of supplier (e.g., wholesaler, pharmacy); and
• quantity received.

The CDR must also record the following information for all Schedule 2 CDs supplied (including by way of administration):

• date supplied;
• name and address of person or firm supplied;
• details of the authority to possess (prescriber or licence holder’s details);
• quantity supplied;
• the 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 the animal owner or animal owner’s representative (yes or no); and
• whether proof of identity of the person collecting was provided (yes or no).

The Register can be ‘maintained’ by a suitably trained person (e.g., a veterinary nurse), but ultimate responsibility lies with the veterinary surgeon.

The VMD has produced an Example CD Register to show how the use of CDs may be recorded.

A requisition is a supply of a CD for stock purposes rather than for a named patient. As of 30 November 2015, a specified form must be used for the requisition of Schedule 2 and 3 CDs. The form is available here.

It is good practice to retain a copy of all requisitions sent to the wholesaler.

Any CDs returned to the practice by clients should not be re-used and should be destroyed as soon as possible. The CD must be clearly labelled as a return and stored in the CD cabinet but separated from practice stock CDs to avoid potential dispensing errors or re-use. The requirements to witness and record the destruction of CDs do not apply to returned CDs, however, veterinary surgeons should consider making a record of any CD that is returned and having the destruction witnessed by another member of staff and signed against. This can be recorded in a separate book, or sheets designed for that purpose.

Where an animal has died part way through treatment, it is recommended that the prescribing veterinary surgeon makes every effort to recover and destroy any remaining product.

Standards Operating Procedures (SOPs) should provide clarity and consistency for all staff handling CDs. SOPs should define who in the practice is responsible for the management of CDs, and should provide guidance on:

• ordering CDs using requisition orders,
• where the CDs are stored,
• who is authorised to access to those CDs requiring secure storage and under what circumstances,
• record-keeping in relation to the use and disposal of CDs (including maintenance of a CDR where required),
• disposal and destruction of CDs (including who can witness Sch 2 destructions), and
• who should be alerted to any anomalies relating to CDs.

SOPs are working documents and should be kept up to date, reflecting current legal and good practice requirements.

The BSAVA Medicines Guide includes guidance for writing SOPs. CDLOs may also be able to provide advice to practices on their SOPs for CDs.

As a Schedule 3 CD, tramadol is exempt from safe custody requirements, however, it is an RCVS requirement that it is securely locked away. This should be in a separate cabinet from Schedule 2 CDs, for example, in a lockable draw.

Tramadol is a human medicine and so its use must be in accordance with the Cascade. The client’s written consent should be obtained for their animal to be treated under the Cascade.

The authority granted to veterinary surgeons to supply CDs is not restricted to the age of the recipient of the drug. However, particular care should be taken in these circumstances and veterinary surgeons should not supply CDs to anyone under the age of 18, unless in their professional judgement it is appropriate to do so.