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 must store CDs securely and appropriately in a suitable cabinet to prevent unauthorised access. All Schedule 2 CDs, with the exception of quinalbarbitone, as well as Schedule 3 CDs containing buprenorphine, diethylpropion, flunitrazepam, and temazepam, are legally required to be stored in a locked cabinet which is compliant with the Safe Custody Regulations.

While all other Schedule 3 CDs, including tramadol, pentazocine, the barbiturates, gabapentin, and pregabalin, as well as Schedule 2 drug quinalbarbitone are not subject to the same Safe Custody Regulations, it is an RCVS requirement that they are securely locked away. They can be locked away in a separate cabinet from Schedule 2 CDs, for example, in a lockable drawer.

The Safe Custody Regulations describe the requirements for CD cabinets, safes and rooms, and the standards to which they must be manufactured and/or built.

Location of the cabinet

Cabinets should be situated in a secure place away from public view.

The room housing the locked cabinet should be lockable and tidy to avoid drugs being misplaced. The room should not normally be accessible to clients, however, if clients do have to enter the area, they should be continuously supervised until they leave. Ideally, CDs should be kept in a separate cabinet from other medicines.

Design and construction of the cabinet

Cabinet design and construction must adhere to the Safe Custody Regulations.

The locked cabinet is constructed and maintained to prevent unauthorised access to the CDs. There should be no indication on the outside of the container that CDs are kept inside.

It is important that cabinets meet the requirements set out in the Safe Custody Regulations as deviation from these requirements increases the risk of theft. The British Standard coding for medicine cabinets is BS 2881:1989 and has three levels of security. An assessment of the risk should be made and a cabinet commensurate with that risk purchased. The most appropriate cabinet should be carefully selected for individual premises.

Schedule 2 of the Safe Custody Regulations stipulate structural requirements in relation to safes, cabinets, and rooms used for storing CDs. Home Office guidance note titled, “Security Guidance for all existing or prospective Home Office Controlled Drug Licensees and/or Precursor Chemical Licensees or Registrants” (2020) summarises cabinet construction requirements.

In addition, it is recommended that:

• The cabinet must be bolted to the wall or floor.
• It is ideally double-locked with separate keys.
• The lock must be different to any other lock in the premises.
• Keys must only be available to authorised members of staff.
• The cabinet must not have anything attached to it which identifies it as a CD cabinet.
• The cabinet must be kept locked when not in use.

Further advice on cabinets

Retailers of CDs cabinets can confirm that they meet the legal requirements and practices may wish to request formal confirmation when purchasing such cabinets. In addition, some police forces in the UK have Controlled Drugs Liaison Officers (CDLOs) who offer advice on various matters, including safe storage. Contact details for CDLOs by area can be obtained from the Association of Police Controlled Drugs Liaison Officers.

If a veterinary surgeon requires a supply of Schedule 2 or 3 drugs for call out visits, the CDs should be transported in a locked glove compartment or in a lockable bag, box, or case which should be kept locked when not in use. If such a bag, box, or case is locked, it is considered a suitable receptacle for storing CDs. Simply being placed in a locked car is not suitable.

Veterinary surgeons should make sure the locked bag, box, or case is not left unattended in a car for any length of time, however, if this is unavoidable, they should be kept within a locked receptacles which is fixed within the boot of the car. If the car cannot be modified to install such a receptacle, it may be reasonable to secure the lockable bag, box, or case to a structure in the car, for example, using a metal cable tethered to an anchor point in the car, such as the seat runners or seatbelt post, or bolting the lockable receptacle to the floor of the car. In any case, the receptacle should be kept out of sight.

Veterinary surgeons should use their professional judgement when storing CDs in cars and they must take reasonable steps to minimise unauthorised access. This might require them to consider particular risk factors, such as whether practice cars are easily identifiable, whether practice cars have been targeted in the past, and where practice cars are parked. Veterinary surgeons considering leaving CDs in their car overnight may have additional considerations and in some cases, it may be safer for them to be removed from the car and returned to the practice.

Veterinary surgeons who keep a stock of CDs in their car must keep a separate controlled drugs register (CDR). This is required for veterinary surgeons who keep CDs in their car for any length of time, except in the case where CDs recorded on the practices’ CDR are taken out of the premises for a short-term.

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.

Veterinary surgeons must ensure that CDs are destroyed (rendered unusable/irretrievable) before safe disposal. There are several methods of doing this.

There are commercially available denaturing kits which can be used to destroy CDs (including out of date and returned CDs). Veterinary surgeons should follow the instructions specific to the kit, as these may differ from kit to kit.

Residual or waste drugs

The VMD advises that 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.

Waste/residual CDs are not usually denatured using kits because, as their destruction is required daily, this would prove too costly. Instead, residual CDs can be rendered irretrievable by collection into clumping cat litter, and tablets may be crushed and mixed with soapy water. These can then be periodically sent as pharmaceutical waste through the waste contractor.

Destruction of CDs is subject to a number of important considerations as set out below.

The legal requirements to witness the destruction of Schedule 2 CDs apply to stock, i.e., CDs that have not been issued or dispensed to a patient. Left over CDs, for example liquids, which are still required for use, are also considered stock. A witness is required if these are to be destroyed on expiry or for other reasons.

There is no legal requirement to have the disposal of waste product witnessed. The VMD advises that 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.

Frequency of destruction

Destruction of CDs should occur with sufficient frequency (for example, monthly) to ensure that excessive quantities are not stored awaiting destruction. The frequency should be determined locally following a risk assessment.

Witnessing

Schedule 2 CDs (and Schedule 3 and 4 CDs that have been prepared extemporaneously for use under the prescribing Cascade) must be destroyed in the presence of, and instructed by, any of the following:

• An Inspector appointed under the VMRs (this includes a VMD inspector or RCVS Practice Standards Scheme Assessor)
• A veterinary surgeon independent of a practice where the destruction takes place
• A person legally authorised to witness the destruction of CDs such as a CDLO

In accordance with the guidance from the VMD, in order to be considered independent of the veterinary practice where CDs need to be destroyed, a veterinary surgeon:

• may not demand or accept any form of payment, beyond the 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.

Although there is no legal requirement to do so, it is good practice that CDs from Schedules 3-5 are also destroyed prior to safe disposal.

Recording destruction and disposal

Where the witness is an independent veterinary surgeon, they should record their RCVS number and confirm their independence in writing in the CDR, and for all destruction and disposal, the following further information should also be recorded and signed by the witness:

• The name of the CD;
• The date of destruction;
• The quantity destroyed;
• The form;
• The strength; and
• The name and signature of the professional destroying the CD.

Residual or ‘waste’ CDs left in single use vial

Any CDs left over in a single use vial which is considered unusable is considered waste product, not stock. Both the amount administered, and the amount denatured, should be recorded on the same line of the CDR to ensure that the running balance tallies, e.g., if 10mg of morphine is dispensed to a patient and only 5mg is administered, the record should show that 5mg was given and 5mg was wasted. This ensures that the whole vial or ampoule is accounted for in the CDR.

It is good practice for the entry in the CDR to be countersigned by another member of practice staff. The most suitable person to provide the countersignature would be another veterinary surgeon or registered veterinary nurse.

Out of date stock and returned CDs

Out of date/expired stock should not be marked out of the running balance in the CDR until it is destroyed.

As returned CDs have been dispensed to a patient, there is no requirement to have the destruction witnessed or recorded. However, it is good practice to have it witnessed by another member of staff. It is also good practice to record returned CDs that are destroyed and to have a second member of staff countersign this. This record should be kept in an alternative register, specifically for this purpose, and not in the CDR.

Returned CDs should be stored in the CD cabinet, but clearly separated from the rest of the stock, until destroyed.

Special requirements

Any special handling or disposal requirements (e.g., for cytotoxic medicines) must be observed.

 

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

Key holders

Practices should have appropriate security arrangements for keys and key holders.

CD cabinets must only be accessed by a veterinary surgeon or a nominated responsible person at the practice who has been authorised by the veterinary surgeon.

It is recognised that sometimes a locum may need to have access to the key if they are in sole charge. A key holder who is not a veterinary surgeon should only remove CDs from the cabinet and/or return them to the cabinet on the specific authority of a veterinary surgeon. While the task itself can be delegated, the legal and professional responsibility will remain with the veterinary surgeon.

Any nominated persons within the practice to hold keys should have appropriate training and, ideally, should be a qualified veterinary surgeon or veterinary nurse. Locums and students should not be given access to the key (unless a locum is in sole charge as above).

Security arrangements for the key

Keys to the CD cabinet should not be kept with keys to other parts of the building. The key should not be left in a ‘secret’ place where there is free access to it and the use of combination key boxes is recommended (see below).

It is recommended that the same level of security controls are applied to all cabinet keys (including spares), as would be to the CDs contained within the CD cabinet, since failure to ensure that will lead to security arrangements being compromised. Further, it is recommended that access to individual keys should be audited and recorded, with a witnessed key signing-in and out procedure. It is accepted that all veterinary surgeons may have their own key, such that signing-in and out is not required.

Detailed information on key security is set out in Home Office, Security guidance for all existing or prospective Home Office Controlled Drug Licensees and/or Precursor Chemical Licensees or Registrants. Veterinary surgeons and veterinary nurses are strongly encouraged to read this document in full.

Key boxes

Practices may use key boxes with combination locks. A combination key box which is wall-mounted is acceptable practice provided that the combination is changed regularly. Where there has been a change in staff members (e.g., locums) it is recommended that the combination is changed.

Key boxes should not be located next to the CD cabinet and should ideally be installed in an area where it is not easily seen.

Key boxes may be considered for holding the key for a cabinet or small safe. It is not considered good key management practice to lock a key in a desk drawer or other office furniture, irrespective of whether the key is locked in an additional box. It is also recommended that spare keys are kept in a separate safe to which only very few employees have access.

Combination locks on CD cabinets

A CD cabinet that has been fitted with a combination lock is encouraged, to avoid the need to make separate arrangements for the safe storage of a key. The Home Office guidance provides detailed information on the use of combination locks. In short, if practices decide to use combination locks, the combination should only be known to those persons authorised to operate the lock. The following rules are regarded as good practice by the Home Office:

• Combinations should not be written down;
• Combinations that are issued to individual members of staff should not be shared with anyone else, including colleagues;
• All combinations should be changed regularly, or at least every six months as a minimum, to prevent the locks from being compromised;
• Combinations should also be changed whenever there are grounds to suspect that they may have become known to an unauthorised person;
• Regardless of whether a combination is shared by a group of people or issued to individuals, it should be changed whenever a member of that group or the individual to whom it was issued leaves the practice or otherwise no longer requires access to the lock.

• 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 (‘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 medicines, 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.

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.

In ordinary circumstances, CDs should not be sent through the post. In exceptional circumstances (e.g., for a client unable to travel to the practice and unable to send a representative), then recorded delivery or ‘signed for’ courier delivery are most appropriate.

Prescription medicines may be sent via Royal Mail, but it is advisable to check current details on prohibited goods and packaging guidelines with the Royal Mail first.

Whilst the Veterinary Medicines Regulations 2013, 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.

Only a veterinary surgeon can prescribe CDs for an animal and CDs (and all POM-Vs) can only be supplied/dispensed where there is a valid prescription as per the VMRs. The prescription can be written or verbal, and records of verbal prescriptions may be written in the clinical notes/on the practice system.

A written prescription is required if the drug is to be supplied somewhere other than the registered veterinary practice premises where the prescribing veterinary surgeon made the prescription.

Written prescriptions

The requirements set out in the VMRs for written prescriptions, i.e. scripts, must be met. To be valid, a written prescription must include:

• the name, address and telephone number of the person prescribing the product;
• the qualifications enabling the person to prescribe the product;
• the name and address of the owner or keeper;
• the identification (including the species) of the animal or group of animals to be treated;
• the premises at which the animals are kept if this is different from the address of the owner or keeper;
• the date of the prescription;
• the signature or other authentication of the person prescribing the product;
• the name and amount of the product prescribed;
• the dosage and administration instructions;
• any necessary warnings;
• the withdrawal period if relevant; and
• if it is prescribed under the cascade, a statement to that effect.

The following additional requirements apply to written prescriptions for CDs listed in Schedule 2 or 3:

• A declaration that the CD is prescribed for an animal or herd under the veterinary surgeon’s care.
• The name of the animal to whom the CD prescribed is to be administered.
• Name and form of the CD, even if only one form exists.
• Amount of the CD prescribed, in both words and figures.
• Strength of the preparation (if more than one strength is available).
• Dose to be administered (‘take as directed’ or ‘take as required’ are not acceptable).
• RCVS registration number of the prescribing veterinary surgeon.

Written prescriptions must be signed in ink by the person issuing them and may be hand-written, typed in a computerised form, or computer generated.

Electronic signatures, or any form of authentication other than a signature in indelible ink is not permitted for prescriptions of Schedules 2 and 3.

The Post-dating of prescriptions for Schedules 2 and 3 CDs is only permitted in specific and exceptional circumstances (e.g., if there is to be a delay in the start of the 28-day period due to a bank holiday). It is a matter for the professional judgement of the prescribing veterinary surgeon as to whether it is appropriate to prescribe in this manner and they must consider the risk of diversion of the CD and responsibility will remain with them.

Validity and repeat prescriptions

The validity period of a prescription relates to the time in which the prescription can be dispensed, i.e., the CD can be dispensed within 28 days of the prescription being made.

CDs in Schedules 1 to 4 have a prescription validity of up to 28 days. Prescriptions for Schedule 5 CDs (and all other prescription medicines) have a validity of up to 6 months. A prescription for a CD in Schedule 2 or 3 can only be dispensed against once and that must be within the 28 days of the validity of the prescription.

Single prescriptions with multiple dispenses (i.e., repeat prescriptions) are not allowed for CDs in Schedules 2 and 3, however an instalment prescription can be used if required (see below).

Repeat prescriptions for Schedule 4 and 5 CDs are permitted. The repeats must be dispensed within the period of validity of the prescription (28 days or six months).

If the prescription is not repeatable, veterinary surgeons should consider stating this on the prescription to avoid prescription misuse. If the prescription has a section that states number of repeats, veterinary surgeons should consider writing ‘no repeats’ or crossing this out if the prescription is not to be repeated.

Quantity

Prescribing for acute conditions

CDs are subject to additional legal requirements as they have been identified as at risk of abuse or misuse. For acute conditions, the maximum quantity of CDs prescribed should not exceed 30 days’ worth; exceptionally, to cover a justifiable clinical need and after consideration of any risk, a prescription can be issued for a longer period, but the reasons for the decision should be recorded in the animal’s clinical notes.

If more than 30 days’ worth of treatment is prescribed, the prescribing veterinary surgeon must be sure that the owner is competent to use the medicine safely.

Prescribing CDs for chronic conditions

Usually, the maximum quantity of CDs prescribed should not exceed 30 days; exceptionally, to cover a justifiable clinical need and after consideration of any risk, a prescription can be issued for a longer period, but the reasons for the decision should be recorded in the animal’s notes.

Where a veterinary surgeon considers that prescribing more than 30 days’ worth is appropriate but does not feel comfortable supplying more than that in one go, they may supply the medicine at intervals (where the client is buying from their practice) or give the client an instalment prescription to be fulfilled elsewhere (see below).

Please note that, generally, CDs should not be sent through the post (see section 17, above).

Prescribing CDs for chronic conditions: what to write in the notes

Where a veterinary surgeon decides it is justifiable to prescribe more than 30 days’ worth of CDs and, exceptionally, decides to supply the whole quantity in one go, they should note their reasons for doing so (as per the above guidance) and ensure that the following details are recorded:

• the product name
• the pack size/volume/quantity of the product
• the dosage instructions
• any necessary warnings or instructions

Where a veterinary surgeon decides it is justifiable to prescribe more than 30 days’ worth of CDs but wishes to supply the medicine at intervals, in addition to the above, they should record how much to be supplied at each interval and the frequency/dates of the intervals.

Instalment prescriptions

Where more than 30 days’ worth of CDs are prescribed and the client requests a prescription to be fulfilled elsewhere, unless there are exceptional circumstances that mean this is not appropriate, veterinary surgeons should issue the client with an instalment prescription to be dispensed by a supplier of their choice in order to reduce the risk of misuse.

Veterinary surgeons should bear in mind that instalment prescriptions are not commonly used in this way in human medicine and, as such, pharmacists used to dealing with prescriptions from doctors may approach these with caution.

Please remember that instalment prescriptions are instructions to supply and must be followed precisely, for example where it has been specified that a specific amount should be supplied on a specific date, the person dispensing is required to do exactly as instructed. This means that when an instalment prescription is used, the client is not able to get it filled a day earlier or later for convenience. As such, veterinary surgeons should ensure the client is fully aware of what has been stated and consider this lack of flexibility before issuing an instalment prescription.

In line with RCVS guidance, veterinary surgeons may make reasonable charges for written prescriptions, but must not discriminate between those who are supplied with a prescription and those who are not, in relation to fees charged for other goods or services.

Retention of prescriptions

Veterinary surgeons supplying Schedule 2 and 3 CDs against another veterinary surgeon’s prescription should:

• Retain the prescription on the premises from which the drug was supplied for at least 5 years;
• Mark on the retained prescription the date on which the supply was made; and
• Record the name of the person who collected the CDs in the CDR (for Schedule 2 CDs only).

Suspected prescription misuse (which could include an alteration to an existing prescription or prescription fraud) can be reported to the Veterinary Medicines Directorate (VMD) via its dedicated prescriptions misuse page.

Making such a report will, in most cases, require a veterinary surgeon to release confidential information about their client to the VMD. Reporting cases of prescription misuse is in the public interest and in most cases a report to the VMD will be a justified breach of client confidentiality. See Chapter 14 of the RCVS Guidance for further advice in relation to breaching client confidentiality.

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.

It is recognised that there are currently no suitable electronic registers for veterinary practices, however, CDLOs may be able to advise further on possible options.

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.

Veterinary nurses may draw up and administer CDs provided that a veterinary surgeon has prescribed them to a specific animal, decided on the dose, has authorised that it be drawn up, and is confident that the veterinary nurse is competent to draw up and administer the prescribed dose. Whether or not to delegate the drawing up and administration to a veterinary nurse should be considered on a case-by-case basis.

A veterinary surgeon does not need to be present when the CDs are drawn up or administered, however, the legal responsibility for the administration of the CDs remains with the prescribing veterinary surgeon. For this reason, it is important that appropriate safeguards are in place. It is good practice, for example, to have a SOP in place which sets out the procedure for accessing CDs and the protocol for recording their use. As well as access to the CD cabinet being limited to authorised individuals within the practice (see above), for added safeguarding, practices should consider having two responsible persons (i.e., two veterinary surgeons, one veterinary surgeon and one veterinary nurse, or two veterinary nurses under veterinary direction) jointly accessing the cabinet, drawing up the medication, and completing the CDR. The medication should then be administered to the patient immediately, witnessed by the second colleague.

Veterinary nurses may be asked to administer CDs out of hours when there is no veterinary surgeon on the premises. In these cases, veterinary surgeons must prescribe the drug to an animal under their care and decide on the dose. They may also wish to draw up the correct dose, labelling it, and leaving it with instructions as to what time it is to be given to a particular patient before going off duty. A veterinary nurse cannot decide to give a CD or change the dose (i.e., make prescribing decisions) and may only act under the direction of a veterinary surgeon in this regard.

CDs for euthanasia in practice

Veterinary nurses may be directed by a prescribing veterinary surgeon to administer a CD for the purposes of euthanasia, however, in practice, it is usually the prescribing veterinary surgeon who performs euthanasia.

CDs for euthanasia at a home visit

In relation to euthanasia at a home visit, because there should be appropriate proximity between the prescribing and directing veterinary surgeon and the administering veterinary nurse, it is not appropriate for a veterinary surgeon to send a veterinary nurse out on a home visit to euthanise an animal with a CD.

Discrepancies between the amounts recorded as used, the volume of the CD left in the vial, and the total stated volume, must be avoided. 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. There may also be some wastage within the needle and hub of the syringe each time the product is withdrawn, known as ‘deadspace’.

The Home Office has advised the VMD that discrepancies of up to 10% should not cause undue concern. Reconciliation at the end of each bottle is recommended to avoid consolidation of errors. A balance of less than expected should be treated with greater concern. While efforts should always be made to minimise wastage, the Home Office, the VMD, and RCVS Practice Standards Assessors are all aware that some wastage due to deadspace will be unavoidable and these small discrepancies should always be recorded.