Requirements for handling of controlled drugs and medicines

The Royal College of Veterinary Surgeons (RCVS) and the Veterinary Medicines Directorate (VMD) have the joint responsibility for ensuring that all registered veterinary practice premises in the UK are inspected and comply with their legal obligations under the VMRs.

 

A reminder from the RCVS and VMD of the requirements for handling of controlled drugs and medicines

Working together, both the RCVS and VMD have pinpointed some common issues found during practice inspections around controlled drugs – with inspections frequently finding issues with:

• record keeping of controlled drugs;
• broach dates for controlled drugs; and
• storage temperatures of medicines.

This joint feature from the RCVS and VMD is intended to support veterinary surgeons and registered veterinary nurses to better understand their responsibilities under the VMR in these areas – so that they can meet their important legal and professional responsibilities under this legislation.

In summary – this feature covers:

• What are controlled drugs?
• What are the requirements around CD record keeping?
• Discrepancies and reporting suspicious activity – what to do
• Broach dates – making sure medicine hasn’t surpassed its shelf-life
• What are the correct storage temperatures for medicines?
• T28 waste exemption

 

What are controlled drugs (CDs)?

Veterinary professionals who are involved in prescribing, supplying, recording, storing, disposing or destroying CDs are required to comply with the law on misuse of drugs and veterinary medicines.

Controlled drugs are listed in Schedules 1 to 5 of the Misuse of Drugs Regulations 2001 (MDR) - which categorises the drugs based on therapeutic usefulness and potential harm caused by misuse.

Schedule 2 CDs include veterinary medicines that are subject to the most restrictions. This is because they are highly addictive and may be subject to abuse. Their use is strictly controlled, including special requirements for prescription, storage, destruction and record keeping. Examples of Schedule 2 CDs include methadone, fentanyl, and ketamine.

Schedule 3 CDs include barbiturates and some benzodiazepines. While less rigorously controlled than Schedule 2 CDs, they are subject to special prescription writing requirements. Some, such as Buprenorphine, are also subject to special storage requirements.

Examples of Schedule 3 CDs include tramadol, gabapentin, and pregabalin. Schedule 3 CDs are exempt from safe custody requirements, however, the RCVS advises that all Schedule 3 CDs should be stored in a CD cabinet.

CDs in Schedule 4 are divided into two parts. Part one contains most of the benzodiazepines and part two contains the anabolic and androgenic steroids. There are no 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 special controls for Schedule 5 CDs. The only authorised Schedule 5 veterinary medicine is Pardale-V. 

 

What are the requirements around CD record keeping?

In 36% of PSS assessments, assessors found that there were issues around recording of CDs, often with inadequate record keeping. This issue has also been identified during VMD inspections, largely because the CD register format was incorrect.

The MDR sets out strict record keeping requirements for CDs, including key requirements that the CDs register must:

• be either a computerised system that does not allow entries to be deleted or edited once made or a bound book, which does not include any form of loose leaf register or card index;
• not have cancellations, obliterations or alterations;
• ensure corrections are made by a signed and dated entry in the margin or at the bottom of the page. The correction author must bracket the mistake and then make a footnote at the bottom of the page detailing the mistake. The running balance is then 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
• be kept for a minimum of 2 years after the date of the last entry.

Receipt and administration of Schedule 2 CDs must be recorded in the register. CDs in Schedules 3, 4 and 5 do not need to be recorded in the register.

The register should record the supplier of the CD and the quantity received. Following supply/administration, the quantity should be recorded as well as client details, animal details, the prescribing vet’s name, and a running balance of each CD. The VMD has produced an example CD register which can be found on the GOV.UK website.

The register can be maintained by a suitably trained person - ideally a registered veterinary nurse. However, ultimate responsibility will remain with the veterinary surgeon. This means that the vet does not have to be the one to sign the CD register and a suitably trained person can instead write in their name. However, it is strongly advised that the name of a vet is also recorded against every entry.

The CD register should be regularly audited to ensure that entries in the register and stock of CDs can be reconciled. Where a practice is a member of PSS, an assessor will expect to see evidence of weekly, full audits.

 

Discrepancies and reporting suspicious activity – what to do

The RCVS advises that there should be a procedure in place for dealing with discrepancies, which details the arrangements for investigating and reporting. The balances in the CD register should always tally with the quantities of CDs in the CD cabinet. If they do not, the discrepancy must be reported to the appointed senior veterinary surgeon and steps must be taken to investigate and resolve the matter.

It is important for veterinary surgeons to store CDs securely and appropriately in a suitable cabinet to prevent unauthorised access. All cabinets must comply with the Misuse of Drugs (Safe Custody) Regulations 1973. 

The practice may wish to consider reporting a discrepancy to the local police or Controlled Drugs Liaison Officer in line with the practice’s policy for reporting incidents. If there are concerns that a veterinary surgeon or veterinary nurse is involved in suspected theft, the RCVS should be notified as well as the police.

Vet practices are potential targets for thieves because controlled drugs, which can be subject to abuse, are often stored on the premises. To prevent crime we encourage you to report any suspicious activity to the police. This can be any incident, event, individual or circumstance that seems unusual or out of place. An example of suspicious activity could include an individual, not registered as a client, coming into your practice to request a CD or suspicious vehicles parked in or around your business premises. Please do not put yourself at any risk to obtain information, but if you have any concerns about a person or a vehicle, please report this to the police.

More information on CDs can be found within the RCVS Controlled Drugs Guidance, along with VMD guidance on controlled drugs and veterinary medicines.

 

Broach dates – making sure medicine hasn’t surpassed its shelf-life

It is an offence under the VMR to supply or administer an out of date or expired medicine. This applies to all veterinary medicinal products, including CDs.

All multi-dose injectables will have an “in use shelf-life” that tells the user how long the vial can be used for, after it has first been broached. It is an offence under the VMR to use a medicine for longer than this period. Multi-dose vials should be marked with the date of first opening, or the date of expiry, and any medicine left in the vial after the specified time must be discarded/denatured. If the medicine is a Schedule 2 CD, denaturing must be independently witnessed.

 

What are the correct storage temperatures for medicines?

In 47% of PSS assessments, assessors found that there was lack of evidence of temperature monitoring for medicines.

Medicines need to be stored at the correct temperature in accordance with the Summary of Product Characteristics.

Where medicines are to be stored at ambient room temperature, the temperature should be kept between 8°C and 25°C and should be monitored. This is especially important where the outside temperature is particularly high or low.

Medicines such as vaccines and insulin need to be refrigerated between 2°C and 8°C. They should only be removed from the refrigerator for immediate use.

Fridge temperatures should be monitored daily, ideally by the same person, and the results logged, or if monitored by using an electronic data logger these should be alarmed, the alarm checked daily to make sure it has stayed within range and the data downloaded weekly.

A written standard operating procedure should be in place, detailing the actions to be taken should the temperatures fluctuate outside the recommended limits.

 

T28 waste exemption

The Environment Agency have advised that pharmacies and veterinary surgeons should apply for a T28 exemption certificate as it enables them to comply with the requirements of the Misuse of Drugs Regulations 2001 by denaturing controlled drugs prior to their disposal. Veterinary surgeons can apply online free of charge.

Further guidance on the T28 Exemption for England is available, as well as information for Wales.

In Scotland, the destruction and disposal of CDs are subject to the Waste Management Licensing (Scotland) Regulations 2011. Veterinary surgeons and pharmacists are required to register with the Scottish Environment Protection Agency (SEPA) under the regulations to enable them to comply with the requirements of the Misuse of Drugs Regulations 2001 by denaturing CDs prior to their disposal. Further details can be found on the SEPA website (see guidance under paragraph 39).

Further guidance on exemption or waste management licences for Northern Ireland can be found on the Northern Ireland Department of Agriculture, Environment and Rural Affairs website and on the legislation.gov.uk website. Alternatively, you can contact the Northern Ireland Environment Agency for information.