Classification
Under the Misuse of Drugs Regulations 2001, Controlled Drugs are classified into five Schedules according to their therapeutic usefulness, need for legitimate access and potential for misuse. Schedule 1 Controlled Drugs have the highest level of restriction, Schedule 5 the lowest. A veterinary surgeon has the authority to supply Schedule 2, 3, 4 and 5 Controlled Drugs.

Schedule 1 drugs

• Schedule 1 includes hallucinogenic drugs, ecstasy and cannabis, which have virtually no therapeutic use.
• Production, possession and supply of these drugs is limited in the public interest and veterinary surgeons have no authority to possess drugs in this Schedule.

Schedule 2 drugs

• Schedule 2 includes morphine, pethidine, fentanyl, alfentanil, methadone, the amphetamines and secobarbital.
• These drugs are subject to safe custody requirements and should be stored in a suitable locked cabinet secured to the fabric of the building at all times.
• Receipt and supply of Schedule 2 Controlled Drugs must be recorded in a Controlled Drugs Register.
• Written requisitions must be made to wholesalers.
• Schedule 2 Controlled Drugs must not be destroyed, except in the presence of a person authorized by the Secretary of State.
• Written prescriptions are valid for 28 days.
• There are special requirements for extra information on written prescriptions.
• Repeat prescriptions are not permitted.
• Prescriptions cannot be faxed or sent electronically.

Schedule 3 drugs

• Schedule 3 includes buprenorphine, pentobarbital, phenobarbital, midazolam and some minor stimulants, including benzphetamine.
• These drugs are subject to safe custody requirements (with some exceptions) but do not have to be recorded in the Controlled Drugs Register.
• Written requisitions must be made to wholesalers.
• Written prescriptions are valid for 28 days.
• Witnessed destruction requirements apply only to importers, exporters and manufacturers.
• There are special requirements for extra information on written prescriptions.
• Repeat prescriptions are not permitted.
• Prescriptions cannot be faxed or sent electronically.

Schedule 4 drugs

• Schedule 4 is split into two parts:  part I includes benzodiazepines and ketamine; part II contains anabolic and androgenic steroids.
• They are not subject to safe custody requirements. However, as ketamine is a substance of abuse, the Royal College of Veterinary Surgeons (RCVS) recommends that it is stored in the Controlled Drugs cabinet and its use recorded in an informal Register.
• Written prescriptions are valid for 28 days.
• Witnessed destruction requirements apply only to importers, exporters and manufacturers.

Schedule 5 drugs

• Schedule 5 includes preparations of certain Controlled Drugs, such as codeine and morphine, which are exempt from full control when present in medicinal products of low strength.
• They are exempt from all Controlled Drug requirements, other than the requirement to keep invoices for 5 years.

Summary of legal requirements

(a) = Except secobarbital.
(b) = Although safe custody requirements apply, currently most Schedule 3 Controlled Drugs are exempted. Those requiring safe custody are buprenorphine, temazepam, flunitrazepam, diethylpropion and midazolam.

A search can be performed to check the legal class of veterinary and human medicines, using the generic name of the drug. Click here to access The Royal Pharmaceutical Society of Great Britain (RPSGB) online search.

Storage

• Schedule 2 and 3 Controlled Drugs should be kept in a locked cabinet. This cabinet should conform to British Standards and be attached to the fabric of the building.
• The specifications with which safes, cabinets and rooms must comply are given in detail in the Misuse of Drugs Regulations 2001 (available from The Stationery Office).
• Special storage boxes are available that can be secured to the car for storage of Controlled Drugs, and these should be used where possible. A locked bag or box can be used to store Controlled Drugs for short periods of time if a veterinary surgeon requires them on a house call, but this bag or box should not be left unattended in the car for any length of time.
• Each veterinary surgeon is responsible for the record keeping on incoming and outgoing Controlled Drugs from their bag, box or car.
• Access to the Controlled Drugs cabinet should be restricted, with keys kept by a responsible person(s) at all times. It is not acceptable to have a communal key kept in a drawer or other non-secure place.
• A key register can be used to pass responsibility from one key holder to another, e.g. for overnight and during the day.
• Alternatively, each veterinary surgeon can be issued with their own key which they are responsible for.
• If a practice is found not to be complying with the Misuse of Drugs Regulations 2001, they can be prevented from keeping Controlled Drugs by the Home Office.

Record keeping

• When ordering Schedule 2 and 3 Controlled Drugs, a written requisition signed by a veterinary surgeon should be supplied to the wholesaler. This requisition must state the veterinary surgeon’s name, address and professional qualifications.
• All invoices relating to Controlled Drugs should be kept for 2 years.
• A separate Register should be kept for each premises and for each cupboard within a premises if there is more than one. This Register should be in the form of a bound book or computerized record.
• Within this Register, each drug, form and strength must have a separate section with the medicine name and strength written at the top of each page.
• Entries must be made in chronological order with no alterations. If a mistake is made, an explanatory note must be made at the bottom of the page or margin.
• Registers may only be kept electronically if safeguards are built into the software to ensure the following:
  – The author of each entry is identifiable
  – Entries cannot be altered at a later date
  – A log of date entered is kept and can be recalled for audit purposes.
• The Register must be completed within 24 hours. For example, it is acceptable during procedures to mark on a white board the quantities administered and complete the Register at the end of the day.
• Legally the Register should be kept for 2 years; however, since all other paperwork relating to the Veterinary Medicines Regulations (VMR) must be kept for 5 years, this is recommended.

Controlled Drugs Register
The following information should be recorded in the Controlled Drugs Register:

• Controlled Drugs received:

– Date received
– Name and address of the person or supplier from whom the drug was obtained
– Amount received
– Form in which received
– Running total (recommended).

• Controlled Drugs supplied:

– Date supplied
– Name and address of the person to whom the drug was supplied
– Name and signature of veterinary surgeon
– Amount supplied
– Form in which supplied
– Running total (recommended).

If a Schedule 2 Controlled Drug is dispensed to a client, the following should also be recorded:

• Name of the person collecting the Controlled Drug
• Was proof of identity of the person collecting the drug requested (yes/no)? Record details.

Standard operating procedures
All healthcare providers holding stock of Controlled Drugs are required to have in place standard operating procedures (SOPs) that cover the following:

• Who has access to the Controlled Drugs
• Where the Controlled Drugs are stored
• Security in relation to the storage and transportation of Controlled Drugs
• Who is to be alerted should complications arise
• Record keeping, including maintaining the Controlled Drugs Register and maintaining a record of Controlled Drugs returned by clients.

Prescription requirements

• One of the changes as a result of the Shipman enquiry is that prescriptions for Controlled Drugs are now only valid for 28 days. Prescriptions for other POM-V drugs are valid for 6 months.
• Written prescriptions for Controlled Drugs should be limited to 30 days’ supply.
• Repeat prescriptions are not allowed for Schedule 2 and 3 Controlled Drugs.
• Unlike prescriptions for Controlled Drugs for human use, written prescriptions for Controlled Drugs for animal use do not have to be on a standard form.
• In addition to the usual prescription requirements, written prescriptions for Schedule 2 and 3 Controlled Drugs must include:
  – The name and form of the drug
  – The quantity to be supplied in words and figures
  – The strength of preparation (if more than one strength available)
  – The dose to be administered (not ‘give as required’ or ‘give as directed’)
  – The name of the person to whom the Controlled Drug is to be delivered
  – The RCVS registration number of the veterinary surgeon
  – The words ‘for animal(s) under my care’ or similar.

Destruction of Controlled Drugs

• Controlled Drugs awaiting destruction should be stored separately from current stock but within the Controlled Drugs cabinet.
• If a client returns a Controlled Drug that the practice has dispensed, it should not be entered into the Controlled Drugs Register.
• A separate book should be kept to record the return and destruction of these products. Although this is not a legal requirement, it is strongly recommended as there is a requirement to have in place an SOP detailing how medicines returned from clients should be handled.
• Destruction of out-of-date Controlled Drugs must be witnessed by either a member of the Animal Medicines Inspectorate, an inspector of the RCVS Practice Standards Scheme, a veterinary surgeon who is independent of the practice, or a police officer (such as a Controlled Drugs Liaison Officer).
• An entry must be made in the Controlled Drugs Register detailing the items destroyed and the running total updated. This entry must be signed by the authorized witness.
• Method of destruction:
  – Use a denaturing kit where possible
  – Wear gloves
  – Crush solid dosage forms in a mortar and pestle and add to the denaturing kit
  – Pour in liquids
  – Add parenteral preparations, open ampoules and empty into denaturing kit, and remove medicines from vials
  – Fold any transdermal patches in on themselves and add
  – Fill denaturing kit with water and store in the Controlled Drugs cupboard for 24 hours until denaturing is complete
  – Incinerate with other pharmaceutical waste.

Controlled Drug Liaison Officers

• Most police forces in the UK have Controlled Drug Liaison Officers (CDLOs) who can advise on all aspects of Controlled Drug use within veterinary medicine, as well as providing information on the abuse of drugs and crime statistics. CDLOs are authorized to witness the destruction of Controlled Drugs.
• A list of CDLOs can be found at www.vmd.gov.uk/VetSQP/pcdl_officers.pdf

Useful websites

Royal College of Veterinary Surgeons (RCVS) – Advise note No. 23
Veterinary Medicines Directorate (VMD) – Guidance note No. 29