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 drugs used in veterinary practice such as 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. Schedule 3 drugs should be disposed of in the same manner as Schedule 2 drugs. 
• 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. 

 Prescriptions

•  In addition to the usual legal requirements for written prescriptions, for Schedule 2 and 3 Controlled Drugs, the written prescription must also contain the following information:
  • The name and form of the drug
  • The amount to be supplied in words and figures
  • The strength of the preparation (if more than one strength is 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 RVCS registration number of the veterinary surgeon
  • A declaration stating that the animal is under the veterinary surgeon's care.
•  It is good practice to prescribe no longer than 28 days' supply for Schedule 2-5 Controlled Drugs, unless in a situation of long-term ongoing medication (e.g. treating epilepsy in dogs).
• It is an offence to supply a Schedule 2 Controlled Drug against a faxed or emailed prescription.
• Written prescriptions for Schedule 2, 3 and 4 Controlled Drugs are valid for 28 days. Written prescriptions for Schedule 5 Controlled Drugs are valid for 6 months.
• Prescriptions for Controlled Drugs must not be altered unless authorized by the prescriber. A pharmacist or supplying veterinary surgeon may supply against a prescription with minor typographical errors, providing that they are satisfied they are supplying in accordance with the prescriber's wishes and they annotate the prescription with the amendment and their initials.

Storage

• A search can be performed to check the legal classification of veterinary medicines.
• An alphabetical list of human drugs and their legal classification can be found here.
• 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 or online).
• Clients should not normally have access to rooms where Controlled Drugs are stored. If they enter the area, they should be supervised at all times.
• 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 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 of 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.

Supply

• A veterinary surgeon can supply Controlled Drugs that they have prescribed themselves or those prescribed by another veterinary surgeon against a written prescription.
• When supplying Schedule 2 or 3 Controlled Drugs, the veterinary surgeon or pharmacist must ensure that the prescription is genuine, that the signature is authentic and the prescriber's address is accurate. This may involve contacting the prescribing veterinary surgeon.
• After supplying a Controlled Drug against a written prescription, the prescription form must be marked with the dispensing date and retained on the premises for 5 years.
• Veterinary nurses are not allowed to possess or supply a Schedule 2 Controlled Drug, unless under the supervision of a veterinary surgeon.
• If the person handing out a Schedule 2 Controlled Drug is not satisfied of the person's identity, they should ask for proof of identification. Whether proof of identification is asked for, and whether it is supplied, should be recorded in the Controlled Drugs Register.

Wholesale supply

• In order for wholesalers to satisfy themselves that a Controlled Drug order is genuine, requisitions for Controlled Drugs to be supplied by a wholesaler to a veterinary practice must be made in writing and signed in ink by the requesting veterinary surgeon.
• Original copies of these requisitions must be supplied to the wholesaler. A faxed copy can be sent, which will allow the wholesaler to prepare the Controlled Drug for delivery, but the original must be provided prior to physical delivery to the practice.
• The requisition must contain the following information:
  • Name, address and profession/occupation of the recipient
  • Purpose for which the drug is supplied
  • Name, form and strength of the drug and the total quantity required
  • Signature of the prescriber
  • Date of order
  • Name and address of the supplier. 

Record keeping

• Any person who purchases or supplies a Controlled Drug must keep a Controlled Drugs Register in addition to the record keeping requirements for the supply of veterinary medicinal products (VMPs).
• All invoices relating to Controlled Drugs should be kept for 2 years; however, since all other paperwork relating to the VMR must be kept for 5 years, this is recommended. 
• 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 bound book or section within a bound book with the product 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 data entered is kept and can be recalled for audit purposes (a secure electronic backup of data held is sufficient).
• 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.
• The task of completing the Controlled Drugs Register can be delegated by the prescribing/supplying veterinary surgeon to another member of staff; however, responsibility for the supply remains with the veterinary surgeon.
• 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
  • Running total (good practice).

• Controlled Drugs supplied:
  • Date supplied
  • Name and address of the person to whom the drug was supplied
  • Name of veterinary surgeon (good practice to record RCVS number)
  • Amount supplied
  • Running total (good practice).

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)?
• Was proof of identity supplied (yes/no)?

Standard operating procedures
All healthcare providers who take part in the Practice Standards Scheme (PSS) and hold 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 medicine returned to the practice by clients if it is no longer required.

Destruction of Controlled Drugs

• Controlled Drugs awaiting destruction should be stored separately from current stock but within the Controlled Drugs cabinet and labelled to identify them as such.
• Controlled Drugs returned by a client should not be entered in the Controlled Drugs Register as incoming stock, but it is good practice to record these in a book kept especially for this purpose.
• The destruction of Controlled Drugs returned by clients does not have to be carried out in the presence of an authorized witness, but it is good practice to have another staff member witness and sign the patient returns book.
• All practices should have an SOP detailing how patient returns should be handled.
• Destruction of out-of-date Controlled Drugs must be witnessed by either a member of the Veterinary Medicines Directorate Inspection team, an inspector of the RCVS Practice Standards Scheme, a veterinary surgeon who is independent of the practice (excluding locums), or a police 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 products 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
  • If a denaturing kit cannot be used, tablets can be crushed and mixed with soapy water and injectable products can be mixed with sawdust or cat litter
  • Incinerate with other pharmaceutical waste labelling the waste to show it contains Controlled Drugs.
• There is no requirement to have the destruction of Schedule 3, 4 and 5 Controlled Drugs witnessed; however, due to its known potential for abuse, it is good practice to have a witness for the destruction of ketamine.
• All Schedule 2, 3, 4 and 5 drugs should be destroyed in the manner described above.

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 on the VMD website. 

Useful websites

Royal College of Veterinary Surgeons (RCVS) – Advise note No. 23

 Veterinary Medicines Directorate (VMD) - Note 20