Receiving controlled drugs (CDs)
The practice’s nominated ‘CD lead’ should check CD orders received from a wholesaler or community pharmacy to ensure they are correct and complete. Delivery notes should be signed and filed.
There is no need for an additional witness to check CD receipts, but it is good practice to do so.
See our article Controlled drugs governance for dental teams (SPS page) for further information on CD leads.
Storing CDs
All medicines should be stored safely. However, Schedule 2 and Schedule 3 CDs are subject to additional safe custody requirements, with some exceptions. Schedule 4 and 5 CDs are not subject to additional safe custody requirements.
The BNF lists which drugs require safe custody.
Your standard operating procedure (SOP) should cover storage and access arrangements for all CDs kept.
CDs subject to safe custody requirements
CDs requiring safe custody include:
- fentanyl and morphine (Schedule 2)
- temazepam (Schedule 3)
Medicines subject to safe custody requirements must be kept in a locked CD cabinet when they are not in use.
Access to the CD cabinet must be restricted to authorised individuals.
CD cabinets must comply with the requirements of the Misuse of Drugs (Safe Custody) Regulations 1973. The NHS regional Controlled Drugs Accountable Officer (CDAO) should be contacted for further information on specifications for allowable CD cabinets.
See Controlled drugs governance for dental teams (SPS page) for guidance on identifying and contacting the NHS regional CDAO.
CDs not subject to safe custody requirements
CDs not requiring safe custody include:
- midazolam (Schedule 3) as it is specifically exempt from the usual safe custody requirements of Schedule 3
- diazepam (Schedule 4)
- dihydrocodeine (Schedule 5)
- nitrous oxide (Schedule 5)
Record-keeping
Legal requirements for record-keeping vary between Schedule 2, 3, 4, and 5 CDs. However, your records should be sufficiently detailed that all CDs can be tracked from receipt to administration or destruction.
Your SOP should cover record-keeping, including what should be recorded, where, how, and by whom.
Invoices
Regulation 24 of the Misuse of Drugs Regulations (MoDR) 2001 requires that invoices for Schedule 3 and Schedule 5 CDs be retained for 2 years.
NICE guidance on Controlled drugs: safe use and management recommends keeping invoices for all controlled drugs for six years.
CD registers for Schedule 2 CDs
Receipt, use, and disposal of Schedule 2 CDs must be recorded in a CD register.
A CD register need not be a commercial design, but it must be a bound book. Regulation 20 of the MoDR 2001 provides instructions on the use of CD registers. They say:
- the register must not be used for any other purpose
- the class of drugs listed to which a page refers should be specified at the top of the page
- entries must be made on the day the transaction occurs, or the day after at the latest
- mistakes should not be obliterated or altered; correct mistakes by making a margin note or a footnote, specifying the date the correction was made
- each class of drugs requiring a register must have a separate register
- organisations with multiple premises must have a register at each location
- a register must be kept at the premises to which it relates
Regulation 19 of the MoDR 2001 specifies what should be recorded in a CD register.
For supplies received, you must record:
- date supply received
- name and address of supplier
- quantity received
For drugs administered, you must record:
- date and time administered
- name, strength, form and quantity of the CD administered
- name of the patient to whom the CD is administered
- name and signature of the person administering the CD and of any witness
Registers must be kept for two years after the last entry was made.
CD registers must be kept securely when not in use.
Recording Schedule 3, 4, and 5 CDs
Receipt, use, and disposal of Schedule 3, 4, and 5 controlled drugs do not need to be recorded in CD registers. However, adequate records, including a running balance, are essential to ensure an audit trail of supply, administration and disposal of CDs.
Stock checks
Regular stock checks must be completed for all CDs held on the premises, including those in the Dental Emergency Kit. Checks should record the balance and ensure stock is in date. The date and the signature of the staff members (ideally two people) conducting the check should be recorded.
The frequency of stock checks should be based on the frequency of use and controlled drug‑related incidents. For most sedation practices, this should be at least once a week. In practices that only hold Dental Emergency Kits, checks may be performed less often.
Your SOP should cover how often stock is checked, by whom, where the checks are recorded, and how often and by whom the results are audited.