Misuse of Drugs Regulations 2001 - Controlled Drugs
The Misuse of Drugs Regulations 2001 classify controlled drugs into five schedules with varying levels of control. Healthcare providers must comply with strict requirements for storing, prescribing, administering and recording controlled drugs.
Controlled drug schedules
- Schedule 1: No therapeutic use (e.g. LSD, cannabis) - special licence required
- Schedule 2: High therapeutic value but high abuse potential (e.g. morphine, diamorphine, fentanyl, methadone, oxycodone) - strictest controls
- Schedule 3: Moderate abuse potential (e.g. buprenorphine, temazepam, midazolam, tramadol) - some exemptions from Schedule 2 requirements
- Schedule 4: Lower abuse potential (e.g. most benzodiazepines except temazepam and midazolam, zopiclone) - minimal controls
- Schedule 5: Very low strength preparations - invoice records only
Safe custody and record keeping
Safe custody: Under the Misuse of Drugs (Safe Custody) Regulations 1973, Schedule 2 drugs and specified Schedule 3 drugs (temazepam, buprenorphine, diethylpropion, flunitrazepam) must be kept in a locked metal cabinet fixed to the wall or floor meeting BS 2881:1989 standard
Record keeping: Schedule 1 and 2 drugs require a Controlled Drugs Register with entries in chronological order, retained for 2 years
Each entry must include:
- Date supply received or administered
- Name and address of supplier (for receipts)
- Quantity received
- Name and address of person supplied (for administrations: patient name, prescriber)
- Quantity supplied/administered
- Running balance
Prescriptions
Schedule 2 and 3 CD prescriptions must be written in indelible ink and include:
- Patient name and address
- Drug name, form and strength
- Total quantity in words and figures
- Dose and frequency
- Prescriber signature and date
CD audits
Designated bodies (NHS trusts and foundation trusts, NHS England and independent hospitals) must appoint a Controlled Drugs Accountable Officer (CDAO). Care homes do not appoint a CDAO - they report CD concerns to the NHS England area CDAO through the local intelligence network. All providers should conduct regular CD stock reconciliations - at least weekly is widely recommended in care settings.
- Step 1
- Install compliant CD cabinet (BS 2881:1989) fixed to structural wall or floor
- Step 2
- Obtain Controlled Drugs Register (bound book with numbered pages, not loose-leaf)
- Step 3
- Implement two-person CD administration checks for Schedule 2 drugs
- Step 4
- Maintain running balance in CD Register, updated after each transaction
- Step 5
- Conduct regular CD stock reconciliation against the register - at least weekly is widely recommended in care settings
- Step 6
- Report CD incidents, errors and discrepancies to your CD Accountable Officer or, for care homes, to the NHS England area CDAO via the local intelligence network
- Step 7
- Report significant CD incidents to CQC via Statutory Notification
- Step 8
- Ensure safe destruction of CDs witnessed by authorised person, recorded in register
- Step 9
- Appoint a CD Accountable Officer if you are a designated body (NHS trust or foundation trust, NHS England, independent hospital) - care homes report to the NHS England area CDAO instead