Record Keeping and Controlled Drugs Registers
🔒 What’s Legally Required?
Under the Misuse of Drugs Regulations 2001, a Controlled Drugs register must be maintained for all Schedule 1 and Schedule 2 Controlled Drugs (CDs) received or supplied by a pharmacy.
Best Practice: Recording Other Controlled Drugs in the CD Register
While the Misuse of Drugs Regulations 2001 require a Controlled Drugs register for all Schedule 1 and Schedule 2 CDs, there are also strong best practice recommendations for maintaining CD register records for certain Schedule 3 and Schedule 4 (Part 1) drugs in specific settings. This is especially important where the risk of diversion or misuse is higher, or where robust audit trails are required.
Common Examples Where CD Register Records Are Recommended
| Controlled Drug | Schedule | CD Register Legally Required? | Best Practice Record-Keeping Recommendation |
|---|---|---|---|
| Buprenorphine | 3 | No | Recommended in prisons, hospitals, and drug treatment settings due to high risk of diversion. |
| Temazepam | 3 | No | Often recorded in community and hospital pharmacies as good practice. |
| Sativex | 4 (Part 1) | No | Strongly recommended by the Home Office to record in the CD register. |
| Diazepam | 4 (Part 1) | No | Recommended in secure environments (e.g. prisons) to maintain a clear audit trail. |
| Tramadol | 3 | No | May be included in CD register depending on local policy or SOPs. |
Settings Where Additional Recording Is Recommended
- Prisons and secure environments: To support accountability and controlled movement of CDs, Schedule 3 and 4 CDs are often recorded in the CD register even when not legally required. (PSI 45/2010)
- Hospitals: Register entries may be expected for high-risk Schedule 3 CDs to maintain traceability across departments.
While not a legal requirement, recording these substances in the CD register contributes to greater transparency, early discrepancy detection, and improved accountability.
📥 For CDs received, record:
- Date received
- Name and address of the supplier
- Quantity received
📤 For CDs supplied, record:
- Date supplied
- Name and address of the recipient
- Prescriber’s name and address (i.e. the authority to possess)
- Quantity supplied
- Who collected the CD (patient, representative, or healthcare worker)
- If a healthcare worker, also record their name and address
- Whether proof of ID was requested
- Whether proof of ID was provided
These are legal minimums. Additional relevant information may be added at the pharmacist’s discretion.
📘 Format and Structure of the Register
- Must be a bound book (or secure electronic register)
- Entries must be made chronologically and on the same day or the following day
- Must be in ink or indelible format (or secure electronic)
- No retrospective alterations — corrections must be marginal or footnotes, and attributable
Each class of CD must have a separate section, and different strengths/forms must be on separate pages.
Registers must be kept at the premises and retained for at least two years from the date of the last entry.
💻 Electronic CD Registers
You may use an electronic CD register only if it complies with all of the following:
- The author of each entry is identifiable
- Entries cannot be altered after entry
- An audit log of all activity is maintained
- The register is accessible on-site and printable
Systems must include access controls and frequent backups. Inspectors should be able to access registers with minimal disruption.
🔁 Running Balances and Stock Checks (Best Practice)
Keeping a running balance is not currently a legal requirement but is strongly recommended following the Shipman Inquiry.
- Recommended frequency: at least weekly (risk-based)
- Visual checks are advised each time a CD is dispensed
- Checks should be signed and dated, ideally by two people
- Liquid CDs should have regular volume checks
For drugs with a long-standing zero balance, you may suspend checks using professional judgement and local SOPs.
⚖️ When CD Register Entries Replace POM Register Entries
Under the Human Medicines Regulations 2012, Schedule 4, you do not need to duplicate entries in the POM register if the CD register entry includes all of the following:
- Date of supply
- Name, strength, and form of the medicine
- Quantity supplied
- Name and address of the prescriber
- Name and address of the patient
⚠️ Example: When a POM Entry Is Still Required
Entry in CD register:
Date: 25 June 2025
Drug: Morphine sulfate 10mg/5ml
Quantity: 100ml
Supplied to: Jane Smith, 45 Rose Avenue
Prescriber: Dr Patel
Issue: Prescriber’s address is missing — therefore, this CD register entry does not fulfil all POM record requirements. A separate entry would be required in the POM register.
Solution: Always include:
Prescriber: Dr Patel, Springhill Medical Centre, 77 Green Lane, Leeds
✅ Summary
| Requirement | Legally Required | Best Practice |
|---|---|---|
| CD Register for Schedule 1 & 2 | ✅ | ✅ |
| Running Balance | ❌ | ✅ |
| Weekly Stock Checks | ❌ | ✅ |
| Prescriber Address (for POM exemption) | ✅ | ✅ |
| Electronic Register Standards | ✅ | ✅ |