Controlled Drugs Record-Keeping Requirements

Controlled drugs (CDs) are medications with the potential for misuse, governed by the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001. Common controlled drugs in care homes include morphine, oxycodone, fentanyl patches, midazolam, and certain benzodiazepines.

CQC inspectors pay particular attention to controlled drugs management. Poor CD record-keeping is one of the most common medication-related findings in inspection reports.

Understanding CD Schedules

Controlled drugs are classified into five schedules with different requirements:

Most care home CD record-keeping requirements apply to Schedule 2 drugs. However, many care homes extend good practice to Schedule 3 and 4 as well.

CD Register Requirements

The CD register must be a bound book (not loose-leaf) or an electronic system that provides an audit trail and prevents deletion. Each entry must include:

On Receipt

• Date received
• Name and address of supplier (usually pharmacy)
• Quantity received
• Form (tablets, liquid, patches, etc.)
• Running balance
• Signature of receiving staff member and witness

On Administration

• Date and time
• Name of patient
• Dose given
• Running balance after administration
• Signature of administering staff member
• Signature of witness

On Destruction or Return

• Date
• Quantity destroyed/returned
• Reason (patient death, medication change, expiry)
• Running balance
• Two signatures (see destruction requirements below)

Witness Requirements

Schedule 2 CD administration requires a witness for every dose. The witness must:

Balance Checks

Running balance checks are critical for CD safety. Best practice includes:

• Every administration: Check balance before and after, with witness confirming
• Weekly stock check: Physical count of all CDs against register, signed by two staff
• Shift change check: Outgoing and incoming shift verify balance together
• Monthly audit: Manager review of register entries and discrepancy investigation

Handling Discrepancies

If the physical stock doesn't match the register:

1. Don't administer: Do not give medication until resolved
2. Investigate immediately: Check all recent entries for errors
3. Document: Record the discrepancy, investigation steps, and outcome
4. Report: Notify manager immediately. Significant discrepancies may need reporting to CQC and police

Destruction and Returns

Unused controlled drugs must be disposed of properly. The method depends on the circumstances:

Patient-Specific CDs (After Death or Discharge)

Can be destroyed by an "authorised person" which includes care home managers. Destruction must:

• Be witnessed by a second authorised person
• Be recorded in the CD register with both signatures
• Render the drug irretrievable (denature with denaturing kit)

Stock CDs (Expired or No Longer Needed)

Must be returned to a pharmacy or destroyed by a pharmacist or other authorised person with appropriate witness.

Documentation

Every destruction or return must be recorded:

• Date
• Drug name, form, and strength
• Quantity destroyed/returned
• Reason
• Method (for destruction)
• Signatures of person destroying and witness

Storage Requirements

Schedule 2 CDs must be stored in a locked cabinet or safe that:

• Complies with Misuse of Drugs (Safe Custody) Regulations 1973
• Is fixed to the wall or floor
• Is used only for controlled drugs (not other medications or valuables)
• Has keys held by authorised persons only

Access should be limited to staff authorised to administer CDs. Key holders should be documented, and key transfers should be recorded.

Common Errors to Avoid

• Retrospective entries: Witness signs later, not at time of administration
• Missing witnesses: Administration without witness signature
• Incomplete entries: Missing date, time, or running balance
• Corrections: Using correction fluid instead of single line through error with signature
• Balance errors: Arithmetic mistakes in running balance
• Stock discrepancies: Not investigating and documenting when found