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Controlled Drugs (CD) records in pharmacy

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Topics: Record keeping

A guide to controlled drug (CD) records in pharmacy, including retention periods, legal requirements and the rationale supporting each recommendation.

This article forms part of a series
  1. Retaining and storing pharmacy records in England
    1. Additional services records in community pharmacy
    2. Clinical governance and patient safety records in pharmacy
    3. Clinical trial records in hospital pharmacy
    4. Controlled Drugs (CD) records in pharmacy
    5. Prescription and dispensing records in community pharmacy
    6. Prescription and dispensing records in hospital pharmacy
    7. Stock management, waste and recall records in pharmacy
    8. Supply and distribution records in pharmacy
    9. Technical service records in hospital pharmacy

Contents

  1. Using our advice
  2. Specific records
    1. CD clinical trial
    2. CD destruction
    3. CD invoice
    4. CD manufacturing worksheets
    5. CD prescription
    6. CD register
    7. CD requisition, signed order and order book
    8. CD transport
  4. Update history

Using our advice

Controlled drug (CD) records support legal compliance, safe handling, governance, traceability and accountability throughout the lifecycle of a controlled drug.

Pharmacy teams create and maintain a range of records relating to the ordering, receipt, supply, administration, destruction, transport and monitoring of controlled drugs.

Retention requirements may arise from legislation, the Records Management Code of Practice (RMCoP), and regulatory guidance.

Where multiple retention periods apply, organisations should normally retain records for the longest applicable period. See Retaining and storing pharmacy records in England (SPS page) for factors that may justify longer retention.

Specific records

Record description

Records such as dispensing logs, receipts and destruction, trial files and reconciliation.

Minimum retention time

  • retain records for at least 25 years after the end of the clinical trial where the records form part of the essential trial documentation

Supporting source

CD trial records should be retained in line with the retention requirements that apply to the wider Trial Master File (TMF) and essential records.

Sponsor requirements may specify longer retention periods.

Record description

Records such as destruction, authorised witness, destruction certificates and reconciliation.

Minimum retention time

  • retain records for at least 2 years where recorded in a CD register
  • retain records of patient own CD destruction for at least 7 years

Supporting source

CD destruction is recorded in a CD register so the Misuse of Drugs Regulations 2001 CD register retention time applies.

NICE guidance (NG46) Controlled drugs: safe use and management advises on patient’s own CD destruction records.

Record description

Records such as supplier invoices, credit notes, procurement, wholesaler dealer invoices and financial reconciliation.

Minimum retention time

  • retain records for at least 6 years

Supporting source

NICE guidance (NG46) Controlled drugs: safe use and management advice.

Record description

Records such as aseptic worksheets, extemporaneous preparation worksheet and quality control records involving CDs.

Minimum retention time

  • retain records for at least 1 year after expiry of the batch or 5 years after certification by the Qualified Person, whichever is longer
  • retain manufacturing worksheets for investigational medicinal products for at least 5 years after completion of the last clinical trial in which the batch was used

Supporting source

Good Manufacturing Practice (GMP) advises on record retention for manufactured products.

Record description

Records such as NHS CD prescriptions and private CD prescriptions.

Minimum retention time

  • retain for at least 2 years

Supporting source

The RMCoP advises on keeping pharmacy prescription records.

Records of individuals who are not NHS funded should be kept in line with NHS record retention times.

Record description

Records such as paper register, digital register, running balance and corrections.

Maintaining an accurate and compliant CD register is a legal requirement for Schedule 2 CDs and certain Schedule 3 CDs. Refer to your local CD policy for advice on which CDs need to be entered into the register.

Minimum retention time

  • retain records for at least 2 years after date of last entry

Supporting source

Misuse of Drugs Regulations 2001 states retention time.

Record description

Records such as requisitions, signed orders, and ward order books.

Minimum retention time

  • retain records for at least 2 years

Supporting source

Misuse of Drugs Regulations 2001 states retention time.

Record description

Records such as delivery manifests, driver identification, recipient signature, and proof of delivery.

Minimum retention time

  • retain driver identification for at least 3 months
  • retain recipient signatures and transport documentation for at least 2 years

Supporting source

Home Office Guidance for the safe custody of controlled drugs and drug precursors in transit states that signatures and transport documentation should be kept in their original form for at least 6 months and be reproducible for a further 18 months.

Update history

  1. Republished
  2. Full review and update
  1. Under CD records for private patients "Sch 2 and 2 CDs..." corrected to read "under Sch 2 and 3 CDs...)
  1. Added additional information about records of destruction of DCs returned by patients.
  1. Link updated for the Records Management Code of Practice (RMCoP).
  1. Published