Controlled Drugs records in pharmacy

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep to demonstrate compliance with GMP.

Minimum period

Retain for 5 years.

Comment

5 years under GMP, but consider keeping for longer due to consumer liability legislation.

Provenance

• Consumer Protection Act (CPA) 1987
• all relevant records must be managed in line with RMCoP

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep to demonstrate compliance with GMP.

Minimum period

Retain for 5 years.

Comment

This may be longer for some trials.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

This is a legal requirement.

Minimum period

Retain for 2 years.

Comment

This applies to prescriptions including out-patient and TTA / TTO, and those prescriptions for patients treated under any NHS-commissioned care service.

Secure environments

In addition to retaining the CD prescription, a copy of the current CD prescription (i.e. Schedule 2 and 3) for a patient should be available on patient transfer to another secure setting. To achieve this either a scanned e-copy or a hard copy transferred with the patient is needed. This is essential for enabling continuity of supply on transfer until the prescription is reviewed.

Provenance

• Misuse of Drugs Regulations 2001
• Ministry of Justice. Integrated Drug Treatment System. PSI IDTS 2010/45
• Royal Pharmaceutical Society. Professional Standards for optimizing medicines for people in secure environments: Prisons, Young Offender Institutions and Secure Training Centres (Edition 2)

Unique record

Yes, this is likely to be the only record.

Reason for keeping

This is a legal requirement.

Minimum period

Send to NHSBSA.

Comment

Private prescriptions for Schedule 2 and 3 CDs must be sent to the relevant agency. The relevant agency is the NHS Business Services Authority (NHSBSA).

Provenance

The Misuse of Drugs (Amendment No. 2) Regulations 2006.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

This is a legal requirement.

Minimum period

Retain for 2 years from the date of the last entry.

Comment

Once electronic CD registers are in widespread use, the Government intends to require anyone required to keep secure copies of a CD register for up to 11 years.

(Department of Health. Safer management of CDs: Changes to the record keeping requirements, guidance for England only. Last revised February 2008)

Secure environments

In organisations and secure environments, Schedule 3 CDs are also recorded in CD registers.

Provenance

• Misuse of Drugs Regulations 2001
• NICE guideline NG46. Controlled drugs: safe use and management
• Ministry of Justice. Integrated Drug Treatment System. PSI IDTS 2010/45
• Royal Pharmaceutical Society. Professional Standards for optimizing medicines for people in secure environments: Prisons, Young Offender Institutions and Secure Training Centres (Edition 2)

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for audit purposes.

Minimum period

• Driver ID: retain for 3 months.
• Recipients’ signature: retain for 6 months in original form; then up to 18 months in reproducible form.
• Orders, signed orders, requisitions, private prescriptions: retain for 2 years.

Provenance

Home Office. Guidance for the safe custody of controlled drugs and drug precursors in transit. Version 1.3

Unique record

No, there is likely to be more than one copy.

Reason for keeping

This is a legal requirement.

Minimum period

Retain for 2 years.

Comment

All CD requisitions should be kept for 2 years. Keep in original paper form or computerised form.

Provenance

The Misuse of Drugs Regulations 2001

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep to enable signature validation.

Minimum period

Retain for the duration of employment.

Comment

A copy of signature of each authorised signatory should be available in the pharmacy department.

Provenance

Controlled drugs: safe use and management. NICE guideline [NG46].

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep to demonstrate compliance with GMP.

Minimum period

Retain for 5 years.

Comment

5 years under GMP, but consider keeping for longer due to consumer liability legislation.

Provenance

• Consumer Protection Act (CPA) 1987
• all relevant records must be managed in line with RMCoP

Unique record

Yes, this is likely to be the only record.

Reason for keeping

This is a legal requirement.

Minimum period

Retain for 6 years.

Comment

Keep for 6 complete tax years.

Provenance

• NICE guideline NG46. Controlled drugs: safe use and management
• Limitation Act 1980. Chapter 58

Unique record

There is no legal requirement to keep any record because the drugs are/were the property of the patient and not of the organisation. If kept, this is likely to be the only record. It would be good practice to keep a record of destruction in case a patient should claim that their property was lost or taken from them without their knowledge.

Reason for keeping

This is a good practice recommendation, as per NICE guideline NG46.

Minimum period

6 years + 1 =7 years

Comment

Patient’s own drugs can be removed and/or disposed of with the agreement of the patient or in the interest of the patient/general safety.

Provenance

• NICE guideline NG46. Controlled drugs: safe use and management
• Royal Pharmaceutical Society. Professional guidance on the safe and secure handling of medicines

Unique record

No, there is likely to be more than one copy.

Reason for keeping

This is a legal requirement.

Minimum period

Retain for 2 years or 2 years from date of last entry for record books.

Comment

This applies to requisitions, orders, order books, delivery notes or other records of receipt, including hospice requisitions, health and justice services, and others not sent to NHSBSA.

Every requisition, order or private prescription on which a CD is supplied must be preserved by the pharmacy department for a minimum of 2 years from the date on which the last delivery under it was made. Although the mandatory period for keeping requisitions is 2 years, health care organisations may wish to store them for longer periods, as cases often come to court at a much later date. Future regulations may increase the period of time for the storage of records.

Secure environments

In secure environments that do not have an in-house dispensing pharmacy, HO advice is that CD requisitions are still required where the requisitioning organisation is a different legal entity to the supplier. The national CD requisition can be used but is not mandatory. HJ providers must ensure that a Practitioner (i.e. a medical Doctor) signs the requisition where this is needed to comply with the regulation.

Provenance

The Misuse of Drugs Regulations 2001