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Record Keeping Controlled Drugs

Source: Information taken from the Pharmaceutical Journal 24/31  July 2010
 

Type of pharmacy record

Unique record?

Reason for keeping

Recommended minimum period

Comments

 

 

 

 

 

Controlled Drugs

 

 

 

 

CD registers (pharmacy based)

Yes

Legal

Two years from date of last entry, but if contain record of destruction, keep for seven years

Safer management of Controlled Drugs: a guide to good practice in secondary care (England), October 2007,

CD registers (ward based)

Yes

Audit

Two years from date of last entry, but if contain record of destruction

Revised Duthie Report (2005) recommends that person in charge of ward should keep the register. See Note 2

CD inpatient prescriptions

Yes

Legal

Two years

Misuse of Drugs Regulations 2001 states that all CD prescriptions should be kept for two years

CD outpatient prescriptions

Yes

Legal

Two years

Misuse of Drugs Regulations 2001 states that all CD prescriptions should be kept for two years

CD order books

No

Legal

Two years from date of last entry

See Note 3

CD Ward orders or requisitions

No

Legal

Two years

Misuse of Drugs Regulations 2001 states that all CD prescriptions should be kept for two years. Keep in original paper form or computerised form

Copy of signature for CD ward order or requisition

Yes

Validation

Duration of employment

Copy of signature of each authorised signatory should be available in the pharmacy department. Safer management of  Controlled Drugs: a guide to good practice in secondary care (England), October 2007

Extemporaneous CD preparation worksheets

Yes

GMP

13 years

See Note 3

External CD orders and delivery notes

Yes

Audit

Two years

See Note 3

Aseptic CD worksheets (adult)

Yes

GMP

13 years

See Note 3

Aseptic CD worksheets (paediatric)

Yes

GMP

26 years

 

CD clinical trials information

Yes

Legal

5 years

This may be longer for some trials

CD destruction (pharmacy based)

Yes

Legal

7 years

Safer management of  Controlled Drugs: a guide to good practice in secondary care (England), October 2007. CD destruction record should be made in the CD register

Destruction of patients’ own CDs

Yes

Audit

7 years

Revised Duthie Report (2005) states that patient’s own drugs are the property of the patient and should only be destroyed with the patients permission

 

Note 2: Once electronic Controlled Drug registers are in common use, the Government intends that anyone required to keep secure copes of a CD register should retain then for up to 11 years. (Department of Health, Safer management of CDs: Changes to the record keeping requirements guidance for England only. February 2008)

Note 3: Every requisition, order or private prescription on which a CD is supplied must be preserved by the pharmacy department for a minimum of two years from the date on which the last delivery under it was made. Although the mandatory period for keeping requisitions is two years, healthcare organisations may wish to store them for longer periods, as cases may come to court at a much later date. Future regulations may increase the period for the storage of records. (Department of Health and Royal Pharmaceutical Society, Safer management of Controlled Drugs – a guide to good practice in secondary care. England 2007).

Source: Information taken from the Pharmaceutical Journal 24/31  July 2010

 

 
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