SAFE AND SECURE HANDLING OF MEDICINES

Appendix 5:
Retention of pharmacy records

1.  INTRODUCTION

Background
This policy has been developed taking into account legislation and national guidance. However, there are specific issues with regard to prescription records. The Consumer Protection Act 1987 covers the liability of producers for defective products and requires that records are retained for at least 13 years. The prescription is the key document in respect of medicines. However, MEL (1993) 152 states; "It will be for ...Organisations... to make their own judgement on whether any health records should be retained for this minimum period in order to defend any action brought under the Consumer Protection Act 1987".

Currently, a copy of the prescription is stored in the patient's notes. The pharmacy also keeps a copy of discharge prescriptions and some other specialist prescriptions. With the notable exceptions of vaccines and a small number of other items, no record is made of either the manufacturer or batch number. This would be very difficult to achieve in practice. Therefore, most retained records provide no details of manufacturer.

Risk
The risk to a patient is greatest with products which have been recently marketed and less so with products which are off patent since there is much more experience of use of the latter. For products within patent, the manufacturer is easily identifiable. Currently the pharmacy receives discharge prescriptions but does not receive copies of in-patient prescriptions. Discharge prescription forms comprise of 4 copies. The original, top copy is sent to the patient's general practitioner, one copy is retained in the patient's notes, one copy sent to Medical Records for coding and one copy retained by pharmacy. Since a copy of all prescriptions is retained in the patient's notes, it is not considered to be necessary to retain pharmacy copies for 13 years.

2.  AIMS AND OBJECTIVES
This policy has been developed to address arrangements for retention of pharmacy records. It takes into account legislation and national guidelines and applies to Managed Pharmacy Services within Tayside. It provides a balanced approach to risk management.

Pharmacy copies of prescriptions should be retained for 2 years, after which they should be destroyed. Other copies of discharge prescriptions shall remain in the patient's case notes for at least 6 years.

a) The enclosed list, Appendix 1, shows the recommended retention period of pharmacy records.
b) The recommendations arise from current legislation and the organisation's Standing Financial Instructions. Any alterations from that required by legislation, meet with the approval of the organisation.
c) Documents may be archived at any time within the recommended retention period. This will depend on the storage facilities available. Such documents will be boxed and clearly labelled to identify document type and retention period; documents must be archived in such a way so as to aid easy retrieval.
d) Any documents removed from their archive location must be recorded in the Archive Register stating exact location to which they have been removed and reason for removal. Such entries must be signed by two members of staff and dated. On return of the document to its archive location, an entry must be made in the Archive Register.
e) When the retention period has elapsed, the records should be destroyed as confidential waste. The destruction should be recorded.

3.  ROLES AND RESPONSIBILITIES

Lead technicians in all pharmacy departments in Tayside are responsible for ensuring that the pharmacy records in their designated areas of responsibility are stored and rotated appropriately throughout assigned storage sites. Records are to be moved and destroyed on an annual basis as detailed in the Ninewells Pharmacy 'Records Management Procedure'. PRI and Stracathro pharmacies have their own versions of this procedure.

4.  KEY CONTACTS

5.  POLICY APPROVAL CHECKLIST

 

Category Record

Unique Record

Reason for Keeping

Recommended Minimum Period

 Comments
Clinical Trial Protocols No Legal 15 years Good Clinical trial Practice (GCP)
Dispensing Records Yes Legal 15 years  
Destruction Records Yes Legal 15 years  
Prescription Yes Legal 15 years  
           
Errors Dispensing error internal Yes Audit 1 year plus current Database kept permanently
Dispensing error external Yes Audit 1 year plus current Database kept permanently
           
Medicines Information Enquiries Yes Audit and reference Medico-legal 8 years (25 years for those relating to paediatrics and obstetrics) UKMI National Standards
           
Orders Order and delivery notes No Audit 2 years Current financial year plus 1 (*Note 1)
Requisition sheets Yes Audit 2 years Current financial year plus 1
Controlled Drug registers - pharmacy based Yes Legal 2 years Misuse of Drugs Act 1971, Misuse of Drugs Regulations 2001
Controlled Drug registers - ward based Yes Audit 2 years Duthie guidance
Controlled Drug prescriptions (TTO's) No Legal 2 years Misuse of Drugs Regulations 2001
Controlled Drug order books No Legal 2 years Misuse of Drugs Regulations 2001
CD ward orders or requisitions No Legal 2 years Misuse of Drugs Regulations 2001
Ward pharmacy requests No Uncertain 1 year Unlikely benefit after 12 months
Picking tickets/delivery notes Yes Uncertain 6 months A reasonable period  for verification of order only
Invoices Yes Legal requirement 6 years Limitation Act
Miscellaneous and retail chemist orders and delivery notes   Audit 2 years  
           
Quality Assurance QC documentation Yes GMP 5 years or 1 year after expiry date  
Certificate of analysis Yes GMP 5 years or 1 year after expiry date  
SOPs Yes Health and Safety 15 years after superseded  
Environmental monitoring results Yes GMP 1 year after expiry date of product  
Validation of operators Yes GMP For duration of employment plus 1 year  
Validation of equipment Yes GMP For life of equipment plus 1 year  
Refrigerator temperatures Yes GMP 1 year  
           
Recalls Recall documentation Yes Audit 5 years Good Distribution Guide especially if holding WDL
           
Stock Control Stock checklists Yes Audit 1 year plus current As in HSC 1999/053
           
Types of Prescription Discharge No Audit 2 years Duplication of records in notes
Outpatient Yes Audit 2 years  
Parenteral nutrition No Audit 2 years Duplication of records in notes
Chemotherapy No Reference 2 years Duplication of records in notes
One stop ordering sheets Yes Audit 2 years  
           
Worksheets Aseptic worksheets Yes Audit 2 years Product liability extend to 11 years after expiry
Radiopharmacy Yes Audit 2 years  
Batch Sheets Yes GMP 5 years Product liability extend to 11 years after expiry
Extemporaneous dispensing worksheet Yes Product liability 5 years Product liability extend to 11 years after expiry
           
Miscellaneous CD Destruction record - pharmacy based Yes Legal 2 years Misuse of Drugs Regulations 2001
CD Destruction record - ward based Yes Audit 2 years Duthie guidelines
Destruction of PODs includes CDs Yes Audit 6 months Property of the patient and should only be destroyed with the patient's permission
Pharmaceutical Care Plans Yes Reference and Audit 2 years A reasonable period for retention
Year end stock take sheets Yes Audit 6 years  
Local contracts/pricing agreements Yes Audit 6 years  
Month end computer data prints Yes Audit 6 years  
Unlicensed medicines dispensing record Yes Legal requirement 5 years  

*Note 1 - Either delivery note or invoice kept for 11 years as product liability records.

Rapid Impact Checklist (RIC)

Policy/Strategy Approval Checklist

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