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Technical service records in hospital pharmacy

Published Last updated See all updates
Topics: Record keeping

Recommendations on the retention of pharmacy records relating to aseptic and technical services within hospitals.

Contents

  1. Technical services records
    1. Consumer liability legislation
  3. Specific types of records
    1. Batch production records
    2. Chemotherapy / aseptic worksheets
    3. Cleaning logs
    4. Environmental monitoring results
    5. Extemporaneous dispensing records
    6. Medical gas pipeline systems
    7. Paediatric products worksheets
    8. Parenteral Nutrition (PN) worksheets
    9. Quality Control (QC) documentation
    10. Resuscitation box worksheet
    11. Validation of equipment and maintenance logs
    12. Validation / training of operators
  5. Other record keeping resources
  6. All record keeping resources
  7. Update history

Technical services records

Everyone within a health and care organisation is responsible for managing records appropriately. It is therefore important that you understand how records relating to aseptic and technical services should be managed within the pharmacy.

Consumer liability legislation should be considered when handling manufacturing records. This is explained under the Consumer Protection Act 1987.

Consumer liability legislation

Consumer Protection Act (CPA) 1987 allows patients to claim for injury due to a defective product (medicine) up to 10 years after a medicine has been administered.

Records of manufactured products (e.g. worksheets) can prove that the product was or was not defective. The prescription or other clinical records will only indicate that the patient was prescribed or dispensed an item, but will not give any indication how the product was made and what ingredients were used. If the problem is a contaminated ingredient, it is possible to partially pass the responsibility to the supplier of the defective ingredient.

Adult patients (18 years and over)

Keep manufacturing records for 11 years (10 years as part of CPA + 1 year best practice safety margin).

Paediatric patients

If a child suffers from unexpected serious adverse effects after taking a medicine, they’ve got:

  • any time up to 3 years after their 18th birthday to sue in negligence (up until they’re 21 years)
  • 10 years from taking the medicine to sue under CPA

RMCoP states that records relating to children should be kept until the child’s 25th birthday (26th birthday if 17 years old at time of treatment), unless there are other factors which indicate the record should be kept for longer.

Therefore, in line with RMCoP recommendation, keep all paediatric manufacturing records for 25 years.

Specific types of records

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

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

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for reference.

Minimum period

Retain for 1 year.

Provenance

This is a best practice recommendation.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep to demonstrate compliance with GMP.

Minimum period

Retain for 1 year after the expiry dates of the products.

Comment

If an electronic record, keep for 10 years; then review and destroy if no longer needed.

Provenance

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

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

Provenance

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for reference.

Minimum period

Retain for the lifetime of the pipeline system.

Provenance

28 Department of Health. Medical Gases. Health Technical Memorandum 02-01: Medical gas pipeline systems. Part B: Operational management. May 2006.

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

Unique record

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

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

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 or 1 year after the expiry date of the batch.

Comment

Whichever is longer

Provenance

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep to demonstrate compliance with GMP.

Minimum period

Retain for 1 year after the expiry of longest dated item.

Comment

If sold or supplied across a legal boundary, retain for 5 years or 1 year after expiry date of batch as per GMP, whichever is longer.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep to demonstrate compliance with GMP.

Minimum period

Retain for 11 years.

Comment

The retention period starts from the date the equipment is decommissioned.

Provenance

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 the duration of employment, plus 5 years after leaving.

Comment

Keep in personal portfolios.

Other record keeping resources

All record keeping resources

Record keeping

Advice and guidance to support appropriate retention and storage of pharmacy-related records.

Update history

  1. Link updated for the Records Management Code of Practice (RMCoP).
  1. Republished
  1. Published