Unique record

Yes, this is likely to be the only record.

Reason for keeping

This is a regulatory requirement.

Minimum period

Retain for 30 years.

Comment

MHRA Guidance on the licensing of biosimilar products states that in terms of traceability, “…removable sticky labels on the product detailing brand name and batch number that can be recorded on patient records or 3D barcoding may be more appropriate for electronic records”. It adds that “Traceability should be fully integrated in the healthcare settings, for example, electronic data recording and record linkage etc. Where necessary, additional training to healthcare professionals should be provided to support reporting of brand name and batch number when reporting adverse reactions.”

In the absence of any other recommendation, it would seem reasonable that the retention period for the batch number and expiry date information for MABs is in line with the recommended retention of patient records (paper or electronic) as outlined in Records Management Code of Practice.

Unique record

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

Reason for keeping

Keep for reference.

Minimum period

Retain for 2 years after the last treatment.

Comment

EPR will eventually hold all details – duplication of record held in notes.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep to demonstrate compliance with GMP and evidence against future claims.

Minimum period

Retain for 5 years after end of the trial.

Comment

This is referring to manufacture under a Specials Licence for a metabolic study, hence the product is not an IMP.

Clinical trial records in hospital pharmacy has further information.

Provenance

• Article 17 of Directive 2005/28/EC for Clinical trials, otherwise good practice.
• UK implementing directive: The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for reference.

Minimum period

Retain for 30 years.

Comment

Blood Bank Register should be kept for 30 years; although there is no specific recommendation for immunoglobulins and other blood products not supplied via Blood Bank, it seems reasonable to require the same retention time.

This enables full traceability of all blood products used.

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

This is a legal requirement.

Minimum period

Retain for 3 years.

Provenance

Security of prescription forms guidance, August 2013 (now archived). Note that the referenced document has been superseded. However, the current document (Management and control of prescription forms: a guide for prescribers and health organisations), does not include the relevant information.

Unique record

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

Reason for keeping

Keep for audit purposes.

Minimum period

Retain for 2 years.

Comment

EPR will eventually hold all details – duplication of record held in note.

Where the electronic system has the capacity to destroy records in line with the retention schedule, and where an archive record can remain demonstrating that a record has been destroyed, then the Records Management Code should be followed in the same way for electronic records as for paper records with a log being kept of the records destroyed. If the system does not have this capacity, then once the records have reached the end of their retention periods, they should be inaccessible to users of the system and upon decommissioning, the system (along with audit trails) should be retained for the retention period of the last entry related to the schedule.

Provenance

All relevant records must be managed in line with RMCoP.

Unique record

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

Reason for keeping

Keep for reference.

Minimum period

Retain for 2 years after the last treatment.

Comment

A copy of the valid prescription or order should be kept in patient’s notes.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for audit purposes.

Minimum period

Retain for 2 years.

Comment

NHS England directly commissions healthcare in all residential Secure Environments (prisons, Immigration Removal Centres and Secure Training Centres). Prescriptions generated in these settings are therefore NHS prescriptions and not private prescriptions. The expectations for prescriptions and other record retention for these settings are in the main as for hospital settings.

A wing or treatment room is considered equivalent to a hospital ward. Health and justice (HJ) prescriptions are all now held on the HJIS EPR system and thus retention of the actual hand signed prescription can be reduced to 3 months (please also see the RPS Professional Standards for optimizing medicines for people in secure environments 2017).

Our community pharmacy section is also relevant where dispensing takes place in-house and where advanced services or additional enhanced services are delivered.

Provenance

• MEP Edition 42 July 2018
• The Human Medicines Regulations 2012 (SI 2012/1916)

Unique record

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

Reason for keeping

Keep for audit purposes.

Minimum period

Retain for 2 years.

Comment

EPR will eventually hold all details – duplication of record held in note.

Where the electronic system has the capacity to destroy records in line with the retention schedule, and where an archive record can remain demonstrating that a record has been destroyed, then the Records Management Code should be followed in the same way for electronic records as for paper records with a log being kept of the records destroyed. If the system does not have this capacity, then once the records have reached the end of their retention periods, they should be inaccessible to users of the system and upon decommissioning, the system (along with audit trails) should be retained for the retention period of the last entry related to the schedule.

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

This is a legal requirement.

Minimum period

Retain for 5 years.

Comment

Record of the batch number should also be kept.

Provenance

• The supply of unlicensed medicinal products (“specials”). MHRA Guidance Note 14. 2014.
• The Human Medicines Regulations 2012 (regulation 170 (1))