PGD, WI and NP documentation

Patient Group Direction (PGD), Written Instruction (WI) and National Protocol (NP) documentation includes master authorised (signed) copies of the documents, lists of authorised practitioners and individual supply/administration records, including electronic records/agreements.

The same rules apply for the retention requirements of these legal mechanisms records as to all other individual clinical records and these are summarised below.

Clinical records

• For adults all PGD/WI/NP documentation in an individual’s clinical record must be kept for eight years after the last entry.
• For children all PGD/WI/NP documentation in a individual’s clinical record must be kept until the child’s 25th birthday (or 26th birthday if the child was 17 when treatment ended) or for eight years after a child’s death.
• Where a PGD/WI/NP is for an implant in an adult then all documentation in an individual’s clinical record must be kept for 10 years. For example this would apply to contraceptive and sexual health PGDs for contraceptive implants or drug eluting coils.

Staff authorisation records

• Staff authorisation records should be kept for 8 years after the expiry date of the PGD/WI/NP if it relates to adults only (10 years if relates to an implant) and for 25 years after the expiry date of the PGD/WI/NP if it relates to children.

Final versions of PGD/WI/NP

• The final authorised copy of the PGD/WI/NP should be kept for 8 years after the expiry date of the document if it relates to adults only (10 years if relates to an implant) and for 25 years after the expiry date if it relates to children
• The main content of a PGD/WI/NP (i.e. an unauthorised final copy), which contains no individual identifiable information or staff authorisation records, may be retained by an organisation for up to 20 years for purposes of business planning/continuity if there is reason to do so (i.e. reference for future PGD development).

PSD documentation

When a medicine is administered or supplied under a Patient Specific Direction (PSD), the PSD forms the legal authorisation to administer/supply the medicine.  A PSD must be retained as part of an individual’s clinical record, as must the record of the subsequent administration or supply.

Clinical records

• For adults all PSD documentation in an individual’s clinical record must be kept for eight years after the last entry.
• For children all PSD documentation in a individual’s clinical record must be kept until the child’s 25th birthday (or 26th birthday if the child was 17 when treatment ended) or for eight years after a child’s death.
• Where a PSD is for an implant in an adult then all documentation in an individual’s clinical record must be kept for 10 years.

Records held across multiple organisations

In commissioned services not all PGD/WI/NP/PSD records will be held in one place or by one organisation.

Master copies of PGD/WI/NPs should be kept by the authorising body with the lists of authorised practitioners and individual clinical records maintained by the organisation operating under the PGD/WI/NP/PSD according to local policy.

Where this is not the same organisation the Memorandum of Understanding (or similar) in place between the organisations should include details of records management.

See Patient Group Directions in Complex Commissioning Scenarios for further advice.

Further information

Further advice on records management is available from SPS in and in the NHS Records Management Code of Practice 2021

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