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Writing a PGD

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Topics: Patient Group Directions

Writing a PGD is a multi-step process, requiring input from all members of the PGD development team.

This article forms part of a series
  1. How to develop a Patient Group Direction
    1. Planning for a PGD
    2. Writing a PGD
    3. Authorising and preparing to use a PGD
    4. Monitoring and reviewing a PGD in practice

Contents

  1. Preparing to write a PGD
    1. Templates
    2. Nationally signed PGDs
    3. Managing workload, deadlines and timeframes
  3. Writing a PGD for submission
    1. PGD content
    2. Reference sources
    3. Establish a working group
    4. Local systems
    5. Structure and format of the PGD
    6. Complying with regulation and guidance
    7. Document management
    8. Governance
    9. Training requirements
    10. Monitoring the PGD during use
  5. Update history

Preparing to write a PGD

Make sure to research available sources of information and advice to assist the authors (such as national and local clinical guidelines) and find out if there is a similar PGD already being used in the organisation.

Nationally signed PGDs and PGD templates are available for certain clinical scenarios.

Templates

Some organisations may have their own standard PGD template.

SPS has also developed exemplar templates which can be locally adapted:

SPS has developed suites of template PGDs for several clinical areas which may be locally adopted:

Nationally signed PGDs

Check if there is a nationally signed PGD already available, such as:

Managing workload, deadlines and timeframes

Agree a plan of action for PGD development with timeframes, and consider workload. If there are several PGDs being developed this may require more time.

Other steps to take:

  • find out if the local PGD policy states timeframes for each stage
  • make sure everyone is aware of their responsibilities and required time commitment in the process, so that work is completed within the agreed timeframes
  • find out when the appropriate governance meetings for sign off are due to take place, so this can be incorporated into planning

Failure to achieve agreed timeframes and deadlines could result in a delay in service delivery.

Writing a PGD for submission

If using a template or adapting a PGD already in use, make sure the information in the PGD is clinically accurate and is appropriate for your organisation and the service. Consider local referral routes, support for practitioners and scope of practice.

PGD content

Remember that all content is the responsibility of the clinical signatories and, where relevant, not that of the previous PGD owner/developer. The PGD clinical signatories must check that the content is clinically accurate and valid and consistent with the summary of product characteristics (SPC), local and national guidelines/policies and other sources of best available evidence.

Reference sources

Always reference the sources used, citing the most robust content, ideally from nationally recognised sources (e.g. NICE, eMC or MHRA for SPCs, including any Risk Minimisation Measures, Green Book, Royal Colleges etc.).

Establish a working group

As part of this working group, identify:

Plan if the meetings and consultation will be virtual or face-to-face.

Ensure a microbiology specialist is part of the team where a PGD for an antimicrobial is being developed. They should be consulted at an early stage in the process and when circulating drafts/final PGDs for approval. This should be documented on the final approved PGD.

Local systems

Consider the local systems used for writing and agreeing the PGD and ensure enough time is allocated to complete all the required actions.

Consider use of electronic document management systems where locally available and approved for use.

Refer to your local PGD policy and Electronic record systems and Patient Group Directions (SPS page) for more information.

Structure and format of the PGD

Use an agreed local template or SPS exemplar template (see Preparing to write a PGD above).

Remember a PGD is a legal mechanism for the supply and/or administration of a medicine – it is not a clinical guideline. Restrict the core content to the required elements and use appendices to cover other local issues, such as examples of local information leaflets associated with the PGD.

Remember that a PGD should be clear and easy to follow.

Complying with regulation and guidance

The PGD content and its use in practice must comply with the regulation and the NICE PGD guidance. There are several supporting SPS PGD resources (SPS page).

Document management

Establish who will manage the process of leading on the review of drafts and a system of numbering to ensure full version control when circulating drafts. Consider the process and the place for storing drafts and recording any agreements at any stage. For example, by saving emails or using document management systems which will have electronic signatures.

Agree how comments and required changes to drafts will be managed. Include the people who are developing the PGD but also consider discussing with other people, such as the person responsible for overall document management of PGDs in the organisation. They may be able to offer advice and support.

Governance

Ensure the following are completed:

  • consider if any organisational change (SPS page) or other recent change impacts on who is involved with the PGD
  • confirm who authorises PGDs in the organisation and ensure they are aware of development (if necessary, consult the local clinical governance or medicines management lead to discuss)
  • ensure everyone involved in the PGD development agrees that the PGD is ready for submission for authorisation
  • plan ahead for submission of the PGD for authorisation, according to your local process and/or PGD Policy

Training requirements

Training requirements for those who will work under the PGD need to be planned and in place before a PGD is published. Further information is available at:

Monitoring the PGD during use

Consider how the PGD use will be monitored/audited early in the process as systems may need to be put in place to ensure effective audits can be undertaken. Further information is available at:

Update history

  1. Republished
  2. Page contents reviewed; no amendments required.
  1. Broken link fixed
  1. Published