Audit
Undertaking audits is one way to monitor PGD use in practice. Plan for these during the development stages as systems may need to be put in place to ensure audits can be undertaken.
Further information is available at:
Planned review, update and re-authorising of a PGD
The principles for authorisation of a reviewed and updated PGD is the same as for new PGDs. See the other articles in this series for more information and ensure the below are considered.
Review ongoing need for the PGD
Review whether the PGD is still appropriate before spending time undertaking a full clinical review and update. Remember, the preferred way for individuals to receive medicines is for a prescriber to provide care for an individual on a one-to-one basis.
Involve the right stakeholders
Establish who will be involved in this process, including a lead author and clinical signatories.
Define the work plan
Use information you have available to inform the work required. Review PGD audit results and any incidents related to the use of the PGD.
Some organisations have many PGDs within different services so there is a need for commissioners, providers and individual services to consider this and collaborate when necessary, to ensure the work programme is realistic for all stakeholders.
Re-authorisation
Even if a PGD requires only a minor amendment following review, it still must be updated and re-authorised and practitioners re-authorised to work under the updated version of the PGD.
Ensure the process specifies a requirement for an updated PGD to be submitted for re-authorisation well in advance (3-6 months if possible) of the expiry date on the current PGD.
In exceptional circumstances, there may be a need to extend the expiry date of a PGD.
Unscheduled review of a PGD
Anyone who is involved with clinical practice under the PGD, or who is a clinical signatory, should be alert for the need for an unscheduled review of the PGD.
This may be due to a change in the licence of the product, new national guidelines or other important new evidence which requires changes in clinical practice under the PGD. Consider implementing a local rolling review process for all PGD-supporting summary of product characteristics and guidance, to ensure all changes and updates are considered for inclusion in a timely manner.
Governance arrangements
The ongoing governance of PGDs should allow for the timely identification and response to:
- changes in governance structure
- clinical signatories leaving the organisation, ensuring replacements are invited to join working groups
- changes in the PGD development or authorisation process (consider consulting the local clinical governance or safety/medicines management lead)
- planned or ongoing parallel pieces of work, such as service redesign
- medicine supply issues or withdrawal of medicines or products (Medicines Shortages and Patient Group Directions has further information)
- organisations merging, ceasing to exist or transferring services (Managing PGDs following organisational change contains further information)
Communication
Identify who will be responsible for communicating that a PGD has been reviewed and:
- a new version is available, which requires practitioners to be authorised before they can practice under it, or
- the PGD is to be withdrawn from practice – communicate any new arrangements for supply or administration of the medicines concerned
Plan how these elements of communication will happen and when.