Patient Group Directions (PGDs) are written instructions, authorised by the organisation(s) in which they are going to be used, for the supply or administration of medicines to groups of patients who may not be individually identified before presentation for treatment. As such, PGDs are legal mechanisms that enable certain registered health professionals to supply/administer medicines to groups of patients with an identified clinical condition and are commonly used in community pharmacy enhanced services.

Changes to Medicines Legislation

Previously PGDs were mainly authorised by PCTs but this needed to change when the new NHS organisational structures were implemented in April 2013. To allow this change , the Medicines and Healthcare products Regulatory Agency (MHRA) and Department of Health amended the medicines legislation to:

• enable Clinical Commissioning Groups and Local Authorities to authorise PGDs from April 2013; and,
• ensure that existing PGDs with an expiry date after 31 March 2013 continued to be legal until the PGD either expires or is replaced.

The National Prescribing Centre (now the Medicines and Prescribing Centre (MPC) at NICE) published Patient Group Directions 2009 – a practical guide and framework of competencies for organisations and professionals developing and using PGDs. This guide is being reviewed and an updated version is due in 2013. In advance of the updated edition, this will remain the current guidance for organisations delivering services under PGDs to help guide them through the legal framework governing the development and authorisation of PGDs, and to provide practical guidance on their use.

Transitional Arrangements

The legislation also incorporates transitional arrangements to ensure:

• the continued availability of PGDs during organisational change; and
• that staff and organisations are not acting outside the law.

These arrangements allow PGDs to remain legal after the original authorising body (e.g. a PCT) has been abolished, and until expiry of the PGD or authorisation by the new body responsible for the service in question. Responsibility for PGDs transferred to these new bodies, and organisations ‘inheriting’ PGDs need to put in place clear arrangements and a timetable for review and adoption or authorisation of all existing PGDs. There should be agreed local processes for extension of expiry dates and this is an organisational not an individual responsibility.

Extension of expiry dates without review or re-authorisation of a PGD is exceptional practice only occurring during organisational or service transition and should be for an agreed and limited period of no longer than one year. It is not without risk as changes may have occurred but the organisation may deem it necessary where it is in the interests of patient safety. It will also need to be balanced with any risk incurred where withdrawing the PGD could result in significant service disruption and potential patient safety issues due to lack of access to medicines. It is not acceptable or legal for an individual practitioner to decide to use a PGD that has expired.

If a period of extension is agreed, then this should be formally noted by the organisation along with an agreed plan of action with timescales for review and re-approval of the PGD.  The re-approval process should include a relevant audit of the PGD and its use.

Organisations need to have an auditable process for managing the adoption of PGDs from any predecessor(s) and it is advised that a nominated group or committee will:

• ensure the relevant systems and processes are in place for the development, authorisation, implementation, review of PGDs and for the adoption of existing PGDs to comply with the legal framework and any associated national guidance;
• collate titles, version numbers and expiry/review dates of all the ‘inherited’ PGDs centrally;
• include PGDs in a ‘clinical governance’ paper to the Board that asks them to adopt all PGDs, etc, from the previous organisations;
• include a statement with reference to which group or committee will manage, review and authorise PGDs and their place within the organisation in the future;
• agree a work plan to prioritise PGDs that are duplicated, need review and/or expire sooner and work towards a common template for the new organisation; and
• ensure explicitly noted in Board minutes

During Transition

During the interim period, more than one PGD for the same medicine(s) and indication(s) may be in use. CCGs and LAs  should ensure that:

• practitioners are aware of transitional arrangements and advise them to continue to practice only under the PGD(s) to which they were originally signed up to until otherwise advised; and
• all managers and practitioners working under the PGDs are made aware of any expiry date extensions of the PGD and any required action such as review or audit.

For more information on this briefing please contact Alastair Buxton, Director of NHS Services

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