Involve the right people

Legislation relating to medicines and associated governance can be complex.

Ensure the following:

• discuss the feasibility of a PGD with an expert in medicines governance before going any further
• find out which group or individuals lead on PGD development and authorisation in, or on behalf of, your organisation
• decide who is best placed to be the lead author, ensuring they have the competencies and experience required to write a PGD
• consider who else needs to be involved (it may involve more than one clinical discipline)
• ensure those involved have the relevant organisational and/or professional indemnity cover before undertaking this role
• involve the commissioning organisation (where applicable) as early as possible, to ensure they agree a PGD is the most appropriate mechanism

Authors must always include a pharmacist and a doctor/dentist with the relevant clinical skills who will be the clinical signatories on the PGD. They should agree to be part of the PGD development team, be aware of their responsibilities and be competent to fulfil the role required.

Further information can be found in Understanding roles and responsibilities of PGD signatories.

Complex commissioning

Consider how the service is being commissioned and/or provided, and if more than one organisation is involved. Further information is available from SPS in the articles below:

• Patient Group Directions in Complex Commissioning Scenarios
• PGD use in services provided by multiple organisations
• Authorising Independent Healthcare Provider (IHP) PGDs
• Patient Group Direction use in Primary Care Networks

Follow local policy

Find out if there is an organisational PGD policy or procedure, including a PGD proposal policy. Whether the organisation is a commissioner or a provider they should have a PGD policy. This will outline the overarching systems and processes used and should cover all aspects of PGD development and use within the organisation.

There should be a formal agreement with the local medicines governance committee, commissioner or any other authorising body that a PGD may be developed.

Roles and responsibilities

Establish who will take on the role of lead author and who will be the PGD signatories. See Understanding roles and responsibilities of PGD signatories for further information.

Where not the responsibility of the lead author, decide who will:

• manage the process including drafting, collation of feedback and making changes
• arrange review meetings
• action any comments during the PGD development process
• lead on taking the PGD through the submission process to obtain PGD authorisation

Service considerations

Scope if there are any parallel pieces of work to be carried out or ongoing within the service, e.g. whether there are any plans for re-design of services.

Scope if there is a plan for an organisational merger which may change the organisational structure.

Estimate how many practitioners will use the PGDs. If only one or two, it may not be viable to develop a PGD.

Medicine considerations

Depending on the medicine(s) included in the PGD, there may be additional factors to consider.

Licensing

Only UK licensed medicines can be included in a PGD. If the PGD includes off label use of a medicine or an antibiotic, there are specific considerations – refer to NICE MPG2 Patient Group Directions 2017.

Controlled drugs

If a PGD includes a controlled drug refer to Supply and/or administration of Controlled Drugs under a PGD.

Risk minimisation measures

Establish if the proposed medicine requires any additional risk minimisation measures to be completed for the medicine to be supplied or administered, and ensure this is appropriate and safe under a PGD.

Number of medicines

If the PGD is to be for more than one medicine, establish if this is practical, safe and auditable and consider if separate PGDs would be preferable. Including more than one medicine in a Patient Group Direction provides further information.

Procurement

Consider how you will source and procure the medicine, as issuing a supply may involve obtaining an appropriately labelled pre-pack, noting medicines cannot be supplied under a PGD from spilt packs (see NICE MPG2 Patient Group Directions 2017).

Ensure time for obtaining the appropriately labelled supply from an appropriately licensed unit has been factored into your service delivery targets. Ensure it is financially viable to obtain the medicines to the required specifications, in the quantities required.

Prescription charges

Consider how any prescription charges are collected if the medicines are supplied to take away.

Legislation other than PGD legislation

Other legislation may apply, resulting in a PGD that does not comply with the law or national guidelines. There are further supporting resources on the SPS website.

Look at other best practice guidelines related to medicines and pharmaceutical care. These might not mention PGDs specifically but are important to consider.

Useful resources include:

• Royal Pharmaceutical Society: Safe and Secure Handling of medicines
• Professional Guidance on the Administration of Medicines in Healthcare Settings
• NICE Guidance website – medicines management
• Professional regulatory body standards e.g. GMC, GPhC, HCPC and NMC

Healthcare professionals using the PGD

Ensure those planned to use the PGD are listed in PGD legislation as being able to do so, and have the training and competencies required to practice under the PGD.

Ensure the following are completed during the PGD planning process:

• identify who will train the practitioners, assess competency and authorise them to practice
• identify training and competency needs of those working under the PGD (see NICE PGD Competency Frameworks and Patient Group Directions e-learning programme)
• establish who will retain and maintain the lists of authorised practitioners

Remember that a registered health professional who is undergoing competency training should not be authorised to use PGDs, where this competency is a requirement for PGD use. For example, a trainee injector cannot use a PGD to administer an injection.

Governance arrangements

Independent healthcare providers

If an organisation is an independent healthcare provider, it cannot authorise its own PGDs for NHS and public health commissioned services. It will therefore need authorisation from the commissioner of the service within which the PGD will be used. The commissioner may wish to:

• receive information about any PGD plans
• agree a PGD is suitable for use in the commissioned service before development
• receive assurance around the governance of PGD development before authorisation, including a copy of the provider’s PGD policy
• be involved in the PGD development or see minutes of relevant meetings
• require further information at a later stage such as lists of PGDs being used by an organisation to provide the service and management/monitoring information

Further information is available in the following SPS articles:

• Patient Group Directions in Complex Commissioning Scenarios
• PGD use in services provided by multiple organisations
• Authorising Independent Healthcare Provider (IHP) PGDs
• Patient Group Direction use in Primary Care Networks

Authorising PGDs

Establish who will authorise the PGDs. This may require consultation with the local clinical governance or medicines management lead.

Where the commissioner and provider organisations are not the same, liaise with the PGD contact within the authorising organisation at an early stage.

Further information can be found in:

• Patient Group Directions in Complex Commissioning Scenarios
• Authorising Independent Healthcare Provider (IHP) PGDs

Record keeping

Decide how, where and who will keep the relevant records. Establish what records are needed when practising under the PGD and which organisation is responsible for maintaining these. Retaining legal mechanism documentation has further information.