Understanding Patient Group Directions and Integrated Care Boards

ICBs and PGDs

ICBs have been recognised as legal bodies that can authorise PGDs in the Human Medicines Regulations 2012 (HMRs) since July 2022.

The use of PGDs within ICB commissioned services can be complex and involve more than one partner organisation as ICBs are usually not the provider of the service(s).

Planning services involving PGDs

If PGDs are being used to provide a commissioned service, ICBs must incorporate appropriate medicines assurance and governance requirements into the commissioning process and plan for authorisation where required.

NHS England has published the statutory guidance: Arrangements for delegation and joint exercise of statutory functions. Guidance for integrated care boards, NHS trusts and foundation trusts (available on the NHS Futures platform – login required). SPS advice should be considered in the wider context of this document.

Governance in ICBs

ICBs should have a defined governance process for considering, reviewing, and authorising PGDs, with consideration of who needs to be involved at each stage and ensuring appropriate reporting within the organisation.

ICBs may wish to consider having a PGD policy including (but not limited to):

• roles and responsibilities of ICB staff with respect to PGD governance
• the organisation’s PGD governance process
• when PGDs may be considered appropriate/where they must not or should not be used in commissioned services/circumstances requiring special consideration e.g. antimicrobials.  For more information refer to Introduction to PGDs (SPS page)
• the process for proposing/agreeing use of a PGD by a commissioned service
• requirements for development of the PGD (content, use of national template(s)), and guidance that is expected to be used e.g. NICE, SPS PGD resources, MHRA, CQC)
• requirements and process for requesting authorisation, including governance arrangements, assurance requirements and conflict resolution
• how complex commissioning arrangements will be dealt with – see Patient Group Directions in Complex Commissioning Scenarios (SPS page)
• communication/distribution of PGDs
• review, including unscheduled review and expiry dates – see Monitoring and reviewing a PGD in practice (SPS page) and Extension of expiry date of a Patient Group Direction (SPS page)
• record keeping/retention – see Retaining legal mechanism documentation (SPS page)
• requirements for organisations using PGDs e.g. auditing and assurance reporting – see Monitoring and reviewing a PGD in practice (SPS page)

Commissioner authorisation of PGDs

The commissioner of the service must first be identified when authorising PGDs.

For public sector (NHS or Local Authority (LA)) commissioned services only, there are two legal ways of authorisation, which depends on the provider organisation status.

NHS or LA organisation

If the provider is an NHS or LA organisation, they may authorise the PGD as permitted by the Human Medicines Regulations (HMR) 2012, which is the more common approach.

Note it is not permitted for a Local Authority to delegate the authorisation of Patient Group Directions using a Section 75 partnership agreement.  For more information please refer to Delegating PGD authorisation by a Local Authority (SPS page).

Independent healthcare providers and others

The PGD must be authorised by the NHS or LA commissioner if the provider is an independent or private healthcare provider, which includes the following groups:

• independent healthcare provider
• General Practice
• general dental practitioner
• Primary Care Network (PCN)/GP Federation
• community pharmacy

Authorising Independent Healthcare Provider (IHP) PGDs (SPS page) and Patient Group Direction use in Primary Care Networks (SPS page) contains further detailed advice.

Acting as a lead commissioner

It can be agreed that a lead commissioner will commission on behalf of a group of commissioners (i.e. ICBs) where the same service is commissioned by more than one ICB. The lead commissioner can then authorise the PGD on behalf of all the ICB commissioners if there is an agreed/signed Memorandum of Understanding (MoU) in place. This MoU should detail the arrangements with all parties including the provider organisation(s).

It is suggested that this is undertaken over a defined, manageable geography.

Patient Group Directions in Complex Commissioning Scenarios (SPS page) contains further detailed advice.

Organisations may wish to seek legal advice on such arrangements.

Common Commissioning scenarios

The current commissioning arrangements and responsibilities for specific services are further clarified.

Community pharmacy

The assurance of these services is the responsibility of ICBs who are required to undertake monitoring and quality improvement.

NHS services provided by community pharmacy can be locally or nationally commissioned.

Locally commissioned services

ICBs are responsible for all local commissioning under the pharmaceutical services contract. This includes Local Enhanced Services and Local Pharmaceutical Services.

The funding and full responsibility for commissioning these services sits with ICBs, encompassing service fees and medicine costs. PGDs used within locally commissioned services must be authorised by the commissioning ICB.

Nationally commissioned services

Services commissioned through the National Community Pharmacy Contractual Framework, additional to core services, are nationally commissioned under an Advanced Service or a National Enhanced Service arrangement (as for Covid-19 vaccination). PGDs for these services are authorised nationally and do not require ICB authorisation.

Dental Services

ICBs are responsible for the commissioning of dental services.

PGDs are a possible legal mechanism for medicine administration and/or supply, but consideration must be given to the process of developing the PGDs. The following must be considered:

• who will act as the clinical signatories
• the availability of appropriate supporting clinical guidance
• how medicines costs/reimbursement will be managed
• labelling of supplied medicines
• how training will be provided

Any PGDs for NHS dental services will need to be authorised by the commissioning ICB.

Dental hygienists and therapists may utilise the exemptions detailed in Schedule 17 of the HMR 2012 but as for PGDs where a medicine is to be supplied consideration must be given to how these medicines would be funded and labelled to the required standard.  For more detail see Labelling medicines supplied without a prescription (SPS page) and the NHS guidance Supply and administration of medicines by dental hygienists and dental therapists

National routine immunisations

The commissioning of national routine immunisation services at present, remains at regional level.

It is expected that this commissioning responsibility will pass to ICBs from April 2027.  The responsibility for authorising immunisation PGDs, developed and clinically signed by UKHSA, is currently expected to pass to ICBs from this time.

For more information refer to NHS England – Direct commissioning update

Primary Care Networks/GP Federations

PCNs/GP Federations are not legal bodies permitted to authorise PGDs within the HMR 2012.

If a PCN or GP Federation wishes to use a PGD for an NHS-commissioned service, they will need to contact their ICB for agreement/commissioning of the service. PGDs will require authorisation by the ICB.

PGD Signatories

The ICB authorising signatory must be aware of their responsibilities.

Where a PGD is developed by an independent healthcare provider for use in an ICB commissioned service, the authorisation will usually only be undertaken by the ICB. The clinical signatories should be part of the PGD working group within the provider organisation that developed the PGD.

If the ICB develops PGDs for use in commissioned services, then both clinical and authorising signatories will the responsibility of the ICB.

Understanding roles and responsibilities of PGD signatories (SPS page) contains further information.

PGD Records Management

The ICB will be responsible for retaining PGD authorisation records where they authorise a PGD for use.

Retaining legal mechanism documentation (SPS page) contains further information.

Related guidance

Regional arrangements for medicines optimisation in the NHS in England.  Guidance for integrated care boards and NHS England regional leadership teams.

NHS England – Direct commissioning update

Update history