ICBs and PGDs

An ICB has been recognised as a legal body that can authorise PGDs in legislation since July 2022.

The use of PGDs within ICB commissioned services can be complex and involve more than one partner organisation.

Planning services involving PGDs

If PGDs are being used in commissioned services, ICBs must incorporate appropriate medicines assurance 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 organisations 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 – see Introduction to PGDs
• 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 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
• communication/distribution of PGDs
• review, including unscheduled review and expiry dates – see Monitoring and reviewing a PGD in practice and Extension of expiry date of a Patient Group Direction
• record keeping/retention – see Retaining legal mechanism documentation
• requirements for organisations using PGDs e.g. assurance reporting – see Monitoring and reviewing a PGD in practice

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, 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.

Independent healthcare providers and others

The PGD must be authorised by the NHS or LA commissioner if the provider is from one of the following groups:

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

Authorising Independent Healthcare Provider (IHP) PGDs and Patient Group Direction use in Primary Care Networks 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. The lead commissioner then authorises the PGD on behalf of all the 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 contains further detailed advice.

Common Commissioning scenarios

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

Community pharmacy

Services to community pharmacy can locally or nationally commissioned.

Locally commissioned services

Since April 2023, ICBs have become responsible for all local commissioning previously undertaken by regional NHSE teams 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.

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.

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

Dental Services

Since April 2023, the commissioning of dental services has transferred to ICBs.

The introduction of exemptions for dental hygienists and therapists in Schedule 17 of the HMR 2012 are under consideration, but are not expected to be in legislation imminently.

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

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

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

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 2026.  The responsibility for authorising immunisation PGDs, developed and clinically signed by UKHSA, will become the responsibility of ICBs from this time.  For more detail please refer to NHS commissioning: plans to April 2026

Primary Care Networks/GP Federations

PCNs/GP Federations are not legal bodies allowed to authorise PGDs within the The Human Medicines Regulations 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. Finalised 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 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 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.

Update history