PGD use in services provided by multiple organisations working in partnership
NHS/publicly funded services may be provided to a defined population or geography by multiple organisations working in partnership. This article outlines the principles organisations need to consider when PGDs are used in the provision of medicines/vaccines in such services.
For example such services are being developed to improve access to and uptake of the seasonal ‘flu vaccine within a defined geography. In this example the vaccine is being made available to qualifying individuals on a drop-in basis at a number of locations and may be given by health care professionals (HCPs) employed by a number of involved organisations.
Note – within this document multiple organisations refers to a group of commissioners/providers of NHS/publicly funded services who are working together to deliver a single programme of care to a local geography/population.
Developing PGDs for use by multiple organisations
It is possible for PGDs to be developed for use by more than one organisation; how a PGD for use by multiple commissioners and/or providers can be developed and managed is covered in detail within Patient Group Directions in Complex Commissioning Scenarios.
PGDs for use across multiple organisations will need to be developed and authorised in line with NICE guidance and the legislation set out in the Human Medicines Regulations 2012. For NHS commissioned services, PGDs must be authorised by an appropriate authorising body (e.g. NHS England, ICB, NHS Trust, Local Authority).
Governance
Where a PGD is to be used by multiple organisations the involved commissioners/providers should ensure that any agreement is written within a Memorandum of Understanding (MOU), Service Level Agreement (SLA) or similar, agreed to by all involved parties and approved by each involved organisation’s clinical governance processes.
Such agreements may be made on a service-by-service basis or as a single overarching agreement to cover all combined services where PGD medicines are involved and may be a standalone agreement or form part of a wider service delivery agreement.
Using PGDs in more than one location
PGDs can be used in more than one location if written appropriately. See Using medicines at more than one location under a single PGD.
Healthcare professionals working under PGDs
When a service is being offered by multiple organisations healthcare professionals (HCPs) operating under the PGD will be employed by different organisations.
If a registered HCP is authorised as appropriately trained and competent to operate under the PGD by their employing organisation, then it can be considered that that HCP is also authorised to operate under the same PGD for the treatment of individuals across the population/geography defined by the multiple organisation agreement, provided this has been agreed by all the involved organisations.
In this model consideration should be given to ensuring appropriate CQC registration is in place, or equivalent appropriate registration, and that for the healthcare professionals working under the PGD appropriate indemnity cover is in place.
Stock management
Where multi organisation services are being established consideration should be given to responsibility for stock ordering, storage and any required transportation of stock and disposal including, where appropriate, ensuring compliance with Wholesaler Dealer legislation.
Other considerations
In addition to the factors outlined above the MOU/SLA or similar should include aspects such as agreed training requirements (including monitoring of ongoing CPD/training in line with the requirements stated in the PGD), record keeping and incident reporting.
Any financial aspects and how any organisation leaving the multi organisation agreement is managed should also be considered and included in a MOU/SLA or similar document.
Many of the principles outlined are included in Patient Group Directions in Complex Commissioning Scenarios.
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