Considerations

Points to consider include:

• Whether there is already an opportunity in the care pathway for the medicine to be prescribed in a safe and timely manner. This may need a review of the systems involved in the provision of medicines to patients to determine if there is or could be an opportunity for prescribing.
• Is a PGD the correct legal mechanism? See When not to use a PGD for further information.
• Non-medical prescriber training – NMPs will remove the need for PGDs.
• PGDs are not intended to replace individual prescribing to save prescribers’ time or to address inefficiencies within systems or pathways.

Involve the right people

Legislation relating to medicines and associated governance can be complex:

• 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.
• Authors must always include a pharmacist and a doctor (or 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.
• Those involved should ensure that they have the relevant organisational and/or professional indemnity cover before undertaking this role.

Complex commissioning

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

• 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

The systems and processes that need to be followed

• 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.
• There should be a formal agreement with the local medicines governance committee, commissioner or any other authorising body that it is agreed to start developing a PGD.
• Decide who will manage the process including drafting, collation of feedback, making changes, arranging review meetings and action any comments during the PGD development process.
• Decide who will lead on taking the PGD through the submission process to obtain PGD authorisation.
• If the PGD is an interim solution, evaluate if is this appropriate/necessary. Be prepared to challenge requests for PGDs. Discuss with colleagues whether it would be helpful to suggest that there should be a plan during the life of the PGD to train a sufficient cohort of non-medical prescribers. This could supersede the need for a PGD in the future.

The service

• Scope if there are any parallel pieces of work to be carried out or ongoing within the service, e.g. are there 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 the PGDs.

The medicine

• First consider if a PGD is the appropriate legal mechanism – refer to When not to use a PGD
• 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.
• If a PGD is to include a controlled drug refer to Supply and/or administration of Controlled Drugs under a Patient Group Direction
• Establish if the proposed medicine requires any additional risk minimisation measures to be completed for the medicine to be supplied or administered. Ensure this is appropriate and safe under a PGD.
• If the PGD is to be for more than one medicine, establish if this is practical, safe and auditable. Consider if separate PGDs would be preferable.
• Consider how you will source and procure the medicine. Issuing a supply of the medicine 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 been factored into your service delivery targets. Ensure it is financially viable to obtain such packs to the required specification(s) in the quantities required.
• 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 who will use the PGD

Ensure the practitioners who will 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:

• Identify who will train the practitioners and assess competency/authorise them to practice.
• Identify their training and competency needs. 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 a trainee should not be authorised to use PGDs. For example, a trainee injector cannot use a PGD to administer an injection.

Governance arrangements

• Establish who will authorise the PGDs. This may require consultation with the local clinical governance or medicines management lead to discuss.
• Where the commissioner and provider organisations are not the same at an early stage, liaise with the PGD contact within the authorising organisation. Patient Group Directions in Complex Commissioning Scenarios and authorisation of Independent Healthcare Provider (IHP) PGDs for NHS and public health commissioned services contain further information.
• 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.

Independent healthcare providers

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

• receive information about any PGD plans
• 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:

• 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

Preparing to write a PGD

If an organisation does not have a standard template, NICE and SPS have developed examples which can be locally adapted.

• Research other available sources of information and advice to assist the authors. For example, national and/or local clinical guidelines.
• Find out if there is a similar PGD already being used in the organisation.
• Check if there is there a national PGD template or nationally signed PGD available (UKHSA).

Workload, deadlines and managing timeframes

Agree a plan of action for PGD development with timeframes and consider workload – if there are several PGDs this may require more time.

• Find out if the local PGD policy states timeframes for each stage.
• Make sure everyone is aware of their responsibilities and required time commitment in the process so that work is completed within the agreed timeframes.
• Failure to achieve agreed timeframes and deadlines could result in a delay in service delivery.

Content

If using a template or adapting a PGD from another organisation, make sure that the information in the PGD is clinically accurate and is appropriate for your locality and the service:

• Take into account local referral routes, support for practitioners and scope of practice.
• Remember that any content that used is the authorising organisation’s responsibility and not that of the previous PGD owner/developer. For example, the PGD signatories must check that the information in the PGD is clinically accurate and valid e.g. against SPC/local and national guidelines.
• Ensure the PGD content is consistent with SPCs, best available evidence and national/local guidelines/policies.
• Always reference the sources used, citing the most robust content, ideally from NICE accredited sources (e.g. eMC or MHRA for SPCs, including any Risk Minimisation Measures/Green Book, etc.).

Establish a working group

Identify who will lead on writing the PGD:

• Identify who will lead the team of authors. This person should ensure the authors are involved at all stages of development, to check for clinical accuracy and validity according to the specialty.
• Identify the clinical signatories at an early stage and ensure they know why they are signing and understand their roles/responsibilities.
• Plan if the meetings and consultation will they be virtual or face to face.
• Ensure a microbiology specialist is part of the team where a PGD for an antimicrobial is being developed. They should be consulted at an early stage in the process and when circulating drafts/final PGDs for approval. This should be documented on the final approved PGD.
• Consider the system/s used for writing and agreeing the PGD.

Structure and format of the PGD

• Use an agreed local or national template.
• Restrict the core content to essential elements and use appendices to cover other local issues e.g. examples of local information leaflets associated with the PGD.
• Remember that a PGD should be clear and easy to follow.

Complying with legislation and guidance

The PGD and practice must comply with the law and the NICE PGD guideline.  There are a number of supporting SPS resources.

Document management

Establish who will manage the process of leading on review of drafts.

• Establish a system of numbering to ensure full version control when circulating drafts.
• Consider the process and the place for storing drafts/recording any agreements at any stage e.g. saving emails or using document management systems which will have electronic signatures.
• Establish how comments and required changes to drafts will be managed.
• Include the people who are developing the PGD but also consider discussing with other people such as the person responsible for overall document management of PGDs in the organisation. They may be able to offer advice.

Governance

• Consider if any organisational change or other recent change impacts on who is involved with the PGD.
• Confirm who authorises PGDs in the organisation and ensure they are aware of development.  If necessary consult the local clinical governance or medicines management lead to discuss.
• Ensure everyone involved in the PGD development agrees that the PGD is ready for submission for authorisation
• Plan ahead for the submission the PGD for authorisation according to your local process and/or PGD Policy.

Training requirements

Training needs to be planned and in place before a PGD is published. Further information is available at:

• NICE PGD Competency Frameworks
• Patient Group Directions e-learning programme

Monitoring the PGD in use

Consider this early on in the process as systems may need to be put in place to ensure audits can be undertaken. Further information is available at:

• NICE Patient Group Directions
• Auditing Patient Group Directions

The authorisation process

Different authorising organisations may have different processes and policies for PGDs:

• Ensure all the signatories (clinical and organisational) are ready to sign.
• Ensure any electronic systems used are robust. See Patient Group Directions and electronic record systems

If you are an independent healthcare provider commissioned to provide NHS or public health services, check which organisation is responsible for the organisational authorisation of your PGDs.

Responsibilities when authorising/signing a PGD

Confirm the signatories know why they are signing and understand their roles/responsibilities.

Management of PGDs in use

Plan ahead and confirm who will ensure management of document and version control of approved PGDs and practitioner authorisation records.  This is likely to involve more than one post holder.

Communication

Plan how these elements of communication will happen and when:

• Identify who will be responsible for communicating to the service or provider that the PGD has been authorised and is available for implementation.
• Identify who will be responsible for communicating to individual practitioners that the PGD has been authorised. This also includes plans for the individual practitioners to undertake any relevant training and obtain authorisation to work under the PGD.

Document management

Identify the following people who will be responsible for:

• The management of authorised PGD documents within the organisation as a whole but also at service level.  These may not be the responsibility of the same person, department or organisation, and there should be close liaison to ensure good governance.
• Keeping a list of authorised PGDs that are in use in the organisation with dates for review/expiry (CQC will expect to see this during inspections).
• Keeping a list of authorised PGDs which are in use in a particular service.
• Organising removal of any old versions of PGDs from clinic areas and intranets so that only the most recent version can be accessed.
• Training and competency assessment of individual practitioners, with logging of completion.

Practitioner authorisation

A senior person should be responsible for ensuring that only fully competent, qualified and trained health professionals are authorised to use the most recently approved version of the PGD.

Authorised health professionals working under PGDs should understand their legal and professional responsibilities before they use PGDs.

Training

Ensure the relevant training available is completed so that practitioners can be assessed for competency to use the PGDs. This can be provided locally or via national resources.

Remember that a registered health professional who is a trainee should not be authorised to use PGDs.

Planned review, update and re-authorising of a PGD

The principles for authorisation of a reviewed and updated PGD is the same as for new PGDs:

• Establish who will be involved in this process including a lead author and clinical signatories.
• Define the work plan.
• Some organisations have many PGDs within different services so there is a need for commissioners, providers and individual services to consider this and collaborate when necessary so that the work programme is realistic for all stakeholders.
• Think about whether the PGD is still appropriate before spending time undertaking a full clinical review and update. Remember, the preferred way for patients to receive medicines is for a prescriber to provide care for an individual patient on a one-to-one basis.
• Review the results of the audit/s of the PGD use that have been undertaken.
• Review any incidents which have been reported as related to the use of the PGD.
• Even if a PGD requires only a minor amendment following review – it still must be updated and re-authorised and practitioner re-authorised to work under the updated version of the PGD.
• Ensure the process specifies a requirement for an updated PGD to be submitted for re-authorisation well in advance (3-6 months if possible) of the expiry date on the current PGD.
• In exceptional circumstances, there may be a need to extend the expiry date of a PGD.

Unscheduled review of a PGD

Anyone who is involved with clinical practice under the PGD, or who is a clinical signatory, should be alert for the need for an unscheduled review of the PGD.

This may be as a result of a change in the licence of the product/new national guidelines or other important new evidence which requires changes in clinical practice under the PGD.

Governance arrangements

The ongoing governance of PGDs should include the following considerations:

• Changes in governance structure.
• Changes in authorisation for PGDs in the organisation.
• If any clinical signatories leave the organisation, ensure replacements are invited to join working groups.
• Confirm the PGD process and consider consulting the local clinical governance or safety/medicines management lead.
• Scope any parallel pieces of work to be carried out or ongoing e.g. plans for services re-design.
• Medicine supply issues/withdrawal of medicines or products. Medicines Shortages and Patient Group Directions has further information.
• Awareness of how to manage PGDs when organisation merge, cease to exist or services transfer.

Communication

Plan how these elements of communication will happen and when:

• Identify who will be responsible for communicating that a PGD has been reviewed and a new version is available, which require practitioners to be authorised before they can practice under it.
• Identify who will be responsible for communicating that a PGD has been reviewed and is to be withdrawn from practice. Communicate any new arrangements for supplying or administration of the medicines concerned.