Essential reading

Ensure you are familiar with the following articles:

Doctor (or dentist) and pharmacist signatory

The Human Medicines Regulations (HMR) 2012 requires that a PGD must be signed by a doctor, or dentist, and a pharmacist and guidance states that they should be involved in the PGD development.

NICE guidance states when signing the PGD the doctor, or dentist, and pharmacist take joint responsibility and accountability for the accuracy of both the clinical and pharmaceutical content of the PGD. This role should be undertaken by senior professionals with full consideration of the clinical service in which the PGD is to be used.

Doctor and dentist responsibilities

As the doctor/dentist signatory you are responsible for ensuring the PGD will provide safe and appropriate clinical treatment to a pre-defined group of individuals within agreed parameters described in the PGD.

During development of the PGD you are responsible for the provision of clinical advice and support. This includes advice on the feasibility of the PGD with reference to the most appropriate options for clinical care and adherence to relevant clinical guidelines.

You are responsible for ongoing provision of clinical advice and support when the PGD is in practice, following audit and during review of the PGD.

Pharmacist responsibilities

As the pharmacist signatory you are responsible for ensuring the PGD will provide safe and appropriate pharmaceutical treatment to a pre-defined group of individuals within agreed parameters described in the PGD.

Prior to and during PGD development, you are responsible for provision of pharmaceutical advice and support. This includes advice on the feasibility of the PGD with reference to licensed status of the medicine, local formulary and other guidelines relating to the medicine.

You are responsible for ongoing provision of pharmaceutical advice and support when the PGD is in practice, following audit and during review.

Professional group signatory

It is good practice for PGDs to be signed by representatives of the registered health professional group(s) intended to work under the PGD.

There is no restriction on how many signatories can be included on a PGD but consideration should be given to the administrative complexity of multiple signatories. For example, it may be advisable to have one signatory signing on behalf of multiple professional groups where more than one is included within a PGD.

Responsibilities

As the representative of the professional group working under the PGD, you are responsible for:

• the provision of specialist professional advice and support including provision of information on service delivery within the clinical area
• ongoing professional advice and support for practitioners when the PGD is in practice
• ongoing professional advice during and following audit and during review of the PGD

Authorising body signatory

A representative of the relevant authorising body must authorise the PGD by signing on behalf of the organisation. The Human Medicines Regulations 2012 Schedule 16 Part 2 defines the relevant authorising bodies.

An organisation’s structure will determine which individual role incorporates the authority and responsibility to be this signatory. Authorising bodies need to consider the knowledge, skills and expertise needed by people who are developing, updating, authorising and using PGDs and ensure that they are aware of their responsibilities and can demonstrate their competency.

Responsibilities

As the individual responsible for organisational authorisation of a PGD on behalf of an organisation, you are signing that a PGD is legal and has followed local processes.

You must have sufficient evidence to be assured that:

• a PGD has previously been agreed as the most appropriate mechanism for supply and administration of the medicine
• there is no opportunity in the care pathway for the medicine to be prescribed in a timely manner
• those involved in the clinical authorisation of the PGD are competent to do so
• local processes and governance arrangements have been followed
• the views of all stakeholders have been considered
• all legal requirements have been met

You have responsibility for ensuring PGDs are developed in line with legislation and local organisational policies and governance arrangements, with full consideration of the service in which the PGD is to be used.

It should be noted that for governance purposes, it is advisable that the authorising body signatory should not be involved in developing the PGD and should not practice under the PGD.

Leaving an organisation

There is no requirement for a PGD to be resigned if a signatory leaves an organisation. This is because the signatory is acting within their role as agreed by their organisation, or detailed in their role specification. The PGD Service Advisory Reference Group has clarified that there is nothing in legislation to state that a PGD becomes invalid if a PGD signatory leaves their role.

Further resources

NICE

NICE PGD guidance sets out the experience and competencies expected of PGD signatories.

Supporting resources include competency frameworks.

eLearning for healthcare

A PGD e-learning programme is available for all professionals involved with PGDs to understand the development, authorisation and safe use.