Patient group directions

1.1.1 Provide the majority of clinical care involving supplying and/or administering medicines on an individual, patient-specific basis. Reserve patient group directions (PGDs) for limited situations in which this offers an advantage for patient care, without compromising patient safety, and where there are clear governance arrangements and accountability.

1.1.2 Explore all the available options for supplying and/or administering medicines in a specific clinical situation. Consider whether 1 option or a range of options is appropriate.

1.1.3 Use the NHS Specialist Pharmacy Service guide about developing PGDs to consider whether a PGD is necessary. Do not use PGDs for medicines when exemptions in legislation allow their supply and/or administration without the need for a PGD.

1.1.4 Consider investing in the training of additional non-medical prescribers to enable redesign of services if necessary, as part of a wider development or review of local medicines policy.

1.1.5 PGDs must be used only by named and authorised registered health professionals who can legally supply and/or administer medicines using a PGD (see recommendation 1.4.9 in the section on authorising patient group directions) in line with The Human Medicines Regulations 2012 (regulation 229).

1.1.6 PGDs must only include medicines with a UK marketing authorisation, in line with The Human Medicines Regulations 2012 (regulation 229).

1.1.7 Ensure that off-label use of a licensed medicine is included in a PGD only when clearly justified by best clinical practice. Clearly state that the medicine is being used outside the terms of the marketing authorisation on the PGD. Consider informing the patient or their carer that the use is off-label, in line with General Medical Council guidance on prescribing unlicensed medicines.

1.1.8 Ensure that a black triangle medicine is included in a PGD only when clearly justified by best clinical practice. Clearly indicate the black triangle status on the PGD.

1.1.9 Ensure that a controlled drug is included in a PGD only when legally permitted and clearly justified by best clinical practice.

1.1.10 Do not jeopardise local and national strategies to combat antimicrobial resistance and healthcare‑associated infections. Ensure that an antimicrobial is included in a PGD only when:

1.1.11 Do not include a medicine needing frequent dosage adjustments or frequent or complex monitoring in a PGD (for example, anticoagulants or insulin).

1.1.12 Do not make dose adjustments to a medicine supplied under a PGD when the medicine is already in the patient's possession.

1.1.13 Carefully consider the risks and benefits of including more than 1 medicine in a PGD on a case-by-case basis. Ensure all legal requirements are met for each medicine in line with The Human Medicines Regulations 2012 (schedule 16, part 1).

1.1.14 Do not use PGDs for managing long-term conditions, such as hypertension or diabetes, or when uncertainty remains about the differential diagnosis.

1.2.1 Establish a robust and transparent process for obtaining the agreement of the authorising body before proceeding to develop a PGD. Ensure that relevant information is clear and easily accessible.

1.2.2 Ensure that a multidisciplinary PGD approval group, with a locally defined mix of members, reviews proposals to develop PGDs. Define the roles and responsibilities of members and consider their training and competency needs.

1.2.3 Ensure that governance arrangements for the PGD approval group are firmly established, with clear lines of accountability and the delegated authority of the authorising body. This should include:

1.2.4 Ensure that the following information is included in proposal documentation for seeking agreement to develop a PGD:

1.2.5 Establish a robust and transparent decision-making process that clearly defines standard criteria for reviewing proposals to develop a PGD. Ensure that:

1.2.6 Record decisions to accept or reject the proposal, including the rationale for the decision. Communicate the decision by writing to the person who submitted the proposal, within a locally agreed timeframe. Ensure that the decision is communicated to other appropriate stakeholders.

1.2.7 Establish and publish a robust and transparent process for appeals of decisions made by the PGD approval group. Clearly define the acceptable grounds and timescale for appeals.

1.3.1 Ensure that a named lead author has responsibility for developing a PGD, supported by a locally determined multidisciplinary PGD working group. Include a doctor (or dentist), pharmacist and representative of any other professional group(s) using the PGD. Define their roles and responsibilities, and consider their training and competency needs.

1.3.2 Liaise with a local specialist in microbiology when developing a PGD that includes an antimicrobial (see recommendation 1.1.10 in the section on considering the need for a patient group direction).

1.3.3 Seek views on draft PGDs and agree final draft PGDs with relevant stakeholders, including clinicians and local medicines decision-making groups.

1.3.4 All legally required information must be included in a PGD in line with The Human Medicines Regulations 2012 (schedule 16, part 1). Use a standard template to ensure that the format is consistent across the organisation.

1.3.5 Ensure PGDs are consistent with the relevant summary of product characteristics, unless the medicine is being used off label or relevant national guidance is being followed (see recommendation 1.1.7 in the section on considering the need for a patient group direction).

1.3.6 Use the best available evidence, such as NICE guidance and other sources of high-quality information, when developing PGDs. Include key references in an appendix to the PGD.

1.4.1 PGDs must be authorised only by an appropriate authorising body in line with The Human Medicines Regulations 2012 (regulation 229).

1.4.2 Address barriers that may delay authorising PGDs, such as lack of clear leadership, ownership and understanding of legislation and governance arrangements.

1.4.3 At an early stage, identify the appropriate senior doctor (or dentist) and senior pharmacist who will sign the PGD, in line with The Human Medicines Regulations 2012 (regulation 213). Define the roles and responsibilities of these people and consider their training and competency needs.

1.4.4 When acting as a doctor, dentist or pharmacist signatory, establish that the clinical and pharmaceutical content is accurate and supported by the best available evidence.

1.4.5 At an early stage, identify the appropriate person who will sign the PGD as a representative of any professional group(s) practising under the PGD. Consider their training and competency needs.

1.4.6 At an early stage, identify the appropriate person, such as the clinical governance or patient safety lead, who has designated responsibility for signing PGDs on behalf of the authorising body, in line with The Human Medicines Regulations 2012 (regulation 229). Define the roles and responsibilities of this person and consider their training and competency needs.

1.4.7 When signing a PGD on behalf of an authorising body, establish that:

1.4.8 Assess local needs and develop a communications plan to support the dissemination of PGDs. Identify an appropriate person who is responsible for ensuring that this occurs.

1.4.9 For each PGD, the provider organisation should:

1.4.10 Publish final signed versions of PGDs on an intranet.

1.4.11 When a PGD is developed and authorised by a commissioning organisation for use across multiple provider organisations, ensure that it is adopted for use within each provider organisation.

1.5.1 When supplying and/or administering a medicine under a PGD, health professionals should follow local organisational policies and act within their code(s) of professional conduct and local governance arrangements (see recommendations 1.8.1 and 1.8.2 in the section on organisational governance).

1.5.2 Before practising under a PGD, health professionals should ensure that they:

1.5.3 When practising under a PGD, health professionals should:

1.5.4 When supplying a medicine(s), provide an appropriately labelled pack. Health professionals (other than pharmacists or dispensing doctors) should not split packs.

1.5.5 Ensure that the patient receives a manufacturer's patient information leaflet with each medicine.

1.5.6 Identify whether patients supplied with medicine(s) under a PGD are exempt from NHS prescription charges. The appropriate prescription charges must be collected from patients who are not exempt, in line with the NHS (Charges for Drugs and Appliances), Amendment (No. 2), Regulations 2000.

1.5.7 Document the following information about the clinical assessment and supply and/or administration of the medicine(s):

1.6.1 Establish and manage a structured work programme for reviewing, updating and reauthorising PGDs. Ensure that sufficient resources are available to deliver the work programme.

1.6.2 Ensure that a named lead author has responsibility for reviewing and updating the PGD, supported by a locally determined multidisciplinary PGD working group. Include a doctor (or dentist), pharmacist and representative of any other professional group(s) using the PGD. Define their roles and responsibilities and consider their training and competency needs (see recommendation 1.3.1 in the section on developing patient group directions).

1.6.3 When reviewing the PGD, conduct an appropriate literature search to identify new evidence. Ensure that this evidence is evaluated to assess its relevance and validity.

1.6.4 When reviewing the PGD, determine whether the PGD remains the most appropriate option to deliver the service. This should be informed by local monitoring and evaluations, frequency of use of the PGD, views of health professionals working under the PGD and views of relevant stakeholders, such as patients or their carers.

1.6.5 Determine the expiry date for an individual PGD on a case-by-case basis, with patient safety paramount. Ensure that this date does not exceed 3 years from the date the PGD was authorised.

1.6.6 Ensure that an updated PGD is reauthorised, in line with The Human Medicines Regulations 2012 (see recommendations 1.4.3 to 1.4.7 in the section on authorising patient group directions).

1.6.7 When a PGD is updated, ensure all relevant documentation is also updated, including the record and signatures of health professionals authorised to practise under the PGD (see recommendation 1.8.6 in the section on organisational governance).

1.6.8 Ensure that an updated PGD is communicated and disseminated effectively to all relevant stakeholders (see recommendations 1.4.8 and 1.4.10 in the section on authorising patient group directions).

1.6.9 Establish a robust and transparent process for the unscheduled review and updating of a PGD, when the need for this has been identified. This should include responding to:

1.7.1 Identify the senior person in each profession who is responsible for ensuring that only fully competent, qualified and trained health professionals use PGDs.

1.7.2 Identify gaps in competency and establish a comprehensive and appropriate training programme for all people involved in considering the need for, developing, authorising, using and updating PGDs.

1.7.3 Ensure that adequate educational materials are available to enable individual people and organisations to deliver safe and effective services in which PGDs are used.

1.7.4 Consider collaborating with other organisations and sharing existing educational materials to ensure a comprehensive approach.

1.7.5 Ensure that training and re-training of health professionals using PGDs incorporates a post-training assessment of competency.

1.8.1 For each PGD, the commissioning and provider organisation(s) should collaborate to firmly establish local governance arrangements with clear lines of responsibility and accountability.

1.8.2 Develop or review the organisational PGD policy and associated procedures to ensure that robust and transparent processes are documented. Ensure that the PGD policy is publicly available.

1.8.3 Ensure that a designated person has overall organisational responsibility for PGDs.

1.8.4 Ensure that patient safety incidents relating to PGD use are reported, collated and reviewed by the appropriate organisations in a planned programme, in line with national patient safety reporting systems.

1.8.5 Agree and undertake a planned programme of monitoring and evaluation of PGD use within the service.

1.8.6 Ensure that appropriate organisational records are maintained, stored securely and archived, in line with relevant legislation and the Department of Health and Social Care's code of practice on records management. These records should include: