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Patient group directions

About

What is covered

This interactive flowchart covers the systems and processes to develop, authorise, use and update patient group directions. It also covers governance arrangements with the aim of ensuring patients receive safe and appropriate care and timely access to medicines, in line with legislation.
A patient group direction is defined in Health Service Circular (HSC 2000/026) as 'Written instructions for the supply or administration of medicines to groups of patients who may not be individually identified before presentation for treatment.'

Updates

Updates to this interactive flowchart

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Your responsibility

Guidelines

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian.
Local commissioners and providers of healthcare have a responsibility to enable the guideline to be applied when individual professionals and people using services wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with complying with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Technology appraisals

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this interactive flowchart is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the recommendations to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Medical technologies guidance, diagnostics guidance and interventional procedures guidance

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take these recommendations fully into account. However, the interactive flowchart does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Commissioners and/or providers have a responsibility to implement the recommendations, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Short Text

Everything NICE has said on systems and processes to develop, authorise, use, and update patient group directions in an interactive flowchart

What is covered

This interactive flowchart covers the systems and processes to develop, authorise, use and update patient group directions. It also covers governance arrangements with the aim of ensuring patients receive safe and appropriate care and timely access to medicines, in line with legislation.
A patient group direction is defined in Health Service Circular (HSC 2000/026) as 'Written instructions for the supply or administration of medicines to groups of patients who may not be individually identified before presentation for treatment.'

Updates

Updates to this interactive flowchart

Sources

NICE guidance and other sources used to create this interactive flowchart.
Patient group directions (2013 updated 2017) NICE guideline MPG2

Quality standards

Quality statements

Effective interventions library

Effective interventions library

Successful effective interventions library details

Implementation

NICE has produced resources to help implement its guidance on:

Pathway information

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Your responsibility

Guidelines

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian.
Local commissioners and providers of healthcare have a responsibility to enable the guideline to be applied when individual professionals and people using services wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with complying with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Technology appraisals

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this interactive flowchart is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the recommendations to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Medical technologies guidance, diagnostics guidance and interventional procedures guidance

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take these recommendations fully into account. However, the interactive flowchart does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Commissioners and/or providers have a responsibility to implement the recommendations, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Supporting information

Ensure that a named lead author has responsibility for developing a patient group direction, supported by a locally determined multidisciplinary patient group direction working group. Include a doctor (or dentist), pharmacist and representative of any other professional group(s) using the patient group direction. Define their roles and responsibilities, and consider their training and competency needs.
Patient group directions must be authorised only by an appropriate authorising body in line with the Human Medicines Regulations 2012.
Develop or review the organisational patient group direction policy and associated procedures to ensure that robust and transparent processes are documented. Ensure that the patient group direction policy is publicly available.

Glossary

in most cases, the pack to be issued under a PGD will need to be labelled to reflect the dose exactly as authorised in the PGD, as if it were being dispensed against a prescription. Separate requirements exist for prescription-only medicines (POMs) and for pharmacy (P) and general sales list (GSL) medicines. In practice, medicines supplied for use under a PGD are often in packs that are pre-labelled by a licensed manufacturing unit. These labels include all the standard labelling requirements, leaving a space on the pack for the patient's name, date of dispensing and address of the supplying service to be added at the time of supply. This is sometimes known as over-labelling
an organisation listed in the Human Medicines Regulations 2012 (and subsequent amendments) that is legally able to authorise a PGD. The commissioning and/or provider organisation may be an authorising body. In the NHS in England, these organisations are: clinical commissioning groups (CCGs), local authorities, NHS trusts or NHS foundation trusts, NHS England and Public Health England
black triangle medicines are licensed medicines that are intensively monitored and subject to special reporting arrangements for adverse events
the organisation with which a contract or agreement for the provision of a service that may require the prescribing, supply or administration of medicines has been made
using a UK licensed medicine outside the terms of its marketing authorisation, such as outside defined indications, doses or routes of administration. For example, when amitriptyline, licensed for the treatment of depression, is used for neuropathic pain
unless stated otherwise, use of the term 'organisation' includes authorising bodies and any other organisations (both NHS and non-NHS) who are considering the need for, developing, authorising, using and updating PGDs to provide public-funded services
patient group direction (PGD) defined in Health Service Circular (HSC 2000/026) as 'Written instructions for the supply or administration of medicines to groups of patients who may not be individually identified before presentation for treatment'
any unintended or unexpected incident that could have or did lead to harm for 1 or more patients receiving healthcare. This includes clinical errors, medication errors, adverse events and near misses
a locally determined multidisciplinary group that considers proposals to develop a PGD to deliver a service. This group may also be involved at other stages of the process, depending on local arrangements. For example, the group may approve a final draft of the PGD before it is submitted for authorisation. The term 'PGD approval group' is used for the purpose of this guidance, but other names for the group may be used locally. The group may be an existing local medicines decision-making group, such as the drug and therapeutics committee, or subgroup
a locally determined multidisciplinary group established for each individual PGD. The PGD working group is responsible for developing the PGD and its subsequent review and updating. The term 'PGD working group' is used for the purpose of this guideline, but other names for the group may be used locally
the organisation responsible for providing the commissioned service, which may require the prescribing, supply or administration of medicines. This may be an NHS organisation or a non-NHS organisation providing public-funded service

Paths in this pathway

Pathway created: December 2014 Last updated: March 2017

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