PGDs are not always appropriate

This guidance is designed to assist organisations in identifying when a Patient Group Direction (PGD) cannot or should not be used.

The aims of this guidance are to:

• sign post users to alternative mechanisms for supply and administration of medicines
• reduce the operational workload of developing, authorising, reviewing and updating unnecessary PGDs where alternative mechanisms for administration and supply are available

Supporting SPS resources provide additional details on the potential mechanisms for the supply and administration of medicines:

• When PGDs can be used
• Medicine administration by registered and non-registered staff
• Legal mechanisms to supply and administer medicines to individuals

PGDs must not be used

A PGD cannot be used in any of the following situations:

Abortifacients

PGDs cannot be used for the supply or administration of abortifacients (Abortion Act 1967). Further information can be found in Patient Group Directions (PGDs) and abortifacients.

Training

PGDs cannot be used for training or as part of training. Further information can be found in Use of PGDs by trainee registered healthcare professionals.

Care homes and independent schools

PGDs cannot be used by or in care homes and independent schools providing healthcare entirely outside the NHS. An NHS body or local authority cannot authorise a care home or independent school to operate under a PGD for the supply or administration of medicines.

The MHRA provide further advice on PGDs in the private, prison and police sectors.

Delegation

A PGD cannot be used where there is delegation of responsibility to supply or administer the medicine. Further information can be found in Delegation of roles under a PGD.

Dose adjustments

A PGD cannot be used to make adjustments to the dose of a medicine already in an individual’s possession. Further information can be found in Using a Patient Group Direction to adjust doses of medicines.

Dressings or medical devices

PGDs can only be used for medicines with a UK marketing authorisation. Medical devices and dressings do not have such authorisations and therefore cannot be supplied or administered under a PGD.

Health professionals not authorised to use PGDs

Certain health professionals are not eligible to use PGDs because they are not one of the registered health professionals listed in part 4 of schedule 16, HMR 2012. Further advice is available regarding profession and competence in Advice by profession and level of competency.

Mixing of medicines

When two or more licensed medicines are mixed together, this results in an unlicensed medicine and unlicensed medicines cannot be supplied or administered under a PGD. Further information can be found in Mixing of medicines and Patient Group Directions.

Radiopharmaceuticals

PGDs cannot be used for the supply or administration of radiopharmaceuticals (Administration of Radioactive Substances Regulations 1978).

Unlicensed medicines

Unlicensed medicines do not have a UK marketing authorisation (UKMA) or a temporary marketing authorisation under Regulation 174 of the HMR 2012 granted by the MHRA, and therefore cannot be included in a PGD. This includes where two or more licensed medicines are mixed together and this results in an unlicensed medicine. However off-label medicines can be used in PGDs. Unlicensed medicines and use of PGDs and Off-label or unlicensed product use under HMR 2012 exemptions provide further information.

Video explainer

This short video explains where PGD use is not within the legislation and when PGDs cannot be legally used.

PGDs should not be used

A PGD is not required and should not be used in any of the following situations. A locally produced protocol or standard operating procedure should be used instead.

Administration of P or GSL medicines

The administration of a P or GSL medicine does not require a PGD. See P and GSL medicines with PGDs for more information.

Supply of GSL medicines

A PGD is not required for the supply of a GSL medicine to an individual. See P and GSL medicines with PGDs for more information.

Medical gases

A PGD should not be used for the administration of medical gases which are not Prescription Only Medicines (POMs), and advice for GSL/P medicines should be followed or the medical gas be prescribed. Note specifically oxygen is classed as a GSL and nitrous oxide a P but organisations should clarify the legal classification of the gases they use in practice.

Where organisations only allow emergency medical gases to be given if prescribed, a pre-printed section of the drug chart or a standard entry within an e-prescribing system may be more appropriate than having an unnecessary PGD in place. This is in line with the British Thoracic Society guideline for oxygen use in adults, which suggests that oxygen should be prescribed or a PGD used. A PGD should only be used if other legal mechanisms have not worked in clinical practice.

Medicines can be prescribed

A PGD is not necessary and should not be used when there is an opportunity in the care pathway for the medicine to be safely prescribed on an individual basis by a qualified prescriber. The majority of clinical care involving supplying and/or administering medicines should be undertaken on an individual, patient-specific basis where this does not compromise individuals’ timely access to care.

Human Medicines Regulations 2012 exemptions

A PGD is not necessary and should not be used when there is an exemption under the Human Medicines Regulations 2012. These are:

Schedule 17 exemptions

There are exemptions within Schedule 17 of the Human Medicines Regulations 2012 which allow certain registered professionals to supply and/or administer the listed medicines without a prescription. Where such exemptions exist a PGD should not be used. Local protocols may be developed to support the use of these medicines.

Exemptions are in place for the following professions:

• Paramedics
• Podiatrists/Chiropodists
• Midwives
• Optometrists
• Orthoptists
• Dental hygienists and dental therapists

Refer to the full regulations for the medicines exempted.

Additionally, there is an exemption allowing those who hold the advanced life support provider certificate issued by the Resuscitation Council (UK) to administer specific medicines in an emergency involving cardiac arrest. Refer to the full regulations for details.

Schedule 19 exemptions

Schedule 19 of the Human Medicines Regulation 2012 allows the administration of certain injectable medicines without a prescription in an emergency. PGDs should not be used for the administration of these medicines but the administration should follow national guidance, such as the Resuscitation Council guidance on the management of anaphylaxis or a local organisation guideline/protocol.

The MHRA have confirmed that where a preparation listed in Schedule 19 requires reconstitution or dilution prior to administration, this vehicle does not require a separate PSD or PGD.

Exemptions for Occupational Health Schemes

Under Schedule 17 of the Human Medicines Regulations 2012, Occupational Health Schemes (OHS) are exempt from the restrictions that apply to prescription only medicines. This is where medicinal products are supplied or administered in the course of the OHS by a registered nurse acting in accordance with the written (and signed) directions of a doctor. This instruction is commonly documented in a written instruction. Specified other professions may become occupational health vaccinators and operate under written instructions, for certain immunisations only.

More information can be found in Occupational health services (OHS) and medicines mechanisms.

Video explainer

This short video discusses when PGD use is not appropriate and when they should not be used.

Unsuitable for a PGD

A PGD would be unsuitable, and therefore should not be used for the following situations.

Long-term condition management

It is not recommended that PGDs are used to initiate or continue treatment for long-term conditions. Long-term conditions should be managed by healthcare professionals prescribing for individual patients on a one-to-one basis.

NICE PGD guidance states: “Do not use PGDs for managing long-term conditions, such as hypertension or diabetes, or when uncertainty remains about the differential diagnosis”.

There may be occasions, however, when a healthcare professional treats someone under a PGD for symptoms arising from a long-term condition e.g. administration of salbutamol in acute asthma in an Urgent Care Centre. This highlights the importance of including clear instructions within PGDs on referral of individuals to an appropriate practitioner/prescriber responsible for their long-term care and any other follow-up action required.

Medicines requiring frequent or complex monitoring

Where the medicines involved require frequent or complex monitoring e.g. anticoagulant or insulin. More information can be found in NICE Guideline MPG2 (2017) recommendation 1.1.11.

Removing unnecessary PGDs from practice

If organisations have PGDs in place where other mechanisms for supply/administration are available, the PGDs can be superseded by a suitable alternative mechanism as detailed in this guidance.

Organisations need to ensure:

• any PGDs removed from practice and the alternative mechanisms identified are reviewed and agreed in accordance with local governance or other relevant processes
• changes to practice are robustly communicated to all relevant personnel
• appropriate governance when transferring administration/supply mechanisms
• consideration is given to service continuity and the training needs of staff

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