Purpose

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

The aims of this guidance are to:

• Sign post users to alternative mechanisms for supply and administration.
• Reduce the operational workload of developing, authorising, reviewing and updating unnecessary PGDs where simpler mechanisms for administration and supply are available.

Additional supporting SPS resources are also available When to use a PGD  and . These resources provide additional details on all the potential mechanisms for supply and administration of medications.

Background

In May 2018 Lord Carter identified the duplication of effort across NHS organisations in producing PGDs and medicines policies. The report recommended that NHS England’s Specialist Pharmacy Service (SPS) developed a national ‘Do Once’ system for organisational medicines governance, including national standardised medicines policies, PGDs and other essential organisational governance documents.

PGDs enable the supply and/or administration of medicines in the absence of a Patient Specific Direction, prescription or a legal exemption in Human Medicines Regulations 2012.

PGDs should only be developed after careful consideration of the legal classification of the medication and all the potential methods of supply and/or administration of medicines, including prescribing by doctors, dentists or independent or supplementary prescribers and consideration of the legal exemptions that may be applicable.

NICE Medicines Practice Guideline Patient Group Directions (2017) states:

• Provide the majority of clinical care involving supplying and/or administering medicines on an individual, patient-specific basis (i.e. using a prescription or a Patient Specific Direction (PSD)). 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.
• Explore all the available options for supplying and/or administering medicines in a specific clinical situation.
• Do not use PGDs for medicines when exemptions in legislation allow their supply and/or administration without the need for a PGD.

Medicines that are classified as Pharmacy (P) or General Sales List (GSL) medicines can be administered without the need for a PGD or PSD, and pre-packed GSL medicines can be supplied without a PGD.

The supply of a P medicine requires a PGD or PSD unless an exemption applies or the supply is made from a registered pharmacy premises under the supervision of a pharmacist or by a registered midwife in the course of their professional practice.

When PGD should not be used

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.

This would include:

• the writing of a PSD
• the issuing of a prescription by a prescriber during the individual’s treatment pathway
• the completion of a pre-printed part of a drug chart
• completed entry on an electronic prescribing and medicines administration system.

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 sell, supply and administer the listed medications 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

Refer to the full regulations for the medications exempted.

Schedule 19 exemptions

Schedule 19 of the Human Medicines Regulation 2012 allows administration of certain parenteral medicine without a prescription in an emergency. PGDs should not be used for the administration of these medicines but 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 then this vehicle does not require a separate PSD or PGD.

Exemptions for Occupational Health Schemes

An Occupational Health Scheme (OHS) is a multidisciplinary service that aims to protect and promote workers’ physical, mental and social health and well-being through actions related both to the work environment and to the workers themselves.

Under Schedule 17 of the Human Medicines Regulations 2012 OHS are exempt from the restrictions that apply to prescription only medicines, where medicinal products are supplied or administered in the course of the OHS by a doctor, or by a registered nurse acting in accordance with the written (and signed) directions of a doctor. This instruction is commonly documented in a written operating protocol.

More information can be found in PGDs and Occupational Health Services

GSL medicines

PGDs should not be used for a GSL medicine administration or supply.  A locally developed and approved protocol can be used to support these tasks – this may be a standalone policy, or incorporated within a broader medicines policy.  Protocols can be used in all healthcare settings.

Local processes for record keeping, staff training and competency assessments, audit, incident reporting and medicines storage, labelling and requisition must all be considered when operating under protocols.

When a GSL medication is administered without a prescription or PGD being in place and where the legal classification of the medicine is based on the pack size (for example paracetamol) SPS have been advised by the MHRA that administration of single doses can be made from a POM, P or GSL pack which has been legally obtained by the organisation.

Supplying a GSL medicine

A PGD is not necessary to supply a GSL medicine, provided the supply takes place from lockable premises and the GSL medication supplied is in an original pre-packed GSL labelled pack only.

If the dosage instructions on the GSL pack reflect the dose required to be administered under the protocol then over-labelling is not required. It is good practice to add the individual’s name/date supplied and address of the supplying unit to any medicine supplied. This information can be as a pre-printed label to which the individual’s name and date of supply is added at the time of supply. Any additional label should be added in such a way that it does not obscure manufacturer’s information on the pack.

Legislation relating to the supply of GSL medicines (Regulation 221 of the HMR 2012) must be adhered to unless an exemption is made within the legislation.  All GSL medicines must be supplied from a premises which is able to be closed as to exclude the public.  Only where there is an exemption to this with the legislation (namely under HMR 2012 Schedule 17, for registered midwives as detailed in HMR 2012 Regulation 223 or under the directions of a prescriber) can a GSL be supplied outside of this legal requirement.

Promote self-care

When considering if a GSL medicine should be supplied refer to the NHS England guidance on over the counter medicines which should not be routinely prescribed in primary care. Whilst this guidance was written for primary care services all NHS services should be mindful of it and practitioners should advise patients to buy over the counter medicines for self-care wherever practicable to do so.

Where a medicine is supplied under an NHS commissioned service then the regulations require that a prescription charge is made unless the individual is exempt from such charges. In most cases it would not be cost effective for an individual to pay a prescription charge for a GSL medicine to be supplied which they can purchase. If any GSL medicines are supplied and a prescription charge levied the organisation should have a mechanism in place for collecting these charges.

P medicines

PGDs should not be used for a P medicine to be administered to an individual.  A locally developed and approved protocol can be used to support the administration – this may be a standalone policy, or incorporated within a broader medicines policy. Protocols can be used in all healthcare settings.

Local processes for record keeping, staff training and competency assessments, audit, incident reporting and medicines storage and requisition must all be considered when operating under protocols.

When a P medication is administered without a prescription or PGD being in place and where the legal classification of the medicine is based on the pack size (for example fluconazole) SPS has been advised by the MHRA that administration of single doses can be made from a POM or P pack which has been legally obtained by the organisation.

Supplying P medicines

A registered pharmacy can legally supply/sell P medications without a PGD or prescription. In addition, a P medicine can be sold/supplied by a registered midwife in the course of their professional practice or where an exemption exists – as such no PGD is required.

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.

Removing unnecessary PGDs from practice

Where an organisation has PGDs in place where other mechanisms for supply/administration are available the PGDs can be superseded by the suitable alterative mechanism as detailed in this guidance.

Organisations need to ensure that any PGDs removed from practice and the alterative mechanisms identified are reviewed and agreed in accordance with local governance or other relevant processes. Organisations need to ensure that changes to practice are robustly communicated to all relevant personnel.

Safety is paramount and organisations should ensure appropriate governance when transferring administration/ supply mechanisms and consideration should be given to service continuity and the training needs of staff.

Template protocol

SPS have developed a template protocol for the administration of GSL/P medicines or the supply of GSL medicines.  This can be locally adapted by organisations noting that it is a template for local adaptation and organisations are responsible for ensuring the clinical and pharmaceutical content is appropriate and that any templates used in practice are approved for use through the appropriate local governance processes.

• GSL P template protocol for local adapation · Word · 39 KB

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