Explaining PGDs

Patient Group Directions (PGDs) enable the supply and/or administration of medicines in the absence of a Patient Specific Direction (PSD), prescription or a legal exemption in Schedule 17 or 223 of the Human Medicines Regulations 2012.

PGDs should only be developed after careful consideration of the legal classification of the medicines and all the potential methods of supply and/or administration. This includes prescribing and consideration of the legal exemptions that may be applicable.

NICE guidance

NICE Medicines Practice Guideline Patient Group Directions (2017) makes recommendations on when PGDs should and shouldn’t be used. It 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 PSD)
• reserve 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 (Schedule 17 or 223) allow their supply and/or administration without the need for a PGD

MHRA advice

The MHRA provides advice on PGD use within the NHS and PGDs in the private, prison and police sectors.

SPS and PGDs

In May 2018 Lord Carter’s review 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) develop a national ‘Do Once’ system for organisational medicines governance, including national standardised medicines policies, PGDs and other essential organisational governance documents. About the SPS Medicines Governance Do Once Programme contains further information.

Defining a PGD

A PGD is a written instruction for the sale, supply and/or administration of medicines to groups of individuals who may not be individually identified before presenting for treatment.

This means an individual can either be known to the service or have an appointment (for example, a baby immunisation clinic), or not be known in advance of presenting at a service, such as a walk in centre.

PGDs can only be used by the registered health professionals listed in schedule 16, part 4 of the HMR 2012.

PGDs are not prescriptions

PGDs are not a form of prescribing.

PGDs allow health care professionals specified within the legislation to supply and/or administer a medicine directly to an individual with an identified clinical condition without the need for a prescription or an instruction from a prescriber.

The health care professional working under the PGD is responsible for assessing that the individual meets the criteria set out in the PGD as no deviations from the PGD are permitted – the supply/administration must exactly follow the PGD for it to be legally undertaken. Therefore, criteria within the PGD must be clear and unambiguous and provide all of the required information.

In practice when supplying and/or administering a medicine under a PGD, the individual must fall exactly into the inclusion criteria stated in the PGD. If they do not exactly fall within the inclusion criteria, or they meet any exclusion criteria, they must not be treated under the PGD and should be referred to an appropriate service in line with the referral advice in the PGD. Additionally only the medicine, its formulation and exact quantity detailed in the PGD can be supplied. Clinical judgement cannot be used to supply/administer a medicine outside the criteria stated in the PGD.

The supply and/or administration of medicines under a PGD cannot be delegated; the whole episode of care must be undertaken by the health care practitioner operating under the PGD.

How PGDs differ from PSDs

This short video explains what Patient Specific Directions (PSDs) and Patient Group Directions (PGDs) are, why they are different, and when each should be considered for use.

Who can work under a PGD

This short video details which registered professions can legally supply and administer medicines under PGDs.

Governance

Organisations should have policies and processes in place to consider all aspects of medicines management for patients within the service or pathway. Before a service is designed or commissioned using PGDs and before a PGD is developed, you must ensure that PGDs are appropriate, legal, and that relevant governance arrangements are in place.

Further information

More information can be found in:

• The Human Medicines Regulations 2012
• The SPS page Patient Group Directions

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