Patient Group Direction use in End of Life Care

Questions are frequently asked around the use of Patient Group Direction (PGDs) use in End of Life Care (EoLC).

As with any other patient pathway clinicians should be mindful that NICE guidance on PGDs states ‘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.’

EoLC specialist clinicians and GPs will be involved in an individual’s EoLC and so able to prescribe on an individual, patient specific basis (see Questions about Patient Specific Directions (PSD)).  As a result the potential need for PGDs in EoLC is likely to be very limited, if at all, and there are several legislative restrictions which organisations must be mindful of if considering PGD use.  These are summarised in the table below.

Organisations are responsible for ensuring that any PGD they develop is not only legal and clinically appropriate in the care pathway but not used to overcome inefficiencies within systems.

Potential issue NICE MPG2 (2017) Link to supporting resource
Syringe drivers/mixing of medicines. PGDs cannot be used for syringe drivers where more than one medication is being given as mixing of medications under a PGD is not permissible: the mixing of medications results in a unlicensed product and PGDs cannot be used to administer or supply unlicensed products (also see unlicensed/off-label medicines below).   https://www.sps.nhs.uk/articles/can-two-licenced-medicinal-products-be-mixed-together-prior-to-administration-under-a-pgd/
Delegation.  Parenteral medications supplied under a PGD can only be self-administered or administered by the healthcare professional who has made the supply under the PGD – this administration cannot be delegated to a carer or another healthcare professional.  This restricts who can administer a parenteral medication supplied under a PGD. NICE MPG 2 (2017): 1.5.3 When practising under a PGD, health professionals should: not delegate their responsibility https://www.sps.nhs.uk/articles/can-supply-or-administration-be-delegated-to-another-practitioner-under-a-pgd/
Controlled drugs.  There are restrictions on the use of controlled drugs under PGDs.  The use of morphine/diamorphine is restricted to registered nurses and pharmacists for the immediate necessary treatment of a sick or injured person. NICE MPG 2 (2017): 1.1.9 Ensure that a controlled drug is included in a PGD only when legally permitted and clearly justified by best clinical practice. https://www.sps.nhs.uk/articles/who-can-supply-or-administer-controlled-drugs-under-the-terms-of-a-patient-group-direction-and-under-what-circumstances/
Dose ranges.  Dose ranges are permissible within a PGD only where there is clear clinical criteria for selecting a dose within the range specified.    NICE MPG 2 (2017): 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. https://www.sps.nhs.uk/articles/is-it-acceptable-to-have-a-dose-range-specified-in-the-pgd-rather-than-a-specified-dose/
Unlicensed/off-label medicines. 

Unlicensed medicines cannot be supplied or administered under a PGD. 

Off label medicines should only be used when supported by best clinical practice. 

 

NICE MPG 2 (2017): 1.1.6 PGDs must only include medicines with a UK marketing authorisation, in line with the Human Medicines Regulations 2012.

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.

https://www.sps.nhs.uk/articles/questions-about-human-medicines-regulations-exemptions/
Care home staff operating under PGDs.  PGDs cannot be used by care home staff.  However they may be used by registered healthcare professionals from an external provider who is able to operate under PGDs  (e.g. NHS Community Services provider) caring for a patient within a care home to administer or supply medications (on-going administration of non-parenteral meds may be undertaken by trained care home staff under local SOP).   https://www.sps.nhs.uk/articles/can-a-care-home-use-pgds-to-supply-or-administer-oral-oseltamivir-to-its-residents/
Labelling.  Note the need to appropriately label any stock supplied under a PGD. NICE MPG 2 (2017): 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. https://www.sps.nhs.uk/articles/what-are-the-legal-requirements-for-labelling-a-prescription-only-medicine-pom-issued-via-a-pgd-before-supply-to-the-patient/