Considerations before starting
PGDs must only be used where there is no other suitable mechanism for the administration or supply of the medicine within the legislation. Careful consideration should be given to opportunities within the care pathway to use a prescription or a written Patient Specific Direction and also consider the use of exemptions.
Patient Group Directions (NICE Guideline MPG2) (2017) states that you should consider investing in the training of additional non-medical prescribers to enable redesign of services if necessary.
Must not use a PGD
A PGD cannot be used in any of the following situations.
PGDs cannot be used for the supply or administration of abortifacients (Abortion Act 1967) Further information Patient Group Directions (PGDs) and abortifacients
As part of training
PGDs cannot be used for training or as part of training. Further information 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.
Controlled Drugs (CDs)
Not all controlled drugs can be supplied or administered under a PGD. Further information Supply and/or administration of Controlled Drugs under a PGD
A PGD cannot be used to make adjustments to the dose of a medication already in an individuals possession. Further information Using a Patient Group Direction to adjust doses of medicines
Dressings or medical devices
PGDs can only be used for medicines with a UK Medicine Authorisation – medical devices and dressings do not have such authorisations and therefore cannot be supplied or administered under a PGD.
Health professionals not registered
Where the health professional is not eligible to use PGDs i.e. is not one of the registered health professionals listed in part 4 of the Human Medicines Regulations 2012. Further advice is available regarding profession and competence.
Mixing of medicines
When two or more licensed medicines are mixed together as this results in an unlicensed medicine – unlicensed medicines cannot be supplied or administered under a PGD. Further detail Mixing of medicines and Patient Group Directions
PGDs cannot be used for the supply or administration of radiopharmaceuticals (Administration of Radioactive Substances Regulations 1978)
Where the medicine is unlicensed, i.e. it does not have a UK marketing authorisation (UKMA) or a temporary marketing authorisation under Regulation 174 of the HMR 2012 granted by the MHRA.
PGD not required
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. Further information When Patient Group Directions are not required
Administration of P or GSL medicines
The administration of a P or GSL medicine does not require a PGD.
Supply of GSL medicines
A PGD is not required for supply of a GSL medicine to an individual.
Emergency administration of parenteral medicines
A PGD is not required if the registered health professional has authority to supply or administer a medicine in accordance with Human Medicines Regulations (HMR) 2012 in the course of their professional activity as listed within the Schedule 17 Human Medicines Regulations 2012
Unsuitable for a PGD
A PGD should not be used for the following situations.
Long-term condition management
For managing long-term conditions, such as hypertension or diabetes, or when uncertainty remains about the differential diagnosis.
Information is available on the use of PGDs to initiate treatment for long term conditions.
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.
Follow the links for specific guidance on including the following medicines into a PGD:
- Antibiotics: (NICE Guideline MPG2) (2017), recommendation 1.1.10
- Black triangle medicines: (NICE Guideline MPG2) (2017), recommendation 1.1.8
- Off label use of licenced medicines: (NICE Guideline MPG2) (2017), recommendation 1.1.7
- End of life care – for further information see Patient Group Direction use in End of Life Care
More information can be found in:
- Link updated