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This publication is available at https://www.gov.uk/government/publications/patient-group-directions-pgds/patient-group-directions-who-can-use-them
Patient group directions (PGDs) are written instructions to help you supply or administer medicines to patients, usually in planned circumstances. They take a significant amount of time and resource to develop and implement.
You can only supply and or administer medicines under PGDs if there is an advantage for the patient without compromising their safety.
PGDs should be put together by a multi-disciplinary group including a doctor, a pharmacist and a representative of any professional group expected to supply the medicines under the PGD. It’s good practice to involve local drug and therapeutics committees, area prescribing committees and similar advisory bodies.
The expiry date for a PGD needs to be decided on a case-by-case basis in the interest of patient safety. The expiry date should not be more than 3 years from the date the PGD was authorised.
Who can supply or administer under a PGD
You can do this if you are a qualified healthcare professional. These are::
- chiropodists and podiatrists
- dental hygienists
- dental therapists
- occupational therapists
- orthotists and prosthetists
- speech and language therapists
What a PGD must include
According to the legal requirements, a PGD must include:
- the name of the business who owns the direction
- the start and end date of the PGD
- a description of the medicine(s)
- the class of the health professional who can supply or administer the medicine
- a signature of a doctor or dentist (as appropriate) and a pharmacist
- authorisation by an appropriate organisation: Authorising PGDS
- the clinical condition or situation to which the direction applies (eg the specified condition/conditions that can be treated)
- a description of patients excluded from treatment under the direction
- a description of when you should get more advice from a doctor (or dentist, as appropriate) and arrangements for referral
- details of appropriate dosage, maximum total dosage, quantity, pharmaceutical form and strength, route and frequency of administration, and minimum or maximum period to administer the medicine
- relevant warnings, including potential adverse reactions
- details of any necessary follow-up actions
- a statement of the records to be kept for audit purposes
See the Human Medicines Regulations 2012 for the legal requirements for PGDs.
Medicines you can supply under a PGD
All medicines are classified according to three legal categories which are:
- prescription only (POM)
- pharmacy (P)
- general sale list (GSL)
POM and P medicines can generally only be sold or supplied at a registered pharmacy premises by or under the supervision of a pharmacist. POMs must be sold or supplied according to a prescription prescribed by a health practitioner. This can be a doctor, dentist, or other independent or supplementary prescriber. GSL medicines can be sold from a wider range of premises such as supermarkets as long as those premises can be closed to exclude the public (i.e. they are lockable) and the medicines are pre-packed.
PGDs provide an exemption from these restrictions. Only certain controlled drugs can be included in a PGD according to The Misuse of Drugs Regulations (2001). See the controlled drugs that can be supplied under a PGD on the NICE website.
Under a PGD you cannot supply:
- unlicensed medicines
- dressings, appliances and devices
- abortifacients, such as mifepristone.
A PGD should have a senior person to ensure only competent, qualified and trained professionals oversee and follow the directions.
The required documents in a PGD need to be signed by each member of the multi-disciplinary group, the clinical governance lead on behalf of the NHS organisation authorising the PGD and the individual health professionals working under the direction.
You need to ensure arrangements are in place for the security, storage and labeling of all medicines. You should supply medicines in pre-packs made up by a pharmacist. There must be a secure system for recording and monitoring how medicines are used including stock control. You must also record names of the health-care professionals supplying or administering treatment, patient identifiers and the medicines provided.
You must use medicines according to the summary of product characteristics for the product (with some exceptions) and any relevant authoritative good practice guidance.
Use of medicines with ‘risk minimisation measures’ in PGDs
Risk Minimisation Measures (RMM) are a regulatory requirement for some medicines, and are a critical part of the product licence (marketing authorisation) to help maintain a favourable benefit-risk profile. Medicines with a requirement for RMM may not be suitable for inclusion in a PGD.
As well as information on contraindications, warnings/precautions and possible side effects routinely described in the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL), some medicines have an extra regulatory requirement for additional ‘risk minimisation measures’ (RMM). RMM are designed to facilitate informed decision making to support risk minimisation when prescribing, dispensing and/or using a medicinal product, and may be imposed on a product at the time of licensure, or at any time thereafter. RMM may differ in their purpose, design, target audience and complexity, and might include measures to guide appropriate patient selection with the exclusion of patients where use is contraindicated, to support on-treatment monitoring relevant to important risks and/or management of an adverse reaction. The format, content and method of distribution of RMM are agreed on a product-specific basis by MHRA. Examples can range from extra information for patients, such as ‘alert’ card, or checklists for health professionals, to the imposition of a controlled access scheme.
When developing a PGD for a medicine, it is important to determine whether the medicine has any RMM associated with the licence.?].
In accordance with NICE guidance, medicines needing frequent dosage adjustments or frequent or complex monitoring, should not be included in a PGD. In line with this, a medicine with RMM for close monitoring and supervision of patients may not be suitable for inclusion in a PGD.
If a decision is taken to include a medicine with RMM in a PGD, the requirements of the RMM must be included in the PGD. As well as routine reference to the important particulars of the SmPC and PIL, the relevant sections of the PGD template should make specific reference to the key points of the RMM where applicable. If RMM has been developed specifically for patients, the PGD should include instructions to give verbal information to the patient on the important risks described in the RMM, as well as the provision of any written RMM for the patient to take away (along with the PIL), and where additional information may be found. If the RMM includes a checklist for prescribers, the use of the checklist should also be incorporated into the RMM.”
Arrangements for independent healthcare providers in Scotland
Currently, PGDs can only be set up for use in independent hospitals and hospices in Scotland. From 1 April 2017, changes in Scottish law will also allow independent clinics to set up PGDs.
A PGD signed by a provider of an independent health care service registered in England and Wales cannot be used to authorise the supply or administration of medicines in Scotland.
An independent healthcare provider registered in England and Wales can enter into an arrangement with a pharmacist based in a Scottish community pharmacy to operate under a PGD.
This applies even if the provider is not registered in Scotland. The same applies pharmacists in England and Wales operating under PGDs authorised by a provider who is only registered in Scotland.
See the NHS Patient Group Directions website for guidance on how to set up and follow a PGD.
Follow the good practice guidelines on the National Institute for Health and Care Excellence (NICE) website.
Email MHRA customer services firstname.lastname@example.org or call 0203 080 6000 with any queries with PGDs.