This section provides guidance on the development, implementation and review of Patient Group Directions in the NHS.
MHRA statement on the supply and administration of repackaged H1N1v pandemic influenza vaccines under Patient Group Directions
For the purposes of Patient Group Directions, the supply and administration of vaccines in smaller packs produced by the repackaging of the authorised (licensed) H1N1v pandemic influenza vaccines Celvapan® (Baxter) and Pandemrix® (GSK) will be deemed, for the duration of the World Health Organization (WHO) declared pandemic, to be equivalent to vaccines in the original packs as placed on the market by the holders of the marketing authorisations.
This statement of equivalence is made on the condition that the repackaging is carried out by either licensed manufacturing sites under appropriate good manufacturing practice or under professional pharmaceutical supervision.
In 1998 a report on the Supply and Administration of Medicines under Group Protocols was published (Patient Group Directions is the legal term for what were known as group protocols). Patient Group Directions (PGDs) are written instructions for the supply or administration of medicines to groups of patients who may not be individually identified before presentation for treatment. The Report recommended that the legal position should be clarified, and in August 2000 the relevant medicines legislation was amended to encompass the national health services (NHS) and those services funded by the NHS that were provided by the private, voluntary or charitable sector.
The majority of clinical care should be provided on an individual, patient-specific basis. The supply and administration of medicines under PGDs should be reserved for those limited situations where this offers an advantage for patient care without compromising patient safety, and where it is consistent with appropriate professional relationships and accountability.
The relevant modifications to the provisions in and under the Medicines Act 1968 are contained in:
- The Prescription Only Medicines (Human Use) Amendment Order 2000 (SI 2000/1917) (external link)
- The Medicine (Pharmacy and General Sale - Exemption) Amendment Order 2000 - SI (SI 2000/1919) (external link)
- The Medicines (Sale and Supply) (Miscellaneous Provisions) Amendment (No2) Regulations 2000 (SI 2000/1918) (external link)
The legislation applies to the NHS including private and voluntary sector activity funded by the NHS. Therefore it covers treatment provided by NHS trusts, primary care trusts, health authorities (including SHAs), GP or dentist practices, walk-in centres and NHS funded family planning clinics.
The patient group direction must be signed by a senior doctor (or, if appropriate, a dentist) and a senior pharmacist, both of whom should have been involved in developing the direction. Additionally the patient group direction must be authorised by the relevant appropriate body as set out in the legislation. Clinical governance leads are probably best placed to do this. Annex A below provides further details about the requirements for authorisation.
The qualified health professionals who may supply or administer medicines under a patient group direction are nurses; midwives; health visitors; optometrists; pharmacists; chiropodists; radiographers; orthoptists; physiotherapists; ambulance paramedics; dietitians; occupational therapists; speech and language therapists; prosthetists, orthotists, and with effect from 1 June 2010, dental hygienists and dental therapists. They can only do so as named individuals.
The legislation specifies that each PGD must contain the following information:
- the name of the business to which the direction applies
- the date the direction comes into force and the date it expires
- a description of the medicine(s) to which the direction applies
- class of health professional who may supply or administer the medicine
- signature of a doctor or dentist, as appropriate, and a pharmacist
- signature by an appropriate organisation
- the clinical condition or situation to which the direction applies
- a description of those patients excluded from treatment under the direction
- a description of the circumstances in which further advice should be sought from a doctor (or dentist, as appropriate) and arrangements for referral
- details of appropriate dosage and maximum total dosage, quantity, pharmaceutical form and strength, route and frequency of administration, and minimum or maximum period over which the medicine should be administered
- relevant warnings, including potential adverse reactions
- details of any necessary follow-up action and the circumstances;
- a statement of the records to be kept for audit purposes.
The recommendations in the Review Team's report are emphasised. In particular:
- PGDs should be drawn up by a multi-disciplinary group involving a doctor, a pharmacist and a representative of any professional group expected to supply medicines under the PGD. It is good practice to involve local Drug and Therapeutics Committees, Area Prescribing Committees and similar advisory bodies
- a senior person in each profession should be designated with the responsibility to ensure that only fully competent, qualified and trained professionals operate within directions
- all professions must act within their appropriate Code of Professional Conduct
- appropriate document(s) should be signed by each member of the multi-disciplinary group, the clinical governance lead on behalf of the authorising NHS organisation and the individual health professionals working under the direction. Generally, a direction should be reviewed every two years. That review should include clinical governance arrangements and as assessment of whether the PGD remains to most effective way of providing the relevant services.
There must be comprehensive arrangements for the security, storage and labelling of all medicines. Wherever possible, medicines should be supplied in pre-packs made up by a pharmacist. In particular there must be a secure system for recording and monitoring medicines use from which it should be possible to reconcile incoming stock and out-goings on a patient by patient basis. Names of the health professionals providing treatment, patient identifiers and medicine provided should all be recorded. The NHS Executive document 'Controls Assurance Standard - Medicines Management (Safe and Secure Handling)' provides guidance on related legislative requirements and best practice.
The EC Labelling and Leaflet Directive 92/27 applies to all supplies of medicines, including those supplied under PGDs. A patient information leaflet should be made available to patients treated under a PGDs.
It is important that the use of any medicine is consistent with the Summary of Product Characteristics for the relevant product (save in special circumstances) and any relevant authoritative good practice guidance.
Particular caution should be exercised in any decision to draw up PGDs relating to antibiotics. Microbial resistance is a public health matter of major importance and great care should be taken to ensure that their inclusion in a direction is absolutely necessary and will not jeopardise strategies to combat increasing resistance. A local microbiologist should be involved in drawing up the PGD. The local Drug and Therapeutics Committee or Area Prescribing Committee, where they exist, should ensure that any such directions are consistent with local policies and subject to regular external audit.
Black Triangle drugs and medicines used outside the terms of the Summary of Product Characteristics
Black triangle drugs (ie, those recently licensed and subject to special reporting arrangements for adverse reactions) and medicines used outside the terms of the Summary of Product Characteristics (eg, as used in some areas of specialist paediatric care) may be included in PGDs provided such use is exceptional, justified by current best clinical practice and that a direction clearly describes the status of the product. Where the medicine is for children, particular attention will be needed to specify any restrictions on the age, size and maturity of the child. Each PGD should clearly state when the product is being used outside the terms of the SPC and the documentation should include the reasons why, exceptionally, such use is necessary.
The use of controlled drugs continues to be regulated under the Misuse of Drugs Act 1971 and associated regulations made under that Act. The Home Office have agreed to allow the supply and administration of substances on Schedule 4 (with the exclusion of anabolic steroids) and all substances on schedule 5 to be included in PGDs. Also the use of diamorphine (Schedule 2) under PGDs by specialist trained nurses in Accident & Emergency Departments and in Coronary Care Units. The relevant amendments to the Misuse of Drugs Regulations 2001 came into force on 15 October 2003.
With effect from 1 January 2008, Midazolam has been rescheduled to Schedule 3. However, it can continue to be used under a PGD.
Other exemptions and restrictions
Paramedics, midwives and chiropodists are already exempt from certain requirements of the Medicines Act. These exemptions, which allow them to administer or supply certain specified medicines without the directions of a doctor will continue and are not affected by the provisions for PGDs. The administration of radiopharmaceuticals continues to be regulated by the Medicines (Administration of Radioactive Substances) Regulations 1978 and should not be included in Patient Group Directions.
Sharing good practice
The national PGD website (external link) is a community of the National electronic Library of Medicines (external link). It is the national resource in England both for public and private sector organisations who use or intend to use PGDs and for healthcare professionals who work with PGDs or are involved in their development and review. Tools are provided to help users consider whether a Patient Group Direction (PGD) would be appropriate for an area of practice that involves the supply or administration of medicines. Other content includes frequently asked questions, examples of local PGDs and access to national templates and a discussion forum.
Persons by whom or on whose behalf a patient group direction used for the provision of health care in NHS settings must be signed
|Class of person by whom a prescription only medicine is supplied or administered||Person on whose behalf the Direction must be signed|
|Common Services Agency||The Agency|
|Health authority||The health authority|
|Special health authority||The special health authority|
|NHS trust||The trust|
|Primary care trust||The trust|
|A person who supplies or administers a prescription only medicine through an arrangement made with the Common Services Agency, a health authority, a special health authority, an NHS trust or a primary care trust.||The Common Services Agency where an arrangement has been made with the Agency, or the health authority, special health authority, NHS trust or primary care trust with which the arrangement has been made.|
For further information on this part of our site, please contact our Sale and Supply section, MHRA, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ, telephone 020 3080 6392 or email MHRA Central Enquiry Point.