- The law
- Authorisation of PGDs
- Arrangements for Scotland
- Additional guidance
- Black triangle drugs and medicines used outside the terms of the Summary of Product Characteristics
- Controlled Drugs
- Other exemptions and restrictions
- Sharing good practice
- Patient Group Directions (PGDs) in the independent healthcare sector and changes to arrangements for registration with the Care Quality Commission (CQC)
- Annex A
Guidance on the development, implementation and review of patient group directions in:
- independent hospitals, agencies and clinics
- dental clinics and practices
- the prison healthcare services
- the police services
- the defence medical services.
In 1998 a report on the Supply and Administration of Medicines under Group Protocols was published1 (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.
Subsequently, in April 2002 proposals were published to further amend medicines legislation to permit the sale, supply or administration of medicines under PGDs in specified healthcare establishments throughout the United Kingdom provided through the private, charitable or voluntary sector, and in certain UK Crown establishments.
PGDs do not extend to independent and public sector care homes or to those independent sector schools that provide healthcare entirely outside the NHS.
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 provisions are contained in the Human Medicines Regulations 2012 (SI 2012 No 1916. This can be accessed www.legislation.gov.uk
Authorisation of PGDs
The patient group direction must be signed by a senior doctor (or, if appropriate, a dentist) and a 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.
Arrangements for Scotland
Independent providers should be aware that in Scotland only independent hospitals and hospices are currently registered under the Regulation of Care (Scotland) Act 2001. As yet a commencement order for independent clinics and independent medical agencies has not been made. Therefore, until the Scottish legislative regime governing the regulation of care services is extended to include independent clinics and medical agencies PGDs can only be set up for use in independent hospitals and hospices. Furthermore, 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 by its own staff in Scotland. However, a 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. The same applies to the use of PGDs in England and Wales by a provider registered in Scotland.
Annex A to this document 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, 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 Committee 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, by the representative of the appropriate authorising body 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 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 – see paragraph 13) 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 has 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. Midazolam (Schedule 3) can also be used under a PGD. From April 2012, nurses and pharmacists, when acting in their capacity as such under a PGD, are authorised to supply, or offer to supply diamorphine and morphine where administration of such drugs is required for the immediate, necessary treatment of sick or injured persons (excluding the treatment of addiction). These amendments remove the restrictions whereby a nurse could only supply or offer to supply diamorphine under a PGD for the treatment of cardiac pain to a person admitted as a patient to a coronary care unit or an accident and emergency department of a hospital.
Other exemptions and restrictions
Paramedics, midwives and chiropodists are already exempt from certain requirements of the Human Medicines Regualtions. 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 new 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 PGD website (NHS Evidence Medicines Information) is the national resource in England both for public and private sector organisations who use or intend to use PGDs and health professionals who work with PGDs or are involved in their development and review. Tools are provided to help users consider whether a PGD would be appropriate for an area of practice that involves the supply or administration of medicines. Another resource is the National Institute for health and Care Excellence Good Practice Guidance website (external link)
Patient Group Directions (PGDs) in the independent healthcare sector and changes to arrangements for registration with the Care Quality Commission (CQC)
From 1 October 2010 the Health and Social Care Act 2008 (HSCA) brought about changes in registration for the independent healthcare sector replacing the previous Care Standards Act 2000. The changes meant in England that providers of specified regulated activities are required to register. The CQC no longer registered independent hospitals, clinics and medical agencies.
The Human Medicines Regulations 2012 continue to allow independent hospitals, clinics and medical agencies to authorise their own PGDs. They must be registered with the CQC for one of the following regulated activities:
- Treatment of disease, disorder or injury;
- Assessment or medical treatment of persons detained under the Mental Health Act 1983;
- Surgical Procedures;
- Diagnostic and Screening procedures;
- Maternity and midwifery services;
- Family planning;
The Regulations also allow dental practices and clinics who are registered with the CQC for the treatment of disease, disorder or injury and/or diagnostic and screening procedures to authorise PGDs.
Registered providers who are independent medical agencies within the meaning of the Human Medicines Regulations 2012 are also able to enter into arrangements with an NHS body to supply and administer medicines under a PGD as part of an NHS funded service. The Agency takes the view that where a PGD is used for NHS/public health funded healthcare under arrangements made with an NHS or public health body the law requires that the PGD is authorised by that body. This applies to PGDs used for the provision of NHS and public health funded services under arrangements between NHS bodies/local authorities and CQC registered independent medical agencies.
Persons by whom or on whose behalf a patient group direction used for the provision of health care in non-NHS settings must be signed.
|Healthcare provider||Person by whom or on whose behalf the Direction must be signed|
|An independent hospital, clinic or medical agency (England and Wales only)||The registered provider and if there is a relevant manager for the hospital, clinic or agency that manager|
|An independent hospital (including a hospice) (Scotland only) NB The current position in Scotland is that PGD’s can only be set up for use in independent hospitals and hospices||The registered provider and if there is a relevant manager for the hospital that manager|
|A nursing home (Northern Ireland only)||The registered provider and if there is a relevant manager for the home that manager|
|A police force in England or Wales||The chief officer of police for that police force and a doctor who is not employed/engaged or providing services to any police force.|
|A police force in Scotland||The chief constable of that police force and a doctor who is not employed/engaged or providing services to any police force.|
|The Police Service of Northern Ireland||The Chief Constable of the Police Service of Northern Ireland and a doctor who is not employed/engaged or providing services to any police force.|
|The prison service in England and Wales||The governor of the prison in relation to which the health care in question is being provided|
|The prison service in Scotland||The Scottish Prison Service Management Board|
|The prison service in Northern Ireland||The Northern Ireland Prison Service Management Board|
|Her Majesty's Forces||(i) the Surgeon General,
(ii) a Medical Director General, or
(iii) a chief executive of an executive agency of the Ministry of Defence
|Dental Practices and Clinics||By, or on behalf of, the registered provider.|
1A report on the Supply and Administration of Medicines under Group Protocols, prepared under the Chairmanship of Dr June Crown, was published in April 1998.
Patient Group Directions (PGDs) in the NHS updated
Patient Group Directions (PGDs) are written instructions about the supply or administration of Prescription Only Medicines (POM) in identified clinical situations, these instructions apply to groups of patients who may not be individually identified before presenting for treatment.
In April 2013, the Health and Social Care Act came into force. As a result changes needed to be made to the PGD legislation. The updated instructions includes information on new bodies who can authorise their own PGDs.
This reflects the Medicines and Healthcare Products Regulatory Agency's interpretation of the law in relation to authorisation of PGDs for NHS/public health funded services when these services are implemented with other providers such as independent medical agencies.
Contact for further information
For further information, 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.