Patient Group Directions in the private sector

Guidance on the development, implementation and review of patient group directions in:

• Independent hospitals, agencies and clinics
• The prison healthcare services
• The police services and
• The defence medical services

Background
1. 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.

2. 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.

3. PGDs do not extend to independent and public sector care homes or to those independent sector schools that provide healthcare entirely outside the NHS.

4. 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 law
5. The relevant modifications to the provisions in and under the Medicines Act 1968 are contained in:

• the Prescription Only Medicines (Human Use) Amendment Order 2003 (SI 2003 No 696)
• the Medicines (Pharmacy and General Sale – Exemption) Amendment  Order 2003 (SI 2003 No 697) and
• the Medicines (Sale and Supply) (Miscellaneous Provisions) Amendment Regulations 2003 (SI 2003 No 698)  

6. All the Orders can be accessed on www.hmso.gov.uk (external site)

Authorisation of PGDs
7. 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
8. 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.

9. Annex A to this document provides further details about the requirements for authorisation.  

10. 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 and ambulance paramedics. They can only do so as named individuals

11. 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.

Additional guidance
12. 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.

13. 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.

14. 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.

15. 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.

Antimicrobials
16. 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  
17. 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 (e.g. 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.

Controlled Drugs
18. 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.

Update: Midazolam
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
19. 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 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
20. A website (www.groupprotocols.org.uk - external site) has been developed to provide examples of model directions in the NHS. Each PGD displayed on that site has been approved for use in a specific locality by the practitioners employed there. PGDs must not be used in localities other than those for which they have been developed. However, health professionals may refer to these PGDs, download and critically evaluate with a view to producing PGDs to meet their local circumstances. It is hoped that independent healthcare providers will also submit their PGDs to this website.

ANNEX A
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.

* “Registered provider” in this context means:

• in England and Wales, registered  under the Care Standards Act 2000
• in Scotland, registered under the Regulation of Care (Scotland) Act 2001
• in relation to a nursing home, registered under Registered Homes (Northern Ireland) Order 1992

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.