NHS HDL(2001)7

Health Department

 



Dear Colleague

PATIENT GROUP DIRECTIONS

Summary

This letter gives details of the new legal requirements and guidance for Patient Group Directions (written instructions for the supply or administration of medicines to groups of patients who may not be individually identified before presentation for treatment).

Action

General Managers and Chief Executives should ensure that any current or new Patient Group Directions comply with the new legal requirements and guidance set out in this circular. Failure to comply with the law could result in a criminal prosecution under the Medicines Act.


Yours sincerely


  January 2001

______________________________

Addresses

For action
General Managers, Health Boards
Chief Executives, NHS Trusts
Directors of Public Health
Scottish Specialists in Pharmaceutical
Public Health

For information

Chief Pharmacists, NHS Trusts
Directors of Nursing, Health Boards
Medical Directors, NHS Trusts
Directors of Nursing, NHS Trusts _________________________


Enquiries to:

Norma Darroch
Room 29F
St Andrew's House
EDINBURGH
EHI 3DG

Tel: 0131-244 2516
Fax: 0131-244 2375
email: Norma.darroch@scotland.gov.uk _________________________

DR E M ARMSTRONG
Chief Medical Officer

 

MISS ANNE JARVIE
Chief Nursing Officer

 
MR W SCOTT
Chief Pharmaceutical Officer		 GODFREY ROBSON
Director of Policy

 

Background

1. NHS MEL(1998)29 enclosed copies of a Report on the Supply and Administration of Medicines under Group Protocols (the legal term for which is now Patient Group Directions) prepared by the Review Team of the Prescribing, Supply and Administration of Medicines (Crown Review). These 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.


Regularising Current Practice

2. Priority must be given to ensuring that current practice complies with the new legal requirements before developing Patient Group Directions in new areas. Current practice should comply by 30 September 2001.

The Law

3. 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, the Medicine (Pharmacy and General Sale - Exemption) Amendment Order 2000 and the Medicines (Sale and Supply) (Miscellaneous Provisions) Amendment (No 2) Regulations 2000. The legislation applies to the NHS, including the private and voluntary sector activity funded by the NHS. Therefore it covers treatment provided by NHS Trusts, Health Boards, GP or dental practices, and NHS funded family planning clinics. It does not otherwise apply to the private and voluntary sectors (further legislation is proposed in due course).

4. 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 Health Board/NHS Trust.

5. 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. Trusts will wish to consider how they maintain a record of the named individuals operating under Patient Group Directions.

6. The legislation specifies that each Patient Group Direction 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 health 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 and 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

7. The majority of clinical care should be provided on an individual, patient specific basis. The supply and administration of medicines under Patient Group Directions 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.

8. NHS bodies should already be following the recommendations in the Review Team's Report. In particular:

  • Patient Group Directions 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 Patient Group Direction. It is good practice to involve Area Drug and Therapeutics 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.

9. 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 outgoings on a patient basis. Names of health professionals providing treatment, patient identifiers and medicine provided should all be recorded.

10. The EC Labelling and Leaflet Directive 92/27 applies to all supplies of medicines, including those supplied under Patient Group Directions.

11. 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 guidance.

Antimicrobials

12. Particular caution should be exercised in any decision to draw up Patient Group Directions 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 Patient Group Direction. The Area Drugs and Therapeutics Committee 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

13. Black triangle drugs (i.e. 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 Patient Group Directions provided such use is exceptional, justified by current best practice and that such 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 Patient Group Direction should clearly state when the product is being used outside the terms of the Summary of Product Characteristics and the documentation should include the reasons why, exceptionally, such use is necessary.

Controlled Drugs

14. The use of controlled drugs continues to be regulated under the Misuse of Drugs Act
1971. However, the Medicines Control Agency is initiating discussion with the Home Office
about a possible amendment to the Misuse of Drugs Regulations to allow the use of
substances on schedules 4 & 5 under Patient Group Directions.

Other exemptions and restrictions

15. Ambulance 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 Patient Group Directions. 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.

Monitoring

16. Scottish Specialists in Pharmaceutical Public Health/Directors of Public Health should develop arrangements for monitoring of Patient Group Directions and the sharing of good practice.