020 7273 0121
Our reference: MLX 295
Date: 19 August 2003
Dear Sir/Madam
ADMINISTRATION OF MEDICINES BY AMBULANCE PARAMEDICS: AMENDMENT TO THE PRESCRIPTION ONLY MEDICINES (HUMAN USE) ORDER 1997
INTRODUCTION
1.I am writing to consult you in accordance with section 129(6) of the Medicines Act 1968 about proposals to extend the range of prescription only medicines which ambulance paramedics can administer on their own initiative without the directions of a doctor or other appropriate prescribing practitioner. This would be achieved by amendments to the Prescription Only Medicines (Human Use) Order 1997 (the POM Order)
2.The proposals are intended to enhance patient care by providing appropriate and timely access to treatment in potentially life-threatening situations. The proposed extension of the paramedic list is complementary to patient group directions as the latter are intended to provide an additional flexibility to meet local needs.
APPLICATION TO ENGLAND, WALES, SCOTLAND AND NORTHERN IRELAND
3. This consultation is also being circulated in Wales, Scotland and Northern Ireland. The proposed changes to the POM Order would apply throughout the United Kingdom.
BACKGROUND
4.The Medicines Act 1968 restricts the administration of parenteral medicines. All medicines for parenteral administration are prescription only and, unless self administered, they may be administered only by or under the directions of an appropriate practitioner. Under the POM Order, exemptions from these restrictions are provided for specified persons in respect of specified medicines.
5.One such exemption is contained in paragraph 9 of Part III to Schedule 5 to the POM Order. Under this exemption, state registered paramedics orparamedics holding a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State are authorised to administer a range of parenteral medicines for the immediate, necessary treatment of sick or injured persons. The relevant medicines are listed at Annex 1. The proposals to extend the list have been developed by the Joint Royal Colleges Ambulance Liaison Committee (JRCALC) which acts as a national focal point for ambulance issues.
PROPOSALS
6.We propose to extend the range of parenteral medicines which can be administered by state registered paramedics orparamedics holding a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State to include:
- Tenecteplase
- Reteplase
for use as a thrombolytic in acute myocardial infarction.
7.State registered paramedics orparamedics holding a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State are already able to administer streptokinase for use as a thrombolytic in acute myocardial infarction. In practice streptokinase is not best suited to pre-hospital admission as it has to be given by intravenous infusion over one hour at a rate that must be carefully controlled. It also has a high incidence of allergic reactions, including anaphylaxis, in some patients. Tenecteplase and Reteplase are more recent agents. They share a relative freedom from allergenicity and can be given by bolus intravenous administration, thus avoiding the need for a carefully timed infusion.
8.The proposed addition of tenecteplase and reteplase to the paramedics list reflect current clinical practice in emergency situations. Administration of these medicines by paramedics will be advantageous to patients in circumstances when avoiding delay in treatment has been shown to be beneficial. As with all medicines listed in Annex 1, paramedics would receive suitable training in the correct circumstances for use and administration of the medicines.
REGULATORY IMPACT ASSESSMENT
9.A Regulatory Impact Assessment is not required for these proposals because they will not impose a cost compliance on business, charities or the voluntary sector, or result in a cost saving.
COMMENTS ON PROPOSALS
10. You are invited to comment on:
- the proposed changes to the POM Order to extend the range of parenteral medicines which can be administered by state registered paramedics orparamedics holding a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State to include tenecteplase and reteplase for use as a thrombolytic in acute myocardial infarction (paragraphs 6-8)
CIRCULATION OF PROPOSALS
11.This consultation letter is being sent in hard copy to those organisations listed. Copies of the consultation are also available from our website - – and replies are welcome from all interested parties. A form is attached for your reply. Comments should be addressed to Mrs Anne Ryan, MHRA, 16-142, Market Towers, 1, Nine Elms Lane, London SW8 5NQ (or e-mail to to arrive no later than 11 November 2003. Comments received after this date will not be taken into account.
12.The Committee on Safety of Medicines will be asked to consider the proposals in the light of comments received and their advice will be conveyed to Ministers. Subject to the agreement of Ministers, we plan to implement changes by Statutory Instrument in early 2004. Statutory Instruments are available from the Stationary Office and may also be viewed on their website
MAKING COPIES OF THE REPLIES AVAILABLE TO THE PUBLIC
13. To help informed debate on the issues raised by this consultation, and within the terms of the Code of Practice on Access to Government Information, the Agency intends to make publicly available copies of comments that it receives. Copies will be made available as soon as possible after the public consultation has ended.
14. The Agency’s Information Centre at Market Towers will supply copies on request. An administrative charge, to cover the cost of photocopying and postage, may be applied. Alternatively, personal callers can inspect replies at the Information Centre by prior appointment (telephone 020-7273 0351).
15. It will be assumed that your comments can be made publicly available in this way, unless you indicate that you wish all or part of them to be treated as confidential and excluded from this arrangement.
Yours faithfully
Anne Thyer
Executive Support
Medicines and Healthcare products Regulatory Agency
ANNEX 1
LIST OF PARENTERAL MEDICINES WHICH CAN BE ADMINISTERED
BY AMBULANCE PARAMEDICS ON THEIR OWN INITIATWE (PART III
OF SCHEDULE 5 TO THE PRESCRIPTION ONLY MEDICINES (HUMAN
USE) ORDER 1997
- Diazepam 5 mg per ml emulsion for injection;
- Succinylated Modified Fluid Gelatin 4 per cent intravenous infusion;
- medicines containing the substances Ergometrine Maleate 500mcg per ml with Oxytocin 5 iu per ml, but no other active ingredient; and
- Prescription only medicines containing one or more of the following substances, but no other active ingredient
- Adrenaline Acid Tartrate,
- Anhydrous Glucose
- Benzylpenicillin
- Bretylium Tosylate
- Compound Sodium Lactate Intravenous Infusion (Hartmann's Solution)
- Ergometrine Maleate
- Frusemide
- Glucose
- Heparin Sodium
- Lignocaine Hydrochloride
- Metoclopramide
- Morphine Sulphate,
- Nalbuphine Hydrochloride
- Naloxone Hydrochloride
- Polygeline
- Sodium Bicarbonate
- Sodium Chloride
- Streptokinase
To :Anne Ryan
MHRA
16-142
Market Towers
1 Nine Elms Lane
LONDON SW8 5NQ
From :______
______
______
______
CONSULTATION LETTER MLX 295: ADMINISTRATION OF MEDICINES BY AMBULANCE PARAMEDICS: AMENDMENT TO THE PRESCRIPTION ONLY MEDICINES (HUMAN USE) ORDER 1997
* 1. I support the proposals contained in the MLX
* 2. I have no comment to make on the proposals in the MLX
*3. My comments on the proposals in the MLX are below/attached.
* My reply may be made freely available.
* My reply is confidential.
* My reply is partially confidential (indicate clearly in the text any confidential elements)
Signed : ______
* Delete as appropriate
MLX 295: HARD COPY CONSULTATION LIST
NB: this list is not intended to be exhaustive. Copies of the consultation are also available from our website - – and replies are welcome from all interested parties.
Ambulance Trusts in England, Wales, Scotland and Northern Ireland
Ambulance Service Association
Advisory Committee on Misuse of Drugs
Association of Anaesthetists of Great Britain and Northern Ireland
Association of Professional Ambulance Personnel
Association of British Cardiac Nurses
Association of British Health Care Industries
Association of Surgeons of Great Britain and Ireland
British Association for A&E Medicine
British Association of Pharmaceutical Physicians
British Cardiac Patients Association
British Dental Association
British Heart Foundation
British Institute of Regulatory Affairs
British Medical Association
British Pharmacological Society
Chemist & Druggist
College of Health
Doctor Magazine
Drug & Therapeutics Bulletin
Drug Information Pharmacists Group
Faculty of Pharmaceutical Medicine
General Dental Council
General Medical Council
Guernsey St John Ambulance Service
Guild of Healthcare Pharmacists
Health & Safety Executive
Health Development Agency
Health Professions Council
Health Professions Wales
Health Promotion England
Health Service Commissioner
Health Which?
Independent Healthcare Association
Isle of Man Ambulance Service
Isle of Wight Healthcare NHS Trust
Joint Consultants Committee
Joint Formulary Committee
Joint Royal Colleges Ambulance Service Liaison Committee (JRCALC)
Medical Defence Union
Medical Protection Society Ltd
MIMS Ltd
National Association of private Ambulance Services
National Care Standards Commission
National Patient Safety Agency
Neonatal and Paediatric Pharmacists Group
Nursing and Midwifery Council
Overseas Doctors Association
Paediatric Chief Pharmacists Group
Patients Association
Pharmaceutical Journal
Pharmaceutical Society for Northern Ireland
Public Health Laboratory Service
Royal College of Anaesthetists
Royal College of General Practitioners
Royal College of Midwives
Royal College of Midwives (Scottish Board)
Royal College of Midwives (Northern Ireland Board)
Royal College of Nursing
Royal College of Nursing (Northern Ireland)
Royal College of Nursing (Scotland)
Royal College of Nursing (Wales)
Royal College of Paediatrics and Child Health
Royal College of Pathologists
Royal College of Physicians (Edinburgh)
Royal College of Physicians (London)
Royal College of Physicians & Surgeons (Glasgow)
Royal College of Psychiatrists
Royal College of Surgeons (England)
Royal College of Surgeons (Edinburgh)
Royal College of Surgeons (Faculty of Dental Surgery)
Royal College of Surgeons of England (Faculty of General Dental Practitioners (UK))
Royal Colleges of Physicians : Faculty of Pharmaceutical Medicine
Royal Colleges of Physicians : Faculty of Public Health Medicine
Royal Pharmaceutical Society of Great Britain
Royal Pharmaceutical Society of Great Britain (Scottish Department)
Royal Pharmaceutical Society of Great Britain (Welsh Department)
Royal Society of Chemistry
Royal Society for the Promotion of Health
Scrip Ltd
Small Business Service
Social Audit Unit
St John Ambulance
States of Jersey Ambulance Service
Unison