To: Interested Organisations
020 7273 0642
020 7273 0121
anne.thyer@mhra.gsi.gov.uk
Our reference: MLX 293
Date:
30 April 2003
Dear Sir/Madam
NURSE PRESCRIBERS EXTENDED FORMULARY: PROPOSALS TO EXTEND
RANGE OF PRESCRIPTION ONLY MEDICINES
NURSE PRESCRIBERS EXTENDED FORMULARY: PROPOSALS TO AMEND
REQUIREMENTS AS TO USE, ROUTE OF ADMINISTRATION, OR
PHARMACEUTICAL FORM OF PRESCRIPTION ONLY MEDICINES
PROPOSAL TO AMEND ARTICLE 12 OF THE PRESCRIPTION ONLY MEDICINES
(HUMAN USE) ORDER 1997 TO INCLUDE INDEPENDENT NURSE PRESCRIBERS
AND SUPPLEMENTARY PRESCRIBERS AND CONSEQUENTIAL AMENDMENT
TO THE MEDICINES (PHARMACY AND GENERAL SALE – EXEMPTION) ORDER
1980
INTRODUCTION
1.
We are 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 (POMs) that may be prescribed by
Extended Formulary Nurse Prescribers, as set out in Schedule 3A to the Prescription
Only Medicines (Human Use) Order 1997 (known as the Nurse Prescribers' Extended
Formulary). This would be achieved by amendment to the Prescription Only
Medicines (Human Use) Order 1997 (“the POM Order”) and the NPEF.

amend the requirements as to use, route of administration, or pharmaceutical form of
certain prescription only medicines set out in the NPEF.

extend the exemption in article 12 of the POM Order to include Extended Formulary
Nurse Prescribers and supplementary prescribers. This would be achieved by
amendment to the POM Order. A Consequential amendment would also be made to
the Medicines (Pharmacy and General Sale – Exemption) Order 1980.
2.
This consultation letter has been produced jointly by the Medicines and Healthcare
products Regulatory Agency (MHRA) and the Department of Health and also seeks views on
wider proposals for Extended Formulary Nurse Prescribing. This consultation is also being
circulated in Wales, Scotland and Northern Ireland.
APPLICATION TO THE NHS IN ENGLAND, WALES, SCOTLAND AND
NORTHERN IRELAND
3.
The proposed changes to the POM Order and the Medicines (Pharmacy and General
Sale – Exemption) Order 1980 would apply throughout the United Kingdom. However, the
pace at which extended nurse prescribing develops, or supplementary prescribing is introduced,
and the arrangements for appropriate training within national health organisations, are matters
for each of the separate administrations.
APPLICATION OUTSIDE THE NHS IN ENGLAND, WALES, SCOTLAND AND
NORTHERN IRELAND
4.
The proposed changes to the POM Order and the Medicines (Pharmacy and General
Sale – Exemption) Order 1980 would also apply to organisations that provide healthcare
outside the national health service. Independent nurse prescribing arrangements or
supplementary prescribing arrangements introduced by such organisations would have to
comply with the legislative requirements and they should also consider developing
accompanying guidance.
NURSE PRESCRIBERS EXTENDED FORMULARY: BACKGROUND TO
PROPOSALS TO EXTEND RANGE OF PRESCRIPTION ONLY MEDICINES
5.
Since April 2002, Extended Formulary Nurse Prescribers (EFNPs), who have
successfully completed a specific programme of preparation and training, are able to prescribe
from a specific list of POMs, alone or in combination. The list of POMs is set out in Schedule
3A to the POM Order and is known as the Nurse Prescribers' Extended Formulary (NPEF).
EFNPs are also able to prescribe all P and GSL medicines that are prescribable by GPs at NHS
expense (with the exception of certain drugs that are subject to controls under the misuse of
drugs legislation). EFNPs are currently able to prescribe for conditions in the four treatment
areas of minor ailments, minor injuries, health promotion and palliative care.
6.
Following the introduction of the NPEF, and at Secretary of State for Health's request,
the Chief Nursing Officer considered how nurse prescribing could be extended further. In turn,
the CNO asked the Committee on the Safety of Medicines (CSM) to advise on expanding the
NPEF and also to offer a view on the range of medical conditions that could safely be managed
by EFNPs. The CSM was assisted in this work by the Joint CSM/Medicines Commission
Working Group. The proposals set out below, which have been recommended by the CSM, are
intended to enhance patient care by providing timely, safe and efficient access to healthcare and
will also make better use of nurses' skills.
7.
The proposals in this letter are complementary to the recent implementation of
supplementary prescribing arrangements. Following the successful completion of specified
training, POMs may be prescribed by a “supplementary prescriber” (a nurse or a pharmacist) as
part of an agreed Clinical Management Plan for an individual patient. In addition to POMs,
supplementary prescribers are able to prescribe all pharmacy (with the exception of those P
products that are schedule 5 controlled drugs) and general sale list (GSL) medicines, appliances
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and devices, foods and other borderline substances, which are prescribable by independent
prescribers (that is, doctors or dentists) under the NHS, where the arrangements relate to the
NHS. Supplementary prescribers need to act in accordance with the individual patient’s
Clinical Management Plan. Further information about supplementary prescribing is available
on www.doh.gov.uk/supplementaryprescribing
PROPOSALS
8.
Proposed new treatment areas (see also paragraph 11): as outlined in paragraph 4
above, EFNPs are able to manage conditions in treatment areas of minor ailments, minor
injuries, health promotion and palliative care. It is proposed to enlarge Extended Formulary
Nurse Prescribing practice to encompass:
 pain relief in specific circumstances: in the course of midwifery practice; and in
coronary care units for patients with suspected myocardial infarction
 treatment of emergencies: acute attacks of asthma; hypoglycaemia
We would welcome views on these proposals.
9.
Proposed additions to the conditions currently treatable under the NPEF (see also
paragraph 11):
 animal and human bites (minor injury)
 Trichomonas vaginalis infection (minor illness)
 laboratory confirmed uncomplicated genital Chlamydia infection (and the sexual
partners of those patients) (minor illness)
 menopausal vaginal atrophy (health promotion)
 symptoms of the menopause (health promotion)
We would welcome views on these proposals.
10.
Proposal concerning “off label” prescribing: under the terms of the NPEF, EFNPs
should not prescribe the “off label” (or “off licence”) use of licensed medicinal products. For
clarification, that means the use of a licensed product outside the licensed indications included
in the product’s Summary of Product Characteristics. CSM has concluded that in certain
circumstances, “off label” prescribing by EFNPs in palliative care would be safe and effective
practice. The proposal is therefore to amend the NPEF so that provision is made for EFNPs to
be able to prescribe the “off label” use of specific medicines in palliative care. We would
welcome views on this proposal.
11.
Proposed amendments to the POM Order (see also paragraph 12): the proposed
changes to the POM Order are shown below and are marked with an asterisk (*). The treatment
areas shown in the first column, with the exception of palliative care, will not form part of the
POM Order and will instead be subject to guidance. (For convenience, substances currently in
the POM Order and proposed for new indications (see paragraph 9) are also included in the
table below.) The proposed changes marked additionally with a hash (#) are controlled drugs
(see paragraph 12):
Treatment area
Substance
Pain relief in midwifery
practice
Diamorphine * #
3
Requirements as to use,
route of administration,
or pharmaceutical form
Parenteral
Treatment area
Substance
pain relief for patients in
coronary care units with
suspected myocardial
infarction
Acute attacks of asthma
Diamorphine * #
Hypoglycaemia

local anaesthetic for
ophthalmic
conditions
 local anaesthetic for
suturing of
lacerations
Acne vulgaris
Animal and human bites
Impetigo
Soft tissue injuries
Laboratory confirmed
uncomplicated genital
chlamydial infection,
plus sexual partners of
those patients
Trichomonas vaginalis
infection
Requirements as to use,
route of administration,
or pharmaceutical form
Parenteral
Salbutamol sulphate *
Terbutaline sulphate *
Prednisolone *
Prednisolone sodium
phosphate *
Glucagon hydrochloride *
Glucose *
Lidocaine hydrochloride *
Inhalation
Inhalation
Oral
Oral
Lymecycline *
Amoxicillin trihydrate
Clavulanic acid *
Doxycycline hyclate
Doxycycline monohydrate
Erythromycin *
Erythromycin ethyl
succinate *
Erythromycin stearate *
Metronidazole
Metronidazole benzoate *
Oxytetracycline dihydrate
Erythromycin *
Erythromycin ethyl
succinate *
Erythromycin stearate *
Fusidic acid *
Sodium fusidate *
Diclofenac sodium *
Diclofenac potassium *
Azithromycin dihydrate *
Doxycycline hyclate
Doxycycline monohydrate
Erythromycin *
Erythromycin ethyl
succinate *
Erythromycin stearate *
Metronidazole
Oral
Oral
Oral
Oral
Oral
Oral
Oral
4
Parenteral
Parenteral
External use, ophthalmic
use, parenteral
Oral
Oral, rectal administration
Oral
Oral
Oral
Oral
Oral
External use
External use
Oral, rectal administration
Oral
Oral
Oral
Oral
Oral
Oral
Oral
Oral, rectal administration
Treatment area
Substance
Contraception
Menopausal vaginal
atrophy (cream and
pessaries)
Etonogestrel (Implanon) *
Conjugated oestrogens (equine) *
Estradiol *
Estriol *
Requirements as to use,
route of administration,
or pharmaceutical form
Implant
External use
External use
External use
Symptoms of the
menopause
Levonorgestrel
Conjugated oestrogens (equine) *
Dydrogesterone *
Estradiol *
Estradiol valerate *
Estriol *
Estrone *
Estropipate *
Medroxyprogesterone acetate *
Norgestrel
Norethisterone
Norethisterone acetate *
Tibolone *
Oral
Oral
Oral
Oral, transdermal use
Oral
Oral
Oral
Oral
Oral
Oral
Oral
Oral, transdermal use
Oral
Neuropathic pain in
palliative care
Amitriptyline hydrochloride *
Imipramine hydrochloride *
Nortriptyline hydrochloride *
Gabapentin *
Carbamazepine *
Oral
Oral
Oral
Oral
Oral, rectal
administration
Oral, rectal
administration, parenteral
Oral, parenteral
Oral
Oral
Pain
relief
palliative care
in Morphine sulphate * #
Buprenorphine hydrochloride *#
Dextromoramide tartrate *#
Dextropropoxyphene
hydrochloride *#
Diamorphine hydrochloride *#
Dihydrocodeine tartrate *#
Fentanyl *#
Meptazinol *#
Meptazinol hydrochloride *#
Methadone hydrochloride *#
Nalbuphine hydrochloride *#
Oxycodone hydrochloride *#
Pethidine hydrochloride *#
Tramadol *#
Oral, parenteral
Oral, parenteral
Transdermal use
Oral
Parenteral
Oral, parenteral
Parenteral
Oral
Oral, parenteral
Oral, parenteral
Note to table: Full details are contained in the Prescription Only Medicines (Human Use)
Order 1997 but for convenience extracts of the definitions of the relevant terms are set out
below:
5
“external use" means application to the skin, hair, teeth, mucosa of the mouth, throat, nose,
ear, eye, vagina or anal canal when a local action only is intended and extensive systemic
absorption is unlikely to occur; and references to medicinal products for external use shall
be read accordingly except that such references shall not include throat sprays, throat
pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or
teething preparations;
"parenteral administration" means administration by breach of the skin or mucous
membrane;
12.
The proposals at paragraph 11, highlighted by #, contain some substances that are listed
as controlled drugs under the Misuse of Drugs Regulations 2001 (SI 3998/2001). Their
inclusion in the NPEF will require an amendment to the 2001 Regulations, which are the
responsibility of the Home Office. The Home Office would need to consider the advice of the
Advisory Council on the Misuse of Drugs before considering such a change to the 2001
Regulations. We would, however, welcome comments on the proposal to include these
controlled drugs within the NPEF.
PROPOSALS TO AMEND REQUIREMENTS AS TO USE, ROUTE OF
ADMINISTRATION, OR PHARMACEUTICAL FORM OF PRESCRIPTION ONLY
MEDICINES SPECIFIED IN THE NPEF
13.
The use, route of administration, or pharmaceutical form of hyoscine hydrobromide is
listed in the NPEF as "oral, parenteral or transdermal administration in palliative care".
Although there is a transdermal product containing hyoscine (but not hyoscine hydrobromide),
we understand that this product is not used in palliative care. In the absence of a product
containing hyoscine hydrobromide for transdermal use, we propose to delete this route of
administration from the NPEF. We would welcome comments on this proposal.
PROPOSAL TO AMEND ARTICLE 12 OF THE PRESCRIPTION ONLY MEDICINES
(HUMAN USE) ORDER 1997 AND THE MEDICINES (PHARMACY AND GENERAL
SALE – EXEMPTION) ORDER 1980
14.
Article 15 of the POM Order sets out the conditions that must be fulfilled before a
medicine can be taken as sold or supplied in accordance with a prescription given by an
appropriate practitioner. An appropriate practitioner for this purpose includes an independent
nurse prescriber in respect of the POMs they are allowed to prescribe and includes
supplementary prescribers for POMs that are specified in the Clinical Management Plan. The
conditions set out in article 15 include the signature and address of the practitioner, the date,
and an indication of whether the person giving the prescription is a doctor, a dentist, an
appropriate nurse practitioner or a supplementary prescriber. However, under Article 12 of the
POM Order, these conditions do not need to be met when the medicine is sold or supplied in
accordance with the written directions of a doctor or dentist in the course of the business of a
hospital. Independent nurse prescribers and supplementary prescribers are not currently
covered by this exemption.
15.
In hospitals, the effect is that a pharmacy must supply medicines against a prescription
written by an independent nurse prescriber or supplementary prescriber. It is common practice
in hospitals to write instructions on the in-patient drug chart as the means of prescribing and
supplying medicines. There is some uncertainty about whether or not this practice complies
with the requirements of Article 15 of the POM Order. The DH/MHRA are therefore taking
this opportunity to clarify the situation beyond doubt. The changes proposed would ensure the
6
legitimacy of existing practice and the DH/MCA do not wish to inhibit current safe practice in
hospitals while this consultation process is underway. The proposals are to:

extend Article 12 of the POM Order to provide an exemption from the requirements of
Article 15 when a medicine is sold or supplied in accordance with the written directions
of an independent nurse prescriber or supplementary prescriber in the course of the
business of a hospital.

amend the Pharmacy and General Sale Exemption Order to allow medicines prescribed
by independent nurse prescribers and supplementary prescribers to be sold or supplied
other than from registered pharmacy premises. The amendment will only apply to
medicines sold or supplied in the course of the business of a hospital for the purpose of
administration.
We would welcome views on these proposals.
COMMENTS ON PROPOSALS
16.
You are invited to comment on:






the proposed new treatment areas - paragraph 8
the additions to the conditions currently treatable under the NPEF – paragraph 9
the principle of “off label” prescribing – paragraph 10
the proposed additions to Schedule 3A of the POM Order – paragraphs 11 and
12
the proposed amendment to the NPEF – paragraph 13
the proposed amendments to Article 12 of the POM Order and the Medicines
(Pharmacy and General Sale – Exemption) Order 1980 – paragraphs 14 and 15
CIRCULATION OF PROPOSALS
17.
This consultation letter is being sent in hard copy to those organisations listed. Copies
are also available from our website - www.mhra.gov.uk.
18.
A form is attached for your reply. Comments should be addressed to: Mr Martin
Bagwell, 16-140, MHRA, Market Towers, 1, Nine Elms Lane, London SW8 5NQ.
Alternatively, they may be e-mailed to martin.bagwell@mca.gsi.gov.uk Replies should arrive
no later than 23 July 2003. Contributions received after 23 July may not be included in the
exercise.
19.
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 later this year.
Statutory Instruments are available from the Stationary Office and may also be viewed on their
website http://www.hmso.gov.uk
MAKING COPIES OF THE REPLIES AVAILABLE TO THE PUBLIC
20.
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.
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21.
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).
22.
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
Paul Robinson
Medicines, Pharmacy and Industry Group
Department of Health
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To: Martin Bagwell
MHRA
16-140 Market Towers
1 Nine Elms Lane
LONDON SW8 5NQ
From : ______________________________
______________________________
______________________________
______________________________
___________________
CONSULTATION LETTER MLX
Extended Prescribing of Prescription Only Medicines (POMs) by Independent Nurse
Prescribers: Amendment to the Prescription Only Medicines (Human Use) Order 1997
* 1.
I support the proposals contained in MLX ***
* 2.
I have no comment to make on the proposals in MLX
*3.
My comments on the proposals in 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
9
MLX 293: HARD COPY CONSULTATION LIST
Action for Sick Children
Advisory Committee on Misuse of Drugs
Age Concern
Arthritis Care
All Party Pharmaceutical Group
Association of British Cardiac Nurses
Association of Nurse Prescribing
Association for Palliative Medicine
Association for Residential Care
Association of Anaesthetists of Great Britain and Northern Ireland
Association of British Dispensing Opticians
Association of British Health Care Industries
Association of British Pharmaceutical Industries
Association of Community Health Councils of England & Wales
Association of Independent Multiple Pharmacies
Association of Medical Microbiologists
Association of Surgeons of Great Britain and Ireland
Birth Control Trust
British Association of Dermatologists
British Association for A&E Medicine
British Osteopathic Association
British Association of Pharmaceutical Physicians
British Association of Pharmaceutical Wholesalers
British Cardiac Patients Association
British College of Optometrists
British Contact Dermatitis Group
British Dental Association
British Dental Trade Association
British Diabetic Association
British Dietetic Association
British Generic Manufacturers Association
British Heart Foundation
British Institute of Regulatory Affairs
British Medical Association
British Oncological Association
British Pharmacological Society
British Association for Allergy and Clinical Immunology
British Society for Antimicrobial Chemotherapy
British Society of Gastroenterology
Carers National Association
Chemist & Druggist
Chiropodists Board
College of Health
College of Optometrists
College of Pharmacy Practice
Community Practitioners and Health Visitors Association
10
Community Pharmacy Magazine
Community Services Pharmacists Group
Company Chemists Association
Consumers Association
Co-operative Pharmacy Technical Panel
Council for Professions Supplementary to Medicine
Dental Defence Union
Dental Formulary Subcommittee of the Joint Formulary Committee
Dental Protection Ltd
Dispensing Doctors Association
Doctor Magazine
Drug & Therapeutics Bulletin
Drug Information Pharmacists Group
European Association of Hospital Pharmacists
Faculty of Family Planning
Faculty of Homoeopathy
Faculty of Pharmaceutical Medicine
Family Planning Association
General Dental Council
General Dental Practitioners Association.
General Medical Council
General Practitioners Committee
Guild of Healthcare Pharmacists
Health & Safety Executive
Health Development Agency
Health Promotion England
Health Service Commissioner
Health Which?
Independent Healthcare Association
Information and Statistics Division
Insulin Dependent Diabetes Trust
Joint Consultants Committee
Joint Formulary Committee
Joint Royal Colleges Ambulance Service Liaison Committee
Long Term Medical Conditions Alliance
Medical Defence Union
Medical Protection Society Ltd
Medical Research Council
MIMS Ltd
National Asthma Campaign
National Association of GP Co-operatives
National Association of Primary Care
National Back Pain Association
National Consumer Council
National Council for Hospices and Specialist Palliative Care Services
National Care Standards Commission
National Eczema Society
National Patient Safety Agency
National Pharmaceutical Association
11
Neonatal and Paediatric Pharmacists Group
NHS Alliance
NHS Confederation
Northern Ireland Consumer Council
Nursing and Midwifery Council
Ophthalmic Group Committee
OTC Bulletin
Overseas Doctors Association in the UK Ltd
Paediatric Chief Pharmacists Group
Patients Association
Pharmaceutical Contractors Committee (Northern Ireland)
Pharmaceutical Journal
Pharmaceutical Services Negotiating Committee
Pharmaceutical Society for Northern Ireland
Prescription Pricing Authority
Primary Care Pharmacists Association
Proprietary Association of Great Britain
Public Health Laboratory Service
Registered Nursing Home Association
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 Obstetricians & Gynaecologists
Royal College of Ophthalmologists
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 Radiologists
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
Shadow Nursing and Midwifery Council
12
Small Business Service
Social Audit Unit
Society of Chiropodists and Podiatrists
Society of Homoeopaths
Society of Pharmaceutical Medicine
Specialist Advisory Committee on Antimicrobial Resistance
St John Ambulance
UK Clinical Pharmacy Association
Unison
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