2002 No. 549
MEDICINES

The Prescription Only Medicines (Human Use) Amendment Order 2002

Made
Laid before Parliament
Coming into force
As respects England, Scotland and Wales, the Secretary of State concerned with health in England, and, as respects Northern Ireland, the Minister of Health, Social Services and Public Safety, acting jointly, in exercise of the powers conferred upon them by sections 58(1), (4), (4A) and (5), 59, 103(2) and 129(4) of the Medicines Act 19681, or, as the case may be, those conferred by the said provisions and now vested in them2, and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by this Order, pursuant to section 129(6) of that Act, and after consulting and taking into account the advice of the Committee on the Safety of Medicines, pursuant to sections 58(6) and 129(7) of that Act, and taking into account the advice of the Medicines Commission, pursuant to section 129(7) of that Act, hereby make the following Order:—

Citation, commencement and interpretation1.

(1)

This Order may be cited as the Prescription Only Medicines (Human Use) Amendment Order 2002 and shall come into force on 1st April 2002.

(2)

In this Order, “the principal Order” means the Prescription Only Medicines (Human Use) Order 19973.

Amendment of article 1 of the principal Order2.

(1)

Article 1 of the principal Order (citation, commencement and interpretation) is amended as follows.

(2)

In paragraph (1)—

(a)

omit the definition of “appropriate nurse practitioner”;

(b)

after the definition of “cyanogenetic substances” insert the following definition—

  • ““district nurse/health visitor prescriber” means—

    1. (a)

      a person who—

      1. (i)

        is registered in Part 1 or 12 of the professional register, and

      2. (ii)
        has a district nursing qualification additionally recorded in the professional register under rule 11 of the Nurses, Midwives and Health Visitors Rules 19834; or
    2. (b)

      a person who is registered in Part 11 of the professional register as a health visitor,

    against whose name (in each case) is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances for patients;”;

(c)

after the definition of “dosage unit” insert the following definitions—

““Extended Formulary” means the Nurse Prescribers’ Extended Formulary Appendix in the current edition of the British National Formulary;

“extended formulary nurse prescriber” means a person—

(a)

who is registered in Parts 1, 3, 5, 8, 10, 11, 12, 13, 14 or 15 of the professional register; and

(b)

against whose name is recorded in that register an annotation signifying that he is qualified to order drugs, medicines and appliances from the Extended Formulary;”;

(d)

in the definition of “health prescription”, for “or nurse prescriber” insert “, a district nurse/health visitor prescriber or an extended formulary nurse prescriber”;

(e)

after the definition of “Primary Care Trust”5 insert the following definition—
““professional register” means the register maintained by the Nursing and Midwifery Council6 pursuant to paragraph 10 of Schedule 2 to the Nursing and Midwifery Order 20017;”;

(f)

in the definition of “registered midwife”, for the words from “the Register” to the end substitute “the professional register”;

(g)

in the definition of “registered nurse”, for the words from “the Register” to the end substitute “the professional register”;

(h)

in the definition of “state registered chiropodist”, for the words from “the Register” to the end substitute “the register of chiropodists maintained by the Health Professions Council8 pursuant to paragraph 11 of Schedule 2 to the Health Professions Order 20019”; and

(i)

in the definition of “state registered paramedic”, for the words from “the Register” to the end substitute “the register of paramedics maintained by the Health Professions Council pursuant to paragraph 11 of Schedule 2 to the Health Professions Order 2001”.

(3)

In paragraph (5)10, for “Schedules 1, 2 and 5” substitute “Schedules 1, 2, 3A and 5”.

Amendment of article 2 of the principal Order3.

In article 2 of the principal Order (appropriate practitioners), for paragraph (b) substitute the following paragraphs—

“(b)

in relation to the descriptions and classes of medicinal products specified in Schedule 3, district nurse/health visitor prescribers;

(c)

in relation to the descriptions and classes of medicinal products specified in article 3A(1), extended formulary nurse prescribers.”.

Amendment of article 3 of the principal Order4.

For article 3 of the principal Order (which specifies classes of prescription only medicines), substitute the following article—

“Medicinal products on prescription only3.

The following descriptions and classes of medicinal products are specified for the purposes of section 58, namely—

(a)

medicinal products in respect of which a marketing authorization has been granted, which in the marketing authorization are classified as being prescription only medicines;

(b)

medicinal products in respect of which no marketing authorization has been granted consisting of or containing a substance listed in column 1 of Schedule 1;

(c)

medicinal products that are for parenteral administration;

(d)

medicinal products that are controlled drugs unless a marketing authorization has been granted in respect of that medicinal product in which the product is classified as being a pharmacy only or on general sale list medicine;

(e)

cyanogenetic substances, other than preparations for external use;

(f)

medicinal products that on administration emit radiation, or contain or generate any substance which emits radiation, in order that radiation may be used.”.

Insertion of article 3A in the principal Order5.

After article 3 of the principal Order, insert the following article—

“Prescribing by extended formulary nurse prescribers3A.

(1)

Subject to paragraph (2), the description and classes of medicinal products in relation to which extended formulary nurse prescribers are appropriate practitioners are those prescription only medicines which consist of, or contain, one or more of the substances specified in column 1 of Schedule 3A, but which do not contain any other substance or combination of substances which is a prescription only medicine not included in Schedule 3A.

(2)

An extended formulary nurse prescriber may—

(a)

give a prescription for a medicinal product referred to in paragraph (1); or

(b)

if that medicinal product is for parenteral administration—

(i)

administer that medicinal product, or

(ii)

give directions for the administration of that medicinal product,

only where he complies with any condition as to the cases or circumstances in which he may do so that is specified by virtue of paragraph (3).

(3)

If the entry in column 2 of Schedule 3A relating to a substance specifies one or more requirements as to use, route of administration or pharmaceutical form, it is a condition for the purposes of paragraph (2) that a medicinal product which consists of, or contains, that substance is administered, or is prescribed or directed for administration, in accordance with the specified requirements.”.

Amendment of article 8 of the principal Order6.

Article 8 of the principal Order (exemptions for emergency sale or supply) is amended as follows—

(a)

in paragraph (2)—

(i)

in sub-paragraph (a), after “doctor” insert “, a district nurse/health visitor prescriber or an extended formulary nurse prescriber”;

(ii)

in sub-paragraph (b), after “doctor” insert “, district nurse/health visitor prescriber or extended formulary nurse prescriber”;

(iii)

in sub-paragraph (c), after “doctor” insert “, district nurse/health visitor prescriber or extended formulary nurse prescriber”; and

(b)

in paragraph (4), in sub-paragraph (a), in head (ii), after “doctor” insert “, district nurse/health visitor prescriber or extended formulary nurse prescriber”.

Insertion of article 13A into the principal Order7.

After article 13 of the principal Order (exemption in cases involving another’s default) insert the following article—

“Exemptions relating to prescriptions given by nurses13A.

(1)

The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a prescription given by a registered nurse or registered midwife who is not an appropriate practitioner in relation to that medicine where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the person is such a practitioner.

(2)

The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a prescription given by an extended formulary nurse prescriber where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the extended formulary nurse prescriber has complied with any condition with which he is required to comply by virtue of article 3A(2) and (3).”.

Amendment of article 15 of the principal Order8.

In article 15 (prescriptions)11, in paragraph (2)(c)—

(a)

in head (iii), for “an appropriate nurse practitioner” substitute “a district nurse/health visitor prescriber, an extended formulary nurse prescriber”; and

(b)

in head (iv), for “or appropriate nurse practitioner” substitute “, a district nurse/health visitor prescriber or an extended formulary nurse prescriber”.

Insertion of Schedule 3A in the principal Order9.

After Schedule 3 to the principal Order, insert the following Schedule—

“SCHEDULE 3ASUBSTANCES WHICH MAY BE PRESCRIBED, ADMINISTERED OR DIRECTED FOR ADMINISTRATION BY EXTENDED FORMULARY NURSE PRESCRIBERS AND CONDITIONS FOR SUCH PRESCRIPTION OR ADMINISTRATION

Article 3A

Column 1

Column 2

Substance

Requirements as to use, route of administration, or pharmaceutical form

Aciclovir

External use

Acrivastine

Oral

Adapalene

External use

Alclometasone dipropionate

External use

Alimemazine tartrate (trimeprazine tartrate)

Oral

Amorolfine hydrochloride

External use

Amoxycillin trihydrate

Oral

Aspirin

Oral

Azelaic acid

External use

Azelastine hydrochloride

Ophthalmic use or nasal

Baclofen

Oral administration in palliative care

Beclometasone dipropionate

External use or nasal

Betamethasone dipropionate

External use

Betamethasone sodium phosphate

Aural or nasal

Betamethasone valerate

External use

Budesonide

Nasal

Carbaryl

External use

Carbenoxolone sodium

Mouthwash

Cetirizine hydrochloride

Oral

Chloramphenicol

Ophthalmic use

Cimetidine

Oral

Cinchocaine hydrochloride

External use

Clindamycin phosphate

External use

Clobetasone butyrate

External use

Clotrimazole

External use

Cyclizine

Parenteral administration in palliative care

Dantrolene sodium

Oral administration in palliative care

Dantron

Oral

Desogestrel

Oral

Desoximetasone (Desoxymethasone)

External use

Dexamethasone

Aural

Dexamethasone isonicotinate

Nasal

Diclofenac diethylammonium

External use

Domperidone

Oral or rectal administration in palliative care

Domperidone maleate

Oral administration in palliative care

Doxycycline

Oral

Econazole nitrate

External use

Erythromycin

External use

Ethinylestradiol

Oral

Etynodiol diacetate (ethynodiol diacetate)

Oral

Famotidine

Oral

Felbinac

External use

Fenticonazole nitrate

External use

Fexofenadine hydrochloride

Oral

Flucloxacillin sodium

Oral

Fluconazole

Oral

Fludroxycortide (Flurandrenolone)

External use

Flumetasone pivalate

Aural

Flunisolide

Nasal

Fluocinolone acetonide

External use

Fluocinonide

External use

Fluocortolone hexanoate

External use

Fluocortolone pivalate

External use

Flurbiprofen

Lozenges

Fluticasone propionate

External use or nasal

Fusidic acid

Ophthalmic use

Gentamicin sulphate

Aural

Gestodene

Oral

Hydrocortisone

External use

Hydrocortisone acetate

External use

Hydrocortisone butyrate

External use

Hydrocortisone sodium succinate

Lozenges

Hyoscine butylbromide

Parenteral administration in palliative care

Hyoscine hydrobromide

Oral, parenteral or transdermal administration in palliative care

Ibuprofen

External use or oral

Ibuprofen lysine

Oral

Ipratropium bromide

Nasal

Isotretinoin

External use

Ketoconazole

External use

Ketoprofen

External use

Levocabastine hydrochloride

Ophthalmic use or nasal

Levomepromazine (methotrimeprazine) maleate

Oral administration in palliative care

Levomepromazine (methotrimeprazine) hydrochloride

Parenteral administration in palliative care

Levonorgestrel

Oral

Lithium succinate

External use

Lodoxamide trometamol

Ophthalmic use

Loperamide hydrochloride

Oral

Loratadine

Oral

Mebendazole

Oral

Medroxyprogesterone acetate

Parenteral

Mestranol

Oral

Metoclopramide hydrochloride

Oral or parenteral administration in palliative care

Metronidazole

External use or oral

Metronidazole benzoate

Oral

Miconazole

Dental lacquer

Miconazole nitrate

External use

Minocycline

Oral

Mometasone furoate

External use or nasal

Nedocromil sodium

Ophthalmic use

Nefopam hydrochloride

Oral

Neomycin sulphate

Aural

Neomycin undecenoate

Aural

Nitrofurantoin

Oral

Nizatidine

Oral

Norethisterone 9

Oral

Norethisterone acetate

Oral

Norethisterone enanthate

Parenteral

Norgestimate

Oral

Norgestrel

Oral

Nystatin

External use

Oxytetracycline dihydrate

Oral

Paracetamol

Oral

Penciclovir

External use

Piroxicam

External use

Prednisolone hexanoate

External use

Prednisolone sodium phosphate

Aural

Ranitidine hydrochloride

Oral

Silver sulphadiazine

External use

Sodium cromoglycate

Ophthalmic use

Streptodornase

External use

Streptokinase

External use

Sulconazole nitrate

External use

Terbinafine hydrochloride

External use

Tetracycline hydrochloride

External use or oral

Tretinoin

External use

Triamcinolone acetonide

External use, aural, nasal or oral paste

Trimethoprim

Oral

Tuberculin PPD

Parenteral

Vaccine, Adsorbed Diphtheria

Parenteral

Vaccine, Adsorbed Diphtheria And Tetanus

Parenteral

Vaccine, Adsorbed Diphtheria And Tetanus For Adults And Adolescents

Parenteral

Vaccine, Adsorbed Diphtheria For Adults And Adolescents

Parenteral

Vaccine, Adsorbed Diphtheria, Tetanus And Pertussis

Parenteral

Vaccine, Adsorbed Diphtheria, Tetanus And Pertussis (Acellular Component)

Parenteral

Vaccine, BCG

Parenteral

Vaccine, BCG Percutaneous

Parenteral

Vaccine, Haemophilus Influenzae Type B (Hib)

Parenteral

Vaccine, Haemophilus Influenzae Type B (Hib) with Diphtheria, Tetanus And Pertussis

Parenteral

Vaccine, Haemophilus Influenzae Type B, Diphtheria, Tetanus And Acellular Pertussis

Parenteral

Vaccine, Hepatitis A

Parenteral

Vaccine, Hepatitis A With Typhoid

Parenteral

Vaccine, Hepatitis A, Inactivated, With Recombinant (DNA) Hepatitis B

Parenteral

Vaccine, Hepatitis B

Parenteral

Vaccine, Influenza

Parenteral

Vaccine, Live Measles, Mumps And Rubella (MMR)

Parenteral

Vaccine, Meningococcal Group C Conjugate

Parenteral

Vaccine, Meningococcal Polysaccharide A and C

Parenteral

Vaccine, Pneumococcal

Parenteral

Vaccine, Poliomyelitis, Inactivated

Parenteral

Vaccine, Poliomyelitis, Live (Oral)

Oral

Vaccine, Rubella, Live

Parenteral

Vaccine, Tetanus, Adsorbed

Parenteral

Vaccine, Typhoid, Live Attenuated (Oral)

Oral

Vaccine, Typhoid, Polysaccharide

Parenteral”.

Amendment of Schedule 7 to the principal Order10.

In Part III of Schedule 7 to the principal Order12 (Patient Group Directions—classes of individuals by whom supplies may be made), for the last three entries substitute the following entries—

“Individuals who are registered in the register of orthoptists maintained by the Health Professions Council pursuant to paragraph 11 of Schedule 2 to the Health Professions Order 2001 (state registered orthoptists).

Individuals who are registered in the register of physiotherapists maintained by the Health Professions Council pursuant to paragraph 11 of Schedule 2 to the Health Professions Order 2001 (state registered physiotherapists).

Individuals who are registered in the register of radiographers maintained by the Health Professions Council pursuant to paragraph 11 of Schedule 2 to the Health Professions Order 2001 (state registered radiographers).”.

Revocations11.

Articles 4 and 6 of the principal Order are revoked.

Signed by authority of the Secretary of State for Health

Hunt
Parliamentary Under Secretary of State
Department of Health
Bairbre de Brún
Minister of Health, Social Services and Public Safety
(This note is not part of the Order)

This Order amends the Prescription Only Medicines (Human Use) Order 1997 (“the principal Order”).

Articles 2, 3, 5 and 9 make provision for nurses meeting certain conditions (“extended formulary nurse prescribers”) to prescribe certain prescription only medicines. Article 2 amends article 1 of the principal Order, so as to insert definitions of “extended formulary nurse prescriber” and “district nurse/health visitor prescriber”, and makes changes consequential on the Nursing and Midwifery Order 2001 (S.I. 2002/253). Article 3 amends article 2 of the principal Order, so as to provide that such persons are “appropriate practitioners” for the purposes of section 58 of the Medicines Act 1968 (restrictions on sale and supply), as amended by section 63 of the Health and Social Care Act 2001. Article 5 inserts a new article 3A into that Order, which makes provision for prescribing by extended formulary nurse prescribers; in particular, for the descriptions and classes of product which they may prescribe and the conditions as to the cases or circumstances in which such a person may prescribe. Article 9 inserts Schedule 3A into that Order; the Schedule lists the substances which such persons are able to prescribe and the requirements which must be complied with in relation to each substance. Articles 6 and 8 make consequential amendments.

Articles 2(2)(h) and (i) and 10 make amendments consequential on the Health Professions Order 2001 (S.I. 2002/254), which makes provision for the regulation of certain health professions, including chiropodists, paramedics, orthoptists, physiotherapists and radiographers.

Article 4 amends article 3 of the principal Order (which specifies classes of products which are prescription only medicines) to provide that medicinal products which have been granted a United Kingdom or Community marketing authorization will be prescription only medicines if so classified in their marketing authorization. Medicinal products for which no marketing authorization has been granted will continue to be classified as prescription only if they contain a substance listed in column 1 of Schedule 1. Article 10 revokes articles 4 and 6 of the principal Order as a consequence of these changes.

Article 7 inserts article 13A into the principal Order, which provides for exemptions from the restrictions in section 58 of the 1968 Act (restrictions on sale and supply) in cases where a pharmacist supplies a medicinal product in accordance with a prescription by a nurse or midwife.

A Regulatory Impact Assessment in relation to this Order has been placed in the libraries of both Houses of Parliament and copies may be obtained from the Department of Health, Medicines Control Agency, Information Centre, Room 10-202, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.