The Prescription Only Medicines (Human Use) Amendment Order 2002
S.I. 2002/549 · Made 7 March 2002
MEDICINES
Made 7th March 2002
Laid before Parliament 11th March 2002
Coming into force 1st April 2002
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 1968f1, or, as the case may be, those conferred by the said provisions and now vested in themf2, 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:—
Annotations to the whole text
Footnotes
- f1
-
1968 c. 67; the expression “the appropriate Ministers” and the expression “the Health Ministers”, which are relevant to the powers being exercised in the making of this Order, are defined in section 1 of that Act as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388, and by articles 2(1) and 5 of, and the Schedule to, S.I. 1999/3142; section 58 of that Act was amended by section 1 of the Prescription by Nurses etc. Act 1992 (c. 28) and by section 63 of the Health and Social Care Act 2001 (c. 15).
- f2
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In the case of the Secretary of State concerned with health in England, by virtue of article 2(2) of, and Schedule 1 to, S.I. 1969/388, and articles 2(1) and 5 of, and the Schedule to, S.I. 1999/3142; and in the case of the Minister of Health, Social Services and Public Safety, by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c. 47).
Contents
- 1Citation, commencement and interpretation
- 2Amendment of article 1 of the principal Order
- 3Amendment of article 2 of the principal Order
- 4Amendment of article 3 of the principal Order
- 5Insertion of article 3A in the principal Order
- 6Amendment of article 8 of the principal Order
- 7Insertion of article 13A into the principal Order
- 8Amendment of article 15 of the principal Order
- 9Insertion of Schedule 3A in the principal Order
- 10Amendment of Schedule 7 to the principal Order
- 11Revocations
- Signature
- Explanatory note
1Citation, commencement and interpretation
This Order may be cited as the Prescription Only Medicines (Human Use) Amendment Order 2002 and shall come into force on 1st April 2002.
In this Order, “the principal Order” means the Prescription Only Medicines (Human Use) Order 1997f1.
2Amendment of article 1 of the principal Order
Article 1 of the principal Order (citation, commencement and interpretation) is amended as follows.
In paragraph (1)—
omit the definition of “appropriate nurse practitioner”;
after the definition of “cyanogenetic substances” insert the following definition—
““district nurse/health visitor prescriber” means—
- (a)
a person who—
- (i)
is registered in Part 1 or 12 of the professional register, and
- (ii)
has a district nursing qualification additionally recorded in the professional register under rule 11 of the Nurses, Midwives and Health Visitors Rules 1983f1; or
- (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;”;
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;”;
in the definition of “health prescription”, for “or nurse prescriber” insert “, a district nurse/health visitor prescriber or an extended formulary nurse prescriber”;
in the definition of “registered midwife”, for the words from “the Register” to the end substitute “the professional register”;
in the definition of “registered nurse”, for the words from “the Register” to the end substitute “the professional register”;
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”.
In paragraph (5)f7, for “Schedules 1, 2 and 5” substitute “Schedules 1, 2, 3A and 5”.
3Amendment of article 2 of the principal Order
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.”.
4Amendment of article 3 of the principal Order
For article 3 of the principal Order (which specifies classes of prescription only medicines), substitute the following article—
“Medicinal products on prescription only
3The 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.”.
5Insertion of article 3A in the principal Order
After article 3 of the principal Order, insert the following article—
“Prescribing by extended formulary nurse prescribers
3A(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.”.
6Amendment of article 8 of the principal Order
Article 8 of the principal Order (exemptions for emergency sale or supply) is amended as follows—
in paragraph (2)—
in sub-paragraph (a), after “doctor” insert “, a district nurse/health visitor prescriber or an extended formulary nurse prescriber”;
in sub-paragraph (b), after “doctor” insert “, district nurse/health visitor prescriber or extended formulary nurse prescriber”;
in sub-paragraph (c), after “doctor” insert “, district nurse/health visitor prescriber or extended formulary nurse prescriber”; and
in paragraph (4), in sub-paragraph (a), in head (ii), after “doctor” insert “, district nurse/health visitor prescriber or extended formulary nurse prescriber”.
7Insertion of article 13A into the principal Order
After article 13 of the principal Order (exemption in cases involving another’s default) insert the following article—
“Exemptions relating to prescriptions given by nurses
13A(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).”.
8Amendment of article 15 of the principal Order
In article 15 (prescriptions)f1, in paragraph (2)(c)—
in head (iii), for “an appropriate nurse practitioner” substitute “a district nurse/health visitor prescriber, an extended formulary nurse prescriber”; and
in head (iv), for “or appropriate nurse practitioner” substitute “, a district nurse/health visitor prescriber or an extended formulary nurse prescriber”.
9Insertion of Schedule 3A in the principal Order
After Schedule 3 to the principal Order, insert the following Schedule—
“SCHEDULE 3A
SUBSTANCES 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 ”.
10Amendment of Schedule 7 to the principal Order
In Part III of Schedule 7 to the principal Orderf1 (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).”.
11Revocations
Articles 4 and 6 of the principal Order are revoked.
Signature
Signed by authority of the Secretary of State for Health
Hunt
Parliamentary Under Secretary of State
Department of Health
7th March 2002
Bairbre de Brún
Minister of Health, Social Services and Public Safety
7th March 2002
Explanatory note
(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.