Statutory Instruments
2002 No. 549
MEDICINES
The Prescription Only Medicines (Human Use) Amendment Order 2002
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 1968( 1 ), or, as the case may be, those conferred by the said provisions and now vested in them( 2 ), 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 interpretation
1. —(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 1997( 3 ).
Amendment of article 1 of the principal Order
2. —(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—
(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 1983 ( 4 ) ; 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; ” ;
(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—
who is registered in Parts 1, 3, 5, 8, 10, 11, 12, 13, 14 or 15 of the professional register; and
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 Council ( 6 ) pursuant to paragraph 10 of Schedule 2 to the Nursing and Midwifery Order 2001 ( 7 ) ; ” ;
(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 Council( 8 ) pursuant to paragraph 11 of Schedule 2 to the Health Professions Order 2001( 9 )”; 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 Order
3. 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 Order
4. For article 3 of the principal Order (which specifies classes of prescription only medicines), substitute the following article—
“ Medicinal products on prescription only
3. 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 Order
5. 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. ” .
Amendment of article 8 of the principal Order
6. 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 Order
7. 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). ” .
Amendment of article 15 of the principal Order
8. 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 Order
9. After Schedule 3 to the principal Order, insert the following Schedule—
Article 3A
“ SCHEDULE 3A SUBSTANCES WHICH MAY BE PRESCRIBED, ADMINISTERED OR DIRECTED FOR ADMINISTRATION BY EXTENDED FORMULARY NURSE PRESCRIBERS AND CONDITIONS FOR SUCH PRESCRIPTION OR ADMINISTRATION
| 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 Order
10. In Part III of Schedule 7 to the principal Order( 12 ) (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). ” .
Revocations
11. 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
7th March 2002
Bairbre de Brún
Minister of Health, Social Services and Public Safety
7th March 2002
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) .
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) .
S.I. 1997/1830 , amended by S.I. 1997/2044 , 1998/108 , 1178 and 2081 , 1999/1044 and 3463 , 2000/1917 , 2899 and 3231 , and 2001/2777 , 2889 and 3942 .
The rules were approved by S.I. 1983/873 ; there are amendments to the rules which are not relevant to this Order.
Inserted by article 2(a) of S.I. 2000/1917 .
See article 3 of the Nursing and Midwifery Order 2001, S.I. 2002/253 .
S.I. 2002/253 .
See article 3 of the Health Professions Order 2001, S.I. 2002/254 .
S.I. 2002/254 .
Paragraph (5) was amended by article 2 of S.I. 2001/2777 .
Article 15 was amended by S.I. 2001/2889 .
Schedule 7 was inserted by article 2(e) of S.I. 2000/1917 .