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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 - 

      (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 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 - 



    " SCHEDULE 3A
    Article 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 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



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.


Notes:

[1] 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).back

[2] 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).back

[3] 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.back

[4] The rules were approved by S.I. 1983/873; there are amendments to the rules which are not relevant to this Order.back

[5] Inserted by article 2(a) of S.I. 2000/1917.back

[6] See article 3 of the Nursing and Midwifery Order 2001, S.I. 2002/253.back

[7] S.I. 2002/253.back

[8] See article 3 of the Health Professions Order 2001, S.I. 2002/254.back

[9] S.I. 2002/254.back

[10] Paragraph (5) was amended by article 2 of S.I. 2001/2777.back

[11] Article 15 was amended by S.I. 2001/2889.back

[12] Schedule 7 was inserted by article 2(e) of S.I. 2000/1917.back



ISBN 0 11 039 674 X


  Prepared 12 April 2002

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