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United Kingdom Statutory Instruments
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URL: http://www.bailii.org/uk/legis/num_reg/2005/20050765.html

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STATUTORY INSTRUMENTS

2005 No. 765

MEDICINES

The Medicines for Human Use (Prescribing) Order 2005

  Made 16th March 2005 
  Laid before Parliament 17th March 2005 
  Coming into force 7th April 2005 

As respects England, Scotland and Wales, the Secretary of State in England, and , as respects Northern Ireland, the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, acting jointly in exercise of the powers conferred upon them by sections 15(1), 58(1), (4), (4A), (4B) and (5) and 129(4) of the Medicines Act 1968[1], or, as the case may be, those powers 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 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, extent and interpretation
     1.  - (1) This Order may be cited as the Medicines for Human Use (Prescribing) Order 2005 and shall come into force on 7th April 2005.

    (2) Subject to paragraph (3), this Order applies to the whole of the United Kingdom.

    (3) Paragraphs (2) and (3) of article 2 extend to Scotland only.

    (4) In this Order - 

Exemption to the restrictions imposed by sections 7 and 8 of the Medicines Act 1968
     2.  - (1) The restrictions imposed by sections 7 and 8 of the Medicines Act 1968 do not apply to anything which is done in a registered pharmacy, a hospital or a health centre and is done there by or under the supervision of a pharmacist and consists of - 

    (2) The restrictions imposed by sections 7 and 8 of the Medicines Act 1968 do not apply to anything which is done in a care home service and is done there by or under the supervision of a pharmacist and consists of - 

    (3) In paragraph (2), "a care home service" has the meaning given by section 2(3) of the Regulation of Care (Scotland) Act 2001[8].

Amendment of article 1 of the POM Order
     3. In article 1 of the POM Order (citation, commencement and interpretation), in paragraph (2) - 

Amendment of article 3B of the POM Order
     4. In article 3B[10] of the POM Order (prescribing and administration by supplementary prescribers), in paragraph (3), omit sub-paragraph (b).

Amendment of article 13A of the POM Order
     5. In article 13A[11] of the POM Order (exemptions relating to prescriptions given by nurses), in paragraph (1) - 

Amendment of article 15 of the POM Order
     6. For Article 15 of the POM Order (prescriptions)[12], substitute the following article  - 

Amendment of Schedule 3A to the POM Order
     7. In the table in Schedule 3A to the POM Order[15], (substances which may be prescribed, administered or directed for administration by extended formulary nurse prescribers) - 

Amendment of Schedule 5 of the POM Order
     8. In the table in Schedule 5 to the POM Order (exemption from restrictions on sale or supply), in paragraph 5 of Part I, in column 2, in sub-paragraph (c) - 



Signed by authority of the Secretary of State for Health


Warner
Parliamentary Under Secretary of State, Department of Health

16th March 2005



Sealed with the Official Seal of the Department of Health, Social Services and Public Safety


Deirdre Kenny
A Senior Officer of the, Department of Health, Social Services and Public Safety

15th March 2005



Sealed with the Official Seal of the Department of Agriculture and Rural Development


Gerald Lavery
A Senior Officer of the Department of Agriculture and Rural Development

15th March 2005


EXPLANATORY NOTE

(This note is not part of the Regulations)


Article 2 of this Order creates a new exemption to the restrictions imposed by sections 7 and 8 of the Medicines Act 1968 (general provisions as to dealing with medicinal products and provisions as to manufacture and wholesale dealing). It provides that the restrictions imposed by those sections shall not apply to the preparation or dispensing or to procuring the preparation or dispensing of a medicinal product for human use in accordance with a presciption given by a supplementary prescriber where this is done by or under the supervision of a pharmacist in a registered pharmacy, hospital or health care centre or, in Scotland, in a care home service.

The remainder of this Order further amends the Prescription Only Medicines (Human Use) Order 1997 "the POM Order" which specifies the description and classes of medicines ("prescription only medicines") which may be sold or supplied only in accordance with the prescription of an "appropriate practitioner", and may be administered only in accordance with the directions of such a practitioner.

Article 3 amends article 2 of the POM Order to extend the definition of "supplementary prescriber" to include chiropodists and podiatrists, physiotherapists and diagnostic or therapeutic radiographers.

Article 4 amends article 3B of the POM Order to remove the restriction in sub-paragraph (3)(b) of that article which provides that supplementary prescribers may only prescribe prescription only medicines in respect of which a product licence, marketing authorisation or homeopathic certificate of registration is in place, or other prescription only medicines only where the medicine is to be administered in the course of a clinical trial.

Article 5 amends article 13A of the POM Order. Paragraph (1) of article 13A provides that the restrictions on sale or supply of prescription only medicines shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a prescription given by person of a type listed in the paragraph where the listed person is not, but the pharmacist on reasonable grounds believes him to be, an appropriate practictioner in relation to that medicine. The listed persons are those professionals who may be supplementary prescribers. To accord with the amendments to the revised definition of "supplementary prescriber", this amendment adds chiropodists and podiatrists, physiotherapists and diagnostic or therapeutic radiographers to that list.

Article 6 substitutes a new Article 15 of the POM Order. Article 15 was amended by the Prescription Only Medicines (Human Use) (Electronic Communications) Order 2001[20].Paragraph 2 of the new Article replicates existing provisions. Paragraphs 3 and 4 of the new Article substitutes new provisions which provide that a prescription, other than one given by a veterinary surgeon or practitioner, or for a controlled drug specified in Schedule 1, 2 or 3 of the Misuse of Drugs Regulations, does not have to be signed and written in ink if it is created in electronic form and signed with an advanced electronic signature and transferred to the person by whom it is dispensed as an electronic communication.

Article 7 makes changes to the list of prescription only medicines, in Schedule 3A of the principal Order, which may be prescribed by extended formulary nurse prescribers.

Article 8 makes changes to the list of prescription only medicines which may be sold or supplied by a registered pharmacist on receipt of an order signed by a registered opthalmic optician, or which may be sold or supplied by a registered opthalmic optician directly in the course of his professional practice in an emergency.

Three Regulatory Impact Assessments in relation to measures in this Order have been placed in the libraries of both Houses of Parliament and copies may be obtained from the Department of Health, Medicines and Healthcare products Regulatory 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 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, by article 5 of, and paragraph 1(1) of the Schedule to, S.I. 1999/3142, and by article 5(1) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794; 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) and by article 54(3) of, and paragraph 2(b) of Schedule 5 to, S.I. 2002/253.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 paragraph 1(1) of the Schedule to, S.I. 1999/3142; and in the case of the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, by virtue of the powers vested in the Ministers in charge of those Departments by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47) which may now be exercised by the Departments by virtue of section 1(8) of, and paragraph 4(1)(b) of the Schedule to, the Northern Ireland Act 2000 (c.1); the Departments were renamed by virtue of Article 3(4) and (6) of S.I. 1999/283 (N.I.I.).back

[3] S.I. 1997/1830; relevant amending instruments are S.I. 1998/1178, 2000/2899, 2001/2889, 2002/549, 2003/696 and 2915, and 2004/2, 696, 1031, 1189, 1771 and 2693.back

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

[5] 1954. c. 61.back

[6] S.I. 1976/1213 (N.I. 22)back

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

[8] 2001 asp8.back

[9] The definition of "supplementary prescriber" was inserted by S.I. 2003/696 and amended by S.I. 2004/1771.back

[10] Article 3B was inserted by S.I. 2003/696 and amended by S.I. 2004/1031.back

[11] Article 13A was inserted by S.I. 2002/549 and amended by S.I. 2003/696.back

[12] Relevant amending instruments are S.I. 2001/2889, 2002/549, 2003/696.back

[13] S.I. 2001/3998.back

[14] 1984 (c.12).back

[15] Schedule 3A was inserted by S.I. 2002/549, and amended by S.I. 2003/696 and 2915, and 2004/2, 1189 and 2693.back

[16] The entry for "Diazepam" was inserted by S.I. 2003/2915.back

[17] The entry for "Diclofenac Sodium" was inserted by S.I. 2004/2.back

[18] The entry for "Lorazepam" was inserted by S.I. 2003/2915.back

[19] The entry for "Midazolam" was inserted by S.I. 2003/2915.back

[20] S.I..2001/2889.back


ISBN 0 11 072565 4


 © Crown copyright 2005

Prepared 22 March 2005

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URL: http://www.bailii.org/uk/legis/num_reg/2005/20050765.html