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United Kingdom Statutory Instruments
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STATUTORY INSTRUMENTS

2003 No. 696

MEDICINES

The Prescription Only Medicines (Human Use) Amendment Order 2003

  Made 13th March 2003 
  Laid before Parliament 14th March 2003 
  Coming into force 4th April 2003 

As respects England, Scotland and Wales, the Secretary of State concerned with health in England, and, as respects Northern Ireland, the Department of Health, Social Services and Public Safety, acting jointly, in exercise of the powers conferred upon them by sections 58(1), (1B), (4), (4A), (4B) and (5) 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 2003 and shall come into force on 4th April 2003.

    (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 (2) - 

    (3) In paragraph (7)[21], for "12C" substitute "12E".

Amendment of article 2 of the principal Order
     3. In article 2 of the principal Order (appropriate practitioners), in paragraph (a), after "dentists" insert ", supplementary prescribers".

Amendment of article 3 of the principal Order
     4. In article 3 of the principal Order (medicinal products on prescription only), after paragraph (f) add the following paragraph - 

Amendment of article 3A of the principal Order
     5. In article 3A of the principal Order[22] - 

Insertion of articles 3B and 3C of the principal Order
     6. After article 3A of the principal Order, insert the following articles - 

Insertion of article 5A of the principal Order
     7. After article 5 of the principal Order (exempt medicinal products), insert the following article - 

Amendment of article 8 of the principal Order
     8. Article 8 of the principal Order (exemptions for emergency sale or supply) is amended as follows - 

Amendment of article 10 of the principal Order
     9. Article 10 of the principal Order (exemption for medicinal products at high dilutions) is renumbered as paragraph (1) of that article and after paragraph (1), insert the following paragraph - 

Amendment of article 12C of the principal Order
     10. In article 12C of the principal Order[23] (exemption for persons conducting a retail pharmacy business who supply or administer prescription only medicines under a Patient Group Direction) - 

Insertion of articles 12D and 12E of the principal Order
     11. After article 12C of the principal Order (exemption for persons conducting a retail pharmacy business who supply or administer prescription only medicines under a Patient Group Direction), insert the following articles - 

Amendment of article 13A of the principal Order
     12. In article 13A of the principal Order (exemption relating to prescriptions given by nurses)[25] - 

Amendment of article 15 of the principal Order
     13. In article 15 (prescriptions)[26], in paragraph (2)(c) - 

Amendment of Schedule 3 to the principal Order
     14. In Schedule 3 to the principal Order (descriptions and classes of prescription only medicines in relation to which appropriate nurse practitioners are appropriate practitioners), at the end insert the following entry - 

Amendment of Schedule 3A to the principal Order
     15. In the table in Schedule 3A to the Order (substances which may be prescribed, administered or directed for administration by extended formulary nurse prescribers and conditions for such prescription or administration) - 

Insertion of Schedule 3B of the principal Order
     16. After Schedule 3A to the principal Order, insert the following Schedule - 



Amendment of Schedule 7 to the principal Order
     17. In Schedule 7 to the principal Order[27] (Patient Group Directions), after Part II, insert the following Part - 






Signed by authority of the Secretary of State for Health


Hunt
Parliamentary Under Secretary of State, Department of Health

13th March 2003



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


D. C. Gowdy
Permanent Secretary, Department of Health, Social Services and Public Safety

11th March 2003


EXPLANATORY NOTE

(This note is not part of the Order)


This Order amends the Prescription Only Medicines (Human Use) Order 1997 ("the principal Order") which specifies the descriptions and classes of medicines ("prescription only medicines") which, subject to exemptions specified in the Order, may be sold or supplied only in accordance with the prescription of an "appropriate practitioner", and may be administered only by or in accordance with the directions of such a practitioner.

Articles 2, 3, 5, 6, 8, 12, 13 and 16 make provision for nurses and pharmacists meeting certain conditions ("supplementary prescribers") to prescribe and administer prescription only medicines in accordance with clinical management plans relating to individual patients. Article 3 amends article 2 of the principal Order, so that supplementary prescribers are "appropriate practitioners" able to prescribe prescription only medicines. Article 5 amends article 3A of the principal Order, so that an extended formulary nurse prescriber may prescribe medicinal products without complying with the conditions in article 3A, if they are a supplementary prescriber complying with the new article 3B. Article 6 inserts new articles 3B and 3C into the principal Order: article 3B specifies the conditions as to the cases and circumstances in which supplementary prescribers may prescribe and administer prescription only medicines, including the requirement to prescribe in accordance with a clinical management plan; article 3C sets out when the conditions on administration by supplementary prescribers and extended formulary nurse prescribers do not apply. Article 16 inserts a new Schedule 3B into the principal Order, which sets out the requirements for clinical management plans. Articles 8, 12 and 13 make consequential amendments.

Articles 4 and 7 provide that certain medicinal products consisting of or containing aloxiprin, aspirin or paracetamol are prescription only medicines, unless the quantity sold or supplied is less than 100.

Article 9 provides that medicinal products are exempt from the restrictions on prescription only medicines, if they consist of or contain solely certain substances at high dilutions.

Articles 2, 10, 11 and 17 make provision for the supply or administration of prescription only medicines under a Patient Group Direction (i.e. a written direction providing for the supply or administration of a description or class of medicines to persons generally) to assist the provision of health care by certain non-NHS health care providers (i.e. a provider of health care other than a National Health Service body or a person providing services under an arrangement with such a body). In particular, Article 10 amends article 12C of the principal Order so as to enable a person conducting a retail pharmacy business to supply or administer prescription only medicines under an arrangement with certain non-NHS health care providers in accordance with a Patient Group Direction. Article 11 inserts new articles 12D and 12E into the principal Order - 

Article 17 inserts new Part IIA of Schedule 7 to the principal Order, which specifies the persons by whom or on whose behalf a Patient Group Direction for the police, prison services or armed forces must be signed.

Articles 14 and 15 make a number of minor amendments to the lists of substances which may be prescribed by nurse prescribers, including the addition of water for injections and, in relation to extended formulary nurse prescribers, the deletion of inactivated polio vaccine and the addition of emedastine and mizolastine.

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, 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).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 for Health, Social Services and Public Safety, by virtue of the powers vested in the Minister in charge of that Department 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 Department by virtue of section 1(8) of, and paragraph 4(1)(b) of the Schedule to, the Northern Ireland Act 2000 (c.1); the Department was renamed by virtue of Article 3(6) of S.I. 1999/283 (N.I.1).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, 2001/2777, 2889 and 3942, and 2002/549 and 2469.back

[4] S.I. 1972/1200.back

[5] S.I. 1974/498.back

[6] S.I. 1995/2808.back

[7] The definition of "Health Authority" was inserted by S.I. 2000/1917.back

[8] 1998 c.29.back

[9] The definition of "homoeopathic certificate of registration" was inserted by S.I. 2000/1917.back

[10] 2000 c.14.back

[11] 2001 asp 8.back

[12] The definition of "NHS trust" was inserted by S.I. 2000/1917.back

[13] S.I. 1992/3204 (N.I. 20).back

[14] The definition of "Primary Care Trust" was inserted by S.I. 2000/1917.back

[15] 1952 c.52.back

[16] 1989 c.45.back

[17] 1953 (c.18 (N.I.)).back

[18] 1954 c.61.back

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

[20] The definition of "Strategic Health Authority" was inserted by regulation 7 of, and Schedule 4 to, S.I. 2002/2469.back

[21] Regulation 1(7) to (9) was inserted by S.I. 2000/1917.back

[22] Article 3A was inserted by S.I. 2002/549.back

[23] Article 12C was inserted by S.I. 2000/1917.back

[24] Sub-paragraph (cc) was inserted by S.I. 2000/2899.back

[25] Article 13A was inserted by S.I. 2002/549.back

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

[27] Schedule 7 was inserted by S.I. 2000/1917.back

[28] 1996 c.16.back

[29] 1997 c.77.back


ISBN 0 11 045350 6


 
© Crown copyright 2003
Prepared 24 March 2003

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