The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2003

Statutory Instruments

2003 No. 2915

MEDICINES

The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2003

Made

13th November 2003

Laid before Parliament

19th November 2003

Coming into force

10th December 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 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 (No. 2) Order 2003 and shall come into force on 10th December 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.  In article 1 of the principal Order (citation, commencement and interpretation), in the definition of “Patient Group Direction”(4), for “12B or 12C” substitute “12B, 12C, 12D or 12E”.

Amendment of Schedule 3A to the principal Order

3.  In the table in Schedule 3A to the principal Order (substances which may be prescribed, administered or directed for administration by extended formulary nurse prescribers and conditions for such prescription or administration), in column 1 insert, at the appropriate place in the alphabetical order of the entries as they appear in that column, each of the entries set out in column 1 below and in column 2 insert, against those entries, the corresponding entries in column 2 below—

Column 1	Column 2
Codeine Phosphate	Oral
Co-Phenotrope	Oral
Diazepam	Oral, parenteral or rectal administration in palliative care
Dihydrocodeine Tartrate	Oral
Lorazepam	Oral or parenteral administration in palliative care
Midazolam	Parenteral administration in palliative care

Signed by authority of the Secretary of State for Health

Warner

Parliamentary Under Secretary of State,

Department of Health

4th November 2003

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

Deirdre Kenny

A Senior Officer,

Department of Health, Social Services and Public Safety

13th November 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.

Article 2 makes a minor amendment to the definition of “Patient Group Direction” to insert appropriate references to Articles 12D and 12E of the principal Order.

Article 3 amends Schedule 3A to the principal Order so as to include in the list of substances which may be prescribed by extended formulary nurse prescribers, subject to certain conditions, the following substances: Codeine Phosphate, Co-Phenotrope, Diazepam, Dihydrocodeine Tartrate, Lorazepam and Midazolam.

(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).

(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).

(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, 2002/549 and 2469 and 2003/696.

(4)

The definition of “Patient Group Direction” was inserted by S.I. 2000/1917.