The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) (No. 2) Order 2005

Statutory Instruments

2005 No. 3324

MEDICINES

The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) (No. 2) Order 2005

Made

2nd December 2005

Laid before Parliament

9th December 2005

Coming into force

6th January 2006

The Secretary of State for Health and the Department of Health, Social Services and Public Safety, acting jointly, make the following Regulations in the exercise of the powers conferred upon them by sections 57(1) and (2), 58(1), (4), (4A), and (5) and 129(4) of the Medicines Act 1968(1), or, as the case may be, the powers conferred by those provisions and now vested in them(2).

In accordance with section 129(6) of that Act, they have consulted such organisations as appear to them to be representative of interests likely to be substantially affected by this Order. In accordance with sections 58(6) and 129(7) of that Act, they have consulted and taken into account the advice of the Committee on Safety of Medicines(3).

Citation, commencement and interpretation

1.—(1) This Order may be cited as the Medicines for Human Use (Prescribing) (Miscellaneous Amendments) (No. 2) Order 2005 and shall come into force on 6^th January 2006.

(2) In this Order—

“the POM Order” means the Prescription Only Medicines (Human Use) Order 1997(4);

“the Pharmacy and General Sale Order” means the Medicines (Pharmacy and General Sale—Exemption) Order 1980(5).

Amendment of Schedule 3A to the POM Order

2.  In the table in Schedule 3A to the POM Order(6) (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, 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
Buprenorphine	Transdermal administration in palliative care
Chlordiazepoxide hydrochloride	Oral
Diamorphine hydrochloride	Oral and parenteral
Fentanyl	Transdermal administration in palliative care
Morphine sulphate	Oral, parenteral and rectal
Morphine hydrochloride	Rectal
Oxycodone hydrochloride	Oral and parenteral administration in palliative care

Amendment of Schedule 5 to the POM Order

3.  In the table in Part I of Schedule 5 to the POM Order (exemption from restrictions on sale or supply), in paragraph 6A, column 2, insert, at the appropriate place in the alphabetical order of the entries as they appear in that column, “Pilocarpine nitrate”.

Amendment of Schedule 1 to the Pharmacy and General Sale Order

4.  In the table in Part I of Schedule 1 to the Pharmacy and General Sale Order, in paragraph 2A, in column 2, insert, at the appropriate place in the alphabetical order of the entries as they appear in that paragraph, “Pilocarpine nitrate”.

Signed by authority of the Secretary of State for Health

Jane Kennedy

Minister of State,

Department of Health

27th November 2005

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

Andrew McCormick

Permanent Secretary,

Department of Health, Social Services and Public Safety

2nd December 2005

Explanatory Note

(This note is not part of the Order)

This Order makes further amendments to certain Orders relating to the prescribing, sale and supply of medicines.

Articles 2 and 3 amend 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 2 amends Schedule 3A to the POM order to make additions to the list of medicines which may be prescribed by extended formulary nurse prescribers.

Article 3 amends Part I of Schedule 5 to the POM Order (exemption from restrictions on sale or supply of prescription only medicines) to make an addition to the list of substances which may be sold or supplied by a registered pharmacist to an “additional supply optometrist”, and may be sold or supplied by an additional supply optometrist in the course of that person’s professional practice in an emergency.

Article 4 amends the Medicines (Pharmacy and General Sale—Exemption) Order 1980 which provides for exemptions from sections 52 and 53 of the Medicines Act 1968 (restrictions on the sale or supply of medicinal products). Article 4 amends Part I of Schedule 1 to the Order to make an addition to the list of substances which may be sold or supplied by an additional supply optometrist in the course of that person’s professional practice in an emergency.

A full regulatory impact assessment has not been produced for this instrument as it has no impact on the costs of business.

(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.1. 2002/794; section 58 of that Act was amended by section 1 of the Prescription by Nurses etc. Act 1992 (c. 28), by section 63 of the Health and Social Care Act 2001 (c. 15), by article 54(3) of, and paragraph 2 of Schedule 5 to, S.I. 2002/253, and by regulation 8 of, and paragraph 10 of Schedule 1 to, S.I. 2005/1094.

(2)

In the case of the Secretary of State for Health, 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, by virtue of the powers vested in the Ministers 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)

See paragraph 1 of Part 2 of Schedule 5 to S.I. 2005/2754.

(4)

S.I. 1997/1830; relevant amending instruments are S.I. 1998/108 and 2081, 2002/549, 2003/696, 1590 and 2915, 2004/2, 1189, 1771 and 2693, and 2005/765, 848 and 1507.

(5)

S.I. 1980/1924; relevant amending instruments are S.I. 2005/766 and 1507.

(6)

Schedule 3A was inserted by S.I. 2002/549, and amended by S.I. 2003/696 and 2915, 2004/2, 1189 and 2693, and 2005/765 and 1507.