2005 No. 3324

MEDICINES

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

Made

Laid before Parliament

Coming into force

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 19681, or, as the case may be, the powers conferred by those provisions and now vested in them2.

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 Medicines3.

Citation, commencement and interpretation1

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 6th January 2006.

2

In this Order—

  • “the POM Order” means the Prescription Only Medicines (Human Use) Order 19974;

  • “the Pharmacy and General Sale Order” means the Medicines (Pharmacy and General Sale—Exemption) Order 19805.

Amendment of Schedule 3A to the POM Order2

In the table in Schedule 3A to the POM Order6 (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 Order3

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 Order4

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 KennedyMinister of State,Department of Health

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

Andrew McCormickPermanent Secretary,Department of Health, Social Services and Public Safety

(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.