The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 2004

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 description 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 in accordance with the directions of such a practitioner.

Article 2 amends article 1 of the principal Order so as to add a definition of “Local Health Board”, a type of NHS body established in Wales.

Article 3 amends article 7 of the principal Order so as to extend the exemption for administration for the purposes of saving life in an emergency to the following medicinal products—

• Atropine sulphate and obidoxime chloride injection

• Atropine sulphate and pralidoxime chloride injection

• Atropine sulphate, pralidoxime mesilate and avizafone injection

• Pralidoxime chloride injection

• Pralidoxime mesilate injection.

Article 4 inserts a new article 7A of the principal Order so as to create an exemption where smallpox vaccine is administered for the purposes of providing protection in the event of a confirmed or suspected case of smallpox, or where the vaccine is administered to members of, or persons working for, Her Majesty’s Forces.

Article 5 amends Schedule 3A to the principal Order so as to provide that certain substances may be prescribed or administered by an extended formulary nurse prescriber only if administered in the course of providing palliative care.

Article 6 amends Part III of Schedule 5 of the principal Order so as to as add amiodarone to the list of substances that may be parenterally administered by paramedics for the immediate, necessary treatment of sick or injured persons.

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 and Healthcare products Regulatory Agency, Information Centre, Room 10-202 Market Towers, 1 Nine Elms Lane, London SW8 5NQ.