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The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2004

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Explanatory Note

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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 3 amends Schedule 3A to the principal Order so as to change the permitted use or route of administration for the following substances, when prescribed or administered by an extended formulary nurse prescriber: hydrocortisone acetate (to include aural use) and hyoscine butylbromide (to remove transdermal administration). Article 3 also adds hyoscine to the list of substances which may be prescribed by extended formulary nurse prescribers, subject to certain conditions. Finally, article 3 amends the reference to the substance clavulanic acid to clavulanic acid (as potassium clavulanate). These changes involve minor corrections to entries inserted by previous orders.

Article 4 amends Part III of Schedule 5 of the principal Order so as to add reteplase and tenecteplase to the list of substances that may be parenterally administered by registered paramedics or persons who hold a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State.

Article 5 amends Part III of Schedule 7 to the principal Order by adding registered dietitians, occupational therapists, orthotists and prothetists and language and speech therapists to the list of classes of individuals who can supply or administer a prescription only medicine under a Patient Group Direction.

A full regulatory impact assessment of the effect that this instrument will have on the costs of business is available from the Medicines and Healthcare products Regulatory Agency, Information Centre, Room 10-202 Market Towers, 1 Nine Elms Lane, London SW8 5NQ and a copy has been placed in the libraries of both Houses of Parliament.

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