The Prescription Only Medicines (Human Use) Amendment Order 2008

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 by or in accordance with the directions of such a practitioner.

Article 2 amends article 2 and articles 4 and 10 omit article 3A of, and Schedule 3A to, the principal Order which provide that nurses and pharmacists who meet certain conditions (“nurse independent prescribers” and “pharmacist independent prescribers”) are able to prescribe and administer prescription only medicines. The amendments allow pharmacist independent prescribers to prescribe and administer medicinal products that are controlled drugs and remove existing limitations on the prescription and administration of controlled drugs by nurse independent prescribers. Articles 5, 6, 8 and 9 make other amendments to the principal Order, as a consequence of these changes.

Article 3 amends article 3 of the principal Order (which specifies classes of medicinal products which are prescription only medicines) to provide that products consisting of or containing pseudoephedrine salts or ephedrine base or salts are prescription only medicines. Article 7 inserts a new article 5B into the principal Order which makes provision for a medicinal product consisting of or containing pseudoephedrine salts or ephedrine base or salts to be exempt from the restrictions on prescription only medicines when sold or supplied to a person at any one time subject to conditions. The conditions are firstly that a product consisting of or containing pseudoephedrine salts is not sold or supplied at the same time as a product consisting of or containing ephedrine base or salts and similarly a product consisting of or containing ephedrine base or salts is not sold or supplied at the same time as a product consisting of or containing pseudoephedrine salts. Secondly, the product or products sold or supplied must not contain in total more than 720mg pseudoephedrine salts in the case of pseudoephedrine salts and 180mg ephedrine base or salts in the case of ephedrine base or salts.

An impact assessment has not been produced for this instrument as there is no significant impact on the private or voluntary sectors.