The Prescription Only Medicines (Human Use) Amendment Order 2003

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 descriptions 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.

Articles 2, 3, 5, 6, 8, 12, 13 and 16 make provision for nurses and pharmacists meeting certain conditions (“supplementary prescribers”) to prescribe and administer prescription only medicines in accordance with clinical management plans relating to individual patients. Article 3 amends article 2 of the principal Order, so that supplementary prescribers are “appropriate practitioners” able to prescribe prescription only medicines. Article 5 amends article 3A of the principal Order, so that an extended formulary nurse prescriber may prescribe medicinal products without complying with the conditions in article 3A, if they are a supplementary prescriber complying with the new article 3B. Article 6 inserts new articles 3B and 3C into the principal Order: article 3B specifies the conditions as to the cases and circumstances in which supplementary prescribers may prescribe and administer prescription only medicines, including the requirement to prescribe in accordance with a clinical management plan; article 3C sets out when the conditions on administration by supplementary prescribers and extended formulary nurse prescribers do not apply. Article 16 inserts a new Schedule 3B into the principal Order, which sets out the requirements for clinical management plans. Articles 8, 12 and 13 make consequential amendments.

Articles 4 and 7 provide that certain medicinal products consisting of or containing aloxiprin, aspirin or paracetamol are prescription only medicines, unless the quantity sold or supplied is less than 100.

Article 9 provides that medicinal products are exempt from the restrictions on prescription only medicines, if they consist of or contain solely certain substances at high dilutions.

Articles 2, 10, 11 and 17 make provision for the supply or administration of prescription only medicines under a Patient Group Direction (i.e. a written direction providing for the supply or administration of a description or class of medicines to persons generally) to assist the provision of health care by certain non-NHS health care providers (i.e. a provider of health care other than a National Health Service body or a person providing services under an arrangement with such a body). In particular, Article 10 amends article 12C of the principal Order so as to enable a person conducting a retail pharmacy business to supply or administer prescription only medicines under an arrangement with certain non-NHS health care providers in accordance with a Patient Group Direction. Article 11 inserts new articles 12D and 12E into the principal Order—

(a) article 12D provides for the supply and administration of prescription only medicines by designated health professionals in the course of the business of an independent hospital, clinic or agency, or nursing home, in accordance with a Patient Group Direction; and

(b) article 12E provides for the supply and administration of prescription only medicines by designated health professionals in order to assist the provision of health care by or on behalf of the police, the prison services or the armed forces, in accordance with a Patient Group Direction.

Article 17 inserts new Part IIA of Schedule 7 to the principal Order, which specifies the persons by whom or on whose behalf a Patient Group Direction for the police, prison services or armed forces must be signed.

Articles 14 and 15 make a number of minor amendments to the lists of substances which may be prescribed by nurse prescribers, including the addition of water for injections and, in relation to extended formulary nurse prescribers, the deletion of inactivated polio vaccine and the addition of emedastine and mizolastine.

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 Control Agency, Information Centre, Room 10-202, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.