MEDICINES Citation, commencement and interpretation 1 1 This Order may be cited as the Prescription Only Medicines (Human Use) Amendment Order 2003 and shall come into force on 4th April 2003. 2 In this Order, “the principal Order ” means the Prescription Only Medicines (Human Use) Order 1997 . Amendment of article 1 of the principal Order 2 1 Article 1 of the principal Order (citation, commencement and interpretation) is amended as follows. 2 In paragraph (2)— a after the definition of “aerosol”, insert the following definitions— “clinical management plan” means a written plan (which may be amended from time to time) relating to the treatment of an individual patient agreed by— the patient to whom the plan relates, the doctor or dentist who is a party to the plan, and any supplementary prescriber who is to prescribe, give directions for administration or administer under the plan; “clinical trial exemption” means an exemption conferred by— section 31(5) of the Act, article 4 of the Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972 , article 2 or 3 of the Medicines (Exemption from Licences) (Clinical Trials) Order 1974 , or article 3 of the Medicines (Exemption from Licences) (Clinical Trials) Order 1995 ; ; b in the definition of “extended formulary nurse prescriber”— i for paragraph (a), substitute the following paragraph— a who is a first level nurse, and , and ii in paragraph (b), for “that register” substitute “the professional register”; c after the definition of “external use”, insert the following definition— “first level nurse” means a person registered in Parts 1, 3, 5, 8, 10, 11, 12, 13, 14 or 15 of the professional register; ; d after the definition of “Health Authority” , insert the following definition— “health care” means services for or in connection with the prevention, diagnosis or treatment of disease; ; e in the definition of “health prescription”, after “dentist” insert “, supplementary prescriber”; f after the definition of “health prescription”, insert the following definition— “health record” has the meaning given by section 68(2) of the Data Protection Act 1998 ; ; g after the definition of “homoeopathic certificate of registration” , insert the following definitions— “independent clinic”— in relation to England and Wales, has the meaning given by section 2(4) of the Care Standards Act 2000 , and in relation to Scotland, has the meaning given by section 77(1) of the Regulation of Care (Scotland) Act 2001 ; “independent hospital”— in relation to England and Wales, shall be construed in accordance with section 2(2), (3) and (6) of the Care Standards Act 2000, and in relation to Scotland, means— an independent hospital, or a private psychiatric hospital, as defined by section 77(1) of the Regulation of Care (Scotland) Act 2001; “independent medical agency”— in relation to England and Wales, has the meaning given by section 2(5) of the Care Standards Act 2000, and in relation to Scotland, has the meaning given by section 77(1) of the Regulation of Care (Scotland) Act 2001; ; h after the definition of “ NHS trust” , insert the following definition— “nursing home” has the meaning given by article 16 of the Registered Homes (Northern Ireland) Order 1992 ; ; i after the definition of “Primary Care Trust” , insert the following definition— “prison service” means— in relation to England and Wales, a Minister of the Crown exercising functions in relation to prisons (within the meaning of the Prison Act 1952 ), in relation to Scotland, the Scottish Ministers exercising functions in relation to prisons (within the meaning of the Prisons (Scotland) Act 1989 ), and in relation to Northern Ireland, the Northern Ireland Department exercising functions in relation to prisons (within the meaning of the Prison Act (Northern Ireland) 1953 ); ; j after the definition of “registered ophthalmic optician”, insert the following definition— “registered provider” means— in relation to an independent hospital, an independent clinic or an independent medical agency— in relation to England and Wales, the person who is registered under Part II of the Care Standards Act 2000 as the person carrying on the establishment or agency, in relation to Scotland, the person who is registered under Part 1 of the Regulation of Care (Scotland) Act 2001 as the person providing the establishment or agency, and in relation to a nursing home, the person registered under Part III of the Registered Homes (Northern Ireland) Order 1992 as the person carrying on the nursing home, other than a manager who is to be treated as carrying on the home by virtue of article 17(2) of that order; “relevant manager” means— in relation to an independent hospital, an independent clinic or an independent medical agency— in relation to England and Wales— a person who is registered under Part II of the Care Standards Act 2000 as the manager of the establishment or agency, but who is not the registered provider for that establishment or agency, or if there is no such person, but the registered provider has appointed a person to manage the establishment or agency, that appointed person, in relation to Scotland, a person, other than the registered provider, who was identified as an individual who is to manage the establishment or agency on the application for registration of that establishment or agency under Part 1 of Regulation of Care (Scotland) Act 2001, and in relation to a nursing home, the manager of the nursing home, unless they are the registered provider for that home; “relevant register” means— in relation to a first level nurse, the professional register, and in relation to a pharmacist, the register maintained in pursuance of section 2(1) of the Pharmacy Act 1954 or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 ; ; and k after the definition of “Strategic Health Authority” , insert the following definition— “supplementary prescriber” means— a first level nurse, or a pharmacist, against whose name is recorded in the relevant register an annotation signifying that he is qualified to order drugs, medicines and appliances as a supplementary prescriber; . 3 In paragraph (7) , for “12C” substitute “12E”. Amendment of article 2 of the principal Order 3 In article 2 of the principal Order (appropriate practitioners), in paragraph (a), after “dentists” insert “, supplementary prescribers”. Amendment of article 3 of the principal Order 4 In article 3 of the principal Order (medicinal products on prescription only), after paragraph (f) add the following paragraph— g medicinal products in respect of which a marketing authorization has been granted consisting of or containing aloxiprin, aspirin or paracetamol in the form of non-effervescent tablets or capsules which in the marketing authorization are classified as being pharmacy only or general sale list medicines. . Amendment of article 3A of the principal Order 5 In article 3A of the principal Order — a at the beginning of paragraph (2), insert “Subject to paragraph (4),”; and b after paragraph (3), add the following paragraph— 4 An extended formulary nurse prescriber may prescribe or administer a medicinal product referred to in paragraph (1), or give directions for administration of such a product, without complying with any condition specified by virtue of paragraph (3) if— a he is a supplementary prescriber; and b he complies with the applicable conditions set out in article 3B(3). . Insertion of articles 3B and 3C of the principal Order 6 After article 3A of the principal Order, insert the following articles— Prescribing and administration by supplementary prescribers 3B 1 Subject to paragraph (2), a supplementary prescriber may— a give a prescription for a medicinal product referred to in article 3; or b if that medicinal product is for parenteral administration— i administer that medicinal product, or ii give directions for the administration of that medicinal product, only where he complies with the conditions as to the cases or circumstances in which he may do so specified in paragraph (3). 2 Paragraph (1) does not apply if— a the supplementary prescriber is a district nurse/health visitor prescriber and the medicinal product prescribed or administered, or in respect of which he gives directions for administration, falls within a description or class of medicinal products specified in Schedule 3; or b the supplementary prescriber is an extended formulary nurse prescriber and— i the medicinal product prescribed or administered, or in respect of which he gives directions for administration, falls within a description or class of medicinal products specified in article 3A(1), and ii he satisfies any applicable condition specified by virtue of article 3A(3). 3 The conditions referred to in paragraph (1) are that— a the supplementary prescriber is acting in accordance with the terms of a clinical management plan which— i relates to the patient for whom the product is prescribed or to whom it is, or is to be, administered, ii is in effect at the time the prescription or direction is given or, as the case may be, the product is administered, and iii includes the particulars specified in Schedule 3B; b at the time the prescription or directions are given or, as the case may be, the product is administered— i a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of the product, or ii the product is, or is to be, administered in the course of a clinical trial and— a the trial is the subject of a clinical trial certificate, or b a clinical trial exemption has effect in relation to the supply of the product for the purposes of the trial; and c the supplementary prescriber has access to the health records of the patient to whom the plan relates which are used by any doctor or dentist who is a party to the plan. Exemptions from conditions in respect of the cases or circumstances in which an extended formulary nurse prescriber or supplementary prescriber may administer a medicinal product 3C The conditions specified by virtue of article 3A(3) and in article 3B(3) shall not apply in relation to the administration of a medicinal product by an extended formulary nurse prescriber or a supplementary prescriber where— a that person is acting in accordance with the directions of another person who is an appropriate practitioner, or b that administration is exempt from the restriction in section 58(2)(b) (restriction on administration) by virtue of any of the subsequent provisions of this Order. . Insertion of article 5A of the principal Order 7 After article 5 of the principal Order (exempt medicinal products), insert the following article— Exemption for products consisting of or containing aloxiprin, aspirin or paracetamol 5A A medicinal product falling within article 3(g) shall be exempt from the restrictions imposed by section 58(2) (restrictions on sale, supply and administration) if the quantity of that product sold or supplied to a person at any one time does not exceed 100 tablets or capsules. . Amendment of article 8 of the principal Order 8 Article 8 of the principal Order (exemptions for emergency sale or supply) is amended as follows— a in paragraph (2)— i in sub-paragraph (a), after “doctor” insert “, a supplementary prescriber”, ii in sub-paragraph (b), after “doctor” insert “, supplementary prescriber”, and iii in sub-paragraph (c), after “doctor” insert “, supplementary prescriber”; and b in paragraph (4), in sub-paragraph (a), in head (ii), after “doctor” insert “, supplementary prescriber”. Amendment of article 10 of the principal Order 9 Article 10 of the principal Order (exemption for medicinal products at high dilutions) is renumbered as paragraph (1) of that article and after paragraph (1), insert the following paragraph— 2 The restrictions imposed by section 58(2) (restrictions on sale, supply and administration) shall not apply to the sale, supply or administration of a medicinal product which is not for parenteral administration and which consists of or contains solely one or more unit preparations of the following substances— Aconite Arsenic Trioxide Belladonna Herb Ignatia Bean Nux Vomica Seed, if each such unit preparation has been diluted to at least one part in a million (6x) . Amendment of article 12C of the principal Order 10 In article 12C of the principal Order (exemption for persons conducting a retail pharmacy business who supply or administer prescription only medicines under a Patient Group Direction)— a in paragraph (1), for sub-paragraph (a) substitute the following sub-paragraph— a the medicine is supplied, or as the case may be, is administered by such a person pursuant to an arrangement made with— i a body referred to in article 12A(a) to (d), ii an authority or person carrying on the business of an establishment or agency referred to in article 12D(1), iii a force or service referred to in article 12E(1)(a)(i) to (iii), or iv Her Majesty’s Forces, for the supply or, as the case may be, the administration of prescription only medicines; ; b in paragraph (2)— i for sub-paragraph (c), substitute the following sub-paragraph— c the Patient Group Direction is signed— i in the case of an arrangement with a body referred to in article 12A(a) to (d), on behalf of that body, ii in the case of an arrangement with an authority or person carrying on the business of an establishment or agency referred to in article 12D(1), by or on behalf of the relevant provider and, if there is a relevant manager for the establishment or agency, that manager, iii in the case of an arrangement with a prison service, by or on behalf of the person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for that service, iv in the case of an arrangement with a police force or the Police Service of Northern Ireland— a by or on behalf of the person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for that force or service, and b a doctor who is not employed or engaged by, and who does not provide services under arrangements made with, any police force or the Police Service of Northern Ireland, and v in the case of an arrangement with Her Majesty’s Forces, by or on behalf of a person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for Her Majesty’s Forces; , and ii in sub-paragraph (cc) , for “designated in writing” to the end substitute the following— designated in writing— i in the case of an arrangement with a body referred to in article 12A(a) to (d), on behalf of that body, ii in the case of an arrangement with an authority or person carrying on the business of an establishment or agency referred to in article 12D(1), by or on behalf of the relevant provider or, if there is a relevant manager for the establishment or agency, that relevant manager, iii in the case of an arrangement with a force or service referred to in article 12E(1)(a)(i) to (iii), by or on behalf of the person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for that force or service, or iv in the case of an arrangement with Her Majesty’s Forces, by or on behalf of a person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for Her Majesty’s Forces, for the purpose of the administration of prescription only medicines under the Patient Group Direction; and . Insertion of articles 12D and 12E of the principal Order 11 After article 12C of the principal Order (exemption for persons conducting a retail pharmacy business who supply or administer prescription only medicines under a Patient Group Direction), insert the following articles— Exemption for the supply and administration of prescription only medicines by independent hospitals, clinics and agencies 12D 1 The restrictions imposed by section 58(2) (restrictions on sale, supply and administration) shall not apply to the supply or, as the case may be, the administration of a prescription only medicine in the course of the business of— a in England, Wales or Scotland— i an independent hospital, ii an independent clinic, or iii an independent medical agency; or b in Northern Ireland, a nursing home, where the medicine is supplied for the purpose of being administered, or, as the case may be, is administered, to a particular person in accordance with a Patient Group Direction and where the conditions specified in paragraph (2) are satisfied. 2 The conditions referred to are that— a the Patient Group Direction relates to the supply or, as the case may be, the administration, by the person who supplies or administers the medicine, of a description or class of prescription only medicine, and the Direction has effect at the time at which the medicine is supplied or, as the case may be, is administered; b the Patient Group Direction contains the particulars specified in Part I of Schedule 7 to this Order (but with the omission of paragraph (c) of that Part in the case of a Direction which relates to administration only); c the Patient Group Direction is signed— i by or on behalf of the registered provider, and ii if there is a relevant manager for the independent hospital, clinic or agency, or nursing home, by that manager; d the individual who supplies or, as the case may be, administers the medicine belongs to one of the classes of individual specified in Part III of Schedule 7 to this Order, and is designated in writing— i by or on behalf of the registered provider, or ii if there is a relevant manager for the independent hospital, clinic or agency, or nursing home, by that manager, for the purpose of the supply or, as the case may be, the administration of prescription only medicines under the Patient Group Direction; and e at the time at which the medicine is supplied or, as the case may be, is administered, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it. Exemption for health professionals who supply or administer prescription only medicines under a Patient Group Direction in order to assist the provision of health care by or on behalf of the police, the prison services or the armed forces 12E 1 The restrictions imposed by section 58(2) (sale, supply and administration) shall not apply to the supply or, as the case may be, the administration of a prescription only medicine by an individual belonging to one of the classes specified in Part III of Schedule 7 to this Order where— a the individual supplies or, as the case may be, administers the medicine in order to assist the provision of health care by, on behalf of, or under arrangements made by— i a police force in England, Wales or Scotland, ii the Police Service of Northern Ireland, iii a prison service, or iv Her Majesty’s Forces; b the medicine is supplied for the purpose of being administered, or, as the case may be, is administered, in accordance with a Patient Group Direction; and c the conditions specified in paragraph (2) are satisfied. 2 The conditions referred to are that— a the Patient Group Direction relates to the supply or, as the case may be, the administration of a description or class of prescription only medicine in order to assist the provision of health care by, or on behalf of, or under arrangements made by the police force or service, the prison service or, as the case may be, Her Majesty’s Forces; b the Patient Group Direction has effect at the time at which the medicine is supplied or, as the case may be, is administered; c the Patient Group Direction contains the particulars specified in Part I of Schedule 7 to this Order (but with the omission of paragraph (c) of that Part in the case of a Direction which relates to administration only); d the Patient Group Direction is signed— i by or on behalf of a person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order (“the authorising person”) against the entry in column 1 of that Table for the police force or service, the prison service or Her Majesty’s Forces by whom, or on whose behalf, the health care is provided, or with whom arrangements are made for the provision of such care; and ii in the case of a police force or the Police Service of Northern Ireland, by a doctor who is not employed or engaged by, and who does not provide services under arrangements made with, any police force or the Police Service of Northern Ireland; e the individual referred to in paragraph (1) is designated in writing, by or on behalf of the authorising person, for the purpose of the supply or, as the case may be, the administration of prescription only medicines under the Patient Group Direction; and f at the time at which the medicine is supplied or, as the case may be, is administered, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it. . Amendment of article 13A of the principal Order 12 In article 13A of the principal Order (exemption relating to prescriptions given by nurses) — a for paragraph (1), substitute— 1 The restrictions imposed by section 58(2)(a) (restrictions in sale and supply) shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a prescription given by— a another pharmacist, b a registered nurse, or c a registered midwife, who is not an appropriate practitioner in relation to that medicine where the pharmacist selling or supplying the medicine, having exercised all due diligence, believes on reasonable grounds that the person is such a practitioner. ; and b in paragraph (2)— i after “extended formulary nurse prescriber”, in both places those words appear, insert “or supplementary prescriber”, and ii for “article 3A(2) and (3)” substitute “articles 3A(2) and (3) or 3B”. Amendment of article 15 of the principal Order 13 In article 15 (prescriptions) , in paragraph (2)(c)— a in head (iii), after “dentist” insert “, a supplementary prescriber”; and b in head (iv), after “dentist” insert “, a supplementary prescriber”. Amendment of Schedule 3 to the principal Order 14 In Schedule 3 to the principal Order (descriptions and classes of prescription only medicines in relation to which appropriate nurse practitioners are appropriate practitioners), at the end insert the following entry— “Water for Injections”. Amendment of Schedule 3A to the principal Order 15 In the table in Schedule 3A to the Order (substances which may be prescribed, administered or directed for administration by extended formulary nurse prescribers and conditions for such prescription or administration)— a in the entry in column 1 for “Doxycycline”, after “Doxycycline” insert “hyclate”; b omit the entry for “Vaccine, Poliomyelitis, Inactivated”; and c in column 1 insert, at the appropriate place in the alphabetical order of the entries as they appear in that column, each of 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 Emedastine Ophthalmic use Doxycycline monohydrate Oral Flucloxacillin magnesium Oral Minocycline hydrochloride Oral Mizolastine Oral Water for Injections Parenteral Insertion of Schedule 3B of the principal Order 16 After Schedule 3A to the principal Order, insert the following Schedule— SCHEDULE 3B PARTICULARS FOR CLINICAL MANAGEMENT PLANS Regulation 3B(3)(a)(iii) A clinical management plan shall contain the following particulars— a the name of the patient to whom the plan relates; b the illnesses or conditions which may be treated by the supplementary prescriber; c the date on which the plan is to take effect and when it is to be reviewed by the doctor or dentist who is a party to the plan; d reference to the class or description of medicinal product which may be prescribed or administered under the plan; e any restrictions or limitations as to the strength or dose of any product which may be prescribed or administered under the plan, and any period of administration or use of any medicinal product which may be prescribed or administered under the plan; f relevant warnings about the known sensitivities of the patient to, or known difficulties of the patient with, particular medicinal products; g the arrangements for notification of— i suspected or known adverse reactions to any medicinal product which may be prescribed or administered under the plan, and ii suspected or known adverse reactions to any other medicinal product taken at the same time as any medicinal product prescribed or administered under the plan; and h the circumstances in which the supplementary prescriber should refer to, or seek the advice of, the doctor or dentist who is a party to the plan. Amendment of Schedule 7 to the principal Order 17 In Schedule 7 to the principal Order (Patient Group Directions), after Part II, insert the following Part— PART IIA PERSONS BY WHOM OR ON WHOSE BEHALF A PATIENT GROUP DIRECTION USED IN THE PROVISION OF HEALTH CARE BY OR ON BEHALF OF THE POLICE, THE PRISON SERVICES OR THE ARMED FORCES MUST BE SIGNED Column 1 Force or service by whom or on whose behalf the health care is provided Column 2 Person by whom or on whose behalf the Direction must be signed A police force in England or Wales The chief officer of police for that police force (within the meaning of the Police Act 1996 ) A police force in Scotland The chief constable of that police force (within the meaning of the Police (Scotland) Act 1997 ) The Police Service of Northern Ireland The Chief Constable of the Police Service of Northern Ireland The prison service in England and Wales The governor of the prison in relation to which the health care in question is being provided The prison service in Scotland The Scottish Prison Service Management Board The prison service in Northern Ireland The Northern Ireland Prison Service Management Board Her Majesty’s Forces i the Surgeon General, ii a Medical Director General, or iii a chief executive of an executive agency of the Ministry of Defence . Signed by authority of the Secretary of State for Health Hunt Parliamentary Under Secretary of State, Department of Health 13th March 2003 Sealed with the Official Seal of the Department of Health, Social Services and Public Safety D. C. Gowdy Permanent Secretary, Department of Health, Social Services and Public Safety 11th March 2003