NATIONAL HEALTH SERVICE, ENGLAND Citation, commencement and application 1 1 These Regulations may be cited as the National Health Service (Amendments Relating to Prescribing by Nurses and Pharmacists etc.) (England) Regulations 2003 and shall come into force on 4th April 2003. 2 These Regulations apply to England only. Amendment of the National Health Service (Pharmaceutical Services) Regulations 1992 2 1 The National Health Service (Pharmaceutical Services) Regulations 1992 are amended as follows. 2 In regulation 2(1) (interpretation)— a insert each of the following definitions at the appropriate alphabetical place— “independent nurse prescriber” means— a person whose name is registered— in Part 1 or 12 of the nurses and midwives' professional register and has a district nurse qualification additionally recorded in the nurses and midwives' professional register pursuant to rule 11 of the Nurses, Midwives and Health Visitors Rules 1983 , or in Part 11 of the nurses and midwives' professional register as a health visitor, and against whose name is recorded in the nurses and midwives' professional register an annotation signifying that he is qualified to order drugs, medicines and appliances from the Nurse Prescribers' Formulary for District Nurses and Health Visitors in Part XVIIB(i) of the Drug Tariff; or a person— whose name is registered in Parts 1, 3, 5, 8, 10, 11, 12, 13, 14 or 15 of the nurses and midwives' professional register, and against whose name is recorded in the nurses and midwives' professional register an annotation signifying that he is qualified to order drugs, medicines and appliances from the Nurse Prescribers' Extended Formulary in Part XVIIB(ii) of the Drug Tariff; ; “nurses and midwives' professional register” means the register maintained by the Nursing and Midwifery Council pursuant to paragraph 10 of Schedule 2 to the Nursing and Midwifery Order 2001 ; ; and “supplementary prescriber” means a person whose name is registered in— Parts 1, 3, 5, 8, 10, 11, 12, 13, 14 or 15 of the nurses and midwives' professional register; the Register of Pharmaceutical Chemists 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 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; ; b in the definition of “prescription form”, for “dentist or nurse prescriber” substitute “dentist, supplementary prescriber or independent nurse prescriber”; and c the definition of “nurse prescriber” is omitted. 3 In Schedule 2 (terms of service)— a in paragraph 3— i in sub-paragraph (1)(a) and (b), after “doctor”, at both places where it occurs, insert “or a supplementary prescriber”, ii in sub-paragraph (1)(d) and (e), for “a nurse prescriber” at both places where it occurs, substitute “an independent nurse prescriber”, iii in sub-paragraph (4), for “dentist or a nurse prescriber” substitute “ dentist, a supplementary prescriber or an independent nurse prescriber”, iv in sub-paragraphs (6) and (7), for “dentist or nurse prescriber” substitute “dentist, supplementary prescriber or independent nurse prescriber ”, and v in sub-paragraph (9), for “doctor or nurse prescriber”, at both places where it occurs, substitute “doctor, supplementary prescriber or independent nurse prescriber”; b in paragraph 7(2), for “Regulations or by a nurse prescriber” substitute “ Regulations, or by a supplementary prescriber or an independent nurse prescriber, ”; and c in paragraphs 11A and 11B, before “a nurse prescriber” at each place where it occurs, insert “an independent prescriber”. Amendment of the National Health Service (General Medical Services) Regulations 1992 3 1 The National Health Service (General Medical Services) Regulations 1992 are amended as follows. 2 In regulation 2(1) (interpretation) the definition of “nurse prescriber ” is omitted. 3 In Schedule 2 (terms of service)— a in paragraph 1, insert each of the following definitions at the appropriate alphabetical place— “independent nurse prescriber” means— a person whose name is registered— in Part 1 or 12 of the professional register and has a district nurse qualification additionally recorded in the professional register pursuant to rule 11 of the Nurses, Midwives and Health Visitors Rules 1983, or in Part 11 of the professional register as a health visitor, and against whose name is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances from the Nurse Prescribers' Formulary for District Nurses and Health Visitors in Part XVIIB(i) of the Drug Tariff; or a person— whose name is registered in Parts 1, 3, 5, 8, 10, 11, 12, 13, 14 or 15 of the professional register, and against whose name is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances from the Nurse Prescribers' Extended Formulary in Part XVIIB(ii) of the Drug Tariff; ; “licensing authority” shall be construed in accordance with section 6(3) of the Medicines Act 1968 ; ; “the POM Order ” means the Prescription Only Medicines (Human Use) Order 1997 ; ; “prescription only medicine” means a medicine referred to in article 3 of the POM Order (medicinal products on prescription only); ; and “supplementary prescriber” means a person whose name is registered in— Parts 1, 3, 5, 8, 10, 11, 12, 13, 14 or 15 of the professional register; the Register of Pharmaceutical Chemists 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 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; ; b in paragraph 28A(1) and (2), for “a nurse prescriber”, at each place where it occurs, substitute “a nurse who is a supplementary prescriber or an independent nurse prescriber”; and c after paragraph 28A, insert the following paragraph— 28B 1 Where a doctor employs a supplementary prescriber and that person’s functions include prescribing, the doctor shall have arrangements in place to secure that that person will only— a give a prescription for a prescription only medicine; b administer a prescription only medicine for parenteral administration; or c give directions for the administration of a prescription only medicine for parenteral administration, as a supplementary prescriber under the conditions set out in sub-paragraph (2). 2 The conditions referred to in sub-paragraph (1) are that— a the person satisfies the applicable conditions set out in article 3B(3) of the POM Order (prescribing and administration by supplementary prescribers), unless those conditions do not apply by virtue of any of the exemptions set out in the subsequent provisions of that Order; b the medicine is not a controlled drug within the meaning of the Misuse of Drugs Act 1971 ; c the medicine is not specified in Schedule 10 to the Medical Regulations (drugs and other substances not to be prescribed for supply under pharmaceutical services); d the medicine is not specified in an entry in column 1 of Schedule 11 to the Medical Regulations (drugs to be prescribed under pharmaceutical services only in certain circumstances), unless— i the patient is a person of a description mentioned in column 2 of that entry, ii the medicine is prescribed for that patient only for the purposes specified in column 3 of that entry, and iii if he is giving a prescription, he endorses the face of the form with the reference “SLS”. 3 Where a doctor employs a supplementary prescriber and that person’s functions include prescribing, the doctor shall have arrangements in place to secure that that person will only give a prescription for— a an appliance; or b a medicine which is not a prescription only medicine, as a supplementary prescriber under the conditions set out in sub-paragraph (4). 4 The conditions referred to in sub-paragraph (3) are that— a he acts in accordance with a clinical management plan (which may be amended from time to time) which is in effect at the time he acts, which has been 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, and which contains the following particulars— i the name of the patient to whom the plan relates, ii the illness or conditions which may be treated by the supplementary prescriber, iii 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, iv reference to the class or description of medicines or types of appliances which may be prescribed or administered under the plan, v any restrictions or limitations as to the strength or dose of any medicine which may be prescribed or administered under the plan, and any period of administration or use of any medicine or appliance which may be prescribed or administered under the plan, vi relevant warnings about known sensitivities of the patient to, or known difficulties of the patient with, particular medicines or appliances, vii the arrangements for notification of— aa suspected or known adverse reactions to any medicine which may be prescribed or administered under the plan, and suspected or known adverse reactions to any other medicine taken at the same time as any medicine prescribed or administered under the plan, bb incidents occurring with the appliance which might lead, might have led or has led to the death or serious deterioration of state of health of the patient, and viii 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; b he 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; c if it is a prescription for a medicine, the medicine is not a controlled drug within the meaning of the Misuse of Drugs Act 1971; d if it is a prescription for a medicine, the medicine is not specified in Schedule 10 to the Medical Regulations (drugs and other substances not to be prescribed for supply under pharmaceutical services); e if it is a prescription for a medicine, the medicine is not specified in an entry in column 1 of Schedule 11 to the Medical Regulations (drugs to be prescribed under pharmaceutical services only in certain circumstances), unless— i the patient is a person of a description mentioned in column 2 of that entry, ii the medicine is prescribed for that patient only for the purposes specified in column 3 of that entry, and iii when giving the prescription, he endorses the face of the form with the reference “SLS”; f if it is a prescription for a medicine— i the medicine is the subject of a product licence, a marketing authorization or a homeopathic certificate of registration granted by the licensing authority or the European Commission, or ii the use of the medicine is for the purposes of a clinical trial, and— aa that trial is the subject of a clinical trial certificate issued in accordance with the Medicines Act 1968, or bb a clinical trial certificate is not needed in respect of that trial by virtue of any exemption conferred by or under that Act; g if it is a prescription for an appliance, the appliance is listed in Part IX of the Drug Tariff; and h if it is a prescription for a restricted availability appliance— i the patient is a person of a description mentioned in the entry in Part IX of the Drug Tariff in respect of that appliance, ii the appliance is prescribed only for the purposes specified in respect of that person in that entry, and iii when giving the prescription, he endorses the face of the form with the reference “SLS”. . 4 In Schedule 11 (drugs to be prescribed under pharmaceutical services only in certain circumstances), after “Tadalafil (Cialis)” in columns 1 and 2, insert in each of those columns “, Vardenafil (Levitra)”. Amendment of the National Health Service (Charges for Drugs and Appliances) Regulations 2000 4 1 The National Health Service (Charges for Drugs and Appliances) Regulations 2000 are amended as follows. 2 In regulation 2(1) (interpretation)— a insert each of the following definitions at the appropriate alphabetical place— “Drug Tariff” means the statement compiled, published and amended from time to time by the Secretary of State pursuant to regulation 18 of the National Health Service (Pharmaceutical Services) Regulations 1992 (standards of, and payments for, drugs and appliances); ; “independent nurse prescriber” means— a person whose name is registered— in Part 1 or 12 of the nurses and midwives' professional register and has a district nurse qualification additionally recorded in the nurses and midwives' professional register pursuant to rule 11 of the Nurses, Midwives and Health Visitors Rules 1983, or in Part 11 of the nurses and midwives' professional register as a health visitor, and against whose name is recorded in the nurses and midwives' professional register an annotation signifying that he is qualified to order drugs, medicines and appliances from the Nurse Prescribers' Formulary for District Nurses and Health Visitors in Part XVIIB(i) of the Drug Tariff; or a person— whose name is registered in Parts 1, 3, 5, 8, 10, 11, 12, 13, 14 or 15 of the nurses and midwives' professional register, and against whose name is recorded in the nurses and midwives' professional register an annotation signifying that he is qualified to order drugs, medicines and appliances from the Nurse Prescribers' Extended Formulary in Part XVIIB(ii) of the Drug Tariff; ; “nurses and midwives' professional registers” means the register maintained by the Nursing and Midwifery Council pursuant to paragraph 10 of Schedule 2 to the Nursing and Midwifery Order 2001; ; and “supplementary prescriber” means a person whose name is registered in— Parts 1, 3, 5, 8, 10, 11, 12, 13, 14 or 15 of the nurses and midwives' professional register; the Register of Pharmaceutical Chemists 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 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; ; b in the definition of “prescription form”, for “dentist or nurse prescriber” substitute “dentist, supplementary prescriber or independent nurse prescriber”; and c the definition of “nurse prescriber” is omitted. 3 In regulation 6(1) (supply of drugs and appliances at Walk-in-Centres), for “doctor or nurse prescriber” substitute “doctor, supplementary prescriber or independent nurse prescriber”. Signed by authority of the Secretary of State for Health Hunt Parliamentary Under Secretary of State, Department of Health 13th March 2003