HEALTH AND PERSONAL SOCIAL SERVICES PART I GENERAL Citation and commencement 1 These Regulations may be cited as the Pharmaceutical Services Regulations (Northern Ireland) 1997 and shall come into operation on 6th October 1997. Interpretation 2 1 In these Regulations— “ appliance ” means an appliance which is included in a list for the time being approved by the Department for the purposes of Article 63 of the Order ; “ appropriate non-proprietary name ” means a non-proprietary name which is not mentioned in Schedule 10 to the Medical Regulations or, except where the conditions in paragraph 49(2) of the doctors' terms of service are satisfied, in Schedule 11 to those Regulations; “ Board ” means a Health and Social Services Board established under Article 16 of the Order for any area; “ chemist ” means— a pharmacist; a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968 ; or a supplier of appliances; who is included in the pharmaceutical list under Article 63 of the Order; “ child ” means a person who has not attained the age of 16 years; “ dentist ” means a dental practitioner; “ Disciplinary Procedures Regulations ” means the Health and Personal Social Services (Disciplinary Procedures) Regulations (Northern Ireland) 1996 ; “ doctor ” means a medical practitioner; "doctors' terms of service" means the terms of service contained in Schedule 2 to the Medical Regulations; “ drugs ” includes medicines and chemical reagents; "Drug Tariff' has the meaning given to it in regulation 9; “ joint discipline committee ” has the same meaning as in the Disciplinary Procedures Regulations; “ listed drugs ” means the drugs included in a list for the time being approved by the Department for the purposes of Article 63 of the Order; “Local Dental Committee”, “Local Medical Committee” and “Local Pharmaceutical Committee” mean the respective committees of those names which are recognised by a Board in relation to its area under Article 55 of the Order ; “ maternity medical services ” has the meaning assigned to it by regulation 34 of and Schedule 5 to the Medical Regulations; “ medical list ” has the meaning assigned to it by regulation 4 of the Medical Regulations; “ Medical Regulations ” means the General Medical Services Regulations (Northern Ireland) 1997 ; “ non-proprietary name ”, in relation to a drug, means— where the drug is described in a monograph in the current edition (as defined in section 103(5) of the Medicines Act 1968 ), as in force at the time of the supply of the drug, of the European Pharmacopoeia, the British Pharmacopoeia, the British Pharmaceutical Codex, the British National Formulary, the International Pharmacopoeia, the Cumulative List of Recommended International Non-proprietary Names or the Dental Practitioners' Formulary, any name, or abbreviation of such name, at the head of that monograph or, where such name consists of two or more words, any name derived from a suitable inversion of such words which is permitted by that publication; or where the drug is not so described but has an approved name, being the name which appears in the current edition (as defined in section 103(5) of the Medicines Act 1968) of the list of names prepared and published under section 100 of that Act, as in force at the time of the supply of the drug, such approved name; “ nurse prescriber ” means a nurse or health visitor of a description specified in paragraph (2); “ obstetric list ” has the meaning assigned to it by regulation 30 of the Medical Regulations; “ the Order ” means the Health and Personal Social Services (Northern Ireland) Order 1972; “ patient ” has the same meaning as in paragraph 3 of Schedule 2 to the Medical Regulations; “ pharmaceutical discipline committee ” has the same meaning as in the Disciplinary Procedures Regulations; “ pharmaceutical list ” shall be construed in accordance with regulation 6; “ pharmacist ” means a pharmacist, other than a supplier of appliances only, whose name is included in the pharmaceutical list under Article 63 of the Order or who is employed by a person (including a body corporate) whose name is so included; “ pharmacy ” means any premises where drugs or appliances are provided by a pharmacist pursuant to arrangements made under Article 63 of the Order; “ prescription form ” means a form provided by the Agency and issued by a doctor or dentist to enable a person to obtain pharmaceutical services under Article 63(1)(a) or (b) of the Order or a form provided by the Agency for the purposes of pharmaceutical services under Article 63(1)(bb) of the Order and issued by a nurse prescriber to enable a person to obtain such services; “ reagent ” means a chemical reagent included in a list for the time being approved by the Department; “ relevant service ” has the same meaning as in section 64(1) of the Reserve and Auxiliary Forces (Protection of Civil Interests) Act 1951 as extended to Northern Ireland by the Reserve and Auxiliary Forces (Protection of Civil Interests) (Northern Ireland) Order 1979 and includes services rendered under the Reserve Forces Act 1980 ; “ Scheduled drug ” means a drug or other substance specified in Schedule 10 to the Medical Regulations or, except where the conditions in paragraph 49(2) of the doctors' terms of service are satisfied, Schedule 11 to those Regulations; “ suspended by direction of the Tribunal ” means suspended as respects the provision of pharmaceutical services by a direction of the Tribunal made pursuant to paragraph 8A(2) or 8B(1) of Schedule 11 to the Order or to equivalent provisions in force in England and Wales or Scotland corresponding to those provisions; “ terms of service ” means the terms of service contained or referred to— in relation to chemists, in Parts I and II of Schedule 2; in relation to doctors who provide pharmaceutical services, in Parts I and III of Schedule 2; and “ working day ” means any week-day other than a public holiday. 2 The specified description of nurse or health visitor mentioned in the definition of “nurse prescriber” in paragraph (1) is— a a person who— i is registered in Part 1 or 12 of the Register maintained by the United Kingdom Central Council for Nursing, Midwifery and Health Visiting under section 10 of the Nurses, Midwives and Health Visitors Act 1979 (referred to in this paragraph as “ the professional register ”); and ii has a district nursing qualification additionally recorded in the professional register under rule 11 of the Nurses, Midwives and Health Visitors Rules 1983 ; and iii is at the time of ordering the listed drug or medicine or appliance, employed by a Board or an HSS trust as a district nurse, or employed as a nurse by a fundholding practice whose recognition as such by virtue of Article 17 of the Health and Personal Social Services (Northern Ireland) Order 1991 (recognition of fundholding practices of doctors) has taken effect; or b a person who— i is registered in Part 11 of the professional register as a health visitor; and ii is, at the time of ordering the listed drug or medicine or appliance, employed by a Board or an HSS trust as a health visitor, or employed as a nurse by a fundholding practice whose recognition as such by virtue of Article 17 of the Health and Personal Social Services (Northern Ireland) Order 1991 has taken effect; against whose name (in each case) is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances for patients. 3 The Interpretation Act (Northern Ireland) 1954 shall apply to these Regulations as it applies to a Measure of the Northern Ireland Assembly. PART II PROVISION OF PHARMACEUTICAL SERVICES BY CHEMISTS Pharmaceutical services 3 1 The arrangements for the provision of pharmaceutical services by chemists shall include arrangements for— a the supply of contraceptive substances and appliances; and b the provision of supplemental services. 2 The arrangements referred to in paragraph (1) shall incorporate the terms of service for chemists set out in Part II of Schedule 2. 3 In these Regulations “ supplemental services ” means— a giving advice, in connection with the safe keeping and correct administration of drugs provided to persons resident in a home, to the person appearing to the chemist to be in charge of the home, or to the person authorised by that person to control such safe keeping and correct administration; and b keeping records of visits made to those homes. 4 In paragraph (3)— a “ home ” means any one of— i a residential home provided under Article 15 of the Order; or ii a residential care home registered under Article 6 of the Registered Homes (Northern Ireland) Order 1992 , but excluding a “ small home ” as defined in Article 4(5) of that Order; or iii a nursing home registered under Article 19 of the Registered Homes (Northern Ireland) Order 1992; b “ records ” in relation to a visit by a chemist to a home shall include— i the name and address of the home; ii the date of each visit by that chemist; and iii the nature of any advice given by him in the course of or following each such visit and to whom it was given. 5 A chemist may at any time give notice in writing to the Board that he wishes to be— a included in or excluded from any arrangements for the supply of contraceptive substances and appliances; or b included in or excluded from any arrangements for the provision of “supplemental services”. Additional professional services 4 1 A chemist may, in addition, undertake to provide additional professional services. 2 In these Regulations, “ additional professional services ” means— a displaying such health promotion leaflets as the Board may, in consultation with the Local Pharmaceutical Committee, approve; and b publishing a leaflet (“practice leaflet”) which shall include— i a list of the pharmaceutical services which the chemist has undertaken to provide and for which his name is included in the pharmaceutical list; ii the name, address and telephone number of the premises from which he provides those services and the hours in each day of the week during which he provides those services from those premises; iii the arrangements made by the chemist to provide, or such arrangements as the chemist has made with any other chemist to provide, pharmaceutical services to any person who needs those services in an emergency or outside of the normal hours during which the chemist provides pharmaceutical services; and iv the procedure by which any person may comment upon the provision of pharmaceutical services provided by the chemist; and c keeping records in connection with drugs supplied to any person— i who claims exemption under regulation 7(1)(c) of the Charges for Drugs and Appliances Regulations (Northern Ireland) 1997 (which provides that those aged 60 or over are exempt from prescription charges); or ii who, in the opinion of the chemist providing the drug, is likely to have difficulty understanding the nature and dosage of the drug provided and the times at which it is to be taken, in circumstances where the nature of the drug is such that, in the opinion of the chemist providing it, the same or a similar drug is likely to be prescribed for that person regularly on future occasions. 3 In paragraph (2)(c) “ records ” includes a record of— a the name and address of the person to whom the drug is supplied; b the name, quantity and dosage of the drug supplied; and c the date on which the drug is supplied. Supply of drugs for terminally ill patients 5 Where— a the Department is satisfied that an institution is wholly or mainly concerned with the care of terminally ill patients; and b that institution has made a special arrangement with the Department, a chemist may supply drugs for patients of that institution on presentation by that institution of a composite order form signed by a doctor. Pharmaceutical list 6 1 Each Board shall prepare a list to be called “the pharmaceutical list” of the names of persons, other than doctors and dentists, who undertake to provide pharmaceutical services and of the addresses of the premises within the Board's area from which these persons undertake to provide such services. A list prepared under this regulation shall also— a state the nature of the pharmaceutical services to be provided; b state the days and hours during which the premises are open; and c show chemists as a separate category of persons within that list. 2 A person (hereinafter referred to in this regulation as an “ applicant ”)— a who wishes to be included in the pharmaceutical list for the provision of pharmaceutical services; or b whose name is already included in the pharmaceutical list, but who intends— i to open within the Board's area, additional premises from which to provide pharmaceutical services; or ii to relocate within the Board's area, the premises from which he provides pharmaceutical services; or iii to provide pharmaceutical services other than those already listed in relation to him from premises which are already included in the pharmaceutical list, shall apply to the Board in accordance with whichever version of Form A set out in Part I (chemists) or in Part II (persons other than chemists) of Schedule 3 is appropriate or in the case of an application under paragraph (4), whichever version of Form A (MR) set out in Part I or Part II of that Schedule is appropriate. 3 Where an application is made and— a the applicant intends to provide the same pharmaceutical services from premises from which, at the time of the application, another person whose name is included in the pharmaceutical list provides those services, in place of that person; and b the condition specified in paragraph (5) is fulfilled, the Board shall grant the application. 4 Where an application is made and— a the applicant intends to relocate to new premises, within the neighbourhood in which he provides pharmaceutical services, from the premises already listed in relation to him, and to provide from those new premises the same pharmaceutical services which he is listed as providing from his existing premises; and b the Board is fully satisfied that the relocation is a minor relocation; and c the condition specified in paragraph (5) is fulfilled, the Board shall grant the application and shall notify its decision in accordance with paragraph 3(1) of Schedule 4. 5 The condition referred to in paragraphs (3)(b) and (4)(c) is that in either case the provision of those particular pharmaceutical services will not be interrupted, except for such period as the Board may allow. 6 In this regulation the reference to a minor relocation is to one where there will be no significant change in the neighbourhood population in respect of which pharmaceutical services are provided by the applicant and other circumstances are such that there will be no appreciable effect on the pharmaceutical services provided by the applicant or any other person whose name is included in the pharmaceutical list and who currently provides pharmaceutical services in the neighbourhood of the premises named in the application. 7 Before satisfying itself that a relocation is a minor relocation the Board shall seek and take into account the views of the Local Pharmaceutical Committee. 8 In the case of an application to which paragraph (4) applies, where the Board is not fully satisfied that the relocation is a minor relocation, it shall not grant the application but shall give notice in writing of its decision in accordance with paragraph 3(1) of Schedule 4. 9 An application made in any case other than one to which paragraph (3) or (4) applies shall be granted by the Board, after the procedures set out in Schedule 4 have been followed, only if it is satisfied that the provision of pharmaceutical services at the premises named in the application is necessary or desirable in order to secure adequate provision of pharmaceutical services in the neighbourhood in which the premises are located by persons whose names are included in the pharmaceutical list. 10 Where an application is granted by the Board, it shall be in accordance with whichever version of Form C, set out in Part I (chemists) or Part II (persons other than chemists) of Schedule 3 is appropriate. 11 Where an application is granted in accordance with paragraph (9), the Board may grant it in respect of some or all of the pharmaceutical services specified in that application. 12 An application, other than one to which paragraph (4)(a) applies, which is made by a person who is qualified to have his name registered under the Pharmacy (Northern Ireland) Order 1976 by virtue of Article 8(2)(c) of that Order (Qualification by European diploma) shall not be granted unless the applicant satisfies the Board that he has the knowledge of English which, in the interests of himself and persons making use of the services to which the application relates, is necessary for the provision of pharmaceutical services in the Board's area. 13 Where an application is granted, the Board shall make the relevant entries in the pharmaceutical list only after the expiry of the period within which an appeal against the decision to grant the application might be intimated or the conclusion of all the appeal procedures, whichever is appropriate. Removal from pharmaceutical list 7 1 Where a chemist has— a died; or b is no longer a chemist, the Board shall remove his name from the pharmaceutical list. 2 Where a Board determines that a chemist, whose name has been included for the preceding 6 months in the pharmaceutical list, has not during that period provided pharmaceutical services, it may, subject to paragraph (5)(b), remove that chemist's name from that list. 3 A period during which the chemist was suspended by direction of the Tribunal does not count towards the period of 6 months referred to in paragraph (2). 4 Before making any determination under paragraph (2) the Board shall— a give the chemist 28 days' notice of its intention; b afford the chemist an opportunity of making representations to the Board in writing or, if he so desires, in person; and c consult the Local Pharmaceutical Committee. 5 Nothing in this regulation shall— a prejudice the right of a chemist to be included again in the pharmaceutical list; or b apply to a chemist who is performing a period of relevant service, and paragraph (2) shall not apply in respect of any such chemist until 6 months after he has completed that relevant service. Scheme for securing proper pharmaceutical services 8 The Board, after consultation with the Local Pharmaceutical Committee, shall prepare a scheme for testing the quality and amount of the drugs and appliances supplied and the accuracy of dispensing. Standards of, and payments for, drugs and appliances 9 1 For the purpose of enabling arrangements to be made for the provision of pharmaceutical services, the Department shall compile and publish a statement (in these Regulations referred to as "the Drug Tariff') which it may amend from time to time and which, subject to paragraph (2), shall include— a the list of appliances; b the list of chemical reagents; c the list of drugs for the time being approved by the Department for the purposes of Article 63 of the Order; d the prices on the basis of which the payment for drugs and appliances ordinarily supplied is to be calculated; e the method of calculating the payment for drugs not mentioned in the Drug Tariff; f the method of calculating the payment for containers and medicine measures; g the dispensing or other fees payable in respect of the supply of drugs and appliances and of the provision of supplemental services and of additional professional services; h arrangements for claiming fees, allowances and other remuneration for the provision of pharmaceutical services; and i the method by which a claim may be made for compensation for financial loss in respect of oxygen equipment. 2 The Drug Tariff may state in respect of any specified fee falling within paragraph (1)(g), or any other specified fee, allowance or other remuneration in respect of the provision of pharmaceutical services by chemists, that the determining authority for that fee, allowance or other remuneration for those chemists is the Board, and in such a case paragraphs (4) and (5) shall apply. 3 The prices referred to in paragraph (1)(d) may be fixed prices or may be subject to monthly or other periodical variations to be determined by reference to fluctuations in the cost of drugs and appliances. 4 The Board shall consult the Local Pharmaceutical Committee before making any determination by virtue of paragraph (2). 5 A determination made by the Board by virtue of paragraph (2) shall include the arrangements for claiming the specified fees, allowances or other remuneration, and shall be published by the Board in such manner as it thinks suitable for bringing the determination to the attention of the chemists in its area. Payments to suspended chemists 10 1 The Board shall make payments to any chemist who is suspended by direction of the Tribunal in accordance with a determination made by the Department in relation to such payments. 2 The Department shall make a determination in accordance with paragraph (1) after consultation with such organisation which is, in the opinion of the Department, representative of the general body of chemists, and that determination shall be published with the Drug Tariff. 3 The determination may be amended from time to time by the Department, after consultation with the organisation referred to in paragraph (2), and any amendments shall also be published with the Drug Tariff. 4 A determination made by the Department by virtue of paragraph (1)— a shall be such as to secure that, as far as reasonably practicable, and after making adjustments for any reduction in expenses, the suspended chemist receives payments at a rate corresponding to his remuneration under the Drug Tariff (but excluding any payments made by virtue of regulation 9(1)(1) and (i)) during the 12 months ending with the direction for suspension by the Tribunal; b may include provision that payments in accordance with the determination are not to exceed a specified amount in any specified period; c in a case to which paragraph 8B(3) of Schedule 11 to the Order applies, shall provide for the payments to be reduced to take account of any payments which the suspended chemist receives for providing pharmaceutical services other than as a principal. PART III PROVISION OF PHARMACEUTICAL SERVICES BY DOCTORS Provision of pharmaceutical services for immediate treatment or personal administration 11 A doctor— a shall provide to a patient any appliance or drug, not being a Scheduled drug, where such provision is needed for the immediate treatment of that patient before a provision can otherwise be obtained; and b may provide to a patient any appliance or drug, not being a Scheduled drug, which he personally administers or applies to that patient. Arrangements for provision of pharmaceutical services by doctors 12 1 Where the Board is satisfied that a person, by reason of distance, inadequacy of means of communication or other exceptional circumstances, would have serious difficulty in obtaining any necessary drugs not being Scheduled drugs or appliances from a chemist it may, unless the person notifies it that, notwithstanding, he desires to obtain such drugs or appliances from a chemist, require the doctor in whose list of patients the person is included to supply to that person until further notice such drugs or appliances as would otherwise under these Regulations have been supplied by a chemist. 2 Where the number of such persons, in respect of whom a doctor has been required to supply necessary drugs and appliances under paragraph (1), exceeds 80 per cent of the total number of persons on his list of patients the Board may require the doctor to supply any necessary drugs and appliances to all persons on his list of patients. 3 Paragraph (2) shall not apply in respect of any person who notifies the Board that, notwithstanding, he desires to obtain any necessary drugs or appliances from a chemist. 4 A doctor shall be entitled to receive reasonable notice from the Board that he is required to undertake the supply of drugs or appliances, or that a requirement to undertake such supply is to be discontinued. 5 The Board may make arrangements with doctors on the obstetric list for the supply of drugs and appliances to patients for whom they have undertaken to provide maternity medical services. PART IV PHARMACEUTICAL COMMITTEE Constitution 13 The Pharmaceutical Committee shall be constituted by the Agency in accordance with Schedule 5 for the purpose of carrying out duties in connection with— a the testing of drugs and appliances; b the accuracy of dispensing; and c payments to chemists. PART V MISCELLANEOUS Publication of particulars 14 1 The Board shall make available for inspection at its offices up to date copies of the following documents— a the pharmaceutical list; b these Regulations; c the Drug Tariff; and d any determination made by the Board by virtue of regulation 9 or by the Department by virtue of regulation 10(1). 2 The Board may— a make copies of documents referred to in paragraph (1) available for inspection at such other places in its area as appear to it convenient for informing all persons interested; or b publish at such places a notice of the places and times at which such copies may be seen. 3 The Board shall send a copy of the pharmaceutical list to the Department, the Agency, each Local Pharmaceutical Committee, each Local Medical Committee and each local Dental Committee, and shall, within 14 days of any alteration in the pharmaceutical list, so inform each of them in writing. Exercise of choice of chemist in certain cases 15 An application to a chemist for the provision of pharmaceutical services may be made (other than by the chemist concerned)— a on behalf of any child by either parent, or in the absence of both parents, the other person who has parental responsibility for or care of the child; or b on behalf of any person by another person authorised by the first mentioned person. Claims and overpayments 16 1 Any claim for fees, allowances or other remuneration by chemists or doctors shall be made in accordance with the provisions of the Drug Tariff or, as the case may be, in accordance with any arrangements for claiming them included in a determination made by the Board by virtue of regulation 9 or by the Department by virtue of regulation 10(1). 2 Where it considers that a payment has been made to a chemist, or to a doctor who provides pharmaceutical services, in circumstances when it was not due, the Board, except to the extent that the Department, on the application of the Board, directs otherwise, shall draw the overpayment to the attention of the chemist or the doctor, and— a where the overpayment is admitted by him; or b where the overpayment is not so admitted but, the matter having been referred under regulation 5(1) of the Disciplinary Procedures Regulations for investigation, the Board, or the Department on appeal, decides that there has been an overpayment, the amount overpaid shall be recoverable by the Board by deduction from the remuneration of the doctor or chemist or otherwise. 3 Recovery of an overpayment under this regulation shall be without prejudice to the investigation of an alleged breach of the terms of service of that chemist or doctor. Transitional provisions 17 Where, before the commencement of these Regulations, an appeal has been made under— a regulation 38(4) of the Health and Personal Social Services (General Medical and Pharmaceutical Services) Regulations (Northern Ireland) 1973 ; or b paragraph 4 of Schedule 4B to those Regulations, by a Board; the provisions of those Regulations shall continue to apply as respects that appeal as if these Regulations had not been made. Sealed with the Official Seal of the Department of Health and Social Services on 15th August 1997. (L.S.) Joan Dixon Assistant Secretary Sealed with the Official Seal of the Department of Finance and Personnel on 15th August 1997. (L.S.) D. Thomson Assistant Secretary