HEALTH AND PERSONAL SOCIAL SERVICES Citation, commencement and interpretation 1 1 These regulations may be cited as the General Medical and Pharmaceutical Services (Amendment) Regulations (Northern Ireland) 1996 and shall come into operation on 1st April 1996. 2 In these regulations, the “principal regulations” means the Health and Personal Social Services (General Medical and Pharmaceutical Services) Regulations (Northern Ireland) 1973 . Amendment of regulation 2 of the principal regulations 2 In regulation 2 of the principal regulations (interpretation), in paragraph (1), in the definition of “suspended by direction of the Tribunal” after “medical” there shall be inserted “and pharmaceutical”. Amendment of regulation 4 of the principal regulations 3 After paragraph (4)(1)( b ) of regulation 4 of the principal regulations (medical list) there shall be inserted the following sub-paragraph— bb if he has made an arrangement under paragraph 14BB(2) of the terms of service transferring responsibility for his patients at certain times to another doctor, and, if so, the name of the doctor to whom, and the times during which, he has so transferred responsibility; . Amendment of regulation 36 of the principal regulations 4 In regulation 36 of the principal regulations (terms of service) sub-paragraphs (3)( c ) and (4)( b )(ii) shall be omitted. Amendment of regulation 36A of the principal regulations 5 In regulation 36A of the principal regulations (additional professional services) after sub-paragraph ( b ) of paragraph (2) there shall be inserted the following— c keeping records in connection with drugs supplied to any person— i who claims exemption under regulation 15(1)( b ) of the Health and Personal Social Services (Charges for Drugs and Appliances) Regulations (Northern Ireland) 1973 (which provides that those aged 60 or over are exempt from prescription charges), or ii who, in the opinion of the pharmacist 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 pharmacist 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 provided, and c the date on which it is provided. . Amendment of regulation 37A of the principal regulations 6 In regulation 37A of the principal regulations (removal from the pharmaceutical list), after paragraph (3) there shall be inserted the following— 4 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 (1). . Insertion of regulation 40B in the principal regulations 7 After regulation 40A of the principal regulations there shall be inserted— Payments to suspended chemists 40B 1 The Board shall make payments to any chemist who is suspended by direction of the Tribunal in accordance with the Department’s determination in relation to such payments. 2 The Department shall make the determination in accordance with paragraph (3) after consultation with such organisations so recognised as representing chemists with whom arrangements for the provision of pharmaceutical services exist, and it shall be published with the Drug Tariff. 3 The determination may be amended from time to time by the Department, after consultation with the organisations referred to in paragraph (2), and any amendments shall also be published with the Drug Tariff. 4 Subject to paragraphs (5) and (6), the Department’s determination 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 40(1)( c ) and ( i )) during the 12 months ending with the direction for suspension by the Tribunal. 5 The Department’s determination may include provision that payments in accordance with the determination are not to exceed a specified amount in any specified period. 6 In a case to which paragraph 8B(3) of Schedule 11 to the Order applies, the determination 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. . Amendment of Schedule 1 to the principal regulations 8 1 Schedule 1 to the principal regulations (terms of service for doctors) shall be amended as follows. 2 In paragraph 1, at the beginning, there shall be inserted the following definition— “notice” means notice in writing; . 3 In paragraph 3 (persons for whose treatment a doctor is responsible), in sub-paragraph (1)— a at the end of head ( h ) there shall be inserted— and i any person for whom he has accepted responsibility under an arrangement made under paragraph 14BB(2). . 4 After sub-paragraph (5) of paragraph 11 there shall be inserted the following sub-paragraph— 6 A doctor who is authorised or required by a Board under regulation 41 to provide drugs or appliances to a patient or who otherwise provides pharmaceutical services shall secure that the practice based complaints procedure he has established and operates in accordance with paragraph 11B applies in relation to any matter reasonably connected with his provision of pharmaceutical services as it applies as respects his provision of general medical services. Accordingly, paragraph 11C also applies in relation to complaints about such matters. . 5 After paragraph 11A (practice leaflet), there shall be inserted the following new paragraphs— Complaints 11B 1 Subject to sub-paragraph (2), a doctor shall establish, and operate in accordance with this paragraph, a procedure (in this paragraph and in paragraph 11C referred to as a “practice based complaints procedure”) to deal with any complaints made by or on behalf of his patients and former patients. 2 The practice based complaints procedure to be established by a doctor may be such that it also deals with complaints made in relation to one or more other doctors. 3 A practice based complaints procedure shall apply to complaints made in relation to any matter reasonably connected with the doctor’s provision of general medical services and within the responsibility or control of— a the doctor; b any other doctor either employed by him or engaged as his deputy; c a former partner of the doctor; d an employee of the doctor other than one falling within head ( b ), and in this paragraph and paragraph 11C, references to complaints are to complaints falling within this sub-paragraph. 4 A complaint may be made on behalf of a patient or former patient with his consent, or a where the patient is a child— i by either parent, or in the absence of both parents, the guardian or other adult person who has care of the child, or ii where the child is in the care of a Board or HSS trust to whose care he has been committed under the provisions of the Children and Young Persons Act (Northern Ireland) 1968 , by a person duly authorised by that Board or trust, or iii where the child is in the care of a voluntary organisation, by that organisation or a person duly authorised by it, or iv where the child is in a training school, by the Manager of that training school; or b where the patient is incapable of making a complaint, by a relative or other adult person who has an interest in his welfare. 5 Where a patient has died a complaint may be made by a relative or other adult person who had an interest in his welfare or, where the patient was as described in head ( a ) (ii), (iii) or (iv) of sub-paragraph (4), by the Board or HSS trust, or voluntary organisation, or the manager of the training school. 6 A practice based complaints procedure shall comply with the following requirements— a the doctor must specify a person (who need not be connected with the practice and who, in the case of an individual, may be specified by his job title) to be responsible for receiving and investigating all complaints; b all complaints must be— i recorded in writing, ii acknowledged, either orally or in writing, within the period of 3 days (excluding Saturdays, Sundays, and Bank and Public Holidays) beginning with and including the day on which the complaint was made or, where that is not possible, as soon as reasonably practicable, and iii properly investigated; c within the period of 10 days (excluding Saturdays, Sundays, and Bank and Public Holidays) beginning with and including the day on which the complaint was received by the person specified under head ( a ) or, where that is not possible, as soon as reasonably practicable, the complainant must be given a written summary of the investigation and its conclusions; d where the investigation of the complaint requires consideration of the patient’s medical records, the person specified under head ( a ) must inform the patient or person acting on his behalf if the investigation will involve disclosure of information contained in those records to a person other than the doctor or a partner, a deputy or an employee of the doctor; and e the doctor must keep a record of all complaints and copies of all correspondence relating to complaints, but such records must be kept separate from patients' medical records. 7 A doctor shall inform his patients about the practice based complaints procedure which he operates and the name (or title) of the person specified under sub-paragraph (6)( a ). 11C 1 A doctor shall co-operate with any investigation of a complaint by the Board in accordance with the procedures which it operates in accordance with directions given under Article 17(1) of the Order, whether the investigation follows one under the practice based complaints procedure or not. 2 The co-operation required by sub-paragraph (1) includes— a answering questions reasonably put to the doctor by the Board; b providing any information relating to the complaint reasonably required by the Board; and c attending any meeting to consider the complaint (if held at a reasonably accessible place and at a reasonable hour, and due notice has been given), if the doctor’s presence at the meeting is reasonably required by the Board. . 6 In paragraph 14 (deputies, assistants and partners), in sub-paragraph (1), after “Subject to sub-paragraphs (1)( a ), (2), (2A) and (2B)” there shall be inserted “and to any out of hours arrangement made under paragraph 14BB(2)”. 7 In paragraph 14B (duration of doctor’s responsibility), at the beginning there shall be inserted “Subject to paragraph 14BB”. 8 After paragraph 14B (duration of doctor’s responsibility) there shall be inserted the following paragraphs— Out of hours arrangements 14BB 1 In this paragraph and in paragraph 14BC— a “out of hours period” means— i the period beginning at 7 pm on Mondays to Fridays and ending at 8 am the following day, ii the period between 1 pm on Saturday and 8 am on the following Monday, and iii Bank and Public Holidays; and “part of an out of hours period” means any part of any one or more of the periods described in sub-heads (i) to (iii); b “out of hours arrangement” means an arrangement under sub-paragraph (2); and c “transferee doctor” means a doctor who has undertaken to carry out the obligations of another doctor under these terms of service during part or all of the out of hours period in accordance with an out of hours arrangement. 2 Subject to sub-paragraphs (3) to (15), a doctor may, with the approval of the Board, make an arrangement with a doctor who is on the medical list to transfer his obligations under the terms of service during part or all of the out of hours period to that other doctor. 3 A doctor may make more than one out of hours arrangement; and may do so (for example) with different transferee doctors and in respect of different patients, different times and different parts of his practice area. 4 A doctor may retain responsibility for or make separate out of hours arrangements in respect of the provision of maternity medical services to patients with whom he has made an arrangement under regulation 28. 5 Nothing in this paragraph prevents a doctor from retaining or resuming his obligations in relation to named patients. 6 Where a doctor is on the obstetric list, he shall not make an out of hours arrangement in respect of the provision of maternity medical services to patients with whom he has made an arrangement under regulation 28 unless the transferee doctor is also on the obstetric list. 7 An application to the Board for approval shall be made in writing and shall state— a the name and address of the proposed transferee doctor, and the number of patients on his list; b the periods during which the doctor’s obligations under these terms of service are to be transferred; c how the proposed transferee doctor intends to meet the doctor’s obligations during the periods specified under head ( b ); d the arrangements for the transfer of the doctor’s obligations under these terms of service to and from the transferee doctor at the beginning and end of the periods specified under head ( b ); e whether the proposed arrangement includes the doctor’s obligations in respect of maternity medical services; f how long the proposed arrangements are intended to last and the circumstances in which the doctor’s obligations under these terms of service during the periods specified under head ( b ) would revert to him; g what arrangements are proposed to enable the doctor’s patients to contact the proposed transferee doctor; and h whether the proposed transferee doctor— i has been notified under regulation 7(4) of the Tribunal Regulations (Northern Ireland) 1995 that the Tribunal intends to hold an inquiry under paragraph 1 of Schedule 11 to the Order as to representations made in relation to him; or ii has been notified under section 42(5) of the Medical Act 1983 that the Preliminary Proceedings Committee of the General Medical Council has decided that he should be referred to the Professional Conduct Committee or to the Health Committee. 8 A Board shall determine the application before the end of the period of 28 days beginning with and including the day on which the Board received it. 9 A Board shall grant approval to a proposed out of hours arrangement if it is satisfied— a having regard in particular to the interests of the doctor’s patients, that the arrangement is reasonable; b having regard in particular to all reasonably foreseeable circumstances, that the arrangement is practicable and will work satisfactorily; c that it will be clear to the doctor’s patients how to seek personal medical services during the out of hours period; and d that if the arrangement comes to an end, the doctor has in place proper arrangements for the immediate resumption of his responsibilities; and shall not refuse to grant approval without first consulting the Local Medical Committee. 10 The Board shall give notice to the doctor of its determination and, where it refuses an application, it shall send the doctor a statement in writing of the reasons for its determination and of the doctor’s right of appeal under sub-paragraph (11). 11 A doctor may, before the end of the period of 30 days beginning with and including the day on which the Board’s notification under sub-paragraph (10) was sent, appeal in writing to the Department against any refusal of an application under sub-paragraph (7). 12 The Department may, when determining an appeal, either confirm the determination of the Board or substitute its own determination for that of the Board. 13 The Department shall give notice to the doctor of its determination and shall in every case include with the notification a written statement of the reasons for the determination. 14 Where the Board (or, on appeal, the Department) has approved an out of hours arrangement— a the transferee doctor may himself employ or engage an assistant or deputy in respect of part or all of the period covered by the out of hours arrangement; and if he does so, paragraph 14 shall apply as if he were the doctor for the purposes of that paragraph; and b a transferee doctor shall not enter into any other out of hours arrangement in respect of the patients for whom he has accepted responsibility under this paragraph. 14BC 1 Subject to paragraph 14BD, where it appears to the Board that it may no longer be satisfied with any of the matters referred to in sub-paragraphs ( a ) to ( d ) of paragraph 14BB(9), it may give notice in writing to the doctor that it proposes to review the approval. 2 On any review under sub-paragraph (1), the Board shall allow the doctor a period of 30 days, beginning with and including the day on which it sent the notice, within which to make representations in writing to the Board. 3 After considering any representations made in accordance with sub-paragraph (2), the Board may determine either to continue or to withdraw its approval but shall not withdraw its approval without first consulting the Local Medical Committee. 4 The Board shall give notice to the doctor of a determination under sub-paragraph (3). 5 Where the Board withdraws its approval, it shall include with the notice a statement in writing of the reasons for its determination and of the doctor’s right of appeal under sub-paragraph (6). 6 A doctor may, within the period of 30 days beginning with and including the day on which the notice referred to in sub-paragraph (4) was sent, appeal in writing to the Department against the withdrawal of approval and sub-paragraphs (12) and (13) of paragraph 14BB shall apply to any such appeal. 7 Subject to paragraph 14BD(1), where the Board withdraws approval, the withdrawal shall not take effect until the end of the period of 2 months beginning with and including the date on which the notice referred to in sub-paragraph (4) was sent or where there is an appeal under sub-paragraph (6) and the appeal is dismissed, the date on which the doctor receives notice of the dismissal of the appeal, whichever is the later. 14BD 1 Where it appears to the Board, whether after a review under paragraph 14BC or not, that it is necessary in the interests of the doctor’s patients to withdraw its approval immediately, it may withdraw its approval. 2 The Board shall give notice to the doctor of a determination under sub-paragraph (1) and shall include with the notice a statement of the reasons for its determination and of the doctor’s right of appeal under sub-paragraph (4). 3 An immediate withdrawal of approval under sub-paragraph (1) shall take effect on the day on which the notice referred to in sub-paragraph (2) is received by the doctor. 4 A doctor may, within the period of 30 days beginning with and including the day on which the notice referred to in sub-paragraph (2) was sent, appeal in writing to the Department against the withdrawal of approval and sub-paragraphs (12) and (13) of paragraph 14BB shall apply to any such appeal. . Amendment of Schedule 1H to the principal regulations 9 In Schedule 1H to the principal regulations (information to be included in practice leaflets), after paragraph 9A there shall be inserted— 9B Where the doctor has made an out of hours arrangement under paragraph 14BB(2) of Schedule 1, the name and address of the doctor with whom the arrangement has been made, the times during which it applies and details of the arrangements whereby the doctor’s patients may contact the doctor concerned. . Amendment of Schedule 1I to the principal regulations 10 In Schedule 1I to the principal regulations (information to be provided in annual reports), at the end there shall be inserted— 5 The number of complaints received in accordance with paragraph 11B of Schedule 1. . Amendment of Schedule 4 to the principal regulations 11 In Schedule 4 to the principal regulations (terms of service for chemists)— a in paragraph 3 after sub-paragraph (1)( d ) there shall be inserted the following sub-paragraph— e if the person presenting the prescription form asks the chemist to do so— i he shall give an estimate of the time when the drugs, medicines or appliances will be ready; and ii if they are not ready by then, he shall give a revised estimate of the time when they will be ready and so on; ; b for paragraph 5 (dispensing of medicines) there shall be substituted the following paragraph— Provision of drugs and fitting of appliances 5 1 Drugs shall be provided either by or under the direct supervision of a pharmacist. 2 Where the pharmacist referred to in sub-paragraph (1) is employed by a chemist, the pharmacist must not be one— a who, having been disqualified under paragraph 3( b ) of Schedule 11 to the Order (or any corresponding provision in force in England and Wales or Scotland) from inclusion in the pharmaceutical list (or, in England and Wales, the pharmaceutical list of a Health Authority or, in Scotland, the pharmaceutical list of a Health Board), is also the subject of a declaration under paragraph 3( c ) of Schedule 11 to the Order (or any corresponding provision in force in England and Wales or Scotland) that he is not fit to be engaged in any capacity in the provision of pharmaceutical services; or b who is suspended by direction of the Tribunal, other than in a case falling within paragraph 8B(3) of Schedule 11 to the Order. 3 Subject to paragraph 3(1)( a ) a chemist shall make all necessary arrangements— a for measuring a person who presents a prescription for a truss or other appliance of a type requiring measurement and fitting by the chemist; and b for fitting the appliance; ; c in paragraph 8 after sub-paragraph (4)( c ) there shall be inserted the following sub-paragraph— d a chemist who has undertaken to provide additional professional services within the meaning of regulation 36A shall on receipt of a written request from the Board make available to the Board all records kept in accordance with regulation 36A(2)( c ) and shall permit the Board or another person on its behalf at any reasonable time to inspect the premises from which those services are provided for the purpose of satisfying itself that those services are being provided in accordance with the undertaking; ; d after paragraph 9 there shall be inserted the following paragraphs— Complaints 9A 1 Subject to sub-paragraph (2), a chemist shall establish and operate in accordance with this paragraph, a procedure (in this paragraph and in paragraph 9B referred to as a “complaints procedure”) to deal with any complaints made by or on behalf of any person to whom he has provided pharmaceutical services. 2 The complaints procedure to be established by a chemist may be such that it also deals with complaints made in relation to one or more other chemists. 3 The complaints procedure to be established by a chemist who provides pharmaceutical services from more than one set of premises may be such that it relates to all those premises together. 4 A complaints procedure shall apply to complaints made in relation to any matter reasonably connected with the chemist’s provision of pharmaceutical services and within the responsibility or control of— a the chemist; b where the chemist is a body corporate, any of its directors or former directors; c a former partner of the chemist; d any pharmacist employed by the chemist; e any employee of the chemist other than one falling within sub-paragraph ( d ); and in this paragraph and paragraph 9B, references to complaints are to complaints falling within this sub-paragraph. 5 A complaint may be made on behalf of any person with his consent, or— a where he is under 16 years of age— i by either parent, or in the absence of both parents, the guardian or other adult person who has care of the child; or ii where the child is in the care of a Board or HSS trust to whose care he has been committed under the provisions of the Children and Young Persons Act (Northern Ireland) 1968 by a person duly authorised by that Board or trust; or iii where the child is in the care of a voluntary organisation, by that organisation or a person duly authorised by it, or iv where the child is in a training school, by the Manager of that training school; or b where he is incapable of making a complaint, by a relative or other adult person who has an interest in his welfare. 6 A complaint may be made as respects a person who has died by a relative or other adult person who had an interest in his welfare, or when he was as described in paragraph ( a )(ii), (iii) or (iv) of sub-paragraph (5), by the Board or HSS trust, or voluntary organisation, or the manager of the training school. 7 A complaints procedure shall comply with the following requirements— a the chemist must specify a person (who need not be connected with the chemist and whom in the case of an individual, may be specified by his job title) to be responsible for receiving and investigating all complaints. b all complaints must be— i recorded in writing, ii acknowledged, either orally or in writing, within the period of 3 days (excluding Saturdays, Sundays and Bank and Public Holidays) beginning with and including the day on which the complaint was received by the person specified under head ( a ) or, where that is not possible, as soon as reasonably practicable, and iii properly investigated; c within the period of 10 days (excluding Saturdays, Sundays and Bank and Public Holidays) beginning with and including the day on which the complaint was received by the person specified under head ( a ) or, where that is not possible, as soon as reasonably practicable, the complainant must be given a written summary of the investigation and its conclusions; d where the investigation of the complaint requires consideration of any records relating to the person as respects whom the complaint is made, the person specified under head ( a ) must inform him or the person acting on his behalf if the investigation will involve disclosure of information contained in those records to a person other than the chemist or a director, partner or employee of the chemist; and e the chemist must keep a record of all complaints and copies of all correspondence relating to complaints, but such records must be kept separate from any records relating to the person by whom the complaint was made. 8 At each of the premises at which the chemist provides pharmaceutical services he must provide information about the complaints procedure, and give the name (or title) and address of the person specified under paragraph (3)( a ); and where he provides supplemental services he must provide the same information to the person referred to in regulation 36(3)( a ). 9B 1 A chemist must co-operate with any investigation of a complaint by the Board in accordance with the procedures which it operates in accordance with directions given under Article 17(1) of the Order, whether the investigation follows one under the chemist’s complaints procedure or not. 2 The co-operation required by sub-paragraph (1) includes— a answering questions reasonably put to the chemist by the Board; b providing any information relating to the complaint reasonably required by the Board; and c attending any meeting to consider the complaint (if held at a reasonably accessible place and at a reasonable hour, and due notice has been given), if the chemist’s presence at the meeting is reasonably required by the Board. ; e after paragraph 9 there shall be inserted the following paragraph— Professional standards 10 1 A pharmacist whose name is on the pharmaceutical list shall provide pharmaceutical services and exercise any professional judgment in connection with the provision of such services in conformity with the standards generally accepted in the pharmaceutical profession. 2 A chemist who employs a pharmacist in connection with the provision of pharmaceutical services shall secure that the pharmacist complies with the requirements set out in sub-paragraph (1). . Sealed with the Official Seal of the Department of Health and Social Services on Joan Dixon Assistant Secretary 29th March 1996. Sealed with the Official Seal of the Department of Finance and Personnel on J. G. Sullivan Assistant Secretary 29th March 1996