The Pharmaceutical Services and Charges for Drugs and Appliances (Amendment) Regulations (Northern Ireland) 2005

Made: 29th April 2005

Coming into operation: 1st May 2005

The Department of Health, Social Services and Public Safety[^f00001] in exercise of the powers conferred on it by Articles 63(1), (2), (2A) to (2D), 64, 98, 106(b) and 107(6) of, and Schedule 15 to the Health and Personal Social Services (Northern Ireland) Order 1972[^f00002] and Article 10 of the Health and Medicines (Northern Ireland) Order 1988[^f00003] and of all other powers enabling it in that behalf, and in conjunction with the Department of Finance and Personnel insofar as they relate to Pharmaceutical Services, and with the approval of the Department of Finance and Personnal insofar as they relate to Charges for Drugs and Appliances, and after consultation with such organisations as appear to it to be representative of the pharmaceutical profession as required by Article 63(3) of the Health and Personal Social Services (Northern Ireland) Order 1972, hereby make the following Regulations:

Citation, commencement and interpretation

1

• (1) These Regulations may be cited as the Pharmaceutical Services and Charges for Drugs and Appliances (Amendment) Regulations (Northern Ireland) 2005 and shall come into operation on 1st May 2005.

• (2) In these Regulations –

• (a) “the Pharmaceutical Regulations” means the Pharmaceutical Services Regulations (Northern Ireland) 1997[^f00003].

• (b) “the Charges for Drugs and Appliances Regulations” means the Charges for Drugs and Appliances Regulations (Northern Ireland) 1997[^f00004].

Amendment of the Pharmaceutical Services Regulations (Northern Ireland) 1997

2

• (1) The Pharmaceutical Services Regulations (Northern Ireland) 1997 are amended as follows.

• (2) In regulation 2(1) (interpretation) –

• (a) for the definition of “appropriate non-proprietary name” substitute –

• “appropriate non-proprietary name” means a non-proprietary name which is not mentioned in Schedule 1 to the Prescription of Drugs Regulations or, except where the conditions in paragraph 40(2) of Schedule 5 to the GMS Regulations are satisfied, in Schedule 2 to the Prescription of Drugs Regulations;

• (b) for the definition of “independent nurse prescriber” substitute –

• “independent nurse prescriber” means a person – who is registered in the Nursing and Midwifery Register, and in respect of whom an annotation signifying that he is qualified to order drugs and appliances from – the Nurse Prescribers' Formulary for District Nurses and Health Visitors in Part IX(B) of the Drug Tariff, or the Nurse Prescribers' Extended Formulary in Part IX(C) of the Drug Tariff, is also recorded in that register;

• (c) for the definition of “patient” substitute –

• “patient” in relation to a GMS contract has the same meaning as in regulation 2 of the GMS Regulations (interpretation);

• (d) in the definition of “prescription form”, at the end insert “and does not include a repeatable prescription”;

• (e) for the definition of “the Remission of Charges Regulations” substitute –

• “the Remission of Charges Regulations” mean the Travelling Expenses and Remission of Charges Regulations (Northern Ireland) 2004[^f00005].

• (f) for the definition of “the charges regulations” substitute the following –

• “the Charges for Drugs and Appliances Regulations” means “the Charges for Drugs and Appliances Regulations (Northern Ireland) 1997.”. after the definition of “the Remission of Charges Regulations”, insert the following definitions – “repeat dispensing chemist” shall be construed in accordance with regulation 4A(1); “repeat dispensing services” means pharmaceutical services which involve the provision of drugs or appliances by a chemist in accordance with a repeatable prescription; “repeatable prescription” means a prescription contained in a form provided by the Agency and issued by a repeatable prescriber to enable a person to obtain pharmaceutical services, and which – is generated by a computer but signed by a repeatable prescriber; and indicates that the drugs or appliances ordered on that form may be provided more than once, and specifies the number of occasions on which they may be provided. ; for the definition of “Scheduled drug” substitute – “Scheduled drug” means a drug or other substance specified in Schedule 1 to the Prescription of Drugs Regulations, or except where the conditions in paragraph 40(2) of Schedule 5 to the GMS Regulations are satisfied, Schedule 2 to the Prescription of Drugs Regulations; ; for the definition of “supplementary prescriber” substitute – “supplementary prescriber” means a person – whose name is registered in – the Nursing and Midwifery Register, the Register of Pharmaceutical Chemists maintained in pursuance of section 2(1) of the Pharmacy Act 1954[^f00006], or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976[^f00007], and against whose name is recorded in the relevant register an annotation signifying that he is qualified to order drugs and appliances as a supplementary prescriber. . omit the following definitions – “doctor’s list”, “doctor’s terms of service”, “medical list”, “Medical Regulations”, “pilot scheme”, and “pilot scheme provider”; insert each of the following definitions at the appropriate alphabetical place – “GMS contract” means a general medical services contract; “the GMS regulations” means the Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004[^f00008]; “medical performers list” means a list of doctors prepared and published pursuant to regulation 4(1) and 5(1) of the Health and Personal Social Services (Performers Lists) Regulations (Northern Ireland 2004[^f00009]; “Nursing and Midwifery Register” means the register maintained by the Nursing and Midwifery Council under the Nursing and Midwifery Order 2001[^f00010]; “patient list” means a list of patients kept by a Board in respect of a GMS contractor, in accordance with paragraph 14 of Schedule 5 to the GMS Regulations; “prescriber” means a doctor, dentist, an independent nurse prescriber or a supplementary prescriber; “the Prescription of Drugs Regulations” means the Health and Personal Services (General Medical Services Contracts) (Prescription of Drugs Etc) Regulations (Northern Ireland) 2004[^f00011]; “relevant GMS contractor”, in relation to any doctor means the GMS contractor by whom the doctor is employed or engaged; “relevant patient list” means, in relation to a doctor who is (or is a legal and beneficial shareholder in a company which is) a GMS contractor, the patient list for that contractor or, where he is not a contractor, means the patient list for the GMS contractor by whom he is engaged or employed; “relevant register” means – in relation to a nurse, the Nursing and Midwifery Register, and in relation to a pharmacist, the register maintained in pursuance of section 2(1) of the Pharmacy Act 1954 (the registers and registration) or the register maintained in pursuance of Articles 6 (the registers) and 9 (the registrar) of the Pharmacy (Northern Ireland) Order 1976; “repeatable prescriber” means a prescriber who is – a GMS contractor who provides repeatable prescribing services under the terms of its contract which give effect to paragraph 39A[^f00012] of Schedule 5 to the GMS Regulations; employed or engaged by a GMS contractor who provides repeatable prescribing services under the terms of a contract which give effect to paragraph 40 of Schedule 5 to the GMS Regulations. .

• (3) For regulation 2(1B)[^f00013] substitute –

(1B) In these Regulations – (a) the term “pharmaceutical services”, in relation to a doctor, means those services referred to in regulation 12; and (b) the term “dispensing services” in relation to a doctor or to a GMS contractor means, any corresponding service provided, not as pharmaceutical services, but under the terms of a GMS contract which give effect to paragraphs 44 to 46 of Schedule 5 to the GMS Regulations.

• (4) After regulation 2(2) add –

(3) For as long as there are in existence contracts entered into under Article 13 of the General Medical Services Transitional and Consequential Provisions (No. 1) (Northern Ireland) Order 2004[^f00014] (“default contracts”) in respect of such contracts any reference to a GMS contract shall be read as including a reference to a contract entered into under that Article, and any reference to a term of a GMS contract shall be read as including a reference to the equivalent term in the default contract.

Insertion of Regulation 4A

3

After regulation 4 insert the following regulation –

(4A) (1) A chemist may provide repeat dispensing services if – (a) he satisfies the conditions in paragraph (2); and (b) he has undertaken, in accordance with paragraphs (3) and (4), to provide repeat dispensing services, and a chemist who satisfies the requirements of sub-paragraphs (a) and (b) is referred to in these Regulations as a repeat dispensing chemist. (2) The conditions referred to in paragraph (1)(a) are that the chemist – (a) is not a supplier of appliances only; and (b) is included in the pharmaceutical list of a Board. (3) A chemist who wishes to provide repeat dispensing services must notify the Board, in whose pharmaceutical list he is included, in writing, that he undertakes to provide those services, and that he intends to begin to provide them on a specified date. (4) The date specified by a chemist pursuant to paragraph (3) must be – (a) the first day of any specified month; and (b) at least ten days after the date on which the notification specified in paragraph (3) is given. (5) A chemist may not provide repeat dispensing services unless he is a repeat dispensing chemist.

Amendment of regulation 6 of the principal Regulations

4

In regulation 6 (pharmaceutical list) in paragraph (2)(b)(iii) after “pharmaceutical services” insert “(other than repeat dispensing services)”.

Amendment of regulation 9

5

In regulation 9 (standards of, and payments for, drugs and appliances) –

• (a) in paragraph (1)(g), after “supply of drugs and appliances” insert “, repeat dispensing services”;

• (b) after sub-paragraph (5) insert –

(6) A chemist shall supply, in response to a request from the Department, within 30 days of the notification of the request, any information which the Department may require for the purpose of conducting any enquiry into the prices, payments, fees, allowances and remuneration specified in paragraphs (1)(d) to (i).

Amendment of regulation 10A

6

In regulation 10A (reward scheme) in paragraph (1) –

• (a) after “paragraph 2(1)”, in the first place it appears, insert “or paragraph 2(1A)”;

• (b) in sub-paragraph (a), for “immediately informed the Board of this action” substitute “informed the Board of this action as soon as practicable”;

• (c) for sub-paragraph (b) substitute –

(b) he provided the drugs and medicines or listed appliances pursuant to paragraph (2)(1) or paragraph (2)(1A) but had reason to believe at that time or subsequently came to have reason to believe that the order was not a genuine order for the person named on the prescription form and informed the Board of this belief as soon as practicable,

; and

• (d) at the end add “and the Board has established that the order referred to in this paragraph was not a genuine order for the person named on the prescription form.”.

Omission of regulation 11

7

Regulation 11 (provision of pharmaceutical services for immediate treatment or personal administration) is omitted.

Amendment of regulation 12

8

For regulation 12 (arrangements for provision of pharmaceutical services by doctors) substitute –

(12) (1) Where a patient satisfies a Board that he would have serious difficulty in obtaining any necessary drugs or appliances from a pharmacy by reason of distance or inadequacy of means of communication he may at any time request in writing that a doctor who falls within paragraph (2) provide him with pharmaceutical services. (2) A doctor falls within this paragraph if he is – (a) the GMS contractor, or (b) engaged or employed by the GMS contractor on whose patient list the patient making the request is included. (3) If a doctor so requested by a patient under paragraph (1) – (a) applies to provide pharmaceutical services to the patient, and sends with his application the patient’s request in writing, the Board shall make arrangements with him for the provision of such services by him; or (b) does not so apply within 30 days, the Board may, subject to paragraph (6), require him to undertake such provision and shall give him notice in writing to that effect. (4) An arrangement made by a Board under paragraph (3)(a) shall – (a) have effect from the date of the patient’s request in writing; and (b) enable that doctor, any other doctor in his practice or any doctor who subsequently joined his practice to provide pharmaceutical services for the patient so long as the arrangement remains in effect. (5) A Board shall not under paragraph (3)(b) require a doctor to provide pharmaceutical services to a person on the relevant patient list for that doctor if that doctor satisfies the Board, or on appeal, the Department that he does not normally provide pharmaceutical services under this regulation. (6) A Board shall give a doctor reasonable notice – (a) that it requires him to provide pharmaceutical services to any person; or (b) subject to paragraph (7), that, where a person no longer satisfies the provisions of paragraph (1), the doctor shall discontinue the provision of pharmaceutical services to that person. (7) A notice under paragraph (6)(b) shall not be given pending any appeal against the decision by a Board to postpone the making or termination of such arrangements. (8) Notwithstanding paragraph (3), where a drug or appliance is one for which a doctor is entitled to an additional payment if he provides it, he may, with the consent of the patient, instead of providing it himself, order it by issuing a prescription to the patient in accordance with paragraph 39 of Schedule 5 to the GMS Regulations. (9) Where under any provision of regulations revoked by, and not re-enacted in, these regulations an arrangement or requirement for a doctor to provide drugs or appliances to a patient was in effect immediately before these regulations came into operation, that arrangement or requirement shall have effect as though made under this regulation. (10) A doctor who provides pharmaceutical services to some or all of the patients on the relevant patients list in accordance with this regulation may provide any necessary pharmaceutical services to a person whom the relevant GMS contractor has accepted as a temporary resident under paragraph 16 of Schedule 5 to the GMS Regulations. (11) An appeal under paragraph (5) shall be made in writing within 30 days from and including the date on which notice of the decision was sent to the doctor and shall contain a concise statement of the grounds of appeal. (12) The Department shall, on receipt of any notice of appeal under this regulation, send a copy of that notice to the Board and the relevant GMS contractor, and the Board and relevant GMS contractor may, within 30 days from and including the date on which the Department sent a copy of the notice of appeal, make representations in writing to it. (13) The Department may determine an appeal pursuant to paragraph (5) in such manner as it thinks fit. (14) The Department shall, upon determination by it of an appeal under this regulation, give notice of it’s decision in writing, together with the reasons for it, to the appellant, to the Board and to the relevant GMS contractor.

Omission of regulation 12A

9

Regulation 12A (doctors who previously performed personal medical services) is omitted.

Amendment of regulation 12B

10

For regulation 12B[^f00015] substitute –

(12B) (1) A Board shall prepare and publish a list, to be called the dispensing doctor list, of the names of those doctors authorised or required by the Board under regulation 12 to provide pharmaceutical services to their patients and who are actually doing so. (2) The dispensing doctor list shall indicate the address of the relevant GMS contractor from whose premises any doctor whose name is included performs primary medical services.

Amendment of regulation 12C

11

For regulation 12C[^f00015] substitute –

(12C) A Board shall remove the name of a doctor from its dispensing doctor list when – (a) the doctor has died; or (b) the doctor is no longer performing primary medical services within the area of the Board; or (c) more than 12 months have elapsed since the doctor last provided pharmaceutical services pursuant to the authorisation or requirement to provide such services given by the Board under regulation 12.

Amendment of regulation 16

12

In regulation 16(2)(b) (claims and overpayments) after the word “where” insert “, in the case of a chemist”.

Amendment of Schedule 2

13

• (1) Schedule 2 is amended as follows.

• (2) In paragraph 1 (incorporation of provisions) –

• (a) the provisions of paragraph 1 are re-numbered as sub-paragraph (1); and

• (b) after sub-paragraph (1) add –

(2) In this Schedule – - “associated batch issue” means, in relation to a repeatable prescription, one of the batch issues relating to that prescription and containing the same date as that prescription; and - “batch issue” means a form provided by the Agency and issued by the repeatable prescriber at the same time as a repeatable prescription to enable a chemist to receive payment for the provision of repeat dispensing services, and which – is generated by a computer and not signed by a repeatable prescriber; relates to a particular repeatable prescription and contains the same date as that prescription; is issued as one of a sequence of forms , the number of which is equal to the number of occasions on which the drugs and appliances ordered on the repeatable prescription may be provided; and specifies a number denoting its place in the sequence referred to in paragraph (c); and