Pharmaceutical Services (Amendment) Regulations (Northern Ireland) 2001

Statutory Rules of Northern Ireland

2001 No. 222

HEALTH AND PERSONAL SOCIAL SERVICES

Pharmaceutical Services (Amendment) Regulations (Northern Ireland) 2001

Made

24th May 2001

Coming into operation

2nd July 2001

The Department of Health, Social Services and Public Safety(1) in exercise of the powers conferred on it by Articles 63(1), (2), (2A) to (2D), 64, 106(b) and 107(6) of the Health and Personal Social Services (Northern Ireland) Order 1972(2) and of all other powers enabling it in that behalf, and in conjunction with the Department of Finance and Personnel and after consultation with such organisations as appear to the Department of Health, Social Services and Public Safety to be representative of the pharmaceutical profession as required by Article 63(3) of that Order, hereby makes the following Regulations:

Citation, commencement and interpretation

1.—(1) These Regulations may be cited as the Pharmaceutical Services (Amendment) Regulations (Northern Ireland) 2001 and shall come into operation on 2nd July 2001.

(2) In these Regulations “the principal Regulations” means the Pharmaceutical Services Regulations (Northern Ireland) 1997(3).

Amendment of regulation 2 of the principal Regulations

2.—(1) Regulation 2 of the principal Regulations (interpretation) is amended as follows.

(2) In paragraph (1)

(a) in the appropriate alphabetical position insert—

• ““dispensing doctor list” shall be construed in accordance with regulation 12B;

• “directed services” means additional pharmaceutical services;

• “doctor’s list” means a list of a doctor’s patients kept by the Agency—

  (i)

  in respect of a doctor providing general medical services, in accordance with regulation 18 of the Medical Regulations, or

  (ii)

  in respect of a doctor performing personal medical services in connection with a pilot scheme, in accordance with paragraph 3 of the Directions to Health and Social Services Boards and the Central Services Agency Concerning Patient Lists (Personal Medical Services) made under Articles 8(1) and 31(5) of the 1997 Order;

• “pilot scheme provider” means a person, other than a Board who is a party to a pilot scheme;”; and

(b) in the definition of “patient”, at the end, insert “except in relation to a doctor who performs personal medical services under a pilot scheme and whose name is not included in the medical list, in which case it has the meaning assigned to it in the directions made by the Department in exercise of powers conferred on it by Articles 17 and 27 of the Order and Articles 8(1) and 31(5) of the 1997 Order.”.

(3) After paragraph (1A), insert a new paragraph—

“(1B) In these Regulations—

(a) the term “pharmaceutical services”, in relation to a doctor whose name is not included in a medical list but who performs personal medical services under a pilot scheme, means those services referred to in regulation 12; and

(b) the term “dispensing services”, in relation to such a doctor, means any corresponding service performed, not as pharmaceutical services, but under a pilot scheme by virtue of Article 3(3) of the 1997 Order.”.

(4) In paragraph (2) (which specifies a description of nurse prescribers who may issue prescription forms) in each of the sub-paragraphs (a)(iii) and (b)(ii), after the words “medical list” insert the words “or by a pilot scheme provider in connection with the provision of personal medical services under a pilot scheme.”.

Amendment of regulation 3 of the principal Regulations

3.  For regulation 3 of the principal Regulations (pharmaceutical services) there shall be substituted—

“Pharmaceutical services

3.— (1) The arrangements for the provision of pharmaceutical services by chemists shall include arrangements for the supply of contraceptive substances and appliances.

(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) A chemist may at any time give notice in writing to the Board that he wishes to be included in or excluded from any arrangements for the supply of contraceptive substances and appliances.”.

Amendment of regulation 6 of the principal Regulations

4.  In regulation 6 of the principal Regulations (pharmaceutical list)—

(a) in paragraph (2)(b)(ii) after the word “relocate” there shall be inserted “, either permanently or temporarily,”;

(b) in paragraph (2) after the word “appropriate” on the last line there shall be inserted “or in the case of an application under paragraph (4A) on whichever version of Form A (TR) set out in Part I or Part II of that Schedule is appropriate”; and

(c) after paragraph (4) there shall be inserted—

“(4A) Where an application is made and—

(a) the applicant intends to relocate for a temporary period to new premises 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, because of exceptional circumstances, relocation on a temporary basis is necessary,

the Board shall grant the application and notify the applicant accordingly.

(4B) An application under paragraph (4A) shall be granted for such period as the Board may determine but that period shall not exceed twelve months.

(4C) The period determined under paragraph (4B) may be extended for a further period not exceeding six months where the Board is satisfied that the applicant has demonstrated good cause for such an extension.

(4D) Where the application is granted under paragraph (4A) the Board shall make the relevant entries in the pharmaceutical list in respect of the premises named in the application.”;

(d) in paragraph (13) after the word “granted” there shall be inserted “other than under paragraph (4A),”.

Amendment of regulation 7 of the principal Regulations

5.  In regulation 7 of the principal Regulations (removal from the pharmaceutical list) after paragraph (4) insert—

“(5) On the expiry of the period determined under regulation 6(4B) the applicant’s name shall be removed from the pharmaceutical list in respect of the premises named in the application.”.

Amendment of regulation 9 of the principal Regulations

6.  In regulation 9 of the principal Regulations (standards of, and payments for, drugs and appliances), in paragraph (1)(g) the words “and of the provision of supplemental services” shall be omitted.

Amendment of regulation 11 of the principal Regulations

7.  In regulation 11 of the principal Regulations (provision of pharmaceutical services for immediate treatment or personal administration) for the words “A doctor” there shall be substituted the words “A doctor whose name is included in the medical list”.

Amendment of regulation 12 of the principal Regulations

8.  In regulation 12 of the principal Regulations (arrangements for provision of pharmaceutical services by doctors)—

(a) in paragraph (1) after the word “included” insert “, or a doctor falling within paragraph (1A),”;

(b) after paragraph (1), insert—

“(1A) A doctor falls within this paragraph if—

(a) he performs personal medical services under a pilot scheme to which the Board is a party;

(b) his name was included in the medical list of the Board immediately before he started to perform personal medical services (whether under that pilot scheme or under another pilot scheme to which the Board was also a party);

(c) the pilot scheme provides for him to have a doctor’s list, and the patient is included in that list; and

(d) by virtue of the pilot scheme, any services of the kind referred to in this regulation provided to persons who receive personal medical services under the scheme are to be carried out under these Regulations as pharmaceutical services rather than as dispensing services under the pilot scheme.”.

9.  After regulation 12 of the principal Regulations insert the following regulations—

“Doctors who previously performed personal medical services

12A.— (1) This regulation applies to a doctor—

(a) whose name is included in the medical list;

(b) who immediately before the inclusion of his name in that list satisfied the requirements of sub-paragraphs (a) and (b) of regulation 12(1A);

(c) who, when his name was included in the medical list as mentioned in regulation 12(1A)(b), was required under regulation 12 to provide pharmaceutical services to any patient; and

(d) who then provided dispensing services under a pilot scheme to any person who received personal medical services under that pilot scheme.

(2) A doctor to whom this regulation applies shall be treated as being required under regulation 12 to provide pharmaceutical services to any patient to whom immediately before his rejoining the medical list he provided dispensing services under the pilot scheme and who wishes him to continue to provide such services.

Dispensing doctor lists

12B.— (1) Subject to paragraph (2), a Board shall prepare and publish a list, to be called the dispensing doctor list, of the names of those doctors required by the Board under regulation 12 to provide pharmaceutical services to their patients and who are actually doing so (below referred to as “dispensing doctors”).

(2) The dispensing doctor list shall be divided into two parts as follows—

(a) Part 1 shall contain the names of those dispensing doctors whose names are included in the Board’s medical list; and

(b) Part 2 shall contain the names of those dispensing doctors whose names are not included in the Board’s medical list but who perform personal medical services in the Board’s area.

(3) The dispensing doctor list shall indicate—

(a) in respect of any doctor whose name is included in Part 1, the address of his practice premises; and

(b) in respect of any doctor whose name is included in Part 2, the address of the place specified in the pilot scheme as the place at which the doctor will normally be available during normal hours to perform personal medical services.

(4) For the purposes of paragraph (3)—

(a) “practice premises” has the same meaning as in regulation 2 of the Medical Regulations; and

(b) “normal hours” means those days and times specified in a pilot scheme as the days on which and times at which a doctor will normally be available to perform personal medical services.

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 providing general medical services or (as the case may be) performing personal medical services; or

(c) more than 12 months have elapsed since the doctor last provided pharmaceutical services pursuant to the requirement to provide such services made by the Board under regulation 12.”.

Amendment of regulation 14 of the principal Regulations

10.  Regulation 14 of the principal Regulations (publication of particulars) shall be amended as follows—

(a) in paragraph (1), omit the word “and” at the end of sub-paragraph (c) and at the end of sub-paragraph (d) insert—

“and

(e) its dispensing doctor list.”; and

(b) in paragraph (3)—

(i) after the words “pharmaceutical list” where first mentioned insert the words “and of its dispensing doctor list”, and

(ii) for the words “in the pharmaceutical list”, substitute the words “in either of those lists,”.

Amendment of Schedule 2 to the principal Regulations

11.—(1) Part II of Schedule 2 to the principal Regulations (terms of service for chemists) shall be amended as follows.

(2) Before paragraph 2 there shall be inserted—

“Directed services

1A.   A chemist with whom a Board makes an arrangement for the provision of any directed service shall comply with the terms and conditions of the arrangement.”.

(3) In paragraph 4 (Premises and hours), for sub-paragraph (23) there shall be substituted the following sub-paragraphs—

“(23) If the Board has been directed under Article 63A(1)(a) or (b) of the Order that it must, or may, make arrangements for a pharmacist to be available to any person in the Board’s area for consultation outside the hours referred to in sub-paragraph (22) no direction shall be given under sub-paragraph (22), unless the requirements of sub-paragraph (23A) have been complied with.

(23A) The requirements referred to in sub-paragraph (23) are that—

(a) the Board must have offered to make such arrangements with the chemist;

(b) the arrangements offered must have been such that under them a pharmacist would have been available as mentioned in sub-paragraph (23) at the revised times which the Board proposes to require in its direction under sub-paragraph (22),

but it is immaterial whether or not the chemist has accepted the offer of such arrangements.

(23B) If the Board has not been directed under Article 63A(1)(a) or (b) of the Order in the manner referred to in sub-paragraph (23) no direction shall be given under sub-paragraph (22) unless a fee, allowance or other remuneration to be paid to any chemist so directed is included in the Drug Tariff or has been determined by the Board by virtue of regulation 9(2) (as the case may be).”.

(4) In paragraph 11 (Complaints), in sub-paragraph (8) the words from “and where” to the end shall be omitted.

12.—(1) Part III of Schedule 2 to the principal Regulations (terms of service for doctors who provide pharmaceutical services) shall be amended as follows.

(2) In paragraph 16, after sub-paragraph (2) insert—

“(3) In relation to a doctor falling within regulation 12(1A), sub-paragraph (1) shall have effect as if “paragraph 41” were substituted for “paragraphs 43 to 47”, and sub-paragraph (2) shall not apply.”.

(3) After paragraph 17 insert—

“18.— (1) In relation to a doctor who—

(a) falls within regulation 12(1A); and

(b) is authorised or required by the Board under regulation 12 to provide drugs or appliances to a person,

the complaints procedure established and operated in accordance with Directions under Article 17 of the Health and Personal Social Services (Northern Ireland) Order 1972 and Articles 11(2) and 31(5) of the Health Services (Primary Care) (Northern Ireland) Order 1997 as to complaints procedures for pilot schemes shall apply in relation to any matter reasonably connected with his provision of pharmaceutical services to that person, as it applies as respects his performance of personal medical services.

(2) Accordingly, any requirement imposed by virtue of such Directions on a person providing personal medical services under the Order as to co-operation with any investigation of a complaint by the Board also applies in relation to complaints about such matters.”.

Amendment of Schedule 3 to the principal Regulations

13.—(1) Part I of Schedule 3 to the principal Regulations shall be amended as follows.

(2) In Form A (MR) (application for minor relocation of pharmacy premises) in the note after section 2(b), after “LEASE” insert “, LEGAL”.

(3) After Form A (MR) insert the following—

Regulation 6(2)

“Form A (TR)

”

14.—(1) Part II of Schedule 3 to the principal Regulations shall be amended as follows.

(2) In Form A (MR) (application for minor relocation of pharmacy premises) in the note after section 2(b), after “LEASE” insert “, LEGAL”.

(3) After Form A (MR) insert the following—

Regulation 6(2)

“Form A (TR)

”

Sealed with the Official Seal of the Department of Health, Social Services and Public Safety on 24th May 2001.

L.S.

D. C. Bingham

A senior officer of the

Department of Health, Social Services and Public Safety

The Department of Finance and Personnel hereby approves the foregoing Regulations.

Sealed with the Official Seal of the Department of Finance and Personnel on 24th May 2001.

L.S.

Rodney Scott

A senior officer of the

Department of Finance and Personnel

Explanatory Note

(This note is not part of the Regulations.)

These Regulations further amend the Pharmaceutical Services Regulations (Northern Ireland) 1997 (“the principal Regulations”), by making provision for a Board to grant a temporary relocation for a designated period, and to allow a dispensing doctor to provide pharmaceutical services to his patients while performing personal medical services.

Regulation 2 inserts and amends definitions in the principal Regulations.

Regulations 3 and 6 remove the provisions relating to supplemental services, which now become directed services.

Regulations 4 and 5 provide for a Board to allow a temporary relocation of pharmacy premises for a specified period.

Regulations 7, 8 and 9 provide for a dispensing doctor to provide pharmaceutical services to those patients on his list to whom he is providing personal medical services under a pilot scheme and requires a Board to keep a list of dispensing doctors required to provide pharmaceutical services to their patients.

Regulation 10 requires a Board to make available for inspection a list of dispensing doctors required to provide pharmaceutical services to their patients.

Regulation 11 provides for any arrangements for the provision of directed services by a chemist to be included as part of the chemist’s terms of service.

Regulation 12 provides for the complaints procedure established for a personal medical services pilot scheme to also apply to the provision of pharmaceutical services under such a scheme.

Regulations 13 and 14 provide for a minor amendment to the wording on the application form used by chemists or persons other than chemists when seeking a minor relocation of pharmacy premises and introduce new forms to be used when applying for a temporary relocation.

(1)

See S.I. 1999/283 (N.I. 1) Article 3(6)

(2)

S.I. 1972/1265 (N.I. 14) relevant amending instruments are S.I. 1978/1907 (N.I. 26) Article 14, S.I. 1986/2023 (N.I. 20) Article 5(1) and (2); S.I. 1991/194 (N.I. 1) Article 31(1) and (2); S.I. 1992/2671 (N.I. 18) Article 3 and S.I. 1997/1177 (N.I. 17) Article 29

(3)

S.R. 1997 No. 381; relevant amending regulations are S.R. 1997 No. 547, S.R. 1998 No. 1995 and S.R. 1999 Nos. 100 and 254