Pharmaceutical Services Regulations (Northern Ireland) 1997

Made: 15th August 1997

Coming into operation: 6th October 1997

The Department of Health and Social Services, in exercise of the powers set out in Schedule 1 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 appeared to the Department of Health and Social Services to be representative of the pharmaceutical profession as required by Article 63(3) of the Health and Personal Social Services (Northern Ireland) Order 1972[^f00001], hereby makes the following Regulations:

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[^f00002];

• “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[^f00003]; 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[^f00004];

• “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[^f00005];

• “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[^f00006];

• “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[^f00007]), 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[^f00008] as extended to Northern Ireland by the Reserve and Auxiliary Forces (Protection of Civil Interests) (Northern Ireland) Order 1979[^f00009] and includes services rendered under the Reserve Forces Act 1980[^f00010];

• “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[^f00011] 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[^f00012] (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[^f00013]; 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[^f00014] (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[^f00015] 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[^f00016], 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[^f00017] (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.