The National Health Service (Pharmaceutical Services) (Scotland) Regulations 1995

Citation and commencement

1.  These Regulations may be cited as the National Health Service (Pharmaceutical Services) (Scotland) Regulations 1995 and shall come into force on 31st March 1995.

Interpretation and application

2.—(1) In these Regulations unless the context otherwise requires—

“the Act” means the National Health Service (Scotland) Act 1978;

“additional professional services” has the meaning assigned to it in regulation 4;

“appliance” means an appliance which is a listed appliance within the meaning of section 27(1) of the Act;

“appropriate non-proprietary name” means a non-proprietary name which is not mentioned in Schedule 10 to the National Health Service (General Medical Services) (Scotland) Regulations 1995(1) or, except where the conditions in paragraph 31(2) of the doctors' terms of service are satisfied, in Schedule 11 to those Regulations;

“Area Medical Committee” means the committee of that name for the area of a Board recognised under section 9 of the Act;

“Area Pharmaceutical Committee” means the committee of that name for the area of a Board recognised under section 9 of the Act;

“Board” means a Health Board within the meaning of the Act;

“chemical reagent” means a chemical reagent included in a list for the time being approved by the Secretary of State for the purposes of section 27 of the Act;

“dentist” means a dental practitioner;

“doctor” means a fully registered medical practitioner;

“drugs” includes medicines and chemical reagents;

“Drug Tariff” has the meaning assigned to it in regulation 9;

“hypodermic needle exchange services” has the meaning assigned to it in regulation 3(5);

“listed drugs” means such drugs and medicines as are included in a list for the time being approved by the Secretary of State for the purposes of section 27(1) of the Act;

“medical list” means a list prepared under section 19 of the Act of medical practitioners who have undertaken to provide general medical services(2);

“medicinal products” are products defined under section 130 of the Medicines Act 1968(3);

“minor relocation” has the meaning assigned to it in regulation 5;

“National Appeal Panel” means the panel constituted under Part II of Schedule 4;

“non-proprietary name” in relation to a drug means (a) where the drug is described in a monograph in the current edition (as defined in section 103(5) of the Medicines Act 1968)(4), as in force at the time of the supply of the drug, of the European Pharmacopoeia, the British 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 (b) where the drug is not so described but has an approved name, being the name which appears in the current edition (as defined in the said section 103(5)) 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;

“pharmaceutical list” has the meaning assigned to it in regulation 5;

“pharmaceutical services” means those services as defined by section 27 of the Act;

“pharmacist” means a pharmacist within the meaning of section 132(1) of the Medicines Act 1968;

“pharmacist contractor” means a contractor who provides pharmaceutical services, or a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968;

“provisional pharmaceutical list” has the meaning assigned to it in regulation 6;

“registered pharmacy” means a registered pharmacy within the meaning of section 74 of the Medicines Act 1968;

“relevant service” means whole-time service in the armed forces of the Crown in a national emergency or otherwise, or compulsory whole-time service in those forces, including service resulting from any reserve liability, or any equivalent service by a person liable for compulsory whole-time service in those forces;

“scheduled drug” means a drug or other substance specified in Schedule 10 to the National Health Service (General Medical Services) (Scotland) Regulations 1995, or except where the conditions in paragraph 31(2) of the doctors' terms of service are satisfied, in Schedule 11 to those Regulations.

“supplemental services” has the meaning assigned to it in regulation 3(3);

“terms of service” means the terms of service for pharmacists contained or referred to in Schedule 1.

(2) These Regulations shall apply to a person, firm or body corporate (other than a doctor or dental practitioner) providing pharmaceutical services (which includes the supply of appliances by appliance suppliers) as they apply to a pharmacist.

(3) Unless the context otherwise requires—

(a) any reference in these Regulations—

(i) to a numbered regulation is a reference to the regulation bearing that number in these Regulations,

(ii) to a numbered Part or Schedule is a reference to the Part of, or Schedule to, these Regulations bearing that number,

(iii) to a form thereby prescribed includes a form substantially the same; and

(b) any reference in a regulation or in a Schedule to these Regulations to a numbered paragraph is a reference to the paragraph bearing that number in that regulation or Schedule.

Pharmaceutical services

3.—(1) The arrangements for the provision of pharmaceutical services shall include arrangements for—

(a) the supply of contraceptive substances and appliances;

(b) the provision of supplemental services;

(c) subject to paragraph (8) the provision of hypodermic needle exchange services.

(2) The arrangements referred to in paragraph (1) shall incorporate the terms of service for pharmacists set out in Schedule 1 to these Regulations.

(3) In these Regulations “supplemental services” means—

(a) where a registered pharmacy regularly supplies drugs and medicines to be taken by persons resident in a home, the giving of advice by him, or by a pharmacist employed by him, following a visit to that home in connection with procedures there for the safe keeping and correct administration of those drugs and medicines;

(b) the keeping of records of such visits as are referred to in sub-paragraph (a);

(c) the keeping of records in connection with drugs and medicines supplied to or to be taken by any person—

(i) who claims exemption under regulation 7(1)(c) of the National Health Service (Charges for Drugs and Appliances) (Scotland) Regulations 1989(5) (exemption from charges for drugs and appliances), or

(ii) who, in the opinion of the pharmacist dispensing the drug or medicine, is likely to have difficulty understanding the nature and dosage of the drug or medicine dispensed and the times at which it is to be taken,

in circumstances where the nature of the drug or medicine is such that, in the opinion of the pharmacist who dispenses it, the same or a similar drug or medicine is likely to be prescribed for that person regularly on future occasions.

(4) In paragraph (3)—

(a) “home” means any one of—

(i) a nursing home within the meaning of the Nursing Homes Registration (Scotland) Act 1938(6), or

(ii) a residential or other establishment within the meaning of Part IV of Social Work (Scotland) Act 1968(7), or

(iii) a private hospital within the meaning of Part IV of the Mental Health (Scotland) Act 1984(8);

(b) “records” shall include—

(i) in the case of those kept pursuant to paragraph (3)(b), a record of the name and address of the home, of the date of each visit and of the nature of any advice given in the course of or following each such visit and to whom it was given, and

(ii) in the case of those kept pursuant to paragraph (3)(c), a record of the name and address of the person to or for whom the drug or medicine is supplied, of the name, quantity, and dosage and of the date on which the supply was made and any advice given in relation to the use of the drugs and medicines supplied.

(5) In these Regulations “hypodermic needle exchange services” means—

(a) the supply, free of charge, by a pharmacist to a person reasonably believed by that pharmacist to be a drug misuser of—

(i) hypodermic needles and syringes; and

(ii) equipment for the safe disposal of such needles and syringes;

(b) the receipt by a pharmacist from such a person and the subsequent safe disposal, both free of charge, of any used hypodermic needle or syringe;

(c) the provision of counselling to such a person by a trained pharmacist.

(6) In paragraph (5)—

(a) “drug misuser” means a person who is misusing drugs by self-injection;

(b) “trained pharmacist” means a pharmacist who has received relevant training prepared by the Post Qualification Education Board for Pharmacists in Scotland.

(7) A pharmacist 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 services and appliances, or

(b) included in any arrangements for the provision of “supplemental services”; or

(c) included in any arrangements for the provision of hypodermic needle exchange services.

(8) A Board shall agree to a pharmacist providing hypodermic needle exchange services only—

(a) after consulting its Chief Administrative Pharmaceutical Officer and its Chief Administrative Medical Officer and Director of Public Health; and

(b) if it is satisfied that such services are necessary or desirable in the area of the premises specified in the application.

(9) A pharmacist participating in arrangements for the provision of hypodermic needle exchange services shall maintain records in relation to those services which shall include—

(a) the number of hypodermic needles and syringes issued by him;

(b) an estimate of the number of used hypodermic needles and syringes received by him for disposal; and

(c) the number of persons to whom he has supplied hypodermic needles and syringes.

(10) A pharmacist may at any time give notice in writing to the Board that he wishes to cease to be included in arrangements for the provision of hypodermic needle exchange services either immediately or at such time as may be specified in the notice.

(11) The Board may at any time, by giving notice in writing to a pharmacist, terminate his involvement in arrangements for the provision of hypodermic needle exchange services either immediately or with effect from such date as may be specified in the notice.

Additional professional services

4.—(1) A pharmacist may undertake to provide additional professional services.

(2) In these Regulations “additional professional services” means—

(a) the setting aside in a pharmacy of an area for the display of health education material;

(b) the provision to the public of advice and counselling on medicines and appliances;

(c) the undertaking of clinical audits; and

(d) the publication by a pharmacist of a practice leaflet which shall—

(i) include the name, address and telephone number of the pharmacy and the hours in each day of the week during which that pharmacist provides pharmaceutical services from those premises;

(ii) detail the arrangements for dealing with after-hours and other urgent requirements from or in relation to that pharmacy;

(iii) state that National Health Service prescriptions are dispensed and which other National Health Service pharmaceutical services are provided; and

(iv) state that a pharmacist is available to advise and answer questions about medicines and the treatment of common ailments.

(3) In paragraph (2)(c) “clinical audit” means the systematic and critical analysis of the quality of clinical care.

Pharmaceutical list

5.—(1) The 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. The said list shall also state the nature of the pharmaceutical services to be provided, and the days and hours during which the premises are open, and show pharmacists 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 of Schedule 2 is appropriate or, in the case of an application to which the applicant proposes that paragraph (4) should apply, Form A(MR) set out in that Schedule.

(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,

(b) the Board is satisfied that the relocation is a minor relocation, and

(c) the condition specified in paragraph (5) is fulfilled,

the Board shall grant the application.

(5) The condition referred to in paragraphs (3)(b) and (4)(c) is that in either case the provision of the particular pharmaceutical services by the applicant will not be interrupted, except for any period during which, in terms of any scheme made under regulation 8(3) that applies to him, or any such longer period as the Board may for good cause allow, the provision of such services is not required.

(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 of the Board.

(7) Before satisfying itself that a relocation is a minor relocation the Board shall seek and take into account the views of the Area Pharmaceutical Committee and of the Chief Administrative Pharmaceutical Officer of the Board.

(8) In the case of an application to which paragraph (4)(a) applies, where the Board is not satisfied that the relation is a minor relocation, it shall not grant the application but shall notify the applicant in writing of its decision and of its reasons.

(9) Nothing in this regulation shall preclude or prevent an applicant from making an application in accordance with Form A or Form A(MR) in circumstances where the applicant considers that paragraph (4) may apply to such an application.

(10) 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 3 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.

(11) Where an application is granted, it shall be notified in accordance with whichever version of Form C set out in Schedule 2 is appropriate.

(12) Where an application is granted in accordance with paragraph (10), it shall be competent for the Board to grant it in respect of some only of the pharmaceutical services specified in that application.

(13) An application, in any case other than one to which paragraph (4) applies, which is made by a person who qualified to have his name registered under the Pharmacy Act 1954(9) by virtue of section 4A of that Act (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.

(14) 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.

Provisional pharmaceutical list

6.—(1) The Board may also in accordance with this regulation prepare a list, to be called “the provisional pharmaceutical list” in which there shall be included the name of any person, other than a doctor or dentist, who undertakes provisionally to provide pharmaceutical services. The provisional pharmaceutical list shall state the particulars required under regulation 5(1) in relation to any such person and also the date (“the provisional date”) from which such person undertakes to provide pharmaceutical services at the premises specified in an application under regulation 5(2).

(2) Where in any application under paragraph (2) of regulation 5 to which paragraph (4) or (10) of that regulation applies—

(a) any one or more of the statements in paragraph 2(b) of Form A or, as the case may be, Form A(MR), is negative, and

(b) the Board is satisfied on the basis of such information as may be submitted with the application that the applicant intends to commence business at the premises specified in the application in the event of his name being included in the pharmaceutical list,

the Board, in the case of an application to which paragraph (10) of regulation 5 applies, shall notify and otherwise deal with the application in accordance with that paragraph and Schedule 3 or, in the case of an application to which paragraph (4) of that regulation applies, shall deal with it in accordance with that paragraph and in either case where the Board grants the application the Board may include the name of the applicant in the provisional pharmaceutical list for its area.

(3) Where an application is determined by the inclusion of the name of the applicant in the provisional pharmaceutical list, the Board shall give notification of the decision to the applicant in Form D set out in Schedule 2, and in this regulation any reference to “the date of inclusion” is to the date of inclusion in the provisional pharmaceutical list as stated in Form D.

(4) Subject to paragraph (5) the applicant shall, as soon as reasonably practicable after the date of inclusion and in any event not later than either—

(a) the date six months after the date of inclusion, or

(b) if earlier, the provisional date, submit Form B set out in Schedule 2 with any information required but not given in paragraph 2(b) of Form A or, as the case may be, Form A(MR), and on receipt of such information the Board shall include the name of the applicant in the pharmaceutical list and remove it from the provisional pharmaceutical list.

(5) Where a person whose name has been included in the provisional pharmaceutical list applies in writing to the Board not later than twenty eight days before the date by which, in terms of paragraph (4) above, he is required to submit Form B, that he wishes the Board to extend the period for submission of that Form and the Board is satisfied that, due to circumstances outwith that person’s control and which could not reasonably have been anticipated at the date of the application, there is no reasonable prospect of his being able to submit that Form by that date, the Board may extend the period for submission of Form B by a further period not exceeding nine months.

(6) Where an applicant, whose name is included in the provisional pharmaceutical list, has not submitted Form B in accordance with paragraphs (4) or (5), his name shall be removed from the provisional pharmaceutical list.

Removal from and amendment to pharmaceutical list

7.—(1) Where the Board determines in accordance with paragraph (3) that a person whose name has been included for the preceding six months in the pharmaceutical list has not during that period provided pharmaceutical services the Board shall remove that person’s name from the said list.

(2) Where a Board determines in accordance with paragraph (3) that the supply of equipment necessary to provide domiciliary oxygen therapy service is no longer required, either in total or in part, and this service or part thereof has not been provided for the preceding six months the Board may cancel or amend the contract to provide the domiciliary oxygen therapy service contracted for.

(3) Before making a determination under paragraphs (1) or (2), the Board shall—

(a) give the person 28 days' notice of its intention so to do,

(b) afford the person an opportunity of making written representations to the Board,

(c) consult the Area Pharmaceutical Committee.

(4) Nothing in paragraphs (1) and (2) shall—

(a) prejudice the right of a person to apply to be included again in the pharmaceutical list, or

(b) prevent a person from applying to increase the supply of equipment for domiciliary oxygen therapy service already provided, or

(c) affect a person who is performing a period of relevant service and in such a case no removal under paragraphs (1) or (2) shall be effected in respect of any such person until six months after he has completed that service.

Schemes for securing proper pharmaceutical service

8.—(1) The Board after consultation with the Area Pharmaceutical Committee shall prepare a scheme for testing the quality and checking the amounts of drugs and appliances supplied, and where appropriate the directions for use. The minimum number of tests to be made annually shall be specified in the scheme.

(2) For the purposes of a scheme prepared in accordance with paragraph (1), a drug or appliance dispensed and awaiting collection shall be deemed to be supplied.

(3) The Board, after consultation with the Area Pharmaceutical Committee, shall prepare a scheme for securing that one or more places of business on the pharmaceutical list in the area of the Board shall at all reasonable times be open. The scheme shall specify the days and hours during which such places shall be open, and the arrangements for the dispensing of medicines required urgently at other times.

(4) The provisions of schemes prepared under paragraph (3) shall be subject to the approval of the Secretary of State.

(5) In the event of the Board and the Area Pharmaceutical Committee failing to agree on any provision of a scheme to be prepared under paragraph (3), the matter shall be referred to the Secretary of State, whose determination shall be final.

(6) Where the Board after consultation with the Area Pharmaceutical Committee, amends the provisions of a scheme approved under paragraph (4), the Area Pharmaceutical Committee or any person whose name is included in the pharmaceutical list may appeal in respect of any such amendment, and any such appeal—

(a) shall be made in writing and received by the Board within 21 days from the date on which notification of that amendment was published; and

(b) may be determined by the Secretary of State, or

(c) if he so decides, be determined in accordance with the procedures set out in paragraph 4(3) to (5) of Schedule 3 and paragraphs 9 to 15 of Schedule 4.

Payments to pharmacists and standards of drugs and appliances

9.  The Secretary of State shall after consultation with an organisation which is, in his opinion, representative of the general body of pharmacists cause to be prepared a statement (in these Regulations referred to as “the Drug Tariff”) which he may after such consultation amend from time to time and which shall include—

(a) the prices on the basis of which the payment for specified drugs (being drugs commonly prescribed) and appliances is to be calculated;

(b) the method of calculating the payment for drugs not specified in the Drug Tariff;

(c) the dispensing fees or other sums payable in respect of the supply of drugs and appliances and of supplemental services and additional professional services;

(d) arrangements for claiming fees, allowances and remuneration in connection with the making and implementation of arrangements for the provision of pharmaceutical services;

(e) the standards of quality for drugs;

(f) the list of appliances approved by the Secretary of State for the purposes of section 27 of the Act and the specifications for such appliances;

(g) the method by which a claim may be made for compensation for financial loss in respect of oxygen equipment;

(h) the list of chemical reagents approved by the Secretary of State for the purpose of section 27 of the Act and the specification for such chemical reagents.

Exercise of choice of pharmacist in certain cases

10.  An application to a pharmacist for pharmaceutical services may be made (other than by the pharmacist concerned) on behalf of any person who is incapable on account of sickness or infirmity by any duly authorised person.

Publication of particulars

11.—(1) The Board shall make available for inspection at its offices copies of—

(a) the pharmaceutical list,

(b) the terms of service for pharmacists,

(c) the Drug Tariff,

(d) any schemes made under regulation 8,

and shall keep them revised and up-to-date.

(2) The Board may make any of the documents described in paragraph (1) of this regulation available for inspection at such other places in its area as appear convenient for informing all persons interested, or may publish at such places a notice of the places and times at which copies of any of those documents may be inspected.

(3) Subject to paragraph (4) the Board shall send a copy of the medical list to all pharmacists providing pharmaceutical services in the area; and at intervals of not more than three months shall notify them of any alteration therein.

(4) If the Board considers that only portions of the medical list, or only some of the alterations thereto, are likely to concern any persons providing pharmaceutical services, it may send to such persons a copy of only those portions, or those alterations.

(5) The Board shall send a copy of the pharmaceutical list to the Secretary of State and to the area medical, dental and pharmaceutical committees, and shall within fourteen days of any alteration in the pharmaceutical list inform each of them thereof.

Service of documents

12.  Except where expressly provided to the contrary, any document which is required or authorised to be given or sent to a person or body under these Regulations (including the terms of service) may be given or sent by delivering it that person, or in the case of a body, to the secretary or general manager of that body or by sending it in a prepaid envelope addressed to him, or in the case of a body, to the secretary or general manager of that body at his usual or last known address.

Revocations

13.  The Regulations specified in column (1) of Schedule 5 are revoked to the extent specified in column (3) of that Schedule.

Fraser of Carmyllie

Minister of State, Scottish Office

St Andrew’s House,

Edinburgh

21st February 1995