Legalize / United Kingdom / Wales / Welsh-Statutory-Instrument

The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020

Type Welsh-Statutory-Instrument

Publication 2020-09-29

Last updated 2026-03-28

State In force

Jurisdiction Wales

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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If outline consent has already been granted a description and map of the area in respect of which consent has been granted.

43

Details of any other medical practice premises which have been granted premises approval or in respect of which an application has already been made but not yet determined by the Local Health Board.

Pharmaceutical services to be provided

44

The pharmaceutical services to be provided and the opening hours and days on which those services will be provided.

Prejudice test

45

The reasons why the applicant considers that granting the application will not prejudice the proper provision of primary medical services, dispensing services or pharmaceutical services in the controlled locality in which the premises specified in the application are situated.

Meeting identified needs

46

The reasons why the applicant considers it is necessary to grant the application in order to meet a need identified in a relevant pharmaceutical needs assessment.

Applicant’s undertaking

47

The applicant must give an undertaking that if the application is granted and outline consent and premises approval is in effect the applicant will provide the pharmaceutical services from the practice premises in respect of which the application is granted in accordance with the terms of service.

SCHEDULE 3 — Procedures to be followed by Local Health Boards to determine applications under the Regulations

PART 1 — Preliminary matters

General principles

1

(1) Except in so far as these Regulations provide to the contrary, a Local Health Board may determine an application submitted to it in such manner as it thinks fit.

(2) A Local Health Board must follow the procedure in regulation 15(4) in respect of an application submitted to it which does not contain all of the information that an applicant is required to provide in accordance with Schedule 2.

(3) A Local Health Board may if it thinks fit consider two or more applications together and in relation to each other but where it intends to do so it must give notice of that intention in writing to—

(a) the respective applicants, and

(b) where the application is one in respect of which notice must be given under paragraph 8, any other person that must be given notice of that application.

(4) Where in accordance with sub-paragraph (3) a Local Health Board considers two or more applications to which regulation 16(2) applies together and in relation to each other, it may refuse an application (notwithstanding the fact that it would if determining the application in isolation grant it) where the number of applications is such, or the circumstances in which they are made are such, that to grant all of them or more than one of them, would prejudice the proper provision of primary medical services, pharmaceutical services or dispensing services in the controlled locality within which the premises specified in the application are situated.

Timetable for determining applications

2

A Local Health Board must endeavour to determine an application as soon as is practicable after its receipt.

Persons prohibited from taking part in decision-making on applications

3

(1) No person is to take part in determining an application if they—

(a) are a person who is included in the pharmaceutical list or dispensing doctor list maintained by the Local Health Board, or are an employee of such a person,

(b) are a shareholder, director or company secretary of a company which runs a retail pharmacy business in the area of the Local Health Board,

(d) are an APMS contractor in the area of the Local Health Board, or is an officer, trustee or other person concerned with the management of a company, society or voluntary organisation or other body which is an APMS contractor, or is employed or engaged by such an APMS contractor, or

(e) are employed or engaged by the Local Health Board for the purposes of providing primary medical services within an LHBMS practice.

(2) No other person is to take part in determining an application if, because of an interest or an association they have, or because of a pressure to which they may be subject, their involvement would give rise to a reasonable suspicion of bias.

PART 2 — Determination of controlled localities

Notice of proposed determination in respect of controlled localities

4

(1) If a Local Health Board decides that an application by a Local Medical Committee or a Local Pharmaceutical Committee cannot be considered by virtue of regulation 13(3) (areas that are controlled localities), the Local Health Board must take no action in relation to that application other than to notify the applicant of that fact and of its right of appeal against that decision under regulation 14 (appeals).

(2) In all other cases, before making a determination under regulation 13(2) a Local Health Board must give a written notice of proposed determination to—

(a) the Local Medical Committee in its area,

(b) the Local Pharmaceutical Committee in its area,

(d) any person included in a pharmaceutical list maintained by the Local Health Board and any provider of local pharmaceutical services under a pilot scheme or any provider of primary medical services in the area for which the Local Health Board is established who, in the opinion of the Local Health Board, may be affected by the determination.

(3) A notice of proposed determination must inform the person notified of their right to make representations (or in the case of a Local Medical Committee or Local Pharmaceutical Committee being notified that applied for the determination any further representations) in writing on the proposed determination within 30 days of the date on which the notice was sent to them.

Deferral of applications

5

Where a Local Health Board has issued a notice of proposed determination it must defer consideration of any application submitted under Part 5 or Part 6 of these Regulations but not determined by it if the application could be affected by the proposed determination until—

(a) it has determined whether or not the locality is or is part of a controlled locality and the period for bringing an appeal relating to that determination has ended, or

(b) the date of the determination of any such appeal.

Imposition of conditions

6

Where a Local Health Board determines whether or not any particular area within the area for which it is established is, because it is rural in character, a controlled locality or part of a controlled locality it—

(a) must consider whether the provision of—

(i) primary medical services by a provider of such services (other than itself),

(ii) pharmaceutical services by an NHS pharmacist or NHS appliance contractor,

(iii) local pharmaceutical services provided under a pilot scheme, or

(iv) pharmaceutical services by a doctor,

is likely to be adversely affected as a consequence of that determination, and

(b) may, where it is of the opinion that any of those services are likely to be adversely affected, impose conditions to postpone, for such period as it thinks fit, the making or termination of arrangements under regulation 26 (arrangements for the provision of pharmaceutical services by doctors) or equivalent provision under the GMS Regulations for the provision by a doctor or GMS contractor of pharmaceutical services or dispensing services to patients on the relevant patient list.

Notification of determination and action following determination

7

(1) Once a Local Health Board has determined the question of whether or not any particular area within the area for which it is established is, because it is rural in character, a controlled locality or part of a controlled locality it must—

(a) as soon as practicable after reaching a determination give notice in writing to those notified under paragraph 4(2) informing them of—

(i) the determination and the reasons for it,

(ii) any conditions that it has imposed under paragraph 6, and

(iii) any rights of appeal under Schedule 4, and

(b) as soon as practicable after the relevant date—

(i) delineate precisely on a map the boundaries of the controlled locality or remove the delineated boundary of a locality that has ceased to be a controlled locality,

(ii) give a doctor that is affected reasonable notice of any conditions that have been imposed under paragraph 6 as a result of the determination, and

(iii) proceed to determine any applications that have been deferred under paragraph 5.

(2) For the purposes of this paragraph, “the relevant date” is the later of—

(a) the date on which the period for bringing an appeal relating to the determination ends, or

(b) the date of the determination of any such appeal.

PART 3 — Applications for inclusion in or amendment to pharmaceutical lists and dispensing doctor lists

Notice of certain applications

8

(1) This paragraph applies to applications for—

(a) inclusion in, or to make an amendment to, a—

(i) pharmaceutical list made under Part 5 of these Regulations, except for applications under regulation 22 (applications involving a change of ownership), and

(ii) dispensing doctor list made under Part 6 of these Regulations,

(b) an extension of the relevant time period under regulation 24, and

(c) a further determination as to whether premises are, or a relevant location is, in a reserved location under regulation 17(2).

(2) The Local Health Board to which the application was submitted must give notice in writing of the application in accordance with paragraph 9.

(3) Those notified of an application may within 30 days of the date on which the notification was sent to them, make representations on the application, in writing, to the Local Health Board to which the application was submitted, except for applications made pursuant to regulation 21 (applications involving temporary relocation).

Persons and bodies to be notified

9

(1) The persons and bodies that must be notified by a Local Health Board are—

(a) the Local Pharmaceutical Committee,

(b) the Local Medical Committee,

(i) included in a pharmaceutical list maintained by it, or

(ii) who has been granted preliminary consent for inclusion in a pharmaceutical list, whose interests might, in the opinion of the Local Health Board, be significantly affected if the application is granted,

(d) any provider of local pharmaceutical services under a pilot scheme in the area for which the Local Health Board is established whose interests might, in the opinion of the Local Health Board, be significantly affected if the application is granted,

(e) the Citizen Voice Body,

(f) any patient group, consumer group or community group in the area of the Local Health Board that it considers has a significant interest in the provision of pharmaceutical services in the area,

(g) where the premises specified in the application are in a controlled locality, any person (except itself) who is a provider of primary medical services within the Local Health Board’s area or who is included in the dispensing doctor list maintained by the Local Health Board whose interests might, in the opinion of the Local Health Board, be significantly affected if the application is granted,

(h) any Local Health Board or equivalent body any part of whose area is within 2 kilometres of the premises or the location of the premises specified in the application, and

(i) in the case of an application made under regulation 20 (applications involving relocation between neighbouring Local Health Board areas), the Local Health Board from whose area the applicant wishes to relocate.

(2) A Local Health Board that provided the notification under sub-paragraph (1)(h) must—

(a) within 14 days of receiving the notification give notice in writing to the persons and bodies specified in sub-paragraph (1)(a) to (g) that are within or that serve the area for which the Local Health Board is established, and

(b) notify the Local Health Board that provided the notification under sub-paragraph (1) that it has provided the notification required by sub-paragraph (2)(a).

(3) An equivalent body notified under sub-paragraph (1)(h) may request the Local Health Board to give notification to such persons in the area for which the equivalent body is established whose interests might in the opinion of the equivalent body, be significantly affected if the application is granted and the Local Health Board must comply with any such request.

Content of notification

10

A notification of an application under paragraph 8 must—

(a) inform the person or body notified—

(i) of their right to make representations on the application under paragraph 8(3),

(ii) the circumstances in which the Local Health Board may require an oral hearing to be held under paragraph 11, and

(iii) if the Local Health Board intends to consider the application together with and in relation to any other application, of that intention,

(b) provide a copy of the application submitted by the applicant to enable the person or body notified to make informed representations with regard to whether or not the application should be granted, and

(c) where regulation 17(1) applies to an application under paragraph 8(1)(a) inform the person or body notified that the Local Health Board will be determining whether the premises or relevant location specified in the application that are in a controlled locality are also in a reserved location.

Oral hearings

11

(1) In the case of an application falling within paragraph 8, a Local Health Board may require an oral hearing to be held if it considers it is necessary to hear oral representations before determining such an application.

(2) If the Local Health Board does decide to hold an oral hearing, it must—

(a) give not less than 14 days’ notice of the time and place of the hearing to—

(i) the applicant, and

(ii) any person who has made representations on the application under paragraph 8(3),

(b) advise the applicant who has been given notice of the hearing, and

(3) Any person mentioned in sub-paragraph (2) wishing to make oral representations at the hearing may be assisted in the presentation of their representations by another person and may be represented by that other person at the hearing, including where the person notified under sub-paragraph (2) is unable to attend the hearing in person.

(4) A Local Health Board may determine the procedure to be followed at the oral hearing.

(5) A Local Health Board is not bound by any recommendations arising from an oral hearing.

Information to which a Local Health Board must have regard

12

In determining an application falling within paragraph 8, a Local Health Board must have regard, in particular, to—

(a) any representations received by the Local Health Board under paragraph 8(3),

(b) any recommendations arising from an oral hearing, if one is held under paragraph 11,

(d) any other information available to the Local Health Board which, in its opinion, is relevant to the consideration of the application.

Imposition of conditions

13

(1) This sub-paragraph applies where a Local Health Board decides to grant an application falling within—

(a) paragraph 8(1)(a)(i) where the premises specified in the application are in a controlled locality, or

(b) paragraph 8(1)(a)(ii).

(2) Where sub-paragraph (1) applies, a Local Health Board—

(a) must consider whether the provision of—

(i) primary medical services by a provider of such services (other than itself),

(ii) pharmaceutical services by an NHS pharmacist or NHS appliance contractor,

(iii) local pharmaceutical services provided under a pilot scheme, or

(iv) pharmaceutical services by a doctor,

is likely to be adversely affected as a consequence of its decision to grant the application, and

(b) may, where it is of the opinion that the provision of any of those services listed in sub-paragraph (2)(a) is likely to be adversely affected, impose conditions to postpone, for such period as it thinks fit, the making or termination of arrangements under regulation 26 (arrangements for the provision of pharmaceutical services by doctors) or equivalent provision by a doctor or GMS contractor of pharmaceutical services or dispensing services to patients on the relevant list.

Notification of decisions: applications for inclusion in or to make an amendment to a pharmaceutical list

14

(1) A Local Health Board must, as soon as is practicable after reaching a decision on an application falling within paragraph 8(1)(a)(i), give notice in writing of its decision (including the questions of the imposition of conditions under paragraph 13 and the determination of a reserved location under regulation 17(1)) to—

(a) the applicant, and

(b) any person who made representations on the application to the Local Health Board in accordance with paragraph 8(3).

(2) In the case of an application which is determined under regulation 22 (applications involving a change of ownership), a Local Health Board must as soon as practicable after reaching a decision give notice in writing in accordance with paragraph 9.

(3) A notification of a decision under this paragraph must include a statement of the reasons for the decision and of any rights of appeal.

Notification of decisions: applications for inclusion in or amendment to dispensing doctor lists

15

(1) A Local Health Board must, as soon as is practicable after reaching a decision on an application falling within paragraph 8(1)(a)(ii), give notice in writing of its decision (including the question of the imposition of conditions under paragraph 13) to—

(a) the applicant, and

(b) any person who made representations on the application to the Local Health Board in accordance with paragraph 8(3).

(2) A notification of a decision under this paragraph must include a statement of the reasons for the decision and of any rights of appeal.

Notification of decisions: applications under regulation 24 for extension of the relevant period

16

(1) A Local Health Board must, as soon as practicable after reaching a decision on an application falling within paragraph 8(1)(b), give notice in writing of its decision to—

(a) the applicant, and

(b) any person who made representations on the application to the Local Health Board in accordance with paragraph 8(3).

(2) Any notification of a decision under this paragraph must include a statement of the reasons for the decision.

Notification of decisions: applications under regulation 17(2)

17

(1) A Local Health Board must, as soon as practicable after reaching a decision on an application falling within paragraph 8(1)(c), give notice in writing of its decision to—

(a) the applicant, and

(b) any person who made representations on the application to the Local Health Board in accordance with paragraph 8(3).

(2) A notification of a decision under this paragraph must include a statement of the reasons for the decision and of any rights of appeal.

Action following determination in respect of reserved locations

18

(1) After determining an application under regulation 17(2) or making a determination in accordance with regulation 17(1), as soon as practicable after the relevant date, the Local Health Board must delineate precisely on a map the boundaries of any reserved location that it has determined, or remove the delineated boundary of a location that has ceased to be a reserved location, as the case may be.

(2) For the purposes of this paragraph, “the relevant date” is the later of—

(a) the date on which the period for bringing an appeal relating to the determination ends, or

(b) the date of the determination of any such appeal.

SCHEDULE 4 — Appeals to the Welsh Ministers

PART 1 — Preliminary matters

General principles

1

Except in so far as these Regulations provide to the contrary, the Welsh Ministers may determine an appeal submitted to them in such manner as they think fit and may, in particular—

(a) consider all information available to them which, in their opinion, is relevant to the determination of an appeal;

(b) consider two or more appeals together and in relation to each other (but they are not obliged to do so where the Local Health Board has determined two or more applications together and in relation to each other) but where they intend to do so they must give notice of that intention to each appellant and those given notice of each appeal in accordance with this Schedule;

(c) where in accordance with sub-paragraph (b) the Welsh Ministers consider two or more appeals to which regulation 15(2) applies together and in relation to each other, they may refuse an appeal (notwithstanding the fact that they would if determining the appeal in isolation grant it) where the number of appeals is such, or the circumstances in which they are made are such, that to grant all of them or more than one of them, would prejudice the proper provision of primary medical services, pharmaceutical services or dispensing services in the controlled locality within which the premises specified in the appeal are situated;

(d) remit an appeal submitted to them to a Local Health Board for re-determination in cases where the information that the applicant is required to provide in accordance with Schedule 2 was incomplete;

(e) dismiss an appeal if they are of the opinion that the notice of appeal—

(i) is not valid because it does not comply with the requirements of this Schedule,

(ii) does not disclose any reasonable grounds of appeal, or

(iii) is otherwise vexatious or frivolous.

Oral hearings

2

(1) The Welsh Ministers may require an oral hearing to be held if they consider that it is necessary to hear oral representations before determining an appeal submitted to them.

(2) If the Welsh Ministers decide to hold an oral hearing, they must—

(a) appoint one or more persons to hear and to report to them on the appeal,

(b) give not less than 14 days’ notice of the time and place of the hearing to the appellant and to any person sent a copy of the notice of appeal under paragraph 4 or 7,

(d) advise those notified that they may make oral representations relating to the appeal at the hearing.

(3) Any person mentioned in sub-paragraph (2) wishing to make oral representations at the hearing may be assisted in the presentation of their representations by another person and may be represented by that other person at the hearing, including where the person notified under sub-paragraph (2) is unable to attend the hearing in person.

(4) The person or persons appointed by the Welsh Ministers to hear the appeal may determine the procedure to be followed at the hearing.

(5) The Welsh Ministers are not bound by any recommendations arising from an oral hearing.

PART 2 — Appeals against decisions determining controlled localities

Right of appeal to the Welsh Ministers

3

(1) Where a Local Health Board has decided that an application by a Local Medical Committee or a Local Pharmaceutical Committee cannot be considered by virtue of regulation 13(3) (areas that are controlled localities), the applicant may submit a notice of appeal against that decision to the Welsh Ministers.

(2) Where a Local Health Board has determined under regulation 13(2) whether or not any particular area within the area for which it is established is, because it is rural in character, a controlled locality or part of a controlled locality, the persons entitled to submit a notice of appeal against that determination to the Welsh Ministers are—

(a) the Local Medical Committee,

(b) the Local Pharmaceutical Committee, and

(c) any person included in a pharmaceutical list maintained by the Local Health Board, any provider of local pharmaceutical services under a pilot scheme or any provider of primary medical services in the area for which the Local Health Board is established and who were given notice of the determination by the Local Health Board under paragraph 7(1) of Schedule 3.

(3) Where a Local Health Board has determined that it should or should not postpone the making or termination of arrangements, as mentioned in paragraph 6(b) of Schedule 3, those that may submit a notice of appeal against that determination to the Welsh Ministers are—

(a) the Local Medical Committee,

(b) the Local Pharmaceutical Committee, and

(c) any person included in a pharmaceutical list maintained by the Local Health Board, any provider of local pharmaceutical services under a pilot scheme or any provider of primary medical services in the area for which the Local Health Board is established and who were given notice of the determination by the Local Health Board under paragraph 7(1) of Schedule 3.

(4) A notice of appeal is valid if—

(a) it is submitted by a person with the right of appeal under sub-paragraph (1), (2) or (3),

(b) it is sent to the Welsh Ministers within 30 days of the date on which notice of the decision being appealed was sent by the Local Health Board to the person making the appeal, and

Notification of appeals

4

(1) The Welsh Ministers must on receipt of a notice of appeal submitted under paragraph 3(1) send a copy of the notice to the Local Health Board.

(2) The Welsh Ministers must on receipt of a notice of appeal submitted under paragraph 3(2) or 3(3) send a copy of the notice to—

(a) the Local Health Board, and

(b) those persons to whom the Local Health Board has given notice of its determination under paragraph 7(1) of Schedule 3.

(3) Those sent a copy of the notice of appeal under sub-paragraphs (1) to (3) must, at the same time, be informed by the Welsh Ministers—

(a) that they may within 30 days of the date on which the notice of appeal was sent to them, make representations on the appeal in writing to the Welsh Ministers, and

(b) of the circumstances in which the Welsh Ministers may require an oral hearing to be held.

Decision on appeals

5

(1) The Welsh Ministers must after reaching a decision on an appeal submitted under paragraph 3 give written notice of their decision together with the reasons for it to those persons sent a copy of the notice of appeal under paragraph 4.

(2) The Welsh Ministers—

(a) must, where they allow an appeal against a decision by a Local Health Board that an application cannot be considered by virtue of regulation 13(3), either—

(i) themselves determine the question of whether or not the particular locality is or is part of a controlled locality, or

(ii) remit the question to the Local Health Board for determination,

(b) may, where the Local Health Board, on determining the application, considered the imposition of conditions under paragraph 6 of Schedule 3, themselves consider whether to impose conditions,

(c) may, where the Local Health Board, on determining the application, has not considered the imposition of conditions under paragraph 6 of Schedule 3 either—

(i) themselves consider whether to impose conditions, or

(ii) remit the question to the Local Health Board for determination,

(d) may, where the Local Health Board, on determining the application, considered the question whether to postpone the making or termination of arrangements under regulation 26 (or equivalent provision under the GMS Regulations) for the provision by a doctor or a GMS contractor of pharmaceutical services or dispensing services to patients, themselves postpone, for such period as they think fit, the making or termination of such arrangements, or

(e) must, where the Local Health Board, did not consider the question whether to postpone the making or termination of arrangements under regulation 26 (or equivalent provision under the GMS Regulations) for the provision by a doctor or a GMS contractor of pharmaceutical services or dispensing services to patients, remit the question to the Local Health Board for determination.

PART 3 — Appeals against decisions for inclusion in or amendment to pharmaceutical lists and dispensing doctor lists

Right of appeal to the Welsh Ministers

6

(1) For applications to which paragraph 8(1)(a) and (c) of Schedule 3 apply, the persons entitled to submit a notice of appeal against the decision of the Local Health Board to the Welsh Ministers are—

(a) the applicant;

(b) any of the following who made representations on the application to the Local Health Board under paragraph 8(3) of Schedule 3—

(i) any person included in a pharmaceutical list,

(ii) any person who has been granted preliminary consent for inclusion in a pharmaceutical list,

(iii) any provider of local pharmaceutical services under a pilot scheme, and

(iv) where the premises specified in an application are in a controlled locality, any person who is a provider of primary medical services or who is included in the dispensing doctor list.

(2) In the case of an application determined under regulation 22 (applications involving a change of ownership), the persons entitled to submit a notice of appeal to the Welsh Ministers are—

(a) the applicant, and

(b) any of the following who were, under paragraph 14(2) of Schedule 3, given notice of the Local Health Board’s decision on the application—

(i) any person included in a pharmaceutical list,

(ii) any person who has been granted preliminary consent for inclusion in a pharmaceutical list,

(iii) any provider of local pharmaceutical services under a pilot scheme, and

(iv) where the premises specified in the application are in a controlled locality, any person who is a provider of primary medical services or who is included in the dispensing doctor list.

(3) A notice of appeal is valid if—

(a) it is submitted by a person with the right of appeal under sub-paragraph (1) or (2),

(b) it is sent to the Welsh Ministers within 30 days of the date on which notice of the decision being appealed was sent by the Local Health Board to the person making the appeal, and

(c) it contains a statement of the grounds of appeal which do not amount to a challenge to the legality or reasonableness of a pharmaceutical needs assessment, or to the fairness of the process by which the Local Health Board undertook that assessment.

Notification of appeals

7

(1) The Welsh Ministers must, on receipt of a notice of appeal submitted under paragraph 6(1), send a copy of the notice to—

(a) the applicant, if the applicant has not submitted the notice of appeal,

(b) the Local Health Board, and

(2) The Welsh Ministers must, on receipt of a notice of appeal submitted under paragraph 6(2), send a copy of the notice to—

(a) the applicant, if the applicant has not submitted the notice of appeal,

(b) the Local Health Board, and

(3) The persons to whom a copy of the notice of appeal is sent under this paragraph must, at the same time, be informed by the Welsh Ministers—

(a) that they may, within 30 days of the date on which the notice of appeal was sent to them, make representations on the appeal in writing to the Welsh Ministers,

(b) of the circumstances in which the Welsh Ministers may require an oral hearing to be held, and

(c) where the Welsh Ministers intend to consider two or more appeals together and in relation to each other, of that intention.

Decision on appeals

8

(1) On determining an appeal made under paragraph 6, the Welsh Ministers must either—

(a) allow the appeal, or

(b) confirm the decision of the Local Health Board.

(2) In the case where the premises specified in an application that is subject to appeal are in a controlled locality, the Welsh Ministers—

(a) may, where the Local Health Board, on determining the application, considered whether to impose conditions under paragraph 13 of Schedule 3 or regulation 17(6)(b), themselves consider whether to impose conditions to postpone, for such period as they think fit, the making or termination of such arrangements, or

(b) must, where the Local Health Board on determining the application has not considered whether to impose conditions under paragraph 13 of Schedule 2 or regulation 17(6)(b) either—

(i) themselves consider whether to impose conditions, or

(ii) remit the question to the Local Health Board for determination.

(3) The Welsh Ministers must after reaching a decision on an appeal, including the imposition of conditions under sub-paragraph (2), give written notice of their decision together with the reasons for it to those persons sent a copy of the notice of appeal under paragraph 7.

Effect of decisions by the Welsh Ministers

9

For the purposes of these Regulations, the Welsh Ministers’ decision becomes the Local Health Board’s decision on the matter (but no further appeal to the Welsh Ministers on that decision is possible, unless the Welsh Ministers’ decision is overruled by a court).

SCHEDULE 5 — Terms of service for NHS pharmacists who provide pharmaceutical services in particular by the provisions of drugs

PART 1 — General

Interpretation

1

In this Schedule, drugs or appliances are to be taken to be requested or provided in accordance with a repeatable prescription even if the person who wishes to obtain pharmaceutical services does not present that prescription, as long as—

(a) the NHS pharmacist has that prescription in their possession, and

(b) that person presents, or the NHS pharmacist has in their possession, an associated batch issue.

Incorporation of provisions

2

Any provisions of the following affecting the rights and obligations of NHS pharmacists who provide pharmaceutical services form part of the terms of service—

(a) the Regulations,

(b) the Drug Tariff in so far as it lists drugs and appliances for the purposes of section 80 of the 2006 Act (arrangements for pharmaceutical services),

(i) investigations made by the pharmaceutical discipline committee and the joint discipline committee and action which may be taken by the Local Health Board as a result of such investigations, and,

(ii) appeals to the Welsh Ministers from decisions of the Local Health Board.

(d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 2 — Essential services

Essential services

3

For the purposes of this Schedule, “essential services” means—

(a) the services described in this Part, and

(b) the activities described in this Part to be carried out in connection with those services.

Dispensing services

4

An NHS pharmacist must, to the extent that paragraphs 5 to 9 require and in the manner described in those paragraphs, provide proper and sufficient drugs and appliances to persons presenting a prescription for that drug or appliance signed by a prescriber in pursuance of their functions in the health service in Wales, England, Scotland or Northern Ireland and persons presenting an order for an ophthalmic listed appliance or an ophthalmic listed medicine signed by a qualifying optometrist in pursuance of their functions in the health service in Wales.

Dispensing of drugs and appliances

5

(1) Subject to the following provisions of this Part, where a person presents on a prescription form—

(a) an order for drugs, not being Scheduled drugs, or for appliances, not being restricted availability appliances, signed by a prescriber,

(b) an order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations (drugs or medicines to be ordered only in certain circumstances), signed by, and endorsed on its face with the reference “SLS” by a prescriber, or

(c) an order for a restricted availability appliance, signed by and endorsed on its face with the reference “SLS” by a prescriber,

an NHS pharmacist must, with reasonable promptness and in accordance with any directions given by the prescriber in the prescription form, provide the drugs so ordered, and such of the appliances so ordered they supply in the normal course of business.

(2) Subject to the following provisions of this Part, where any person—

(a) presents a non-electronic repeatable prescription which contains—

(i) an order for drugs, not being Scheduled drugs or controlled drugs within the meaning of the Misuse of Drugs Act 1971³⁴, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001³⁵ (which relate to controlled drugs excepted from certain prohibitions under the Regulations), signed by a repeatable prescriber,

(ii) an order for appliances, not being restricted availability appliances, signed by a repeatable prescriber, or

(iii) an order for a restricted availability appliance, signed by, and endorsed on its face with the reference “SLS” by a repeatable prescriber,

and also presents an associated batch issue, or

(b) requests the provision of drugs or appliances in accordance with an electronic repeatable prescription which contains an order of a kind specified in paragraph (a)(i) to (iii),

an NHS pharmacist must, with reasonable promptness and in accordance with any directions given by the repeatable prescriber in the repeatable prescription, provide the drugs so ordered, and such of the appliances so ordered as they supply in the normal course of their business.

(3) For the purposes of this paragraph, a non-electronic repeatable prescription for drugs or appliances is to be taken to be presented even if the person who wishes to obtain the drugs or appliances does not present that prescription, where—

(a) the NHS pharmacist has that prescription in their possession, and

(b) that person presents, or the NHS pharmacist has in their possession, an associated batch issue.

Supply in accordance with a SSP

6

(1) This sub-paragraph applies where—

(a) a person requests a drug or appliance from an NHS pharmacist in accordance with a prescription form or repeatable prescription, and

(b) a SSP has effect in respect of—

(i) the requested drug or appliance, or

(ii) drugs or appliances of a specified description, and the requested drug or appliance is of that description.

(2) Where sub-paragraph (1) applies, the NHS pharmacist must consider whether it is reasonable and appropriate to supply in accordance with the SSP instead of in accordance with the prescription form or repeatable prescription.

(3) Where sub-paragraph (1) applies, the NHS pharmacist may provide a different product or quantity of product to the product or quantity of product ordered on the prescription form or repeatable prescription, where—

(a) the NHS pharmacist is able to do so with reasonable promptness,

(b) to do so is in accordance with the SSP, and

(c) the supply of a different product or quantity of product to that ordered by the prescriber is by or under the direct supervision of a registered pharmacist who is of the opinion, in the exercise of their professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is reasonable and appropriate.

(4) Where an NHS pharmacist, in accordance with sub-paragraph (3), provides a different product or quantity of product to that ordered by the prescriber—

(a) the registered pharmacist mentioned in sub-paragraph (3)(c) must endorse the prescription or the associated batch issue accordingly (if the manner for making the endorsement is provided for in the Drug Tariff, in the manner provided for in the Drug Tariff), and the prescription or associated batch issue as so endorsed is treated as being the prescription for product reimbursement purposes (even though the supply is not in pursuance of that prescription), and

(b) if the patient to or for whom the product is provided is on a patient list, and the supply—

(i) by virtue of regulation 226A(5)(c)(iii) of the Human Medicines Regulations 2012 (sale etc. by a pharmacist in accordance with a serious shortage protocol), is of a prescription only medicine that is different to but has a similar therapeutic effect to the product ordered by the prescriber, or

(ii) is of any other type, and the Welsh Ministers and the person who is, for the time being, the person consulted under section 89(1)(a) of the 2006 Act in respect of pharmaceutical remuneration of NHS pharmacists, acting jointly, have issued and publicised in such manner as they see fit a recommendation to the effect that, for clinical reasons, in the case of supplies of that type, providers of primary medical services should be notified of a supply to a patient on their patient list that is in accordance with a SSP instead of in accordance with a prescription form or repeatable prescription,

the NHS pharmacist must notify the provider of primary medical services on whose patient list the patient is, of the supply in accordance with the SSP instead of in accordance with the prescription form or repeatable prescription.

(5) Where—

(a) sub-paragraph (1) applies,

(b) a registered pharmacist is of the opinion, in the exercise of their professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate, and

(c) the NHS pharmacist is able to supply the product or quantity of product ordered by the prescriber within a reasonable timescale but not with reasonable promptness,

the requirements to act with reasonable promptness in paragraph 5(1) and (2) are to be read as requirements to act within a reasonable timescale.

Urgent supply without a prescription

7

(1) This paragraph applies where, in a case of urgency, a prescriber requests an NHS pharmacist to provide a drug or appliance.

(2) The NHS pharmacist may provide the drug or appliance requested before receiving a prescription form or repeatable prescription in respect of that drug or appliance, provided that—

(a) in the case of a request for a drug, the drug is neither—

(i) a Scheduled drug, nor

(ii) a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001, and

(b) in the case of a request for a drug or an appliance, the prescriber undertakes to—

(i) give the NHS pharmacist a non-electronic prescription form or non-electronic repeatable prescription in respect of the drug or appliance within 72 hours of the request being made, or

(ii) give the NHS pharmacist an electronic prescription form or electronic repeatable prescription complying with the ETP service within 72 hours of the request being made.

Preliminary matters before providing ordered drugs or appliances

8

(1) If the person presenting the prescription form or repeatable prescription, or requesting the provision of drugs or appliances in accordance with a repeatable prescription, asks the NHS pharmacist to do so—

(a) the NHS pharmacist must give an estimate of the time when the drugs or appliances will be ready, and

(b) if they are not ready by then, the NHS pharmacist must give a revised estimate of the time when they will be ready (and so on).

(2) Before providing any drugs or appliances in accordance with a prescription form or a repeatable prescription—

(a) the NHS pharmacist must ask any person who makes a declaration that the person named on the prescription form or the repeatable prescription does not have to pay the charges specified in regulation 3(1) of the Charges Regulations (supply of drugs and appliances by chemists) by virtue of either—

(i) entitlement to exemption under regulation 8(1) (exemptions) of the Charges Regulations, or

(ii) entitlement to remission of such charges under regulation 5 of the Remission of Charges Regulations (remissible NHS charges),

to produce satisfactory evidence of such entitlement, unless the declaration is in respect of entitlement to exemption by regulation 8(1) of the Charges Regulations or in respect of entitlement to remission by virtue of sub-paragraphs (a) to (f) of regulation 5(2) of the Remission of Charges Regulations, and at the time of the declaration such evidence is already available to the NHS pharmacist, and

(b) if no satisfactory evidence, as required by paragraph (a), is produced to the NHS pharmacist, the NHS pharmacist must endorse the form on which the declaration is made to that effect.

(3) Sub-paragraph (2) applies to the provision of a drug or appliance in accordance with a SSP as it does to the provision of a drug or appliance in accordance with a prescription form or a repeatable prescription (or an associated batch issue), and for these purposes, the prescription for product reimbursement purposes, as mentioned in paragraph 6(4)(a), is treated as being the prescription in accordance with which the drug or appliance is provided (even though the supply is not in pursuance of that prescription).

Providing ordered drugs or appliances

9

(1) Where an NHS pharmacist is presented with a prescription form or a repeatable prescription, the NHS pharmacist must only provide the drugs or appliances so ordered—

(a) if the prescription form or repeatable prescription is duly signed and endorsed as described in paragraph 5(1) or (2), and

(b) in accordance with the order and any directions given by the prescriber on the prescription form or repeatable prescription,

subject to any regulations in force under the Weights and Measures Act 1985³⁶ and the following provisions of this Part.

(2) Drugs or appliances so ordered must be provided either by or under the ... supervision of a registered pharmacist.

(3) Where the pharmacist referred to in sub-paragraph (2) is employed by an NHS pharmacist, the registered pharmacist must not be someone—

(a) who is disqualified from inclusion in a relevant list, or

(b) who is suspended from the General Pharmaceutical Council Register.

(4) If the order is for, or a product to be provided in accordance with a SSP is, an appliance of a type requiring measuring and fitting (for example a truss), the NHS pharmacist must make all necessary arrangements—

(a) for measuring the person named on the prescription form or repeatable prescription for the appliance, and

(b) for fitting the appliance.

(5) If the order is for, or a product to be provided in accordance with a SSP is, a drug or appliance included in the Drug Tariff, the British National Formulary (including any Appendix published as part of that Formulary), the Dental Practitioner’s Formulary, the European Pharmacopoeia or the British Pharmaceutical Codex, the drug or appliance provided must comply with the standard or formula specified therein.

(6) If the order—

(a) is an order for a drug, but

(b) is not an order for a controlled drug within the meaning of the Misuse of Drugs Act 1971 other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001,

and does not prescribe its quantity, strength or dosage, an NHS pharmacist may provide the drug in such strength and dosage as in the exercise of their professional skill, knowledge and care they consider to be appropriate and, subject to sub-paragraph (7), in such quantity as they consider to be appropriate for a course of treatment for a period not exceeding 5 days.

(7) Where an order to which sub-paragraph (6) applies is for—

(a) an oral contraceptive substance;

(b) a drug, which is available for supply as part of pharmaceutical services only together with one or more other drugs, or

(c) an antibiotic in a liquid form for oral administration in respect of which pharmaceutical considerations require its provision in an unopened package,

which is not available for provision as part of pharmaceutical services except in such packages that the minimum size available contains a quantity appropriate to a course of treatment for a period of more than 5 days, the NHS pharmacist may provide the minimum size available package.

(8) Where any drug to which this paragraph applies (that is, a drug that is not one to which the Misuse of Drugs Act 1971 applies, unless it is a drug for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001), ordered by a prescriber on a prescription form or repeatable prescription, is available for provision by an NHS pharmacist in a pack in a quantity which is different to the quantity which has been so ordered, and that drug is—

(a) sterile,

(b) effervescent or hygroscopic,

(d) a coal tar preparation,

(e) a viscous preparation, or

(f) packed at the time of its manufacture in a calendar pack or special container,

the NHS pharmacist must provide the drug in the pack whose quantity is nearest to the quantity which has been so ordered.

(8A) Subject to sub-paragraphs (8B) to (8E) and without prejudice to sub-paragraphs (10) and (11), for the purposes of sub-paragraph (1)(b), a drug is provided in accordance with the order on a prescription form or repeatable prescription if (in addition to where the provision is exactly in accordance with the order)—

(a) a different quantity is provided to that ordered on the prescription form or repeatable prescription to allow for the provision of the drug in its manufacturer’s original outer packaging, and

(b) the provision is otherwise in accordance with the order.

(8B) In the case of an order for a prescription only medicine, sub-paragraph (8A) only applies if sub-paragraph (8) applies or one of the following applies—

(a) the provision is in accordance with regulation 217B(1) to (3) of the Human Medicines Regulations 2012 (original pack dispensing), and accordingly, regulation 217B(1) to (3) of those Regulations is expressly applied to such supplies, or

(b) the medicine must be provided in the manufacturer’s original outer packaging to comply with regulation 217C of the Human Medicines Regulations 2012 (original pack dispensing: medicinal products containing a relevant substance).

(8C) In the case of an order for a drug that is not a prescription only medicine, sub-paragraph (8A) only applies if sub-paragraph (8) applies or the provision of a different quantity to that ordered on the prescription is in circumstances where—

(a) the different quantity is no more than 10% greater or no more than 10% less than the quantity ordered; and

(b) the registered pharmacist carrying out or ... supervising the provision does not consider, in the exercise of their professional skill and judgement, that the provision of a different quantity to that ordered may mean that the patient does not, or is not able to, follow the medication regimen as intended by the prescriber.

(8D) Where the NHS pharmacist may, pursuant to sub-paragraph (8A) and sub-paragraph (8B)(a) or (8C)(a) and (b), provide a different quantity of a drug to that ordered on a prescription form or a repeatable prescription, the NHS pharmacist must consider, in the exercise of their professional skill and judgement, whether it is reasonable and appropriate to do so, having regard to the benefits to patients where they are provided with drugs in their manufacturer’s original outer packaging.

(8E) Sub-paragraphs (8B)(a) and (8C)(a) and (b) do not apply to the provision of any drug which is—

(a) for the time being specified in Schedules 2 to 4 of the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain provisions under the Regulations), or

(b) a special medicinal product for the purposes of regulation 167 of the Human Medicines Regulations 2012 (supply to fulfil special patient needs).

(9) In this paragraph, “special container” means any container with an integral means of application or from which it is not practicable to dispense an exact quantity.

(10) Where a drug is ordered by a prescriber, or is to be provided in accordance with a SSP is, in a quantity that is, or is a multiple of a quantity that is, readily available in a pack size manufactured for a marketing authorisation holder for the drug, the NHS pharmacist must provide the drug in an original pack (or in original packs) of that size which have been assembled by a manufacturer of the drug for such a marketing authorisation holder, unless—

(a) it is not possible for the NHS pharmacist to obtain such a pack (or packs) with reasonable promptness in the normal course of business, or

(b) it is not practicable for the NHS pharmacist to provide such a pack (or packs) in response to the order (for example because of patient needs or the method of administration of the drug).

(11) Except as provided in sub-paragraph (12), an NHS pharmacist must not provide a Scheduled drug in response to an order by name, formula or other description on a prescription form or repeatable prescription.

(12) Where a drug has an appropriate non-proprietary name and it is ordered on a prescription form or repeatable prescription either by that name or by its formula, an NHS pharmacist may provide a drug which has the same specification notwithstanding that it is a Scheduled drug, provided that where a Scheduled drug is in a pack which consists of a drug in more than one strength, such provision does not involve the supply of part only of the pack.

(13) Where a drug which is ordered as specified in sub-paragraph (12) combines more than one drug, that sub-paragraph must apply only if the combination has an appropriate non-proprietary name, whether the individual drugs which it combines do so or not.

(14) An NHS pharmacist must provide any drug which they are required to provide under paragraph 5, or provides under paragraph 6, in a suitable container.

(15) Where an NHS pharmacist provides a drug or appliance under paragraph 6, the NHS pharmacist must include in the dispensing label on the packaging of the product, for the patient’s benefit, information to the effect that the product is being supplied in accordance with a SSP, identifying the particular SSP.

Refusal to provide drugs or appliances ordered

10

(1) An NHS pharmacist may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription where—

(a) the NHS pharmacist reasonably believes that it is not a genuine order for the person named on the prescription form or the repeatable prescription (for example because they reasonably believe the form has been stolen or forged),

(b) it appears to the NHS pharmacist that there is an error on the prescription form or on the repeatable prescription or its associated batch issue (including a clinical error made by the prescriber) or that, in the circumstances, providing the drugs or appliances would be contrary to the NHS pharmacist’s clinical judgement,

(c) the NHS pharmacist or other persons on the premises are subjected to or threatened with violence by the person presenting the prescription form or repeatable prescription, or by any person accompanying that person, or

(d) the person presenting the prescription form or repeatable prescription, or any other person accompanying that person, commits or threatens to commit a criminal offence.

(2) An NHS pharmacist must refuse to provide a drug ordered on a prescription form or repeatable prescription where the order is for a prescription only medicine which the prescriber was not entitled to prescribe.

(3) An NHS pharmacist must refuse to provide a drug or appliance ordered on a prescription form or a repeatable prescription where—

(a) a SSP has effect in respect of—

(i) the requested drug or appliance, or

(ii) drugs or appliances of a specified description, and the requested drug or appliance is of that description, and

(b) alternative provision has already taken place in accordance with the SSP.

(4) An NHS pharmacist may refuse to provide a drug or appliance ordered on a prescription form or a repeatable prescription where—

(a) a SSP has effect in respect of—

(i) the requested drug or appliance, or

(ii) drugs or appliances of a specified description, and the requested drug or appliance is of that description,

(b) a registered pharmacist is of the opinion, in the exercise of their professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate, and

but if the NHS pharmacist does refuse to do so, they must provide the patient or the person requesting the drug or appliance on behalf of the patient with appropriate advice, as necessary, about reverting to the prescriber for the prescriber to review the patient’s treatment.

(5) An NHS pharmacist must refuse to provide drugs or appliances ordered on a repeatable prescription where—

(a) the NHS pharmacist has no record of that prescription,

(b) the NHS pharmacist does not, in the case of a non-electronic repeatable prescription, have any associated batch issue and such batch issue is not presented to them,

(d) to do so would not be in accordance with any intervals specified in the prescription,

(e) it would be the first time a drug or appliance had been provided pursuant to the prescription and the prescription was signed more than 6 months previously,

(f) the repeatable prescription was signed more than 1 year previously,

(g) the expiry date on the repeatable prescription has passed, or

(h) the NHS pharmacist has been informed by the repeatable prescriber that the prescription is no longer required.

(6) Where a patient requests the supply of drugs or appliances ordered on a repeatable prescription (other than on the first occasion that they make such a request), an NHS pharmacist must only provide the drugs and appliances so ordered if they are satisfied—

(a) that the patient in respect of whom the prescription was written—

(i) is taking or using, and is likely to continue to take or use, the drug or appliance appropriately, and

(ii) is not suffering from any side effects of the treatment which indicates the need or desirability of reviewing the patient’s treatment,

(b) that the medication regimen of, or manner of utilisation of the appliance by, the patient in respect of whom the prescription was written has not altered in a way which indicates the need or desirability of reviewing the patient’s treatment, and

(c) there have been no changes to the health of the patient in respect of whom the prescription was written which indicate the need or desirability of reviewing the patient’s treatment.

Further activities to be carried out in connection with the provision of dispensing services

11

(1) In connection with the services provided under paragraph 4, an NHS pharmacist must—

(a) ensure that appropriate advice is given to patients about any drugs or appliances provided to them—

(i) to enable them to utilise the drugs or appliances appropriately, and

(ii) to meet the patient’s reasonable needs for general information about the drugs or appliances,

(b) provide appropriate advice to persons to whom they provide drugs or appliances on—

(i) the safe keeping of the drugs or appliances, or

(ii) returning unwanted drugs or appliances to the pharmacy for safe destruction,

(c) when providing drugs to patients in accordance with a repeatable prescription, provide appropriate advice in particular on the importance of only requesting those items which they actually need,

(d) when providing appliances to patients in accordance with a prescription form or repeatable prescription—

(i) provide appropriate advice in particular on the importance of only requesting those items which they actually need, and

(ii) for those purposes, have regard to the details contained in the records maintained under paragraph (f) in respect of the provision of appliances and prescribing pattern relating to the patient in question,

(e) provide a patient with a written note of any drug or appliance which is owed, and inform the patient when the drug or appliance becomes available,

(f) keep and maintain records—

(i) of drugs and appliances provided, where it is necessary or desirable to do so in order to facilitate the continued care of the patient,

(ii) in appropriate cases, of advice given and any interventions or referrals made (in particular of clinically significant interventions in cases involving repeatable prescriptions), and

(iii) of notes provided under paragraph (e),

(g) undertake appropriate training in respect of repeat prescribing, having regard to any recommendations in respect of such training set out in the Drug Tariff,

(h) if they take possession of a repeatable prescription or an associated batch issue, securely store that repeatable prescription or associated batch issue,

(i) maintain records of repeatable prescriptions in such a form as to provide a clear audit trail of supplies under the repeatable prescription (including dates and quantities supplied),

(j) destroy any surplus batch issues relating to drugs or appliances—

(i) which are not required, or

(ii) where a patient is refused the drugs or appliances pursuant to paragraph 10,

(k) ensure that where a person is refused drugs or appliances pursuant to paragraph 10(1)(b), (2), (3) or (4), the patient is referred back to the prescriber for further advice,

(l) where a patient is provided with drugs or appliances under a repeatable prescription, notify the prescriber of any clinically significant issues arising in connection with the prescription and keep a record of that notification,

(m) notify the prescriber of any refusal to provide drugs or appliances pursuant to paragraph 10(4),

(n) when providing appliances, provide a patient with a written note of the NHS pharmacist’s name, address and telephone number, and

(o) when providing specified appliances, comply with the additional requirements set out in paragraph 12.

(2) Where, on presentation of a prescription form or repeatable prescription in connection with dispensing services under paragraph 4, an NHS pharmacist is unable (having regard to any relevant SSP) to provide an appliance, or stoma appliance customisation is required and the NHS pharmacist is unable to provide that, the NHS pharmacist must—

(a) if the patient consents, refer the prescription form or repeatable prescription to another NHS pharmacist or to an NHS appliance contractor, or

(b) if the patient does not consent to a referral, provide the patient with contact details of at least two people who are NHS pharmacists or NHS appliance contractors who are able to provide the appliance or stoma appliance customisation (as the case may be), if these details are known to the NHS pharmacist.

Additional requirements in relation to specified appliances

12

(1) This paragraph sets out the additional requirements referred to in paragraph 11(1)(o) relating to the provision of specified appliances.

(2) An NHS pharmacist who dispenses specified appliances in the normal course of business must provide a home delivery service in respect of those appliances and, as part of that service—

(a) the NHS pharmacist must offer to deliver the specified appliance to the patient’s home,

(b) if the patient accepts that offer, the delivery must be made with reasonable promptness and at such time as is agreed with the patient,

(c) the specified appliance must be delivered in a package which displays no writing or other markings which could indicate its content, and

(d) the manner of delivery of the package and any supplementary items required by sub-paragraph (3) must not convey the type of appliance being delivered.

(3) In any case where a specified appliance is provided (whether by home delivery or otherwise), the NHS pharmacist must provide a reasonable supply of appropriate supplementary items (such as disposable wipes and disposal bags) and—

(a) must ensure that the patient may, if the patient wishes, consult a person to obtain expert clinical advice regarding the appliance, or

(b) if the NHS pharmacist believes it is appropriate to do so, must—

(i) refer the patient to a prescriber, or

(ii) offer the patient an appliance use review service.

(4) If the NHS pharmacist is unable to provide an appliance use review service in accordance with sub-paragraph (3)(b)(ii), the NHS pharmacist must give the patient the contact details of at least two people who are NHS pharmacists or NHS appliance contractors who are able to arrange for the service to be provided, if these details are known to the NHS pharmacist.

(5) Where an NHS pharmacist provides a telephone care line in respect of the dispensing of any specified appliance, the NHS pharmacist must ensure that during out of hours periods—

(a) advice is made available to patients through that telephone care line, or

(b) the telephone number of NHS Direct Wales, or the website address of NHS Direct Wales³⁷, are made available to patients through that telephone care line.

(6) For the purposes of this paragraph—

“expert clinical advice” (“cyngor clinigol arbenigol”), in relation to a specified appliance, means advice which is given by a person who is suitably trained and who has relevant experience in respect of the appliance;

“out of hours periods” (“cyfnodau y tu allan i oriau”), in relation to a pharmacy, means the periods outside the periods during which the NHS pharmacist—is obliged to provide pharmaceutical services at the pharmacy by virtue of paragraph 22(1) or 26(1), ordoes provide pharmaceutical services at the pharmacy in accordance with a notification under paragraph 22(2).

Disposal service in respect of unwanted drugs

13

An NHS pharmacist must, to the extent paragraph 14 requires and in the manner described in that paragraph, accept and dispose of unwanted drugs provided to the NHS pharmacist for disposal.

Basic procedure in respect of unwanted drugs

14

(1) Subject to sub-paragraph (2), where a person presents to an NHS pharmacist or any of the NHS pharmacist’s staff any drugs provided for a patient in, and which have been kept in—

(a) a private household, or

(b) a residential care home,

the NHS pharmacist must accept the drugs and dispose of them in accordance with sub-paragraph (3).

(2) An NHS pharmacist must not be required to accept any drugs for disposal unless the Local Health Board in whose pharmaceutical list the NHS pharmacist is included has made arrangements with the NHS pharmacist for the collection and disposal of drugs of that description.

(3) On receipt of the drugs, the NHS pharmacist must—

(a) where required to do so by the Local Health Board or by a waste disposal contractor retained by the Local Health Board, separate solid drugs or ampoules, liquids and aerosols from each other,

(b) store the drugs in containers provided by the Local Health Board, or by a waste disposal contractor retained by the Local Health Board for the purpose of storing drugs of that description, and

(c) comply with any other statutory requirements in respect of storing or the disposal of drugs of that description (meeting those requirements are therefore an essential service for the purposes of these Regulations),

and must co-operate with any suitable arrangements that the Local Health Board has in place for regular collection of the drugs from the NHS pharmacist’s premises by or on behalf of the Local Health Board.

Further activities to be carried out in connection with the disposal of unwanted drugs

15

In connection with the services provided under paragraph 13, an NHS pharmacist must—

(a) ensure that they and any of their staff, are aware of the risks associated with the handling of waste drugs and the correct procedures to be used to minimise those risks, and

(b) ensure that they and any of their staff have readily available and close to any place where waste drugs are stored appropriate protective equipment, including gloves, overalls and materials to deal with spillages.

Promotion of healthy lifestyles

16

An NHS pharmacist must, to the extent paragraphs 17 and 18 require and in the manner set out in those paragraphs and, generally, where in the opinion of the NHS pharmacist it is appropriate to do so, promote public health messages to members of the public.

Prescription linked intervention

17

(1) Where a person using a pharmacy—

(a) presents a prescription form or repeatable prescription to an NHS pharmacist, and

(b) it appears to the NHS pharmacist that the person is suffering from or at risk of developing an adverse health issue,

the NHS pharmacist must, as appropriate, provide advice to that person with the aim of increasing that person’s knowledge and understanding of the health issues which are relevant to that person’s personal circumstances.

(2) Advice given under sub-paragraph (1) may be backed up, as appropriate—

(a) by the provision of written material (for example leaflets), and

(b) by referring the person to other sources of information or advice.

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