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The National Health Service (Pharmaceutical Services) (Amendment) (Wales) Regulations 2010

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Title, commencement, application and interpretation

1.—(1) The title of these Regulations is the National Health Service (Pharmaceutical Services) (Amendment) (Wales) Regulations 2010 and they come into force on 1 April 2010.

(2) These Regulations apply in relation to Wales.

(3) In these Regulations “the principal Regulations” (“y prif Reoliadau”) means the National Health Service (Pharmaceutical Services) Regulations 1992(1).

Amendment of the principal Regulations

2.—(1) The principal Regulations are amended in accordance with the following provisions of this regulation.

(2) In regulation 2(1) (interpretation) of the principal Regulations, in the appropriate alphabetical position, insert —

  • “advanced electronic signature” means an electronic signature which is—

    (a)

    uniquely linked to the signatory;

    (b)

    capable of identifying the signatory;

    (c)

    created using means that the signatory can maintain under his sole control; and

    (d)

    linked to the data to which it relates in such a manner that any subsequent change of data is detectable;;

“appliance” means an appliance which is included in a list for the time being approved by the Welsh Ministers for the purposes of section 80 (arrangements for pharmaceutical services) of the 2006 Act;;

“appliance use review service” means arrangements made in accordance with section 81 of the 2006 Act (arrangements for additional Pharmaceutical Services) for a pharmacist or specialist nurse to review a person’s use of any specified appliance;;

  • “associated batch issue” means, in relation to a non-electronic repeatable prescription, one of the batch issues relating to that prescription and containing the same date as that prescription;;

  • “batch issue” means a form provided by a Local Health Board and issued by a repeatable prescriber at the same time as a non-electronic repeatable prescription to enable a chemist to receive payment for the provision of repeat dispensing services which is in the required format, and which—

    (a)

    is generated by a computer and not signed by a repeatable prescriber;

    (b)

    relates to a particular non-electronic repeatable prescription and contains the same date as that prescription;

    (c)

    is issued as one of a sequence of forms, the number of which is equal to the number of occasions on which the drugs or appliances ordered on the non-electronic repeatable prescription may be provided; and

    (d)

    specifies a number denoting its place in the sequence referred to in sub-paragraph (c);;

“contingent removal” means removal from a pharmaceutical list contingently, within the meaning of section 108 (contingent removal) of the 2006 Act, and “contingently remove” shall be construed accordingly;;

“electronic prescription” means an electronic prescription form or an electronic repeatable prescription;;

“electronic prescription form” means a prescription which falls within paragraph (b) of the definition of “prescription form;;

“electronic repeatable prescription” means a prescription which falls within paragraph (a)(ii) of the definition of “repeatable prescription;;

“employment” means any employment whether paid or unpaid and whether under a contract for services or a contract of service, and “employed” and “employer” shall be construed accordingly;;

“equivalent body” means a Primary Care Trust in England, a Health Board or an NHS trust in Scotland, a Health and Social Services Board in Northern Ireland, (in relation to any time prior to 1 October 2002) a Strategic Health Authority in England or (in relation to any time prior to 1st April 2003) a Health Authority in Wales or an NHS trust in England or in Wales;;

“equivalent lists” means lists kept by an equivalent body;;

“ESP scheme” means an Essential Small Pharmacies Local Pharmaceutical Services scheme;;

“ETP service” means the 2-dimensional barcoded prescription service which forms part of the information technology systems in prescribing and dispensing systems in Wales and used by the health service in Wales to transfer and hold prescription information relating to patients;.

“fraud case” means a case where a person meets the second condition for removal from the pharmaceutical list, set out in section 107(3) (disqualification of practitioners) of the 2006 Act, or by virtue of section 109 (fraud and unsuitability cases: supplementary) of the 2006 Act is treated as doing so;;

“health care professional” means a person who is a member of a profession regulated by a body mentioned in section 25 of the National Health Service Reform and Healthcare Professions Act 2002(2);;

“licensing or regulatory body” means a body that licenses or regulates any profession of which the person is or has been a member, and includes any body which licenses or regulates any such profession in a country other than the United Kingdom;;

  • “list”, unless the context otherwise requires, means —

    (a)

    a list referred to in section 115(1) (national disqualification) of the 2006 Act;

    (b)

    a list of persons undertaking to provide general medical services prepared in accordance with regulations made under section 29 (arrangements and regulations for general medical services) of the Act, as the list existed on or before 31 March 2004;

    (c)

    a list of persons approved by a Local Health Board for the purpose of assisting in the provision of general medical services prepared in accordance with regulations made under section 43D(1) (supplementary lists) of the Act as the list existed on or before 31 March 2004; or

    (d)

    a services list referred to in section 8ZA(1)(a) (lists of persons who may perform personal medical services or personal dental services) of the 1997 Act as the list existed on or before 31 March 2004;;

  • LPS chemist” means—

    (a)

    a registered pharmacist,

    (b)

    a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968(3), or

    (c)

    a supplier of appliances,

    who provides local pharmaceutical services under a pharmacy scheme or an LPS scheme;;

  • “LPS scheme” has the same meaning as in paragraph 1(2) of Schedule 7 to the 2006 Act;;

“NHS Business Services Authority” means the NHS Business Services Authority (Awdurdod Gwasanaethau Busnes y GIG) established by the NHS Business Services Authority (Awdurdod Gwasanaethau Busnes y GIG) (Establishment and Constitution) Order 2005(4);;

“NHS Individual Health Record” means the records relating to an individual patient held by the NHS individual Health Record Service;;

“NHS Individual Health Record Service” means the information technology systems which hold medical records relating to patients in Wales;;

“NHS services” means services provided as part of the health service in Wales;;

“National Health Service Counter Fraud and Security Management Service” means the NHS Business Services Authority;;

“non-electronic prescription form” means a prescription form which falls within paragraph (a) of the definition of “prescription form;;

“non-electronic repeatable prescription” means a prescription which falls within paragraph (a)(i) of the definition of “repeatable prescription”;;

“originating events” means the events that gave rise to the conviction, investigation, proceedings, suspension, refusal to admit, conditional inclusion, removal or contingent removal that took place;;

  • “professional conduct” includes matters relating both to professional conduct and professional performance;;

  • “specified appliance” means —

    (a)

    any of the following appliances listed in Part IXA of the Drug Tariff —

    (i)

    a catheter appliance (including a catheter accessory and maintenance solution),

    (ii)

    a laryngectomy or tracheostomy appliance,

    (iii)

    an anal irrigation system,

    (iv)

    a vacuum pump or constrictor ring for erectile dysfunction, or

    (v)

    a wound drainage pouch;

    (b)

    an incontinence appliance listed in Part IXB of the Drug Tariff; or

    (c)

    a stoma appliance listed in Part IXC of the Drug Tariff;.

  • “stoma appliance customisation” means the customisation of a quantity of more than one stoma appliance, where —

    (a)

    the stoma appliances to be customised are listed in Part IXC of the Drug Tariff;

    (b)

    the customisation involves modification to the same specification of multiple identical parts for use with each appliance; and

    (c)

    that modification is based on the patient’s measurements or a record of those measurements and, if applicable, a template;; and

“supplier of appliances” means a person with whom a Local Health Board has entered into arrangements for the provision of pharmaceutical services, being terms of service under regulation 3;.

(3) In regulation 2(1) of the principal Regulations for the definition of “local pharmaceutical services” there is substituted —

  • “local pharmaceutical services” means local pharmaceutical services under —

    (a)

    an LPS scheme established under paragraph 1(1) of Schedule 7 to the 2006 Act; or

    (b)

    an ESP scheme;;

(4) In regulation 2(1) of the principal Regulations, for the definition of “prescription form” there is substituted —

  • “prescription form” means —

    (a)

    a form provided by a Health Board, a Health and Social Services Board, a Local Health Board, a Primary Care Trust, an NHS Trust or NHS Foundation Trust, and issued by a prescriber; or

    (b)

    a form containing data that are created in an electronic format, uniquely identified using a prescriber’s code and transmitted as an electronic communication to a nominated dispensing contractor by the ETP service,

    to enable a person to obtain pharmaceutical services or local pharmaceutical services, and does not include a repeatable prescription.

(5) In regulation 2(1) of the principal Regulations, in the definition of “repeatable prescriber” there is substituted —

  • “repeatable prescriber” means a person who is —

    (a)

    a pharmacist independent prescriber who —

    (i)

    is included in a pharmaceutical list, and —

    (aa)

    with whom a Local Health Board has made an arrangement for the provision of a directed service which is an independent prescribing service; and

    (bb)

    who is issuing or creating a repeatable prescription as part of that arrangement;

    (ii)

    is employed or engaged by a person who is included in a pharmaceutical list, and —

    (aa)

    a Local Health Board has made an arrangement with that person for the provision of a directed service which is an independent prescribing service; and

    (bb)

    the pharmacist independent prescriber is issuing or creating a repeatable prescription as part of that arrangement;

    (iii)

    is a party to an LPS scheme or LPS arrangements, and —

    (aa)

    with whom a Local Health Board has made an arrangement for the provision of an Independent Prescribing Service; and

    (bb)

    who is issuing or creating a repeatable prescription as part of that arrangement; or

    (iv)

    is employed or engaged by a party to an LPS scheme or LPS arrangements (other than a Local Health Board), and —

    (aa)

    a Local Health Board has made an arrangement with that party for the provision of an independent prescribing service; and

    (bb)

    the pharmacist independent prescriber is issuing or creating a repeatable prescription as part of that arrangement;.

(6) In regulation 2(1) of the principal Regulations, for the definition of “repeatable prescription” there is substituted —

  • “repeatable prescription” means a prescription contained in a form provided by a Local Health Board and issued by a prescriber to enable a person to obtain pharmaceutical services which is in the format specified in Part I of Schedule 1 to the NHS (General Medical Services Contracts) (Wales) Regulations 2004(5) and which is either —

    (a)
    (i)

    generated by a computer but signed by a prescriber; or

    (ii)

    a form containing data that are created in an electronic format, identified using a repeatable prescriber’s code and transmitted as an electronic communication to a nominated dispensing contractor by the ETP service;

    (b)

    is issued or created to enable a person to obtain pharmaceutical services or local pharmaceutical services; and

    (c)

    indicates that the drugs or appliances ordered on that form may be provided more than once, and specifies the number of occasions on which they may be provided;.

(7) In regulation 2(1)(c) of the principal Regulations, after the words “where these words occur” there is added —

  • except in the definition of “equivalent body”.

Amendments to Schedule 2 to the principal Regulations

3.  Schedule 2 to the principal Regulations is amended in accordance with regulations 4 to 13.

Amendment of paragraph 1

4.  Remove sub-paragraph 1(2) of Schedule 2 to the principal Regulations and renumber sub-paragraph 1(3) as 1(2).

Amendment of paragraph 6

5.  For paragraph 6 substitute —

6.  Urgent supply without a prescription

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

(2) The 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(6), other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001(7); and

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

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

Amendment of paragraph 9

6.  In paragraph 9 (Refusal to provide drugs or appliances ordered), in sub-paragraph (4)(b), after “the medication regimen of” insert “, or manner of utilisation of the appliance by,” and after “prescription was written has” insert “not”.

Amendment of paragraph 10

7.—(1) Amend paragraph 10 (Further activities to be carried out in connection with the provision of dispensing services) as follows.

(2) Renumber the existing provision as sub-paragraph (1).

(3) In that sub-paragraph —

(a)for paragraph (c) substitute —

(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;

(ca)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 sub-paragraph (e) in respect of the provision of appliances and prescribing pattern relating to the patient in question;;

(b)omit “and” at the end of sub-paragraph (k); and

(c)after sub-paragraph (l) insert —

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

(n)when providing specified appliances, comply with the additional requirements set out in paragraph 10A..

(4) After sub-paragraph (1) insert —

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

(a)if the patient consents, refer the prescription form or repeatable prescription to another pharmacist or to a supplier of appliances; and

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

Insertion of new paragraph 10A

8.  After paragraph 10 insert —

Additional requirements in relation to specified appliances

10A.(1) This paragraph sets out the additional requirements referred to in paragraph 10(1)(n) relating to the provision of specified appliances.

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

(5) Where a pharmacist provides a telephone care line in respect of the dispensing of any specified appliance, the 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 Wales, are made available to patients through that telephone care line.

(6) For the purposes of this paragraph —

  • “expert clinical advice”, 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”, in relation to a pharmacy, means the periods outside the periods during which the pharmacist —

    (a)

    is obliged to provide pharmaceutical services at the pharmacy by virtue of paragraph 21(1) or 25(A)(1); or

    (b)

    does provide pharmaceutical services at the pharmacy in accordance with a notification under paragraph 21(1A).

Amendment of paragraph 18

9.—(1) Amend paragraph 18 (service outline in respect of signposting) as follows.

(2) After sub-paragraph (1) insert —

(1A) Where, on presentation of a prescription form or repeatable prescription, a pharmacist is unable to provide an appliance or stoma appliance customisation because the provision of the appliance or customisation is not within the pharmacist’s normal course of business, the pharmacist must —

(a)if the patient consents, refer the prescription form or repeatable prescription to another pharmacist or to a supplier of appliances; and

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

(3) In sub-paragraph (3), after “under sub-paragraph (1)” insert “or (1A)”.

Amendment of paragraph 21

10.  After paragraph 21(1) (pharmacy opening hours: general) insert—

(1A) A pharmacist shall also notify the Local Health Board of other hours during which the premises from which the pharmacist has undertaken to provide pharmaceutical services will be open, which are hours in addition to those during which the pharmacy is obliged to open by virtue of sub-paragraph (1) (and which are referred to as “supplementary opening hours”).

Amendment of paragraph 25

11.  In paragraph 25 (clinical governance), in sub-paragraph (2), for paragraph (d) substitute —

(d)a clinical effectiveness programme, which includes arrangements for ensuring that appropriate advice is given by a pharmacist —

(i)in respect of the provision of drugs in accordance with a repeatable prescription,

(ii)in respect of the provision of appliances in accordance with a prescription form or repeatable prescription, or

(iii)to people caring for themselves or their families,

and arrangements for ensuring that the pharmacist, when giving advice to any patient on a matter mentioned in paragraph (d)(ii), has regard to the details contained in the records maintained under paragraph 10(1)(e) in respect of the provision of appliances and the prescribing pattern relating to the patient in question;.

Insertion of paragraph 24A

12.  After paragraph 24 insert —

24A.(1) Notwithstanding the provisions of this Schedule, during an emergency requiring the flexible provision of pharmaceutical services, Local Health Board may, on application from a pharmacist (“P”), permit P a temporary change to the days on which or times at which P is obliged to provide pharmaceutical services at the premises from which P has undertaken to provide pharmaceutical services, or permit temporary closure of those premises, if —

(a)P gives at least 24 hours notice of the change or closure; and

(b)the reasons given by P for the request are, in the opinion of the Local Health Board, adequate reasons.

(2) The Local Health Board need not approve the request in advance of the change or closure, and if it does not do so but decides subsequently that P’s reasons are not, in its opinion, adequate reasons, then the days on which or times at which P is obliged to provide pharmaceutical services at the premises are to revert to the overridden days or times, from the day after the date on which that decision is given to P.

Amendment of paragraph 27

13.  After paragraph 27(2) (inducements) insert —

(3) In the case of the provision of appliances, neither a pharmacist nor any person employed or engaged by a pharmacist must accept or receive any gift or reward in respect of only —

(a)providing contact details of alternative pharmacists or suppliers of appliances pursuant to paragraph 10(2)(b), 10A(4) or 18(1A)(b); or

(b)referring a prescription form or repeatable prescription to another pharmacist or supplier of appliances pursuant to paragraph 10(2)(a) or 18(1A)(a) and providing no additional service in connection with the item on that prescription..

Amendment of paragraph 42(1)

14.  In paragraph 42(1) (inspections and access to information), in paragraph (b)(i), after “patient care and treatment,” insert “including any arrangement made with a person in respect of provision of appliances,”.

Insertion of the Schedule into the principal Regulations

15.  Immediately after Schedule 2 of the principal Regulations, insert the Schedule.

Transitional arrangement

16.—(1) This regulation has effect only in relation to the provision of pharmaceutical services at any time before the end of the transitional period by any pharmacist or supplier of appliances whose name was, immediately before 1 April 2010, already on a pharmaceutical list maintained by a Local Health Board under the principal Regulations.

(2) Subject to paragraph (3), during the transitional period the pharmacist or supplier of appliances is not bound by such amendments to terms of service as are made by these Regulations, if they choose instead to comply with the terms of service as they had effect prior to those amendments (in these circumstances, the terms of service that are binding upon them are the terms of service as they had effect on 31 March 2010).

(3) Paragraph (2) does not apply in any case where the pharmacist or supplier of appliances first notifies the Local Health Board of its intention to enter into new arrangements, which are to be made in accordance with the Pharmaceutical Services (Wales) Directions 2010, to provide services for stoma appliance customisation or appliance use reviews (or has entered into such arrangements).

(4) Nothing in this regulation affects the duty of a pharmacist or supplier of appliances —

(a)before the end of the transitional period, to comply with the terms of service as they otherwise have effect; and

(b)at or after the end of the transitional period, to comply with the terms of service as amended by these Regulations.

(5) In this regulation —

“the terms of service”—

(i)

in relation to a pharmacist, means the terms of service set out in Schedule 2 to the principal Regulations;

(ii)

in relation to a supplier of appliances, means the terms of service set out in Schedule 2A to the principal Regulations; and

(iii)

“transitional period” means the nine month period that ends at the end of 31 December 2010.

Gwenda Thomas

Minister for Health and Social Services, one of the Welsh Ministers

18 March 2010

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