Chwilio Deddfwriaeth

The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013

Status:

Point in time view as at 25/05/2023.

Changes to legislation:

The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, SCHEDULE 6 is up to date with all changes known to be in force on or before 17 November 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations. Help about Changes to Legislation

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Regulation 47(1)(a)(i)

SCHEDULE 6U.K.Terms of service of dispensing doctors

This Atodlen has no associated Memorandwm Esboniadol

Persons duly authorised to dispense on behalf of dispensing doctorsU.K.

1.—(1) Where this Schedule imposes a requirement on a dispensing doctor in respect of an activity which the dispensing doctor has duly authorised another person to undertake, if that other person undertakes that activity instead of the dispensing doctor—

(a)that other person must comply with that requirement; and

(b)the dispensing doctor must secure compliance with that requirement by that other person.

(2) Where reference is made in this Schedule to a dispensing doctor—

(a)being the subject of an activity, and in fact a person duly authorised by the dispensing doctor is the subject of that activity; or

(b)forming a view, and in fact a person duly authorised by the dispensing doctor is to form that view,

that reference is to be construed as referring, as appropriate, to that duly authorised person.

(3) References in this Schedule to a dispensing doctor are to be construed in accordance with sub-paragraphs (1) and (2).

Dispensing of drugs and appliances ordered by another prescriberU.K.

2.—(1) In this paragraph, “signed” includes signature with a prescriber's advanced electronic signature.

(2) Subject to the following provisions of this Schedule, where—

(a)any person presents to a dispensing doctor (D) a non-electronic prescription form which contains—

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

(ii)an order for drugs specified in Schedule 2 to the Prescription of Drugs Regulations M1 (drugs, medicines and other substances that may be ordered only in certain circumstances), signed by a prescriber other than D, and including the reference “SLS”, or

(iii)an order for restricted availability appliances, signed by a prescriber other than D and including the reference “SLS”; F1...

(b)subject to sub-paragraph (4), D receives [F2as a nominated dispensing contractor] from the Electronic Prescription Service an electronic prescription form which contains an order of a kind specified in paragraph (a)(i) to (iii) and—

(i)any person requests the provision of drugs or appliances in accordance with that prescription, or

(ii)D has previously arranged with the patient that D will dispense that prescription on receipt[F3; or]

[F4(c)any person—

(i)presents D with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iii), and

(ii)requests the provision of drugs or appliances in accordance with the related electronic prescription form,]

and D is authorised or required by virtue of Part 8 to provide the drugs or appliances so ordered, D must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as D supplies in the normal course of business.

(3) Subject to the following provisions of this Schedule, where—

(a)any person presents to D 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 1971 M2, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 M3 (which relate to controlled drugs excepted from certain prohibitions under the Regulations), signed by a prescriber other than D,

(ii)an order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations, not being 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, signed by a prescriber other than D and including the reference “SLS”,

(iii)an order for appliances, not being restricted availability appliances, signed by a prescriber other than D, or

(iv)an order for a restricted availability appliance, signed by a prescriber other than D, and including the reference “SLS”,

and also presents an associated batch issue; F5...

(b)D receives [F6as a nominated dispensing contractor] an electronic repeatable prescription from the Electronic Prescription Service which contains an order of a kind specified in paragraph (a)(i) to (iv) and—

(i)any person requests the provision of drugs or appliances in accordance with that repeatable prescription, or

(ii)D has previously arranged with the patient that D will dispense that repeatable prescription on receipt[F7; or]

[F8(c)any person—

(i)presents D with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iv), and

(ii)requests the provision of drugs or appliances in accordance with the related electronic repeatable prescription,]

and D is authorised or required by virtue of Part 8 to provide the drugs or appliances so ordered, D must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as D supplies in the normal course of business.

(4) D must not provide under an electronic prescription form 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 [F9Schedules 2 to 5] to the Misuse of Drugs Regulations 2001.

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

(a)D has that prescription in D's possession; and

(b)that person presents, or D has in D's possession, an associated batch issue.

(6) Drugs and appliances provided under this paragraph must be provided in a suitable container.

Textual Amendments

Marginal Citations

M1Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680 and 1043.

M21971 c.38; see section 2(1)(a) of that Act, which defines “controlled drug” for the purposes of that Act.

M3S.I. 2001/3998. Schedule 4 has been amended by S.I. 2003/1432, 2005/3372, 2007/2154, 2009/3136 and 2012/973, and Schedule 5 has been amended by S.I. 2005/2864.

Dispensing of drugs and appliances ordered by the dispensing doctorU.K.

3.  In circumstances where paragraph 2 does not apply and subject to the following provisions of this Schedule, where a dispensing doctor (D) is authorised or required by virtue of Part 8 to provide a drug or appliance to a person—

(a)D must record any order for the provision of any drugs or appliances which are needed for the treatment of the patient, before the drugs or appliances are dispensed (unless it is personally administered)—

(i)on a prescription form completed in accordance with the term of the contract under which primary medical services are provided to the patient which gives effect to paragraph 39 of Schedule 6 to the GMS Regulations M4 (other contractual terms – prescribing) or an equivalent provision applying in relation to that contract,

(ii)if paragraph 39A of Schedule 6 to the GMS Regulations M5 (other contractual terms – electronic prescriptions) or an equivalent provision applies in relation to the contract under which primary medical services are provided to the patient, on an electronic prescription form, or

(iii)in the case of a personally administered vaccine in respect of which the NHS BSA does not require an individual prescription form in order to process payment, on the form provided by the NHS BSA for the purposes of claiming payments for administering that vaccine (as well, potentially, as claiming other payments), and in the manner required by the NHS BSA (which may be as part of an aggregate total);

(b)D must provide those drugs or appliances in a suitable container (unless it is personally administered);

(c)D must provide for the patient a drug specified in Schedule 2 to the Prescription of Drugs Regulations M6 (drugs, medicines and other substances that may be ordered only in certain circumstances) only where the conditions in paragraph 42(2) of Schedule 6 to the GMS Regulations M7 (other contractual terms – a restrictions on prescribing by medical practitioners) are satisfied; and

(d)D must provide for the patient a restricted availability appliance only if the patient is a person, or it is for a purpose, specified in the Drug Tariff.

Marginal Citations

M4Paragraph 39 has been amended by S.I. 2005/893, 2007/3491 and 2009/2230.

M5Paragraph 39A was inserted by S.I. 2005/893 and has been amended by S.I. 2007/3491.

M6Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680 and 1043.

M7Paragraph 42 has been amended by S.I. 2005/893 and 2009/2230.

[F10Supply in accordance with a SSPU.K.

3A.(1) This sub-paragraph applies where, in relation to an order for a drug or an appliance on a prescription form or a repeatable prescription—

(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 appliance is of that description.

(2) Where sub-paragraph (1) applies and D provides a different product or quantity of product to the product or quantity of product ordered on the prescription form or repeatable prescription, in accordance with the SSP—

(a)D 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

(b)the prescription or associated batch issue as thus endorsed is treated as being the prescription for product reimbursement purposes (even though the supply is not in pursuance of that prescription).

(3) Where D provides a drug or appliance under this paragraph, D 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.]

[F11Supply in accordance with a PTP [F12or a PTPGD] U.K.

3B.(1) Subject to the following provisions of [F13this Schedule,] where—

(a)a dispensing doctor (D) receives, via a secure service approved by the NHSCB for this purpose, an electronic message that amounts to an order for the supply of a drug in accordance with a PTP [F14or a PTPGD]; and

(b)a person who is entitled to be supplied with that drug [F15by D (Part 8 and this Schedule having that effect)] in pursuance of that order requests the provision of the drug in accordance with that order,

D must, with reasonable promptness, provide the drug so ordered.

[F16(1A) Where D considers—

(a)on the basis of a request for the supply of a drug in accordance with a PTP or a PTPGD that has been approved by the NHSCB as a basis for supply as part of pharmaceutical services;

(b)having made the appropriate checks; and

(c)having regard to what is reasonable and appropriate,

that a person is entitled to be supplied with the drug [F17by D (Part 8 and this Schedule having that effect)] in accordance with the PTP or PTPGD as part of pharmaceutical services, D must, with reasonable promptness, provide the drug requested.]

(2) If a person requesting the provision of the drug asks D to do so—

(a)D must give an estimate of the time when the drug will be ready; and

(b)if they are not ready by then, D must give a revised estimate of the time when they will be ready (until they are ready).

(3) Where D provides a drug under sub-paragraph (1) [F18or (1A)], D must include a dispensing label on the packaging of the product and include in the label (in addition to the particulars required or permitted by Part 1 of Schedule 26 to the Human Medicines Regulations 2012), for the patient’s benefit, information to the effect that the product is being supplied in accordance with a PTP [F19or a PTPGD], identifying the particular PTP [F20or PTPGD].

[F21(4) Sub-paragraph (1) does not apply where arrangements are in place for the provision of the drug ordered pursuant to the PTP or PTPGD as part of a directed service which includes arrangements for the provision of such a drug ordered in accordance with such a PTP or PTPGD.

(5) Sub-paragraph (1A) does not apply where arrangements are in place for the provision of the drug requested in accordance with the PTP or PTPGD as part of a directed service which includes arrangements for the provision of such a drug requested in accordance with such a PTP or PTPGD.]]

Textual Amendments

[F22Supply in accordance with a LPIVU.K.

3C.(1) Subject to the following provisions of this Schedule, where—

(a)a dispensing doctor (D) receives a LPIV; and

(b)a person who is entitled to be supplied by D (Part 8 and this Schedule having that effect) with a prescription item ordered on the LPIV requests the provision of the item in accordance with that LPIV,

D must, with reasonable promptness, provide the prescription item so ordered.

(2) If a person who is entitled as mentioned in sub-paragraph (1)(b) asks D to do so—

(a)D must give an estimate of the time when the prescription item will be ready; and

(b)if they are not ready by then, D must give a revised estimate of the time when the item will be ready (until it is ready).

(3) Sub-paragraph (1) does not apply where arrangements are in place for the provision of the item ordered on the LPIV as part of a directed service which includes arrangements for the provision of such an item ordered on such a LPIV.]

Preliminary matters before providing ordered drugs or appliancesU.K.

4.  Before providing any drugs or appliances in accordance with paragraph 3 [F23or 3A], or in the circumstances set out in paragraph 5—

(a)a dispensing doctor (D) must ask any person who makes [F24or duly completes a declaration as or on behalf of the person named on the prescription form or repeatable prescription] that the patient does not have to pay the charges specified in regulation 4(1) of the Charges Regulations M8 (supply of drugs and appliances by doctors) by virtue of either—

(i)entitlement to exemption under [F25regulation 10(1)] of the Charges Regulations M9 (exemptions), or

(ii)entitlement to remission of charges under regulation 5 of the Remission of Charges Regulations M10 (entitlement to full remission and payment),

to produce satisfactory evidence of such entitlement, unless the declaration is in respect of entitlement to exemption by virtue of [F25regulation 10] of the Charges Regulations or in respect of entitlement to remission by virtue of regulation 5 of the Remission of Charges Regulations, and at the time of the declaration D has such evidence available to D;

(b)if, in the case of a non-electronic prescription form or non-electronic repeatable prescription, no satisfactory evidence, as required by sub-paragraph (a), is produced to D, D must endorse the form on which the declaration is made to that effect; and

(c)in the case of an electronic prescription, D must [F26ensure that the following information is duly entered into the records managed by [F27NHS England] that are accessible as part of the Electronic Prescription Service (if either it is not already recorded in those records or a check, known as a real time exemption check, has not produced satisfactory evidence as mentioned in sub-paragraph (a))]

(i)in a case where exemption from or remission of charges is claimed for all or some of the items included in the prescription, a record of—

(aa)the exemption category specified in [F28regulation 10(1)] of the Charges Regulations or the ground for remission under regulation 5 of the Remission of Charges Regulations which it is claimed applies to the case, and

(bb)whether or not satisfactory evidence was produced to D as required by sub-paragraph (a),

(ii)in any case where a charge is due, confirmation that the relevant charge was paid, and

(iii)in a case of a prescription for or including contraceptive substances, confirmation that no charge was payable in respect of those substances.

Textual Amendments

Marginal Citations

M8Regulation 4 has been amended by S.I. 2000/2393, 2001/2887, 2002/548 and 2352, 2005/578, 2008/571, 2009/411, 2010/1727 and 2011/518.

M9Regulation 7 has been amended by S.I. 2000/3189, 2002/2352, 2004/696, 2005/578 and 2009/29.

M10Regulation 5 has been amended by S.I. 2004/663 and 936, 2006/562, 2008/1697 and 2009/411.

[F29Charge exemption and remission of charges: declarations and checksU.K.

4A.(1) For the purposes of paragraph 4, satisfactory evidence includes evidence derived from a check, known as a real time exemption check, of electronic records that are managed by the NHS BSA for the purposes (amongst other purposes) of providing advice, assistance and support to patients or their representatives in respect of whether a charge is payable under the Charges Regulations.

(2) If D dispenses an electronic prescription, D must send the form duly completed by or on behalf of the patient, if one is required under regulation 4(2)(b) or (3A) of the Charges Regulations in respect of that electronic prescription (which may be the associated EPS token), to the NHS BSA.]

[F30Checks and records in the case of supply in accordance with a SSPU.K.

4B.  In a case involving providing drugs or appliances in accordance with paragraph 3A, the references in paragraph 4 to a prescription form or repeatable prescription are to be construed as references to the prescription for product reimbursement purposes, as mentioned in paragraph 3A(2)(b).]

Provision of Scheduled drugsU.K.

5.—(1) A dispensing doctor (D) must only provide for a patient any Scheduled drug if—

(a)it is ordered as specified in sub-paragraph (2) or (4); or

(b)in the case of a drug specified in Schedule 2 to the Prescription of Drugs Regulations M11 (drugs, medicines and other substances that may be ordered only in certain circumstances), it is ordered in the circumstances prescribed in that Schedule.

(2) A Scheduled drug that is a drug with an appropriate non-proprietary name may be provided in response to an order on a prescription form or repeatable prescription for a drug (“the prescribed drug”) that is not a Scheduled drug but which has the same non-proprietary name as the Scheduled drug if—

(a)the prescribed drug is ordered by that non-proprietary name or by its formula; and

(b)the prescribed drug has the same specification as the Scheduled drug (so the Scheduled drug may be dispensed generically).

(3) If a Scheduled drug is a combination of more than one drug, it can only be ordered as specified in sub-paragraph (2) if the combination has an appropriate non-proprietary name, whether or not the drugs in the combination each have such names.

(4) Nothing in this Schedule prevents D providing, otherwise than under pharmaceutical services, a Scheduled drug or a restricted availability appliance for a patient.

Marginal Citations

M11Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680 and 1043.

Refusal to provide drugs or appliances orderedU.K.

6.—(1) A dispensing doctor (D) may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription where—

(a)D reasonably believes that it is not a genuine order for the person named on the prescription form or the repeatable prescription (for example because D reasonably believes it has been stolen or forged);

(b)it appears to D that there is an error on the prescription form or on the repeatable prescription or, in the case of a non-electronic repeatable prescription, 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 D's clinical judgement; or

(c)where the prescription form or repeatable prescription is incomplete because it does not include the information relating to the identification of the prescriber that the NHSCB (or a person exercising its functions) requires in order to perform its functions relating to—

(i)the remuneration of persons providing pharmaceutical services, and

(ii)any apportionment of, or any arrangements for recharging in respect of, that remuneration,

unless D (or the person who employs or engages D) is to receive no pharmaceutical remuneration of any kind in respect of the drug or appliance.

[F31(1A) D may refuse to provide a drug or appliance ordered on an electronic prescription if the access that D has to the Electronic Prescription Service is not such as to enable D to dispense that prescription promptly (or at all).]

(2) D must refuse to provide drugs or appliances ordered on a repeatable prescription where—

(a)D has no record of that prescription;

(b)D does not, in the case of a non-electronic repeatable prescription, have any associated batch issue and it is not presented to D;

(c)it is not signed by a prescriber;

(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 (whether electronically or otherwise) more than 6 months previously;

(f)if the repeatable prescription was signed (whether electronically or otherwise) more than one year previously;

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

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

(3) Where a patient requests the supply of drugs or appliances ordered on a repeatable prescription (other than on the first occasion that the patient makes such a request), D must only provide the drugs or appliances ordered if D is satisfied—

(a)that the patient to whom the prescription relates—

(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 the patient to whom the prescription relates 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 to whom the prescription relates which indicate the need or desirability of reviewing the patient's treatment.

[F32(4) D 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.]

[F33(5) D may refuse to [F34fulfil an order or a request] for a drug that is or is purportedly in accordance with [F35a LPIV,] a PTP [F36or a PTPGD] where—

(a)D reasonably believes it is not a genuine order [F37or valid request] for the person who requests, or on whose behalf is requested, the provision of the drug;

(b)providing it would be contrary to D’s clinical judgement;

(c)D or other persons are subjected to or threatened with violence by the person who requests the provision of the drug, or by any person accompanying that person; or

(d)the person who requests the provision of the drug, or any person accompanying that person, commits or threatens to commit a criminal offence.

(6) D must refuse to provide, pursuant to [F38a LPIV,] a PTP [F39or a PTPGD], an order [F40or a request] for a drug that is or is purportedly in accordance with [F41the LPIV,] the PTP [F42or PTPGD] where D is not satisfied that it is in accordance with [F41the LPIV,] the PTP [F42or PTPGD].]

[F43(7) D may refuse to provide a prescription item ordered on a prescription form or repeatable prescription where—

(a)more than one prescription item has been ordered on the prescription form or repeatable prescription;

(b)at least one of those prescription items is a listed HRT prescription item and at least one of those prescription items is not; and

(c)the person named on the prescription form or repeatable prescription is claiming entitlement to exemption under regulation 10(1)(j) of the Charges Regulations (exemptions) in respect of any of those prescription items which is a listed HRT prescription item.]

Textual Amendments

Dispensing doctors issuing prescription forms which may be presented to an NHS chemistU.K.

7.  Notwithstanding the existence of arrangements under which a dispensing doctor (D) is to provide pharmaceutical services to a patient (P), if D determines that P requires a drug or appliance that is available on prescription from an NHS chemist—

(a)D may with the agreement of P issue; or

(b)if P so requests, D must not unreasonably refrain from issuing,

a prescription form that P may present to any NHS chemist instead of D supplying that drug or appliance to P.

[F44Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.U.K.

7A.(1) Before dispensing any item on a prescription form or supplying it in accordance with a serious shortage protocol, a dispensing doctor (D) must provide a home delivery option to eligible patients in respect of the item where, as a consequence of a disease being or in anticipation of a disease being imminently—

(a)pandemic; and

(b)a serious risk or potentially a serious risk to human health,

the NHSCB with the agreement of the Secretary of State has made an announcement to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, eligible patients are advised to stay away from listed dispensing premises in the area specified, in the circumstances specified and for the duration of the period specified in the announcement.

(2) If D’s listed dispensing premises are in the area specified in the announcement, during the period when, in the circumstances specified in the announcement, eligible patients need to stay away from D’s premises, D must ascertain from—

(a)an eligible patient—

(i)who has contacted D about the home delivery of prescription items, or

(ii)who is a person whom D considered, on the basis of the nature of an item on a prescription form, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; or

(b)a person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted D about the home delivery of prescription items,

whether or not the item could be supplied by a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which D must provide.

(3) Where paragraph (2) does not apply, if D’s listed dispensing premises are in the area specified in the announcement, during the period when, in the circumstances specified in the announcement, eligible patients need to stay away from D’s premises, the home delivery option that P must provide must comprise—

(a)D delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);

(b)D arranging for an item dispensed by D to be delivered by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; or

(c)if D is unable to deliver the item or arrange for its delivery by another dispensing doctor, or by an NHS pharmacist or by an LPS contractor, D arranging for the dispensing or supply of the item by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, who would be able to deliver the dispensed item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.

(4) Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at D’s listed dispensing premises for the purposes of receiving dispensing services.

(5) Notwithstanding the foregoing provisions of this Schedule, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, D may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale.]

[F45Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.U.K.

7AA.(1) Before dispensing a notified item on a prescription form or supplying it in accordance with a serious shortage protocol, a PTP or a PTPGD, a dispensing doctor (D) must provide a home delivery option to eligible patients in respect of that item.

(2) For the purposes of this paragraph, a “notified item” is an item that, as a consequence of a disease being or in anticipation of a disease being imminently—

(a)pandemic; and

(b)a serious risk or potentially a serious risk to human health,

is the subject of an announcement made by the NHSCB, with the agreement of the Secretary of State, to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, eligible patients are entitled to be provided with a home delivery option in respect of that item, if it is supplied to them as part of pharmaceutical services.

(3) Where D is to, or may be required to, dispense a notified item on a prescription form or supply it in accordance with a serious shortage protocol, a PTP or a PTPGD, D must ascertain from—

(a)an eligible patient—

(i)who has contacted D about the home delivery of a notified item, or

(ii)who is a person whom D considered, on the basis of an order or request for a notifiable item, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; or

(b)a person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted D about the home delivery of a notified item,

whether or not the item could be supplied via a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which D must provide.

(4) Where paragraph (3) does not apply, the home delivery option that D must provide must comprise—

(a)D delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);

(b)D arranging for an item dispensed by D to be delivered by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; or

(c)if D is unable to deliver the item or arrange for its delivery by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, D arranging for the dispensing or supply of the item by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, who would be able to deliver the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.

(5) Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at D’s listed dispensing premises for the purposes of being supplied with the notifiable item.

(6) Notwithstanding the foregoing provisions of this Schedule, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, D may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale.]

Complaints proceduresU.K.

8.  Where a dispensing doctor is a provider of primary medical services, or is employed or engaged by such a provider, the complaints procedure established by—

(a)the provider or practice; or

(b)the provider or practice that employs or engages the dispensing doctor,

to deal with complaints in relation to the provision of primary medical services is also to apply in relation to a complaint about any matter reasonably connected with the provision of pharmaceutical services by that provider, practice or individual.

Inspections and access to informationU.K.

9.—(1) A dispensing doctor (D) must allow persons authorised in writing by the NHSCB to enter and inspect any premises D uses for the provision of pharmaceutical services at any reasonable time, for the purposes of—

(a)ascertaining whether or not D is complying with the requirements of this Schedule;

(b)auditing, monitoring and analysing—

(i)the provision made by D, in the course of providing pharmaceutical services, for patient care and treatment, and

(ii)the management by D of the pharmaceutical services D provides,

where the conditions in sub-paragraph (2) are satisfied.

(2) The conditions are that—

(a)reasonable notice of the intended entry has been given;

(b)the Local Medical Committee for the area where the premises are situated have been invited to be present at the inspection, where this is requested by D;

(c)the person authorised in writing (X) carries written evidence of X's authorisation, which X produces on request; and

(d)X does not enter any part of the premises used solely as residential accommodation without the consent of the resident.

(3) D must, at the request of the NHSCB or of X, allow it or X access to any information which it or X reasonably requires—

(a)for the purposes mentioned in sub-paragraph (1); or

(b)in the case of the NHSCB, in connection with its functions that relate to pharmaceutical services.

Voluntary closure of premisesU.K.

10.—(1) Where a dispensing doctor (D) wishes—

(a)to withdraw from a dispensing doctor list, or

(b)except in the circumstances described in paragraph (2), for particular listed dispensing premises no longer to be listed in relation to D,

D must notify the NHSCB of D's wish at least 3 months in advance of the date on which pharmaceutical services are no longer to be provided, unless it is impracticable for D to do so, in which case D must notify the NHSCB as soon as it is practicable for D to do so.

(2) If particular listed dispensing premises no longer need to be listed in relation to D as a consequence of a relocation application under regulation 55, before the date on which D commences the provision of pharmaceutical services at the new premises, D must give notice to the NHSCB of when, before that date, D is to cease to provide pharmaceutical services at the existing premises.

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