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

Regulation 12

SCHEDULE 7 E+W Terms of service for doctors providing pharmaceutical services

Interpretation E+W

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 doctor has that prescription in their possession, and

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

Commencement Information

I1 Sch. 7 para. 1 in force at 1.10.2020, see reg. 1(2)(b)

Incorporation of provisions E+W

2.  Any provisions of the following affecting the rights and obligations of doctors 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),

(c) so much of Part 2 of the National Health Service (Service Committees and Tribunal) Regulations 1992 as relates to—

(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, and

(d) so much of regulation 29 of the Community Health Councils (Constitution, Membership and Procedures) (Wales) Regulations 2010(1) (entry and inspection of premises) as relate to the entry and inspection of premises either owned by the dispensing doctor or where pharmaceutical services are provided by that dispensing doctor.

Commencement Information

I2 Sch. 7 para. 2 in force at 1.10.2020, see reg. 1(2)(b)

Persons duly authorised to dispense on behalf of dispensing doctors E+W

3.  Where this Schedule imposes a requirement on a dispensing doctor in respect of an activity which they have 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) that dispensing doctor must secure compliance with that requirement by that other person,

and references in this Schedule to a dispensing doctor are to be construed accordingly.

Commencement Information

I3 Sch. 7 para. 3 in force at 1.10.2020, see reg. 1(2)(b)

Dispensing of drugs and appliances ordered by another prescriber E+W

4.—(1) Subject to the following provisions of this Schedule, where any person presents to a dispensing doctor a prescription form which contains—

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

(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 a prescriber other than the dispensing doctor, and including the reference “SLS”, or

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

and the dispensing doctor is authorised or required by virtue of regulation 26 (arrangements for the provision of pharmaceutical services by doctors) of these Regulations to provide the drugs or appliances so ordered, the dispensing doctor must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as they supply in the normal course of their practice or business.

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

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

(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 the dispensing doctor who is a repeatable prescriber and including the reference “SLS”,

(iii) an order for appliances, not being restricted availability appliances, signed by a prescriber other than the dispensing doctor who is a repeatable prescriber, or

(iv) an order for a restricted availability appliance, signed by a prescriber other than the dispensing doctor who is a repeatable prescriber, and including the reference “SLS”,

and also presents a batch issue, or

(b) the dispensing doctor receives an electronic repeatable prescription 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) the dispensing doctor has previously arranged with the patient that they will dispense that repeatable prescription on receipt,

and the dispensing doctor is authorised or required by regulation 26 to provide the drugs or appliances so ordered, the dispensing doctor must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as they supply in the normal course of their practice or business.

(3) For the purposes of this paragraph, a non-electronic repeatable prescription for drugs or appliances will 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 dispensing doctor has that prescription in their possession, and

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

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

Commencement Information

I4 Sch. 7 para. 4 in force at 1.10.2020, see reg. 1(2)(b)

Dispensing of drugs and appliances ordered by the dispensing doctor E+W

5.  In circumstances where paragraph 4 does not apply and subject to the following provisions of this Schedule, where a dispensing doctor is authorised or required by virtue of Part 6 of these Regulations to provide drugs or appliances to a person, the dispensing doctor must—

(a) record an order for the provision of any drugs or appliances which are needed for the treatment of the patient on a prescription form completed in accordance with a GMS contract which gives effect to paragraph 39 of Schedule 6 to the GMS Regulations (other contract terms: prescribing),

(b) provide those drugs or appliances in a suitable container,

(c) provide for the patient a drug specified in Schedule 2 to the Prescription of Drugs Regulations only where the conditions in paragraph 42(2) of Schedule 6 to the GMS Regulations (restrictions on prescribing by medical practitioners) are satisfied, and

(d) 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.

Commencement Information

I5 Sch. 7 para. 5 in force at 1.10.2020, see reg. 1(2)(b)

Preliminary matters before providing ordered drugs or appliances E+W

6.  Before providing drugs or listed appliances recorded on a prescription form in accordance with paragraph 4, or in the circumstances set out in paragraph 7—

(a) the dispensing doctor must ask any person who makes a declaration that the patient does not have to pay the charges specified in regulation 4(1) of the Charges Regulations (supply of drugs and appliances by doctors) by virtue of either—

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

(ii) entitlement to remission of charges under regulation 5 of the Remission of Charges Regulations (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 regulation 8 of the Charges Regulations or in respect of remission by virtue of regulation 5(1)(e) or 5(2)(e) or (f) of the Remission of Charges Regulations, and at the time of the declaration the dispensing doctor already has such evidence available to them, and

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

Commencement Information

I6 Sch. 7 para. 6 in force at 1.10.2020, see reg. 1(2)(b)

Provision of Scheduled drugs E+W

7.—(1) Subject to sub-paragraph (2), a dispensing doctor must not provide for a patient any Scheduled drug, except that, where the dispensing doctor or an independent prescriber has ordered a drug which has an appropriate non-proprietary name either by the name or by its formula, they may provide a drug which has the same specification notwithstanding that it is a Scheduled drug (but, in the case of a drug which combines more than one drug, only if the combination has an appropriate non-proprietary name).

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

Commencement Information

I7 Sch. 7 para. 7 in force at 1.10.2020, see reg. 1(2)(b)

Refusal to provide drugs or appliances ordered E+W

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

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

(b) it appears to the dispensing doctor 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 dispensing doctor’s clinical judgement.

(2) A dispensing doctor may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription, or which they are otherwise authorised or required to provide by virtue of regulation 26, where—

(a) the dispensing doctor or other persons on the premises are subjected to or threatened with violence by the person presenting the prescription or repeatable prescription, or by any person accompanying that person, or

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

(3) A dispensing doctor must refuse to provide drugs or appliances ordered on a repeatable prescription where—

(a) the dispensing doctor has no record of that prescription,

(b) it is not signed by a repeatable prescriber,

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

(d) 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,

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

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

(g) where the dispensing doctor has been informed by the repeatable prescriber that the prescription is no longer required.

(4) Where the 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), a dispensing doctor may only provide the drugs or appliances ordered if 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 that indicates the need or desirability of reviewing the patient’s treatment, and

(c) that 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.

Commencement Information

I8 Sch. 7 para. 8 in force at 1.10.2020, see reg. 1(2)(b)

Fees and charges E+W

9.—(1) The terms of a GMS contract giving effect to regulation 24 of, and Schedule 5 to, the GMS Regulations (fees and charges) apply in respect of the provision of any drugs or appliances by a dispensing doctor as they apply in relation to prescriptions for drugs and appliances.

(2) Where a dispensing doctor provides a drug or appliance under pharmaceutical services or provides any additional service associated with the dispensing of such drugs and appliances—

(a) in accordance with this Schedule or an agreement with the Local Health Board, and

(b) had the drug, appliance or additional service been provided by a contractor providing dispensing services under a GMS contract, the contractor would have been entitled by, by virtue of directions given by the Welsh Ministers under section 45 of the 2006 Act (GMS contracts: payments), to a payment—

(i) in respect of the drug or appliance, or

(ii) in respect of the additional service provision,

the Local Health Board will credit the dispensing doctor with the payment.

Commencement Information

I9 Sch. 7 para. 9 in force at 1.10.2020, see reg. 1(2)(b)

Complaints and concerns E+W

10.—(1) Where a dispensing doctor—

(a) is a GMS contractor, or is engaged or employed by a GMS contractor, the complaints procedure established in accordance with the terms of a GMS contract which give effect to paragraphs 89A and 90 of Schedule 6 to the GMS Regulations (concerns and complaints);

(b) is an APMS contractor, or is engaged or employed by an APMS contractor, the complaints procedure established by the relevant APMS contract to deal with complaints in relation to the provision of primary medical services;

(c) is employed or engaged by a Local Health Board for the purposes of providing pharmaceutical services within an LHBMS practice, the complaints procedure established by that LHBMS practice to deal with complaints in relation to the provision of primary medical services,

applies in relation to any matter reasonably connected with the provision of pharmaceutical services as it applies as respects to services provided under that contract or agreement, or within that practice.

(2) Accordingly, a GMS contract which gives effect to paragraph 95 of Schedule 6 to the GMS Regulations (co-operation with investigations) also applies in relation to complaints or concerns notified about such matters.

Commencement Information

I10 Sch. 7 para. 10 in force at 1.10.2020, see reg. 1(2)(b)

Inspections and access to information E+W

11.—(1) A dispensing doctor must allow persons authorised by the Local Health Board to enter and inspect any premises that they use for the provision of pharmaceutical services at any reasonable time, for the purposes of—

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

(b) auditing, monitoring and analysing—

(i) the provision made by the dispensing doctor, in the course of providing pharmaceutical services, for patient care and treatment, including any arrangement made with a person in respect of provision of appliances, and

(ii) the management by the dispensing doctor of the pharmaceutical services the dispensing doctor 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 in which the premises are situated has been invited to be present at the inspection, where this is requested by the dispensing doctor,

(c) the person authorised in writing carries written evidence of their authorisation, which must be produced on request, and

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

(3) A dispensing doctor must, at the request of the Local Health Board or of a person authorised in writing mentioned in sub-paragraph (1), allow it or that person access to any information which it or that person reasonably requires—

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

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

Commencement Information

I11 Sch. 7 para. 11 in force at 1.10.2020, see reg. 1(2)(b)

Welsh language E+W

12.—(1) Where a dispensing doctor provides pharmaceutical services through the medium of Welsh, the dispensing doctor must notify the Local Health Board in writing.

(2) A dispensing doctor must make available a Welsh language version of any document or form for use by patients and/or members of the public, provided by the Local Health Board.

(3) Where a dispensing doctor displays a new sign or notice in connection with pharmaceutical services, the text on the sign or notice must be in English and Welsh, and a dispensing doctor may utilise the translation service offered by the Local Health Board for this purpose.

(4) Where a dispensing doctor is Welsh speaking, they are encouraged to wear a badge provided by the Local Health Board, to convey that the dispensing doctor is able to speak Welsh.

(5) A dispensing doctor is encouraged to utilise information and/or attend training courses and events provided by the Local Health Board, so that the dispensing doctor can develop—

(a) an awareness of the Welsh language (including awareness of its history and its role in Welsh culture), and

(b) an understanding of how the Welsh language can be used in connection with the pharmaceutical services provided.

(6) When delivering pharmaceutical services, a dispensing doctor is encouraged to establish and record the Welsh or English language preference expressed by or on behalf of a patient.

Commencement Information

I12 Sch. 7 para. 12 in force at 1.10.2020, see reg. 1(2)(b)

(1)

S.I. 2010/288 (W. 37).