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

Regulation 47(1)(a)(i)

SCHEDULE 6 Terms of service of dispensing doctors

Persons duly authorised to dispense on behalf of dispensing doctors

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 prescriber

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(1) (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”; or

(b) subject to sub-paragraph (4), D receives 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,

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(2), other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001(3) (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; or

(b) D receives 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,

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 Schedule 4 or 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.

Dispensing of drugs and appliances ordered by the dispensing doctor

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(4) (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(5) (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(6) (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(7) (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.

Preliminary matters before providing ordered drugs or appliances

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

(a) a dispensing doctor (D) 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(8) (supply of drugs and appliances by doctors) by virtue of either—

(i) entitlement to exemption under regulation 7(1) of the Charges Regulations(9) (exemptions), or

(ii) entitlement to remission of charges under regulation 5 of the Remission of Charges Regulations(10) (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 7 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 transmit to the Electronic Prescription Service—

(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 regulation 7(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.

Provision of Scheduled drugs

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(11) (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.

Refusal to provide drugs or appliances ordered

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.

(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.

Dispensing doctors issuing prescription forms which may be presented to an NHS chemist

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.

Complaints procedures

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 information

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 premises

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.

(1)

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

(2)

1971 c.38; see section 2(1)(a) of that Act, which defines “controlled drug” for the purposes of that Act.

(3)

S.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.

(4)

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

(5)

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

(6)

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

(7)

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

(8)

Regulation 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.

(9)

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

(10)

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

(11)

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