5. Schedule 4 to the PLPS Regulations (terms of service of NHS pharmacists) is amended in accordance with this Part.
6. After paragraph 5A(1) (supply in accordance with a SSP) insert—
5B.—(1) Subject to the following provisions of this Part, where—
(a)an NHS Pharmacist (P) 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; and
(b)a person who is entitled to be supplied with that drug in pursuance of that order requests the provision of the drug in accordance with that order,
P must, with reasonable promptness, provide the drug so ordered.
(2) If a person who is entitled as mentioned in sub-paragraph (1)(b) asks P to do so—
(a)P must give an estimate of the time when the drug will be ready; and
(b)if they are not ready by then, P must give a revised estimate of the time when they will be ready (until they are ready).”.
7. In paragraph 8(2) (providing ordered drugs or appliances)—
(a)in sub-paragraph (15), after “paragraph 5A” insert “or 5B”; and
(b)after sub-paragraph (16) insert—
“(17) Sub-paragraphs (5) to (10) apply to the provision of a drug in accordance with a PTP as they apply to the provision of a drug in accordance with a prescription form or a repeatable prescription (or an associated batch issue).
(18) Where P provides a drug under paragraph 5B, P 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 2 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, identifying the particular PTP.”.
8. In paragraph 9(3) (refusal to provide drugs or appliances ordered)—
(a)in sub-paragraph (2A), after “(or at all)” insert—
“, but where P does so, P must take all reasonable steps to ensure that the product ordered by the prescriber is supplied within a reasonable timescale, which may include (depending on what steps or combination of steps the circumstances require)—
(a)providing details of other NHS pharmacists or LPS chemists whose premises are situated in the same area and who may be able to provide the product ordered by the prescriber;
(b)urgent supply without a prescription in accordance with paragraph 6;
(c)arranging for the urgent provision of a non-electronic prescription form by the prescriber.”; and
(b)after sub-paragraph (4) insert—
“(5) P may refuse to provide an order for a drug that is or is purportedly in accordance with a PTP where—
(a)P reasonably believes it is not a genuine order for the person who requests, or on whose behalf is requested, the provision of the drug;
(b)providing it would be contrary to P’s clinical judgement;
(c)P 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) P must refuse to provide, pursuant to a PTP, an order for a drug that is or is purportedly in accordance with the PTP where P is not satisfied that it is in accordance with the PTP.”.
9. In paragraph 10(4) (further activities to be carried out in connection with the provision of dispensing services), in sub-paragraph (1)—
(a)in paragraph (e), after “written note” insert “(which may be in an electronic form)”; and
(b)omit paragraph (g).
10. In paragraph 11(5) (additional requirements in relation to electronic prescribing)—
(a)in sub-paragraph (1)—
(i)omit paragraph (a), and
(ii)in paragraph (b), for “not available” substitute “temporarily unavailable”; and
(b)in sub-paragraph (2), omit “Where the Electronic Prescription Service is available through P’s premises,”.
11.—(1) Paragraph 18 (health campaigns) is amended as follows.
(2) Omit “public” from its heading.
(3) In paragraph (a)—
(a)for “calendar” substitute “financial”; and
(b)omit “public”.
(4) At the end of sub-paragraph (b) insert “; and”.
(5) After sub-paragraph (b) insert—
“(c)where requested to do so by the NHSCB, P sends to the NHSCB by means of an electronic communication of the type specified in the request—
(i)the number recorded pursuant to sub-paragraph (b), and
(ii)information which is reasonably requested by the NHSCB, and which is in an anonymised form if it would otherwise identify any person to whom information was provided as part of the campaign, for the purposes of evaluating the effectiveness of the campaign and policy development.”.
12. In Part 2 (essential services), after paragraph 22A(6) (home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.) insert—
22B. An NHS pharmacist (P) must, to the extent that paragraph 22C requires and in the manner set out in that paragraph, provide advice, assistance and support to and in respect of a health service patient—
(a)recently discharged from hospital who is referred to P for advice, assistance and support in respect of the patient’s medication regimen by the staff of the hospital in which the patient stayed; or
(b)who is otherwise referred to P for advice, assistance and support in respect of the patient’s medication regimen by the staff of an NHS trust or NHS foundation trust as part of arrangements linked to the transfer of care between different providers of NHS services.
22C.—(1) An NHS pharmacist (P) must have procedures in place (as part of its standard operating procedures) for checking at appropriate intervals on days on which P’s pharmacy premises are open for business whether P has received any referrals, which are in the form and manner approved for this purpose by the NHSCB, for the services set out in this paragraph (“DMS referrals”).
(2) If P receives a DMS referral in respect of a health service patient (X) requesting from P stage 1 of the service (as well as stages 2 and 3), P must, as soon as possible but in any event within 72 hours of receiving the DMS referral (excluding hours of days on which the pharmacy premises are not open for business), as stage 1 of the service—
(a)review the actions requested, and act on those requested actions, to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so;
(b)use the information that P has or is able to access about X’s medication regimen before the discharge or transfer to compare it (so far as is possible) with X’s medication regimen on discharge or transfer;
(c)check any prescriptions for X that P may be asked to dispense (including electronic repeatable prescriptions) or has part dispensed in order to assess whether, in P’s clinical judgement, any changes are appropriate or there are any other issues of concern;
(d)where necessary, discuss changes that may be appropriate or raise any issues of concern identified, to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so with—
(i)the staff of the hospital or other provider of NHS services that made the referral, and
(ii)any provider of primary medical services on whose patient list X is; and
(e)keep and maintain records of the DMS referrals received and of any actions taken, as appropriate (in particular, to support delivery of stages 2 and 3 of the service).
(3) This sub-paragraph applies—
(a)if P receives—
(i)in respect of X an electronic prescription for a medicinal product or is presented by X with a non-electronic prescription form, a non-electronic repeatable prescription or an EPS token in respect of a medicinal product, and
(ii)is on notice as a result of a DMS referral requesting from P stage 2 of the service (whether or not it is the referral mentioned in sub-paragraph (2)) that the prescription is the first prescription for a medicinal product to be dispensed by P to X following X’s discharge from hospital or the transfer of X’s care between different providers of NHS services; or
(b)in the following circumstances—
(i)P receives in respect of a health service patient (Y) an electronic prescription for a medicinal product or is presented by Y with a non-electronic prescription form, a non-electronic repeatable prescription or an EPS token in respect of a medicinal product,
(ii)P is on notice as a result of a DMS referral requesting from P stage 2 of the service (and potentially stage 3) that it is the first prescription for a medicinal product to be dispensed to Y following Y’s discharge from hospital or the transfer of Y’s care between different providers of NHS services (a different NHS pharmacist having provided stage 1 of the service in respect of Y), and
(iii)P is on notice that Y, or where appropriate a carer of Y, wishes P to provide the services described in sub-paragraphs (4) and (5) to or in respect of Y.
(4) Where sub-paragraph (3) applies, P must, as stage 2 of the service, prior to or as part of the process of dispensing the prescription—
(a)review (or further review) the medication regimen of X or Y, using the information that P has or is able to access about that medication regimen, including from the prescription, in order to assess whether, in P’s clinical judgement, appropriate account has been taken of any changes to X’s or Y’s medication regimen during X’s or Y’s stay in hospital or prior to the transfer of X’s or Y’s care between different providers of NHS services;
(b)if any issues of concern are identified, raise these to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so with any provider of primary medical services on whose patient list X or Y is; and
(c)keep and maintain records of any actions taken as part of this stage of the process, as appropriate (in particular, to support delivery of stage 3 of the service).
(5) At the point at which P, in P’s clinical judgement is to, or would normally, discuss the prescription as mentioned in paragraph (3)(a)(i) or (b)(i) with X or Y, or where appropriate with a carer of X or Y, P must, as stage 3 of the service—
(a)engage in a discussion with X or Y, or where appropriate a carer of X or Y, in a manner which is in accordance with P’s duty of confidentiality to X or Y and which is—
(i)to assess their understanding of what medicinal products X or Y should be taking, and
(ii)to offer to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so advice, assistance and support in respect of X’s or Y’s medication regimen;
(b)draw to X’s or Y’s attention (where appropriate via a carer of X or Y)—
(i)P’s disposal service in respect of unwanted drugs, and
(ii)any other pharmaceutical services that P, in the exercise of P’s clinical judgement, considers X or Y may benefit from following X’s or Y’s stay in hospital or the transfer of X’s or Y’s care between different providers of NHS services;
(c)if any issues of concern are identified, raise these to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so with any provider of primary medical services on whose patient list X or Y is; and
(d)keep and maintain records, as appropriate—
(i)of the discussion pursuant to paragraphs (a) and (b), and of any raising of concerns and any actions taken, and
(ii)for service evaluation purposes.
(6) If the DMS referral requesting that P provides services under this paragraph includes circumstances in which P is not to provide, or is to cease to provide, services under this paragraph, P is not to, or is to cease to, provide services under this paragraph in those circumstances (for example, X’s or Y’s admission or re-admission to hospital).”.
13. After paragraph 27A(7) (pharmacy opening hours: arrangements while a disease is or in anticipation of a disease being imminently pandemic etc.) insert—
27B.—(1) Notwithstanding the forgoing provisions of this Part, in order to assist in the management of a serious risk or potentially serious risk to human health which arises as a consequence of a disease being, or in anticipation of a disease being imminently, pandemic, an NHS pharmacist (P) may, with the agreement of the NHSCB, limit for a specified period (within P’s core and supplementary opening hours) the pharmaceutical services provided at or from P’s pharmacy premises to relevant immunisation services.
(2) If the NHSCB has made an announcement to the effect that there are particular arrangements under this paragraph that it is prepared to agree, and P limits P’s provision of pharmaceutical services to relevant immunisation services in a manner that is consistent with that announcement, it is to be assumed (in the absence of a contrary notification from the NHSCB to P) that P has the agreement of the NHSCB to those arrangements.
(3) In this paragraph, “relevant immunisation services” means directed services that provide for the administration of a medicinal product for vaccination or immunisation against coronavirus or influenza virus in accordance with—
(a)a patient group direction that meets the conditions of regulation 233 of the Human Medicines Regulations 2012(8) (exemption for supply etc under a PGD by a person conducting a retail pharmacy business); or
(b)a protocol that meets the conditions of regulation 247A of the Human Medicines Regulations 2012(9) (protocols relating to coronavirus and influenza vaccinations and immunisations),
and for these purposes, “coronavirus” has the meaning given in section 1(1) of the Coronavirus Act 2020(10).”.
14.—(1) Paragraph 28(11) (clinical governance) is amended as follows.
(2) In its heading, after “clinical governance” insert “and the promotion of healthy living”.
(3) In paragraph (1), after “clinical governance” insert “and for the promotion of healthy living”.
(4) In paragraph (2)—
(a)after “clinical governance” at the first place where it occurs, insert “and for the promotion of healthy living”;
(b)in sub-paragraph (a)—
(i)omit “and” at the end of paragraph (vi),
(ii)insert “and” at the end of paragraph (vii), and
(iii)after paragraph (vii), insert—
“(viii)undertaking at least once in each financial year an approved community engagement exercise in relation to the promotion of healthy living.”;
(c)in sub-paragraph (c)(v), after “in respect of” insert “the discharge medicines service”;
(d)in sub-paragraph (e)(iv), for “in respect of the provision of directed services” substitute “, certification or declarations of competence in respect of any role they are asked to perform”; and
(e)in sub-paragraph (g)(ii), after “receive health care” insert “and for the promotion of healthy living”.
15.—(1) After paragraph 28 (clinical governance and the promotion of healthy living) insert—
28A.—(1) An NHS pharmacist must ensure that at pharmacy premises, other than distance selling premises, there is a consultation room which is—
(a)clearly designated as a room for confidential conversations;
(b)distinct from the general public areas of the pharmacy premises; and
(c)a room where both a person accessing pharmaceutical services and a person performing pharmaceutical services are able to be seated together and communicate confidentially.
(2) Where, in the opinion of the NHSCB, pharmacy premises other than distance selling premises included on a pharmaceutical list on the relevant day are too small for a consultation room—
(a)the NHS pharmacist in respect of those premises may, with the agreement of the NHSCB, comply with paragraph 28B instead of sub-paragraph (1); and
(b)for these purposes, references to distance selling premises in paragraph 28B are to be treated as a reference to the premises about which the NHSCB has formed the opinion that they are too small for a consulting room.
(3) An NHS pharmacist in respect of premises that were on a pharmaceutical list on the relevant day but no advanced services were provided at or from those premises during the year before the relevant day need not comply with sub-paragraphs (1) or (2) in respect of those premises before 1st April 2023.
(4) In this paragraph, “the relevant day” means the day of the coming into force of regulation 15(1) of the National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020.
28B. An NHS pharmacist in respect of distance selling premises must ensure that there are arrangements in place at those premises which enable a person performing pharmaceutical services to communicate confidentially with a person accessing pharmaceutical services—
(a)by telephone or another live audio link; and
(b)via a live video link.”.
(2) After paragraph 28B insert—
28C. An NHS pharmacist (P) in respect of distance selling premises must ensure that P has a website for use by the public for the purpose of accessing pharmaceutical services from those premises, on which there is an interactive page, clearly promoted to any user of the website when they first access it, which provides public access to a reasonable range of up to date materials that promote healthy lifestyles by addressing a reasonable range of health issues.”.
16. In paragraph 29A(12) (accessing summary care records), for sub-paragraphs (1) and (2) substitute—
“(1) An NHS pharmacist (P) must have access to summary care records at P’s pharmacy premises, and must ensure that the access that P has to summary care records at those premises is constant and reliable during core and supplementary opening hours, in so far as that is within the control of P.
(2) P must access the summary information in a patient’s summary care record whenever P is providing pharmaceutical services to the patient, to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so.”.
17. After paragraph 29A (accessing summary care records) insert—
29B. An NHS pharmacist (P) must have access to the EPS at P’s pharmacy premises, and must ensure that the access that P has to the EPS at those premises is constant and reliable during core and supplementary opening hours, in so far as that is within the control of P.
29C.—(1) An NHS pharmacist (P) must ensure that pharmacy staff at pharmacy premises (including locums) have access to, and are able to send and receive NHSmail from, a premises specific NHSmail account.
(2) P must ensure that at least two members of the pharmacy staff have live, linked NHSmail accounts to the premises specific NHSmail account (unless fewer than two members of the pharmacy staff are engaged in the provision of NHS services).
(3) P must ensure that there is a comprehensive and accurate pharmacy profile in respect of P’s pharmacy premises in the NHS Digital directory of services, and P must verify and where necessary update the information contained in that profile at least once each quarter of the financial year.
(4) P must ensure that there is a comprehensive and accurate pharmacy profile in respect of P’s pharmacy premises on the NHS.uk website, and P must verify and where necessary update the information contained in that profile at least once each quarter of the financial year.
(5) As regards the Central Alerting System (CAS) operated by the Medicines and Healthcare products Regulatory Agency(13) (MHRA)—
(a)P must register P’s premises specific NHSmail address with MHRA as an address at which P is content to accept notifications as part of the CAS (unless they are content with the address already in the system);
(b)if P changes P’s premises specific NHSmail address, P must immediately notify MHRA of P’s new premises specific NHSmail address, in accordance with paragraph (a); and
(c)P must monitor P’s premises specific NHSmail account with sufficient frequency to ensure the safe and effective supply of medicinal products at or from P’s pharmacy premises, and must act on the alerts P receives as part of the CAS, as appropriate.”.
18. After paragraph 32 (other information to be supplied) insert—
32A.—(1) An NHS pharmacist (P) must, to the extent reasonable—
(a)facilitate remote access to the pharmaceutical services provided at or from P’s pharmacy premises, where users wish to access those services under arrangements that make those services available using remote access; and
(b)establish, maintain and keep under review procedures to facilitate remote access to those services under arrangements that make those services available using remote access.”.
19. In paragraph 35 (inspections and access to information), after sub-paragraph (3) insert—
“(4) P must, at the request of the NHSCB, send to the NHSCB by means of an electronic communication of the type specified in the request any information to which a person authorised in writing by the NHSCB would have access during an inspection of P’s pharmacy premises pursuant to sub-paragraph (1), if—
(a)P has that information in a form which means it may be sent by that form of electronic communication; or
(b)it is reasonable for the NHSCB to request that P convert that information into a form which means that it may be sent by that form of electronic communication (and the NHSCB does so request).
(5) P must, at the request of NHSCB or a person authorised in writing by the NHSCB to make the request, send to the NHSCB or that person by means of an electronic communication, a duly completed questionnaire, which is—
(a)in a format approved by the NHSCB; and
(b)for the purpose of enabling NHSCB, or a person authorised in writing by the NHSCB, to determine whether or when it is necessary or expedient for a person authorised in writing by the NHSCB to undertake an inspection of P’s premises pursuant to sub-paragraph (1).
(6) Before information is requested pursuant to sub-paragraph (5), the NHSCB must consult the person who is, for the time being, the person consulted under section 165(1)(a) of the 2006 Act, in respect of pharmaceutical remuneration of NHS pharmacists on the terms of the request.”.
Paragraph 5A was inserted by S.I. 2019/990.
Amended by S.I. 2019/990.
Amended by S.I. 2018/1114 and 2019/990.
Amended by S.I. 2015/58 and 2019/990
Amended by S.I. 2018/1114.
Inserted by S.I. 2020/351.
Inserted by S.I. 2020/351.
S.I. 2012/1919; the relevant amending instruments are S.I. 2013/235, 2015/1503, 2019/775 and 2020/1125.
Inserted by S.I. 2020/1125.
Amended by S.I. 2015/58 and 2016/1077.
Inserted by S.I. 2016/296.
The Medicines and Healthcare products Regulatory Agency is an executive agency of the Department of Health and Social Care. Its address is 10 South Colonnade, Canary Wharf, London E14 4PU.