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

Clinical governance [F1 and the promotion of healthy living] U.K.

28.—(1) An NHS pharmacist (P) must, in connection with the pharmaceutical services provided by P, participate, in the manner reasonably required by the NHSCB, in an acceptable system of clinical governance [F2 and for the promotion of healthy living].

(2) For these purposes a system of clinical governance [F3 and for the promotion of healthy living] is “acceptable” if it is considered acceptable by the NHSCB and comprises the following components—

(a) a patient and public involvement programme, which includes—

(i) a requirement that P produces in an approved manner, and makes available in an appropriate manner, a practice leaflet containing approved particulars in respect of P's pharmacy premises,

(ii) a requirement that the pharmacist publicises the essential services and any advanced services[F4 , other than an advanced service in respect of the supply of drugs in accordance with regulation 225 of the Human Medicines Regulations 2012 (emergency sale etc by pharmacist: at patient’s request),] that are available at or from the pharmacist's pharmacy,

(iii) a requirement that where a pharmacist publicises the essential services or any directed services that are available at or from the pharmacist's pharmacy (whether the pharmacist is producing their own publicity material or advertising services in material published by another person), the pharmacist does so in a manner which makes clear that the services are funded as part of the health service,

F5 (iv) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(v) P's monitoring arrangements for drugs or appliances owed to patients but which are out of stock,

(vi) a requirement that P co-operates appropriately with any reasonable inspection or review that the NHSCB or any relevant statutory authority wishes to undertake, F6 ...

(vii) P's monitoring arrangements in respect of P's compliance with the Equality Act 2010; [F7 and]

[F8 (viii) undertaking at least once in each financial year an approved community engagement exercise in relation to the promotion of healthy living.]

[F9 (b) an audit programme, which in each financial year includes at least one clinical audit specified by P, and whichever of the following that the NHSCB specifies—

(i) a clinical audit carried out in a manner which is compatible with the NHSCB’s arrangements for the receiving and processing of data from the audit, or

(ii) a policy based audit (to support the development of the commissioning policies of the NHSCB) carried out in a manner which is compatible with the NHSCB’s arrangements for the receiving and processing of data from the audit;]

(c) a risk management programme, which includes—

(i) arrangements for ensuring that all stock is procured and handled in an appropriate way,

(ii) arrangements for ensuring that all equipment used in the provision of pharmaceutical services is maintained appropriately,

(iii) an approved incident reporting system, together with arrangements for analysing and responding to critical incidents,

(iv) arrangements, including record keeping arrangements, for dealing appropriately and timeously with any communications concerning patient safety from the Secretary of State M1 and the NHSCB,

(v) appropriate standard operating procedures, including standard operating procedures in respect of [F10 the discharge medicines service] dispensing drugs and appliances, repeatable prescriptions and providing advice and support to people caring for themselves or their families,

(vi) appropriate waste disposal arrangements (in addition to those required under Part 2) for clinical and confidential waste,

(vii) a clinical governance lead person for each pharmacy, appointed as such by the pharmacist (or who is the pharmacist), who is knowledgeable about both the pharmacy procedures of that pharmacy and the other NHS services that are available in the locality of that pharmacy,

(viii) appropriate safeguarding procedures for service users,

(ix) P's monitoring arrangements in respect of P's compliance with the Health and Safety at Work etc. Act 1974 M2 ;

[F11 (ca) at the request of the NHSCB, a pandemic response programme, which includes—

(i) conducting an infection control risk assessment, in the approved manner,

(ii) appropriate infection control measures at P’s pharmacy premises, having regard to that infection control risk assessment and to any approved particulars designed to support, in a proportionate manner, the safety of service users and pharmacy staff in particular in circumstances where services users or pharmacy staff may be, or are known or suspected to be, suffering from the pandemic disease,

(iii) arrangements, which may be approved arrangements, for communicating with potential service users about service availability and service provision at or from P’s pharmacy premises during the pandemic,

(iv) arrangements for appropriate updating of the standard operating procedures mentioned in sub-paragraph (c)(v) and any business continuity plan of P, and

(v) arrangements for appropriate updating of the premises standards programme mentioned in sub-paragraph (g) (including in response to any new approved particulars under sub-paragraph (g)(ii) that are in response to the pandemic),

but prior to making such a request (or revising the terms of such a request), the NHSCB must consult the body that is, for the time being, the body consulted under section 165(1)(a) of the 2006 Act in respect of pharmaceutical remuneration of NHS pharmacists;]

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

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

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

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

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

(e) a staffing and staff management programme, which includes—

(i) arrangements for appropriate induction for staff (including locums),

(ii) appropriate training for all staff in respect of any role they are asked to perform,

(iii) arrangements for the checking of qualifications and references of all staff engaged in the provision of NHS services,

[F12 (iiia) a requirement that P undertakes an approved workforce survey annually, in an approved manner,]

(iv) arrangements for identifying and supporting the development needs of all staff engaged in the provision of NHS services, including continuing professional development for registered pharmacists and registered pharmacy technicians, and any necessary accreditation [F13 , certification or declarations of competence in respect of any role they are asked to perform],

(v) arrangements for addressing poor performance (in conjunction with the NHSCB as appropriate), and

(vi) arrangements (which must include a written policy) for ensuring that all staff and locums who, arising out of their employment with the pharmacist—

(aa) make what is a protected disclosure within the meaning given in section 43A of the Employment Rights Act 1996 M3 (meaning of protected disclosure) have the rights afforded in respect of such disclosures by that Act, and

(bb) provide information in good faith and not for purposes of personal gain to the General Pharmaceutical Council or to the NHSCB which includes an allegation of a serious nature which they reasonably believe to be substantially true, but disclosure of it is not a protected disclosure within the meaning given in section 43A, have the right not to be subjected to any detriment or to dismissal as a consequence of that act;

(f) an information governance programme, which provides for—

(i) compliance with approved procedures for information management and security, and

(ii) submission of an annual self assessment of compliance (to an approved level) with those procedures via approved data submission arrangements which allow the NHSCB to access that assessment; and

(g) a premises standards programme, which includes—

(i) a system for maintaining cleanliness at the pharmacy which is designed to ensure, in a proportionate manner, that the risk to people at the pharmacy of health care acquired infection is minimised, and

(ii) arrangements for compliance, in the areas of the pharmacy in which patients receive NHS services, with any approved particulars that are designed to ensure, in a proportionate manner, that those areas are an appropriate environment in which to receive health care [F14 and for the promotion of healthy living],

and for the purposes of this sub-paragraph, “approved” means approved by the NHSCB.

Textual Amendments

F1 Words in Sch. 4 para. 28 heading inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(2)

F2 Words in Sch. 4 para. 28(1) inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(3)

F3 Words in Sch. 4 para. 28(2) inserted (1.1.2021) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(a)

F4 Words in Sch. 4 para. 28(2)(a)(ii) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 25

F5 Sch. 4 para. 28(2)(a)(iv) omitted (1.10.2022) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2022 (S.I. 2022/930), regs. 1(2), 8(3)(a)

F6 Word in Sch. 4 para. 28(2)(a)(vi) omitted (1.1.2021) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(b)(i)

F7 Word in Sch. 4 para. 28(2)(a)(vii) inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(b)(ii)

F8 Sch. 4 para. 28(2)(a)(viii) inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(b)(iii)

F9 Sch. 4 para. 28(2)(b) substituted (1.3.2015) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2015 (S.I. 2015/58), regs. 1(1), 8(3) (with reg. 10)

F10 Words in Sch. 4 para. 28(2)(c)(v) inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(c)

F11 Sch. 4 para. 28(2)(ca) inserted (1.1.2022) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(b), 8(2)

F12 Sch. 4 para. 28(2)(e)(iiia) inserted (1.10.2022) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2022 (S.I. 2022/930), regs. 1(2), 8(3)(b)

F13 Words in Sch. 4 para. 28(2)(e)(iv) substituted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(d)

F14 Words in Sch. 4 para. 28(2)(g)(ii) inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(e)

Marginal Citations

M1 The Medicines and Healthcare Products Regulatory Agency, which is an executive agency of the Department of Health, issues safety advice, warnings, alerts and recalls in respect of medical devices on behalf of the Secretary of State, and also safety advice, warnings, alerts and recalls in respect of medicines on behalf of the Secretary of State and the Minister for Health, Social Services and Public Safety, acting jointly. The Department of Health also, separately, issues other communications concerning patient safety, on behalf of the Secretary of State.

M2 1974 c. 37.

M3 1996 c. 18; section 43A was inserted by the Public Interest Disclosure Act 1998 (c. 23), section 1. See also section 43K(1)(c) (i) of the Employment Rights Act 1996 (inserted by the Public Interest Disclosure Act 1998, section 1, and amended by: the National Health Service Reform and Health Care Professions Act 2002 (c. 17), Schedule 2, paragraph 63; the National Health Service (Consequential Provisions) Act 2006 (c. 43), Schedule 1, paragraphs 177 and 178(b); and S.I. 2007/961).