The National Health Service (Pharmaceutical Services) Amendment Regulations 2011

Amendment of paragraph 26 of Schedule 1 to the principal Regulations

3.—(1) Paragraph 26(2) of Schedule 1 to the principal Regulations(1) (clinical governance) is amended as follows.

(2) In paragraph (a)—

(a) for sub-paragraph (ii) substitute the following sub-paragraphs—

“(ii) a requirement that the pharmacist publicises the essential services and any advanced services that are available at or from the pharmacist’s pharmacy,

(iia) 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,”; and

(b) omit sub-paragraph (v).

(3) In paragraph (b), for “multi-disciplinary” substitute “other”.

(4) In paragraph (c)—

(a) after sub-paragraph (iii) insert the following sub-paragraph—

“(iiia) arrangements, including record keeping arrangements, for dealing appropriately and timeously with communications concerning patient safety from the Secretary of State(2) and the National Patient Safety Agency,”;

(b) for sub-paragraph (vi) substitute the following sub-paragraph—

“(vi) a clinical governance lead person for each pharmacy, appointed as such by the pharmacist (or that 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,”; and

(c) omit the “and” at the end of sub-paragraph (vii), and after that sub-paragraph insert the following sub-paragraph—

“(viia) appropriate vulnerable adult (as construed in accordance with section 59 of the Safeguarding Vulnerable Groups Act 2006(3) (vulnerable adults)) protection procedures, and”.

(5) In paragraph (e)—

(a) in sub-paragraph (iv), after “registered pharmacists” insert “and registered pharmacy technicians,”;

(b) omit the “and” at the end of sub-paragraph (iv);

(c) for the semicolon in sub-paragraph (v) substitute a comma; and

(d) after sub-paragraph (v) insert the following sub-paragraph—

“(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(4) (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 a Primary Care Trust 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;”.

(6) For sub-paragraph (f) substitute the following sub-paragraph—

“(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 Primary Care Trust to access that assessment; and”.

(7) After sub-paragraph (f) add the following sub-paragraph—

“(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,”.

(1)

Paragraph 26 has been amended by S.I. 2008/528 and 683 and 2009/3340.

(2)

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.

(3)

2006 c. 47; section 59 has been amended by: the Education and Skills Act 2008 (c. 25), section 147(8); the Health Act 2009 (c. 21), Schedule 1, paragraphs 12 and 15, and Schedule 6; and S.I. 2008/919.

(4)

1996 c. 18; section 43 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), which extends the meaning of “worker” for the Part of that Act that deals with protected disclosures so that it covers all individuals who provide pharmaceutical services in accordance with arrangements made by a Primary Care Trust under section 126 of the National Health Service Act 2006.