2011 No. 2136
The National Health Service (Pharmaceutical Services) Amendment Regulations 2011
Made
Laid before Parliament
Coming into force
The Secretary of State makes the following Regulations in exercise of the powers conferred by sections 126, 129 and 272(7) and (8) of the National Health Service Act 20061.
Citation and commencementI11
1
These Regulations may be cited as the National Health Service (Pharmaceutical Services) Amendment Regulations 2011 and come into force on 1st October 2011.
2
In these Regulations, “the principal Regulations” means the National Health Service (Pharmaceutical Services) Regulations 20052.
Amendment of regulation 2 of the principal RegulationsI22
In regulation 2(1) of the principal Regulations3 (interpretation), insert the following definitions in the appropriate alphabetical position—
“advanced services” means the directed services for which the Secretary of State determines the remuneration under section 164 of the 2006 Act4 (remuneration for persons providing pharmaceutical services);
“registered pharmacy technician” means a person registered as a pharmacy technician in Part 2 or 5 of the register maintained under article 19 of the Pharmacy Order 20105 (establishment, maintenance of and access to the Register);
Amendment of paragraph 26 of Schedule 1 to the principal RegulationsI33
1
Paragraph 26(2) of Schedule 1 to the principal Regulations6 (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,
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 State7 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,
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 20068 (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 19969 (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,
Transitional arrangementsI44
1
This regulation has effect only in relation to the provision of pharmaceutical services at any time before the end of the transitional period by a pharmacist whose name was, immediately before these Regulations come into force, already on a pharmaceutical list maintained by a Primary Care Trust under the principal Regulations.
2
Subject to paragraph (3), during the transitional period the pharmacist is not bound by—
a
any particular amendment to paragraph 26(2) of Schedule 1 to the principal Regulations (clinical governance) made by regulation 3(2)(a), (4)(b), (5)(a) or (6), if they choose instead to comply, and do comply, with the provision modified or substituted by that particular amendment as it had effect prior to that particular amendment; or
b
the amendments to paragraph 26(2) of Schedule 1 to the principal Regulations made by regulation 3(4)(a), (4)(c), (5)(b) to (d) and (7).
3
Nothing in this regulation affects the duty of a pharmacist—
a
before the end of the transitional period, to comply with paragraph 26(2) of Schedule 1 to the principal Regulations, as it otherwise has effect; and
b
at and after the end of the transitional period, to comply with paragraph 26(2) of Schedule 1 to the principal Regulations as amended by these Regulations.
4
In this regulation, “transitional period” means the period that begins on the day that these Regulations come into force and ends at the end of 31st March 2012.
Signed by authority of the Secretary of State for Health
(This note is not part of the Regulations)