The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2016
Citation, commencement and interpretation1.
(1)
These Regulations may be cited as the National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2016 and—
(a)
apart from regulations 4(2) and 5(2), come into force on 1st April 2016;
(b)
regulations 4(2) and 5(2) come into force on 1st July 2016.
(2)
Amendment of regulation 75 of the principal Regulations2.
(1)
Regulation 75 of the principal Regulations (voluntary and automatic removal of listings: change of ownership, relocation, temporary provision and voluntary closure) is amended as follows.
(2)
In paragraph (2)—
(a)
in sub-paragraph (a), for “regulation 67(4)(b)” substitute “regulation 67(4)”; and
(b)
in sub-paragraph (b)(ii), for regulation 67(4)(a)(ii), substitute “regulation 67(4)”.
Substitution of regulation 121 of the principal Regulations3.
“Review of these Regulations121.
(1)
The Secretary of State must, in accordance with paragraphs (2) to (4)—
(a)
carry out reviews of these Regulations;
(b)
set out the conclusions of each review in a report; and
(c)
publish each report.
(2)
Each report must in particular—
(a)
set out the objectives intended to be achieved by these Regulations;
(b)
assess the extent to which those objectives have been achieved;
(c)
assess whether those objectives remain appropriate; and
(d)
if those objectives remain appropriate, assess the extent to which they could be achieved in another way which involves less onerous regulatory provision.
(3)
The first report under this regulation must be published before the end of 31st August 2017.
(4)
Each subsequent report must be published before the end of the period of five years beginning on the day on which the previous report was published.”.
Amendment of Schedule 4 to the principal Regulations4.
(1)
(2)
“(3A)
In any case where no satisfactory evidence, as required by sub-paragraph (3), is produced to P, P must ensure before the drugs or appliances are provided that the person who was asked to produce that evidence is advised, in appropriate terms, that checks are routinely undertaken to ascertain entitlement to—
(a)
exemption under the Charges Regulations4; or(b)
remission of charges under the Remission of Charges Regulations5,where such entitlement has been claimed, as part of the arrangements for preventing or detecting fraud or error in relation to such claims.”.
(3)
“Accessing summary care records29A.
(1)
If an NHS pharmacist (P) is providing pharmaceutical services to or in respect of a patient and has access to the summary information that comprises a summary care record of that patient, P must access that summary information where the conditions in sub-paragraph (2) are satisfied.
(2)
The conditions are that—
(a)
in P’s clinical judgment it is in the best interests of the patient to do so; and
(b)
in doing so P is acting in accordance with the guidance known as “The NHS Care Record Guarantee”, published in the document entitled “The Care Record Guarantee – Our Guarantee for NHS Care Records in England” that was published by the National Information Governance Board for Health and Social Care in January 20116.(3)
In this paragraph, a “summary care record” and “summary information” mean a summary care record and summary information within the meanings given in—
(a)
regulation 68 of the GMS Regulations7 (summary care records); and(b)
regulation 61 of the PMS Regulations8 (summary care records).”.
Amendment of Schedule 7 to the principal Regulations5.
(1)
(2)
“(3A)
In any case where no satisfactory evidence, as required by sub-paragraph (3), is produced to C, C must ensure before the drugs or appliances are provided that the person who was asked to produce that evidence is advised, in appropriate terms, that checks are routinely undertaken to ascertain entitlement to—
(a)
exemption under the Charges Regulations10; or(b)
remission of charges under the Remission of Charges Regulations11,where such entitlement has been claimed, as part of the arrangements for preventing or detecting fraud or error in relation to such claims.”.
(3)
“Accessing summary care records13A.
(1)
If an LPS chemist (C) is providing local pharmaceutical services to or in respect of a patient and has access to the summary information that comprises a summary care record of that patient, C must access that summary information where the conditions in sub-paragraph (2) are satisfied.
(2)
The conditions are that—
(a)
in C’s clinical judgment or the clinical judgement of a registered pharmacy technician employed or engaged by C, it is in the best interests of the patient to do so; and
(b)
in doing so C or the registered pharmacy technician is acting in accordance with the guidance known as “The NHS Care Record Guarantee”, published in the document entitled “The Care Record Guarantee – Our Guarantee for NHS Care Records in England” that was published by the National Information Governance Board for Health and Social Care in January 201112.(3)
In this paragraph, a “summary care record” and “summary information” mean a summary care record and summary information within the meanings given in—
(a)
regulation 68 of the GMS Regulations13 (summary care records); and(b)
regulation 61 of the PMS Regulations14 (summary care records).”.
Signed by authority of the Secretary of State for Health.
These Regulations amend the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (“the 2013 Regulations”). The 2013 Regulations govern the arrangements in England, under Part 7 of the National Health Service Act 2006, for the provision of pharmaceutical services and local pharmaceutical services.
Regulation 2 corrects two typographical errors in the 2013 Regulations.
Regulation 3 substitutes the review provision in the 2013 Regulations with a new provision that requires further reviews after the first review (which previously had been provided for), sets out in greater detail what the reports following each review are to include, and sets a five year maximum interval between reviews.
Regulations 4 and 5 amend the terms of service of chemists that provide NHS community pharmaceutical services.
Before providing a drug or appliance that has been ordered on an NHS prescription, if entitlement to non-payment of an NHS prescription charge is being claimed, the chemist must ask for evidence of that entitlement. If evidence is not supplied, the chemist is now required, before the drug or appliance is supplied, to advise the person who was asked to produce that evidence that checks are routinely undertaken to ascertain entitlement to non-payment of NHS prescription charges, where this is claimed, as part of the relevant arrangements for preventing or detecting fraud or error (regulations 4(2) and 5(2)).
Some chemists have access to NHS patients’ summary care records, which are electronic records under the management of the Health and Social Care Information Centre. If chemists do have this access, they are required to access those records when they are providing NHS community pharmaceutical services, where it is in the best interests of a patient to do so and doing so accords with the guidance known as “The NHS Care Record Guarantee” (regulations 4(3) and 5(3)).