The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019

Document Number:2019 No. 990
Coming into force:Coming into force on the 01/07/2019
 
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Statutory Instruments

National Health Service, England

Made

5 th June 2019

Laid before Parliament

7 th June 2019

Coming into force

1 st July 2019

The Secretary of State makes the following Regulations in exercise of the powers conferred by sections 126(2) , 129(6) , 132 , 172(1) , 178 , 182 , 184(1) and 272(7) and (8) of, and paragraph 3(1) and (3)(c) and (d) of Schedule 12 to, the National Health Service Act 2006(1).

PART 1 Introductory

Citation, commencement and interpretation

  1. —(1) These Regulations may be cited as the National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 and come into force on 1 st July 2019.

    (2) In these Regulations—

    “the Charges Regulations” means the National Health Service (Charges for Drugs and Appliances) Regulations 2015(2); and

    “the PLPS Regulations” means the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013(3).

    PART 2 Amendments to the PLPS Regulations

    Amendment of regulation 2 of the PLPS Regulations

  2. —(1) Regulation 2(1) of the PLPS Regulations(4) (interpretation) is amended as follows.

    (2) At the appropriate places insert—

    ““serious shortage protocol” means—

    in the case of a prescription only medicine, a serious shortage protocol for the purposes of regulation 226 A of the Human Medicines Regulations 2012(5) (sale etc. by a pharmacist in accordance with a serious shortage protocol); or

    in the case of any other drug or appliance, a written protocol that—

    is issued by the Secretary of State in circumstances where England or any part of England is, in the opinion of the Secretary of State, experiencing or may experience a serious shortage of—

    a specified drug or appliance, or

    drugs or appliances of a specified description,

    provides for the supply by a provider of pharmaceutical or local pharmaceutical services, where there is an order on a prescription form or a repeatable prescription for—

    the specified drug or appliance, or

    a drug or appliance of the specified description,

    of a different product or quantity of product to the product or quantity of product ordered, subject to such conditions as may be specified in the protocol, and

    specifies the period for which, and the parts of England (which may be all of England) in which, the protocol is to have effect;”; and

    ““SSP” means a serious shortage protocol;”.

    New regulation 119 A of the PLPS Regulations

  3. After regulation 119 of the PLPS Regulations (transitional provisions) insert—

    “Transitional provisions in respect of drugs or appliances supplied in accordance with SSPs

    119 A.—(1) This paragraph applies where—

    (a) pursuant to paragraph 5 A(4)(a) of Schedule 4 , paragraph 4 A(4)(a) of Schedule 5 , paragraph 3 A(2)(a) of Schedule 6 or paragraph 3 A(4)(a) of Schedule 7 , an NHS chemist, an LPS chemist or a dispensing doctor is required to endorse a prescription or an associated batch issue; and

    (b) the Secretary of State (or the NHS BSA acting on the Secretary of State’s behalf) is only able, or is also able, to process a claim for pharmaceutical reimbursement in respect of the product being provided if the claim is made using a separate token (“a dispensing token”) , which is in a form approved by the Secretary of State for the purposes of making such claims (and for prescription charge purposes).

    (2) Where paragraph (1) applies—

    (a) to the extent required or permitted by the Drug Tariff, a dispensing token recording the provision of the product is treated as being, as regards that product, the prescription for product reimbursement purposes;

    (b) if the manner for recording the provision of the product in the dispensing token is provided for in the Drug Tariff, the recording of the provision of the product in the dispensing token must be in the manner provided for in the Drug Tariff; and

    (c) the manner of the endorsement of the original prescription or associated batch issue (where provided for in the Drug Tariff) may vary, depending on whether or not it is to be used for product reimbursement purposes.

    (3) Where, by virtue of paragraph (2)(a) , a dispensing token is treated as being the prescription for product reimbursement purposes—

    (a) paragraph 7(6) of Schedule 4 applies as if the reference to paragraph 5 A(4)(a) of that Schedule included a reference, in the alternative, to paragraph (2)(a);

    (b) paragraph 6(3 B) of Schedule 5 applies as if the reference to paragraph 4 A(4)(a) of that Schedule included a reference, in the alternative, to paragraph (2)(a);

    (c) paragraph 4 B of Schedule 6 applies as if the reference to paragraph 3 A(2)(b) of that Schedule included a reference, in the alternative, to paragraph (2)(a); and

    (d) paragraph 5(6) of Schedule 7 applies as if the reference to paragraph 3 A(4)(a) of that Schedule included a reference, in the alternative, to paragraph (2)(a).

    (4) For the purposes of this regulation, “pharmaceutical reimbursement” has the meaning given in paragraph 19(3) of Schedule 7.”.

    Amendment of Schedule 4 to the PLPS Regulations

  4. —(1) Schedule 4 to the PLPS Regulations (terms of service of NHS pharmacists) is amended as follows.

    (2) After paragraph 5 (dispensing of drugs and appliances) insert—

    “Supply in accordance with a SSP

    5 A.—(1) This sub-paragraph applies where—

    (a) any person requests a drug or appliance from an NHS pharmacist (P) in accordance with a prescription form or repeatable prescription; and

    (b) a SSP has effect in respect of—

    (i) the requested drug or appliance, or

    (ii) drugs or appliances of a specified description, and the requested drug or appliance is of that description.

    (2) Where sub-paragraph (1) applies, P must consider whether it is reasonable and appropriate to supply in accordance with the SSP instead of in accordance with the prescription form or repeatable prescription.

    (3) Where sub-paragraph (1) applies, P may provide a different product or quantity of product to the product or quantity of product ordered on the prescription form or repeatable prescription, where—

    (a) P is able to do so with reasonable promptness;

    (b) to do so is in accordance with the SSP; and

    (c) the supply of a different product or quantity of product to that ordered by the prescriber is by or under the direct supervision of a registered pharmacist who is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is reasonable and appropriate.

    (4) Where P, in accordance with sub-paragraph (3) , provides a different product or quantity of product to that ordered by the prescriber—

    (a) the registered pharmacist mentioned in sub-paragraph (3)(c) must endorse the prescription or the associated batch issue accordingly (if the manner for making the endorsement is provided for in the Drug Tariff, in the manner provided for in the Drug Tariff) , and the prescription or associated batch issue as thus endorsed is treated as being the prescription for product reimbursement purposes (even though the supply is not in pursuance of that prescription); and

    (b) if the patient to or for whom the product is provided is on a patient list, and the supply—

    (i) by virtue of regulation 226 A(5)(c)(iii) of the Human Medicines Regulations 2012(6) (sale etc. by a pharmacist in accordance with a serious shortage protocol) , is of a prescription only medicine that is different to but has a similar therapeutic effect to the product ordered by the prescriber, or

    (ii) is of any other type, and the Secretary of State and 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, acting jointly, have issued and publicised in such manner as they see fit a recommendation to the effect that, for clinical reasons, in the case of supplies of that type, providers of primary medical services should be notified of a supply to a patient on its patient list that is in accordance with a SSP instead of in accordance with a prescription form or repeatable prescription,

    P must notify the provider of primary medical services on whose patient list the patient is of the supply in accordance with the SSP instead of in accordance with the prescription form or repeatable prescription.

    (5) Where—

    (a) sub-paragraph (1) applies;

    (b) a registered pharmacist is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate; and

    (c) P is able to supply the product or quantity of product ordered by the prescriber within a reasonable timescale but not with reasonable promptness,

    the requirements to act with reasonable promptness in paragraph 5(2) and (3) are to be read as requirements to act within a reasonable timescale.”.

    (3) In paragraph 7(7) (preliminary matters before providing ordered drugs or appliances) , after sub-paragraph (5) insert—

    “(6) Sub-paragraphs (3) to (5) apply to the provision of a drug or appliance in accordance with a SSP as they apply to the provision of a drug or appliance in accordance with a prescription form or a repeatable prescription (or an associated batch issue) , and for these purposes, the prescription for product reimbursement purposes, as mentioned in paragraph 5 A(4)(a) , is treated as being the prescription in...

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