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

CitationSI 2019/1330 (W229)

2019No. 1330 (W. 229)

NATIONAL HEALTH SERVICE, WALES

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

Made8October2019

Laid before the National Assembly for Wales10October2019

Coming into force31October2019

The Welsh Ministers make the following Regulations in exercise of the powers conferred by sections 80(2), 83(6), and 203(9) and (10) of the National Health Service (Wales) Act 2006( 1).

Title, commencement and interpretation

1.—(1) The title of these Regulations is the National Health Service (Amendments Relating to Serious Shortage Protocols) (Wales) Regulations 2019.

(2) These Regulations come into force on 31 October 2019.

(3) In these Regulations, “the Pharmaceutical Services Regulations” means the National Health Service (Pharmaceutical Services) (Wales) Regulations 2013( 2).

Amendment of regulation 2 of the Pharmaceutical Services Regulations

2.—(1) Regulation 2(1) of the Pharmaceutical Services Regulations( 3) (interpretation) is amended as follows.

(2) At the appropriate places insert—

““serious shortage protocol” (“protocol prinder difrifol”) means—

(a) in the case of a prescription only medicine, a serious shortage protocol for the purposes of regulation 226A of the Human Medicines Regulations 2012( 4) (sale etc. by a pharmacist in accordance with a serious shortage protocol); or

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

(i) is issued by the Welsh Ministers in circumstances where Wales or any part of Wales is, in the opinion of the Welsh Ministers, experiencing or may experience a serious shortage of—

(aa) a specified drug or appliance, or

(bb) drugs or appliances of a specified description,

(ii) provides for the supply by an NHS pharmacist or an NHS appliance contractor providing pharmaceutical or local pharmaceutical services, where there is an order on a prescription form or a repeatable prescription for—

(aa) the specified drug or appliance, or

(bb) 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

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

““SSP” (“PPD”) means a serious shortage protocol;”.

Amendment of Schedule 4 to the Pharmaceutical Services Regulations

3.—(1) Schedule 4 to the Pharmaceutical Services Regulations( 5) (terms of service for NHS pharmacists who provide pharmaceutical services in particular by the provision of drugs) is amended as follows.

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

“Supply in accordance with a SSP

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

(a) a person requests a drug or appliance from an NHS pharmacist 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, the NHS pharmacist 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, the NHS pharmacist 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) the NHS pharmacist 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 their 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 an NHS pharmacist, 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 so 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 226A(5)(c)(iii) of the Human Medicines Regulations 2012 (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 Welsh Ministers and the person who is, for the time being, the person consulted under section 89(1)(a) of the 2006 Act( 6) 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...

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