Regulation 4 Amendment of Schedule 2 to the Pharmaceutical Regulations

Schedule 2 to the Pharmaceutical Regulations is amended in accordance with paragraph (2) and (3) as follows.

After paragraph 5 (supply of drugs and fitting of appliances) insert—

“Supply in accordance with a SSP

5A.

(1)

This sub-paragraph applies where—

(a)

any person requests a drug or appliance from a chemist 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 chemist 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 chemist 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 chemist 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 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 the chemist, in accordance with sub-paragraph (3), provides a different product or quantity of product to that ordered by the prescriber—

(a)

the 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 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 Department has issued and publicised in such manner as it sees 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 the prescription form or repeatable prescription,

the chemist 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 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)

the chemist 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.

(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 5A(4)(a), is treated as being the prescription in accordance with which the drug or appliance is provided (even though the supply is not in pursuance of that prescription).

5B.

(1)

Where the chemist provides a drug or appliance under paragraph 5A, the chemist must include in the dispensing label on the packaging of the product, for the patient’s benefit, information to the effect that the product is being supplied in accordance with an SSP, identifying the particular SSP.

(2)

A chemist must refuse to provide a drug or appliance ordered on a prescription or a repeatable prescription where—

(a)

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; and

(b)

alternative provision has already taken place in accordance with the SSP.

(3)

A chemist may refuse to provide a drug or appliance ordered on a prescription or a repeatable prescription where—

(a)

an 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;

(b)

a 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)

the chemist is unable to provide the drug or appliance within a reasonable timescale,

but if the chemist does refuse to do so, the chemist must provide the patient or the person requesting the drug or appliance on behalf of the patient with appropriate advice, as necessary, about reverting to the prescriber to review the patient’s treatment.”.

In Part 3 (terms of service for doctors who provide pharmaceutical services), after paragraph 15 insert—

“Supply in accordance with a SSP

15A.

(1)

This sub-paragraph applies where, in relation to an order for a drug or an appliance on a prescription or a repeatable prescription—

(a)

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 and the dispensing doctor provides a different product or quantity of product to the product or quantity of product ordered on prescription or on repeatable prescription, in accordance with the SSP—

(a)

the dispensing doctor 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

(b)

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).

(3)

Where the dispensing doctor provides a drug or appliance under this paragraph, the dispensing doctor must include in the dispensing label on the packaging of the product, for the patient’s benefit, information to the effect that the product is being supplied in accordance with an SSP, identifying the particular SSP.

(4)

A dispensing doctor must refuse to provide a drug or appliance ordered on a prescription or on a repeatable prescription where—

(a)

an 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; and

(b)

alternative provision has already taken place in accordance with the SSP.”.