The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) (No. 2) Regulations 2024

Amendment of Schedule 7 to the PLPS Regulations

5.  In Schedule 7 to the PLPS Regulations (mandatory terms for LPS schemes), in paragraph 6 (providing ordered drugs or appliances)(1), after sub-paragraph (1) insert—

“(1A) Subject to sub-paragraphs (1B) to (1E) and without prejudice to sub-paragraphs (8) and (9), for the purposes of sub-paragraph (1)(b), a drug is provided in accordance with the order on a prescription form or repeatable prescription if (in addition to where the provision is exactly in accordance with the order)—

(a) a different quantity is provided to that ordered on the prescription form or repeatable prescription in order to allow for the provision of the drug in its manufacturer’s original outer packaging; and

(b) the provision is otherwise in accordance with the order.

(1B) In the case of an order for a prescription only medicine, sub-paragraph (1A) only applies if sub-paragraph (6) applies or one of the following applies—

(a) the provision is in accordance with regulation 217B(1) to (3) of the Human Medicines Regulations 2012(2) (original pack dispensing), and accordingly, regulation 217B(1) to (3) of those Regulations is expressly applied to such supplies; or

(b) the medicine must be provided in the manufacturer’s original outer packaging in order to comply with regulation 217C of the Human Medicines Regulations 2012(3) (original pack dispensing: medicinal products containing a relevant substance).

(1C) In the case of an order for a drug that is not a prescription only medicine, sub-paragraph (1A) only applies if sub-paragraph (6) applies or the provision of a different quantity to that ordered on the prescription is in circumstances where—

(a) the different quantity is no more than 10% greater or no more than 10% less than the quantity ordered; and

(b) the registered pharmacist carrying out or directly supervising the provision does not consider, in the exercise of their professional skill and judgement, that the provision of a different quantity to that ordered may mean that the patient does not, or is not able to, follow the medication regimen as intended by the prescriber.

(1D) Where C may, pursuant to sub-paragraph (1A) and sub-paragraph (1B)(a) or (1C)(a) and (b), provide a different quantity of a drug to that ordered on a prescription form or a repeatable prescription, C must consider, in the exercise of their professional skill and judgement, whether it is reasonable and appropriate to do so, having regard to the benefits to patients where they are provided with drugs in their manufacturer’s original outer packaging.

(1E) Sub-paragraphs (1B)(a) and (1C)(a) and (b) do not apply to the provision of any drug which is—

(a) for the time being specified in Schedules 2 to 4 of the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain provisions under the Regulations); or

(b) a special medicinal product for the purposes of regulation 167 of the Human Medicines Regulations 2012 (supply to fulfil special patient needs).”.

(1)

Paragraph 6 has been amended by S.I. 2019/775 and 990 and 2021/1346.

(2)

Inserted by S.I. 2023/1015.

(3)

Inserted by S.I. 2023/1015.