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(This note is not part of the Regulations)
These Regulations amend the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (“the PLPS Regulations”). The PLPS Regulations govern the arrangements in England, under Part 7 of the National Health Service Act 2006 (“the 2006 Act”), for the provision of pharmaceutical and local pharmaceutical services. Dispensing services are provided as part of these services by retail pharmacy businesses, dispensing appliance contractors (which are only allowed to dispense appliances, not drugs) and, in some rural areas, dispensing doctors.
These Regulations also amend the National Health Service (Charges for Drugs and Appliances) Regulations 2015 (“the Charges Regulations”), which provide for the making and recovery of charges for drugs and appliances supplied in England, most often on prescription, under the 2006 Act.
These Regulations make provision in relation to serious shortage protocols (SSPs). SSPs allow the Secretary of State to put in place alternative arrangements for supply where a drug or appliance is ordered on prescription but there is, or may in the future be, a serious shortage of the drug or appliance.
SSPs under the Human Medicines Regulations 2012 (“the 2012 Regulations”) allow pharmacists at retail pharmacy businesses to supply a different prescription only medicine, or a different quantity of a prescription only medicine, to that ordered by a prescriber, without breaching the restrictions on the sale or supply of prescription only medicines in Part 12 of the 2012 Regulations. These Regulations extend the potential scope of SSPs to all drugs and appliances that may be dispensed as part of the provision of pharmaceutical and local pharmaceutical services in England – not just prescription only medicines (regulations 2 and 8).
Where a SSP is in place for a particular product, a retail pharmacy business or a dispensing appliance contractor must consider supplying in accordance with the SSP rather than fulfilling an NHS prescription for that product. It may, instead of fulfilling the NHS prescription, supply a different product, or a different quantity of the ordered product, in the circumstances and subject to the conditions set out in the SSP. If the retail pharmacy business or dispensing appliance contractor – or a dispensing doctor – does supply in accordance with the SSP (rather than, in the case of a dispensing doctor, issuing a new prescription), the original NHS prescription must be endorsed accordingly (regulations 4(2), 5(2), 6(2) and 7(2)).
If a product supplied by a retail pharmacy business in accordance with a SSP is a prescription only medicine that is different to but has a similar therapeutic effect to the product originally ordered, it must notify the patient’s NHS GP practice of the substitution (if the patient has one). A retail pharmacy business or dispensing appliance contractor must also notify a patient’s NHS GP practice in other cases of a supply in accordance with a SSP, if a requirement to notify has been agreed between the Secretary of State and the relevant representative body for consultation in relation to pharmaceutical remuneration (regulations 4(2), 5(2) and 7(2)).
When a pharmacy retail pharmacy business, dispensing appliance contractor or dispensing doctor supplies a product in accordance with a SSP instead of fulfilling a prescription, a notification that the supply is in accordance with the SSP must be included in the dispensing label on the packaging of the product supplied or, in the case of a supply by a dispensing appliance contractor, in a separate note for the patient (regulation 4(4)(e), 5(4)(c), 6(2) and 7(4)(e)).
A number of consequential changes are made to the NHS terms of service for retail pharmacy businesses, dispensing appliance contractors and dispensing doctors in Schedules 4 to 7 of the PLPS Regulations. In particular, if a retail pharmacy business, a dispensing appliance contractor or a dispensing doctor makes a supply in accordance with a SSP, the original NHS prescription can no longer be fulfilled – and the original prescription from, in an endorsed form, is repurposed as the record of the SSP supply for payment and prescription charges purposes. If a retail pharmacy business or dispensing appliance contractor does not think it reasonable or appropriate to supply in accordance with protocol, but is unable to fulfil the original prescription with reasonable promptness (the normal timescale required for fulfilling prescriptions), it does not breach its NHS terms of service if it nevertheless fulfils the original prescription within a reasonable timescale. However, if it does not think it reasonable or appropriate to supply in accordance with the SSP but cannot fulfil the original prescription within a reasonable timescale, it may simply refuse to dispense the product in question. If it does refuse to do so, it must provide the patient or the patient’s representative with appropriate advice, as necessary, about reverting to the prescriber for the prescriber to review the patient’s treatment (regulations 4(2), (3), (4)(a) to (d), (5) and (6), 5(2), (3), (4)(a) and (b) and (5), 6 and 7(2), (3), (4)(a) to (d) and (5)).
Consequential changes are also made to the provisions of the Charges Regulations that apply where retail pharmacy businesses, dispensing appliance contractors or dispensing doctors provide pharmaceutical or local pharmaceutical services.
In parallel with the changes to the PLPS Regulations, if a retail pharmacy business, a dispensing appliance contractor or a dispensing doctor makes a supply in accordance with a SSP, the original prescription from, in an endorsed form, is repurposed as the record of the SSP supply for prescription charge exemption and remission of charges purposes. Additionally if, as a consequence of a supply being in accordance with a SSP instead of being in accordance with the original prescription, a patient who would otherwise pay a prescription charge is supplied with a smaller quantity of a drug or fewer appliances, no prescription charge is payable (regulations 9 to 11).
There is a transitional provision that allows for the issuing of tokens (“dispensing tokens”) that can function, instead of the endorsed original prescription, as the record of the supply in accordance with an SSP for prescription charge, prescription charge exemption and remission of charges purposes – and for the purposes of reimbursing the dispenser. These transitional arrangements are to apply while reimbursement systems are not able to process payments to dispensers on the basis of the endorsed original prescriptions, or while reimbursement systems permit the use of both forms (regulations 3, 9(3) and 10(3)).
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