# The Pharmaceutical Services (Amendments Relating to Serious Shortage Protocols) Regulations (Northern Ireland) 2019, Note: Explanatory note


(This note is not part of the Regulations)
These Regulations amend the Pharmaceutical Services Regulations Northern Ireland 1997 (“the Pharmaceutical Services Regulations”) which govern the arrangements for the provision of pharmaceutical services under the Health and Personal Social Services (Northern Ireland) Order 1972 (“the 1972 Order”).
They make provision in relation to serious shortage protocols (SSPs). SSPs allow the Department 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 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 medicine 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 services in Northern Ireland – not just prescription only medicines.
Where an SSP is in place for a particular product, a chemist must consider supplying in accordance with the SSP rather than fulfilling a Health Service prescription for that product. It may, instead of fulfilling the Health Service 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 chemist or dispensing doctor does change a Health Service prescription (rather than, in the case of a dispensing doctor, issuing a new prescription), the original Health Service prescription must be endorsed with the change.
If a product supplied by a chemist in accordance with an SSP is a prescription only medicine that is different to but has the same therapeutic effect as the product originally ordered, it must notify the patient’s Health Service GP practice of the substitution (if the patient has one). A chemist must also notify a patient’s Health Service GP practice in other cases of supply in accordance with an SSP, if a requirement to notify that substitution has been recommended, for clinical reasons, by the Department.
A number of consequential changes are also made to the Health Service terms of service for chemists and dispensing doctors in Schedule 2 to the Pharmaceutical Regulations. In particular, the original Health Service prescription remains the essential record of the transaction for payment, and if a chemist or dispensing doctor makes a supply in accordance with an SSP, the original prescription can no longer be fulfilled. Also, when a chemist or dispensing doctor changes an order for a product so that there is a supply in accordance with an SSP, a warning about the change must be included in the dispensing label on the packaging of the product supplied.
There is a transitional provision that allows for the issuing of tokens (“dispensing tokens”) that can function, instead of a prescription, as the record of the supply for the purposes of reimbursing the dispenser (regulation 3).

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Source: https://www.legislation.gov.uk/nisr/2019/186/note (the official version)
Page: https://openlegislation.uk/pharmaceutical-services-amendments-relating-to-serious-shortage-protocols-regulations-northern-ireland-2019/note
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.