To ask the Secretary of State for Health and Social Care, with reference to the Human Medicines (Amendment) Regulation 2019, what the system will be by which clinicians will be able to indicate whether or not an alternative (a) quantity, (b) strength, and (c) pharmaceutical form of medicine can be dispensed in line with the protocol; and how this system will be applied to regular repeat prescriptions.
A Serious Shortage Protocol is an additional tool to manage and mitigate medication shortages and may be used in the exceptional and rare situation when other measures have been exhausted or are likely to be ineffective. It can only be issued by Ministers and would only be introduced in the case of a serious shortage, if it would help manage the supply situation and if clinicians think it is appropriate, after discussion with the manufacturer and/or marketing authorisation holder.
Any protocol would need to set out what alternative quantity, pharmaceutical form, strength, therapeutic equivalent or generic equivalent can be supplied. Supply in accordance with a protocol can only be made if the protocol is in date when a prescription is presented for dispensing, whether that prescription is an acute or a repeat prescription. If appropriate, the protocol could stipulate that it does not apply to a certain type of prescription.