Safety recommendation
HSIB recommends that the Medicines and Healthcare products Regulatory Agency engages with other national regulators and relevant stakeholders to develop design guidance on labelling and packaging specific to fluids to reduce selection errors.
Response:
We acknowledge that clear labelling of fluid bags and packaging of fluids is very important.
Current packaging requirements for licensed medicines (such as the saline solutions in the reference case) in the UK are set out in Schedule 24 of the Human Medicines Regulations (HMR) 2012.
Our Best Practice guidance on Labelling and Packaging of Medicines is intended to support safe use alongside the regulatory framework and provides guidance to Marketing Authorisation Holders (MAHs) on the content, design and layout of the presented information. Whilst MHRA guidance on labelling does not specifically include information relating to fluids for infusion presented in flexible infusion bags, the general advice is applicable.
In addition, the European Medicines Agency produces guidance on labelling requirements; it should be noted that EU decisions are required to be applied in Northern Ireland and harmonisation of fluid bag labelling across the UK is desirable to ensure conformity.
There is limited evidence that risk minimisation measures related to changes in labelling, such as colour, font size, Tallman lettering, or symbols/icons mitigate selection errors as described in the reference case. Furthermore, unintended consequences of labelling changes have not been explored.
Labelling designs are global and without international support it would be difficult to deliver a UK specific labelling change especially when labelling requirements have been met. It is anticipated that above uncertainties complicate achieving a consensus on label changes amongst international regulators and manufacturers especially as, following discussion with international regulators, it appears that this safety issue was not recognised in their local reporting systems.
Barcode scanning has been shown to be effective in reducing the number of medication errors in a scheme initiated by the Department for Health and Social Care (DHSC). The saline solutions used in the reference case carry barcodes as part of their label which can be used for scanning of the medicine in schemes such as scan4safety. To improve patient safety, we will therefore be exploring options to ensure that manufacturers provide adequate space for Unique Device Identifier (UDI) barcodes (ACTION) on the labels of fluid bags used as medical devices.
There is currently no specific guidance regarding the labelling of fluid. Any new MHRA guidance will need to be aligned with the requirements of the new UK Medical Devices Regulation (MDR), when implemented.
Response received on 7 November 2022.