Lords report backs two-dimensional barcodes to strengthen medicines security

The report, “Medicines security — a national priority”, recommends that government accelerate the digitisation of medicine supply chains, building on work already underway in secondary care. It says a digitised system should let stakeholders across the supply chain access accurate, near real time and predicted information on stock so they can act earlier, and that, as part of this, government should mandate 2D barcodes for medicines to support effective stock management These are recommendations to Government, which will now consider its response. 

It draws on submissions from across the health system, including GS1 UK’s written evidence, on how interoperable standards and 2D barcodes support medicines traceability, verification and safe, efficient dispensing.

From 1 January 2025, following the Windsor Framework arrangements, EU Falsified Medicines Directive safety features ceased to apply in the UK. The MHRA confirms that use of a 2D barcode on UK only packs is now at the marketing authorisation holder’s discretion.

Independent safety bodies have highlighted the practical risks this creates. The MHRA Inspectorate reports that missing or inaccurate Global Trade Item Numbers (GTINs) and GS1 DataMatrix data have disrupted automated dispensing, delayed care and led to preventable harms in real settings. England’s Patient Safety Commissioner has described barcode errors as a critical patient safety risk with potentially fatal consequences, noting that “mislabelled packs can result in wrong medicines, dosages or formulations reaching patients with potentially harmful or even fatal consequences. Barcode accuracy, in modern healthcare, is literally life or death.”

The World Health Organization’s Medication Without Harm initiative sets the wider context, estimating the annual global cost of medication errors at forty-two billion US dollars and identifying medicines as a major source of preventable harm in healthcare, highlighting the value of system level safeguards such as reliable identification and verification.

NHS bodies are already required to use GS1 standards and PEPPOL in eprocurement and NHS Supply Chain expects GTINs and UDI compliant labels on products supplied to the NHS.

Committee members heard that when packs arrive without a scannable 2D barcode, or with poorly encoded data, medicines cannot be verified or processed reliably by automated systems and staff must revert to manual checks. The MHRA Inspectorate has documented failure modes including GTINs that scan as the wrong product, unreadable or missing GS1 DataMatrix codes and incorrectly formatted data that automated systems reject, each of which introduces delay and risk. 

GS1 UK’s written submission set out how consistent, standards-based barcoding supports safe dispensing and administration, faster and more precise recalls, and compatibility with modern dispensing and stock systems, while explaining the operational and safety risks when such barcodes are absent or inconsistently encoded. The Committee cites this evidence in sections addressing digitisation and barcoding.

GS1 UK welcomes the Committee’s focus on patient safety and resilience and its call to mandate 2D barcodes.

In a digital-first NHS, accurate identifiers and scannable codes are a safety control that helps staff check the right product, dose and expiry and makes recalls faster and safer. 

The Committee’s report now goes to Government for consideration. The Committee has recommended that Government mandate 2D barcodes within a digitised medicines supply chain and strengthen national leadership and information sharing. Government will set out its response in due course. 

The report also records departmental activity already in progress: 

• Potential consultation on barcoding or verification: DHSC told the Committee it is considering consulting on the use of an approach “akin to the FMD” in the UK, in the context of serialisation and wider supply chain digitisation.
• Improving digital tools with industry: DHSC states it plans to work with suppliers and wholesalers to understand how to improve digital tools so supply issues can be addressed more robustly and quickly.
• Shortages reporting framework: DHSC said it is proposing to consult on amendments to the regulations governing the shortages reporting framework, including the use of sanctions where reporting requirements are not met. 

The Committee has set the direction. The next step is delivery. By applying open standards consistently and getting barcode data right on every pack, the system can move faster on shortages and make care safer at the point of use.