Barcode standards and patient safety

Pharmacist scanning price on medicine boxes with barcode reader in pharmacy store
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Barcode standards and patient safety

Position statement

Published: 1 February 2026

Recommendations

  • Manufacturers and market authorisation holders need to include 2D barcodes voluntarily and providers need to implement contingency plans for managing medicines packs without barcodes. These could include manual verification or expiry checks
  • The Royal College of Pharmacy joins the call from NHS England for regulatory changes to mandate 2D barcodes on UK medicines packaging and include GTIN information in the licensing process for medicines. Minimum data required is GTIN, batch number and expiry date
  • We encourage all pharmacists to continue to report issues caused by recycled GTINs or the impacts of the lack of 2D barcodes to help build the evidence for the need for change.
Background

Our members have raised concerns that 2D barcodes are no longer being printed on all medicines that are destined for the UK supply chain and, in addition, that there is no assurance or process that verifies that the information on the barcode is accurate. This includes insuring that GTINs are not reused and that the physical product in terms of name, strength etc. is represented accurately by the barcode

Since the end of 2020, the European Union’s Falsified Medicines Directive (FMD), which mandated unique identifiers (including Global Trade Item Numbers (GTINs) within 2D barcodes) for medicine verification, no longer applies in Great Britain, owing to the withdrawal of the United Kingdom (UK) from the European Union (EU). The UK Government have not yet proposed any legislation or policy for a UK authentication system, linked to the European hub. Such a system / policy would help outline the measures needed to support the detection of potential counterfeit medicines that may enter the UK, which are essential to maintain the integrity of the supply chain and patient safety.

Since the implementation of the Windsor Framework in January 2025, the inclusion of a two-dimensional (2D) barcode on medicine packaging has become optional. This change has led to a growing number of packs without 2D barcodes, creating significant real-time challenges across all areas of care. The absence of these barcodes means the loss of critical data such as product identifiers, batch numbers, and expiry dates which undermines key safety and operational processes.

As healthcare increasingly transitions from analogue to digital systems, including the adoption of robotics and automation, the need for manufacturers to consistently use GTINs and 2D barcodes has never been more important. Their omission raises serious concerns within the pharmacy sector regarding patient safety, operational efficiency, and alignment with NHS digital transformation goals.

Barcode standards are not just a technical detail. They are fundamental to patient safety, operational resilience, and the NHS digital future.

The Global Trade Item Number (GTIN) on a medicine is a unique, internationally recognised number that acts like the product’s digital fingerprint. It is encoded in the barcode or 2D data matrix you see on the medicine packaging and is used to identify that specific product worldwide. When a barcode is scanned, the GTIN instantly pulls up all the correct information about that exact medicine, enhancing safety and accuracy at every step.

Unlike the Product Information Management (PIM) system for medical devices, there is no central database of GTINs for medicinal products. In the absence of this database, the NHS dictionary of medicines and devices (dm+d, the NHS Standard for medicines interoperability) provides a link from its packaged entity level concepts (‘AMPPs’) to GTINs. This enables implementers to scan a pack and return human readable text and to enter medications directly into electronic healthcare systems without the need for error-prone manual rekeying of information.

Impact on patients and pharmacy practice

Patient Safety: Barcode errors, duplication or absence can lead to the wrong medicine or wrong dose reaching patients, with potentially fatal consequences. Barcode errors and missing 2D barcodes are causing critical patient safety risks and have led to multiple Class 4 Medicines Defect Notifications being issued by the Medicines and Healthcare Regulatory Agency (MHRA) in 2025. The lack of 2D barcodes is causing disruption to robotic dispensing and supply, stock management and closed loop medicine administration processes affecting patient safety, interoperability and operational efficiencies

Efficiency: Pharmacy teams are having to implement manual workarounds which then negate the benefits of automation and increases workload.

Digital Strategy: The lack of barcodes and GTIN on medicines undermines NHS ambitions for Scan4Safety and closed-loop medicines management (CLMM). The NHS Standards DAP0108: Automatic Identification and Data Capture (AIDC) and DCB1077: AIDC for Patient Identification.

The lack of GTIN barcodes has led to the following issues:

Loss of Safety Features
The EU Falsified Medicines Directive (FMD) requirements for unique serialisation no longer apply. Many UK-only packs now lack 2D barcodes, removing the ability to automatically confirm the product and capture critical data such as LOT and EXPIRY with a simple scan.

Operational Risks for Pharmacies
There is an increased risk of dispensing expired or incorrect medicines. It also means slower and less effective product recalls. There are disruptions to automated dispensing, stock control, and barcode medication administration. Work arounds that are put in place reduce operational efficiency and increase the risk of data entry errors.

Data Integrity Challenges
GTINs are not part of the licensing process meaning that data are inconsistent and often incorrect. The NHS systems (dm+d, EPMA/EPR) rely on accurate GTINs for interoperability.

Examples of errors with GTINs:

Pharmacists and others can report issues with barcodes by completing this form.

What needs to happen

  • In the short term, manufacturers and market authorisation holders need to include 2D barcodes voluntarily and providers need to implement contingency plans for managing medicines packs without barcodes. These could include manual verification or expiry checks
  • The Royal College of Pharmacy joins the call from NHS England for regulatory changes to mandate 2D barcodes on UK medicines packaging and include GTIN information in the licensing process for medicines. Minimum data required is GTIN, batch number and expiry date
  • We encourage all pharmacists to continue to report issues caused by recycled GTINs or the impacts of the lack of 2D barcodes to help build the evidence for the need for change.

Further reading