The use of automation in healthcare is helping transform how patient care is delivered and robotic dispensing systems and barcode verification are now widespread amongst pharmacy operations across both primary and secondary environments, aiming to reduce human error and improve efficiency. However, these systems rely entirely on the accuracy of the data printed on medicinal products, specifically the Global Trade Item Number (GTIN) and the 2D GSI DataMatrix barcode, which encodes the GTIN, batch number, and expiry date. As with many automated processes, when this data is incorrect, incomplete, or poorly formatted, the outcomes are more than just an inconvenience. It can directly lead to delays, dispensing errors, stock rejection, and most seriously, patient harm.
Robotic dispensing systems and barcode scanning are used to identify medicines accurately, automate storage and retrieval, verify expiry dates and batch numbers, ensure the right product reaches the right patient (including automated dispensing or specific checks of the products due to administered on hospital wards) and this process is only as safe as the data it relies on. Incorrect or inconsistent barcode data causes these systems to fail. Examples of recent issues reported by healthcare professionals include:
GTINs that scan as a different medicinal product, compared to the physical medicinal product name and details Incorrect data formats that cause robotic systems to reject valid stock Unreadable or missing 2D barcodes, rendering products unscannable and unusable Uncontrolled GTIN reuse across different products, leading to dangerous product confusion in existing systemsThese errors often result in stock being quarantined or completely discarded, or untimely manual workarounds that reintroduce human error into an otherwise safe system.
Whilst the use of GTINs and 2D barcodes has been well understood throughout the supply chain, the implications are far more serious than logistical inconvenience. The Defective Medicines Report Centre have seen an increase in these artwork errors, which have a real world consequence on patient safety. The potential for administration of incorrect medicines and missed doses due to stock rejection or delays have led to preventable harms, which should be avoidable by the robust systems that have been implemented. This can lead to reduced trust in automation and reduced trust with the Marketing Authorisation Holder (MAH).
The MAH is responsible for ensuring that the artwork and encoded data on a medicine pack is accurate, compliant, and aligned with regulatory and operational standards. While the MHRA recognises that there is currently limited legislation in relation to the standardisation of this data, the following points can be used to ensure that all patient safety risks are mitigated as effectively as possible. The MAH should:
Assign unique and correct GTINs to every licensed product presentation Ensure accurate encoding of batch number and expiry date in the 2D barcode Validate artwork and barcode functionality during the artwork approval process and before release to market Avoid reuse of GTINs that have previously been used for different products. This practice could lead to incorrect robotic product selection and compromise traceability Ensure compliance with system expectations for machine-readable data and utilise barcode verification tools (e.g. ISO/IEC 15415 scanners) to ensure readability Proactively review complaints or rejection reports at pace, to ensure that immediate risks are mitigatedAs healthcare providers expand their use of robotic dispensing, ePMA (electronic prescribing and medicines administration, hub and spoke models), and closed-loop medication systems, barcode integrity is central to safety and efficiency. However, beyond compliance, this is a matter of patient trust. Every unreadable or incorrect barcode risks breaking the chain of safety that patients and healthcare providers are now dependent upon.
See further information and contact details for the Defective medicines reporting centre (DMRC):
Email: dmrc@mhra.gov.uk DMRC (office hours) 020 3080 6574 (8:45am to 4:45pm Monday to Friday). DMRC (out of hours) 07795 641 532 (urgent outside of normal working hours, at weekends or on public holidays). Do not leave voicemail messages at this number during normal working hours as they will only be picked up out of hours. seen at 16:38, 18 November in MHRA Inspectorate.