{"id":297658,"date":"2025-11-20T19:03:11","date_gmt":"2025-11-20T19:03:11","guid":{"rendered":"https:\/\/www.newsbeep.com\/au\/297658\/"},"modified":"2025-11-20T19:03:11","modified_gmt":"2025-11-20T19:03:11","slug":"barcode-errors-potentially-fatal-warns-patient-safety-commissioner","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/au\/297658\/","title":{"rendered":"Barcode errors \u2018potentially fatal\u2019, warns patient safety commissioner"},"content":{"rendered":"<p>Barcode errors on medicines \u201cpose critical patient safety risks\u201d and could have \u201cpotentially fatal consequences,\u201d Henrietta Hughes has warned.<\/p>\n<p>The patient safety commissioner for England\u2019s warning comes as a petition launched by pharmacists <a href=\"https:\/\/www.barcode.pillsorted.com\/\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">report growing problems<\/a> with barcode data errors and missing 2D barcodes on UK medicine packs.<\/p>\n<p>The issue has been highlighted by several \u2018Class 4 medicines defect notifications\u2019 during 2025 that were linked to barcode or labelling problems, <a href=\"https:\/\/www.gov.uk\/drug-device-alerts\/class-4-medicines-defect-notification-fexofenadine-hydrochloride-120mg-film-coated-tablets-chanelle-medical-unlimited-company-el-25-a-slash-41\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">including fexofenadine hydrochloride tablets<\/a> in August 2025, and <a href=\"https:\/\/assets.publishing.service.gov.uk\/media\/686534e86569be0acf74db4d\/CLASS_4_ALMUS_SIMVASTATIN_TABLETS.pdf\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">simvastatin tablets<\/a> in July 2025.<\/p>\n<p>A Class 4 Medicines Defect Notification is\u00a0a \u2018caution in use\u2019\u00a0notice issued by the Medicines and Healthcare Regulatory Agency (MHRA)\u00a0for defects such as errors in packaging or printed materials.<\/p>\n<p>In comments made to The Pharmaceutical Journal, Hughes said: \u201cMislabelled packs can result in wrong medicines, dosages or formulations reaching patients with potentially harmful or even fatal consequences.<\/p>\n<p>\u201cBarcode accuracy, in modern healthcare, is literally life or death.\u201d<\/p>\n<p>Under the EU\u2019s Falsified Medicines Directive (FMD), which was in place since 2013, 2D barcodes following the GS1 standards and containing the Global Trade Item Number (GTIN), medicine packs in the UK were required to include a batch number, expiry date and unique serial number.<\/p>\n<p>However, since the FMD no longer applied in Great Britain from 31 December 2020, when the UK exited the EU \u2014 and in Northern Ireland following the Windsor Framework changes introduced from 1 January 2025 \u2014 manufacturers are no longer required to include 2D barcodes on UK-only packs, meaning expiry date and batch number information is lost.<\/p>\n<p>In June 2025, the UK\u2019s four chief pharmaceutical officers wrote <a href=\"https:\/\/mcusercontent.com\/440612f6fe24f0dac190dac6a\/files\/7bd39e2b-ff96-c59c-4ec9-c0e240aa25c6\/250620_CPhOs_The_Safety_and_Operational_Benefits_of_2D_Barcodes_Final_Letter.pdf\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">an open letter<\/a> urging pharmaceutical companies in the UK to continue 2D barcodes on all medicine packs \u201cgiven the safety and operational benefits\u201d, despite this no longer being mandatory.<\/p>\n<p>And, in October 2025, 32 pharmacy professionals across NHS trusts and digital groups wrote to Lawrence Tallon, chief executive of the MHRA, and Alison Cave, its chief safety officer, urging the Agency to mandate 2D barcodes and include GTINs in the medicine licensing process, especially given the government\u2019s shift from \u2018analogue to digital\u2019 in the <a href=\"https:\/\/pharmaceutical-journal.com\/article\/news\/cuts-to-integrated-care-boards-could-set-nhs-ambitions-back\" data-type=\"news\" data-id=\"385106\" rel=\"nofollow noopener\" target=\"_blank\">NHS ten-year plan<\/a>.<\/p>\n<p>Iain Davidson, chief pharmacist at the Royal Cornwall Hospitals NHS Trust and one of the signatories to the letter, seen by The Pharmaceutical Journal: \u201cIf you remove traceability across the supply chain, you can\u2019t do recalls as effectively. The whole point of barcode medication administration is that it\u2019s the right product for the right patient at the right dose.\u201d<\/p>\n<p>Another signatory, Richard Bowers, lead pharmacist of innovation at Leeds Teaching Hospitals NHS Trust (LTHT), warned barcode inconsistency was undermining efforts to digitise medicine supply and administration.<\/p>\n<p>\u201cOur vision at LTHT is to implement automated and integrated systems for the management and supply of medicines to our patients, and this hinges on medicine packs having GS1 barcodes,\u201d he said.<\/p>\n<p>\u201cManually bypassing this process for a significant proportion of medicines due to lack of barcodes negates the safety benefits and calls into question the robustness of the whole process.\u201d<\/p>\n<p>Kristy McGlynn, a digital medicines pharmacist at Manchester University NHS Foundation Trust, commented: \u201cMedications are coming through the supply chain with barcodes that are not listed on the Dictionary of Medicines and Devices, therefore are not uploaded into the integrated pharmacy stock control and EPMA\/EPR database.<\/p>\n<p>\u201cThis presents a challenge for drug recalls if the lot and expiry aren\u2019t captured at goods receipt and during barcode medication administration.\u201d<\/p>\n<p>\u201cAdditionally, we have seen increases incidences of barcode recycling or incorrect barcodes printed on the packaging in which we have had to report to the MHRA, resulting in Caution In Use notices,\u201d she added.<\/p>\n<p>A spokesperson for the MHRA told The Pharmaceutical Journal it was \u201caware of the current reported issues in relation to barcode errors\u201d but noted that it does not regulate GTINs, adding \u201cthe management of these is not within our remit\u201d.<\/p>\n<p>The regulator said it was \u201cconsidering broader industry feedback\u201d and was \u201cengaged with healthcare professionals and stakeholders who use automated systems to better understand the impact of the incorrect data\u201d.<\/p>\n<p>It added that it would \u201ccontinue to monitor the situation\u201d.<\/p>\n<p>A spokesperson for Medicines UK, which represents generic and biosimilars manufacturers, said that some manufacturers dispensed with \u201cthe serialisation aspect of FMD\u201d post-Brexit to speed production, and argued that counterfeiting was rare for low-cost generic medicines.<\/p>\n<p>\u201cDispensing errors can occur for a number of\u00a0different\u00a0reasons,\u00a0which are complex and\u00a0interrelated,\u201d they said.<\/p>\n<p>\u201cManufacturers play their\u00a0part to help avoid dispensing errors by carefully designing and user testing their packaging designs, which have to be approved by the MHRA.\u201d<\/p>\n<p>David Watson, executive director of patient access at the Association of the British Pharmaceutical Industry (ABPI), told The Pharmaceutical Journal that there was \u201can opportunity for further discussion\u201d to ensure a system that \u201cprotects patient safety and supporting supply chain resilience\u201d.<\/p>\n<p>The Department of Health and Social Care (DHSC) was contacted but declined to comment for this article.<\/p><\/p>\n","protected":false},"excerpt":{"rendered":"Barcode errors on medicines \u201cpose critical patient safety risks\u201d and could have \u201cpotentially fatal consequences,\u201d Henrietta Hughes has&hellip;\n","protected":false},"author":2,"featured_media":297659,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[34],"tags":[64,63,137,500],"class_list":{"0":"post-297658","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-healthcare","8":"tag-au","9":"tag-australia","10":"tag-health","11":"tag-healthcare"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/297658","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/comments?post=297658"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/297658\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media\/297659"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media?parent=297658"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/categories?post=297658"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/tags?post=297658"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}