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A patient safety issue surrounding the re-use of Global Trade Item Numbers

Date: October 15, 2019

Category: Industry news


This is a joint alert from NHSX, NHS Digital, NHS Business Services Authority, the Medicines and Healthcare Products Regulatory Agency and GS1 UK in relation to GTIN re-use.

It has been identified that a number of manufacturers have re-used GTINs on medicines. As a critical patient safety risk, this is an immediate CALL TO ACTION, for all pharmaceutical manufacturers, to ensure that their company is accurately following GTIN allocation best practice requirements.

As you will be aware when a medicine is marketed in the NHS, a pharmaceutical company is issued with a dm+d SNOMED code by the NHS Business Services Authority (BSA). This dm+d SNOMED code is mapped across to the global trade item number (GTIN) which the company has obtained from GS1 and assigned to the medicine. This mapping is essential for the safe supply and administration of medicines in robotic and closed loop environments where the dm+d SNOMED code is the default.

There have been recent incidences of some pharmaceutical companies reusing or recycling GTINs and applying them to different medicines. Additionally, in some instances, there is evidence to suggest that medicine GTINs may have been incorrectly communicated to the BSA.

These GTINs are unique identifiers which allow healthcare professionals to be able to make clear distinction between medicines. They should only ever be allocated to one medication, to prevent serious incidences of incorrect dispensing and administration. Reuse of GTINs in such instances, is a major patient safety risk.

Whilst the GTIN is not part of the approved data supporting the marketing authorisation, it is nonetheless part of the labelling. The primary purpose of the labelling of a medicine is the unambiguous identification of the product at the point of supply and administration. GTINs being recycled in this manner compromises this principle and puts patients at risk of harm.

Reuse of GTINs is also contrary to the GS1 Healthcare Standard. Guidance is also available specifically on the management of GTINs in relation to mergers and acquisitions. Please read the extract from the GS1 General Specifications for more information.

For further information on this and other important rules around GTIN management, including GTIN non-reuse please refer the GS1 Healthcare Allocation Rules.

For any help and support with such issues or concerns, please contact the GS1 UK pharma support team at pharma.support@gs1uk.org.