GS1 issues track-and-trace guideline for US healthcare

As the US moves closer to the adoption of some form of traceability system for medicines, standards organisation GS1 has developed a guideline to help drugmakers add serial numbers to their products.

The first draft - which can be downloaded here - provides a model for pharma companies to trace the movement of products through the distribution network and has been developed as part of GS1's readiness programme for the California electronic pedigree system, which comes into effect in 2015 unless prompted by a federally-mandated system.

The guideline "focuses primarily on best practices and methodologies for product serialisation and sharing pedigree and traceability data to support implementation for pending state regulations," says GS1.

Siobhan O'Bara, senior vice president of industry engagement at GS1 US, said the new guideline "should be the 'first stop' for all organisations that are preparing their pharmaceutical supply chain systems and business processes to meet pending improved supply chain security regulatory requirements."

Its publication draws together the findings from a series of pilots and other collaborative endeavours by GS1 and its 50-plus pharma supply chain partners - the GS1 Healthcare US Secure Supply Chain Task Force - and in the initial draft covers a basic forward logistics model based on GS1's one-up-one-down traceability model.

According to this scheme each trading partner captures transaction data, but they only share pedigree information with players immediately before and after them in the supply chain. The guideline covers product serialisation, supply chain data exchange for pedigree and traceability under this model, and pilot learning and best practices.

"Future releases of this guideline will provide examples for additional forward logistics scenarios (e.g., drop shipments, repackaging, kitting, etc.), reverse logistics (e.g., recalls, returns, withdrawals, refusals, etc.) and exceptions (e.g., shortages, overages, data discrepancy, etc.)," notes the guide.

"The guideline will help companies leverage their existing technology investment and move forward with effective implementation strategies,” said Michael Ventura, serialisation and security manager (Americas) at GlaxoSmithKline (GSK).

"Working on this initiative has given me a much greater appreciation for the importance of non-proprietary, standards-based solutions and trading partner collaboration."

The overall aim is to develop a for pedigree and track and trace system that will allow companies to make consistent use of the GS1 Electronic Product Code Information Services (EPCIS) standard.

"To have true security in the supply chain, there needs to be consistency in terms of how the standards are implemented by individual trading partners to support collaborative supply chain solutions like pedigree and traceability," said Ron Bone, senior vice president, distribution support, McKesson Pharmaceutical.

"The guideline takes the best of what we know, and puts that against real implementation activities."

The GS1 Healthcare US Secure Supply Chain Task Force said it will now focus its efforts on developing formal test criteria that will ultimately serve as the basis for certification against the guideline.