GS1 updates on serialisation model for US drug market

GS1 has started a programme aimed at simulating and troubleshooting  pharmaceutical track-and-trace systems as envisaged in California's proposed pedigree requirements, which are currently scheduled to come into force in 2015.

The simulation would model the flow of data gathered from barcodes or radiofrequency identification (RFID) chips as pharmaceuticals flow from the manufacturer though the supply chain to the pharmacy, and back again in the case of recalls or product withdrawals.

The details of the serialisation modelling programme were revealed in a free-to-access webinar recorded last month (available here) which was presented by Bob Celeste, director of GS1 Healthcare US.

California's 2015 plans have been "underlined by the FDA's activity in the last year" and also a growing number of requests for pilot serialisation studies to wholesalers, mainly originating from pharmaceutical manufacturers, according to Celeste.

Throughout the year GS1 is planning to model various elements of the pharmaceutical supply chain, including forward and reverse logistics, kitting and repackaging, to help companies test their proposed implementations against a reference model even before they invest in technology.

GS1's 2015 readiness programme will use supply chain simulation tools to test more than 39,000 potential pedigree and trace-and-trace scenarios. Some of the questions the simulation hopes to answer include:

• how much transactional data will be required for a particular outcome?
• how long could a counterfeit exist in the system before being detected?
• what happens with serialised and non-serialised products side-by-side in the supply chain?
• what happens if a player or product drops out of the supply chain?

Earlier this week GS1 ran its first meeting on the programme for the pharmaceutical industry at its offices in New Jersey. The group plans to issue quarterly reports on progress, said Celeste.