No national requirement for pharmaceutical track and trace has materialized to supersede California’s 2015 law, and Unique Device Identification has just been proposed in draft form.

With U.S. mandates slowly emerging, pharmaceutical and medical device companies should consider business needs as they prepare for unique product coding, GS1 representatives urge. The identification standards organization promotes its systems for standardizing product identification throughout the supply chain.

The healthcare industry could benefit today from the efficiencies that automated, standardized product identification could bring about, explained Siobhan O’Bara, who recently became vice president, healthcare, for GS1 US, told the GS1 Connect audience in “State of the Healthcare Industry: 2012 and Beyond.” Before joining GS1 US, O’Bara was vice president, Customer Operations and Supply Chain Systems and Solutions, Covidien. In her 15 years at Covidien, O’Bara managed supply-chain functions at multiple Covidien divisions, including medical supplies, retail, imaging, pharmaceutical, and respiratory technologies.

“With such national attention on healthcare data visibility and transparency, and improved security in the medical/surgical and pharmaceutical supply chains, GS1 Healthcare US has an unprecedented opportunity to guide industry efforts and make a real change in U.S. healthcare,” O’Bara said.

O’Bara later told PMP News that “several healthcare product transactions and processes could be optimized using standards.” GS1 has developed a family of standards that include the GS1 Global Trade Item Number (GTIN) for identifying products, the GS1 Global Location Number (GLN) for identifying locations, and the GS1 Global Data Synchronization Network (GDSN) for sharing standardized product information.

The healthcare industry is facing many supply chain threats, including counterfeiting, economic adulteration, recalls, and shortages, she explained. But it also needs to reduce operating expenses by “10 to 15 to 20%,” she said. “To do so, you need quality in data. It needs to be clean, complete, accurate, and timely.”

Currently, medical device identification is too varied today, or simply nonexistent for some products, says O’Bara. “The complexity in the absence of standards is enormous.” O’Bara struggled with such complexity while working at Covidien. “I saw the light—we need standards!” She merged six different ERPs into a single platform and began Covidien’s process of implementing GS1 standards to prepare for UDI.

While the pharmaceutical industry does have its National Drug Code in place, it must add unique serial numbers to salable units to comply with California’s 2015 deadline. GS1 Healthcare US is supporting those working toward the law with its 2015 Readiness workshops and pilot resources. Companies can begin pilots or test implementation approaches following GS1’s standards, structure, and support tools. GS1’s EPCIS is being used to manage supply-chain events in the workshops, explained Bob Celeste, Director, Healthcare at GS1 US.

But utility could go beyond compliance. Through the use of simulation software tools, GS1 program participants have been able to evaluate their technical abilities to support business processes and exceptions. More than 100 pharma business processes have been identified that can be enhanced by the use of standards. “Five or six of these relate directly to electronic drug pedigrees, and then there are processes related to forward logistics, recalls, withdrawals, and repackaging,” explained Celeste to PMP News. “We then found 40 or so exception processes that could be supported. As the supply chain uses such data, they’ll see more benefit internally.”

Aggregation remains a particular challenge for pharmaceutical companies. “The problem is that to track units, you must track every case and tote in the unit’s lifecycle,” Celeste told the GS1 Connect audience. “California’s law doesn’t say that you have to track the case, but if you don’t, you cannot track the item, unless you use RFID.” Accuracy becomes critical, he added.

GS1 is finalizing its Traceability Guidelines to support aggregation and other processes needed to comply with California’s law. They will include best practices; to follow this fall are certification criteria needed to meet the guidelines. “Users will be able to test data against the system to determine readiness to connect with a trading partner,” said Celeste.

While EPCIS in its native format “won’t satisfy California’s law, its revised format is expected to do so. “Security issues are being worked out in the working group,” Celeste said.

O’Bara sees a tipping point toward the use of GS1 standards. She points out the 2012 GTIN Sunrise this December with a number of healthcare organizations calling for the following use of GTINs:

• GTINs assigned to healthcare products.
• GTINs used in business transactions.
• GTINs marked on appropriate packaging levels.
• GTINs scanned at points-of-delivery to enhance clinical process.
• GTINs used in product returns and recalls.
• GTINs registered in a GS1 GDSN-certified Data Pool.

“Once we reach the tipping point, these GPOs will only operate with the GTIN. Noncompliant companies that are not geared for change or don’t have a vision will find their business going from great to mediocre to floundering quickly.”

Waiting for a mandate isn’t prudent, she adds. “A mandate will come and will bring you clarity, but by the time it happens, companies won’t be able to implement in time. You can’t apply GTINs quickly. It’s a process that cannot be rushed. Companies have legacy systems that take years to update. Even the best organizations see years of implementation. You simply have to start now, and start with baby steps.”

While preparations involve IT and logistics professionals, packaging and labeling work is just as urgent. “Don’t wait to get involved. These items must be validated and cannot be changed quickly,” O’Bara told PMP News. GS1 US can help with peer groups and toolkits, she added. “To do it alone, you could make a lot of mistakes.”

GS1’s team in Dayton, OH, can walk packagers through label changes, and there are tool kits available, O’Bara said. “People shouldn’t be hesitant. A peer support network is available.”

Based on industry feedback, GS1 continues to set up working groups to tackle specific challenges. “Kits offer ease of use, but they can be the bane of our existence,” O’Bara said. “They are one SKU, but we haven’t figured out how to handle kits. A working group is being formed, and we encourage dialogue.”

Another effort is the Secure Supply Chain Task Force, which is finalizing the draft document “Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes.” It is also working on an inference paper using a statistical sampling model with Stanford University.

GS1 is even working to address “the level below the each” for small or hard-to-mark items such as sutures or tablets in a 1000-count bottle.

GS1 Connect 2012 was held in Las Vegas June 4-7. For details about GS1 Connect 2013 to be held in San Antonio, TX, visit http://uconnect.gs1us.org/