3 Serialization Issues Even GS1 Is Concerned About
By Lori Clapper
“It’s not much of a leap to say that if you had $750 and a refrigerator, you could have been a pharmaceutical wholesaler in Florida in the late 1990s,” said Bob Celeste, senior director, pharmaceutical sector lead, GS1 US. The latter is an industry group driving the adoption and implementation of GS1 Standards in the U.S. healthcare industry to improve patient safety and supply chain efficiency. During my recent interview with him, he also stated, “There were more than 3,000 wholesalers in the state at that time. The situation has drastically changed since then, but it highlights why a lot of this work (i.e. GS1) was initiated.”
He referred me to the book Dangerous Doses, by Katherine Eban, which describes the frightening tale of the filtration of counterfeit drugs into the U.S. pharmaceutical supply chain and its potentially horrific impact on the patients that unknowingly receive them. Although it reads like a crime novel, it’s nonfiction — but Celeste experienced it firsthand. When he began his career with GS1 US in the early 2000s, the state of Florida’s pharmaceutical distribution system was a mess, to say the least. The state government had extremely low penalties for shipping and trading counterfeit pharmaceuticals, so it was essentially a prime market for illegal distribution.
“Dealers of illegal drugs like cocaine and heroin already had a pretty good supply chain on their hands through their illegal movements,” he said. “So, they started to move counterfeit and altered drugs, as well. As an example, they would buy a low-dose drug, slip the label on for a high-dose medication, and sell it back into the supply chain.”
That’s when the Florida government decided to enact a more stringent pedigree program than what was required from the FDA at the time. The state would require the first wholesaler to start the pedigree, but did not require serialization.
Fast Forward to California
The California Board of Pharmacy’s impending track-and-trace regulation is now top of mind for all facets of the pharmaceutical industry, as well as GS1. The January 1, 2015 California deadline is standing, and GS1 US and its industry members have now been a source for best practices for track and trace for the pharmaceutical industry. Although GS1 US has published an extensive guidance on traceability, Celeste said there are still several concerns regarding serialization, including:
- Will the final pedigree be lot-level or item-level? Right now, the published guideline details item-level serialization. If it turns out to be lot-level, adjustments will be made to the final guidance. But, companies need to know that changes could happen, and GS1 US and its industry partners are paying close attention to both legislation and the industry.
- Architectural models have not been established, and could change. There are different architectures that other countries have employed. For example, Turkey uses a central architecture, with all information recorded into one database. The U.S. has considered a central database, but has not ruled out distributed architectures. In that setup, everybody has their own information and shares it with their trading partners as they see fit. It is possible the U.S. could even try a hybrid, more semicentralized architecture.
- There are still a lot of exceptions — or all the things that could go wrong in a serialized pedigree world. For example, if you have a case of 12 products — and for a particular case, only 11 get into that case — what could your trading partner do with that case? If there are 13 there, instead of 12, can you actually use that thirteenth item?
“The answer is no, until you have pedigree data for it,” Celeste said. “We are working on automated ways of solving the bulk of those issues. It’s vital that we reconcile between systems and make changes and corrections, without introducing holes that counterfeiters can take advantage of.”
What Is GS1 US Doing To Handle The Concerns?
“Right now GS1 US is working closely with the industry on version two of our document, which will now include reverse logistics, recalls, returns, withdrawals, and exception processing,” Celeste explained. “We’re also working on making the whole system more efficient – possibly by incorporating data trails that will lead back to the manufacturer.” He also told me that, as new legislation comes into play, GS1 US will be charged with performing gap analyses, as well. And, since the U.S. Senate and House recently released revised bills on serialization at the national level, they will be keeping a watchful eye on them as they unfold. He believes, with the release of these bills, the government is finally recognizing the importance of a protected and efficient supply chain. After all, having 51 different regulations (one for each state, as well as one at a federal level) — to track movement of a product throughout one country — isn’t efficient in the least.
How Can You Keep Up?
Bob recommends that members of the pharmaceutical supply chain read and understand the regulation, download the recently published guideline, and take advantage of the many training opportunities they offer. He said there will be six workshops throughout the year that will cover serialization in detail. GS1 US will also continue its educational workshops for industry members to learn how to best prepare for the post-2015 U.S. pharmaceutical supply chain world.
"The pharmaceutical industry is marching full steam ahead toward the 2015 readiness date for serialization. A fully serialized supply chain will help the industry address a number of scenarios and activities that are affecting our supply chain today, including counterfeiting, theft, and diversion," Celeste shared.
The 2015 Readiness Workshops will help participants understand both the business and technical aspects of tracking and tracing serialized product through the supply chain —as well as meeting pedigree requirements —and how to leverage this data to increase visibility into business processes. Most importantly, the workshop will enable participants to make the decisions needed to be ready for 2015.
Upcoming dates for these one-day workshops are Wednesdays, May 22, June 19, October 16, and November 6, 2013. All workshops are held at the GS1 US Corporate Headquarters in Lawrenceville, N.J. For more information and to register, visit: http://www.gs1us.org/hc2015workshop