Track And Trace: 4 Most-Asked Questions And 2 Things That Should Be Of Concern
By Lori Clapper
A Q&A with Dirk Rodgers, serialization consultant, Dirk Rodgers Consulting, LLC
Globally, it’s estimated that nearly 100,000 people die from ingesting fake medicines that could contain dangerous substances like sawdust, powder, and cement. That number does not even include those who live through potentially horrid adverse effects from taking counterfeit drugs. If you’re like me, stats like that are startling no matter how many times you read them.
Despite human lives being at stake, a solution to the counterfeit-drug epidemic still seems worlds away. The United States government didn’t come to terms on a uniform serialization mandate in the 2012 renewal of the Prescription Drug User Fee Act (PDUFA). Throughout the past year, both the pharmaceutical industry and U.S. government continued to debate over supply-chain protection. Even as late as October 2012, the U.S. Senate HELP committee released a 115-page draft bill that the U.S. Department of Health and Human Services and the FDA will be charged with “developing standards for the interoperable exchange of transaction information for tracking and tracing prescription drugs.” However, those people leading track-and-trace efforts feel the “fill-in-the-blank” wording within the document causes more head scratching than clear direction.
Still, the 2015 California ePedigree Law is fast approaching, and drug manufacturers are required to have 50% of product packages serialized by January 1, 2015. Since this is the closest the United States has to a serialization standard, I decided to dig a little deeper on the issue. Who better to turn to than consultant Dirk Rodgers? Dirk is a highly respected serialization expert in the pharmaceutical industry, as well as the author of the RxTrace blog. In this Q&A, he answers his most frequently asked questions about track and trace, as well as highlights the two issues he feels are most important for the pharmaceutical manufacturing industry to address.
What are the top questions you receive from companies who are beginning their serialization preparation and/or implementation?
1. Will the California dates will be pushed out again?
No doubt about it, this is the top question I am asked. I do not think California will push back the compliance dates — barring some kind of federal action — because any further delay risks causing companies to conclude that it will never happen, thus causing them to stop all preparations. Back at the time that the California legislature agreed to push the dates out from 2011 to the current 2015 through 2017, they asked the industry to agree to meet the new dates as a condition to the schedule change. Thirty-five companies and organizations representing the bulk of all members of the U.S. pharmaceutical supply chain made that agreement.
Clearly, some companies will not be ready — that would happen no matter when you set the deadline — but I believe that most of the larger brand and generic manufacturers, wholesalers, and chain pharmacies will be ready on their date or soon after.
2. What approach to ePedigree data exchange will be used by the industry?
Regarding the approach to ePedigree data exchange, the California law doesn’t specify exactly how the contents of a pedigree must be formatted. They leave that up to the industry to figure out and agree on. But the law does provide a very specific list of data elements that must be present before the pedigree can be considered valid.
There are two basic technology approaches that people in the industry are considering for passing the pedigree data: the GS1 Drug Pedigree Messaging Standard (DPMS) and a Network Centric ePedigree (NCeP) approach that is based on GS1’s Electronic Product Code Information Services (EPCIS) standard.
Without going into the technical details of each, I can summarize the difficulties that people are having with this choice by saying that few people currently like the DPMS approach, but at least it is known to be usable for compliance. Also, the NCeP approach, so far, does not include all of the data elements that are listed by the law, so there is a big question on the ability for companies who use it to comply with the law. For that reason, DPMS may end up being the approach that is used, at least initially. Watch what the big three wholesalers do, because they would be the first companies fined if they can’t produce a valid pedigree when inspected.
3. Will the federal government — whether Congress or the FDA — impose a nationwide track-and-trace or ePedigree system anytime soon?
Regarding the odds of federal action that would preempt the California law, I do think it will happen someday. Sadly, with the current political climate in Washington, I think it could end up sitting on the back burner until the next major incident occurs, before this issue is addressed. Last summer’s attempt to add nationwide track and trace to the FDA Security and Innovation Act (FDASIA) was a better opportunity to get it done than we will likely see for a few years — and that effort failed.
4. Do you think RFID will be used in the supply chain?
Surprisingly, I frequently still get asked this question. I believe that it will not be used on drug packages, but that it might be used on cases. That said, unit-level RFID will someday sweep the pharmaceutical industry, but the trigger for that will come from a clear demonstration of lower overall costs that make it back to the manufacturers.
Conversely, what are your biggest concerns about the readiness of the nation’s pharma companies when 1/1/15 rolls around?
I have two primary concerns about the industry’s readiness.<
1. The indecision over the ePedigree format
We are now less than two years away from manufacturers being required to serialize and pedigree half of their drug production, and we still don’t have general agreement within the industry on how ePedigrees will be formatted. The problem is that the wholesalers don’t need to be ready to receive ePedigrees until mid-2016 so they have more time to prepare than the manufacturers. They can afford to defer the decision to see if GS1 can come up with an NCeP that will comply with the California law.
Since the ePedigree format(s) the manufacturers must produce will be determined by what format(s) the wholesalers will accept, drug makers may need to scramble to make adjustments at the last minute. At least the pedigrees they produce through mid-2016 don’t have to be received by anyone, so the format isn’t a drop-dead issue until that time.
2. The lack of an industry agreement on the use of inference and the aggregation information necessary to make it work
Inference is the process that all supply chain members will use to “infer” the unit-level serial numbers contained within a sealed case during shipping and receiving processes without actually opening them. The supply chain would take a huge efficiency hit if inference couldn’t be used after the California law goes into effect.
The problem is that when regulators fully accept the use of inference, they may make it harder to prosecute criminals who might claim that they didn’t know the cases they sold contained counterfeit drugs because they simply “inferred” that they contained valid drugs.
For inference to work, the company that packs drugs into cases and totes must capture “aggregation information” that is later used to “infer” the contents. That would typically be the manufacturer for homogeneous cases and the wholesaler for mixed totes. Inferring container contents using inaccurate aggregation information will cause companies to receive drugs that do not have valid pedigrees. Even when this happens as the result of an honest error, the drugs that do not have valid pedigrees cannot be sold or dispensed until the pedigrees are corrected. That’s a very complex and inefficient process, and it could result in a large amount of drugs being unusable for a period of time, which could lead to limited shortages.
The key to the successful use of inference is the quality of the aggregation information. To capture it properly requires very carefully designed processes. It doesn’t work to simply hand workers a bar-code reader and ask them to scan the case bar code and then all the unit bar codes. That approach will lead to unacceptably high defects in the data. I fear we will see that happening way too often at the beginning of the compliance dates.
How do pharmacies come into play with serialization implementation?
The whole track-and-trace process relies on pedigree data exchange that is fully interoperable across all members of the supply chain — including pharmacies. That’s the one uncertainty that I haven’t mentioned yet.
Pharmacies don’t have to comply with the law until mid- 2017, which is far enough away that most are not paying much attention to all this yet. Chain pharmacies have the resources to make it all happen in that time, but it is a big question how the large number of independent pharmacies will be able to comply. Those who make use of commercial pharmacy management software for inventory control and claims processing may find that their software vendor will include California ePedigree capabilities as a new feature within that package, but we haven’t seen that happening yet. Those who do all that with paper will be the hardest hit by the law because they will be forced to invest in new computer systems able to receive and update electronic pedigrees. Will that happen in time? It’s uncertain.
Where is a good place to start for life-sciences companies?
My recommendation for those who are just beginning to prepare is to find an ePedigree solution provider who has a solution that can make use of both DPMS and EPCIS. This approach should allow you to remain flexible so that when the wholesalers finally make their choice you will be able to format your acceptable pedigrees. Fortunately, most solution providers are taking this approach for exactly this reason.
Dirk Rodgers is an independent consultant and founder of RxTrace.com where he writes regularly in an exploration of the intersection between the pharmaceutical supply chain, track-andtrace technology, and standards and regulatory compliance. An electrical and computer engineer by education, Dirk has worked as a consultant, software architect, and automation engineer during a career spanning 30 years. He served as co-chair of the GS1 EPCglobal Drug Pedigree Messaging (DPMS) work group and the GS1 Network Centric ePedigree (NCeP) work group, among others.