Track & Trace Update
Serialization moves along to another deadline
It was the last week of July when a company salesman sent Robb Robles an e-mail about a major, international pharmaceutical manufacturer located in the Midwest. Mr. Robles is a product manager for Cognex Corp., a major machine vision vendor. His chief responsibility is selling Cognex’s In Sight vision system for pharmaceutical and medical device track-and-trace applications. The salesman told Mr. Robles that a big pharma company was about to issue a request to bid to vendors for equipping two of its packaging lines with a soup-to-nuts track-and-trace (T&T) system. This was big news for him; until now, European pharma companies have led the way on track-and-trace. To the extent that U.S. companies have stuck their toes in the water, it has been with small-scale pilot projects devoted to single, high value products. The Midwest company, which Mr. Robles declined to name, was the first American firm that he knew of to begin to qualify vendors with the intent of achieving full serialization on two packaging lines by mid-2011.
Are U.S. pharma companies finally get out of the gate on track and trace in advance of California’s 2015 deadline for item-level serialization and e-Pedigree tracking of one-half of a company’s drug products coming into California (with the second half to be tagged and followed starting January 2016)? Apparently, engines are starting to turn over in the wake of the Food and Drug Administration’s (FDA’s) publication last May of final guidance on a Standardized Numerical Identifier (SNI) to be used on an item-level drug package as the basis of an e-Pedigree. The FDA didn’t explicitly endorse the GTIN format published by GS1, the voluntary healthcare standards group. But there was an implicit endorsement that the GTIN would work fine as the SNI; that allowed companies in the U.S. to move forward on T&T knowing that the serialization format they use here will jive with the systems they are required to use in some European and South American countries.
Mr. Robles and others expect the T&T adoption pace to pick up further as manufacturers get the word from wholesalers, group purchasing organizations (GPOs) and hospitals that the manufacturers must have Global Location Numbers (GLNs) on their shipping documents. These are 13-digit numbers that are company- and location-specific, and while they are not tied to GTINs, they are necessary in the implementation of a T&T system. GS1 and its members — companies up and down the pharma drug distribution chain — have adopted a January 1, 2011 GLN “Sunrise” deadline. Robert Celeste, director, healthcare, GS1 US, says the GS1 registry already has GLNs for 235,000 locations. A major hospital company such as Kaiser may have thousands of numbers, a different prefix for each hospital and different digits for each department within that particular hospital. “Hospitals have the dollars and the purchasing power to make this happen,” explained Mr. Celeste, meaning they can “force” a drug manufacturer to apply to GS1 for a GLN.
Of course, a manufacturer can get GLNs without necessarily putting GTINs on package labels, per the California mass serialization requirement. But the process of applying for GLNs probably has forced many manufacturers to take an integrated look at what they will have to do in the very near future to get a T&T system up and running to comply with the California mandate. “The GLN and GTIN are the two foundational cornerstones for track and trace,” said Mr. Celeste.
Another sign of the turn up in volume on T&T is the introduction of new vendor products aimed at helping companies side step some of the California requirements, which were previously seen as roadblocks. One of the continuing controversies surrounding California is the issue of inference: how can a manufacturer insure the integrity of individual item-level packages either shrink-wrapped together or placed in a carton at the point of “aggregation” on the packaging line? Wholesalers face a parallel issue with regard to the cartons they receive from manufacturers; the cartons may contain 12 or 24 individual packages and the wholesaler has no way of establishing a “mother-child” relationship between the carton and the individual packages inside the carton, at least not if the items are serialized with a 2D Data Matrix barcode, as is nearly always the case. Barcode readers cannot detect GTIN codes through cartons, but radio frequency identification (RFID) readers can. Of course, wholesalers would not have to open each carton if the items were serialized with an RFID tag. But manufacturers are not using RFID in that application — although they sometimes use it on cartons and pallets — because of the cost of the tag.
Douglas S. Boothe, executive vice president U.S. Commercial & Administration, Actavis Inc., a major generics manufacturer, said, “Actavis has investigated the currently-available RFID technologies and believes that the failure rate in scanning RFID is unacceptably high.” The company currently sells more than 420 Rx SKUs in the U.S., manufacturing them in four U.S. plants as well as through contract manufacturers.
The response to this problem by manufacturers like Actavis is to push for the use of “inference” through the supply chain. Inference means that if a manufacturer certifies the contents of a given case, and that case has not been opened and standard business processes have been followed, then the supply chain partners can “infer” that the contents of that case have not changed since manufacture and packaging. Mr. Boothe says Actavis supports either inference or authentication; either would be effective in establishing and guaranteeing the “parent-child” relationship through the distribution chain to the pharmacy. Authentication, based on what three European countries require, would mean serializing packages with 2D with the GTIN, and then entering that GTIN in a web portal linked by index to allow lookup from a retail location. The entire “middle” of the supply chain would be excluded from compliance, eliminating much of the cost and complexity, and undoubtedly thrilling wholesalers, who have favored RFID tags, not 2D, at the item level. The cost would be much lower than that for the existing ePedigree / Serial-ization model, according to Mr. Boothe.
Virginia Herold, executive officer of the California Board of Pharmacy, says California definitely requires inference for users of 2D barcodes starting January 1, 2015. The Board will hold hearings sometime in the next year to get public input on what the requirements should be, specifically. A regulation will be written.
Omega Design, a packaging machinery manufacturer located in Exton, PA, contends it can make the parent-child certification requirement work with 2D labels, at least at the manufacturer level. Its new system utilizes a serialized side label and a unique synchronized marking ink-jetted or lasered on the bottom of each container. When 12 packages or bottles are plucked off the packaging line at its end and aggregated — think four rows of three bottles — by a robot, and before they are placed into a carton, the bottom bottle numbers or GTINs can be read (the printed labels on the inner bottles cannot be read) and the “parent-child” relationship between those 12 packages and the bundle is assured.
Randy Caspersen, vice president, sales and marketing at Omega, says he believes his company is the only one who offers a “system” — that is, the entire packaging line — where bottles and packages can have printed GTINs on both a label and the bottom of the container and have those GTINs read at every point along the packaging line. The “bottom GTINs” also allow the packaging line to move faster than would be possible if container side labels had to be read at each point along the line. Mr. Caspersen said one major pharma company is using the Omega system, but declined to identify that company. It is worth noting, however, that the Omega solution might not necessarily help wholesalers, who would still have to open a carton to authenticate the relationship between each of the packages to the carton.
Reading item-level serial numbers on the packaging line is one thing, but capturing them, massaging them through an e-Pedigree system, and authenticating them is quite another. That is where the Oracle Pedigree and Serialization Manager comes in. It generates, stores, transmits and authenticates drug product serialization data and e-Pedigree data as pharmaceutical products move across the supply chain. This facilitates counterfeit threat identification and streamlines compliance. In addition, integrated analytics within the solution provide pharmaceutical manufacturers with expanded insight into possible threats.
Arvindh Balakrishnan, vice president, life sciences business unit, Oracle, says other companies offer pedigree tracking systems, but Oracle’s is cheaper because it comes pre-engineered, the implication being, among other things, that it is more risk free because Oracle supports it. “It also has a lot of business processes built in it so customers will not make ugly mistakes,” stated Mr. Balakrishnan.
While new vendor solutions aimed at California e-Pedigree compliance are appearing, both the vendors, drug manufacturers, wholesalers, hospitals and pharmacies all agree that the federal government must step in and establish a national e-Pedigree requirement. The Food and Drug Administration Amendments Act (FDAAA) Congress passed in 2007 required the FDA to “do something” to promote mass serialization of drug packaging on a national basis, and the FDA has done the minimum, releasing final guidance last March on an SNI which dovetails with the RFID and 2D Data Matrix versions approved by GS1. But the FDA guidance on an SNI is only that . . . guidance . . . it has no legal standing. Moreover, the FDAAA required the FDA to develop “standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded or expired drugs.” There was no deadline set for the FDA to accomplish this, and the agency has not made much progress.
The pharma industry would much prefer a national e-Pedigree/T&T standard than having to comply with California’s, or any other state standards that crop up. Vice President Biden provided a flicker of hope on that score in June when he headlined a press conference called to announce the release of the 2010 Strategic Plan on Intellectual Property Enforcement. The plan, which was prepared under the aegis of Victoria A. Espinel, the first U.S. Intellectual Property Enforce-ment Coordinator, covers a variety of product areas and federal agencies and departments with enforcement authority for them. One of those was pharmaceuticals. Vice President Biden mentioned the administration will be asking Congress for legislation giving FDA ability to track counterfeit drugs, but was no more specific than that. He talked big about the administration getting tougher on counterfeit products generally, and mentioned drugs a number of times. A spokeswoman at the FDA says, “We are working closely with Congress and have provided technical assistance on track and trace legislation, as appropriate.”
Two congressmen did introduce a bill called the Safeguarding America’s Pharmaceuticals Act in the last Congress, in 2008. It would establish a national T&T system. But Reps. Steve Buyer (R-IN) and Jim Matheson (D-UT) have not reintroduced that bill in the 2009-2010 Congress. It is not clear what the hold up is. It is clear, however, that no bill will pass in 2010.
Stephen Barlas is a freelance writer who has written several articles on pharmaceutical packaging and tracking issues for Contract Pharma. He can be reached at firstname.lastname@example.org.