Congress should have mandated randomization of drug serial numbers, but they did not, so it is up to each manufacturer to recognize the importance it would bring to the protection of their brands and of the supply chain. Let me explain.
In my last essay I touched on the use of Product Identifier Authentication, or PIA, as an alternative to the collection and distribution of aggregation data to allow wholesale distributors and repackagers to meet the verification requirements of the Drug Supply Chain Security Act (DSCSA). Starting in November of 2018 for repackagers and in November of 2019 for wholesalers, the DSCSA will require these companies to verify that the standardized numerical identifier (SNI)—commonly referred to as “the serial number”—corresponds with one that the manufacturer originally applied to drugs that are found to be suspect, and for any returned drug that will be resold.
As I pointed out in my previous essay (see “The Aggregation Hoax and PIA”), manufacturers and repackagers may be able to choose to pass on aggregation information that would allow wholesale distributors to meet their requirements, or they might choose to offer a PIA service that would allow these companies to check the authenticity of one or more SNIs via a web service. Continue reading Product Identifier Authentication (PIA)→
What was his crime? He was the person who ran the licensed wholesale drug distribution company formerly in South Carolina, Ocean Pharmed, that bought the Novo Nordisk insulin that was stolen in a cargo theft back in 2009. In his plea, Rodriguez admitted that all of the drugs that Ocean had sold into the supply chain had been obtained from unlicensed or otherwise illegitimate sources, like the stolen insulin.
Most Warehouse Management Systems (WMS) available on the market today do a fine job of allowing their users to manage inventories in the warehouses of drug manufacturers, distributors and chain drug stores. A WMS is a software system that may be a part of a larger Enterprise Resource Planning (ERP) system, or it may be a third-party application that is interfaced with the owner’s ERP system.
All WMS systems that I am aware of are intended to be sold into multiple industries, not just in pharma. That’s so that the WMS vendor can maximize their sales. The more industries, the more sales and the more profitable it is. Because some industries have long had serial numbers on some of their products (computers and peripheral equipment, cell phones, electronics, medical equipment, appliances, etc.) WMS vendors have included serial number handling in their software for decades. In fact, I would bet that a serial number handling feature was included in WMS systems since the very beginning of that category of software.
But at least one news source seemed to do some additional investigating. Bill Berkrot and John Acher of Reuters published the excellent article “Fake Avastin’s path to U.S. traced to Egypt” on Thursday. In the article they provide a little more background on the path the drugs allegedly took before apparently arriving on the shelves of U.S. physicians and potentially in the bodies of unsuspecting U.S. patients.
And Pharmaceutical Commerce Online reports that Avastin isn’t the only incident of recent counterfeit injectable cancer drugs making it into the U.S. market that the FDA is currently investigating.
HOW COUNTERFEIT AVASTIN MADE IT INTO THE LEGITIMATE U.S. SUPPLY CHAIN
At the end of my last essay I said I had recently concluded that the jump to a fully automated pharma supply chain upstream visibility system is too big and complex to be achievable by every company in the U.S. supply chain by the California dates. I want to explain that statement in a future essay (soon), but before I do I want to explore some of the track and trace models that are being considered by both GS1 and the FDA. I particularly want to look at the viability of each model because I think we will find that some just aren’t (viable), and that will help narrow the search.
I’ll look at the three basic models that the FDA mentioned in their recent workshop: Centralized, Semi-Centralized and Distributed (or Decentralized as the FDA called it). There are others, but it seems that they can all be either based on, or reduced to, one of these three basic models.
In this essay I am looking at track & trace models from a global viewpoint, which is something that GS1 is doing but the FDA may not. Attacks on the pharma supply chain are a global problem and global problems demand global solutions or gaps will be left for criminals to exploit.
In an essay published in April, I explained my theory that “RFID is DEAD…at Unit-level in Pharma”, which, if true, would mean that most drugs in the U.S. supply chain would be serialized by manufacturers with 2D barcodes by 2015 for California. In my last essay, “Inference in the Pharmaceutical Supply Chain”, I carried that theory one step further by showing how the widespread reliance on 2D barcodes to serialize at the unit level would lead directly to the widespread use of the practice of inference in the supply chain. This would be out of necessity since the unit-level serial numbers would not be readable without opening their containers, something that can’t happen because it is so inefficient that it would cripple the supply chain. So let me say it this way, the widespread use of 2D barcodes for unit-level serialization will necessitate the widespread reliance on inference. The former leads to the latter just like excessive sunshine leads to sunburn.
But the projections of widespread reliance on inference lead directly to a new concern. Let me explain. Successful use of inference for determining the contents of cases is totally dependent on the accuracy of the aggregation information established and provided by the manufacturer, or whoever packed them. If a packer uses a casepacking process that is incapable of yielding highly accurate aggregation information, inference will not work well.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.