Dangerous Doses

If you have chosen to read this blog but you still haven’t read Dangerous Doses by Katherine Eban, you have made the wrong choice. The book is a great read. It documents the events in the early 2000’s that led the State of Florida to pass the first state pedigree law in 2003. You can draw a straight line between those events and all of the state pedigree laws that came after it. The book is a detailed accounting of crimes that occurred after a few criminals realized that law enforcement and the courts would not take seriously any drug crime that did not involve illegal drugs. But a small group of detectives and a lone prosecutor took them on and eventually brought them to justice. The book alternates between narratives of the crimes, the pursuit of the criminals by the detectives, and Eban’s explanation of how the pharmaceutical supply chain worked back at that time.

But that’s just it. The book was written at a time when things were different than they are now in some very important ways. As I understand it, back then, you could have spent less money on a license to distribute pharmaceuticals than you would if you obtained a license to open a bar. As a consequence, there were thousands of drug wholesalers licensed in Florida. But in 2003 the state toughened its licensing laws, greatly increased the cost of the licenses and increased the penalties for crimes related to wholesale distribution of pharmaceuticals. The HDMA cataloged the significant changes to Florida’s drug distribution regulations as the result of those changes. The number of licensed wholesalers plummeted to only a few hundred in the following years.

Oh, and they passed a pedigree requirement too.

I have to admit that I don’t have a good window into what exactly is going on in the Florida crime scene today but given the heightened awareness in the press of counterfeiting and diversion stories, I have to think that there is not nearly the problem that there was back in 2002, or we would hear about it.

So that pedigree requirement really worked, right? Maybe, but I have to think that the increased licensing fees and other requirements, the increased penalties and the increased interest by the courts are the things that really caused criminals to think twice about getting into that business.

Dangerous Doses is a great book and I still highly recommend it to anyone, especially those like me, who are responsible for working on pedigree, serialization and track & trace systems for companies in the supply chain. But as you read it try to keep in mind, that era doesn’t exist anymore. Since that time many other states have taken comparable steps to strengthen their licensing and toughen penalties. And many of them have also passed some type of pedigree law. Stay tuned for more about some of those laws in later posts.

Do drugs still get counterfeited and sold in the U.S.? Probably, but the criminal activity seems to have moved from the supply chain to the internet where criminals can hide just across the borders. Check your spam folder for the evidence.

The Importance of Standards

I’ve written before about the importance of supply chain standards and how pedigree standards can be categorized as “communications standards”. I drew the analogy of the importance of standards in making cell phones work together. Because U.S. cell phone companies agreed to make use of certain standards, you are able to call your friends who chose to buy service from Sprint, when you have chosen to buy your service from Verizon, or any of a number of other U.S. carriers. Without those standards and the agreement of each company to use them, you would only be able to call people who happened to sign up with the same phone company that you did.

I won’t reproduce the whole article here but its contents are just as pertinent today as they were two years ago when it was published in Pharmaceutical Commerce magazine. That article stressed the importance of the GS1 Drug Pedigree Messaging Standard (DPMS, a.k.a. the GS1 Pedigree Ratified Standard), but any approach selected by an individual company to address pedigree legislation has to consider interoperability with whatever approach their trading partners choose. Interoperability is the goal of standards but right now there are two standards-based approaches to pedigree out there and they are not currently interoperable. That’s a problem for everyone, because the supply chain is so interconnected and diverse at the same time.

The two standards are DPMS and EPCIS–both from GS1. The history of these two standards and the differentiating characteristics of each one is too complex to cover in a single post so I’ll just provide an introduction here. I’ll continue the discussion in later posts, although I don’t plan to make the whole thing contiguous because there are other topics that I also want to cover over the same timeframe.

EPCIS (Electronic Product Code Information Services) is a GS1 standard that defines a set of interfaces for the purpose of capturing and querying serial number “visibility” data. “Visibility” data is meant to be observations and transactions that are based on observations of serial numbers that are attached to items and logistical containers of products within supply chains. I still haven’t found an easy-to-understand way to explain it, but I think those two sentences describe it fairly concisely and accurately. If you have a better way to explain it, please post a comment below.

Notice that the description doesn’t say anything about pedigree or regulatory compliance. EPCIS is a standard, but it’s a general purpose IT thing that you have to apply a specific way in order to make it work as a pedigree system. The standard is designed to be very flexible and for serialized product, it could be quite powerful if used right. There are a couple of problems for those who want to use it as a pedigree system, however.

  • There is currently no standard that describes exactly how to apply it as a drug pedigree system that would ensure interoperability across the supply chain;
  • There is the general tendency to talk about ways to turn EPCIS into a pedigree system, but I haven’t heard one yet that is likely to comply with existing pedigree laws.

I’ll cover those issues in more detail in later posts.

DPMS (Drug Pedigree Messaging Standard) is a GS1 standard that was specifically created to assist the pharmaceutical supply chain with creating an interoperable system to trace drugs in a way that can comply with existing pedigree laws. That includes Florida, California, the PDMA and all of the other states that currently have pedigree laws. The problem is, it doesn’t do much to assist companies with all of the many problems they face dealing with serial numbers on items. DPMS can take serial numbers and use them to trace those items, but there are a lot of other, non-compliance issues that must be dealt with first.

So there are problems with both standards. Perhaps an obvious solution is one that I, and others, proposed last year to combine EPCIS and DPMS to create a system that benefits from the best of both standards.

As you might imagine, there is a lot more I could discuss on this topic in later posts. But I’m going to try to stay out of the details and talk more about implications of each approach. Stay tuned…

Fundamental Law of Commerce

Over the last few years I have been kicking around an idea that helps identify an important characteristic that will be necessary in any successful supply chain pedigree or track and trace technology/regulation. I can sum it up as follows:

When regulations mandate that a product’s value is determined by the ability to show, at any time, specific information about the product’s history, then the buyer of that product must receive all of the necessary information from the seller at the same time the product is received.

Take, for instance, a secondary wholesaler in Florida today. Florida requires a secondary wholesaler to be able to show an inspector a complete pedigree for any prescription drug in their possession. If the wholesaler cannot show the proper pedigree, then the product cannot be sold in Florida. The value of the item is reduced, perhaps to zero. If this drug-without-a-pedigree can legally be shipped to sites or customers outside of Florida the reduction in value is equal to the cost of the extra shipment, extra handling and perhaps a temporary out-of-stock situation until the unexpected loss can be backfilled (and possibly a fine).

Now imagine what would happen if there were no other place to legally ship drugs whose pedigree information is unavailable when called upon. The value of the drugs would certainly be zero, or worse. That’s a risk that can be avoided by ensuring that all of the information necessary for the pedigree is in the possession of the secondary wholesaler at the time they purchase the drug.

What would cause the information to not be available? Some technical approaches to maintaining pedigree information under discussion within the industry right now might result in something I call a “distributed” pedigree. That is, one that is stored across multiple organizations; the previous owners of the drug. When it is necessary to show a complete pedigree–to an inspector, a law enforcement organization, or just to a buyer–these other organization must be called upon to provide their part of the pedigree. The occasion that leads to the need to show a complete pedigree will probably occur somewhat unexpectedly (especially in the instance of a regulatory inspection or a law enforcement action). If one or more of the organizations holding part of the pedigree information are temporarily or permanently unable to provide their part of the pedigree, the product cannot be sold and thus has lost all of its value.

The real problem with a distributed pedigree occurs when the supply chain extends beyond just two trading partners. For example, the third owner of a drug in the supply chain probably doesn’t have any business relationship with the manufacturer (the first owner). That’s why they bought the product from the second owner. There is probably no contract between the current owner of the drug and the previous owners (except the most recent seller) so there is no way to ensure that these earlier owners will provide their necessary components to the pedigree when it is called for.

The solution is to make sure that all of the necessary data for the pedigree is always supplied by the seller at the time of purchase. That way, if any of the earlier owners have technical (or other) difficulties that prevent them from being able to serve up data, it won’t affect the value of the drugs that are downstream in the supply chain. In short, a “distributed” pedigree won’t work.

I believe this concept is a corollary to the fundamental law of commerce known as “Buyer Beware”. Transmitting a full pedigree at the time of the sales transaction is one way of arming the buyer with sufficient information so they can beware.

Welcome to rxTrace

My intent for this blog is to publish my personal ideas and opinions regarding technology issues related to regulatory compliance within the U.S. pharmaceutical supply chain. I hope to cover topics like GS1 Standards, pedigree, track and trace, and issues surrounding those things, using publicly available information. This blog contains my own ideas and opinions and not those of my current or former employers and so I am solely responsible for them.

In general, the more ideas presented for consideration, the better. Most ideas will end up in the scrap heap. When I present ideas here and elsewhere, I try not to worry whether or not they might end up being rejected, because sometimes an idea that sounds bad initially can turn out to be the most innovative. Sitting on it for fear that it will be rejected would limit the chances of discovering the best idea.

All ideas benefit from collaboration with other people where they can be refined into better ideas. I hope my readers will respond often with refinements and counter-ideas. Please don’t hesitate to respond.

Thanks for reading. I hope this blog remains interesting to you.

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.

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