In this essay, I’m not going to discuss the attributes of a track & trace system from a regulator’s point of view. I’m not going to discuss input into the FDA’s Track & Trace workshop that occurs this week and I’m not going to speculate on the outcome of that meeting. Instead, I’m going to talk about the attributes of a track & trace application from the viewpoint of any global pharma manufacturer who is facing the regulatory mandates for serialization and traceability in a growing list of countries around the world, and from the viewpoint of any solution provider who is thinking about what they need to include in their solution offering so that those global pharma companies find it attractive enough to buy.
To those kinds of companies, the potential for new non-binding guidance from the U.S. is important, but perhaps less so than an increasing number of binding regulations from around the world. Whatever the FDA—and especially the U.S. Congress—may do in the future will be important when selecting a track & trace solution, but the U.S. is only one of the countries in the world and pharma companies that do business in those other countries do not have time to wait for the U.S. to figure out their approach before making investments.
Digital electronic messages can be transmitted from one party to another using a wide range of communications technologies. Today, businesses that make use of the internet to transmit their business messages to and from their trading partners make use of standards-based Electronic Data Interchange (EDI) message formatting.
EDI messages are typically transmitted point-to-point, from one business to one other business. There are a large number of EDI message types defined but in the pharmaceutical supply chain the most common messages are purchase orders, purchase order acknowledgments, invoices and advance shipment notices (ASN’s). (While I have the chance, I’d like to point out that ASN’s are not pedigrees for multiple reasons that I will not cover in this essay.)
In the U.S. pharma supply chain AS2 is the most common communications protocol in use for EDI message exchange. AS2 provides generalized message security to ensure that the messages cannot be understood or tampered with by unauthorized parties during movement from sender to recipient. According to Wikipedia, these are achieved through the use of digital certificates and encryption. Messages can optionally be digitally signed by the sender to provide non-repudiation within the AS2 payload context.
Over the last few years I’ve taken part in many conversations that touched on the question of how to achieve a Return On Investment (ROI) with serialization in the pharmaceutical supply chain. It seems intuitive that there should be an ROI because serial numbers provide increased data granularity and accuracy, but those characteristics in themselves do not guarantee a positive return.
For that, you must figure out a way to take advantage of those things in a way that increases productivity through decreased errors and reduced physical handling. Serialization might do that if you can increase the amount of automation in supply chain operations within your own facilities. Without automatic serial number reading and material handling, dealing with serial numbers will likely have the opposite effect on productivity.
Another way to take advantage of mass serialization of pharmaceuticals in the supply chain is to use it to help automate certain existing business processes between trading partners. Whenever it is valuable to Continue reading Pharma Serialization ROI→
I want to thank everyone for reading and commenting on RxTrace in 2010 and wish you all HAPPY HOLIDAYS and a HAPPY NEW YEAR. Due to our family party schedule I don’t expect to post any more essays this year.
I’m planning to see a number of movies in the next few weeks with my wife, two daughters and son-in-law. One of our favorite holiday activities is to debate which ones to see. Debating with my kids is probably what it must be like debating with me, but in the end we all have fun and always have a lot to talk about (and Dad pays).
So drive carefully, don’t drink and drive and don’t eat too much. On the other hand, do make peace with your family members, sing a lot, say thanks to members of our armed forces and give to charity. And, OK, you can eat too much just once.
Currently well over half of the U.S. states have a drug pedigree law of some kind either on the books, in the process of being enacted or proposed in their legislature. No two laws are exactly the same. That fact is quite painful for the national participants in the supply chain and it gets a little worse every time a new law is enacted or a change is made to an existing law. For this reason, the conventional wisdom among many supply chain participants, industry organizations, solution providers, and even the regulators themselves is that a nationwide pedigree law would be better than 50 different local laws.
Noted writer, editor, literary critic and teacher, William Zinsser, is known for the quote “writing is thinking on paper”. Today I don’t think paper has much to do with it, but what I think he means is, the very process of writing something forces a person to think about the thing they are writing about, and then embody that thinking clearly in the written output (paper or electronic). As you might imagine, I agree with this. I like to write and I believe that my own experience with writing has greatly improved my thinking. For a really great essay on the topic of writing and thinking, see The Secret About Writing That No One Has The Balls To Tell You by Pete Michaud…and don’t miss the many excellent comments below his essay.
I’ve been writing about ideas surrounding my professional experience much longer than the year and a half I have been writing RxTrace. In fact, I have written some pretty legendary emails and other essays over my career. Legendary because they raised ideas that were either unpopular or otherwise not wanted by the recipient(s). If you know me very well then chances are you’ve read one or two of those.
I think there is a significant difference between the traceability repositories we see on the market today and those that I think we are likely to see in the future. Today, traceability repositories are typically implemented by software suppliers as standalone applications or modules that we end users refer to as “an EPCIS”. We call it that because the most defining characteristic of these modules is that they implement GS1’s Electronic Product Code Information Services (EPCIS) standard. Today, traceability repository vendors expect customers to buy their traceability module and integrate it with existing applications. For a long time now I have felt that this approach was less than optimal and I think we will eventually see a switch occur in the software market toward existing application vendors adding traceability repositories and EPCIS interfaces as new features added to their existing functionality. Let me explain. Continue reading The Future of Traceability Repositories and Inventory Management Systems→
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.