Tag Archives: EPCIS

U.S. Pharma Supply Chain Complexity

May 23, 2011 Dirk Rodgers 8 Comments

© Copyright 2011 Duncan Champney. used with Permission. This image was created with FractalWorks, a high performance fractal renderer for Macintosh computers. FractalWorks is available on the Mac App Store. — © Copyright 2011 Duncan Champney. used with Permission. This image was created with FractalWorks, a high performance fractal renderer for Macintosh computers. FractalWorks is available on the Mac App Store (Click on image).

The debate over pedigree regulatory models in the U.S. pharmaceutical supply chain often centers around how much data for each package of drugs needs to be moved between trading partners as those drugs move down the supply chain from the manufacturer to distributor(s) and ultimately to the pharmacy. The ideal model would minimize the amount of data moved yet always allow each member of the supply chain to check the prior history—the pedigree—of the drugs they are about to buy.

At a superficial level this appears to be all you need to do, but when you take a closer at the details of how the supply chain actually works in the U.S. you will see that there are other characteristics besides data volume per package that need to be considered.

FOUR VIEWS OF THE U.S. SUPPLY CHAIN

In the debates and discussions over pedigree regulatory models we are used to seeing a view of the supply chain that shows one manufacturer, one distributor and one pharmacy. That view masks so much important complexity that if we were to select a regulatory model or solution based on that view it would be far from ideal.

Here is a view of the supply chain where the vertical scale shows something closer to the true proportions between those three segments. Continue reading U.S. Pharma Supply Chain Complexity →

track and trace

The Viability of Global Track & Trace Models

May 2, 2011 Dirk Rodgers 3 Comments

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.

GS1’s goal is to develop standards that apply globally as much as possible and the FDA will likely find that Continue reading The Viability of Global Track & Trace Models →

track and trace

Attributes Of A Global Track & Trace Application

February 14, 2011 Dirk Rodgers 6 Comments

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.

The goal is to make investments today that will be Continue reading Attributes Of A Global Track & Trace Application →

pedigree certification, security

Electronic Message Security and More on Certifications

January 24, 2011 Dirk Rodgers

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.

Electronic pedigrees as defined by the states of Florida and California are messages that contain fairly complex legal documentation which describe the chain of custody or ownership of a given package of drugs, but they also contain several types of legally required certifications. Continue reading Electronic Message Security and More on Certifications →

Writing

Writing Is Thinking. For Example, Ken Traub

November 29, 2010 Dirk Rodgers 3 Comments

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.

In a previous job, I did a fair amount of Continue reading Writing Is Thinking. For Example, Ken Traub →

EPCIS

The Future of Traceability Repositories and Inventory Management Systems

November 8, 2010 Dirk Rodgers 1 Comment

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 →

Digital Signatures

Certifications In A California-Compliant Drug Pedigree

October 26, 2010 Dirk Rodgers 7 Comments

I’ve been involved in a number of conversations lately that included differing opinions about what will be necessary to “certify” a drug pedigree in California after their pedigree law goes into effect (2015-2017, depending on your role in the supply chain). It’s a contentious issue, especially for those who wish that a distributed pedigree model would comply.

The California Law is fairly clear that the pedigree must contain, “A certification under penalty of perjury from a responsible party of the source of the dangerous drug that the information contained in the pedigree is true and accurate.” And that, among a list of other things, it must include “…the name and address of each person certifying delivery or receipt of the dangerous drug.”

In the California language, a “dangerous drug” is Continue reading Certifications In A California-Compliant Drug Pedigree →

HDMA

Terminology: Track and Trace, and Pedigree

October 7, 2010 Dirk Rodgers 2 Comments

I don’t get paid for endorsements. I don’t sell my opinion. No one has my thoughts under their control. So when I tell you that the Healthcare Distribution Management Association’s HDMA Track and Trace Seminar is my favorite pharmaceutical industry serialization and pedigree seminar every year, you should know that’s my honest opinion. This year, the event will be held on November 8-10 in National Harbor, MD (just south of Washington DC).