Tag Archives: DPMS

pharmaceutical supply chain, stolen insulin

Reliance on Trust in the U.S. Pharma Supply Chain

April 26, 2011 Dirk Rodgers 7 Comments

Trust plays a big role in today’s U.S. pharmaceutical supply chain. Patients trust that their doctors know what they are doing when they prescribe a medicine and they trust their pharmacist to fill their prescriptions with real medicines that were:

manufactured to tight quality specifications,
are well within the expiration date,
have not been tampered with,
have always been kept within recommended environmental tolerances,
and have been in the control of companies who have a strong interest in supply chain integrity and in the safety of the drugs within the supply chain.

When we receive our little amber bottles of repackaged drugs from our pharmacist, we aren’t given any way to check on any of those things ourselves. We trust that the pharmacy has done something to ensure all that. And fortunately in the U.S., we are almost always justified in that trust. We enjoy the safest supply chain in the world.

A WHOLE LOT O’ TRUSTIN’ GOIN’ ON

But, now if the pharmacy doesn’t get the drugs directly from the manufacturer, they trust that their wholesaler will supply them with drugs that have those characteristics too. And if the pharmacy’s wholesaler doesn’t get the drugs directly from the manufacturer, they trust that their wholesaler’s wholesaler provides them with drugs like that too. And if the pharmacy’s wholesaler’s wholesaler doesn’t get the drugs directly from the manufacturer, they trust that Continue reading Reliance on Trust in the U.S. Pharma Supply Chain →

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 →

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).

BTW, This opinion wasn’t solicited and I am paying full (member) price to attend the event. This isn’t an advertisement. It’s what I believe.

It’s an event that is intensely focused on Continue reading Terminology: Track and Trace, and Pedigree →

GS1 Healthcare US

Before You Participate in The GS1 US 2015 Readiness Program, Read This

October 4, 2010 Dirk Rodgers 2 Comments

GS1 US is dedicated to expanding the adoption of GS1 Global’s standards for supply chain interaction in the U.S. market. Almost every country in the world has a GS1 “Member Organization” (M.O.) that is dedicated to the same thing within their borders. With the local M.O.’s primary focus on driving adoption, their most valuable tool is that country’s government. If they can get the government to reference GS1 standards in their laws, their work is much easier.

This isn’t unique to GS1, or course. All standards organizations know this and they all have various approaches to getting the attention of each country’s government. There is nothing wrong with this. In fact, it makes perfect sense since, unlike standards organizations themselves, countries always have very large enforcement wings.

But what happens when those governments are too big to sway easily? What if it costs too much and takes too long to get them to see the light? This is when a standards adoption organization needs to get creative. In my opinion, that’s what has led GS1 Healthcare US to create the “2015 Readiness Program”. It was out of frustration with the California State Government and with the U.S. Food and Drug Administration (FDA) and their, so far, unwillingness to create laws and regulations that mandate the use of GS1 standards. Let me explain. Continue reading Before You Participate in The GS1 US 2015 Readiness Program, Read This →

pedigree

A Semi-Centralized, Semi-Distributed Pedigree System Idea

September 27, 2010 Dirk Rodgers 6 Comments

Four years ago the GS1 EPCglobal Software Action Group (SAG) Drug Pedigree Messaging Work Group was wrapping up the standard specification for the GS1 Drug Pedigree Messaging Standard (DPMS, aka GS1 Pedigree Ratified Standard). That standard was developed through collaboration between U.S. pharmaceutical supply chain members, industry associations, solution providers and GS1. DPMS 1.0 was ratified by the EPCglobal Board in early January 2007.

DPMS has many benefits. It results in a self-contained, self-secure electronic document that clearly shows the chain of ownership and/or custody of a given drug package (or a set of packages if they all have the same history). It works equally well with serialized and non-serialized products. The security of DMPS documents comes from within the electronic documents themselves rather than just from a security layer wrapped around a given server. A self-contained, self-secure document model should work well as evidence in a criminal trial.

But even before DPMS was ratified people were raising questions and concerns about it. Those concerns were Continue reading A Semi-Centralized, Semi-Distributed Pedigree System Idea →

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance