PDMA

How Pedigrees Protect The Drug Supply: The Case Against Cumberland Distribution

January 28, 2013 Dirk Rodgers 4 Comments

On January 17, 2013 a federal grand jury indicted three individuals in 28 counts connected with Cumberland Distribution, a pharmaceutical distribution company licensed in Tennessee, on charges of conspiracy, mail fraud, money laundering and obstruction of justice. Notably, some of the evidence used against the alleged co-conspirators are the pedigrees that they allegedly forged in an attempt to make their business look legitimate to their unsuspecting customers.

Now, as the press release about the indictment from the U.S. Department of Justice (DoJ), Middle District of Tennessee points out, “An indictment is merely an accusation and is not evidence of guilt. All defendants are presumed innocent unless and until proven guilty in a court of law.” So let’s just look at the evidence and how the DoJ is using it to build their case against the defendants in this case. From that we can see what impact pedigrees might have in other cases like this.

The charges are for activities that Continue reading How Pedigrees Protect The Drug Supply: The Case Against Cumberland Distribution →

Inference

How Should Inference Work?

January 23, 2013 Dirk Rodgers 2 Comments

The wide-scale use of “inference” in the pharmaceutical supply chain is essential to the successful operation of a track & track or ePedigree system. Companies cannot be expected to open every case they plan to ship, or that they receive, so that they can figure out exactly which package-level serial numbers are involved. The use of the serial number packaging hierarchy, or, “Aggregation information”, to “infer” which packages are being shipped or received is the only way to maintain a level of supply chain efficiency that is close to pre-serialization levels. On the other hand, regulator acceptance of the use of inference in the supply chain has the potential to complicate their investigation of criminals.

In recognition of its importance in maintaining efficiencies, the California legislature instructed the Board of Pharmacy to draw up rules that would allow companies to optionally make use of it (see my essay “Inference in the Pharmaceutical Supply Chain” for the exact text of the inference provisions of the California Business and Professions Code). It leaves the important question about who Continue reading How Should Inference Work? →

Holidays

Celebrating Martin Luther King Jr.

January 21, 2013 Dirk Rodgers 1 Comment

Martin_Luther_King_Jr_NYWTS — Martin Luther King Jr. Thinker of powerful thoughts, and with the skill to assert them as undeniable truths.

Don’t expect to reach me today. For the first time in my career I work for a company that celebrates Reverend Dr. Martin Luther King Jr.’s birthday as a holiday. I am particularly happy about that, because I rank Dr. King behind only George Washington, Thomas Jefferson, and Abraham Lincoln as the greatest American Founding Father.

Neither Lincoln nor King were present at the beginning of our country so most people don’t consider them to be “Founding Fathers”, but because they both caused major course corrections in our nation’s direction that actually straightened our path and lead us to achieve freedom for all Americans, I count them that way.

The United States is among only a few nations Continue reading Celebrating Martin Luther King Jr. →

Good News

Walgreens, Automation, And Erasing Disabilities

January 16, 2013 Dirk Rodgers 4 Comments

Randy Lewis, Sr. VP, Walgreens, retired — Randy Lewis, Sr. VP, Walgreens

Amid news of our disfunctional Congress, more mass gun violence and negative economic news last week, I received the links to the following uplifting videos about Walgreen’s Anderson, South Carolina distribution center. After watching them, I have determined that you must see them.

Click the link to watch what I think should have been called, “Walgreens, Automation, and Erasing Disabilities, Part 1” (but instead is called “The Coolest DC in the World…Part 1”):

http://www.moveitshow.com/clips/2057658540001/

and, “The Coolest DC in the World…Part 2”:

http://www.moveitshow.com/clips/2057658530001/

My original interest in watching these videos was to see all the automation they have added to this particular distribution center. (“What? They’re running pharmaceuticals down a tilt-tray sorter? How unique! I’ve got to see that.”) but after the first minute or so Continue reading Walgreens, Automation, And Erasing Disabilities →

data ownership

Data Ownership In The Track & Trace Cloud

January 14, 2013 Dirk Rodgers 3 Comments

Who will own the data that supply chain trading partners store in some future cloud-based, semi-centralized Network Centric ePedigree (NCeP) data repository? I met one potential future repository service provider who seemed to think that they would own that data. Imagine their excitement. All the data about where drugs go throughout the supply chain! Think of the value they could mine from that.

Well, that’s never going to happen because companies in the supply chain won’t sign up for handing over all of their supply chain data to some third-party just so they can comply with regulations, especially when there exists an alternative approach that would allow them to avoid using a third-party and still comply (by using DPMS). And regulatory agencies are Continue reading Data Ownership In The Track & Trace Cloud →

California Pedigree Law

“The Shadows Of Things That MAY BE, Only” : EPCIS and California Compliance

January 7, 2013 Dirk Rodgers 1 Comment

Currently, we know that companies can use GS1’s Drug Pedigree Messaging Standard (DPMS) to comply with the California pedigree law. That’s been known for a long time now. But many companies have been hoping to use GS1’s more general purpose Electronic Product Code Information Services (EPCIS) standard instead for almost as long. For just as long, it has been known that a number of problems arise when you try to figure out exactly how to apply EPCIS to California compliance.

The problem is, EPCIS was originally envisioned by its creators to share supply chain “visibility” data. That is, event data that was to be collected automatically based on Radio Frequency IDentification (RFID) reads picked up by readers that were to be spread around the supply chain by each of its members. The collection of RFID readers were to form a kind of “visibility” of each RFID tag applied to the products in the supply chain. From this visibility would come benefits. One of those benefits was to be Continue reading “The Shadows Of Things That MAY BE, Only” : EPCIS and California Compliance →

California Pedigree Law

California Board of Pharmacy Clarifies Use Of GS1 EPCIS

December 17, 2012 Dirk Rodgers 2 Comments

mick-jagger-steve-martin-snl-californians — “The Californians”

As I indicated last week, I wanted to write about a specific dialog that occurred at the December 4, 2012 California Board of Pharmacy Enforcement Committee meeting. The important exchange came at the end of the meeting during the catchall agenda item called “General Discussions” when topics that are not on the agenda can be raised by Board members or the general public in attendance.

As soon as the Chair opened that agenda item, Michael Ventura of GlaxoSmithKline rose and strode to the microphone. The exchange that followed was captured on the meeting video. I transcribed the exchange below as it happened because I think it provides a number of important clarifications about Continue reading California Board of Pharmacy Clarifies Use Of GS1 EPCIS →

Sad News

Robert J. “Bob” Bergantino (1960-2012)

December 10, 2012 Dirk Rodgers 4 Comments

I received very sad news last night of the loss of another friend and co-worker in the serialization and track and trace industry. Bob Bergantino, most recently of Excellis Health Solutions, worked for SupplyScape at the same time I did. We didn’t work on any projects or sales together but Bob was such a cheerful and inviting person that I couldn’t help but know and love him. Bob had a magnetic personality and was full of wit, charm and love for everyone around him. We will all miss him. Continue reading Robert J. “Bob” Bergantino (1960-2012) →

RxTrace