All posts by Dirk Rodgers

Dirk is the founder of RxTrace where he writes regularly on the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance. He has written hundreds of essays on those specific topics. A logical thinker, Dirk is skilled at making complex technical topics understandable to non-technical readers and listeners. An Electrical and Computer Engineer by education, Dirk has worked as a consultant, software architect and automation engineer during a career spanning 30 years. Overall, Dirk's thought leadership has helped to expose hidden complexities and reveal surprising consequences and implications of drug serialization and pedigree laws around the world. Dirk is the author of "The Drug Supply Chain Security Act Explained". View Dirk's LinkedIn Profile Follow Dirk on Twitter
Cancer, Pelotonia

Summer News

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Photo by Jennifer Rodrequez
Photo by Jennifer Rodriguez

When I was in sixth grade at Lincoln Elementary School in Galva, Illinois, the town built a swimming pool at a new park that was within sight of the school.  My friends and I could not believe our luck.  In the entire history of the town, nothing as big had ever happened (well, for sixth graders anyway).  When the grand opening was scheduled for the day school was let out for the summer, we laid our plans to be the first in line.  That’s just what we did.  We checked in on the first day and did not leave until the day it closed at the end of the summer.  We had so much fun!

That was a long time ago in the days before Continue reading Summer News →

California Pedigree Law

Falling Between The Cracks Of The California Pedigree Law

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Photo by Jose Mora
Photo by Jose Mora

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.Most prescription pharmaceuticals distributed in California pass from manufacturer to pharmacy through wholesale distributors, but a small percentage are sold by the manufacturer directly to doctors and clinics.  An even smaller percentage are sold through small companies licensed as kit manufacturers or distributors to dental offices, fire departments, ambulance companies and other carriers of emergency medical kits.  These transactions are just as open to the introduction of illegitimate products as the larger transactions that we normally think of when we talk about the use of drug pedigrees, but because they are outside of the ordinary, they are at risk of falling between the cracks.  That is, they might be a lot more complex, or not even possible, under the California pedigree law. Continue reading Falling Between The Cracks Of The California Pedigree Law →

California Pedigree Law

Should Pharmacies Decommission EPCs Upon Dispense?

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Santa Monica Pier
Santa Monica Pier

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.I finally had a chance to listen to the recording of the rfXcel webinar with Virginia Herold, Executive Officer of the California Board of Pharmacy, and Joshua Room, Deputy Attorney General, California Department of Justice assigned to the Board of Pharmacy.  The webinar was recorded on May 29, 2013.  Ms. Herold and Mr. Room have done these kind of webinars before (see “Q&A With Virginia Herold, Executive Officer, California Board Of Pharmacy”).  But don’t worry, while there is a fair amount of repetition as you might expect, the Q&A is different enough that I always learn something new.  I found this one to be entertaining as well as informative.

One of the questions they addressed was Continue reading Should Pharmacies Decommission EPCs Upon Dispense? →

Congress, Federal Pedigree

InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives

Seal_of_the_United_States_House_of_RepresentativesImportant Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.Late yesterday The Hill, a political news website, began reporting that the U.S. House of Representatives has passed H.R. 1919, Safeguarding America’s Pharmaceuticals Act in a voice vote that required a two-thirds majority vote.  I was watching the House floor streaming feed live as it happened and I must admit that the parliamentary proceedings were slightly confusing to me regarding the vote, so now that The Hill is reporting passage I feel more comfortable saying the same thing.  😉

The text of the bill as it was before the vote appears here.

During the debate leading up to the vote, Continue reading InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives →

Congress, Federal Pedigree

InBrief: CBO Estimates H.R. 1919 Would Exceed Unfunded Mandate Threshold For Private Entities

WASHINGTON - JANUARY 26: The Congressional Budget Office made copies of its Budget and Economic Outlook for FY 2010 to 2020 available to reporters and the public January 26, 2010 in Washington, DC. The CBO's latest estimates see a $1.35 trillion deficit for the current budget year, dropping to $980 billion next year only if a host of tax cuts enacted under President George W. Bush are allowed to expire at the end of the year. (Photo by Chip Somodevilla/Getty Images)Just one business day before the U.S. House of Representatives is scheduled to vote on H.R. 1919, Safeguarding America’s Pharmaceuticals Act of 2013, the Congressional Budget Office (CBO) published their estimates for the public and private costs to implement it relative to the Federal Unfunded Mandates Reform Act (UMRA).

CBO has determined that the costs to State, local, and tribal governments would be “…small and below the intergovernmental threshold established by UMRA…”.  However, they also estimate that the costs to private entities “…would exceed the threshold established in UMRA ($150 million in 2013, adjusted annually for inflation)”.

Interestingly, the CBO used Continue reading InBrief: CBO Estimates H.R. 1919 Would Exceed Unfunded Mandate Threshold For Private Entities →

Congress, Federal Pedigree

The Federal Lot-Based Pedigree Before Congress

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SANYO DIGITAL CAMERAImportant Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.The current drafts of the nationwide pharmaceutical track and trace (Pedigree) bills on the floors of the U.S. Senate and House of Representatives both include an initial lot-based pedigree requirement that may be based on paper or electronic documentation (see “The Politics Of Federal Track & Trace Legislation”).  What is a lot-based pedigree and how is it different from one based on package-level serial numbers?  Let’s take a closer look at the kind of system that these bills would require.  Keep in mind that the Senate bill would mandate this kind of pedigree system for the next 10 years and the House bill would make it permanent.

First of all, according to both bills, pharma manufacturers would be required to Continue reading The Federal Lot-Based Pedigree Before Congress →

Federal Pedigree

The Politics Of Federal Track & Trace Legislation

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US CapitolWatching the progress of the nationwide pharmaceutical track & trace bills in the U.S. Congress has been very educational.  Now that different track & trace bills are on the floors of the Senate and the House of Representatives (see “InBrief: A Track And Trace Bill Has Made It To The House Floor” and “InBrief: A Track & Trace bill Has Made It To The Senate Floor”) I have been trying to pick up on the politics that underlies the current situation in an attempt to figure out what is likely to happen next.

Both of the current bills have been described as “bipartisan”.  I don’t think that’s exactly true, but before I explain why, Continue reading The Politics Of Federal Track & Trace Legislation →

Federal Pedigree

Would A U.S. Federal Pedigree Law Require A New UFA?

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Bag-O-MoneyOne of the questions that must be answered is, “how will an ePedigree and track & trace system be funded?”.  Who pays, who gets paid, and how much?  The answer to these questions are partly determined by which technology model is in use.  One reason a distributed model is usually the first model people think of is that the funding is so obvious:  it is localized.  In that model each company would arrange for their own services.  No pooling is needed.  That’s simple to understand and quantify because everyone is in control of the services they need.

But because distributed models have so many points of failure—any one of which would Continue reading Would A U.S. Federal Pedigree Law Require A New UFA? →