Tag Archives: pharmaceutical supply chain

PDMA, RxUSA Lawsuit

Impact of RxUSA v. HHS On Future Pedigree Legislation

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I attended the Partnership for Safe Medicines (PSM) Interchange 2011 conference on October 27 in Washington DC.  (I’ll cover that event more fully in a future essay.)  For me, the event couldn’t have been better, but I measure events like this perhaps a little differently than most people.  The agenda is important and the quality of the speakers is absolutely important, but in my view those are simply the things that lead to the one thing that can transform a merely good conference into a great conference:  the quality of the attendees.

(The quality of the attendees is exactly why I like the HDMA Track and Trace Seminar.  BTW, this year’s HDMA event starts this Thursday).

In the case of this year’s PSM event, I rate the quality of the attendees very high, and that’s because I had a number of great conversations with some very knowledgeable people during the breaks and at the social event the evening before.  That was my interaction with the attendees, not the speakers.  One of the topics of conversation surrounded the question of what exactly it was the led to the successful challenge to the Prescription Drug Marketing Act (PDMA) pedigree provisions in the RxUSA v. HHS court case and appeal and whether or not the same thing might occur with other drug pedigree laws.

AN IMPORTANT QUESTION GOES UNANSWERED

One of the first speakers at the PSM event was U.S. Representative Jim Matheson (D-UT), sponsor of H.R.3026, the “Safeguarding America’s Pharmaceuticals Act of 2011” which was introduced into the House of Representatives on September 22, 2011.  There are some differences, but the core of this new bill is basically the same as Continue reading Impact of RxUSA v. HHS On Future Pedigree Legislation →

Reimportation

Safe Prescription Drug Reimportation: An Oxymoron

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Every couple of years it seems that someone introduces a bill into the U.S. Congress that would one way or another legalize the reimportation of prescription drugs into the U.S. from other countries.  In December of 2009, right around the time that the Patient Protection and Affordable Care Act was being debated intensely Senator Byron Dorgan (D-ND) introduced a bill to do just that.

You may recall that there was a dustup about how Senator Barack Obama had introduced a similar bill only a few years before that, but now as President, he made a deal with the drug industry that supposedly assured that drug reimportation wouldn’t be added to the Healthcare Reform bill in exchange for the industry supporting the Reform bill.  Senator Dorgan’s bill did not pass but Healthcare Reform did (See Dr. Adam Fein’s coverage of the failure of Senator Dorgan’s bill, “Drug Importation: Dead Again”).

The reason I’m thinking about reimportation this week is that I came across an interesting document that was published last week by the Partnership for Safe Medicines (PSM) called “A Risky Proposition:  How Opening The U.S. To Foreign Medicines Poses A Risk To Chronically Ill Americans”, a second edition.  I’m not sure why it was released now—maybe someone is thinking about introducing another reimportation bill again (I guess it’s not Senator Dorgan anyway!)—but I have an opinion about the topic Continue reading Safe Prescription Drug Reimportation: An Oxymoron →

Anti-counterfeiting

Pharmaceutical Anti-Counterfeiting, A First-Rate New Resource

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Earlier this summer J. Wiley & Sons published a new book called “Pharmaceutical Anti-Counterfeiting, Combating the Real Danger from Fake Drugs” by Mark Davison, CEO of Blue Sphere Health, a pharmaceutical consultancy.  I pre-ordered it on Amazon.com in the spring and it was finally delivered in July.  You may have noticed the image and link I added to the left margin under “RxTrace Recommends” shortly after I started reading it.  The hardbound book is 400 pages, including the main text, notes, references, glossary and index, but it took me until now to finish reading it.  I’ve been so busy lately that I could only read a few pages at a time, that is until my vacation when I finally had time to sit down and read the whole book.

The book is broken up into five parts.  Part 1, General Themes, provides an in-depth examination of the problem of drug counterfeiting around the world including its formal definition, the origins, costs, risks, and the contrast (and controversy) between intellectual property and anti-counterfeiting.  In the last chapter of Part 1, Davison explains the difference between “Traceability” and “Authentication”.  He points out that the term “Traceability” is sometimes known as “digital authentication”, where the term “Authentication” by itself is usually used to Continue reading Pharmaceutical Anti-Counterfeiting, A First-Rate New Resource →

California Pedigree Law

California Board of Pharmacy Re-awaken

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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.For the first time in over two years the topic of pedigree appears on the agenda of the California Board of Pharmacy for their upcoming meeting on September 7.  Earlier this year in a presentation at the FDA Track & Trace Workshop Board Executive Office Virginia Herald mentioned that the Board would take up the topics of inference, drop shipments, decommissioning and linkage between shipping orders and invoices at a future meeting in 2011.  It’s hard to tell if those will be the actual topics discussed in next week’s meeting because they aren’t called out explicitly.  Here is the item as it actually appears on the agenda: Continue reading California Board of Pharmacy Re-awaken →

serialization

Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2011

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Last year at this time I started an annual estimate of the rise in the percentage of drugs in the U.S. supply chain that will have serial numbers attached.  Click here to read last year’s essay that explains the concept.  It’s not an estimate of the actual percentage today.  Rather, it’s a prediction of the rise from an immeasurably small percentage in early 2010 to 100% at some time in the future.  My plan is to revisit my prediction each year at this time to see how it is faring.  (click the drawing to enlarge it.)

Last year I said I would need to update my prediction if anything in the legal landscape changes.  Nothing has really changed in the last year that would lead me to change my prediction so here is my graph with no changes to the data over last year.  I have simply updated the year and placed an arrow on the X-axis to show the current point in time.

As I pointed out last year, it will be kind of hard to tell how well my prediction is doing if some authority with the means to measure the actual percentage doesn’t step up and make it public.  In the last 12 months no entity has stepped up to Continue reading Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2011 →

Heparin

Pew Prescription Project: After Heparin

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Last week the Pew Prescription Project, an arm of the Pew Charitable Trust, released a report on the risks of substandard and counterfeit drugs.  This is a meticulously researched report that will likely be used by legislators and regulators to better understand the problems and potential solutions of U.S. pharmaceutical supply chain security.  For this reason it is a must-read for anyone interested in the topics that RxTrace routinely explores.  You can get a copy of the full report PDF, view the associated webcast and graphic here:  After Heparin: Protecting Americans from the Risks of Substandard and Counterfeit Drugs.  I’ll have more to say about the webcast in a subsequent essay.

According to the “Introduction and Background”,

“The U.S. Congress, the U.S. Food and Drug Administration (FDA), the pharmaceutical industry and other organizations have renewed their commitments to remedy existing weaknesses.  This white paper seeks to inform these efforts by presenting a holistic picture of the pharmaceutical supply chain and its problems (illustrated by case studies), and to propose a set of meaningful reforms that will better protect patients.”

The report is 77 pages of text with 24 additional pages of references.  The text is peppered with numbered references for those who want more details on a particular topic.

There are three Chapters.

  1. Pharmaceutical Manufacturing:  Globalization and Quality Management
  2. Barriers to FDA Oversight
  3. Pharmaceutical Distribution

Chapter 1 contains Continue reading Pew Prescription Project: After Heparin →

supply chain security

Illegitimate Drugs In The U.S. Supply Chain: Needle In A Haystack

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West-African countries have been under attack by drug counterfeiting criminals for decades with little resistance until the last one.  The result, in 2002 Mohammed Yaro Budah, then president of the Pharmaceutical Society of Nigeria, estimated that 70% of the drugs in Nigeria were fake or substandard.  That’s an incredible figure, but starting around that time the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) under the direction of Professor Dora Akunyili began fighting back.

Initially they focused on inspecting drug imports at the Nigerian ports and airports and they were able to bring the percentage of fake or substandard drugs to come down considerably.  More recently they have begun employing a number of Raman Spectroscopy-based devices called TruScan (recently acquired by Thermo Scientific) to inspect drugs and anti-viral medicines being sold in pharmacies during “unscheduled” visits.

Even more recently, a number of pharma manufacturers have begun to add low cost scratch-off stickers to the drugs sold in Nigeria that cover a random number that can be scratched off and checked for authenticity by patients and healthcare professionals using SMS text message-based technology from Sproxil.  The service was launched in 2010 on a single product but that number is growing quickly as a number of large U.S.-based drug companies add the scratch-off stickers to their products.  The service is sponsored by NAFDAC.

WOULD THESE TECHNOLOGIES WORK IN THE U.S.?

That is, would these technologies help to reduce the number of illegitimate drugs in the U.S. supply chain? I believe that the answer is Continue reading Illegitimate Drugs In The U.S. Supply Chain: Needle In A Haystack →

Pedigree models

U.S. Pharma Supply Chain Complexity

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© 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 →