The Abrupt Surge of Interest in Serialization and ePedigree Topics

I’ve been tracking the number of pageviews of RxTrace for the last two years and I can report to you that I have recently observed a fairly abrupt rise of those numbers that I describe as a “surge” when compared with the previous trend.  The surge I am seeing started in November (discounting December when the holidays interfere with readership stats) and continues to this day.  I have seen a comparable surge of the number of new subscription requests for RxTrace.

What is the cause of this development?  I have a theory which I will share with you.  With this essay I am also announcing that I have formalized an RxTrace advertising program to enable companies to advertise their events, products and services unobtrusively in the margins.  More about that in a minute, but first, here is a graph of the relative number of pageviews each month for the last two years. Continue reading The Abrupt Surge of Interest in Serialization and ePedigree Topics

The Surprise Consequence of the California Pedigree Law

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.The California pedigree law will have a surprising influence on how the pharmaceutical supply chain operates in another state.  I’ll get to that in a minute, but first, the law will change some things about the way the supply chain operates in all states.  Prescription drug manufacturers who want to continue offering their products to patients within California after 2015-2016 must add unique serial numbers to each drug package and start an electronic drug pedigree.

California is the only state that requires both of those things but most manufacturers are forced to treat the California state law as if it applies nationwide.  That’s because most drug manufacturers sell through distributors in the United States and so they have no way of knowing which drug package will end up being shipped into California and which ones will not.  Voila!  Pharma manufacturers end up having to serialize and create a pedigree for every single package that enters the U.S. supply chain.

This almost certain outcome will likely affect the full nationwide supply chain in a couple of interesting ways.

AFTER 2015:  ALL DRUGS IN THE U.S. SUPPLY CHAIN ARE SERIALIZED AND PEDIGREED BY THE MANUFACTURER

That will be a big change, even outside of California.  Here are some of the things I think we will see happen: Continue reading The Surprise Consequence of the California Pedigree Law

Will the FDA Accept RFID for Drug Identification?

It has been almost two years since I published “RFID is DEAD…at Unit-Level in Pharma” and we are approaching a pivotal decision by the Food and Drug Administration (FDA) that will determine whether or not RFID will be acceptable for identifying drugs in the U.S. supply chain.  Last Thursday was the scheduled final closing of the recent request for comment issued by the FDA formally known as “Bar Code Technologies for Drugs and Biological Products; Retrospective Review Under Executive Order 13563; Request for Comments, 76 Fed. Reg. 66,235” (Oct. 26, 2011) [Docket No. FDA-2011-N-0719].

The closing of this request for comment (RFC) means that it is now time for the FDA to figure out what they might do with the original questions.  That is, should they change the requirement for all packages of prescription drugs and many over-the-counter (OTC) drugs in the U.S. to contain the National Drug Code (NDC) encoded into a linear barcode?  And if so, what should they replace it with?  The RFC doesn’t give any hints about how far they might go and simply asks a series of questions of the industry and interested parties, letting the respondents propose whatever they think the agency should do.

I have spent my Sunday afternoon reading (OK, in some instances, skimming) through all of the responses.  They are available for anyone to read (or skim) at http://www.regulations.gov (search for FDA-2011-N-0719).  Considering that the input received from this RFC may influence the FDA’s decision about what to replace the linear barcode requirement with, I think Continue reading Will the FDA Accept RFID for Drug Identification?

How Counterfeit Avastin Penetrated the U.S. Supply Chain

Counterfeit Avastin

The internet lit up last week when the U.S. Food and Drug Administration (FDA) posted an announcement that they are aware of counterfeit Avastin in the U.S. pharmaceutical supply chain (see “Counterfeit Version of Avastin in U.S. Distribution” on the FDA website and Genentech’s announcement).

I found out about it when I received notice of Dr. Adam Fein’s (PhD) excellent blog posting “Greedy Physicians Invite Fake Avastin Into the Supply Chain” on his DrugChannels.net blog, but multiple national news agencies picked the story up and many articles were written about it.  Most simply reflected the contents in the FDA’s announcement.

But at least one news source seemed to do some additional investigating.  Bill Berkrot and John Acher of Reuters published the excellent article “Fake Avastin’s path to U.S. traced to Egypt” on Thursday.  In the article they provide a little more background on the path the drugs allegedly took before apparently arriving on the shelves of U.S. physicians and potentially in the bodies of unsuspecting U.S. patients.

And Pharmaceutical Commerce Online reports that Avastin isn’t the only incident of recent counterfeit injectable cancer drugs making it into the U.S. market that the FDA is currently investigating.

HOW COUNTERFEIT AVASTIN MADE IT INTO THE LEGITIMATE U.S. SUPPLY CHAIN

Now keep in mind, this is only investigative journalism so far, and while the information source listed in the Reuters article is the Danish Medicines Agency, criminal investigators may already know more than this and in the end, some or all of the contents of the Reuters article may eventually be found to be untrue.  Whether ultimately true or not Continue reading How Counterfeit Avastin Penetrated the U.S. Supply Chain

Why NOW Is The Time To Move Away From Linear Barcodes

Linear barcodes have served us well for almost half a century, but NOW is the time to move on to something else in the global pharmaceutical supply chain.  I think most people already agree with that but I’m not sure everyone fully appreciates exactly why that is.  It’s important to fully understand the reason why so that your resolution to move away from linear barcodes is strong and you won’t drag your feet or look back.  So let me show you.

                      SERIALIZATION
THE DAWN OF ^ CIVILIZATION

No matter what you might think is going to happen to ePedigree or track & trace regulations going forward, more and more governments around the world are concluding that legitimate pharmaceuticals should come with unique identifiers—serial numbers—attached to them by the manufacturers and repackagers.

Serialization is upon us and I believe that in 10 years the ongoing benefits from it around the globe will significantly exceed the ongoing costs.  Whether you agree to the benefits or not you certainly must accede to the fact that Continue reading Why NOW Is The Time To Move Away From Linear Barcodes

Repackaging Drugs Under A Serialization Regulation

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.The California ePedigree law goes into effect for manufacturers in 2015/2016.  In mid-2016 distributors and repackagers will need to comply.  The California pedigree law includes the need for manufacturers and repackagers to serialize drugs at the smallest level of distribution to pharmacies.  That’s just one of the requirements, they also need to make reference to those serial numbers in the ePedigrees that they create (manufacturers) or update (repackagers, distributors and pharmacies).  (For more on the full pedigree regulation see my essays “The California Pedigree Law” and “California Pedigree Law:  Historic Change To Commerce”).  The implications of this to repackagers are unique.  Let’s explore why. Continue reading Repackaging Drugs Under A Serialization Regulation

Anatomy Of An FDA SNI

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.The U.S. Food and Drug Administration (FDA) published their “Standardized Numerical Identification (SNI) for Prescription Drug Packages – Final Guidance” document almost two years ago (see my essay “FDA Aligns with GS1 SGTIN For SNDC” from back then).  The guidance was published as purely non-binding recommendations that reflected the Agency’s current thinking, but in my opinion it is a nice piece of work and can be used as a practical guide, as far as it goes, for implementing drug serialization programs today.

Why is that?  It’s because drug manufacturers and repackagers need to serialize all of their prescription drugs that enter the state of California in 2015/2016.  Can those companies make use of the FDA’s SNI guidance to comply with the serialization requirements of the California Pedigree Law?  I will answer that question in this essay, but first Continue reading Anatomy Of An FDA SNI

Depicting An NDC Within A GTIN

In recent essays I have covered the “Anatomy of an NDC”, the “Anatomy of a GTIN” and the “Updated HDMA Bar Code Guidance: A Must Read“.  Now let’s put them all together.  Why would we need to do that?  Because the U.S. FDA requires many Over-The-Counter (OTC) and all prescription drugs marketed in the United States to have their National Drug Code (NDC) presented in the form of a linear barcode on the package.  Pure and simple.  To do that in a way that your trading partners can understand—that is, to do it interoperably—you need to follow a standard.  You have two realistic choices for standard approaches to this problem:  HIBCC or GS1.

The use of HIBCC standards is fairly common in the U.S. medical surgical devices supply chain but in the pharmaceutical supply chain it is very rare.  Most companies choose GS1’s barcode standards so that’s all I’m going to focus on in this essay.  If you want more information Continue reading Depicting An NDC Within A GTIN

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DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer.
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