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 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
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.
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
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.
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.
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→
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→
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→
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
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. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.