Last Friday was the five year anniversary of RxTrace and this is the 255th essay. I started RxTrace on July 4, 2009 as an outlet for ideas (see my very first essay, “Welcome to rxTrace”). The results of the last five years have been very rewarding.
Rather than looking back this year, let’s look to the future. What is coming next?
I always maintain a fairly informal RxTrace list of ideas I want to explore when I get the chance. With the switch in attention from the California pedigree law to the new Federal Drug Supply Chain Security Act (DSCSA) in the last year, my list grew pretty long and continues to grow. Here is a list of things I’ve been thinking about and may end up exploring in full RxTrace essays in the coming twelve months: Continue reading Five Years of Pharma Supply Chain Analysis→
Congress should have mandated randomization of drug serial numbers, but they did not, so it is up to each manufacturer to recognize the importance it would bring to the protection of their brands and of the supply chain. Let me explain.
In my last essay I touched on the use of Product Identifier Authentication, or PIA, as an alternative to the collection and distribution of aggregation data to allow wholesale distributors and repackagers to meet the verification requirements of the Drug Supply Chain Security Act (DSCSA). Starting in November of 2018 for repackagers and in November of 2019 for wholesalers, the DSCSA will require these companies to verify that the standardized numerical identifier (SNI)—commonly referred to as “the serial number”—corresponds with one that the manufacturer originally applied to drugs that are found to be suspect, and for any returned drug that will be resold.
As I pointed out in my previous essay (see “The Aggregation Hoax and PIA”), manufacturers and repackagers may be able to choose to pass on aggregation information that would allow wholesale distributors to meet their requirements, or they might choose to offer a PIA service that would allow these companies to check the authenticity of one or more SNIs via a web service. Continue reading Product Identifier Authentication (PIA)→
About 30 years ago Newsweek devoted an entire issue to the topic of Cancer. In the introduction to the issue they made the point that we will never see “a cure for cancer”, because, unlike many other diseases like heart, kidney, liver diseases and diabetes, cancer is actually a family of diseases. And the family is very diverse. While some cancers have known cures, others remain challenging. One important element toward developing a cure for a given type of cancer is to fully understand the conditions and processes that lead to its development, and that takes basic research. The kind that public and private universities do so well. Continue reading One Goal: End Cancer.→
About 3 years ago I published an essay called “U.S. Pharma Supply Chain Complexity” where I attempted to provide a more realistic understanding of the U.S. pharma supply chain than the typical supply chain drawing offers. That essay was aimed at helping the industry select an approach to meeting U.S. state pedigree laws, which are now preempted by the Drug Supply Chain Security Act (DSCSA). But, as with many of my older essays, the underlying ideas still have value despite preemption.
In this case, the ideas also provide a clear explanation for why pharma manufacturers should expect to meet the electronic data exchange requirements that are dictated by the large U.S. wholesale distributors, rather than attempting to get them to accept some alternate approach.
…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 RxTrace. The material contained in RxTrace is not legal advice. The writers of RxTrace are not lawyers. 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 RxTrace.
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