It’s time to think about what is likely to happen in 2016 with regard to pharma serialization and traceability. As part of that, let me remind you right off the top to fill out the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz. You don’t have to be a subscriber to respond and the results will also be open to everyone in the coming months.
I would be willing to bet that almost every regular reader of RxTrace knows who Bob Celeste is, and most of you have probably already heard that he is ending his long tenure with GS1 US. Last fall that organization announced that Bob would continue into the new year as a consultant, and shortly after that, he would transition his GS1 Healthcare US work group facilitation work to others. Bob reminded everyone on his weekly industry calls of that schedule about two weeks ago and by the end of this month he will no longer fill that role.
I often write about the fact that drug manufacturers and repackagers that sell into the U.S. market must put “serial numbers”, or “serialize” their drug packages and homogeneous cases before November 27, 2017, but what exactly does that mean?
The term ‘product identifier’ means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.” (Section 581[14])
It is pretty clear that there is not much interest in the use of Radio Frequency IDentification (RFID) in the pharmaceutical supply chain because every time I publish an essay in RxTrace about some aspect of it, there is a drop in readership. So at the risk of taking another hit in readership, let’s take a look at the case against the use of RFID in the pharma supply chain.
Back in 2010 I published an essay that really rattled my friends in the RFID vendor community (see “RFID is DEAD…at Unit-Level in Pharma”). Since that essay was published, the two or three drug companies that were previously shipping drugs with package-level RFID tags on them have ended that practice, replacing the RFID tags with 2D barcodes. This includes Purdue Pharma and Pfizer, the two flag carriers for RFID in pharma back in the late 2000s Continue reading The Case Against RFID In Pharma→
Over the next two weeks I have a very special treat for RxTrace readers. It is an interview with Ken Traub, GS1 standards expert and independent consultant. The subject is GS1 serial number randomization, something so important that I think pharma companies ought to give deep thought to it before they turn on their serial number applications.
Pharma manufacturer who sell into the E.U. and/or Brazil markets will be forced to randomize their serial numbers because of regulatory requirements, but even those who only sell into the U.S. market should strongly consider randomization. I’ll have more to say about why in a follow-up essay after this series is over.
Because the interview with Ken covers the topic so thoroughly, it is long. That’s good, because it provides readers with an easy to understand explanation of everything they need to know about randomizing. But it also makes for a very long essay, so I have broken the interview down into five RxTrace essays. Read sequentially, they contain the complete interview. The subtopics covered by those essays include:Continue reading Randomization—An Interview with Ken Traub—Part 1: GS1 Serial Number Considerations→
Let’s take a brief pause from our in-the-moment work on meeting today’s healthcare supply chain security needs and consider what the supply chain will look like in the future. Because of regulations and laws enacted in 2012 and 2013 in the U.S., and expected in 2014 in the E.U., we know more today about how healthcare supply chain security will work In 2024 than looking forward in any previous 10 year period. In the last two years the U.S. and the E.U. have enacted legislation and introduced regulations that will have a profound impact on the security of these major supply chains in ten years. These include:
To be honest, I was somewhat surprised when Jay Crowley announced during last week’s UDI Conference that the U.S. FDA had published the final rules for Unique Device Identification (UDI). Its publication starts the clock on a host of new requirements designed to identify most medical devices in the U.S. market with the same standard approach. That is expected to result in the reduction of errors made by medical professionals and also increase the accuracy and efficiency of the supply chain. I’ve become a little jaded about healthcare Automatic Identification and Data Capture (AIDC) deadlines lately and so the fact that one actually happened caught me slightly off-guard. Of course, UDI was Continue reading UDI And The Approaching End Of The NDC→
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
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