If your email inbox is anything like mine it has recently been swamped with articles and webinar notices about the possible use of blockchain technology to solve multiple challenges in healthcare. I recently attended a very interesting day-long workshop on that very topic.
So is blockchain a real solution, or is it just the latest over-hyped buzzword that is being promoted by people who don’t understand the real needs of healthcare companies? I’ll tell you what I think. But first, a little background.
Blockchain technology is a way of encapsulating information within a layer of structured data that multiple parties can use as the basis for trust in the accuracy of the source of that information. It’s all about adding trust to information that is shared between parties. Trust is just one of the many Continue reading Could Blockchain Technology Be Used For DSCSA Compliance?
Drug manufacturers, contract manufacturers (CMOs) and contract packagers (CPOs) are all working hard right now preparing to meet the November 27, 2017 deadline when all prescription drugs entering the U.S. market must contain the new machine- and human-readable product identifier defined in the Drug Supply Chain Security Act (DSCSA) (see “The DSCSA Product Identifier On Drug Packages“). The date for repackagers is one year later (see “Who Is A DSCSA Repackager?”). From what I hear around the industry, some companies are going to make that date, but some will not. What will happen next for those how are not ready? I discussed this from a regulator perspective last year in one of my personal favorite essays, “An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?”, but what about from the perspective of those who will be late? Continue reading How Will The DSCSA Serialization Mandate Be Enforced After 2017?
One of the problems with trying to respond overnight to big announcements made by regulators is that it’s easy to leave something significant out. And in the ensuing days you find out what you should have included in those original essays. That’s what happened with my two essays from last week: “Brazil Suspends Pharma Serialization And Tracing Requirements” and “FDA Posts Wholesale Distributor and 3PL License Database“.
So let me add a few more thoughts and observations regarding Continue reading More Thoughts On FDA and ANVISA
It’s August and that means it is time to check in on the progress toward full serialization of drugs in the U.S. supply chain. This is an annual look I’ve been doing for five years now. For my previous essays, see:
In each essay I produced a graph of my own personal estimate Continue reading Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2015
I wrote this essay on Vendor Managed Inventory (VMI) back in 2013 which was aimed at what would likely happen to VMI under the California pedigree law (see “Vendor Managed Inventory Under California ePedigree”). But even though that law is now obsolete (see “The California Pedigree Law Is Now Officially Inoperative“), surprise, some of the same issues crop up when VMI is performed under the DSCSA. So I converted the original essay to speak to VMI under the DSCSA. I think you will agree, it is still pertinent…
One of the complexities of the modern pharmaceutical supply chain occurs when a pharmaceutical dispensing organization “outsources” the management of their on-premises inventory to their supplier, or “vendor”. This is known as Vendor Managed Inventory, or VMI. There are several Continue reading Vendor Managed Inventory Under the DSCSA
In Brazil, the National Agency of Sanitary Surveillance (ANVISA) has built their pharma serialization regulation around GS1 standards. They embrace the GS1 Datamatrix and GS1-128, both encoded with GS1 Application Identifiers (AI) and using GS1 Human Readable Interpretation (HRI) (see my previous essay, “The ANVISA Unique Medicine Identifier (IUM) on Drug Packages”, for my thoughts on HRI), the GS1 Global Trade Item Number (GTIN) and the GS1 Serial Shipping Container Code (SSCC) to be specific. But there is one GS1 standard they steer clear of: the GS1 serial number. Why is that? Continue reading Why Does ANVISA Embrace GS1 Standards, Except The Serial Number?
Last week I announced the availability of the 2015 RxTrace U.S. Pharma Traceability Survey Results that are sponsored by Frequentz. You should download a free copy of the report here. This week I want to look at another interesting finding taken directly from the report. It shows that progress is being made by drug manufacturers, repackagers and CMO/CPOs toward meeting the 2017 (2018 for repackagers) deadline for adding serial numbers to the drug packages they produce for the U.S. market. That requirement comes from the Drug Supply Chain Security Act (DSCSA) enacted in November of 2013.
One of the many questions we asked Continue reading Progress Toward Serialization!?