Tag Archives: SNI

What If RxTEC Isn’t Adopted?

I did not participate in the development of the Pharmaceutical Traceability Enhancement Code (RxTEC), a proposed Congressional bill that was created by the industry lobbying group known as the Pharmaceutical Distribution Security Alliance (PDSA).  In fact, while I was aware that a group had been formed last year I wasn’t aware that they were working on drafting an actual proposed bill until their discussion draft (dated February 27, 2012) appeared on the internet about 10 days ago.  I first saw it on Ed Silverman’s Pharmalot blog.

I also saw a presentation by one of the members of the PDSA last week that touched on the RxTEC proposal.  It was characterized as a “stepping-stone” to full traceability in the U.S. supply chain someday down the road.  In other words, the PDSA apparently means that their RxTEC proposal isn’t the final destination but it is only the first step toward that ideal.  At least, that’s how I interpreted that “stepping-stone” comment.

PLATEAUS OF SECURITY

Now this is a concept that is familiar to me.  In fact, as an idea stripped of all of the RxTEC-specific details, it is identical to the idea beneath the approach I proposed in a pair of RxTrace essays last May and June called “Plateaus of Pharma Supply Chain Security” and “SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach”.

This single underlying idea originates, on both accounts, from the fact that the amount of illegitimate activities within the U.S. supply chain is really quite small compared with the rest of the world (see my essay, “Illegitimate Drugs In The U.S. Supply Chain: Needle In A Haystack”), and to reduce it further will take Continue reading What If RxTEC Isn’t Adopted?

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

Should Regulations Dictate Technology?

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.In the U.S. pharmaceutical supply chain this question becomes, should regulators—state legislatures, state Boards of Pharmacies, Congress or the FDA—mandate specific technology for serialization, ePedigree and other regulations?  This question arises whenever a new regulation is considered by any of these bodies or agencies.  It’s an important question now that the FDA is considering standards for ePedigree, Track & Trace and related things and I think there are some natural conclusions that can be drawn from past examples that lead to a potential answer.  Let’s review the history first.

EXAMPLE:  EXISTING ePEDIGREE LAWS

The language of the U.S. Prescription Drug Marketing Act (PDMA) specified the kind of data that must be in a compliant pedigree but it did not identify any particular technology to carry that information.  Of course, compared with today, what kind of technology was available back in 1987 when the PDMA was first introduced in the U.S. House of Representatives?  Is it a paper pedigree?  Can it be electronic?  What is the format?  Can GS1’s Drug Pedigree Messaging Standard (DPMS) be used to comply? Continue reading Should Regulations Dictate Technology?

SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach

I recently published an essay on RxTrace called “Plateaus of Pharma Supply Chain Security” in which I proposed that a better timeline for the introduction of technology to secure the U.S. pharmaceutical supply chain was one based on plateaus.  Each succeeding plateau would add the adoption of new technology and/or data communications among the participants in the supply chain with the intent of elevating the security over the previous plateau.

In that essay I included illustrative dates for each of the four plateaus that I offered as an example of the concept, but you could easily imagine the overall program having open-ended dates that would allow the supply chain to adopt one plateau at a time and move to the next plateau only if/when a security problem is discovered at the current plateau.  That is, jump to the next plateau only when necessary.  Taking this approach, you may never actually need to get to the later plateaus.

For example, imagine that the first plateau were for manufacturers to serialize all drugs at the pharmacy-saleable package level (what I normally call “unit-level”) with an FDA Standardized Numeric Identifier (SNI) and all supply chain owners of drugs were to read the SNI’s and simply keep records of who they bought them from and who they sold them to.

With no data communications between trading partners that includes the SNI’s it might seem that little
security has been gained over what is done today.  But this small step (“small” compared to a full pedigree or track & trace system) would allow criminal Continue reading SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach

Plateaus of Pharma Supply Chain Security

One of the most recent improvements that California made to their drug pedigree law was to spread out the compliance dates by supply chain segment.   Previously, all segments had to comply with the regulation by January 2011.   Now drug manufacturers will need to comply with half of the products (or sales) by January 2015 and the remainder one year later, distributors must comply by mid-2016 and the pharmacies by mid-2017.   As I understand it, this spread was intended to help the industry fully prepare for the new requirements in their businesses.   Companies would now have time to adjust to the changes implemented by their upstream trading partners according to their earlier deadlines.

This staggered start pleased a lot of people—particularly distributors and pharmacies.   However, to me, the staggered start of the current California regulation doesn’t address the issue of complexity very well and a different kind of ramp up to full operation would be more practical and have better odds for success.

I discussed complexity in my last essay, “U.S. Pharma Supply Chain Complexity”.   I tried to show what it is about the supply chain that leads to difficulty in the setup and execution of a drug pedigree system.   On its own, the U.S. pharma supply chain is naturally complex.   A truly workable and protective pedigree system needs to deal with that natural complexity without exploding in its own complexity and cost.   As I pointed out in that essay, the problem with the more popular pedigree models (like DPMS and the various distributed pedigree models) is the large number of the point-to-point data connections that are necessary to reflect the natural complexity of the supply chain.   That adds a lot of complexity.

THE PLATEAUS OF SECURITY

No matter which model the industry implements, starting it up will have its own complexities.   In my view, regulators and industry should Continue reading Plateaus of Pharma Supply Chain Security

U.S. Pharma Supply Chain Complexity

© Copyright 2011 Duncan Champney. used with Permission. This image was created with FractalWorks, a high performance fractal renderer for Macintosh computers. FractalWorks is available on the Mac App Store.
© Copyright 2011 Duncan Champney. used with Permission. This image was created with FractalWorks, a high performance fractal renderer for Macintosh computers. FractalWorks is available on the Mac App Store (Click on image).

The debate over pedigree regulatory models in the U.S. pharmaceutical supply chain often centers around how much data for each package of drugs needs to be moved between trading partners as those drugs move down the supply chain from the manufacturer to distributor(s) and ultimately to the pharmacy.  The ideal model would minimize the amount of data moved yet always allow each member of the supply chain to check the prior history—the pedigree—of the drugs they are about to buy.

At a superficial level this appears to be all you need to do, but when you take a closer at the details of how the supply chain actually works in the U.S. you will see that there are other characteristics besides data volume per package that need to be considered.

FOUR VIEWS OF THE U.S. SUPPLY CHAIN

In the debates and discussions over pedigree regulatory models we are used to seeing a view of the supply chain that shows one manufacturer, one distributor and one pharmacy.  That view masks so much important complexity that if we were to select a regulatory model or solution based on that view it would be far from ideal.

Here is a view of the supply chain where the vertical scale shows something closer to the true proportions between those three segments. Continue reading U.S. Pharma Supply Chain Complexity