InBrief: ePedigree Models and Points of Failure

April 10, 2012 Dirk Rodgers 3 Comments

Over the last year in GS1, in many of the members of the U.S. pharma supply chain and even in the FDA, the focus has turned to the analysis and discussion of three classes of electronic pedigree models:

Fully Centralized,
Semi-Centralized, and
Fully Distributed.

I’ve discussed some of the pros and cons of these models here in RxTrace too (see “The Viability of Global Track & Trace Models”, “Should Regulations Dictate Technology?”, and “Could This Be Your Future Track & Trace/ePedigree Exchange Solution?”).

One of the characteristics included in many of these discussions is the “points of failure” of each model. For example, I’ve heard it said several times that the Fully Centralized model suffers from a “single point of failure”, with the implication being that Fully Distributed models do not have this problem. In fact, this is incorrect and in reality, both the Fully and Semi-Centralized models are much less likely to fail than models that fall within the Fully Distributed category when “failure” is defined as not being able to provide an ePedigree on demand in any given instance.

RELIABILITY ENGINEERING OF COMPLEX SYSTEMS

Wikipedia has a pretty good article on Reliability Engineering so I’ll spare you the background of the discipline that studies points of failure. The mistake people sometimes make Continue reading InBrief: ePedigree Models and Points of Failure →

Pedigree models, standards, Uncategorized

GS1 Standards – Betcha Can’t Use Just One!

April 2, 2012 Dirk Rodgers 3 Comments

The title is a paraphrase of a TV commercial from the 1960’s, ’70’s and ’80’s for Lay’s Potato Chips but the sentiment is the same. You really can’t get away with using only a single GS1 standard. That’s why they are sometimes referred to as “The GS1 System of Standards“. It’s a “system” of standards. Multiple standards that are designed to work for you together in concert; as a whole; not independently.

So when your customer demands that you make use of Global Location Numbers (GLN) and/or Global Trade Item Number (GTIN), they are starting you down the path of adoption of much more than just those two “entry-level” standards (see my essay “So a customer demands that you use GLN’s and GTIN’s. What next?”). Here is a partial list of other GS1 standards that you may benefit from adopting once you fully embrace GLN and GTIN: Continue reading GS1 Standards – Betcha Can’t Use Just One! →

Federal Pedigree

InBrief: FDA To Publish Track & Trace Standard By Year End

March 28, 2012 Dirk Rodgers

I stumbled across the FDA’s recently published “Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2012” while surfing the PharmTech website late last week. The guide is published each year in the spring to provide a “heads-up” on which guidance documents the FDA thinks they will be able to complete and publish by the end of the calendar year.

I first learned about the significance of the annual document about 18 months ago when an FDA official explained it in a conference presentation. In response to a question from the audience about when she thought the FDA would publish the Track & Trace (T&T) standard for pharmaceuticals, she recommended that people watch for a notice of it in the “Guidance Agenda…” each year. She said Continue reading InBrief: FDA To Publish Track & Trace Standard By Year End →

Aggregation, Inference

Pharma Aggregation: How Companies Are Achieving Perfection Today

March 26, 2012 Dirk Rodgers 7 Comments

Bottle ID photo courtesy of Optel Vision

One of the biggest challenges for companies in the U.S. pharmaceutical supply chain when the California pedigree law becomes operational after December 31, 2014 will be the need to maximize the efficiency of dealing with serial numbers on each drug package. One way to do that is to maximize the use of “inference” where the case serial number is read and the unit package-level serial numbers are “inferred” from the unit-to-case aggregation information supplied by the upstream trading partner (See my essays “Inference in the Pharmaceutical Supply Chain” and “Will The Pharma Supply Chain Be Able To Use Inference? Maybe Not!”).

But the problem with the use of inference is that you need to be able to rely on the accuracy of the aggregation information that your supplier provides to you. There is an element of trust in that—not just that you trust your supplier to be truthful with you but that you trust that your supplier’s case packing processes and systems will always accurately capture and document the unit-to-case hierarchy—or “aggregation”. You must be able to trust that the aggregation information your supplier provides to you will be 100% accurate. That’s a lot of trust. Continue reading Pharma Aggregation: How Companies Are Achieving Perfection Today →

California Pedigree Law

California Enforcement Subcommittee Moves To Require FDA SNI

March 23, 2012 Dirk Rodgers 2 Comments

During the California Board of Pharmacy, Enforcement Subcommittee meeting on Wednesday the members voted unanimously to recommend to the full board the approval of a regulation that would require the use of the Food and Drug Administration’s (FDA) Standardized Numerical Identifier (SNI) as the unique identifier that is required on all drugs packages as part of their pedigree law. That law currently requires pharmaceutical manufacturers to apply unique identifiers to 50% of all their prescription drug packages by January 1, 2015 and the remainder by January 1, 2016.

The approved text reads as follows: Continue reading California Enforcement Subcommittee Moves To Require FDA SNI →

Federal Pedigree

What If RxTEC Isn’t Adopted?

March 19, 2012 Dirk Rodgers 5 Comments

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? →

Advertising

The Abrupt Surge of Interest in Serialization and ePedigree Topics

March 12, 2012 Dirk Rodgers 3 Comments

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 →

California Pedigree Law, Florida Pedigree Law

The Surprise Consequence of the California Pedigree Law

March 5, 2012 Dirk Rodgers 10 Comments

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

That will be a big change, even outside of California. Here are some of the things I think we will see happen: Continue reading The Surprise Consequence of the California Pedigree Law →

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