Category Archives: Inference

California’s Draft Inference Regulation

Thinking cardboard boxImportant 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.Yesterday I published an essay about the new discussion draft of a Federal track and trace regulation bill from the Senate HELP Committee.  It is definitely worth watching closely, but don’t let it take your eye off of the California regulations.  Those are real today and will move forward unless Congress and the President complete the enactment of a bill that preempts the California law.  That’s a long and uncertain road and the discussion draft released last week is only the first unofficial step.

Last week I wrote about the new draft regulation on certifications in California e-pedigrees.  In the same document—distributed by Joshua Room, Supervising Deputy Attorney General, California Department of Justice assigned to the California Board of Pharmacy, at the March 14, 2013 Enforcement Committee meeting (and converted to MS Word document form by me)—on page 3, you will find the draft regulation for the use of inference.  This draft regulation is Continue reading California’s Draft Inference Regulation

How Should Inference Work?

5 Boxes
Drawing by Jasmaine Mathews

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 wide-scale use of “inference” in the pharmaceutical supply chain is essential to the successful operation of a track & track or ePedigree system.  Companies cannot be expected to open every case they plan to ship, or that they receive, so that they can figure out exactly which package-level serial numbers are involved.  The use of the serial number packaging hierarchy, or, “Aggregation information”, to “infer” which packages are being shipped or received is the only way to maintain a level of supply chain efficiency that is close to pre-serialization levels.  On the other hand, regulator acceptance of the use of inference in the supply chain has the potential to complicate their investigation of criminals.

In recognition of its importance in maintaining efficiencies, the California legislature instructed the Board of Pharmacy to draw up rules that would allow companies to optionally make use of it (see my essay “Inference in the Pharmaceutical Supply Chain” for the exact text of the inference provisions of the California Business and Professions Code).  It leaves the important question about who Continue reading How Should Inference Work?

Pharma Aggregation: How Companies Are Achieving Perfection Today

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

Will The Pharma Supply Chain Be Able To Use Inference? Maybe Not!

In an essay published in April, I explained my theory that “RFID is DEAD…at Unit-level in Pharma”, which, if true, would mean that most drugs in the U.S. supply chain would be serialized by manufacturers with 2D barcodes by 2015 for California.  In my last essay, “Inference in the Pharmaceutical Supply Chain”, I carried that theory one step further by showing how the widespread reliance on 2D barcodes to serialize at the unit level would lead directly to the widespread use of the practice of inference in the supply chain.  This would be out of necessity since the unit-level serial numbers would not be readable without opening their containers, something that can’t happen because it is so inefficient that it would cripple the supply chain.  So let me say it this way, the widespread use of 2D barcodes for unit-level serialization will necessitate the widespread reliance on inference.  The former leads to the latter just like excessive sunshine leads to sunburn.

But the projections of widespread reliance on inference lead directly to a new concern.  Let me explain.  Successful use of inference for determining the contents of cases is totally dependent on the accuracy of the aggregation information established and provided by the manufacturer, or whoever packed them.  If a packer uses a casepacking process that is incapable of yielding highly accurate aggregation information, inference will not work well.

This is a problem.  A big problem, because Continue reading Will The Pharma Supply Chain Be Able To Use Inference? Maybe Not!

Inference in the Pharmaceutical Supply Chain

In my recent essay, “RFID is DEAD…at Unit-level in Pharma”, I used relative cost estimates to theorize that Radio Frequency IDentification (RFID) will not be the predominant carrier of serial numbers applied to drug packages for compliance with U.S. pedigree laws.  My theory is that there will actually be a mix of RFID and 2D barcodes, and that barcodes will be the predominant carrier technology.  As you might expect, that was a little controversial with the RFID industry (See RFID Journal’s blog post in response to my essay).  Hey, it’s just a theory.  I too, wish everything would be RFID, and for all of the reasons cited by RFID Journal.  It’s just that I don’t believe it’s going to turn out that way and that’s based on the logic I laid out in my essay.  (Also see FiercePharma Manufacturing’s more neutral post in response to my essay.)

BARCODES WILL PREDOMINATE.  LET’S MOVE ON…

In a mixed-but-predominantly-barcode-serialized U.S. pharmaceutical supply chain, companies will not be able to tell which unit serial numbers are inside of each sealed case at receiving or at shipping.  Because barcodes are a “line-of-sight” technology, the only way to tell with absolute certainty what the sealed-up unit serial numbers are will be to cut the tape seal, open the case, expose the barcodes, scan each unit and tape the case closed again.

It is a ridiculous notion to believe that Continue reading Inference in the Pharmaceutical Supply Chain