Tag Archives: serialization

InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2012

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In August 2010 I started an annual estimate of the rise in the percentage of drugs in the U.S. supply chain that will have serial numbers attached.  Click here to read my first essay on the topic which explains the concept.  Click here to read my 2011 essay.  These are not estimates of the actual percentage today.  Rather, it is a prediction of the rise from an immeasurably small percentage in early 2010 to 100% at some time in the future.  My plan is to Continue reading InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2012

Who Will Decide Which Pedigree Model You Will Invest In?

[This essay is one of two long lost essays that have now been restored on RxTrace.  It was originally published on November 15, 2010.  See “Return Of Two Classics” for an explanation.]

In one of my most widely read essays, “RFID is DEAD…At Unit-Level in Pharma”, I pointed out that the choice of serial number carrier technology to be used for compliance with the California Pedigree Law would be decided solely by the pharmaceutical manufacturers.  I pointed out that most of them would end up choosing 2D barcodes because their ongoing costs for Radio Frequency IDentification (RFID) would be too high.

Since the law doesn’t specify a carrier technology, and because the manufacturers will foot the bill for whatever technology is used, naturally, they get to lead the supply chain in that choice.  If you don’t like what they are choosing, then please, step up and pay them to put your preferred carrier technology on their packages.  I’m sure the manufacturer’s would put whatever you want to pay for on their packages as long as it would comply with the law.

But what about the pedigree model that the supply chain will use for compliance?  Can we apply similar logic to determine who will get to choose the technology that defines what a compliant pedigree is?  Yes we can!  And here it is. Continue reading Who Will Decide Which Pedigree Model You Will Invest In?

The Serial Number Handling In Your WMS Probably Isn’t Sufficient For Pharma Serialization

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.Most Warehouse Management Systems (WMS) available on the market today do a fine job of allowing their users to manage inventories in the warehouses of drug manufacturers, distributors and chain drug stores.  A WMS is a software system that may be a part of a larger Enterprise Resource Planning (ERP) system, or it may be a third-party application that is interfaced with the owner’s ERP system.

All WMS systems that I am aware of are intended to be sold into multiple industries, not just in pharma.  That’s so that the WMS vendor can maximize their sales.  The more industries, the more sales and the more profitable it is.  Because some industries have long had serial numbers on some of their products (computers and peripheral equipment, cell phones, electronics, medical equipment, appliances, etc.) WMS vendors have included serial number handling in their software for decades.  In fact, I would bet that a serial number handling feature was included in WMS systems since the very beginning of that category of software.

However, buyers of WMS systems in the pharma supply chain should be very careful not to confuse a “serial number handling” or even “serialization” checkbox on the WMS vendor’s spec sheets with the kind of “serialization” they will need for compliance with modern pharma serialization regulations.  I include Continue reading The Serial Number Handling In Your WMS Probably Isn’t Sufficient For Pharma Serialization

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

California Enforcement Subcommittee Moves To Require 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.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

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?

The Surprise Consequence of the California Pedigree Law

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 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

How Counterfeit Avastin Penetrated the U.S. Supply Chain

Counterfeit Avastin

The internet lit up last week when the U.S. Food and Drug Administration (FDA) posted an announcement that they are aware of counterfeit Avastin in the U.S. pharmaceutical supply chain (see “Counterfeit Version of Avastin in U.S. Distribution” on the FDA website and Genentech’s announcement).

I found out about it when I received notice of Dr. Adam Fein’s (PhD) excellent blog posting “Greedy Physicians Invite Fake Avastin Into the Supply Chain” on his DrugChannels.net blog, but multiple national news agencies picked the story up and many articles were written about it.  Most simply reflected the contents in the FDA’s announcement.

But at least one news source seemed to do some additional investigating.  Bill Berkrot and John Acher of Reuters published the excellent article “Fake Avastin’s path to U.S. traced to Egypt” on Thursday.  In the article they provide a little more background on the path the drugs allegedly took before apparently arriving on the shelves of U.S. physicians and potentially in the bodies of unsuspecting U.S. patients.

And Pharmaceutical Commerce Online reports that Avastin isn’t the only incident of recent counterfeit injectable cancer drugs making it into the U.S. market that the FDA is currently investigating.

HOW COUNTERFEIT AVASTIN MADE IT INTO THE LEGITIMATE U.S. SUPPLY CHAIN

Now keep in mind, this is only investigative journalism so far, and while the information source listed in the Reuters article is the Danish Medicines Agency, criminal investigators may already know more than this and in the end, some or all of the contents of the Reuters article may eventually be found to be untrue.  Whether ultimately true or not Continue reading How Counterfeit Avastin Penetrated the U.S. Supply Chain