Tag Archives: pharmaceutical supply chain

The Built-in Protections Of The U.S. Pharma Supply Chain

May 7, 2012 Dirk Rodgers 13 Comments

Last week we learned that 11 people were charged with the record-breaking $75 Million drug heist from the Eli Lilly warehouse in Enfield, Connecticut back in March of 2010 (see the excellent article by Jay Weaver in the Miami Herald, including a copy of one of the multiple indictments). Importantly, all of the stolen drugs from the Lilly warehouse were apparently recovered before they could be re-introduced into the legitimate supply chain. But this investigation and the charges go well beyond the infamous Lilly warehouse theft. They include other pharmaceutical, liquor, cigarette and cell phone cargo thefts around the country, allegedly perpetrated by members of the same criminal organization. Cracking this organization could end up disrupting the most prolific source of cargo theft in the United States over the last five years.

Congratulations are due to the law enforcement organizations who contributed to the investigation and to bringing the charges. They include DEA, ATF, FBI, U.S. Attorney of Florida, Miami-Dade Police Department, Florida Highway Patrol, U.S. Attorney of Illinois and U.S. Attorney of New Jersey.

This episode highlights one of the things I call the built-in protections of the U.S. pharmaceutical supply chain—the things that, combined, result in the U.S. having the safest supply chain in the world. In this case, it is strong and cooperative law enforcement organizations. While far from perfect, would you trade our system of justice, including law enforcement, with that of any other country in the world? I don’t think you would (unless you’re one of the Villa brothers or their associates!).

But what are the other components that result in the safest drug supply chain in the world? It’s certainly doesn’t occur by accident, so what are the built-in protections? Continue reading The Built-in Protections Of The U.S. Pharma Supply Chain →

WMS

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

April 30, 2012 Dirk Rodgers 2 Comments

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 →

FDA, standards

Should FDA Cede All Standards Development To GS1?

April 16, 2012 Dirk Rodgers 1 Comment

Back in 2007 the U.S. Congress passed the Food and Drug Administration Amendments Act (FDAAA) and it was signed into law by President Bush. One of the provisions of that law was an instruction to the FDA to “…develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs”, and “…develop standards for the identification, validation, authentication, and tracking and tracing of prescription drugs.”

The FDA fulfilled these instructions for one of the specific standards that the law identified when the agency published their Standardized Numerical Identifier (SNI) standard back in 2010. That standard was fairly high level and for the vast majority of drugs, use of GS1’s Serialized Global Trade Item Number (SGTIN) (or “GTIN plus serial number”) for drug package identification would comply with it. The text of the FDA’s standard says as much.

By defining the SNI in this way did the FDA surrender the development of the real SNI standard to GS1 (at least the sNDC portion of it)? I don’t think so. In my essay about the SNI standard I described it as the FDA “aligning” with GS1’s SGTIN (see my essay “FDA Aligns with GS1 SGTIN For SNDC”). Alignment shouldn’t be confused with surrender. The choice of alignment with SGTIN was good for the FDA, good for patients and good for the industry.

WHAT WE GOT WHEN THE FDA ALIGNED THEIR SNI STANDARD WITH GS1’S SGTIN TECHNICAL STANDARD

In the case of the SNI aligning with GS1’s SGTIN we got the following things: Continue reading Should FDA Cede All Standards Development To GS1? →

Pedigree models

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! →

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 →

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? →

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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