Tag Archives: California Pedigree Law

pharmaceutical supply chain, stolen insulin

Reliance on Trust in the U.S. Pharma Supply Chain

April 26, 2011 Dirk Rodgers 7 Comments

Trust plays a big role in today’s U.S. pharmaceutical supply chain. Patients trust that their doctors know what they are doing when they prescribe a medicine and they trust their pharmacist to fill their prescriptions with real medicines that were:

manufactured to tight quality specifications,
are well within the expiration date,
have not been tampered with,
have always been kept within recommended environmental tolerances,
and have been in the control of companies who have a strong interest in supply chain integrity and in the safety of the drugs within the supply chain.

When we receive our little amber bottles of repackaged drugs from our pharmacist, we aren’t given any way to check on any of those things ourselves. We trust that the pharmacy has done something to ensure all that. And fortunately in the U.S., we are almost always justified in that trust. We enjoy the safest supply chain in the world.

A WHOLE LOT O’ TRUSTIN’ GOIN’ ON

But, now if the pharmacy doesn’t get the drugs directly from the manufacturer, they trust that their wholesaler will supply them with drugs that have those characteristics too. And if the pharmacy’s wholesaler doesn’t get the drugs directly from the manufacturer, they trust that their wholesaler’s wholesaler provides them with drugs like that too. And if the pharmacy’s wholesaler’s wholesaler doesn’t get the drugs directly from the manufacturer, they trust that Continue reading Reliance on Trust in the U.S. Pharma Supply Chain →

pedigree certification, security

Electronic Message Security and More on Certifications

January 24, 2011 Dirk Rodgers

Digital electronic messages can be transmitted from one party to another using a wide range of communications technologies. Today, businesses that make use of the internet to transmit their business messages to and from their trading partners make use of standards-based Electronic Data Interchange (EDI) message formatting.

EDI messages are typically transmitted point-to-point, from one business to one other business. There are a large number of EDI message types defined but in the pharmaceutical supply chain the most common messages are purchase orders, purchase order acknowledgments, invoices and advance shipment notices (ASN’s). (While I have the chance, I’d like to point out that ASN’s are not pedigrees for multiple reasons that I will not cover in this essay.)

In the U.S. pharma supply chain AS2 is the most common communications protocol in use for EDI message exchange. AS2 provides generalized message security to ensure that the messages cannot be understood or tampered with by unauthorized parties during movement from sender to recipient. According to Wikipedia, these are achieved through the use of digital certificates and encryption. Messages can optionally be digitally signed by the sender to provide non-repudiation within the AS2 payload context.

Electronic pedigrees as defined by the states of Florida and California are messages that contain fairly complex legal documentation which describe the chain of custody or ownership of a given package of drugs, but they also contain several types of legally required certifications. Continue reading Electronic Message Security and More on Certifications →

Digital Signatures

Certifications In A California-Compliant Drug Pedigree

October 26, 2010 Dirk Rodgers 7 Comments

I’ve been involved in a number of conversations lately that included differing opinions about what will be necessary to “certify” a drug pedigree in California after their pedigree law goes into effect (2015-2017, depending on your role in the supply chain). It’s a contentious issue, especially for those who wish that a distributed pedigree model would comply.

The California Law is fairly clear that the pedigree must contain, “A certification under penalty of perjury from a responsible party of the source of the dangerous drug that the information contained in the pedigree is true and accurate.” And that, among a list of other things, it must include “…the name and address of each person certifying delivery or receipt of the dangerous drug.”

In the California language, a “dangerous drug” is Continue reading Certifications In A California-Compliant Drug Pedigree →

GS1 Healthcare US

Before You Participate in The GS1 US 2015 Readiness Program, Read This

October 4, 2010 Dirk Rodgers 2 Comments

GS1 US is dedicated to expanding the adoption of GS1 Global’s standards for supply chain interaction in the U.S. market. Almost every country in the world has a GS1 “Member Organization” (M.O.) that is dedicated to the same thing within their borders. With the local M.O.’s primary focus on driving adoption, their most valuable tool is that country’s government. If they can get the government to reference GS1 standards in their laws, their work is much easier.

This isn’t unique to GS1, or course. All standards organizations know this and they all have various approaches to getting the attention of each country’s government. There is nothing wrong with this. In fact, it makes perfect sense since, unlike standards organizations themselves, countries always have very large enforcement wings.

But what happens when those governments are too big to sway easily? What if it costs too much and takes too long to get them to see the light? This is when a standards adoption organization needs to get creative. In my opinion, that’s what has led GS1 Healthcare US to create the “2015 Readiness Program”. It was out of frustration with the California State Government and with the U.S. Food and Drug Administration (FDA) and their, so far, unwillingness to create laws and regulations that mandate the use of GS1 standards. Let me explain. Continue reading Before You Participate in The GS1 US 2015 Readiness Program, Read This →

serialization

Estimated Rise In Serialized Drugs In The U.S. Supply Chain

August 3, 2010 Dirk Rodgers 4 Comments

Back in 2005 I created a line graph of my personal prediction of the percentage of pharmaceuticals in the U.S. supply chain that would be unit-level serialized by the manufacturer and I circulated it among my co-workers at the time. I based it purely on guesses that were “supported”–very flimsily–by the number of large pharmaceutical manufacturers who were participating in the GS1 EPCglobal Healthcare and Life Sciences (HLS) Business Action Group (BAG) (the group is now defunct), and the existence of an early version of the California Pedigree Law. The graph included a high and low line that formed a band that I thought would be where the reality would fall. In that prediction I didn’t think most manufacturers would achieve 100% serialization of their products until sometime between 2010 (high) and 2015 (low).

In my analysis at that time, I theorized that the actual percentage would start out following my “low” estimate line, but at some unpredictable point, something would happen that would cause the percentage to jump up to the “high” estimate line. At the time, I assumed the event that would cause that jump would be the U.S. Federal government issuing some kind of pedigree regulation that included a unit-level serialization requirement.

As it turned out, things moved slower than I had guessed. Here it is 2010 and the percentage of drugs in the supply chain with unit-level serial numbers on them is so small that it’s tough to give it a percentage. But I think my estimate from way back in 2005 was not bad for its time (but notice I’m not publishing the actual graph). After all, the California Pedigree deadline has been pushed out at least three times since then (from 2007 to 2009, to 2011, to 2015/1016).

I think the future is a little less murky now because, since 2005, Continue reading Estimated Rise In Serialized Drugs In The U.S. Supply Chain →

Normal Distribution

The “Normal Distribution” Concept

June 21, 2010 Dirk Rodgers

Understanding the concept of “Normal Distribution” is important in understanding the status of pedigree regulations in the United States pharmaceutical supply chain. The term itself didn’t exist back in the late 1980’s when the federal Prescription Drug Marketing Act (PDMA) pedigree provisions were originally enacted by Congress but the concept is built into that law as the “Authorized Distributor of Record” (ADR) concept. When states began enacting their own pedigree legislation back in the early 2000’s, the term “normal distribution channel” was defined to describe the path of drugs when they move through the most common–or “normal”–sequence of supply chain owners. It’s a concept that is explicitly defined in most state pedigree legislation.

When a pedigree law is a “normal distribution” law, it generally means that pedigrees are not needed for any shipment or change of ownership where the drugs do not leave this common/typical/normal path as defined in the law. But as soon as a change of ownership or custody occurs where the drug leaves this “normal” path, a pedigree is then necessary.

Typically, when a pedigree is required outside the “normal distribution channel”, that pedigree must Continue reading The “Normal Distribution” Concept →

California Pedigree Law

California Pedigree Law: Historic Change to Commerce

June 14, 2010 Dirk Rodgers 7 Comments

“…[C]ommencing on July 1, 2016, a wholesaler or repackager may not sell, trade, or transfer a [prescription] drug at wholesale without providing a pedigree.

…[C]ommencing on July 1, 2016, a wholesaler or repackager may not acquire a [prescription] drug without receiving a pedigree.

…[C]ommencing on July 1, 2017, a pharmacy may not sell, trade, or transfer a [prescription] drug at wholesale without providing a pedigree.

…[C]ommencing on July 1, 2017, a pharmacy may not acquire a [prescription] drug without receiving a pedigree.”

With these words the State of California introduced a significant change to the way the pharmaceutical supply chain works (see section 4163 of the California Business and Professions Code) and has written a new page in the history of commerce. It brings pharmaceutical commerce fully into the computer age. Adam Smith would not recognize it. Today, and up to the effective dates of these provisions, the value of a legitimate pharmaceutical in the legitimate U.S. supply chain is determined by the physical condition of the product and its package. After July 1, 2016, the value of a legitimate pharmaceutical in the supply chain in California will be determined by the combination of the physical condition of the product and its package, and the sellers ability to provide the buyer with an electronic pedigree.

The intended effect of this new regulatory requirement is to place a significant roadblock in front of counterfeiters, diverters and others who would try to scam patients and the legitimate participants in the supply chain. This is a noble cause. By requiring sellers to provide buyers with a pedigree at each change in ownership in the supply chain, illegitimate parties will find it very hard to inject illegitimate drugs without exposing their actions and, at the same time, creating evidence that can be used against them in their own prosecution. By providing a pedigree at each change in ownership, supply chain buyers will be able to check the authenticity of the full supply chain transaction history provided by the seller, maximizing the likelihood that any suspicious activity would be detected long before a patient would receive the drugs.

But I’m more interested today in exploring a surprising unintended effect of these requirements. I’ve touched on this briefly in past essays but I’ve recently concluded that the implications of these requirements are much more significant than I realized before. This may be the first time in the history of commerce that Continue reading California Pedigree Law: Historic Change to Commerce →

Inference

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

June 7, 2010 Dirk Rodgers 13 Comments

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! →

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