Tag Archives: wholesaler

Congressional Legislation Development: Mad Libs Edition!

October 29, 2012 Dirk Rodgers 3 Comments

I’ve now finished studying the latest Congressional Discussion Draft to Improve Drug Distribution Security. As promised last Thursday, here is my analysis. Overall I’d say it is a very serious attempt to develop a raw text that everyone can agree on.

But the only reason everyone can agree on it is that there are literally hundreds of multiple-choice options (they call them “policy choices”) built in–kind of like Mad Libs. Anyone can use a marker to go through and cross out all the choices that they don’t like and they would end up with a bill that their constituency would probably accept. The problem is Continue reading Congressional Legislation Development: Mad Libs Edition! →

Drug recalls

We Should Be Ashamed Of The U.S. Approach To Pharma Recalls

October 22, 2012 Dirk Rodgers 5 Comments

That’s right. We should all be ashamed of the way our supply chain handles drug recalls and we should do something about it. I will explain, but first, what is a drug recall?

Today, when the manufacturer decides that a recall is necessary—either on their own or through a request by the FDA—they issue a recall for it. The FDA website is a great resource for learning about what a recall is (see “What is a recall?”, and “FDA 101: Product Recalls – From First Alert to Effectiveness Checks” and their recalls homepage at “Drug Recalls”).

Recalls can be issued for a number of reasons including Continue reading We Should Be Ashamed Of The U.S. Approach To Pharma Recalls →

crimes

InBrief: Pharma Supply Chain Criminals Get Justice

September 24, 2012 Dirk Rodgers 1 Comment

Two weeks ago, confessed pharma supply chain criminal William Rodriguez of South Florida was sentenced to 10 years of prison time, and then two years of supervised release. He was also required to hand over $55 million, which represents the proceeds from his crimes.

What was his crime? He was the person who ran the licensed wholesale drug distribution company formerly in South Carolina, Ocean Pharmed, that bought the Novo Nordisk insulin that was stolen in a cargo theft back in 2009. In his plea, Rodriguez admitted that all of the drugs that Ocean had sold into the supply chain had been obtained from unlicensed or otherwise illegitimate sources, like the stolen insulin.

This is the story that was so well documented by Katherine Eban in her excellent March 2011 article, “Drug Theft Goes Big” in Fortune Magazine online, and which I discussed in my essay “Lessons from ‘Drug Theft Goes Big’” and further Continue reading InBrief: Pharma Supply Chain Criminals Get Justice →

California Pedigree Law

Who Will Decide Which Pedigree Model You Will Invest In?

July 30, 2012 Dirk Rodgers 5 Comments

[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? →

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 laws

Do We Even Need To Mandate Drug Pedigrees Anymore?

December 6, 2010 Dirk Rodgers 2 Comments

pedigree drag — Drawing by Zsuzsanna Kilian

A CHALLENGE TO THE CURRENT CONVENTIONAL WISDOM

Currently well over half of the U.S. states have a drug pedigree law of some kind either on the books, in the process of being enacted or proposed in their legislature. No two laws are exactly the same. That fact is quite painful for the national participants in the supply chain and it gets a little worse every time a new law is enacted or a change is made to an existing law. For this reason, the conventional wisdom among many supply chain participants, industry organizations, solution providers, and even the regulators themselves is that a nationwide pedigree law would be better than 50 different local laws.

Many of these entities are in favor of replacing those state laws with one administered by the U.S. Food and Drug Administration (FDA). I don’t challenge that. In this essay, I’m challenging the very need for any U.S. pedigree requirement at all. Let me explain. Continue reading Do We Even Need To Mandate Drug Pedigrees Anymore? →

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 →

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 →

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