Tag Archives: Katherine Eban

Pew Prescription Project: After Heparin

Last week the Pew Prescription Project, an arm of the Pew Charitable Trust, released a report on the risks of substandard and counterfeit drugs.  This is a meticulously researched report that will likely be used by legislators and regulators to better understand the problems and potential solutions of U.S. pharmaceutical supply chain security.  For this reason it is a must-read for anyone interested in the topics that RxTrace routinely explores.  You can get a copy of the full report PDF, view the associated webcast and graphic here:  After Heparin: Protecting Americans from the Risks of Substandard and Counterfeit Drugs.  I’ll have more to say about the webcast in a subsequent essay.

According to the “Introduction and Background”,

“The U.S. Congress, the U.S. Food and Drug Administration (FDA), the pharmaceutical industry and other organizations have renewed their commitments to remedy existing weaknesses.  This white paper seeks to inform these efforts by presenting a holistic picture of the pharmaceutical supply chain and its problems (illustrated by case studies), and to propose a set of meaningful reforms that will better protect patients.”

The report is 77 pages of text with 24 additional pages of references.  The text is peppered with numbered references for those who want more details on a particular topic.

There are three Chapters.

  1. Pharmaceutical Manufacturing:  Globalization and Quality Management
  2. Barriers to FDA Oversight
  3. Pharmaceutical Distribution

Chapter 1 contains Continue reading Pew Prescription Project: After Heparin

Illegitimate Drugs In The U.S. Supply Chain: Needle In A Haystack

West-African countries have been under attack by drug counterfeiting criminals for decades with little resistance until the last one.  The result, in 2002 Mohammed Yaro Budah, then president of the Pharmaceutical Society of Nigeria, estimated that 70% of the drugs in Nigeria were fake or substandard.  That’s an incredible figure, but starting around that time the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) under the direction of Professor Dora Akunyili began fighting back.

Initially they focused on inspecting drug imports at the Nigerian ports and airports and they were able to bring the percentage of fake or substandard drugs to come down considerably.  More recently they have begun employing a number of Raman Spectroscopy-based devices called TruScan (recently acquired by Thermo Scientific) to inspect drugs and anti-viral medicines being sold in pharmacies during “unscheduled” visits.

Even more recently, a number of pharma manufacturers have begun to add low cost scratch-off stickers to the drugs sold in Nigeria that cover a random number that can be scratched off and checked for authenticity by patients and healthcare professionals using SMS text message-based technology from Sproxil.  The service was launched in 2010 on a single product but that number is growing quickly as a number of large U.S.-based drug companies add the scratch-off stickers to their productsThe service is sponsored by NAFDAC.

WOULD THESE TECHNOLOGIES WORK IN THE U.S.?

That is, would these technologies help to reduce the number of illegitimate drugs in the U.S. supply chain? I believe that the answer is Continue reading Illegitimate Drugs In The U.S. Supply Chain: Needle In A Haystack

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

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

Lessons from “Drug Theft Goes Big”

If you are a regular reader of RxTrace but you still haven’t read Fortune Magazine’s recent article, “Drug Theft Goes Big” by Katherine Eban, then I suggest that you stop reading this essay right now and spend the next 15 minutes absorbing her article carefully.  And then return here for my analysis.  It’s that good and that important.

Many of you will remember Katherine Eban as the author of the excellent book “Dangerous Doses, A True Story of Cops, Counterfeiters and the Contamination of America’s Drug Supply”.  See my comments on the book here where I point out that a lot has changed since the events that are documented so well in the book.

The new Fortune article is a great update on what drug supply chain criminals have been up to since “Dangerous Doses” was published back in 2005.  The greatest thing about the article is Continue reading Lessons from “Drug Theft Goes Big”

Dangerous Doses

If you have chosen to read this blog but you still haven’t read Dangerous Doses by Katherine Eban, you have made the wrong choice. The book is a great read. It documents the events in the early 2000’s that led the State of Florida to pass the first state pedigree law in 2003. You can draw a straight line between those events and all of the state pedigree laws that came after it. The book is a detailed accounting of crimes that occurred after a few criminals realized that law enforcement and the courts would not take seriously any drug crime that did not involve illegal drugs. But a small group of detectives and a lone prosecutor took them on and eventually brought them to justice. The book alternates between narratives of the crimes, the pursuit of the criminals by the detectives, and Eban’s explanation of how the pharmaceutical supply chain worked back at that time.

But that’s just it. The book was written at a time when things were different than they are now in some very important ways. As I understand it, back then, you could have spent less money on a license to distribute pharmaceuticals than you would if you obtained a license to open a bar. As a consequence, there were thousands of drug wholesalers licensed in Florida. But in 2003 the state toughened its licensing laws, greatly increased the cost of the licenses and increased the penalties for crimes related to wholesale distribution of pharmaceuticals. The HDMA cataloged the significant changes to Florida’s drug distribution regulations as the result of those changes. The number of licensed wholesalers plummeted to only a few hundred in the following years.

Oh, and they passed a pedigree requirement too.

I have to admit that I don’t have a good window into what exactly is going on in the Florida crime scene today but given the heightened awareness in the press of counterfeiting and diversion stories, I have to think that there is not nearly the problem that there was back in 2002, or we would hear about it.

So that pedigree requirement really worked, right? Maybe, but I have to think that the increased licensing fees and other requirements, the increased penalties and the increased interest by the courts are the things that really caused criminals to think twice about getting into that business.

Dangerous Doses is a great book and I still highly recommend it to anyone, especially those like me, who are responsible for working on pedigree, serialization and track & trace systems for companies in the supply chain. But as you read it try to keep in mind, that era doesn’t exist anymore. Since that time many other states have taken comparable steps to strengthen their licensing and toughen penalties. And many of them have also passed some type of pedigree law. Stay tuned for more about some of those laws in later posts.

Do drugs still get counterfeited and sold in the U.S.? Probably, but the criminal activity seems to have moved from the supply chain to the internet where criminals can hide just across the borders. Check your spam folder for the evidence.