Tag Archives: pedigree

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

June 6, 2011 Dirk Rodgers 1 Comment

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 products. The 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 →

Industry Adoption

Plateaus of Pharma Supply Chain Security

May 31, 2011 Dirk Rodgers 6 Comments

One of the most recent improvements that California made to their drug pedigree law was to spread out the compliance dates by supply chain segment. Previously, all segments had to comply with the regulation by January 2011. Now drug manufacturers will need to comply with half of the products (or sales) by January 2015 and the remainder one year later, distributors must comply by mid-2016 and the pharmacies by mid-2017. As I understand it, this spread was intended to help the industry fully prepare for the new requirements in their businesses. Companies would now have time to adjust to the changes implemented by their upstream trading partners according to their earlier deadlines.

This staggered start pleased a lot of people—particularly distributors and pharmacies. However, to me, the staggered start of the current California regulation doesn’t address the issue of complexity very well and a different kind of ramp up to full operation would be more practical and have better odds for success.

I discussed complexity in my last essay, “U.S. Pharma Supply Chain Complexity”. I tried to show what it is about the supply chain that leads to difficulty in the setup and execution of a drug pedigree system. On its own, the U.S. pharma supply chain is naturally complex. A truly workable and protective pedigree system needs to deal with that natural complexity without exploding in its own complexity and cost. As I pointed out in that essay, the problem with the more popular pedigree models (like DPMS and the various distributed pedigree models) is the large number of the point-to-point data connections that are necessary to reflect the natural complexity of the supply chain. That adds a lot of complexity.

THE PLATEAUS OF SECURITY

No matter which model the industry implements, starting it up will have its own complexities. In my view, regulators and industry should Continue reading Plateaus of Pharma Supply Chain Security →

Pedigree models

U.S. Pharma Supply Chain Complexity

May 23, 2011 Dirk Rodgers 8 Comments

© Copyright 2011 Duncan Champney. used with Permission. This image was created with FractalWorks, a high performance fractal renderer for Macintosh computers. FractalWorks is available on the Mac App Store. — © Copyright 2011 Duncan Champney. used with Permission. This image was created with FractalWorks, a high performance fractal renderer for Macintosh computers. FractalWorks is available on the Mac App Store (Click on image).

The debate over pedigree regulatory models in the U.S. pharmaceutical supply chain often centers around how much data for each package of drugs needs to be moved between trading partners as those drugs move down the supply chain from the manufacturer to distributor(s) and ultimately to the pharmacy. The ideal model would minimize the amount of data moved yet always allow each member of the supply chain to check the prior history—the pedigree—of the drugs they are about to buy.

At a superficial level this appears to be all you need to do, but when you take a closer at the details of how the supply chain actually works in the U.S. you will see that there are other characteristics besides data volume per package that need to be considered.

FOUR VIEWS OF THE U.S. SUPPLY CHAIN

In the debates and discussions over pedigree regulatory models we are used to seeing a view of the supply chain that shows one manufacturer, one distributor and one pharmacy. That view masks so much important complexity that if we were to select a regulatory model or solution based on that view it would be far from ideal.

Here is a view of the supply chain where the vertical scale shows something closer to the true proportions between those three segments. Continue reading U.S. Pharma Supply Chain Complexity →

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 →

cargo theft, pedigree

Lessons from “Drug Theft Goes Big”

April 19, 2011 Dirk Rodgers 5 Comments

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” →

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 →

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 →

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance