Cdex, Inc. (fka CDEX)

[capnmike]

Is Your Pharmaceutical Supply Chain Safe?

http://www.pppmag.com/documents/V3N5/V3N5p2-4supplychain.pdf

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"The drug supply in the United States is probably among the safest in the world, but any counterfeit incident is a concern to us, so we want to make sure that the U.S. drug supply chain is as safe and secure as it can be," said Ilisa B.G. Bernstein, the FDA's director of pharmacy affairs.

ASD's RxSpec system, launched in late 2004, shines a light on a drug, developing a "near-infrared chemical fingerprint," chief executive Dave Rzasa said, and compares it to a known library of such prints to make sure they match.

The device currently is used by high-output pharmacies, including the Veterans Administration's Consolidated Mail Outpatient Pharmacies. But the company is also developing smaller systems for use in individual drugstores.

Drug verification, which some estimate could be a $2-billion industry, grew after a Kansas City case five years ago when a pharmacist confessed to diluting four chemotherapy drugs dispensed to 34 patients so he could pocket the difference. He later amended his count to include more than 60 diluted drugs, but FBI officials believe the count is much greater, affecting 98,000 prescriptions issued through 400 doctors to about 4,200 patients.

"The [counterfeit cases] we're identifying are the tip of the iceberg. I don't think anyone really knows how big the submerged part of the iceberg is," said Jerry Blair, vice president of marketing and sales for CDEX.

His company's ValiMed system, the first commercialized product for the 5-year-old business, works with drugs in liquid and solid form while ASD uses solids, like tablets, only at this point.

ValiMed beams a high-energy source through a drug, exciting its electrons and releasing photons, which then leave an individual "spectral signature" that the machine can read. The company hopes to find a customer base for it among border patrol agents, Homeland Security divisions and hospital pharmacists.

CDEX Chief Executive James O. Griffin conducted a demonstration for a reporter at his Rockville offices last month with what appeared to be a package of the anti-viral Tamiflu. At least that's what the box said.

Griffin mixed the drug in a liquid solution and popped it into a ValiMed prototype that looked like a typewriter case. A light flashed, a clicking noise ensued and seconds later a female voice announced: "Not validated." A stoplight graphic appeared on a screen for good measure.

"It's a very simple interface," said Griffin.

http://www.tmcnet.com/usubmit/2006/02/26/1407525.htm

www.cdex-inc.com/Exposing-deception.pdf

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"meth gun" site:thesopranos.com
http://www.google.com/search?num=100&hl=en&lr=&q=%22meth+gun%22+site%3Athesopranos.com&a...

"supply chain" site:ValiMed.com

http://www.google.com/search?hl=en&q=%22supply+chain%22+site%3AValiMed.com&btnG=Google+Searc...

[PDF] Patient Safety Insert 3.qxdFile Format: PDF/Adobe Acrobat - View as HTML
postulated that terrorists could attack our medication supply chain by ... supply chain: from the manufacturer to the wholesaler to the distributor to the ...

www.valimed.com/counterfeit_medications/Counterfeit_Insert.pdf

Counterfeit MedicationsThe ValiMed Counterfeit Medication Solution diminishes the risk of counterfeiting at any point in the supply chain: from the manufacturer to the wholesaler ...

www.valimed.com/counterfeit_medications/counterfeitmed.htm

"supply chain" site:cdex-inc.com
http://www.google.com/search?num=100&hl=en&lr=&q=%22supply+chain%22+site%3Acdex-inc.com&...

CDEX, Inc.Ultimately, it is vulnerabilities in the pharmaceutical supply chain that make it ... At its core, the medication supply chain is inherently complex, ...

www.cdex-inc.com/MDbill1190.html

[PDF] Exposing deceptionFile Format: PDF/Adobe Acrobat - View as HTML
drug supply chain is as safe and secure as it can be," said Ilisa BG Bernstein, the. FDA's director of pharmacy affairs. Matching up ...
www.cdex-inc.com/Exposing-deception.pdf

CDEX Testimony for the Maryland House of Delegates
House Bill 1190 Prescription Drug Safety Act

March 8, 2006

Counterfeit medications have been a worldwide problem for many years now. However, over the last several years, there has been a dramatic increase the number of known counterfeit medications found in the United States, and the problem is expected to grow significantly in the coming years if left unchecked. In other countries there are already alarming reports that more than 50 percent of medications are counterfeit, and the combined forces of Internet sales and a global economy now provide an efficient infrastructure for dramatically increasing illegal importation of these dangerous drugs into the U.S.

The economics of medications make them a prime target for criminals. The risk to reward ratio is very favorable to the criminal. When illicit drug traffickers can make a larger profit on counterfeiting prescription medications than they can with cocaine or heroin, and when the penalties if caught are merely trademark infringement violations, then it becomes abundantly clear that we will continue to see increases in this trend.

Ultimately, it is vulnerabilities in the pharmaceutical supply chain that make it possible for counterfeiters to get their products into the legitimate marketplace, and subsequently into the hospitals, pharmacies, homes, and bodies of U.S. consumers. At its core, the medication supply chain is inherently complex, and it is this complexity, which has evolved for any number of reasons, that has become the Achilles’ heel of our system.

In its simplest form, the supply chain would be a fairly straightforward, linear process with pharmaceuticals traveling from the manufacturer to the wholesaler to the retailer, and then the consumer. In reality, however, most pharmaceuticals only get to consumers after moving through a complex, multi-tiered distribution system involving primary wholesalers, secondary wholesalers, distributors, and very often yet another level of wholesalers. This layering of ownership, repeated transportation and warehousing provides an easy entry for counterfeits into the supply chain.

Some proposed solutions to the problem have included: mandating a less complex supply chain; introducing stronger, counterfeit-proof packaging; and better monitoring of documentation (paper pedigree, electronic pedigree). Unfortunately, all of these solutions have significant drawbacks. Pedigrees and packaging can be counterfeited more readily than the medications themselves. Over time, criminals have developed ever more sophisticated ways to forge manuscripts, copy documents, hack computer files, duplicate holograms, and in time, even RFID chips will be hacked.

Costs are also a very real deterrent to implementation of these solutions. While manufacturers have a legitimate financial incentive to protect their brands and reduce liabilities, the distribution system sits mainly outside of their direct control. Wholesalers operate on very narrow margins, and cost increases could devastate their business. Finally, retail pharmacy profits are mainly dictated by third party insurance plans, making it difficult to build in new costs.

However, there is a financially realistic and technologically feasible method for identifying counterfeit medications and ensuring the safety of U.S. consumers. That method is product authentication, and it is being implemented today in some locations.

Product authentication can be accomplished in two ways: 1) by adding a taggant—a unique, traceable substance-- to the product itself. This does require manufacturers to change the formulation of their products, which takes time, or; 2) authentication of the chemical formulation of the product as is. This requires no change to the manufacturing process, and can be performed in a test that takes seconds using affordable, tabletop validation devices, or field portable units. A layperson could be trained on use of the system in less than an hour.

Of course, the affordability of any solution is a major concern. The good news is that validation testing of a medication’s chemical formulation can be implemented today without costly changes, and actually provides the highest level of security possible (again, by actually testing the authenticity of the product itself, not just the packaging). Not only do manufacturers approve of this type of testing, since it does not require changes to the original chemical formulations, it is affordable for wholesalers, distributors, pharmacies, and hospitals as well.

Using technology currently on the market, random validation testing of batches or shipments (comprising a multitude of individual doses) could cost as little as $15 per random test, and as the volume of testing increases, costs would decrease as well. In other words, a single $15 dollar test could be used to expose thousands of doses of counterfeit medication that would have otherwise endangered the lives of untold numbers of Marylanders. This is a small price to pay for the health and security of the citizens of this state.

Ultimately, a total solution to this problem may require a clever combination of all of the solutions mentioned, but the key to public safety now is to begin testing the products in the supply chain prior to dispensing to the patient.

Public policy should include random product authentication in the state’s licensure process for medication wholesalers and retailers. This would be a simple addition to the existing policies which are enforced by the Maryland State Board of Pharmacy.

Respectfully Submitted by:

Jerry Blair, R. Ph., MBA
Vice President, Sales and Marketing
CDEX Inc.
1700 Rockville Pike
Suite 400
Rockville, MD

301-881-0080

See FDA Testimony link below:

http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/110603/03n-0361-c000012-vol3.pdf


http://www.cdex-inc.com/MDbill1190.html