Pharmaceuticals Represent 5.5% of U.S. Cargo Thefts

As reported by FreightWatch International in its October 2009 Cargo Theft Report, pharmaceuticals represent 5.5% of all cargo thefts by commodity in the United States in a 12 month period from November 2008 to October 2009.

The 5.5% reflects a percentage of the number of cargo theft incidents by commodity not by dollar value. Given the high dollar value of pharmaceutical cargo loads it is estimated that pharmaceutical commodities represent a significant percentage of thefts by dollar.

Regarding cargo theft trends, Freightwatch quoted the following in the October 2009 report:

· Continuing the trend from the past several months, FreightWatch is seeing an increase in the number of thefts from terminal and carrier lots, as well as public access parking lots, and a decrease in the number of thefts from truck stops, which are traditionally where cargo theft is known to occur in the highest amounts volume.
· These trends coincide with intelligence reports and activity that show cargo thieves are becoming more proactive in targeting specific loads or products, conducting surveillance and stealing the loads at their first opportunity. Pre-loading and staging trailers, or dropping in lots prior to shipment, are prime theft opportunities being seized by cargo thieves.

It is anticipated that the trend of pharmaceutical commodities being specifically targeted will continue to increase in 2009.

FreightWatch International (USA), an international logistics security company, is expert in identifying threats and vulnerabilities to high-value supply and distribution chains. FreightWatch compiles a monthly, quarterly and annual report that lists cargo thefts by location and commodity.

To learn more about FreightWatch, visit their website at: http://www.freightwatchusa.com/.

To learn more about XStream Systems, supply chain security solutions that allows members of the supply chain to molecularly screen and authenticate their inventories, visit their website at: http://www.xstreamsystems.net/.

New England Journal Medicine: Multinational Medicines — Ensuring Drug Quality In an Era of Global Manufacturing

In the August 20, 2009 issue of the New England Journal of Medicine, Susan Okie, MD writes about the emerging health care issue regarding the quality of branded and generic drugs in the new era of a globalized pharmaceutical supply chain.

In this new global economic age, Dr. Okie describes the problem and proliferation of a major global health care epidemic due to quality control and fraudulent prescription medications that are manufactured overseas in countries with a poor record of quality processes. In the article Dr. Okie also writes about the challenge of regulation and oversight as many pharmaceutical manufacturers and providers move their supply chain overseas to make and procure medications.

One of the more disturbing examples of the potential danger of lack of quality oversight regards the super potency of Digitek in 2008:

"…FDA’s Adverse Event Reporting System (AERS) contains data on adverse reactions to medications in a self selected subgroup of an exposed population of unknown size. In April 2008, the FDA and Actavis Totowa, the manufacturer of Digitek, a widely prescribed generic digoxin, announced a nationwide recall of 800 million tablets, triggered by concern that double-thickness tablets containing twice the approved dose might have been released commercially. Between April and September 2008, AERS received reports of 2,912 serious injuries and 1,094 deaths associated with digoxin, about 80% of them linked to the recalled product. Thomas Moore and colleagues at the nonprofit Institute for Safe Medication Practices have called for systematic testing of the recalled tablets, commenting that “if many of these cases prove to be linked to manufacturing problems, then the nation has experienced a little noted drug disaster of major proportions.”

As have been reported in this blog for sometime the incidents of recalls related to lack of quality control and oversight connected to product production has spiked in the past several years and according to Dr. Okie may continue to increase due to the FDA’s lack of resources.

XStream Systems endorses the concept that both private industry and government regulatory agencies use technology such as XStream’s XT250 to screen, authenticate and verify the contents of products within the supply chain from point of production to the consumer. By using a material screening process, which verifies the material inside its unit-of-sale container, the entire supply chain mitigates its liability and ensures the consumer that the product is safe and efficacious. The current costs of the issue of poor quality medications within both the supply chain and the health care of the consumers, seems nearly impossible to effectively gauge or predict but it seems reasonable that whatever the price, the costs in both dollars and human suffering are far too high. Through proper verification within the supply chain, XStream feels that many of these incidents can be averted and the health care of the consumer protected.

To view Dr. Okie’s article in the August 20, 2009 issue of the New England Journal of Medicine, visit their website at: http://www.nejm.org/.

To learn more about XStream Systems verification technology, visit: http://www.xstreamsystems.net/.

Scales “Weigh In” and are Found Inadequate

By Brian Mayo, President and CEO, XStream Systems, Inc.

While analytical instruments work well in a forensic laboratory environment, the pharmaceutical industry is struggling to detect counterfeit medications throughout the distribution chain. Sophisticated analytical instruments typically require access to the exposed medications and a highly trained operator to interpret the results. But what about the warehouse worker handling sealed prescription medicine? How does he/she know if any counterfeit products have been received in the large shipments that have been received? The bottles cannot be opened, and the warehouse workers are clearly not trained well enough to operate the analyzers even if they could get access to the medicines inside the bottles.

Often times wholesalers, dispensers, and re-packagers settle for an inexpensive and fast solution: a scale that weighs the bottles. Bottles are simply checked by weighing them and verifying if the weight is proper. Unfortunately counterfeiters can and have been matching the weights contained within each prescription bottle. The industry is being lured into a false sense of security. Checks are being done along the way and everything appears ok. Only after passing through many hands and finally being opened does one discover the truth, that the contents inside are not what was expected. By that time, the counterfeiter is long gone and untraceable.

The war against counterfeits is always a cat and mouse game. As new methods of checking for counterfeits are created, new methods of avoiding it usually follow. Multiple protection measures may be required over time. Hopefully enough checkpoints are put into place to discourage counterfeiters, who then go off looking for easier prey elsewhere. Just take a close look at a $20 bill to see its layered checking methods such as the serial numbers, special inks, special paper, imbedded thread, holographic images, and fine print resolution. These have evolved over time, as the counterfeiting schemes became more sophisticated.

Unfortunately the pharmaceutical industry is now the easy prey. Here we are, in the 21st century, with many companies still relying on weighing bottles of drugs to protect the public against counterfeit drugs. Why? Well, for one thing when this was implemented, counterfeit drugs did not seem prevalent. Counterfeit drugs did not seem to be such a big problem. Now they are a $40B industry and growing rapidly. A second reason is that the right authentication technology has, until now, not been available.

The next phase of combating counterfeit drugs centers around three very important requirements.

1. There needs to be the ability to penetrate inside sealed bottles and packages to reveal what’s truly inside.

2. There needs to be an analytical tool that somehow determines exactly what the drug is, and not just simply how much it weighs.

3. The new method needs to be easily done by anyone, anywhere in the supply chain.
All three of these very important requirements are met by the XT250™ Material Identification System offered by XStream Systems. Any warehouse worker can rapidly and easily authenticate drugs inside sealed bottles, by automatically verifying the drug’s molecular structure.

The majority of counterfeit drugs detected so far by the XT250 system had previously passed the weighing test. This indicates that counterfeiters are well aware of the weighing process in the supply chain and successfully circumvented those checks. Now that the XT250 system is verifying the molecular structure of the drug, counterfeiters can only reproduce the actual drug to avoid detection by the XT250 system. The counterfeiter’s job just got a whole lot harder… Counterfeiters, it’s now your move.