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.
Friday, November 21, 2008
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