Anti-Counterfeiting: Thinking Inside the Box

The Autumn 2009 issue of Pharmaceutical Manufacturer and Packing Sourcer (PMPS) features an editorial article written by XStream Systems’ Senior Vice President, Alan Clock.

The editorial piece discusses analyzes the various segments of anti-counterfeiting technology and introducing EDXRD and material screening as a robust tool in combating counterfeit, adulterated and fraudulent medications within the global supply chain.

The phrase, “Thinking Inside the Box” refers to EDXRD’s capability to screen and authenticate materials inside their sealed, unit-of-sale containers without destroying or degrading the materials. This unique solution allows all members of the pharmaceutical supply chain to efficiently, accurately and inexpensively test and screen product to ensure that their inventories are safe and efficacious.

Here is an excerpt from the article:

Today, the various members of the pharmaceutical supply chain find themselves in an expanding global marketplace and in the midst of an ever growing epidemic that threatens each relevant party. As globalization increases, so too does the risk of counterfeit, substandard or fraudulent medications within the supply chain. This increase in risk threatens both the economic and physical health of the pharmaceutical industry and its consumers. Here are a few staggering statistics related to this scourge:

• The World Health Organization (WHO) conservatively estimates that counterfeit medications will be a $75 billion global industry in 2010.
• The WHO projects the annual growth of counterfeit medications to be between 12 and 16 per cent annually, worldwide.
• According to the WHO, more than 2,000 children in Africa alone die each day as a result of taking counterfeit medications.
• The WHO reports that, across the world, 10 per cent of pharmaceuticals are counterfeit, fraudulent or adulterated. Proliferation and percentages are much higher in developing countries in Asia, Africa and South America, with up to 50 per cent of the supply chain projected to be identified as counterfeit or adulterated.

TRACK AND TRACE

To date, nearly all of the solutions for this global epidemic emphasize what are known as ‘track and trace’ methods (such as barcodes, holograms, RFID, pedigree, taggants and serialization). These solutions are primarily based on traditional technology for inventory control and security and are common within most sophisticated supply chains. They are incredibly effective in tracking products, especially in direct or short supply chains, where the additional cost can be justified in their inventory control capabilities because the members of the supply chain use common systems and tools for tracking, distribution and sales. However, track and trace solutions have their limitations. They generally require some sort of addition to the outside of the box or package, and a common technology to be read and documented. These processes and technologies add further cost to the product and are difficult to maintain across large global supply chains. In addition, because of its external placement, the track and trace item may be easily replicated, and it does not verify that the material inside the package is safe and efficacious.

To read the complete article either visit PMPS at www.samedanltd.com/magazine/15/issue/122/article/2531 or visit XStream Systems website at www.xstreamsystems.net.

Recent Adulteration of Heparin Drives Newly Proposed USP Standards

This month the U.S. Pharmacopeia (USP) proposed a second revision to their standards for the blood thinner, Heparin. This measure is to increase patient safety particularly because adulterated heparin resulted in the reported deaths of more than 200 patients worldwide in 2007 - 2008.

Most standards tests are generated to ensure manufacture quality and not equipped to look at unknown contaminants that may be added deliberately—as was the case with heparin. In the recent heparin recall the drug was adulterated with over-sulfated chondroitin sulfate and was not detected by current methods available then.

While we applaud the USP for answering this new threat to our citizen’s health, it does indicate that our pharmaceutical security measures need to be more proactive rather than reactive. Current science now offers methods to scan products to alert the user of unknown contaminants through the use of EDXRD technology. For more information on this revolutionary solution, visit: www.xstreamsystems.net.

To read more on the proposed USP revisions visit: http://www.usp.org/pdf/EN/aboutUSP/heparinStatement.pdf

For more information on specific changes to the monograph standards, visit www.usp.org or contact mediarelations@usp.org.

Obama and McCain Both Support Drug Re-Importation

As the 2008 Presidential Campaign heads into its inevitable heated conclusion and the individual campaigns separate themselves on the issues, it may be time to reflect briefly on an issue that both Barrack Obama and John McCain seem to be in agreement.

Both Barrack Obama and John McCain have publically stated their support of drug re-importation as a way to curb the high price of pharmaceuticals.

Given this seemingly rare consensus it is important to realize that there is a significant possibility that drug re-importation may become a reality once the new administration comes into power.

There are certainly many pros and cons to the issue and many reasons why there is significant support for this stance by both candidates. It is important however to understand the considerable danger that re-importation magnifies if it becomes law.

As we all know by now, the issue of counterfeit, adulterated and contaminated drugs has been proliferating both domestically and globally dramatically in recent years. To date the United States has little in the way of regulations or solutions in place to adequately protect the domestic pharmaceutical supply chain from this threat, outside of weak state pedigree laws which attempt to track the transaction of drugs from the manufacturer to the drug store.

If the re-importation of drugs becomes a reality, the potential threat of even more counterfeit, adulterated and contaminated medications reaching the American consumer will automatically triple given the supply chain’s inability to adequately track and authenticate the actual contents of the medication.

This is where XStream Systems technology can save the day. XStream’s XT250 system has the ability to authenticate and verify the contents of a sealed container in a non-destructive manner. Authenticating the contents of the imported pharmaceuticals will be critical in making certain that pharmaceuticals imported from other countries are clinically safe and efficacious.

Please visit XStream Systems website at www.xstreamsystems.net for more information on this technology.

Track and Trace versus Inspection and Authentication Technologies?

In a comparison of Track and Trace versus Inspection and Authentication technologies it is apparent that Track and Trace solutions such as RFID, bar coding, holograms, tracing and pedigree products are not a one-size-fits-all solution to protecting the domestic and global pharmaceutical supply chain.

Track and Trace products might be sufficient, when employed throughout the Supply Chain to protect it from Drug Diversion which is one source of counterfeit activity, but these Track and Trace technologies cannot provide full protection for the product within the package. For example, how can anyone expect a Track and Trace product to determine if, either in the manufacturing or distribution process, the wrong ingredient was purposely or accidentally added into the product? Pedigree or Serialization may help, after a threat has propagated to the general public and was detected by other means, to help backtrack to the source of the problem. But by then it may be too late and the consumer will have already suffered.…

Only through the use of Inspection and Authentication technology such as XStream Systems’ XT250 Pharmaceutical Authentication System can those within the drug supply chain immediately inspect and authenticate the product within the container. Don’t let problems reach the general public. Stop the issues in their tracks.

For more information on XStream Systems and the XT250™ Pharmaceutical Authentication System, visit their website at www.xstreamsystems.net.