Friday, February 29, 2008

Opinion: Recent Rx Recalls

It seems like in the past several months, a day does not go by when there is a report published in nearly every media outlet regarding globally produced products being recalled due to issues with their raw materials or their production. In many cases these products contain toxic or life threatening substances that cause a major health risk to the consumer.

Keep in mind that we in the US continue to increase our dependence upon foreign manufacture of everything from dog food to pharmaceuticals. In 2008 nearly 80% of the raw materials used in the manufacture of all pharmaceuticals consumed in the US will come from overseas.

These recalls are especially serious when these products involve consumables such as food products and pharmaceuticals that are ingested and often times will continue to be consumed or administered over a period of time with no immediate side effects until a serious health concern is apparent.

Two recent recalls are especially relevant to the Team at XStream Systems because we as a company feel that if our XT250 system was in place, we would have detected the issue before it threatened the well being of the public at large.
  • In November 2007, Ranbaxy had a recall within the US of nearly 73 million doses of its 600mg and 800mg Gabapentin. According to Ranbaxy which produces pharmaceuticals for export world wide in India, certain lots of Gabapentin showed "impurities" outside of the approved limits. Originally it was reported that Ranbaxy either had difficulties with the raw materials or in finished goods of this product.
  • The recent saga of Baxter's recent recall of all of its Heparin products. As of today it is reported that there have been over 448 adverse reactions, 21 possible related deaths to the product. Nearly 1 million doses of Heparin are sold in one month in the US. Nearly half of these doses are produced overseas and sold by Baxter. The cause of the difficulties with the Baxter Heparin apparently is being blamed on the raw materials that were used in its production.

Unfortunately these two examples only represent a fraction of the tainted, counterfeited or adulterated consumable products that are exported into the US on a daily basis.

This is especially relevant to XStream given the fact that our technology has the capability to be deployed in pre-production raw materials testing, in-production quality assurance, post-production quality control and in random distribution channel testing. The XT250's ability to be deployed on-site and be operated within seconds by non-technical resources make it the perfect technology in the collective effort to secure our Global Pharmaceutical Supply Chain.

As we have talked about before, most of the mainstream pharmaceutical manufacturers, distributors and regulatory agencies seem fixated on securing the Global Pharmaceutical Supply Chain through pedigrees, RFID tags and 2D bar codes, none of which would have or could have discovered the issues with these two particular pharmaceutical entities. Only the XT250, which has the ability to penetrate and look inside sealed packaging would have detected that there were issues with the material that made up the product.

Here's hoping that we at XStream continue to make headway in our efforts to deploy our products in pharmaceutical manufacturing, distribution and in regulatory agencies so that the instances of these tainted products reaching the consumer become less and less an issue.

We at XStream are committed to making the Global Supply Chain Safe and making certain that our partners pharmaceutical inventories are Detected-Protected and Connected.

XSI to Exhibit at Pittcon- Booth #2215

XSI will be displaying the XT250 technology at Pittcon 2008, Booth #2215, March 3 – 6, 2008. If you are planning to attend the Pittcon 2008 Expo, please stop by the booth!

XStream Systems Attends Leading Industry Event

Sales Executives from XStream Systems, Inc. attended the Secure Pharma 2008 Conference in Philadelphia this week.

Attending from XStream were Alan Clock, Senior Vice President of Sales and Marketing and John Lundquist, Vice President of Sales and Business Development.

The Secure Pharma 2008 is billed as The Comprehensive Supply Chain Security Conference For the Pharmaceutical Industry and this year's event certainly lived up to that billing.

Attending the conference were dozens of representatives from pharmaceutical manufacturing, pharmaceutical distribution and various pharmaceutical software and security companies.

XStream representatives networked with a variety of attendees including representatives from manufacturing, distribution and several trade publications.

Although XStream did not present at the meeting, it was very apparent that through individual meetings and networking, the capabilities of XStream Systems' technology became one of the highlight take aways from the show.

The overarching message from those that presented at the conference, is that the pharmaceutical industry is relying totally on RFID, pedigree, tracing and bar code technology to combat counterfeiting and provide security for the every increasing threats posed to the pharmaceutical supply chain. It seemed very clear that although these technologies are robust, they are only half of the overall solution. RFID chips, bar codes and pedigrees do not offer complete protection and a proper comprehensive defense against sophisticated threats to raw materials, production and distribution.

All of the technology and systems formally demonstrated at Secure Pharma 2008 showed that they can only verify the packaging and pedigree within the supply chain but these technologies do nothing to authenticate the actual contents and materials of the products inside the packaging.

The technology of RFID's, bar codes and pedigrees cannot protect the pharmaceutical supply chain against issues of tainted raw materials, poor quality production or degradation.

XStream Systems, XT250 system, which has the ability to authenticate and verify the contents of a sealed container compliments and completes the overall solution to a secure pharmaceutical supply chain. Coupled with the ability to network with pedigree, inventory and security systems, the XT250 is the missing component to assuring the safety of a pharmaceutical product from manufacturing, through distribution and dispensing to the end consumer.

"John Lundquist and I came away from the meeting very excited about the potential of our solutions in all of the various members of the pharmaceutical supply chain," stated Alan Clock. "The capabilities of the XT250 surprised many attending the meeting and it was very apparent that the technology and complete solution that the XT250 provides, fills a gaping hole in all of their current QC, safety and security initiatives."

John Lundquist commented. "This was a very important event for XStream Systems, it validated our technology and solutions and gave us access to those who are responsible for securing the Global Pharmaceutical Supply Chain."

Friday, February 22, 2008

Drug Verification Technology to be Presented

XStream Systems, Inc. is scheduled to present our technology and pharmaceutical industry applications at a symposium in Orlando, Florida. The Seventh Pharmaceutical Powder X-Ray Diffraction Symposium (PPXRD-7) will take place February 25-28, 2008 at the Florida Hotel and Conference Center.

The title of the oral presentation to be given is “EDXRD Probe for Pharmaceutical Verification.” While speaking, Dr. Noureddine Anibou will discuss the importance of pharmaceutical verification and give an explanation of XStream Systems’ technology and its documented accuracy rates.

Here's a link to the conference's website:
...and a link to view a .pdf of the presentation: EDXRD_Probe-Pharmaceutical_Verification.pdf

Sunday, February 3, 2008

Product Shot

XStream Systems has designed a revolutionary unit which can authenticate pharmaceuticals while still in their package - their sealed package. Here is the latest pic of the unit: