Drug Topics: Counterfeit Drug War Continues, Threatens Supply Chain

Kathryn Foxhall writes an outstanding article in Drug Topics on new efforts by federal authorities to attack the growing issue of counterfeit medications.

The article includes industry insight and relevant statistics. Highlights of Ms. Foxhall’s Drug Topics article include:

• To jump-start efforts to deal with supply-chain threats that include counterfeiting, economically motivated adulteration, diversion, and cargo thefts, FDA is creating a new Drug Integrity and Security Program within the Office of Compliance of the FDA's Center for Drug Evaluation and Research.

• FDA is developing standards for track-and-trace and authentication systems that would enable the identification of substandard prescription drugs as they move along the supply chain.

• The counterfeiters are winning the global counterfeit drug war, with counterfeit medications more abundant than ever before, according to Jeffrey Gren, director of the Office of Health and Consumer Goods in the U.S. Department of Commerce.

• According to FDA, Gren said, 80% of active pharmaceutical ingredients (API) in drugs consumed in the United States come from other countries, mostly from nations that don't have sophisticated regulatory regimes. An API, he said, "may come from China, it may be packaged in the Middle East, it may be sent through Brazil; ultimately it makes it to the United States or other parts of the world," making the problem difficult to solve.

• Nancy Kennedy, senior operations manager of drug investigations in FDA's Office of Criminal Investigations, said that some years ago imported, unapproved, and counterfeit drugs came into the United States addressed to individuals or packaged in small quantities. Then quantities increased, and counterfeits started going to drop-shippers and distributors working from online pharmacy operations. "Now we see quantities of these drugs coming in and going directly to doctors, clinics, brick-and-mortar-pharmacies— and these are for use and distribution directly to patients," Kennedy said.

• Kennedy said that for some time Congress and others have been saying, "Show us the bodies." But there may not be many bodies at one time, she said, unless an event occurs such as the mass poisonings that have happened in other countries.

With the pharmaceutical supply chain threatened by dangerous fakes from all over the globe, it is vital for the supply chain to take proactive steps to protect itself and not wait for regulatory mandates or law enforcement action.

Deploying technologies, solutions and best practices protect both the supply channel and the consumer.

Businesses that take these proactive steps will be able to differentiate themselves and will be in a prepared protected position when there is a large counterfeit drug incident within the supply chain.

To read the entire Drug Topics article, visit: http://drugtopics.modernmedicine.com/drugtopics/Modern+Medicine+Now/Counterfeit-drug-war-continues-threatens-supply-ch/ArticleStandard/Article/detail/699610?contextCategoryId=40159

To learn about pharmaceutical supply chain solutions, visit: http://www.xstreamsystems.net/

Anti-Counterfeiting: Thinking Inside the Box

The following is a re-post of blog that was originally posted in Secure Pharma Chain in November 2009. This blog is an excerpt of an article on an authentication as a pharmaceutical anti-counterfeiting solution.

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 http://www.xstreamsystems.net/.

RFID is Dead...

RFID is Dead…at Unit Level in Pharma or so says Dirk Rodgers, an industry veteran and active blogger.

Supported by excellent data, Mr. Rodgers in his opinion blog RxTrace.com posted a very good op/ed regarding RFID and its place within the pharmaceutical supply chain.

RFID technology originally developed as an inventory management tool was considered the panacea to the issue of fraudulent, adulterated and counterfeit medications by many industry insiders but their implementation and use as a solution has fallen short.

Bogus medications have now proliferated into a $75 billion annual worldwide criminal activity as the pharmaceutical supply chain has become more global.

In Mr. Rodgers' piece, he gives the historical perspective, graphs on costs, supply chain perspectives and insight into the reason that RFID has failed and will continue to fail as the ultimate solution within the supply chain.

Mr. Rodgers' concludes that RFID still has a place for use in bulk/case containers but feels that barcodes on individual units will ultimately become the norm because of costs.

Secure Pharma Chain Blog agrees in essence with Mr. Rodgers' case regarding RFID and barcodes. Ultimately we believe that tags, barcodes and other track and trace technologies are effective in what they do and that they are an import part but not the definitive solution to solving the issue of fraudulent, adulterated and counterfeit medications. Unfortunately these technologies only tell you information on the transaction and packaging.

What is most important in supply chain security is what is inside the box.

Secure Pharma Chain Blog believes in a multiple layered approach that includes transactional tracing but ultimately relies on material identification of the product to authenticate the product as it migrates throughout the supply chain.

To read Mr. Rodgers' entire blog, visit: http://www.rxtrace.com/2010/04/rfid-is-dead-at-unit-level-in-pharma.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+rxtrace%2Fvqly+%28RxTrace%29.

To learn more about supply chain material authentication solutions, visit: http://www.xstreamsystems.net/.

Using EDXRD to Look Inside the Box for Pharmaceutical Safety

By: Alan Clock, Senior Vice President, XStream Systems

Until recently the only true way to test quality and identify fraudulent medications was through laboratory analytical methods. The inadequacies of these solutions are obvious. They are expensive and cumbersome, and usually require sending to an outsourced laboratory.

Additionally, laboratory testing requires highly trained personnel and typically destroys the product. The testing method generally requires that the tester be cognizant of a potential problem in order to properly focus the analysis.

Unfortunately, in this day and age, by the time the suspicious product gets to a laboratory environment, it has most likely already been in the supply chain for some time all the while placing consumers at risk. Furthermore, following laboratory testing, the only element of certitude is the exact product that was tested, but does not reveal any information about other similar products in the supply chain.
The best way to effectively purge the pharmaceutical supply chain of poor quality, fraudulent or counterfeit medications is to look inside the box to screen, verify and authenticate the product inside its package.

Ideally, a quality control and anti-counterfeit solution for the pharmaceutical supply chain should not require any alterations to the product or the package. The model remedy would allow packaged drugs to remain intact and be returned to the supply chain.

The perfect solution would be readily deployable with placement of the solution at strategic points within the supply chain or deployed throughout without onerous costs or extensive implementation.

This type of innovative technology would provide a level of confidence that public safety is ensured. Bottom line . . . it checks to see what is inside the box.
The One new technology which fits the definition of the ideal solution in this challenge within the supply chain is known as Energy Dispersive X-Ray Diffraction (EDXRD). This innovative technology allows the user to molecularly screen the product inside its original container without destroying or degrading the product and ultimately minimizes the need for Track and Trace technologies as the only robust solution.

EDXRD transforms the process from looking at the outside of the box with Track and Trace to looking inside the box with Molecular Screening. Ultimately, this truly provides all of the members of the supply chain, from manufacturer to consumer, the confidence to know that the medications in their inventories or that they are taking are safe and efficacious.

EDXRD was first proposed in the 1960's as a simple and high speed way to analyze remotely the crystalline structure of material within a container. EDXRD uses high powered X-Ray beams, thus generating very high penetration power. EDXRD was first tested as a detection tool in the late 1980's, for detection of explosives hidden within luggage/packages by Philips Medical Systems. EDXRD instruments function by matching the diffraction pattern obtained by the instrument with a library of patterns previously obtained for comparison. The EDXRD diffracted spectral patterns of crystalline substances are markedly different, even to an untrained eye. Much like a human fingerprint, although there may be a few features that are common to both patterns, they are nonetheless very different. In current iterations of the technology, which is fitted with a computer-based detection device, the system relies on a mathematical algorithm to extract a unique feature set from the pattern and use them to identify the material giving rise to that pattern.

In general, the EDXRD methods are highly material specific, since the diffraction patterns of crystalline materials are unique. As it relates to pharmaceuticals, the signature of diffracted aspirin is very different from ibuprofen, acetaminophen, codeine, etc. Equally important is the fact that the diffracted patterns of the excipients specific to the unique recipe of the formulation are unique and one can determine differences in manufacturer, packaging, dosage, etc. For example, acetaminophen, 325mg from one vendor, will differ from acetaminophen 325mg from another vendor unless they follow the exact same recipe, density, pill configuration and utilize the exact same packaging.

This material sensitivity of EDXRD has two important ramifications - high detection/verification rates and low false alarm rates. Under ideal conditions (i.e. - low absorption and high test mass), the detection rate is close to 100% and the false alarm rate is 0.1% or lower. In addition because it uses high powered X-Ray, EDXRD technology can penetrate through nearly all plastics, cardboard, wood and metals in order to screen the material.

XStream Systems has succeeded in its mission of taking EDXRD through its evolution to a robust Molecular Screening tool. XStream has conceptualized and architected the world’s first countertop EDXRD machine, the XT250 Material Identification System. This machine made a historically complex technology easy to operate for the average end user. The XT250 system is now fully deployed in drug wholesalers, pharmaceutical manufacturers and pharmaceutical reverse logistics companies. The system is designed to be used either in a standalone or integrated capacity anywhere along the supply chain; the deployment can be in a warehouse setting and operated by a non-technical warehouse worker.

EDXRD’s first intended use is in the pharmaceutical industry where the XT250 material identification system detects fraudulent, adulterated or counterfeit drugs. The system also enhances quality in the manufacturing processes and provides consumer protection to the end user. With its superior X-Ray penetrating power, fast results and scalability, EDXRD can verify and detect materials in both small and large packages. Also, due to the vast flexibility of the technology, EDXRD will be well suited for many other markets.

In subsequent versions, now in development, EDXRD technology will incorporate high speed and larger capacity. These improved systems will increase the scale and capabilities of the technology and allow for high levels of integration within all stages of supply chains from manufacturing all the way through, including dispensing.

In summary, EDXRD provides a near perfect what you see is what you get (WYSIWYG) environment for the pharmaceutical industry. While Track and Trace technologies like RFID, Serialization, Taggants and Pedigree’s are important elements in supply chain security, EDXRD is the ultimate “completer” for patient safety and supply chain integrity. With an aggressive Molecular Screening Program which is offered by XStream Systems, each member of the pharmaceutical supply chain can minimize risk to the consumer, severely undermine liability risks of all members of the pharmaceutical supply chain, and thwart nefarious criminal enterprises that prey on the healthcare of others.

To learn more about XStream’s EDXRD technology, visit us at: www.xstreamsystems.net.

The Limitations of Track and Trace Technologies in Fighting Counterfeit Drugs

Alan Clock, Senior Vice President, XStream Systems, Inc.

To date, nearly all of the solutions for the global epidemic of counterfeit and adulterated drugs has emphasized technologies that are known as Track and Trace methods (e.g. barcodes, holograms, RFID, pedigree, taggants, and serialization).

Track and Trace methods were developed and are based on technology designed for inventory control/security and are common within most sophisticated supply chains. These solutions are very effective in tracking product, 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.

That being said, Track and Trace solutions have their limitations:

• They generally require some sort of an addition to the outside of the box or package and a common technology to be read and documented.


• These processes and technologies add additional cost to the product and are difficult to maintain across large global supply chains.


• Because of its external placement of these methods on the material’s packaging, the Track and Trace item may be easily replicated, and, at the very least, does not verify that the material inside the package is safe and efficacious.

The costs for a global supply chain to implement Track and Trace solutions are staggering. According to an EU Commission Consultant, the initial cost for deploying a Mass Serialization pharmaceutical program in the European Union would include:

• An industry wide one-time cost of €11.5 billion to set up the proper systems within all members of the pharmaceutical supply chain in Europe.


• Annual “running costs” for serialization with European pharmaceutical companies to be €185.5 million for non-OTC companies.


• EU pharmacies would incur costs of installing the right IT and reading devices to support serialization estimated to be approximately €157 million, with no estimates on the annual costs of running the system.

Although Track and Trace solutions are useful to a point, they are significantly limited in their effectiveness. When additional costs to all members of the supply chain are added, they include significant changes to the manufacturing, packaging and distribution processes. Additionally, as we have seen lately, many of the incidents of substandard, fraudulent and counterfeit product all had perfect pedigrees and their packaging was either original or perfect facsimiles.

The best way to effectively purge the pharmaceutical supply chain of poor quality, fraudulent or counterfeit medications is to look inside the box to screen, verify and authenticate the product inside the package.

Ideally, a quality control and anti-counterfeit solution for the pharmaceutical supply chain would not require any alterations to the product or the package. The remedy would allow packaged drugs to remain intact and will be readily deployable. The placement of the testing unit could be at strategic points within the supply chain or deployed throughout without onerous costs or prohibitive timelines.
This new cure would provide a level of confidence that public safety is ensured by verifying the material inside the package.

We at XStream Systems are very excited about our technology which meets the needs as an effective quality control and anti-counterfeit technology solution for the pharmaceutical supply chain. The XT250 system allows the members of the pharmaceutical supply chain to screen and verify the contents of product inside its unit of sale container without opening it, changing its label, or destroying or degrading the material inside.

To learn more about XStream’s XT250 and its revolutionary technology, visit: http://www.xstreamsystems.net/.

IBM Study: Pharma Executives Concerned About Supply Chain Safety

Supply chain executives at pharmaceutical and life sciences companies are increasingly concerned about the risk of counterfeit drugs and contaminated medications amid the complexity of global manufacturing, according to an IBM study.

In a September 9th, press release by IBM, the company describes how they conducted a study which surveyed executives at pharmaceutical, biotechnology, medical device and consumer health care industry companies who are responsible for planning, logistics, procurement and coordination throughout the life of a drug or medical device. Here are some of the key findings from the study:

• Reducing the risk of counterfeit drugs and contaminated medications amidst the complexity of global manufacturing are among the top concerns of the pharmaceutical and life sciences industries today.
• Tracking every step of how drugs are manufactured and distributed are key priorities for more than 70 percent of companies.


• Monitoring risk to prevent counterfeiting, drug and device recalls, or even the loss of intellectual property, is a priority for 75 percent of executives, as margins become slimmer and supply chain complexity rises. Three-quarters have risk and performance initiatives such as surveillance programs, anti-tamper devices and specialized labeling, but with mixed results.


• 46 percent consider vendor-managed inventory for their customers extremely effective but only 4 percent use it to ensure they are precisely meeting customer demands for products.


• Compared to 18 other key industries, the life sciences business is one of the most highly globalized, particularly in the area of Research and Development. From a supply chain perspective, the industry is not as advanced. In general, global sourcing brings with it challenges including daunting capacity, quality, lead times and delivery issues.


• For the life sciences industry, seventy-six percent of respondents suffer quality issues linked to global sourcing while nearly fifty percent reported increased sales from their globalization efforts due to the growing population of consumers in rapidly developing markets.


• "As the industry faces a time of transition, supply chain executives are outsourcing more business processes, turning to emerging markets and becoming more globally integrated, all while actively managing risk," said Dr. Philippe Cini, IBM Global Business Services, Life Sciences Supply Chain Management Partner.


• Counterfeiting is one of the biggest risks facing the pharmaceutical industry today. According to the World Health Organization, approximately 10 percent of the worldwide drug supply is counterfeit. To combat such risks, sophisticated simulations and data models help companies calculate risk, and building intelligence into products and packaging such as barcodes, RFID tags and other smart devices, supply chain executives can prevent theft. This type of new intelligence along with e-pedigree and track-and-trace capabilities also enables the entire supply chain to respond quickly in the event of a recall.

The study -- "The Smarter Supply Chain of the Future: Life Sciences Edition" -- was developed by IBM Global Business Services' Supply Chain Management Practice in conjunction with the IBM Institute for Business Value, which develops fact-based strategic insights for senior business executives.

While XStream endorses this study, much of IBM’s conclusions regarding the solution to supply chain safety center on taggants and smart track and trace solutions. XStream acknowledges that these are a part of the overall solution but also believes that it is also crucial for the entire supply chain to incorporate materials authentication and verification into an entire suite of solutions to monitor quality, handling, fraud and counterfeiting. Sophisticated supply chains not only require knowing where a product has been, but what is in package.

To view the press release visit: www-03.ibm.com/press/us/en/pressrelease/28352.wss
To learn more about XStream Systems’ solutions, visit: http://www.xstreamsystems.net/

UPS Supply Chain Survey: Nearly Half Worry about Product Tampering and Counterfeiting

In UPS’s 2nd Annual Supply Chain Survey, conducted by Harris Interactive, there was a somewhat surprising discovery as it relates to fraudulent and counterfeit products in the supply chain.

The survey was reported in the June 2009 issue of Pharmaceutical Commerce.

In the survey, decision makers at bio-pharma and med device companies were asked a variety of questions to identify supply chain issues beyond simple transportation and delivery.

The somewhat surprising discovery was that 48% of the large company respondents (companies with revenues in excess of $1 billion annually) while 34% of smaller companies, listed product tampering and counterfeiting as one of their biggest supply chain concerns for the year.

Pharmaceutical Commerce is quoted in the June 2009 issue:

It is worth noting that nearly half (48%) of large-company respondents cited product tampering and counterfeiting as a concern, which belies the relatively quieter scene in drug pedigree, tracking and tracing as a result of the postponement of the pedigree rules in California.

This survey validates much of what XStream Systems is finding in the pharmaceutical supply chain as well. Although much of the pressure has been lifted from the delayed pedigree rules, there is a realization among decision makers that there remains a significant amount of stress with few solutions within the supply chain as it relates to fraudulent, tampered and counterfeit product. To date many key executives have seemingly ignored the threat of increased liability and brand erosion because they have few if any solutions to adequately meet the issue. Pedigree and track and trace technologies although mandated in specific states, provides minimal protection against diverted products but do nothing to decrease their liability and protect their inventories from counterfeiting or tampered products.

XStream Systems, with its revolutionary EDXRD technologies, has a technology solution that enhances the ability of the members of the supply chain to authenticate the product, within its sealed container, without destroying or degrading the medication. This solution, allows the user to authenticate and verify the contents of the product, not just the package and properly secure their inventories and overall liability.

To read the June 2009 article in Pharmaceutical Commerce, visit: http://www.pharmaceuticalcommerce.com/frontEnd/main.php?idSeccion=1239.

To learn more about XStream Systems and it solution, visit: http://www.xstreamsystems.net/.

Turkish Government to Delay Implementation of Barcode System to Stamp Out counterfeit Drugs

Initiative officially delayed until October, but industry experts anticipate the process to be pushed back further.

The Turkish newspaper, Today’s Zaman recently published a story about the implementation of a drug tracking barcode system in place to combat counterfeit drug in Turkey. However since the publication of the article, pressure from pharmacies has delayed the implementation from July to October. Most industry experts expect the delays to go beyond the October schedule because of the significant costs to small dispensing pharmacies.

According to the article:

• Turkey is identified as being one of the largest global purveyors of counterfeit drugs.


• The ambitious tracking system, which industry insiders estimate has already cost more than $200 million this year alone in the run-up to its implementation, has been fraught with difficulties.


• Dr. Roger Bate in last week's Journal of the American Enterprise Institute, his limited study of a small sample of drugs in the US purchased over the Internet revealed that Turkey is the largest single supplier of drugs bought online in the US. He documented a number of raids in Turkey that revealed all aspects of the counterfeit drug trade -- importers and local manufacturers of counterfeit products, wholesale distributors repackaging fake and old medicines that should have been destroyed and printers making packaging for the manufacturers. “The products I have seen,” he told Today's Zaman, “were manufactured by large Western companies in Turkey for the Turkish market which were diverted -- possibly illegally -- to the US by Internet sellers.”


• The implementation of this system is also meant to act as a prevention of fraud against the medical insurance system, which is being defrauded by unscrupulous doctors and pharmacists hungry to take advantage of the easily cheated system.


• Pharmaceutical companies -- the ones whose pocket books are arguably most affected by the proliferation of counterfeit drugs in Turkey -- have been amongst those who were resisting the implementation of the barcode system.

Most have said that this program which is slated to use a GS1-compliant 2D barcode will cost the country over $150m per year. The delay in this program is seen as a major setback to companies who tout track and trace technologies as the answer to counterfeit and adulterated medications.

XStream endorses all solutions to the issue of counterfeit, adulterated and diverted medications and believes that a comprehensive suite of technologies are necessary to adequately protect the global pharmaceutical supply chain. XStream believes that autentication and verification of the contents of the unit of sale, which is available via its XT250, is a critically important componant to securing medications from production to dispensing.

To read the entire article, access the link below:
http://www.todayszaman.com/tz-web/news-184271-105-barcode-system-to-stamp-out-counterfeit-drugs.html

To learn more about the XT250 visit us at:

http://www.xstreamsystems.net/

California governor signs e-pedigree bill,

SACRAMENTO, Calif. - Gov. Arnold Schwarzenegger handed California pharmacies a major victory Tuesday, signing into law a bill that gives the state's drug retailers some breathing room in their effort to comply with electronic pedigree and track-and-trace technology requirements for prescription drugs.

Schwarzenegger signed into law SB 1307, which revised the technology requirements for establishing the origin and movement of prescription drugs through the supply chain. Included in the law is a provision that pushes back the deadline for compliance for California pharmacies from Jan. 1, 2011, to Jan. 1, 2017.

The decision reflects the recommendations of pharmacy leaders for a gradual and more workable implementation process for new e-pedigree requirements. A number of pharmacy representatives testified before the Enforcement Committee of the California State Board of Pharmacy, asking for an extension that would allow them enough time to adopt the track-and-trace technology needed to establish every drug's pedigree.

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.

World Health Organization Statistics on Counterfeiting Worldwide

As reported in our last blog post, most experts agree (including the Chairman of Sanofi-Aventis) that the incidents of drug counterfeiting and adulterations are:

a) completely under reported
b) significantly on the rise

Just to put this into perspective, the following are the statistics from the World Health Organization on the Prevalence of Counterfeit Drugs in the West and the Developing World. These statistics represent WHO's 2006 estimates as to the percentage of counterfeit or adulterated drugs within that country or regions total drug supply chain.

• United States, less than 1%


• United Kingdom, less than 1%


• Europe, less than 1%, some estimate percentages as high as 10%


• Nigeria, 16%


• Kenya, 30%


• Lebanon, 35%


• Cambodia, 13%


• China, 8% on OTC medications


• India, 10-20%


• Indonesia, 25%


• Russia, 10%


• Former Soviet Republics, 20%


• Colombia, 5%


• Mexico, 10%


• Peru, 15-20%


• Venezuela, 25%

Realize that these numbers are all presumed to be very low and many of the percentages may have nearly doubled since 2006. Consider the tainted Heparin as a good example of the rise of counterfeit, adulterated or otherwise tainted drugs within the United States and other developed countries in 2008. Even the United States figure of less than 1% equals many billions of dollars in undetected counterfeit medications within our drug supply.

Most importantly realize that now, in the era of a Global Pharmaceutical Supply Chain that many drugs that are being imported into the United States and other developed countries now owe their source of raw materials, production and packaging to less developed countries like India, China and other countries whose pharmaceutical supply chain is riddled with counterfeit and adulterated medications.

Encourage your lawmakers and dispensers of medications to demand an authentication technology to double check the pharmaceuticals that your family consumes. Authentication of the pharmaceuticals is the only answer to properly knowing that the drugs you and your family are taking to maintain their health are not in fact harming them instead.

Current initiatives that are being debated in Washington and other regulatory agencies are almost exclusively centered on track and trace technologies that do not authenticate the drug. All the Heparin that has to date caused over 149 deaths in the United States all had a perfect pedigree and would have passed as authentic with track and trace technology.

Track and Trace an Expensive Proposition for Retail Drug Stores

The Coalition of Community Pharmacy Action, which is a group formed by the National Community Pharmacists Association and the National Association of Chain Drug Stores, released a study on June 18th that examined the safety of the prescription drug supply chain and the potential effects of the implementation of a federally mandated track and trace system to protect consumers from counterfeit medications.

Of note, the CCPA estimated in its study that it would cost drug store chains $84,000to $110,000 or more per store in the first year to implement a track and trace system. The cost estimate was based on costs of computer hardware, software, infrastructure, labor and other resources.

Not included in the study was the cost to the other members of the pharmaceutical supply chain; manufacturers and distributors to implement this process. All members of the pharmaceutical supply chain must be involved in the process to make the track and trace process a useful tool in protecting medications.

This is why it important to include an authentication technology either in conjunction with or in lieu of track and trace. An authentication technology, EDXRD verifies the content and make up of the contents of the medication and does not rely on tracking the various stops along the supply chain.