New French Crackdown on “Counterfeit Tourism”

As reported in several major European publications, new laws have customs officials in France starting to crackdown on what they are calling “counterfeit tourism” – that is people from other countries who buy or bring in counterfeit goods while they are visiting France.

This is a significant shift in the enforcement of anti-counterfeiting laws. While other country’s police and customs authorities only target suppliers of counterfeit goods, in France, the authorities are now focusing on those who buy fake goods or bring counterfeit products into the country.

These new laws mean that French tourists could now be fined up to a maximum of €300,000 ($450,000) or face up to three years in jail if they are found to be in possession of or purchasing fake goods.

While certainly outside a traditional law enforcement tactic, this is seen as a significant step in changing the perception of the purchase of counterfeit goods with consumers. As with some crimes, many feel that the issue of fake goods is a “victimless” crime and do not understand the macro consequences of safety, health and economic well being that are impacted heavily by counterfeit goods.

It will be interesting to observe the enforcement, repercussions and effectiveness of these new laws in France.

Contract Pharma: Assuring Quality in the Global Supply Chain-Measuring Risk in Sourcing

In the September 2009 issue of Contract Pharma magazine, Helena Champion the Principal Consultant with Drug Quality Assurance LLC, writes a must read article for senior to mid level pharmaceutical executives about dealing with the risk of quality assurance of pharmaceuticals in this era of globalization of the pharmaceutical supply chain.

As posted on previous stories and blogs at Secure Pharma Chain Blog, the issue of the globalization of the pharmaceutical supply chain has led to a worldwide epidemic that affects the quality of medications and a proliferation of counterfeit drugs.

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 the point of production to the consumer. The use of a material screening process, which verifies the material inside its unit-of-sale container, enables the entire supply chain to mitigate its liability and ensures the consumer that the product is safe and efficacious.

In the article titled Assuring Quality in the Global Supply Chain-Measuring Risk in Sourcing, Ms. Champion outlines a compelling history and case for quality assurance measures along with a Supplier Risk Scoring Tool for use by a Material Supplier/Provider Combination. Ms. Champion states in the introduction that, “this article explores the risks of depending, without reliable verification, on remote suppliers to maintain the quality and safety of their supply chain and the materials we buy from them.” Although Ms. Champion primarily focuses on manufacturing, much of her article is relevant and could be applied and used by members of any supply chain-from production to dispenser.

Here are some of interesting portions pulled from Ms. Champion’s article:

• Heparin Tragedy-In early 2008 there were numerous adverse events, some fatal associated with Baxter International’s heparin parenteral products and they voluntarily recalled nearly all their heparin products in the United States…at least 80 people in the United States died from contaminated heparin products.


• Experiences in Other Industries-Experiences in other industries moving production and supply to low-cost suppliers have not been very different from the heparin experience. The Economist recently reviewed a book by Paul Midler, Poorly Made in China: An Inside Account of the Tactics Behind China’s production Game. Mr. Midler is fluent in Chinese and has consulted in China since 2001 for Western companies replacing factories in Europe and America with sub-contracting relationships in China. His Western clients were delighted with how Chinese factories could do things so well, so fast and so cheaply, but were puzzled as to how this was possible. There was reason to question the low prices-he soon found that “quality fade” was common, as Chinese factories transformed what were, in fact profitless contracts into lucrative relationships.


• Even if test are made more specific, third party testing is certainly not enough to assure the quality of pharmaceuticals and especially biologics and biopharmaceuticals.


• The tryptophan dietary supplement disaster over 20 years ago provides an example of the risks of changing a process without extensive testing to validate the new process-a manufacturer made a change to the process and did not anticipate that a very toxic impurity would result, which killed at least 37 people and permanently disabled more than 1,500 people in the United States.


• The existence of a United States affiliate or a United States Agent does not guarantee real knowledge of the supply chain or its integrity.


• Economic fraud is not new and nor is it confined to any one country or industry…In the 1990’s Flavine International, a NJ-based broker of bulk drugs, bought bulk gentamicin sulfate at low prices from unapproved sources in China. Flavine repackaged the bulk drug to resemble gentamicin sulfate manufactured by Long March Pharmaceutical...there were a number of adverse events linked to drug product made with the counterfeit gentamicin…Flavine, its owner and its vice president were fined and the owner got a two-year prison sentence.


• You are Responsible For Your Supply Chain-It has become obvious that companies in general need to know much more about their supply chains than in the past and that there are hazards in taking supplier information at face value.


• Five Steps To Achieve and Maintain Comprehensive Supplier Qualification:

Step One-Quality in Depth, A company needs to perform a comprehensive, in-depth evaluation of a supplier for a particular material. API and component manufacturers often do not allow a customer to audit their operations in detail, to protect proprietary knowledge and confidentiality, but a superficial audit is no long a viable approach.

Step Two-Use Experienced, Technically Expert Auditors to Perform On-Site in Depth Audits-They Can Change the Game

Step Three- Need to Identify and Audit the Upstream Supply Chain for Critical Materials - Audits conducted by You or Your Agent

Step Four-Trust But Verify Regularly, After initially qualifying the supplier of an API or components and demonstrating that the supplier can consistently provide material that meets specifications, drug product and device manufacturers still need to regularly check supplier compliance through reliable means.

Step Five-Management Responsibility to Understand and Mitigate Supplier Risk, Senior management should be informed and updated regularly as to the security and integrity of critical supply chains.

• The best suppliers will accept the new reality of increased transparency, and brokers and distributors who can establish and guarantee the level of quality assurance associated with more rigorous auditing and supply chain verification will be invaluable.

Written for and from the standpoint of quality assurance at the point of manufacture, this very detailed article gives a solid roadmap for executives and managers to gauge and or build a process that protects their supply chains and begin to understand the potential for catastrophic consequences economically and to the general health of a population if they do not take the issue seriously.

Not mentioned by Ms. Champion in this article is the role that technology can be deployed and used to screen and protect manufacturers, packagers, distributors, dispensers and ultimately the consumers in authenticating at each step of the supply chain the veracity of their products. By using the processes described in the article with a suite of technology it is possible for the supply chain to protect itself from the various nefarious sources that threaten it.

To read Ms. Champion’s article in full in the September 2009 issue of Contract Pharma, visit their website at: www.contractpharma.com.

To learn more about XStream Systems and its revolutionary technology that allows the pharmaceutical supply chain to verify and authenticate materials inside their sealed unit-of-sale container, visit their website at: www.xstreamsystems.net.

FDA: Supplier Audits, Qualification Needed to Protect Supply Chain

At the Parenteral Drug Association-FDA 2009 Joint Regulatory Conference the FDA was on record stating that manufacturers should secure their supply chains through testing and anticipate risks to head off issues like the recent contamination of imported ingredients.

Steven Wolfgang, FDA Consumer Safety Officer is quoted as saying, “ the FDA is looking more closely at quality management systems as a first step toward that goal.”

This reinforces XStream’s position that material screening should be done throughout the supply chain to verify and authenticate materials from raw materials, to production, through distribution and to the point of dispense. Material screening is the most effect way to make certain that the product is protected and maintains it effectiveness to the consumer.

XStream’s XT250 solution allows the entire supply chain to quickly screen products, within the supply chain, inside it unit-of-sale container without degradation or the destruction of the material.

To view more about the FDA statement, follow this link: http://www.fdanews.com/newsletter/article?articleId=120738&issueId=13038

To learn more about XStream’s XT250 system, visit: www.xstreamsystems.net.

Law Enforcement Examiner: Operation CYBERx

In yet another fascinating article from Jim Kouri at the Law Enforcement Examiner, the September 23, 2009 issue spotlights a recent DEA-led investigation targeting the e-trafficking of drugs within the United States.

The investigation, which is part of a larger initiative named Operation CYBERx was conducted by the DEA and other law enforcement agencies. This collaboration targeted internet pharmaceutical drug traffickers, operating within the United States that pose as legitimate pharmacies which in fact are peddling dangerous narcotics and prescription drugs, many of which are counterfeit.

Here are some of the highlights from the article:

• Recognizing that criminals are facilitating more drug-related crimes through the use of 21st century technology, the DEA, along with their law enforcement counterparts recently arrested 18 people for allegedly selling pharmaceutical drugs illegally over the Internet. Those arrested include the ringleaders of more than 4,600 rogue Internet pharmacy websites.


• The alleged drug dealers who operated these rogue internet pharmacies received prescription orders for controlled substances over the Internet, which were then shipped to the doors of many US citizens — sometimes without any prescription needed. These alleged criminal pharmaceutical drug traffickers averaged more than $50,000 a day in profits from their illegal Internet based enterprise.


• Operation CYBERx is part of the DEA's "Virtual Enforcement Initiative (VEI)." This new DEA cyber initiative acknowledges that criminals in the drug trade are embracing the use of state-or-the-art technology to peddle their narcotics and dangerous drugs into US communities, all with an air of respectability.


• DEA Administrator Karen P. Tandy said, "Operation CYBERx puts out of business alleged cyber criminals who [are] selling powerful narcotics without legitimate prescriptions to anyone with a computer and cash. These high-tech drug dealers were fueling addictions by selling the very drugs intended to prevent and treat ailments — not inflict them. Just as important, this Operation makes more Americans aware that buying prescription drugs from these rogue websites is illegal and dangerous."


• The VEI concept was realized last April when DEA led Operation "Cyber Chase," which resulted in more than 20 arrests in eight US cities and four foreign countries; shutting down an organization that ran over 200 web sites illegally selling what were identified as pharmaceutical drugs. This year-long investigation targeted international Internet pharmaceutical traffickers operating in the United States, India, Asia, Europe and the Caribbean. These e-traffickers also distributed drugs world-wide using rogue Internet pharmacies.

XStream Systems endorses the efforts of the DEA in cracking down on the illegal trafficking of prescription drugs and narcotics. This effort highlights the vulnerabilities of the pharmaceutical supply chain in the 21st century and XStream encourages all members of the supply chain to utilize material screening to verify, authenticate and protect their inventories. XStream also encourages health care consumers to only buy prescriptions from licensed, known pharmacies within your area and always use health care professionals (physicians, pharmacists) when taking medications.

To read Mr. Kouri’s Law Enforcement Examiner article in full, follow the following link: http://www.examiner.com/examiner/x-2684-Law-Enforcement-Examiner~y2009m9d23-Health-care-crime-Combating-rogue-Internet-pharmacy-operations

To learn more about XStream Systems visit us at: 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.

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/.

Counterfeit Drugs: An International Safety Problem

In the current economic crisis, it seems counterfeits and knock-offs are on the rise. In the case of counterfeit or adulterated drugs, this causes a real safety issue. If the medication does not contain the correct amount of the active pharmaceutical ingredient (API), it may not be effective or may cause undesirable and sometimes very dangerous adverse reactions. Also any inexpensive substituted filler ingredients that the counterfeiters may use, are used for appearance only and can turn what was meant to be a remedy for the patient into a poison.

We at XStream Systems encourage all throughout the pharmaceutical distribution cycle to screen their products through molecular pharmaceutical authentication. By ensuring that the products that pass through your hands are genuine, you are doing your part to protect the public health.

Canadian Drug Maker Apotex Recalls Medications

CanWest News Service Reported September 17th that Canadian generic drug giant Apotex voluntarily recalled some of its drugs late Thursday following a Health Canada investigation launched last July into the company's manufacturing practices.

The investigation was initiated after U.S. regulators found "significant deviations" from good manufacturing practices during an inspection at Apotex's Toronto plant.

In a news release, Health Canada said Thursday the recall applies to three lots of drugs including:

• Apo-Amilzide (5 to 50 mg),
• Apo-Meloxicam (7.5 and 15 mg)
• Apo-Ranitidine (75 and 150 mg)

These medications are used to treat rheumatoid arthritis, osteoarthritis, excess stomach acid or liver cirrhosis.

Health Canada said that it will continue to inspect the Apotex facilities for the next few weeks to ensure that there is compliance.

It urges any Canadians currently taking the drugs to contact their family doctor.
The FDA warned Apotex in June that officials would begin blocking drugs at the border by the Toronto-based company if it did not begin complying with good manufacturing practices, which are universally accepted standards for product quality control.

To read the entire CanWest article visit: www.canada.com.

Counterfeit Drug Situation Like the Wild West

The counterfeit drug trade has changed over the last decade. Prominent Leaders in the pharma industry all agree, counterfeiters have become more sophisticated. This has presented challenges to manufacturers to protect the brand security and safety of their products.

As Pat Ford, Pfizer's Senior Director for Global Security, said the situation is "like the Wild West," which poses a particular problem for those dispensing the drugs. "It gets to the point that pharmacists can't tell the difference. That's why we educate them on features in the packaging that help distinguish the real from the fake. And it's not just an international problem, but one unfolding right here in the United States.

Recall on Heart Worm Prevention Meds Due to Lack of Quality Control

In yet another recall of a medication due to quality assurance, dosage control and sub potency, the manufacturer that produces the heartworm prevention medicine, Worm Shield, has been taken off of store shelves because there's not enough medicine in the product to prevent heartworms.

No adverse reactions or illnesses have been reported as a result of taking this product.

Affected product lots:

• WORM SHIELD Dogs Small 0-25 lbs., lot #090073


• WORM SHIELD Dogs Large 51-100 lbs., lot #090095

If your dog weighs 75 pounds or more, it may not be currently protected against heartworm. All owners who have a dog that weigh 75 pounds or more, should schedule an appointment as soon as possible with your local veterinarian for heartworm testing. Your dog will need to be tested again in five to six months after its last dose to ensure it was not infected.


According to the manufacturer, dogs that weigh less than 75 pounds are currently protected against heartworm, but the product may not work at acceptable levels through the expiration date. Owners should return any WORM SHIELD from the recalled lots as soon as possible so it can be replaced to ensure your Pet’s protection from heartworm infection. If you are concerned about your Pet’s health, please contact your veterinarian for further advice.

Clearly this is yet another example of lack of quality control as it relates to the clinical effectiveness of the medication. XStream advocates that manufacturers, distributors and dispensers of all medications utilize technology like XStream’s XT250 in maintaining quality assurance of the efficacy of the product, while protecting against fraud and counterfeiting.

The attached links are several stories linked to the recall:

http://www.cbs42.com/content/links/story/Recall-on-Heart-Worm-Prevention-Meds/eejNhh04f067XDJoYngnfA.cspx

http://www.banfield.net/r/client-information-regarding-recall-of-two-lots-of-worm-shield-%20

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/.

How Common are Counterfeit Drugs?

That is the question. The World Health Organization estimates that 10% of the world 's supply of medicines are counterfeit, but the density of counterfeits vary from region to region. Some areas are estimated at as low as 1% - 3% while other areas may have up to 60% counterfeits for certain medications.

Most statistical data given is based on arrests, raids and seizures within a country or region. These are the cold hard facts, but most authorities believe these cold hard facts are but a small piece in the overall picture - just "the tip of the iceberg".

Euractive.com: Commission Slammed Over Internet Medicines

According to Euractive.com:

The Minister responsible for steering the Counterfeit Medicines Directive through the European Parliament has lashed out at the EU executive for failing to include online sales in the scope of the proposal.

Adamos Adamou (GUE/NGL, Cyprus) described the Internet as a "Trojan horse" in the medicines supply chain that the Commission has left the Parliament to deal with.

He said there were a number of flaws in the proposed directive, including the failure to provide a definition of counterfeit medicines and the omission of excipients such as the capsules used to package active ingredients.

Adamou said he had drafted amendments which would extend the scope of the directive to include over-the-counter medicines and to harmonize safety features on medicine packaging.

"Today, there is no guarantee of buying safe medicines. Counterfeit medicines are a form of terrorism against human health. It doesn't matter whether a pill contains sugar or poison. If the safety is compromised, so is our health," he said.

To View entire piece, visit: www.euractiv.com.

Counterfeit Malaria Drugs Responsible for Thousands of Deaths throughout Africa

According to the September 13th issue of Media Global, a global media outlet based in the United Nations Secretariat, the World Health Organization has revealed some disturbing statistics as it relates to the deathly impact of counterfeit medications in Africa. Some of the most revealing and interesting portions of the article are:

• The World Health Organization (WHO) has increased efforts to fight the distribution and manufacture of counterfeit malaria drugs in Africa.



• According to the World Health Organization, upwards of 2,000 children per day die as a result of taking these counterfeits medications.



• Due to their high demand and price, malaria drugs are a prime target for counterfeiters.



• Many of these counterfeits contain little to no active ingredients or even the wrong active ingredient. The active ingredient may temporarily soothe the symptoms but have no real effect on the disease itself.



• "There is usually a low amount of active ingredient, like the pain reliever paracetamol, in fake malaria medications,” according to Dr. Lembit Rago, Coordinator of WHO Essential Medicines and Pharmaceutical Policies," in order to “cheat qualitative screening tests that just react to the presence of certain actives, and thus may mimic false positive results.”

Although known to many within global health organizations and those with insight into the issue of counterfeiting the death toll and scope of the issue is nonetheless shocking. The insidious nature of counterfeit drugs and the cost in human life should be galvanizing and accelerating industry and governments around the globe to combat this plague before it continues its proliferation around the globe.

XStream Systems and its EDXRD technology offer a solution to this issue by being able to screen and test materials within their unit of sale, penetrating through the packaging and being able to do a complete molecular screening of the product (active ingredients, excipients, dosage) without destroying or degrading the medication.

To read the Media Global article, ("Counterfeit Malaria Drugs Kill Thousands in Africa," Media Global, September 13, 2009), visit: mediaglobal.org.

To learn more about XStream Systems, visit: www.xstreamsystems.net.

Uganda Health News: Interpol Impounds 200 Cartons of Counterfeit Drugs

A joint operation conducted by the Interpol and the Ugandan National Drug Authority against counterfeit drugs have started yielding good results.

The operation has discovered 200 cartons of fake drugs in Central and eastern districts of Uganda.

The operation, code named Mamba 2, was carried out on selected medical drugs such as metakelfin and quinine, by separating them for preliminary laboratory analysis.

The Mamba 2 operation focused on regional operations in Eastern Uganda registering cases in Mbale, Jinja, Iganga, Kamuli and Busia.

Wakiso, Masaka and Mpigi were among the districts in Central region that were cited in the fake drug scam.

The head of Interpol in Uganda, Fred Kiyaga says the two agencies also managed to impound 200 cartons of fake drugs, 38 cases were registered and 19 suspects apprehended in connection with selling fake drugs.

To view entire article visit: http://www.ugpulse.com/articles/daily/news.asp?about=Interpo+impounds+200+cartons+of+counterfeit+drugs+in+Uganda+&ID=11798.

Dey Labs: Update on Stolen Albuterol Sulfate Inhalation Solution

As posted on the FDA Website and as a service to those interested in combating fraudulent, adulterated and counterfeit medications, the following is an announcement from Dey Labs:

In keeping with its commitment to “Put Patients First,” Dey, L.P. (“Dey’) would like to take this opportunity to inform its healthcare partners regarding a recent occurrence of stolen medication.

On or about August 6, 2009, a truck tractor-trailer which was not affiliated with Dey, containing 35,760 cartons of Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials was stolen. The truck theft occurred in the town of McKinney Texas.

The tractor-trailer contained two (2) complete Lots of product, each identified with the Dey label and NDC number. The specific product information is as follows:

Product Description:Albuterol Sulfate Inhalation Solution 0.083% 30-vials per carton (Product NDC #49502-697-29)

OT #	CARTON QUANTITY				Lot Expiration Date
9FE2	17,712				June 2011
9G01	18,048				July 2011

These two Lot numbers were not available commercially prior to the theft. All of the product cartons in these two Lots were stolen. Therefore, no vial or carton of either Lot is part of the legitimate pharmaceutical supply chain.

Pharmacies are encouraged to verify pedigree documentation for all purchases of Dey labeled Albuterol Sulfate, 0.083%, 30-vial cartons and product with either of these two Lots numbers should not be sold, distributed or dispensed.

If you have any information regarding the theft of these two Lots, or if you receive any suspicious or unsolicited offers for the Albuterol in question, please contact the Food and Drug Administration (“FDA”) Office of Criminal Investigations (“OCI”) by calling 1-800-551-3989.

For Customer Service inquiries, contact Dey, L.P. Customer Service at 1-800-527-4278.

For medical or other clinically related inquiries about this matter, contact Dey’s Senior Vice President of Quality Systems at 1-800-755-5560, ext. 2476.

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/

India: Blowing the Whistle on Fake Drugs

In the August 30th issue of Telegraph India, the Union health minister, Ghulam Nabi Azad, was reported as announcing a “whistle blower policy”, aimed at encouraging the common man to provide information about the manufacture of fake drugs

• Based on the information gathered by the Central Drugs Standard Control Organization, the office of the Drug Controller General of India raids places suspected of manufacturing or selling such drugs


• The tip-off often comes from a member of the general public


• The government hopes that a cash reward will lead to more people coming forward with such information.

To view the article visit: www.telegraphindia.com.

K-V Pharma: FDA Accepts Plan to Resolve Manufacturing Issue

Reuters on September 2nd reported that K-V Pharma has announced that the U.S. Food and Drug Administration had accepted its work plan to address previously identified deficiencies in its manufacturing practices. In March, the U.S. Department of Justice sued the drugmaker to block it from making and distributing adulterated and unapproved drugs, after an inspection by the FDA found the company had violated manufacturing guidelines and continued to manufacture unapproved drugs.

K-V Pharma has begun implementing certain measures set forth in the work plan but does not expect to resume product shipments before the third quarter of fiscal 2010, it said in a filing with the U.S. Securities and Exchange Commission on Wednesday.

The drugmaker said it anticipates it will request Lachman Consultants, its independent current good manufacturing practices (cGMP) expert, to conduct its certification review later this calendar year.

To view entire article visit: www.reuters.com.

Daily Times: 9 Clinics and 28 Drug Stores Shut Down for Counterfeit Drugs

In the September 2nd edition, the Pakistan Daily Times reports on Inspectors shutting down clinics in Pakistan for Counterfeit Drugs. Here are some of the highlights:

• On September 1, Pakistani drug inspectors in Rawal and in Potohar raided clinics and pharmacies, sealing nine clinics and fining 28 medical stores for sale of expired and unregistered medicines.


• Inspectors took 106 samples from these locations and submitted them for laboratory testing.

To read the story online, follow this link:
http://www.dailytimes.com.pk/default.asp?page=2009\09\02\story_2-9-2009_pg11_4

To learn more about XStream Systems and their revolutionary anti-counterfeiting technology, visit: www.xstreamsystems.net.

Markets and Markets: Global Anti-Counterfeit Market for Food and Pharmaceuticals Worth US $79.3 Billion by 2014

According to a new market research report, ‘Global Anti Counterfeit Market for Food and Pharmaceuticals (2009-2014)’, published by Markets and Markets (www.marketsandmarkets.com):

• Increasing cases of counterfeiting have resulted in implementation of anti- counterfeit technologies. Anti-counterfeit technologies are of two types namely authentication packaging and track and trace packaging technologies. North America holds a major share of the global anti counterfeit market. Asia has the highest growth rate due to untapped market and significant level of counterfeiting. Europe has a lower growth rate due to a relatively lower number of cases of counterfeiting.


• The global anti counterfeit packaging market for food and pharmaceuticals market is expected to be worth US$79.3 billion by 2014, with an estimated CAGR of 8.6% from 2009 to 2014.


• The North American packaging market is expected to account for nearly 62% of the total revenues. North America is the largest segment in the anti-counterfeit market and is expected to reach US $49 billion by 2014, accounting for nearly 62% of the revenues growing at a CAGR of 6.8%.


• Asia is the second largest market and is expected to reach US$14 billion by 2014 with a highest CAGR of 19.7%.

While XStream Systems feels that the data presented in this report is valid it believed that Markets and Markets may have overlooked significant technology solutions in their research.

Most of the report seemingly centered on packaging technologies and ignored material screening technologies such as XStream’s XT solutions which allow the end user to verify the authenticity of a material inside its sealed unit of sale container.

How large is this market if material screening technologies were included in the mix?

To view a synopsis of the report, visit:
http://blog.taragana.com/pr/marketsandmarkets-global-anti-counterfeit-market-for-food-and-pharmaceuticals-worth-us793-billion-by-2014-5427/

Business Standard: WHO to Revive Talks on Fake Drugs

Joe C. Mathew of the India Business Standard in their Saturday, September 5, 2009 edition reports on the upcoming meeting annual meeting of the World Health Organization. The World Health Organization Meeting will be tackling the fake drugs and their definition:

• The matter had to be taken out of WHO’s annual meet — the World Health Assembly (WHA) — agenda early this year due to protests from countries like India, which felt the proposed definition would harm seamless movement of genuine medicines between developing and least developed nations.


• The meeting of the WHO’s South-East Asia region, beginning in Nepal on September 7, is to revive the talks on counterfeit definition. The meeting is expected to hear various lobby groups on the possible changes that can be made to the current definition.


• The main point of contention is known to be the way ‘substandard medicine’ will be described.


• “A medicine which does not meet the quality standards is easy to be classified as a substandard medicine. But how do you classify a medicine that meets the quality standards but has been given marketing approval based on information that was deliberately false? This is the issue that needs to be tackled,” said an official.


• Representatives of the domestic drug industry said they were not aware of the development. The issue of counterfeit medicines was on the agenda of the 62nd WHA in May 2009, but was deferred till the next year’s meet due to lack of consensus.

To view the entire article visit: http://www.business-standard.com/india/news/who-to-revive-talksfake-drugs/369038/

Times of India: Drug Inspectors to Finally Get the Power to Arrest

The Times of India recently reported that India’s Drug Control Administration (DCA) “will soon be powered to arrest a pharmaceutical company owner for manufacturing spurious drugs or a medical shop owner for selling substandard drug and investigate the case.”

According to the article up to now, the DCA had no arrest powers, could not detain individuals for investigation or seize suspect material. The DCA has until now had to hand over all of their cases to civil police for further investigation or arrest.

XStream Systems endorses higher standards of regulatory standards, enforcement, inspection and penalties as it relates to securing the quality and standards of the pharmaceutical supply chain. It is especially important for those nations who are expanding the export of pharmaceutical products and raw materials used to make them globally.

Here are some of the interesting points and quotes from the article:

• Further, if a particular drug leads to the death of a person, the manufacturer will get life imprisonment and a fine of Rs 10 lakh will be imposed under a new amendment. The fine amount will go to the family of the victim.


• "This amendment will be a boon for the drugs inspectors. As of now even investigation is being done through correspondence with the accused or companies as there are no powers to take a manufacturer or a medical shop owner into custody for inquiry," DCA director general RP Meena told STOI. Trials of the cases would be speeded up and conviction rate would be increased with the vast powers, he added.


• Last year the DCA raided units and shops and made 48 seizures worth of Rs 1.97 crore drugs and handed over them to the police. The authorities launched prosecutions in 535 cases since 2004. Of which, 234 cases ended up in convictions and in 212 cases the accused were acquitted. For now, trials are going on in various courts in 1,012 cases.


• Also, last year 70 pharma companies were asked to stop production of drugs as they were not of standard quality. Interestingly, 84 more companies were accused of manufacturing substandard and misbranded drugs but are located in other states. "Our state requires such stringent laws as as many as 1,703 drugs manufacturing units and 50,238 medical shops are located in the state," DCA joint director K Subbi Reddy told STOI.

To view the entire story visit the following link:

http://timesofindia.indiatimes.com/NEWS/City/Hyderabad/Drug-inspectors-to-get-tonic/articleshow/4949626.cms

Mayo Clinic: The Do’s and Don’ts of Buying Prescriptions Online

The following pointers are from MayoClinic.com about the do’s and don’ts to buying prescription drugs online:

Things to do:

• Do consult your doctor. Only take medications prescribed for you by your doctor or another health care professional who knows you. He or she can determine if a particular drug is safe for you or if another treatment would be more appropriate.
  
• Do use a licensed pharmacy. The National Association of Boards of Pharmacy can tell you whether an online pharmacy is licensed and in good standing. Some sites carry a seal of approval from Verified Internet Pharmacy Practice Sites (or VIPPS). To gain this approval, sites must maintain state licenses and allow inspections by the National Association of Boards of Pharmacy.
  
• Do insist on access to a registered pharmacist. Reputable sites offer toll-free access to registered pharmacists to answer your questions. Some online pharmacies have traditional physical locations as well. If you have questions about a medication after you begin taking it or you're concerned about drug reactions, it may be valuable to speak with a pharmacist in person.


• Do read the privacy and security policies. Before placing an order, be confident that your credit card number, personal health information and other personally identifiable information will be protected.


• Do compare prices. You may find great deals online, but there aren't any guarantees. Check your local drugstore's price—it might beat the online price. If online prices are significantly lower than your local pharmacy, you should question whether the site is legitimate.


• Do be alert for counterfeits. In some cases, drugs ordered online turned out to contain no active ingredient or to contain the wrong medicine. Reduce your risk by only using legitimate online pharmacies. Don't use any medicine that arrives in altered or unsealed packaging.

Things not to do:

• Don't use a site that bypasses prescriptions. Online pharmacies that dispense medication without a valid prescription are violating U.S. law. Don't be lured in by sites that give you a prescription if you complete an online questionnaire. Only your doctor can safely prescribe medication for you.


• Don't order medication that's not approved by the Food and Drug Administration (FDA). It's illegal to import unapproved drugs into the United States. Taking an inappropriate or unsafe drug can have life-threatening consequences.


• Don't overlook the address and phone number. Steer clear of sites that don't provide a street address and phone number or that list only foreign contact information. Use only U.S. pharmacies. International pharmacies may sell drugs that do not have FDA approval or that are illegal in the United States.


• Don't succumb to false claims. Don't buy medication from sites that advertise "miracle cures" or those that use impressive terminology to disguise a lack of good science.


• Don't keep complaints quiet. If your order doesn't arrive, you find unauthorized charges on your credit card or you have another problem with an online pharmacy, report it to the FDA. Speaking up can help promote a safer marketplace for everyone.

As offered in this blog before, it is very important to be vigilant in buying any prescription medications online.

Remember, “if a deals sounds too good to be true, it probably is” is the best advice when dealing with online products. Counterfeit and fraudulent drugs permeate the web with some estimates as high as 60% of online medications as counterfeit product. Protect yourself and your family and follow these do’s and don’ts.

For more helpful tips visit: http://www.mayoclinic.com/.

To learn more about XStream Systems revolutionary anti-counterfeiting technology and 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/.