Rep. Buyer's Eight Minute Blitz on Counterfeit Drugs

On August 17th Postscript Community Catalyst Kate Petersen blogged about Rep. Steve Buyer’s (R-IN) exchange with FDA officials in July at a Energy and Commerce Subcommittee hearing on antibiotic drug resistance in farm animals.

This blog has the text of the testimony of Rep. Buyer, engaging in some animated exchanges with FDA officials over the state of pharmaceutical counterfeits in the United States.

Rep. Buyer has established for himself a reputation as a watchdog on counterfeit drug issues. In 2008, he joined with Rep. Jim Matheson (D-UT) to introduce the Safeguarding America’s Pharmaceutical Act.

Below are highlights from this portion of the hearing:

Mr. {Pallone.} Next is the gentleman from Indiana, who has 8 minutes. Mr. Buyer.

Mr. {Buyer.} Thank you very much. Dr. Clifford, I have a question that deals with adulterated, counterfeit, knockoff drugs. We have a problem in our country, and countries around the world are challenged by this. Do you see any escalation or any evidence of adulterated counterfeit drugs in animal health?

Dr. {Clifford.} Congressman, since this really falls under FDA’s jurisdiction, I would have to turn to them to answer that question.…

Dr. {Sharfstein.} For animal health, I think we are going to have to get back to you. I am not prepared to answer that. I have not heard of a significant counterfeit problem in the United States but I want to make sure and get back to you.

Mr. {Buyer.} You know, as our problem is growing, it is only time before it migrates. It is going to follow the money, right? Bad guys follow the money. And that is why I asked the question.
I want to thank the FDA for continuing the blitzes that you are doing at international mail facilities, so thank you for doing that. You are trying to “get the word out” to Americans that if you go on the Internet and you think that that is an approved website to order your pharmaceutical products, that you are really playing Russian roulette with your life, and so thank you for keeping these blitzes going and trying to get the word out. I noted in your testimony when you were with us in March, you had in your testimony, “Protecting Americans from unsafe or contaminated drugs is not just an important responsibility of the FDA, it is our core charge.” Do you agree with that today?

Dr. {Sharfstein.} I do believe that. I think it is one of the reasons that FDA—

Mr. {Buyer.} So–

Dr. {Sharfstein.} –was established.

Mr. {Buyer.} You also then in your testimony talked about FDA must adopt a new approach. Now, I think when you talked about your new approach, also you were concerned about the production, i.e., raw ingredients, that are used within our supply chain for which people are buying at retail outlets within the gold standard of our own country. So ensuring that we maintain that gold standard, you are putting your eyes on that supply chain and production. I don’t have any problems with that. I think that is wonderful. I think the Administration is doing what it is supposed to do. I applaud you with regard to your striking the agreements with other countries, putting more inspections on other soils. That is awesome.

…Now, as we are doing this, we have got both of these going on at the same time, is we are trying to then do our electronic pedigree, and Mr. Dingell has a bill, and we are going to do work and do this electronic pedigree, but let me tell you what I was bothered about what I read in the Miami Dade about your last blitz. I think it is great. Like I said, you are doing the blitz. You did a 3-day blitz. You did everything you were supposed to do, your coordination with Customs, Border Protection, thousands of pieces of foreign mail. You X-rayed them. You separated them. You identified them, the suspicious pharmaceutical products. You ID’d them. You showed how many of them were counterfeit and knocked off, and then you sent them back.

America has to be shocked, and the counterfeiters have to be excited that America is a place where you can counterfeit your drugs, send them to America, steal people’s money, and the American government will send the counterfeit drugs back to you so you can then send them to someone else that you can steal more money from. This is like one of the dumbest policies I think we have in this country…

I know you have got to be uncomfortable with that as a policy. Are you?

Dr. {Sharfstein.} Yes. I mean, I have spoken to some of the inspectors who are, you know, as frustrated as you are.

Mr. {Buyer.} All right. Now, if you are willing to step into a new–and that was your testimony that you gave to us in March, that you embrace and wanted to adopt a new approach with regard to the raw ingredients, through production and distribution always to U.S. consumers, I think I have an opportunity. I think, Mr. Dingell, we have an opportunity to help protect America, and that is embrace what the FDA is saying here, Mr. Dingell, and let us figure out how we can destroy these when they are identified, when your inspectors identify them. Let us not send them back to the counterfeiters so they can continue to rip off people. You know, Doc, come on, they are preying upon the most vulnerable of our population, which is awful. Would you be willing to work with Mr. Dingell and I to come up with a policy here that can give your inspectors the ability to destroy these counterfeit, knockoff, adulterated drugs?

Dr. {Sharfstein.} Yes, and I believe we have been already starting that process by working with your staff and Congressman Dingell’s staff on this issue.

Mr. {Buyer.} All right. Well, I want to be as proactive as we possibly can. John Dingell, to his credit, started this a long time ago with his paper pedigree, and he has always had a great interest. It goes all the way back many years into the 1970s, and I applaud what he has done. I think he has got to be pretty shocked on where America is today compared to where we were in the 1970s, and as a policy and I know you adopted this, I was just as frustrated with the last Administration but I am embracing your spirit, and if we are able to move ahead, Mr. Dingell, I want to join with you today and I want to work with the FDA and I want to resolve this matter. I want to yield to the chairman for a second.

Mr. {Dingell.} I thank the gentleman. He is most kind to me, and I want to thank him for the kind comments he has made about me. I want to assure him that my assurances of the last Congress, I would be happy to work with him, and I happen to agree with the gentleman about the problem of imports, about tracing pharmaceuticals and other drugs, and I am pleased to report to the gentleman that very shortly we will be circulating a draft for comments about pharmaceutical safety, and I hope that the gentleman when that occurrence happens that he will look at it with sympathy and I look forward to working with him because he is a valuable member of the committee, and I thank him.

Mr. {Buyer.} I thank the gentleman. The last, can I do this piece of math? Thirteen-

-

Mr. {Pallone.} The gentleman’s time has expired, but all the love–

Mr. {Buyer.} I ask unanimous consent for 30 seconds.

Mr. {Pallone.} Yes, with all the love and bipartisan here–

Mr. {Buyer.} God bless you.

Mr. {Pallone.} I certainly don’t want to stop the gentleman.

Mr. {Buyer.} Thirteen international mail facilities, on average 35,000 are pharmaceutical packages, times 365 days, that is 1,666,075 packages a year. If 80 percent are counterfeit, adulterated or knocked off, that means there are 132,860 pharmaceutical packages that are coming into the country that are either adulterated, counterfeit or knockoff, and people are taking these and they are not metabolizing in the body in ways in which as doctors you intend.

With that, I yield back.

To read the entire blog, visit: http://postscript.communitycatalyst.org/?cat=126.

To learn about pharmaceutical anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/.

Stolen Drugs Found Back in US Supply Chain

The US Food and Drug Administration is alerting the pharmaceutical supply chain regarding the reappearance of drugs stolen in a 2008 cargo theft.

On October 17, 2008, a shipment of Carbatrol and Adderall XR made by Shire Pharmaceuticals was stolen en route between the company's manufacturing facility in North Carolina and a distribution center in Florence, Kentucky.

In the theft nearly 35,000 capsules of Carbatrol, which expired between April 30 and May 31 of this year, were stolen.

Shire recently announced that some of these stolen pharmaceuticals have begun to appear in its expired returns and that some of the stolen medication may still be on the pharmaceutical market and a possible threat to consumers.

Shire warns that the drugs taken during pharmaceutical cargo thefts are unsafe because they may have experienced improper storage and handling or tampering outside of the secure supply chain. Additionally the drugs may have been adulterated or their packaging used for counterfeit medication.

The product lot numbers for the stolen Carbatrol are 2172127 and Adderall XR are 2385012.

Those who come in contact with these products should contact the FDA's Office of Criminal Investigations at 1-800-551-3989.

Secure Pharma Chain encourages all within the pharmaceutical supply chain to verify and authenticate the medications that they distribute and dispense to make certain that the product within their inventories are safe and efficacious.

To learn more about pharmaceutical authentication technologies, visit: http://www.xstreamsystems.net/

Interpol: Over 80 Arrested in Africa in Police Operation on Counterfeit Drug Rings

In a story published in The Telegram on August 26th, Interpol is announcing that more than 80 people have been arrested and at least 10 tons of counterfeit and illegal medical products seized as part of a joint police operation in five east African nations since July 1st.

According to the story :

· "Operation Mamba III" involved the Lyon, France-based international police organization and a World Health Organization unit and targeted alleged networks of counterfeit drugs makers, traffickers and vendors.
· Interpol said Thursday about 300 sites were inspected or raided in Burundi, Kenya, Rwanda, Tanzania and Uganda. The operation was the third of its kind in three years.
· Many nations have noticed a recent increase in police seizures of fake medicines. Interpol said they are becoming more prevalent, sophisticated and dangerous.

International law enforcement agencies working across borders is a significant step forward in combating the global epidemic of fraudulent, adulaterated and counterfeit medications. Continued and enhanced international cooperation is vital in making a significant impact on this deadly criminal act.

Along with enhanced enforcement, Secure Pharma Chain encourages all within the global pharmaceutical chain to deploy anti-counterfeiting technologies to protect their businesses and consumers from deadly bogus medications.

To read the entire story, visit: http://www.thetelegram.com/Canada---World/Arts/2010-08-26/article-1700417/Interpol%3A-Over-80-arrested-in-Africa-in-two-month-police-operation-on-counterfeit-drug-rings/1

To learn more about anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/.

Canadian Man Sentenced to 33 Months in Prison for Online Cancer Drug Scam

This week, Hazim Gaber, 22, of Edmonton, Canada, was sentenced in Phoenix by U.S. District Court to 33 months in prison for selling counterfeit cancer drugs using the Internet. He was ordered to pay a $75,000 fine, as well as $53,724 in restitution, and to serve three years of supervised release following his prison term.

Garber admitted to selling counterfeit experimental cancer drug sodium dichloroacetate, also known as DCA, to at least 65 victims in the United States, Canada, the United Kingdom, Belgium and the Netherlands between October and November 2007.

DCA is a highly sought cancer drug for its reputed ability to shrink tumors in lung cancer, breast cancer and brain cancer. However, the drug is experimental and not yet approved for use in either the United States or Canada.

The white powdery substance that Garber supplied to the victims was later determined through laboratory tests to contain starch, dextrin, dextrose or lactose, and contained no DCA. The packages also contained a fraudulent certificate of analysis from a fictitious laboratory and instructions on how to dilute and ingest the bogus DCA.

The sentencing is part of a larger department-wide effort led by the Department of Justice Task Force on Intellectual Property (IP Task Force) to combat the growing problem of IP violations and to protect the health of American consumers.

The case was prosecuted by Trial Attorney Thomas S. Dougherty of the Criminal Division’s Computer Crime and Intellectual Property Section and Assistant U.S. Attorney Peter Sexton of the U.S. Attorney’s Office for the District of Arizona. Significant assistance has been provided by the Edmonton Police Service, the Alberta Justice Office of Special Prosecutions-Edmonton, the Competition Bureau of Canada, the U.S. Postal Inspection Service, the Federal Trade Commission and the Alberta Partnership Against Cross Border Fraud. The Criminal Division’s Office of International Affairs provided assistance in this case. The case was investigated by the Phoenix FBI Cyber Squad.

XStream Systems applauds the IP Task Force and the FBI Cyber Squad for bringing this criminal to justice and cautions consumers against buying medications from questionable sources.

This story appears to be a classic case of a relatively unsophisticated individual taking advantage of and preying on the frantic needs of the sick with bogus drugs being peddled over the internet. His global scheme was aided by the relative anonymity and world wide access of the Internet which allowed him to market and sell his fakes to the desperately ill.

Unfortunately this tale is not an isolated occurrence but is something that happens all over the world on a daily basis. This appalling crime is being perpetrated by far more sophisticated and nefarious criminals who take advantage of people’s frantic need for healthcare and kill millions each year.

For more information visit:

US. Justice Department at http://www.justice.gov/opa/pr/2010/August/10-crm-958.html

“Canadian Man Charged in Online Cancer Drug Scam” at SecurePharmachain Blog

2010, The Year That Counterfeit Drugs Becomes a $75B Global Business

Alan Clock, SVP, XStream Systems, Inc.

As we find ourselves with a little over four months left in 2010, Secure Pharma Chain is re-posting a blog from January regarding the proliferation of counterfeit drugs globally this year.

In 2005, the Center for Medicines in the Public Interest (CMPI), released a report projecting global counterfeit drug sales to reach $75 billion in 2010. At the publication of the report, this projection was a 92% increase from the 2005 estimate of $39 billion of worldwide counterfeit drug sales. Most global experts then and now do not dispute this estimate. In fact, many would not argue the point that today, this estimate may be entirely too conservative and the real financial impact and overall number is much higher.

In 2010, we as a society face a global health catastrophe that will impact people of all countries, race, religion and economic strata.

What will be the key factor that will turn this issue around in the new decade?

"The business of selling fake prescription drugs to unsuspecting consumers is burgeoning, and is a global industry," stated Peter Pitts in 2005, senior fellow for health care studies at the Pacific Research Institute and director of the CMPI. "Nearly $39 billion, or 11 per cent of global pharmaceutical commerce will be counterfeit this year (2005)," added Mr. Pitts. "By 2010, that number will nearly double. We must enact controls to strengthen the security of our health care system from outside threats."

At the time that this report was published, Dr. Scott Gottlieb, Deputy Commissioner for Medical and Scientific Affairs at the U.S. Food and Drug Administration stated. "The increasing flow of counterfeit drugs represents a significant public health threat. We must step up our efforts to safeguard the drug supply -- we certainly should not weaken those controls."

Even with these dire predictions and public support for action in 2005, there has been little appreciable progress in the domestic and international efforts to stem the flow of this worldwide health care crisis. Regulatory, law enforcement and industry efforts to date have been inconsistent overall and seemingly lack an overall perspective of the severity and impact of this issue.

One of the most startling examples of the deadly impact of the global counterfeit medication epidemic is the World Health Organization’s (WHO) estimate that nearly 2,000 children die each day in Africa as a result of bogus drugs. Counterfeit medications in underdeveloped countries not only do not treat illness and disease but are now a major factor in creating drug resistant strains of deadly diseases such as malaria, tuberculosis and HIV/AIDS.

With the proliferation of counterfeit medications and the impact to people all over the world, the issue, in its extreme, is only now beginning to garner important public awareness.

The public awakening to this deadly scourge is the first critically important step in motivating public and industry leadership to move forward and take action.

With a motivated and aware public, elected and industry leaders will be encouraged to step up their efforts to protect their constituents, businesses and customers.

When properly inspired, these leaders will look to strengthening regulatory authority and in expanding their technology/ processes to thwart these nefarious sources of a deadly criminal act.

To learn more about technologies that are used to combat counterfeit medications, visit: http://www.xstreamsystems.net/.

How the Current Economy Will Drive Counterfeit and Fraudulent Medications

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

The following is a re-post of a Secure Pharma Chain commentary blog from October 30th, 2009.

The World Health Organization (WHO) has estimated that in 2010 the value of counterfeit medications worldwide will be approximately $75 billion. This is an increase from $35b in 2006 and it is now estimated that 10% of the global pharmaceutical supply chain is or will be counterfeit or fraudulent.

Although this estimate is dramatic in its size and growth, the WHO came up with this estimate prior to the true realization of the global financial meltdown and its impact on the world’s economies. As the impact of the financial meltdown continues to trickle through the populations of the developed countries it is anticipated by many that the worldwide estimates of counterfeit and fraudulent drugs may in fact grow beyond the $75b and begin to mirror the growth to those of emerging and non-developed countries.

Several economic factors will likelly drive this growth beyond the 2010 WHO estimates:

The rising costs of pharmaceuticals will simply become too much for many consumers to afford, especially when coupled with job loss, loss of health benefits or underemployment. Affordability will drive many to nefarious sources like the internet and many will fall prey to unscrupulous deals for bogus medications.

The lack of comprehensive laws or the ability to catch those who counterfeit, adulterate or fraudulent deal in bogus pharmaceuticals. Simply put it is very unlikely that those who perpetrate the crime will be caught or suffer any real consequence for their deeds.

The high profitability of the crime of counterfeit and fraudulent medications. It is widely accepted that anyone dealing in this crime will likely profit many times more than others dealing illicit street drugs.

Lack of regulatory oversight of the legitimate pharmaceutical supply chain which allows for systematic gaps in the supply chain that can be exploited by those with criminal intent.

The globalization of the manufacturing and raw materials process. Most medications consumed in developed countries have been outsourced to non-developed countries for economic reasons. This creates huge gaps in the quality of the product and lack of regulatory oversight which is critical and necessary for the protection of the supply chain from criminal enterprises.

Solutions to this issue within the pharmaceutical supply chain are also heavily impacted by the global economy. Track and Trace, Taggants, Serialization, Pedigree and Authentication solutions are all very effective in dealing with counterfeit, fraudulent and adulterated drugs but diminishing capital expenditures budgets and tight margins by manufacturers, repackagers, distributors and dispensers are hampering the deployment of the tools needed to eradicate this very dangerous threat to public health. Without regulatory mandates or incentives, businesses cannot easily justify the expense of solutions until or unless their business is or has been affected by counterfeit and fraudulent medications.

The initial WHO estimates were troubling enough but it would appear that based on the current economic conditions their predictions may prove to be more optimistic than what we may ultimately realize in our global pharmaceutical supply chain.

To learn more about solutions to combat counterfeit, fraudulent and adulterated medication, visit: http://www.xstreamsystems.net/.

Comparison and Combination of Spectroscopic Techniques for Detection of Counterfeit Medicines

ScienceDirect.com has made available an online report comparing spectroscopic techniques in the detection of counterfeit medications.

In this highly technical report, scientists studied Fourier transform infrared spectroscopy (FT-IR), near infrared spectroscopy (NIR) and Raman spectroscopy to determine which techniques and associations were the best for discriminating genuine from counterfeit and imitations samples.

The medications tested were counterfeit and imitations of Viagra and Cialis two of the most counterfeited products globally.

According to the report:

It is shown that for the Viagra® samples, the best results were provided by a combination of FT-IR and NIR spectroscopy. On the other hand, the best results for the Cialis® samples were provided by the combination of NIR and Raman spectroscopy (1400–1190 cm−1).

These techniques not only permitted a clear discrimination between genuine and counterfeit or imitation samples but also the distinction of clusters among illegal samples. This might be interesting for forensic investigations by authorities.

Secure Pharma Chain endorses all techniques and testing as it relates to being able to detect and interdict fraudulent, adulterated and counterfeit medication however technologies are in use today within the supply chain that allow for the accurate testing of pharmaceuticals within their sealed, unit of sale container.

Unlike Spectroscopy, these technologies do not require destruction or degradation of the product, laboratory testing or technicians to run and analyze testing results.

EDXRD allows the end user to deploy forensic level testing without opening up the container for testing or sample prep. Additionally EDXRD can accurately test products within the supply chain by warehouse resources within seconds.

To date the EDXRD testing has accurately, efficiently and effectively protected the supply chain end user from receiving or shipping adulterated, fraudulent or counterfeit drugs including Cialis and Viagra.

Spectroscopy is an excellent technology when you need very specific forensic sampling, but when you need to know if your inventories are safe before you ship them,

you don't need a laboratory to interdict counterfeit medications.

To read the entire survey report, visit: http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TGX-504127R-1&_user=10&_coverDate=11%2F02%2F2010&_rdoc=1&_fmt=high&_orig=search&_sort=d&_docanchor=&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=f9acd7f0661b04a5da0138dbac9966fa.

To learn more about EDXRD anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/.

'What's in the Bottle': Launch of New Series in Pharmacy Today

Pharmacy Today, the magazine published by the American Pharmacists Association (APA) in July started a new series of articles about "What's in the Bottle".

As the publisher L. Micheal Posey in the July edition so aptly writes in his Today's Perspective:

Pharmacists and the public recently have faced a rash of extensive and disheartening recalls of medications. It's difficult to know whether something is amiss in the world of quality control or if this is just another symptom of the general problems in today's world. We do, after all, seem to be living in an era where humanity's technologic and scientific prowess seems to be exceeding the ability to predict and handle problems (think oil spill) and where some companies appear to be viewing product-liability problems as remote possibilities or perhaps another line on their balance sheet (consider some of the settlements and fines paid by pharmaceutical companies in recent years, with amounts in the hundreds of millions or even billions of dollars).

As detailed in FDA inspection reports and other documents, some companies in the ethical pharmaceutical industry are engaging in practices once thought of as completely out of the question: use of contaminated raw materials, product of medications outside current Good Manufacturing Practices, and release of products that have failed quality control tests.

At the same time, the shift of contract pharmaceutical manufacturing to other countries is taxing the U.S.-based FDA's ability to oversee manufacturing processes of companies making prescription medications, nonprescription products, and dietary supplements. Counterfeit medications are found far too often in the medication-supply chain in the United States and elsewhere. Drug products are being stolen by the truckload from warehouses and during interstate transport and diverted to the largely illegal Internet-based market or to collaborating buyers in the health profession who are eager for the "savings". Pharmacies are being robbed and burglarized for the valuable medications they stock, with diversions going mostly to the illicit market bu perhaps some back int the pharmaceutical supply chain.

These situations have pharmacist wondering. "What's in the bottle?"

The July edition of Pharmacy Today has an excellent first piece in the series titled, Empty Shelves: Med Recalls Creating Questions which details to newest challenges faced by the pharmaceutical supply chain and industry giants Baxter and McNeil.

Secure Pharma Chain is excited that publications that cater to pharmacists are begining to weigh in on the critical issue of supply chain safety and the huge business that fraudulent, adulterated, diverted and counterfeit medications have become.

Ultimately Secure Pharma Chain believes that pharmacists as with other members of the pharmaceutical supply chain must take measures to authenticate and validate their inventories before they pass them onto the consumer.

Technologies exist today that enable the supply chain to efficently and economically authenticate pharmaceuticals within their sealed unit-of-sale container.

To read the Pharmacy Today series, visit: http://www.pharmacytoday.org/.

To learn more about pharmaceutical authentication solutions, visit: http://www.xstreamsystems.net/.

Counterfeiting, Adapt or Perish

By: Alan Clock, Senior Vice President, XStream Systems

"Adapt or perish, now as ever, is nature's inexorable imperative." - H.G. Wells

The following is a re-post of a Secure Pharma Chain commentary blog originally posted in February 2010.

For those of us knowledgeable about the issue of counterfeiting, we have long been aware of the huge growing menace that has seemingly lurked in the shadows of the collective consciousness of the public at large for some time now.

Even for those who have been at the forefront of this serious threat, which the FBI dubs “the crime of the 21st century”, currently there seems to be a heightened sense of concern about how quickly this criminal activity is proliferating. It would appear now that this threat is advancing well beyond even our own alarmist predictions.

To date, much of the death and destruction associated with counterfeiting activity has occurred off the radar screen from the populace of privileged, developed nations and instead in the isolated world of underdeveloped areas and their residents.

For some of us with the advantage of a prosperous free market system, we have been somewhat immune to the spectacle of the criminal poisoning of disadvantage populations, which happens routinely in Africa and Asia by the purveyors of this insidious transgression.

In 2010, the widely accepted World Health Organization’s estimate is that pharmaceutical counterfeits are a $75 billion industry with an annual growth percentage of 12-16%. The World Customs Institute estimates that food counterfeiting is a $49 billion annual enterprise.

According to the study of Counterfeiting Intelligence Bureau of the International Chamber of Commerce counterfeit goods make up conservatively 5 - 7% of World Trade which the International Anti-Counterfeiting Coalition calculates would make the current global counterfeit economy the world’s biggest single business.

We now find ourselves in a perfect storm that will expand counterfeit criminal activity well beyond our wildest estimates and make it far more deadly in scope and size. The primary elements feeding this calamity include:

· a worldwide economy in a downward spiral

· ineffective regulations and laws on the crime of counterfeiting

· spotty or careless enforcement of existing laws on counterfeiting

· disjointed supply chains that cross multiple governmental boundaries and jurisdictions

· huge taxes on critical commercial markets like health care that are squeezing both the business and the consumer to look for cheaper goods

· a collective lack of knowledge and leadership by governments around the globe to protect their constituents

· industries that choose to ignore the threat to their businesses instead of protecting their brand and customers

· a collective lack awareness of the deadly nature of the threat of counterfeits by consumers worldwide, most consider this a harmless act

Until now, this criminal activity, although grand in its size has really been driven by single individuals or disparate organized entities that realize how lucrative and safe this nefarious criminal activity has become. Criminals understand that counterfeiting is the perfect crime:

· there are few ways to get caught

· if they do get caught their activity carries almost no significant ramifications

· most often their crime will not be discovered for some time giving them plenty of time to cover their tracks and escape

· they have a global marketplace where they can carry out transactions anonymously in cyberspace

· the profit margin derived from counterfeiting transcends what most businesses make in a legitimate activity

Even as this perfect crime expands to educated and developed nations, we now seem at the precipice of something far more dangerous and deadly as this menace seems likely to evolve into something much larger in size and scope and far more insidious as a whole.

Many experts now fear the inevitable, when terror organizations, who are not driven by greed but rather destruction, realize the relative ease and deadly effectiveness that a purposeful counterfeiting event could trigger in a region or nation. Be it in a consumer good, food stuff, electronics or medication, one single, simple adulteration could literally harm millions with relative impunity.

Adapt or Perish. The time is now for governments, industry and consumers to understand the need for solutions to protect themselves from the various nefarious sources that threaten their health and well being.

Today there are many technologies and services available that can offer protection to industry and consumers from those who would seek to profit or cause destruction. Leaders in governments and industry around the globe need to act now to protect entire populations.

Although no one solution, to date provides a single, "iron clad" solution to this scourge, when appropriately layered, these existing solutions can and do create effective and efficient security to protect supply chains and consumers from fraudulent, adulterated and counterfeit products.

To learn more about, anti-counterfeiting solutions, visit: http://www.xstreamsystems.net/.

Johnson & Johnson Announces Plan To Revamp Its Quality Controls

On the heels of the massive recalls due to quality control issues with some of it most popular and profitable lines, J&J is announcing its plans to appoint Chief Quality Officers for each of its three major divisions.

J&J company spokesman Bill Price stated, "the chief quality officers and the creation of a new position are part of a 'more comprehensive remediation plan' for the company."

Given the state of the pharmaceutical supply chain, as globalization proliferates and even industry giants find themselves suffering from poor quality, raw material adulteration, fraudulent products and counterfeits, it seems logical that all members of the supply chain integrate technologies to authenticate and verify the product within its individual inventories is genuine, safe and clinically efficacious.

Stakeholders in the supply chain have too much at stake to rely solely on inventory control measures, pedigrees, bar codes and serialized numbers, they must take measures to insure the safety of the products that they sell. It is important to know where the box has been but it is vital to know what is in the box.


To learn more about pharmaceutical supply chain authentication technologies, visit: www.xstreamsystems.net.

Baxter's Heparin Saga Continues

The Wall Street Journal writes about the preliminary legal wrangling by Baxter regarding their class action lawsuit over the 2008 contamination of heparin products which led to 81 deaths in the United States.

In the class action lawsuit, Baxter and its heparin supplier Scientific Protein Laboratories are cited as being negligent because they did not do enough to check the quality of the contaminated active pharmaceutical ingredient that ended up in heparin products distributed to patients.

According to the story in the Wall Street Journal, “Baxter and SPL are trying to block an attempt by Amphastar Pharmaceuticals to force disclosure of documents relating to the case which they claim contain proprietary and commercially-sensitive information.”

Amphastar claims that the documents could reveal important information about the origins of the tainted API.

Among the documents under dispute is the deposition of another company, Momenta Pharmaceuticals, which assisted the US Food and Drug Administration in its investigation of the scandal.

This story, like several other high profile issues regarding the quality and efficacy of pharmaceuticals, is a cautionary tale to all within the pharmaceutical supply chain to protect their products.

With an entire criminal industry that focuses on counterfeiting and what many call economically-motivated adulteration, in which ingredients are deliberately adulterated to fool lab testing and increase their value, the pharmaceutical industry, the value of their individual brand and the health and well being of the average consumer is in the cross hairs. Manufacturers, distributors and dispensers need to deploy and integrate technologies to verify and authenticate their raw materials, products, inventories and dispensed medications.

As it relates to Baxter, the FDA believes that the heparin was purposely laced with cheaper, toxic contaminants - oversulphated chondroitin sulphate – which ultimately lead to the deaths of 81 people.

To read The Wall Street Journal article, visit: http://online.wsj.com/article/SB10001424052748704868604575433960537183170.html?mod=googlenews_wsj.

Pharmaceutical Cargo Theft and Recovery

As organized criminal elements continue to target the pharmaceutical supply chain, FreightWatch International has reported a pharmaceutical theft and its subsequent recovery of a drug courier shipment in Michigan on August 17th.

According to FreightWatch International, the courier van that contained pharmaceutical products destined for multiple stops, originated in Livonia, Michigan on August 17th.

The van and its contents were stolen while the driver had stopped and was making a delivery at a distribution point in the Greater Detroit Metro area.

Fortunately the pharmaceutical product was equipped with a covert GPS tracker and the Detroit Metro Police was notified and they were able to recover the stolen products and arrest two suspects.

The value of the recovered stolen goods was not reported.

This is a victory in pharmaceutical supply chain security and illustrates the need and value of the deployment of a variety of technologies and solutions in properly protecting the legitimate supply chain from theft, fraud, adulteration and counterfeit product.

Secure Pharma Chain encourages that all members of the supply chain deploy a layered suite of technologies to protect their inventories and consumers.

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

CNNMoney: Drug Recalls Surge

Parija Kavilanz in an August 16 CNNMoney story, writes about the incredible surge in recalls of prescription and over-the-counter drugs which is raising questions and concern regarding the quality of drugs within the United States’ supply chain.

This excellent article contains statistics, industry expert quotes and examples of a problem that is impacting both industry giants and small pharmaceutical companies. Ultimately drug recalls are impacting the overall health and well being of the average consumer.

The CNNMoney story accurately encapsulates a very real global pharmaceutical industry issue that is impacting the lives and overall health of the domestic population.

According to the story:

• The Food and Drug Administration reported more than 1,742 recalls last year, skyrocketing from 426 in 2008, according to the Gold Sheet, a trade publication on drug quality that analyzes FDA data.

• One company, drug repackager Advantage Dose, accounted for more than 1,000 of those recalls. Even excluding Advantage Dose, which has shut down, recalls jumped 50% last year.

• "We've seen a trend where the last four years are among the top five for the most number of drug recalls since we began tallying recalls in 1988," said Bowman Cox, managing editor of the Gold Sheet. "That's a meaningful development."

• The fast pace of drug recalls seems to be continuing in 2010. Drug recalls totaled 296 from January through June of this year, said Cox. "If we continue at this same rate, we could get 600 or more recalls by the end of the year," he said. "That's still a very high rate of recalls."

The issue is not limited to small manufacturers, high-profile recalls of Tylenol and other popular over-the-counter brands from McNeil Consumer Products, a unit of Johnson & Johnson, have drawn significant scrutiny because of quality concerns in pharmaceutical production.

Also in the CNNMoney story:

• The mounting problems over recalls have also drawn attention from lawmakers. Two bills introduced this year would impose stricter regulations on the industry and give the FDA authority to mandate recalls.

• The spike in recalls, especially of generic and over-the-counter drugs, is being driven by manufacturing lapses, experts say. Some of the biggest culprits: the quality of raw materials, faulty labeling and packaging and contamination.

• An FDA official told the Gold Sheet that 2009 saw no increase in recall "incidents" -- or recalls involving one product problem at a company -- just more recalls per incident.

• "Since every recall situation is unique, it would be difficult to assess whether there are any trends or increases in recalls this year," FDA spokeswoman Elaine Gansz Bobo told CNNMoney. "At this time, however, we have not identified any trends."

Kavilanz, in the story attributes several factors to this surge, including the speed of drugmakers to bring generic versions of branded drugs and cost cutting pressures of these manufacturers, including lack of total oversight of the product as they outsource production and raw materials increasingly from overseas.

• Generic drugs account for about three quarters of all prescription drug sales, according to industry group PhRMA.

• In their hurry, drugmakers sometimes fail to spend enough time time learning how best to make the drug.

• For example, Detroit-based Caraco Pharmaceutical Laboratories issued four "tablet-thickness" recalls on March 31, 2009, an additional one on June 8 and yet another recall on April 17 for products that might have been contaminated, said Cox.

• "So they get the application. They make and market the drug, but they could still have problems down the road if they haven't really understood the optimum way to make that drug," said Cox.

• Drugmakers aren't the only ones that have run into problems. Repackagers that relabel drugs into smaller units for resale or distribution to health care facilities, have also had serious lapses.

• Advantage Dose, which led last year's recalls by far, is one such company. It issued 1,106 recalls last year following the FDA's inspection of its facility in late 2008. According to the Gold Sheet report, the FDA's inspection listed a wide range of manufacturing problems.

• Drugmakers, facing intense competition, are trimming manufacturing investment or outsourcing production, said Prabir Basu, executive director of the National Institute for Pharmaceutical Technology and Education, a nonprofit scientific and research organization.

• "It is very expensive to make drugs. It also costs a lot of money to maintain adequate quality controls," Basu said. "You have to invest a lot."

• "We still have the best at drug manufacturing here in the United States. But if we're seeing signs of trouble, imagine what's happening outside of the U.S. in other countries from where we import drugs," said Basu.

• The Gold Sheet report said that 165 recalls last year were of products made, or believed to be made, abroad. That was up 58% from 2008.

• "Overall, I am concerned about the quality of drugs," said Basu.

CNNMoney, with it first-rate story with great industry insight, highlights an industry issue that has the potential to create a huge health care issue. As the pharmaceutical supply chain continues to globalize not only will quality control issues continue to proliferate but the issue of fraudulent, adulterated and counterfeit medications also penetrating into the legitimate supply, will escalate as well.

Secure Pharma Chain, encourages all members of the pharmaceutical supply chain and regulatory agencies, to embrace and deploy authentication technologies that verify the efficacy and quality of products within their sealed unit-of-sale container.

Current industry solutions and methods of tracking the pedigree and serialization track the product’s transaction through the supply chain do nothing to protect the consumer from poor quality, fraud, adulteration and counterfeit pharmaceutical product.

Understanding and verifying the authenticity and quality of the end use product to the consumer is vital in protecting both the industry and well being of the population.

To read the entire CNNMoney story, online, visit: http://money.cnn.com/2010/08/16/news/companies/drug_recall_surge/index.htm?hpt=T2.

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

Pharmalot: FDA Commish 'Feels Very Encouraged' About China

Ed Silverman in his excellent blog, Pharmalot offers his opinions and commentary on comments made by FDA Commisioner Margaret Hamburg during her recent tour of China.

Some of Mr. Silverman’s commentary includes:

· There she is in Shanghai, touring some facility with Chinese government officials who, of course, will do their best to make sure she doesn’t catch a whiff of a contaminated active ingredient or come within 100 miles of a gray market supplier. And there is international diplomacy to consider, after all - who buys all that US government debt?
· Despite being labeled a paper tiger by a pair of Congressman who are angry over the lack of progress into the Heparin probe the FDA commish was all smiles as she explained her view of the relationship between her agency and its Chinese equivalent.
· “I leave feeling very encouraged by the partnership we’ve developed here,” Hamburg tells the Associated Press. “This is a priority for China as it is for the United States.” She adds the two agencies are pursuing a “common agenda” to improve manufacturing practices and regulate supply chains.
· The FDA has set up offices in three Chinese cities and is cooperating in training and joint inspections, among other areas. But as the AP notes, more than 20 million imports of FDA-regulated products are expected this year, and less than 1 percent are inspected. Earlier this year, the FDA began using an automated system to sort through millions of foreign shipments and identify food and drugs that are most likely to be contaminated.
· But “we will never have the resources physically and financially to inspect all those facilities,” Hamburg readily concedes. “It is not a simple problem to eliminate in terms of the practice of bad actors who are willing to put human health at risk to make more money. It is an area we are continuing to monitor very carefully.”

Clearly it does not appear that the US and the FDA is coming into this process with a strong hand.

It seems doubtful that in the near term unless there is some epic tragic event that disables or kills a large population within a developed nation that the Chinese will cooperate or make the necessary changes within their system to demand a higher level of regulatory and industry compliance to basic good standards and practices.

As China continues to produce more and more raw materials and finished pharmaceutical products that are consumed around the globe, it is vital that the members of the global pharmaceutical chain (manufacturers, distributors and dispensers) verify the quality of the products within their inventories to protect both their businesses and more importantly the consumer.

To read the entire Pharmalot blog post: http://www.pharmalot.com/2010/08/fda-commish-feels-very-encouraged-about-china/#more-25617.

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

SecuringPharma: German Pharmacies Infiltrated by Fake Medicines

Phil Taylor wrote and posted a story August 12th in SecuringPharma about a scandal that involves dozens of pharmacies in the northern portion of Germany that are being investigated about the distribution of illegal medicines, including counterfeits.

Mr. Taylor reports that “the case suggests that far from being mainly a risk associated with purchase of medicines over the Internet, in some parts of Germany counterfeit and otherwise illegal drugs may be on pharmacy shelves and getting into the hands of patients.”

Also included in the posted story:

· Prosecutors have brought charges against one pharmacist from the Braunschweig region who is accused of handling €1.68m-worth and are investigating several others, according to a report by German business magazine Markt.

· The affairs of other pharmacies in Hamburg, Celle, Verden and Kiel are also being probed, according to the report, which notes that the counterfeit goods being traded included not only lifestyle medicines such as impotency drugs and bodybuilding products, but also painkillers, antibiotics and cancer treatments.

· Among the practices alleged to have been carried out by the pharmacists is mixing of illegally-acquired medicines with legitimate, genuine product.

· Last year, Germany suffered other high-profile cases in which counterfeit versions of GlaxoSmithKline's Combivir (lamivudine and zidovudine) and Boehringer Ingelheim's Viramune (nevirapine) - both used to treat HIV infection. The fakes were discovered in the legal supply chain, Combivir in Bremen and Viramune on the island of Sylt in northern Germany.

The suspected introduction and mixing of counterfeit medications into the trusted supply that consumers rely upon to be safe, make this a very troubling story.

When one of the most trusted health care professionals, pharmacists, poison their own supply chain with fraudulent, counterfeit medications, the only protection is in the members of the supply chain routinely verifying the safety and clinical efficacy of the product through authentication technologies.

Secure Pharma Chain encourages everyone within the pharmaceutical supply chain to deploy a variety of technologies, specifically authentication solutions to protect their inventories from fraudulent, adulterated and counterfeit medications. Authentication solutions go beyond pedigree or track and trace solutions and verifies to the end user what is inside the box within their inventories.

Knowing where the box has been is important but knowing what is inside the box is critical.

To read the SecuringPharma post, visit: http://www.securingpharma.com/40/articles/548.php.

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

Freightwatch International: July 2010 Cargo Theft Report

FreightWatch International, an industry leader in providing cargo theft intelligence through data collection, analysis, and customized reporting, released their monthly report on cargo theft for July 2010.

FreightWatch recorded 49 cargo thefts for the month of July; a 9% decrease from the incidents recorded in June. The states with the highest theft rates continue to be California, Florida, and Texas, followed by Pennsylvania, Georgia and New Jersey.

By location, 41% of cargo theft occurred at truck stops and 84% of thefts consisted of full truckloads being stolen.

This month, an average of $259,732 per load results from the 40% of thefts that contained the amount of loss value.

By commodity, electronics and food/drinks persisted as the most targeted commodities. Building/Industrial also appears on the top of the list with six additional thefts compared to June with only two thefts recorded in this category.

Pharmaceuticals as a commodity experienced three reported incidents in July, all on July 16th. The three pharmaceutical thefts in the report include:

• July 16th theft of a trailer at a truck stop in Jefferson, Ohio of an unreported value.

• July 16th high jacking of a truck transporting pharmaceuticals of an unreported value in Detroit, Michigan.

• July 16th a second theft of a trailer on the same day at a truck stop in Jefferson, Ohio of an unreported value.

The issue of pharmaceutical cargo theft energizes the need for material screening of products within the supply chain, from manufacturer to dispenser, to properly protect consumers everywhere.

As the value and prevalence increases, so too does the potential risk to consumers.

To read the entire report from Freightwatch International, visit:

http://www.freightwatchintl.com/.

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

Safety First

The following is the re-posting of a blog written and posted in Secure Pharma Chain by Patricia A. Earl, Vice President, Business Development , XStream Systems in December 2007.

As succinctly stated in the earlier blog post, it is a near certainty that the United States pharmaceutical industry will face growing counterfeiting issues in the coming years.

These increasing occurrences will impact the industry in a number of important ways. The primary, and most obvious, concern is the liability problem. Trial lawyers have eagerly pursued businesses throughout the chain of custody when filing claims in other product liability areas.

A second issue regarding counterfeiting is integrity. From a professional and personal standpoint, members of the pharmaceutical industry do, and should, want to assure the end users of the products that they are safe and effective. Add to this the desire for safety and efficacy in a regulatory environment that when functioning properly will demand accountability. When companies within this industry sell or distribute products, they should be exactly what the customer expects.

The third issue is trust…and reliability. In order for our industry to grow effectively and for each of our companies or institutions to thrive, our customers must be able to trust us and the products that we deliver. Counterfeits, regardless of where they exist in the distribution chain, undermine the customers’ faith in the industry as a whole.

A final issue that I wish to discuss is the possibility of government intervention in the pharmaceutical distribution process. If counterfeiting becomes more prevalent and risks to patients are growing, then Congress, the Executive branch and its regulatory agencies will face increasing public pressure to “do something.” In this scenario is likely that they will respond with knee jerk mandates. Given government history in other industries, those mandates can be too severe, and at the same time, generally ineffective.

Finally, the pharmaceutical distribution chain should address a proactive posture to assure the integrity of the product. If done thoughtfully, this would limit liability, maintain integrity, enhance trust and reliability and, perhaps, preempt overreaching government meddling. Leaders in the pharmaceutical industry should implement counterfeit detection technology now to protect our reputations and our bottom lines.

Sudan Combats Sale of Counterfeit Drugs

Countries in Africa continue to fight the incredibly deadly crime of counterfeit medications which attacks and kills many within underdeveloped nations.

The following story comes from the August 7th edition of the Sudan Tribune and describes how the Sudanese government wages a war against counterfeiters who blatantly shop their dangerous wares on an unsophisticated population.

In Africa, where counterfeit medications can make up over 50% of a nation’s pharmaceutical supply chain, the issue of bogus drugs is at epidemic proportions and its impact on the health and well being of these populations is increasingly more deadly.

Consumers in developed nations should not feel comfortable that they are immune from the dangers of these criminal acts.

Because of huge profits, the likelihood that they will avoid legal punishment and without consumers or regulatory agencies on guard against it, counterfeiters are even more incentivized to ply their deadly inventories within developed nation’s legitimate supply chains.

The following are the highlights from the Sudan Tribune article:

· A megaphone atop a double cabin land cruiser roamed Luonyaker main market on Friday warning customers that some unscrupulous persons have flooded most of the rural towns with fake medicines purportedly to cure all diseases.
· In Southern Sudan, even those selling fake drugs are vulnerable to counterfeiting. Wol Kon Laau, head of Yiik Adoor Primary Health Care Unit in Gogrial East County, Warrap State, said the common use of counterfeit or sub-standard pharmaceuticals means many patients wait too long to seek proper medical attention.
· "As a practitioner I have had examples to give. I encountered most of them when I was practicing as a medical student that certain drugs were brought in into the system even in the normal delivery system which were of low quality and it even becomes worse with the drug peddlers who are going about villages killing people," he added.
· A salesman without medical background says his Capsule cures high blood pressure, arthritis, kidney disease, premature menopause, cardiovascular disease, and infertility, saying it might be correct but this requires prescription from medical practitioners not by assumption.
· "Fake and counterfeited products usually involve products that are either high volume or high cost. So you look mostly at anti-Malarial currently the Artemisinine combination therapy. In addition to that there are products for erectile dysfunction and because these are often sold at pubs and places where people try to get them without prescription they go for high value, they go for high cost," he explained.
· "With me in the committee we go on the market. We sample products, and we publish the results so that we can name and shame. We hope that within 18 months Southern Sudan in general and Warrap state in particular should be able to have very decent data on the extent of the quality problem in the area," said Laau.
· He says that this will give health officials a better sense of the scale of the problem and allow for the eventual prosecution of those purposely endangering public health.

To learn more about technology and solutions to combat counterfeit medications, visit: http://www.xstreamsystems.net/.

To read the entire Sudan Tribune article, visit: http://www.sudantribune.com/spip.php?article35875.

Cargo Thefts on the Rise-Threaten Security of Pharmaceuticals

The following is a re-post of a blog written by Patricia Earl, V.P. Business Development, XStream Systems for Secure Pharma Chain in October 2009.

Since this posting the issue of the security of pharmaceuticals while in the supply chain and in transit has become more prevalent with major criminal organizations targeting pharmaceuticals distribution points and warehouses.

As pointed out here by Purdue Pharma’s Chuck Forsaith, one of the key speakers at the recent 2009 National Cargo Theft Summit, Americans have an increasing issue with pharmaceuticals being stolen in transit from the manufacturer’s dock to the distributor’s dock or to the retailer.

Chuck talked about why transportation – and trucking in particular – is so vulnerable to cargo theft these days and what shippers and carriers alike can do about it.“On the street, one milligram of OxyContin is worth between 50 cents to $1, with single pill containing 80 milligrams. That means the street value of just ONE OxyContin tablet is between $40 and $80 – and Purdue Pharma typically ships 50 to 100 DRUMS worth in a single tractor-trailer load. Now you know why cargo thieves stalk the pharmaceutical industry like so many hungry wolves circling a herd of fat deer. While pharmaceuticals remain a relatively small part of the goods stolen by cargo thieves – making up just 6% of the total cargo theft “pie” as it were – the average value of a pharmaceutical cargo theft is very high, Forsaith explained; roughly $1.4 million per shipment. Overall pharmaceutical truckload shipments themselves can average anywhere from $10,000 per load (for over the counter or “OTC” products) to several million dollars (for the expensive bio-tech drugs).”And that’s not the total picture, either, Mr. Forsaith stressed, cargo thieves have exactly zero overhead – meaning the entire shipment is 100% profit to them, no matter what they sell it for. And when it comes to potentially addictive medicines such as OxyContin, the sky’s the limit.

The National Cargo Theft Prevention Initiative created the original National Cargo Theft Strategy to combat cargo theft and this action has been sponsored by the federal government, in cooperation with private industry and state and local governments. Cargo theft incidents in the U.S present a clear and rising threat to the U.S. economy, the well being and the national security of the United States of America. Since the first Cargo Theft Summit held in 2005 and subsequent gatherings held since, Cargo Theft has continued to be a rising nationwide issue with a significant economic impact on the U.S. economy and has a very high potential for use by terrorist organizations. Cargo crime accounts for an estimated direct merchandise loss of up to $ 25 billion dollars per year in the United States.

You can find more information on the website http://www.nationalcargothefttaskforce.org/.

Members of the pharmaceutical supply chain and domestic consumers should be aware of the proliferation and prevalence of counterfeit, adulterated, stolen, diverted or fraudulent medications. Distributors and dispensers should only purchase their inventories from legitimate supply chain members that utilize pedigrees and material authentication technologies to verify the medication and the chain of the transaction.

Consumers need to only buy medications from licensed, known pharmacies that procure their inventories from the legitimate pharmaceutical supply chain and who use best, safe medication practices when dispensing drugs.

To learn more about material screening technology, visit: http://www.xstreamsystems.net/.

SecuringPharma: Philippines Government Under Fire Over Counterfeit Medicines

As reported in SecuringPharma.com, a healthcare advocacy group in the Philippines is taking issue with the government's stance on counterfeit medicines, claiming that its policies are exacerbating the problem.

The advocacy group, Samahan Lavansa Pekeng Gamot, claims that percentage of fake drugs within the Phillipines is three times higher than the government claim of 10% according to a report in the Malay Business Insight.

According to the SecuringPharma story:

· Samahan claims that counterfeits make up around 60 billion pesos ($1.3bn) of the 200 billion peso Philippines pharmaceutical market, and that the situation is made worse by parallel imports of medicine and the actions of some of the government-run Biotika retail outlets.

· The 16,300 Biotika stores in the Philippines have problems restocking medicines from the Department of Health and this encourages them to source medicines from elsewhere, creating a potential entry point for counterfeits into the supply chain. They also tend to stock a wide range of medicines, despite only being supposed to offer a limited list of 42 essential medicines.

The Philippines is a classic example of a pharmaceutical supply chain whose members are not either properly regulated or commercially incentivized to protect its inventories and ultimately the consumers.

With a supply chain inundated with 10-30% of its medications that are fraudulent, adulterated, sub-standard or counterfeit the financial and human toll on the society and its healthcare system is immeasurable.

The deployment of a bundle of solutions and technologies, including material authentication within the supply chain is an easy solution to protect both the financial and physical well being of the population.

To read the entire SecuringPharma story, visit: http://www.securingpharma.com/40/articles/541.php

To learn more about anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/.

Life Science Leader: A Guide to Pharmaceutical Serialization

In the August 2010 issue of Life Science Leader, Gunter Schilpp, Marketing Manager for Mettler Toledo writes a very interesting primer on the application of serialization within the pharmaceutical market.

This piece gives some interesting highlights on the basics of serialization, the minimum implementation requirements, equipment, complexity and regulatory uncertainty involved in pursuing this process.

Mr. Schilpp does an excellent job explaining the various issues and positives of this important evolution of the track and trace solution of supply chain security.

Mr. Schilpp conclusions are that pharmaceutical supply chain serialization should be “considered as an overall strategy of supply chain safety, security, and efficiency.”

Secure Pharma Chain certainly agrees that serialization will become an important component of an overall strategy of supply chain safety but does not believe that there is any one solution or technology that will simply solve supply chain safety and security.

Secure Pharm Chain feels that serialization will be an important tool as part of a larger tool set of solutions that the supply chain uses in defending their inventories and protecting consumers from those intent on tainting the market with fraudulent, adulterated, substandard or counterfeit medications.

Secure Pharma Chain endorses a strategy which incorporates the inclusion of a variety of tools, solutions and technologies, with material authentication as a centerpiece, as the most comprehensive, cost effective and efficient way for the global pharmaceutical supply chain to manage risk and protect both their brand and consumer.

There is no one technology that will solve this problem of supply chain safety and security.

Serialization, like other Track and Trace solutions, follow the transaction from point to point and are important piece of the puzzle, but they require a sophisticated and expensive process that all members of the supply chain must comply with or the chain is broken. Ultimately it does not tell the person handling that product that what is inside the box is authentic and safe.

Authentication, with its ability to verify and authenticate the product and its components at any point in the chain, allows each member of the supply chain the vital assurance of the safety and efficacy of a product from manufacturer to the point of dispense.

Coupled together both tools can protect consumers from those intent on making a profit at the expense of their health.

Knowing where the box has been is important but verifying what is inside the box is vital.

To read the Life Science Leader article, visit:
http://www.lifescienceleader.com/index.php?option=com_jambozine&layout=article&view=page&aid=4091&Itemid=56

To learn more about pharmaceutical supply chain authentication technologies, 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/.