Secure Pharma Chain Blog

Can You Believe It? J&J Announces Another Recall...

2011-01-16T08:44:00.005-05:00

McNeil Consumer Healthcare Initiates Yet Another Voluntary Recall Of Certain Products.

Just when you thought it could not get much worse for J &J, on Friday Johnson & Johnson’s McNeil Consumer Healthcare Division, in consultation with the U.S. Food and Drug Administration recalled certain lots of TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, and TYLENOL® upper respiratory products, and certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB® products distributed in the United States, the Caribbean, and Brazil.

The J &J company statement said that the recalled products were manufactured at the McNeil plant in Fort Washington, Pennsylvania prior to April 2010, when production at the facility was suspended. The company is initiating the recall as a precautionary measure after an extensive review of past production records found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented. It is very unlikely that this impacted the quality of these products.

In addition, McNeil Consumer Healthcare is also initiating a voluntary recall of certain product lots of ROLAIDS® Multi-Symptom Berry Tablets distributed in the United States, in order to update the labeling. The company initiated the recall after determining that the product labeling does not include the language “Does not meet USP” as required by regulation.

According to the press release, McNeil identified the inadequacies as part of a thorough, proactive product quality and process assessment of all McNeil produced products.

On all levels this is a saga of an industry giant that has poorly managed the entire process of production, product quality control, regulatory affairs and public relations. J&J’s entire corporate image, trusted brands, executive management and financial future is in a significant state of decline.

J&J’s announcement of a comprehensive plan to clean up its production and public image is a operational and PR process that should have been initiated many months ago.

The lost sales, enormous expense in recalls and cost to the brands has to be a huge hit to J&J's bottom line.

This story is a cautionary tale for all, not making an investment in and failure to take the necessary steps to assure quality control and to protect your brand from sub-standard production, poor quality raw materials, fraud, adulteration and counterfeit will cost the stakeholders and consumer.

What are the odds that we will see another recall from J&J soon?

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

Freightwatch International: December 2010 Cargo Theft Report

2011-01-12T01:41:00.005-05:00

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 December 2010.

FreightWatch recorded 64 incidents in December, a slight decrease in the average theft rate per month at the end of a very busy fourth quarter.

By location, California, Florida and Texas accounted the highest number of incidents in December, with 17, 13, and seven thefts respectively. This month, an average loss value of $383,350 resulted from the 25 incidents with reported loss values.

Violence in cargo theft remained low in 2010, however, three incidents occurred in December in which weapons were used in the acquisition of cargo, including two hijackings in Southern California and an armed robbery in Memphis.

FreightWatch is reporting four, very publicized pharmaceutical thefts in December:

• December 7th in Dallas, Texas, the theft of a trailer of pharmaceuticals of an unreported value.
• December 13th in Baltimore, Maryland the hijacking of a delivery van of pharmaceuticals of an unreported value.
• December 17th in Memphis, Tennessee a warehouse robbery and hijacking of delivery vans of an unreported value.
• December 23rd in Memphis, Tennessee a delivery van robbery valued at $439,000

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 pharmaceutical material screening technologies, visit: http://www.xstreamsystems.net/

Caution: The Rising Price of Fake Drugs

2011-01-09T04:51:00.004-05:00

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

The following is a re-post of a Secure Pharma Chain opinion blog from 2010:

Industry security experts are noticing a significant trend in the illegal counterfeit medication trade and unfortunately it does not bode well for the unsuspecting consumer.

Apparently the sophisticated drug counterfeiter is realizing that as the consumer and supply chain becomes more aware of this deadly crime, they must be more clever in marketing their wares publicly.

With the Internet and its anonymity the counterfeiter has been able to market directly to the supply chain and consumer. In the past all they had to do was to offer their bogus goods online at a dramatically lower price than the genuine product and they would automatically have a ready supply of buyers.

Today as the consumer becomes more aware of the exploding issue of fake medications they are heeding the buyer beware mantra of "if a deal is too good to be true, it probably is" and avoiding nefarious deals.

Naturally the smart counterfeiter is now raising his price, just enough to appear as if it is a dramatically discounted, genuine product but not too good to appear to be "too good to be true" to the end user.

The perfect, high margin crime of pharmaceutical counterfeiting is becoming even more lucrative.

Now more than ever, the pharmaceutical supply chain needs to protect itself by deploying a variety of safeguards and technologies to make certain that products that flow through their inventories are authentic and safe. Consumers need to be very diligent and cautious to make certain that they are buying their medications from a reliable and trusted pharmacy and not from sources that do not require prescriptions from your personal physician.

As it relates to your medications, "buyer beware" not only means protecting your pocketbook but protecting your health and well being as well.

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

Drug Counterfeiting, Adapt or Perish

2011-01-07T03:05:00.004-05:00

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

The following is a re-posting of an opinion blog in Secure Pharma Chain blog from 2010:

By: Alan Clock, Senior Vice President, XStream Systems

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 healthcare that are squeezing both the business and the onsumer 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 wellbeing.

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/

Straight Talk: Fake Drugs Are Real

2011-01-06T03:05:00.001-05:00

US Pharmacist magazine prints an excellent “straight talk” editorial about counterfeit drugs in its December 2010 issue.

Harold E. Cohen, Editor-in-Chief of US Pharmacist writes an extremely frank and insightful editorial on the problem of counterfeit medication globally and encapsulates it concisely.

Mr. Cohen's entire “Straight Talk” editorial titled Fake Drugs Are Real follows:

Now that the hoopla and celebrations over the midterm election results are quickly fading, Congress, with its newly elected members, will soon have to get down to the serious and daunting tasks of fixing the economy, reducing unemployment, exploring defense spending, and paying more attention to health care in the United States. While the provisions of the original health care bill will continue to be hotly debated, there is another health care crisis in the U.S. and other countries that has been growing exponentially for more than a quarter of a century and that seems to get little or no political attention.

According to the World Health Organization (WHO), the appearance of counterfeit medicines in international commerce was first mentioned as a problem at a WHO conference in Kenya in 1985. The proliferation of fake drugs is so widespread that no organization or business analyst can accurately predict the value of this trade to the counterfeiters or the number of lives it has affected; but by some estimates, 10% of all global drug sales are counterfeit, with some observers saying the total could be as high as 25%. And fake drugs put some $75 billion into the pockets of their distributors. While the pundits may argue over the actual figures, one thing virtually all of them agree on is that the widespread use of the Internet is the fuel powering the enormous growth in the distribution of counterfeit drugs worldwide. The WHO estimates that 50% of all medicines sold online are counterfeit. According to the Pharmaceutical Security Institute, last year nearly 1,700 incidents of counterfeit drugs were reported, triple the number in 2004.

The counterfeiters apparently spare no therapeutic category. The WHO reports that 60% of all the counterfeit drugs are manufactured to treat the most popular therapeutic categories, including antibiotics, hormones, analgesics, steroids, and antihistamines. Most recently, counterfeit drugs have popped up in very unlikely products as well. For example, the FDA recently reported that counterfeiters have infiltrated the surgical mesh market. Surgical mesh is used to reinforce soft tissue during surgery. And this past summer, the FDA warned about fraudulent Tamiflu sold over the Internet as “generic tamiflu.” In this particular scam, the product did not contain Tamiflu's active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin. And as if that were not enough, earlier this year the FDA issued a warning about a counterfeit version of the OTC weight-loss product Alli 60-mg capsules (120-count refill pack). A favorite arena for selling this particular product was online auction sites.

To put the profitability of fake drugs into perspective, an associate director for global security at Pfizer in Europe reports that the profit margin from counterfeit Viagra is some 10 times higher than that of the street drug heroin. A former FBI agent is quoted as saying, “Instead of punching out ecstasy tablets, counterfeiters can reload pill-producing machinery and make Lipitor.” At a recent drug seizure in Istanbul, investigators nabbed 700,000 fake Viagra pills alongside 51 kg of heroin.

It is estimated that the number of lives taken by counterfeit drugs could be as high as a million worldwide. For this reason, it is incumbent on pharmacists to continue warning their patients about the risks of buying drugs on the Internet and to be vigilant about checking the credibility of their suppliers. Fake drugs are real and are not going away anytime soon.

The final sentence from Mr. Cohen’s editorial is very encouraging and spot on, clearly the pharmacist, one of the most important healthcare providers to consumers around the globe, is a critical resource in informing the consumer and in making certain that the members of the supply chain maintain high standards in deploying solutions to protect their inventories from fraudulent, adulterated, sub-standard and counterfeit medications.

To access the editorial in the December 2010 of US Pharmacist, visit: http://www.uspharmacist.com/content/d/straight%20talk/i/1281/c/24574/

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

The Decade of the Counterfeit-Part Two

2011-01-05T03:55:00.001-05:00

The is the second and final installment of a two part opinion blog by Alan Clock, Senior Vice President at XStream Systems, Inc. that was first posted last January on Secure Pharma Chain. Part One was posted yesterday.

How do we as a society both domestically and globally solve this growing threat and eliminate the danger that looms as its deadly consequence to us all?

We now live in a worldwide, global economy. Trade and industry superpowers have emerged beyond the traditional European and North American developed nations. Comprehensively all industries have had enormous movement of production into underdeveloped nations, even those that have a tradition of trade riddled with fraud, counterfeiting and corruption. These countries with well know nefarious sources of supply, now find themselves as a primary producers of everyday consumer products that are in foodstuffs, household goods and medications on the retail shelves of Main Street USA.

The reality, unknown by many, is that this counterfeit phenomenon is growing and going well beyond the borders of the undeveloped world. Today, not one product, not one place, not one person is immune from the impact of counterfeit and fraudulent products. It is likely that we will continue to see this counterfeit boom continue unabated indefinitely.

How this phenomenon is happening is both complex and simple. This is a global event which adds to its complexity, but it is driven by easy money which is very straightforward to understand.

As such, some of the major factors driving the unprecedented proliferation of counterfeit products around the globe decade include:

• Global economies and worldwide supply chains. As companies become more global and procure raw materials and contract production overseas due to lower costs and expense, the supply chains become much more difficult to control and monitor. Companies lose control over their production, intellectual property and quality control. Regulatory processes and enforcement in third world countries lag behind the developed world and institutional control. Nefarious vendors can contaminate for quick profit a product by providing poor quality or adulterated raw materials prior to production. Without adequate controls manufacturers, distributors, retailers and consumers find themselves vulnerable to poor quality, contaminated or fraudulent materials. Often by the time an issue is discovered the product is well within distribution, its source difficult to pinpoint with the perpetrators long gone. Unfortunately by that time the impact of the bogus product has been borne by thousands.

• Ineffective laws and regulations. As a global economy expands, products move across multiple borders making them increasingly vulnerable and allowing for organizations to take advantage of legal loopholes, breaks in regulatory authority and the ability for law enforcement to adequately monitor movement of goods and services. Penalties for criminal activities also exacerbate the situation. A criminal organization can make more profit with less risk of being caught or with any significant legal ramifications by counterfeiting than almost any other criminal activity. Basically it is easier to counterfeit products, with much less risk and much more profit than in any other legitimate or illegitimate activity.

• Growth of the internet and unrestricted, instant access to millions of consumers. In the 21st century, counterfeit organizations can directly or indirectly market and sell their wares online, 24 hours a day in relative anonymity. These organizations can set up websites and fulfill transactions with only a few key strokes and completely camouflage their operation. By the time a regulatory body, law enforcement agency or consumer finds a fake product the marketing source or website and operation is long gone into a hazy cyber world.

• The global financial meltdown that occurred in the last half of the decade has caused many retailers and consumers to look at the price of materials, focusing less on quality and authenticity. As incomes and profits fall, so do the standards of the producer or consumer as they scramble to find the products and materials that they rely on. This is a dangerous environment where counterfeit organizations thrive. A perfect scenario for fraudulent activity occurs when members of the supply chain focus on price over cost and fraud. The criminals know that by the time their crime is discovered they have little chance of being held accountable.

• The lack of brand protection and security by members of the supply chain. Many manufacturers, distributors and retailers have been slow to realize the huge impact that counterfeit products have and could have to their businesses. Many have had and continue to show a lack of strategy in dealing with this issue, ostensibly because they have not educated themselves on the problem or they do not have the necessary solution to effectively deal with it. Regrettably until most of these organizations face the liability or brand erosion of a catastrophic event caused by fraudulent activity they simply ignore the issue altogether.

• The lack of implementation or acceptance of comprehensive solutions to combat counterfeiting. There have been scores of regulatory bodies, legislation and industry groups make attempts to implement comprehensive solutions to counterfeit activities. Most initiatives prove to be ineffective, based on their lack of acceptance, expense and their complicated approach. Functionally most of these solutions are based on a transactional approach. A transactional approach relies on the supply chain to continually interact and exchange data. This constant information exchange in real time is difficult at best and extraordinarily expensive at worst especially when you are dealing with a far reaching, global supply chain.

Additionally transactional methods only deal with the product package and not the material or product itself. Some of the largest and most egregious fraud and counterfeit events of the past several years were products that had pristine transactional pedigrees but the product on the inside of the package was adulterated or fraudulent, causing harm to thousands of end use consumers and millions in losses to the brand.

To date, most industries seem to have taken a wait-and-see approach driven by the cost of current solutions, which ultimately means that the initiatives die as the events which caused the activity loses momentum over time. The reality is that eventually business leaders within the supply chain have a “hear-no-evil, see-no-evil” attitude as it relates to this issue because they posses few answers and have little to no government or industry leadership to the mandate or guide them.

The dilemma of the next decade is how to marshal our resolve as a society globally and properly respond to the multiple factors which have driven this decade of fraudulent, adulterated and counterfeit products that have proliferated in the 21st century.

First and foremost, to win this battle, there needs to be a universal awareness of how prevalent and how dangerous this issue actually has become. Consumer’s awareness and their rejection of products that are not vetted and authenticated is critical.

Additionally, regulatory authorities across the globe need to be motivated, synchronized and resourced appropriately so as to eliminate the shadows and safe havens that allow counterfeiters to thrive.

Finally, industry and supply chains need to understand and realize the profit, loss and liability that exist if they do not deal with counterfeits head on. Each of the stakeholders of the consumer supply chain, from corporations to consumer, need to push for sophisticated solutions and eliminate this potentially deadly threat.

Vital to these three primary steps is the realization from all; manufacturer to consumer, is the understanding what this counterfeiting is currently, but what it can become if not properly addressed.

Most ominous is the potential for counterfeiting to evolve beyond the simple criminal act to becoming a massive terror threat is very real. As it stands today, millions die each year from individual criminal counterfeit acts, if done with a coordinated murderous intent; a terrorist element could comprehensively impact the health and mortality of an entire country or society.

Fortunately the solutions are at hand, today there are technologies that can be comprehensively layered to protect the various members of the supply chain, within individual channels to follow transactions, screen materials and authenticate the validity of products at each step of the sequence as it makes its way to the consumer.

One such solution is a technology known as EDXRD. This innovative technology allows the user to molecularly screen the product inside its original container without destroying or degrading the product, thus minimizing the need for Track and Trace or transactional solutions. Basically this solution adds functionality from the transactional and looking at the outside of the container to looking inside the container with Molecular Screening. Ultimately, this type of solution provides each member of the supply chain the confidence to know that their inventories safe and efficacious.

In the end, layered deployment of technology solutions, consumer awareness and a coordinated regulatory/law enforcement process will be the most effective strategy to lessen this very dangerous, criminal activity. When the criminal elements realize that there is little profit and a realistic chance that they will be held accountable for their actions, the deadly issue of counterfeit and fraudulent products will drastically decline and the Decade of the Counterfeit will become a brief historical story of how technology and public awareness save the day.

Alan Clock, Senior Vice-President of XStream Systems has over 20 years of pharmaceutical, healthcare and sales distribution experience. Mr. Clock has an impressive track record of promoting comprehensive solutions to healthcare providers, distributors, large corporate entities, group purchasing organizations, employer groups and managed care organizations. He has held senior sales executive and national account roles for major Fortune 100 healthcare industry leaders and has successfully negotiated and sold billions of dollars in multi-year pharmaceutical service, software, equipment, packaging and consulting agreements.

The Decade of the Counterfeit-Part One

2011-01-04T03:55:00.003-05:00

This is the first installment of a two part opinion blog by Alan Clock, Senior Vice President at XStream Systems, Inc. that was posted last January on Secure Pharma Chain.

The first decade of the 21st century could carry many labels given the rise of global terrorism, a bursting housing bubble and a worldwide financial meltdown. However one very appropriate label, albeit lesser known by the masses, would be the Decade of the Counterfeit.

Although counterfeit materials and fraudulent supplies have been around for centuries, with the emergence of far reaching global supply chains and an expanding worldwide economy, the criminal activity of producing counterfeit goods have propagated and is impacting a greater number of consumers more than ever before.

In modern times counterfeit products go well beyond the conventional bogus purses and knock off apparel that we traditionally associate with this fraudulent activity. The scope and audacity of the contemporary counterfeiter goes well beyond what has traditionally been considered to be a victimless crime.

Today’s counterfeit products include every product that is used today. This runs the gamut from commercial aircraft parts to sophisticated electronics, and from consumer goods to food and life saving healthcare products. Counterfeited products include all of the goods that consumers rely upon for their safety and well being. At best, these bogus products fall short of their consumer’s expectation while at worst they threaten a population’s safety and overall health.

An insidious example of how counterfeit activity can create a deadly consequence and cause thousands to die is documented by the issue of counterfeit drugs causing drug resistant disease strains in underdeveloped countries in Africa and Asia.

With medical science producing drugs that can effectively cure or curb diseases such as tuberculosis, malaria and HIV/AIDS, unscrupulous counterfeiters are producing fake drugs with only a trace of the real drug’s active ingredient. The counterfeiters put only enough of the real ingredients in to fool rudimentary testing processes. The unfortunate side effect of these bogus treatments is that not only do they not provide any therapeutic cure, they actually create more dangerous strains of the disease that are impervious and resistant to the known drug regimens used to treat the illness.

The World Health Organization estimates that upwards of 2,000 children per day die as a result of taking counterfeits medications in Africa alone.

Well over 1 million children die in Africa and Asia die each year because of counterfeit drug medications.

A few global statistics from the World Health Organization regarding pharmaceuticals, even further energizes the debate regarding the label Decade of the Counterfeit:

• In 2010, the World Health Organization (WHO) conservatively estimates that counterfeit medications will be a $75 billion industry worldwide.

• The WHO projects growth of counterfeit medications to be over 12-16% annually, worldwide.

• The WHO Reports that globally 10% of Pharmaceuticals are counterfeit, fraudulent or adulterated.

How do we as a society both domestically and globally solve this growing threat and eliminate the danger that looms as its deadly consequence to us all?

Alan Clock, Senior Vice-President of XStream Systems has over 20 years of pharmaceutical, healthcare and sales distribution experience. Mr. Clock has an impressive track record of promoting comprehensive solutions to healthcare providers, distributors, large corporate entities, group purchasing organizations, employer groups and managed care organizations. He has held senior sales executive and national account roles for major Fortune 100 healthcare industry leaders and has successfully negotiated and sold billions of dollars in multi-year pharmaceutical service, software, equipment, packaging and consulting agreements.

View Part Two of the opinion blog tomorrow on Secure Pharma Chain.

MD News: Counterfeit Drugs Prove to be an Increasing Problem

2011-01-03T08:14:00.003-05:00

The economic downturn and continuously rising drug prices can influence consumers to seek cheaper prescriptions and over-the-counter drugs from unauthorized providers and online sources.

MD News, America's leading business and practice management magazine for physicians reports on the Pharmaceutical Security Institute report regarding growth of counterfeit drugs and how physicians need to be counseling their patients on the dangers of bogus medications.

Highlighted in the MD News story:

• The Pharmaceutical Security Institute (PSI) reports that counterfeit drugs have tripled since 2004 to a startling 1,700 incidents worldwide in 2009. It is estimated that the size of the counterfeit drug market ranges from $75 billion to $200 billion each year. PSI suspects this number to likely be much larger since most cases of counterfeit drugs are hard to detect.

• Stress to your patients the serious consequences of purchasing counterfeit drugs. These fakes may include too much, too little or none of the ingredients found in the real medications, which could be detrimental to a patient’s health.

Healthcare professionals need to a primary conduit in informing their patients and the healthcare consumer of the dangers of fraudulent, adulterated, sub-standard and counterfeit drugs.

Today more than ever the populations around the globe are all at risk from the effects of the proliferation of these potentially lethal fakes.

To read the entire MD News story, visit: http://www.mdnews.com/news/2010_12/national_dec10_counterfeit-drugs-prove-to-be-an-increasing-problem

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

Two Part Series: The Decade of the Counterfeit

2011-01-02T22:49:00.002-05:00

Starting Tuesday, January 4th, Secure Pharma Chain will be re-posting a two part series of an opinion blog titled, The Decade of the Counterfeit.

The piece is authored by Alan Clock, Senior Vice President of XStream Systems a twenty five year veteran of the pharmaceutical supply chain.

Secure Pharma Chain is re-posting the series given its relevance and timeliness to the issue that the global pharmaceutical supply chain will be facing in 2011 and the coming decade.

Will 2011 Be The Year of the Anti-Counterfeiter?

2011-01-01T00:43:00.011-05:00

Several positive signs, point to the new year of 2011 becoming the tipping point in the battle against the deadly scourge of counterfeit drugs?

Even though in recent year's it would appear that there have been few significant victories in the war against fake drugs, there are hopeful signs that in the new year there will be a significant tipping point or sea change in this important crusade...

Governments, law enforcement and regulatory agencies in developed countries are now publicly taking action and proactive steps in stemming the onslaught of the criminal enterprises engaged in counterfeit pharmaceuticals. The actions by the authorities in the developed world are also aiding officials in underdeveloped nations in their efforts. New laws, with well thought out legal direction and meaningful penalties shrink the criminals return and make them more vulnerable.

The mainstream media outlets are finally recognizing the issue and are now routinely reporting on and informing consumers that this deadly problem impacts the health and well being of people all around the globe. In year's past it was rare to find a story about drug counterfeiting coming from a major media outlet, now it is rare not to have the issue, its enforcement and the consequences not reported on by a major news organization.
Because of the media attention, consumers are now understanding the scope of the threat and there is evidence that they are using their buying power to encourage the supply chain to take action.

The pharmaceutical supply chain is becoming more proactive in their recognition of the problem. In the past they have routinely passed the responsibility of adulterated, fraudulent, sub-standard and counterfeit drugs to others in the supply chain not realizing the costs and liability that ultimately gets spread out to all. Not so long ago the status quo and "hear no evil, speak no evil, see no evil" was the standard response from industry leaders when the issue of bogus drugs was mentioned. In 2010, there was a collective awakening from manufacturers, distributors and dispensers that hopefully will evolve into a full blown revolution of action.

Technologies and solutions are coming into into the market that give the supply chain the tools they need to both attack and defend their inventories from the introduction of these dangerous fakes. As these technologies are deployed, the drug counterfeiter will be disadvantaged in introducing his bogus wares onto the consumer.

These are all positive signs but clearly individually or collectively they do not mean that the issue of counterfeit medications will not continue to grow and proliferate or that millions around the globe will not die or have their health negatively impacted.

What these signs do mean collectively is that the meaningful pieces of the overall solution of the global epidemic of counterfeit drugs are finally coming together so that true progress can finally begin in earnest.

Cheers to 2011!

Alan Clock, Senior Vice President, XStream Systems

WHO Fears Growing Malaria Drug Resistance May Be Spreading

2010-12-30T07:43:00.003-05:00

WHO officials say counterfeit drugs and poor storage are to blame.

Ron Corben in the November 28th issue of the Voice of America News, reports on a story from the World Health Organization regarding the growing issue of malaria drug resistance in Asia primarily caused by adulterated, fraudulent, sub-standard and counterfeit medications.

Highlights from the Voice of America News article include:

• World Health Organization officials say there are signs of growing drug resistance to mosquito-borne malaria, raising concern millions of people in Asia may be at risk.

• The Asia region accounts for more than 60 per cent of the global population at risk of the parasite with the main focus on India, Burma, Bangladesh, Indonesia and Papua New Guinea.

• But World Health Organization officials point to troubling signs a current drug combination based on artemisinin, originally drawn from a Chinese herb, is losing its potency against the malaria parasite.

• Artemisinin is largely given to patients in combination with other drugs rather than by itself in a bid to preserve the drug's long term effective strength.

• "The place where we are really concerned is on the Cambodian-Thai border," said Eva Marie Christophel a World Health Organization official in the Phillipines. "It would be disastrous if that spread because there's hardly anything in terms of new drugs in the pipeline for malaria or what is in the pipeline will take years, so we're really very much relying on arthemisinin based combination therapy."

• The World Health Organization is concerned that drug resistance could spread from the Cambodian-Thailand border region to Africa, following a similar pattern with anti-malaria drugs such as cloroquine and sulfadoxine-pyrimethamine in the 1960s and 1970s.

• In February 2009, WHO confirmed anti-malarial resistance at the Cambodian-Thailand border. But recent WHO studies found up to 20 per cent of patients at the Burma-Thailand border also showed signs of malarial parasites in the blood after the normal artemisinin combination therapy.

• "We noticed years ago that the disappearance time for parasites to disappear from the blood is increasing. Usually they disappear in two days or less," said Dr. Charles Delacollette, coordinator of the Bangkok-based WHO Mekong Malaria Program. "And we observe that there are an increasing proportion of patients showing parasites, still parasites in their blood after two days of artemisinin treatment, which was not the case before."

• Dr. Delacollette says the growing drug resistance is in part due to the sale of substandard and counterfeit drugs. In recent years, authorities cracked down against illegal factories in China. Meanwhile, counterfeit producers have been found elsewhere, including Cambodia and Burma.

• "Drugs are not quality, the quality of the drugs sold in private sector is selling any kind of drugs which are stored in very bad conditions, so they becoming substandard and also you have sellers which are selling counterfeit - purposely made counterfeit," said Dr. Delacollette.

The crime of adulterated, fraudulent, sub-standard and counterfeit drugs is a dangerous threat to populations around the globe.

To think that unscrupulous organized gangs can impact the health and well being of populations around the globe, especially for diseases and maladies that have long since been conquered by the advances in medical science is unconscionable.

Unfortunately the issue with malarial drugs is just the beginning of a much larger issue of drug resistant strains of diseases around the world. Drug resistant diseases know no borders and impact all societies, rich and poor.

The global supply chain must take proactive measures to protect their inventories from this insidious crime by deploying solutions to track and authenticate their inventories.

To read the entire Voice of America News story, visit: http://www.voanews.com/english/news/WHO-fears-growing-malaria-drug-resistance-may-be-spreading---110934814.htmlmalaria-drug-resistance-may-be-spreading---110934814.html

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

North Carolina Man Charged with Conspiring to Sell Fake Viagra

2010-12-28T14:57:00.002-05:00

A 54-year-old North Carolina man was indicted Thursday for transporting and selling hundreds of counterfeit erectile dysfunction pills.

Cleve R. Wootson Jr. in the December 16th issue of the Charlotte Observer, reports on the story of a North Carolina man charged with conspiring and traffic of bogus medications.

According to the Charlotte Observer story:

• Federal authorities say Awni Shuaib Zayyad, 54, of Wilson, has been charged with several counts of trafficking in Viagra and Cialis and with conspiracy to sell counterfeit drugs.

• The U.S. Attorney's Office says he sold more than 500 fake Viagra pills on May 25. In August, authorities say, he transported 600 fake Viagra pills and 226 counterfeit Cialis pills.

• If convicted, Zayyad faces a maximum of 10 years in prison for trafficking and five years for the conspiracy. He also faces a total fine of $7 million.

This arrest is a good sign that law enforcement and industry in the United States is becoming more active in pursuing criminals engaged in the potentially lethal felony.

For too long now, counterfeit drugs has taken a back seat in enforcement and public awareness.

Hopefully consumers and the pharmaceutical supply chain will become more aware and proactive in their approach to dealing with fraudulent, adulterated, sub-standard and counterfeit medications.

To read the entire Charlotte Observer story, visit: http://www.charlotteobserver.com/2010/12/16/1915936/nc-man-charged-with-conspiring.html#ixzz19RArld6L

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

Counterfeit Drugs More Deadly Than Terrorism

2010-12-27T04:22:00.000-05:00

“While 65,000 people have died in the past 40 years as a result of terrorism, fake medicine has killed 200,000 people in China in one year alone.”

Interpol Secretary-General Ronald Noble quoted in a presentation at an anti-counterfeiting conference in Africa.

Thieves Commandeer Pharmaceutical Delivery Truck and Abduct Driver

2010-12-26T05:42:00.001-05:00

Police report of another pharmaceutical shipment hijacked by gunmen.

The Baltimore Sun reports on the story of a pharmaceutical delivery driver who was abducted December 13th while making his deliveries in Baltimore by thieves who made off with a truckload of drug products

Highlights from The Baltimore Sun article include:

• Police called the morning heist “incredibly thought-out,” and were looking for three suspects.

• The 55-year-old driver was forced at gunpoint into the back of his delivery truck and transported to an unknown location where the suspects unloaded about 80 crates of drug products.

• “The value of the drugs is significant,” said Baltimore Police spokesman Anthony Guglielmi, who said he could not place a dollar figure. “We believe the individuals responsible might have had knowledge about where and when the truck was going to be.”

• Guglielmi said police were in contact with the local FBI and DEA.

Clearly theft of prescription pharmaceuticals is proliferating given the high value and additional profitability of both the product and their packaging.

Organized criminal gangs are seizing the high profits and relative low risk in the criminal activity of pharmaceutical theft and drug counterfeiting.

The crime is has a double return to the criminal-prescription drugs are a valuable commodity and their packaging, used in the introduction of fraudulent, adulterated or counterfeit goods carries equal significance.

Members of the pharmaceutical supply chain must be on guard to protect their inventories from theft and fraudulent, adulterated, sub-standard and counterfeit drugs.

Consumers need to be made more aware of the prevalence and danger of bogus medications.

To read the entire Baltimore Sun article, visit: http://weblogs.baltimoresun.com/news/crime/blog/2010/12/thieves_commandeer_pharmaceuti.html

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

SecuringPharma: Survey Results Suggest Drug Counterfeiting is on the Rise

2010-12-25T05:56:00.000-05:00

A survey of 1,000 specialists in pharmaceutical anti-counterfeiting measures surveyed have suggested that faking of medicines will become increasingly severe in the coming years, and that drugmakers will invest more in defensive measures.

SecuringPharma, in a December 24th post, reports on a survey that was created as a part of the pre-conference research for IQPC's Pharmaceutical Anti-Counterfeiting conference to be held in Amsterdam on February 15th-17th.

According to the SecuringPharma post:

• Almost two third of those polled in the survey (61.5 per cent) expected the threat of counterfeiting to increase in 2011, while more than half (53.8 per cent) said they were planning to increase their budget for investment in anti-counterfeiting area.

• With regard to the anti-counterfeiting technology they were using, just 53 per cent indicated they were satisfied with it and 23 per cent said they were not content with their current protection.

• A vast majority (84 per cent) said that they were looking to invest in new anti-counterfeiting measures, according to Pharma IQ, a division of conference organiser IQPC which carried out the poll.

• Emerging markets in Asia - and especially China - were perceived as the major source of the anti-counterfeit drugs by half of the respondents.

• 21 per cent cited the Internet as the major threat for the pharmaceutical market in the context of counterfeiting, with around the same proportion identifying organised crime as their top concern.

• On a positive note, while the results indicated that the perceived threat of counterfeit medicines was significant, most of those polled (84.6 per cent) said they believed it is possible to win the war with pharmaceutical counterfeiters.

The results of the survey are in line with all of the most recent media reports and statistics that are emerging at the close of 2010. The criminal enterprise of drug counterfeiting is on the rise and the threat to supply chains and populations around the world is very real.

Of comfort is the increased realization and reaction by governments, industry and consumers of this threat. In the past most members of the supply chain were looking for government mandates before moving to protect their inventories. Based on this survey it would appear that they are now in a more proactive mindset.

Ultimately it is incumbent on the supply chain members and the consumer to be vigilant in protecting themselves from this threat.

To read the entire SecuringPharma post, visit: http://www.securingpharma.com/40/articles/815.php

To learn more about the IQPC Pharmaceutical Anti-Counterfeiting Conference, visit: http://www.pharmaceuticalanticounterfeiting.com/Event.aspx?id=405182

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

Happy Holidays from Secure Pharma Chain Blog

2010-12-24T03:58:00.002-05:00

The Team at Secure Pharma Chain Blog wishes everyone a Happy Holiday and a Prosperous, Safe and Secure New Year!

The Fake Drug Menace

2010-12-22T20:36:00.006-05:00

In China Counterfeiters are turning out bogus 'life-saving' medicines.

In Part 1 of a two-part special report, Straits Times correspondent Grace Ng focus on the huge underground trade in China of fake pharmaceutical drugs and the dangers it poses to the population.

Ms. Ng writes an excellent essay with personal stories, statistics and examples of the danger posed to the consumer.

Some of the highlights of Ms. Ng’s story include:

• The estimate from the US-based Centre for Medicine in the Public Interest shows global sales of counterfeit drugs almost doubling in the past five years.

• The World Health Organisation also believes that in some developing regions, more than 30 per cent of medications sold are fake. Online retailing has only made it worse: As much as half of what is offered online could be fake.

• Interpol secretary-general Ronald Noble has described this trade as more deadly than terrorism. While 65,000 people have died in the past 40 years as a result of terrorism, fake medicine has killed 200,000 people in China in one year alone, he said at a recent conference on anti-counterfeiting in Africa.

• The world's second largest economy [China] is also one of the main sources - possibly the biggest - of counterfeit drugs.

• A significant share of the revenue from the global sale of fake drugs is pocketed by Chinese manufacturers, who are becoming increasingly savvy in exploiting online sales and technology to grow their business.

• Chinese counterfeiting syndicates used to make most of their money from sales in Africa, inundating countries like Nigeria with fake anti-malarial drugs that were labeled 'Made in India'.

• Investigations have also revealed the technological savviness and sophistication of Chinese manufacturers. Not only do they have the laser printers and chemical labs to churn out perfect replicas of genuine drug packaging, down to the holograms, but they are also using major websites to market their wares aggressively.

As this outstanding article points out, China has become the epicenter of bogus medications and the threat to consumers’ world wide continues to grow.

Consumers around the globe must be made aware of the very real threat to their health and well being while members of the pharmaceutical supply chains must take proactive efforts to protect their brands and inventories.

To view the entire Straits Times story, visit: http://admpreview.straitstimes.com:90/vgn-ext-templating/v/index.jsp?vgnextoid=29b07cac3afec210VgnVCM100000430a0a0aRCRD&vgnextchannel=f511758920e39010VgnVCM1000000a35010aRCRD

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

Pharmacists Caught Selling Fake Viagra

2010-12-21T04:05:00.000-05:00

Fake Viagra Imported from China.

Park Si-soo in the Korea Times reports on a group of pharmacists in Seoul, South Korea who were charged with selling counterfeit drugs.

According to the Korea Times article:

• A group of pharmacists were caught selling fake Viagra pills imported from China.

• The Seoul Metropolitan Police Agency said 15 pharmacists were booked on suspicion of selling the fake pills that could cause consumers to die of a heart attack in the worst case.

• Each pill was purchased for 2,000 won and resold to consumers for 15,000-18,000 won each.

• Experts called for a tough crackdown on the circulation of fake Viagra pills.

• Offenders without a prior criminal record face a fine of up to 5 million won or a business suspension for up to 15 days.

Clearly the selling of dangerous, potentially deadly counterfeit drugs by healthcare professionals to their unsuspecting patients is troubling.

Especially troubling is the light penalties for those convicted of this potentially lethal criminal act.

When pharmacists, healthcare providers or members of the supply chain have few legal barriers or no imposing penalties to protect their inventories from bogus drugs, the potential for the introduction of fraudulent, adulterated, sub-standard and counterfeit drugs into the legitimate pharmaceutical supply chain increases significantly.

The proliferation of fraudulent, adulterated, sub-standard and counterfeit drugs has become one of the most lethal criminal acts and healthcare epidemics in the 21st century. All members of the pharmaceutical supply chain-regulators, raw material providers, manufacturers, distributors and providers-must take proactive steps in protecting the consumer from these lethal fakes.

To read the entire Korea Times article, visit: http://www.koreatimes.co.kr/www/news/nation/2010/12/113_77963.html

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

Details on the Memphis Pharmaceutical Distribution Center Hijacking

2010-12-19T08:20:00.004-05:00

Two men are in custody, one man still at large in hijacking that occurred early Friday.

According to an article written by Scott Carroll which appeared in the December 19th edition of the Memphis Commercial Appeal:

• Two men are in jail and another remains at large following a hijacking early Friday in which gunmen robbed eight employees and stole vans containing $200,000 worth of pharmaceuticals from a South Memphis distribution center.

• Ralph Jones, 22, and Patrick Dotson, 20, each were charged with eight counts of aggravated robbery, eight counts of aggravated kidnapping and one count of aggravated assault for the robbery of Hackbarth Delivery Service.

• The incident began around 5 a.m., as the loading dock doors were opening. The three gunmen confronted eight Hackbarth employees and demanded money, cell phones and personal items before forcing them to load three company vans with prescription drugs, according to a police affidavit.

• Employees told investigators they were then stripped of their clothes and locked in a fenced area.

• Hidden tracking devices embedded in the pharmaceutical products led police later that day to a house at 1279 College, where they recovered two of the vans and arrested Jones and Dotson.

• Dotson gave a statement of confession to police in which he implicated Jones, police said. Both are being held on bonds of $1 million.

• A Memphis Police Department spokesman said no information on the third gunman, who is still at large, was available Saturday.

The value of pharmaceutical drugs as both a high value commodity for their contents and for their packaging-which is used in drug counterfeiting-has made the theft of prescription drugs one of the more profitable and prolific crimes of the 21st century.

Consumers need to be made aware of the danger that this crime imposes on their safety and buy and consume medications only from known legitimate health care professionals.

Members of the supply chain need to take proactive measures to protect their inventories from theft, adulteration, fraud, sub-standard and counterfeit drugs.

To read the entire Commercial Appeal article, visit: http://www.commercialappeal.com/news/2010/dec/19/2-charged-in-theft-of-vans-full-of-drugs/

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

Drug Topics: Counterfeit Drug War Continues, Threatens Supply Chain

2010-12-19T05:35:00.003-05:00

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

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

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

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

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

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

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

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

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

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

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

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

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

FreightWatch: Armed Hijacking at Pharmaceutical Distribution Center

2010-12-17T20:51:00.004-05:00

Gunmen hijack delivery vans at a pharmaceutical distribution center, police recover product and apprehend the suspects.

FreightWatch International, an industry leader in providing cargo theft intelligence released a news bulletin regarding the armed hijacking of a pharmaceutical distribution center.

According to the bulletin:

• Three armed men entered a pharmaceutical distribution facility as the dock doors were rolled up in the early hours of December 17, in Memphis, Tennessee.

• The armed men held 9 people at gunpoint and proceeded to drive away with three delivery vans full of product.

• Through the use of redundant covert tracking devices embedded in the pharmaceutical products, the suspects and product were tracked to a house where police were able to recover the product and apprehend several of the suspects.

Pharmaceuticals have become a valuable currency and organized gangs realize the high profitability in the theft, adulteration, fraud and counterfeiting of all medications.

All members of the pharmaceutical supply chain must take proactive steps to protect their inventories from theft, adulteration and counterfeited products.

To read the entire bulletin from Freightwatch International, visit:
http://www.freightwatchintl.com/

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

36 Million Americans Have Bought Rx’s From Illegal Online Pharmacies

2010-12-17T03:20:00.002-05:00

Tens of millions of Americans have bought medications online without a prescription, according to a new study.

Alaric DeArment in Drug Store News writes about a study funded by the Alliance for Save Online Pharmacies and released by The Partnership at DrugFree.org, which finds that illegal online pharmacies have sold drugs to 36 million Americans.

According to the Drug Store News story:

• Many independent and chain retail pharmacies operate websites and there also are reputable online pharmacies, such as Drugstore.com. However, a number of illegal online pharmacies also exist, and buying drugs from them opens consumers to the risk of taking counterfeit, adulterated or unapproved medications.

• “Those who sell prescription drugs online without a valid prescription are operating illegally, undercutting the laws that were put in place to protect patients, and are thereby endangering the public health,” U.S. intellectual property enforcement coordinator Victoria Espinel said. “It is a real wake-up call that so many Americans have engaged in this dangerous behavior.”

• At the White House Intellectual Property Health and Safety Forum on Tuesday, Espinel said 11 companies had joined to create a nonprofit group designed to target illegal online pharmacies, including American Express, Visa, MasterCard, PayPal, eNom, Google, Microsoft, Neustar, Network Solutions, Yahoo! and Go Daddy.

The purchase of drugs from illegal online sites is a dangerous practice that impacts the health and safety of entire consumer populations.

With these illegal purchases, the consumer is potentially bringing dangerous fakes into the legitimate supply chain. It is critical that all members of the legitimate pharmaceutical supply chain take measures to protect themselves from these dangerous sources of supply.

To read the Drug Store News story, visit: http://www.drugstorenews.com/article/companies-band-together-end-illegal-online-pharmacies

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

Illinois Man Charged in Counterfeit Drug Bust

2010-12-16T12:00:00.004-05:00

Thousands of fake valium found in an Illinois business after FDA and CBP intercept a United States Postal Service package.

Authorities charged an Illinois businessman with unlawful possession of a controlled substance after authorities discovered a package, sent to his address, contained bogus drugs.

According to a report from Sun-Times Media story:

• Bond has been set at $30,000 for a Naperville man found in possession of thousands of counterfeit Valium pills, Cook County Sheriff Tom Dart’s office announced Monday.

• Amin Rupani, 40, of the 2600 block of Salix Circle in Naperville, has been charged with unlawful possession of a controlled substance, a release from the sheriff’s office said. He was arrested at his computer business, Precision Technologies.

• The Sheriff’s Police Special Operations Unit began its investigation into Rupani’s activities after the U.S. Food and Drug Administration, along with the U.S. Customs and Border Patrol, detained a package containing counterfeit Valium pills. The 20,000 pills packed inside plastic containers had Rupani’s business address, but a fake name.

• On Dec. 9, sheriff’s office investigators, along with agents from the FDA and the U.S. Postal Service, wired the Valium package with a monitoring and tracking device and conducted a controlled delivery to Rupani’s office. When officers received a radio transmission signal that the package had been opened, they entered the business and placed Rupani under arrest.

• Rupani told investigators he received the packages from a friend who lives in Karachi, Pakistan, and that he was told the pills were vitamins and weight loss drugs. Forensic tests of the seized pills show they contain the active ingredient in Valium, but they were manufactured by a criminal enterprise in China. The estimated street value of the drugs is $200,000.

• Rupani admitted he forwarded the packages sent by his co-conspirator to addresses in Texas and California on a regular basis, using his company’s UPS account. After a search of Rupani’s business, officers also recovered nine plastic bags containing an estimated 20,000 light green triangular pills, suspected counterfeit Xanax, and a box of diet pills.

Kudos to the FDA and CBP for the interception of this particular shipment but it begs the question as to the extent of the greater issue of these types of dangerous fakes within the pharmaceutical supply chain.

Certainly this particular bust must be but a tiny fraction of a much larger pipeline of counterfeit drugs that are introduced into the United States each day.

This type of crime is proliferating at an epic pace given the high profits and extremely low risk of getting caught or doing time. In this particular instance because the fakes were of a controlled substance, the suspect may be in for a significant penalty, however those that fake prescription drugs like Viagra have fewer penalties.

Members of the legitimate pharmaceutical supply chain must take proactive measures from these types of deadly fake products ending up in their inventories.

To read the entire Sun-Times Media story, visit: http://napervillesun.suntimes.com/news/crime/2828874-418/rupani-pills-valium-business-office.html

To learn more about anti-counterfeiting technologies for the pharmaceutical supply chain, visit: http://www.xstreamsystems.net/

Freightwatch International: November 2010 Cargo Theft Report

2010-12-15T04:58:00.001-05:00

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 November 2010.

FreightWatch recorded 70 incidents in November. Prior to the Holiday season, Electronics and Food/Drinks continue to be the most stolen commodities.

By location, California, New Jersey and Texas accounted 64% of all the thefts recorded in November with 28, 11, and 6 thefts respectively.

This month, an average loss value of $642,371 resulted from the 24 incidents that contained an estimated load value.

On November 10, a load of pharmaceuticals worth $10.9 million was stolen a few miles away from its point of origin. The driver left the load unattended for approximately 15 minutes when it was stolen.

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 pharmaceutical material screening technologies, visit: http://www.xstreamsystems.net/

FDA: Don’t “Man Up Now”

2010-12-14T11:04:00.008-05:00

FDA issues warning against supplement marketed for sexual enhancement which contains potentially dangerous ingredient.

In a government recent press release the U.S. Food and Drug Administration is warning consumers not to use Man Up Now capsules, marketed as a dietary supplement for sexual enhancement, because they contain a variation of an active drug ingredient found in Viagra that can dangerously lower blood pressure.

Man Up Now claims to be “herbal” and “all natural,” and consumers may mistakenly assume the product is harmless and poses no health risk.

Consumers who have Man Up Now capsules should stop using them immediately. The FDA analyzed Man Up Now and determined that it contains sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Like sildenafil, this chemical may interact with prescription drugs such as nitrates, including nitroglycerin, and cause dangerously low blood pressure. When blood pressure drops suddenly, the brain is deprived of an adequate blood supply that can lead to dizziness or lightheadedness.

Man Up Now, distributed by Synergy Distribution LLC, is sold on Internet sites, online marketplaces, and possibly in retail outlets in single, double, and triple blister packs, and in six-, 12-, and 30-count capsule bottles.

Consumers should take great care when purchasing or taking dietary supplements products, the FDA has found many products marketed for sexual enhancement can be harmful because they contain active ingredients in FDA-approved drugs or variations of these ingredients.

To read the FDA Press Release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm236538.htm

Holiday Cargo Theft: A Concern for the Pharmaceutical Supply Chain

2010-12-14T04:53:00.000-05:00

During the seven major holidays in the United States, cargo theft rates increase by 28% on a per-day basis compared with the remaining calendar days.

FreightWatch International, an industry leader in providing cargo theft intelligence through data collection, analysis, and customized reporting, released a report outlining the statistics and concern over the increase of cargo theft during the holiday season.

The FreightWatch report analyzes the statistics supporting this commonly understood maxim in an attempt to better explain the increased risk faced by shippers and their supply chain providers.

By commodity, pharmaceutical thefts increases from 6% to 8% during the holiday.

It is critical that all members of the supply chain protect their inventories from theft, adulteration, fraud, and counterfeiting through increased vigilance and by deploying solutions and technologies.

To read the FreightWatch International Holiday Cargo Theft report, visit: http://www.freightwatchintl.com/?q=webfm_send/31

Fake Drug Factory Seized

2010-12-13T00:38:00.000-05:00

Bangladesh’s BDNews24 is reporting that several fake counterfeit drug factories have been raided and closed this week by authorities.

According to the December 7th report in BDNews24:

• The Rapid Action Battalion has sealed a fake drug factory and arrested three people in a special drive at Babubazar Bhuiyan Medicine Market in the capital.

• Magistrate A B M Anwar Pasha told bdnews24.com that they seized fake drugs worth Tk 500,000 conducting the special raid at Lakkhi Drug House and Joy Corporation of Bhuiyan Medicine Market on Tuesday and arrested three in this connection.

• Pasha alleged that the arrestees used to manufacture fake drugs rapping covers [packaging labels] of different well-known drug companies and release those in the markets.

• The RAB on Monday also sealed a fake drug factory at Nagarzanj of Keraniganj Upazila in Dhaka.

With its proximity to China and India and its stifling poverty, Bangladesh’s population is significantly impacted by the proliferation of counterfeit medications within its pharmaceutical supply chain.

It is encouraging that authorities are taking proactive action against the criminal elements that are attempting to insert their fakes into the legitimate supply. It is especially important to interdict the point of production to keep these lethal fakes from impacting the health and well being of millions. Apparently these were organizations posing as legitimate businesses that were selling their fakes into traditional medication markets.

To read the entire news story, visit: http://bdnews24.com/details.php?id=180957&cid=2

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

The Recalls Keep Piling Up for J&J

2010-12-11T05:29:00.005-05:00

McNEIL CONSUMER HEALTHCARE ANNOUNCES VOLUNTARY RECALL OF ALL LOTS OF ROLAIDS® EXTRA STRENGTH SOFTCHEWS, ROLAIDS® EXTRA STRENGTH PLUS GAS SOFTCHEWS, AND ROLAIDS® MULTI-SYMPTOM PLUS ANTI-GAS SOFTCHEWS SOLD IN THE UNITED STATES

No sooner had Secure Pharma Chain posted it blog from Pharmalot but comes more bad news from the pharmaceutical industry giant.

In a seemingly never-ending story, Johnson & Johnson’s embattled McNeil Consumer Healthcare unit has issued yet another recall, this time for its ubiquitous Rolaids brand.

It remains to be seen how many hits to its venerable brands can the industry giant take and retain its trust regarding the safety and efficacy of its respected and ever-present products with consumers.

J&J explains the recall in its press release with the following:

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is voluntarily recalling all lots of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews distributed in the United States. McNeil is taking this action following some consumer reports of foreign materials in the product, including metal and wood particles. The company’s investigation has determined that the materials were potentially introduced into the product during the manufacturing process at a third party manufacturer. While the risk of serious adverse health consequences is remote, McNeil Consumer Healthcare advises consumers who have purchased these recalled products to discontinue use.

J&J is feeling the immediate financial impact of the loss of sales, expense of recalls and operational expenses. The long term impact in liabilities, brand erosion and loss of consumer confidence will continue to accrue for many years to come.

Members of the pharmaceutical supply chain (manufacturers, distributors and dispensers) should take heed from the woes of J&J. Testing and protection of the brand and inventories from poor quality, fraud, adulteration and counterfeiting does not stop at any one point of the supply chain process. Measures must be deployed at all stops of the supply chain to test the quality and authenticate that the product being consumed is safe and efficacious.

To read the entire official J&J Press Release regarding the recall and its details, visit: http://www.rolaids.com/page.jhtml?id=rolaids/include/recall_dec.inc

To learn about supply chain authentication technologies, visit: http://www.xstreamsystems.net/

Pharmalot: The Sorry List of Johnson & Johnson Troubles

2010-12-10T05:10:00.001-05:00

“We now see a strong likelihood of near-term FDA enforcement action.”

Once again Ed Silverman in his Pharmalot blog outlines the issues that have plagued the pharmaceutical industry giant over mandated recalls, “phantom recalls”, other regulatory misdeeds that have impacted their venerable brands including Tylenol, Mylanta, Motrin, Rolaids and Benadryl.

In his blog, Mr. Silverman cites Wells Fargo Securities analyst Larry Bigelsen regarding the potential impact of continued FDA scrutiny on their operations and to J&J stock.

This blog presents some interesting, whimsical insight into the depth of the problem and the potential impact operationally and financially to J&J.

Secure Pharma Chain sees this as a cautionary tale to the pharmaceutical supply chain- protect the production, quality, efficacy and distribution of your product and inventories within the supply chain or risk the reputation and viability with the consumer. The stakes are high and the consequences to the brand and the consumer can be lethal.

It is vital that all members of the pharmaceutical supply chain deploy and utilize technologies that protect consumers from adulterated, fraudulent, sub-standard, poor quality and counterfeit drugs.

To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/12/the-sorry-list-of-johnson-johnson-troubles/

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

Court Told of Multi-Million Pound Medicines Scam

2010-12-09T03:07:00.001-05:00

“This is considered the most serious breach of medicine control, the importation of counterfeit medicines into the system,”

The Tuesday, December 7th edition of the Bath Chronicle reports on the court case of five accused of a multi-million pound pharmaceutical plot involving bogus Chinese-manufactured life-saving drugs.

According to the Bath Chronicle story:

• A jury was told the people behind Europe’s biggest ever scam of its kind were motivated by “pure greed.”

• The court was told that as a result of the scam, medicine watchdogs ordered a recall of all suspected drugs – taken by heart and cancer patients and people with mental health problems – resulting in shelves being cleared in pharmacies all over the country.

• “They were prepared to make profits by feeding duff drugs to people with serious illnesses, prostrate cancer, heart disease and psychiatric issues,” prosecutor Andrew Marshall told Croydon Crown Court.

• All five have pleaded not guilty to conspiring between January 1, 2006 and June 30, 2007 together and with others to defraud pharmaceutical wholesalers, pharmacists, the public and holders of intellectual property rights in pharmaceuticals by dishonestly distributing for gain counterfeit medicines.

• Charges were brought following a two-year investigation by the Medicines and Health Care Products Regulatory Agency, part of the Department of Health, into Consolidated Medical Supplies Ltd.

• The company, of Unit 14, Sherrington Way, Lister Road, Industrial Estate, Basingstoke, had its wholesale dealer’s licence revoked by the agency on January 8, 2008.

• “This is considered the most serious breach of medicine control, the importation of counterfeit medicines into the system,” Mr Marshall told the jury.

• “The most serious in the European Union, with far-reaching effects for pharmaceutical companies, patients and the confidence of the general public.

• “The purpose is just greed. To obtain the profits of buying illegal goods cheaply.”

• The charges relate to ‘Casodex‘, used to treat advanced prostate cancer, ‘Plavix‘, a drug prescribed to prevent blood clots and prevent heart attacks for angina patients and ‘Zyprexa’ a anti-psychotic drug prescribed to schizophrenic and bipolar patients.

• “They are just importing danger,” Mr Marshall told the jury. “The drugs imported are not extensively and expensively tested, but instead have been smuggled into the EU and distributed regardless of their chemical qualities.”

• The drugs were said to be manufactured by a notorious Chinese pharmaceutical counterfeiter currently serving a prison sentence for a similar scam in the United States.

• “No one pretended these were cheap counterfeits, they were pretended to be real. These men are not a charity importing cheaper drugs, it is I am afraid, pure greed in order to make money, working totally outside the system.

Hopefully the pharmaceutical supply chain and consumers will use this story to educate themselves about the danger that counterfeit drugs pose, even in sophisticated health care delivery systems within developed nations.

There are bad guys everywhere that realize that huge profits with little risk are involved in the sale of bogus medications.

Secure Pharma Chain encourages all within the regulatory and supply chain to take measures to protect their constituents from fraudulent, adulterated, sub-standard and counterfeit medications.

To read the Bath Chronicle article, visit: http://www.thisisbath.co.uk/health/Court-told-multi-million-pound-medicines-scam/article-2976972-detail/article.html

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

‘Made in India,’ Faked in China

2010-12-08T04:45:00.000-05:00

China is implicated in key fake-drug rings recently broken up across the Middle East and Latin America. Beijing must do more to clamp down on the entire fake industry, which flourishes within its borders.

Roger Bate a Legatum Fellow at the American Enterprise Institute and Tom Woods President of Woods International write an excellent article in The American, the Journal of the American Enterprise Institute about the huge role that China is playing in polluting the pharmaceutical supply chains around the globe by producing massive amounts of fake drugs that often times with lethal consequences.

Mr. Bate, a long time favorite of Secure Pharma Chain, along with Mr. Woods once again provides insightful analysis into one of the most insidious and deadly crimes of the 21st century.

Highlights of The American article include:

• Chinese manufacturers are faking drugs, endangering patients' lives, and undermining legitimate brands, especially those from India. Indian companies provide vast amounts of generic drugs to mid-income and developing nations. By some estimates, 80 percent of HIV drugs for the developing world come from India, and probably half the anti-malarials and antibiotics, too.

• From the counterfeiters' perspective, faking Indian drugs makes sense. Even in those categories where Indian products do not dominate the market, they may still be copied. In part this is because Western brand owners are more likely to go after those faking their brands, whereas Indian drug makers have smaller margins and hence spend less on brand enforcement.

• Criminals often manage to bypass… inspections by inserting their fake versions further along the distribution chain. So more often tip-offs from underworld contacts, probably disaffected parts of criminal networks, provide the greatest likelihood of intercepting fakes.

• Of course, sometimes the fakes make it to market, often with lethal effect. In 2009, our Nigerian colleague Thompson Ayodele came across another fake of an Indian drug in a Lagos pharmacy, this time an antibiotic. Later, we found out it too had been made in China. It is impossible to know how many patients had taken this fake antibiotic before authorities were alerted.

• Chinese gangs do not discriminate—every major drug company and every country has probably had drugs faked by the Chinese. China is implicated in key fake-drug rings recently broken up across the Middle East and Latin America. In fact, Chinese operators will fake in or for any location and they will fake anything popular. Take Artesunat, the brand of a Vietnamese anti-malarial made by the Ho Chi Minh–based company Mekophar Chemical Pharmaceutical, which is also widely faked. Ongoing research shows that fake Artesunat was found in Nigeria, Ghana, Kenya, Uganda, Tanzania, and Thailand; and it was all the handiwork of Chinese counterfeiters.

• Beijing must do more to clamp down on the entire fake industry, which flourishes within its borders.

Clearly China has become the primary incubator and exporter of the counterfeiting drug trade which now stretches beyond the globe. China must do more to protect supply chains from a criminal act that can cause death and create health care catastrophes among entire populations. All members of the pharmaceutical supply chain must take proactive steps to interdict and eradicate these deadly fakes and protect the consumer.

To read Mr. Bate and Mr. Woods article, visit: http://www.american.com/archive/2010/december/made-in-india-faked-in-china

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

Pharmaceutical Counterfeiting: The Effect of Technology, Regulation, and Legislation on Manufacturer Liability

2010-12-06T15:44:00.004-05:00

“As more technologies become available and affordable, plaintiffs will contend that companies not employing technological protections—especially for drugs highly likely to be counterfeited—breach some duty to consumers.”

Caitlin Blanche an Associate with Snell & Wilmer out of Orange County, writes an outstanding essay in the American Bar Associations Mass Torts, Winter 2010 edition regarding the legal and liability perspective of the pharmaceutical supply chain stakeholder and the overall issue of pharmaceutical supply as it relates to fraudulent, adulterated, sub-standard and counterfeit drug.

While clearly written for a pharmaceutical industry General Counsel, Ms. Blanche’s article should be a must read for all industry insider’s as they look at dealing with one of the most insidious threats to the pharmaceutical industry and health care consumers at large.

Ms. Blanche outlines the issue, discusses relevant technologies/solutions and reports on regulatory initiatives while concluding with:

"Now, more than ever, attorneys should counsel clients about supply chain management, internal audits, the careful analysis and adoption of track-and-trace and anti-counterfeit technology, remedial measures, and monitoring of all relevant legislation introduced. Although courts have not yet imposed common-law liability for drug counterfeiting, there are a number of evolving variables in play, and plaintiffs could use any one of them to allege a new standard of care for manufacturers."

Secure Pharma Chain endorses Ms. Blanche's conclusions and encourages all within the supply chain to take proactive steps to secure their inventories from adulterated, fraudulent, sub-standard and counterfeit medications.

To read Ms. Blanche’s essay visit: http://www.swlaw.com/assets/pdf/news/2010/12/01/ABAMassTortsPharmaceuticalCounterfeiting_Blanche.pdf

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

42 Police Raids In Argentinean Counterfeit Drug Probe

2010-12-03T04:48:00.003-05:00

In Argentina, 42 raids were conducted as part of continuing investigations into counterfeit and illegal drug distribution by organized crime.

According to the Argentinean news organization, Momento 24, Argentinean authorities are continuing their two year investigation of counterfeit drug sellers that operate within workers' unions that involve the use of expired drugs, counterfeiting and murder.

Last week Judge Norberto Oyarbide ordered over 40 raids on suspected workers’ union sites in Capital Federal, Avellaneda, San Justo and other interior locations within Argentina.

As reported by Partnership for Safe Medicines: Among the organizations raided were employment organizations for truckers, metalworkers, air navigators, lottery, port, petrochemical, turf, post and telecommunications, teachers and automotive industries.

In Argentina, healthcare including doctor care and prescription drugs are distributed to the majority of Argentineans’ through their employment union organizations.

According to Momento 24:

• Police collected documentation on the purchase and distribution of cancer drugs, hemophilia medication and AIDS drugs.

• Police are looking for possible connections with drug companies, including San Javier of businessman Nestor Lorenzo, previously arrested and prosecuted for organized crime medicine distribution in 2009.

In earlier reports by Momento 24, Mr. Lorenzo has testified in the investigation for the murders of Sebastián Forza, Damian Ferron and Leopoldo Bina. He testified on the chain of suppliers and creditors of Forza, who, allegedly, sold a shipment of counterfeit hemophilia medications to the National Drug and Technology Agency (Anmat).

According to an earlier Momento 24 story, one of Mr. Lorenzo’s previous business partners in a small chain of drug stores, Luis Marcelo Tarzia died in jail after his arrest for allegedly being the local manager of a Mexican drug gang that set up a methamphetamine lab in Ingeniero Maschwitz.

This is a cautionary tale to industry stakeholders and consumers of pharmaceuticals within developed countries over the possible interdiction of dangerous medications within the legitimate supply chain.

Unfortunately this type of crime is becoming commonplace within the legitimate supply chain in the UK, Germany and even the United States.

Because of its high profit and low risk, counterfeiting or dealing in adulterated, fraudulent or sub-standard medications has become a lucrative trade and has drawn the attention of organized criminal elements. The real danger however is that it not only impacts those involved with the transaction but has potentially lethal implications for unsuspecting consumers who take these dangerous knock offs.

All members of the pharmaceutical supply chain must proactively take measures to protect their inventories.

To read the entire Momento 24 story, visit: http://momento24.com/en/2010/11/26/at-least-42-police-raids-on-the-case-of-counterfeit-drugs/

To read the entire story on Partnership for Safe Medicine, visit: http://www.safemedicines.org/2010/12/argentina-federales-investigate-fake-drug-crime-ring-60.html

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

Chinese Court Jails Four for Fake Medicine

2010-12-02T04:57:00.003-05:00

Chinese gang sentenced to jail for selling expired and bogus medications.

According to a story in the Shanghai Daily, four members of a group that sold expired medicine and produced fake prescription drugs without a license were given jail sentences ranging from eleven months to five and a half years yesterday.

According to the Shanghai Daily story:

• The drugs produced by the gang were tested and found to be fake. Fortunately, none of them were sold thanks to quick action by the police.

• The Putuo District People's Court heard that the gang collected expired medicine around the city at low prices and then sold them outside Shanghai, after changing the production and expiration dates on the labels.

• Zhang Dezhi, 45, from Liaoning Province, and Zhang Wenzhong, 48, from Anhui Province, who do not have licenses to sell or produce drugs, began to collect medicines around the city last year, the court heard.

• Police seized more than 3,100 boxes of medicine in Zhang Dezhi's home in Shanghai on February 3 and intercepted more than 20,000 boxes on their way to Shen-yang. They were estimated to be worth around 550,000 yuan (US$82,614).

• Police later confiscated medicine valued at 230,000 yuan from Wang's home in Shenyang, and drugs in Zhang Wenzhong's residence in Shanghai valued at more than 400,000 yuan.

• In addition to collecting and selling the drugs, Zhang Dezhi also produced fake drugs by buying in cheap and inferior medicines and attaching false labels of more expensive brands.

Hopefully this is a sign that as reported previously in Secure Pharma Chain, Chinese officials are becoming proactive and more diligent in aggressively prosecuting a lethal crime that impacts the lives of their population and that they export around the world.

China and India have become the epicenter of a global counterfeit drug issue that is worth billions annually and is estimated to kill and impact the health of millions.

To read the entire Shanghai Daily story, visit: http://english.eastday.com/e/101126/u1a5572554.html

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

China Launches New Product Piracy Crackdown

2010-12-01T03:02:00.000-05:00

According to Bloomberg News and the Associated Press, China's government is launching a new six-month crackdown on rampant copying and counterfeiting of software, medicines and other goods.

According to the reported announcement:

• The announcement comes amid complaints by industry groups that piracy of software and some other goods is growing despite repeated government pledges to stamp it out.

• Cabinet officials said the crackdown will target a wide array of products from illegally copied computer software to corn that is falsely labeled as organic.

• Fake or illegally copied music, designer clothes, medicines and other goods are widely available in China. Industry groups say Chinese piracy costs legitimate producers billions of dollars a year in lost sales.

China leads the way in fraudulent, adulterated, sub-standard and counterfeit medications that is exported to the developed and underdeveloped nation’s pharmaceutical supply chains.

Hopefully this announcement is a serious effort on behalf of the Chinese government to protect consumers around the globe from this potentially lethal crime.

To read the entire Bloomberg News story, visit: http://www.bloomberg.com/news/2010-11-30/china-launches-new-product-piracy-crackdown.html

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

The Lancet: Tackling the Booming Trade in Counterfeit Drugs

2010-11-30T04:33:00.001-05:00

The black market in counterfeit drugs is worth billions, but it does untold damage to the health of the poorest populations.

Nayanah Siva writes an exceptional article in the November 20th issue of The Lancet on international efforts to tackle the problem of counterfeit drugs.

The importance of this article is the excellent timely information and its historical perspective.

Highlights of The Lancet editorial article include:

• WHO are of the opinion that “studies can only give snapshots of the immediate situation. Counterfeiters are extremely flexible in the methods they use to mimic products and prevent their detection. They can change these methods from day to day, so when the results of a study are released, they may already be outdated.

• “In many cases where successful actions against counterfeit, illegal and substandard drugs were undertaken by authorities, little public information is forthcoming about the case…As a consequence it is difficult for the stakeholders to understand the nature and extent of the problem, let alone to develop strategies to combat illegal medicines.”

• Steve Allen, Senior Director of Pfizer Global Security told The Lancet “I saw [counterfeiting] first hand in Tanzania last year, where we had anti-malarial products being counterfeited, to the degree that they were using identical batch numbers, identical expiry dates, the packaging, to all intents and purposes, seemed to be absolutely genuine, the blisters looked genuine, the tablets looked as if they were genuine, you would not be able to tell the difference, I can promise you, I've seen them myself.” It was only after these tablets were tested in a laboratory in the UK that it was discovered they had no active ingredients at all. “I can't think of many more worst-case scenarios, you have a counterfeiter somewhere in the world manufacturing a medicine for someone [pregnant women], she believes she might die anyway from malaria but it also impacts the unborn child, it is one of the most despicable of crimes.”

• The problem, Allen explains, is that counterfeiting is a “relatively low-risk, high-reward business to be in…and that is why organized crime gangs are using this far more frequently. In 2006 our colleagues in the narcotics units in Istanbul raided a manufacturing plant for narcotics but actually discovered a large quantity of our erectile dysfunction products and at the same time recovered 378,000 ecstasy tablets alongside the ingredients to manufacture 150 kg of heroin.”

• Newton is deeply concerned about the substantial detrimental effects counterfeit medicines have on African populations. “The main consequences…are increased mortality and morbidity, endangering drug resistance and loss of medicine efficacy, loss of confidence in health systems and health workers, economic loss for patients, their families, health systems, and the producers and traders in good-quality medicines, adverse effects from incorrect active ingredients, a waste of enormous human efforts and financial outlay in the development and manufacture of medicines…”

• Allen emphasizes the importance of international collaboration among regulators, the pharmaceutical industry and political representatives, and thinks this strategy will have the best chances of tackling counterfeiting. “This is not just an issue for one company, it is not an issue for one country, it is an issue for all of us.”

• Counterfeit drug crime is a complex issue requiring international and regional initiatives among industry, government, charities, and law enforcement…More political will and collaboration between medicine regulatory authorities, police and customs is essential.

All members of the legitimate pharmaceutical supply chain (governments, manufacturers, distributors and dispensers) must take it upon themselves to proactively protect and interdict their inventories from adulterated, fraudulent, sub-standard and counterfeit medications. This is a critical step by all of the supply chain stakeholders as a way to protect their industry, individual businesses and most importantly the consumer.

Everyone must be made aware that the impact of counterfeit drugs knows no borders. What happens in underdeveloped nations will ultimately impact and effect populations in developed nations around the globe.

To read the entire The Lancet editorial article which appeared in Volume 376, visit: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2962118-6/fulltext

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

Counterfeit Medicines: Health and Harm

2010-11-29T04:55:00.001-05:00

Counterfeiting has a long history. For most commodities it is simply the theft of brand owners' intellectual property, a trademark violation. But fake medicines can also kill.

Political wrangling over language, and confusion over how to deal with the public health and private property aspects of counterfeiting, is hampering international action.

Charles Clift writes an excellent article for the December 2010 issue of The World Today that goes into detail and insightfully probes into the issues, aspects and consequences surrounding drug counterfeiting.

Mr. Clift’s article is a must read for both those who are schooled on the issue and the uninitiated.

Here are a few insights from Mr. Clift’s The World Today article:

• Counterfeit, falsified and substandard medicines pose a considerable threat to health. Although detailed knowledge of their prevalence and impact on human well-being is limited, they can fail to cure, promote antimicrobial resistance, and ultimately kill. The threat from these medicines is probably growing, particularly in poorer countries with weak regulation and poorly monitored distribution networks.

• Counterfeiting can be very profitable, and those who do it are becoming increasingly sophisticated, which makes patients in developing countries, who usually have to buy medicines from their own resources, particularly vulnerable.

• In the case of food, medicines, cosmetics and some other goods, counterfeiting can also pose a serious threat to human health because products are likely to be either substandard or contain positively dangerous components or ingredients. This kind of counterfeiting is thus qualitatively different from, for example, a fake Rolex watch.

• Pharmaceutical products are a rather special case for several reasons. Typically it is more difficult to decide whether a product is counterfeit or not, not least because the consumer or prescriber cannot know the contents of the medicine. Before they can be legally marketed, medical products are, at least in principle, subject to much stronger regulation concerning their safety and quality than other items. Bodies such as the Food and Drug Administration in the US are responsible, so counterfeit products will also contravene drug safety, as well as intellectual property, laws.

• The general war on counterfeits is principally about protecting markets and private intellectual property rights, but in the case of pharmaceuticals this self-interested motive is overlaid by a concern to protect public health. The combination of self-interested and altruistic motives can be confusing to observers, and suspicious to some.

• However, the issue of counterfeit medicines has recently become extremely controversial. The definition that the World Health Organization (WHO) first developed in 1992 has generated continuing controversy by conflating the concept of counterfeiting - which has a specific meaning in relation to intellectual property - with issues concerned with the quality, safety and efficacy of medicines.

• Thus, counterfeits become inextricably confused with medicines that are falsified in some other way - for example by concealing their true identity and source - and medicines that are simply substandard: not containing ingredients to the specifications required by regulatory authorities.

• In addition, concerns have been raised that anti-counterfeiting measures might lead to threats to the legitimate trade in generic drugs. These concerns were made worse by the detention in the European Union (EU) in 2008 of generic versions of brand name drugs in transit from India to other developing country markets on the grounds they were infringing European patents.

• Undoubtedly, no one supports the work of the counterfeiters, with the harm they can do to sick people. The controversies are a reflection, in part, of perceived conflicts of economic interest between countries with brand name and generic pharmaceutical industries in the means used to tackle counterfeiting, as well as substandard medicines in general.

• Overcoming these perceptions of conflicting interest, including ensuring that definitions and rules and procedures do not discriminate between generic and brand name products, will be the key to more effective anti-counterfeiting measures.

Mr. Clift’s article is an excellent encapsulation of the problem of counterfeit medications and the complexity in dealing with this deadly crime.

To read and download the entire The World Today article, visit: http://www.chathamhouse.org.uk/publications/twt/archive/view/-/id/2102/

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

SafeMeds: Mississippi Stores Selling Counterfeit Drugs Raided

2010-11-27T04:00:00.000-05:00

Operation Knock Out Knock Offs- A law enforcement partnership in Mississippi between federal, state and local officials, yields approximately 30 federal search warrants in search of counterfeit pharmaceuticals.

According to a press release from the Mississippi’s Attorney General’s Office and a blog post in SafeMeds:

• On November 18, a team of nearly 100 law enforcement agents from the U.S. Attorney’s Office-Northern and Southern Districts (MS), the Department of Homeland Security/Immigration and Customs Enforcement (ICE), the Food and Drug Administration and the Mississippi Attorney General’s Office, participated in raids via Mississippi’s Operation Knock Out Knock-Offs Task Force.

• "[The raids are] a key example of how Operation Knock Out Knock-Offs is working in Mississippi," said Attorney General Jim Hood. "By partnering with federal and local officials, we can help protect consumers from dangerous fakes."

• The first part of the operation focused on creating the state task force and the second phase centered around educating consumers and vendors about the dangers of counterfeit drugs. The operation received additional federal funding in October and will continue into next year.

• "We are just getting started," said Hood. "Counterfeiters are on notice that we mean business."

• From February 2010 to November 2010 undercover agents made dozens of purchases of counterfeit drugs at “convenience type businesses” throughout the Magnolia State. These counterfeit drugs reportedly included fake pain killers, antibiotics and birth control medication along with supplements not approved for sale in America.

• "Unapproved, uncleared, or misbranded products pose a clear and present danger to the public health," said David W. Bourne, Special Agent in Charge of U.S. Food and Drug Administration's Office of Criminal Investigations Miami Field Office. "We will continue to join with our law enforcement counterparts to aggressively pursue those who place consumers at risk for their own financial gain."

• "The smuggling of substandard, tainted or counterfeit products violates U.S. laws and regulations and threatens public health and safety," said, Raymond R. Parmer, Jr., special agent in charge of the ICE Homeland Security Investigations (HSI) office in New Orleans. "Our ability to work together across the federal government and with agencies around the world is a strong and appropriate response to a growing international threat."

The deadly criminal phenomenon of counterfeit medications is not limited to underdeveloped countries. These products exist, have significant consequence to the consumer and have the ability to become part of the legitimate supply chain.

All members of the legitimate supply chain must proactively protect their inventories and customers from these lethal fakes.

To read the entire SafeMeds post, visit: http://www.safemedicines.org/2010/11/mississippi-stores-selling-counterfeit-drugs-raided-51.html

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

Pharmalot: Another Day, Another Johnson & Johnson Recall

2010-11-25T04:51:00.001-05:00

Ed Silverman continues his insightful and humorous blogging on yet another recall from J&J’s McNeil Consumer Health unit:

Highlighted in Mr. Silverman's blog:

• Once again, Johnson & Johnson has yanked a huge amount of over-the-counter medicines. This time, the recall involved about 4 million packages of children’s Benadryl allergy tablets and about 800,000 bottles of children’s Motrin caplets from pharmacies and distributors due to “inefficiencies” in manufacturing.

• Specifically, all product lots of Children’s Benadryl Allergy Fastmelt Tablets in cherry and grape flavors distributed in the US, Belize, Barbados, Canada, Puerto Rico, St. Martin, and St. Thomas and all product lots of Junior Strength Motrin Caplets distributed in the US. However, there was no indication of any adverse event reports or that the products “do not meet quality standards,” she wrote. Consequently, consumers can continue to use the products.

• Unlike the series of previous recalls, the health care giant did not issue a press release to announce these moves. When asked to explain the difference in procedure, the spokeswoman wrote this is considered a distributor recall, but that the info was posted on the individual product web sites on Nov. 15.

• Tens of millions of bottles have since been recalled; a plant in Fort Washington, Pa., has been shuttered and may be retrofitted; some 300 plant workers lost their jobs; Congressional hearings have been held; federal and state investigations are under way; consumer confidence in the company is falling; a quality control guru was appointed at the corporate level and at least $600 million in sales will be lost this year.

Since the posting of the Pharmalot blog, J&J has added another recall, this time of nearly 9 million bottles of Tylenol.

At some point, it seems logical that J&J would aggressively be doing everything in its power to alleviate these quality control issues.

To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/11/another-day-another-johnson-johnson-recall/

Feds Drop Counterfeit Drug Charges Against Prominent Pharmacist

2010-11-24T03:26:00.003-05:00

Federal prosecutors have dismissed charges against a prominent Madison pharmacist accused of importing and selling fake Viagra and other drugs.

In an update to a fascinating story that had been blogged about previously in Secure Pharma Chain, the Green Bay Press Gazette is reporting:

• Online court records show prosecutors in the Eastern District of New York dropped the case against Marla Ahlgrimm on Nov. 5. The records don't offer any explanation. Robert Nardoza, a spokesman for the U.S. attorney's office involved in the case, declined comment. Ahlgrimm's attorney, Lester Pines, also declined comment.

• Ahlgrimm and a Middleton man named Balbir Bhogal were charged in September with working together to deliver counterfeit drugs, including Oxycodone, Hydrocodone and Viagra, to FBI informants. Bhogal's case is still pending.

• Ahlgrimm founded Women's Health America, a Madison-based umbrella company that includes a pharmacy and a laboratory. The University of Wisconsin Foundation's website lists her as a board member.

This story has been very interesting to watch because of the prominance of the people implicated and the proximity of counterfeit drugs to the legitimate pharmaceutical supply chain.

Clearly as the facts become known it will become even more apparent that all members of the pharmaceutical supply chain must take sufficent measures to protect their inventories from fraudulent, adulterated, sub-standard and counterfeit medications. There are far too many ways for bogus drugs to enter the legitimate supply chain and poison the consumer.

Secure Pharma Chain will follow this story as it continues to unfold.

To read the entire Green Bay Press Gazette story, visit: http://www.greenbaypressgazette.com/article/20101122/GPG0101/11220532/Feds-drop-drug-charges-against-Madison-pharmacist

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

ICE: Chinese Counterfeit Drug Distributor Sentenced to Prison

2010-11-23T05:44:00.001-05:00

Chinese national convicted of dealing in counterfeit drugs in Texas sentenced to prison and deportation.

U.S. Immigration and Customs Enforcement released a press release on November 15th detailing the sentence of 12 months and a day in prison for conspiring to distribute counterfeit pharmaceuticals, and trafficking in pharmaceuticals with false labeling and counterfeit trademarks to Kum Leung Chow.

The sentence was announced by U.S. Attorney José Angel Moreno, Southern District of Texas.

Kum Leung Chow, aka Lawrence Chow, 59, pleaded guilty to the federal charges on June 28 and sentenced on Monday to 12 months in prison by U.S. District Judge Kenneth M. Hoyt. Chow was arrested on Jan. 27 and has been in federal custody since that date and will remain in custody to serve out his sentence. Chow is subject to deportation after he completes his sentence.

The ICE HSI investigation began in January 2009 and revealed that Chow used a Hong Kong-based company named Kingdom International Enterprises LTD to obtain and distribute counterfeit Viagra and Cialis pharmaceutical drugs in the United States. Viagra and Cialis are prescription drugs that are FDA-approved and used to treat erectile dysfunction. They are registered trademarks on the principal register in the U.S. Patent and Trademark Office. Viagra is manufactured and distributed exclusively by Pfizer Pharmaceuticals, while Cialis is manufactured and distributed exclusively by Eli Lilly.

Chow offered boxes containing four Viagra tablets and boxes containing eight Cialis tablets for $10 a box on two Internet websites. The retail cost for each Viagra tablet is about $20, while each Cialis tablet is about $15.20. Working in an undercover capacity, ICE agents purchased about 1,120 Viagra tablets and about 360 Cialis tablets from Chow via the Internet on March 25, 2009, and April 28, 2009. Shipping documents accompanying the pharmaceuticals indicated they were exported from mainland China and Hong Kong.

The pharmaceuticals were later analyzed by the trademark holders and the FDA Forensic Chemistry Center which indicated the pharmaceuticals were counterfeit. These counterfeit pharmaceutical products may have harmed the public if law enforcement were not involved in monitoring the Internet.

Chow has been in federal custody since he was arrested Jan. 27; he will remain in custody to serve out his sentence.

The investigation of Chow was conducted by agents with the U.S. Immigration and Customs Enforcement (ICE) Office of Homeland Security Investigations (HSI), and the Food and Drug Administration's (FDA) Office of Criminal Investigations. Assistant U.S. Attorney Samuel Louis, Southern District of Texas, prosecuted the case.

Continued enhanced enforcement is critical in dealing with the deadly criminal act of counterfeit medications.

All stakeholders of the pharmaceutical supply chain must take steps from bogus drugs ending up in their inventories.

To read the entire ICE Press Release, visit: http://www.ice.gov/news/releases/1011/101115houston.htm

To learn about technologies that can detect fraudulent and counterfeit drugs inside their sealed container, visit: http://www.xstreamsystems.net/.

WHO: Fake Drugs Major Factor in New Malaria Strain

2010-11-22T02:40:00.001-05:00

The World Health Organization (WHO) raised the alarm about a new strain of drug resistant malaria in South East Asia.

According to SafeMedicines, a newly published report on antimalarial drug efficacy and resistance, scientists believe that fake and substandard malarial medications are a major factor in the development of new drug-resistant strains of malaria.

According to SafeMedicines:

• Resistance to artemisinin has emerged along the border of Cambodia and Thailand, and WHO is putting together a global panel of stakeholders to work to contain this new strain before it spreads to Africa, as other strains did in the 1960s and 1970s. Scientists believe that once a new strain occurs through spontaneous change in the parasite, its ability to survive is promoted by substandard medications.

• Current containment activities involve long-lasting insecticide-treated mosquito nets, recruitment and training of village health workers equipped with rapid diagnostic tests, and most importantly free malaria treatment and follow-up. Free treatment is key to the success of the containment effort because “free treatment and care helps to undermine the sale of counterfeit and substandard antimalarial drugs,” states WHO in the “Global Report on Antimalarial Drug Efficacy And Drug Resistance: 2000-2010.

• “Efforts have also been made to stop the sale of counterfeit and substandard drugs, which are a major factor in the development of resistance,” states the report.

• WHO’s report states that the Cambodian government is working closely to monitor malarial medications and educating consumers in workshops and through reading materials on the extensive dangers fake malaria drugs may cause them.

• “History has shown that once resistance to antimalarial treatment emerges it is only a question of time before it spreads. For the first time, the global malaria community has the opportunity to contain resistance before it spreads,” states the report.

• Artemisinin is a plant-based antimalarial medicine, which due its potency very quickly reduces the number of malaria parasites in humans. Artemisinin compounds are combined with other anti-malarial drugs in therapies called artemisinin-based combination therapies (ACTs). Using combination therapies provide multiple possible agents to kill the plasmodium parasites that cause malaria.

Drug resistant diseases know no borders and effect wealthy and the poor.

Counterfeit drugs have become one of the most insidious criminal and health care epidemics of the 21st century.

All members of the global pharmaceutical supply chain (manufacturers, distributors, regulatory agencies, dispensers and consumers) must insist on it members to use all laws, solutions and technologies to fight this lethal crime.

To view the entire SafeMedicines post, visit: http://www.safemedicines.org/2010/11/fake-drugs-major-factor-in-new-malaria-strain-says-who-49.html

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

Veterinarians Warn of Fake Online Medications

2010-11-20T05:35:00.001-05:00

The Australian Veterinary Association (AVA) has warned medications purchased over the internet could be counterfeited drugs.

According to a report by ABC News, the AVA believes the trade in internet drugs for animals is growing as farmers try to contain costs:

• AVA president Dr Barry Smyth says livestock producers need to be particularly careful with what they buy.

• "We know that somewhere between 5 and 10 per cent of these products are counterfeit and not what they're supposed to be so there's a real danger you may not be getting what you're paying for," he said.

• "For people in the livestock industries they need to be very careful what they treat their animals with, because of residues in animal products."

The danger of fraudulent, adulterated, sub-standard and counterfeit drugs are everywhere but seem to proliferated online via the internet.

All pharmaceutical supply chain experts agree, never purchase pharmaceuticals online via sources that are not directly connected to an actual, legitimate pharmacy and/or does not require a physician or in this case veterinarian’s prescription.

To read the ABC News story, visit: http://www.abc.net.au/news/stories/2010/11/05/3057896.htm

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

Probe Into Fake Cancer Drugs

2010-11-19T04:32:00.000-05:00

Cypriot police investigating counterfeit cancer treatment drugs which are being smuggled into the European Union.

In a story by Constantinos Ioannou which appeared in the November 11 issue of the Cyprus Mail, two pharmaceutical companies within Cyprus have been implicated in a case of counterfeit cancer treatment drugs which are being illegally smuggled into the European Union.

According to the Cyprus Mail article:

• Cypriot police received a court order from the German Federal Police on Tuesday and searched four premises on the island, two in Larnaca district and two in Limassol district.

• The premises searched belong to two pharmaceutical companies which have been operational since March. There were also simultaneous searches conducted in Germany, Norway and Switzerland.

• Police spokesman Michael Katsounotos yesterday said: “From investigations conducted so far it does not appear that any crime was committed on Cypriot soil.” Katsounotos also assured the public that none of these counterfeit drugs were available in the Cypriot market.

• According to Katsounotos the counterfeit cancer treatment drugs were manufactured in England and were due to be distributed outside the European Union only. However upon receiving them, pharmacists in an unnamed third country modified the drugs and sold them to various other countries, some of which are based in the European Union. Investigators in Norway and Germany came to the conclusion that the modified counterfeit drugs were brought to Cyprus and then distributed to markets around the world.

• The two pharmaceutical companies on the island which have been implicated in the investigations are alleged to have purchased the counterfeit cancer treatment drugs before distributing them to Norway and Germany.

• Katsounotos said that the owners of the companies have been questioned but it appears at this point that no crime was committed on Cypriot soil. However he added: “Further investigations are due to take place and the completed file will be given to the Attorney-general who will make the final decision if there are any charges to be brought against the companies.” Katsounotos also added that some of the drugs were taken to the Netherlands where documents were falsified to show that they came from Cyprus.

• Katsounotos assured the public that none of the drugs were available in Cyprus, although he could not clarify if the counterfeit cancer treatment drugs were in Cyprus at any point.

• “That is the object of our investigation, what we know as fact is that documents were falsified in Holland to show that these drugs came from Cyprus,” he said.

• The Director of the State Laboratory Popi Kanari also warned yesterday that the use of counterfeit drugs, which can be usually purchased via the internet or other unofficial sources may pose serious risks to a person’s health.

• Kanari stressed that these drugs have not gone through the proper procedure of registration at the ministry of health. Kanari said: “Such drugs have been tested numerous times by the lab and have been found to contain toxic substances that can cause serious problems to one’s health”.

The criminal act of counterfeit medications is not limited to undeveloped countries and traditional black market activities.

Adulterated, fraudulent, sub-standard and counterfeit medications are making their way into the legitimate supply chains in developed countries by using illegal transactions and documentation.

The fraud of altering the transactional drug pedigrees, basically authenticating counterfeit or sub-standard drugs as real and efficacious is as dangerous and lethal to the patient as the poisons inside the bogus drugs.

The danger counterfeit drugs represent to entire health care populations is very real and all members of the pharmaceutical supply chain should take proactive measures to protect their inventories and consumers.

Authenticating and verifying what is inside the medications is the only way to make certain that the consumer is taking the real thing.

To read the entire Cyprus Mail article, visit: http://www.cyprus-mail.com/healthcare/probe-fake-cancer-drugs/20101111

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

USP Building Database of Fake & Substandard Meds

2010-11-18T03:49:00.000-05:00

USP is building a database of counterfeit medicines to support international drug procurement organizations, such as WHO, and the timely sharing of information between national regulators.

In a November 16th article in the In-PharmaTechnologist, Nick Taylor reports on the development of a new database that is due to launch early next year by the US Pharmacopeia (USP).

USP’s database will allow regulators and organizations the ability to monitor counterfeit and substandard drugs and to support more informed enforcement actions and procurement-related decisions.

According to Mr. Taylor’s article:

• Speaking to in-PharmaTechnologist at AAPS 2010 Patrick Lukulay, director of the promoting the quality of medicines (PQM) initiative at USP, outlined how timely sharing of information can support enforcement actions.

• Lukulay said the database could have supported a more effective response to counterfeit medicines that spread to Mali after first being seized in Ghana. Using the database regulators in Mali would have been aware of the products, which had the same batch numbers as the products seized in Ghana, and acted accordingly.

• Having created the architecture the USP is now inputting information about counterfeit or substandard drugs into the database. Listed on the database will be the name of the product, the country it was seized in, what was wrong with it and other descriptors, said Lukulay. If countries agree the database will be shared with the public.

• The benefits of sharing information also underpin the USP's creation of a 'virtual forum'. This will allow users to pose questions, share alerts and discuss best practices among a network of people involved with ensuring the quality of medicines.

Secure Pharma Chain, supports all efforts to share information in fighting the deadly crime of adulterated, fraudulent, substandard and counterfeit drugs.

All members of the pharmaceutical supply chain must use all tools including technologies, solutions and cooperative intelligence databases to interdict these dangerous products

It is critical that each member of the supply chain bear the responsibility of securing their inventories in order to protect their business brand and ultimately the health care consumer.

To read the entire story, visit: http://www.in-pharmatechnologist.com/Processing-QC/USP-building-database-of-fake-substandard-meds

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

Freightwatch International: October 2010 Cargo Theft Report

2010-11-17T04:31:00.001-05:00

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 October 2010.

FreightWatch recorded 77 incidents for the month of October, a substantial increase over the 55 incidents recorded in September.

As the holiday season approaches, increasing freight movement becomes an opportunity for thieves to target high-value loads.

California continues to report the highest number of thefts accounting for 34% of all incidents reported in October. Florida, Texas, New Jersey and Georgia remain at the top of the list and continually report slight variances in the number of thefts from month to month.

By commodity, pharmaceuticals had six reported incidents in October which doubles the number from the previous month:

• October 1st in Jacksonville, Florida a last mile delivery of pharmaceuticals was taken of an unreported value.

• October 3rd in Hollywood, California a warehouse burglary of a pharmaceutical distribution center of an unreported value.

• October 7th in San Fernando, California there was a theft of a trailer roadside of an unreported value.

• October 10th in Fort Smith, Arkansas there was a theft of a trailer from a public access lot valued at $50,000.

• October 13th in Dallas, Texas there was a theft of a container of pharmaceuticals of an undetermined value in a public access lot.

• October 15th in Gardena, California there was the theft of a trailer of pharmaceuticals 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 pharmaceutical material screening technologies, visit: http://www.xstreamsystems.net/

WHO Names Kenya as Safe Haven for Fake Drug Cartels

2010-11-16T06:34:00.003-05:00

World Health Organization (WHO) has estimated that the Kenyan market for counterfeit, expired, diverted and otherwise illegal medicines is around $130m and propagated by weak border controls and cartels-believed to include Health Ministry Officials.

George Omondi and Mwangi Muiruri in Business Daily Africa, write an excellent article about a recent World Health Organization newsletter report describing Kenya as a “safe haven” for counterfeit drugs.

Included in the Business Daily Africa story:

• Kenya is a safe haven for a cartel that has choked the domestic market with counterfeit and untested medicine smuggled through informal channels, the World Health Organization has said, warning that the country could incur huge costs in mitigating the side effects of the drugs.

• The value of both genuine and fake medicines sold illegally to unsuspecting consumers is roughly $130 million annually, says the organization in its October newsletter.

• The value includes drugs donated by international agencies, those stolen from hospitals and expired or fake ones made by backstreet firms and routinely smuggled in through East Africa’s porous borders.

• The cartel — believed to include senior Health ministry officials— runs a complex web of informal trade, spanning the five East African Community countries, DR Congo and Southern Sudan.

• The rogue merchants, who devise elaborate schemes to disguise their activities, are aggressive and smart, according to WHO, which blames the menace on weaknesses in border controls. “They (cartel) establish fictitious front companies and use falsified documents to exploit weaknesses in border control as governments reduce border inspections to encourage free trade,” WHO says in the Newsletter.

• The concern over drugs safety comes just weeks after local pharmaceutical producers complained of frequent theft of narcotics in their premises by what they termed “ well co-ordinated cartels.” Drug companies are allowed to buy narcotics which they use as raw materials in making medicines under the strict watch of regulators.

• “This has become a well co-ordinated business because in most cases, we realise that up to five pharmaceutical companies have been raided and all their narcotics stolen in one night without any clue for arrests,” said a manager at one of the local pharmaceutical firms, which cannot be named for security reasons.

• The raids have sparked widespread fears over the authenticity of drugs sold over the counters and hospitals with the Pharmacy and Poisons Board (PPB), the government agency that regulates the sale of medicines, saying yesterday it had issued strict cross-border trade rules to tighten the noose on the cartels.

• The board’s head of pharmacovigilance department, which tracks the movement of drugs, Dr Jayesh Pandit, said the recent designation and gazettement of all entry and exit points for drugs would push the cartels out of business. “Our instruction to all regulatory and law enforcement agencies in the region is that any drug that is not inspected and cleared at the designated points should be confiscated immediately,” he said, adding that the international community had taken long in stamping out the cartels because of “too much” focus on infringement of intellectual property rights of big pharma, loss of monopoly or financial losses.

• “Unfortunately, lesser attention is given to the number of lives lost, number of severe drug reactions experienced and the morbidity associated with the murderous trade of counterfeiting,” said Dr Pandit

While disturbing, unfortunately this article and WHO report is not surprising.

Much like the more infamous illegal drug cartels in Central and South America, these bogus drug criminal organizations exact a tremendous amount of influence within small countries. The return on investment in fake medications is significantly higher than nearly all criminal endeavours. Populations will continue to be at risk as long as law enforcement and the legitimate supply chain allow these crooks to poison their consumers.

Hopefully this type of story will stimulate the pharmaceutical supply chain and average health care consumer in developed countries to become more engaged in pharmaceutical supply chain safety.

To read the entire Business Daily Africa article, visit: http://www.businessdailyafrica.com/Corporate%20News/WHO%20names%20Kenya%20as%20safe%20haven%20for%20fake%20drug%20cartels/-/539550/1050938/-/jud3flz/-/

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

Entire Bristol Myers Squibb Shipment Stolen

2010-11-15T06:00:00.002-05:00

As reported earlier in Secure Pharma Chain Blog, according to Freightwatch International, Bristol Myers Squibb’s entire truckload of pharmaceuticals, valued at several million dollars was stolen from a rest area in Florence, Kentucky on November 11th.

Products in the shipment included Avapro, Avalide, Coumadin, Abilify, Reyataz and Plavix.

The stolen truck - which was plain white with no unique markings - was taken from a rest area in Florence, Kentucky, after being left unattended for approximately 15 minutes by the driver and a passenger.

The driver had been forced to park some distance away from the main facility because the rest area was full. Evidence from the scene indicated the thieves made entry by breaking the lower window on the passenger side.

FreightWatch has recorded 27 pharmaceutical theft incidents year-to-date in the United States, with an average loss per shipment of $5.1M, up from $4M in 2009.

Secure Pharma Chain is encouraging all members of the pharmaceutical supply chain to be vigilant in protecting their inventories from all suspicious offers of medications from unknown sources. Stolen products are especially dangerous in that the actual drugs will not be handled properly-while the product containers will likely be emptied of the legitimate drugs- replaced with counterfeit drugs and sold within the supply chain.

The most effective solution for the interdiction of fraudulent, adulterated, sub-standard and counterfeit drugs is verifying the drug inside a sealed container with an material authentication technology.

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

USAID: Substandard and Counterfeit Drugs Found By Cooperative Aid Program

2010-11-13T06:43:00.002-05:00

Fake Medications in Use in Public Hospital, Many Other Sites

In a press release from the U.S. Agency for International Development (USAID), they announced that substandard and counterfeit versions of thirteen key anti-malarial medicines were uncovered in multiple locations across Ghana by the Medicines Quality Monitoring surveillance program.

Set up by the Ghana Food and Drugs Board (FDB) in collaboration with the U.S. Pharmacopeial Convention (USP) and the U.S. Agency for International Development (USAID), the program samples anti-malarials across the public and private sectors.

The program was established in 2008 and is implemented by USP's Promoting the Quality of Medicines (PQM) initiative. USP is a scientific nonprofit organization that develops globally recognized standards for the quality of medicines. Through the PQM program, USP works in developing countries to help verify and improve the quality of medications intended to treat life-threatening neglected diseases such as malaria, HIV/AIDS and tuberculosis.

"Few people fully realize the devastation that distribution of substandard or counterfeit medications can wreak on vulnerable populations," said Stephen Opuni, M.D., chief executive officer of the FDB. "In this case some of the drugs discovered contained no active pharmaceutical ingredient, while others failed to meet required quality standards. This causes great harm in two ways: the individual patients taking the drugs get no relief, and drug-resistant strains of malaria may grow stronger. In addition, people lose confidence in the efficacy of medicines and may be reluctant to seek medical help when they need it. I'm very pleased with the outcomes we're seeing from the Medicines Quality Monitoring program."

In 2009 the same program uncovered a counterfeit version of Novartis' Coartem®, another widely used anti-malarial. In that case, an alert citizen notified the authorities after suspecting the drug he bought might be fake.

"Last year's seizure of counterfeit drugs showed the importance of public education," said Patrick Lukulay, Ph.D., director of the PQM program. "In the current case, rigorous surveillance worked very well. The fact that the fake and poor quality drugs were so widespread—found in many areas across Ghana, and in many types of outlets—underscores the need not only for continuing surveillance but also for active enforcement of anti-counterfeiting laws."

The discovery of the counterfeits—tragically, in use at a government-run hospital and private clinic, and being distributed through many pharmacies—has resulted in a nationwide recall of all thirteen drugs, including publicizing the names of the outlets where they were found.

This is intended as a strong deterrent, making pharmacy and hospital procurement personnel more vigilant about their suppliers. Manufacturers of some of the recalled medications will be required to meet with the FDB for required regulatory sanctions.

Noted Dr. Lukulay, "It's important to keep in mind that all these fake and substandard medicines were found just in one round of post-market surveillance, just of anti-malarials. The existence of many more substandard and counterfeit medications for other types of medicines and in other locations and facilities must be assumed. Public education and official collaborations between public and private sectors are both essential to protecting public health here in Ghana and in many other developing nations."

The American people, through the U.S. Agency for International Development, have provided economic and humanitarian assistance worldwide for nearly 50 years.

Secure Pharma Chain agrees with the conclusions of enhanced public education, more rigorous enforcement of laws and official collaborations between public and private standards as essential in combating this lethal crime.

The members of the global pharmaceutical supply chain (manufacturers, distributors and dispensers) need to take the lead on defeating this crime. Waiting for agencies and regulations is not an option, proactive deployment of solutions and technologies designed to interdict and protect inventories from fraudulent, adulterated, sub-standard and counterfeit medications by the commercial interests seemingly is the most effective and efficient way to eradicate this deadly epidemic.

To read the USAID press release, visit: http://www.prnewswire.com/news-releases/substandard-and-counterfeit-antimalarial-drugs-in-ghana-discovered-by-cooperative-program-of-usp-ghana-food-and-drugs-board-106891733.html

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

Freightwatch: Truckload of Pharmaceuticals Stolen

2010-11-12T14:19:00.002-05:00

A full truckload of pharmaceuticals was stolen from a rest area in Florence, Kentucky at approximately 10 pm, Wednesday, November 11.

According to an email alert, Freightwatch International, an industry leader in providing cargo theft intelligence through data collection, analysis, and customized reporting, the theft occurred approximately 225 miles from the shipment’s point of origin.

The load value of the shipment has not been established, but is reported to be worth several million dollars.

The driver and his passenger reportedly left the truck alongside the exit ramp from the rest area because all the parking spaces were full. The vehicle was reportedly left unattended for approximately 15 minutes.

FreightWatch highly recommends that shippers of highly targeted goods such as electronics and pharmaceuticals ensure their transportation providers are aware of all in-transit security requirements and that the shipper has the capability to audit their compliance at any time.

Members of the pharmaceutical supply chain need to be on alert for these stolen goods and their containers. It is likely that the criminals will sell the products which may be harmful if not properly stored and use their containers to introduce counterfeit medications into the legitimate supply chain.

To read more about this, visit: http://www.freightwatchintl.com/

To learn more about verification technologies that can test the authenticity of pharmaceuticals inside their sealed, unit-of-sale container, visit: http://www.xstreamsystems.net/.

WSJ: Watchdog Says FDA Risked Integrity

2010-11-09T22:41:00.006-05:00

GAO criticizes FDA saying that it risked giving the appearance of compromised integrity.

Alicia Mundy in a Wall Street Journal article reports on a Government Accountability Office (GAO) report criticizing the Food and Drug Administration (FDA) for creating the appearance of favoritism toward a Boston company that won lucrative first rights to sell a generic drug after providing free consulting work to the agency.

According to the Wall Street Journal article:

• A congressional committee plans to release a report by the Government Accountability Office that says the FDA risked giving the appearance that it had compromised its integrity because of its dealings with the company, Momenta Pharmaceuticals Inc.

• Winning the first right in July to sell the generic version of the blood thinner Lovenox has already meant hundreds of millions of dollars in sales for Momenta and its partner, Novartis AG's Sandoz unit.

• Also critical of the FDA's actions are Momenta's rivals—including Teva Pharmaceutical Industries Ltd., the world's largest generic drug manufacturer, and Amphastar Pharmaceuticals Inc.—as well as a recently retired official in the FDA's generic-drug division. The drug companies' applications are still awaiting FDA action.

• The controversy centers around Momenta's performance of months of free work for the FDA during a high-profile investigation of tainted Chinese drug imports in 2008. At the same time, agency officials were reviewing the company's application to sell the generic version of a blockbuster blood thinner.

• As a result, "agency officials ran the risk of undermining public confidence in the integrity of FDA's operations," including heparin-related drug approvals, the report says,

• In response to the report, requested by Rep. Joe Barton (R., Texas), the FDA said it needed to draw on Momenta's expertise to find the cause of the tainted Chinese imports, but it acknowledged it should have considered potential conflicts of interests and done more to disclose them.

• The FDA has said its reliance on Momenta's free work had nothing to do with its approval of the company's drug ahead of competitors'.

• Momenta said it conducted the investigation for the FDA in the interest of public health, not because of its drug application.

• Since Momenta and Sandoz won FDA approval for their rapid-acting heparin in July, the drug's sales have topped $300 million.

• Richard Adams, a former official in the FDA's generic-drug division who retired this year, agreed with the bias allegation . "Everyone closely involved saw that it was stacked and the whole direction was toward Momenta," he said.

• The FDA turned to Momenta for help in early 2008, when it was trying to figure out what was tainting a widely used older form of heparin. Hundreds of people were suffering severe shock after taking the drug, which was linked to 81 U.S. deaths that year.

• The FDA said that Momenta's researchers did an excellent job identifying the contaminant. "This successful effort to protect public health would not have been possible without the unique expertise and extraordinary efforts of the outside scientists," it wrote in a response to the GAO.

• Rep. Barton criticized the FDA for failing to name the culprit for the tainted heparin and said the report shows the agency's "fundamental weakness" in dealing with the surge of Chinese medical imports.

Although this article spends most of its time dealing with potential conflict of interest and integrity issues within the FDA, Rep. Barton’s final quote is the most important as it relates to the safety of the domestic pharmaceutical supply chain.

Making certain that the health care consumer here in the United States is protected from unsafe and ineffective medications is paramount.

Instead of reports and interagency finger pointing, the United States government needs to figure out who attempted to poison the American consumer and bring them to justice. Without this resolution, it seems clear that these criminal acts will continue.

Members of the pharmaceutical supply chain must take it upon themselves to make certain that their inventories are safe from adulterated, sub-standard, fraudulent and counterfeit medications.

To read the entire Wall Street Journal article, visit: http://online.wsj.com/article/SB10001424052748703514904575602781097808598.html?KEYWORDS=heparin

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

11% of Ghana's Children Under 5 Die - More Can Live if Counterfeit Drugs are Reduced

2010-11-08T11:59:00.001-05:00

Ghanaian religious leaders committed to decreasing child mortality rates decried counterfeit drug purveyors at the 8th Annual National Catholic Health Services Conference.

In a post that appeared on-line at SafeMedicines, the 8th National Catholic Health Services Conference (NCHS) Annual Conference met in October to discuss “Monitoring for Continuous Improvement: Using Whole System Measures”.

The NCHS annual conference was instituted to create a forum for Catholic Church health institutions to share common and peculiar concerns and experiences.

According to the SafeMedicines' post:

• Ghana’s children suffer 110 deaths for each 1000 children under five years of age, or 11%. One of the most common sources of mortality is malaria. Anti-malarial drugs are among the most common counterfeited in Africa and Southeast Asia where malaria is pervasive.

• The Most Reverend Joseph Afrifa-Agyekum Chairman for Catholic Health Services argued that purveyors of dangerous counterfeit drugs take advantage of unsuspecting people who buy their fake medicines. He said drug counterfeiters take advantage of countries where regulations and law enforcement on drug safety are limited to exploit them and indicated that developing countries where regulatory and enforcement agencies are poorly underfunded and understaffed are a haven for the distribution of fake drugs.

• He (Afrifa-Agyekum) then went on to ask the government of Ghana to take action through the Food and Drugs Board, the Ministry of Health, regulatory bodies and security agencies against the threat of counterfeit medications, stressing that the Catholic Church was committed to working alongside the government.

• According to the source, Upper East Regional Minister Mark Woyongo praised Afrifa-Agyekum and the Catholic Church for their involvement in and aid for the fight against counterfeit drugs.

This story is a cautionary tale and a wake up to those within developed countries. Counterfeit products, specifically medications are not a victimless crime. Fraudulent, adulterated, sub-standard and counterfeit drugs have far reaching implications to entire populations. Drug resistant strains of diseases know no borders nor do they differentiate between the rich and poor.

This crime of counterfeit drugs has the potential to create heath care epidemics and deadly disasters and is one of the largest criminal and health issues of the 21st century.

To read the entire SafeMedicines post, visit: http://www.safemedicines.org/

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

ASHP: Counterfeit Drugs Pose Growing Health Threat

2010-11-05T23:35:00.005-04:00

Counterfeit and substandard medicines constitute a real and growing threat to public health, say federal officials and others who deal with the issue.

Kate Traynor in the American Society of Health-Systems Pharmacists Health Systems News writes an excellent report with some insightful quotes about the October symposium on counterfeit medications that was sponsored by the Partnership for Safe Medicines in Washington D.C.

Included in Ms. Traynor’s story:

• "The problem is getting worse each year. The counterfeiters are winning," said Jeffrey Gren, director of the Office of Health and Consumer Goods at the U.S. Department of Commerce.

• Nancy Kennedy, senior operations manager at FDA's Office of Criminal Investigations, said that counterfeiters previously limited their activities to bringing small amounts of fake medicines into the United States. "Now you see quantities of these drugs coming in and going directly to doctors, clinics, brick-and-mortar pharmacies and...directly to patients," Kennedy said. "I can see international cases' connections growing, and the type and amount of counterfeit drugs and unsafe drugs coming into the country is significantly growing. So I don't like what I see."

• More than 60 nonprofit organizations, including ASHP, are members of PSM, whose stated goal is to raise awareness about the risks of counterfeit medications. The symposium was sponsored by several pharmaceutical companies and other corporate stakeholders.

• FDA Commissioner Margaret Hamburg, the event's keynote speaker, said that in some parts of the world, 30–50% of drugs used to treat serious illnesses are counterfeit products.

• "Still, it's hard to really know the full extent of the problem," she said. "Estimates...vary a lot, and we do need better surveillance and data to truly define the magnitude and scope of the problem."

• FDA announced in the October 13 Federal Register that the agency will commit up to $3.5 million to the World Health Organization for the development of a rapid global surveillance and monitoring system for counterfeits, if the health agencies agree on a cooperative approach to the project.

Industry leadership and consumers in developed countries must be made aware of the danger of counterfeit and substandard medications and that this is no longer just a threat that exists within the third world.

Real solutions and technologies exist today that can eradicate the threat from this dangerous, lethal criminal activity. The global pharmaceutical supply chain must be incentivized to deploy these solutions to protect their brands and the consumer.

To read the entire ASHP article, visit: http://www.ashp.org/import/news/HealthSystemPharmacyNews/newsarticle.aspx?id=3428

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

IPS: Fake Medicines May Kill a Million a Year

2010-11-04T04:46:00.001-04:00

Central and Eastern Europe is facing "significant challenges" in combating a multi-billion euro, and often lethal, trade in fake medicines, security and pharmaceutical groups have warned.

Pavol Strancansky writes a disturbing if not interesting story about the size, scope and danger of counterfeit medication in Europe for the Inter Press Service. The story is full of insider insight and current statistics.

Included in Mr. Strancansky’s story:

• Millions of counterfeit tablets and medicines, some of them containing lethal heavy metals, are smuggled annually. The World Health Organisation (WHO) estimates that 50 percent of medicines sold online are fake.

• But while some Eastern European states have brought in strict laws and procedures to fight fake medicine smugglers, criminals in the region are thought to be working with international gangs in neighbouring states to bring contraband medicines into the EU.

• Gabriel Turcu, partner at the European anti-counterfeiting organisation REACT, told IPS: "It has been shown that there are people in Central and Eastern European EU member states working with organised gangs in neighbouring countries to bring counterfeit medicines into the European Union and westwards. This is a significant challenge for the region."

• Just like the drug and people trafficking trade, the counterfeit medicine industry is estimated to be worth tens of billions of euros per year for crime gangs, and is mushrooming every year.

• The United Nations Office on Drugs and Crime has estimated that this year the illegal market in counterfeit medicines will provide more than 75 billion euros in revenues for smugglers -- a rise of 92 percent on 2005.

• Police forces say that fake medicines, sometimes so well-prepared and packaged that they can fool even healthcare professionals, are being shipped out by crooks in the same illegal consignments as narcotics. Gangs then sell them on to unscrupulous medicine wholesalers or direct to the public online.

• Health experts estimate that fake medicines -- made from anything from crushed brick to arsenic -- cause up to one million deaths a year, and the UN has said they are contributing to growing drug resistance.

• India and China are thought to be the main source countries for the fake medicines, but customs officers in central and Eastern Europe have said that they are being brought into Europe on the same smuggling routes used for narcotics and people -- through Eastern Europe and the Balkans.

• Pfizer issued a report earlier this year saying that the market in counterfeit medicines in Europe is worth an estimated 10.5 billion euros annually, with people in Italy and Germany spending the most on what later turn out to be fake medicines -- an estimated 3.6 billion and 2.7 billion euros respectively.

• EU officials have said that in a two-month period last year 34 million fake tablets were seized by customs officials while the Council of Europe says that in some parts of Europe fake medicines make up between six and 20 percent of the market.

• Public awareness of the risks of counterfeit medicines is also low, according to research.

• While punishments for drug running and people smuggling are severe and risks high, those for counterfeit medicines are generally far less. In some countries production and selling of counterfeit medicines is not considered a crime and in many Western states it was until relatively recently viewed legally as being on a par with trading in fake branded clothes.

• Turcu, who last week attended a special conference in Bucharest which brought together country representatives and law enforcement officials from across the region to discuss the threat of counterfeit medicines, told IPS: "What is needed is a directive from the EU making it mandatory for countries at national level to qualify counterfeiting as a crime and counterfeiting that harms people as a serious crime."

Along with regulatory action, public awareness and action by industry leaders and members of the pharmaceutical supply chain are crucial in eradicating this very serious, potentially lethal crime.

To read the entire IPS story, visit: http://ipsnews.net/news.asp?idnews=53318

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

GAO: FDA Fails to Inspect Foreign Drug Plants Sufficiently

2010-11-03T01:49:00.000-04:00

US General Accountability Office writes a scathing report on the FDA’s failure to inspect foreign drug manufacturing facilities.

Ed Silverman in Pharmalot blogs about the US General Accountability Office recent report which has determined that the FDA failed to implement earlier recommendations that would close the gap between the agency’s approach to inspecting domestic and foreign drug manufacturing facilities.

According to the Pharmalot post:

• The GAO writes that it is unclear if steps being taken by FDA “will prove successful” and there is an “urgent need” to better protect public health by putting GAO suggestions into practice.

• Here are some key findings:

o The FDA boosted its budget for foreign inspections to $41 million in fiscal 2009 compared with $12 million in fiscal 2008 and $10 million in fiscal 2007, and increased the number of foreign inspections.
o In fiscal year 2009, for instance, the FDA conducted 424 foreign inspections, compared to 333 and 324 inspections conducted in fiscal years 2007 and 2008, respectively.

• The GAO examined a list the agency kept to prioritize foreign inspections and estimated only 11 percent of the facilities were completed in fiscal year 2009.

• “At this rate, GAO estimated it would take FDA about 9 years to inspect all establishments on this list once.” That same year, 1,015 domestic inspections were made, or about 40 percent of domestic facilities.

• The FDA did not know how many foreign drug establishments were subject to inspection, because of inaccurate info in agency database. There were 3,765 facilities in the FDA databases, but 2,394 may never had been inspected. Most of these, not surprisingly, are located in China and India.

• The FDA continues to emphasize inspections of establishments listed on applications for a new drug, instead of those already producing drugs for US consumption. The FDA’s approach is “inconsistent” with the GAO’s 2008 recommendation that the FDA inspect plants, “at a comparable frequency,” that are identified as posing the greatest public health, regardless whether these are foreign or domestic, if there is a manufacturing problem.

• The US Department of Health and Human Services acknowledged the need for improvement, but cites obstacles toward progress, such as the need to obtain permission from the foreign government of the country in which an establishment is located in order to conduct an inspection.

Clearly this report is very troubling to the average health care consumer given the proliferation of raw material contamination's, recalls due to poor manufacturing process, adulteration, fraud and a myriad of other issues that plague our pharmaceutical supply chain.

Historically pharmaceutical companies are outsourcing more of their raw materials, production and packaging than ever before and the FDA does not have the capacity or ability to identify all of the manufacturing plants are that produce the drugs that are taken every day by US consumers.

Along with more robust inspections, it is incumbent upon all members of the supply chain to take measures to make absolutely certain that the products of their brand or the products they distribute or dispense are safe and efficacious.

Secure Pharma Chain encourages all members of the pharmaceutical supply chain to implement a variety of solutions and technologies to test and authenticate the products within their inventories to protect their brand and most importantly the consumer.

To read the entire Phamalot post, visit: http://www.pharmalot.com/2010/11/fda-fails-to-inspect-foreign-plants-sufficiently-gao/#more-27487

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

Pharmalot: Hold Your Nose, Pfizer Recalls More Smelly Lipitor

2010-11-02T04:23:00.000-04:00

For the second time in three months, Pfizer is recalling thousands of bottles of its Lipitor cholesterol pill after smelling a musty odor.

Ed Silverman in Pharmalot is blogging on another Pfizer Lipitor recall due to the product containing a musty, unpleasant odor.

According to Mr. Silverman:

• The drugmaker already recalled 191,000 bottles of Lipitor - but only the 40mg dose - after receiving consumer reports last July. Once again, the problem is blamed on packaging supplied by another company.

• “The company has identified the source of the problem - the bottle manufacturer’s plant in Puerto Rico, which had shipped empty bottles to the Pfizer plant in Freiburg, Germany for use in packaging Pfizer products,” according to a Pfizer statement.

• The drugmaker adds that the risk of health consequences to patients “appears to be minimal, and steps are being taken to preserve product quality and patient trust,” although still more recalls may occur.

• Musty odors are a growing problem for Pharma. The recall scandal enveloping J&J’s McNeil Consumer Healthcare unit came to light after the FDA earlier this year released a warning letter that the health care giant failed to take sufficient action in response to batches of Tylenol Arthritis Relief Caplets that had a musty smell.

• This is getting costly for Pfizer. Assuming these are the same 90-count bottles that were recalled last time and that these sell for at least $1.50 each, or roughly $135 a bottle, that amounts to $5.13 million at retail, since the pricing comes from PharmacyChecker.com.

• Add that to the $25.7 million from the last recall and the total retail value is now north of $30 million.

Pharmaceutical companies need to protect their brand and the consumer by deploying quality assurance testing of their product, post-production within the supply chain.

Not considered in Mr. Silverman's cost calculations are the cost of managing and returning the recalled product which easily doubles the actual retail cost of the product.

Once mighty brands are losing consumer confidence due to quality control problems that could and should be easily resolved.

Like the issue with J&J this contamination occurred because of issues with a chemical used in the pallets used to store and ship the product. Many things can impact the quality and efficacy of the drug within the supply chain.

To read the entire Pharmalot post, visit: http://www.pharmalot.com/

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

Health Minister: Proliferation of Counterfeit Drugs More Serious Than Drug Trafficking

2010-11-01T10:44:00.006-04:00

The proliferation of counterfeit pharmaceutical drugs has become a global problem more serious than illegal drug trafficking.

The China Post is reporting on comments Taiwanese Health Minister Yang Chih-liang made during a press conference recently.

According to the story in the China Post:

-The government has been strongly cracking down on counterfeit drugs since March; as of September, the number of TV ads featuring fake medicine increased by 260 cases while the amount of the fake drugs confiscated is 4.1 that of the year before.

-Yang said in order to combat counterfeit drugs, authorities must tackle manufacturers, distribution, promotion channels and educate the public all at once.

-Pharmaceuticals are usually issued by doctors and pharmacists with prescriptions and proper doses, Yang said, adding that the public needs to develop the mindset that while drugs can cure illness, it can also become a poison.

-Aside from the DOH, the Ministry of Justice, Ministry of the Interior, Ministry of Finance, Coast Guard Administration, the National Communications Commission, the Government Information Office and Consumer Protection Commission have all come together to crack down on fake drugs.

-The total number of illegal fake pills confiscated from January to September is 7,341,958, 4.1 times that from last year.

Secure Pharma Chain encourages all regulatory agencies to take a more aggressive approach in cracking down on this dangerous criminal activity and in educating the general public.

It is important that members of the pharmaceutical supply chain take proactive measures in protecting their inventories and interdicting illicit, adulterated, fraudulent and counterfeit medications.

To read the story in the China Post, visit: http://www.chinapost.com.tw/taiwan/national/national-news/2010/11/01/278201/Proliferation-of.htm

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

Fake Drugs Mean Prison for St. Louis County Man

2010-10-30T04:10:00.000-04:00

Man to be sentenced for trafficking in bogus erectile dysfunction drugs that were purchased on-line.

Robert Patrick in the St. Louis Post Dispatch reports about a St. Louis County man who has pleaded guilty to federal charges and admitted to selling thousands of counterfeit erectile dysfunction pills over the last several years.

According to the St. Louis Post Dispatch story:

• Mark Hughes, 47, ordered counterfeit versions of the drugs Viagra and Cialis online from China and India, and sold them either in an illegal and unlicensed pharmacy or via word of mouth, Assistant U.S. Attorney John Bodenhausen said in court.

• Hughes' last shipment, of 1,000 pills, was intercepted by U.S. Customs and Border Protection in 2009 and delivered by investigators. Hughes house was then searched and he admitted buying roughly 11,000 pills. He sold them for $5 each, roughly one-third of the wholesale price, Bodenhausen said.

• Bodenhausen said that the pills either did not contain the correct drug or contained a less potent dose of the drug.

• In court, Hughes pleaded guilty to trafficking in counterfeit goods and misbranding a drug, and could face at least two years in prison under federal sentencing guidelines when sentenced in January, depending on a number of factors.

This is an excellent cautionary tale regarding those who set out to scam people by buying bogus goods online.

Mr. Hughes is fortunate that the bogus drugs that he sold did not adversely effect the health or kill someone or he would be facing a far more serious consequences.

Bogus drugs are becoming one of the more significant health care issues of the 21st century. 11,000 doses of a potentially lethal, fraudulent or adulterated drug could poison and create a huge health care disaster within a communities population.

Kudos to U.S. Customs and Border Protection for intercepting these bogus medications.

To read the entire story, visit: http://www.stltoday.com/news/local/article_0ac42318-dad5-11df-a1ce-0017a4a78c22.html

To learn about pharmaceutical anti-counterfeit solutions, visit: http://www.xstreamsystems.net/.

State of Connecticut Medicaid Program to Receive Part of GSK Settlement

2010-10-29T16:09:00.006-04:00

GlaxoSmithKline will pay Connecticut $1.72 million as part of a larger nationwide settlement related to selling tainted, sub-standard and defective prescription drugs.

Related to a post earlier this week regarding GSK's huge financial settlement, the money will be paid to Connecticut's Medicaid program as a small fraction of a $750 million overall settlement.

"GlaxoSmithKline's dumping of defective drugs on Connecticut Medicaid recipients is shocking and shameful," said Attorney General Richard Blumenthal. "Such a massive failure to follow formulation and sanitation standards is unacceptable and inexplicable. The company endangered patient health -- and pumped up profits -- by providing tainted tablets."

GlaxoSmithKline allegedly sold four drugs to Medicaid that were contaminated at the company's plant in Cidra, Puerto Rico. Those drugs were:

-Paxil CR, an antidepressant that had either no active ingredient or only the active ingredient without the controlled-release aspects of the pill.

-Avandament, a diabetes medication that had too much or too little of the active ingredient.

-Kytil, an anti-nausea drug that had some impurities.

-Bactroban, antibiotic ointments and creams that contained microorganisms.

The company's head of global litigation, Elpidio Villarreal, said, "We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice requirements and with GSK's commitment to manufacturing quality. GSK worked hard to resolve fully the manufacturing issues at the Cidra facility prior to its closure in 2009 and we are committed to continuous improvement in our manufacturing processes."

Secure Pharma Chain is noticing an influx of quality control or poor manufacturing issues that are not just related to overseas contract manufacturing.

The dangers that these incidents pose to consumers all over the globe are serious and significant.

It is important that all members of the pharmaceutical supply chain authenticate and verify the quality and efficacy of their inventories to avoid liability and to protect their individual brands.

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

B Braun Recalls Possibly Tainted Heparin

2010-10-28T12:22:00.003-04:00

Recall linked back to the 2007/2008 Heparin crisis that poisoned hundreds.

Andrew Zajac from the Los Angeles Times is reporting about the recent announcement by B. Braun Medical Inc., of a recall of seven lots of the anticoagulant heparin because of concerns they may be contaminated with trace amounts of oversulfated chondroitin sulfate, or OSCS, the same substance implicated in the 2008 heparin crisis that killed or seriously sickened dozens of people.

According to the Mr. Zajac’s report:

• The company said in a statement that based on current information, the recalled lots did not pose a significant health risk, but they're being pulled from the market "with the support of the U.S. Food and Drug Administration."

• "There is not a significant public health threat," FDA spokeswoman Karen Riley said.

• The active ingredient in the suspect heparin was manufactured by Scientific Protein Laboratories Inc. of Waunakee, Wis., the same company that supplied the active ingredient for the heparin distributed by Baxter International that poisoned hundreds of patients in late 2007 and early 2008.

• Riley said B. Braun's announcement reflected a decision by Scientific Protein to recall three lots of the heparin ingredient that were distributed to manufacturers in the United States, Canada and Japan. It was not immediately clear how many, if any, other manufacturers are affected by the recall.

• Both the heparin in the poisonings and in the B. Braun recall were manufactured with raw material – pig intestines – from China. An FDA-led inquiry at the time of the heparin crisis identified OSCS as the contaminant. The substance apparently was added in an effort to stretch heparin, which is subject to significant fluctuations in supply because of changes in the Chinese pig population.

• The FDA has not identified who was responsible for the adulteration, or where in the lengthy Chinese supply chain it occurred. The heparin in the B. Braun recall also is from the same batch discussed in a recent FDA inspection that found that Scientific Protein waited a year to investigate a complaint about possible OSCS contamination.

• Riley said the heparin ingredient was manufactured by Scientific Protein in 2006 and was determined to contain traces of OSCS by one of the company's medical industry customers, which called it to the company's attention in October 2008.

• Scientific Protein's "quality department did not initiate a formal investigation into this complaint until 9/9/09," according to the FDA inspection report. It's not clear whether the complaining customer was B. Braun.

Many of the facts of this incident remain to be seen and or made public. It is anticipated that there will be more voluntary recalls and information over the next several days.

Secure Pharma Chain is puzzled with this recent turn of events given the amount of scrutiny that the 2007/2008 Heparin crisis elicited within the government, industry and consumers world wide. It would appear that not all the bases were covered within the supply chain following the deaths of some many back in 2007/2008.

Secure Pharma Chain encourages all within the supply chain to avoid the issues of fraudulent, adulterated, sub-standard and counterfeit drugs by deploying authentication technologies to verify that their inventories are safe and efficacious.

To read the entire story, visit: http://www.chicagotribune.com/health/la-heb-heparin-recall-braun-20101027,0,2834227.story

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

New York Times: Glaxo to Pay $750M for Sale of Bad Products

2010-10-28T05:18:00.002-04:00

Regulators say that GlaxoSmithKline, the British drug giant, knowingly sold tainted baby ointment, an ineffective antidepressant and contaminated drugs.

In an article written by Gardiner Harris and Duff Wilson which appeared in the New York Times-GlaxoSmithKline, the drug giant, has agreed to pay $750 million to settle criminal and civil complaints that the company for years knowingly sold contaminated baby ointment and an ineffective antidepressant.

The following are the highlights from the New York Times article:

• This settlement is the latest in a growing number of whistle-blower lawsuits that drug makers have settled with multimillion-dollar fines.

• Altogether, GlaxoSmithKline sold 20 drugs with questionable safety that were made at a huge plant in Puerto Rico that for years was rife with contamination.

• Cheryl D. Eckard, the company’s quality manager, asserted in her whistle-blower suit that she had warned Glaxo of the problems but the company fired her instead of addressing them.

• Among the drugs affected were Paxil, an antidepressant; Bactroban, an ointment; Avandia, a troubled diabetes drug; Coreg, a heart drug; and Tagamet, an acid reflex drug.

• No patients were known to have been sickened, although such cases would be difficult to trace.

This is the latest in a string of quality control issues at pharmaceutical manufacturers both domestically and abroad.

Most troubling is that the contamination's impact to consumers is difficult to trace. No one can be certain if bad product may have had a significant or even lethal impact on its consumer.

While the financial settlements to GSK and others is large, overiding these amounts is the cost to their brands in lost trust and consumer confidence.

It is critical that all members of the pharmaceutical supply chain utilize technologies to protect their products, inventories and ultimately the consumer from poor quality, adulteration, fraud and counterfeiting.

To read the entire New York Times article, visit: http://www.nytimes.com/2010/10/27/business/27drug.html?_r=1&th&emc=th

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

Healthcare Fraud Costing EU €56bn a Year

2010-10-27T09:58:00.008-04:00

In Europe alone, the fake drugs market is estimated to be worth more than €10.5bn every year.

Euractiv.com posted a story about a study stating that €56 billion is lost to healthcare fraud each year in the EU.

In the October 6th post, Euractiv.com claims that experts say conflicts of interest in the pharmaceutical sector mean that the true extent of expenditure being directed away from patients remains unknown.

The study by The European Healthcare Fraud and Corruption Network (EHFCN) was done to determine “the burden healthcare fraud places on society and facilitate the exchange of best practice on its detection.”

The research was conducted in the countries of Belgium, France, the Netherlands, Northern Ireland, Norway, Poland, Slovenia and Scotland and was presented at the EHFCN conference in Brussels in September.

According to the EHFCN report:

• The vast number of parties involved in the healthcare sector and the subsequent potential complexity of fraud schemes means that special fraud detectors - professionals already working in health care - have to be employed in order to carry out investigations into bills, patient notes and medication receipts.

• Trade in counterfeit medicines has exploded and it is now estimated that global counterfeit drug sales will reach €60 billion this year. In Europe alone, the fake drugs market is estimated to be worth more than €10.5bn every year.

• Low quality treatment - including from unqualified practitioners, forged receipts and sickness certificates, price cartels and the provision of counterfeit medicines - were identified as contributing to a phenomenon difficult to measure but ringing alarm bells at a time when austerity measures are being undertaken across the EU.

• 4,188 instances of suspected fraud were identified in the study, which was carried out in seven member states. The Netherlands and Belgium - working under a 'pay for service' system where doctors have an incentive to provide as much treatment as possible - hold the highest rates.

Hopefully this study will bring awareness to government, industry leaders and consumers to the negative impact that fraudulent, adulterated, sub-standard and counterfeit drugs have on health care and populations as a whole.

Secure Pharma Chain believes that it is important that all members of the pharmaceutical supply chain take proactive measures to deploy solutions to protect their inventories and provide themselves with a competitive edge as consumers begin to understand the potential risks of counterfeit and fraudulent medications.

To read the entire Euractiv.com story, visit: http://www.euractiv.com/en/health/healthcare-fraud-costing-eu-56bn-a-year-news-498480

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

Officials Investigating Fake Avastin Production

2010-10-26T05:43:00.002-04:00

Chinese health officials and police are investigating a pharmaceutical plant, Cancer Center, hospital employees and pharmaceutical dealers for the use and production of fake Avastin that harmed 61 patients last month.

Caj Wenjun in the October 23rd edition of the Shanghai Daily reports on the Chinese State Food and Drug Administration (SDFA) and the Shanghai Public Security Bureau investigating a Beijing pharmaceutical plant for allegedly producing a counterfeit version of the drug Avastin.

The fake Avastin caused eye infections in 61 patients at the Shanghai No. 1 People's Hospital last month according to officials from the Shanghai Health Bureau.

Shanghai No. 1 People’s Hospital illegally treated patients with Avastin on people with eye complaints, though its key component is believed to have a positive effect on some eye conditions, it is only officially approved for treatment of certain cancer conditions.

Roche, Avastin's producer, said the drug is only approved for colorectal cancer treatment in China. It is used in the treatment of five types of cancer in the United States, but is not permitted for use on eyes.

Avastin was not officially approved for use for colorectal cancer until October 22nd nearly a month after the incident at the hospital.

According to the Shanghai Daily story:

• Local police will also investigate the Avastin case.

• The Shanghai Ruijin-AmMed Cancer Center is under suspicion as it allegedly purchased the bogus Avastin and sold it on to hospitals.

• Several employees at the cancer center, along with some pharmaceutical dealers, have been detained. The relevant head of Shanghai No.1 People's Hospital will be charged with poor management and negligence, said health bureau officials.

• Only three patients from the case remain in the hospital. Many of those discharged have received compensation.

This incident features many culprits and plenty of criminal activity. The production of dangerous fake medications, dealing in counterfeit drugs and unofficial medical treatment to name just a few.

In this incident, each member of the supply chain perpetrated some level of criminal, fraudulent and unethical behavior with the consumers suffering serious injury.

It is critical for all members of the global pharmaceutical supply chain to protect their inventories by deploying best practices, solutions and technologies to authenticate and verify the efficacy of the products that flow through their operations.

To read the entire Shanghai Daily article, visit: http://www.shanghaidaily.com/article/?id=452464&type=Metro#ixzz13SEBnJZr

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

Securing Pharma: Cambodian Study Finds Only 3% of Medicines are Counterfeit

2010-10-24T07:13:00.005-04:00

Low figure compares to historical estimates of 4% to 90% in studies reported since 2000, according to the researchers.

Phil Taylor in an October 22nd post in Securing Pharma writes a blog about a recent study by Japanese researchers that shows a low percentage of counterfeits as it relates to past studies.

This research is significant because at face value the study paints a very different, more positive picture of the Cambodian pharmaceutical supply chain from previous studies which may lead to a false sense of the totality of the problem.

Highlights from the Securing Pharma post include:

• The results of a medicine sampling study in Cambodia reveals that just 3% of products were counterfeit, although between 5 and 9 % failed HPLC or dissolution-based quality testing.

• That relatively low figure compares to historical estimates of 4% to 90% in studies reported since 2000, according to the researchers, who were from Kanazawa and Nagasaki Universities in Japan and Cambodia's National Health Product Quality Control Center.

• A total of 710 samples of a wide range of commonly-used medicines were collected by the researchers in three tranches (in 2006, 2007 and 2008) at pharmacies and other forms of retail outlet in both rural and urban areas.

• A little over half (55%) of the samples collected had their packaging intact, but in 45% of cases it was open. Counterfeits were 20 times more likely to be encountered among open containers than closed one, were more likely to fail quality testing and were encountered more often in rural outlets, according to the researchers.

• Four of the counterfeits were labeled as originating from China, six were from India, two were from Malaysia and there was one each from Hong Kong, Cambodia and the UK.

Clearly the outcome of this research needs to be followed up given the apparent disparity between the results of this testing and what has been found in the past.

After one looks at the data however it would appear that although 3% were found to be specifically counterfeit there was a significant amount of issues with up to 9% of the sampling as to leave doubts to its efficacy. Simply put Cambodia has a huge health care issue as it relates to the safety of its pharmaceutical supply chain.

Adulterated, sub-standard, fraudulent and counterfeit drugs impact the health and safety of entire populations in developed and underdeveloped nations by poisoning the consumer, not properly treating diseases, creating drug resistant disease or at best scamming the patient out of his or her intended treatment.

Secure Pharma Chain encourages all within the pharmaceutical supply chain (regulatory agencies, manufacturers, distributors and dispensers) to use best procurement practices when purchasing their raw materials and inventories and to deploy technologies and solutions that will interdict these potentially lethal fakes from reaching the consumer.

To view Phil Taylor’s Securing Pharma article, visit: http://www.securingpharma.com/40/articles/624.php

To view the research published in Pharmaceutical Research, visit: http://www.springerlink.com/content/kj17835007x13471/

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

Eastern Europe Confronts Fake Medicines

2010-10-22T06:24:00.004-04:00

“Fighting back counterfeiters can't be done by one country or by one organization, it calls for a synergy of efforts."

Eastern Europe is a key route in a multi-billion-dollar trade in often-dangerous counterfeit medicines that has grown exponentially on the Internet. Agence France-Presse reports on a meeting of more than 120 anti-counterfeit specialists from six Eastern European countries in Romania held recently. The meeting was an effort to bring experts together and collaborate in combating this deadly crime which impacts the health of entire populations.

Highlights from the Agence France-Presse story include:

• "There is an important Balkan route for fake medicines, which is the same as for heroin and other narcotics," Hungarian customs officer Karolyi Szep told AFP at the meeting called by the world's leading pharmaceutical company Pfizer.

• Such drugs can contain no active ingredients at all or 8,000 times the required amount, or heavy metals such as arsenic, lead-based paint, brick dust or floor wax -- content that poses major health risks and can lead to death.

• Today most of the sales are done via the Internet, which has multiplied the trade -- and the risks -- exponentially.

• According to the World Health Organization, one in two medicines sold online are fake.

• "People who buy medicines on the Internet are playing Russian roulette with their own lives," Steve Allen, senior director of Pfizer Global Security, told AFP.

• Allen said 63 million fake Pfizer tablets, vials and capsules as well as enough active ingredient to manufacture an additional 64 million have been seized worldwide since 2004. "But this is just the tip of the iceberg," he warned.

• “Fighting back counterfeiters can't be done by one country or by one organization, it calls for a synergy of efforts," he said. "We are dealing with organized crime gangs, there is no doubt about it."

• Considered a low-risk and high-reward business, counterfeit medicines have become increasingly alluring to narcotics smugglers.

• "Supply techniques are identical, but the punishment is not," Allen said, stressing that in certain countries manufacturing or selling fake medicines is not considered a crime.

• In one case of narcotics and fake medicines going hand in hand, Turkish police seized 6,000 counterfeit Viagra pills smuggled with 378,000 ecstasy tablets and enough ingredients to manufacture 51 kilogrammes (110 pounds) of heroin.

• The former Soviet bloc has made important progress in recent years in fighting counterfeit medicines, said Gabriel Turcu, a senior partner in leading European anti-counterfeiting network REACT.

• Most countries in the region have toughened legislation and some are even setting an example for their Western neighbors. In Romania, fake drugs smugglers have for the first time been sentenced to prison this year.

• "Years ago, judges would deem counterfeiting T-shirts or medicines was the same. Now their perception has changed," Turcu said.

• Calling for increased public awareness, experts and law enforcement authorities stressed that deaths caused by fake medicines are often attributed to natural causes.

Secure Pharma Chain encourages collaborations as an important step forward in fighting this deadly criminal act.

Working partnerships between regulatory agencies and industry along with public awareness and the deployment of technologies are the vital components to the “synergy of efforts” in ending the threat of counterfeit medications to consumers around the globe.

To read the entire Agence France-Presse story, visit: http://www.abs-cbnnews.com/global-filipino/world/10/21/10/eastern-europe-confronts-fake-medicines-trade

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

Pharmaceutical Delivery Driver Kidnapped, Drugs Stolen

2010-10-21T04:25:00.001-04:00

Delivery truck high-jacked and driver kidnapped by gunmen posing as police for its cargo of prescription drugs.

In an incident that occurred early this month, according to Los Angeles Police, two robbers dressed as police officers held up a pharmaceutical delivery truck and kidnapped the driver before stealing its entire cargo of drugs.

According to the Associated Press:

• The truck was making an early-morning delivery to a Rite Aid in the San Fernando Valley when two men brandishing semiautomatic handguns approached the driver, Los Angeles police Sgt. Mitzi Grasso said. They were wearing dark clothing with "Police" emblazoned across the back.

• "They must have planned it," Grasso said. "They obviously knew the delivery schedule because they were waiting."

• One of the men got into the truck with the driver, and they drove to a spot about two miles away, where the driver was ordered out. He was unharmed.

• Grasso said the truck was making its first delivery of the day and was filled with a range of drugs, including narcotics such as Vicodin and OxyContin. The robbers made off with everything.

• "It was completely cleaned out," Grasso said. "They must have had people standing by."

This incident illustrates the value that criminals are placing on prescription drugs both for its use and value. Specifically these crimes are taking place routinely, not just for narcotics but because of the high cost of prescription drugs and their value on the black market.

All members of the pharmaceutical supply chain should protect their inventories, not only from theft and stolen goods but from the introduction of adulterated, sub-standard, fraudulent and counterfeit drugs.

To read the story on-line via Associated Press, visit: http://www.google.com/hostednews/ap/article/ALeqM5g5iQE5qKwtMeWzTB5P1rDAB38AWwD9IN46582?docId=D9IN46582

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

Freightwatch International: September 2010 Cargo Theft Report

2010-10-20T04:10:00.001-04:00

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 September 2010.

FreightWatch recorded 42 cargo theft incidents in September; a substantial decrease in the average number of thefts per month this year. The states with the highest number of thefts were California and Florida followed by New Jersey and Texas.

This month, Clothing/shoes, Electronics and Building/Industrial were the most targeted commodities. By Location, 50% of the incidents occurred at truck stops and secure DC/Terminal lots.

Finally, an average of $322,657 resulted from the 15 incidents showing loss value amounts.

By commodity, pharmaceuticals had three reported incidents in September which matches the previous month:

• September 10th in Daytona, Florida a last mile delivery of pharmaceuticals was taken of an unreported value.

• September 14th in Chicago, Illinois there was a theft of a trailer with a pharmaceutical cargo of an unreported value.

• September 24th in Dandridge, Tennessee there was a theft of a trailer with a pharmaceutical load valued at $160, 848.

As a commodity, pharmaceuticals from October 2009 to September 2010 represent 5% of actual incidents of cargo theft.

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 pharmaceutical material screening technologies, visit: http://www.xstreamsystems.net/.

Pill Mix Leads to Cancer Drug Recall

2010-10-19T03:36:00.001-04:00

Cross contamination has led to the recall of a cancer drug shipped to the U.S.

According to a report written by George Miller in FiercePharma, the recalled drug is Fresenius Kabi's anastrozole, and it was made by the German company's subsidiary in India, Fresenius Kabi Oncology.

The voluntary recall involves two batches of the tablets, which are used to treat breast cancer. They were made available in the U.S. by APP Pharmaceuticals, Kabi's U.S. unit based in Schaumburg, Illinois.

The drug was made at the Indian unit's plant in Baddi. Operators found drugs other than anastrozole in some of the 1-mg anastrozole bottles, according to the Economic Times. The recall comprises 7,192 bottles, each containing 30 tablets.

The specifics of the FDA recall are:

PRODUCT
Anastrozole tablets, 1 mg, 30 Tablets per HDPE Bottle, Rx only; NDC #63323-129-30; Product Code: 129030. Recall # D-906-2010

CODE
Lot numbers 870AF0010, Exp. date: 05/2012; Lot number: 870AF00201; Exp. date: 05/2012

RECALLING FIRM/MANUFACTURER
Recalling Firm: APP Pharmaceuticals LLC, Schaumburg, IL, by letters dated September 1, 2010. Manufacturer: Fresensius Kabi Oncology Limited (Baddi), Baddi, India. Firm initiated recall is ongoing.

REASON
Cross Contamination w/Other Products: A potential for some foreign tablets to be in bottles of anastrozole tablets 1 mg.

VOLUME OF PRODUCT IN COMMERCE
7,192 bottles

DISTRIBUTION
Nationwide

As more and more pharmaceutical products are outsourced from underdeveloped countries and nation's with a checkered history of regulatory control, it is important that all members of the pharmaceutical supply chain, especially the contracting entity, utilize authentication technologies to make certain of the quality of the products that make up their brand.

To read the FiercePharma post, visit: http://www.fiercepharmamanufacturing.com/story/pill-mix-leads-cancer-drug-recall/2010-10-13#ixzz12RCjXsX9

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

U.S. Embassy in Sri Lanka Funding Campaign to Combat Counterfeit Drugs

2010-10-18T13:05:00.000-04:00

U.S. to host series of seminars to help various groups work together to protect Sri Lankan consumers from the dangers of counterfeit drugs.

According to the October 15th posting of The ColomboPage, Sri Lanka’s leading Internet newspaper, the United States Embassy in Colombo, Sri Lanka together with the Sri Lanka Chamber of Pharmaceutical Industry (SLCPI), the National Intellectual Property Office and the American Chamber of Commerce, will be hosting a series of seminars across the country to show how pharmacists, doctors, and government officials how they can work together to protect Sri Lankan families against the dangers of counterfeit drugs.

The announcement was made from a press release from the U.S. Embassy. According to the press release:

• The first of the seminar series will be held on October 17 in Colombo with the participation of Sri Lanka's Minister of Health Maithripala Sirisena and U.S. Ambassador Patricia A. Butenis.

• Approximately 200 pharmacists, pharmacy owners, students, police, customs, and government health officials are expected to participate in the inaugural training, the Embassy said.

• Three more workshops are planned in Galle, Kandy, and Jaffna during the coming months.

• The program includes four workshops under the theme "Protecting Sri Lankan Families from Counterfeit Drugs." Each workshop will include a discussion of ways to safeguard intellectual property rights by registering and controlling genuine pharmaceuticals and medicines and enforcing the procedures established to do so.

• The U.S. Department of State is the principal sponsor of the campaign. The U.S. Embassy in Colombo and the SLCPI are also providing funds for this important program.

• The U.S. Embassy, the Pharmaceutical Chamber, AmCham and the NIPO have jointly developed the series of workshops to examine the problem of counterfeit drugs which can irreparably harm patients and even cause death.

Clearly this is a significant first step in the United States working with countries pharmaceutical supply chain stakeholders in combating this deadly disease. Counterfeit drugs that are made in underdeveloped countries often end up imported into developed countries like the United States.

Recently it has been evident that the United States government is beginning a broad international campaign to work with countries against counterfeit goods and Intellectual Property crimes.

Secure Pharma Chain endorses these efforts but also encourages members of the pharmaceutical supply chain to deploy technologies and solutions to protect their inventories and their end user consumers from this deadly criminal act.

To read the entire article, visit: http://www.colombopage.com/

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

Interpol: Chad's Story - Don't Let this Happen to YOU

2010-10-17T04:58:00.001-04:00

Interpol in an effort to educate consumers regarding the dangers of purchasing on-line pharmaceuticals created a marketing campaign directly to the consumer.

This Interpol video tells the story of Chad and his purchase of blood pressure medicine over the internet. His story, initial rationale and end result to the purchase hopefully will drive home the dangers to consumers-at-large regarding the dangerous consequences of buying prescription drugs over the internet.

Secure Pharma Chain endorses agencies and the pharmaceutical industry in general, creating more consumer campaigns that warn and educate about the dangers of adulterated, fraudulent, substandard and counterfeit medications.

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

Yahoo Finance: Top 5 Counterfeits that Endanger Consumers

2010-10-15T04:21:00.001-04:00

Yahoo Finance airs a video on the top five most dangerous counterfeits and explains the ever growing global counterfeiting industry which now is valued at over $600 Billion annually.

Counterfeit Prescription Drugs were listed as number one on the list of the top five counterfeits that are of most risk to consumers.

US Customs and Border Patrol reports that seizure of counterfeit pharmaceuticals totaled $11 Million in 2009. The 2010 number is anticipated to easily exceed that value.

Secure Pharma Chain believes that it is important that consumers understand the danger that counterfeit drugs pose to their health. Fraudulent, adulterated, substandard and counterfeit medications are one of the most significant and dangerous health care issues of the 21st century. This video is a great way to share that message.

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

Global Pharmaceutical Sales Expected to Rise to $880bn in 2011

2010-10-14T05:31:00.005-04:00

IMS Health predicts that global drug sales will increase 5 to 7 per cent next year, driven by development of innovative pharmaceuticals and growth of emerging markets. Secure Pharma Chain sees this as a major driver to continued proliferation of counterfeit medications.

In-PharmaTechnologist published a story yesterday on the IMS report regarding the rise in global drug sales for 2011.

The report shows that although there will “constraints” to the traditional developed markets because of the loss of major drugs to patent protections, significant growth in emerging markets globally will still mean continued growth.

Secure Pharma Chain anticipates that based on the information in this report, the growth in the emerging markets in China will result in still higher growth in substandard, fraudulent, adulterated and counterfeit medications in 2011.

This estimation is driven by industry experts like Terry Hisey from Deloitte and the World Health Organization, significantly raising their estimates in 2010 as to the annual global value of counterfeit medications to a range from $75b to $200b with a annual growth rate of 12to 15 per cent.

These factors and the state of the global economy in general mean that the global pharmaceutical market place will face many challenges going forward.

Secure Pharma Chain encourages all members of the pharmaceutical supply chain to protect their inventories from this growing threat by deploying technologies and solutions designed to authenticate and validate products within the supply channel.

Included in the In-PharmaTechnologist article:

• China is expected to enter 2011 as the third largest pharmaceutical market after the US and Japan, overtaking Germany with a predicted 25 per cent growth and $50bn in sales.

• By 2015, annual spending on prescription drugs in another 16 emerging markets is expected to increase by at least $1bn, which for the lowest spender in the group, Vietnam, will mark a doubling of this year’s expenditure.

• Innovative products in areas of stroke prevention, melanoma, multiple sclerosis, breast cancer and hepatitis C are expected to enter the market next year, representing 30-35 new chemical and biological entities with five predicted to reach blockbuster status.

• While 2011 is expected to bring global drugs sales of $880-890bn, “the underlying constraints to growth in developed markets are stronger than ever”, according to Murray Aitken, Senior Vice President at IMS, with “major drugs losing patent protection and facing generic competition for the first time”. The new potential blockbuster drugs are not expected to provide market growth “beyond what we’ve seen in the past 3 years which is at historically low levels”.

To read the entire In-PharmaTechnologist article, visit: http://www.in-pharmatechnologist.com/Industry-Drivers/IMS-prediction-Emerging-markets-front-5-7-rise-in-drug-sales-for-2011

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

Partnership for Safe Medicines Interchange Conference Quote

2010-10-13T03:41:00.001-04:00

By all accounts, the First Annual Interchange Partnership for Safe Medicines Interchange Conference was a huge success and a great step forward to coordinating a domestic agenda with all of the supply chain stakeholders in the fight against counterfeit drugs.

The following quote was by FDA Commissioner Dr. Margaret A. Hamburg during her keynote address at the conference:

“It is sad to realize that we live in a world in which some criminals are willing to maximize profits by placing poisons in products like infant formula, toothpaste and medically necessary drugs. But it is a reality we must face. And, more importantly, it is a reality that we must become more proactive in dealing with. “

Secure Pharma Chain is excited about the success of the conference and encourages all members of the pharmaceutical supply chain to protect their inventories and the consumer by deploying a variety of solutions and technologies.

Commissioner Hamburg’s admonition to become more proactive in the fight against this deadly crime of fraudulent, adulterated and counterfeit drugs is especially relevant with the emergence of a global pharmaceutical supply chain.

To read about the Safe Medicines Conference, visit: http://www.safemedicines.org/2010/10/partnership-for-safe-medicines-first-annual-interchange-conference-huge-.html.

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

Thai Government Promises to Crack Down on Counterfeit Drugs

2010-10-12T03:24:00.000-04:00

Thailand has decided to crack down seriously on counterfeit medicine, and nine concerned government agencies have inked a memorandum of understanding to join forces.

According to a September 29th issue of The Nation, nine Thai government agencies are signing a Memo of Understanding linking their efforts to fight counterfeit drugs in part due to the United States putting Thailand on a Priority Watch List as it relates to Intellectual Property Rights and Trade.

The nine Thai agencies are the Customs Department, Food and Drug Administration, Department of Special Investigation, Pharmaceutical Research and Manufacturers Association, Royal Thai Police, Information and Communications Technology Ministry, Central Institute of Forensic Science, Office of the Attorney-General for Intellectual Property and International Trade, and the Commerce Ministry's Intellectual Property Department.

According to The Nation:

• Deputy Commerce Minister Alongkorn Ponlaboot said yesterday that these agencies would suppress not just the distribution of counterfeit medicines, but also trademark violators. The sale of fake medication not only costs the country thousands of billions of baht a year but also adversely affects consumers' health, he warned.

• The government is promising to crack down on violators of intellectual-property rights so Washington can review Thailand's status in relation to trade.

• "These fake products have caused more damage than we can estimate because the agencies working on this do not share information enough," Alongkorn said.

• Last year, the government seized 145,000 tablets of counterfeit medicine worth Bt58 million. This does not include the many illegal products that have been smuggled across the border.

• Under the MoU, the agencies will join forces not just to suppress fake products but to demolish processing plants, Alongkorn said.

• The plan is also to inform the public about the adverse effects of purchasing counterfeit goods.

• "The US will review its trading partners' status under Article 301 of the Trade Law next month. Our plan is to persuade Washington to remove Thailand from its Priority Watch List," he said.

Secure Pharma Chain is encouraged by the actions of the Thai government and by the United States in pressuring their trading partners to be more active in their enforcement.

To read the entire The Nation article, visit: http://www.nationmultimedia.com/home/2010/09/29/business/Serious-crackdown-on-counterfeit-drugs-planned-30138956.html

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

Interpol Starting Operation Against Counterfeit Drugs in Russia

2010-10-11T04:48:00.003-04:00

First large scale initiative by Interpol in Russia against bogus medications.

ITAR-Tass reported on September 27th that Interpol Russia is initiating a large-scale operation against fake medicines.

Police Major General Timur Lakhonin, who heads Russia’s Interpol Bureau, is quoted in an interview with the Rossiyskaya Gazeta :

• “At present, a special raid was launched to detect the channel of counterfeit medicines. This is a new direction in our work. We found 1,200 websites in the Internet that sell fake medicines. These medicines are now being seized. The operation is underway in 25 countries and now it begins in Russia,” he said.

• “The most dangerous segment of the black market is counterfeiting of different antibiotics, contraceptives, steroids and weight loss medicines,” Lakhonin said.

This is a significant step forward for enforcing a critical health care problem and major criminal activity in Russia a country who is considered to have a relatively high percentage of its pharmaceutical supply chain impacted by fake drugs.

Secure Pharma Chain endorses more aggressive law enforcement against this criminal act but also encourages pharmaceutical supply chain members to proactively deploy technologies and best practice solutions to protect their inventories and consumers from these potentially lethal fakes.

To read the ITAR-TASS article, visit: http://www.itar-tass.com/eng/level2.html?NewsID=15533991&PageNum=0

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

FDA Commissioner Margaret Hamburg Joins with Public and Private Sector Leaders in Call to Address Global Counterfeit Drug Crisis

2010-10-09T07:05:00.005-04:00

"It is clear that FDA needs new regulatory tools that provide the authority we need to meet the challenges we face in today's increasing globalized marketplace, “ stated Dr. Margaret Hamburg, Commissioner of the FDA.

Dr. Hamburg made this statement at the inaugural Counterfeit Drug Interchange Conference hosted by the Partnership for Safe Medicines (PSM).

This conference brought together more than a hundred cross-industry stakeholders to discuss ways to stem the rising tide of counterfeit and unsafe medicines.

Highlights from the press release by PSM included:

• "The FDA is firmly committed to doing all that we can to further strengthen our nation's drug supply and ensure the quality and safety of all drugs and medical products on the U.S. market," said Hamburg. "It is clear that FDA needs new regulatory tools that provide the authority we need to meet the challenges we face in today's increasing globalized marketplace. And we look forward to working with Congress on legislation that will give FDA the ability to protect Americans from harmful drugs and medical products-and fulfill our fundamental public health mission."

• Today's forum underscores the severity of the problem and the interest among all segments of the pharmaceutical sector - law enforcement, patient groups, government regulators, academics and manufacturers - to come together to discuss practical solutions.

• "The U.S. has the safest drug system in the world, but that does not mean American consumers are immune. The instances of counterfeit drugs are increasing and the counterfeiters are becoming more sophisticated, which means that our drug safety is at risk," said Scott LaGanga, executive director of PSM. "PSM's goal with the Interchange is to raise awareness of the scope of this epidemic, as well as the need for global collaboration, information sharing and tools and resources that will help protect consumers across the globe."

• In addition to Dr. Hamburg, speakers included an American victim of counterfeit drugs, representatives from the Drug Enforcement Agency and the Centers for Disease Control and Prevention, law enforcement officers, and patient advocacy groups.

• At the event, PSM also announced that the Generic Pharmaceuticals Association (GPhA) has joined the organization, adding their expertise and network to PSM's efforts to keep all medicines - generic and branded - safe for consumers.

• "Given the role that generic drugs play in the global marketplace, PSM today is even more positioned to continue its battle to keep prescription medicines safe for consumers," said LaGanga. "We welcome GPhA to our membership and look forward to working together on this critical health issue."

Secure Pharma Chain endorses the need form more FDA regulatory authority especially as it pertains to dealing with adulterated, fraudulent and counterfeit medications and raw materials in the proliferating global pharmaceutical supply chain.

Secure Pharma Chain also believes that it is incumbent on all members of the pharmaceutical supply chain to proactively protect their industry, inventories and most importantly the consumer by deploying best practices, solutions and technologies to combat this deadly criminal act.

To view the entire PSM press release, visit: http://www.safemedicines.org/2010/10/fda-commissioner-margaret-hamburg-joins-with-public-and-private-sector-leaders-in-call-to-address-global-counterfeit-drug-cri.html

To learn more about anti-counterfeiting technologies for pharmaceuticals, visit: www.xstreamsystems.net.

Customs Agents Seize $21M in Counterfeit Items at Cincinnati Airport

2010-10-08T06:03:00.003-04:00

Operation Safe Summer with agents from Customs and Border Protection, Immigration and Customs Enforcement and Homeland Security Investigations discovered a variety of counterfeit items including counterfeit drugs.

As reported by Dan Horn and posted on-line at Cincinnati.com on September 28th, the seizures are part of a nationwide campaign by U.S. Customs and Border Protection to crack down on imports of knock-off products, which cost American companies and consumers hundreds of millions of dollars a year:

• Most of the counterfeit items came from China and all were seized between Sept. 7 and Sept. 17 as they passed through DHL's hub at the airport.

• "Pretty much anything that can be counterfeited, we came across," said Brian Bell, spokesman for Customs and Border Protection. "They were very good. The Chinese have perfected the art of duplicating our products."

• U.S. officials have said for years that the theft of intellectual property through counterfeit goods poses a major threat to the U.S. economy and to consumers, who could spend thousands of dollars for lower quality products or suffer injury because of defective parts or dangerous medicine.

• Federal agents seized almost 15,000 counterfeit shipments valued at more than $260 million nationwide last year, with China accounting for 79 percent of the illegal imports.

• The value of seizures dropped for the first time in 2009 - down from $272 million in 2008 - but federal officials say that may be because the global economic downturn reduced all imports by 25 percent. Until last year, intellectual property seizures increased steadily from about $93 million in 2005.

• He said counterfeiters are savvy, fast and getting better at mastering the technology needed to produce believable fakes. When the iPad came out earlier this year, Bell said, border protection officers began seizing knock-off versions within weeks. "The importation of counterfeit merchandise really damages the U.S. economy," he said.

• He said the DHL hub at the airport was targeted because so many goods pass through each day, not because the problem is worse here. He said DHL cooperated with federal officials and, as the shipping company, was not responsible for verifying the authenticity of the products it was paid to fly overseas.

• Criminal charges against the manufacturers of the counterfeit goods are unlikely because they are based overseas.

The fact that counterfeit products and dangerous fake drugs are becoming a semi-mainstream global export from emerging economies is very troubling and a significant threat.

This type of law enforcement confiscation, which will not likely lead to many if any criminal charges is becoming all too much the norm and represents a small fraction of the amount that comes into this country on a daily basis.

Industry leaders and consumers around the globe need to insist on regulatory/enforcement measures and need to take proactive steps to protect themselves from harmful goods that threaten populations.

To read the Mr. Horn’s article, visit: http://news.cincinnati.com/article/20100928/NEWS010703/309280053/Fake-items-seized-at-CVG.

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