ABC News: FDA Looking into Tylenol Arthritis Pain Caplets Recall

ABC World News is reporting that the US Food and Drug Administration is investigating the process of the recall and the way that it has been communicated to consumers.

November, Tylenol posted a small recall on its website. Twelve days ago, all six million bottles were recalled. However, it wasn't until a nationwide FDA medical alert just this Monday that most people learned the bottles had been recalled.

In an analysis piece aired on ABC World News, ABC’s Senior Medical Editor Richard Besser, MD, advised consumers what actions to take if they have the recalled Tylenol. Dr. Besser explained that consumers who have the Tylenol arthritis caplets in the Easy Cap bottles should get rid of them by safely disposing them in their trash.

On Wednesday, the deputy commissioner of the FDA, Joshua M. Sharfstein, MD, said the agency is "looking into...the case," additional stating "a system that relies on the consumer to either visit websites or to sign up for multiple web blogs or email alerts, I don't think is the way we want to alert consumers about recalls."

Tylenol Pain Caplets Recalled Due to Trace Chemical Which Causes Nausea and Vomiting

The Associated Press and other major media outlets are reporting that Johnson & Johnson is expanding a voluntary recall of Tylenol Arthritis Caplets due to consumer reports of a moldy smell that can cause nausea and sickness.

The FDA released a statement on their website that Johnson & Johnson is now recalling all product lots of the Arthritis Pain Caplet 100 count bottles with the red EZ-Open Cap. Johnson & Johnson had previously recalled five lots of the product last month after consumers complained of a musty, mildew-like odor that triggered nausea, stomach pan, vomiting and diarrhea.

Johnson & Johnson is saying that the odor results from trace amounts of a chemical called 2, 4, 6-tribromoanisole. That chemical is believed to result from the breakdown of another chemical used to treat wooden pallets that transport and store packaging materials. To date, the side effects, which also include vomiting and diarrhea, have been "temporary and non-serious," although the health effects of the compound have not been studied.

The company will reintroduce Tylenol Arthritis Pain Caplets 100 count by January after moving production to a new facility.

For more information on the recall visit the Tylenol website: http://www.tylenol.com/.

This recall, based on onsite product contamination, energizes the need for material screening of products within the supply chain to protect consumers from fraud, adulteration, contamination and counterfeit products.

To learn more about onsite pharmaceutical material screening solutions, visit: www.xstreamsystems.net.

PETN Explosives Are Visible to EDXRD Technology

As everyone breathes a sigh of relief over the near miss that happened on Christmas Day in Detroit on Northwest # 253, it brings to mind the issues over current screening technologies used in security applications and their ability to efficiently detect various threats that we currently face from terrorist around the globe.

While nothing is fool proof, it is apparent that most of the x-ray technologies in place are based solely on image density screening and cannot adequately differentiate between common everyday items and significant threats. With current x-ray screening an image of a block of plastic explosive (i.e. C4), which is roughly the same density as chocolate or cheese, would be nearly identical to these common food items and almost impossible for a TSA Operator to properly distinguish without a thorough secondary inspection.

There are however alternatives to the current technologies, many that have been tested or used periodically in Homeland Security applications, that may be one of the solutions to consider as we begin to face a seemingly renewed and more sophisticated terrorist threat.

EDXRD or Energy Dispersive X-Ray Diffraction, is one such alternative that bears a looking at as our threats become more sophisticated and resolute.

EDXRD utilizes x-ray beams to screen crystalline materials, penetrating a container like luggage, while giving the operator molecular spectra of the material instead of an image and a clear cut way to distinguish real threats and common items. The EDXRD spectrum is essentially a fingerprint which can be automatically “matched” against a known library of threats and the operator notified immediately.

PETN, a crystalline based material that was used by the suspected terrorist is a perfect example of a material that EDXRD would detect. PETN comes in a substance form as a powder. The powder would show up as any other powdered material in a current magnetometer used in airports around the globe. EDXRD would be able to differentiate its molecular spectra fingerprint and recognize the threat in real time as it was being passed through the system.

EDXRD technology is currently in use within the pharmaceutical supply chain as a way to detect fraudulent, adulterated and counterfeit medications inside the material’s unit-of-sale container without destroying or degrading the products and has proven extremely accurate and reliable.

As we continue to face new and more dangerous threats it is important for both industry, regulators and government officials that we need to stretch our technology as the solution to these clear and present dangers.

To learn more about EDXRD technology and its current applications, visit: www.xstreamsystems.net.

UK Gets Tough with Bogus Drug Website Operators

Those operating bogus online pharmacies could face stiffer penalties, up to 12 years jail time under a new law developed by Britain’s Medical and Healthcare Products Regulatory Agency (MHRA).

Specific criminal sentences for counterfeiting medicines are to be introduced in the UK. Convicted individuals would face a maximum penalty of 10-12 years' imprisonment, the agency has announced. Individuals could be found guilty of either supplying or offering to supply counterfeit medicines.

Stronger enforcement is in answer to the increase of counterfeit medicines in the United Kingdom. Earlier this year a British newspaper survey indicated that one out of four general practitioners believes they have treated a victim of counterfeit drugs.

To view the entire article visit: http://www.healthcarerepublic.com/news/975201/Bogus-drug-website-operators-face-12-year-jail-sentences/.

Pharmaceutical Commerce: FDA Counterfeit Drug Investigations Reach New High in 2009

In the December 23rd online edition of Pharmaceutical Commerce, they reported on the FDA’s statistics on Counterfeit Drug Investigations. It is believed that the number of investigations is an indicator of the increase in counterfeit drug activity and represents a fraction of the overall activity within the United States. The entire online posting appears below:

At the HDMA Track & Trace Seminar (National Harbor, MD, Nov. 30-Dec. 1), David Dorsey, Acting Deputy Administrator for Policy at FDA, revealed the FY 2009 (which ended last September) figure for counterfeit-drug investigations opened by FDA’s Office of Criminal Investigations: a new record of 65.

FDA cautions that this count is not a direct measure of the volume of counterfeit activity—but on the other hand, where there’s smoke there’s fire. Dorsey also said that the agency is working toward its mandated March 2010 deadline for making recommendations on a “serial numeric identifier” program for drug tracking, as specified in the FDA Amendments Act of 2007.

Meanwhile, newer legislation, such as the Buyer-Matheson bill from the 2008 session (H.R. 5389) is expected to be re-introduced in the current Congress. That bill would mandate a national track-and-trace system to prevent counterfeiting and diversion.

Visit Pharmaceutical Commerce and read the story online at: www.pharmaceuticalcommerce.com/frontEnd/1339-counterfeit_drugs_FDA_Office_of_Criminal_Investigations_OCI.html

XStream Systems Presents Quad Layer of Protection against Counterfeit Drugs

With an invitation from Pfizer Inc.. and Dr. Mohammed Abuelkhair, Head, Pharma/Medicine and Medical Products Regulation Section – Health Authority Abu Dhabi, XStream Systems had the opportunity to present at the joint Regional Conference on Fighting Counterfeit Medicines in Dubai December 15 and 16, 2009.

Representing XStream Systems were Brian Mayo, President and CTO, Patricia Earl, Vice President Business Development and Simon Irish, XStream Systems’ Director.

XStream Systems representatives had an opportunity to interact with officials from the Ministries of Health, Police, and Customs representing governments of the Middle East and North Africa region.

On the second day of the conference XStream Systems’ President formally presented the company’s vision of the “Quad-Layer Approach” that integrates molecular screening, serialization, sealants and pedigree. He shared with the attendees that this was an all-encompassing system that will deliver a seamless method of counterfeit control and product integrity assurance, and, in this regard discussed XStream Systems’ on-going collaboration with the Kodak Security Solutions and use of the Traceless System for Anti-Counterfeiting.

To view entire article visit: www.xstreamsystems.net.

Ministry Plans Ban on Re-export of Medicines

The UAE is taking measures to combat counterfeit drugs. One of those measures is to ban re-exportation of medication.

An article published this week in Khaleej Times quotes prominent industry and regulatory leaders on the scope of the counterfeit drug trade in the Middle East, the challenges, and current initiatives to combat it.

Below are some key fact listed in the article:

The scope of the counterfeit drug trade and seizures in the Middle East

• Nearly one per cent of the fake medicines detected in the European Union comes from the UAE, said Dr Amin Al Amiri, CEO, Medical Practice and License at the UAE Health Ministry


• During the first five months of 2008, Dubai Customs seized and destroyed 293 tonnes of counterfeit medical products.


• During 2006-2008, the UAE ranked sixth in the region with 36 numbers of raids in which counterfeit medicines were seized. Israel topped the list of 10 countries with 162 raids. “Four other incidents in the UAE discovered goods that were being diverted to another country,” said Ashley How, regional director for Pharmaceutical Security Institute.


• In 2008, $3.1 million worth of Pfizer counterfeit drugs were seized in the region. “It is not only expensive drugs that are duplicated but even common ones such as Ponstan,” said Steve Allen, Pfizer’s senior director for 
Global Security. “This is because people would prefer buying a drug from a known company rather than an unknown,” he said, adding that 30 of the company’s well known drugs including Viagra, Ponstan, Xanax and weight loss drug Lipitor had 
been copied.

Dependence on imports are a challenge

• The expanded volume of imported medical products and medicinal ingredients is a challenge for the country, said Dr Mohammed Abu Elkhair, Head of Pharma/Medicine and Medical Products Regulation Section, Health Authority of Abu Dhabi.


• Only 20 per cent of the medicines needed in the UAE are manufactured locally, thus increasing a chance of counterfeit trade. “Only increased penalties as proposed in the law can help curb the trade,” he said.


• Quoting a recently held study in Abu Dhabi, Dr Elkhair said only 40-50 per cent of the registered medicines are available in the country.

Current Initiatives

• The UAE will soon end re-exporting of medicinal drugs from its ports to curb a growing regional trade in counterfeit products, according to a senior health official.


• The Health Ministry has also increased raids and inspections and toughened punishments against violators. “Two doctors have recently been blacklisted GCC-wide while in 2008 we closed two factories. This year, 35 pharmacies have been shut down for selling fake drugs,” said Dr Amin Al Amiri.


• Other measures taken by the ministry include quality control analysis, inclusion of new technologies to identify fake medicines, tougher imports control, and advertisement control.

To view the article in its entirety, visit: www.khaleejtimes.com.

The National: Tighter Controls on Fake Drugs Sought

The Regional Conference on Fighting Counterfeit Medicines recently held in Dubai, examined the issue and solutions to fighting counterfeit medications. The conference, sponsored by Pfizer, attracted representatives from 15 countries.

XStream Systems President and Chief Technology Officer, Brian Mayo presented XStream’s revolutionary material screening technology at the conference.

Reported by Mitya Underwood and published by The National the following are some excerpts from the article:

• The UAE must tighten its border controls and increase co-operation between enforcement agencies if it hopes to turn back the rising tide of counterfeit drugs, officials said yesterday.


• The Ministry of Health said it would work with customs and free zone officials to stop fake medicines and medical equipment from entering the country or passing through its ports.


• Dr Amin al Amiri, the chief executive of medical practices and licensing, said the ministry would ask customs officials to stop clearance for medicines and equipment until it had approval for each consignment.


• Speaking at the Regional Conference on Fighting Counterfeit Medicines, Dr al Amari said the ministry hoped to reduce the UAE’s role in the global trafficking of illegal products. He declined to say how much counterfeit material was coming into or passing through the country.


• Figures from the European Commission’s Taxation and Customs Union recently showed that the UAE was the origin of almost nine per cent of all counterfeit medicines seized at European borders in 2008. The UAE was the third largest importer after India and Syria.


• Dr al Amiri said in addition to increased inspections and raids, a federal pharmaceutical law would be introduced to tighten penalties and introduce jail terms and larger fines.


• Dr Mohammed Abuelkhair, the head of drugs and medical products registration at the Health Authority-Abu Dhabi, said the law should deter pharmacies from knowingly stocking counterfeit drugs and stop importers from targeting the UAE market.

To read the entire article, visit: http://www.thenational.ae/apps/pbcs.dll/article?AID=/20091216/NATIONAL/712159821/1010

Six Chinese Sentenced to Death for Selling Fake Drugs Labeled “Made in India”

Six Chinese traders who exported fake anti-malaria drugs to Africa Labeled as “Made in India” have been sentenced to death. Chinese officials have offered apologies to India, but no further information on the traders’ identities was given.

The issue became a major controversy last June when Nigeria's National Agency for Food and Drug Administration and Control said it had seized a large consignment of spurious anti-malaria drugs worth $210,000.

Indian officials had received complaints that drugs exported from China but mislabeled as manufactured in India were being exported to South Africa, Ghana, Ivory Coast and other parts of Africa.

To view the entire article visit: timesofindia.indiatimes.com.

November 2009 Pharmaceutical Cargo Theft Report

Freightwatch International, an industry leader in providing cargo theft intelligence through data collection, analysis, and customized reporting, released its November 2009 cargo theft report.

There have been 64 cargo theft events for the month of November. There were three documented incidents of pharmaceutical theft which included H1N1 Vaccines, OTC Medications and Infant Formula.

Two months ago FreightWatch noted that cargo theft incidents are occurring from terminal and carrier lots, as well as public access parking lots. This trend has continued through November, where almost 45% of known theft locations were in terminal or carrier lots, in lieu of truck stops (approximately 20%), which are traditionally where cargo theft is known to occur in the highest amounts volume

These trends coincides with intelligence reports and activity that show cargo thieves are becoming more organized and proactive in targeting specific loads or products, conducting surveillance and stealing the loads at their first opportunity.

Members of the pharmaceutical supply chain should be aware of the incidents of pharmaceutical cargo thefts and the overall safety and security implications. XStream Systems encourages manufacturers, distributors and dispensers to utilize a variety of tools and solutions including EDXRD screening to secure, authenticate and verify that the inventories and products within their control are authenticate and safe. Nefarious sources of supply are known to infiltrate the legitimate supply chain with fraudulent, adulterated and counterfeit medications which impact the safety, security and efficacy of supply to healthcare consumers.

To see the November 2009 report, visit Freightwatch International’s site at: www.freightwatchintl.com.

To learn more about XStream Systems supply chain security solution visit our site at: www.xstreamsystems.net.

Washington Post: US Crackdown Targets Counterfeit Drugs

Fake medicines are a growing enterprise. In a November 20th article in the Washington Post they give out excellent statistics and report on an international law enforcement effort, code named Pangea that we have blogged about several times recently.

Operation Pangea conducted organized raids on five continents to combat counterfeit drugs.

In the U.S. the crackdown uncovered 700 alleged packages of fake or suspicious prescription drugs including Viagra, Vicodin, and Claritin, and shut down 90 alleged rogue online pharmacies. The international operation took down 72 Web sites, seized nearly 1,000 packages and found more than 167,000 suspected illicit and counterfeit pills. Some may have as much as three times more of an active ingredient than is typically prescribed; others may be placebos.

According to the National Association of Chain Drug Stores, a trade group, Americans spent $254 billion on prescription drugs last year, up 1.8 percent from 2007.

The increase of internet pharmacies has given rise to rogue pharmacies posing as legitimate sites. One site under federal investigation for selling erectile dysfunction medications like Viagra and Cialis states that it is headquartered in Canada, has a warehouse in India and is licensed to sell in the U.S. through Minnesota. However, the website is registered in China and is hosted in Russia.

These sites are very hard to track and the Food and Drug Administration discourages consumers from purchasing medication online except through Verified Internet Pharmacy Practice (VIPP) pharmacies, which are certified by the National Association of Boards of Pharmacy (NABAP). The National Association of Boards of Pharmacy maintains a list of roughly 4,000 online pharmacies it says are questionable.

The global crackdown involved a half a dozen U.S. agencies and 24 countries in a week long intensive sweep. "For the criminals, at least," said Richard Halverson, unit chief at the National Intellectual Property Rights Coordination Center, "we're telling them that everybody's looking."

To view the entire article visit: http://www.washingtonpost.com/wp-dyn/content/article/2009/11/20/AR2009112002772.html.

CBI Probes Bulk Drugs Imported from China

The office of the Drugs Controller General of India (DCGI) is investigating bulk pharmaceutical ingredients imported in from China. The DCGI has handed over 4 cases of “alleged” unregistered bulk drugs to the Central Bureau of Investigation (CBI) with an additional 3 cases to follow.

The Directorate of Revenue Intelligence was alerted after the apex drug regulator noticed that such unregistered drugs accounted for almost half of the country’s recent bulk drugs import.

According to official sources, CBI has been asked to inquire into the import of drugs such as Roxithromycin ($81.5 per kg), Progesterone ($187.5 per kg) and Cimetidine ($14.5 per kg) by Gujarat-based Envee Drugs Pvt Ltd, and Mumbai-based firms J B Khokhani & Co and Sheetal Pharmaceuticals, respectively.

Samples of all three consignments are being tested for quality at Central Drugs Laboratory, Kolkata. The fourth case has been registered against Mumbai-based C J Shah & Co.

The products showed discrepancies in labeling, packaging and documentation. The documentation names Chinese manufacturers that have denied the products were sourced from them.

Many of the cases are labeled as chemicals, which do not undergo the same inspection as raw materials used in pharmaceuticals. This is of particular concern as these bulk drugs are used by local manufacturers to make the final medicine for domestic as well as export purposes.

The Indian drug industry is highly dependent on Chinese bulk drugs. “There is an urgent need to ensure the quality and authenticity of these drugs,” said a senior government official. India imported Rs 6,700 crore ($USD 144.23 Million) worth of mostly bulk drugs in 2007-08.

To view more on the investigation visit: www.business-standard.com.

FDA Permanently Debars Two for Fraud and Counterfeits

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Anthony W. Albanese from providing services in any capacity to a person that has an approved or pending drug product application.

On November 5, 2004, the U.S. District Court for the District of Rhode Island entered judgment against Mr. Albanese for one count of conspiracy to sell drug samples; one count of unlawful sale of drug samples ; one count of health care fraud; and one count of money laundering .

Additionally the FDA is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Niaja Kane from providing services in any capacity to a person that has an approved or pending drug product application.

On January 22, 2007, the U.S. District Court for the Eastern District of Pennsylvania accepted Niaja Kane's guilty plea and entered judgment against her for trafficking in counterfeit goods, holding counterfeit drugs for sale with intent to defraud, and attempted possession with intent to distribute a counterfeit controlled substance. The actions underlying these convictions were associated with Ms. Kane's order of counterfeit Percocet, Viagra, and Cialis on or about February 28, 2006. These drugs included approximately 2,040 tablets purporting to be Viagra, 1,200 tablets purporting to be Cialis, 2,333 tablets purporting to be Percocet 7.5 milligrams (mg), and 6,573 tablets purporting to be Percocet 10 mg.

These actions are seen as tighter control and enforcement against counterfeit and fraudulent medications within the domestic supply chain.

Counterfeit Medicines - Filled With Empty Promises

You can avoid counterfeit medicine by purchasing only from U.S. state-licensed pharmacies. The following is a guide that appears online at www.fda.gov regarding what steps healthcare consumers should use in protecting themselves from counterfeit medications:

While counterfeit medicines are not as common in the United States as in other parts of the world, you must take an active role in managing your medicines to ensure you’re not at risk. Here are some important facts about counterfeit medicine from the Food and Drug Administration (FDA).

Counterfeit medicines are fake or copycat medicines. They may:

• be contaminated
• contain the wrong active ingredients (the formula that makes the medicine work)
• be made with the wrong amount of ingredients
• contain no active ingredients at all
• be packaged in phony packaging.

Medicines that are counterfeit may not help the condition the medicine was intended to treat and may lead to dangerous side effects. How can you avoid counterfeits?

• Purchase ONLY from state-licensed pharmacies that are located in the United States, where FDA and state authorities can assure the quality of drug manufacturing, packaging, distribution and labeling. This way, you know your medicine is coming from a reputable source, and you can get help if you have any problems with your medicine. If you buy over the Internet:


• Check to see if a pharmacy is licensed, is in good standing, and is located in the United States. Contact your local state board of pharmacy or the National Association of Boards of Pharmacy (NABP) at http://www.nabp.net or 1-847-698-6227, or
• Check to see if an Internet pharmacy site has the VIPPS Seal, the seal of the Verified Internet Pharmacy Practice Sites Accreditation Program. This program was established by the NABP to help protect you and guide you through Internet pharmacy shopping. Legitimate pharmacies that carry the VIPPS Seal are listed at http://www.nabp.net/vipps/consumer/listall.asp.


• Know your medicine. Any time you get a prescription refilled, check the color, texture,
• taste and shape of the medicine. Anything different? Talk to your pharmacist.
• Give your doctor and pharmacist a complete list of all medicines (over-the-counter and prescription) that you use. They will also want to know what dietary supplements you use, including vitamins and herbals.

Securing Pharma: Survey Reveals European Views on Counterfeits

A study posted online on SecuringPharma.com on November 25th, was conducted by ICM and sponsored by Aegate.

The results demonstrate the awareness of counterfeit products in general and drugs in particular on the European continent. The research was based on interviews with 5,000 consumers in five European countries between October 15 -21, 2009.

The findings show a growing awareness of counterfeit drugs which seemingly correlates with the growth of issue within developed countries globally. The following are several interesting findings from the study:

· One in 20 Europeans suspect they have received a counterfeit prescription drug and 1 per cent believe they definitely have, according to consumer research group ICM. Which translates to as many as 12.8 million European consumers could have been exposed to counterfeit drugs.
· Awareness of the phony drugs market was moderate, with 61 per cent of those polled saying they know prescription drugs can be faked. Awareness was higher in the UK, at 75 per cent.
· Medicines topped the list of counterfeit items that respondents said would most concern them - at 79 per cent - with all other items mentioned in the poll (clothes, toys, cosmetics, alcohol, CDs and DVDs, cigarettes and golf clubs) in the low single digits.
· Consumers see the fake drugs trade to be largely the responsibility of medicines suppliers, with 45 per cent saying the manufacturer is responsible for keeping counterfeits out of the supply chain, 31 per cent saying it is the responsibility of the wholesaler and 30 per cent pointing to the pharmacist.
· Consumers also want tougher punishments. Over two thirds of them believe the penalty for counterfeiting medicines should be between five and 15 years in prison, despite the current penalties being far lower - while 19 per cent felt a life sentence was warranted by the crime.
· Meanwhile, 85 per cent of consumers said they would feel more confident if medicine packs contained a safety feature that enabled the pharmacist to verify the medicine is genuine before dispensing.
· In addition, 90 per cent said they would not buy drugs on-line if pharmacies in Europe had a tool to authenticate prescription drugs.

To read the entire article online in SecuringPharma, visit their website at: www.securingpharma.com.

To learn more about XStream Systems robust solution to counterfeit products, visit our website at: www.xstreamsystems.net.

Are Counterfeit Products Contributing to Drug Resistant Strains of H1N1?

As reported in many media outlets, European physicians and the World Health Organization (WHO) are investigating drug resistant strains of the H1N1 virus.

To date, H1N1 has been effectively treated by anti-viral medication Tamiflu and Relenza.

As also reported in many media outlets and in SecurePharmChainBlog.com there is an emerging proliferation of organized crime organizations making hundreds of millions of dollars by counterfeiting and selling via the Internet the anti-viral drugs used to treat the H1N1 virus.

With the malaria and tuberculosis healthcare epidemics in Africa and Asia, counterfeit medications have been a significant contributor to the increase of drug resistant strains and are a considerable factor in the deaths of hundreds of thousands across the globe. In these incidents, unscrupulous counterfeiters manufacturer medications with just enough of the active ingredient to fool rudimentary testing devices. These counterfeit medications are more than just worthless, they actually facilitate drug resistant strains of the illness.

This begs the question of the correlation and impact on counterfeit drugs to the emergence of drug resistant strains of the H1N1 virus.

Are counterfeit medications contributing to drug resistant strains of the H1N1 virus?

XStream Systems encourages all drug regulatory agencies to utilize robust screening methods in the testing of all medications within the pharmaceutical supply chain. XStream's XT250 allows the end users to deploy as system within the supply chain and materially screen products for active ingredients, excepients and packaging, non-destructively, within its sealed unit-of-sale container.

To learn more about the XT250, visit XStream at: http://www.xstreamsystems.net/.

INTERPOL and World Health Organization: International Operation Combats Online Supply of Counterfeit and Illegal Medicines

In a related story to a previous blog, INTERPOL and the World Health Organization's International Medical Products Anti-Counterfeiting Taskforce (IMPACT) coordinated a 24 country wide operation named Operation Pangea II in response to an ever-increasing number of websites supplying dangerous and illegal medicines and the dangers of buying medicines online.

"Our primary goal in Operation Pangea II is to protect the public by removing counterfeit and illicit medicines from the market, by shutting down illegal sales on the web, and by prosecuting those potentially putting lives of innocent consumers at risk," said INTERPOL Secretary General Ronald K. Noble.

Medicine regulators, police and customs officials around the world worked closely together during the crackdown from November 16th though the 20th, focusing on the three principal components used by illegal websites to conduct trade – the Internet Service Provider (ISP), payment systems and the delivery services.

During the operation, Internet monitoring revealed 751 websites engaged in illegal activity, including offering controlled or prescription only drugs, 72 of which have now been taken down. In addition, more than 16,000 packages were inspected by regulators and customs, 995 packages were seized and nearly 167,000 illicit and counterfeit pills - including antibiotics, steroids and slimming pills, confiscated.

The operation received significant support from the Permanent Forum on International Pharmaceutical Crime (PFIPC) the World Customs Organization, the UK's Medicines and Health Care products Regulatory Agency (MHRA), the US Food and Drug Administration (FDA) and Immigration and Customs Enforcement (ICE), the Royal Canadian Mounted Police and Health Canada.

Countries involved in Operation Pangea II were - Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, UK and the USA.

To read more about this international operation, visit: blog.taragana.com.

LA Times: Growth of Counterfeit Drugs Sparks International Response

As reported in the November 21 addition of the Los Angeles Times, authorities in the U.S. and across the globe conduct raids this week to intercept fake medications. Highlights from the story appear below:

New York - In highly orchestrated raids around the world this week, Interpol officers in Europe, drug agents in the United States and task forces from Sweden to Singapore confiscated counterfeit prescription drugs in an attempt to stem a rapidly growing criminal business that preys on financially pressed consumers looking for bargains.

The operation, code-named Pangea, is an effort to fight back against fraudulent prescription drug businesses, which have become a $28-million industry in the United States alone.

The national crackdown uncovered nearly 800 packages of fake or suspicious prescription drugs, including Viagra, Vicodin, and Claritin, and shut down 68 rogue online pharmacies, authorities said. They said some counterfeit drugs may have as much as three times more of an active ingredient than is typically prescribed; others may be placebos. Drywall material, antifreeze and yellow highway paint have been found in counterfeit pills.

The operation is centered in a sprawling mail center at New York's Kennedy Airport where hundreds of packages of suspected fake medicines were dumped into orange bins, piled on skids and stacked high waiting to be examined by agents from numerous government agencies. Overseas, Interpol officers and task forces stormed suspected counterfeit drug warehouses and distribution centers.

Counterfeit drugs are the latest -- and potentially most dangerous -- front in the long-running battle against intellectual-property crimes. Law enforcement officials said consumers typically think of counterfeited products such as fake Louis Vuitton purses or Nike sneakers. Although shoes are the most common phony product, accounting for 38%, or $102 million, of counterfeit products seized by customs officials last year, pharmaceuticals are one of the fastest-growing categories.

In 2007, they made up about 6% of total seizures. Last year, they accounted for 10% to become the third-largest category, with an estimated market value of $28 million. Federal officials say that trend is particularly disturbing because of the health dangers that such drugs present.


Counterfeit drugs have a history as old as snake oil, and now the high cost of many prescription drugs has driven consumers to hunt for cheaper alternatives on the Internet. According to the National Assn. of Chain Drug Stores, a trade group, Americans spent $254 billion on prescription drugs last year, up 1.8% from 2007. The long-running recession has made such costs more difficult for many consumers to bear, experts said.

The National Assn. of Boards of Pharmacy maintains a list of roughly 4,000 online pharmacies it says are questionable.

In New York, federal agents spent the week at Kennedy Airport pulling suspicious packages from China, India, Peru, Pakistan, Brazil, Turkey, Taiwan and Russia, trying to spot distribution trends and gathering leads. The leads can take months or years to track down, but officials said they needed to start somewhere.

"For the criminals, at least, we're telling them that everybody's looking," said Richard Halverson, unit chief at the National Intellectual Property Rights Coordination Center.

To see the entire story that appeared in the Los Angeles Times, visit: http://www.latimes.com/business/la-fi-counterfeit21-2009nov21,0,274882.story

Freightwatch International: Holiday Pharma Cargo Theft Awareness Alert

FreightWatch International, an industry leader in providing cargo theft intelligence through data collection, analysis, and customized reporting has issued a Holiday Cargo Theft Awareness Alert over the Thanksgiving holiday.

Freightwatch is encouraging shippers, manufacturers and transportation companies to remain aware of the increased security risks during the upcoming Thanksgiving holiday. Cargo theft tracking organizations are seeing continuing cargo theft activity, specifically targeting electronics, pharmaceuticals and other high end products. Shippers of these commodities in particular should avoid putting any loads on the road that will not travel directly to their destination.

All members of the pharmaceutical supply chain should be aware of the proliferation of pharmaceutical cargo theft and should be vigilant in their security and procurement procedures to protect their inventories from counterfeit, fraudulent, adulterated and stolen medications which pose a threat to end use consumers.

Voice of America Editorial: Warning! Counterfeit Medicines

In the November 18th online edition of Voice of America (VOANews.com), an editorial describing the issue of counterfeit medications in developing countries and USAID new program to combat this issue was posted. The complete editorial appears below:

"Substandard and counterfeit medicines represent a threat to public health worldwide but pose a particular problem in developing countries, where lack of financial, technical and other resources make it difficult to protect the drug supply chains," said United States Agency for International Development, or USAID, Acting Assistant Administrator for Global Health, Gloria Steele.

That is why USAID is launching a new program to combat this menace over the next five years. The USAID program will be conducted jointly with the U.S. Pharmacopeial Convention, or USP, a non-profit, non-governmental scientific organization that sets globally recognized standards for medicines and health care products.

The Promoting the Quality of Medicines, or PQM, Program, a $35 million cooperative agreement, will help improve the quality, safety and efficacy of medicines in countries around the world. These medicines are critical for the treatment of serious disease such as AIDS, tuberculosis, and malaria, and essential to USAID's priority health programs.

"Such medicines undermine decades of investments in public health," said USAID Acting Assistant Administrator Steele. "Without good quality, safe medicines to treat such diseases as malaria and tuberculosis, the impact of other health initiatives is severely weakened if not negated completely. The PQM Program focuses on this critical aspect of combating these diseases."

"The lives of patients are put in serious jeopardy when they take substandard or counterfeit drugs," said Dr. Roger L. William, chief executive officer of USP. He noted that these dangerous substances "contribute to the development of drug-resistant strains of infectious diseases. Such strains are a leading challenge in the fight against malaria, HIV/AIDs and tuberculosis."

Building on a 10-year USAID-USP partnership in this arena that assists health officials and others in 28 countries around the world, the program will increase efforts to address the significant public health challenge posed by substandard or counterfeit medicines.

Specifically, the program will help countries strengthen their medicines regulatory bodies; increase the supply of good-quality medicines; reduce the availability of counterfeit and substandard medicines; and conduct global advocacy to raise awareness of the dangers of substandard and counterfeit drugs.

The PQM Program builds on the work of USAID and USP over the past decade through a predecessor program, the Drug Quality and Information [DQI] Program. The new program will expand on these and other activities in Asia, Eastern Europe, Latin America, and sub-Saharan Africa. The United States is committed to working with its international partners to combat the growing global threat posed by counterfeit and substandard medicines.

XStream Systems endorses USAID’s efforts and recommends the use of technology such as material screening as an efficient and robust solution to this issue.

To view the editorial online visit: www.voanews.com/uspolicy/2009-11-17-voa1.cfm.
To learn more about XStream Systems, visit our website at http://www.xstreamsystems.net/.

Anti-Counterfeiting: Thinking Inside the Box

The Autumn 2009 issue of Pharmaceutical Manufacturer and Packing Sourcer (PMPS) features an editorial article written by XStream Systems’ Senior Vice President, Alan Clock.

The editorial piece discusses analyzes the various segments of anti-counterfeiting technology and introducing EDXRD and material screening as a robust tool in combating counterfeit, adulterated and fraudulent medications within the global supply chain.

The phrase, “Thinking Inside the Box” refers to EDXRD’s capability to screen and authenticate materials inside their sealed, unit-of-sale containers without destroying or degrading the materials. This unique solution allows all members of the pharmaceutical supply chain to efficiently, accurately and inexpensively test and screen product to ensure that their inventories are safe and efficacious.

Here is an excerpt from the article:

Today, the various members of the pharmaceutical supply chain find themselves in an expanding global marketplace and in the midst of an ever growing epidemic that threatens each relevant party. As globalization increases, so too does the risk of counterfeit, substandard or fraudulent medications within the supply chain. This increase in risk threatens both the economic and physical health of the pharmaceutical industry and its consumers. Here are a few staggering statistics related to this scourge:

• The World Health Organization (WHO) conservatively estimates that counterfeit medications will be a $75 billion global industry in 2010.
• The WHO projects the annual growth of counterfeit medications to be between 12 and 16 per cent annually, worldwide.
• According to the WHO, more than 2,000 children in Africa alone die each day as a result of taking counterfeit medications.
• The WHO reports that, across the world, 10 per cent of pharmaceuticals are counterfeit, fraudulent or adulterated. Proliferation and percentages are much higher in developing countries in Asia, Africa and South America, with up to 50 per cent of the supply chain projected to be identified as counterfeit or adulterated.

TRACK AND TRACE

To date, nearly all of the solutions for this global epidemic emphasize what are known as ‘track and trace’ methods (such as barcodes, holograms, RFID, pedigree, taggants and serialization). These solutions are primarily based on traditional technology for inventory control and security and are common within most sophisticated supply chains. They are incredibly effective in tracking products, especially in direct or short supply chains, where the additional cost can be justified in their inventory control capabilities because the members of the supply chain use common systems and tools for tracking, distribution and sales. However, track and trace solutions have their limitations. They generally require some sort of addition to the outside of the box or package, and a common technology to be read and documented. These processes and technologies add further cost to the product and are difficult to maintain across large global supply chains. In addition, because of its external placement, the track and trace item may be easily replicated, and it does not verify that the material inside the package is safe and efficacious.

To read the complete article either visit PMPS at www.samedanltd.com/magazine/15/issue/122/article/2531 or visit XStream Systems website at www.xstreamsystems.net.

IDS Sports Recalls 5 Products – Supplements Found to Contain Steroids

Friday, IDS Sports voluntary recalled five of their dietary supplement products that contained the following undeclared substances, which FDA considers to be steroids: “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione.”

The nationally recalled products sold under the following names: Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR.

The recalled products listed below were distributed in either black boxes containing blister packs of 60 capsules or white bottles with black labels containing 30 or 60 capsules.

Brand Name	Size	UPC	Lots
Bromodrol	1 box	6 75941 00250 7	All lots
Dual Action Grow Tabs	1 box	6 75941 00252 1	All lots
Grow Tabs	1 bottle 60 capsules	6 75941 00252 1	All lots
Mass Tabs	1 bottle 30 capsules	6 75941 00149 4	Purchased during or after 4/09
Mass Tabs	1 bottle 60 capsules	6 75941 00149 4	Purchased during or after 8/09
Ripped Tabs TR	1 box	6 75941 00162 3	Purchased during or after 12/08
Ripped Tabs TR	1 bottle 60 capsules	6 75941 00162 3	Purchased during or after 12/08

Possible known side effects from steroid use include liver damage, shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.

To view more on the recall visit: www.fda.gov.

Fox News: Gangs Making 'Millions of Dollars' Selling Fake H1N1 Drugs Online

The Reuters new story was posted on Fox News on November 16, 2009 and deals with the ever increasing issue of counterfeit, fraudulent and adulterated drugs related to the H1N1 pandemic.

Criminal gangs are making millions of dollars out of the H1N1 flu pandemic by selling fake flu drugs over the internet, a web security firm said on Monday.

Sophos, a British security software firm said it had intercepted hundreds of millions of fake pharmaceutical spam adverts and websites this year, many of them trying to sell counterfeit antiviral drugs like Tamiflu to worried customers.

Tamiflu, an antiviral marketed by Switzerland's Roche Holding and known generically as oseltamivir, is the frontline drug recommended by the World Health Organization to treat and slow the progression of flu symptoms. GlaxoSmithKline makes another antiviral for flu, known as Relenza.

Sophos said many of the gangs behind the sites were based in Russia and the top five countries buying fake Tamiflu and other medicines on the internet were the United States, Germany, Britain, Canada and France.

Sophos spokesman Graham Cluley said a "worrying trend" toward stockpiling Tamiflu had already been seen in Britain — Europe's worst-hit country in the H1N1 pandemic so far.

"As more and more cases of swine flu....come to light, it is essential that we all resist the panic-induced temptation to purchase Tamiflu online," he said.

The criminal gangs working behind the scenes at fake internet pharmacies are putting their customers' health, personal information and credit card details at risk."

The Geneva-based WHO, which declared H1N1 swine flu a pandemic in June, updated its guidance to doctors last week to say that antiviral drugs should be given even before tests conclude that an at-risk patient has the pandemic virus.

Sophos said criminal gangs were operating medicines websites branded as the "Canadian Pharmacy" to try to appear genuine.

It said its research showed that on one network operated out of Russia, called Glavmed, it was possible to earn an average of $16,000 a day promoting pharmaceutical websites.

"But the criminals can be members of more than one affiliate network, and some have boasted of earning more than $100,000 per day," it said in a statement.

The pandemic H1N1 flu virus has now spread to 206 countries since it was first discovered in March. There have been more than 6,250 deaths to date, mostly in the Americas region, according to the latest WHO toll.

To view the story on-line visit:
http://www.foxnews.com/story/0,2933,575327,00.html?test=l

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

Counterfeit Pharmaceutical ROI

The following quote from Martin Van Triest, Interim Director of Rx-360, illustrates the high profitability of counterfeiting pharmaceuticals:

“If a counterfeiter invests $2,000 in faking a DVD, he may turn that into $20,000; if he invests $2,000 into faking cocaine, he may turn that into $200,000; but if he invests $2,000 into faking a pharmaceutical drug, he may turn that money into $2 million! At the same time, the punishment for getting caught counterfeiting pharmaceuticals is far less severe than for counterfeiting illegal recreational drugs such as cocaine. “

To learn more about solutions to fight counterfeit pharmaceuticals, visit: http://www.xstreamsystems.net/.

Pharmaceuticals Represent 5.5% of U.S. Cargo Thefts

As reported by FreightWatch International in its October 2009 Cargo Theft Report, pharmaceuticals represent 5.5% of all cargo thefts by commodity in the United States in a 12 month period from November 2008 to October 2009.

The 5.5% reflects a percentage of the number of cargo theft incidents by commodity not by dollar value. Given the high dollar value of pharmaceutical cargo loads it is estimated that pharmaceutical commodities represent a significant percentage of thefts by dollar.

Regarding cargo theft trends, Freightwatch quoted the following in the October 2009 report:

· Continuing the trend from the past several months, FreightWatch is seeing an increase in the number of thefts from terminal and carrier lots, as well as public access parking lots, and a decrease in the number of thefts from truck stops, which are traditionally where cargo theft is known to occur in the highest amounts volume.
· These trends coincide with intelligence reports and activity that show cargo thieves are becoming more proactive in targeting specific loads or products, conducting surveillance and stealing the loads at their first opportunity. Pre-loading and staging trailers, or dropping in lots prior to shipment, are prime theft opportunities being seized by cargo thieves.

It is anticipated that the trend of pharmaceutical commodities being specifically targeted will continue to increase in 2009.

FreightWatch International (USA), an international logistics security company, is expert in identifying threats and vulnerabilities to high-value supply and distribution chains. FreightWatch compiles a monthly, quarterly and annual report that lists cargo thefts by location and commodity.

To learn more about FreightWatch, visit their website at: http://www.freightwatchusa.com/.

To learn more about XStream Systems, supply chain security solutions that allows members of the supply chain to molecularly screen and authenticate their inventories, visit their website at: http://www.xstreamsystems.net/.

Bodybuilding.com Recalls 65 Dietary Supplements

Bodybuilding.com and the Food and Drug Administration (FDA) have recalled 65 dietary supplement products that were sold through the Company's website, www.bodybuilding.com.

FDA believes that the recalled products contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol." All lots and expiration dates for products label with these brands have been recalled.

Steriods are known to cause long-term side effects such as acute liver failure, male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.

Customers who have any of the products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking one or more of the ingredients listed above. Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online at www.fda.gov/MedWatch/report.htm.

Fake Meds Lure 7 M Adults in UK - But it could cost them more than just a charge on their credit card!

Pfizer shocked the world early this year when they release anti-counterfeiting campaign in the theaters in the United Kingdom. They are now continuing this campaign for public awareness with posters and commercials on TV. Due to their graphic nature, the commercial was only shown after 11 p.m.

The main message is an elaboration of “Buyer Beware” – especially when it comes to online purchases of medications. In an age where consumers are buying more of their products online, they need to be cautious when it comes to medications.

New research indicating the scale of the counterfeit medicine culture was released last week as part of this hard-hitting campaign to educate the public of the risks involved in purchasing fake medicines from unregulated websites. The Get Real, Get A Prescription public awareness campaign is being launched in a partnership between Pfizer, the Medicines and Healthcare products Regulatory Agency (MHRA), the Royal Pharmaceutical Society of Great Britain (RPSGB), The Patients Association and HEART UK.

More than one in seven British Adults survey (15%) admitted to bypassing the healthcare system to get medication without a prescription. That would equate to around 7 million adults who are gambling with their lives. So why would consumers take this risk? - A majority (60%) of adults agree that they're more trusting of all purchases they make online today compared to five years ago. About one fifth stated they believe offering medications online at discounted pricing is a public service and about a third believe the medication to be true. But 78% of General Practitioners believe this practice puts their patient’s health and potentially their lives at risk, due to the prevalence of counterfeit drugs online.

David Pruce from the Royal Pharmaceutical Society of Great Britain said: "Pharmacists are very concerned about the increase in fake or counterfeit medicines. As expert professionals in medicines and medicines use, we know only too well that fake medication does not work and that it can cause harm. Stay safe by ensuring that you always get your prescriptions dispensed at a registered UK pharmacy. If you want to buy medicines online, always check that you are dealing with a genuine pharmacy. Don't go on face value - some of the illegal sites look very professional but supply dangerous fakes. Check our website for a list of sites that have been awarded the RPSGB's internet pharmacy logo so that you can be sure that you are dealing with a UK registered pharmacy supplying genuine medicines. This campaign is important. We want the UK to be the safest place to obtain medicines."

Consumers can go to http://www.realdanger.co.uk for more information and advice.

To read entire article visit: http://www.medicalnewstoday.com.

UK Man Sentenced for Distribution of Counterfeit Anti-Anxiety and ED Drugs

Yesterday, Mr Harish Gami, a 41-year old man, was sentenced in Aylesbury Crown Court, to 8 months jail time suspended for 2 years for distributing unlicensed and counterfeit drugs.

The Medicines and Healthcare products Regulatory Agency (MHRA) investigation uncovered over 100,000 dosages of medicine including controlled drugs (benzodiazepine derivatives) used for anxiety, insominia, seizures and muscle relaxants. The controlled drugs seized were Valium, Diazepam, Alpazolam, Clonazepam, Temazepam, Lorazepam and Zolpidem.

There was also counterfeit Viagra, Levitra and Cialis uncovered as part of the operation as well as the unlicensed erectile dysfunction drug Kamagra.

The fake drugs were presumably shipped from Pakistan and then stored in plastic baggies in plastic bins underneath the accused stairwell with the intent to distribute them on the internet.

MHRA Head of Enforcement, Mick Deats, said that successful prosecutions such as this send a clear signal to those contemplating the sale and supply of counterfeit medicines.

"The MHRA strongly advises people against buying medicines online from unregulated websites where the risk of being provided with a dangerous product is greatly increased."

To view more on the sentencing, visit: www.pharmaceuticalonline.com.

“Buyer Beware” List of Products for Shoppers to Steer Clear on Auction Sites

The National Retail Federation (NRF) has updated their list of products most susceptible to retail theft. Some of these household items are being sold on online auction site. The danger for these products is the consumer has no idea in what conditions the items were stored and when the items are medicinal in nature this poses a health risk to the buyer.

“Though retailers suffer billions of dollars in losses each year from organized retail crime, they are not the only group who’s hurt,” said Joe LaRocca, NRF senior asset protection advisor. “Most stolen merchandise is not stored properly and could expose unsuspecting shoppers or their children to a host of risks from spoiled baby formula and pain medication to inaccurate results from diabetic test strips or pregnancy tests.”


Medicinal products listed included:

• Abreva
• Advil
• Aleve
• Alli weight loss pill
• Claritin
• diabetic testing strips
• e.p.t. pregnancy tests
• Pepcid AC
• Prilosec
• Sudafed
• Tylenol Extra Strength
• Visine
• Zantac

For information about the dangers of using expired or improperly stored medication, visit the U.S. Food and Drug Administration.

To view the entire list of household products visit: www.nrf.com

USP Develops New Testing to Identify Deadly adulterants for Two Pharmaceutical Ingredients

The U.S. Pharmacopeial Convention (USP) this week announced revised standards for two ingredients widely used in pharmaceuticals as sweetening agents and solvents.

USP is a nonprofit, scientific organization that sets legally recognized standards designating the identity, quality, purity, strength and consistency of prescription and over-the-counter medications and their ingredients in the United States. These standards are enforced by the U.S. Food and Drug Administration (FDA).

The revisions respond to a request from FDA to revise the USP Propylene Glycol and Sorbitol Solution standards to include limits for diethylene glycol (DEG) to help prevent future episodes of pharmaceutical adulterations with this poisonous chemical. DEG is commonly used in antifreeze and has no legitimate place in medicines.

DEG historically has been substituted for Glycerin with deadly results.
Adulterations of cough syrups and other products with DEG have occurred many times and in many countries, including a tragic episode between November 2008 and January 2009 in which 84 children in Nigeria died after ingesting teething syrup contaminated with DEG. A similar episode occurred in July 2009 in Bangladesh, killing at least 24 children.

To view the press release from USP visit: http://www.eurekalert.org/pub_releases/2009-10/up-ntf103009.php

For more information, visit www.usp.org/hottopics/propyleneGlycolSorbitolInformation.html or email mediarelations@usp.org.

How the Current Economy Will Drive Counterfeit and Fraudulent Medications

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

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

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

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

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


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


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


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


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

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

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

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

Drug Authentication Evolves to Use Molecular Screening to Combat Fake Drugs

Life Science Leader, a magazine for key executives in the life science industry, recently published an article "Molecular Screening: It's Time to Stop Thinking Outside the Box with Counterfeit Drugs" by Brian Mayo, President and CTO of XStream Systems.

In the article, Mr. Mayo discusses the advancement of analytical methods as they have moved from the lab setting to the next generation of authentication by allowing screening of the product itself throughout the pharmaceutical supply chain.

By putting this non-destructive screening method in the hands of non-scientific personnel the industry has evolved it’s protection services from merely deterrents for diversion and counterfeit drugs to real authentication of the product “inside the box”.

It’s so simple and it makes sense that we spend so much money and time developing the drugs themselves – shouldn’t our authentication be centered on them as well.

To view more on molecular screening technology, please visit www.xstreamsystems.net

To view more on Life Science Leader…

Cargo Thefts on the Rise - Threaten Security of Pharmaceuticals

By Patricia Earl, V.P. Business Development, XStream Systems

As pointed out here by Purdue Pharma’s Chuck Forsaith, one of the key speakers at the recent 2009 National Cargo Theft Summit, Americans have an increasing issue with pharmaceuticals being stolen in transit from the manufacturer’s dock to the distributor’s dock or to the retailer. Chuck talked about why transportation – and trucking in particular – is so vulnerable to cargo theft these days and what shippers and carriers alike can do about it.

“On the street, one milligram of OxyContin is worth between 50 cents to $1, with single pill containing 80 milligrams. That means the street value of just ONE OxyContin tablet is between $40 and $80 – and Purdue Pharma typically ships 50 to 100 DRUMS worth in a single tractor-trailer load. Now you know why cargo thieves stalk the pharmaceutical industry like so many hungry wolves circling a herd of fat deer. While pharmaceuticals remain a relatively small part of the goods stolen by cargo thieves – making up just 6% of the total cargo theft “pie” as it were – the average value of a pharmaceutical cargo theft is very high, Forsaith explained; roughly $1.4 million per shipment. Overall pharmaceutical truckload shipments themselves can average anywhere from $10,000 per load (for over the counter or “OTC” products) to several million dollars (for the expensive bio-tech drugs).”

And that’s not the total picture, either, Mr. Forsaith stressed, cargo thieves have exactly zero overhead – meaning the entire shipment is 100% profit to them, no matter what they sell it for. And when it comes to potentially addictive medicines such as OxyContin, the sky’s the limit.

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

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

Members of the pharmaceutical supply chain and domestic consumers should be aware of the proliferation and prevalence of counterfeit, adulterated, stolen, diverted or fraudulent medications. Distributors and dispensers should only purchase their inventories from legitimate supply chain members that utilize pedigrees and material authentication technologies to verify the medication and the chain of the transaction. Consumers need to only buy medications from licensed, known pharmacies that procure their inventories from the legitimate pharmaceutical supply chain and who use best, safe medication practices when dispensing drugs.

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