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/.