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.