FDA Accelerating Stricter Enforcement Campaign

The Food and Drug Administration in the past several months has employed a broad array of tools-consent decree, drug seizures and 68 warning letters about products used to treat influenza A (H1N1) in its efforts to accelerate its stricter enforcement campaign within the pharmaceutical industry according to Edwin Rivera-Martinez, Chief of the International Compliance Branch in CDER Division of Manufacturing and Compliance.

To view article visit: www.fdanews.com.

FDA Announces Fraudulent H1N1 Influenza Products List

The Food and Drug Administration released a listing to warn consumers about Web sites that are illegally marketing unapproved, unclear and unauthorized products in relation to the H1N1 Flu Virus.

The listing includes a wide variety of Web sites that promote unapproved supplements, masks, gels, sanitizers, kits, teas and testing products.

The FDA also announced that until evidence to the contrary is presented to it formally, the owner of the listed Web site is considered responsible for promoting the unapproved, uncleared, or unauthorized products.

To view the entire listing, visit the web link: http://www.accessdata.fda.gov/scripts/h1n1flu/

GSK Advisory: Warehouse Theft of Advair

GlaxoSmithKline is advising that two lots of Advair Diskus medication were stolen from the company’s distribution facility near Richmond, Virginia on August 2nd. The stolen medicine, could represent a health risk because it has been removed from the legitimate supply chain and storage conditions. Inhalers from these lots should not be dispensed, sold or used.

The lot numbers and quantities are:

• Lot 9ZP2255 - NDC 0173-0696-00, Advair Diskus 250/50, 60 Dose (14,400 inhalers)
• Lot 9ZP3325 - NDC 0173-0697-00, Advair Diskus 500/50, 60 Dose (11,200 inhalers)

These lots were awaiting distribution to retail pharmacies at the time of the theft. Neither of these lots are part of the legitimate pharmaceutical supply chain. GSK has alerted its distributors and customers to the stolen lots.

Anyone who has information regarding this incident, has received suspicious or unsolicited offers for the Advair Diskus lots in question, or has received product from these lots is encouraged to contact the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations at 1-800-551-3989. Patient or customer inquiries for the company should be directed to GSK's Customer Response Center at 1-888-825-5249.

GSK discourages patients from purchasing any medication sold outside of legitimate channels.

XStream Systems encourages all members of the pharmaceutical supply chain to use pedigrees and authenticate their receiving and returns by using authentication technologies like the XT250 system which verifies materials inside its sealed unit-of-sale container without destroying or degrading the medication.

To view entire article click here.

AP: Patients Have Suffered Effects from Stolen Insulin

FDA Warns Consumers of Safety Issues with Stolen Vials of Novo Nordisk Insulin

As repeated earlier in June on Secure Pharma Chain Blog and updated by Matthew Perrone from the Associated Press on August 27 the "The Food and Drug Administration is warning consumers to avoid certain vials of insulin made by Novo Nordisk that were stolen earlier this year and may not be safe for use." Regulators stated that "the vials may not have been stored properly and could be dangerous to consumers."

In fact, "the FDA has received multiple reports of patients who suffered unsafe blood sugar levels after using the products." The agency "issued an alert in June after three lots of Novo Nordisk's Levemir insulin were stolen during shipment through Johnson County, NC." According to regulators, "only about two percent of the 129,000 vials have been returned."

To view the entire article visit: www.charlotteobserver.com.

Law Enforcement Examiner: “1 in 20 Pharmaceutical Products on the Market is Counterfeit”

The following are the key points from Jim Kouri in an article written in the Law Enforcement Examiner, which is a publication associated with the National Association of Chiefs of Police.

Mr. Kouri cites some excellent statistics and quotes from several industry thought leaders and properly encapsulates the issue.

Counterfeit Prescription Drugs a Deadly Problem
August 23, 2009; Law Enforcement Examiner; by Jim Kouri

According to the World Health Organization's definition a counterfeit medicine "is one which is deliberately and fraudulently mislabeled with respect to identity and/or source.

Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging."

It is estimated that one in 20 pharmaceutical products on the market is counterfeit, with the number rising to one in three in some developing countries.

Counterfeit pharmaceuticals are manufactured and distributed by criminals, companies or individuals who have the desire to make money unlawfully. They may contain too much, too little or no active ingredient, the wrong ingredients or high levels of impurities, contaminants and even toxic substances. They could be reject or out-of-date formulations withdrawn from the market which are obtained by counterfeiters, re-labeled as bona fide product and introduced back into circulation. They have killed and injured thousands around the world.

The consequences of such counterfeits can vary. They can either fail to treat the illness or condition for which they are being taken (resulting in prolonged illness or death and wastage of valuable healthcare resources) or they can be the direct cause of death by containing lethal ingredients. Whether they fail to promote or restore health, or are the direct cause of death, they are fast becoming a global menace — both to their unwitting consumers and to the pharmaceutical industry as a whole.

Participants at the Global Forum on Pharmaceutical Anti-counterfeiting in Paris recently demanded increased cooperation at all levels and a framework convention to fight counterfeiting of medicines. Combating counterfeit drugs requires the involvement of all parties in the healthcare and pharmaceutical delivery system, placing the onus on manufacturers, all supply chain stakeholders, patients and health professionals as well as regulators and law enforcement to mobilize against fake medicines. Counterfeit drugs penetrate health systems throughout the world, both in industrialized and in developing countries.

Julian Mount, Senior Director European Trade, Pfizer Inc. said "there is a need for stakeholder accountability, uniform systems and regulation leading to accountable supply chain management by all players delivering medicines to patients in Europe. This means pan-European legislation, regulatory coordination, appropriate technologies and the need to better enforce the repackaging of medicines to ensure patient safety and medicine integrity."

"As long as the fight against counterfeits is not a concerted effort, criminals will be able to exploit the loopholes in the system," says Ian Lancaster, Director of Reconnaissance International, specialists in anti-counterfeiting strategies and organizers of the Global Forum. "The fight includes prevention measures by manufacturers, communication and effective education of professionals and patients, and ensuring that punishments are appropriate to this deadly crime."

Jim Kouri, CPP is currently fifth vice-president of the National Association of Chiefs of Police and he's a staff writer for the New Media Alliance (thenma.org). In addition, he's the new editor for the House Conservatives Fund's weblog. Kouri also serves as political advisor for Emmy and Golden Globe winning actor Michael Moriarty.

He's former chief at a New York City housing project in Washington Heights nicknamed "Crack City" by reporters covering the drug war in the 1980s. In addition, he served as director of public safety at a New Jersey university and director of security for several major organizations. He's also served on the National Drug Task Force and trained police and security officers throughout the country. Kouri writes for many police and security magazines including Chief of Police, Police Times, The Narc Officer and others. He's a news writer for TheConservativeVoice.Com and PHXnews.com. He's also a columnist for AmericanDaily.Com, MensNewsDaily.Com, MichNews.Com, and he's syndicated by AXcessNews.Com. He's appeared as on-air commentator for over 100 TV and radio news and talk shows including Oprah, McLaughlin Report, CNN Headline News, MTV, Fox News, etc.

To subscribe to Kouri's newsletter write to COPmagazine@aol.com and write "Subscription" on the subject line.

To view article visit: www.examiner.com.

Turkish Government to Delay Implementation of Barcode System to Stamp Out counterfeit Drugs

Initiative officially delayed until October, but industry experts anticipate the process to be pushed back further.

The Turkish newspaper, Today’s Zaman recently published a story about the implementation of a drug tracking barcode system in place to combat counterfeit drug in Turkey. However since the publication of the article, pressure from pharmacies has delayed the implementation from July to October. Most industry experts expect the delays to go beyond the October schedule because of the significant costs to small dispensing pharmacies.

According to the article:

• Turkey is identified as being one of the largest global purveyors of counterfeit drugs.


• The ambitious tracking system, which industry insiders estimate has already cost more than $200 million this year alone in the run-up to its implementation, has been fraught with difficulties.


• Dr. Roger Bate in last week's Journal of the American Enterprise Institute, his limited study of a small sample of drugs in the US purchased over the Internet revealed that Turkey is the largest single supplier of drugs bought online in the US. He documented a number of raids in Turkey that revealed all aspects of the counterfeit drug trade -- importers and local manufacturers of counterfeit products, wholesale distributors repackaging fake and old medicines that should have been destroyed and printers making packaging for the manufacturers. “The products I have seen,” he told Today's Zaman, “were manufactured by large Western companies in Turkey for the Turkish market which were diverted -- possibly illegally -- to the US by Internet sellers.”


• The implementation of this system is also meant to act as a prevention of fraud against the medical insurance system, which is being defrauded by unscrupulous doctors and pharmacists hungry to take advantage of the easily cheated system.


• Pharmaceutical companies -- the ones whose pocket books are arguably most affected by the proliferation of counterfeit drugs in Turkey -- have been amongst those who were resisting the implementation of the barcode system.

Most have said that this program which is slated to use a GS1-compliant 2D barcode will cost the country over $150m per year. The delay in this program is seen as a major setback to companies who tout track and trace technologies as the answer to counterfeit and adulterated medications.

XStream endorses all solutions to the issue of counterfeit, adulterated and diverted medications and believes that a comprehensive suite of technologies are necessary to adequately protect the global pharmaceutical supply chain. XStream believes that autentication and verification of the contents of the unit of sale, which is available via its XT250, is a critically important componant to securing medications from production to dispensing.

To read the entire article, access the link below:
http://www.todayszaman.com/tz-web/news-184271-105-barcode-system-to-stamp-out-counterfeit-drugs.html

To learn more about the XT250 visit us at:

http://www.xstreamsystems.net/

FDA MedWatch: Barr Laboratories Recall On Potentially Super-Potent Tablets

Barr Laboratories, Inc. issued a voluntary recall of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product) 20mg Tablets, 100 count bottles, lot number 311756. The product is being recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets.

Clinically significant adverse reactions to a supra-therapeutic dose could include cardiovascular, neurologic, psychiatric and gastrointestinal reactions. Customers who have this lot in their possession are instructed to cease using the product and return it to their pharmacy/distributor.

XStream Systems, endorses material screening of medications within the supply chain from manufacturer to dispenser to significantly reduce issues with product quality, adulterated and counterfeit medications. By using solutions like XStream’s XT250, a user can verify and authenticate medications inside their sealed, unit-of-sale container without opening or destroying the product.

Read the MedWatch safety summary, including a link to the firm's Press Release, at:
www.fda.gov.

China News: UN Concerned About Clandestine Drugs Manufacturing in Guinea

In an article which appeared in chinanews.cn on August 5th, the United Nations is quoted as voicing concern over evidence recently uncovered in Guinea, suggesting that clandestine narcotics operations are producing illicit drugs on a large scale in the small West African country.

Here are some of the significant points from the UN:

• UN spokesperson Michele Montas told reporters that the UN Office on Drugs and Crime (UNODC) and Interpol, investigated a haul of chemicals seized by government forces in mid-July, revealed quantities far in excess of the legitimate demands of the country.


• "Among the evidence -- the best found by the UN in West Africa to date -- were tools for making counterfeit antibiotics, substances used to produce ecstasy, and solvents commonly used in cocaine and heroin processing," Montas said.

The UNODC launched an initiative last month to tackle the scourge in the region, which sees 1 billion U.S. dollars worth of cocaine pass through its borders annually.

To read the report online: http://news.xinhuanet.com/english/2009-08/06/content_11834912.htm

Business Standard: Validation Check Imposed on Medicine Exports in India

The August 5th edition of the Business Standard reports on Drug Controller General of India (DCGI) requiring all pharmaceutical contracted manufacturing exports will be required to furnish validation certificates of authenticity for importing firms overseas.

• The move, initiated by the office of the Drugs Controller General of India (DCGI), is expected to boost India’s image as a supplier of quality, low cost medicines.


• According to the official directive, all contract manufacturers exporting medicines using neutral code (which do not mention the name of the manufacturing or marketing firm) will have to present certificates from the regulators of the importing country to prove the genuine nature of the importing firm. In other words, the foreign regulator will have to endorse the product name and marketing registration these companies have obtained from the regulator.


• The drug exporters hailed the intention of the DCGI, but expressed concern over the sudden implementation of the circular. “There are hundreds of medicine products that are being exported to all parts of world”, they said adding: “ If DCGI wants the credentials of all the foreign sourcing companies from respected drug regulators, the consignments will not be cleared for the next three months. It will affect our credentials and credit worthiness.”


• The exporters wanted the directive to be confined to less regulated markets, where there is scope for mischief. Indian drug exports had recently come under regulatory scrutiny in several countries due to alleged complaints of spurious and counterfeit medicines.

XStream System applauds the move by DCGI and encourages screening and validation within all points of the supply chain as an important solution to counterfeit, substandard and adulterated pharmaceuticals.

XStream’s XT250 system can be easily deployed within the supply chain to screen, validate and authenticate pharmaceuticals within their sealed, unit-of-sale container without opening, destroying and degrading the product.

To view the entire article visit: www.business-standard.com

DEA: Black Market Steroids

In a presentation to the Organization of Black Law Enforcement Executives in Norfolk, Virginia in July, Joseph Rannazzisi, Deputy Assistant Administrator at the Drug Enforcement Administration’s Office of Diversion Control made a presentation on Anabolic Steroids, Performance Enhancing Drugs and Dietary Supplements.

In his presentation, Mr. Rannazzisi disclosed an important statistic related to counterfeit products:

“Significant quantities of counterfeit steroids are available on the black market. Based on seizure statistics, this number could be 15% or higher.”

Obviously the implications as a healthcare related issue are significant even for illicit or black market goods.

Freightwatch International: July 2009 Pharma Cargo Thefts

FreightWatch International (USA), an international logistics security company, whose expertise is in identifying threats and vulnerabilities to high-value supply and distribution chains, publishes a monthly Cargo Theft Report that contains some very interesting statistics and observations.

The July 2009 Cargo Theft Report is available on-line and outlines statistics and vulnerabilities of various supply chains, specifically reporting on pharmaceutical cargo theft incidents. In the July 2009 Report they list four Pharma cargo theft incidents worth tens of millions of dollars:

• July 4th in Breezewood, Pennsylvania a cargo theft of pharmaceutical healthcare products worth $262,000.


• July 9th in Forest Park, Georgia a cargo theft of pharmaceuticals worth in excess of $10,000,000.


• July 29th in Plainville, Connecticut a cargo theft of pharmaceutical products of an unreported value.


• July 30th in Effingham, Illinois a cargo theft of baby formula products of an unreported value.

XStream Systems encourages all within the pharmaceutical supply chain to verify and authenticate the products that they receive from all sources. XStream System’s solution of non-destructive screening of products within their sealed unit of sale containers protects inventories from nefarious sources of supply.

To view the entire July 2009 report visit Freightwatch’s website at: www.freightwatchusa.com

SafeMeds Alert: FDA Warns Healthcare Professionals and Public About Stolen Asthma Drug

Nearly 36,000 Cartons of Dey Brand Generic Albuterol Sulfate Inhalation Solution Stolen in Texas

SafeMed via their on-line and email alert system is sending out information on the FDA alert to patients and healthcare professionals regarding a cargo theft of 35,760 cartons of Dey brand generic Albuterol Sulfate Inhalation Solution that occurred on approximately August 5, 2009.

On August 7, 2009, it was reported that in McKinney, Texas, a tractor-trailer containing a 35,760-carton shipment of an asthma drug belonging to the RiteDose Corporation was stolen. The product in question is Albuterol Sulfate Inhalation Solution 0.083%. The NDC number is 49502-697-29. Each carton displays the brand name "DEY" and contains thirty 3ml single-dose vials. The lot numbers of the stolen product were "9G01" and "9FE2." These two lot numbers were not commercialized prior to the theft. All the product units in these lots were stolen. The product could represent a health risk because the required temperature-controlled supply chain may have been broken.

If you receive any offers for these stolen drug products or think that you may have been sold the stolen drug products referenced in this notice, FDA is asking your help in reporting this information to FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site, http://www.fda.gov/ICECI/CriminalInvestigations/ucm123025.htm.

To learn more about SafeMed Alerts, go online at www.safemeds.org.

Global Health Change: Counterfeit Medicine

Alanna Shaikh, in a July 17th GlobalHealth.Change.Org posting reports on “a future of cat and mouse between manufacturers of fake medicines and the technology that detects it.”

Here are several strong quotes from the posting:

• The proliferation of new medicines will make it easier to slip a fake into the mix; so will the increasing capacity to produce authentic looking fake pills and packaging. At the same time, a host of innovation ideas for authenticating medicine are taking hold. At any given moment, the balance will be in favor of either the black market or the legitimate manufacturers.


• The drugs that get counterfeited tend to be the most important ones. Anti-retrovirals, tuberculosis drugs, anti-malarial medications.


• The worst fake medicines contain the drugs they claim to, but in amounts too small to do any good. Instead, they lead to resistance from the microbes they are meant to eliminate.


• According to one source, between 50% and 90& of drugs in some African and Asian countries are counterfeit.


• Technology is neutral. It's also increasing the ways that we can detect and eliminate counterfeit medicines.

XStream Systems believes that its technology, which uses EDXRD and allows the user to authenticate medications non-destructively inside their sealed container is a significant step forward in combating this global issue.

To read the entire posting follow this link:
http://globalhealth.change.org/blog/view/friday_futures_counterfeit_medicine

We All Need To Be On The Lookout for Fake Anti-Viral Medications and Vaccines

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

As the United States slowly moves into the traditional flu season, it bears repeating to be on the lookout for scams regarding fake vaccines and anti-viral medications. These fake drugs seem to proliferating within the legitimate global pharmaceutical supply chain as we speak.

Anti-viral medications like Tamiflu and Relenza are being used worldwide to treat and lessen the impact of the H1N1 flu epidemic (formally known as the Swine Flu) and we are expecting shortly a flu vaccine for the H1N1 virus.

As stated before and predicted here on Secure Pharma Chain Blog, it would soon follow that unscrupulous counterfeiters would seize the opportunity of the epidemic and flood the market with counterfeit, adulterated and sub potent knock offs of these important medications. Unfortunately our predictions were right on target.

Those within the Southern Hemisphere, who are in the grip of flu season can attest, counterfeiters are attempting to flood the market with these dangerous knock offs and the impact of these fakes may impact more than just those who take the bogus medications.

A new dangerous consequence has emerged in this fight against H1N1 and counterfeit drugs.

Many global healthcare officials are now concerned that some counterfeit or knock off vaccines/ anti-viral medications could contain some of the active ingredients of the legitimate medications used in the fight against this epidemic and build drug resistant strains of the H1N1.

Much like what is seen in third world with Malaria, some counterfeiters use just enough active ingredients in their knock off drug to fool rudimentary screening tools but not enough for any therapeutic value against the disease.

The insidious practice of partially active ingredients in fake drugs adds injury to insult. It essentially creates super strains of a disease that resist the drugs used against them. This means that we all suffer the consequence of counterfeit drugs not just the unfortunate suckers who bought and consumed them. Because of counterfeit medications we may now all face a super charged H1N1 virus with limited medications to protect ourselves.

As it relates to the H1N1 epidemic, we all need to be on the lookout for counterfeit vaccines and anti-viral medications, here are a few tips to keep in mind:

• Only buy anti-viral medications with a prescription from your physician and from a licensed, established local or chain pharmacy in your area.


• Only get vaccinations from licensed, established local healthcare providers.


• Make certain that your pharmacy only buys product from reliable wholesalers and distributors that utilize transactional pedigrees and use some sort of verification process to screen their inventories.


• Never buy anti-viral medications or vaccines on-line from unknown vendors that do not require a prescription from your physician.


• Never buy anti-viral medications on-line from international sources or from sites that are not accredited by the National Association of Boards of Pharmacy.


• Always remember, if it sounds to good to be true, it probably is…

As this epidemic runs its course over the next several months or years, it is especially important for us all to be on the lookout for fake medications.

US Anti-Depressant Market Drives Counterfeit Medications

By: Alan Clock, Senior Vice President, XStream Systems

An article printed in the August issue of the Archives of General Psychiatry has been reported on by every major US media outlet. The crux of the article centers on the statistic that “about 10 percent of Americans -- or 27 million people -- were taking antidepressants in 2005. This was double the number from the same study in 1996.

This surge in prescriptions vaulted anti-depressants, as a therapeutic class of pharmaceuticals, to become some of the top selling medications in the United States. Although the data used in the study is no longer tracked, it is presumed the number of Americans using anti-depressants continues to climb at a steady rate.

Most of the stories and reporting of this study has primarily focused on the prescribing and demographics of the study but as an additional take for Secure Pharma Chain Blog, we consider the proliferation as a correlation to anti-depressants now becoming, as a therapeutic class of pharmaceuticals, some of the most highly counterfeited and adulterated drugs both in the United States and worldwide.

In nearly every study, regulatory or published report within the United States and abroad, anti-depressants are among the top in value and in volume, highly counterfeited and adulterated drugs.

Clearly this is not a huge revelation, the cost of these medications are high, the number of people who take these medications is high and the issue regarding the wish for patients to conceal that they are taking these medications have led to many concealing their efforts to procure these products.

In many cases, it is difficult for the patient or health care provider to discover that they are not taking the proper prescribed therapy because of the nature of the illness that it is intended to relieve. Most patients will never realize that their drugs are counterfeit at all and will attribute their ineffectiveness to other issues.

As the market for anti-depressants continues to climb so will the need for patients and providers to diligently seek out authentic medications.

Here are a few thoughts on how to protect you and your family as a patient against counterfeit medications:

• Always buy pharmaceuticals from a trusted, brick and mortar, licensed pharmacy in your community.


• If you purchase from the internet, only purchase from sites that are sponsored by a licensed, established pharmacy like a retail chain or from site that is verified by the National Association of Boards of Pharmacy.


• Never, ever purchase prescription drugs from an internet site or a pharmacy that does require a prescription from your physician. Sites that offer a physician prescription on-line are not legitimate.


• Carefully examine your medications for differences in size, color, consistency and taste. If you notice any differences immediately notify your pharmacist or physician.

The best way to protect you and your family from counterfeit medications is that if the price or the deal sounds too good to be true, it probably is and you should not purchase those drugs.

Realize that in this world where a criminal individual or enterprise can make far more money with far less risk by manufacturing, distributing and selling counterfeit medications than in selling illicit drugs, everyone needs to be on guard against this crime that will impact your health and the health of your family.

SafeMeds Weekly: Counterfeit Drug Sentencing Less Than Adequate

In an opinion piece posted on SafeMeds Weekly on August 10, 2009, Marvin D. Shepherd, PhD discusses the issue of light sentencing given to those convicted of counterfeiting medications around the globe. Dr. Shepherd asserts that inadequate sentencing “undermines the seriousness and true threat that counterfeit drugs pose to society and public health.”

Dr. Shepherd sites several examples:

• After nearly two years under investigation, the final sentence for running an international multi-million pound counterfeit medication operation was issued in the United Kingdom. The first four convictions were made in September 2007 and on July 6, the final member of the operation received a 12 month sentence, suspended for two years, for masterminding an industrial scale conspiracy of supplying counterfeit drugs between 2002 and 2005. In total, the seven convicted members of this international counterfeit drug ring received a combined 17.5 years imprisonment-an average of 2.5 years for each participant-for their part in the U.K. distribution arm of a global ring operating from China, India and Pakistan, extending to the Caribbean and the United States.


• In March 2009, an Arizona couple received at most eight years imprisonment for running an illegal drug business netting more than $2.5 million from 2004 to 2006. In comparison, convicted members of an illegal recreational drug ring would receive mandatory minimum sentences starting at 20 years up to life imprisonment for distribution in the United States.

In this article Dr. Shepherd questions the logic of not holding those responsible for the distribution and sale of counterfeit drugs to the same severity to those who commit similar offenses with illicit drugs. Basically he believes that until this is done the individuals and organizations responsible for this very real threat will continue to flourish.

XStream Systems favors stricter and more stringent enforcement and criminal penalties across the globe for those convicted of manufacturing, distributing or selling counterfeit or adulterated medications. XStream also encourages those within the pharmaceutical supply chain to screen and test their inventories with solutions such as XStream’s XT250 which allows the user to test and authenticate product inside its sealed container without destroying product or opening the container. The XT250 is designed to be deployed and used within the supply chain onsite and does not require technical resources to operate.

To read the opinion piece and to learn more about SafeMeds Weekly, visit their site at www.safemedicines.org.

To learn more about XStream Systems, XT250, visit us at www.xstreamsystems.net.

Bing Hosting Spam Ads for Counterfeit Drugs

MxLogic.com on August 6, 2009 reported that Microsoft's Bing search engine hosts sponsored ads for online pharmacies of the type that generate spam to sell drugs illegally, according to a report from LegitScript.com, an online pharmacy verification service, and KnujOn.com, an internet compliance company.

• The websites issued a report saying that an analysis of sponsored search results for internet pharmacies displayed on bing.com turned up ads that were nearly 90 percent for spam internet pharmacies that could be connected to organized crime.


• KnujOn, an anti-spam company that says it has removed over 100,000 spam websites from the web, said the spam pharmacy sites are typically connected "organized crime and vast illicit drug networks, many of them based in Russia and Eastern Europe."

XStream encourages all to only buy prescriptions from known and licensed pharmacies. The only type of internet purchasing of pharmaceuticals should be with pharmacies that have regular “brick and mortar” licensed pharmacies in your area. If any pharmacy does not require a prescription from your physician it is likely to be unlicensed and the medication that it sells you counterfeit or adulterated material.

To view the MxLogic.com report visit: http://www.mxlogic.com/securitynews/spam/bing-hosting-spam-ads-for-counterfeit-drugs405.cfm

FDA Instructs Pharma Companies to Watch for Melamine

Pharmaceutical-Technology.com reported in its August 7, 2009 on-line edition on FDA guidance and instructions on protection to the pharmaceutical supply chain, specifically as it relates to Melamine. Melamine is a synthetic chemical with a variety of industrial uses including the production of resins and foams, cleaning products, fertilizers and pesticides.

Here are some highlights from the article:

• The US Food and Drug Administration (FDA) warned drug companies to scrutinize certain pharmaceutical ingredients for the presence of melamine and has issued industry guidance on how to protect against contamination.


• The FDA has stressed that there is no evidence that melamine, which if ingested in significant amounts can lead to kidney failure or death, has entered the pharmaceutical chain but that recent contaminations in pet food and in infant milk in China have proven the need to be vigilant.


• The FDA has released guidance as an initial measure with pharmaceutical manufacturers, re-packers, other suppliers and pharmacists to conduct melamine testing.


• The FDA identified specific pharmaceutical ingredients recommended for screening, and has also recommended specific FDA-published methods for this testing.


• "The FDA urges the implementation of appropriate controls to assure consumers that melamine contamination will not happen in the pharmaceutical supply chain," Hamburg said.

XStream’s authentication and verification technology tests the product inside its sealed, unit-of-sale container and can protect the pharmaceutical supply chain by screening inventories at the point of production, distribution and dispense without destroying the medication or disrupting the container by opening.

To learn more about XStream Systems, visit us at www.xstreamsystems.net.

To read the article in full, follow the link below:
http://www.pharmaceutical-technology.com/news/news61460.html?WT.mc_id=DN_News

Did You Know?

This fascinating youtube.com clip presents forward looking statistics and trends in a compelling way.

The presentation allows the viewer to look forward and consider the opportunities. Although not specific to the pharmaceutical supply chain, it is easy to consider what type of forward thinking statistics one might add to this video if counterfeit and adulterated pharmaceuticals were a topic. Clearly the speed of the proliferation of counterfeit medications and the necessity for forward thinking solutions are serious matters to ponder.

• In 2006 the World Health Organization estimated counterfeit medications to be a $35 billion business globally.
• In 2010 the World Health Organization estimates that business to more than double to $75 billion.

FDA Highlights Agency’s Plans for 2010

The FDA has some interesting plans for 2010. According to FDAnews here are a few highlights of the agency's plans:

• More than double the number of drug import field examinations
• 346 new hires for the signature Safer Medical Products initiative
• A 43 per cent increase in foreign GMP surveillance inspections
• New field offices in New Delhi, Beijing, Shanghai, Mexico, Costa Rica and other overseas hot-spots, manned by at least 60 staffers

Although XStream is supportive of increased enforcement and inspection, we encourage all commercial members of the pharmaceutical supply chain to increase their screening, verification and authentication of materials and products. Protecting your brand beyond regulatory enforcement is the key to success and avoidance of catastrophic failures within the supply chain.

CRS Report for Congress: Intellectual Property Rights and International Trade

The Congressional Research Service (CRS) prepared a report on Intellectual Property Rights and International Trade. The report is authored by Shayerah Ilias and Ian F. Fergusson and was published in July 2008. There were many interesting pieces of information as it relates to the pharmaceutical supply chain and although somewhat dated the data points are very relevant as it relates to the size, scope and impact on commercial interests globally.

In the opening summary, Ilias and Fergusson wrote:

“This report provides background on intellectual property rights (IPR) and discusses the role of U.S. international trade policy in enhancing IPR protection and enforcement abroad. IPR are legal rights granted by governments to encourage innovation and creative output by ensuring that creators reap the benefits of their inventions or works and they may take the form of patents, trade secrets, copyrights, trademarks, or geographical indications. U.S. industries that rely on IPR contribute significantly to U.S. economic growth, employment, and trade with other countries. Counterfeiting and piracy in other countries may result in the loss of billions of dollars of revenue for U.S. firms as well as the loss of jobs. Responsibility for developing IPR policy, engaging in IPR-related international negotiations, and enforcing IPR laws cuts across several different U.S. Government agencies. The main structures for coordinating interagency efforts are the National Intellectual Property Law Enforcement Coordinating Council (NIPLECC) and the Strategy Targeting Organized Piracy (STOP!).”

Here are some of the interesting pieces of information contained within the CSR report as it relates to pharmaceuticals:

• Department of Homeland Security (DHS) provides data on counterfeit goods seized by category. Seizures of counterfeit pharmaceuticals increased significantly, from $2.3 million in 2006 (1% of total) to $11.1 million in 2007 (6%).


• According to U.S. customs data, pharmaceuticals accounted for only 1% of all goods seized in 2006, with a domestic value of $2.2 million. Still, there is growing concern about the vulnerability of the U.S. medicine supply and distribution chain, especially in light of recent high-profile cases about counterfeit drugs entering the United States.


• PhRMA provides annual estimates of U.S. pharmaceutical industry losses from foreign violations of data exclusivity and patent protection. In its 2007 Special 301 submission to the USTR (covering the period of October 2006 to September 2006), PhRMA contended that its member companies sustained damages totaling an estimated $21.7 million from data exclusivity and patent violations in 24 countries. Damages reported in the 2007 submission were nearly double those reported in the prior year’s submission (covering October 2005 to September 2005). While the total loss associated with IPR infringement grew, damages as a percentage of sales declined from the 2006 submission to the 2007 submission. At the time of reporting for 2008 Special 301 submissions, PhRMA was not able to provide damage estimates due to trade barriers associated with intellectual property protection and market access.


• U.S. CBP and L.A. Strategic Trade Center, “FY2006 Top IPR Commodities Seized,” November 7, 2006, [http://www.cbp.gov]. Because of the costs and resources required to conduct physical inspections, many counterfeit products escape inspection, making it difficult to determine the fraction of pirated goods caught. As a result, seizure statistics from the DHS agencies do not reflect on the overall size of the counterfeit market and total losses.

As we have said many times, XStream Systems believes in a comprehensive strategy to combat counterfeit and adulterated pharmaceuticals. XStream believes that this solution should include verification and screening of the materials inside their unit of sale containers. XStream’s XT250, using EDXRD, allows for the complete verification of the material, without opening the container or destroying/degrading the product being authenticated.

To view the CRS report, follow this link:
http://fpc.state.gov/documents/organization/109543.pdf

COMBATING THE SPREAD OF FAKE DRUGS

In the June 28, 2009 Online Issue Daily Policy Digest, the National Center for Policy Analysis highlights a very relevant policy document titled, "Keeping It Real: Combating the Spread of Fake Drugs in Poor Countries" by Julian Harris, Philip Stevens and Julian Morris of the International Policy Network.

XStream endorses the primary assertion that one of the most effective ways in combating this international problem is for the private sector of the pharmaceutical supply chain to take advantage of its innovative capacity to experiment with various technological solutions that enable it to protect the identity of its products. Members of the pharmaceutical supply chain need to utilize a variety of technologies, like XStream’s XT250 solution which allows the end user to verify and authenticate medications inside its sealed manufacturer’s unit of sale container without destroying or degrading the material.

The text of the Daily Policy Digest review on "Keeping It Real":

Counterfeit and substandard drugs are a serious and growing problem around the world -- especially in less developed countries. These fake drugs pose three direct threats to patients: failure to provide effective treatment; adulteration with toxic chemicals, often leading to death or injury; and if a drug contains some active ingredient but too little to kill all the disease agents, it can lead to the emergence of drug resistant strains of disease.

These problems are caused in large part by a combination of defective legal systems and government-imposed distortions of the pharmaceuticals market, say researchers at the International Policy Network:

Poor countries tend to have highly inefficient, slow and expensive legal systems, which makes it very difficult for people to be assured of the quality of the medicines they purchase.

Lack of enforceable trademarks and civil liability are instances of a wider problem; in such an environment, legal decisions tend to be arbitrary and designed to benefit the elite.

Price control measures, like tariffs, on imported medicines are very common in poor countries and drive up the price of high quality medicines creating opportunities for suppliers of fakes, who can then more easily undercut them.

Tariffs can also lead to unnecessary delays in ports, where improper storage conditions can cause drugs degrade.

However, bolstering the rule of law is a long term process in many countries. In the short-term, the private sector should take advantage of its innovative capacity to experiment with various technological solutions that enable it to protect the identity of its products. Governments, meanwhile, should reduce those interventions which undermine the supply of quality drugs, such as taxes, tariffs, price controls and other arbitrary regulations, say researchers.

Source: Julian Harris, Philip Stevens and Julian Morris, "Keeping it Real: Combating the spread of fake drugs in poor," International Policy Network, 2009.

The National Center for Policy Analysis (NCPA) is a nonprofit, nonpartisan public policy research organization, established in 1983. The NCPA's goal is to develop and promote private alternatives to government regulation and control, solving problems by relying on the strength of the competitive, entrepreneurial private sector.

To read the entire piece by Harris, Stevens and Morris, follow the link below:
http://policynetwork.net/uploaded/pdf/keeping_it_real_2009.pdf

Bangladesh: Tainted pain reliever kills 25 children

An Industrial solvent was added to a popular over-the-counter pain reliever rendering it toxic. It is estimate that the tainted paracetamol syrup is responsible for killing over 25 children in Bangladesh. Tests revealed that diethylene glycol was substituted for propylene glycol in the formula.

Diethylene glycol is often used as a solvent for dyes and resins. It is also used as a coolant, a substance found in antifreeze. Diethylene glycol is often illegally used as counterfeit glycerin in some nations and sold internationally as a component of cough syrup, toothpaste, and mouthwash because it is less expense than the legitimate ingredient. However, because it is toxic, this often leads to disastrous results.

In Bangladesh, twenty-five children age 1 to 5 have died in the past six weeks. According to authorities, the tainted medicine killed most if not all of the children. Most of the deaths have been reported in the district of Comilla, where the factory is. The plant has since been shut down.

Last year in the United States, two New Yorkers, Saifoulaye Diallo and Habib Bah, pleaded guilty to importing counterfeit Colgate toothpaste tainted with Diethylene glycol. In their testimony they admitted to buying the Chinese toothpaste and repacking it to look like the Colgate brand, but were unaware that the toothpaste itself was toxic. The packaging of the counterfeit toothpaste was mostly indistinguishable from real Colgate, although the wording did contain some spelling and grammatical errors. Additionally, the toothpaste was identified as being made in South Africa, in an effort to avoid scrutiny from customs officials.

These individuals and various additional importers of the tainted Chinese toothpaste sold under different brands popular at dollar stores and state institutions (such as prisons). The imports accounted for over a million tubes of counterfeit toothpaste distributed in the U.S. throughout several states between 2007 – 2008.

This along with other recent examples of substandard medications, emphasize the need to have molecular pharmaceutical authentication along the supply chain route to protect consumer sagainst toxic substitutions. To view more on molecular authentication, visit www.xstreamsystems.net.

Dramatic Rise in Drug Seizures by EU Customs

SecuringPharma.com posted a story by Phil Taylor on July 24th, outlining and giving background on an astounding increase in drug seizures by EU Customs Officials.

Some interesting tidbits include:

• Seizures of pharmaceutical products at the European Union’s borders rose 57 per cent last year, while the total number of items detained more than doubled to around 8m items.


• That increase came against a backdrop of a 13 per cent hike across all product categories to nearly 50,000 seizures overall, with the number of detained articles swelling to 180m from 80m in 2007.The report notes that seizures of medicines were among the most controversial developments in 2008.


• There were cases in which generic medicines destined for a developing nation being seized in transit at EU borders, even though they did not infringe intellectual property rights in their destination markets (such as Latin America and Africa).


• Around 70 per cent of all seizures were carried out at the request of an intellectual property rights holder, with the remainder ex officio actions by customs officials where there was a suspicion of infringement.

To read the story visit SecuringPharma.com at the following link: http://www.securingpharma.com/40/articles/184.php

Repeating the Dangerous Statistics of Counterfeit and Fraudulent Medications

In the past we have blogged on quite a few statistics and on these in particular. It seems reasonable and relevant to repeat some of these statistics as it relates to counterfeit, fraudulent and adulterated medications.

These statistics are taken from both the World Health Organization (WHO) and Peter Pitts who is the Director for Medicine in the Public Interest and are often quoted in presentations as it relates to this very dangerous subject. No industry thought leaders challenge these statistics:

• Globally 10% of Pharmaceuticals are Counterfeit or Adulterated
• $35 Billion in Sales of Counterfeit Drugs in 2006
• $75 Billion in Sales of Counterfeit Drugs Projected by 2010
• 12-16% Growth Expected Globally
• 1-2% Pharmaceuticals in the United States are Counterfeit or Adulterated
• With 3.4 Billion prescriptions (filled in 2008) in the United States
• 34 Million of these prescriptions were estimated to be filled with counterfeit medications

Given these startling statistics, we at XStream encourage all within the global pharmaceutical supply chain to deploy and variety of solutions and technologies to protect the worldwide consumer. Specifically XStream believes that by screening the contents of the medications inside its sealed container and authenticating the product protects the manufacturer, distributor, provider and consumer. XStream’s XT250 utilizes EDXRD which allows the user to verify the contents of the medication without opening the container, destroying the product or degrading the material inside.