How the Current Economy Will Drive Counterfeit and Fraudulent Medications

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

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

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

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

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


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


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


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


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

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

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

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

Drug Authentication Evolves to Use Molecular Screening to Combat Fake Drugs

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

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

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

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

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

To view more on Life Science Leader…

Cargo Thefts on the Rise - Threaten Security of Pharmaceuticals

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

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

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

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

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

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

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

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

FreightWatch Releases September 2009 Cargo Theft Report

FreightWatch International (USA), an international logistics security company, has released it September 2009 Cargo Theft Report by commodity, location and date.

Of interest is the high level of cargo theft volume in California and Florida. The September Report shows eight incidents labeled as a pharmaceutical commodity:

• September 6th, a theft of a trailer in Clearwater, Florida which contained Albuterol.


• September 8th, a theft of a trailer in Evansville, Indiana containing $500,000 in baby formula.


• September 8th, a theft of a trailer in Tampa, Florida with an unreported pharmaceutical cargo.


• September 8th, a theft of a trailer in Jacksonville, Florida of pharmaceutical soy protein worth $50,000.


• September 16th, a theft of a trailer in Whiteland, Indiana which contained $50,000 of OTC medications.


• September 16th, a theft of a trailer in Louisville, Kentucky which contained OTC medications.


• September 25th, a theft of a trailer in Jacksonville, Florida which contained OTC medications worth $250,000.


• September 29th, a theft of a trailer in Jacksonville, Florida which contained Tylenol.

Members of the pharmaceutical supply chain and domestic consumers should be aware of these incidents and the prevalence of counterfeit, adulterated, stolen or fraudulent medications.

To learn more about FreightWatch’s September 2009 Cargo Theft Report visit: www.freightwatchusa.com.

U.S. Customs Seizes Fifty Pounds Of Counterfeit Viagra in Miami

As reported on many newswires and through an official press release, the United States Customs and Border Protection announced that in October, they intercepted 21,600 counterfeit Viagra tablets bound for another country.

The interception of counterfeit product, which weighed in at nearly 50 lbs. was passing through the Miami International Airport from India and was spotted by a suspicious Customs and Border Patrol Agent.

"We just know it's not authentic, but we don't know what's in it," said Customs and Border Protection spokesman Jose Castellano. "If something is counterfeit, there's no telling what they were manufactured with, and it could be harmful."

This is yet another cautionary tale about the prevalence and potential danger of counterfeit medications. This fraudulent shipment, valued at well over $300,000 (at the wholesale acquistion cost of the legitimate drug), could have negatively affected the health or caused a fatal reaction to nearly 22,000 consumers.

Know where you are buying your prescriptions and make certain that they purchase drugs from a trustworthy source of supply that utilizes track and trace and material screening technologies to verify and authenticate their pharmaceuticals inventories. Never purchase any drug from a source other than a licensed, well established pharmacy that requires a prescription from your physician.

To learn more about material screening technologies used to protect the pharmaceutical supply chain, visit: http://www.xstreamsystems.net/.

To view a News Video on the seizure visit: cbs4.com.

20,000 or more Patients Receive Adulterated Prescriptions in “Medicine Mafia” Scheme

As the investigation proceeds in the “Medicine Mafia” Story, officials are just getting a glimpse of the extent of the problem. Authorities are uncovering well-entrenched criminal organizations going back maybe 5 years. At least seven large unions are involved in the scheme and up to fifty unions are under investigation.

Most of the substances in question were for life saving medications for cancer, HIV/AIDS, genetic disorders, and hemophilia. Suspects are accused of distributing expired, diluted, and fake medications.

Argentina’s Superintendent of Health Services estimated that a minimum of 20,000 patients received the illegal pharmaceuticals.


To view more information on counterfeit drugs, read the International Federation of Pharmaceutical Manufacturers and Associations (IFRMA) document on “Counterfeit Medicine: The Global Public Health Risks” at: www.ifpma.org.

Zanola to Remain Free Pending the "Medicine Mafia" trial

Recent events in Argentina have shocked citizens as those in the power to protect their health have been implicated in the "Medicine Mafia" scandal where top leaders are accussed of distributing counterfeit, aduterated,and expired medications for life threatening diseases. Here is one of the latest developments in the case from Buenos Aires Herald:

Federal Judge Norberto Oyarbide authorized Bank Clerks' union leader Juan José Zanola to remain free pending a trial in which he is charged with adultering medicines.

Zanola will have to pay three million and and his girlfriend Paula Aballay, a million pesos bail money for that freedom.

According to Federal Judge Norberto Oyarbide, Zanola would have been "highly compromised" in the purchase of the adulterated medicine from San Javier pharmaceuticals for the Bank Clerks' health centre. The pharma company is owned by businessman Néstor Lorenzo, currently in prison. San Javier manufactured drugs for cancer and aids patients.

To view entire article visit: www.buenosairesherald.com.

Five Businessmen Charged with Multi-Million Dollar Bogus Medicine Scheme

Five business men appeared in the City of London Magistrates' Court accused of multi-million pound pharmaceutical plot involving bogus Chinese-manufactured life-saving drugs.

The charges were brought forth after a two-year investigation conducted by Medicines and Health Care Products Regulatory Agency, Britain’s regulatory equivalent of the Food and Drug Administration in the United States.

One of the accused is Ian Harding, a 57 year old businessman from Bradford on Avon. He is charged with conspiring with others to defraud pharmaceutical wholesalers, pharmacists, the public and brand pharmaceutical companies by distributing counterfeit medicines. He is accused of selling bogus life saving medications portrayed as the brand names Casodex, Plavix and Zyprexa. Casodex is used to treat prostate cancer; Plavix is a drug prescribed to prevent blood clots to the heart and Zyprexa is an anti-psychotic drug.

Between 2005 and 2007 Harding allegedly acquired and sold counterfeit drugs through Consolidated Medical Supplies Ltd. This caused a massive recall forcing suspicious product to be pulled from pharmacists’ shelves, resulting in huge losses to the pharmaceutical industry.

Harding and his fellow defendants were sent for trial to Southwark Crown Court and will appear for a plea and directions hearing on December 15.

To view the entire article visit The Bath Chronicle at: www.thisisbath.co.uk.

Up to 30 per cent of EU generics 'contain falsified APIs'

On Friday, SecuringPharma, published an interesting article on the quality of active pharmaceutical ingredients (APIs) in European generics.

The European Fine Chemicals Group claims that 20 to 30 percent of the APIs come from unapproved sources.

EFCG board member Guy Villax quoted that figure, which he attributed to EU inspectors, at a press conference at the Conference on Pharmaceutical Ingredients (CPhI) held last week in Madrid, Spain.

This causes a huge challenge to the validity and efficiency of the finished product as a single batch of an API can reach from 10,000 to 1,000,000 patients. Currently a manufacturer receives Good Manufacturing Practice (GMP) certification based not only on their own practices, but those of their suppliers as well. If their suppliers are in reality not as they have stated, you can see how this circumvents the inspection process.

Council of Europe is drafting legislation on counterfeit medicines to be reviewed by 40 countries. However, EFCG does not agree with the current wording of the EU's draft directive which suggests that API manufacturers can be inspected by their own domestic authorities, providing their enforcement systems are deemed 'equivalent' by the EU, i.e. they conform to ICH Q7 and are based on regular inspections.

This would work with countries such as the USA, Japan and Australia, said Villax, but he is concerned that equivalence could be granted for political reasons to other countries where the systems may be prone to fraud and corruption.

We at XStream Systems agree that the quality of the finished product is only as good as the quality of the ingredients that are contained therein. In the United States this was only too evident in last year’s case of tainted heparin, where the active ingredient had been tainted by unapproved suppliers and resulted in the death of over 80 people.

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

FDA Warns Consumers Internet Flu Drugs May Not Be What you Think!

Agency goes Covert to Pull the Plug on Fake and Unapproved H1N1 Drugs

Friday, the Food and Drug Administration issued a warning against purchasing drugs over the Internet that claim to diagnose, prevent, treat, or cure H1N1 influenza virus. The FDA has gone undercover to secretly purchased Tamiflu, an antiviral drug used to treat the H1N1 flu, online. Afterwards, the samples were analytically tested to determine their quality and authenticity.

The two antiviral drugs approved by the FDA for treatment and prophylaxis of the 2009H1N1 influenza virus are Tamiflu (oseltamivir phosphate) and Relenza (zanamivir).

What they found in the purchased online samples was shocking. One package contained nothing more than talc and acetaminophen. Four contained various levels of oseltamivir but were not approved for use in the United States. Several of the products purchased did not even require a prescription from a health care professional. Additionally, the products did not arrive in a timely enough fashion to treat someone infected with the H1N1 influenza virus, or with an immediate exposure to the virus.

FDA warned consumers that purchasing prescription drugs online results in products that are from an unknown origin, uncertain quality, and could pose an undue risk to your health. Consumers are urged to purchase their prescriptions from only licensed pharmacies approved for distribution of these medicines.

To view entire FDA warning visit:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186861.htm.

To view the FDA consumer guide to purchasing drugs online visit:
http://www.fda.gov/Drugs/ResourcesForYou/ucm080588.htm.

Cargo of Tylenol Stolen in Jacksonville Florida

Cargo thefts seem to be on the rise… The latest alert comes via FDA press release this week:

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is working with the U.S. Food and Drug Administration, Office of Criminal Investigations (FDA), and other law enforcement officials to recover cases of select lots of TYLENOL® Arthritis and TYLENOL® PM products that were stolen from a cargo terminal at the Jacksonville Port Authority in Jacksonville, Florida on September 25, 2009.

The products stolen were cases of:

• TYLENOL® Arthritis Pain Caplet 150 count bottles (57,456 bottles) Lot 09XMC112


• TYLENOL® PM Caplet 2 count packets (180,000 2 caplet pouches) Lot 09XMC110

Consumers who received or purchased either of these products should check to see if they are from the stolen lots (lot numbers listed above).

McNeil Consumer Healthcare and the FDA are asking for the public's help in reporting any information regarding the stolen TYLENOL® products to FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

To view the entire announcement visit: http://www.fda.gov/ICECI/CriminalInvestigations/ucm186269.htm.

RID Pharmaceutical Execs Charged with Manufacturing Adulterated Drugs that Killed Over 25 Children

On Monday, October 12, 2009; Mizanur Rahman and his wife Sheuly Rahman, two executives from RID Pharmaceuticals were formally charged in Dhaka court with producing toxic syrup that lead to the deaths of over 25 children.

In August 2008, the Directorate of Drug Administration filed the case against five officials of Rid Pharma for the manufacturing of substandard paracetamol syrup. In July 2008, the administration seized products and halted RID Pharmaceuticals’ production of all pharmaceuticals.

Further investigation and laboratory tests confirmed the presence of the toxic chemical diethylene glycol in spurious paracetamol syrup produced by Rid Pharmaceutical Company. Diethylene glycol, normally used in the textile and leather dying industries, was allegedly used in the preparation as a cheap but deadly substitute for propylene glycol.

Rid Pharma initially denied producing the paracetamol syrup linked to children's deaths, as reported in media. Officials of the drug company were quoted in the press as saying Rid Pharma "does not produce paracetamol syrup, but only suspension".

Bail hearing is set for Oct 19, 2009.

To view entire article view: bdnews24.com

Report Notes Rise in Adverse Drug Events, Patient Deaths

As reported by Shawn Rhea in Modern Healthcare, the Food and Drug Administration has announced that adverse drug events increased by 25% in 2008 compared with 2007. This data came from a new QuarterWatch report from the Institute for Safe Medication Practices, a Philadelphia-based not-for-profit dedicated to the prevention of medical errors.

• The increase was the largest over a one-year period since the FDA began collecting data in 1998.


• According to researchers, the FDA received reports of nearly 100,800 cases of serious injury related to drug use in 2008 compared with 80,600 in 2007. Those numbers included a 56% increase in patient deaths—from 9,700 in 2007 to 15,200 in 2008.


• The ISMP credited the surge in reported events to both the FDA's efforts to better identify adverse drug events and a slew of recalls on generic drugs such as heparin vials, and morphine and digoxin tablets during 2008.

As blogged about repeatedly in Secure Pharma Chain Blog it has been predicted that this increase is consistent with the increase in instances of counterfeit, adulterated and fraudulent medications within the domestic pharmaceutical supply chain. Although industry and regulatory authorities continue to use Track and Trace technologies to combat this issue, it is apparent that additional solutions are needed to protect the healthcare consumer.

Material screening by using EDXRD, allows the members of the pharmaceutical supply chain to verify and authenticate the medications inside of its unit-of-sale container without degrading or destroying the material inside the package. This solution can be used at all areas of the supply chain from raw materials, to production, packaging, distribution and dispensing and will authenticate both the medication and protect against medication errors.

To learn more about EDXRD technology as a solution to counterfeit, adulterated and fraudulent medications, visit: www.xstreamsystems.net.

Fake Malaria Drugs Spread, Breed Resistance to Lethal Parasite

In an October 9th story written by Simeon Bennett which appeared on Bloomberg.com, fake malaria drugs from China are breeding resistance to life-saving medications in Cambodia and threatening to derail global efforts to eradicate the disease, a study funded by the Bill and Melinda Gates Foundation found.

The following are some interesting facts from Mr. Bennett’s story about the study:

• Among more than 700 packets of pills sold at private drugstores in Cambodia and Thailand, 60 percent were found to be substandard or counterfeit around the border, compared with less than 5 percent in other areas in Thailand. Previous studies have suggested about one-third of malaria drugs in western Cambodia are fake.


• Substandard treatments are contributing to growing resistance to genuine medicines in the area, he said. That threatens to unravel progress made against the disease in Africa, which has 90 percent of the world’s malaria cases, if the resistant strain spreads there, researchers have warned.


• The pills tested in the $350,000 Gates-funded study were mostly from China and touted to contain artesunate, part of a family of drugs called artemisinins that are the most potent weapons against malaria… the study completed last week found that some had no active ingredient, while others contained small amounts, which fuel resistance by favoring the survival of the hardiest parasites, he said.


• Treatments derived from artemisinin are taking almost twice as long to clear the parasites in patients in western Cambodia than in northwestern Thailand, showing the drugs are losing their potency against the disease, a study published in July in the New England Journal of Medicine showed.


• “This is a very, very large problem potentially for the whole world,” said Nick White, director of the Bangkok-based Mahidol Oxford Tropical Medicine Research Unit, which is studying drug-resistant malaria in the areas around the Thai- Cambodia border. “The scale and the speed of the response have been unfortunately too small,” he said.

The worldwide epidemic of counterfeit drugs continues to grow and impact the healthcare of people around the world.

XStream Systems’ revolutionary technology allows for those within the supply chain to screen and verify medications inside their unit-of-sale container without degrading or destroying the material. This type of verification is a vital solution to the proliferation of counterfeit, adulterated and fraudulent drugs and it impact to the healthcare of populations around the world.

To read the story, follow this link: www.bloomberg.com.

Two Minnesota Men Accused of Distributing Counterfeit Drugs

Two Minnesota men, Nicholas Lundsten, 26, of Spring Lake Park, and Patrick Barron, 29, of Fridley were charged Wednesday for distributing misbranded medication. The pair sent 10,419 pills labeled as Viagra; 3,600 pills labeled as Cialis; 1,582 pills labeled as Propecia; and 340 pills labeled as Levitra.

Viagra is manufactured by Pfizer; Cialis by Eli Lilly; and Levitra by Bayer; all treat erectile dysfunction. Propecia, manufactured by Merck, treats male pattern hair loss.

Lundsten and Barron are also accused of illegally importing about 40,000 pills of alprazolam — used to control anxiety disorders — and about 27,000 pills of sibutramine — an appetite suppressant used to treat obesity — into the United States. Both are classified as "Schedule IV" controlled substances.

The indictments are the result of an investigation by the FDA, U.S. Immigration and Customs Enforcement and the U.S. Postal Inspection Service, with assistance from U.S. Customs and Border Protection.

If convicted, Lundsten and Barron face up to six years in prison.

To view entire article, visit: www.startribune.com.

Time: Call To Establish International Convention on Counterfeit Drugs

Peter Gumbel in the October 8th issue of Time magazine reported on the worldwide surge of counterfeit drugs.

In this excellent article, Mr. Gumbel notes:

• The World Health Organization (WHO) said "more than 50 percent of drugs sold online have either been falsified or altered in some way. And Internet sales are just the tip of a much bigger problem."


• Falsified medicines are especially prevalent in developing countries; the WHO estimates that up to 30% of drugs sold in parts of Africa, Asia and Latin America are fake, including ones used to fight diseases like malaria and tuberculosis.


• The issue has long been a preoccupation of major pharmaceutical companies, which lose as much as $75 billion in business every year to counterfeit-drug makers, according to WHO estimates.


• The Pharmaceutical Security Industry tracked more than 1,800 incidents of drug-counterfeiting around the world last year, 10 times the number when it first started monitoring seven years ago. Getting governments and law enforcers around the world to work more effectively to counter the problem has proved hard.


• The Presidents of two African countries, Thomas Boni Yayi of Benin and Blaise Compaore of Burkina Faso, will be among a cluster of international dignitaries and industry experts who will make an international call for action against counterfeit drugs.


• There is a upcoming meeting in Benin which is “a worldwide campaign aimed at raising awareness of the problem and persuading governments to impose tougher penalties and improve routine testing of medications. The larger goal is to establish an international convention on counterfeit drugs as early as next year."


• When Pfizer recalled 120,000 packs of its cholesterol drug Lipitor in Britain in 2005 after it discovered a counterfeit version, it found that 60% of all the returned packs were fakes. Jacques Franquet, who heads security operations for the French drugmaker Sanofi Aventis, says his teams routinely find fake versions of about 15 of the company's drugs worldwide.


• Marc Gentilini, a French medical professor and expert on tropical diseases says the problem is urgent. The lack of clear international rules governing counterfeit medicines, he says, means that trafficking them is currently "less risky and more lucrative than trafficking narcotics."


• Certainly, there's now an abundance of evidence of brazen criminal activity. More than 80 babies in Nigeria died earlier this year from teething medicine that contained the toxic coolant diethylene glycol. In July, authorities in Bangladesh seized supplies of a poisonous acetaminophen syrup that had killed 24 children. In Argentina, several women died in 2004 after receiving injections of a falsified iron-based medicine to treat anemia. And in 2006 more than 100 people in Panama died after taking medicines made with fake glycerin. Many times, the counterfeit drugs just don't work. This leads to a large number of preventable deaths, particularly in the developing world.

To view the entire story, visit the following link: http://www.time.com/time/health/article/0,8599,1929147,00.html

Doctor of Pharmacology Dies from Counterfeit Medication

In a sad and incredibly ironic story, a 29 year old with a doctorate in physiology and pharmacology, died recently after injecting herself with substandard buprenorphine. Buprenorphine, a drug used to treat addiction, had been purchased by the victim from an online pharmacy based in the Philippines.

Carrie John of Baltimore, a post graduate research fellow at the University Of Maryland School Of Medicine, died September 27 after diluting the drug in water from its original pill format and injecting the drug. John earlier this year co-authored and published a study on her research of "compulsions and habit formation”.

Buprenorphine is a narcotic known on the street as "bupe" and commonly used to treat heroin addiction. The woman and her boyfriend, also a post graduate researcher, apparently have been purchasing various narcotics for recreational use for the past two or three years from New Mikee Online Pharmacy, a Web site pharmaceutcal supplier based in the Philippines.

According to the boyfriend the couple used the pharmacy to buy not only buprenorphine but morphine, OxyContin and marijuana.

This terrible story is a cautionary tale to all about the evils of drug addiction and the real life danger of counterfeit, adulterated and fraudulent drugs. When a highly educated, pharmaceutical professional falls victim to both addiction and fraudulent drugs bought online, it begs the question as to what kind of risk average consumers face when drugs that are purchased online find their way into the legitimate drug supply.

To read the entire story, which appeared in the Baltimore Sun, follow the link:
http://www.baltimoresun.com/news/maryland/baltimore-city/bal-md.overdose30sep30,0,1002971.story

American Pharmacists Month: Know Your MEDICINE, Know Your Pharmacist

American Pharmacists Month is October and the American Pharmacists Association (APhA) is using the theme of “Know Your MEDICINE, Know Your Pharmacist” as it core message for the month.

One of the APhA’s objectives for the month is - To stress the importance of Knowing Your Medicine and Knowing Your Pharmacist to ensure drug therapy is as safe and effective as possible.

As often blogged about in Secure Pharma Chain Blog, globally the entire pharmaceutical supply chain is facing a proliferating epidemic of counterfeit, adulterated and fraudulent medications which threaten to impact the healthcare of consumers worldwide. Literally hundreds of thousands of people die each year globally, with millions more suffering from the impact of fraudulent drugs that they consume. Domestically, even though the percentage of the supply chain, impacted by counterfeit medications is estimated at 1-3% (well below the global average of 10%) this still means that over 35 million prescriptions are filled with fraudulent drugs each year within the United States.

The pharmacist is a consumer’s primary line of defense in protecting themselves from the impact of fraudulent and counterfeit medications and making certain that their drug therapy is as safe and effective as possible.

Secure Pharma Chain Blog’s Consumer Tips for Maximizing the Safety and Effectiveness of Your Medications:

1. Only buy medications from a licensed pharmacy that has locations near your home.

2. If you buy prescriptions on-line, only buy from licensed on-line pharmacy that is approved by the National Association of Boards of Pharmacy and/or one that is part of a chain or otherwise affiliated with a drug store that you visit regularly.

3. Never buy prescription medications from a source that does not require a physician’s prescription or offers you a physician’s prescription without a physical examination.

4. Develop a rapport with your local pharmacist and visit regularly with them about your medications and your healthcare in general.

5. If you notice that your medications have changed in appearance, smell, taste or otherwise appear different, contact your pharmacist immediately.

6. If you notice side effects that have not been explained to you, or your medications are not properly treating your condition as they have before, notify your pharmacist and physician immediately.

7. Remember, if the price of a medication sounds too good to be true, it probably is.

In today’s current economic climate, there are many who are using healthcare and medications as a way to make a quick buck, it is important that you work with healthcare professionals that diligently protect their patients from nefarious sources of supply that may negatively impact your health.

“Medicine Mafia” Supplies Fake Drugs to 50 Trade Union Hospitals

Lives at Risk – In the Name of Greed

Corruption, greed, and scandal have hit the headlines in Argentina. The crowds stand accusingly of those in charge of protecting them. The sense of betrayal can be heard in their voices as they scream “Assassin!” as the deputy director of a union health clinic is arrested by police for distributing fake medication to cancer, AIDS, hemophiliacs and other severe illnesses.

The majority of Argentina's workforce gets healthcare through schemes run by their respective trade unions. A group of pharmaceutical businessmen, now dubbed the 'medicine mafia' have been accused of distributing fake, expired, stolen, and counterfeit medication to union-run hospitals.

One union official, Hugo Dessal, who blew the whistle on the operation, asks why both union-run hospitals and regulatory officials did not question the hundreds of adverse reactions reported in the last five years. Doctors and cancer patients became suspicious when medications did not cause hair loss.

Investigators are now looking into a total of 50 trade unions suspected of purchasing the fake medication either knowingly or unknowingly. The scandal deepens as other union and government officials are investigated including the president of the Bank Clerk Union, the wife of a murdered pharmaceutical company owner, and even president Cristina Kirchner, whose election campaign funds may have benefited from the sale of these adulterated drugs. It impossible to say how long this has been going on, but tens of thousands are expected to have consumed fake drugs.

And the whole incident leaves many asking the question - How many have died in the name of GREED?

FDA: New Manufacturing Standards May Decrease Heparin Potency by 10%.

Given Secure Pharma Chain Blog’s extensive covering of the issues with Heparin the past year, the following involves the widely reported story which appeared in a variety of news publications regarding changes to the manufacturing Heparin in an effort to prevent further complications with the often used medication.

The FDA recently announced that "New manufacturing standards designed to prevent contamination of the blood-thinner heparin will decrease the drug's potency and may require patients to get higher doses." Beginning October 8th, "heparin products...will be about 10 percent less potent than the current medicine used to prevent blood clots, which was posted on the" agency's website.

Dr. John Jenkins, director of the FDA's office of new drugs, stated that "healthcare providers should consider the change in potency of heparin when making decisions about which dose to administer.”

• Although "older vials of heparin will remain on the market after the new formula begins shipping," which may "cause confusion, the agency said it was necessary to ensure there is adequate supply of the drug."


• The Dow Jones Newswire reports that the agency has asked manufacturers to change labels on the new products to help pharmacies and physicians identify them from the older vials.


• According to the Chicago Tribune, the new standards are intended to help "manufacturers...spot impurities during the quality-control process." The new controls follow "last year's recall by...Baxter International Inc. of its heparin vials linked to a spike in deadly allergic reactions."


• CQ HealthBeat reports. Jenkins noted that "the change 'may have clinical implications in some situations' where the drug is given in a large dose to produce an immediate anti-coagulant effect." But, Jenkins added that "the change in potency is expected to be less clinically significant when administered subcutaneously,"

XStream endorses any opportunity to enhance the safety and security of medication within the supply chain. To learn more about XStream Systems’ revolutionary supply chain security solutions, visit us at: www.xstreamsystems.net.

Daily Times: Government to Investigate Reports of Counterfeit Drugs Supplied to Hospitals

Pakistan’s Daily Times reported on September 12th about the Senate Standing Committee on Health’s concern over reports of counterfeit medications being supplied to Pakistan’s government hospitals. The Committee has called for a full report from Director General Rasheed Jumma on this issue.

Also mentioned by the Senate Committee was their concern over the importation of over 1,000 Chinese medicines, including critical lifesaving medications and their direction to the Health Ministry for a complete review of their imported medicines’ registration.

To view the entire Daily Times story, link to: http://www.dailytimes.com.pk/default.asp?page=2009\09\12\story_12-9-2009_pg11_6

Associated Press: FDA Announces Plans to Improve Public Announcements on Food, Drug Safety

The Associated Press on September 30, 2009 reported, "The Food and Drug Administration is laying out plans to improve its public announcements on food and drug safety, more than three years after federal advisers recommended major changes." The agency "will begin studying public response to its announcements on potentially dangerous food and drugs."

Given the recent proliferation of counterfeit, adulterated, fraudulent and production issues on medications and consumer products produced and distributed in the United States, this is announcement is seen as an important step forward in protecting the domestic consumer.

Caraco: FDA to Eventually Allow Manufacturing Operations

The Associated Press and several major news outlets reported that Caraco Pharmaceutical Laboratories announced on Tuesday that it has agreed to a series of measures with the FDA that will allow the company to resume manufacturing operations.

As reported on Secure Pharma Chain Blog, Caraco has had their manufacturing operations halted by the FDA after they found repeated violations of manufacturing standards and seized inventories. Recalls have been made on certain Caraco products that were found to have manufacturing defects, including oversized tablets and possible formulation errors.

The manufacturing restrictions will be in place until regulators give written notification of compliance with the agreement measures and regulations. Caraco will continue to distribute FDA-approved products manufactured by third parties.

XStream endorses the concept that all members of the pharmaceutical supply chain utilize material screening process in all points of the process; raw materials, production, quality assurance, packaging, distribution and dispensing in order to protect the supply chain and the consumer.

To learn more about XStream’s revolutionary material screening technology visit: www.xstreamsystems.net.