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.

Swine Flu (H1N1 Flu) – Is There Really Cause for Worry?

So consumers want to know about the H1N1 influenza A (otherwise known as Swine Flu) and what does it mean to them? Is it all hype or is this something they should worry about? Well…the best answer is to stay informed, be cautious and be prepared.

Authorities agree that this strain of H1N1 Flu should not be dismissed as a threat just because it has started off as mild cases. This particular flu is genetically a descendant of the Spanish flu of 1918, which started mild, but returned to infect two-thirds of the population and kill over 50 million people. Scientists believe that the current flu will return at the peak of flu season this fall and it will be a stronger more viable foe than the one that stands before us today.

The H1N1 Flu currently has around 6500 confirmed cases in 33 countries globally, of which about 3,400 are in the United States. As to date, most deaths due to this strain have occurred in Mexico. The United States has three confirmed deaths, but those individuals also had underlying health issues that contributed to a more severe case that required hospitalization.

So what about natural immunization? There is very little natural immunity to this strain. There is a possibility that individuals who are in their 90’s and above would be immune since they were most likely exposed to the Spanish Flu. However, the rest of us are probably out of luck.

So what about immunization shots? There are several pharmaceutical companies working on these shots to be delivered in the fall. The problem is that vaccines are developed in hen eggs and take about 4 months for completion. It is unlikely that a mass immunization of the population is feasible and will probably be restricted to those most vulnerable.

So what about medication treatment for those with the flu? This is where the real danger is and consumers need to be cautious. When demand exceeds supply, unscrupulous individuals take advantage of the public. No country has enough flu medication to serve its entire population. Some areas such as UK have enough to accommodate around 80% of their population. This is rare as most do not have enough to cover 50%. Some areas such as California only have enough to cover around 25% of their population.

Beware! Already the public is being spammed with individuals trying to sell Tamiflu over the internet only to steal their credit card information. Expect to see some cases of counterfeit Tamiflu as this was the case when SARS became an issue a few years ago and resulted in counterfeit flu remedies infiltrating the marketplace.

So what can a consumer do to protect themselves? The H1N1 Flu travels the same way as other flues. If you don’t have the flu yet practice good hygiene (i.e. wash your hands frequently; always cover your mouth when you cough) to lessen the spread of the disease to yourself or others. If you think you have the flu, stay home. If you suspect the H1N1 flu see your doctor and get tested. Whatever you do, don’t order medication online except through a known pharmacy. You will need a prescription from your doctor and you should only buy medication through known sources!

For pharmaceutical wholesalers, test your inventories. Pharmacists trust you to give them safe efficient medication to supply the public. Forewarned is forearmed. Be prepared - Get your security procedures in place now to ensure you have the safest medication possible for your distribution chain.

Below are some helpful links for information on the H1N1 Flu:

For General Information and preventative measures visit: http://www.cdc.gov/h1n1flu/qa.htm

To view “How Time and Mutations Engineered the New H1N1 Strain” visit: www.washingtonpost.com.

To view statistics on US confirmed cases by state visit the Center for Disease Control at:www.cdc.gov.

To view statistics on global confirmed cases visit the World Health Organization at: www.who.int.

XStream's XT250 System Verifies WHO Figure for Counterfeit Drugs in U.S.

Based on XStream Systems' usage data from end user XT250 systems, they can verify that the World Health Organization’s (WHO) estimate of 1% of the United States pharmaceutical supply chain being counterfeit, is accurate.

XStream System’s XT250 Materials Identification System verifies and authenticates materials within its sealed, unit of sale container. The standalone system is currently deployed in several pharmaceutical distribution companies that distribute pharmaceuticals throughout the United States.

“Based on our macro look at the data from the end user, we can confirm that the WHO estimates are reasonably accurate”, stated Alan Clock, Senior Vice President at XStream. “Our system is the only technology that can accurately authenticate pharmaceuticals within the supply chain without destroying the product or packaging so we have excellent visibility on what is going on literally inside the supply chain .”

“The XT250 is the only materials analysis technology that can keep up with the tremendous flow of drugs throughout the supply chain. We are seeing data that suggest between 0.67% and 1.4% of receivables and returns within these pharmaceutical distributor end users are likely counterfeit products or fraudulent medications,” explained Mr. Clock.

From the data, XStream is learning that authentication rejection/failure rates vary between pharmaceutical products, and even within a given pharmaceutical product the rejection rates can vary significantly over time. In some cases isolated bottles have been rejected, while in other cases entire lots have been rejected. “You can’t predict when the counterfeits will show up,” said Mr. Clock.

XStream’s data validates that the members of the pharmaceutical supply chain (manufacturers, distributors and dispensers) should be using authentication technology more and taking steps to screen as many pharmaceuticals as possible, as often as possible. Currently many regulatory officials have been advocating more frequent inspections at foreign manufacturing facilities as the primary solution to the problem of poor manufacturing and counterfeit medications in the supply chain. While inspections are needed, given the sheer quantity of places to inspect and global nature of these sites, inspectors have little chance of catching counterfeits. In addition, XStream’s data suggests that counterfeits are inserted at a multitude of sources all along the supply chain. The point of production is not the primary starting point for fake medications. Verification and authentication at each point along the supply chain is the most effective way to detect and interdict fraudulent and counterfeit pharmaceuticals.

“The good news is that the United States is one of the last of the developed countries to see an increase in counterfeit medications. The United Kingdom has already seen an increase in the last three years and it stands to reason it will not be long till we see significant increases domestically as well. Because of this impending proliferation, the XT250 is essential for the protection of the consumer since it is one of the only tools available which can act as a roadblock to counterfeiters.”, said Mr. Clock.

Are Lawmakers Finally Showing Concern Over Counterfeit Medications and Bioterrorism?

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

Drug Store News reported that US Lawmakers and Analysts are finally beginning to question the globalization of the pharmaceutical supply chain, namely the disproportionate amount of manufacturing and raw materials that are produced overseas in countries like China and India.

With the rapid rise of counterfeit medications and food products in these countries within their own population it seems likely that the US domestic pharmaceutical supply will also see a significant rise in reported and unreported incidents of counterfeit medications and the rise in likelihood of bioterrorist threats.

Without the use of a variety of anti-counterfeiting methods and solutions, the US consumer will be at greater risk in 2009 than ever before.

XStream continues to work with agencies, regulators and industry thought leaders to introduce its authentication technology as a solution to safeguarding supply chain inventories. Its technology allows the manufacturer, distributor and dispenser the ability to authenticate the product within its sealed, unit-of-sale container.

The full Drug Store News article is available here:

http://www.drugstorenews.com/story.aspx?id=91433

LAWMAKERS CONCERNED INTERNATIONAL DRUG MANUFACTURING PRESENTS RISK OF COUNTERFEITS

By Alaric Dearment

New York (Jan. 20)Concern has arisen about the manufacturing of ingredients for drugs in other countries, especially antibiotics like penicillin, according to published reports.

Drug manufacturing has mostly moved to countries such as India and China, but some lawmakers and analysts have said it increases the risks of counterfeits and bioterrorism.

Already, more than 200 Americans have experienced dangerous drug reactions since November 2007 after taking counterfeit versions of the blood-thinning drug heparin manufactured in China containing a toxic chemical that merely mimics heparin. Last November, the Food and Drug Administration confiscated 11 lots of counterfeit heparin from a company based in Cincinnati.

Largest European Seizure: Two Million Counterfeit Pills Seized in Brussels Airport

Two million counterfeit pills have been seized in Brussels Airport. The seizure of the drugs which originated in Mumbai, Indian and were bound for West Africa is the largest confiscation of counterfeit medicine in Europe.

The three Indian shipments contained counterfeit pharmaceuticals labeled as Tramal, a painkiller, and Fansidar, an anti-malaria drug.

Africa already has the daunting task of trying to control its malaria outbreaks without further obstacles of fake treatments. Many countries, organizations, and businesses have been aiding Africa to fight malaria and therefore, counterfeit medicine is a real threat to their work. In some countries up to 60% of anti-malaria drugs are fake and are aiding in the drugs resistance to current therapies.

Furthermore, the biggest victims are the children, because according to the Worlds Health Organization (WHO) a majority of malaria deaths are children under the age of five and Fasidar is one of the drugs given to pregnant women for the prevention of malaria.

The scope and intent of this particular case leads us to ask – Is any medication safe? How can we protect our most vulnerable medications? We believe the answer can be found in pharmaceutical authentication which verifies the drug itself. With nothing added and nothing destroyed; the method can be programmed to test various oral medications.

To learn more of this fascinating technology, see XStream Systems website at http://www.xstreamsystems.net/products.html.