WHO: Poor Quality Drugs Used to Treat Malaria

Both the BBC and the Associated Press are reporting on a new World Health Organization study regarding the quality of drugs used to treat malaria in Africa.

The study goes into some depth regarding the findings that up to 40% of the artemisinin drugs used to treat malaria in poor African nations are of such poor quality they are ineffective in treating the disease. In addition because these poor quality drugs contain some of the active ingredient of the drugs, they are now causing drug resistant strains of malaria.

Here are some of the highlights from the BBC story:

• The group, conducting the study for the World Health Organization, said low-grade drugs were being used in both public and private health practices.



• Some 90% of malaria deaths in the world occur in Africa.



• They found 44% of the drugs from Senegal failed the testing, followed by 30% from Madagascar and 26% from Uganda.

To read the entire BBC story, visit: http://news.bbc.co.uk/2/hi/africa/8504137.stm

Some of the highlights of the Associate Press story which was published in the Chicago Tribune include:

• Between 16 percent and 40 percent of artemisinin-based drugs sold in Senegal, Madagascar and Uganda failed quality testing, including having impurities or not containing enough active ingredients, the survey found.


• Artemisinin-based drugs are the only affordable treatment for malaria left in the global medicine cabinet. Other drugs have already lost effectiveness due to resistance, which builds when not enough medicine is taken to kill all of the mosquito-transmitted parasites.



• If artemisinin-based drugs stop working, there is no good replacement and experts worry many people could die.


• "It is worrisome that almost all of the poor-quality data that was obtained was a result of inadequate amounts of active (ingredients) or the presence of impurities in the product," said Patrick Lukulay, director of a nongovernmental U.S. Pharmacopeia program funded by the U.S. government, which conducted the survey. "This is a disturbing trend that came to light."


• The study is the first part of a 10-country examination of anti-malarials in Africa by the U.S. and the World Health Organization. It follows evidence from the Thai-Cambodian border that artemisinin-based drugs there are taking longer to cure malaria patients, the first sign of drug resistance.


• The three-country report also found bad drugs in both the public and private health sectors, meaning governments — some buying medicines with donor funds — are not doing enough to keep poor-quality pills out. All of the drugs tested from the public sector in Uganda, however, passed the quality tests. But 40 percent of the artemisinin-based drugs in Senegal failed.


• "There are countries where donated medicines are not subjected to quality controls, they're just accepted," said Lukulay. "There are countries in Africa where Chinese products have been donated and found to be unacceptable later in the public sector."

To read the entire Associated Press story, visit: http://www.chicagotribune.com/health/sns-ap-med-africa-malaria-drugs,0,1354782.story.

This issue of counterfeit, fraudulent and adulterated medications, which is causing a deadly healthcare crisis around the globe, energizes the need for material screening of products within the supply chain, from raw materials to dispensing, to properly protect consumers everywhere.

To learn more about material authentication solutions, visit: www.xstreamsystems.net.

Anti-Counterfeiting: Thinking Inside the Box

The Autumn 2009 issue of Pharmaceutical Manufacturer and Packing Sourcer (PMPS) features an editorial article written by XStream Systems’ Senior Vice President, Alan Clock.

The editorial piece discusses analyzes the various segments of anti-counterfeiting technology and introducing EDXRD and material screening as a robust tool in combating counterfeit, adulterated and fraudulent medications within the global supply chain.

The phrase, “Thinking Inside the Box” refers to EDXRD’s capability to screen and authenticate materials inside their sealed, unit-of-sale containers without destroying or degrading the materials. This unique solution allows all members of the pharmaceutical supply chain to efficiently, accurately and inexpensively test and screen product to ensure that their inventories are safe and efficacious.

Here is an excerpt from the article:

Today, the various members of the pharmaceutical supply chain find themselves in an expanding global marketplace and in the midst of an ever growing epidemic that threatens each relevant party. As globalization increases, so too does the risk of counterfeit, substandard or fraudulent medications within the supply chain. This increase in risk threatens both the economic and physical health of the pharmaceutical industry and its consumers. Here are a few staggering statistics related to this scourge:

• The World Health Organization (WHO) conservatively estimates that counterfeit medications will be a $75 billion global industry in 2010.
• The WHO projects the annual growth of counterfeit medications to be between 12 and 16 per cent annually, worldwide.
• According to the WHO, more than 2,000 children in Africa alone die each day as a result of taking counterfeit medications.
• The WHO reports that, across the world, 10 per cent of pharmaceuticals are counterfeit, fraudulent or adulterated. Proliferation and percentages are much higher in developing countries in Asia, Africa and South America, with up to 50 per cent of the supply chain projected to be identified as counterfeit or adulterated.

TRACK AND TRACE

To date, nearly all of the solutions for this global epidemic emphasize what are known as ‘track and trace’ methods (such as barcodes, holograms, RFID, pedigree, taggants and serialization). These solutions are primarily based on traditional technology for inventory control and security and are common within most sophisticated supply chains. They are incredibly effective in tracking products, especially in direct or short supply chains, where the additional cost can be justified in their inventory control capabilities because the members of the supply chain use common systems and tools for tracking, distribution and sales. However, track and trace solutions have their limitations. They generally require some sort of addition to the outside of the box or package, and a common technology to be read and documented. These processes and technologies add further cost to the product and are difficult to maintain across large global supply chains. In addition, because of its external placement, the track and trace item may be easily replicated, and it does not verify that the material inside the package is safe and efficacious.

To read the complete article either visit PMPS at www.samedanltd.com/magazine/15/issue/122/article/2531 or visit XStream Systems website at www.xstreamsystems.net.

USP Develops New Testing to Identify Deadly adulterants for Two Pharmaceutical Ingredients

The U.S. Pharmacopeial Convention (USP) this week announced revised standards for two ingredients widely used in pharmaceuticals as sweetening agents and solvents.

USP is a nonprofit, scientific organization that sets legally recognized standards designating the identity, quality, purity, strength and consistency of prescription and over-the-counter medications and their ingredients in the United States. These standards are enforced by the U.S. Food and Drug Administration (FDA).

The revisions respond to a request from FDA to revise the USP Propylene Glycol and Sorbitol Solution standards to include limits for diethylene glycol (DEG) to help prevent future episodes of pharmaceutical adulterations with this poisonous chemical. DEG is commonly used in antifreeze and has no legitimate place in medicines.

DEG historically has been substituted for Glycerin with deadly results.
Adulterations of cough syrups and other products with DEG have occurred many times and in many countries, including a tragic episode between November 2008 and January 2009 in which 84 children in Nigeria died after ingesting teething syrup contaminated with DEG. A similar episode occurred in July 2009 in Bangladesh, killing at least 24 children.

To view the press release from USP visit: http://www.eurekalert.org/pub_releases/2009-10/up-ntf103009.php

For more information, visit www.usp.org/hottopics/propyleneGlycolSorbitolInformation.html or email mediarelations@usp.org.

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…

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.

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.

Counterfeit Drugs: An International Safety Problem

In the current economic crisis, it seems counterfeits and knock-offs are on the rise. In the case of counterfeit or adulterated drugs, this causes a real safety issue. If the medication does not contain the correct amount of the active pharmaceutical ingredient (API), it may not be effective or may cause undesirable and sometimes very dangerous adverse reactions. Also any inexpensive substituted filler ingredients that the counterfeiters may use, are used for appearance only and can turn what was meant to be a remedy for the patient into a poison.

We at XStream Systems encourage all throughout the pharmaceutical distribution cycle to screen their products through molecular pharmaceutical authentication. By ensuring that the products that pass through your hands are genuine, you are doing your part to protect the public health.

The Limitations of Track and Trace Technologies in Fighting Counterfeit Drugs

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

To date, nearly all of the solutions for the global epidemic of counterfeit and adulterated drugs has emphasized technologies that are known as Track and Trace methods (e.g. barcodes, holograms, RFID, pedigree, taggants, and serialization).

Track and Trace methods were developed and are based on technology designed for inventory control/security and are common within most sophisticated supply chains. These solutions are very effective in tracking product, especially in direct or short supply chains, where the additional cost can be justified in their inventory control capabilities because the members of the supply chain use common systems and tools for tracking, distribution and sales.

That being said, Track and Trace solutions have their limitations:

• They generally require some sort of an addition to the outside of the box or package and a common technology to be read and documented.


• These processes and technologies add additional cost to the product and are difficult to maintain across large global supply chains.


• Because of its external placement of these methods on the material’s packaging, the Track and Trace item may be easily replicated, and, at the very least, does not verify that the material inside the package is safe and efficacious.

The costs for a global supply chain to implement Track and Trace solutions are staggering. According to an EU Commission Consultant, the initial cost for deploying a Mass Serialization pharmaceutical program in the European Union would include:

• An industry wide one-time cost of €11.5 billion to set up the proper systems within all members of the pharmaceutical supply chain in Europe.


• Annual “running costs” for serialization with European pharmaceutical companies to be €185.5 million for non-OTC companies.


• EU pharmacies would incur costs of installing the right IT and reading devices to support serialization estimated to be approximately €157 million, with no estimates on the annual costs of running the system.

Although Track and Trace solutions are useful to a point, they are significantly limited in their effectiveness. When additional costs to all members of the supply chain are added, they include significant changes to the manufacturing, packaging and distribution processes. Additionally, as we have seen lately, many of the incidents of substandard, fraudulent and counterfeit product all had perfect pedigrees and their packaging was either original or perfect facsimiles.

The best way to effectively purge the pharmaceutical supply chain of poor quality, fraudulent or counterfeit medications is to look inside the box to screen, verify and authenticate the product inside the package.

Ideally, a quality control and anti-counterfeit solution for the pharmaceutical supply chain would not require any alterations to the product or the package. The remedy would allow packaged drugs to remain intact and will be readily deployable. The placement of the testing unit could be at strategic points within the supply chain or deployed throughout without onerous costs or prohibitive timelines.
This new cure would provide a level of confidence that public safety is ensured by verifying the material inside the package.

We at XStream Systems are very excited about our technology which meets the needs as an effective quality control and anti-counterfeit technology solution for the pharmaceutical supply chain. The XT250 system allows the members of the pharmaceutical supply chain to screen and verify the contents of product inside its unit of sale container without opening it, changing its label, or destroying or degrading the material inside.

To learn more about XStream’s XT250 and its revolutionary technology, visit: http://www.xstreamsystems.net/.

Counterfeit Malaria Drugs Responsible for Thousands of Deaths throughout Africa

According to the September 13th issue of Media Global, a global media outlet based in the United Nations Secretariat, the World Health Organization has revealed some disturbing statistics as it relates to the deathly impact of counterfeit medications in Africa. Some of the most revealing and interesting portions of the article are:

• The World Health Organization (WHO) has increased efforts to fight the distribution and manufacture of counterfeit malaria drugs in Africa.



• According to the World Health Organization, upwards of 2,000 children per day die as a result of taking these counterfeits medications.



• Due to their high demand and price, malaria drugs are a prime target for counterfeiters.



• Many of these counterfeits contain little to no active ingredients or even the wrong active ingredient. The active ingredient may temporarily soothe the symptoms but have no real effect on the disease itself.



• "There is usually a low amount of active ingredient, like the pain reliever paracetamol, in fake malaria medications,” according to Dr. Lembit Rago, Coordinator of WHO Essential Medicines and Pharmaceutical Policies," in order to “cheat qualitative screening tests that just react to the presence of certain actives, and thus may mimic false positive results.”

Although known to many within global health organizations and those with insight into the issue of counterfeiting the death toll and scope of the issue is nonetheless shocking. The insidious nature of counterfeit drugs and the cost in human life should be galvanizing and accelerating industry and governments around the globe to combat this plague before it continues its proliferation around the globe.

XStream Systems and its EDXRD technology offer a solution to this issue by being able to screen and test materials within their unit of sale, penetrating through the packaging and being able to do a complete molecular screening of the product (active ingredients, excipients, dosage) without destroying or degrading the medication.

To read the Media Global article, ("Counterfeit Malaria Drugs Kill Thousands in Africa," Media Global, September 13, 2009), visit: mediaglobal.org.

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

UPS Supply Chain Survey: Nearly Half Worry about Product Tampering and Counterfeiting

In UPS’s 2nd Annual Supply Chain Survey, conducted by Harris Interactive, there was a somewhat surprising discovery as it relates to fraudulent and counterfeit products in the supply chain.

The survey was reported in the June 2009 issue of Pharmaceutical Commerce.

In the survey, decision makers at bio-pharma and med device companies were asked a variety of questions to identify supply chain issues beyond simple transportation and delivery.

The somewhat surprising discovery was that 48% of the large company respondents (companies with revenues in excess of $1 billion annually) while 34% of smaller companies, listed product tampering and counterfeiting as one of their biggest supply chain concerns for the year.

Pharmaceutical Commerce is quoted in the June 2009 issue:

It is worth noting that nearly half (48%) of large-company respondents cited product tampering and counterfeiting as a concern, which belies the relatively quieter scene in drug pedigree, tracking and tracing as a result of the postponement of the pedigree rules in California.

This survey validates much of what XStream Systems is finding in the pharmaceutical supply chain as well. Although much of the pressure has been lifted from the delayed pedigree rules, there is a realization among decision makers that there remains a significant amount of stress with few solutions within the supply chain as it relates to fraudulent, tampered and counterfeit product. To date many key executives have seemingly ignored the threat of increased liability and brand erosion because they have few if any solutions to adequately meet the issue. Pedigree and track and trace technologies although mandated in specific states, provides minimal protection against diverted products but do nothing to decrease their liability and protect their inventories from counterfeiting or tampered products.

XStream Systems, with its revolutionary EDXRD technologies, has a technology solution that enhances the ability of the members of the supply chain to authenticate the product, within its sealed container, without destroying or degrading the medication. This solution, allows the user to authenticate and verify the contents of the product, not just the package and properly secure their inventories and overall liability.

To read the June 2009 article in Pharmaceutical Commerce, visit: http://www.pharmaceuticalcommerce.com/frontEnd/main.php?idSeccion=1239.

To learn more about XStream Systems and it solution, visit: http://www.xstreamsystems.net/.