How Common are Counterfeit Drugs?

That is the question. The World Health Organization estimates that 10% of the world 's supply of medicines are counterfeit, but the density of counterfeits vary from region to region. Some areas are estimated at as low as 1% - 3% while other areas may have up to 60% counterfeits for certain medications.

Most statistical data given is based on arrests, raids and seizures within a country or region. These are the cold hard facts, but most authorities believe these cold hard facts are but a small piece in the overall picture - just "the tip of the iceberg".

Euractive.com: Commission Slammed Over Internet Medicines

According to Euractive.com:

The Minister responsible for steering the Counterfeit Medicines Directive through the European Parliament has lashed out at the EU executive for failing to include online sales in the scope of the proposal.

Adamos Adamou (GUE/NGL, Cyprus) described the Internet as a "Trojan horse" in the medicines supply chain that the Commission has left the Parliament to deal with.

He said there were a number of flaws in the proposed directive, including the failure to provide a definition of counterfeit medicines and the omission of excipients such as the capsules used to package active ingredients.

Adamou said he had drafted amendments which would extend the scope of the directive to include over-the-counter medicines and to harmonize safety features on medicine packaging.

"Today, there is no guarantee of buying safe medicines. Counterfeit medicines are a form of terrorism against human health. It doesn't matter whether a pill contains sugar or poison. If the safety is compromised, so is our health," he said.

To View entire piece, visit: www.euractiv.com.

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.

Uganda Health News: Interpol Impounds 200 Cartons of Counterfeit Drugs

A joint operation conducted by the Interpol and the Ugandan National Drug Authority against counterfeit drugs have started yielding good results.

The operation has discovered 200 cartons of fake drugs in Central and eastern districts of Uganda.

The operation, code named Mamba 2, was carried out on selected medical drugs such as metakelfin and quinine, by separating them for preliminary laboratory analysis.

The Mamba 2 operation focused on regional operations in Eastern Uganda registering cases in Mbale, Jinja, Iganga, Kamuli and Busia.

Wakiso, Masaka and Mpigi were among the districts in Central region that were cited in the fake drug scam.

The head of Interpol in Uganda, Fred Kiyaga says the two agencies also managed to impound 200 cartons of fake drugs, 38 cases were registered and 19 suspects apprehended in connection with selling fake drugs.

To view entire article visit: http://www.ugpulse.com/articles/daily/news.asp?about=Interpo+impounds+200+cartons+of+counterfeit+drugs+in+Uganda+&ID=11798.

Dey Labs: Update on Stolen Albuterol Sulfate Inhalation Solution

As posted on the FDA Website and as a service to those interested in combating fraudulent, adulterated and counterfeit medications, the following is an announcement from Dey Labs:

In keeping with its commitment to “Put Patients First,” Dey, L.P. (“Dey’) would like to take this opportunity to inform its healthcare partners regarding a recent occurrence of stolen medication.

On or about August 6, 2009, a truck tractor-trailer which was not affiliated with Dey, containing 35,760 cartons of Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials was stolen. The truck theft occurred in the town of McKinney Texas.

The tractor-trailer contained two (2) complete Lots of product, each identified with the Dey label and NDC number. The specific product information is as follows:

Product Description:Albuterol Sulfate Inhalation Solution 0.083% 30-vials per carton (Product NDC #49502-697-29)

OT #	CARTON QUANTITY				Lot Expiration Date
9FE2	17,712				June 2011
9G01	18,048				July 2011

These two Lot numbers were not available commercially prior to the theft. All of the product cartons in these two Lots were stolen. Therefore, no vial or carton of either Lot is part of the legitimate pharmaceutical supply chain.

Pharmacies are encouraged to verify pedigree documentation for all purchases of Dey labeled Albuterol Sulfate, 0.083%, 30-vial cartons and product with either of these two Lots numbers should not be sold, distributed or dispensed.

If you have any information regarding the theft of these two Lots, or if you receive any suspicious or unsolicited offers for the Albuterol in question, please contact the Food and Drug Administration (“FDA”) Office of Criminal Investigations (“OCI”) by calling 1-800-551-3989.

For Customer Service inquiries, contact Dey, L.P. Customer Service at 1-800-527-4278.

For medical or other clinically related inquiries about this matter, contact Dey’s Senior Vice President of Quality Systems at 1-800-755-5560, ext. 2476.

IBM Study: Pharma Executives Concerned About Supply Chain Safety

Supply chain executives at pharmaceutical and life sciences companies are increasingly concerned about the risk of counterfeit drugs and contaminated medications amid the complexity of global manufacturing, according to an IBM study.

In a September 9th, press release by IBM, the company describes how they conducted a study which surveyed executives at pharmaceutical, biotechnology, medical device and consumer health care industry companies who are responsible for planning, logistics, procurement and coordination throughout the life of a drug or medical device. Here are some of the key findings from the study:

• Reducing the risk of counterfeit drugs and contaminated medications amidst the complexity of global manufacturing are among the top concerns of the pharmaceutical and life sciences industries today.
• Tracking every step of how drugs are manufactured and distributed are key priorities for more than 70 percent of companies.


• Monitoring risk to prevent counterfeiting, drug and device recalls, or even the loss of intellectual property, is a priority for 75 percent of executives, as margins become slimmer and supply chain complexity rises. Three-quarters have risk and performance initiatives such as surveillance programs, anti-tamper devices and specialized labeling, but with mixed results.


• 46 percent consider vendor-managed inventory for their customers extremely effective but only 4 percent use it to ensure they are precisely meeting customer demands for products.


• Compared to 18 other key industries, the life sciences business is one of the most highly globalized, particularly in the area of Research and Development. From a supply chain perspective, the industry is not as advanced. In general, global sourcing brings with it challenges including daunting capacity, quality, lead times and delivery issues.


• For the life sciences industry, seventy-six percent of respondents suffer quality issues linked to global sourcing while nearly fifty percent reported increased sales from their globalization efforts due to the growing population of consumers in rapidly developing markets.


• "As the industry faces a time of transition, supply chain executives are outsourcing more business processes, turning to emerging markets and becoming more globally integrated, all while actively managing risk," said Dr. Philippe Cini, IBM Global Business Services, Life Sciences Supply Chain Management Partner.


• Counterfeiting is one of the biggest risks facing the pharmaceutical industry today. According to the World Health Organization, approximately 10 percent of the worldwide drug supply is counterfeit. To combat such risks, sophisticated simulations and data models help companies calculate risk, and building intelligence into products and packaging such as barcodes, RFID tags and other smart devices, supply chain executives can prevent theft. This type of new intelligence along with e-pedigree and track-and-trace capabilities also enables the entire supply chain to respond quickly in the event of a recall.

The study -- "The Smarter Supply Chain of the Future: Life Sciences Edition" -- was developed by IBM Global Business Services' Supply Chain Management Practice in conjunction with the IBM Institute for Business Value, which develops fact-based strategic insights for senior business executives.

While XStream endorses this study, much of IBM’s conclusions regarding the solution to supply chain safety center on taggants and smart track and trace solutions. XStream acknowledges that these are a part of the overall solution but also believes that it is also crucial for the entire supply chain to incorporate materials authentication and verification into an entire suite of solutions to monitor quality, handling, fraud and counterfeiting. Sophisticated supply chains not only require knowing where a product has been, but what is in package.

To view the press release visit: www-03.ibm.com/press/us/en/pressrelease/28352.wss
To learn more about XStream Systems’ solutions, visit: http://www.xstreamsystems.net/

India: Blowing the Whistle on Fake Drugs

In the August 30th issue of Telegraph India, the Union health minister, Ghulam Nabi Azad, was reported as announcing a “whistle blower policy”, aimed at encouraging the common man to provide information about the manufacture of fake drugs

• Based on the information gathered by the Central Drugs Standard Control Organization, the office of the Drug Controller General of India raids places suspected of manufacturing or selling such drugs


• The tip-off often comes from a member of the general public


• The government hopes that a cash reward will lead to more people coming forward with such information.

To view the article visit: www.telegraphindia.com.