in-Pharma Technologist: Sanofi Works to Secure Egyptian Drug Supply Chain

French drug maker Sanofi-Aventis continues to spearhead the fight for a more secure pharmaceutical supply chain by launching an anti-counterfeit medication initiative in Egypt

Wai Lang Chu on June 23rd posted a story on in-Pharma Technologist about the mega Pharma manufacturer working within Egyptian authorities on addressing and countering the growing problem of drug manufacturing infiltration and drug counterfeiting in Egypt.

The following are some of the highlights of the posting:

· The move (by Sanofi) is the first of a three-phase initiative undertaken by the drug company and the Egyptian Ministry of Health to try to address and counter the growing problem of drug manufacturing infiltration and medicine counterfeiting in the country.
· Under the new project, Sanofi have worked alongside the country’s authorities providing them with guidance and training on the latest techniques in identifying counterfeit medication.
· Staff from Sanofi led an Egyptian delegation including officials from the Ministry of Health, the Customs Authority and the Ministry of Interior's Anti-smuggling Unit from the Ministry of Finance, to its Central Anti-Counterfeit Laboratory based in Tours, France.
· The delegation also visited the Customs Authority located in Le Havre to examine its anti-smuggling measures before visiting the French Ministry of Health.
· Over the last couple of years Sanofi have been making significant ground on tackling the problem of counterfeit drugs. Its Tours laboratories, opened in 2008, are the first of its kind and illustrate the measures pharma companies have to go to in order to secure it manufacturing and worldwide production capabilities.
· For example, Sanofi’s laboratories routinely conduct direct examinations of packaging items and leaflets as well as definitive chemical tests on suspect samples of commonly counterfeited products.
· Staff at the lab have developed test methods, distributing them globally in order to allow industrial plants to inspect and test, with the same criteria, the suspect products corresponding to those manufactured by Sanofi-Aventis.
· The drug firm have also introduced centralised ‘Identity Cards’ for the counterfeit drugs found, in a single, central data base, to make it possible to compare different types of counterfeit. · Sanofi’s collaboration with Egypt is part of efforts by its Government to tackle a problem that is picked up on globally and tarnishes the county’s reputation. Data from Business Monitor International (BMI) has identified Egypt as having made significant progress in tackling the counterfeit drug problem in the last two years.

Secure Pharma Chain Blog endorses the joint effort of industry and regulatory authorities working together to solve this insidious, deadly criminal act and encourages all members of the global pharmaceutical chain to work closely with government agencies in their anti-counterfeiting efforts.

The most effective processes to interdict fraud, adulteration and counterfeit medications includes a multi-layered approach of authentication technology solutions within the supply chain from production to dispensing.

It will take all members of the pharmaceutical supply chain, working together to solve this deadly crime to the consumer. No single link in the chain can effectively or successfully eradicate bogus drugs by itself.

To read the entire in-Pharma Technologist story, visit: http://www.in-pharmatechnologist.com/Industry-Drivers/Sanofi-works-to-secure-Egyptian-drug-supply-chain/?c=qendTuKNp6H%2BO0zFmrXycw%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily.

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

MHRA Press Release: £150,000 Fake Drug Stash Seized in Sting Operation

MHRA, the United Kingdom’s agency responsible medicines and medical devices work, released a press announcement regarding a large seizure of counterfeit, unlicensed medicines and controlled drugs in London on June 9th.

The following is the Press Release from MHRA:

Counterfeit and unlicensed medicines, along with controlled drugs to the street value of approximately £150,000, were seized by the MHRA yesterday as part of a simultaneous raid on six locations across London, and two in Yorkshire with the assistance of local police.

Six people in the UK believed to be linked to a gang in Asia were arrested in connection with the illegal sale and supply of a range of medicinal products, most of which are suspected to be counterfeit.

Information was initially passed to the MHRA by pharmaceutical manufacturers Pfizer, Lilly and Sanofi-Aventis.

MHRA Head of Intelligence Nimo Ahmed said, “Large boxes containing counterfeit and unlicensed medicines together with packaging, computers and cash were seized and the suspect medicines will now be sent to government laboratories to assess their authenticity.

“The products seized relate to treatment for depression, erectile dysfunction, as well as painkillers, sedatives and injectable anabolic steroids.

“At this stage it is suspected that these medicines would have been supplied illegally over the internet.”

Mr. Ahmed said people should be vigilant when buying medicines online and should only do so from registered websites that clearly display a contact name, number, the logo from the Royal Pharmaceutical Society of Great Britain (RPSGB), and from premises that are registered with the RPSGB. Buying medicines from unregistered websites is dangerous as people would not know what they are actually taking. The dosages could be either too high or too low, or worse, the tablet could contain harmful ingredients.

“Better still, the safest way to obtain Prescription Only Medicines is from a ‘bricks and mortar’ pharmacy following a consultation with a GP or a healthcare professional,” he said.

“Those involved in this type of criminality do not care about your health. They are only in it for one reason, and that is to make money.”

The MHRA are grateful for the assistance provided by the Metropolitan Police, West Yorkshire Police, South Yorkshire Police and the pharmaceutical manufacturers in this case.

This seizure is an excellent example of the continued proliferation of counterfeit medications within developed countries and sophisticated pharmaceutical supply chains. Since 2006 the MHRA has seized more than £6 million worth of counterfeit medicines.

Secure Pharma Chain Blog endorses continued regulation and enforcement related to fraudulent, adulterated and counterfeit medications and encourages all within the supply chain, including regulatory agencies to deploy solutions and technologies to protect their inventories and consumers from the deadly effects of this criminal act.

To read the entire Press Release on the MHRA website, visit: http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON084731.

To learn more about anti-counterfeiting technologies, visit: www.xstreamsystems.net.

Chain of Custody Dilemma: Recovering Stolen Pharma Products

By: Alan Clock, Senior Vice President, XStream Systems

What happens to pharmaceutical products that are recovered intact, meaning in their original packaging or shipping containers, following a theft or high jacking?

According to most experts, the policy of Pharma companies is to destroy these recovered products because they have broken the chain of custody or transaction. The logic is that no one wants to assume the liability of the efficacy of the products because they are uncertain if the products were affected or somehow altered during their time spent outside of legitimate charge.

This is an obviously an expensive and wasteful expense especially if there is a technology available that would allow the supply chain to test these products, within their sealed, unit-of-sale container. A technology that will verify that the material inside is safe and has not been altered, tampered or somehow counterfeited without destroying or degrading the drug.

Recent statistics are showing a significant surge in criminal organizations targeting Pharma products within the pharmaceutical supply chain (manufacturer, distributor, dispenser and consumer). These groups are stealing large shipments; in transit to sell within gray or black markets for significant profits. Fortunately as the problem escalates, law enforcement and security often are recovering or interdicting these criminal acts quickly.

The following are some recent examples:

- Polish police have recovered eleven tons of human blood plasma that had been stolen at a truck rest stop in Germany while in transit to Austria. The owner of the plasma, BioLife Plasma Services, a subsidiary of Baxter International, valued the shipment at around $1.4m. All of the product had been recovered in its original boxes and packaging.

- Police recovered intact a shipment of Alcon Labs and Teva Pharmaceutical products, stolen on February 22. The value of the shipment has not been disclosed but included 70 pallets of assorted prescription, over-the-counter and personal healthcare products.

- A pharmaceutical shipment including products valued at over $500,000 belonging to Sanofi-Aventis was hijacked in Puerto Rico on January 29. A wide range of prescription medicines and vaccines was taken in the incident.

- AstraZeneca lost in transit, a FedEx shipment in late December/early January. The total value of the shipment, which included Casodex, Seroquel, Nexium, Toprol XL and Crestor and Zomig was in excess of $500,000.

As it stands today, even with the product recovered intact and within its original containers the product will be slated for destruction because of the lost chain of custody. However there is a readily available technology solution.

The most effective way to effectively know that the lost chain of custody has not impacted the quality, efficacy or somehow adulterated the stolen medications is to look inside the sealed container to screen, verify and authenticate the product inside the package.

An ideal solution, it allows packaged drugs to remain intact and is readily available to test products once they are retrieved. This technology provides a level of confidence that the temporary loss of chain of custody has not altered the product and that public safety is ensured.

XStream System’s technology solution is the ideal solution for the pharmaceutical industry's chain of custody challenge by using Energy Dispersive X-Ray Diffraction (EDXRD). This innovative technology allows the user to molecularly screen the product inside its original container without destroying or degrading the product.

This solution transforms the process from looking at the chain of custody and/or transaction to looking inside the packaging with Molecular Screening. Ultimately, this truly provides all of the members of the supply chain, from manufacturer to consumer, the confidence to know that the medications in their inventories or supply chain are safe and efficacious.

EDXRD solutions function by matching the diffraction pattern obtained by the instrument with a library of patterns previously obtained for comparison. The EDXRD diffracted spectral patterns of crystalline substances are markedly different, even to an untrained eye. Much like a human fingerprint, although there may be a few features that are common to both patterns, they are nonetheless very different. In current iterations of the technology, which is fitted with a computer-based detection device, the system relies on a sophisticated mathematical algorithm to extract a unique feature set from the pattern and use them to identify the material giving rise to that pattern.

In general, the EDXRD methods are highly material specific, since the diffraction patterns of crystalline materials are unique. As it relates to pharmaceuticals, the signature of diffracted aspirin is very different from ibuprofen, acetaminophen, codeine, etc. Equally important is the fact that the diffracted patterns of the excipients specific to the unique recipe of the formulation are unique and one can determine differences in manufacturer, packaging, dosage, etc. For example, acetaminophen, 325mg from one vendor, will differ from acetaminophen 325mg from another vendor unless they follow the exact same recipe, density, pill configuration and utilize the exact same packaging.

This material sensitivity of EDXRD has two important ramifications - high detection/verification rates and low false alarm rates. Under ideal conditions (i.e. - low absorption and high test mass), the detection rate is close to 100% and the false alarm rate is 0.1% or lower. In addition because it uses X-Ray, EDXRD technology can penetrate through nearly all plastics, cardboard, wood and metals in order to screen the material.

XStream Systems has succeeded in establishing EDXRD as a robust Molecular Screening tool that can be used within the supply chain. XStream has conceptualized and architected the world’s first countertop EDXRD machine, the XT250 Material Identification System.

The XT250 has turned a complex technology into an easy to operate solution for the average end user. The XT250 system is now fully deployed in drug wholesalers, pharmaceutical manufacturers and pharmaceutical reverse logistics companies. The system is designed to be used either in a standalone or integrated capacity anywhere along the supply chain; the deployment can be in a warehouse setting and operated by a non-technical warehouse worker.

With the XT250, there no longer needs to be the very expensive and wasteful dilemma of product destruction because the product has lost its chain of custody. Because the XT250 can authenticate products non-destructively, will no longer be incumbent on the supply chain to absorb multi-million dollar losses as the threat of cargo theft proliferates.

To learn more about XStream Systems, material identification solutions, visit: http://www.xstreamsystems.net/.

RxPatrol Alert: Drug Cargo Theft in Puerto Rico

RxPatrol has reported about a recent pharmaceutical cargo theft that occurred on January 29th in Bayamon, Puerto Rico.

An unmarked truck and driver was high jacked at gun point near an industrial area and taken to a different town and put out of the vehicle. Ultimately the truck was left nearby and was recovered without the shipment.

The high jacked shipment was a delivery of drugs valued at $516,412 that was being shipped from Cesar Castillo to Borshow Drug. The items were the property of Sanofi Aventis

The stolen drugs included:
• 48 bottles of 100 ct. Ambien CR Tablets 6.25mg.
• 1,000 units of Lantus injection Vials

According to RxPatrol, for further information, law enforcement and other interested parties should contact the Puerto Rico Police, Detective Edward Rodriguez assigned, phone # 787-269-2030 or 787-269-4140. Incident # 2010-232-593.

Douglas Liptak is the security contact for Sanofi Aventis, phone # 908-981-4510

To learn more about RxPatrol and its various reports on pharmaceutical safety, visit: http://www.rxpatrol.com/

To learn more about pharmaceutical supply chain safety technology, visit: http://www.xstreamsystems.net/.

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

Thieves Hijack $8.8m in Sanofi-Aventis Products

As reported by the Associated Press and SecuringPharma.com, authorities are investigating the reported theft of a tractor-trailer carrying approximately $8.8 million in pharmaceutical drugs from a truck stop in Temple, Georgia.

The July theft, at the Pilot Truck Stop was a shipment of Sanofi-Aventis products which included blood thinners and cold and nasal medicine. It was the second theft of an entire truck at this particular truck stop in recent months.

SecuringPharma.com quotes Freightwatch International (FWI) which indicates that “in 2008 pharmaceutical thefts in the USA rose by a third, with criminals actively targeting drug shipments on an unprecedented scale”

The US Food and Drug Administration (FDA) said it has asked for help from pharmaceutical drug distributors and pharmacies, which may have received unsolicited or suspicious offers for the Sanofi-Aventis drug products, in tracing the stolen batches. They also urge those involved in the pharmaceutical supply chain to verify pedigrees received with any wholesale drug purchases.

XStream Systems encourages distributors and dispensers to verify their transactions via pedigree but also to properly screen their receivables and returns to authenticate the medications inside the packaging.

“FDA is committed to protecting the public from receiving stolen drug products that may not have been stored and handled properly and may be dangerous for patients to use,” said the agency in a statement.

Full details of the batch and lot numbers are as follows:

LOVENOX 120MG - batch/lot numbers: 12210, 12221, and 12218
LOVENOX 30MG - batch/lot number: 29395
LOVENOX 80MG - batch/lot number: 28534
XYZAL 5MG - batch/lot number: 8047787
NASACORT AQ 16.5G - batch/lot number: N09108A
BENZACLIN GEL 50G PUMP - batch/lot number: 8047564

For the full story from SecuringPharma visit: SecuringPharma.com

"Drug counterfeiting underestimated for too long..." states the Chairman of Sanofi-Aventis

As reported by the Dow Jones News Service, "Drug counterfeiting has been underestimated for too long, Sanofi-Aventis Chairman said Thursday, also calling for more action from the European Union."

At the annual meeting of the European Federation of Pharmaceutical Industries and Associations, Jean-Francois Dehecq said that "drug counterfeiting 'used to be marginal, it is now totally industrialized.'" Counterfeit pharmaceuticals "represented approximately EUR45 billion in sales in 2006, making up for almost 10 percent of the world pharmaceutical market the World Health Organization estimates.

Link to the full story at Dow Jones.