Fake Flu Vaccine Warning in the Philippines

The Philippines Daily Inquirer ran the following story about Bureau of Food and Drugs warning consumers and pharmacy providers about a fake flu vaccine.

As previously warned in the blog, it is anticipated that the incidents of counterfeit and fraudulent vaccines and anti-viral medications will grow as the H1N1 epidemic continues throughout the flu seasons globally.

XStream cautions all members of the pharmaceutical supply chain to all transactional and verification procedures available to properly authenticate their inventories while warning all consumers to purchase medications only from legitimate, licensed pharmacies.

Bureau of Food and Drugs Warn Public vs Flu Vaccine Imitation

MANILA, Philippines (07/29/2009) – (UPDATE) The Bureau of Food and Drugs (BFAD) warned the public and drugstore owners against a fake flu vaccine using the brand name Vaxigrip.

"Reports have it that this flu vaccine purportedly contains only distilled water," the BFAD said in a public health advisory dated July 28, but issued only on Wednesday.

"In view of these (news) reports, the BFAD strongly warns all drugstore owners and their pharmacists to exercise due diligence in buying this vaccine and any other drugs and medicines" from the manufacturers of Vaxigrip, the BFAD stated in its advisory.

“Finally, all consumers are advised to purchase vaccines and other drugs and medicines only from outlets duly licensed by BFAD and to demand receipts as well,” BFAD continued.

It asked the public to report cases of counterfeit drugs to BFAD’s Regulation Division at 809-4390 local 1131.

To view article visit: newsinfo.inquirer.net

Bi-Annual Cargo Theft Report: Value of Pharmaceutical Cargo Theft Has Skyrocketed in the First Half of 2009

FreightWatch International (USA), an international logistics security company, whose expertise is in identifying threats and vulnerabilities to high-value supply and distribution chains, publishes a Bi-Annual Cargo Theft Report that contains some very interesting statistics and observations.

The Bi-Annual Cargo Theft Report is available on-line and outlines statistics and vulnerabilities of various supply chains, specifically reporting on pharmaceutical cargo theft incidents.

As you read through the Cargo Theft Report it is striking how sophisticated and prevalent cargo theft has become. Additionally as it relates to the domestic pharmaceutical supply chain it is illuminating on how cargo theft can impact the amount of fraudulent, counterfeit and adulterated medications within our medication supply.

The following are some striking statistics from January to June 2009 as it relates to the pharmaceutical cargo theft incidents:

• The first six months of 2009 has seen a decrease in cargo theft incidents involving pharmaceuticals from 25 reported incidents in 2008 to 14 incidents in 2009. However, the total value of pharmaceutical products lost as a result of cargo theft has skyrocketed in the first half of 2009.


• From January to June 2009 over $73,000,000 in pharmaceutical products has been stolen. One loss was valued at $37 million, which was subsequently recovered, however, not after the chain of custody was broken for a short period of time.


• The average pharmaceutical loss for the first six months in 2009 is $6,712,500 per theft, a tremendous increase from 2008’s six month average of $704,685 per theft.

Both in 2008 and 2009, the vast majority of pharmaceutical thefts occurred on the East and South Eastern U.S., particularly along major interstate highways as well as in Florida.

The statistics and relevance of this Report supports XStream Systems’ assertion that it is important that pharmaceutical inventories be screened through a level of material verification that is available via our XT250 and its revolutionary EDXRD technology. This exciting technology allows the XT250 to authenticate pharmaceuticals inside their unit of sale containers without destroying or degrading the medication inside.

With so many millions lost each month in cargo theft and presumably re-introduced into the supply chain at various points, it is critical that the provider and consumer are assured that the medications they are taking are safe and effective.

To learn more about FreightWatch’s services or to view the entire Bi-Annual Cargo Theft Report January-June 2009, visit their website at www.freightwatchusa.com.

Drug Counterfeiting Burden Remains a Guess, Experts Say

In the July 15 edition of AJHP News, Kate Traynor writes an excellent article regarding the proliferation of counterfeit medications and experts opinions on the solid data as to the scope of the problem.

This article highlights the difficulties in sizing and dealing with this ever growing healthcare issue. XStream Systems believes that its XT250 Materials Identification technology, which allows the user to screen and verify the contents of a medication inside its unit of sale container, will be a significant contributor to both understanding the scope and defeating counterfeit medications within the supply chain.

In this article Traynor includes quotes and statistics from government and industry experts including Ilsa Bernstein from the FDA, World Health Organization, IMPACT, Patrick Ford from Pfizer and Jeffery Gren from the Office of Health and Consumer Goods at the U.S. Department of Commerce.

Several of the quotes from the article include:

• FDA’s Ilsa Bernstein from a June 10th seminar on fake medicines, "People are always asking us for numbers of how many counterfeits are in the Unites States," said Ilisa Bernstein, director of pharmacy affairs in FDA's Office of the Commissioner. "We have no idea what the prevalence of counterfeiting is in the United States."


• Patrick Ford, Senior Director of Global Security at Pfizer, Ford said Pfizer last year seized more than 11 million counterfeit tablets, capsules, and vials masquerading as trademarked Pfizer products, including more than 2 million units seized in the Americas. Despite the company's actions, Ford said, there likely remain "a lot of patients that took these products and didn't even know that they were counterfeit."


• Jeffrey Gren, Director of the Office of Health and Consumer Goods at the U.S. Department of Commerce, said “The profit levels in counterfeiting are enormous and much greater than narcotics, and...The penalties are significantly less," Gren said. In addition, he said, the Internet has provided "an easy and lucrative way" for counterfeiters to distribute their products. Gren said that although some counterfeiters run fly-by-night operations, others have sophisticated factories capable of making medications that are difficult to visually distinguish from legitimate products.
  

To read the article in its entirety connect to the link below:
http://www.ashp.org/import/news/HealthSystemPharmacyNews/newsarticle.aspx?id=3115

Indian Drugmakers Seen as Benefiting from Increased FDA Regulation

The Wednesday, July 29th edition of the Wall Street Journal reports that Indian generic drug makers are most likely to benefit in the long run because of increased FDA Regulation and scrutiny. The Journal sites sources that predict that with this scrutiny by the FDA these manufacturers will be in a better position than their rivals in the United States or China when over $100 billion drugs go off patent in the next five years. Indian manufacturers have over 107 FDA approved manufacturing plants which is the highest number outside of the United States.

To read the entire story online: http://online.wsj.com/article/SB124876915285586265.html.

XStream Systems speculates that drug makers and importers/exporters globally can mitigate this advantage presumably enjoyed by Indian manufacturers by increasing their internal scrutiny and quality control measures by increasing their use of technology as they export pharmaceuticals into developed nations. Technology solutions such as XStream System’s XT250 allow the manufacturer or importer to screen and verify the quality and efficacy of medications post-manufacturer, within the pharmaceutical supply chain and its sealed unit-of-sale container.

FDA Cracks Down on Apotex in Canada

Apotex has experienced a high number of rejected batches and FDA is cracking down on this generic brand company in Toronto. XStream endorses a comprehensive materials analysis process within the supply chain to protect end users to appropriate quality and control.

Canada's Apotex Inc could face a freeze on new drug applications in the United States as well as a ban on products entering the country after the U.S. Food and Drug Administration warned it of a number of
manufacturing breaches at a Toronto factory.

The June 25 warning, which followed a late 2008 inspection of the Etobicoke, Ontario facility, cited a number of manufacturing deviations from U.S. manufacturing codes.

Among the breaches, the agency charged that Apotex did not thoroughly investigate the failure of batches of some drugs and also noted an unusual high number of rejected batches.

To view article visit: www.reuters.com

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

Washington Post: Pelosi Puts Onus on Industry

The following news story from Friday's Washington Post discusses some of the more recent quotes from Nancy Pelosi regarding Health Care Reform. We believe that reforms may impact the quality, cost and access of pharmaceuticals.

Deals Aside, She Says, Hospital and Drug Firms Can Do More

By Lois Romano
Washington Post Staff Writer
Friday, July 24, 2009

House Speaker Nancy Pelosi said Thursday that she doesn't feel bound by the $235 billion in deals that the White House and the Senate Finance Committee cut with hospital and pharmaceutical companies to defray costs of a new health-care plan, stating that she thinks the industries could do more.

"When we're trying to cut costs, certainly we know that there are more costs to be cut in hospitals and pharmaceuticals. . . . So we'll be subjecting everything to some very harsh scrutiny as we see whether we can get more savings," Pelosi said in a late-afternoon interview, shortly after she left a marathon negotiating session with White House Chief of Staff Rahm Emanuel and conservative "Blue Dog" Democrats, who have put the brakes on the House version of the health-care reform bill. "As we look, there may be some more ways to get money out of pharmaceutical companies."
The nation's hospitals have agreed to forgo $155 billion in government health-care reimbursements, and drug companies promised $80 billion, to help keep the cost of President Obama's health-care reform plan under $1 trillion.

Pelosi said she is eager to see the Senate's version, which is currently held up in the Finance Committee, and she indicated she is sympathetic to House Democrats' concerns about voting on a bill before the Senate shows its hand. Conservative Democrats say privately that they worry about being asked to spend political capital by voting for a measure far too liberal for their districts -- when the final bill hashed out by the House and Senate could be dramatically different.

"That's fair. That's fair," she said. "And I don't think the bills will be that dramatically different. Now, we don't know the rest of the Senate proposal, and we're eager to see that, but the House sets the pace at ground zero a good deal of the time."

Asked if she could accept a final bill that didn't have a "public option" -- or government-run health insurance plan -- she said, "I don't think so." "But it has to be a level playing field," she added. "It has to be an option that is administratively sound -- actuarially sound, too -- and that it's sustainable in every way, has to pay back to the government any start-up funds that it has, so that it can be a true competitor and not a subsidized entity."

Pelosi declined to comment on the negotiations, which ended Thursday without a deal.
She dismissed the notion that some House members are skittish about voting for health-care reform because they are already facing a hard time in their districts over their recent votes supporting energy legislation. Republicans have framed that issue as a tax increase.

"The Chinese have an expression: 'Shoot the chickens to scare the monkeys.' They use one issue to scare you on another issue, and I don't think they're scaring our members," she said. "I think they, many of them, are just taking a good, hard look at what is in the [health-care] bill, have we squeezed the cost out that we can, and that's very fair. We all want to do that."

Counterfeit Drug Quote-Like the Wild West

Pat Ford, Pfizer's Senior Director for Global Security, said the situation of counterfeit drugs is "like the Wild West," which poses a particular problem for those dispensing the drugs. "It gets to the point that pharmacists can't tell the difference. That's why we educate them on features in the packaging that help distinguish the real from the fake. And it's not just an international problem, but one unfolding right here in the United States.

ABC News Internet Ventures Sept. 14, 2008 Global Black Market, Potential for Health and Safety Issues Concerns Officials

The World Health Organization estimates Poland spends up to $31.6M USD Annually on Fake Medicine

The following report from Polish Radio estimates the annual spend by Polish consumers on counterfeit products and seizures by customs officials:

Customs officials say that medications are the third most often falsified product, giving the example of the popular sexual enhancement drug Viagra as often being made of Plaster of Paris.

WHO adds that it is particularly easy to purchase false drugs in Poland as one can acquire medication through the internet – on auction sites and on sites who claim to be pharmacies.

According to WHO, Poles spend around 100 million zloty (over $31.6 Million USD) a year on fake medicine – most often on sexual performance, weight loss and psychotropic drugs.

Cases have been regularly reported in the press, however, of Poles being taken for a ride by unscrupulous dealers. Recently a teenager from Silesia took Chinese booster drugs that turned out to contain significant quantities of lead. A resident of Elk, northern Poland, was arrested three weeks ago for selling false sexual enhancement drugs over the internet – made of plaster.

In 2008, Polish customs officials seized over 100,000 false drugs. Medications are the third most often falsified products following cigarettes and electronic devices.

To view article visit: polskieradio.pl

Using Scientific Tools in an International War on Fake Drugs

The July 20th edition of the New York Times published an excellent article written by Thomas Fuller about using mass spectrometers and other forensic laboratory technologies to identify and interdict fraudulent and counterfeit medications.

The article is an excellent source of information on counterfeit drugs and the efforts to use authentication technology as an effective tool in finding and securing international pharmaceutical supply chain.

Laboratory instruments are an excellent resource in gaining granular and exact information on suspect materials and fake medications.

XStream’s XT250 Material Identification solution like these laboratory technologies has proven to be an effective tool in identifying fake medication but has been developed to be deployed within the supply chain and used by a non-technical resource for instant and exact information on suspected product. The XT250 does not require the destruction of the material and allows the testing of the material inside its sealed unit-of-sale container so that material found to be good can remain in the supply chain and go onto the consumer. To find out more about XStream’s revolutionary technology visit our website at www.xstreamsystems.net.

XStream endorses all technologies used in the fight against counterfeit drugs because we realize that there is no one solution to protect the vital health care supply chain.
To read the Thomas Fuller’s article please follow the link:

http://www.nytimes.com/2009/07/21/science/21coun.htl?pagewanted=1&_r=1&emc=eta1

Why We Need A Suite of Solutions To Secure the Pharmaceutical Supply Chain — Now!

By: Alan Clock, Senior Vice President, XStream Systems

Gary Noon the CEO of Aegate, argues the case for mass serialization in an editorial titled “Why We Need Mass Serialization – Now!” which appeared in the June issue of Pharmacy Technology Europe. In this article, Noon explains why point of dispensing drug authentication is not only a guarantee of medicine integrity, but also a beneficial and cost-effective solution for the pharmaceutical industry.


Noon cites many compelling statistics in his piece, most of these are statistics are centered on the European medication supply chain but their points are global:

• Approximately 1.5 million counterfeit medicine packs enter the legal supply chain each year — in other words; one pack in every 20,000 is counterfeit.
• Between now and 2020, the spread of counterfeit drugs is estimated to rise to either an 'optimistic' 19.5 million or a pessimistic 192 million packs in the legal supply chain.

Noon also correctly points out the danger of products that hit the legitimate market and the costs:

• In 2005, 2,500 packets of fake Lipitor, Pfizer's widely used anti-cholesterol medicine, were believed to have entered the UK market. Research by Frost & Sullivan estimates that fewer than 15% of the packs were recovered. Aside from the potential danger to patients this inability to effectively recall drugs poses, the damage to the reputations of individual manufacturers and to the industry as a whole is vast.
• According to the EU Commission consultation on combating counterfeiting medicines for human use, released in December 2008, the annual direct and indirect societal costs of counterfeiting are approximately €950 million. The overall costs of inaction will reach €9.5 billion–€116 billion by 2020, and this does not take into account the intangible yet significant damage to brand reputation and trust.

After Noon points out the compelling need for a solution, he leaps to the assumption that the only solution for this problem is via mass serialization of the supply chain. Basically he asserts that only a complex serialization solution from manufacturer to dispenser, which according to the an EU Commission consultant would result in staggering set up and annual costs across the supply chain, is the best and only way to secure the Pharmaceutical Supply Chain:

• An industry wide one- time cost of €11.5 billion to set up the proper systems within all members of the supply chain in Europe alone.
• Annual “running costs” for serialization with European companies to be €185.5 million for non-OTC companies. There were no estimates of costs associated to OTC companies.
• EU pharmacies would incur costs of installing the right IT and reading devices to support serialization estimated to be €157 million. Noon offered no estimates on the annual costs of running this the system.

We at XStream take a different view, frankly it doesn’t matter with what currency or market that you are serializing, Euros or Dollars, the costs are astronomical, very unrealistic given the current global economic malaise and the solution is so complex to implement it is very unlikely to impact the problem. Additionally it doesn't seem a stretch to make the point that the estimated costs are overly optimistic and and he is only referencing Europe.

What Noon does not factor in or discuss in this piece are the basic realities necessary to make serialization work:

• Mass serialization requires that each member of the supply chain be perfectly in synch, every link in the chain and each company has to be in a virtual daisy chain process to make it work.
• Each member's system and technology has to work seamlessly to process and communicate the serialization throughout the chain.
• Although Noon makes this serialization synchonization sound simple and seemingly downplays the costs, practically it would prove to be nearly as impossible to globally integrate and effective as herding cats.

In any industry there is little hope that an entire supply chain could be efficiently managed, globally integrated and synchronized across the spectrum without significant effort and coordination. Mass serialization would require massive regulatory mandates, huge cost overruns in the billions (Euros and Dollars) and many years of significant legal arm twisting across multiple borders.

Even if, by chance, the supply chain was all properly serialized, integrated, managed and set up, all it would take would be one link failing in this “daisy chain” even temporarily for the entire system to fall apart.

Bottom line one single failure and the multiple billions in Euros or Dollars becomes wasted and the security and efficacy of the product in doubt.

Although we see limited merit in serialization, where we differ from Noon is that we realize, as most who have studied the issue of global pharmaceutical counterfeiting, is that there is no one single technology or solution to the problem.

Even though there is no technology or singular solution that can offer comprehensive protection from raw materials to dispensing and ultimately consumption by the consumer; it is a battle that all within the pharmaceutical supply chain should join in to solve.

Serialization, like other Track and Trace solutions such as RFID, Pedigrees and Bar Codes has its place and uses and we believe can and should be a part of any sophisticated supply chain. But in order to properly protect the supply chain and the consumer comprehensively, a system and process of screening the actual product, not just the transaction or package, is necessary to eliminate fraudulent and counterfeit medications.

In recent memory there have been a variety of fraudulent and counterfeit medications that have passed through the global pharmaceutical supply chain, in most cases nearly all would have passed a pedigree, packaging tag or serial code but their contents impacted the health of those who consumed it.

Analytical screening throughout the process takes away the “daisy chain” effect which mandates and requires participation by all to be effective. By using technology like EDXRD, XStream’s XT250 can screen and validate the medication inside its sealed container, creating an instant pedigree while authenticating the medication inside the package is efficacious.

Screening and authentication technologies do not require complex integrations and can be deployed anywhere within the supply chain to validate the safety of the inventories on hand. Additionally screening solutions, at the point of dispense, can assist providers from averting medication and dispensing errors. The cost of implementing screening solutions would be a fraction of a mass serialization solution and could be deployed almost immediately.

Overall, we are not completely dismissing Mr. Noon’s point as it relates to the need for a solution; we do however take exception to his conclusion that Serialization is the only answer. XStream Systems believes that governments and industry need to deploy a variety of tactics and technology to defeat fraudulent and counterfeit medications and we do not believe that it will requires tens of billions of Euros or Dollars to begin the process. XStream suggests that each member of the supply chain needs to understand their place and responsibility within the chain and deploy the proper tools to secure it so that we can all have faith that the medications we supply and consume are safe.

Israel Ranks High in Counterfeit Pharmaceutical Trade

The following commentary from Ronny Linder-Ganz appeared in Haaretz.com regarding the proliferation in counterfeit medications within Israel:

By Ronny Linder-Ganz, Haaretz Correspondent

We're on the map, but the wrong map: In 2008 Israel ranked eighth in the world's counterfeit pharmaceuticals trade, with 78 reported cases of fake drugs worth up to NIS 100 million. And those were only the cases that were caught.

The figures, based on data from the World Health Organization, Health Ministry and drug safety watchdogs, were released at a conference on drug counterfeiting last week, sponsored by the Federation of Chambers of Commerce and Pharma Israel. But clearly, the figures reveal only part of the problem, as they reflect only fake drugs that were caught.

"Alongside the safe supply chain, which passes through drug stores, health maintenance organizations and businesses licensed to sell non-prescription drugs, there is a criminal, counterfeit trade network that includes a wide variety of criminal practices," says Micky Arieli, who manages the Health Ministry's pharmaceutical crime unit.


The network includes anything "from drug store break-ins to drug production to smuggling," he said.

The counterfeit drug trade has been booming everywhere in recent years. Industry sources estimate that the scope of the plague will double between 2005 and 2010, reaching $75 billion annually.

The Health Ministry and pharmaceutical companies warn that aside from causing the latter financial damage, the trade poses a danger to consumers. Counterfeit drugs kill thousands of people around the world every year, due to the drugs' poor quality and the fact that no prescription is required, which can result in improper use, says the WHO.

Federation president Uriel Lynn says the problem poses a mortal danger, and should be addressed as such. He called on authorities to increase deterrence, and to punish offenders as if they were drug dealers.

Knesset member Yohanan Plesner recently submitted a legislative amendment that cracks down on counterfeiting.

"Pharmaceutical enforcement manpower should be doubled, and entities beyond the police, such as the Health Ministry and the Tax Authority, should be authorized to deal with the problem," Plesner said. "The emphasis should be on immediate sanctions rather than extended legal proceedings, so that this trade won't pay."

To view article visit: www.Haaretz.com

Swiss Say Seizures of Counterfeit Meds Nearly Doubled

This week, Earthtimes reported that Switzerland stated their seizure figures for fake drugs rose 92 percent for the first half of this year. A majority of the counterfeit product came from Asia region, but several regions were also named including eastern and Western Europe.

Swiss say illegal medicines imports nearly double
(July 16, 2009) Geneva - Switzerland reported Thursday a 92 per cent increase in the amount of illegal and counterfeit medicines seized at its border crossings in the first half of this year, compared to the same period last year. The medicine consignments confiscated by Swiss customs officers came from several regions, including eastern and western Europe, the federal authorities said in a statement, though the majority arrived from Asia.

Erectile dysfunction drugs made up 24 per cent of the caught shipments. Slimming products were 14 per cent of the found products followed by muscle enhancers, at 12 per cent.

Slimming products made the largest increase, and health officials warned the public to take care that they only bought official and licensed drugs. The counterfeit products do not always contain the appropriate amounts of active and inactive chemicals and can cause health problems.

The authorities also warned about buying medicines through dubious Websites.

To view the entire article visit the Earth Times website at: www.earthtimes.org.

FDA Issues Guidance on Anti-Counterfeiting Techniques: Physical-Chemical Identifiers for Drugs

The Food and Drug Administration continues in its efforts to regulate and provide guidance on anti-counterfeiting solutions. This press release from July 13, describes their latest efforts on providing guidance on physical-chemical identifiers (PCIDs) which are added to medications by the manufacturers to make drugs more difficult to counterfeit and adulterate.

XStream supports and believes that a variety of solutions and techniques are vital in protecting the pharmaceutical supply chain and healthcare consumer from fraudulent, adulterated and counterfeit medications. PCIDs are one component of a secure pharmaceutical supply chain.

Currently the FDA is seeking comments on this guidance:

The FDA July 13 issued a draft guidance on PCIDs used by manufacturers to make drugs more difficult to counterfeit and to make genuine versions of drugs easier to identify.

The draft “Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anti-Counterfeiting” is intended to provide guidance on the use of PCIDs in pills and capsules.

According to the agency, PCIDs have unique physical or chemical properties used to identify and authenticate a drug product or dosage. The substances include inks, pigments and flavors, as well as various chemicals that can be used as molecular tags to form a PCID. The FDA anticipates that many of the potential ingredients for PCIDs already are used as food additives, colorants or other “inactive ingredients with established safety profiles.”

The draft guidance recommends using the lowest level of PCID possible to ensure identification of the product. The PCID also should be a substance with no medicinal effect and no potential to interact with the drug’s active ingredient, according to the FDA.

Comments on the draft guidance may be submitted electronically at http://www.regulations.gov. The comments, due by Oct. 12, should be identified with docket number FDA-2009-D-0212.

Ghana: Food and Drug Board Detects Fake Anti-Malaria Drugs

The Foods and Drugs Board (FDB) this month warned the public of fake cortem tablets, anti-malaria drugs, in the market in Kumasi, Ghana.

The Board has confiscated 150 packs of the product from nine wholesale and retail pharmacies involved in the distribution and sale of the fake products.

Ashanti and Brong Ahafo Zonal Officer of the FDB, Joseph Bennie, said the board has adopted a name-and-shame strategy to fight drug counterfeiting. The following wholesale and retail pharmacies, and licensed chemical sellers were mentioned as distributing the counterfeit Coartem with batch numbers X0089 and M1200:

Wholesale and retail pharmacies included Salom Pharmacy Limited (Kejetia), Habmay Pharmacy Limited (Asafo), Pharmax Ghana Limited, (Bantama), New Tafo), Edikay Pharmacy, (Buokrom Estates), Tracmar Pharmacy (Anwomaso), Fredimens (KO-Ashtown).

The Licensed Chemical Sellers included Martin Owusu Licensed Chemical Seller (Tanoso), Augustine Evans Adu Chemical Shop (Old Tafo).

FDB announced they will soon be handing over to the police the 9 institutions caught trading in counterfeit drugs.

China, South Korea, Brazil and Turkey-Top Countries for Counterfeit Drugs

At a recent meeting in Istanbul, the Association of Rearch-Based Pharmaceutical Companies [Araştirmaci Ílaç Firmalan Demiği (AIFD)], met to discuss developments in the fight against counterfeit drugs in Turkey and throughout the world.

Turkey is the fourth largest market for counterfeit medicines according to a speech by Cengiz Gümüştüs, head of Esfor Security Consultants and former member of the Turkish National Police and Interpol. Turkey arrests for counterfeit drugs numbered 68 in 2008. Other countries with serious problems in counterfeit pharmaceuticals are China, South Korea and Brazil.

According to Gümüştüs: “In Turkey, counterfeit drugs are marketed over the Internet, pushed by street vendors or by counterfeit drug smugglers who we call “pouchers”. Our law enforcement units are waging an effective effort against counterfeit drugs and making wide-scale raids. However, the success of this effort ultimately depends on the collaboration between the state, industry and the society.”

The Association of Research-Based Pharmaceutical Companies consists of 39 pharmaceutical companies with a focus on biotechnology and R&D, including Abbott, Actelion, Alcon, Astra Zeneca, Amgen, Astellas, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Chiesi, Daiichi-Sankyo, Eczacıbaşı–Baxter, Ferring, Fresenius Kabi, Fresenius Medical Care, Gilead, GlaxoSmithKline, İ.E. Ulagay, Indentis, Johnson & Johnson, Lilly, Lundbeck, Merck Serono, Merck Sharp & Dohme, Nestle, Novartis, Novo Nordisk, Nutricia Klinik Beslenme, Pfizer, PharmaSwiss, Pierre Fabre, Reckitt Benckiser, Sanofi Aventis, Schering-Plough, Servier, Solvay İlaç Türkiye, UCB Pharma, Wyeth, who are responsible for the greater part of new drug research worldwide.

For more information visit the AFID website at: www.afid.org.tr

Caraco to Eliminate Nearly 350 Employees Due to FDA Seizures

Caraco Pharmaceutical Laboratories has announced that it will eliminate approximately half of its employees and curb overhead by suspending all manufacturing following the seizure by the US Food and Drug Administration (FDA) of up to 33 of the company's generic drugs due to manufacturing violations. This is anticipated to impact over 350 employees.

In June 2009 the FDA seized drugs made at the company's Michigan facilities in Detroit, Farmington Hills and Wixom. The seized drugs included generic versions of heart, pain and psychiatric drugs as well as the epilepsy treatment Tegretol and a generic copy of the diabetes drug Glucophage.

Earlier in 2009 Caraco had been charged with repeated violations of FDA’s current Good Manufacturing Practice (cGMP) requirements. Beginning in January 2009, Caraco initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.

XStream Systems endorses the concept of material screening of pharmaceuticals from raw materials, through the various points of production, within the distribution supply chain and at the point of dispense.

Validation at all points of the pharmaceutical supply chain from the manufacturer to the consumer verifies quality and protects against counterfeiting, fraud and adulteration.

Netherlands Health Care Inspectorate Warns of Counterfeit Insulin Needles

Counterfeit insulin pens have been discovered in the Netherlands. Of which 30,000 needles are still in circulation in the Netherlands with an estimated 2 Million that have made their way into the regular European distribution channels.

The public warning from The Netherlands Health Care Inspectorate appears below. The original warning can be viewed at the IGZ website: www.igz.nl

Netherlands Health Care Inspectorate (IGZ) Public Warning

The Netherlands Health Care Inspectorate [Inspectie voor de Gezondheidszorg (IGZ)] has issued a public warning following the discovery of counterfeit needles for insulin delivery systems (insulin pens). Use of these needles could present a health risk. It is known that some 200,000 counterfeit needles have been introduced to the Netherlands, of which 30,000 remain unaccounted for and may still be in circulation.

A Dutch company purchased 2,000 packs of needles (with 100 needles in each pack) from a wholesaler in Malaysia. The wholesaler claims that the needles derive from Iran. The supply line cannot be traced beyond this point. The Health Care Inspectorate continues to investigate the matter.

Some 200,000 counterfeit needles were released onto the Dutch market, a further 500,000 in the United Kingdom and over 1.3 million in Poland. A total of over two million counterfeit needles have therefore found their way into the regular European distribution channels.

Novo Nordisk B.V., the licensed distributor of genuine NovoFine® insulin needles in the Netherlands, received a patient complaint stating that a recently purchased needle did not fit properly onto the insulin delivery pen. Novo Nordisk submitted a large quantity of needles to its parent company in Denmark for inspection. It was determined that the needles were counterfeit, whereupon the manufacturer reported to matter to the appropriate authority, the Netherlands Health Care Inspectorate.

The Inspectorate advises any users who are unsure of the origins of their needles to contact their pharmacist or supplier. All information about the current situation can be found on the manufacturer's website at www.novonordisk.nl.

The Health Care Inspectorate consulted the Royal Dutch Association for the Advancement of Pharmacy (KNMP) prior to issuing this press release. The Association informed its members of the situation on Friday, June 19.

How Can Users Identify a Counterfeit Needle?

• Packaging information in English: genuine needles distributed in the Netherlands have packaging information in Dutch.
• The packaging of the counterfeit needles has no barcode.
• Being of inferior quality, the counterfeit needles may not fit the screw thread of the insulin delivery pen properly.
• Counterfeit needles found thus far have the Batch/Lot number 08J02S and an expiry date of 08/2013.
• Traces of transparent adhesive may be apparent where the needle is affixed to the plastic holder.

Drug Companies Need to Improve Their Screening for Quality and Counterfeits

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

Recent massive recalls on generic drugs imported from overseas contract manufacturers are making significant reverberations within the pharmaceutical industry and making the case for more stringent screening of drugs both in finished form and in raw materials.

Manufacturers in the past have seemingly been immune to this level of public scrutiny because it has often been perceived that their products are at their most pristine at the point of manufacture however with the continued proliferation of contract manufacture of product and raw material sourcing from companies located in lesser developed countries the need for more robust screening from point of manufacture through the supply chain seems obvious.

These global recalls are not just happening to the smaller generic companies that contract their manufacturing overseas but also the generic divisions of big Pharma companies are feeling the sting of substandard product within their brand.

Although the liability to the stakeholders of these impacted companies is great, the impact and consequence to the consumers of these inferior medications should remain paramount. For those in the know within the pharmaceutical supply chain, the message and actions seem clear.

XStream Systems supports the concept of screening products throughout the pharmaceutical supply chain from raw materials, to the point of manufacture, packaging, throughout the supply chain and finally at the point of dispensing to the patient.

The level of screening required is important as well, realize that all of the poor quality recently recalled product in question were passed or would have been passed on to the consumer through the process of pedigree, serialization, bar codes and RFID tags.

End-to-end screening does not have to be costly, overly time consuming or onerous to the various members of the supply chain. Current technologies exist to rapidly screen raw materials at the point of production while XStream’s XT250 has a robust solution of analytical testing of products within the sealed container in the supply chain. At the point of dispense there are a variety of technologies available currently which test for product quality and medication errors before they reach the consumer. We at XStream believe that the most effective way of protecting the product is to employ a variety of solutions at each link of the supply chain.

As the world continues to move to a global economy and the pieces of the pharmaceutical supply chain scatter beyond borders a watchful eye towards quality and security are in the interest to all of those who either make a business of or consume pharmaceuticals.

UK Recalls Multiple Generic Drugs

Violations of European standards by an outsourced Indian manufacturer have prompted the recall of multiple generic drugs in the United Kingdom.

Novartis's generics unit was one of about eight companies that recalled drugs this week because of "serious" deficiencies in so-called good manufacturing practices found during inspections of the contract manufacturer, MJ Biopharm, in India, according to the U.K. Medicines and Healthcare Products Regulatory Agency.

Novartis generic unit, Sandoz recalled fluoxetine, an antidepressant which is the generic version of Eli Lilly’s Prozac. Other drugs recalled by Sandoz included Baclofen for muscle spasms, and metformin for diabetes.

Other recalled drugs included hypertension pills amlodipine and doxazosin and pain-reliever naproxen. The other companies that recalled drugs included Strandhaven Ltd., LPC Medical Ltd., Karib Kemi Pharm Ltd., Milpharm Ltd., Greystone Ltd., Jubilant Pharmaceuticals NV and Wockhardt UK Ltd.

To view the entire article visit the Wall Street Journal Online at: www.wsj.com.