Eastern Europe Confronts Fake Medicines

“Fighting back counterfeiters can't be done by one country or by one organization, it calls for a synergy of efforts."

Eastern Europe is a key route in a multi-billion-dollar trade in often-dangerous counterfeit medicines that has grown exponentially on the Internet. Agence France-Presse reports on a meeting of more than 120 anti-counterfeit specialists from six Eastern European countries in Romania held recently. The meeting was an effort to bring experts together and collaborate in combating this deadly crime which impacts the health of entire populations.

Highlights from the Agence France-Presse story include:

• "There is an important Balkan route for fake medicines, which is the same as for heroin and other narcotics," Hungarian customs officer Karolyi Szep told AFP at the meeting called by the world's leading pharmaceutical company Pfizer.

• Such drugs can contain no active ingredients at all or 8,000 times the required amount, or heavy metals such as arsenic, lead-based paint, brick dust or floor wax -- content that poses major health risks and can lead to death.

• Today most of the sales are done via the Internet, which has multiplied the trade -- and the risks -- exponentially.

• According to the World Health Organization, one in two medicines sold online are fake.

• "People who buy medicines on the Internet are playing Russian roulette with their own lives," Steve Allen, senior director of Pfizer Global Security, told AFP.

• Allen said 63 million fake Pfizer tablets, vials and capsules as well as enough active ingredient to manufacture an additional 64 million have been seized worldwide since 2004. "But this is just the tip of the iceberg," he warned.

• “Fighting back counterfeiters can't be done by one country or by one organization, it calls for a synergy of efforts," he said. "We are dealing with organized crime gangs, there is no doubt about it."

• Considered a low-risk and high-reward business, counterfeit medicines have become increasingly alluring to narcotics smugglers.

• "Supply techniques are identical, but the punishment is not," Allen said, stressing that in certain countries manufacturing or selling fake medicines is not considered a crime.

• In one case of narcotics and fake medicines going hand in hand, Turkish police seized 6,000 counterfeit Viagra pills smuggled with 378,000 ecstasy tablets and enough ingredients to manufacture 51 kilogrammes (110 pounds) of heroin.

• The former Soviet bloc has made important progress in recent years in fighting counterfeit medicines, said Gabriel Turcu, a senior partner in leading European anti-counterfeiting network REACT.

• Most countries in the region have toughened legislation and some are even setting an example for their Western neighbors. In Romania, fake drugs smugglers have for the first time been sentenced to prison this year.

• "Years ago, judges would deem counterfeiting T-shirts or medicines was the same. Now their perception has changed," Turcu said.

• Calling for increased public awareness, experts and law enforcement authorities stressed that deaths caused by fake medicines are often attributed to natural causes.

Secure Pharma Chain encourages collaborations as an important step forward in fighting this deadly criminal act.

Working partnerships between regulatory agencies and industry along with public awareness and the deployment of technologies are the vital components to the “synergy of efforts” in ending the threat of counterfeit medications to consumers around the globe.

To read the entire Agence France-Presse story, visit: http://www.abs-cbnnews.com/global-filipino/world/10/21/10/eastern-europe-confronts-fake-medicines-trade

To learn more about pharmaceutical anti-counterfeiting solutions, visit: http://www.xstreamsystems.net/

Teva Expands Nationwide Recall of Ketamine

Teva Animal Health Inc. is expanding a nationwide recall of its Ketamine Hydrochloride Injection which effect products under seven manufacturer’s labels because of adverse events including the death of some animal patients. The labels include specific lots of Ketamine products from Fort Dodge Animal Health, Vedco, AmTech Group, Butler, Phoenix Pharmaceuticals, Rx Veterinary Products and Lloyd Laboratories. This enhanced recall energizes the need for material screening of products within the supply chain to protect consumers from fraud, adulteration, contamination and counterfeit products. The following press releases include details on the recall:

Teva Animal Health, Inc. Expands a Voluntary Nationwide Recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials

December 21, 2009 - Teva Animal Health, Inc. is expanding a nationwide voluntary recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials for all lot numbers within their expiration dates to the Veterinary Level. This product had previously been recalled to the distributor level and is being expanded as a result of an increased trend in serious adverse events associated with this product.

Veterinarians who have this product in their possession are instructed to cease using the product immediately and return it to their distributor.

Ketamine Hydrochloride is a rapid acting, non-narcotic, non-barbiturate agent for anesthetic use in cats and for restraint in subhuman primates. This recall is being conducted as a result of an increased trend in serious adverse events associated with this product, including lack of effect, prolonged effect, and death and involves all lot numbers within expiration.

Teva Animal Health, Inc is voluntarily recalling the aforementioned product. The FDA has been apprised of this action.

Consumers with questions may contact 800-759-3664 from 8:00am – 5:00pm CST Monday-Friday. http://www.fda.gov/Safety/Recalls/ucm195118.htm

Seven Labels Tied to Teva Ketamine Recall, FDA says

In the wake of Teva Animal Health’s massive ketamine recall, the U.S. Food and Drug Administration (FDA) reports that the action extends to lot numbers of Fort Dodge Animal Health’s Ketaset, Vedco’s Ketaved and five other private labels.

An e-mail to the VIN News Services (VNS) from the FDA’s Center for Veterinary Medicine (CVM) confirms that the labels include:

• AmTech Group Inc. Ketamine Hydrochloride Injection, USP, manufactured by IVX Animal Health Inc..
• Butler KetaThesia, distributed exclusively by Butler Animal Health Supply, Dublin, Ohio
• Fort Dodge Ketaset, manufactured for Fort Dodge Animal Health, Fort Dodge, Iowa
• VEDCO KetaVed, distributed by Vedco Inc., St. Joseph, Mo.
• Phoenix Ketaject, manufactured for Phoenix Pharmaceutical Inc., St. Joseph, Mo.
• LLOYD Laboratories VetaKet, manufactured for Lloyd Laboratories in
• Shenandoah, Iowa
• RXV Keta-Sthetic, manufactured for RXVeterinary Products, Westlake, Texas

This latest recall stems from the reported death of five cats, inconclusively linked to the drug's use. But troubles within Teva Animal Health surfaced last July, when the FDA shut down the company via a permanent injunction and filed a lawsuit, alleging that regulatory inspectors had uncovered adulterated animal drugs at Teva’s main facilities in St. Joseph, Mo. The generics manufacturer agreed to cease production of its drugs and its DVM Pharmaceuticals line of products following FDA's much-publicized crackdown on the company’s quality control practices.

http://news.vin.com/VINNews.aspx?articleId=14720

To learn more about onsite pharmaceutical material screening solutions, visit: www.xstreamsystems.net.

Report Notes Rise in Adverse Drug Events, Patient Deaths

As reported by Shawn Rhea in Modern Healthcare, the Food and Drug Administration has announced that adverse drug events increased by 25% in 2008 compared with 2007. This data came from a new QuarterWatch report from the Institute for Safe Medication Practices, a Philadelphia-based not-for-profit dedicated to the prevention of medical errors.

• The increase was the largest over a one-year period since the FDA began collecting data in 1998.


• According to researchers, the FDA received reports of nearly 100,800 cases of serious injury related to drug use in 2008 compared with 80,600 in 2007. Those numbers included a 56% increase in patient deaths—from 9,700 in 2007 to 15,200 in 2008.


• The ISMP credited the surge in reported events to both the FDA's efforts to better identify adverse drug events and a slew of recalls on generic drugs such as heparin vials, and morphine and digoxin tablets during 2008.

As blogged about repeatedly in Secure Pharma Chain Blog it has been predicted that this increase is consistent with the increase in instances of counterfeit, adulterated and fraudulent medications within the domestic pharmaceutical supply chain. Although industry and regulatory authorities continue to use Track and Trace technologies to combat this issue, it is apparent that additional solutions are needed to protect the healthcare consumer.

Material screening by using EDXRD, allows the members of the pharmaceutical supply chain to verify and authenticate the medications inside of its unit-of-sale container without degrading or destroying the material inside the package. This solution can be used at all areas of the supply chain from raw materials, to production, packaging, distribution and dispensing and will authenticate both the medication and protect against medication errors.

To learn more about EDXRD technology as a solution to counterfeit, adulterated and fraudulent medications, visit: www.xstreamsystems.net.

FDA: New Manufacturing Standards May Decrease Heparin Potency by 10%.

Given Secure Pharma Chain Blog’s extensive covering of the issues with Heparin the past year, the following involves the widely reported story which appeared in a variety of news publications regarding changes to the manufacturing Heparin in an effort to prevent further complications with the often used medication.

The FDA recently announced that "New manufacturing standards designed to prevent contamination of the blood-thinner heparin will decrease the drug's potency and may require patients to get higher doses." Beginning October 8th, "heparin products...will be about 10 percent less potent than the current medicine used to prevent blood clots, which was posted on the" agency's website.

Dr. John Jenkins, director of the FDA's office of new drugs, stated that "healthcare providers should consider the change in potency of heparin when making decisions about which dose to administer.”

• Although "older vials of heparin will remain on the market after the new formula begins shipping," which may "cause confusion, the agency said it was necessary to ensure there is adequate supply of the drug."


• The Dow Jones Newswire reports that the agency has asked manufacturers to change labels on the new products to help pharmacies and physicians identify them from the older vials.


• According to the Chicago Tribune, the new standards are intended to help "manufacturers...spot impurities during the quality-control process." The new controls follow "last year's recall by...Baxter International Inc. of its heparin vials linked to a spike in deadly allergic reactions."


• CQ HealthBeat reports. Jenkins noted that "the change 'may have clinical implications in some situations' where the drug is given in a large dose to produce an immediate anti-coagulant effect." But, Jenkins added that "the change in potency is expected to be less clinically significant when administered subcutaneously,"

XStream endorses any opportunity to enhance the safety and security of medication within the supply chain. To learn more about XStream Systems’ revolutionary supply chain security solutions, visit us at: www.xstreamsystems.net.

New England Journal Medicine: Multinational Medicines — Ensuring Drug Quality In an Era of Global Manufacturing

In the August 20, 2009 issue of the New England Journal of Medicine, Susan Okie, MD writes about the emerging health care issue regarding the quality of branded and generic drugs in the new era of a globalized pharmaceutical supply chain.

In this new global economic age, Dr. Okie describes the problem and proliferation of a major global health care epidemic due to quality control and fraudulent prescription medications that are manufactured overseas in countries with a poor record of quality processes. In the article Dr. Okie also writes about the challenge of regulation and oversight as many pharmaceutical manufacturers and providers move their supply chain overseas to make and procure medications.

One of the more disturbing examples of the potential danger of lack of quality oversight regards the super potency of Digitek in 2008:

"…FDA’s Adverse Event Reporting System (AERS) contains data on adverse reactions to medications in a self selected subgroup of an exposed population of unknown size. In April 2008, the FDA and Actavis Totowa, the manufacturer of Digitek, a widely prescribed generic digoxin, announced a nationwide recall of 800 million tablets, triggered by concern that double-thickness tablets containing twice the approved dose might have been released commercially. Between April and September 2008, AERS received reports of 2,912 serious injuries and 1,094 deaths associated with digoxin, about 80% of them linked to the recalled product. Thomas Moore and colleagues at the nonprofit Institute for Safe Medication Practices have called for systematic testing of the recalled tablets, commenting that “if many of these cases prove to be linked to manufacturing problems, then the nation has experienced a little noted drug disaster of major proportions.”

As have been reported in this blog for sometime the incidents of recalls related to lack of quality control and oversight connected to product production has spiked in the past several years and according to Dr. Okie may continue to increase due to the FDA’s lack of resources.

XStream Systems endorses the concept that both private industry and government regulatory agencies use technology such as XStream’s XT250 to screen, authenticate and verify the contents of products within the supply chain from point of production to the consumer. By using a material screening process, which verifies the material inside its unit-of-sale container, the entire supply chain mitigates its liability and ensures the consumer that the product is safe and efficacious. The current costs of the issue of poor quality medications within both the supply chain and the health care of the consumers, seems nearly impossible to effectively gauge or predict but it seems reasonable that whatever the price, the costs in both dollars and human suffering are far too high. Through proper verification within the supply chain, XStream feels that many of these incidents can be averted and the health care of the consumer protected.

To view Dr. Okie’s article in the August 20, 2009 issue of the New England Journal of Medicine, visit their website at: http://www.nejm.org/.

To learn more about XStream Systems verification technology, visit: http://www.xstreamsystems.net/.

AP: Patients Have Suffered Effects from Stolen Insulin

FDA Warns Consumers of Safety Issues with Stolen Vials of Novo Nordisk Insulin

As repeated earlier in June on Secure Pharma Chain Blog and updated by Matthew Perrone from the Associated Press on August 27 the "The Food and Drug Administration is warning consumers to avoid certain vials of insulin made by Novo Nordisk that were stolen earlier this year and may not be safe for use." Regulators stated that "the vials may not have been stored properly and could be dangerous to consumers."

In fact, "the FDA has received multiple reports of patients who suffered unsafe blood sugar levels after using the products." The agency "issued an alert in June after three lots of Novo Nordisk's Levemir insulin were stolen during shipment through Johnson County, NC." According to regulators, "only about two percent of the 129,000 vials have been returned."

To view the entire article visit: www.charlotteobserver.com.

EPA Investigating Adverse Reactions to Flea and Tick Products

An increase in reports of adverse reactions among pets to topical flea and tick medicines has prompted the Environmental Protection Agency (EPA) to intensify its scrutiny of these products. The products have not been recalled, but the agency is warning pet owners that the treatments may have serious, even fatal, side effects.

This investigation, according to the EPA, is due to some 44,000 complaints over the past year that the EPA has received from consumers. This represents a 53% increase over the previous year. Approximately 1,200 of those reports accounted for animal deaths.

Spot-on flea and tick treatments are applied topically, usually between the animal’s shoulder blades or along the spine. A majority of products being investigated appear to be Over-the-Counter (OTC) products rather than those obtained through a veterinarian. A list of more than 200 brands of registered products appear on EPA’s website.

According to agency spokesman Dale Kemery, the adverse reactions included skin irritations, hair loss and tremors. The E.P.A.’s report on liquid flea and tick treatments is expected by October and will be published on the agency’s Web site.

The appearance of counterfeit pesticide products for dogs and cats has further complicated the picture. On April 28, the E.P.A. warned distributors and retailers to stop selling counterfeit products with the brand names Advantage and Frontline, and to recall those already sold.

Consumers may call the National Pesticide Information Center at (800) 858-7378 to report a problem with the products. The agency has also advised veterinarians to report adverse reactions at the center’s Veterinary Pesticide Adverse Effects reporting portal.

To view registered products list visit EPA website at: www.epa.gov

To view more information on counterfeit Advantage and Frontline, visit: www.epa.gov

For the Veterinary Pesticide Adverse Effects reporting portal visit: http://pi.ace.orst.edu/vetrep/

FDA Investigating Deaths of Heparin Patients

Two patients have died from adverse reactions to heparin at Beebe Medical Center in Delaware. Another patient hospitalized at Beebe is also experiencing the same adverse reaction. The deaths are being investigated by the Food and Drug Administrations (FDA) and Baxter Healthcare, who supplied the blood thinner to facility. It is uncertain what caused the reaction. Unlike last year’s recall in which patients developed low blood pressure, these patients developed intracranial bleeding.

Baxter stated that the active ingredient in the product was obtained from Pfizer and not bulk suppliers in China. Pfizer commented that while they do source heparin raw materials from China, they believe that the lot number in question was purchased domestically.

This reaction seems to be an isolated case and has not been reported as any other facilities.

The Delaware hospital where both patients died emphasized that it's not sure heparin caused the deaths. "We are not pointing fingers at Baxter," a Beebe Medical Center spokesman stated. "We don't know what's going on, but heparin is the only commonality that we were able to see ourselves."

China's Bad Medicine and Its Impact on the US

The Wall Street Journal features an informative editorial by Roger Bate in today's issue on the counterfeiting drug trade in China. Roger Bate is an expert on counterfeit drugs and is the author of the book “Making a Killing: The Deadly Implications of the Counterfeit Drug Trade.”

Mr. Bates discusses the scope of the problem in China and what the Chinese government can do to combat the issue. The black market is a huge enterprise in China employing as many as 5 million Chinese citizens in the counterfeit market. This is an alarming fact seeing as China is the fourth largest pharmaceutical exporter and supplies 40% of the global supply of active pharmaceutical ingredients (API).

The scope of Chinese counterfeiting has been felt globally as shown in these most recent incidents cited by Mr. Bates: In the United Kingdom in March of this year, Chinese counterfeit pharmaceuticals amounting to $745,000 were seized. In January of this year, two people died and nine were hospitalized due to counterfeit diabetes drugs in Xinjiang province. Last year hundreds suffered adverse reactions and at least 95 died due to a chemical ingredient that is believe to have been deliberately adulterated by Chinese suppliers.

In his paper “The Problems and Potential of China’s Pharmaceutical Industry” Bates further discusses the problem and why the world should be concerned. He states:

“With more Americans opting to procure drugs directly from overseas, often by purchasing over the Internet, understanding the causes of the counterfeit and substandard problem in China—and what can be done to combat it—has never been more important.”

To combat counterfeit drugs, he stresses the importance of collecting reliable information and coordinating consistent unbiased regulatory enforcement.

To view the editorial visit the Wall Street journal at www.wsj.com.

To view the paper "The Problems and Potential of China’s Pharmaceutical Industry” by Roger Bates and Karen Porter, visit the American Enterprise Institute for Public Research at: www.aei.org

One in Four British Doctors has Treated Victims of Counterfeit Drugs

A story in the British News site, Daily Mail, portrays the danger of purchasing prescriptions online. An estimated 2 million Britons regularly buy medicines, including prescription drugs and those not available on the NHS, over the internet for a range of conditions.

In the GP Newspaper Poll, 25% of the doctors surveyed said they had treated patients for adverse reactions resulting from medicines purchased online. What’s more an additional 8% felt they would be treating such a case in the future.

General Practitioners are calling for stricter regulations to ensure the safety of their patients. Over 85% of them want stricter laws because as they state - a majority of the individuals behind the sites have no professional qualifications to administer medications.

Dr Sarah Jarvis, a GP in west London and spokesman for the Royal College of GPs, said: "Surveys looking at many online medications suggest that the proportion of counterfeits is enormously high and that many of them contain very worrying ingredients."

The UK drug safety watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), has also been running a campaign warning about fake medicines. A spokesman said: 'Anyone who self-medicates and buys their medicines from internet sites could be in danger of receiving counterfeit or substandard medicines. At best these will be a waste of money, at worst they can kill.

FDA Expands List Of Tainted Weight Loss Pills

This past week, the U.S. Food and Drug Administration (FDA) expanded their list of tainted weight loss pills. Originally in late 2008, FDA warned consumers about 28 products which contained undeclared pharmaceutical ingredients and were marketed for weight loss. This list has since been updated twice. This latest update brings the total to 72 products, some of which are marketed as dietary supplements.

"These tainted weight-loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed maximum recommended dosages," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a news release. "Consumers have no way of knowing that these products contain dangerous drugs that could cause serious consequences to their health."

The active pharmaceutical ingredients contained in the products but not identified, the FDA said, include:

• fenproporex -- a controlled substance not approved for sale in the United States
• fluoxetine -- an antidepressant available by prescription only
• bumetanide -- a potent diuretic available by prescription only
• furosemide -- a potent diuretic available by prescription only
• rimonabant -- a drug not approved for sale in the United States
• cetilistat -- an experimental obesity drug not approved for sale in the United States
• phenytoin -- an anti-seizure medication available by prescription only
• phenolphthalein -- a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for sale in the United States

The health risks posed by these products can be very serious and include high blood pressure, seizures, tachycardia (rapid heartbeat), palpitations, heart attack, and stroke. Sibutramine, a controlled substance, was found in many of these products at levels much higher than the maximum daily dosage for Meridia, the only FDA-approved drug product containing sibutramine. These higher levels of sibutramine can increase the incidence and severity of these health risks. Fenproporex, another controlled substance, can cause arrhythmia and possible sudden death.

According to the FDA, these products are marketed at websites, convenience stores and some beauty shops. Consumers are encourage to discontinue their use and report any side effects to the FDA MedWatch website at www.fda.gov/MedWatch/getforms.htm

A complete list of the tainted weight-loss products is available at the FDA.

Heparin Contaminant found in 11 Countries!

China is continuing to deny their part in the contamination of the Heparin supply and the related deaths. They have even gone so far as to imply that the contamination could have occurred in a US plant. There is no denying on their part now, as the countries affected have climbed to 11 including: Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States.

With this latest revelation, China has at least accepted responsibility for the contaminant (oversulfated condroitin sulfate, or OSCS), but denies this resulted in the over 800 adverse reactions and the 81 deaths the FDA has attributed to it in the U.S. alone. FDA has conducted testing which has linked the OSCS to the adverse reactions observed. Additionally, The FDA has traced the lots in question to 12 Chinese companies involved in the heparin’s manufacturing.

Worldwide, the heparin recalls have expanded to include recalls from numerous companies that use heparin in a variety of medicinal products: Baxter (heparin); B.Braun (heparin solutions); Covidien (pre-filled syringes); American Health Packaging (heparin sodium vials); Hospira (heparin syringes, vials, and bags); AstraZeneca (heparinized saline); Sanofi-Aventis (Clexane drug); Rotexmedica (heparin products); Opocrin (heparin API); Sierra Pre-Filled Inc.(heparin lock and normal saline flushes); G. Bichsel AG (heparin products); and Arseus NV -Fagron (heparin).

The FDA has updated their testing to include two screening tests and is currently working with US Pharmacopeia, a non-profit organization dedicated to safety in the pharmaceutical industry on further testing.

Clearly, the magnitude of these recalls echo the need for more encompassing and rapid screening tests in the pharmaceutical arena. As the saga continues, manufacturers and suppliers should ask the question – Am I doing everything possible to ensure my supply is secure?

As the number of deaths stemming from the Heparin tragedy increases, so must our vigilance to make sure this does not happen again.