Tuesday, November 30, 2010
Nayanah Siva writes an exceptional article in the November 20th issue of The Lancet on international efforts to tackle the problem of counterfeit drugs.
The importance of this article is the excellent timely information and its historical perspective.
Highlights of The Lancet editorial article include:
• WHO are of the opinion that “studies can only give snapshots of the immediate situation. Counterfeiters are extremely flexible in the methods they use to mimic products and prevent their detection. They can change these methods from day to day, so when the results of a study are released, they may already be outdated.
• “In many cases where successful actions against counterfeit, illegal and substandard drugs were undertaken by authorities, little public information is forthcoming about the case…As a consequence it is difficult for the stakeholders to understand the nature and extent of the problem, let alone to develop strategies to combat illegal medicines.”
• Steve Allen, Senior Director of Pfizer Global Security told The Lancet “I saw [counterfeiting] first hand in Tanzania last year, where we had anti-malarial products being counterfeited, to the degree that they were using identical batch numbers, identical expiry dates, the packaging, to all intents and purposes, seemed to be absolutely genuine, the blisters looked genuine, the tablets looked as if they were genuine, you would not be able to tell the difference, I can promise you, I've seen them myself.” It was only after these tablets were tested in a laboratory in the UK that it was discovered they had no active ingredients at all. “I can't think of many more worst-case scenarios, you have a counterfeiter somewhere in the world manufacturing a medicine for someone [pregnant women], she believes she might die anyway from malaria but it also impacts the unborn child, it is one of the most despicable of crimes.”
• The problem, Allen explains, is that counterfeiting is a “relatively low-risk, high-reward business to be in…and that is why organized crime gangs are using this far more frequently. In 2006 our colleagues in the narcotics units in Istanbul raided a manufacturing plant for narcotics but actually discovered a large quantity of our erectile dysfunction products and at the same time recovered 378,000 ecstasy tablets alongside the ingredients to manufacture 150 kg of heroin.”
• Newton is deeply concerned about the substantial detrimental effects counterfeit medicines have on African populations. “The main consequences…are increased mortality and morbidity, endangering drug resistance and loss of medicine efficacy, loss of confidence in health systems and health workers, economic loss for patients, their families, health systems, and the producers and traders in good-quality medicines, adverse effects from incorrect active ingredients, a waste of enormous human efforts and financial outlay in the development and manufacture of medicines…”
• Allen emphasizes the importance of international collaboration among regulators, the pharmaceutical industry and political representatives, and thinks this strategy will have the best chances of tackling counterfeiting. “This is not just an issue for one company, it is not an issue for one country, it is an issue for all of us.”
• Counterfeit drug crime is a complex issue requiring international and regional initiatives among industry, government, charities, and law enforcement…More political will and collaboration between medicine regulatory authorities, police and customs is essential.
All members of the legitimate pharmaceutical supply chain (governments, manufacturers, distributors and dispensers) must take it upon themselves to proactively protect and interdict their inventories from adulterated, fraudulent, sub-standard and counterfeit medications. This is a critical step by all of the supply chain stakeholders as a way to protect their industry, individual businesses and most importantly the consumer.
Everyone must be made aware that the impact of counterfeit drugs knows no borders. What happens in underdeveloped nations will ultimately impact and effect populations in developed nations around the globe.
To read the entire The Lancet editorial article which appeared in Volume 376, visit: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2962118-6/fulltext
To learn more about anti-counterfeiting technologies designed to authenticate pharmaceuticals, visit: http://www.xstreamsystems.net/.
Monday, November 29, 2010
Political wrangling over language, and confusion over how to deal with the public health and private property aspects of counterfeiting, is hampering international action.
Charles Clift writes an excellent article for the December 2010 issue of The World Today that goes into detail and insightfully probes into the issues, aspects and consequences surrounding drug counterfeiting.
Mr. Clift’s article is a must read for both those who are schooled on the issue and the uninitiated.
Here are a few insights from Mr. Clift’s The World Today article:
• Counterfeit, falsified and substandard medicines pose a considerable threat to health. Although detailed knowledge of their prevalence and impact on human well-being is limited, they can fail to cure, promote antimicrobial resistance, and ultimately kill. The threat from these medicines is probably growing, particularly in poorer countries with weak regulation and poorly monitored distribution networks.
• Counterfeiting can be very profitable, and those who do it are becoming increasingly sophisticated, which makes patients in developing countries, who usually have to buy medicines from their own resources, particularly vulnerable.
• In the case of food, medicines, cosmetics and some other goods, counterfeiting can also pose a serious threat to human health because products are likely to be either substandard or contain positively dangerous components or ingredients. This kind of counterfeiting is thus qualitatively different from, for example, a fake Rolex watch.
• Pharmaceutical products are a rather special case for several reasons. Typically it is more difficult to decide whether a product is counterfeit or not, not least because the consumer or prescriber cannot know the contents of the medicine. Before they can be legally marketed, medical products are, at least in principle, subject to much stronger regulation concerning their safety and quality than other items. Bodies such as the Food and Drug Administration in the US are responsible, so counterfeit products will also contravene drug safety, as well as intellectual property, laws.
• The general war on counterfeits is principally about protecting markets and private intellectual property rights, but in the case of pharmaceuticals this self-interested motive is overlaid by a concern to protect public health. The combination of self-interested and altruistic motives can be confusing to observers, and suspicious to some.
• However, the issue of counterfeit medicines has recently become extremely controversial. The definition that the World Health Organization (WHO) first developed in 1992 has generated continuing controversy by conflating the concept of counterfeiting - which has a specific meaning in relation to intellectual property - with issues concerned with the quality, safety and efficacy of medicines.
• Thus, counterfeits become inextricably confused with medicines that are falsified in some other way - for example by concealing their true identity and source - and medicines that are simply substandard: not containing ingredients to the specifications required by regulatory authorities.
• In addition, concerns have been raised that anti-counterfeiting measures might lead to threats to the legitimate trade in generic drugs. These concerns were made worse by the detention in the European Union (EU) in 2008 of generic versions of brand name drugs in transit from India to other developing country markets on the grounds they were infringing European patents.
• Undoubtedly, no one supports the work of the counterfeiters, with the harm they can do to sick people. The controversies are a reflection, in part, of perceived conflicts of economic interest between countries with brand name and generic pharmaceutical industries in the means used to tackle counterfeiting, as well as substandard medicines in general.
• Overcoming these perceptions of conflicting interest, including ensuring that definitions and rules and procedures do not discriminate between generic and brand name products, will be the key to more effective anti-counterfeiting measures.
Mr. Clift’s article is an excellent encapsulation of the problem of counterfeit medications and the complexity in dealing with this deadly crime.
To read and download the entire The World Today article, visit: http://www.chathamhouse.org.uk/publications/twt/archive/view/-/id/2102/
To learn about anti-counterfeiting technologies and solutions, visit: http://www.xstreamsystems.net/
Saturday, November 27, 2010
According to a press release from the Mississippi’s Attorney General’s Office and a blog post in SafeMeds:
• On November 18, a team of nearly 100 law enforcement agents from the U.S. Attorney’s Office-Northern and Southern Districts (MS), the Department of Homeland Security/Immigration and Customs Enforcement (ICE), the Food and Drug Administration and the Mississippi Attorney General’s Office, participated in raids via Mississippi’s Operation Knock Out Knock-Offs Task Force.
• "[The raids are] a key example of how Operation Knock Out Knock-Offs is working in Mississippi," said Attorney General Jim Hood. "By partnering with federal and local officials, we can help protect consumers from dangerous fakes."
• The first part of the operation focused on creating the state task force and the second phase centered around educating consumers and vendors about the dangers of counterfeit drugs. The operation received additional federal funding in October and will continue into next year.
• "We are just getting started," said Hood. "Counterfeiters are on notice that we mean business."
• From February 2010 to November 2010 undercover agents made dozens of purchases of counterfeit drugs at “convenience type businesses” throughout the Magnolia State. These counterfeit drugs reportedly included fake pain killers, antibiotics and birth control medication along with supplements not approved for sale in America.
• "Unapproved, uncleared, or misbranded products pose a clear and present danger to the public health," said David W. Bourne, Special Agent in Charge of U.S. Food and Drug Administration's Office of Criminal Investigations Miami Field Office. "We will continue to join with our law enforcement counterparts to aggressively pursue those who place consumers at risk for their own financial gain."
• "The smuggling of substandard, tainted or counterfeit products violates U.S. laws and regulations and threatens public health and safety," said, Raymond R. Parmer, Jr., special agent in charge of the ICE Homeland Security Investigations (HSI) office in New Orleans. "Our ability to work together across the federal government and with agencies around the world is a strong and appropriate response to a growing international threat."
The deadly criminal phenomenon of counterfeit medications is not limited to underdeveloped countries. These products exist, have significant consequence to the consumer and have the ability to become part of the legitimate supply chain.
All members of the legitimate supply chain must proactively protect their inventories and customers from these lethal fakes.
To read the entire SafeMeds post, visit: http://www.safemedicines.org/2010/11/mississippi-stores-selling-counterfeit-drugs-raided-51.html
To learn more about anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/.
Thursday, November 25, 2010
Highlighted in Mr. Silverman's blog:
• Once again, Johnson & Johnson has yanked a huge amount of over-the-counter medicines. This time, the recall involved about 4 million packages of children’s Benadryl allergy tablets and about 800,000 bottles of children’s Motrin caplets from pharmacies and distributors due to “inefficiencies” in manufacturing.
• Specifically, all product lots of Children’s Benadryl Allergy Fastmelt Tablets in cherry and grape flavors distributed in the US, Belize, Barbados, Canada, Puerto Rico, St. Martin, and St. Thomas and all product lots of Junior Strength Motrin Caplets distributed in the US. However, there was no indication of any adverse event reports or that the products “do not meet quality standards,” she wrote. Consequently, consumers can continue to use the products.
• Unlike the series of previous recalls, the health care giant did not issue a press release to announce these moves. When asked to explain the difference in procedure, the spokeswoman wrote this is considered a distributor recall, but that the info was posted on the individual product web sites on Nov. 15.
• Tens of millions of bottles have since been recalled; a plant in Fort Washington, Pa., has been shuttered and may be retrofitted; some 300 plant workers lost their jobs; Congressional hearings have been held; federal and state investigations are under way; consumer confidence in the company is falling; a quality control guru was appointed at the corporate level and at least $600 million in sales will be lost this year.
Since the posting of the Pharmalot blog, J&J has added another recall, this time of nearly 9 million bottles of Tylenol.
Wednesday, November 24, 2010
In an update to a fascinating story that had been blogged about previously in Secure Pharma Chain, the Green Bay Press Gazette is reporting:
• Online court records show prosecutors in the Eastern District of New York dropped the case against Marla Ahlgrimm on Nov. 5. The records don't offer any explanation. Robert Nardoza, a spokesman for the U.S. attorney's office involved in the case, declined comment. Ahlgrimm's attorney, Lester Pines, also declined comment.
• Ahlgrimm and a Middleton man named Balbir Bhogal were charged in September with working together to deliver counterfeit drugs, including Oxycodone, Hydrocodone and Viagra, to FBI informants. Bhogal's case is still pending.
• Ahlgrimm founded Women's Health America, a Madison-based umbrella company that includes a pharmacy and a laboratory. The University of Wisconsin Foundation's website lists her as a board member.
This story has been very interesting to watch because of the prominance of the people implicated and the proximity of counterfeit drugs to the legitimate pharmaceutical supply chain.
Clearly as the facts become known it will become even more apparent that all members of the pharmaceutical supply chain must take sufficent measures to protect their inventories from fraudulent, adulterated, sub-standard and counterfeit medications. There are far too many ways for bogus drugs to enter the legitimate supply chain and poison the consumer.
Secure Pharma Chain will follow this story as it continues to unfold.
To read the entire Green Bay Press Gazette story, visit: http://www.greenbaypressgazette.com/article/20101122/GPG0101/11220532/Feds-drop-drug-charges-against-Madison-pharmacist
Tuesday, November 23, 2010
U.S. Immigration and Customs Enforcement released a press release on November 15th detailing the sentence of 12 months and a day in prison for conspiring to distribute counterfeit pharmaceuticals, and trafficking in pharmaceuticals with false labeling and counterfeit trademarks to Kum Leung Chow.
The sentence was announced by U.S. Attorney José Angel Moreno, Southern District of Texas.
Kum Leung Chow, aka Lawrence Chow, 59, pleaded guilty to the federal charges on June 28 and sentenced on Monday to 12 months in prison by U.S. District Judge Kenneth M. Hoyt. Chow was arrested on Jan. 27 and has been in federal custody since that date and will remain in custody to serve out his sentence. Chow is subject to deportation after he completes his sentence.
The ICE HSI investigation began in January 2009 and revealed that Chow used a Hong Kong-based company named Kingdom International Enterprises LTD to obtain and distribute counterfeit Viagra and Cialis pharmaceutical drugs in the United States. Viagra and Cialis are prescription drugs that are FDA-approved and used to treat erectile dysfunction. They are registered trademarks on the principal register in the U.S. Patent and Trademark Office. Viagra is manufactured and distributed exclusively by Pfizer Pharmaceuticals, while Cialis is manufactured and distributed exclusively by Eli Lilly.
Chow offered boxes containing four Viagra tablets and boxes containing eight Cialis tablets for $10 a box on two Internet websites. The retail cost for each Viagra tablet is about $20, while each Cialis tablet is about $15.20. Working in an undercover capacity, ICE agents purchased about 1,120 Viagra tablets and about 360 Cialis tablets from Chow via the Internet on March 25, 2009, and April 28, 2009. Shipping documents accompanying the pharmaceuticals indicated they were exported from mainland China and Hong Kong.
The pharmaceuticals were later analyzed by the trademark holders and the FDA Forensic Chemistry Center which indicated the pharmaceuticals were counterfeit. These counterfeit pharmaceutical products may have harmed the public if law enforcement were not involved in monitoring the Internet.
Chow has been in federal custody since he was arrested Jan. 27; he will remain in custody to serve out his sentence.
The investigation of Chow was conducted by agents with the U.S. Immigration and Customs Enforcement (ICE) Office of Homeland Security Investigations (HSI), and the Food and Drug Administration's (FDA) Office of Criminal Investigations. Assistant U.S. Attorney Samuel Louis, Southern District of Texas, prosecuted the case.
Continued enhanced enforcement is critical in dealing with the deadly criminal act of counterfeit medications.
All stakeholders of the pharmaceutical supply chain must take steps from bogus drugs ending up in their inventories.
To read the entire ICE Press Release, visit: http://www.ice.gov/news/releases/1011/101115houston.htm
To learn about technologies that can detect fraudulent and counterfeit drugs inside their sealed container, visit: http://www.xstreamsystems.net/.
Monday, November 22, 2010
According to SafeMedicines, a newly published report on antimalarial drug efficacy and resistance, scientists believe that fake and substandard malarial medications are a major factor in the development of new drug-resistant strains of malaria.
According to SafeMedicines:
• Resistance to artemisinin has emerged along the border of Cambodia and Thailand, and WHO is putting together a global panel of stakeholders to work to contain this new strain before it spreads to Africa, as other strains did in the 1960s and 1970s. Scientists believe that once a new strain occurs through spontaneous change in the parasite, its ability to survive is promoted by substandard medications.
• Current containment activities involve long-lasting insecticide-treated mosquito nets, recruitment and training of village health workers equipped with rapid diagnostic tests, and most importantly free malaria treatment and follow-up. Free treatment is key to the success of the containment effort because “free treatment and care helps to undermine the sale of counterfeit and substandard antimalarial drugs,” states WHO in the “Global Report on Antimalarial Drug Efficacy And Drug Resistance: 2000-2010.
• “Efforts have also been made to stop the sale of counterfeit and substandard drugs, which are a major factor in the development of resistance,” states the report.
• WHO’s report states that the Cambodian government is working closely to monitor malarial medications and educating consumers in workshops and through reading materials on the extensive dangers fake malaria drugs may cause them.
• “History has shown that once resistance to antimalarial treatment emerges it is only a question of time before it spreads. For the first time, the global malaria community has the opportunity to contain resistance before it spreads,” states the report.
• Artemisinin is a plant-based antimalarial medicine, which due its potency very quickly reduces the number of malaria parasites in humans. Artemisinin compounds are combined with other anti-malarial drugs in therapies called artemisinin-based combination therapies (ACTs). Using combination therapies provide multiple possible agents to kill the plasmodium parasites that cause malaria.
Drug resistant diseases know no borders and effect wealthy and the poor.
All members of the global pharmaceutical supply chain (manufacturers, distributors, regulatory agencies, dispensers and consumers) must insist on it members to use all laws, solutions and technologies to fight this lethal crime.
To view the entire SafeMedicines post, visit: http://www.safemedicines.org/2010/11/fake-drugs-major-factor-in-new-malaria-strain-says-who-49.html
To learn more about anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/
Saturday, November 20, 2010
According to a report by ABC News, the AVA believes the trade in internet drugs for animals is growing as farmers try to contain costs:
• AVA president Dr Barry Smyth says livestock producers need to be particularly careful with what they buy.
• "We know that somewhere between 5 and 10 per cent of these products are counterfeit and not what they're supposed to be so there's a real danger you may not be getting what you're paying for," he said.
• "For people in the livestock industries they need to be very careful what they treat their animals with, because of residues in animal products."
The danger of fraudulent, adulterated, sub-standard and counterfeit drugs are everywhere but seem to proliferated online via the internet.
All pharmaceutical supply chain experts agree, never purchase pharmaceuticals online via sources that are not directly connected to an actual, legitimate pharmacy and/or does not require a physician or in this case veterinarian’s prescription.
To read the ABC News story, visit: http://www.abc.net.au/news/stories/2010/11/05/3057896.htm
To learn more about anti-counterfeit technologies for pharmaceuticals, visit: http://www.xstreamsystems.net/.
Friday, November 19, 2010
In a story by Constantinos Ioannou which appeared in the November 11 issue of the Cyprus Mail, two pharmaceutical companies within Cyprus have been implicated in a case of counterfeit cancer treatment drugs which are being illegally smuggled into the European Union.
According to the Cyprus Mail article:
• Cypriot police received a court order from the German Federal Police on Tuesday and searched four premises on the island, two in Larnaca district and two in Limassol district.
• The premises searched belong to two pharmaceutical companies which have been operational since March. There were also simultaneous searches conducted in Germany, Norway and Switzerland.
• Police spokesman Michael Katsounotos yesterday said: “From investigations conducted so far it does not appear that any crime was committed on Cypriot soil.” Katsounotos also assured the public that none of these counterfeit drugs were available in the Cypriot market.
• According to Katsounotos the counterfeit cancer treatment drugs were manufactured in England and were due to be distributed outside the European Union only. However upon receiving them, pharmacists in an unnamed third country modified the drugs and sold them to various other countries, some of which are based in the European Union. Investigators in Norway and Germany came to the conclusion that the modified counterfeit drugs were brought to Cyprus and then distributed to markets around the world.
• The two pharmaceutical companies on the island which have been implicated in the investigations are alleged to have purchased the counterfeit cancer treatment drugs before distributing them to Norway and Germany.
• Katsounotos said that the owners of the companies have been questioned but it appears at this point that no crime was committed on Cypriot soil. However he added: “Further investigations are due to take place and the completed file will be given to the Attorney-general who will make the final decision if there are any charges to be brought against the companies.” Katsounotos also added that some of the drugs were taken to the Netherlands where documents were falsified to show that they came from Cyprus.
• Katsounotos assured the public that none of the drugs were available in Cyprus, although he could not clarify if the counterfeit cancer treatment drugs were in Cyprus at any point.
• “That is the object of our investigation, what we know as fact is that documents were falsified in Holland to show that these drugs came from Cyprus,” he said.
• The Director of the State Laboratory Popi Kanari also warned yesterday that the use of counterfeit drugs, which can be usually purchased via the internet or other unofficial sources may pose serious risks to a person’s health.
• Kanari stressed that these drugs have not gone through the proper procedure of registration at the ministry of health. Kanari said: “Such drugs have been tested numerous times by the lab and have been found to contain toxic substances that can cause serious problems to one’s health”.
The criminal act of counterfeit medications is not limited to undeveloped countries and traditional black market activities.
Adulterated, fraudulent, sub-standard and counterfeit medications are making their way into the legitimate supply chains in developed countries by using illegal transactions and documentation.
The fraud of altering the transactional drug pedigrees, basically authenticating counterfeit or sub-standard drugs as real and efficacious is as dangerous and lethal to the patient as the poisons inside the bogus drugs.
The danger counterfeit drugs represent to entire health care populations is very real and all members of the pharmaceutical supply chain should take proactive measures to protect their inventories and consumers.
Thursday, November 18, 2010
In a November 16th article in the In-PharmaTechnologist, Nick Taylor reports on the development of a new database that is due to launch early next year by the US Pharmacopeia (USP).
USP’s database will allow regulators and organizations the ability to monitor counterfeit and substandard drugs and to support more informed enforcement actions and procurement-related decisions.
According to Mr. Taylor’s article:
• Speaking to in-PharmaTechnologist at AAPS 2010 Patrick Lukulay, director of the promoting the quality of medicines (PQM) initiative at USP, outlined how timely sharing of information can support enforcement actions.
• Lukulay said the database could have supported a more effective response to counterfeit medicines that spread to Mali after first being seized in Ghana. Using the database regulators in Mali would have been aware of the products, which had the same batch numbers as the products seized in Ghana, and acted accordingly.
• Having created the architecture the USP is now inputting information about counterfeit or substandard drugs into the database. Listed on the database will be the name of the product, the country it was seized in, what was wrong with it and other descriptors, said Lukulay. If countries agree the database will be shared with the public.
• The benefits of sharing information also underpin the USP's creation of a 'virtual forum'. This will allow users to pose questions, share alerts and discuss best practices among a network of people involved with ensuring the quality of medicines.
Secure Pharma Chain, supports all efforts to share information in fighting the deadly crime of adulterated, fraudulent, substandard and counterfeit drugs.
It is critical that each member of the supply chain bear the responsibility of securing their inventories in order to protect their business brand and ultimately the health care consumer.
To read the entire story, visit: http://www.in-pharmatechnologist.com/Processing-QC/USP-building-database-of-fake-substandard-meds
Wednesday, November 17, 2010
FreightWatch recorded 77 incidents for the month of October, a substantial increase over the 55 incidents recorded in September.
As the holiday season approaches, increasing freight movement becomes an opportunity for thieves to target high-value loads.
California continues to report the highest number of thefts accounting for 34% of all incidents reported in October. Florida, Texas, New Jersey and Georgia remain at the top of the list and continually report slight variances in the number of thefts from month to month.
By commodity, pharmaceuticals had six reported incidents in October which doubles the number from the previous month:
• October 1st in Jacksonville, Florida a last mile delivery of pharmaceuticals was taken of an unreported value.
• October 3rd in Hollywood, California a warehouse burglary of a pharmaceutical distribution center of an unreported value.
• October 7th in San Fernando, California there was a theft of a trailer roadside of an unreported value.
• October 10th in Fort Smith, Arkansas there was a theft of a trailer from a public access lot valued at $50,000.
• October 13th in Dallas, Texas there was a theft of a container of pharmaceuticals of an undetermined value in a public access lot.
• October 15th in Gardena, California there was the theft of a trailer of pharmaceuticals of an unreported value.
The issue of pharmaceutical cargo theft energizes the need for material screening of products within the supply chain, from manufacturer to dispenser, to properly protect consumers everywhere.
As the value and prevalence increases, so too does the potential risk to consumers.
To read the entire report from Freightwatch International, visit:
To learn more about pharmaceutical material screening technologies, visit: http://www.xstreamsystems.net/
Tuesday, November 16, 2010
George Omondi and Mwangi Muiruri in Business Daily Africa, write an excellent article about a recent World Health Organization newsletter report describing Kenya as a “safe haven” for counterfeit drugs.
Included in the Business Daily Africa story:
• Kenya is a safe haven for a cartel that has choked the domestic market with counterfeit and untested medicine smuggled through informal channels, the World Health Organization has said, warning that the country could incur huge costs in mitigating the side effects of the drugs.
• The value of both genuine and fake medicines sold illegally to unsuspecting consumers is roughly $130 million annually, says the organization in its October newsletter.
• The value includes drugs donated by international agencies, those stolen from hospitals and expired or fake ones made by backstreet firms and routinely smuggled in through East Africa’s porous borders.
• The cartel — believed to include senior Health ministry officials— runs a complex web of informal trade, spanning the five East African Community countries, DR Congo and Southern Sudan.
• The rogue merchants, who devise elaborate schemes to disguise their activities, are aggressive and smart, according to WHO, which blames the menace on weaknesses in border controls. “They (cartel) establish fictitious front companies and use falsified documents to exploit weaknesses in border control as governments reduce border inspections to encourage free trade,” WHO says in the Newsletter.
• The concern over drugs safety comes just weeks after local pharmaceutical producers complained of frequent theft of narcotics in their premises by what they termed “ well co-ordinated cartels.” Drug companies are allowed to buy narcotics which they use as raw materials in making medicines under the strict watch of regulators.
• “This has become a well co-ordinated business because in most cases, we realise that up to five pharmaceutical companies have been raided and all their narcotics stolen in one night without any clue for arrests,” said a manager at one of the local pharmaceutical firms, which cannot be named for security reasons.
• The raids have sparked widespread fears over the authenticity of drugs sold over the counters and hospitals with the Pharmacy and Poisons Board (PPB), the government agency that regulates the sale of medicines, saying yesterday it had issued strict cross-border trade rules to tighten the noose on the cartels.
• The board’s head of pharmacovigilance department, which tracks the movement of drugs, Dr Jayesh Pandit, said the recent designation and gazettement of all entry and exit points for drugs would push the cartels out of business. “Our instruction to all regulatory and law enforcement agencies in the region is that any drug that is not inspected and cleared at the designated points should be confiscated immediately,” he said, adding that the international community had taken long in stamping out the cartels because of “too much” focus on infringement of intellectual property rights of big pharma, loss of monopoly or financial losses.
• “Unfortunately, lesser attention is given to the number of lives lost, number of severe drug reactions experienced and the morbidity associated with the murderous trade of counterfeiting,” said Dr Pandit
While disturbing, unfortunately this article and WHO report is not surprising.
Much like the more infamous illegal drug cartels in Central and South America, these bogus drug criminal organizations exact a tremendous amount of influence within small countries. The return on investment in fake medications is significantly higher than nearly all criminal endeavours. Populations will continue to be at risk as long as law enforcement and the legitimate supply chain allow these crooks to poison their consumers.
To read the entire Business Daily Africa article, visit: http://www.businessdailyafrica.com/Corporate%20News/WHO%20names%20Kenya%20as%20safe%20haven%20for%20fake%20drug%20cartels/-/539550/1050938/-/jud3flz/-/
To learn about pharmaceutical supply chain safety solutions, visit: http://www.xstreamsystems.net/
Monday, November 15, 2010
Products in the shipment included Avapro, Avalide, Coumadin, Abilify, Reyataz and Plavix.
The stolen truck - which was plain white with no unique markings - was taken from a rest area in Florence, Kentucky, after being left unattended for approximately 15 minutes by the driver and a passenger.
The driver had been forced to park some distance away from the main facility because the rest area was full. Evidence from the scene indicated the thieves made entry by breaking the lower window on the passenger side.
FreightWatch has recorded 27 pharmaceutical theft incidents year-to-date in the United States, with an average loss per shipment of $5.1M, up from $4M in 2009.
Secure Pharma Chain is encouraging all members of the pharmaceutical supply chain to be vigilant in protecting their inventories from all suspicious offers of medications from unknown sources. Stolen products are especially dangerous in that the actual drugs will not be handled properly-while the product containers will likely be emptied of the legitimate drugs- replaced with counterfeit drugs and sold within the supply chain.
The most effective solution for the interdiction of fraudulent, adulterated, sub-standard and counterfeit drugs is verifying the drug inside a sealed container with an material authentication technology.
To learn about material authentication technologies, visit: http://www.xstreamsystems.net/
Saturday, November 13, 2010
In a press release from the U.S. Agency for International Development (USAID), they announced that substandard and counterfeit versions of thirteen key anti-malarial medicines were uncovered in multiple locations across Ghana by the Medicines Quality Monitoring surveillance program.
Set up by the Ghana Food and Drugs Board (FDB) in collaboration with the U.S. Pharmacopeial Convention (USP) and the U.S. Agency for International Development (USAID), the program samples anti-malarials across the public and private sectors.
The program was established in 2008 and is implemented by USP's Promoting the Quality of Medicines (PQM) initiative. USP is a scientific nonprofit organization that develops globally recognized standards for the quality of medicines. Through the PQM program, USP works in developing countries to help verify and improve the quality of medications intended to treat life-threatening neglected diseases such as malaria, HIV/AIDS and tuberculosis.
"Few people fully realize the devastation that distribution of substandard or counterfeit medications can wreak on vulnerable populations," said Stephen Opuni, M.D., chief executive officer of the FDB. "In this case some of the drugs discovered contained no active pharmaceutical ingredient, while others failed to meet required quality standards. This causes great harm in two ways: the individual patients taking the drugs get no relief, and drug-resistant strains of malaria may grow stronger. In addition, people lose confidence in the efficacy of medicines and may be reluctant to seek medical help when they need it. I'm very pleased with the outcomes we're seeing from the Medicines Quality Monitoring program."
In 2009 the same program uncovered a counterfeit version of Novartis' Coartem®, another widely used anti-malarial. In that case, an alert citizen notified the authorities after suspecting the drug he bought might be fake.
"Last year's seizure of counterfeit drugs showed the importance of public education," said Patrick Lukulay, Ph.D., director of the PQM program. "In the current case, rigorous surveillance worked very well. The fact that the fake and poor quality drugs were so widespread—found in many areas across Ghana, and in many types of outlets—underscores the need not only for continuing surveillance but also for active enforcement of anti-counterfeiting laws."
The discovery of the counterfeits—tragically, in use at a government-run hospital and private clinic, and being distributed through many pharmacies—has resulted in a nationwide recall of all thirteen drugs, including publicizing the names of the outlets where they were found.
This is intended as a strong deterrent, making pharmacy and hospital procurement personnel more vigilant about their suppliers. Manufacturers of some of the recalled medications will be required to meet with the FDB for required regulatory sanctions.
The American people, through the U.S. Agency for International Development, have provided economic and humanitarian assistance worldwide for nearly 50 years.
Secure Pharma Chain agrees with the conclusions of enhanced public education, more rigorous enforcement of laws and official collaborations between public and private standards as essential in combating this lethal crime.
The members of the global pharmaceutical supply chain (manufacturers, distributors and dispensers) need to take the lead on defeating this crime. Waiting for agencies and regulations is not an option, proactive deployment of solutions and technologies designed to interdict and protect inventories from fraudulent, adulterated, sub-standard and counterfeit medications by the commercial interests seemingly is the most effective and efficient way to eradicate this deadly epidemic.
To learn more about anti-counterfeiting technologies for pharmaceuticals, visit: http://www.xstreamsystems.net/.
Friday, November 12, 2010
According to an email alert, Freightwatch International, an industry leader in providing cargo theft intelligence through data collection, analysis, and customized reporting, the theft occurred approximately 225 miles from the shipment’s point of origin.
The load value of the shipment has not been established, but is reported to be worth several million dollars.
The driver and his passenger reportedly left the truck alongside the exit ramp from the rest area because all the parking spaces were full. The vehicle was reportedly left unattended for approximately 15 minutes.
FreightWatch highly recommends that shippers of highly targeted goods such as electronics and pharmaceuticals ensure their transportation providers are aware of all in-transit security requirements and that the shipper has the capability to audit their compliance at any time.
Members of the pharmaceutical supply chain need to be on alert for these stolen goods and their containers. It is likely that the criminals will sell the products which may be harmful if not properly stored and use their containers to introduce counterfeit medications into the legitimate supply chain.
To read more about this, visit: http://www.freightwatchintl.com/
Tuesday, November 9, 2010
Alicia Mundy in a Wall Street Journal article reports on a Government Accountability Office (GAO) report criticizing the Food and Drug Administration (FDA) for creating the appearance of favoritism toward a Boston company that won lucrative first rights to sell a generic drug after providing free consulting work to the agency.
According to the Wall Street Journal article:
• A congressional committee plans to release a report by the Government Accountability Office that says the FDA risked giving the appearance that it had compromised its integrity because of its dealings with the company, Momenta Pharmaceuticals Inc.
• Winning the first right in July to sell the generic version of the blood thinner Lovenox has already meant hundreds of millions of dollars in sales for Momenta and its partner, Novartis AG's Sandoz unit.
• Also critical of the FDA's actions are Momenta's rivals—including Teva Pharmaceutical Industries Ltd., the world's largest generic drug manufacturer, and Amphastar Pharmaceuticals Inc.—as well as a recently retired official in the FDA's generic-drug division. The drug companies' applications are still awaiting FDA action.
• The controversy centers around Momenta's performance of months of free work for the FDA during a high-profile investigation of tainted Chinese drug imports in 2008. At the same time, agency officials were reviewing the company's application to sell the generic version of a blockbuster blood thinner.
• As a result, "agency officials ran the risk of undermining public confidence in the integrity of FDA's operations," including heparin-related drug approvals, the report says,
• In response to the report, requested by Rep. Joe Barton (R., Texas), the FDA said it needed to draw on Momenta's expertise to find the cause of the tainted Chinese imports, but it acknowledged it should have considered potential conflicts of interests and done more to disclose them.
• The FDA has said its reliance on Momenta's free work had nothing to do with its approval of the company's drug ahead of competitors'.
• Momenta said it conducted the investigation for the FDA in the interest of public health, not because of its drug application.
• Since Momenta and Sandoz won FDA approval for their rapid-acting heparin in July, the drug's sales have topped $300 million.
• Richard Adams, a former official in the FDA's generic-drug division who retired this year, agreed with the bias allegation . "Everyone closely involved saw that it was stacked and the whole direction was toward Momenta," he said.
• The FDA turned to Momenta for help in early 2008, when it was trying to figure out what was tainting a widely used older form of heparin. Hundreds of people were suffering severe shock after taking the drug, which was linked to 81 U.S. deaths that year.
• The FDA said that Momenta's researchers did an excellent job identifying the contaminant. "This successful effort to protect public health would not have been possible without the unique expertise and extraordinary efforts of the outside scientists," it wrote in a response to the GAO.
• Rep. Barton criticized the FDA for failing to name the culprit for the tainted heparin and said the report shows the agency's "fundamental weakness" in dealing with the surge of Chinese medical imports.
Although this article spends most of its time dealing with potential conflict of interest and integrity issues within the FDA, Rep. Barton’s final quote is the most important as it relates to the safety of the domestic pharmaceutical supply chain.
Instead of reports and interagency finger pointing, the United States government needs to figure out who attempted to poison the American consumer and bring them to justice. Without this resolution, it seems clear that these criminal acts will continue.
Members of the pharmaceutical supply chain must take it upon themselves to make certain that their inventories are safe from adulterated, sub-standard, fraudulent and counterfeit medications.
To read the entire Wall Street Journal article, visit: http://online.wsj.com/article/SB10001424052748703514904575602781097808598.html?KEYWORDS=heparin
To learn more about pharmaceutical anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/.
Monday, November 8, 2010
In a post that appeared on-line at SafeMedicines, the 8th National Catholic Health Services Conference (NCHS) Annual Conference met in October to discuss “Monitoring for Continuous Improvement: Using Whole System Measures”.
The NCHS annual conference was instituted to create a forum for Catholic Church health institutions to share common and peculiar concerns and experiences.
According to the SafeMedicines' post:
• Ghana’s children suffer 110 deaths for each 1000 children under five years of age, or 11%. One of the most common sources of mortality is malaria. Anti-malarial drugs are among the most common counterfeited in Africa and Southeast Asia where malaria is pervasive.
• The Most Reverend Joseph Afrifa-Agyekum Chairman for Catholic Health Services argued that purveyors of dangerous counterfeit drugs take advantage of unsuspecting people who buy their fake medicines. He said drug counterfeiters take advantage of countries where regulations and law enforcement on drug safety are limited to exploit them and indicated that developing countries where regulatory and enforcement agencies are poorly underfunded and understaffed are a haven for the distribution of fake drugs.
• He (Afrifa-Agyekum) then went on to ask the government of Ghana to take action through the Food and Drugs Board, the Ministry of Health, regulatory bodies and security agencies against the threat of counterfeit medications, stressing that the Catholic Church was committed to working alongside the government.
• According to the source, Upper East Regional Minister Mark Woyongo praised Afrifa-Agyekum and the Catholic Church for their involvement in and aid for the fight against counterfeit drugs.
This story is a cautionary tale and a wake up to those within developed countries. Counterfeit products, specifically medications are not a victimless crime. Fraudulent, adulterated, sub-standard and counterfeit drugs have far reaching implications to entire populations. Drug resistant strains of diseases know no borders nor do they differentiate between the rich and poor.
This crime of counterfeit drugs has the potential to create heath care epidemics and deadly disasters and is one of the largest criminal and health issues of the 21st century.
To read the entire SafeMedicines post, visit: http://www.safemedicines.org/
To learn more about anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/.
Friday, November 5, 2010
Kate Traynor in the American Society of Health-Systems Pharmacists Health Systems News writes an excellent report with some insightful quotes about the October symposium on counterfeit medications that was sponsored by the Partnership for Safe Medicines in Washington D.C.
Included in Ms. Traynor’s story:
• "The problem is getting worse each year. The counterfeiters are winning," said Jeffrey Gren, director of the Office of Health and Consumer Goods at the U.S. Department of Commerce.
• Nancy Kennedy, senior operations manager at FDA's Office of Criminal Investigations, said that counterfeiters previously limited their activities to bringing small amounts of fake medicines into the United States. "Now you see quantities of these drugs coming in and going directly to doctors, clinics, brick-and-mortar pharmacies and...directly to patients," Kennedy said. "I can see international cases' connections growing, and the type and amount of counterfeit drugs and unsafe drugs coming into the country is significantly growing. So I don't like what I see."
• More than 60 nonprofit organizations, including ASHP, are members of PSM, whose stated goal is to raise awareness about the risks of counterfeit medications. The symposium was sponsored by several pharmaceutical companies and other corporate stakeholders.
• FDA Commissioner Margaret Hamburg, the event's keynote speaker, said that in some parts of the world, 30–50% of drugs used to treat serious illnesses are counterfeit products.
• "Still, it's hard to really know the full extent of the problem," she said. "Estimates...vary a lot, and we do need better surveillance and data to truly define the magnitude and scope of the problem."
• FDA announced in the October 13 Federal Register that the agency will commit up to $3.5 million to the World Health Organization for the development of a rapid global surveillance and monitoring system for counterfeits, if the health agencies agree on a cooperative approach to the project.
Industry leadership and consumers in developed countries must be made aware of the danger of counterfeit and substandard medications and that this is no longer just a threat that exists within the third world.
Real solutions and technologies exist today that can eradicate the threat from this dangerous, lethal criminal activity. The global pharmaceutical supply chain must be incentivized to deploy these solutions to protect their brands and the consumer.
To read the entire ASHP article, visit: http://www.ashp.org/import/news/HealthSystemPharmacyNews/newsarticle.aspx?id=3428
To learn more about anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/.
Thursday, November 4, 2010
Pavol Strancansky writes a disturbing if not interesting story about the size, scope and danger of counterfeit medication in Europe for the Inter Press Service. The story is full of insider insight and current statistics.
Included in Mr. Strancansky’s story:
• Millions of counterfeit tablets and medicines, some of them containing lethal heavy metals, are smuggled annually. The World Health Organisation (WHO) estimates that 50 percent of medicines sold online are fake.
• But while some Eastern European states have brought in strict laws and procedures to fight fake medicine smugglers, criminals in the region are thought to be working with international gangs in neighbouring states to bring contraband medicines into the EU.
• Gabriel Turcu, partner at the European anti-counterfeiting organisation REACT, told IPS: "It has been shown that there are people in Central and Eastern European EU member states working with organised gangs in neighbouring countries to bring counterfeit medicines into the European Union and westwards. This is a significant challenge for the region."
• Just like the drug and people trafficking trade, the counterfeit medicine industry is estimated to be worth tens of billions of euros per year for crime gangs, and is mushrooming every year.
• The United Nations Office on Drugs and Crime has estimated that this year the illegal market in counterfeit medicines will provide more than 75 billion euros in revenues for smugglers -- a rise of 92 percent on 2005.
• Police forces say that fake medicines, sometimes so well-prepared and packaged that they can fool even healthcare professionals, are being shipped out by crooks in the same illegal consignments as narcotics. Gangs then sell them on to unscrupulous medicine wholesalers or direct to the public online.
• Health experts estimate that fake medicines -- made from anything from crushed brick to arsenic -- cause up to one million deaths a year, and the UN has said they are contributing to growing drug resistance.
• India and China are thought to be the main source countries for the fake medicines, but customs officers in central and Eastern Europe have said that they are being brought into Europe on the same smuggling routes used for narcotics and people -- through Eastern Europe and the Balkans.
• Pfizer issued a report earlier this year saying that the market in counterfeit medicines in Europe is worth an estimated 10.5 billion euros annually, with people in Italy and Germany spending the most on what later turn out to be fake medicines -- an estimated 3.6 billion and 2.7 billion euros respectively.
• EU officials have said that in a two-month period last year 34 million fake tablets were seized by customs officials while the Council of Europe says that in some parts of Europe fake medicines make up between six and 20 percent of the market.
• Public awareness of the risks of counterfeit medicines is also low, according to research.
• While punishments for drug running and people smuggling are severe and risks high, those for counterfeit medicines are generally far less. In some countries production and selling of counterfeit medicines is not considered a crime and in many Western states it was until relatively recently viewed legally as being on a par with trading in fake branded clothes.
• Turcu, who last week attended a special conference in Bucharest which brought together country representatives and law enforcement officials from across the region to discuss the threat of counterfeit medicines, told IPS: "What is needed is a directive from the EU making it mandatory for countries at national level to qualify counterfeiting as a crime and counterfeiting that harms people as a serious crime."
Along with regulatory action, public awareness and action by industry leaders and members of the pharmaceutical supply chain are crucial in eradicating this very serious, potentially lethal crime.
To read the entire IPS story, visit: http://ipsnews.net/news.asp?idnews=53318
To learn more about anti-counterfeiting technologies designed for pharmaceuticals, visit: http://www.xstreamsystems.net/.
Wednesday, November 3, 2010
Ed Silverman in Pharmalot blogs about the US General Accountability Office recent report which has determined that the FDA failed to implement earlier recommendations that would close the gap between the agency’s approach to inspecting domestic and foreign drug manufacturing facilities.
According to the Pharmalot post:
• The GAO writes that it is unclear if steps being taken by FDA “will prove successful” and there is an “urgent need” to better protect public health by putting GAO suggestions into practice.
• Here are some key findings:
o The FDA boosted its budget for foreign inspections to $41 million in fiscal 2009 compared with $12 million in fiscal 2008 and $10 million in fiscal 2007, and increased the number of foreign inspections.
o In fiscal year 2009, for instance, the FDA conducted 424 foreign inspections, compared to 333 and 324 inspections conducted in fiscal years 2007 and 2008, respectively.
• The GAO examined a list the agency kept to prioritize foreign inspections and estimated only 11 percent of the facilities were completed in fiscal year 2009.
• “At this rate, GAO estimated it would take FDA about 9 years to inspect all establishments on this list once.” That same year, 1,015 domestic inspections were made, or about 40 percent of domestic facilities.
• The FDA did not know how many foreign drug establishments were subject to inspection, because of inaccurate info in agency database. There were 3,765 facilities in the FDA databases, but 2,394 may never had been inspected. Most of these, not surprisingly, are located in China and India.
• The FDA continues to emphasize inspections of establishments listed on applications for a new drug, instead of those already producing drugs for US consumption. The FDA’s approach is “inconsistent” with the GAO’s 2008 recommendation that the FDA inspect plants, “at a comparable frequency,” that are identified as posing the greatest public health, regardless whether these are foreign or domestic, if there is a manufacturing problem.
• The US Department of Health and Human Services acknowledged the need for improvement, but cites obstacles toward progress, such as the need to obtain permission from the foreign government of the country in which an establishment is located in order to conduct an inspection.
Clearly this report is very troubling to the average health care consumer given the proliferation of raw material contamination's, recalls due to poor manufacturing process, adulteration, fraud and a myriad of other issues that plague our pharmaceutical supply chain.
Historically pharmaceutical companies are outsourcing more of their raw materials, production and packaging than ever before and the FDA does not have the capacity or ability to identify all of the manufacturing plants are that produce the drugs that are taken every day by US consumers.
Along with more robust inspections, it is incumbent upon all members of the supply chain to take measures to make absolutely certain that the products of their brand or the products they distribute or dispense are safe and efficacious.
Secure Pharma Chain encourages all members of the pharmaceutical supply chain to implement a variety of solutions and technologies to test and authenticate the products within their inventories to protect their brand and most importantly the consumer.
To read the entire Phamalot post, visit: http://www.pharmalot.com/2010/11/fda-fails-to-inspect-foreign-plants-sufficiently-gao/#more-27487
To learn more about pharmaceutical verification technologies, visit: http://www.xstreamsystems.net/.
Tuesday, November 2, 2010
Ed Silverman in Pharmalot is blogging on another Pfizer Lipitor recall due to the product containing a musty, unpleasant odor.
According to Mr. Silverman:
• The drugmaker already recalled 191,000 bottles of Lipitor - but only the 40mg dose - after receiving consumer reports last July. Once again, the problem is blamed on packaging supplied by another company.
• “The company has identified the source of the problem - the bottle manufacturer’s plant in Puerto Rico, which had shipped empty bottles to the Pfizer plant in Freiburg, Germany for use in packaging Pfizer products,” according to a Pfizer statement.
• The drugmaker adds that the risk of health consequences to patients “appears to be minimal, and steps are being taken to preserve product quality and patient trust,” although still more recalls may occur.
• Musty odors are a growing problem for Pharma. The recall scandal enveloping J&J’s McNeil Consumer Healthcare unit came to light after the FDA earlier this year released a warning letter that the health care giant failed to take sufficient action in response to batches of Tylenol Arthritis Relief Caplets that had a musty smell.
• This is getting costly for Pfizer. Assuming these are the same 90-count bottles that were recalled last time and that these sell for at least $1.50 each, or roughly $135 a bottle, that amounts to $5.13 million at retail, since the pricing comes from PharmacyChecker.com.
• Add that to the $25.7 million from the last recall and the total retail value is now north of $30 million.
Pharmaceutical companies need to protect their brand and the consumer by deploying quality assurance testing of their product, post-production within the supply chain.
Not considered in Mr. Silverman's cost calculations are the cost of managing and returning the recalled product which easily doubles the actual retail cost of the product.
Once mighty brands are losing consumer confidence due to quality control problems that could and should be easily resolved.
Like the issue with J&J this contamination occurred because of issues with a chemical used in the pallets used to store and ship the product. Many things can impact the quality and efficacy of the drug within the supply chain.
To read the entire Pharmalot post, visit: http://www.pharmalot.com/
Monday, November 1, 2010
The China Post is reporting on comments Taiwanese Health Minister Yang Chih-liang made during a press conference recently.
According to the story in the China Post:
-The government has been strongly cracking down on counterfeit drugs since March; as of September, the number of TV ads featuring fake medicine increased by 260 cases while the amount of the fake drugs confiscated is 4.1 that of the year before.
-Yang said in order to combat counterfeit drugs, authorities must tackle manufacturers, distribution, promotion channels and educate the public all at once.
-Pharmaceuticals are usually issued by doctors and pharmacists with prescriptions and proper doses, Yang said, adding that the public needs to develop the mindset that while drugs can cure illness, it can also become a poison.
-Aside from the DOH, the Ministry of Justice, Ministry of the Interior, Ministry of Finance, Coast Guard Administration, the National Communications Commission, the Government Information Office and Consumer Protection Commission have all come together to crack down on fake drugs.
-The total number of illegal fake pills confiscated from January to September is 7,341,958, 4.1 times that from last year.
Secure Pharma Chain encourages all regulatory agencies to take a more aggressive approach in cracking down on this dangerous criminal activity and in educating the general public.
It is important that members of the pharmaceutical supply chain take proactive measures in protecting their inventories and interdicting illicit, adulterated, fraudulent and counterfeit medications.
To read the story in the China Post, visit: http://www.chinapost.com.tw/taiwan/national/national-news/2010/11/01/278201/Proliferation-of.htm
To learn more about anti-counterfeiting solutions, visit: http://www.xstreamsystems.net/