Pharmacy Industry and Regulatory Mimic Our Warning During This Flu Epidemic

Earlier this week, XStream warned in several of its blogs about the risks of scammers, spammers and counterfeiters taking advantage of the Swine Flu Pandemic to exploit the public into buying their disreputable fakes and forgeries on-line.

It would appear that now healthcare officials around the globe are similarly offering their own warnings to the public at large. The Royal Pharmaceutical Society of Great Britain (RPSGB) is offering their warning in an article that appeared in healthcarepublic.com news.

David Pruce, Director of Policy at the RPSGB stated: “ With the current fears about swine flu, we are concerned that unscrupulous people are exploiting the public’s fears about swine flu by offering to sell the antiviral drugs Tamiflu and Relenza over the internet. This is a golden opportunity for counterfeiters to offer fake supplies of these drugs. People can be at real risk if they buy medicines from unknown sources.”

As stated before, it is critical that consumers and those within the supply chain use common sense and professional ethics when dealing with this global epidemic. Many are out to scam you with fraudulent product:

1. Only buy from legitimate pharmacies, licensed in your state or country.

2. Do not buy from any on-line pharmacy that does not require a prescription.

3. If the price or deal sounds too good to be true, it probably is.

4. Professionals within the supply chain should only deal with the drug manufacturers or reputable suppliers.

5. They should have a verified pedigree of the product and verify the authenticity of the drug with a materials identification system.

6. Distributors and Providers should not be accepting returns on these products during this pandemic.

In the 21st century we live in a global economy that is connected at light speed via the internet. There are few barriers to being caught up in these scams outside of your own common sense. Buyer beware!

Swine Flu Spam in your InBox

MacAfee has confirmed it! - Swine Flu Spam emails accounted for 2 – 3% of the global spam yesterday. We knew this was inevitable – especially since “Swine Flu” is the topic of discussion everywhere. Those internet pharmacies are trying to sell you their “Tamiflu” before the supply runs out. But buyers should beware!

Many of those spam emails direct the reader to online pharmacies. Readers are warned some of the sites were simply a ploy to scam credit card information out of buyers. Other sites are of questionable origin and may expose the consumers to dangerous counterfeit drugs.

Consumers should be aware that buying medications online from an unknown pharmacy puts their health at risk. Tamiflu is a prescription and needs to be prescribed by a doctor, any pharmacy attempting to sell the drug without a prescription is not thinking of your health and well being. Secondly, you should only buy medications from your local pharmacy or a mail order pharmacy that is tied to a brick and mortar pharmacy.

Wholesale suppliers should heighten their awareness and their security measures. We at XStream suggest adding molecular pharmaceutical authentication to your validation methods. It provides the confidence that both you and your consumers need that only top quality products cross through your doors!

Swine Flu Panic: Beware of Counterfeit Anti-Viral Medications

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

As the world prepares to do battle with the emerging pandemic of Swine Flu, it bears discussing the potential for unscrupulous entities or individuals preying on and taking advantage of the panic for their personal gain.

The global marketplace, already in a deep economic recession is seeing an unprecedented rise in the percentage of counterfeit medications. These counterfeits run the gambit from fake HIV and malarial drugs in Africa and Asia to phony ED and cholesterol drugs in North America and Europe. Even in developed countries, with sophisticated supply chains like the United Kingdom, the statistics are troubling; one in four doctors have already treated patients suffering from the effects of counterfeit medications and their current estimate of percentage of counterfeit medications within the supply chain stands at 10%.

As industry leaders know, when a healthcare panic occurs, supplies of the drugs used to treat the issue become scarce and expensive. Unfortunately drug counterfeiters know that as well.

It does not take long to remember how quickly Cipro became scarce and very expensive during the anthrax scare of 2001.

According to most published reports, basic anti-viral medications seem to work against this particular flu strain for those that are already infected. The proper use of these medications will go a long way in containing and defeating this particular dangerous strain of flu. The brand names of these life saving medications include; Tamiflu, Relenza, Symmetrel and Flumadine.

Realize that the drug counterfeiters of the 21st Century are already producing counterfeit medications. Unfortunately they also have the most efficient and effective way to introduce their fake wares to the consumer at their disposal, the internet. Not only can they create visual facsimiles of the product that they are copying but they can also anonymously sell around the globe without leaving home. Through the internet they can have their fake product shipped to their victim’s doorstep by legitimate means. The counterfeiter also has the luxury of having the money extracted from their victims credit card's into disguised bank accounts. It is very difficult to heed the warning, buyer beware, when can be conned with only a few self-inflicted keystrokes and mouse clicks.

Please heed this important warning: because of the Swine Flu Epidemic anti-viral drugs will become scarce, they will be counterfeited and people will die because they consume these fake drugs.

As a consumer the best way to protect yourself is:

• Only purchase these drugs from a brick and mortar, state approved pharmacy.
• Make sure that you speak with a licensed pharmacist that knows your medical history.

Never buy pharmaceuticals from an internet site that is not affiliated with a state licensed pharmacy and that does not require a physician’s prescription.

If you are a supplier or provider within the pharmaceutical supply chain, XStream recommends:>

• You verify and authenticate your anti-viral medications and inventories through its transactional pedigree.
• You verify and authenticate your anti-viral medications and inventories through material authentication.
• By no means should you accept receivables into your inventories from unknown sources.
• You should not accept return goods products on these specific medications.
• Providers should realize that they are the only barrier to these fake drugs and the consumer, they should remain their professional integrity and diligence.
  
  The best advice for all involved during this scare is for both the consumer and the suppliers to use common sense and understand the dangers that lurk from the panic can come from other sources outside of the actual disease.
  

Compounded Drug Responsible for the 21 Horse Deaths

A Florida pharmacy announced that an ingredient in a drug which they compounded was responsible for the deaths of the 21 polo horses from a Venezuelan polo team that died Sunday at the U.S. Open Polo Tournament in Wellington, Florida.

Fourteen of the horses died while on the field prior to the scheduled match while another seven horses died while in transit to an equine hospital for treatment.

The Florida Department of Agriculture and various other regulatory agencies are performing necropsies and blood tests on the animals. The agencies expect to announce their findings shortly.

Franck's Pharmacy in Ocala revealed that a lawyer it hired to investigate the case concluded one ingredient was off during the mixing process.

"The strength of an ingredient in the medication was incorrect," said Jennifer Beckett, of Franck's Pharmacy. "We will cooperate fully with the authorities as they continue their investigation." She declined to answer questions but offered condolences to the team: "We share their grief and sadness."

The pharmacy was compounding a drug similar to Biodyl, a drug that is not FDA approved or available in the United States. Biodyl described as a vitamin supplement for livestock is used primarily in animals that are engaged in sporting activities or following transport to assist them in their performance or recovery.

This tragedy again strengthens the case for authentication and verification of both the materials used as ingredients and the end use medications for both human and animal consumption. Similar to the adulterated raw material used to produce the Heparin that killed nearly 250 in the United States last year; this incident demonstrates the vulnerability of the United States pharmaceutical supply chain which includes production, distribution and dispensing. Suspicion is now centering on the raw materials that were used in the compounded drugs and the source of supply of these ingredients.

Khaleej Times: No Country Immune to Menace of Counterfeit Medicines

The following story from the Khaleej Times Online, outlines the overall issue and fight against fake drugs in the UAE. The story in full appears below:

Khaleej Times Online
23 April 2009

DUBAI - Though counterfeit drugs are not readily available in the UAE, they still exist since dealing in fake medicines can be lucrative, say experts.

“In the UAE we don’t see too much, but counterfeit medicines are definitely available. It will always be there. There is big money to be made from dealing in counterfeit medicines and there will always be people who try to exploit this, even if it is at the expense of someone’s life,” he said.

“We are looking at different technologies in the fight against counterfeit medicine,” said Dr Mohammed Abu Elkhair, Head, Pharma/Medicine and Medical Products Regulation Section, Abu Dhabi Health Authority (HAAD).

Providing quality pharmaceutical products to the public is a priority for the health ministries across the region.

“The problem of counterfeit drugs is relevant in the Middle East without being a major cause for concern,” Minister of Health Humaid Mohammed Obaid Al Quttami said while inaugurating the Pharmaceutical and Biotechnology Middle East (PABME) congress and exhibition on Tuesday.

He said the issue is less about fake drugs and more about regulating the market. “Legislation has an important part to play,” he added.

The newly formed Saudi Food and Drug Authority (SFDA) in the Kingdom of Saudi Arabia is also aware of the need to maintain a watch over the trade in counterfeit medicines.

Ibrahim Alshowaier, Consultant, SFDA, indicated that a proactive approach should yield best results.

“Counterfeit drugs are a big problem all over the world. It’s not big in Saudi Arabia, but this doesn’t mean we’re immune from the problem. We’re working closely with pharmaceutical companies, the customs people and the police to tackle this issue and maintain vigilance,” he said.

“We’re actively taking measures to block the traffic of counterfeit drugs. For example, we advise customs and the police about what to specifically look for, and we’ll have SFDA personnel operating at border controls and working with the customs officials there. We see this as preventive, and the best way to proceed, rather than targeting the counterfeits once they’re already here,” he added.

However, the UAE Health Minister placed training in the forefront of developing life sciences, specifically the pharmaceutical industry, in
the country.

“The challenges we face in this area are the quality of the industry, and this includes the quality of our human resources available,” he said.

“The people working in this industry need high levels of training, and I think with training, we need to see international practices adopted that will allow us to see solutions developed.

“The pharmaceutical industry will add value to the health services in the country and the region. The economy will benefit also. By providing access to the right level of training, this will be achieved.”

asmaalizain@khaleejtimes.com

Canary in the Coal Mine; Why Everyone Should Be Concerned Over the Death of Polo Ponies in Florida

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

Back in the days before high tech ventilation and gas detectors, one of coal mining’s earliest tools for detecting dangerous levels of methane gas in a mine shaft was a canary. Basically if the bird died, miners had to get out the shaft, quickly.

In a tragic 21st century adaptation of this low tech scenario, last Sunday in Florida, 21 polo ponies died from what is being initially reported as injections believed to be of a steroid derivative potentially contaminated with a toxin. Details are still sketchy and forensic tests are being conducted but this was not a random or unfortunate mistake of spoiled feed or un-potable water, but likely an unintentional mass poisoning at the hands of trained animal healthcare professionals through medications.

According to published reports, apparently prior to the incident, shots were injected by a Team Veterinarian and are suspected to be the cause of this toxic reaction and heart failure in these horses. It is still not clear as to why and for what purpose the horses were receiving the injection.

Bear in mind that these horses are some of the most pampered equines on the planet. Their diet and exercise are closely monitored and regulated by their very demanding owners. Most polo ponies live and receive a higher level of care than 95% of the world’s human population. Their average value is well over $100,000 each, which make this a $2.1m tragedy presumably caused by contaminated product that was thought to enhance their health and performance.

Why is this important to humans? Much like the miners of long ago, we humans are basically sharing the medications literally and figuratively that are used on animals. Although not specifically shared, most of the raw materials and basic production of our medications are identical or the same. Similarly the value and supply chain of medications share many commonalities. Basically, if the high priced pampered pets of the rich can receive contaminated pharmaceuticals, so will humans.

Just like the heparin contamination that caused over 250 deaths in the United States last year, we should take heed of this equine tragedy and realize that our safety is in peril. The drugs that we consume must be protected and analyzed within their supply chain so that we have a level of confidence in the products we are taking to make us or keep us healthy. Not unlike the miners of the 21st century, it is time to protect ourselves with modern technology instead of relying on a canary or in this case a polo pony to keep us safe.

Tainted Drugs Kill 21 Horses in Florida

(Details Developing)

Various news sources, including the South Florida Sun Sentinel, are reporting that as many as 21 horses have died after receiving injections of a drug from an Argentine Veterinarian. It is believed that shots from the veterinarian, who is not licensed in the United States, may have been tainted with some sort of toxic agent.

The horses, or pedigreed polo ponies, belonged to a single Venezuelan team competing in the U.S. Open Polo Tournament at the Palm Beach Polo Club in Wellington, Florida. Each of the horses is estimated to be valued in excess of $100,000.

Fourteen of the horses collapsed on the polo grounds before the start of their scheduled match and seven others died at or while in route to an equine animal hospital several hours later. Efforts to treat the horses at the polo grounds and the hospital were unsuccessful.

The story and details are still developing but Florida officials are conducting necropsies and blood analysis on the animals to determine what specifically caused their death.

It still remains to be determined if the drugs that were injected were legal in the US, where they came from and the source of contamination of the drug.

This tragedy seems to be a harbinger of concern as it relates to medication and product safety for both animals and humans in the United States. The issue of counterfeit, adulterated and tainted medications worldwide continue to kill and injure hundreds of thousands of people and animals annually and now appears to be poised to significantly impact the population here in the United States. There is little distinction between human and animal medications as it relates to the production of pharmaceuticals, any issue that impacts one group of consumers will ultimate impact the other.

XStream believes that materials analysis of all medications within the supply chain (production, distribution and dispensing) is vital as it relates protecting all health care consumers from counterfeit, adulterated and contaminated medications.

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 stops Neilgen Pharmaceuticals and Advent Pharmaceuticals from making unapproved drugs

This week FDA obtained a permanent injunction barring Neilgen Pharmaceuticals and Advent Pharmaceuticals and two of the companies officers Bharat Patel and and Pragna Patel, from manufacturing and distributing any unapproved, adulterated, or misbranded drugs

FDA noted that between the two companies they manufacturered over 50 unapproved drugs. These medicines are primarily prescription cough and cold products. Furthermore, FDA is requiring that their existing drug supply be destroyed and are advising consumers to discontinue their use.

These actions were sought after the companies failed to comply to previous warnings and continue to manufacture the unapproved drugs.

To view the entire announcement, visit the FDA website.

Pirated Pills

The Sunday Leader reported that: Leading medical professionals claim that 30% of the medical drugs currently circulating in the country of Sir Lanka are fakes…

Several doctors at leading universities have voiced their concern over the validity of the drugs administered to patients and the difficulty in discerning the real version from the fake. “They (the counterfeiters) have all the packaging equipment — they look and feel exactly the same as genuine tablets even I, as a doctor, wouldn’t be able to tell them apart — but they are fake and sometimes harmful.”

The fake prescription can contain a variety of ingredients from sugar to borax, cement, toxic dyes, or other harmful chemicals. The scope of the counterfeits in Sir Lanka is enormous. At a current rate of $300 million in imports a year and a 30% counterfeit rate, the fake drug market would be valued at $90 million a year.

While counterfeit medicines are seen worldwide, two reasons cited for their prevalence in Sir Lanka is the lack of testing facilities locally and the lack of proper regulation. Regulatory authorities often rely on the importing pharmaceutical company testing and certification to document the medicines validity. (This in some cases is rather like putting the fox in charge of guarding the hen house.)


Disheartened, these doctors feel there is no valid way for them to check for substandard drugs in their county. We at XStream understand first hand the importance of pharmaceutical screening. There are options for checking the authenticity and quality of your medicines beyond packaging and traditional security measures. If you would like more information on this quick easy method of pharmaceutical authentication, please visit www.xstreamsystems.net.

Taiwan Survey Finds 8% of Drug Stores Have Fake Pills

In a March 27th story in the China Post it was reported that the Taiwan Medical Product Anti-Counterfeit Task Force (TMPACT) surveyed pharmacies and consumers and found that 8% of the surveyed pharmacists reported that they had counterfeit pills in their stores.

The survey was conducted in 2008 with over 90% of those surveyed responding to the questionnaire.

According the report, Taiwanese consumers of Viagra, Viartril-S and Reductil are the most at risk for consuming counterfeit medicines. Susceptible and targets in general are afrodyn drugs, diet pills, joint and arthritis pills, stomach pills and vitamins.

TMPACT is currently using authentication technology to identify counterfeit medications and is hoping to work with the Department of Health in the future to combat the issue of fake medications.

UK Associations Supporting MHRA Requirements to Combat Drug Counterfeits

Medical News Today reported that several prominent pharmacy associations within the UK are supporting proposals for the MHRA to strengthen the pharmaceutical supply chain and reduce the risk from counterfeit medications.

This endorsement, seemingly unprecedented within the US and EU, is another telltale sign that the impact of fake and counterfeit medications within this highly regulated and developed nation has reached a point where significant measures need to be in place to protect the pharmaceutical supply and its consumers. Hopefully other pharmacy organizations within the US and EU will follow suit to protect their populations.

Read the story below:

Pharmacy Bodies Response To Reducing The Risk From Counterfeit Medicine

(March 26, 2009) The Association of Independent Multiples (AIMp), Community Pharmacy Wales (CPW), Company Chemists Association (CCA), The National Pharmacy Association (NPA) and The Pharmaceutical Services Negotiating Committee (PSNC) have responded to the MHRA consultation on measures to strengthen the medicines supply chain and reduce the risk from counterfeit medicines.

The pharmacy bodies support the proposals for the MHRA to strengthen the requirements for holding a Wholesalers dealer licence (WDL) and also the new proposals for Responsible Persons with the establishment of a Code of Conduct against which Responsible Persons can be judged. The MHRA should also have the power to remove a Responsible Person from the register. The bodies also support the introduction of a due diligence obligation for the holder of a WDL.

Whilst supporting the proposals to ensuring that potential offences relating to counterfeit medicines are provided for in legislation the bodies oppose the introduction of an offence for failing to report a suspect counterfeit medicine. A criminal sanction is inappropriate for failure to report.

To view the article visit www.medicalnewstoday.com

Russia: Four Pharma Execs Found Guilty of Counterfeiting 50 Brands of Medicine - Get Slap on the Hand

Four pharmaceutical executives from a prominent Russian pharmaceutical company, Bryntsalov A, were convicted in Moscow of counterfeiting over 50 different brands of medicine but all they got was a slap on the hand. Tatyana Bryntsalova, Oleg Zharov Sergey Novikov, and another executive received a suspended sentence, parole and fines of 30,000 – 50,000 rubles (about $900 - $1,500).

The knock-offs were sophisticated immitations, which made it difficult for doctors or patients to distinguish the fakes from the genuine products. According to police investigators around $2.5 million of medicines were manufactured by the company in 2004 and 2005.

TheraFlu, Viagra, No-Spa, Mezim-Forte, Nootropil and Baralgin are among the American and European drugs that were imitated. So far, however, only the American company Pfizer has indicated that it will take any action to seek restitution from Bryntsalov A.

Some of these medications were found in Russian hospitals. One of the fake medicines, Cavinton, made its way to a large research hospital in Siberia. The doctors there unknowingly administered around 3,000 doses of the fake Cavinton to their patients. The investigation eventually traced the fakes to a warehouse in Moscow registered to Tatyana Bryntsalova.

Tatyana Bryntsalova, former director of Bryntsalov A, is known to have strong political ties in Russia. She is a sister of the pharmaceuticals and vodka business tycoon, Vladimir Bryntsalov, the founder of Bryntsalv A and a former presidential candidate.

To view the entire article visit MosNews.com.

SecuringPharma – a New Counterfeit Drugs News Site Launched

Recently, SecuringPharma.com, a new free-to-access information service that covers the issues surrounding supply chain and brand security in the pharmaceutical industry went live. SecuringPharma.com provides practical advice and intelligence to help manufacturers define and pursue their own strategies for tackling the problem of counterfeit drugs and supply chain security.

XStream Systems, in an ongoing effort to provide our readers with the latest news regarding counterfeit drug issues, have included a link to this resource for your convenience under “Other Sites of Interest”.

Also included in this listing is another website, KnockoffReport.com. This site is dedicated to an overview of all counterfeiting and IP violation issues as well as counterfeit drugs.

We believe our readers will find these sites helpful and look forward to adding additional links in the future to help keep you informed on all the pharmaceutical security news.

Another Recall Concerning Inferior Drugs

Pharmaceutical recalls concerning the substandard production, size, dosage and quality of the product already within the domestic supply chain have proliferated recently within the United States.

These broad recalls seemingly demonstrate a broad lack of regulatory control and inspection at the point of manufacturing and import.

We believe that it is important that all of the members of the pharmaceutical supply chain engage in materials authentication and verification in order to protect their inventories from shoddy product that will impact the health of the consumer.


Caraco Recalls Generic Pills Over Irregular Sizes (Update1)

Caraco Pharmaceutical Laboratories Ltd. recalled generic heart tablets that may contain the wrong amount of medicine, sending the drugmaker down the most in four months in New York trading.

The voluntary recall covers 0.125 milligram and 0.25 milligram digoxin tablets distributed before today and within the expiration date of September 2011, according to statements released today by the company and the U.S. Food and Drug Administration. Size differences among the pills may mean they have too much or too little of the active ingredient.

The full article can be viewed on www.bloomberg.com.

Counterfeit Drugs are No Joke - Counterfeit and Substandard Cancer Drugs Sold to Consumers in India

Counterfeit drugs have a serious impact on the public’s health. As those who produce the spurious drugs have become more sophisticated and organized, they have stepped up their inventory to include life-saving medications, thus intensifying the dangers to the consumer.

Reported in The Times of India this week, The State Health Department in India has uncovered a counterfeit drug ring where crucial anti-cancer drugs have been illegally manufactured, re-bottled, and sold after their expiration dates.

The initial investigation has proved that these products have reached the public and have been consumed. Officials involved in the investigation have not determined yet if any deaths have resulted in the distribution of these spurious drugs due partly to the expanse of their distribution.

Officials have stated that the criminal ring posed as at least four legitimate manufacturing facilities and those manufacturers have denied any part in the production of these medicines.

The investigation is ongoing as officials examine the numerous outlets that sell anti-cancer drugs.