Government Agencies Guiding Pharmacists to Dispense Information on Counterfeit Drugs

Counterfeit drugs within the mainstream supply chain have become so prevalent that the Royal Pharmaceutical Society of Great Britain (RPSGB) and the Medicines and Healthcare Products Regulatory Agency (MHRA), leading regulatory agencies within the United Kingdom, are guiding pharmacists to distribute information on the dangers of counterfeit drugs with the prescriptions that they dispense to all of their patients.

This is a cautionary story for all developed countries, including the United States that the issue of counterfeit medications invading its safe and ethical supply channels is coming your way.

Until now many, including leading pharmaceutical industry experts, have considered it remote that a developed country could and would be infiltrated by the scourge of counterfeit medications.

Patients to get counterfeit warning with each prescription
Tuesday , March 31, 2009

New guidance to patients to raise public awareness of fake medicine and its dangers has been launched by the RPSGB and MHRA.

Pharmacies nationwide will receive the guidance, which has been developed in conjunction with patient groups to ensure it is clear and easy to read. Pharmacies will be asked to distribute the new double-sided postcard-sized leaflet to patients in their prescription bags.

The leaflet offers advice to patients about what counterfeit medicine are, how to minimise purchasing fakes and what to do if they suspect they have been sold or supplied counterfeits.

One side of the postcard explains the safest way to purchase medicines and the other outlines 'The dangers of faking it'.

The RPSGB's head of practice Heidi Wright says: "Counterfeit medicine does not work and can make you seriously ill. It's important that people are aware that they should always get their medicine from a reputable source such as a pharmacist or a registered online pharmacy site which has the RPSGB's Internet Pharmacy Logo - and I hope these postcards will help to achieve that."

The MHRA is also looking at ways to target those that use the internet to buy counterfeit medicine.

Guidance for pharmacists explains the background to counterfeit medicine production and highlights how organised criminal gangs have become involved in the production of illegal medicines, supplying them through the internet, often to unwitting patients.

It offers pharmacists invaluable practical advice on the correct steps to take when they encounter suspected counterfeit medicines. These steps include reporting illegal websites to the MHRA to ensure immediate patient safety.

pharmafocus.com

Conference Attendees Share Concerns About Counterfeits

This month, XStream Systems’ Sales Team had the opportunity to discuss counterfeiting issues with pharmaceutical executives from pharmacy providers, manufacturers and pharmaceutical wholesalers at two industry conferences.

In an effort to ascertain industry thought leaders viewpoint on risk liability and current available anti-counterfeiting technologies, a voluntary survey was conducted. Though the survey was conducted on a relatively small statistical sampling, it represents an excellent cross section and a diverse variety of pharmacy experts from national entities, regional players, large corporations and small entrepreneurs.

The following are specific excerpts from the surveys:

• 2/3 of respondents consider the greatest vulnerability of the U.S. pharmaceutical supply chain is with pharmaceuticals from foreign countries, internet sales and loosely regulated suppliers.



• Nearly 75% of distributors and pharmacy providers who responded use some process of pharmaceutical supply security including pedigree tracking, sensor based technologies (RFID, barcodes, etc.), visual inspection, weight inspections and materials analysis but their methods are not uniform. All respondents who do use some procedure ultimately use a variety of processes because collectively they seem uncertain that the methods they have in place can properly protect their inventories from fraudulent or counterfeit products.



• 75% of all respondents were aware of drug identification and authentication system technology but 50% were not familiar with a specific technology or a particular solution.



• 75% of respondents are concerned about counterfeit drugs impacting medication safety to their distributors/providers/patients.

• 75% of respondents are concerned over their financial liability of counterfeit drugs within their inventories.



• 75% of respondents are concerned about their professional reputation being ruined if they were to have counterfeit pharmaceutical in their inventories.

• 2/3 of respondents expressed concern over the issue of counterfeit drugs within the supply chain.



• 75% of the respondents were concerned that their current methods and processes for supply security were not enough to protect their inventories.



• 50% of respondents fear a catastrophic counterfeit event within the U.S. pharmaceutical supply chain in 2009.

A complete report will available shortly on XStream Systems' website at http://www.xstreamsystems.net/

Dallas Man Convicted for Distributing Counterfeit Drugs: Viagra, Cialis, Levitra

Richard Fletcher, 57, of Dallas Texas has been convicted of distributing counterfeit drugs and trafficking in pharmaceuticals bearing false labeling and counterfeit trademarks.

He used the Internet to obtain and distribute counterfeit versions of Viagra®, Cialis® and Levitra® pharmaceutical drugs. These drugs are used to treat erectile dysfunction. Their patents are held by Pfizer Pharmaceuticals, Eli Lilly, and Bayer Corporation respectively.

Fletcher offered the medication over the internet at a discounted price of $1 - $1.40 a tablet. This rate was far below the normal retail price of $11 - $13 a tablet.

The U.S. Immigration and Customs Enforcement (ICE), a division of U.S. Department of Homeland Security, began an investigation in October 2007. Undercover ICE agents posing as customers purchase prescriptions through his website between February and June of 2008. The drugs were later analyzed by the trademark holders and the FDA's Forensic Chemistry Center, and determined to be counterfeit. Also found during the investigation was proof that Fletcher purchased the counterfeits from China and engaged in discussions with Chinese individuals on how to evade detection and seizure of the product.

During this time, agents were also contacted by U.S. Customs and Border Protection (CBP) who had seized 960 Viagra tablets in package addressed to Fletcher at a mail facility in California. The counterfeit Viagra and Cialis tablets obtained as a result of the investigation are valued at more than $46,000.

Watson Recalls Propafenone HCL Tablets Due to Oversized Tablets

Recent increases in recalls due to quality issues have highlighted a need for Quality Assurance (QA) and Quality Control (QC) post packaging within the supply chain especially given the high concentration of contract production/packaging done overseas. One such recall is listed below:

This week Watson Pharmaceuticals, a leading specialty pharmaceutical recalled one lot of Propafenone HCL 225 mg tables in 100 count bottles. This lot number 1112680A with an expiration date of July 31, 2010 is being recalled due to slightly higher levels of the active ingredient.

Propafenone is a medication used to treat cardiac arrhythmias (irregular heartbeats). Some patients who are sensitive may experience potentially serious side effects, including irregular heartbeats or low blood sugar.

More information on this recall is available at: www.watson.com.

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.

Origin of Our Medicine - Does the Consumer Have a Right to Know?

The following is a summary of an editorial that appeared in the Los Angeles Times about the transparency of the global supply chain and more specifically the pharmaceutical supply chain.

We feel that it is important for the safety and security of the American Consumer to understand the extent of how many global imports affect their health and the need for adequate measures to secure them. Many of the products that we consume in the United States come directly or indirectly from countries whose track record on adulterated raw materials and counterfeit products is incredibly poor. How many contaminated or fraudulent products exist within our supply chain and what can we do to protect ourselves from them?

Before I pop this pill, I'd like to know where it came from
(Summary of an editorial by David Lazarus that appeared in Los Angeles Times March 22, 2009)

In his editorial, David Lazarus discusses the issue of the consumer’s right to know not only where their food comes from, but also pharmaceuticals. To prove his point he follows a rather in depth search for the origins of his Sunmark pain reliever, a generic equivalent of extra-strength Tylenol.

He shares with his readers some interesting little know facts he learned along his quest, for instance:

“What I did learn, though, is that more than half of the world's aspirin now comes from China, as does more than a third of acetaminophen and almost all synthetic vitamin C. Chinese drug imports into the United States top $700 million a year.”

He uses two recall examples to emphasis why consumers should be aware of where their medicines originate. One is the recent recall of heparin that occurred last year after more than a dozen deaths. In this case an adulterated ingredient was traced back to Shanghai, China. The second is a recall which occurred in 2006 by Perrigo, one of the world's largest manufacturers of store-brand over-the-counter medicines. Perrigo recalled 11 million bottles of acetaminophen sold under various brands due to small metal fragments which were discovered in some batches. The cause was stated as raw materials obtained from a third party, but Perrigo would not comment on the name or location of the party.

Finally, he gives his suggestions on what he sees as critical information that should be listed on each label. This is necessary in his opinion because as he states: “I'm not saying that drug makers should be required to do everything in-house. But as a consumer, I'm entitled to know exactly what I'm putting in my mouth and how it got there.”

To view the entire editorial, visit the Los Angeles Times at www.latimes.com.

Fake Drugs – Where Do They Come From and Who’s Distributing Them?

Profile of a Counterfeiter – 26 Busted in Purported International Drug Ring

It seems like every week we see a news story on fake drugs being found, being seized, or worse their effects on the unsuspecting buyer. So it lends the questions – Where do they come from? Who’s distributing them?

The answer can be almost as scary as the fake drugs themselves. Counterfeiters come from a variety of backgrounds, some with pharmaceutical experience and some not --such as in our last story about the self-taught chemist, Fernando Reis, who started off counterfeiting steroids and then expanded his operation to Fake Viagra. Perhaps the most unsettling of the group are those who are professional criminals. These individuals have a variety of interests including gun trafficking, illegal drugs, counterfeit apparel and other illegal activities.

Newsday recently reported on an international Drug Ring that was also trafficking Oxycodone, anabolic steroids, untaxed cigarettes and counterfeit sneakers. The Federal authorities have charged 26 people in the case. Twenty-one have been arrested and five are still at-large. Among those being sought are two New Jersey men, Myfit Dika of Wyckoff and Kujtim Lika of Little Falls, both 44, who are believed to be major figures in the ring.

The investigation began in 2003 in the Balkans, Canada and the Netherlands and they eventually tracked the suspects to New Jersey, New York, Philadelphia and Chicago, the FBI said.

This particular case portrays the dangers and challenges of tackling counterfeiting. Investigations into organized crime rings take longer and global supply chains involve cooperation between governmental regulatory agencies to bring them down. The longer the investigation, the longer the public is exposed.

Most disturbing is the question of medication safety and are they getting into the legitimate supply chain? Many would say not, but they have….

...And do you really feel comfortable wondering if that same guy who is supplying the fake Nikes made overseas just may be supplying the same medicine that controls your heartbeat????