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• How do you know when you’ve purchased a counterfeit product?
• What are the dangers of taking counterfeit products?
• How can you avoid buying or receiving counterfeit products?
• How serious a problem is the counterfeiting of prescription medicines?
• What are the causes of counterfeiting?
• What are the consequences of counterfeiting?
• What is Pfizer doing to combat the counterfeiting problem?
• What can be done to improve the situation?
• What can you do to help?

How do you know when you’ve purchased a counterfeit product?

Consumers may not know that the medicines they’ve purchased are counterfeits. That’s why it’s important to purchase prescription products from a pharmacy and pharmacist with whom you’re familiar.

In some cases, patients have noticed a different taste, consistency, or appearance of products that are later identified as being counterfeit, or they may have a different reaction to the counterfeit drug.

If you suspect the Pfizer product you have pruchase may be counterfeit, contact us at 1-800-438-1985.

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What are the dangers of taking counterfeit products?

One of the biggest concerns is that you may not be getting the therapeutic benefit you expect from the product. For example, a drug you count on to lower your cholesterol level—or to shrink a cancerous tumor—may not be providing any benefit at all because it’s counterfeit. Or the product may contain too much active ingredient, which also could be harmful. A fake drug also could interact with other medications you’re taking and create potential health issues.

Counterfeit products may be manufactured in substandard environments without appropriate controls that ensure their safety and efficacy and they could contain dangerous contaminants.

Given the present environment in which we live, there also is a concern that counterfeit drugs could be used as a tool by terrorists.

Finally, counterfeit products undermine the basic tenet of our health care system: to enable people to live healthier, happier lives.

Read the rest of these Q&A’s on counterfeit medicines.

Counterfeit medicines are any brand (or generic) medicines and active pharmaceutical ingredients (APIs) that are deliberately and fraudulently mislabelled by unauthorised parties with respect to source, and / or composition and / or therapeutic quality. They include products without active ingredients, or with the wrong active ingredients, or with insufficient active ingredients, or with fake packaging. Sometimes they contain substitutes, or are diluted with foreign or toxic bodies, to increase the quantity of the original medicine.

The World Health Organisation (WHO) estimates that 8% to 10% of the medicines in the global medicine supply chain are counterfeit, reaching as high as 25% in some countries. The largest counterfeit market with close proximity to the EU is Russia, where it is estimated that 12% of medicines are counterfeit (1). Counterfeit medicines are entering Europe’s legitimate supply chain in increasing numbers. More than 4.081 million counterfeit medicines packs were seized at Europe’s borders in 2007, a 51% increase on the previous year (2). According to the World Health Organisation, around one percent of medicines in Europe are now counterfeit (3).

To date Ireland has had few incidences of counterfeits attempting to enter the legitimate supply chain however continued vigilance is required. The reality is that as long as repackaging and breaking of seals in the distribution chain is allowed, patient safety will be at risk and the potential for more incidences will only increase.

IPHA encourages patients to purchase prescription medicines through authorised distribution channels only and continues to raise awareness of the dangers of purchasing medicines online. A report published in 2008 revealed that a frightening 62% of medicines purchased on the internet were fake or substandard (4). The pharmaceutical industry spends billions in developing reliable, safe, life-saving and life-enhancing medicines. The system that enables such medicines to reach patients, through the collaboration of regulators, pharmacists, healthcare professionals and the manufacturers of medicines, has protected Irish consumers very successfully.

The European pharmaceutical industry recently proposed a European track and trace system to enhance product security. A pilot project which will see the mass serialisation of pharmaceutical products was launched in Sweden in 2009. Industry has also called for a ban on repackaging of pharmaceutical products; clearly defined liabilities for all involved in the distribution chain (including brokers, traders and agents); stricter auditing rules and controls of the supply chain; application of penalties for trafficking in counterfeits and for patients to be encouraged to purchase prescription medicines through authorised distribution channels only.

The EU Pharmaceutical Package which has begun the co-decision procedure in the European Parliament includes draft counterfeit medicines legislation which has taken note of industry’s calls and includes proposals for increased Good Manufacturing Practice inspections on a risk basis in non EU countries; the use of tamper evident packaging; strengthening of product identification at individual pack level; a ban on repackaging of medicines and auditing of the entire medicines supply chain.

Only when these are implemented will European patients be guaranteed a genuine pharmaceutical product.

1. Association of International Pharmaceutical Manufacturers (AIPM) and the Coalition for Intellectual Property Rights (CIPR) 2002
2. 2006 Customs Seizures of Counterfeit Goods. European Commission. 31 May 2007. http://ec.europa.eu/taxation_customs/customs/customs_controls
   /counterfeit_piracy/statistics/index_en.htm
3. Counterfeit Medicines – a New Update on Estimates. Position statement by the International Medical Products Anti-Counterfeiting Taskforce (WHO). November 2006.
4. Counterfeiting Superhighway (EAASM) 2007 http://www.eaasm.eu/Media_centre/News/
   The_Counterfeiting_Superhighway

Dallas Police Department officials initially proclaimed 2001 a banner year for drug busts, reportedly seizing 1,440 pounds of cocaine and 238 pounds of methamphetamine with an estimated street value of $65 million.

An investigation by WFAA-TV (Channel 8), however, discovered that nearly half the cocaine and a quarter of the methamphetamine seizures contained little or no illegal drugs. Through extensive interviews while tracking lab results and court records, WFAA-TV found that a key ingredient in at least several seizures was gypsum, the main component of Sheetrock.

In a series of broadcasts beginning Dec. 31, WFAA-TV reporter Brett Shipp and producer Mark Smith questioned the legitimacy of dozens of drug cases made by a cadre of street-level DPD narcotics officers and their paid confidential informants.

The suspects in the "fake drug" cases often were curiously similar. Most were recent Mexican immigrants working as auto mechanics or day laborers; few spoke English or had prior criminal records. Often, the alleged drugs were found in duffel or trash bags inside vehicles parked at auto shops or loaned to the suspect.

Many suspects only learned that they faced drug charges days after their arrests. Most, if not all, claimed to have never seen the alleged drugs; several passed polygraphs when asked if they knew about the seized items.

Facing minimum 15-year-to-life prison sentences, many defendants languished in jail for three months or more before the seized substances were sent off for lab tests that later revealed little or no drugs. The findings contradicted the results of field tests police say they conducted during the arrests.

Cases often were based primarily on the word of informants. Police say one of the informants received more than $210,000 - about a third of all the money DPD paid its nearly 150 informants for 2001. Despite dozens of arrests, police produced only a single videotape to help corroborate the drug charges. Few of the seizures - several dubbed the largest in Dallas County history - led to the confiscation of money, weapons or other assets.

Because of the questions raised by several dozen fake-drug cases, prosecutors have dismissed more than 80 cases - including legitimate busts. Nearly all the cases involved two undercover officers and three informants. The FBI is investigating several officers and their payments to these informants.

The cases have also prompted Dallas police and prosecutors to enact a number of policy changes, including:

* all seized drugs are sent immediately for lab analysis

* prosecutors will not seek to indict a suspect until the lab results are completed

* the police chief will be notified of any payment to an informant greater than $1,000

* every three months, audits will be performed on funds used in DPD narcotics cases

* narcotics officers will receive additional training in conducting field tests on drugs

This timeline charts the major developments in the ongoing investigation.

Check out the rest of this time line on fake drugs and the Dallas Police investigation.

LONDON (England) — A slim, easy-to-use device that checks the authenticity of medicines would be available in every pharmacy if Facundo Fernandez had his way.

The gadget he has in mind would provide consumers peace of mind about the safety and quality of prescription drugs — something that is increasingly a concern amid a rise in fake medicines.

A self-described optimist, Fernandez doesn’t think his dream is that far-fetched. “I think it’s possible,” he told CNN. “The technology is available. It’s a matter of making this really widespread.”

An analytical chemist and assistant professor at Georgia Tech, Fernandez has spent the better part of the last decade fighting the global battle against counterfeit drugs.

Taken with the intention of curing illness, phony pharmaceuticals undermine treatment, and in some cases, can have lethal consequences for their unsuspecting buyers.

Fernandez’s work revolves around a technique, called mass spectrometry, that identifies the chemical make-up of a compound. The process is usually time consuming, but Fernandez developed a procedure for speeding up the process.

The ability to analyze the authenticity of hundreds of samples of drugs in a single day played a key role in an international operation that resulted in catching a Chinese manufacturer of fake anti-malaria drugs last year.

Are you worried about the safety of your medicines? What do you think should be done to combat the problem?

Many of the world’s bogus drugs originate in Asia, particularly China, according to the U.S. Center for Medicine in the Public Interest. The fakes oftentimes are exported and change hands many times before reaching their unwitting consumers.

“These are criminal organizations that are manufacturing, distributing and selling counterfeit medicines,” says Thomas Kubic, a former FBI agent and president of the Pharmaceutical Security Institute, a group funded by drugmakers.

The growing trade has been fueled by the growth of Internet drug sales and the lure of lucrative profits. The Center for Medicine in the Public Interest expects global sales of fake drugs to reach $75 billion by 2010.

Victims include those like Nneka and Chimezie Ononaku, a couple in Nigeria who unwittingly poisoned their infant son last month after feeding him teething medicine that was contaminated with antifreeze.

Corporations, too, get hit. Drugmakers like Pfizer, whose erectile dysfunction drug Viagra is one of the most counterfeited drugs in the world, potentially can lose billions in revenue to fakes every year.

Read the rest of this article on fake drugs from CNN.com.

In Southeast Asia, forensic investigators using cutting-edge tools are helping stanch the deadly trade in fake anti-malaria drugs

By Andrew Marshall
Smithsonian magazine, October 2009

In Battambang, Cambodia, a western province full of poor farmers barely managing to grow enough rice to live on, the top government official charged with fighting malaria is Ouk Vichea. His job—contending with as many as 10,000 malaria cases a year in an area twice as large as Delaware—is made even more challenging by ruthless, increasingly sophisticated criminals, whose handiwork Ouk Vichea was about to demonstrate.

Standing in his cluttered lab only a few paces wide in the provincial capital, also called Battambang, he held up a small plastic bag containing two identical blister packs labeled artesunate, a powerful antimalarial. One was authentic. The other? “It’s 100 percent flour,” he said. “Before, I could tell with my eyes if they were good or bad. Now, it’s impossible.”

The problem that Ouk Vichea was illustrating is itself a scourge threatening hundreds of thousands of people, a plague that seems all the more cruel because it is brought on by cold, calculated greed. Southeast Asia is awash in counterfeit medications, none more insidious than those for malaria, a deadly infectious disease that is usually curable if treated early with appropriate drugs. Pharmacies throughout the region are stocked with the fake malaria medicine, which is generally cheaper than the real thing.

Artesunate, developed by Chinese scientists in the 1970s, is a leading antimalaria drug. Its active ingredient, artemisinin, comes from the wormwood plant, which ancient Chinese herbalists prized for its fever-reducing properties. Between 1999 and 2003, medical researchers conducted two surveys in which they randomly purchased artesunate from pharmacies in Cambodia, Myanmar (formerly Burma), Laos, Thailand and Vietnam. The volume of fake pills rose from 38 percent to 53 percent.

“This is a very, very serious criminal act,” Nicholas White, a malaria expert at Mahidol University in Bangkok, Thailand, says of the counterfeiting. “You’re killing people. It’s premeditated, coldblooded murder. And yet we don’t think of it like that.”

Nobody knows the full scope of the crime, although the World Health Organization (WHO) estimates that counterfeit drugs are associated with up to 20 percent of the one million malaria deaths worldwide each year. Reliable statistics in Southeast Asia are hard to come by, partly because the damage seldom arouses suspicion and because victims tend to be poor people who receive inadequate medical treatment to begin with.

That dimension of the problem was made clear to me by Chem Srey Mao, a 30-year-old farm laborer in Pailin, Cambodia. She said she had been sick with malaria for two weeks before she finally visited the district’s main health clinic, a one-story building with a handful of rooms. She had been dosing herself with painkillers so she could work in the fields, sometimes collapsing in the afternoon with fevers and chills. “I needed the money for medicine and food,” she said. “I had to work.”

The most afflicted populations live in remote, rural areas and have limited access to health facilities. An estimated 70 percent of malaria patients in Cambodia seek treatment at local village vendors, who don’t have the expertise or resources to distinguish real pills from counterfeits.

“The first time they get sick they go to a private clinic or small pharmacy,” Ouk Vichea says. “Only when it’s severe do they go to the hospital.” And then it’s often too late.

Read the rest of this Smithsonian Magazine article on counterfeit drugs.