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The Very Real Dangers of Counterfeit Medicines
Counterfeiting medicines is on the rise in the United States and around the globe, putting patients at risk.
Counterfeit medicines are dangerous by their very nature—they are not produced under safe manufacturing conditions or inspected by the regulatory authorities. Therefore, it is impossible for consumers to know what ingredients these products actually contain.
In recent years we have seen a spike in counterfeit medicines in the legitimate medicine supply chain. While the United States is fortunate to have a pharmaceutical distribution system that is generally considered to be among the safest in the world, new cases of counterfeit medicines are emerging every day and Pfizer is not exempt from being targeted.
Even in countries generally considered safe, such as Canada, the United States, and much of the European Union, counterfeit medicines have entered the legitimate supply chain, including counterfeit Lipitor®, Norvasc®, Viagra®, Zithromax®, and Celebrex®
During 2013, authorities from 49 countries seized more than 11.8 million tablets, capsules, and vials of counterfeit Pfizer medicines. Many of the raids resulted from leads developed by Pfizer Global Security.
A number of factors have contributed to this rise in criminal counterfeiting activity. Included among them are the growing involvement in the medicine supply chain of underregulated wholesalers and repackagers, the proliferation of internet pharmacies, advancements in technology that make it easier for criminals to make counterfeit medicines, the increased importation of medicines from Canada and other countries, and the relatively small risk and penalty faced by counterfeiters.
We believe that there is no higher priority than ensuring that consumers have safe and effective medicines.
To realize this goal, both the industry and regulators must work cooperatively around the globe to fight counterfeiting and secure the integrity of the pharmaceutical supply chain.
We have a team of experts who constantly assess new and existing technologies to identify those that will make it more difficult for those who counterfeit our medicines to make convincing copies and for patients and healthcare professionals to distinguish authentic from counterfeit Pfizer medicines.
Recognizing that there is no “catch-all” solution, we work closely with the US Food and Drug Administration (FDA) and other regulatory authorities to ensure that pharmaceutical companies have the resources they need to implement the anticounterfeiting technologies that work most effectively for their products.
We are also working collaboratively with wholesalers, pharmacies, worldwide customs offices, and law enforcement agencies to increase inspection coverage, monitor distribution channels, and improve surveillance of distributors and repackagers.
We’ve also created a diversified international team to rapidly address product integrity issues as they arise and work proactively to stop them from occurring. The team has focused on putting into place business practices designed to protect patient health, increase cooperation with law enforcement agencies to prosecute counterfeiters, and promote public policy that will help eliminate counterfeiting.
Addressing this rising threat requires a sophisticated, coordinated, and united response.
We recognize that in addition to our own initiatives, partnerships must be forged across government agencies, the healthcare community, patients, and third-party stakeholders to ensure that patients have a safe supply of medicines and that justice is served to those who put patients' lives at risk.
We ask you to join us as a partner in this fight to protect patient safety.
This product information is intended only for residents of the United States.
- 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.
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.
How can you avoid buying counterfeit products?
The best way to avoid counterfeit drugs is to purchase prescription medicines at your local pharmacy from a reputable pharmacist whom you know.
Before you fill your prescription online, always see your doctor and get a written prescription first. You should also use an online pharmacy certified by the National Association of Boards of Pharmacy (NABP) when you buy prescription medicines online. This association helps ensure the quality and safety of every online prescription. The NABP’s Verified Internet Pharmacy Practice Sites (VIPPS™) program only certifies pharmacies that meet state licensing and inspection requirements. Use the VIPPS certified pharmacy list to choose a VIPPS™–approved online pharmacy when buying prescription medicines online.
Don't buy medications from online pharmacies that aren't licensed in your country or that offer to write prescriptions or sell medications without prescriptions.
Where available, ask for the product in the manufacturer's original package.
Avoid drugs in foreign packaging because unregulated imports have been a way for counterfeits to enter the U.S. market.
Closely scrutinize the appearance of your medicine and its packaging. Talk to your pharmacist if you notice anything unusual, or if you have a different reaction to your medicine.
Report suspected counterfeiting to the FDA MedWatch Program (or 800-FDA-1088) and to the manufacturer. If you suspect the Pfizer product you have purchased may be counterfeit, contact us at 1-800-438-1985. Remember that if the price of a medicine seems too good to be true, it probably is.
How serious a problem is the counterfeiting of prescription medicines?
The United States has a distribution system that is generally considered to be among the safest in the world.
While the vast majority of the prescription drugs that U.S. consumers buy are safe and effective, counterfeiting is increasingly becoming a more serious problem. The U.S. Food and Drug Administration (FDA) reports that counterfeiting investigations have increased dramatically over the past several years. In 2000 the FDA opened six counterfeit drug cases and in 2004 they opened 58 cases - a nearly ten-fold increase. And it is not just the U.S. that is seeing an increase. In the United Kingdom in 2004, seventeen incidents were reported and in 2005, forty-six; a 270% increase in counterfeiting incidents in one year.
In June 2005, following the discovery that an accredited pharmacy in Canada had dispensed counterfeit Norvasc®, Pfizer’s popular blood pressure medicine – 11 reported deaths were examined for a link to the fakes. The regional coroner reported that of the 11 deaths, the counterfeit medicine could not be ruled out as a cause for four of them. Also in 2005, the United Kingdom saw the recall of medicines from the legitimate supply chain when a counterfeit version of Pfizer’s cholesterol drug Lipitor®(atorvastatin calcium) was found. The resulting nationwide recall of 120,000 packs of the 20 mg Lipitor involved 240 pharmacists. After analysis it was found that approximately 60% of all packs returned were counterfeit.
In 2003, 18 million repackaged Lipitor® tablets – a mix of counterfeit tablets and authentic tablets intended for non-US markets – were recalled from the legitimate supply chain. According to authorities, it was the largest recall of a prescription medicine in the U.S.
It is not just Pfizer whose medicines are being counterfeited. For example, counterfeiters have soaked the labels off vials of a low-strength version of Johnson & Johnson's anemia drug Procrit®, used by cancer patients—and affixed fake labels for the highest strength. And counterfeit vials of the human growth hormone Serostim®, used to treat severe symptoms of AIDS—have been discovered in New Jersey, Texas and Hawaii.
Weaknesses in the drug-distribution system, importation of medicines, the rise of Internet pharmacies, a weak economy, and reductions in health benefits all have contributed to the recent increase in counterfeiting.
The FDA, along with other organizations such as Pharmaceutical Research and Manufacturers of America (PhRMA), Health Distribution Management Association, (HDMA), National Association of Chain Drug Stores (NACDS) and state agencies are actively working to reduce the threat of counterfeiting.
What are the causes of counterfeiting?
Technology to produce everything from labels to active pharmaceutical ingredients is now widely available.
Globalization has made distribution channels easy targets for introducing counterfeit products.
The Internet provides counterfeiters with ready access to consumers and markets.
Regulations governing the drug distribution system do not provide a strong enough deterrent, in terms of enforcement and penalties, to discourage counterfeiters.
Organized crime has become increasingly involved in counterfeiting as it becomes more profitable.
What are the consequences of counterfeiting?
Counterfeiting has significant social and economic consequences.
Most importantly, consumers don't get the safe and effective products they pay for and, instead, may be put at significant risk.
On the economic side, legitimate manufacturers of pharmaceuticals suffer from patent and copyright infringement. Counterfeiting, in reality, "hijacks" the brand.
Additionally, counterfeiters take full advantage of the fact that someone else paid the upfront money for research and development expenses; all counterfeiters have to do is to copy the product.
Governments lose as well. Huge amounts of resources are necessary to combat counterfeiting, there is also a negative affect on tax revenues. In fiscal year 2001, U.S. Customs seized over $57 million in counterfeited and pirated products, which represented a significant loss in taxes.
Additionally, health plans are being defrauded.
Counterfeiting is a "lose-lose" situation for consumers, governments, and legitimate manufacturers as well.
What is Pfizer doing to combat the counterfeiting problem?
Because of the threat that counterfeit medicine pose to patients, Pfizer has implemented an aggressive and focused campaign to detect, disrupt and deter major manufacturers and distributors of counterfeit Pfizer medicines.
We initiate investigations and refer the results to enforcement authorities for their action.
We conduct “market surveys”, making test purchases from pharmacies, to monitor the integrity of our medicines sold in the legitimate supply chain.
Through those efforts we have, since 2004, prevented almost 165 million doses of counterfeit Pfizer medicines from reaching patients around the world.
Pfizer continues to explore and implement new technological developments to deter counterfeiting.
The company uses special packaging and printing techniques that make counterfeiting both more difficult to accomplish and easier to spot.
Pfizer also has put in place business practices designed to 1) protect patient health, 2) increase cooperation with law enforcement agencies to successfully prosecute counterfeiters, and 3) promote proactive public policy that will help eliminate counterfeiting.
Pfizer is working with the FDA, wholesalers, the pharmacy community and others to determine how to best keep the American drug distribution system safe for patients.
Pfizer is working with wholesalers, the pharmacy community, and all regulatory and law enforcement agencies, such as the FDA, the British Medicines and Healthcare products Regulatory Agency (MHRA), the Australian Therapeutic Goods Administration (TGA), and others globally to determine how to best keep the drug distribution system safe for patients.
What can be done to improve the situation?
Strengthen accountability within the drug distribution system through tougher enforcement and penalties.
Evaluate and improve, where necessary, the business practices of all those who distribute or dispense prescription medicines.
Employ new technology that has been proven to be effective against counterfeiting. Determine whether increased regulation is needed at both the state and federal levels. Evaluate whether the FDA will need additional resources to deter counterfeiting. FDA collaborative efforts with industry have been a very positive first step.
What can you do to help?
Ask questions and express your concerns about drug counterfeiting, poorly repackaged products, confusing or foreign labeled packs, or any other issues regarding your medication that you do not feel confident in or would like more help from your pharmacist to explain and resolve. Do not leave the pharmacy if you are unhappy, concerned or confused about any aspect of your medicines, the way the medicine is packaged, or the condition of the medicine or packaging.
Consult your doctor or pharmacist and join a patient organization that represents your interests and seek advice from them on your medicine, how it should be packaged, its appearance, the effects of switching to generic or different formulations, and your rights to refuse any medicine you are not confident in or are confused about. Ask about your rights to your standard, long-term medicine packaging. Inform Pfizer in your country that you are not happy - as this allows us to let the authorities know that patients are also concerned.