Counterfeit Drug Q&A

 

A. 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.

 

 

A. 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.

 

 

A. The United States has a distribution system that is generally considered to be among the safest in the world.  While U.S. consumers can rest assured that the vast majority of the prescription drugs they 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 fourfold over the past several years (from an average of only about five per year through the late 1990s to over 20 per year since 2000).

 

In spring 2003 in the U.S., thousands of bottles of a counterfeit version of Pfizer's cholesterol drug Lipitor® (atorvastatin calcium) were recalled. Also recently, counterfeiters 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. Counterfeit vials of the human growth hormone Serostim—used to treat severe symptoms of AIDS—were 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 Associate (HDMA), National Association of Chain Drug Stores (NACDS) and state agencies are actively working to reduce the threat of counterfeiting.

 

 

A. 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.

 

 

A. 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.

 

The government loses as well. An incredible amount of resources are necessary to combat counterfeiting, not to mention the 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.

 

Counterfeiting is a lose-lose situation for consumers, the government, and legitimate manufacturers as well.

 

 

A.

• 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.

 

 

A. 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.

 

Join a patient organization that represents your disease and seek advice from them on your medicine, how it should be packaged, it's 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.