February 1, 2007 Immunochemists have now devised a range of nanoscale materials that can be embedded in drug packaging or in the pills themselves to distinguish medicines from counterfeits. Traces of these FDA-accepted ingredients, which are odorless, colorless, and tasteless, can be detected by a simple field test similar to a pregnancy test. If used in the packaging, the materials have unique spectral properties that make them detectable with light of a specific wavelength.
Imagine taking a drug that was supposed to keep you alive, only to have it almost kill you. That happened to one man, and it could happen to you. Estimates are that up to 10 percent of all drugs in the world are fake. But companies are now creating special detection tools to stop it.
Five years ago, Tim Fagan had an emergency liver transplant. But the real nightmare began when he started taking his anti-anemia medicine. Tim's dad, Kevin, says, "Several hours after the first injection, Tim woke up with violent pains. He was screaming." Tim's doctors couldn't find what was wrong. For eight weeks, it happened after each injection.
"I was absolutely scared for my son's life," Kevin tells DBIS.
It turned out the drug from the pharmacy was counterfeit. Fake packaging disguised the fact that it was 20 times less than Tim's required dose.
Immunochemist Jim Rittenburg says drug counterfeiting is a growing problem, especially because of drugs sold on the Internet.
"The Internet is totally uncontrolled, and it's still a lot like the Wild West," Rittenburg, of the brand protection company Authentix in Philadelphia, tells DBIS. "There are no controls, and you don't know where the product is coming from."
That's why he's working to stay one step ahead of the counterfeiters by putting nanotechnology "fingerprints" into products. The device detects if a drug's seal has been tampered with. For drug packaging, tiny markers are mixed with inks or coatings that change color, indicating the real thing.
Drug containers can also be verified by shining an ultraviolet ray highlighting these markers. For individual pills, the markers are inserted into each pill and confirmed using a test similar to a home pregnancy test that can detect if it's a fake.
"I don't think we'll ever get rid of the counterfeiters -- they'll just move from one thing to another -- but we can make it a lot more difficult," Rittenburg says.
Tim's dad is taking matters into is own hands by working with lawmakers to enact "Tim Fagan's Law" and keep what happened to his son from happening to you.
Ways to protect yourself: Be careful buying drugs off the internet. Instead, get your meds from a legitimate pharmacist. Pay attention to how the drug looks, smells and tastes. If it seems different than usual, let the pharmacist or manufacturer know.
BACKGROUND: Authentix has created incredibly small identifying markers that can be put into pharmaceutical products or on packaging to help field testers spot the genuine from the fakes, by using special sensors. These nano-sized markers (ranging from 50 nanometer to 5,000 nanometer in size -- are FDA-approved and safe for consumption. Fake drugs are not only inefficient -- and therefore potentially life-threatening -- but could also contain hazardous material, such as dangerous bacteria, that could get into the tablets during unsafe production conditions. Authentix also makes markers to thwart currency counterfeiters and for military uniforms so they can be detected in remote locations by aircraft and troops.
HOW IT WORKS: For example, to authenticate drugs pill by pill, Authentix inserts molecular markers made up of travel levels of FDA-accepted ingredients. These markers are odorless, colorless and tasteless organic compounds several nanometers in size, and can be detected through simple field-testing kits that take only a few minutes to perform. A tablet is placed in a bit of liquid. The test works like a receptor-binding pregnancy test: if the tablet contains the right marker, it shows up within one minute on a test strip dipped into the liquid. When used in packaging, nanomarkers can be mixed into inks and coatings and applied onto labels, cartons, closure seals, vial crimps and tops. Because of their unique spectral properties, they can later be detected by shining a light with a specific wavelength onto the packaging.
WHAT IS PHARMACOLOGY? Pharmacology is the study of how drugs work. Understanding how drugs work is not only important for the development of new safe therapies for disease, but also for our understanding of how the body works. Basic pharmacologists develop new drug molecules and study their mechanisms of action and side-effects, while clinical pharmacologists are more involved with the use of drugs in human health and disease. Related disciplines include toxicology (the study of the toxic effects of drugs and chemicals), and medicinal chemistry (the study of the chemical properties of drugs).
The American Society for Microbiology contributed to the information contained in the video portion of this report.
Editor's Note: This article is not intended to provide medical advice, diagnosis or treatment.