THE BLOG
09/29/2010 08:58 am ET Updated Dec 06, 2017
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How to Watch Out for Counterfeit Pharmaceutical Drugs

As an avid golfer, I go through my fair share of golf equipment. Recently, I purchased a new set of Titleist wedges from someone online. Having an older set of the exact same wedges, I felt comfortable purchasing from a third party and thought I could ensure that these were authentic clubs made by Titleist. Well, it turns out, that these are counterfeits and when I went to the Titleist web site to file a report on the incident, there was a special link on the main site just to report counterfeit products. So clearly I am not the only one who's been duped.

Using counterfeit golf equipment may damage my handicap and mental well-being, but it certainly wouldn't be harmful to my health. However, consuming counterfeit drugs could cost me a lot more than just money.

The U.S. Federal Drug Administration issued an advisory in June about a bogus version of Tamiflu that improperly contains a synthetic antibiotic often found in penicillin, and which presents a danger to people allergic to penicillin. Since the H5N1 bird flu pandemic in 2006, Tamiflu has been regular target of counterfeiters. Roche, the world's largest biotech company that developed Tamiflu, offers a fact sheet on how to detect the phony versions. But the criminals have the same access to that information and could also be working hard to reduce the different features.

Just like counterfeit consumer goods, it's hard to pinpoint the extent of counterfeit pharmaceutical drugs, but the World Health Organization (WHO) says they are pervasive. We're all familiar with those annoying e-mails urging us to buy pharmaceuticals online. More than half the time, however, drugs sold on web sites that hide their physical Internet Protocol (IP) addresses were found to be counterfeit, according to the WHO.

"Counterfeit medicines are found everywhere in the world. They range from random mixtures of harmful toxic substances to inactive, ineffective preparations," says WHO's counterfeit medicine fact sheet. Incidences tend to be lower in countries where there's strong regulation and enforcement, such as the U.S. and European nations.

There are many counterfeit drugs that look like the real thing. In some instances, only a detailed chemical analysis can determine not only if the right active ingredient is present but also in the right amount. I recently visited a drug manufacturing facility where pharmaceuticals are made under the strictest supervision. Donned in a bunny suit in a clean room, one of the drug company executives showed me a sample of what they manufacturer alongside a fake. To the untrained eye, or even to a trained eye of a pharmacist, they appeared identical. To the consumer, they taste like the real thing, but it isn't the real thing. And this is true of very critical drugs like cancer and AIDS drugs and even vaccines designed to protect our children.

Since 2004, the FDA has encouraged the use of serialization technology such as RFID and barcodes to track real drugs as they make their way through the supply chain. The idea is "traceability," that is, to capture barcode data and share it with trading partners to secure the supply chain, manage inventory, expiration dates and assure the drugs were maintained at the proper temperature.

One of the newest anti-counterfeit technologies undergoing testing comes from GB Innomech in the U.K. It is evaluating a dot-matrix code that can be laser-etched or printed on any substrate including tablets and capsules.

The code, which can be as small as 2 millimeters by 2 millimeters and hold the code for up to 10 billion numbers, can be entered as a "key" into a database to get more detail and to validate the drug's authenticity.

In other words, a doctor in a remote area of Africa could take a picture of the product packaging code, send it to a centralized online database and within seconds have a response to confirm the validity of a product to treat malaria, according to a report in the Cambridge (U.K.) Network on Aug. 16. Leveraging traditional technology such as barcodes, along with modern cell and mobile device technologies, could easily combat the counterfeit problems. When a third-world country in Africa can deploy this type of technology, there is really no reason why the U.S., E.U. and other developed nations can't.

Already, tighter regulations at the state and federal level in the U.S. are on their way, so when you pop a pill before bedtime or get a shot, you have confidence it's a dose of the real thing. In the meantime, information technology, drug packagers, pharmaceutical companies and even pharmacists must keep a wary eye open to ensure the authenticity of drugs.

For more on this growing issue and how to protect yourself, check out this video: