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The FDA, consumer groups, and a number of American politicians have expressed concerns about counterfeit (or outright fake) drugs coming into the United States from pharmacies abroad. Senator Charles Shumer (D-NY) leads the fight, saying, "We shouldn't have to play Russian roulette with our prescription medication." (1)
The FDA suggests that a goodly number of prescription drugs purchased from outside the US are counterfeit or fake - in some countries, as much as 50% of the prescription drug supply. "Dr. Dora Nkem Akunyili, head of Nigeria's equivalent to FDA, says the counterfeit rate in her country could be as high as 90%."(2) These counterfeits can be deadly, but estimating the death toll is elusive. Most experts put it in the thousands, however.
So it's clear that one risks getting a counterfeit or fake drug when ordering from abroad. But this begs the question, how many prescription drugs supplied wholly within the US are counterfeit or fake? The answer, put succinctly, is: no one really knows. The FDA is trying to figure that out, but it's tricky - it's not like counterfeiters put a special label on their packaging. As the chart from FDA (below) shows, counterfeit drug investigations by the FDA increased fourfold from 2000-2004.
Updating the information, Bloomberg.com points out, "The FDA opened 32 counterfeiting investigations in the fiscal year that ended last September [2005] and 58 in fiscal 2004, FDA officials said in June."(3)
According to the FDA, "…these investigations have involved well-organized criminal operations that seek to introduce finished drug products that may closely resemble legitimate drugs yet may contain only inactive ingredients, incorrect ingredients, improper dosages, sub-potent or super-potent ingredients, or be contaminated."(4)
There used to be a national list of the drugs most counterfeited, but the FDA eliminated it in 2006 because it was unused. As of 2005, Katherine Eban of Harcourt, Inc., reported that lots of the following medicines were found to be "diluted, mislabeled" and counterfeited (5):
Here's a short list of drugs that are considered the "top counterfeits", by the National Association of Boards of Pharmacy, in 2006 (6):
Nationwide in 2007, the FDA is implementing RFID (Radio Frequency Identification) coding systems, called "Mass Sterilization," to follow the drugs from manufacturer to market. The FDA will be enacting rules to use a pedigree system to trace medicines that come from outside the US as well, though one wonders how effective such a system might be in tracking medicines from developing countries.
Despite FDA's efforts, consumers do get suspicious, counterfeit or fake medicines from both inside and outside the US. There is a program for consumers to report "serious reactions," "product quality problems," and "product use errors" regarding prescription drugs, medical devices, and biological products. If you think you've gotten a counterfeit drug you can report it at a special site set up by the FDA. The FDA also offers advice on spotting and reporting counterfeits.
The FDA says, "To respond rapidly to a report of a suspect counterfeit, FDA is further streamlining its internal processes to respond quickly to reports of suspect counterfeit drugs by improving coordination and communication among all initial responders in the agency."
Internet pharmacies are targeted most often by the FDA. If you think there's something fishy about the internet pharmacy you've been dealing with, or are considering dealing with, here's where you can report unlawful sales of prescription drugs on the internet (you're not buying anything, it's just a poorly named web page).
Overall, it's a good idea to be aware of the packaging and look of your prescription medications. If those change, even subtly, you might want to do some research before you take a dose, perhaps checking with a local pharmacy, or your doctor. It is better to replace a suspicious prescription at a reputable, local pharmacy than to take a chance on getting poisoned or have adverse health effects from an ineffective dose of a prescription medicine.
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