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Inside the World of Counterfeit Drugs

Part 3: Implications for the U.S. and the Drug Importation Debate – As the debate surrounding the possible ban on the repackaging of medicines in Europe simmers to a boil, here in the United States the potentially dangerous practice of ordering prescription medicines via the Internet is mushrooming. Enticed by the promise of cheaper drugs and convenience by buying online, patients are largely unaware of the risks that come with online pharmacies. These risks can range from receiving products with too much, too little or no active ingredients, to being exposed to counterfeit products, which in some rare cases have been found to contain rat poison, boric acid and even inkjet cartridges!

Gregory N. Zec, Guest BloggerZec

Part 3: Implications for the U.S. and the Drug Importation Debate 

As the debate surrounding the possible ban on the repackaging of medicines in Europe simmers to a boil, here in the United States the potentially dangerous practice of ordering prescription medicines via the Internet is mushrooming.  Enticed by the promise of cheaper drugs and convenience by buying online, patients are largely unaware of the risks that come with online pharmacies.  These risks can range from receiving products with too much, too little or no active ingredients, to being exposed to counterfeit products, which in some rare cases have been found to contain rat poison, boric acid and even inkjet cartridges!

As one major pharmaceutical company executive has pointed out, in the case of narcotics, patients understand the risks they are taking by using the product and knowing what they are taking.  In the case of counterfeit drugs, neither of these conditions hold true.  In fact, less than one in ten patients ordering from an online “pharmacy” is aware that online prescription medicines can be contraband or counterfeit drugs.  And who among us has not opened up his or her email inbox to find spam emails offering delivery of lifestyle medications “to your door” with no need for a prescription?

Frequently, these rogue suppliers deal in products manufactured in Asia that have never been approved by the U.S. Food and Drug Administration (FDA).  It’s no wonder that some U.S. states sharing a border with Canada have disclaimed responsibility for the quality of medicines purchased over the Internet through their online importation programs.  Minnesota, for example, requires these Internet purchasers to hold the state harmless for any damages before they can access the online pharmacies they sanction for Internet purchases of medicines. 

Purchasing drugs from “Canadian” online pharmacies offers no further degree of protection.  FDA officials have advised that only 15 percent of drugs claimed to be of Canadian origin actually originated there.  Most of these “Canadian” online pharmacies offer products that originated in Asia.  Indeed, counterfeit drugs originating in Asia entering the United States via “Canadian” online pharmacies are totally unregulated by Health Canada (Canada’s equivalent of the FDA) because they are not intended for consumption by Canadian citizens.

Last year, Representative Steve Buyer (R-IN) introduced H.R. 5839, the “Safeguarding America’s Pharmaceuticals Act of 2008,” in order to improve the safety of drugs by reducing the risk of counterfeits entering the nation’s drug supply.  Among other provisions, the bill would require e-pedigrees for pharmaceuticals as well as track and trace systems.  Significantly, the bill would authorize the FDA to seize and destroy drugs suspected of being counterfeit at the point of entry into the country.  As Rep. Buyer noted, such suspected drugs from abroad are clogging the U.S. mail system:

In one day, up to 360,000 packages containing counterfeit drugs enter our 12 international mail facilities—that is up to 10 million packages a month and 130 million counterfeit drug packages in a year.  The Food and Drug Administration (FDA) screens less than one percent of these packages before they are sent through our domestic mail system.  The less than one percent of the packages that are screened and found to contain counterfeit drugs are returned to the sender by the FDA.  Time and time again, FDA screeners see packages make a one to two week turn around for re-entry into the mail facilities, after initially being rejected and returned to the sender, making way to unassuming Americans. 

There is a clear need for regulation of online pharmacies, including mandatory licensing for all Internet drug sellers and state licensure for any state in which these online pharmacies sell and dispense drugs.  As of today, of the thousands of online pharmacies selling drugs to Americans, only 15 are licensed by the National Association of Boards of Pharmacy* (NABP).  The NABP’s Verified Internet Pharmacy Practice Sites (VIPPS) program offers a rigorous evaluation system of pharmacies that that distributes drugs through the Internet.  VIPPS offers an antidote to unregulated, rogue online pharmacies, focusing on drug safety and legitimacy for the benefit of American consumers.

*NABP is a member of the Partnership for Safe Medicines

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