The Porous U.S. Medication Supply: Dangers of Counterfeit Drugs

giorgiannis.JPG Today's guest blog was brought to you by Dr. Giorgianni, a practicing consultant pharmacist and is a Science Advisor to the Men’s Health Network. He is also the Vice-Chair/Chair-Elect of the American Public Health Association caucus on men’s health.

As a practicing pharmacist, pharmacy educator and public health consultant, I am increasingly concerned about the integrity, quality and safety of the U.S. medication supply. I have been in practice for four decades and I have never seen the U.S supply of prescription and non-prescription medications at greater risk of infiltration by counterfeit, adulterated and illegally imported products than now. Not a week goes by that I do not read a report about an illegal on-line drug purveyor posing as a legitimate pharmacy or about a shipment of products seized because of adulteration with putrid or toxic substances such as antifreeze or manufactured in an area that most Americans would not feel safe drinking water. 

Regrettably it is all too often that I review a medical case report that shows how a patient has suffered terribly because of taking an illegally imported or counterfeit product purchased on-line. Severe and life-threatening problems are reported in the literature, caused by product integrity issues from grey-market and illegal providers. Many other patients may not have the desired clinical effects because of taking products that have been diluted or stored and shipped under conditions that cause the active ingredient to deteriorate or that have had labels altered to make expired products appear to be within dating.

A high percentage, although not the exclusive source, of these problems can be traced back to on-line sites that advertise amazingly low cost drug products and claim that they come from legitimate sources. But the evidence gathered by the National Association of Boards of Pharmacy, the U.S. Food and Drug Administration and numerous individual state Boards of Pharmacy tell a different story. They tell a story of unscrupulous individuals posting false advertising and promotions that hearken back to bold tactics of 1900s snake oil salesmen which became the basis for development of our modern day drug regulatory framework. Dr. Margaret Hamburg, FDA Commissioner, has been outspoken about FDAs concerns regarding policing an increasingly complex global economy and this dangerous new breed of illegal-drug dealers and counterfeiters.

When going on-line to purchase medicines, it is important for consumers to know the facts about counterfeit medicines for common and life threatening conditions such as high blood pressure, diabetes and anticoagulation therapy. The unfortunate reality is that many criminals caught selling counterfeit or adulterated products obtained them from sources they claim are legitimate, but were made in sub-standard facilities or have blatantly adulterated them. National professional pharmacy associations, FDA, and boards of pharmacy have put in place systems to increase consumer awareness of this dangerous problem and have developed systems with legitimate wholesale drug companies to insure products distributed though legitimate pharmacies have proper and tractable pedigrees. The National Association of Boards of Pharmacy has also developed a system, called the VIPPS program where consumers can check the legitimacy of on-line pharmacies.

From a public policy perspective, there is an increasing need for regulation, enforcement and funding for these consumer information, product integrity and regulatory initiatives to return the integrity of the medication supply chain to the high standard that Americans have counted on to insure they have cost effective and convenient access to legitimate life saving and life sustaining products. Organizations such as the Partnership for Safe Medicines and the Men’s Health Network are working diligently to inform consumers, serve as a resource to policy makers and enhance the integrity of our nation’s drug supply.