The Illicit Sale of Medications for the Treatment of Erectile Dysfunction

Philip J. Dorsey, Jr; Wayne J.G. Hellstrom, MD, FACS


Medscape Urology 

In This Article

What Is Being Done to Reduce Counterfeit Medications

The FDA's Combating Counterfeit Drugs Plan involves improving laws and enforcement by regulatory bodies, exploring new technologies to monitor products, and collaboration with organizations within the United States and in other countries to create a comprehensive solution.

Although the Prescription Drug Marketing Act signed into law in 1988 and amended in 1994 was written in part to address the problems of counterfeit drugs, the effectiveness of this legislation in combating counterfeit medications has been limited.[8] The Act requires state licensure for drug wholesalers and stipulates that pedigree must be proved by wholesalers who are not considered "authorized distributors" of the products for a given manufacturer. Implementation of this pedigree requirement has been problematic due to a lack of funding for the project, and licenses can be obtained in some cases with only a nominal fee. The lack of inspections following the approval for a license has been cited as one possible reason counterfeit drugs are able to penetrate the market.[8] In addition to poor oversight, state and federal penalties for drug counterfeiting have been substantially less than for other types of counterfeiting. The Counterfeit Drug Task Force Report recommends that the FDA begin to fully implement the pedigree system and increase surveillance and penalties.[6,8]

Another means for preventing the sale of counterfeit drugs is the use of radiofrequency identification (RFID) to track and trace medications in the drug supply chain. Although this new technology has promise as a means of preventing unauthorized products from entering the market, there have been many delays in its implementation, and it is likely it may be 10 years before it is fully utilized.

The FDA has issued consumer alerts that contain hints on how to identify healthcare fraud and information on how to report suspicious sites. As of 2006, about 60,000 complaints are being filed per month.[11] A printable brochure called "Buying Prescription Medicine Online: A Consumer Safety Guide" can be found on the FDA's Web site, at[20] Additionally, the most up-to-date information from the FDA regarding consumer information, press releases, and reports can be found at[21]

In addition to increasing awareness and reporting, the FDA has improved its ability to investigate and prosecute proprietors of Internet pharmacies that sell counterfeit medication. During the Clinton Administration, the FDA received $10 million to investigate Internet pharmacies, enough to fund 100 agents.[11] This campaign resulted in an enforcement action against 800 Web sites for false product claims or misleading information. This program was continued under President Bush as the "rogue" Internet pharmacy program, but as this is a global issue, continued alliance with and support from other countries will be the only way to ensure definitive progress.

In recent years, professional accreditation bodies have contributed to efforts to reduce the prevalence of rogue pharmacies via accreditation mechanisms designed specifically for Internet-based pharmacies. The Verified Internet Pharmacy Practice Sites (VIPPS) was started in 1999 by the National Association of Boards of Pharmacy to ensure that Internet pharmacies maintain the standards of the profession.[22] The certification process involves very strict program criteria to ensure authenticity and security of prescription orders, quality assurance, and consultation with registered pharmacists.[11] Additionally, the National Association of Boards of Pharmacy has created the "National Specified List of Susceptible Products," available at, to maintain an up-to-date listing of the medications that pose the greatest risk to public health.[23,24] Other alliances with professional organizational counterparts are under way in Canada, and the American Medical Association is working on standards for Web-based healthcare.[11]

A comprehensive initiative is under way to reduce the prevalence of counterfeit medications, but it is uncertain when the gains of these efforts will be realized. It is ultimately the interactions patients have with their healthcare providers that will have the greatest impact on helping patients understand the risks of counterfeit drugs and how to reduce their risk for exposure or complications.


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