The Illicit Sale of Medications for the Treatment of Erectile Dysfunction

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

Disclosures

Medscape Urology 

In This Article

Introduction

Drug fraud is not a new phenomenon. Warnings about the dangers of adulterated medications can be found as early as the 4th century BC.[1,2] In more recent times, "salves" and "tonics" with only the most dubious evidence of efficacy have been sold in the United States for generations. However, recent developments - such as the great increase in the number of relatively expensive medications only available by prescription and heightened opportunities for surreptitious global distribution offered by the Internet -- appear to have raised the incidence of drug fraud exponentially. The US Food and Drug Administration (FDA) has been issuing regular reports on counterfeit medications since 1990; the World Health Organization (WHO) has put out its own reports since 1985.[3] Legitimate pharmaceuticals are rigorously tested in large randomized controlled trials and manufactured under strictly monitored conditions. Counterfeiters bypass all of these safeguards, manufacturing and selling potentially harmful substances without any regulatory oversight. As such, counterfeit medications represent a significant public health concern. Physicians need to be made aware of the importance of this problem and counseled on how they may protect their patients from the risks these fraudulent drugs pose.

What Is a Counterfeit Medication?

American law defines counterfeit drugs as "those sold under a product name without proper authorization." This term may be applied to "both brand name and generic products, where identity of the source is deliberately and fraudulently mislabeled in a way that suggests that it is the authentic approved product."[3,4] This may also include "...products without active ingredient, with insufficient ingredient, with wrong active ingredient, or with fake packaging."[3,4] Similarly, WHO defines a counterfeit pharmaceutical product as one "which is deliberately and fraudulently mislabeled with respect to identity and/or source."[1,2]

The following categories of counterfeits address both how these drugs enter the market and their potentially dangerous health consequences:

Look-alike medications

  • Those containing little or no active ingredient

  • Illegal imitations (illegal generics)

  • Reformulations of branded drugs

Rejects

  • Medications rejected by the manufacturer or regulatory authority because of poor quality

Relabeled medications

  • Expired medications with the label fraudulently altered with a later expiration date

  • Medications discontinued or otherwise banned from US use relabeled for sale in the United States

Adulterated medications

  • Those containing active ingredients not explicitly stated in package inserts or product descriptions[5]

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