High-Tech Pharmaceutical Labeling Best Hope for Combating Counterfeit Market

Counterfeit Pharmaceuticals

Counterfeit pharmaceuticals are a significant health concern worldwide. The Internet is a principle outlet for sales of counterfeit medications, which offer significant savings over drug store prescriptions. The World Health Organization (WHO) estimates that more than half of the medications obtained from illegal websites that do not publish their physical addresses are counterfeit.

However, the problem is even more pervasive. Organized counterfeit pharmaceutical rings target impoverished people in emergent economies whose lives depend on medications that they cannot afford. Hot spots for distribution of illegal medicines include India, Africa and Latin America.

WHO identifies illicit medications as spurious/falsely-labeled/falsified/counterfeit (SFFC) substances. SFFC products range from therapeutics for life-threatening diseases to over-the-counter remedies such as antihistamines. They may contain no active ingredients or too many. In either case, they can be life-threatening so the pharmaceutical label must be thoroughly inspected.

The Dangers Associated with Illegitimate Medicines

According to Interpol, “criminal networks are attracted by the huge profits to be made through pharmaceutical crime.” However, this huge illicit gain means significant losses to legitimate drug companies in terms of reputation, revenue, and return on their investment in research and development.

Human health threats posed by the illegal pharmaceutical trade continue to grow throughout the world despite efforts of such entities as Interpol and WHO. The European Union reports significant expansion of illegal medicines detained at border crossings in 2010, with pharmaceuticals constituting 60 percent of all postal goods intercepted in transit.

According to the Pharmaceutical Security Institute, Latin America and Asia were the top regions in 2010 for pharmaceutical crime. A Smithsonian article entitled “The Fatal Consequences of Counterfeit Drugs” details a thriving counterfeit malaria medicine market in Southeast Asia. Malaria victims save by buying the fake medicine, but the cost to their health is devastating.

While developed countries like the U.S. have strict guidelines in place that make it difficult for counterfeiters to do business, the Internet provides an attractive global venue for sales of illegal medications. In September of 2011, an Interpol operation targeting online sales of counterfeit drugs shut down over 13,000 websites engaged in the illegal distribution network. Nevertheless, the counterfeit pharmaceutical problem is far from solved.

Pharmaceutical Label Strategies

Drug packaging serialization, also called track and trace, represents the best hope for combating the illicit pharmaceutical market. In March of 2010, the FDA published guidelines for Standard Numerical Identification (SNI) on prescription drug packaging. In addition, the state of California is setting the policy with its 2015 deadline for e-Pedigree packaging on pharmaceuticals for tracking purposes. The European Union is also working on traceable package labels that allow handlers throughout the supply system to verify the legitimacy of the products via a centralized database.

Meanwhile, pharmaceutical manufacturers, retailers and the medical packaging industry are fine-tuning individual labeling ideas designed to outsmart the counterfeit market. Through such markers as holographic images or three-dimensional embossing on package labels, consumers can visually verify legitimate medications.

With the help of high-level visual inspection technology, forensic experts can pinpoint minute variations in labeling that even the most meticulous copies cannot completely avoid. To the untrained eye, a skillful counterfeit pharmaceutical label may appear virtually identical to the genuine article right down to the hologram on the box. As illegal medicine distribution networks become increasingly sophisticated, this visual inspection technology constitutes a critical tool for identifying fakes.

Although the counterfeit pharmaceutical network is pervasive, track and trace systems and other high-tech pharmaceutical label techniques can combat this significant health threat. Thanks to the efforts of organizations like the FDA, WHO and Interpol, people worldwide will be able to verify that their medications are genuinely effective.