Fighting Fake Drugs

Google told me today (based on the search autofill) that the word 'counterfeit' has three popular associations: 'counterfeit money', 'counterfeit pens', and 'counterfeit gods'. While the last one is specifically the title of a book (Tim Keller's Counterfeit Gods, a great read IMO), the other two are, as expected, related to money. But the crime of fake duplication is not exclusive to money; it pervades every industry in which money can be made. The pharmaceutical industry is no exception, as I was reminded about in a recent C&EN article by the American Chemical Society.

It was only this past May when the Food & Drug Administration released a warning to consumers about counterfeit versions of Adderall, an attention deficit hyperactivity disorder (ADHD) drug in short supply. The forgers were taking pain pills with no markings and of the wrong color, packaging them in blister packs (rather than bottles) with poor labels and misspellings, and selling them on the internet. Not surprisingly, these counterfeits were easy to spot (Frank William Abagnale, Jr. would be shaking his head).

(Credit: The American -->)

Not all counterfeits are so blatant. Many counterfeiters are true professionals and know how to make fake drugs (and more importantly their packaging) more convincing. Pharmaceutical companies have resorted to more sophisticated, harder-to-copy packaging with labels and identification technology designed to track their products. But like many types of criminals, counterfeiters have a way of getting around these barriers. True counterfeit identification needs to come largely from the chemistry.

The difference between a fake drug and a genuine drug is often subtle, involving minor variations in the concentration of active pharmaceutical ingredients (APIs), formulations, or shape. Counterfeiters will do this to delay detection by simple analytical tests and initial reports from patients (who will experience at least some of the intended effects upon use). Typically, counterfeits that are very similar to the actual drug are the greatest financial threats because they can be sold in multiple iterations before detection. Those that are very chemically different post the greatest risks to people's health, and have also been said to be a leading cause for growing drug resistance among disease-causing parasites. In both extremes of counterfeiting, early detection solutions are thus extremely important.

Past methods of anticounterfeiting involved taking samples of suspicious drugs back to a lab for analysis. Unfortunately, the time this takes causes more problems than it solves. Testing for counterfeits at transit, distribution, and sale locations demands devices that are portable, rugged, and reliable, such as Thermo's handheld TruScan RM instruments and Bruker Optics' Fourier transform infrared (FTIR) analyzers. The TruScan allows drug substances to be identified through packaging, aiding in anticounterfeit efforts on multiple levels. The FTIR analyzer is used in mobile labs as an alternative to time consuming and work-intensive chromatography methods.

(<-- TruScan Analyzer. Credit: R&D Magazine)

Similar portable devices have recently been developed to make numerous different laboratory detection methods more efficient and available. For quick detective work, mid-IR, near-IR, and Raman spectroscopy are considered the most popular approaches. They are simple, fast, and selective, and can analyze solids with little or no sample preparation. The equipment itself is designed to give a pass/fail response (rather than data) when comparing the spectra of a sample with the known product. This provides quick answers on possible fakes, and saves the 'why' for later analysis.

Sometimes even this is not good enough, as many drug inspectors want to avoid opening shipping containers for fear of destroying valuable genuine products. For this, a group led by King's College is working on a quadruple resonance (QR) device that uses radio frequency methods in real time to detect APIs through layers of plastic, wood, glass, and cardboard. Through this method, inspectors can tell how much of the active ingredient is there and compare that to the form consistent with the manufacturer.

(Credit: Apothecurry -->)

In the end, counterfeit drug detection needs will vary based on the type of drug, the location, and the resources available. Certainly these portable technologies are a big step towards stopping counterfeit successes, helping ensure that people are getting the medications they need and legitimate pharmaceutical companies are making the profits they deserve.

References

Finding Fakes - C&EN