Counterfeiting of medications is an ever growing, seemingly successful, industry throughout the known world. Both in well-developed and developing countries the pharmaceutical industry is seeing this as a major problem. But what is being done to combat counterfeit medications?
News of counterfeiting appears regularly. Just last week about $182,000 worth of fake medicines for diabetes, high blood pressure, and cancer were seized in China, and almost 2,000 people were arrested.
And, as we have reported in the past, the United States is just as vulnerable to these problems. First, in 2008, was the scandal over tainted batches of heparin, a blood-thinner that had been imported from China, which caused a number of deaths and allergic reactions. And then more recently, a counterfeit version of a widely used cancer drug, Avastin, was distributed throughout the U.S. last winter. This fake did not contain the active medicine, causing patients to miss their chemotherapy for a period of time.
While efforts by both governmental and private sector institutions to eliminate counterfeiting have had some success, the problem is ongoing, and perhaps increasing.
But what is being done to fix this mounting problem?
Since 2003, pharmaceutical companies have been more forthcoming, having agreed to report problems promptly to the FDA. And since 2006, there has been an International Medical Products Anti-Counterfeiting Taskforce — IMPACT—including pharmaceutical manufacturers, NGOs, regulatory and enforcement agencies.
A major obstacle to the elimination of counterfeit medications has been the difficulty of rapidly and inexpensively determining whether a medication is authentic or not. A number of different approaches are being undertaken to identify fake drugs.
So, how can we detect counterfeited medications? And, what approaches are being made to identify them?
Colorimetric assays were used to identify artesunate, which turned yellow, from the fakes, which were colourless. But then the counterfeit drug was modified to contain trace amounts of artesunate in order to trick colorimetric assays. That was a successful ploy.
Holograms were developed for packaging of artesunate. The sophistication of the counterfeiters was impressive—in Bangkok, Dr. Paul Newton (of the Wellcome Trust-Mahosot Hospital-Oxford University Tropical Medicine Research Collaboration in Laos) showed us packaging with holograms that was very much like the real artesunate drug and could readily pass casual visual inspection.
One newer approach is the use of radio-frequency identification (RFID) tracking system, somewhat akin to bar coding on packages. Another approach, being taken in India, is to have unique PIN numbers on packets of drugs. A unique identifier number is revealed on a scratch-off card. A buyer can then SMS (Short Message Service, or text message) this code number to the provider to verify the drug’s authenticity via a free product like Sproxil’s Mobile Product Authentication™ (MPA).
Research just presented at a meeting of the American Chemical Society shows great promise for detecting fakes more quickly, including in low resource settings.
Chemistry professor Toni Barstis and her team at Saint Mary’s and Notre Dame in Indiana have developed a paper analytical device or PAD to detect Panadol, an overseas brand of acetaminophen (Tylenol), often used to adulterate other medications because it provides some symptomatic relief of pain and fever, thereby fooling patients into believing the drug is effective. Their technique relies on a color change when the paper, swiped over the pill in question, is dipped in water—rather like a litmus test.
Dr. Facundo M. Fernández and colleagues at Georgia Institute of Technology are using a different approach, with an ambient mass spectrometry technique. This works by breaking down the compound into individual components, and the mass of the molecules is used to identify individual chemicals. Although more complex, this technique has the advantage of having both qualitative and quantitative detection modes, as well as identifying specific adulterants.
So although nothing is positively being done to effectively and once and for all defeat this problem, there is hope on the horizon. And, as lives weigh in the balance, our only anticipation is that we can universally come up with a way to successfully shut down this vile operation.