It's not just illicit drug dealers that are getting rich from selling pills. Those dealing in counterfeit drugs are also reaping lucrative profits according to the 2012 International Journal of Clinical Practice (IJCP). In this press release, Dr. Graham Jackson, IJCP editor, said, "Latest estimates suggest that global sales of counterfeit medicines are worth more than 75 billion dollars, having doubled in just five years between 2005 and 2010."
Jackson also said, "Particularly worrying examples include counterfeit cancer and heart drugs, and fake vaccines sold during the bird and swine flu scares."
According to the World Health Organization: Counterfeit pharmaceutical drugs are fraudulently produced, or mislabeled medicines purchased by consumers who believe them to be legitimate. What's disconcerting is how counterfeit pills have the potential to cause serious harm by exposing innocent patients to ineffective (too little or no active ingredients), or dangerous (containing harmful substances) treatments that may cause unexpected side effects, worse health, or even death.
How counterfeit pills enter the market
One would not expect it possible for counterfeit drugs to enter the US market due to the FDA's Pedigree system. The FDA defines pedigree as a statement of origin that identifies each prior sale, purchase, or transfer of a drug, including transaction dates plus the names and addresses of all involved parties.
A drug's pedigree assures that all ensuing pill transactions have a chain of custody all the way back to the company that produced the pills. However, if there is a way to game the system, bad guys will find and leverage it. One recent example was profiled in this FiercePharma Manufacturing blog post, "The U.S. has gotten guilty pleas out of a Texas couple who ran a fake-drug wholesaling business that sold nearly 60 million dollars' worth of drugs obtained off the street."
The wholesaling scam was lucrative for the couple to the tune of 14 million dollars profit. To sell real, but illegally obtained pills and counterfeit pills, the couple employed a front business in order to create provenance. Next, the illegal and or counterfeit pills were moved to a facility where the pills were packaged, provided fake pedigrees, and ultimately sold to pharmacies.
Counterfeit drugs are low-hanging fruit for bad guys, simply because methods to determine whether a drug
is real or counterfeit are limited. If you did not have a real pill to compare, would you be able to tell which if either of the two pills in the image to the right is counterfeit?
There are currently two methods to test drugs: using a mobile Transmission Raman spectroscope or sending samples to a lab capable of testing pills for content. Both methods have drawbacks. Each approach is expensive and requires skilled technicians. In the case of sending samples to a lab, that usually means a lengthy wait as well.
There is now a third method
A few years ago, two medical doctors, Patrick Hymel and Stephen Brossette, were trying to simplify how pills were identified in order to remove costly and dangerous mistakes between clinicians and patients. During a phone conversation with Hymel, he explained that doctors and pharmacists often are required to trust Electronic Health Records (EHR) as to what pills patients are taking. If an EHR is inaccurate, it could have serious consequences. Seeing a real need and opportunity, Hymel and Brossette, who also holds a PhD in computer science, gathered a high-powered group of scientists and engineers to work on a solution.
Their answer was MedSnap ID. The application, using an iPhone's camera and a reusable Snap Surface, provides health-care clinics and pharmacies the following:
- Definitive medication histories that recognize serious drug interactions early in a patient's interview process.
- Insight into the patient's understanding of their medications, and verify possession.
- Integration with EHRs to speed the medication history taking and documentation process.
It did not take long for the people at MedSnap to realize they had a viable solution for the counterfeit-drug problem as well. So, MedSnap's imaging and software engineers got busy and came up with MedSnap Verify Services—a simple, inexpensive way for those in the field to determine if pills are authentic or counterfeit.
During a trip to Birmingham, Alabama, under the auspices of the Birmingham Business Alliance, I visited MedSnap's home office in the Innovation Depot, and met with Angela Jones, the company's Vice President of Clinical Services. I asked Jones how it was possible to find subtle physical differences using the camera on a consumer-grade smartphone.
Jones explained that taking pictures of the sample pills placed on the Snap Surface (shown above) allows the algorithms in the company's application MedSnap VR to analyze the sample, taking 25 different measurements in the following categories:
- Size and shape
Regarding size and shape, MedSnap can distinguish 0.1 mm difference in lengths, angles, and thickness. That's not as simple as it sounds. The Snap Surface plays an integral part in allowing the iPhone camera to measure minute differences, but more accuracy was required. Hymel mentioned most computer-vision applications are about 90-percent accurate regarding object identification. The MedSnap team worked through the imaging algorithms, upping the accuracy to more than 99.5 percent for single-pill identification.
As for color, MedSnap VR first accounts for ambient light conditions, as that could influence the colors reflecting from the sample. Then MedSnap VR judges the sample pill's color. The technology can differentiate between 244,000 different shades of pill color. MedSnap VR also can evaluate text imprints—notice the imprint differences in the second image. MedSnap is currently in the process of obtaining four patents related to the MedSnap ID application and Snap Surface.
Hymel mentioned something else interesting. Because MedSnap VR looks at 25 different measurements for each set of potential counterfeits, the bad guys have to get all of these characteristics right in order to defeat the system—a difficult thing to accomplish according to Hymel.
Finally, there is the MedSnap pill database containing physical characteristics of prescription pills and known counterfeit pills—the vital back-end component queried by MedSnap applications when testing samples. The database currently contains 4,700 medication samples.
MedSnap's Verify-ID enables a simple solution that can be deployed right at the clinician/patient interface, dramatically reducing the risk of patient harm. I told a friend of mine who works in a drug and alcohol treatment center. She said MedSnap would be an incredible tool, as many clients come in with loose medications.
Although, the MedSnap team is focused on pill identification, it is easy to see how this cutting-edge technology could help detect other counterfeit objects like fake electronic components.
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