According to data from the World Health Organisation (WHO), around 1% of all medicines offered to patients in the developed world are believed to be counterfeit.
The situation is typically far worse in the developing world, with 10% of medicines thought to be fake globally, and in some countries, as many as half. The burgeoning market for medicines online has exacerbated this problem, with WHO suggesting that around half of all medicines sold online are fake.
Whereas the web has undoubtedly created a booming market for counterfeit drug peddlers, research from Purdue University highlights how web-based technology could also help us to fight back against fraudsters. The researchers highlight how our smartphones can be used to test whether medicine is legitimate or not, thus giving people peace of mind that what they’re putting into their body is not only likely to help their illness but also not cause them physical harm.
The method revolves around a cyber-physical watermark that people can take a picture of using their phone, with the software then confirming whether the medicine is legitimate or not. The researchers highlight how the growth in online pharmacies has resulted in a booming trade for counterfeit medicines, due in large part to the unregulated nature of the sector.
The risks associated with this trend have prompted regulators to act, with the U.S. Food and Drug Administration leading the way. With their Drug Supply Chain Security Act, they have mandated that by 2023, medications need to have a unit-level traceability function built in. It has long been the case that pharma companies have been able to track either entire boxes of medicines or individual sheets, but adding traceability to individual pills will require a number of additional steps in both data management and manufacturing.
The software developed by the Purdue team will allow patients to check the watermark attached to their medicine to not only determine its legitimacy but also to check the dosage regime, the frequency, and even additional information about the medicine. The researchers highlight that watermarks are commonly used on things such as passports or currency to help discourage counterfeiting. By adding watermarks to medicines they hope similar deterrents will be provided in this crucial domain, too, especially if the watermarks can be easily checked via a smartphone.
The researchers build on a strong track record of developing watermarking in other fields, and they’re confident that their expertise can make a real difference in the vital domain of anti-counterfeiting in medicine. The watermark is printed on a unique and specialized fluorescent silk via an FDA-approved food dye that is delivered through an inkjet printer. It’s a similar approach used by bakers when they print edible photos onto cakes. As a result, the silk is made entirely of protein and is thus safe for humans to consume.
“Silk is a great choice for eating, as we also were not wanting to use synthetic or artificial materials and fluorescent silk makes a counterfeiter very difficult to duplicate the watermark,” the researchers explain.
A scalable solution
As well as being edible, silk is an attractive substance to use because it is so flexible that its shape and structure of it can be changed relatively easily. The researchers also worked hard to ensure that the technology was functional with a wide range of smartphone models as well as with a variety of different photo quality and light settings.
“A person can take a photo under different light conditions and will have different images. It’s the same issue when patients take photos of our watermark in their phone,” the researchers continue. “The reference colors on the watermark’s periphery allow us to know the true color value of the watermarked image as each smartphone has different spectral sensitivity.”
Each watermark is designed to be placed onto the pills via a sugar-based glue, which allows the team to develop a watermark as small as 5 millimeters by 5 millimeters. As well as developing the solution for pills the team is also working on a solution that works effectively for liquids too.
They hope that they could be deployed on name-brand medications to begin with and even on restricted narcotics before ultimately being rolled out to a wider range of over-the-counter medications and generic medicines. Suffice to say, the path of innovations to market is seldom quick or straightforward, but given the literally life-and-death nature of this problem, we can only help this innovation proves to be the exception to the rule.
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