Counterfeit drugs generate sales of $75 billion each year. Despite increasing public awareness through such trusted online services such as CSIP and LegitScript’s Pharmacy Verification Tool, the problem remains a significant public health issue. Every questionable drug represents a threat. As a result, there is a real need for advanced technologies to combat the problem.
In 2013, The Drug Quality and Security Act (DQSA), which mandates the creation of a track-and-trace system, was signed into law. Prior to that, the U.S. Food and Drug Administration (FDA) issued a guidance that states that medication needs to be authenticated even if it has been separated from its packaging. An effective way to meet this requirement is through on-dose authentication, which offers enhanced security.
The company, TruTag, rose to the task of developing on-dose authentication in the form of microtags that can be coated onto medicine and serve as edible bar codes. The edible tags are incorporated into the drugs themselves and reveal if a pill is authentic, as well as other product intelligence.
How do edible microtags work?
- Each edible microtag is about the size of a dust particle, making it virtually invisible to the human eye.
- The tags are made of high-purity silica (SiO2), which has been affirmed as safe by the U.S. Food and Drug Administration.
- A single gram of “TruTags” contains approximately 12 million micro-particles, each encoded with a unique optical pattern that allows people along the pharmaceutical supply chain to scan a pill with their special readers and confirm its authenticity.
- TruTags also reveal other vital information, such as the product strength, manufacturing plant, expiration date, and where is it authorized to be sold.
A recent pilot study has shown that the edible, covert tags are effective in checking whether tablets and capsules are genuine. In addition, the study revealed that adding the tags to the pills is safe and had no impact on the active pharmaceutical ingredient.
Anti-counterfeiting technologies, such as edible tags, is an important part of patient safety, and we at CSIP are encouraged by the progress being made in developing and testing them. We will continue to keep readers aware of this and other authenticating technologies, that make the internet a safer place for consumers and health care professionals to buy safe and authentic prescription drugs.
The Center for Safe Internet Pharmacies (CSIP) and our 12 member companies have the shared goal of helping address the growing problem of consumer access to illegitimate pharmaceutical products on the Internet. Continue to read this blog for updates on CSIP’s education, enforcement and information-sharing efforts.