'Edible' radio tags could stifle sales of bogus meds
February 20, 2015 12:14 AM
Radio-frequency identification, or RFID, technology is already used to track how prescription drugs move across international borders and through the medical supply chain.
By Bill Toland / Pittsburgh Post-Gazette
With sales of bogus prescription drugs amounting to tens of billions of dollars worldwide, imperiling public health systems and pharmaceutical supply chains, counterfeit medications are an enormous threat — but the solution to that threat could be smaller than the period at the end of this sentence.
And it could be designed here in Pittsburgh.
Oh, and you’d have to swallow it.
Researchers at Carnegie Mellon University are working on a radio-frequency tagging system that could be embedded into pills and encrypted with codes that would guarantee the provenance and authenticity of the medication.
“Think of a grain of salt. A fraction of a millimeter,” said L. Richard Carley, one of three primary researchers on the project. “You could swallow that. It wouldn’t do anything to you.”
Radio ID tags are everywhere, in various sizes and forms — they have replaced the stamped due-date cards in the back of your library books, and they are fastened to leather coats to make sure you don’t steal them. They are implanted in pets, in case they get lost. Runners wear them on their shoes or ankles so they know their exact marathon time. And if you have an E-Z Pass transponder in your car, that, too, is a radio tag.
Radio-frequency identification, or RFID, technology is already used to track how prescription drugs move across international borders and through the medical supply chain. Mainly, it’s deployed on packages and pill bottles — but not on the pills themselves, which allows for the possibility that counterfeiters could get their hands on a properly tagged box or bottle, then fill it with fake meds.
The CMU proposal is not without precedent — two years ago, the U.S. Food and Drug Administration approved an ingestible radio ID tag. Designed by California’s Proteus Digital Health in partnership with Oracle Health Sciences, the sensors are meant to track whether a patient has actually taken the medicine, and they also may be able to communicate vitals information, such as heart rate, to the radio readers. Others have proposed using edible RFID tags in foods to track their calorie content.
One of the hardware challenges for CMU is to shrink the radio tag even further, said Mr. Carley, a professor in CMU’s Electrical and Computer Engineering department..
The team plans to employ a “passive” tag system, meaning there’s no on-board battery; the cryptographic data that’s stored on the chip can be read only when the circuitry on board is powered up by a nearby external radio-frequency energy source. The antennae, which receives the radio power then transmits the signal back out, must be shrunken, too, and placed right on the silicon die. The entire cube would then be encased in a glass wrapper and dropped into the pill during the manufacturing process.
“If we can miniaturize it, we make a larger number of them,” which makes the devices more cost effective, he said. The team, he said, is aiming for a chip that’s a quarter-millimeter by a quarter-millimeter by a tenth of a millimeter. The Proteus prototype was about 1 millimeter by 1 millimeter by a quarter-millimeter, still quite small but roughly 40 times of the volume of the CMU team’s ultimate goal.
Ken Mai and Larry Pileggi, both of CMU’s Electrical and Computer Engineering School, and several graduate students make up the rest of the team and are working on the encryption, the circuitry and the overall fabrication process, Mr. Carley said. Their project is one of several to be funded this year by CMU’s Disruptive Healthcare Technology Institute, a joint venture among CMU, Highmark and the Allegheny Health Network. It’s a two-year grant worth about $100,000 a year.
The coding challenge is to embed a secure, encrypted ID tag into each pill, readable only if someone is armed with the key that unlocks the code, perhaps by way of a device attached to a smartphone. The ID code must be unique for every single pill — otherwise, counterfeiters could buy a bottle of pills, extract the serial number, and try to manufacturer their own bogus RFID tags to embed in the pills.
But with a unique, encrypted identifier in each dose, the pill can be “read” by a pharmacist to learn where and when it was made. “We would offer a capability that really would stymie the black market drug manufacturers,” Mr. Carley said. “While it could be used in every prescription drug, my expectation would be that pharmaceutical companies would only roll these out in their more expensive drugs first, or ones where they are losing a lot of money to black market versions.”
It’s a black market that, while primarily active overseas and in underdeveloped countries, has infiltrated the American supply chain from time to time. In 2012, a counterfeit batch of the cancer drug Avastin made it onto U.S. shores after being purchased from a supplier in Turkey and routed through a U.K. middleman. That case was particularly alarming because Avastin is a complex injectable drug — and not a pill, which is easier to counterfeit — and the incident raised new worries about the security of the chain of custody for prescription drugs, which are manufactured all over the world.
While most bogus drugs that enter the U.S. are ordered online or procured through illicit means, in other countries, counterfeit drugs enter the “legitimate” commercial supply chain regularly, and copycat drugs routinely show up at trusted dispensaries and doctors’ offices. India and China are the two largest producers of counterfeit drugs, according to the World Health Organization, and there’s no way to tell how many tens (or hundreds) of billions are in play each year.
“It’s a global problem,” and there are lots of potential side doors into the supply chain, said Timothy K. Mackey, director of the Global Health Policy Institute and a public health professor at the University of California at San Diego. While customers might assume that medications go straight from the manufacturer to the clinic or drug store, there actually might be four or five pit stops along the way at various middleman warehouses and wholesalers.
The scope of the problem is hard to determine, both in terms of its dollar value and lives cost, because most of the data is spotty, based on the occasional seizure or arrest. And because the medications (and the raw materials that make up the medications) move from country to country, there’s little coordination among countries on how to police the issue.
Even in the U.S., the issue of counterfeit drugs might involve any number of agencies — the FBI, the FDA, the Drug Enforcement Administration and Immigration and Customs Enforcement, among others. The problem is most acute when it involves potentially lifesaving medications, such as the anti-malarial pills that are routinely counterfeited.
“WHO has been working on it since 1988, and we’re not getting any closer” to solving the problem, Mr. Mackey said.
Bill Toland: firstname.lastname@example.org or 412-263-2625.
To report inappropriate comments, abuse and/or repeat offenders, please send an email to
email@example.com and include a link to the article and a copy of the comment. Your report will be reviewed in a timely manner.