Smart pill sends message when medication is swallowed
■ Its creators hope it can make clinical trials cheaper and increase patient prescription compliance.
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University of Florida researchers think they might have a solution to the seemingly intractable problem of monitoring prescription adherence: a "tattletale pill" that can alert physicians when it's been swallowed.
The system attaches a microchip and digestible antenna to a standard-size capsule. When the pill is swallowed, it communicates with a small electronic device carried by the patient. That device in turn signals a cell phone or laptop, informing doctors or family members.
The Florida researchers say such a system could make clinical trials more efficient by alleviating the need to have researchers watch every participant take every pill.
If trial subjects are noncompliant, "you can't correlate the outcome of the study with the efficacy of the drug itself. So that requires additional time, excess patients, a lot of money -- tens of millions of dollars," said Rizwan Bashirullah, PhD, assistant professor of electrical and computer engineering at the University of Florida, who helped develop the device. "So the real question is, if you can use this technology and improve compliance by a little bit, even a few percentage points, it could have an impact which eventually gets translated to the consumer and insurers."
The device could also be used in clinical practice, Bashirullah said, by giving physicians an accurate read on whether prescriptions are being filled and taken. "You can envision it having an impact if this picks up for the elderly, mental health or addiction patients."
When patients don't follow a prescription order as written, costs can mount to $100 billion a year for avoidable hospitalizations and more than 200,000 deaths annually, various studies have found.
In a study published online Feb. 4 by the Journal of General Internal Medicine, researchers, looking at nearly 200,000 prescriptions written by 1,217 prescribers over 12 months, found that 18% of new prescriptions were never filled. Other studies have put noncompliance rates -- either from not filling a prescription or failing to take the medication as prescribed -- as high as half of all prescriptions, depending on the population.
The Florida researchers developed a way to print nontoxic, conductive silver lines on the outside of a capsule to serve as an antenna for the microchip embedded inside. Once swallowed, the microchip, via the antenna, sends its message that the pill has been taken.
Bashirullah said the pill has tested successfully on artificial models and cadavers. After breaking down, it leaves only a small byproduct of silver, less than what is present in tap water, he said.
The university has created a spin-off company that hopes to take the device to market. Bashirullah said the next step is obtaining FDA approval, which will require more rigorous testing of the pill system.
In terms of potential pricing, Bashirullah compared it to radio frequency identification technology. Now that RFID tags are in the mass market, they can be purchased for as little as 25 cents. Once the pill technology is produced in high volumes, "there's no reason we couldn't use the same [pricing] model," he said.
Bashirullah expects the system to go to market in about two years. It's not expected to replace other strategies to address medication adherence, which Bashirullah notes is a complex problem that should be addressed with a multipronged approach. The system could be used in conjunction with other strategies such as patient education, complimentary technologies or better labeling, he said.
An editorial published online April 7 by the New England Journal of Medicine suggested that financial incentives, such as reducing co-payments for patients and changing the physician payment structure so doctors get rewarded for compliance, could help improve adherence rates. The piece also recommended strategies to identify which patients are most likely to be noncompliant, which can help in developing corrective strategies.