New opioid adherence pilot program utilizes digital pill

Brigham and Women’s Hospital asked 26 patients discharged from the ER with acute fracture pain to participate in the study.
By Dave Muoio
10:52 AM
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Opioid adherence remains a hot topic in healthcare amidst the ongoing epidemic in the U.S., and a solution may lie within the pills themselves. In a study recently published in Anesthesia & Analgesia, researchers testing eTectRx’s digital pill technology could allow practitioners to better understand patient opioid adherence, thereby paving the way to more appropriate dosage and use of the drugs.

“We’ve developed a problematic use of opioids in our country. Opioids are some of our most powerful medications, but also our most lethal. The problem is no one really knows how people take pain medications on an as-needed basis,” Dr. Ed Boyer, senior author, of the Division of Medical Toxicology within the emergency department at Brigham and Women’s Hospital, told MobiHealthNews. “So, when eTect came out with a functional system that we could actually deploy in the field, we were excited.”

[Also: FDA approves first digital pill, a drug that comes with ingestible sensor]

eTectRx’s digital pill consists of a standard capsule containing an embedded wireless ingestible sensor.  Chemicals in the stomach activate the sensor, which then emits a radio frequency that can be captured by a wearable reader. A corresponding app sends these readings to a cloud-based platform, where a care team can view time-stamped dose adherence data for their patients.

To validate the technology and investigate opioid adherence, Boyer and colleagues approached 26 patients (with no previous experience with opioids) discharged from an emergency department with acute fracture pain. The researchers trained each on the operation of the digital pill system and provided them with 21, 5mg oxycodone digital pills. Along with identifying adherence remotely through eTectRx’s platform, the researchers conducted brief patient interviews at the end of the 7-day study period.

Of the 26 patients, 10 did not wish to be enrolled and one was unable to complete the study. The remaining 15 patients ingested a median of six of their 21 oxycodone pills, Boyer and colleagues wrote, with the majority taken within the first three days. Although there was substantial variability in ingestion patterns between the participants (the range was three pills to nine-and-a-half), they wrote that the findings indicate many opioid-naive patients who self-administer will stop taking their painkillers well before exhausting their supply.

“Rather than prescribing medications on [an as needed] basis, we propose that clinicians consider instructing patients to begin tapering the dose of opioid analgesics beginning at 24 hours after injury, which would also reduce the number of pills dispensed, and ultimately wasted or made available for diversion,” they wrote.

Along with painting a clearer picture of opioid abuse, Boyer said that the study acts as a proof of concept for eTectRx’s system as a tool to combat abuse and improve prescription practices.

“The take-home message is that with this technology, with a few tweaks here and there, we can have a tool which we can use to identify when someone is transitioning from normal therapeutic use to the potentially dangerous behavior of developing opioid tolerance, which is the first step toward misuse, dependence and abuse,” he said. “It’s a really exciting time. We can begin to measure things physicians have only dreamed of measuring before.”

Currently, eTectRx’s pills are only available for institutional review board-approved research and are unavailable for sale in the U.S. However, last week another digital pill offering, Proteus Digital Health and Otsuke Pharmaceuticals’ Abilify MyCite, made the news with its receipt of FDA approval for mental health conditions including schizophrenia and bipolar disorder. While Proteus’ patch and the pill were respectively cleared in 2010 and 2012, last week’s FDA nod marked the first time a sensor/drug combination received approval as a pharmaceutical.

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