In November, the U.S. Food and Drug Administration approved a first-of-its-kind “digital pill” researchers say could be used to help prevent patients from becoming addicted to prescription opiates.
Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The FDA approved the self-tracking product for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and for use as an add-on treatment for depression in adults.
The eTectRx ID-Cap system was developed by Florida-based EtectRx. It uses a gel capsule that fits over standard pills; when swallowed, it is dissolved by stomach acids and emits a radio signal to a wearable patch. The patch transmits the information to a mobile application, enabling patients to track the ingestion of the medication on their smart phone. Patients can also allow their caregivers and physician to access the information through a web-based portal.
“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”
The FDA also cautioned that Abilify MyCite should not be used to track drug ingestion in “real-time” or during an emergency because detection may be delayed or may not occur.
In a recent pilot study, researchers at Brigham and Women’s Hospital in Boston tested the new technology with 15 patients who had received prescriptions for oxycodone digital pills as needed following treatment for acute fractures. Emergency medical physicians and toxicologists Edward Boyer, M.D., and Peter Chai, M.D. used it to monitor how and when patients took the opioids they had been prescribed for the first time.
In a paper published in the December issue of Anesthesia & Analgesia, the team found that most of the opioid-naïve patients took the opioids to manage pain for only a brief period and only took a fraction of the number of pills they were given. One participant in Boyer and Chai’s study reported that the digital pills helped him be more aware of how much oxycodone he was ingesting.
Chai says being able to detect a pattern in how patients are taking pills can enable physicians to quickly intervene if there’s a change in that pattern: for example, if patients start taking more pills, or take them before they go to bed at night, which is considered a dangerous time to ingest opioids.
“It is fascinating to see this technology literally live and in action, especially in light of recent data from the Centers for Disease Control and Prevention about the risk of long-term opioid addiction in patients who have even short courses of oxycodone,” Chai said. “These data are important as we continue to have more careful and directed conversations regarding the expectant management of pain, and the dangers associated with opioid use.”
“As an investigational tool, the digital pill provides a direct measure of opioid ingestion and changes in medication-taking behavior,” Boyer told Science Daily. “This technology may also make it possible for physicians to monitor adherence, identify escalating opioid use patterns that may suggest the development of tolerance or addiction and intervene for a specific medical condition or patient population.”
“We would hope that one day the reader would become integrated into wearables that people use every day—think the watch band of the Apple Watch, or the case of your smartphone,” Chai told Technology Review. “That would really allow the reader to start to meld into the everyday life of patients.”
Boyer and Chai have interviewed emergency room patients who use heroin and asked if they would be willing to use the technology. About 83 percent said they would. Their next study will test the technology in chronic pain patients who have been taking prescription opioids on a long-term basis.