Kirollos Hanna, PharmD, BCPS, BCOP
There have been many efforts in recent years to improve patient adherence to oncology medications. Sticking to a regime that causes adverse events is not easy, and sometimes simple forgetfulness is to blame, but intervention by providers has been shown to work.1
Now, oncologists may soon have 1 more tool in the form of digital pills that transmit from inside the stomach to portable devices whenever patients take their medication. The technology, which has been deployed in limited extent across other areas of medicine, including cardiovascular and metabolic conditions, is being tested with oral oncology medication and could potentially make a dent in the problem of patient nonadherence. Some believe outcommes may be improved and more reliable clinical trials data may result from use of digital pill technology.
In 2012, Proteus Digital Health of California became the first company to receive FDA clearance for marketing an ingestible sensor. In 2017, the company got FDA appoval to combine this sensor with medication in a single pill: the Abilify MyCite system. Since September 2018, Proteus has pioneered a digital pill chemotherapy program in Minnesota, where the pills are being used to promote adherence and improve treatment guidance. Estimates by health authorities put overall adherence in developed countries at just 50% among patients with chronic diseases.2,3
“If digital pills get more people to take medicine as prescribed, these will be a major breakthrough, not only for conditions such as hypertension or diabetes, but for cancer care as well,” said Kirollos Hanna, PharmD, BCPS, BCOP, an assistant professor of pharmacy at Mayo Clinic College of Medicine and Science.
The Proteus ingestible pills come in various forms and are activated by the digestive process, which causes them to transmit to external receivers worn by patients. The receivers then relay that information to software loaded onto the patients’ smart phones or tablets (Figure
If these signals indicate that patients are taking the right amount of medication at the right time, the software logs the data, along with some extra information on patient heart rate and activity levels that can help providers gauge how well patients are responding to treatment. The software tracks the number of pills patients are taking and when, so that patients and their providers can be alerted if patients don’t follow dosage or the medication schedule.
The potential for disclosing patient behavior to others in something approaching real time has raised concerns about patient privacy, but it also leads many to hope that “digital pills” will save lives and money. Small trials performed to date provide a basis for optimism, but the real test of the technology should come in the next few years when increasing usage provides enough real-world data to evaluate the effects of these pills on behavior.
Hanna notes that recent years have seen a major shift in cancer care, from administering entire treatment regimens in the office to delivering at least some component of care via medications that patients take at home. As a result, patient adherence has become a greater concern in oncology.
“Often, patients with cancer are elderly, so their memories can fail them at the best of times, and both their tumors and ‘chemo brain’ tend to increase the problem,” said Hanna, who is also a clinical pharmacist at Mayo and at the University of Minnesota Medical Center, where he is participating in a small trial of digital pills among patients with cancer. “There aren’t reliable adherence figures, but I’d guess that 40% to 50% of oral chemotherapy users have some adherence issues. If smart pills can reduce that by even a quarter, it would greatly improve outcomes.”
Figure. How The Proteus Digital Health Smart Pill System Works
Digital Tracking Devices Proliferate
The digital pill revolution extends to the use of wireless devices for colonoscopies which enable providers to inspect previously unreachable zones and conduct less-invasive procedures. Digital pills are just 1 product in the rapidly growing area of digital medicine. The bestknown segment of that market consists of wearable devices designed to monitor health or treat disease, such as Fitbits. Last year, the FDA approved the electrocardiogram software on the Series 4 Apple Watch,4
as well as its software for detecting an irregular heart rhythm.5
Wearables that treat disease range from insulin pumps for diabetes to electrotherapy for people with glioblastoma.