Technology 4 min read

A High-Tech Pill to Swallow

A newly-approved pill and smartphone system tracks medication use with the hope of increasing patient adherence to antipsychotics.

By Greg Uyeno featured image Image courtesy Proteus Digital Health

We live in an age of smartphones. Their rise in popularity and accessibility has been accompanied by criticism that they serve as constant distractions, upset sleep cycles, and generally degrade mental health.

But what if those same remarkable, ubiquitous technologies could be fine-tuned to promote mental health? Smartphones could help connect patients with healthcare providers and communities with each other. They could help patients maintain healthy lifestyles, with reminders for diet and exercise. And they could theoretically make it easier for willing patients to track their meds and stick with a medication plan, whether it’s with a smart pill bottle or even a smart pill.

In a first, the Food and Drug Administration (FDA) has approved a pill which contains miniscule electronics that can send out a signal when dissolved in the stomach. The signals, received by a small skin patch, are designed to help patients keep track of the medication that they’ve taken. The drug, Abilify MyCite, is a new version of the second-generation antipsychotic Abilify (aripiprazole). It is approved for adults with schizophrenia or bipolar I disorder, and as an add-on for treatment of major depression.

“I think it’s an encouraging step, especially for the field of psychiatry, especially for those with psychotic disorders like schizophrenia,” says John Torous, a co-director of the digital psychiatry program at Beth Israel Deaconess Medical Center in Boston and an advocate for technology in mental health.

The new pill sends a small electrical signal once it’s swallowed and reaches the stomach. A temporary patch worn on the abdomen relays the signal to a nearby smartphone, from which data can optionally be forwarded to healthcare providers. But the manufacturers note that the signal isn’t perfect. It may be delayed or occasionally never received at all.

“I’m of two minds,” says Jennifer Miller, a medical ethicist at New York University. “On the one hand, it has a lot of potential. On the other hand, it carries a lot of unknowns.” Those unknowns include digital privacy concerns; benefits and risks that will vary from patient to patient; and financial costs that have yet to be announced, she says.

The FDA announcement is clear that the new pill is approved to track medication, although it hasn’t yet been shown to improve whether or not patients actually take their pills. This behavior, known as adherence, is of interest, says Miller, because patients with severe mental illnesses are less likely to stick with doctors’ orders than patients with other conditions. And those who don’t take their medications may get sicker or even end up hospitalized.

“I think that it’s a useful start,” says Torous, “Tracking is related to adherence.” And patient adherence depends on individual circumstances, he says. The FDA is simply being careful not to overstate the evidence. “There’s clearly going to be careful monitoring of how this will work. I think we’ll quickly learn the outcomes. We’ll see what happens in the real world.”

Any new technology, no matter how convenient or innovative, may never be enough on its own to improve adherence to prescriptions.

“The issue remains the same as it always was — the individual patient needs to see a personal value in adherence and the clinician needs to work with them to find that value,” says clinical psychologist Mitchell Byrne, who studies medication adherence at the University of Wollongong in Australia. Byrne does not, however, rule out roles for new technologies in that process.

Currently, bipolar I disorder, major depression, and schizophrenia annually affect roughly 2.6 percent , 6.7 percent, and 1.1 percent of U.S. adults, respectively. Schizophrenia sometimes includes symptoms of delusion or paranoia, which has raised concerns regarding a medicine that integrates consensual monitoring, Torous says. But the disorder is multi-faceted, and some patients may engage with the technology and find it helpful with symptomatic planning and memory difficulties, he says.

Small details of the patient experience could also make big differences. For example, an easy-to-navigate user interface in the smartphone app is critical, according to Miller. Patients who are less tech-savvy may require clear directions for how to opt out of sharing information with doctors.

For now, the Abilify MyCite pill, patch, and accompanying app will be available only through a limited rollout, beginning in the first quarter of 2018. The drug manufacturer, Otsuka, says it will work with health plans and physicians who have experience introducing novel healthcare products. No limit or target number of patients has been specified. Moreover, no price structure has been set, but will be announced closer to beginning of the rollout, Otsuka confirmed to Genome.

The actual cost to patients and payers may include discounts or rebates, Miller says. That price should be compared to treatment alternatives, such as generic aripiprazole, which has been available since 2015, he adds. The difference could play a significant role in how the new drug is viewed publicly once it’s available: as a technological convenience worth a try for certain patients or a coercive technique for monitoring compliance.

“It will be important to pay attention to how they price this,” Miller says.