They are among new approaches to dealing with a big problem in American health care
This drug delivery system folds up to fit in a capsule, then would reopen in the stomach
November 22, 2017
For all the complex analysis of why health care costs in America continue to rise, one big reason is rather prosaic—a lot of people just don’t take their meds.
Research has found that drugs prescribed to treat chronic conditions are taken correctly only about half the time, and that roughly 20 to 30 percent of the time, patients don’t even get the prescriptions filled.
The consequences are staggering. According to the Centers for Disease Control and Prevention (CDC), what’s known as “nonadherence” results in as many as 125,000 deaths a year in the U.S., and the financial costs—including those associated with hospitalizations and emergency room treatments—have been estimated at between $100 billion and $300 billion annually.
The reasons are varied. Some people want to avoid a drug’s side effects. Some don’t want to be reminded that they’re ill. Others can’t afford to pay for them. But one of the more common explanations is that people simply forget.
So, the announcement last week that the FDA had, for the first time, approved use of a “digital pill” that can itself monitor a patient’s usage has raised hopes that a new wave of technological innovation can start to make a difference in curbing nonadherence.
The drug, called Abilify MyCite, is used to treat mental disorders such as schizophrenia and bipolar disease. It’s activated when a tiny sensor inside the pill comes into contact with stomach acid, which causes it to begin transmitting a signal to a patch along the patient’s left rib cage. The patch, in turn, connects to a smartphone app that notes when the pill was taken. The result is a digital record of the meds consumed.
Making meds easier
Giovanni Traverso certainly appreciates the promise of digital pills. As a researcher at MIT and a gastroenterologist and biomedical engineer at Harvard Medical School and Brigham and Women’s Hospital in Boston, he’s been wrestling with the challenge of nonadherence for years.
“I think the Abilify digital pill is exciting,” he says. “It opens up a new way of monitoring that patient population. It will be interesting to see how the community utilizes this tool to maximize the health of patients.”
Traverso and a team of scientists at MIT and Brigham and Women’s Hospital have taken a somewhat different approach to addressing the issue, one based on research showing that how often a person is supposed to take a drug can make a difference.
“There have been studies on medications used daily, weekly and monthly,” he says. “It’s been found that when a medication is prescribed more infrequently, folks are more likely to take them, even when you stretch it out to once a week or even once a month.”
So, Traverso and his research team have been focusing on ways to have drugs stay in the stomach for a long period of time, enabling a slower, extended release of medication. The challenge is that anything taken orally generally leaves the body within a day.
One approach has been the development of an ingestible system that Traverso describes as looking like a starfish. The key is that its six “arms”—which contain drug molecules—can fold so that it can fit inside a capsule. Once the capsule dissolves in the stomach, the starfish opens up, and its shape, size and mechanical properties allow it to resist being pushed farther down the digestive tract. Once all the medication has been released, the material holding the arms in place dissolves and they break off and pass through the body. He says one of the “stars” could stay in a human stomach for one to two weeks, and the goal is to extend that even longer.
Traverso has worked with other scientists on another aspect of ingestible drug delivery systems. It involves the use of hydrogels—polymer gels with high water content that can expand when hydrated and can withstand the gastric environment in the stomach. A normal-sized capsule would be swallowed, and then swell up to a size that would prevent it from passing through to the small intestine. If any problems would arise, such as an allergic reaction, the patient could be given an antidote that would cause the material to break apart.
“It’s gastric residency to make adherence easier,” he says. “We want to make it easier for people to receive their medication over a long period of time.”
A matter of privacy
Traverso also has worked with other scientists to see how ingestible sensors and electronics can be powered wirelessly from an antenna outside the body. So he understands the great potential of digital pills and ingestible sensors, not only in boosting adherence, but also in long-term monitoring of patients’ vital signs or signals in the GI tract.
He also appreciates the challenges, particularly concerns about privacy. Patients using Abilify MyCite can have their adherence data sent directly to their doctors.
“As a doctor, I feel that having this information is valuable. If one of my patients isn’t taking their medication, I’d like to know and help them navigate that,” Traverso notes. “But I also recognize that the documentation of nonadherence could be applied for insurance purposes. We need safeguards that protect the patients, who are the most vulnerable in this situation.”
Another approach to dealing with nonadherence involves high-tech pill bottles and caps. There’s AdhereTech, which produces bottles with sensors that can track when the lid is opened and closed, as well as the amount of medication still inside. If a patient misses a dose, they’re reminded first by a light on the bottle, then a chime. If that doesn’t work, the patient receives a text message or phone call, which can also be sent to a family member or caregiver.
Other options are Pillsy, a Bluetooth-enabled bottle cap that alerts patients when it’s time to take a pill through a sound, a blinking light and a text message sent by a mobile app, and Vitality GlowCap, which similarly fits onto a standard pill bottle and emits an escalating series of lights and sounds to let people know when they’ve missed a dosage.
AdhereTech’s smart bottles aren’t sold directly to consumers, but instead the company partners with pharmaceutical companies, pharmacies and hospitals that provide them to patients with conditions often treated with very expensive drugs, such as cancer and HIV. The devices are designed also to gather a lot of data on when and how consistently people take the drugs, which the company says can help doctors and pharmaceutical companies better understand how well—or not—patients follow prescriptions for different medications.
Questions have been raised, however, about just how effective these devices really are. AdhereTech’s founder and CEO, Josh Stein, says the company’s own data suggests that its pill bottle improved patient adherence by an average of 24 percent. But research focused on the efficacy of high-tech bottle caps has largely determined that their impact on nonadherence wasn’t very significant.
One recent study of 1,000 patients with heart failure found that even reminders from GlowCap lids and cash rewards for taking their medicine on time didn’t make much difference. And, a randomized clinical trial involving more than 50,000 people determined that none of three reminder devices—a bottle cap with a digital timer, a standard pillbox with separate compartments for different days of the week, or a system with toggles that people engage when they take a pill—brought much better results in terms of adherence than what occurred in a control group without any reminders.
Researchers in the latter study concluded that “…the devices may have been more effective if coupled with interventions to ensure consistent use…” In other words, technology alone may not be enough to motivate patients who have trouble sticking to their prescriptions.
It’s still too early to say if digital pills or drug-dispensing systems designed to stay in the stomach are the answer to the nonadherence challenge. Traverso believes that it’s too complex an issue to be resolved with a single approach.
“We need many different kinds of interventions to address nonadherence,” he says. “It’s important to come at this from many different angles.”