Care4Today by Janssen Healthcare Innovation

For one reason or another, as many as half the patients in the United States don't take the medication that is prescribed to them at a cost to the US healthcare system of $290 billion a year in waste. That's according to NEHI, formerly known as the New England Healthcare Institute, which has been tracking the medication adherence problem for years.

Mobile and digital health's potential to help bring about healthy behavior changes has led a number of companies to target the problem with new connected devices, applications, and services. Some of these have claimed to be highly effective: MediSafe recently stated that their app raised users' adherence rate to 81 percent over the course of its first eight weeks that it was made available, and Vitality GlowCaps once reported pushing adherence rates to as high as 98 percent, both well above the World Health Organization average of 50 percent. NEHI has stated that digital health offerings similar to these have considerably improved adherence, but the market penetration for these tools is still low.

The challenge for these companies is not just to develop an effective product, but also to figure out who will pay for it. That means addressing the sticky question of whose problem med adherence really is.

Patients don't take their medication for a number of reasons. Forgetfulness is one, particularly in chronic disease patients who have a large regimen of pills to keep track of and in elderly patients who may have poor memories or become confused easily. But other patients don't take their meds for psychological reasons: some patients "feel fine" and skip a drug, some are concerned about real side effects. Some, according to NEHI Senior Health Policy Associate Nick McNeill, are concerned about imagined side effects. Finally, many patients stop taking medications because they simply can't afford the co-pay. This, of course, is not a complete list but it does include some of the more commonly referenced reasons. Digital health could play a role in resolving some of them.

Apps, caps, and pillboxes

Several startups working in this space originally launched as direct to consumer plays but many have since pivoted (or appear poised to pivot) and now market to providers, insurers, or pharmacies. The relevant digital health products for medication adherence typically fit into one of three categories: apps, smart pillboxes, and smart pill caps. Apps, like Janssen's Care4Today and the Walgreens app, offer reminders and calendars to help keep track of meds, and even tools for communicating with the pharmacy to refill prescriptions. These are likely to remain patient-facing, and they primarily address the problems of forgetfulness and inconvenience.

Vitality's GlowCap is a smart pill cap that launched in 2009. Once a user enters a medication dose schedule into an online portal, the pill cap glows and plays a melody when it's time to take a pill. Vitality started out offering the product directly to consumers via Amazon.com. The product, with its attractive display and branding, was marketed as a consumer electronic device. After the company was acquired by Nant Health, it pivoted on that strategy and currently only distributes GlowCaps through partnerships with employers and pharmaceutical companies. However, The Wall Street Journal reported last week that the company plans to make Glowcaps commercially available once more in February through an undisclosed retailer.

MedMinder, a company that makes large, smart pillboxes, also launched in 2009. MedMinder does target consumers, specifically elderly people who take a lot of medications. The pillbox connects via satellite so patients can use it even if they don't have Internet or even a phone line at home. It has multiple trays for different medications and sends reminders if patients don't open the trays when they should -- first to the patient, and then to a family member.

"We don't see it only as 'adherence', we also see it as helping people stay independent at home," MedMinder President Eran Shavelsky told MobiHealthNews. "Adherence has several aspects to it that we are trying to solve. Obviously one aspect is that people forget. They need to get nice, friendly reminders that help them take medication on time, and if they don't then we inform the family. Another problem is overdosing." Toward that end, MedMinder's newest product is a locking version of their pillbox, to guard against patients becoming confused and trying to take a pill twice.

MedMinder does sell directly to patients, but with its focus on elderly patients they're also marketing to the patients' caregivers and grown-up children. The company also partners with pharmacies and some health insurers.

A newer company, MediSafe Project, also leverages family to improve medication adherence. MediSafe is a cloud-based app solution -- the patient gets a reminder to take their meds on their smartphone app, and a prompt to tell the app when they do. If they don't indicate that they've taken their dose, a graduated series of friends and family -- the MediSafe Safety Net -- is informed.

"It pushes you a notification when its time to take your meds," said MediSafe CEO Omri "Bob" Shor. "The first one is a quiet one, like a text message. The second one is a louder one. The third one you can't ignore, and the fourth one goes to your wife."

Vitality's GlowCap.

MediSafe wants to use big data as an incentive to encourage pharmaceutical companies to partner with them by aggregating anonymous adherence data for various drugs.

At the recent CES 2013 event, two companies showed off their digital health adherence solutions to drum up support for their crowdfunding campaigns on Indiegogo: uBox by Abiogenix and GeckoCap.

GeckoCap is an adherence offering for kids who have asthma. The system consists of a smart inhaler cap and an app that helps parents track their kids' inhaler use and uses gamified features to encourage kids to keep up with their medication as well.

The uBox, on the other hand, is a general purpose smart pillbox. A locking, spinning carousel, the uBox is also connected to an app that includes schedules, a calendar, and the ability to notify family members about missed doses.

"Adherence is a very complex and very human problem," said Abiogenix co-founder Sara Cinnamon. "Medication, the way it's delivered today, is an open system. Maybe the patient fills it at the pharmacy, maybe they don't. The doctor has no idea, and at a followup if the treatment's not going well they don't have any objective information."

That highlights another feature of several of these solutions -- self-tracking. Not only does a mobile app or smart pillbox remind you to take your pills, it gives you a record you can give to your doctor that shows your adherence.

Cinnamon said the company is starting out by marketing directly to consumers, but it plans to partner with pharmacies, possibly so patients can get their pills pre-filled. The company has also run some pilots with the uBox at addiction treatment centers.

"I don't see them as direct competitors," she said of the other companies in the space. "We're all trying to solve the same problem and there are different ways of solving it. We're trying to focus on younger patients who have a more active lifestyle, who want to be proactive in taking care of themselves."

"Adherence" by any other name

But just because its patients who don't take their drugs, does that make medication adherence a patient problem? Patient engagement advocates like ePatient Dave have suggested that words like "adherence" and "compliance" advance a paternalistic attitude; that the doctor knows best and the patient should just sit down and follow instructions.

Perhaps if patients could take a more active role in their own medical treatment decisions, they might not have so much trouble taking their medications.

That's the philosophy of Proteus Digital Health, the company best known for developing "smart pills" that, in conjunction with a sensor-laden adhesive patch, can track and report whether pills are being taken. Apps and smart pillboxes work well against forgetfulness and confusion, but even the smartest pillbox can be fooled by a patient who takes the pill out of the box and throws it away. Proteus's smart pills would give the most reliable tracking data about when patients take their drugs. The company aims to reinvent the pill-taking experience.

"We have to have the perspective that this is a behavioral medicine and product design problem, not a patient adherence problem," Proteus Chief Products Officer David O'Reilly told MobiHealthNews. "We [pharmaceutical companies] are essentially selling a flawed, confusing product that can cause side effects. The challenge is to make it a product that's desirable and usable and will lead to sustained and persistent usage. And that's language from the consumer electronics industry that tends to be quite foreign to a pharmaceutical or medical device company."

A GeckoCap and companion app.

O'Reilly believes that by collecting data on when patients take their pills along with other metrics the smart pill can track, like sleep and heart rate, patients can come to understand the direct benefits coming to them when they take their medication. Having this sort of data might help with some of the "imagined side effects" that NEHI's McNeill described, by allowing people to see how their body is functioning relative to when they were taking their medications. Ideally, the patient will begin to link med-taking behavior with other things that are important to them. Proteus's philosophy is to not just sell drugs, but to sell individualized behavioral feedback loops.

Care coordination is a proven solution

What NEHI has found is that one of the simplest, most effective solutions to improving medication adherence is to improve communication channels between providers and patients and between care teams.

"The patient is at the bottom of the pole," said McNeill. "That's the last person you should expect to address this issue. To expect patients to be accountable and to fail them for it is a poor way to frame the problem. The right way to frame the problem is 'How do you engage the patient?' And it starts with communication."

NEHI reported that, for instance, diabetic patients who received case management, including biweekly calls, were 21 percent more adherent to their care regimens. Depression patients who received one-on-one follow-up were twice as likely to refill their medications. Unfortunately, McNeill said, the present system doesn't allow for much doctor-patient communication outside of the office. There's no structure in place for doctors to be reimbursed for those calls.

Medication reconciliation -- making sure that all of a patient's prescriptions from different providers are compatible and don't cause unpleasant side effects when combined -- is another part of adherence, since a patient whose meds don't react well together is likely to stop taking one or more of them. There are a number of mobile solutions, including improved hospital communication systems and drug reference apps like Epocrates, that address this problem.

McNeill says NEHI sees the $290 billion in potential savings as a good reason to keep looking for solutions.

"This is a problem, but it truly is an opportunity," he said. "This is a commonsense break-forward solution for reducing healthcare costs if we can get our arms around it and our heads around it and start talking about it."