A "Device" For Providing Better Drug Outcomes

By Bob Marshall, Chief Editor, Med Device Online

Nonadherence to medications is a significant issue that has recently garnered much attention. Patients who don’t take their medication regularly often experience poor health outcomes, increased hospitalizations, and even death — all of which are very expensive to healthcare systems, according to the American Journal of Managed Care.

Nonadherence is certainly not the sole cause of medication-related problems (MRPs): other MRPs, such as “dose too low” and “needs additional drug therapy,” also contribute to the overall problem and need to be addressed. However, researchers studied the frequency of MRPs in patients within the Fairview Health System from Jan. 1, 2013, through Dec. 31, 2014, across 7 categories, and the study found that 40 percent of patients had an MRP associated with medication nonadherence.

A Mayo Clinic Proceedings article highlighted a similar outcome on medication nonadherence, highlighting these notable observations:

• Approximately 50 percent of patients do not take medications as prescribed
• Medication adherence is not exclusively the responsibility of the patient
• Increasing adherence may have a greater effect on health than improvements in specific medical therapy
• Medication-taking behavior is complex and involves patient, physician, and process components
• Identification of nonadherence is challenging and requires specific interviewing skills
• Solutions include encouraging a “blame-free” environment, opting for less frequent dosing, improving patient education, assessing health literacy, and paying attention to rational nonadherence

One company trying to be a guiding light for medication adherence is Dublin-based HealthBeacon, which also keeps offices in Boston and Montreal. I spoke with HealthBeacon CEO Jim Joyce to learn about how his company attempts to improve clinical outcomes by using smart tools to support adherence for rheumatoid arthritis (RA) medications, long-acting insulin, and treatments for multiple sclerosis (MS), among others. The idea for HealthBeacon came from a question that Joyce and his colleagues asked themselves:

“Since you cannot just throw a used injection into a normal trash container throughout most of the Western world, for safety and contamination reasons, could we capture the moment that a patient dropped their injection into a special bin to get a proxy of when they had taken their medication?” Joyce said “So, we started studying that idea, and found if you have a medical waste bin in your home, you are going to discard your injection within about three minutes of taking the medication, with a 97 percent confidence interval. This made us think about encasing the medical waste bin and putting technology around it to become a sort of medical assistant.”

The treatment of chronic conditions like RA, diabetes, and MS typically use auto-injectors. According to Joyce, once you are prescribed one of these medications, the pharmaceutical company steps in to provide a broad set of patient support tools, one of which could be HealthBeacon.

“A nurse will visit the patient to train them on how to administer their medication, and provide them with the HealthBeacon adherence and waste management tool. The patient’s prescription will be loaded into our cloud software prior to the visit and, on the day they need to take [their] medication, they will receive a text message and the ‘beacon’ on the top of their bin will light up, signaling it’s time for their injection,” Joyce explained. “The patient takes their injection as they normally would, then drops the injection into the mouth of the bin. This trips an infrared sensor and causes the system to capture an image of the injection sitting in the chamber before moving it to the normal ‘sharps’ container of the bin. The captured image is time-stamped, sent to the cloud, and compared to when the patient was supposed to take their medication.”

Joyce continued, “HealthBeacon captures data on medication administration to enable healthcare professionals to evaluate your response (or lack thereof) to medicine, in light of your adherence behavior. The really exciting thing would be to mirror adherence behavior with clinical endpoints. We could mirror exact drug consumption with desired clinical outcomes we were expecting after six months being on the medication.”

This describes precisely one of the FDA’s descriptions of real world data in its overview of Real World Evidence – patient-related activities in out-patient or in-home use settings.

At the moment, HealthBeacon is looking to partner its tool with specific medicines through pharmaceutical companies and manufacturers. Its current route to market exists as a supplementary adherence tool that pharmaceutical companies can offer to patients who use their medications. HealthBeacon has submitted the tool for clearance by the FDA, and anticipates a response in Q2 of this year.

“As we move toward entry into the U.S. market, we are thinking beyond the pharmaceutical manufacturers. We are thinking about how we might position our product for reimbursement by payers,” Joyce commented.

I asked Joyce about some of the challenges HealthBeacon has faced in developing the product. He first described the need to keep it very simple to use: the device comes pre-loaded with the patient’s treatment schedule on it, so no programming by the patient is necessary. The device does not use Wi-Fi; rather, it has a global SIM card for cellular communication. The device is AC mains-powered to avoid batteries and charging issues.

“We made all of those choices from the standpoint of keeping it simple. We wanted to make sure a user would almost accidentally use the product correctly if we just gave it to them,” Joyce said. “We also learned that, when you build hardware, you can’t just change it on the fly. Dealing with a structured design process and a supply chain made this very different than building other kinds of tech. This emphasizes the importance of planning, because you are making decisions that you are going to have to live with for a while.”

Fortunately for HealthBeacon, it appears their hard work and thoughtful decision-making are paying off, as the product really shines — in more than one way. Joyce shared some metrics that HealthBeacon carefully measures around product acceptance. User acceptance rate is currently at 95 percent, while the acceptance rate for clinicians is even better: 97 percent. Let’s hope, for patients everywhere, Acceptance = Adherence.