THE ADVENT OF WIDESPREAD INTERNET access and possession of mobile devices such as smartphones and tablet computers has increasingly led to the expansion of new services that were unthought of a decade ago. In an era in which an individual can order food to be delivered, request a ride, and search for a date all with just a few finger gestures, it comes as no surprise that there is a booming field looking at how we can leverage the internet and mobile devices to impact healthcare. Companies such as Amazon, Apple, and Google, which were before known for their tech or commodity supplies, are now moving into the medical space, looking to expand services and capitalize on a booming market. The only question is, what can they do with technology and who will use it?
With that being the case, the pharmacy market is itself an open feast of possibilities. While leveraging technology to impact the delivery and packaging of medications for patients may be on the forefront, alternative services are being explored as well. Medication adherence, drug safety, and access are large areas of interest, and the exponential growth of devices that can be used for medication management has spurred many disruptive technologies to arise in the start-up sector. The advent of small sensors and the internet of things (IoT) infrastructure has increased the prospect of patients being monitored digitally for health and clinical outcomes. Wearables are perhaps at the current forefront of such technology. Many devices have entered the market that can be worn peripherally on the patient (e.g., wrist mounted) or attached directly to the body for higher data collection (e.g., blood glucose). Of particular interest to the pharmacy field, these technologies may pave the way for increased opportunities for medication oversight by pharmacists with an eye on improved clinical outcomes and patient safety, as seen in the figure.
THERAPEUTIC OUTCOMES WITH WEARABLES
Wearables as a whole have made major advances compared to devices available less than a decade ago. Past wearables were focused primarily on health and wellness, via such things as step measurements and calculations of caloric expenditure; we have arrived at new standards for the metrics available from wearables. For example, almost all wrist-mounted wearables — from fitness trackers to smartwatches — now incorporate heart rate measurement. Alongside this, we are seeing other vital measurements being advanced, including body temperature and oximetry.
Digital Health Guided Medication Management: Illustrating where wearables and devices help meet clinical support.
Perhaps two therapeutic areas merit primary focus at this time, given health and wellness goals and the specter of widespread diabetes and cardiovascular disease in the U.S. population: Blood pressure and blood glucose are becoming areas in which which the wearable market is quickly gaining traction.
While multiple products exist on the U.S. market that are Bluetooth-enabled blood pressure devices, there is an increased interest in wearable devices that allow for continuous monitoring. One example of a blood pressure-monitoring device is Omron’s Zero, which is a wrist-mounted device to measure and track blood pressure throughout the day. There are also recent patents from Apple that indicate they are looking for their own blood pressure measurement device. This could be a standalone device or another form factor (e.g., wristband) that can be integrated with the Apple Watch. Given current recommendations in the ACC/AHA hypertension guidelines for the ambulatory monitoring of blood pressure, these devices may find greater importance in patient care than in the past.
The blood glucose market is seeing more disruptive innovation overall and seems to be viewed by many companies as the golden goose. Traditional blood glucose measurement has routinely been handled in the patient’s home using self-monitored blood glucose (SMBG) devices, relying on the use of a lancet to access a drop of blood collected on a testing strip and read through an intermediary device. These devices have seen some upgrades, similar to blood pressure cuffs, with the addition of Bluetooth to upload data via a mobile app to the user’s smartphone. While SMBG will likely be a mainstay of care for the time being, continuous glucose monitoring (CGM) technology is also undergoing drastic innovation. Companies like Dexcom and FreeStyle (which utilize a wearable patch with a microneedle to track blood glucose) are bringing CGM devices to the market, with the later finding a spot on many pharmacy shelves. Perhaps even more interesting is the push for an alternative means of CGM with technology that eliminates the need for a microneedle through the skin and instead uses either light or other means to track blood glucose indirectly. Notably, part of Google has teamed up with Alcon/Novartis to investigate the creation of eye contact lenses that can track blood glucose, with others looking for wrist-mounted passive devices for CGM.
At this time these devices are in their infancy, but with payers and insurance companies increasingly covering the devices for patients, mainstream adoption is around the corner. Utilizing these devices for patient monitoring will become a pressing concern in the near future, along with not only who prescribes and dispenses them but also who guides patients in their utilization and monitoring.
TRACKING ADHERENCE WITH SENSORS
Sensor-based technology has also significantly impacted how the medical field can measure and assess patient adherence with pharmacotherapy in their daily lives. Foremost are companies like Proteus Digital Health and etectRx, which are manufacturing bioingestible sensors that send out a data burst when they dissolve, indicating a patient took his or her medication. A limiting factor to these devices is that a peripheral device must be worn to capture the data burst and pass it on to a mobile device or tertiary data repository for tracking adherence. The Proteus system relies on a patch worn above the patient’s stomach, that can also track other data about the patient, including activity and related vitals. This system is being adopted by the broader market, with the first FDA-approved “smart pill,” Abilify MyCite, from Otsuka Pharmaceuticals in conjunction with Proteus, coming to market in 2018. The Abilify MyCite is designed to track adherence in patients with bipolar disorder, depression, and schizophrenia. At this time, there are over 20 other drugs in the pipeline exploring sensor integration, with primary emphasis on being infectious disease, oncology, and mental health.
Outside of oral medications, inhalers and injectable therapy delivery devices are also being investigated. Companies like Adherium and Propeller Health are creating sensors that can be attached to inhalers and detect when a patient uses an actuation of his or her therapy. All of this data can then be broadcasted to a central repository for providers and caregivers to monitor and get insights into adherence.
LIMITATIONS TO WEARABLE MARKET
The hype behind the wearable market and its role in healthcare is quite high at this time, but some skepticism is warranted. One of the most significant limiting factors for the use of wearable- and sensor-based technology in healthcare practice is global integration into the workflow. At this time, most companies utilize their own stand-alone platform that does not integrate into an EHR (electronic health record) or pharmacy system, thus creating another system a team or workforce must master, creating a barrier to use. Other considerations include cost, whereby the use of the technology may not have demonstrated clinical evidence significant enough to justify inclusion in clinical guidelines and uptake of coverage by insurance companies and related payers (e.g., federal agencies, pharma). Lastly, the rapid pace of technology has seen many companies invest in hardware only to be usurped by the “next big thing,” which is a concern for an organization that spends heavily on research and development of a form of technology one year that’s then outdated the next.
While there are many companies and organizations currently interested in the use of wearable technology, pharmacy would do well to pause and carefully assess the market. Determining what technology is worth investigating and possibly integrating is the prominent issue at this time. Could such technology use be beneficial in an MTM (medication therapy management) service or patient-monitoring program? Perhaps, but ultimately, there’s the question of which staff would be responsible for the use of this technology and how it can benefit patients overall. No matter what, the next step is the integration of the technology with pharmacological products supported by pharmaceutical company backing, such as the Abilify MyCite system. It may be that at first only the specialty pharmacy market and specific ambulatory pharmacy systems may utilize this technology, but odds are that it will slowly trickle down everywhere. CT
Timothy Dy Aungst, Pharm.D., is an associate professor of pharmacy practice at Massachusetts College of Pharmacy and Health Science University. He also works as a freelance writer and consultant. Find him on twitter at @TDAungst and contact him at firstname.lastname@example.org.