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Technological advances have widened the potential solutions to improve adherence to high-cost specialty drugs.
The Problem
Today, medication adherence is a large financial burden on the US health care system. The World Health Organization (WHO) claims medication non-adherence is responsible for nearly $300 billion of avoidable health care costs each year. In fact, WHO estimates that medication non-adherence accounts for 10% of total health care costs.
Unfortunately, medication non-adherence is more than just an economic problem. It is estimated that approximately 125,000 deaths are related to medication not being taken as prescribed. Furthermore, up to two-thirds of medication-related hospital admittances are a direct result of poor medication adherence.
Thanks to modern-day technological advancements, more innovations are being made to help making medication non-adherence a thing of the past.
The Answer
When I was a kid growing up, I used to be obsessed with The Jetsons. Everything about the show fascinated me. The Jetsons was an animated cartoon show that was premised on a family that was living in the future.
The Jetsons communicated in what were revolutionary ways for that time. They communicated via video chat on a screen, a handheld device, as well as a watch. At the time of the cartoon airing, video-chatting and communicating on a watch weren’t even in the foreseeable future.
If you are old enough to remember this show you are probably smiling from the delectable whiffs of nostalgia. Otherwise, if you’re not old enough to remember The Jetsons cartoon, then you are probably yawning, wondering why you are still reading this article.
Those futuristic means of communication may not seem like a big deal in this day and age because they all exist now. These have become the standard in today’s computing era. I remember watching the Apple keynote on June 7, 2010, when Apple unveiled the iPhone 4.
Steve Jobs introduced the world to live video-chat with a product called FaceTime. He exhibited a live demonstration, whereby touching a single button would allow you to stare at the intended recipient face-to-face in real time.
This was a monumental step forward in terms of technological evolution. During the presentation, Jobs likened FaceTime to The Jetsons, citing his same enthusiasm of how the future is finally here now.
Digital Health: Smartwatches
The Jetsons predicted the future. Digital health can be defined as digital instruments that aid in a person’s health or wellbeing, such as a smartwatch or Fitbit. In present day, you’re hard-pressed to find someone who isn’t wearing some sort of smart-wearable on their wrist.
The likes of the Apple Watch, Fitbit devices, Android watches have become the ideal devices for most people. These devices are most commonly referred to as smartwatches and offer convenience in a small form factor.
From having the ability to take and place inbound and outbound calls to viewing and responding to text messages, they have become synonymous for health-enabled tracking. Smartwatches continue their rise as the most attractable mobile platform to help health care professionals better manage their patients, but also for patients to better manage themselves.
These wrist-size devices are empowering people to take more control of their health. Popular standard features of most smartwatches now include the ability to capture activities such as multi-sport tracking, sleep tracking, elevation climbed, calories burned, and heart rate tracking.
In partnership with Stanford Medicine, Apple launched a clinical trial called the Apple Heart Study. The objective of this research study is to accelerate the discovery in heart science.
Specifically, the study was set forth to detect irregular heart rhythms known as atrial fibrillation (Afib). Afib is a quiver—or irregular heart rhythm—that can lead to a blood clot, heart failure, stroke, or other potentially life-threatening heart-related condition.
Afib, particularly in an older population, can be particularly dangerous. In fact, Afib increases your risk of experiencing a stroke five-fold.
In the United States, Afib is the primary driver for 750,000 hospitalizations each year and 130,000 deaths. This deadly disease often goes undiagnosed and symptoms are typically not experienced by a person until they are in Afib.
After being live for less than 1 full year, the Apple Heart Study closed enrollment to new participants on August 1, 2018, and ended the study on September 1, 2018. The study is slated to be officially complete in early 2019 after the final data collection phase.
This unique clinical trial is considered the largest-ever screening study for Afib in history. In less than 365 days, more than 419,000 participants had enrolled in the Apple Heart Study.
Although the study has ended, it was open to anyone aged 22 years or older residing in the United States who is using at minimum an iPhone 5s (or newer), running iOS (Apple’s mobile software), and using an Apple Watch (series 1 or newer). Exclusion criteria were self-reported diagnosis and history of already having Afib, atrial flutter, or currently on an anti-coagulant therapy.
If you met the aforementioned criteria, getting enrolled in the study was rather easy. Simply download the study app from the Apple app store. It will ensure enrollees meet all eligibility criteria, ask their consent, and require signing an electronic version of a Health Insurance Portability and Accountability Act of 1996 consent form.
Using the heart rate sensor, the Apple Watch would continually monitor for any irregular heart rhythms. If enough episodes of arrhythmias were detected, individuals would receive a notification informing of such.
Following the notification, enrollees would receive a free video consultation on their iPhone with a board-certified, licensed primary care provider via American Well for further follow-up and examination. American Well is an industry leader in telehealth services whose focus is to improve access to quality care.
The participant would then be sent electrocardiography patches and be asked to record the electrical rhythm of their heart for up to 7 days. On September 11, 2018, the FDA announced that it had cleared 2 Apple-designed mobile medical applications to work on the Apple Watch.
A day later, Apple revealed their newest iteration of the Apple Watch (known as Series 4), which included 1 of these 2 FDA-approved mobile applications: a built-in electrocardiogram (ECG) app. Using electrodes built into the digital crown, along with the back crystal sensor of the new Apple Watch, the ECG app will read your heart’s electrical signals.
By simply placing your finger of the physical side digital crown of the watch for 30 seconds, the watch will record you heart rhythm, interpreting the data in real-time to indicate if your heart shows signs of Afib. Specialty pharmacies have begun to take notice of this trend. Diplomat Pharmacy, the country’s largest independent provider of specialty services, has announced a partnership with Fitbit.
The collaboration between these 2 global leaders will focus on chronic disease management by providing patients with the right information at the right time. Furthermore, Fitbit hopes to integrate Diplomat’s digital health platform to help oncology patients better manage their therapy regimen.
Other nationally recognized specialty pharmacies are also beginning to use smartwatches to help manage specialty conditions. As this arena continues to find ways to reinvent itself, specialty pharmacies are continually challenged to find ways to evolve.
This trend is also being aided by prescription drug manufacturers who are requiring special requirements from pharmacies to ensure their patients are getting the care they deserve.
Digital Medicine
Proteus Discover
Proteus Discover is the world’s first digital medicine offering (DMO) comprised of ingestible sensors and a wearable patch. This provides insight that was once otherwise unknown to providers. This DMO allows for more informed decision-making, patient engagement, optimized therapies, and improved outcomes.
Proteus Discover works by using an ingestible sensor that is the size of a grain of sand that is built into the medication. The sensor becomes activated once the patient ingests the pill.
When it reaches the stomach, the sensor will transmit a signal to the patch being worn by the patient. Once the information is transmitted to the patch, it will then be transmitted to the mobile application for the patient to view, as well as a portal for providers to access.
The pill is made from elements that are found in traditional dieting and the patch tracks medication adherence, steps, activity, sleep, and heart rate.
Digital Pills
Abilify MyCite
Digital pills have long been discussed in the medical community and now they are exactly just that—a thought. Manufacturers are continuing to find innovative ways to deploy this technology to specific conditions that could benefit from having a digital pill track its ingestion.
On November 13, 2017, the FDA approved Abilify MyCite. Abilify’s new product is a digital pill with a sensor that tracks whether a patient has ingested it. This approval of a digital ingestion tracking system by the FDA is the first-of-its-kind in the United States.
Abilify is indicated for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar l disorder, and the treatment of major depressive disorder. Being able to track whether a medication was taken by a patient with a mental illness is a profound innovation.
This ingestion tracking system also works by sending a message from the sensor inside of the pill to a wearable patch worn by the patient, which is then transmitted to a mobile application, allowing the patient to track the ingestion of the medication via their smartphone. The system allows the patient to grant access to caregivers and medical personnel to access this information via a web-based portal.
Specialty Pharmacy Implications
The Journal of Managed Care & Specialty Pharmacy (JMCP) conducted a study to determine the effect that a DMO would have on patient adherence. The study focused on hepatitis C virus, which has a patient population who is historically notorious for poor adherence rates.
The study used Proteus Discover as a way to measure adherence, physical activity, and heart rate. The patients were prescribed sofosbuvir/ledipasvir (Harvoni) and each tablet was co-encapsulated with an ingestible sensor.
Medication adherence was measured by assessing the number of medication ingestions the DMO recorded—or the patient recorded, if the DMO missed it—divided by the number of prescribed doses. The study found that 89% of patients were adherent at least 95% of the time.
The JMCP concluded the DMO provided optimal adherence in a population in which it is otherwise suboptimal. The data are indicative that the DMO may begin to play a critical part of specialty pharmacy practice.
Digital Assistant
Pillo is the digital assistant that’s fully focused on your health and wellbeing.
If you’ve ever used a smart-speaker, also known as a digital assistant, you know how wonderful of an advantage these devices can be. They allow you to get tasks done by simply talking to the device. You talk to the speaker saying, for example, “Alexa, find me the closest pharmacy.” Alexa will then provide audible results and let you choose with a dictated response.
Now, there is a digital assistant focused entirely on your health and wellbeing, called Pillo. This intelligent home robot can handle basic inquires found with other digital assistants, along with questions such as:
I think Pillo’s best feature is its ability to actually dispense a patient’s medication. The patient simply says “OK Pillo, dispense my meds,” and their desired medications will dispense out of the circular-shaped digital assistant into a small pill cup.
If a patient requests their medication before its due, an alert will pop-up on Pillo’s 7-inch display asking them if they want to consent to take it early or wait until it’s due. Pillo has the capacity to store up to 4 weeks of medications in a tamper-proof container inside the device.
Furthermore, Pillo will automatically place a refill order of your medications to your preferred pharmacy once the device detects that it’s low on pills.
Pillo allows for patients to have caregivers get notifications about their medication. For example, the patient misses or forgets to take their dose, the designated caregiver(s) will get a notification saying, “Your dad missed his morning medication.”
“Alexa, take note.”
Although adherence continues to be a topic of discussion, it may finally be meeting its match as technologies continue to advance and become more accessible. While I don’t expect Amazon to release a digital assistant capable of handling health-related inquires like Pillo tomorrow, it makes me wonder why they haven’t already.
Amazon continues to expand its presence in homes across the country with arguably the most popular digital assistant, Alexa. Although Pillo is a remarkable first iteration, it’s not without its flaws; however, such devices can play a critical part in the medication non-adherence problem in America.
Now that Amazon has acquired online pharmacy PillPack, developing an extension of the voice-enabled Alexa could create the perfect harmony to cause tremendous disruption in the marketplace. Consider that adherence is a clear problem in the United States and Amazon developed a digital assistant capable of placing automatic refill orders for patients to their online pharmacy, PillPack.
This opens multiple revenue streams for Amazon while attempting to address one of the biggest problems with medication adherence: access. These factors create a prime opportunity for Amazon to cause a tsunami-like wave as they continue their entrance into the health care sector.
“Alexa, are you listening?”
About the Author
Mark Thomas earned his Doctor of Pharmacy degree from Lake Erie College of Osteopathic Medicine (LECOM) and is currently enrolled in the Master of Science in Pharmacy Business Administration (MSPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines. Mark spent the past 4 years as a clinical pharmacist in a specialty pharmacy working on high profile initiatives to expand his organization’s national footprint, as well as directly coordinating with patients, prescribers and other healthcare providers to educate and promote the utilization and uptick of generic specialty medication. In his current role as a clinical advisor in the managed care setting, he works directly with clients to help manage and develop strategies that promote optimal health outcomes in the most cost-effective manner.
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