On The Cover
Loren Bonner & Sonya Collins
If recent trends are any indication, digital health is now a mainstream market. Funding for digital health startups already surpassed 2020 levels, with $14.7 billion invested across 372 U.S. digital health deals, according to a report from Rock Health released this summer. Mental health, cardiovascular disease, and diabetes were the top-funded clinical indications, according to the report.
The COVID-19 pandemic has, in many ways, sped up the revolution in digital health. Patients and their health outcomes have traditionally been characterized using data sets visible only in clinical settings. But advances in remote patient monitoring could turn that on its head.
One key question looms large: If we are entering an era of digital health, where will pharmacists fit in?
“I think the one low-hanging disease is hypertension,” said Timothy Aungst, PharmD. “We have so much data showing that pharmacists can manage hypertension.”
Several digital blood pressure monitors validated to meet American Medical Association (AMA) criteria, many with Bluetooth-enabled technology, already exist. AMA lists 16 such devices on its website. Aungst thinks the big game changer will be smartwatches with enabled technology for heart health and blood pressure, especially if Apple is headed in this direction. The company already has an FDA-cleared ECG feature on the Apple Watch that can detect atrial fibrillation.
“I anticipate they will have blood glucose and blood pressure [monitoring devices] within the next five to ten years,” said Aungst, who is an associate professor of pharmacy practice at Massachusetts College of Pharmacy and Health Sciences University.
In 2019, FDA granted clearance to Biobeat for their wearable patch and smartwatch, which can measure blood pressure—the first time FDA has approved a blood pressure monitor without a cuff.
“Once you have a huge amount of the population with these devices, and payers get on board and subsidize the cost of these devices, I think it could be huge for pharmacists and remote patient monitoring, and then titration of services,” said Aungst.
He explained other health care providers often worry that pharmacists do not have the data to intervene. “But this equals out the footing and we could have more insight and utilize that,” said Aungst.
Right now, it is hard to know the role that pharmacists play in this digital health ecosystem, which will soon become the standard, but Aungst and other experts want pharmacists to start wrapping their heads around what is to come—or, better yet, try to lead the profession toward a robust digital health future.
“I would rather us be prepared for what is inevitable versus when it comes on our doorstep, we have to figure out how to adapt,” said Aungst.
Digital inhalers
While most applications for chronic disease management are still in development, digital technologies like smart inhalers with built in sensors or attachable sensors already exist.
For example, the Digihaler by Teva is FDA-approved for albuterol, fluticasone propionate, and fluticasone propionate combined with salmeterol. The device connects to a smartphone and notifies the patient when to take a maintenance dose, gives feedback on inhalation technique, and tracks dosing over a month. A warning is given off if a patient is using too much albuterol. The patient can also email data to their prescriber or print out graphs.
Like the Digihaler, some sensors are built into the body of the smart inhaler device itself, while others—for example, propeller sensors—are external sensors that can be attached to various kinds of inhalers.
While the smart inhaler industry is a relatively new field and is still growing, FDA approval of the Digihaler signaled a step forward.
Amber Lanae Martirosov, PharmD, BCACP, BCPS, an ambulatory care clinical pharmacy specialist at Henry Ford Health System, said her clinic at the Detroit health system is currently in the process of evaluating how this technology, specifically the Digihaler device, can help certain patients.
“We believe there is a specific niche population that will benefit from these devices, [like] our patients who don’t appear to respond to traditional inhalers,” said Martirosov. “The dashboard available is [a] really amazing technology that would provide better insight for technique, but also timing of use.”
She said she does not think the technology is meant for every patient.
“Our hope is that we can engage our patients in their care and truly improve their drug utilization,” Martirosov said.
While the biggest challenge right now for Martirosov and her team is identifying the “who,” cost will be the next concern since one of the biggest challenges with all new technology is getting it covered by insurances.
“With the newer ‘generic’ inhalers on the market, it’s going to be very difficult to have this covered by most insurance companies,” Martirosov explained. “Even with a copay assistance card, Medicare and Medicaid patients will likely not be eligible for cost savings for this technology for a while—if ever.”
She believes Medicare and Medicaid patients comprise a large portion of the patients who would actually benefit from the technology.
Yet another challenge is making sure that providers, including pharmacists, have access to the data.
“Patients will have to consent to share their data,” said Martirosov. “Creating workflows to ensure this is accomplished at the time of prescribing will be important for success. This is another area that the pharmacist could assist with in all settings—inpatient, ambulatory care, and community.”
Megan Fleischman, PharmD, BCACP, a clinical pharmacist at a pulmonary clinic at Froedtert Hospital in Milwaukee, reported she has been trying to see if pharmacists at her clinic could be involved in eventually using digital inhalers to improve outcomes for patients with poorly controlled asthma or COPD.
Fleischman would like to replicate a pharmacist-led diabetes clinic model, but for asthma and COPD instead. Pharmacists in such diabetes clinics are in charge of tracking data from continuous glucose monitoring (CGM), and there could be a similar scenario using patient data from digital inhalers.
Unlike glucometers, the Digihaler device and other attachable sensors do not have an umbrella program. Therefore, if an organization chooses Digihaler devices, they would be limited to the short-acting ß agonist, inhaled corticosteroid, and combined inhaled corticosteroid-long-acting ß agonist pharmaceutical classes.
Martirosov agrees that as this market for smart inhalers grows, pharmacists could ideally be involved in care for patients with asthma in a situation similar to what takes place with ambulatory blood pressure monitoring or CGM.
“As the ‘drug experts,’ there really is a huge opportunity here to utilize this technology to support the disease as a whole, factoring in technique, timing, and other details that are reported out on the dashboards. I also think it provides a really novel way to interact with patients and help them visualize how they can improve their disease state too,” Martirosov said.
What’s new with CGM?
“You are going to see more CGM [devices] coming through the pharmacy, and you are going to see more types,” Diana Isaacs, PharmD, BCPS, BCACP, from the Cleveland Clinic Endocrinology & Metabolism Institute predicted. “It’s an area that is certainly growing.”
Research has demonstrated that CGM improves glycemic control, A1C levels, and comorbidity from diabetes. Studies also support its use in decreasing hypoglycemia in people with diabetes.
“You don’t want glycemic variability, because that leads to diabetes complications—it’s a good argument for continuous glucose monitoring,” explained Evan M. Sisson, PharmD, BCACP, a professor at Virginia Commonwealth University’s School of Pharmacy. However, he noted that monitoring itself does not improve glycemic control. “The issue is what you do with it,” he said.
Both Isaacs and Sisson presented on this topic at APhA’s 2021 Virtual Annual Meeting & Exposition, which was held this spring.
There are obvious benefits to CGM for patients, but what are the available device options out there to choose from?
CGM is divided into professional—where the technology is owned by a clinic—or personal—where it is owned by the person with diabetes. Professional CGM can be blinded or unblinded, which determines whether a patient can see their readings in real time. When a patient is given a blinded CGM device to wear for a certain period of time, the data are downloaded and viewed when they come back to the clinic. With an unblinded CGM, a patient can see their readings in real time while they are wearing the device.
With personal CGM, the patient is wearing the sensor on an ongoing basis. But there are also some other differences, according to Isaacs. “Depending on the device, [personal CGM] is compatible with smartphones, insulin pumps, and smart-pens, versus with professional [devices], there is only one that is compatible with a smartphone and the rest do not have that compatibility,” she said.
Perhaps the biggest difference between professional and personal CGM is the insurance coverage.
“You might wonder why everyone doesn’t have personal [CGM devices], and it really varies on the insurance coverage,” said Isaacs. Professional CGM is more often covered, however. “It’s actually a benefit that a lot of patients have that they may not realize,” she noted. Most insurance plans cover it anywhere from 2 to 4 times per year on average.
“It’s one thing to have CGM, but what type of CGM product is good and best for which patients?” Aungst asked.
Each device has different features. For example, the FreeStyle Libre 14 day system does not tell the person if they have developed hypoglycemia, but the FreeStyle Libre 2 and the Dexcom G6 do alert a person of this condition.
“You could look at that and say the FreeStyle Libre 14 day system is great for someone who is not at risk for hypoglycemia and it’s also cheaper,” said Aungst.
Sisson has observed that patients who like CGM are those who are older, on multiple daily injections, and are concerned about hypoglycemia.
Isaacs said pharmacists can try to help patients understand their options and what is best suited for them based on each device’s features. One resource pharmacists can consult is diabeteswise.org. The site, which is not industry-sponsored, includes information about all CGM devices on the market today.
Overall, Isaacs said the main benefit of CGM is the real-time data. “With all of these devices, whether you are using them intermittently scanned or in real-time, you can see the glucose number and the direction it’s going.”
According to Aungst, the question of monitoring the data is most relevant. “You have many startups that want physicians to take charge of that data,” he said. “That’s fine, but the physicians don’t want to monitor the data, they don’t have the time for it. So, it’s either going to come down to nursing or pharmacy, I’d say. I think we are a natural fit to monitor data and utilize it.”
The real question
Black and Hispanic adults in the United States are less likely than white adults to own a personal computer or have access to high-speed internet at home, according to a Pew Research Center survey conducted in early 2021.
However, the survey did conclude that there were no racial and ethnic differences when it came to smartphones and tablets.
“A mobile-first engagement with society is through a smart device, and most people have access to that,” said Aungst.
But the real question as it pertains to equal access, said Aungst, is whether the person can easily obtain the peripheral device, such as the sensor for a smart inhaler or a Bluetooth-enabled adjunctive tool.
“Would a health system or provider make it available, and would a payor subsidize it?” said Aungst.
This speaks to a bigger issue: the need for more data showing the cost benefit of a particular device or intervention in order for payors to cover it and make it available to everyone.
“We spend so much time focusing on clinical outcomes to show we can do something, but we don’t focus so much on economical outcomes—like what is the value?” said Aungst.
If payors cannot be convinced of the financial outcome, Aungst said, there is no reason they will pay for such services or devices.
“This is where I think digital health helps pharmacists and the pharmacy profession,” he said. “Now we have access to more data than we had in the past where we can show the clinical outcomes and the economic value.”
Is telehealth here to stay?
Even if telehealth usage has plateaued since the COVID-19 pandemic began, perception of it by both patients and providers has shifted in a positive direction. Roughly 40% of patients said they will continue to use telehealth going forward, and 58% of physicians view telehealth more favorably than they did before the pandemic, according to a July 2021 report released by McKinsey & Company.
Supporters of telehealth have been pushing to expand its availability and codify the telehealth flexibilities that were put in place because of COVID-19. At the start of the pandemic, the former Trump administration and U.S. Department of Health and Human Services relaxed many telehealth barriers that have historically prevented its widespread adoption. These expansions are part of the federal Public Health Emergency, which remains in effect until at least October 18, 2021. Currently, a significant number of bipartisan bills related to telehealth—many specifically focused on telehealth reimbursement, which remains a hurdle—have been introduced in Congress.
Pharmacists, like many other health care providers, familiarized themselves with telehealth during the COVID-19 pandemic or began using telehealth platforms more regularly.
According to Starlin Haydon-Greatting, MS-MPH, BSPharm, CDM, FAPhA, telehealth has been helpful for pharmacists who provide ongoing monitoring and management to patients with chronic conditions.
While pharmacists have been delivering Medicare Part D medication therapy management (MTM) services via telephone for years now, many more started providing components of Medicare chronic care management and transitional care management services virtually since the pandemic began.
“We believe we need to meet our pharmacists and their patients where they are; telehealth expands our reach and increases access to quality pharmacy care,” said Haydon-Greatting, who currently serves as the Illinois Pharmacists Association’s (IPhA) director of clinical programs and population health.
She said IPhA’s MyHealthRx patient self-management programs have expanded to use digital health and virtual telehealth platforms to support and deliver hybrid clinical pharmacy services with community-based members. Services pharmacists offer include: lifestyle and diabetes prevention, chronic disease management, MTM, comprehensive medication management, immunization, travel health, CLIA-waived testing, and other care services.
“Implementing or expanding your clinical practices with telehealth will provide added value for your patients and your pharmacists and pharmacy staff,” said Haydon-Greatting. Plus, she noted pharmacists have an advantage in becoming successful with telehealth because of the trust they have gained with patients.
“My insight is that this COVID impact is an excellent opportunity for community-based pharmacists to expand their patient care services,” Haydon-Greatting said. “Reaching out to underserved persons or home bound elderly will help create a pharmacy home that will increase loyalty and improve outcomes.”
Telehealth considerations going forward
While telehealth has been a welcomed service for both patients and health care providers during the COVID-19 pandemic, a study published in the American Journal of Preventive Medicine in March 2021 found that these services were mostly accessed by those living in affluent and metropolitan areas.
Researchers said the findings raise concerns that the pandemic may be worsening existing disparities in overall health care use.
In their analysis of insurance claims from individuals with employer-based health insurance in 2019 and 2020 (6.4 million and 6.8 million, respectively), the researchers found the greatest increase in telehealth use was among patients in counties with low poverty levels (about 48 visits per 10,000 people vs. 15 per 10,000 people in high-poverty areas) and among patients in metropolitan areas (about 50 visits per 10,000 people vs. about 31 visits per 10,000 people in rural areas). While there was a twentyfold increase in the rate of telemedicine use when COVID-19 lockdowns began in March 2020, the study showed that the rate of office-based medical encounters, which declined by nearly 50%, were not fully offset by the increase in telehealth visits.
The study authors acknowledged some limitations of the study, including using data from a single employer-insured sample. “[T]he results will not be generalizable to low-income individuals on Medicaid and older individuals on Medicare,” they wrote.
Previous research has demonstrated that prior to the pandemic, communities with poor geographic access to health care disproportionately used telehealth services.
The American Medical Association has also stated that equity needs to be considered in any expansion of telehealth in the future.
Yet another important consideration for telehealth going forward is ensuring patient privacy is protected and systems are properly secured. Patients as well as providers have felt anxious about HIPAA violations as flexibility has been granted to incorporate popular technology and applications into telehealth services.
The Department of Health and Human Services’s Office of Civil Rights has a set of Frequently Asked Questions on Telemedicine and HIPAA Waivers, which can offer helpful guidance and clarification.
AI frees up pharmacists to do the thinking tasks
People generate more than 2.5 quintillion bytes of data every day. A quintillion is a thousand to the sixth power. Much of that data relates—either directly or indirectly—to human health, and it’s powering artificial intelligence (AI) solutions that are affecting health care right now, including in the pharmacy space.
AI in the pharmacy has the potential to improve patient outcomes and professional satisfaction.
“A lot of people are scared of AI. It’s like ‘What are we going to need pharmacists for?’” said Scott Nelson, PharmD, assistant professor of biomedical informatics at Vanderbilt University in Nashville. “But AI does some of the repetitive work that we humans typically don’t see as very exciting, so pharmacists can do more high-level executive thinking and offer compassion and support to patients—things that computers can’t do.”
Machine learning and predictive algorithms
Machine learning is already in use and making a big impact in health care.
“These technologies are great at finding the needle in the haystack when it comes to anomalies within the data,” said Amey Hugg, BSPharm, who is director of member relations for the Section of Pharmacy Informatics and Technology at the American Society of Health-System Pharmacists.
Computers can process large data sets and generate algorithms to aid in clinical decision making, detect early signs of disease, or predict drug interactions, among other potential uses.
Machine learning can also help identify deviations from normal patterns that may indicate drug diversion. Trained computers can mine administrative records, dispensing cabinet releases, waste documentation, and other patterns related to the movement of controlled substances through a clinic or health system.
“It won’t say ‘This person is diverting drugs,’ but it flags an abnormality and says, ‘There appears to be some risk here. You should probably look into this,’” Nelson said.
These systems are already in place at inpatient facilities and may be coming to outpatient settings soon, Hugg said. “It’s likely we aren’t that far from harnessing EHR data within the Health Information Exchanges that we see within and external to each state and performing comparisons of existing data to written and electronic prescriptions coming into our pharmacies to find patterns of illegal activity,” she said.
Pharmacists can also create algorithms themselves that can serve up useful information for their practice. “Pharmacists are great at creating these algorithms to help capture when patients may have significant interactions or other issues related to data that are present within systems,” Hugg said.
Natural language processing
Computers that process natural language can streamline workflow in health care facilities. These AI programs can take dictation or process an informal note and transcribe it into a prescription to send to the pharmacy or transform the information into data to be entered into the patient’s electronic medical record. The technology even allows patients to provide additional information to providers from their homes.
“Speech technology will be a simple way to connect with a patient and for them to enter the requested information for further analysis and review, and perhaps escalate with providers responsible for their care,” Hugg said.
AI-driven patient support
Rather than call the pharmacy and ask for the pharmacist, patients can open the store’s app and answer a few questions via chat. In many cases, there is an automated solution to the patient’s problem, which does not require any human interaction, or the chatbot can direct the patient’s call to a technician rather than the pharmacist. This can reduce the burden of unnecessary triage on pharmacists while they focus on tasks that only a human clinician with their training can do.
Robotic process automation
Many health care tasks are repetitive. Pharmacists or other professionals do these tasks the same way and for the same reasons every day. AI can help automate tasks like these, such as those related to billing compliance, auditing, prior authorizations, data collection, and prescribing.
“The computer doesn’t tire out and it doesn’t make mistakes,” Hugg said. “This helps reduce unnecessary work and elevates humans to more thinking tasks rather than doing tasks.”
Through AI, some computers can see a screen the way that humans do. With this technology, computers could verify pill counts or recognize the markings on tablets.
“An advanced technician or pharmacist can then audit the process instead of checking every prescription,” Hugg said. “This would allow the pharmacist to provide more patient-facing services, such as counseling, vaccines, lab monitoring, and overall patient workup.”
AI is augmented intelligence
Nelson proposes that a better term for AI is “augmented intelligence.” It doesn’t replace human intelligence, but rather enhances it. “The computer plus the human is better than either one alone,” he said.