Brent I. Fox, Pharm.D., Ph.D and Joshua C. Hollingsworth, Pharm.D., Ph.D.

For some of us, it is still difficult to accept that we are 20 years into the new millennium. Some of us recall that night — Dec. 31, 1999 – when we were diligently (and somewhat begrudgingly) sitting at our computer stations at work waiting for the chaos that was supposed to follow the clock striking midnight. Fortunately, the predictions were largely wrong. Life – and our information technology systems — kept trudging along. Here we are 20 years later. We have witnessed both evolutionary and revolutionary change in the world of health information technology. Much of this change has been positive, while some has led to unintended consequences. In this, the first issue in the 20th year of the new millennium, we devote our focus to recent developments that deserve your attention.

Immunization Information Services

The provision of vaccination services is one of the best examples of pharmacists extending beyond traditional dispensing roles. The accessibility and hours of community pharmacies provide expanded access to vaccination services compared to traditional providers. Whereas traditional providers of vaccination services routinely require appointments, the walk-in nature of vaccination services in community pharmacies enhances access.

However, we know that there are challenges associated with vaccination services in community pharmacies. An especially important challenge is the inconsistent (and sometimes complete lack of) use of immunization information systems (IIS) to document vaccines administered in community pharmacies. One of our colleagues who recently completed her graduate studies at Auburn University devotes much of her research efforts to this very topic. Her research indicates that IIS integration into routine workflow can be particularly challenging for independent pharmacy settings. Regardless of the setting, inconsistent use of IIS leads to incomplete immunization records, which can result in both incomplete and duplicate vaccine administration.

We are following a recent development that holds considerable promise in the quest to address incomplete immunization records. In the December 18 issue of Science Translational Medicine, Kevin McHugh and colleagues described their use of microneedle patches to code liver vaccines and near-infrared fluorescent microparticles into the skin of pigs and human cadavers. The general idea is to deliver a vaccine and near-infrared fluorescent particles to an individual’s skin simultaneously. The “near-infrared fluorescent” aspect is important because McHugh’s research team was able to modify the camera on a commercially available smartphone to visualize the infrared particles. The goal is to create a persistent vaccination record that travels with the person.

The research team believes its work is primarily applicable in developing countries, but we envision utility virtually anywhere that immunization records are incomplete. There are two primary perspectives in terms of incomplete immunization records. First, healthcare providers may not know the vaccination status of the patient in front of them. Second, patients may not remember their vaccination status. In fact, one of your authors received two tetanus boosters in the same year due to a memory lapse. As this technology continues to develop, we see use cases where a provider uses an app to scan a patient’s skin and obtain their latest immunization status. Similarly, a patient can do the same, and can use secure communication (e.g., Direct) to share his or her immunization record with caregivers. One argument against this approach is that it will not result in a centralized immunization record that is accessible anytime from anywhere. But that’s actually the current state of IIS, as the immunization registries are on a state-by-state level.

Adherence Technology

In related news, the FDA recently approved several medication-related digital health tools. We previously wrote about the medication adherence platform from Proteus Health. This tool includes a sensor embedded in an oral dosage form, a reader (patch) worn on the skin, and a smartphone app. When ingested, the sensor sends a signal to the patch, which then relays the administration data to the app. In early December 2019, the FDA cleared the second digital pill, from etectRx. While reports indicate that Proteus is experiencing financial difficulties, the approval of a second “digital pill” suggests continued interest and innovation in this space. Of note, the primary difference between Proteus’s and etectRx’s digital pill systems is that etectRx’s reader does not require skin contact to receive the message from the ingested sensor. Regardless of what happens to Proteus, and regardless of the location of the reader, the digital pill system is the state of the art in adherence measurement. How great it would be to have access to adherence data generated by the patient ingesting the medication!

Adherence and careful monitoring of glucose levels are important to optimal management of diabetes. For patients with type 1 diabetes, a range of automated devices exist to monitor glucose levels and manage insulin administration. However, these devices do not talk to each other. The Control-IQ automated insulin dosing controller (Tandem Diabetes Care) is the first FDA-approved device intended for interoperable use with devices from different vendors. For patients, Control-IQ’s approval paves the way for a customized approach to closed-loop diabetes management. Other related developments that we are following in this space focus on the creation of a smartphone app that is interoperable with the components of automated insulin delivery systems. Control-IQ and the aforementioned smartphone app provide the ability to mix and match the components of an automated insulin delivery system, giving patients the power of choice in selecting preferred devices to manage their condition. This philosophy reflects the ongoing transition to patient-centric care.

We have highlighted a few digital health developments that we will closely monitor in 2020. In reality, there are many others that we could have included. Artificial Intelligence remains an area of extensive activity both within and external to healthcare. The use of consumer electronics for health-related reasons continues to receive considerable attention. We are optimistic that there are innovations of which we are not aware but that will come to prominence in 2020. What are the developments that receive your continued attention? We welcome your thoughts. CT

Brent I. Fox, Pharm.D., Ph.D., is an associate professor in the Department of Health Outcomes Research and Policy, and Joshua C. Hollingsworth, Pharm.D., Ph.D., is an assistant professor, Pharmacology and Biomedical Sciences, Edward Via College of Osteopathic Medicine, Auburn Campus, Harrison School of Pharmacy, Auburn University. The authors can be reached at foxbren@auburn.edu and jch0010@auburn.edu.

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