The Value of Digitized Medicines for Patient Engagement
Jeannette Tighe
TruTag Technologies
@TruTags
T

he pharmaceutical industry has embraced digital transformation as a means of generating data that enables faster and better-informed decision making. Digitization has resulted in improved cohesion and overall effectiveness across the pharmaceutical value chain.

A new wave of technologies, specifically digitized medicine solutions, is set to expand on this trend by digitizing medicines themselves. The digitization of medications offers the industry the potential to engage and communicate with patients through personalized, digital interventions that can shape behaviors and offer meaningful improvements to health outcomes.

What are Digitized Medicines?

Digitized medicines, sometimes referred to as “smart medicines,” are tablets and capsules that have been given a digital identity. This digitization transforms each dose into a channel for patient engagement and communication. Two components are typically needed to digitize a product: a target and a sensor. In the case of oral medications, the target is applied directly to the medicine and then a sensing device is used to detect the target and convert the signal into a digital format. For oral medications, the target should be made of a material that does not affect clinical efficacy, safety, or medication aesthetics in any way nor add any regulatory burden.

One such “smart” digitized oral medication solution involves the incorporation of spectrally encoded microparticles made of high-purity silicon dioxide, a material generally recognized as safe for ingestion by FDA (Figure 1). The microparticles are added onto tablets and capsules using existing processes and carriers.

Example of a digitized oral medicine solution
Figure 1. Example of a digitized oral medicine solution. Figure courtesy of TruTag Technologies. All rights reserved.
In this solution, a common smartphone camera acts as a sensor. It detects the microparticles on the medicine and creates a digital signature that can be recorded and stored.

Value of Digitized Medicines?

Digitized medicines offer a novel and practical means of patient engagement and communication. With digitized medicines, every dose has the potential to become a data point. This data can be used to generate significant value at disparate points in the pharmaceutical value chain (Figure 2).
Driving value through digitization
Figure 2. Driving value through digitization. Figure courtesy of TruTag Technologies. All rights reserved.
These benefits have three broad dimensions: improved clinical trial efficacy, increased patient engagement, and enhanced patient safety.

Improving Clinical Trial Validity through Digital Engagement

Our industry-level shift toward decentralization often makes clinical trials increasingly complicated. Managing patient compliance and preventing administration errors are two major challenges of decentralized clinical trials.

Linking patient engagement to clinical endpoints: Digitized medicine solutions offer patients the ability to directly interact with their medicines through smartphone applications. This engagement provides clinical trial administrators with a real-time view of participant medication adherence which can then be cross-referenced with clinical outcomes.

Identifying administration errors: Distribution of medicines in decentralized clinical trials is vulnerable to medication errors. Introducing digitized medicines into a trial has the potential to mitigate this risk by ensuring that the right patient has the right oral medication and dose. The ability for administrators to directly validate patients and medications is an enormous benefit in ensuring the integrity of decentralized trials. Critically, this can be achieved without affecting study blinding.

Improving Health Outcomes through Patient Digital Engagement Loops

Medication adherence is the extent to which patient behavior corresponds with the recommendations of their healthcare provider to adhere to their therapy regimen. On a global basis, it is estimated that only 50% of patients take their medication as prescribed.

Medication nonadherence is linked to poor health outcomes, increased hospitalizations, and even death. It costs healthcare systems billions of dollars on an annual basis. While reasons for medication nonadherence vary by patient, research suggests that most nonadherence is driven by communication and behavioral issues.

One approach to mitigating medication nonadherence is to use digitized medicine solutions to drive digital interventions that engage and educate patients while developing feedback loops that reinforce adherence and seek to change patient behavior (Figure 3).

Digital medication adherence feedback loop
Figure 3. Digital medication adherence feedback loop. Figure courtesy of TruTag Technologies. All rights reserved.
These digital interventions can be standard tools such as a medication reminder feature, or custom interventions based on behavioral science that have been designed specifically for a given patient cohort and/or therapy.

Safeguarding the Patient through Digital Engagement

Operational challenges of the modern pharmaceutical supply chain are well established. Globalization, outsourcing, and online retailing have led to a loss of control and visibility. This has led to an influx of unauthorized and illegitimate drugs that pose a significant risk to public health and safety. Smart or digitized medicines offer a means to reclaim supply chain visibility and safeguard patients by facilitating the instant and unequivocal identification of a product anywhere in the world.

Mitigation of medication errors is another critical safety aspect that smart medicine solutions can address. In the US alone, it is estimated that medication errors cause at least one death every day and injure about 1.3 million people annually. By linking smart or digitized medicines to patient information, healthcare professionals can ensure that the right drug gets to the right patient in the right dosage.

Conclusion

With FDA approving the first digitized medicine product in 2017, “smart” digitized oral medicines represent the continuation of the pharmaceutical industry’s digital transformation. Every dose of a digitized medicine supplies the basis for patient communication, engagement, and data generation. The transition to digitized medicines offers a significant source of value creation to the pharmaceutical industry and for stakeholders across the healthcare ecosystem.