Digital pills come under fire for privacy, patient-provider issues

The technology is seen as a way to ensure medication adherence, but critics are raising red flags about the tools.

There is no evidence that digital pills, prescription medications with ingestible wireless sensors, are beneficial to patients and, in fact, the technology poses a danger to the provider-patient relationship.

That’s the contention of researchers at the University of Illinois at Chicago who caution that, despite the Food and Drug Administration’s 2017 approval of the first drug in the U.S. with a digital ingestion tracking system, it is premature for providers to allow this new tool into clinical settings.

These “smart” pills are designed to digitally track if patients have ingested their prescription medications in an effort to ensure drug regimen compliance.

However, Eric Swirsky, clinical associate professor of biomedical and health information sciences in the UIC College of Applied Health Sciences, warns that this new technology “dumbs down an issue that is often very complex in the hopes of quickly solving an expensive medical challenge," namely the lack of medication adherence among patients.

Digital pills represent a “dangerous reduction of the provider-patient relationship and there is no shortcut to improving patient adherence, which happens in a larger framework of home, work and clinical environments, not to mention perceptions and emotions,” Swirsky contends.

But, Scooter Plowman, MD, medical director at digital medicine company Proteus Digital Health, challenges the assertion that medication ingestion tracking systems negatively impact the provider-patient relationship. In fact, he says, the opposite is true.

“Transparency unfolds between the patient and the provider,” comments Plowman. “The patient is receiving regular and continual feedback on how they’re doing. And, the provider is getting regular and continuous feedback on how they’re doing and how their medical decision making is going.”

Still, Swirsky makes the case that compelling patients to take medications may only serve to incentivize them to be more “ingenious” about being non-compliant with their drug regimen. For instance, Swirsky notes that while pill sensor technology emits a signal when it interacts with stomach fluid, a patient could vomit the pill back up once the system records that the medication was successfully taken.

Plowman acknowledges that a patient could vomit some of the medicine. But, he argues that for the sensor to dissolve “a significant portion of the medication will also to have needed to dissolve.”

“All we know is that a pill went through somebody’s stomach—we don’t know if it was in fact the patient, it could have been somebody else who took the medicine,” contends Swirsky.

Last year, the FDA approved Abilify MyCite used to treat schizophrenia, bipolar disorder and major depressive disorder, which utilizes an ingestible sensor embedded in the pill that records the medication was taken by sending a message to a wearable patch that transmits the information to a mobile app so patients can track it on their smartphones. The regulatory agency granted the approval of Abilify MyCite to Otsuka Pharmaceutical. The sensor technology and patch are made by Proteus Digital Health.

Also See: FDA approves digital pill that tracks patient compliance

Although Proteus Digital Health makes the sensor and patch, Plowman emphasizes that Abilify MyCite is “a drug that was taken to the market by Otsuka Pharmaceutical.”

For its part, Proteus Digital Health offers a digital medicine platform—separate from Abilify MyCite—called Proteus Discover, which is comprised of ingestible sensors, a patch, an app on a mobile device, and a provider portal—all have been in commercial use in the U.S. for more than two years. Plowman contends that data from both randomized clinical trials and real-world use demonstrate that patients have significantly improved outcomes using digital medicines.

“We’ve got almost 150,000 ingestions now to date and well over 1,000 patients who have used digital medicines, so there’s definitely mounting evidence,” adds Plowman. “There are more than 100 studies to show that there’s significant evidence that digital medicines are having a clinical impact.”

Studies are underway at Brigham and Women’s Hospital in Boston to determine the feasibility of similar technology for medication adherence developed by another vendor. Edward Boyer, MD, director of academic development in BWH’s Department of Emergency Medicine, believes that digital pills will not be useful for many patients.

“We also know that they are likely useful in high-risk patients, high-risk medications and high-risk conditions,” Boyer says. “In these settings, it’s easy to envision how digital pills, when linked properly to both the patient and the clinician, actually improve the patient care experience and improve engagement with care.”

Also See: Brigham and Women’s Hospital leverages digital pills to track opioid use

However, the problem with Abilify MyCite, according to Swirsky, is that “there is a lack of evidence regarding the clinical efficacy and benefit” of the technology.

While Otsuka was not available for comment, according to the FDA, Abilify MyCite’s prescribing information (labeling) “notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown.” Likewise, Otsuka has stated previously that “the impact of the Abilify MyCite system on treatment adherence has not been demonstrated.”

An FDA spokeswoman said that “being able to track ingestion of medications prescribed for mental illness may be useful for some patients but it is too soon to gauge what implications this might have overall.”

Further, while Abilify MyCite is intended to track if the drug has been taken, Otsuka says it can take 30 minutes to two hours to detect ingestion of the tablet and that “sometimes the system might not detect that the medication has been taken.”

Nonetheless, Otsuka announced late last month that it signed a collaboration agreement with managed healthcare company Magellan Health as part of an “initial rollout” to facilitate access to Abilify MyCite to select regional provider networks in order “for physicians and adult patients to gather experience in a real-world setting.”

At the same time, Swirsky says there are serious concerns about patient privacy, consent and data sharing associated with the use of these kinds of digital pills. While patients using Abilify MyCite can allow their caregivers and physicians access to the information via a dashboard (web-based portal), he believes the privacy issue gets short shrift—especially in light of the fact that Abilify is for patients with serious mental illness.

Swirsky says tablet ingestion data is sent to the Abilify MyCite smartphone app and acknowledges that—with patient consent—providers and caregivers can also access this information, as well as daily activity level and self-reported mood and rest. But, he worries that no one is “tracking the trackers” of this data to ensure it is being handled appropriately.

“Digital pharmacopic surveillance moves beyond the nudge in that it appears to eliminate choice and give more control to providers and private companies, which come to control and in many cases claim ownership of patient data,” wrote Swirsky and his colleague Andrew Boyd, an associate professor of biomedical and health information sciences in the UIC College of Applied Health Sciences, in a paper published last week in the American Journal of Bioethics.

Plowman insists that Proteus Digital Health takes patient privacy, consent and data sharing very seriously and acts responsibly in that regard.

“We go to tremendous efforts to protect this data and, of course, comply with all the HIPAA regulations,” Plowman says. “We can’t control everything about this data. Obviously, there is no fool-proofing of data, but we’ve not seen any data breaches to date. The data has been completely secure. We actually have our own standards that we’ve elected—codes of conduct, which we stand behind very firmly. We believe patients control this data and is theirs to share. We will never sell this data.”

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