In an effort to combat patient non-compliance with medications, the FDA just approved the first pill with an ingestible tracking sensor. But, will it be used for good or evil? The old proverb the road to hell is paved with good intentions comes to mind.
Improper medication use is a real problem, particularly in the realm of chronic disease. Medication mistakes outside of a healthcare facility are on the rise and resulting in serious outcomes—with home locations leading the pack. According to a new study that tracked unintentional therapeutic pharmaceutical errors and focused on those causing profound impairment, disability and death, there was a 100% rate increase from 2000 to 2012. All age groups reflected such an increase, except those under six years of age (likely explained by the FDA’s 2007 restriction of cold and cough suppressant sales to children under six due to their lack of proven efficacy and their ability to do harm). See Serious Medication Mistakes Happening At Home—The Why Depends On The Who.
Many solutions attempting to make a dent in the issue are already in play, like containers that alarm if a person misses a dose. This new digital pill hopes to disrupt the market. Here, I will tackle if this yet-to-be-proven answer to adherence is a worthy one.
The facts (that we know so far)
The FDA approved Abilify MyCite which contains the known antipsychotic drug, Abilify (or aripiprazole), plus an attached ingestible tracking sensor. This medicine is traditionally used for those with mental illness like schizophrenia or acute manic or mixed episodes in bipolar disorder, even as adjunct for depression in adults.
It is described that the embedded sensor portion is the size of “a grain of sand” and is “activated by stomach juices.” When this takes place, a signal is sent to a skin-adherent wearable patch which can send information to a smartphone and eventual web portal. With patient consent, a doctor can access this data.
Two studies on very small sample sizes were done to determine usability. The adverse effects reported included skin irritation from the adhesive portion or known side effects to Abilify. Whether the system improves patient adherence is not yet proven.
It claims to track if a medication was taken, but as per the FDA, it currently should not be used to identify this in “real-time” or during emergencies as the information can be delayed or not occur.
Benefits
If it ultimately solves medication errors and enhances patient compliance, then it helps save and improve many lives. As of now, it does not seem to be particularly invasive in terms of adding any discomfort or major risks. If these hold true, then there can be many applications for its use, especially in situations of polypharmacy where many untoward events occur.
Drawbacks of the device itself
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It is stated the sensor has elements made of copper, gold and magnesium, for instance. What is unclear given there is only preclinical and early clinical literature available is what the cumulative effects the sensor portion might have once expanded to drugs beyond Abilify. Expecting this is around-the-corner, it must be considered what the impact will be with multiple medications that require more frequent dosing in the same individual. In those scenarios:
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If absorbed, then cumulatively can there be an issue with Copper and Magnesium levels, for example-- particularly when used with other medications that might be taken multiple times per day? Do those or other levels need to be monitored based on the actual sensor components? This can be a manageable scenario if it is the case and might be more of an issue down the line if the device is expanded to many medications. In the early studies, it doesn’t appear to be an issue.
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Because it is creating an electrical, integrated circuit transferring data to a torso skin patch, could it be problematic for those with arrhythmias or pacemaker/defibrillators?
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Should this get embedded in many more medications, is there an issue of local trauma to the gastrointestinal (GI) tract?
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There have been some issues with the adhesive portion on skin which also appear to be relatively minor in number and nature, described as “self-limited.”
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Patient privacy is always a concern and are there enough protections to prevent breaches in confidentiality and third party access to health data?
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The company claims due to the multi-factorial reasons behind non-compliance-- as they describe e.g. side effects, lack of understanding of the disease, and dosing schedule-- this can help providers get more timely and quicker information. This has yet to be shown with this technology.
How might such a digital pill backfire
This first effort with a psychiatric drug seems a peculiar choice. Yes, the drug itself has been around a long time with a known side effect profile, so these are likely ideal factors for Abilify’s selection given this predictability. But, the population this medication treats often endure delusions or paranoias of being followed or tracked so from an ethics perspective it walks a very fine line. Even the FDA’s statement includes “symptoms of those with schizophrenia include hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn.”
As per the company’s site, “the patch also measures and shares patient activity and rest.” We are riding a cultural wave of data for data’s sake. As I have repeatedly expressed, good data in medicine can save lives, while bad data can end them. Once such data is collected future regulations and restrictions can change to permit expanded usage. What someone is originally consenting for may not be what is later upheld. Look no further than recent court battles over federal agency access to prescription drug monitoring programs, originally intended to empower doctors, patients and pharmacies to prevent misuse and abuse of drugs like narcotics, that is now likely to wind up in the Supreme Court. See here to learn how that fight over eroding patient privacy rights can amount to impeding and significantly altering care.
Another substantial issue is the coercive role that hospitals, insurance companies and potentially the government can play in the process. The sanctity of the doctor-patient relationship is already being egregiously intervened upon on many levels. Maintaining the therapeutic nature of it is directly tied to trust and fully informed consent. When it comes to patient compliance, there are already certain perverse incentives institutions that employ physicians have in place. A longstanding debate over preserving patient autonomy is at odds with a lot of them. So, it is not outside the realm of possibility that such facilities would tie reimbursement to patient compliance, since it is already happening on a multitude of fronts.
But, that conversation should be between the individual and his doctor --not the government or hospital administration, let alone insurance companies. Information and data on personal health should not be weaponized to punish patients and their providers. It is a doctor’s obligation to communicate completely the risks and benefits of treatment plans and be an active guide, and it is a patient’s right to follow them or select not to do so.
Also, there are way more factors than described as to the complexities behind non-adherence and already many ways to determine if a patient is being non-compliant (e.g. going through prescriptions too quickly, out-of-sync refill requests). Oh, and actually being a conscientious physician and examining the patient, checking in with them, evaluating their history thoroughly and monitoring them as expected. In this era of not letting doctors be doctors, this message is often getting lost in the discussions of so-called “innovation.”
Pandora’s box is opening, but whether patient safety and the highest quality of medical practice remain the core tenets in much of digital health is rather dubious at present.
