On Monday, Nov. 13, the FDA approved Abilify MyCite, a revolutionary pill that is expected to go a long way to improving adherence issues for medication.

The pill consists of a small Proteus microchip covered by aripiprazole, a drug used for the treatment of schizophrenia, bipolar disorder and as a complement for major depressive disorder. The microchip contains a sensor that is activated by the stomach acids, sending a signal to a receptor in a wearable patch. The receptor communicates to a smartphone which is accessed by the patient and whoever he or she chooses to communicate this information.

Source: Boehringer Ingelheim.

This comes in response to a problematic struggle between patient and doctor. A 2008 study published in Pharmacotherapy measured the rates of adherence in chronic patients depending on the conditions and determined that only 72 percent of patients with high blood pressure took their medications as prescribed 80 to 100 percent of the time. Results were even lower for hypothyroidism (68 percent), Type 2 diabetes (65 percent), seizure disorders (61 percent), high cholesterol (55 percent), osteoporosis (51 percent) and gout (37 percent). This last case showed the smallest patient adherence with 24 percent of patients taking their medications as prescribed only from 0 to 19 percent of the time.

The consequence of this attitude might be devastating for individuals and healthcare systems. For the former, it might mean a prolonged illness, worsening of symptoms and eventual death; for the latter it means increased costs of medicine and re-hospitalization, placing a larger burden on healthcare systems.

With this in mind, several companies set up to find a way to ensure or at least measure whether patients were taking their pills. This led to the development of “smart pills”. These are microchips embedded in standards pills that send a signal to a receptor that can then tell a doctor, other healthcare professional or caregiver whether the patient took their pill or not. The first smart pill was approved in 2012 by the FDA, which signed off Proteus microchips in sugar placebos, a move that was intended to be followed by applications with medicines.

Some feel that medications containing smart pills are a step forward in addressing low adherence to medications. “Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. But the FDA itself warns that no studies have been made measuring improvement of patient adherence through the use of said pills.

These medicines, on the other hand, have raised privacy concerns. Some fear that these medicines have potential to be used by authorities to monitor medication use with legal implications. Bioethicist Arthur Caplan told The Verge, “The temptation in the legal system to say, ‘I can monitor you and make sure you’re not a threat’ is going to be huge.” Proteus, the manufacturer of these smart pills, claims to be aware of potential bioethics concerns and working to address them.

Just as there is no data on whether these pills can measure patient adherence, there are no governmental bodies tracking their use. There is only potential for both. Smart pills are just being introduced to the market and only time will tell whether they are good, bad or both.


Sources: FDA, BA Briesacher et al. (2008). Pharmacotherapy 28(4):437-43, Proteus Digital Health and The Verge.

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