Abilify IoT-enabled digital pills approved amid privacy concerns

In a first for the US, the Food and Drug Administration (FDA) has approved digital pills that include an ingestion tracking system.

A phenomenal amount of time and effort goes into identifying wasted resources in healthcare systems throughout the world. It’s hardly surprising, when twenty to thirty percent of health spending in the US has been identified as wasteful. Given that the cost of healthcare in the US exceeded $2.7 trillion in 2010 (almost 18% of GDP), there is huge pressure on providers and administrators to contain costs.

One of the most significant ways this is done is by trying to improve the effectiveness of the care delivered. Of course, medicine can only be effective if it is actually taken by the patient. Health services have numerous ways of measuring ‘adherence’, from indirect measures such as refill rates, to more direct means like self-reporting, direct observation and pill counting.

Nearly three-quarters of American adults do not adhere to their physicians’ prescription orders, including taking less than the recommended dose. When medication isn’t consumed, unwanted expense is caused by the misuse of the drug and the need for direct observation by already overworked staff. If a patient’s condition deteriorates from not taking the necessary drugs, they also often require expensive further treatment.

Could digital pills be the answer?

Now IoT has enabled another solution for the issue of adherence. The newly approved Abililfy MyCite are aripiprazole tablets that contain a sensor that digitally tracks whether a patient has ingested their medication.

According to the The Food and Drug Administration [FDA], they have approved the digital pills for, “the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.”

The pill’s sensor sends a signal to a patch worn by the patient. The patch then transmits the information to a smartphone app, where patients can track the medication’s ingestion and record their mood and rest levels. Users can also permit their caregivers, family and doctor to see the data via a web-based platform.

“The approval of Abililfy MyCite, the first digital medicine system, means that for the first time in my years of experience as a psychiatrist, there is an innovative way to provide individuals with serious mental illness, and selected members of their families and care teams, with information on objective medication taking patterns,” said John Kane, MD, senior vice president of behavioral health services at Northwell Health and Chair of Psychiatry, at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell.

“Until now, pharmacologic therapy for serious mental illness has been missing a systematic approach to objectively track and signal that a patient has taken their drug.”

A spoon full of silicon

Abilify’s producer Otsuka, worked with sensor tech creators Proteus Digital Health, to create the US’s first digital pills. When the metals (including magnesium, copper and silicon) in the sensor come into contact with stomach acid, they generate an electrical signal that is picked-up by the patch.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis MD, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

It is important to note that the ability of the product to improve patient compliance with their treatment regimen has not been shown. Abilify MyCite’s prescribing information notes that it should not be used to track drug ingestion in real-time, or during an emergency, because detection may be delayed or may not occur (it can take between 30 minutes and two hours to record ingestion).

An intelligent approach to smart pills

The system is perhaps most useful to those wanting to take their medication but prone to forgetting. Allowing others to see your ingestion data is optional, but for patients who reluctantly agree, the pill raises privacy concerns and could serve to sow mistrust – especially in a drug used to treat schizophrenia, an illness that counts paranoia under its potential symptoms.

Yet, as Andrew Thompson, president and chief executive officer of Proteus Digital Health points out, many of us are comfortable with the numerous ways in which the digital world is permeating our day-to-day lives:

“The time is right for the category of Digital Medicines to be available to appropriate patients with serious mental illness. Consumers already manage important tasks like banking, shopping, and communicating with friends and family by using their smart phones, as they go about their daily lives. With this FDA approval, Otsuka can help enable individuals with serious mental illness to engage with their care team about their treatment plan in a new way.”

Looking at its broader applications, digital pills could prove useful for tracking ingestion in clinical trials. Insurers, justice systems and, controversially, psychiatric hospitals may all have an interest in tracking drug adherence.

I have no doubt that this is the first of many ‘smart pills’ but, given the lack of appropriate studies, there are still fundamental questions around whether they will help to ensure medication gets taken when its needed, and topple the towering cost of the adherence problem.