In a groundbreaking decision on Monday, the Food and Drug Administration approved a drug with a “digital ingestion tracking system,” which senses when a pill is swallowed and sends the data to a smartphone.
The new drug/device combination product called Abilify MyCite is approved for the treatment of schizophrenia and mood disorders. The Abilify (aripiprazole) tablets come embedded with an Ingestible Event Marker (IEM) sensor, the size of a grain of sand, that sends information to a patch the patient wears. The patch then transmits the data to smartphones and online healthcare portals -- which can be accessed by health care professionals and caregivers if the patient approves.
This new concept could mean significant advancements in treatment for many disorders -- specifically psychiatric illnesses, which rely heavily on patients who must consistently take their medication if they are to achieve stability.
Schizophrenia, a chronic psychiatric disorder, affects approximately 1 percent of the U.S. population. The disabling condition includes delusions, thought disorders and hallucinations that can ruin jobs, relationships and day-to-day functions. People with schizophrenia have the greatest success in treatment if they take their medications.
This, however, can be difficult. If they don’t take the medication, they relapse, are re-hospitalized and have to start over again. It’s both disturbing to their lives and an extra expense for them to carry.
Psychiatric diseases are not the only illnesses that may benefit form a drug/device. This innovative way to track medications could help manage a variety of chronic illnesses.
Approximately half of all people with heart disease, for instance, don’t take their medication regularly. For patients with diabetes, studies show that hospital costs are 41 percent higher every year for those who don’t take their medication as directed, compared to those who do.
In general, medication “non-adherence” results in additional cost to the U.S. health care system of $290 billion annually.
While the potential benefits are easy to see, these pharmacological strides also raise concerns about diminished patient autonomy and suspicion of the medical system. Now, it’s the patient who controls who has access to this electronic data. But this type of system could erode the trust traditionally shared between the physician and patient. That trust is particularly important for patients with psychiatric diseases.
“I would want a study conducted to see how the technology impacts the doctor-patient relationship,” Dr. Paul Applebaum, director of the Division of Law, Ethics and Psychiatry at Columbia University, said. “What kind of message are we communicating?”
It is also important to note that the improvement in patient compliance with treatment is the ideal outcome, but so far, nobody has shown that this pill will do it.
Applebaum sees how the new technology may prove beneficial in certain populations, such as “patients with early dementia, since the culprit for non-adherence is memory.”
However, he notes it may not be as effective in patients who are worried about side effects or have other common reasons for not taking their prescriptions.
Sandy Walsh, a spokesperson for the FDA, comments “it is too soon to gauge” what implications this may have on a broader scale.
However, she points out that “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.”