FDA approves pill with embedded sensor to monitor compliance

First Digital Pill

FDA approves pill with embedded sensor to monitor compliance

For the first time the Food & Drug Administration (FDA) has released a digital pill, i.e., a drug with an embedded sensor that monitors and reports when a patient has taken a dose, according to Pam Belluck in The New York Times. This first such drug is Abilify My Cite, a treatment for schizophrenia. Produced by a partnership between drug maker Otsuka and Proteus Digital Health, the drug contains a mineral-based sensor that dissolves in contact with stomach acid, sending a signal to a patch on the patient’s ribs that then uses Bluetooth to transmit data about drug intake to a Smart Phone app that will be seen by the patient’s doctor and other designated people.

This is seen as a digital answer to the problem of patient noncompliance with prescriptions, which costs more in wasted medication and keeps patients from getting well, leading to still greater costs for more medical attention. Noncompliance costs some $100 billion per year.

Dr. William Shrank of the University of Pittsburgh Medical Center says, “When patients don’t adhere to lifestyles or medications that are prescribed for them, there are really substantive consequences that are bad for the patient and very costly.”

Harvard medical School instructor Ameet Sapatwari agrees that a digital pill “has the potential to improve public health,” but also warns that “if used improperly, it could foster more mistrust instead of trust.” Psychiatrists and author Peter Kramer also sees a negative side, noting that a digital drug could be a “potentially coercive tool” and “medication with a tattletale.” Patients taking the new drug will need to sign a consent form and will be free to block recipients of their data.

Digital pills are now being developed to treat cardiac diseases, diabetes, stroke and HIV. Those concerned with patient compliance and its costs are enthusiastic for this concept and foresee insurers offering discounts for its use; prison and mental hospital inmates agreeing to it to obtain earlier release; and seniors with memory problems benefitting from it.

But again on the other side Dr. Eric Topol, director of the Scripps Translational Science Institute, says that the digital pill could be “so much incentivized that is almost is like coercion,” and Dr. Paul Applebaum of Columbia University says, “A system that will monitor their behavior and send signals out of their body and notify their doctor? You would think, whether in psychiatry or medicine, that drugs for almost any other condition would be better.”

Another question is whether the ability to document when a patient takes a drug will actually lead to greater compliance. There is no guarantee of this, concedes Robert McQuade of Otsuka:  “We don’t have any data currently to say it will improve adherence.”

Other companies have been making digital patient dosing devices. AiCure has an optical system using cell phones, and etectRx plans to offer another digital pill, the ID-Cap, now being tested. It uses another mineral-based signaling sensor in the pill.