U.S. gives green signal to 'sensor' pill to track patient's medication

Thursday, 16 Nov, 2017

Regulators in the USA have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, offering a new way of monitoring patients but also raising privacy concerns. In cases where it's vital ifor patients to take a medication on a regular schedule, a digital pill would allow a physician to be alerted to a missed dose.

Abilify MyCite may raise some privacy concerns, but patients must also agree to the pill and sign a release prior to taking it. Patients can also opt out of the program at any time. Symptoms of Schizophrenia include hallucinations, delusions, thought disorders, and movement disorders.

The pill has not yet been shown to improve patients' medication compliance - a feature insurers are likely to insist on before paying for the pill. Subjects could feel pressured to take their medication because their doctors are monitoring them.

Abilify MyCite's safety has not been established in children and adolescents.

Though it's not approved for elderly patients diagnosed with dementia-related psychosis, the new technology still comes with a Boxed Warning alerting healthcare professionals that elderly patients diagnosed with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

About the size of a grain of salt, the sensor has no battery or antenna and is activated when it gets wet from stomach juices. Then, the sensor is digested and eliminated from the body. The MyCite patch records the date and time of the ingestion, as well as some physiological data.

The patch then transmits info to a mobile app on your phone. They can also indicate through the app which members of their care team have access to information about their medication ingestion, activity and self-reported mood and rest. Once ingested it's able to send a message from the sensor packed into the pill to a wearable smart patch that's worn on the rib cage.

CEO of the Consumers Health Forum of Australia, Leanne Wells, said as technology made such devices more common and feasible, they could become more common. Abilify MyCite should not be used to track drug ingestion in real time or during an emergency because detection may be delayed or may not occur, FDA stated.

Dr. Michael Birnbaum, director of the Early Treatment Program (for psychosis) at Lenox Hill Hospital in NY, said the "continual adoption of new and innovative technological tools is ubiquitous". The pill is one way to address the prevalent problem of patients not taking their medication correctly, with the IMS Institute estimating that the improper and unnecessary use of medicine cost the USA healthcare sector over $200 billion in 2012. The company said that the product would see an initial limited rollout with a select number of health plans and providers, who will select certain patients, on whose experiences Otsuka said I would base future enhancements. "This is a step forward in obtaining more focused and precise information regarding medication adherence".

But people with schizophrenia and bipolar disorder can also have impaired executive functions, including short-term memory, and may forget to take-or forget if they've taken-their medication for the day.

Otsuka and Proteus did not respond to requests for further comment.