This trackable pill has just been approved by USA health regulators
Nov 16, 2017, 02:02
Abilify MyCite is expected to hit the market next year, but the price has not yet been set. In the short term, it's being paired with Abilify, a drug used to treat bipolar disorder, schizophrenia, and other mental illnesses.
Before this Otsuka Pharmaceutical Co Ltd's established drug Abilify, equipped with sensors was given approval in 2012.
"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".
The information that the sensors can send out can include the dosage, the exact time when the pill was taken, and even what the patient was doing at the time.
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. 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.
The FDA has announced its first ever approval of a pill with an embedded sensor that digitally tracks if patients have ingested it, ushering the United States into a new era of smart pharmaceuticals - and medical surveillance. The patch records the date and time the pill was ingested, and relays this information to a smartphone app.
The technology carries risks for patient privacy too if there are breaches of medical data or unauthorised use as a surveillance tool, according to James Giordano, a professor of neurology at Georgetown University Medical Centre.
"With the patient's consent, this information could be shared with their health care professional team and selected family and friends, with the goal of allowing physicians to be more informed in making treatment decisions that are specific to the patient's needs", it said. "Our rollout of the Abilify MyCite system will be done in phases to obtain, and respond to, feedback from healthcare providers and their patients".
Studies have not yet shown whether the addition of a digital tracking system will improve how well people comply with their medication regimen. FDA said in the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements, anxiety, insomnia, and restlessness. But the device may be particularly beneficial for certain patients with mental illness since taking medications as prescribed is particularly crucial for these people. A person who suffers from this mental disorder appears to be out of touch with reality. "The fact that someone might use this computer readout to decide if you are compliant-and that could affect your degree of freedom in society-is an issue that needs to be discussed and debated", she says.
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