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FDA Approves Digital Pill


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Sam’s struggle with schizophrenia has led to substance abuse. His doctors say medication could help get both diagnoses under control, but he finds it difficult to maintain a regular dosage schedule. He simply forgets to take his pills, or he thinks he took them when he never did.

Sam’s doctor tells him a new type of pill could be the cure for this issue. Sam can now take a digital pill, armed with a sensor that can record when he takes his pill and alert his doctor, too.

Some view this recent medical development as a breakthrough that will help patients with addiction and other mental health issues. Others see it as Big Brother taking things a step too far.

How It Works

The FDA has approved the drug/device combination product, Abilify MyCite, designed for the treatment of schizophrenia and mood disorders. The pill includes a sensor that is the size of a grain of sand. The patient wears a patch that receives a signal from this sensor. Once swallowed, this Ingestible Event Marker transmits data through the sensor to a smartphone and online healthcare portals. With the patient’s permission, this online data can be accessed by health care professionals to alert their doctor when they take their medication.

The Benefits

This digital ingestion tracking system could prove helpful. It adds an element of accountability to medications. It could also help those with memory issues stay on track with their doses.

Since medication non-adherance costs the U.S. health care system $290 billion a year, we know a huge number of patients are not taking their medications as prescribed. Perhaps this medical advancement is the answer.

The Caution

Does this pill cross the line? Is it an invasion of privacy? Patients are able to control who has access to the data. However, this new dynamic could change the doctor-patient relationship. Nay-sayers point out it could erode the trust between physician and patient that is crucial for patient care.

Others point out that so far, no one has proven the pill actually improves patient compliance. The hope is to help patients stay on track with their medications, but it remains to be seen if this method is effective.

Sandy Walsh of the FDA admits “it is too soon to gauge” what implications the digital pill may have on a broader scale. However, she notes 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.”

  • http://abcnews.go.com/Health/digital-pill-talks-smartphone-approved-time/story?id=51161456

  • Addictions