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FDA Approves First Digital Pill

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Remembering to take daily medication can sometimes seem like a tall task. Some people leave their pills on the counter so they see them while others set an alarm at a specific time each day when they know they’ll be able to take their daily dose. But what do people with significant health concerns do, especially when their condition itself might interfere with taking the medication that helps them function?

The FDA made an announcement that’s a huge step toward integrating technology into the landscape of our healthcare. They’ve just approved a new drug called Abilify MyCite, and it’s aimed at helping patients and doctors work together to manage their medication.

What Makes Abilify MyCite Different?

From a pharmaceutical standpoint, Abilify MyCite is an antipsychotic that works to treat schizophrenia, depression, bipolar disorder, and major depressive disorder. While there are certainly other drugs on the market that work to improve symptoms in patients with these conditions, Abilify MyCite adds another element to its pill.

Inside of this pharmaceutical wonder is a Proteus® sensor that transmits information to both an app and to a patch worn by the patient. The data transmitted by the sensor can be used by family members and physicians to ensure that patients are taking their medication as directed.

Non-Compliance With Mental Health Drugs

Some might be wondering why an antipsychotic is the first pharmaceutical to receive an ingestible sensor, as there are a plethora of drugs on the market. Patients who don’t take the correct dose of their medication, or skip it entirely, cost the US healthcare system between $100 and $289 billion per year, so it makes sense that this is an area of focus.

But why an antipsychotic? Studies have shown that there is a high rate of individuals with mental health conditions who fail to comply with their prescribed medication schedule. Rates have been seen as high as 50% when it comes to patients who decide on their own to reduce or completely stop taking their pills, most likely because they “feel fine.” However, stopping treatment for a mental health condition usually leads to an increase in hospitalization and adverse behavior from patients.

Tracking Changes With Ease

It makes sense that anyone might forget to take a pill every now and again, but allowing physicians to actually track their patient’s rate of compliance is crucial. The FDA hopes that three major changes will take place as digital pills revolutionize the healthcare field:

  1. Less reliance on self-reporting – It’s impossible for our doctors to be at home with us every single day, let alone at all, so they trust us to be honest when it comes to taking our prescription drugs. However, there’s a strong correlation between antipsychotics and judgment, causing many patients to lie about their adherence to their medication schedule. They assume this will appease their doctor while also allowing them to seem stable to others and not the kind of person who needs drugs.
  2. Ability to personalize medication – It’s widely publicized that clinical drug trials are not diverse enough to get a truly accurate snapshot of what a pharmaceutical will do in a person’s body. Whether it’s due to one’s weight, gender, or ethnicity, the one-size-fits-all approach to medication dosage doesn’t always have the intended outcomes. With Abilify MyCite, physicians are hoping they’ll be able to track how a patient’s body responds to their medication and can adjust it accordingly.
  3. Real-time modifications – By utilizing the sensor in Ability MyCite as well as the patch worn by the patient, it’s another hope that physicians can have a real-time approach when it comes to antipsychotics. With the ability to also monitor blood pressure, breathing rate, and a variety of other indications, those in the healthcare world are betting on using this technology for more drugs down the line.

Concerns About Patient Privacy Are Noted

While taking Abilify MyCite is completely voluntary and patients can control who has access to the data received by the app, many are calling into question how a patient’s privacy will be viewed. Although there’s confidence that HIPAA laws will surely be maintained, it’s more of an ethical issue that’s being called into question. Will physicians use the data to coerce their patients? How will the doctor/patient relationship change now that physicians get a sneak peek into our daily lives?

Only time will tell what digital pills will do for healthcare as a whole, but it’s an interesting direction for pharmaceuticals to take. As our methods of tracking compliance become more sophisticated, perhaps new advancements in the drugs themselves will also come to light.