Author: Nicole Burns, PharmD; PGY-1 Pharmacy Resident: Christian Hospital
Adherence is just one of many potential barriers that may prevent patients from reaping the benefits of their prescribed therapies. Fortunately, there are a number of tools available to assist them with the task of remembering to take their medication. Many patients utilize applications on their smart phone as well as alarms, calendars, pill boxes, and various other reminders. Although non adherence is common across all areas of medicine, patients with psychiatric disorders may possess additional barriers to adherence.
Abilify MyCite®, aripiprazole with an Ingestible Event Marker (IEM), was approved by the Food and Drug Administration in November of 2017. This is the first approved medication in the United States with a digital ingestion tracking system. If your first thought was that this technology could potentially bring a schizophrenic patient’s delusion to life, you aren’t alone. It is rather ironic that the first roll-out of an ingestible medication tracking system is in a medication used for patients with psychiatric disorders.
The Abilify MyCite® system is composed of three main components: an oral tablet with a built-in IEM, a patch, and a smart phone application. The Abilify MyCite® Patch should be applied to the left side of the body just above the lower edge of the rib cage. After ingestion, the IEM in the Abilify MyCite® tablet will become activated upon interaction with gastric fluid and will then send a signal to the patch that the medication has been taken. Patients must also download the MyCite® application to their phone and have Bluetooth enabled in order for the data to be recorded. Of note, it may take up to two hours for the system to detect ingestion although most ingestions are detected within 30 minutes.
Patients may take this medication with or without food. The MyCite® Patch should remain on the individual during activities such as showering, swimming, and exercising. The MyCite® Patch should be replaced at least one weekly. Otherwise, the phone application will conveniently prompt patients to change their patch when needed.
This technology serves additional purposes other than tracking ingestion. Abilify MyCite® also has the capability to measure a patient’s physical activity via step counting and detect sleep duration and disruptions by recording changes in posture. This information may be incredibly helpful to healthcare providers, as sleep disturbances and abrupt changes in amount of physical activity may serve as markers of a worsening psychological condition that could require immediate intervention.
During a small four-week observational pilot study in 12 patients with bipolar and 16 patients with schizophrenia, feasibility and patient acceptance of the digital ingestion tracking technology was evaluated. Patients included in the pilot were required to be on a stable regimen of oral mood stabilizers or antipsychotics for at least 14 days with no anticipation of changes being made during the study.
Candidates were excluded if they scored a three or higher on the suspiciousness/paranoia section of the Brief Psychiatric Rating Scale (BPRS). This tool is utilized to assess the severity of a patient’s psychiatric symptoms with a score from 1-7, with 1 being not present, 3 being mild, and 7 being extremely severe. Patients were also excluded if they had diagnoses or symptoms of substance use disorder, unstable medical illnesses, implanted electrical devices, or were pregnant.
In this particular patient population, Abilify MyCite® did not lead to worsened psychosis. In fact, 70% of the patients in this pilot found the concept of the digital tracker easy to understand. A total of 89% thought the digital tracker could be useful to them and 78% wanted reminders sent to them if they forgot to take their medication.
The most common adverse effect in this study was skin irritation at the patch site (occurred in 18% of participants). One patient was withdrawn from the study due to worsening paranoia and development of a BPRS score of >3. The patient was known to have a prior history of paranoia, but did not express any concerns related to the ingestible tracker or study staff. It was determined that the exacerbation was unrelated to the patient’s participation in the study.
Although the first medication to be marketed with this digital tracking technology was tested in a clinically stable patient population with psychiatric ailments, the clinical utility of the tracking device itself is limitless. There are many ongoing studies pertaining to application of this technology to medications for cardiovascular diseases, Hepatitis C, and tuberculosis with promising preliminary results in hundreds of patients. Additionally, future generations of patients will be excellent candidates for digital tracking of medication adherence for a wide variety of medical conditions, as more advanced technology is already largely present and welcomed in their daily lives.
1. Abilify MyCite® (aripiprazole tablets with sensor) [package insert]. Otsuka America Pharmaceutical Inc., Rockville, MD; 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207202lbl.pdf. Accessed February 15, 2018.
2. Rosenbaum L. Swallowing a spy- The potential uses of digital adherence tracking. N Engl J Med. 2018;378(2):101-103.
3. Kane JM, Perlis RH, DiCarlo LA, Au-Yeung K, Duong J, and Petrides G. First experience with a wireless system incorporating physiologic assessments and direct confirmation of digital tablet ingestions in ambulatory patients with schizophrenia or bipolar disorder. J Clin Psychiatry. 2013;74(6):e533-540.
4. Proteus Digital Health, Inc. Proteus Digital Health website. https://www.proteus.com. Accessed February 20, 2018.