The Future of Medication Prescribing in Psychiatry? – Digital Medicine Systems & Smart Pills
Time to read: 4 minutes
Psychiatric patients with serious mental illnesses such as major depressive disorder (MDD), bipolar disorder, and schizophrenia, have been shown to have poor medication adherence. For these patients, pharmacological therapy reduces the severity and improves rates of relapse. However, pharmacological approaches are only effective if a medication schedule is adhered to.
It is estimated that between 40-50% of patients with serious mental illness are non-compliant, which results in suboptimal treatment. There is also a greater risk of relapse as is suggested by psychiatric hospitalisation rates and the incidences of violence and suicide attempts. For example, mean rate of medication non-adherence in cases of schizophrenia have been recorded to be as low as 41.2%.
To improve adherence, long-acting injectable formulations are an effective component of many rehabilitation programs. However, they have historically not been broadly accepted by the medical profession due to fears associated with side effects and presumed lack of efficacy. Therefore, there is a need to improve assessment and adherence in patients with serious mental illnesses.
CURRENT ASSESSMENT METHODS
To determine whether patients with serious mental illnesses are adhering to their medication, assessments include self-reporting and psychometric testing by a relevant healthcare professional. However, these have questionable accuracy and may underestimate non-adherence.
Means of objectively assessing medication adherence include pill counts and pharmacy-refill counts. Alternatively, a smart pillbox can be used which has an electronic device that records the opening and closing but obviously do not confirm the actual ingestion of the medication.
Finally, a biological assay can be carried out to detect the drug in the bloodstream. However, these are invasive, time-consuming and costly and therefore do not offer a viable alternative to monitoring medication adherence.
DIGITAL MEDICINE SYSTEM (DMS)
A newly developed digital medicine system (DMS) offers an innovative approach to objectively report actual medication adherence. This technology incorporates a sensor embedded in an ingestible tablet, a wearable sensor and a cloud-based computing system.
Briefly, the development of a DMS for psychiatric purposes involves an ingestible sensor, which when activated, communicates to a wearable sensor that is paired with a Medical Device Data System (MDDS) application on a smartphone or tablet computer.
The MDDS communicates the information to another application on the same device known as the Patient Component App (APP). The APP connects, bi-directionally, with a cloud-based server, which analyses the data on patient medication adherence.
Data from the DMS is then displayed graphically through a web portal and allows healthcare professionals, caregivers and family members to easily access and summarise medication adherence trends for that individual.
RESEARCH AND DEVELOPMENT OF DMS
An umbrella-master study was recently set up by Otsuka Pharmaceutical to oversee a series of studies to assess performance, safety and tolerability of their DMS. Two recently published papers describe the research and development of this DMS, which show it is user-friendly, effective, and accurate.
Profit, et al., Developing a Digital Medicine System in Psychiatry: Ingestion Detection Rate and Latency Period. Journal of Clinical Psychiatry, 77:9, Sept 2016.
1. Digital Health Technology Development
Digital health technologies require extensive validation to ensure they are informative and qualitative. However, more importantly, they need to be flexible enough to adapt to users’ behavioural and cognitive needs. For example, it is well known that poor usability in software can cause an increase in frustration and user error.
To meet this need, a 16-week open-label, single-arm, clinical usability trial was conducted in 58 stable patients with bipolar disorder (n = 35) or MDD (n=23). Patients feedback on the usability of the mobile and web software showed that by the end of the study, 83% of patients felt very confident using the software and 60% of patients were very, or extremely, satisfied with the system.
2. Detection of Ingestion and Mean Latency Time
The researchers investigated the ability of the ingestible sensor to detect either aripiprazole (an atypical antipsychotic) or a placebo across two studies. These were both 1-day non-randomized, prospective phase-4 trials with patient cellphones switched off or not to assess signal interference.
In both these studies, healthy volunteers were provided with one ingestible sensor in a 10 mg aripiprazole tablet and four placebo tablets. The aripiprazole tablet was consumed at 0 hours and the three placebo tablets were ingested after 2, 4 and 6 hours. The placebo tablet ingested after 4 hours was consumed with a high-fat meal.
The overall ingestion detection rate was 98.3% in substudy A (n=30) and 96.6% in substudy B (n=29). The mean latency time from ingestion to detection by the wearable sensor was between 1.1 and 1.3 minutes across each time point whereas the mean latency period between the wearable sensor and the cloud-based server was between 6.2 and 10.3 minutes.
In addition, consumption of food did not affect detection accuracy, and cellphone disruption was not considered to be an issue. Overall, 90% of the ingestible sensors were successfully detected and registered within 30 minutes of ingestion of the sensor.
Note: Informed consent and Ethics approval were obtained.
SUMMARY
The DMS technology incorporates a multicomponent system that is user-friendly, reproducible and effective at reporting on patient medication adherence. These recent studies show that the use of DMS in psychiatry is possible after demonstrating the accurate detection and short latency times between ingestion of sensors and the subsequent detection by the software.
LATEST
On November 13th 2017, the FDA approved Abilify MyCite, a pill with a sensor that digitally tracks if patients have ingested their medication.
Read the FDA news release.
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References
Rohatagi, et al., Optimization of a Digital Medicine System in Psychiatry. Journal of Clinical Psychiatry, 77:9, September 2016.
Profit, et al., Developing a Digital Medicine System in Psychiatry: Ingestion Detection Rate and Latency Period. Journal of Clinical Psychiatry, 77:9, Sept 2016.