Question

should a psychiatrist prescribe a nanodrug to help parents monitor a teen adherence

Answer 1

Ans) Aripiprazole, the active ingredient in the nanodrug described in the case, works via a digital health feedback system (DHFS).

- A patient swallows the drug, and then a nanosensor in the pill is activated by the patient’s stomach acid, triggering release of an antipsychotic used to treat mental illness.

- The sensor sends a signal to a patch worn on a patient’s torso; the patch logs the date and time of ingestion and communicates this information to a smartphone app, usually within 2 hours.

- The patch also logs daily activity (steps) and time spent at rest (sleeping and reclining), which is sent to a smartphone app. When registered users (caregivers, family members, or others invited—that is, authorized—by the patient) login to an application (app), this data is displayed on a dashboard and can be viewed, along with a patient’s daily rating of her mood and her subjective experience of rest.

- There is a high prevalence of low adherence to treatment among adolescents with chronic health conditions.2, 3 Mental health disorders affect approximately 25% of children and adolescents worldwide, and early intervention is essential in improving outcomes for this group. Adolescent-onset schizophrenia is less common than adult-onset schizophrenia and phenotypically more severe.

- This severity entails comparatively greater compromise of social and occupational function. The purpose and promise of DHFSs is to promote better adherence to medications among adolescents, thus translating into better outcomes for these patients.

- Ethical issues raised by this case are discussed here within the framework of a risk-benefit analysis. The benefits involve the promise. The question of risks, however, is primary in the ethical analysis of this DHFS, particularly given that its benefit as an adherence tool is not established. The basis for Food and Drug Administration (FDA) approval relied on the safety and usability of the device and the bioequivalence of the active ingredient, aripiprazole, whose efficacy was previously established.

Promise of Benefit
- Poor adherence to medications among adolescents with any chronic health condition is associated with poor outcomes, including increased complications, increased mortality, and increased utilization of health services.7 In contrast, getting care early improves outcomes. Part of that treatment includes use of antipsychotics.

- Adolescents have adopted communication technology as a part of their everyday lives. The technology required in implementing the DHFS—an app—would not be unfamiliar to them.

- In addition, participants in the initial studies of aripiprazole with sensor reported the system was relatively easy to use. A survey published in the JMIR Mental Health in 2015 found that young adults, ages 18-35, with first-episode psychosis were comfortable with receiving information digitally and more than half had a positive view of receiving reminders to take medication by text or email.

- Combined with DHFS’s ease of use and the prevalence of and familiarity with communication technology, this receptiveness to reminders could confer on DHFS a unique advantage in improving self-management skills in adolescents. Unfortunately, there is currently a dearth of evidence that these apps improve adherence to prescribed medications.