By: Jonathan Mercado, PharmD Candidate c/o 2019

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In November of 2017, the FDA approved the first drug to contain digital sensors.¹ Abilify MyCite® (aripiprazole) is indicated for schizophrenia and is manufactured by Japanese company, Otsuka Pharmaceutical.² While patients may be hesitant to use a medication that digitally tracks whether or not they’ve taken it, the goal of the technology is to increase adherence to drug therapy and help healthcare providers identify potential issues that make adherence difficult for patients.

To better understand the significance of Abilify MyCite®, a review of the contemporary standards of schizophrenia treatment is necessary. Typically schizophrenia is managed using a single antipsychotic medication. Antipsychotics are divided into two general classes – first-generation antipsychotics (FGAs) and second generation antipsychotics (SGAs). Both classes work primarily by blocking dopamine receptors in the brain which is essential because excessive dopaminergic activity in the brain causes schizophrenia as well as hallucinations, disorganized speech and other symptoms patients experience. SGAs are unique and preferred because they also target a variety of other receptors in the brain rather than solely dopamine receptors, which reduces the risk of extrapyramidal symptoms (EPS). EPS are characterized as movement disorders that occur when the dopaminergic blockade invades the nigrostriatal pathway of the brain and leads to symptoms such as tremors, dystonia, and akathisia. They can eventually become irreversible if left untreated, a condition known as tardive dyskinesia. Typically one agent is chosen depending on patient-specific factors and the niches of each antipsychotic. If it fails, the medication is switched because some patients respond better to other drugs in the same class. Most antipsychotics are taken orally once or twice a day which can be difficult for schizophrenic patients to remember. If a patient is responding well to an oral agent, they can be given the long-acting injectable (LAI) version of the drug. LAIs are available for select antipsychotics and last several weeks which significantly improves medication adherence³. Aripiprazole is one of the safest SGAs and is available as an LAI, making it a great candidate for this new sensor containing dosage form which has the propensity to be more convenient for certain patients long-term.

Abilify MyCite® operates by having a miniature digital sensor comparable to the size of a spec of salt, in a capsule, which is inactive until it comes into contact with intestinal fluid. Upon contact, the sensor sends a message to a patch worn by the patient with information about the date and time the capsule was taken. The information sent to the patch is further forwarded to a phone application that can be accessed by healthcare providers, family and guardians.² While this may seem like a brilliant step forward in pharmacotherapy, the most notable issue for patients is the lack of trust and invasion of privacy.

Trust between healthcare providers and patients is essential in providing effective treatment. Decades of practice have helped healthcare providers understand that only when they believe in their patients does a rapport founded in trust begin to form. That trust is what opens up meaningful conversations between clinicians and patients that can guide treatment in the right direction. It keeps patients open-minded regarding clinical recommendations and has been associated with positive health outcomes.⁴ Abilify MyCite® has a mechanism of monitoring that is counter-intuitive to the idea of trust, and can in many ways maim the patient-provider relationship that is often necessary for cooperation in therapy. However, the risk may be worth it considering statistics illustrating non-adherence, particularly in psychiatric patients.

It is estimated that thirty-three to sixty-nine percent of medication-related hospital visits are due to non-adherence. While non-adherence is not a rare sight, it is significant issue in psychiatric patients. The mean rate of medication adherence among all psychiatric patients is estimated to be seventy-six percent, leaving roughly a quarter of patients that do not take their medications as prescribed, if at all. Among schizophrenic patients, the target population of Abilify MyCite®, only fifty to sixty percent are adherent to their medication.⁵ Many barriers to adherence exist for patients with any disease state, including but not limited to a dislike of the adverse effects of their medication, the cost of the medication, forgetfulness, and a lack of understanding about what the medication is or how it helps their condition. For psychiatric patients, the predominant reason for non-adherence is due to side effects which can range from drowsiness to metabolic issues such as weight gain.⁶

Abilify MyCite® exhibits new technology, but its method of monitoring has existed for some time. Already we have medication bottles that register the time and date that they are opened, very similarly to how Abilify MyCite® intends to. In many cases these self-tracking bottles and awareness that they are being monitored have helped patients and provided them with motivation to keep up with their medication regimen. However, in practice, such bottles are rare because most patients do not find comfort in having a big brother-like system for something as personal as their medications. Considering the nature of the disease it tackles, Abilify MyCite® has a clear role in therapy but should never become the default, especially when initiating treatment with a new patient. The positive outcomes of a healthy patient-provider relationship are more likely to lead to better health outcomes and patient satisfaction than an impersonal mechanism used to track patients. For the minority of patients that are repeatedly non-adherent and open minded towards innovative therapies, this new medication is an excellent option that may motivate them to be adherent. Whether this technology will be implemented in medications which are indicated for other disease states remains to be seen, but its advancement in pharmacotherapy is surely a bold one despite its niche role.

SOURCES:

1. U.S. Food and Drug Administration. FDA approves pill with sensor that digitally tracks if patients have ingested their medication. Updated 2/22/2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm. Accessed: 1/30/18.
2. Wamsley L. FDA approves first digital pill that can track whether you’ve taken it. Npr.org. https://www.npr.org/sections/thetwo-way/2017/11/14/564112345/fda-approves-first-digital-pill-that-can-track-if-youve-taken-it. Published 11/04/2017. Last Updated 11/04/2017.
3. Stroup T, Marder S. Pharmacotherapy for schizophrenia: Acute and maintenance phase treatment. UpToDate.com. Updated 5/23/2017. https://www-uptodate-com.jerome.stjohns.edu/contents/pharmacotherapy-for-schizophrenia-acute-and-maintenance-phase-treatment?search=schizophrenia&source=search_result&selectedTitle=2~150&usage_type=default&display_rank=2. Accessed: 5/9/18.
4. Lynn-McHale D, Deatrick J. Trust between family and health care provider. Journal of Family Nursing. 2000;6(3):210-230.
5. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353(5):487-97.
6. Niroljini P, Bollu M, Nadendla R. Prevalence of medication non-adherence among the psychiatric patients- results from a survey conducted in a tertiary care hospital. International Journal of Pharmacy and Pharmaceutical Sciences. 2014;6(4):461-463.

Published by Rho Chi Post