Abilify’s Adherence Sensor: Thoughts to Consider in the Regulatory Process

Oct 29, 2015 | Labs Blog

By Anikka Hoidal for BiolawToday.org.

Anikka-HoidalAbilify is a medication frequently used to treat schizophrenia and bipolar disorder. Japan-based Otsuka Pharmaceutical Company developed the drug. Otsuka has teamed up with Proteus Health to use its sensor technology, which can provide notification that a pill has been ingested. The sensor works in combination with a patch patients wear on their arms and a software application. When the pill is ingested, the sensor sends a message to the patch, noting the time the pill reached the patient’s stomach, as well as information about the patient’s activity, including “rest, body angle and activity patterns.”[1] That information is then relayed to the patient’s Bluetooth-enabled device. With the patient’s consent, the information can also be sent to a caregiver or physician. Last month, the FDA determined that the companies’ application for the new drug is ready to be reviewed by regulators. Though the drug is ready for review, is the U.S. ready for the drug?

Here I will try to illuminate both the potential benefits of this new drug, as well as to identify reasons for legal concern. Let’s begin with the benefits. According to the Proteus Health website, their technology contributes to personalized medicine, where physicians have access to their patients’ individual health habits and can tailor treatment based on those habits. Similarly, combining the sensor with Abilify can positively impact medication compliance, thereby improving an individual’s ability to function and contribute productively to society. Medication compliance can be an issue with individuals diagnosed with schizophrenia or bipolar disorder due to the nature of the illness and the often intense side effects of the medications. Having another person looped in on whether or not an individual took their medication can help that individual as well as the individual’s doctor and loved ones to be aware of and engaged in treatment.

Subscribe to email from the Center for Law and Biomedical Sciences »

Now, the reasons for concern. One reason for concern arises regarding the patient’s ability to consent to this medication. Especially prior to taking the medication, individuals with schizophrenia or bipolar disorder may have capacity that is diminished in some way and so their ability to consent may be compromised. Or, they may lack legal competence and thus the ability to consent on their own behalf. The potential for inability to consent opens the door for coercion from physicians and caregivers to consume the sensor-enhanced Abilify. This coercion, or forced treatment, exposes the individual to the automatic transmission of their personal health information to physicians or caregivers. Coercion may also become an issue if patients change their minds about wanting to take the sensor-enhanced drug. Given that delusions of paranoia about surveillance are a frequent symptom of schizophrenia, the drug may also exacerbate that symptom.

One of the biggest concerns is privacy—the U.S. has already seen instances where hackers have accessed patients’ medical records. UCLA Health was hacked earlier this year; Anthem, Inc., a large health insurance company, was also hacked this year. Does the sensor system provide another access point where hackers can retrieve specific and sensitive patient information? Also, considering the information is sent to a Bluetooth-enabled device, there is a concern about what security protections are in place on those devices and the level of responsibility the device owner demonstrates. There may also be a potential threat to privacy regarding information misuse by a patient’s family, caregivers, or doctors. The drug can allow these parties to gain access to sensitive and personal health information. In some, but not all, cases, patients’ capacity is so compromised that they are appointed a guardian. Imagine a guardianship case where the guardian and their ward disagree on what is in the ward’s best interest. The guardian with access to the information provided by the sensor may wield the power of information as coercion, despite their best intentions to care for their ward. Or what about a custody battle where a spouse has been receiving their partner’s sensor transmissions? Could the spouse introduce medication noncompliance into evidence that the partner is an unfit parent? Does the sensor open the door for a new realm of evidence in legal battles?

A final concern is the potential for this technology to be introduced into fields other than healthcare, such as law enforcement. Law enforcement or corrections officers could make medication compliance part of a person’s parole or probation, and then manage that medication compliance using the ingestible sensor technology. Bargaining power increases dramatically with the use of this technology, essentially coercing individuals to engage in a certain form of treatment. Given the often intense side effects of psychiatric medications, it is somewhat worrisome to consider non-medical professionals gaining access or control over an individual’s medication compliance and health information.

Though there are numerous benefits to Abilify being enhanced with an adherence sensor, there are also numerous concerns. Hopefully the legal and ethical world will be able to keep up with the medical advancements to ensure individuals with mental illness are treated fairly and appropriately in light of changing medication technology.

Anikka is currently a second year law student at the S.J. Quinney College of Law and is a member of the Utah Law Review. Anikka graduated from the University of Southern California in 2008 with a B.A. in Psychology. She also holds a Master of Social Work degree from the University of Utah. Anikka’s legal interests include health law and policy. Anikka enjoys riding horses, running, and spending time with family and friend.

[1] Press Release, Proteus Health, U.S. FDA Accepts First Digital Medicine New Drug Application for Otsuka and Proteus Digital Health (Sept. 10, 2015).