The US Food and Drug Administration has approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology.
The new tracking form of a psychiatric drug, called Abilify MyCite, contains a sensor that sends information about its ingestion to a patch worn on a patient’s arm, which is then transmitted to a smartphone app.
This way, the pill keeps track of if and when a patient is taking the drug. The information can also be shared with up to four caregivers and doctors, with the patient’s consent.
Abilify is used primarily to treat schizophrenia and bipolor disorders. One expert cautions that the drug may not be a ‘prudent’ first use of this tracking technology, because it ‘almost seems like of a confirmation of [these patients’] worst paranoias.’
The medicine is a version of Otsuka Pharmaceutical’s established drug Abilify for schizophrenia, bipolar disorder and depression, containing a tracking device developed by Proteus Digital Health.
Shares in Otsuka rose 2.5 percent on Tuesday after news of the US Food and Drug Administration (FDA) late on Monday.
The system offers doctors an objective way to measure if patients are swallowing their pills on schedule, opening up a new avenue for monitoring medicine compliance that could be applied in other therapeutic areas.
In 2014, the World Health Organization (WHO) reported that as much as 50 percent of patients on prescription medications do not take their drugs as directed.
In psychiatric medicine in particular, taking medications between 70 and 80 percent of the time is seen as ‘good’ adherence to a treatment plan, according to previous research.
‘There are major problems with patient adherence to prescribed medications’ for disorders like bipolar and schizophrenia, says Dr Paul Appelbaum of Columbia University.
‘Sometimes that’s due to the nature of the conditions themselves which often lead patients to deny that they’re ill and in need of treatment, and sometimes it’s due to the medication’s side effects,’ he says.
Recent research has suggested that digital healthcare and data analytics could improve tailored mental health care, but the American Psychiatric Association cautions that the relationship between between psychiatric care, privacy and ‘the need to know’ is a ‘delicate balance.’
Dr Appelbaum, a psychiatrist and ethicist, says that he can see why Abilify ‘looks like a tempting target for the first trial of this new technology.’
‘High rates of non-adherence often lead to relapses of patients with these disorders, which can result in hospitalization and disruption of their lives,’ he says.
While patients tend to struggle to keep up with daily dosages of all sorts or requirements, ‘missing doses of medications – even consistently irregular adherence – has particularly catastrophic impacts in psychotic disorders, whereas may not have such profound or immediate impacts with other medications or conditions,’ says Dr Appelbaum.
There are more drastic consequences to missing doses of antipsychotics for patients with schizophrenia or bipolar disorder, but there may also be far more drastic consequences to taking the medication, if it is tracking the behaviors of paranoid patients.
‘Psychotic disorders are often characterized by some degree of paranoia, often reaching delusional proportions, in which patients may believe that outside forces are trying to monitor and control them, including cont minds or bodies or harm them in some way,’ explains Dr Appelbaum.
‘The idea that we’re giving this group of patients a pill that, in fact, transmits info about them from inside their body to the people that are involved in their treatment almost seems like a confirmation of the worst paranoias of the worst patients,’ he says.
He suggests that using the tracking technology to track more ‘neutral’ therapies ‘would have been a more conscientious way of introducing it to the public.’
The FDA said that being able to track ingestion of medicines prescribed for mental illness may be useful ‘for some patients’, although the ability of the digital pill to improve patient compliance had not been proved.
‘The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers,’ said Mitchell Mathis of the FDA’s Center for Drug Evaluation and Research.
The system works by sending a message from the pill’s sensor to a wearable patch, which then transmits the information to a mobile application so that patients can track the ingestion of the medication on their smartphone.
About the size of a grain of salt, the sensor has no battery or antenna and is activated when it gets wet from stomach juices. That completes a circuit between coatings of copper and magnesium on either side, generating a tiny electric charge.
Proteus has been working on the pill tracking system for many years and the sensor used in Abilify MyCite was first cleared for use by the FDA in 2012.
The unlisted Californian company has attracted investments from several large healthcare companies, including Novartis AG, Medtronic Inc and St. Jude Medical Inc, as well as Otsuka.
Abilify MyCite is not approved to treat patients with dementia-related psychosis and contains a boxed warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
In the longer term, such digital pills could also be used to manage patients with other complicated medicine routines, such as those suffering from diabetes or heart conditions.
Dr Appelbaum says that monitor done through the new technology could help doctors make decisions to ask their patients to come into the office more frequently, or even switch them to so-called ‘depot’ injections, which are longer-lasting and need to be administered only every few weeks.
Patients with psychiatric disorders are liable to commit crimes, or be committed to outpatient treatment by the courts as a result of their symptoms. Courts sometimes order patients to use depot treatments to ensure they comply.
‘We need to anticipate that the availability of this technology might result in courts ordering patients to take this particular pill, so that they can monitor compliance with the threat of – particularly in a criminal context – revocation of parole and incarceration,’ he says.
‘There are some fairly intrusive or drastic consequences that could follow from this technology.’