Digital pill raises doubts
EMBEDDED SENSOR WILL REVEAL PATIENTS’ MEDICATION DISCIPLINE
Embedded sensor that reveals patient’s medication discipline termed potentially coercive tool
For the first time, the US Food and Drug Administration has approved a digital pill — a medication embedded with a sensor that can tell doctors whether, and when, patients take their medicine.
The approval, announced last week, marks a significant advance in the growing field of digital devices designed to monitor medicine-taking and to address the expensive, long-standing problem that millions of patients do not take drugs as prescribed.
Experts estimate that nonadherence or non-compliance to medication costs about $100 billion (Dh367 billion) a year, much of it because patients get sicker and need additional treatment or hospitalisation.
“When patients don’t adhere to lifestyle or medications that are prescribed for them, there are really substantive consequences that are bad for the patient and very costly,” said Dr William Shrank, chief medical officer of the health plan division at the University of Pittsburgh Medical Center.
Ameet Sarpatwari, an instructor in medicine at Harvard Medical School, said the digital pill “has the potential to improve public health”, especially for patients who want to take their medication but forget. But, he added, “if used improperly, it could foster more mistrust instead of trust”.
Patients who agree to take the digital medication can sign consent forms allowing their doctors and up to four other people, including family members, to receive electronic data showing the date and time pills are ingested.
A smartphone app will let them block recipients any time they change their mind. Although voluntary, the technology is still likely to prompt questions about privacy and whether patients might feel pressure to take medication in a form their doctors can monitor.
Dr Peter Kramer, a psychiatrist and the author of Listening
to Prozac, raised concerns about “packaging a medication with a tattletale”.
While ethical for “a fully competent patient who wants to lash him or herself to the mast”, he said, “‘digital drug’ sounds like a potentially coercive tool”.
Other companies are developing digital medication technologies, including another ingestible sensor and visual recognition technology capable of confirming whether a patient has placed a pill on the tongue and has swallowed it.
Not all will need regulatory clearance, and some are already being used or tested in patients with heart problems, stroke, HIV, diabetes and other conditions.
Because digital tools require effort such as using an app or wearing a patch, some experts said they might be most welcomed by older people who want help remembering to take pills and by people taking finite courses of medication, especially for illnesses such as tuberculosis, in which nurses often observe patients taking medicine.
The technology could potentially be used to monitor whether post-surgical patients took too much opioid medication or clinical trial participants correctly took drugs being tested.
Insurers might eventually give patients incentives to use them, such as discounts on copayments, said Dr Eric Topol, director of Scripps Translational Science Institute, adding ethical issues could arise if the technology was “so much incentivised that it almost is like coercion”.
Until now, the sensor could not be embedded in pills, but pharmacies could be commissioned to place it in a capsule along with another medication.
In 2016, the encapsulated sensor started being used outside clinical trials, but commercial use is still limited, Thompson said.
Nine health systems in six states have begun prescribing it with medications for conditions including hypertension and hepatitis C, the company said, adding that it has been found to improve adherence in patients with uncontrolled hypertension and others.
AiCure, a smartphone-based visual recognition system in which patients document taking medicine, has had success with tuberculosis patients treated by the Los Angeles County Health Department and is working with similar patients in Illinois, said Adam Hanina, AiCure’s chief executive.
He said AiCure has shown promising results with other conditions, including in schizophrenia patients whose pilltaking would otherwise require direct observation.
A Florida company, etectRx, makes another ingestible sensor, the ID-Cap, which has been or is being tested with opioids, HIV medication and other drugs.
Made of magnesium and silver chloride, it is encapsulated with pills and avoids using a patch because it generates “a low-power radio signal that can be picked up by a little an-
tenna that’s somewhere near you”, said Harry Travis, etectRx’s president, who said the company plans to seek Food and Drug Administration (FDA) clearance next year.
“I get questions all the time, ‘Hey is the government going to use this, and can you track me?’” said Eric Buffkin, an etectRx senior vice president. “Frankly, there is a creepiness factor of this whole idea of medicine tracking. The thing I tell them first and foremost is there’s nothing to reach out of this technology to pry your mouth open and make you take a pill. If you are fundamentally opposed to this idea of sharing the information, then say, ‘No thank you’.”