FDA Approves First Digital Pill to Track Adherence to Medication
등록일 2019년 01월 07일 수요일
수정일 2017년 11월 29일 수요일

Photo by: Nesterenko Maxym via Shutterstock

The FDA has approved the first pill to have an embedded sensor that reports whether patients have taken it, ushering in a new era of smart pharmaceuticals.With this treatment, called Abilify MyCite, doctors can know first-hand if their patients are adhering to the prescription.The drug is a product of Otsuka Pharmaceutical Co., Ltd., while the sensor technology comes from Proteus Digital Health.

Although Abilify has been around since being approved in 2002 for the treatment of schizophrenia, the approval of such a digital pill-technology combo opens up a wide range of possibilities, even as pills continue to affect more lives each day.According to a 2015 study published in JAMA, the percentage of adults taking five or more prescription medication in the US rose from approximately 8.2 percent in 1999 to about 15 percent in 2011.With so many pills to prescribe, it has become increasingly difficult for patients to remember taking the right medicine at the right time.

And the problem doesn't end there: one review published in Annals of Internal Medicine five years ago found that prescription adherence problems are costing the US healthcare system between 100 billion dollars and $289 billion, causing up to 10 percent of hospitalizations, and leading to 125,000 deaths annually.

Non-adherence is also a public concern, such as in the case of tuberculosis, where a patient has to take all the necessary medications to avoid infecting others.Consequently, doctors, researchers, and healthcare workers have been working round the clock trying many different interventions such as telephone or text reminders, timers, apps, pillboxes, and education and counseling.

Ameet Sarpatwari, a medical instructor at Harvard Medical School, believes the pill "has the potential for improving public health," especially for those who are willing to follow through their prescription but fail to remember.

The sensor is made up of safe ingredients found in foods, such as copper, magnesium, and silicon.It generates an electrical signal upon contact with stomach fluid, just like a potato battery, says Andrew Thompson, President and Chief executive of Proteus.

After a few minutes, the signal is detected by a patch that is worn on the left rib cage like a band-aid and must be replaced every seven days.The date and time of pill ingestion, as well as the patient's level of activity, are then sent to a smartphone via Bluetooth.A mobile app allows one to add their mood and resting hours before transmitting the information to a database that physicians and others who have permission from the patient can access.The app also allows patients to block or add recipients whenever they want.

Though the technology is only available for the drug Abilify, it has many potential uses.For one, it could be used to monitor opioid consumption in post-surgical patients or to determine whether participants in clinical trials took the drugs being tested.

What's more, insurers might eventually offer incentives to patients who use them, such as discounts on copayments, says Dr.Eric Topol, the director of Scripps Translational Science Institute.He warned that ethical issues could arise should the technology be "incentivized so much that it appeared to be coercion."

One more situation that might be requiring patients to take digital medication is as a condition for parole or getting released from psychiatric facilities.

Meanwhile, another technology – AiCure – has already had success with tuberculosis patients at the Los Angeles County Health Department as well as in Illinois, according to AiCure's chief executive, Adam Hanina.AiCure uses facial recognition to detect consumption of medication in real time.

etectRx, a Florida company, also makes an ingestible sensor – the ID-Cap – which is being tested with HIV medication, opioids, and other drugs.ID-Cap is made of silver chloride and magnesium, and generates a radio signal that is picked up by an antenna.etectRx plans to fit the receivers into watchbands, cellphone cases or necklaces.

Experts argue, however, that Abilify is a somewhat unusual choice for the first sensor-embedded pill, given that it is prescribed to people with mental disorders whose symptoms include paranoia and delusions.They fear that if misused, Abilify MyCite could foster mistrust instead of trust.

Photo by: Evgeniya Krutova via Shutterstock

"Many schizophrenic patients skip taking meds because they dislike side effects, or don't accept they have an illness, or because of paranoia about the doctor or the doctor's intentions," said Paul Appelbaum, a psychiatrist from Columbia University. "Technology that will monitor their behavior and transmit signals from their body to notify a doctor?You would think that whether in the field of psychiatry or general medicine, medication for almost any other condition would be better for a start than a drug for schizophrenia."

While introducing digital technology in pills opens up lots of exciting treatment avenues, it is clear that many individuals will be reluctant to take up the idea due to privacy concerns. "Who is to tell what else a sensor in medication could eventually track and how that data may be exploited?" said associate professor Bruce Y.Lee of the Johns Hopkins Bloomberg School of Public Health, in an article he wrote for Forbes.

Abilify MyCity is set to hit the market next year, but Otsuka has yet to determine the price.Besides privacy concerns, pricing, and whether the pills improve adherence will significantly influence how widely the medication will be accepted.

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