FDA Approves Device That Tracks Medication Use: The First Digital Pill That Reports When Taken
How many times have you had difficulty knowing for sure whether study subjects took their study drug as instructed? Relying on reports from study volunteers is far from accurate, even when medication diaries are utilized. Subjects often forget to document that they took their medications, or rely on memory to guestimate what time they took them. Family members are enlisted to help ensure study drugs are taken as directed. Money is spent on a variety of methods to remind subjects to take their study drugs: everything from refrigerator magnets to stickies placed in obvious places to newer methods such as automatic e-mails or phone messages on smart phones have been employed to try to assist subjects with compliance.
Well, the FDA approved a “digital pill” with a device in it, a digestible chip. When a patient swallows it, the chip responds to digestive juices and it is prompted to generate a slight voltage, which sends a message to devices such as smart phones of doctors.
Summary: The sensor is the size of a sand-particle. The silicon chip contains trace amounts of magnesium and copper, according to the drug maker. This “intelligent pill” provides reports that track what medications individuals take and when they took them.
Article: FDA approves ‘intelligent’ pill that reports back to doctors
Thursday – Aug 2, 2012, 8:12am ET | Randi Martin, wtop.com
WASHINGTON – Digital medication may be the new remedy for those who often forget to take daily medication.
The Food and Drug Administration recently approved digestible microchips. The chips could change how doctors prescribe medication in the future.
The chips, which resemble ordinary pills, will have embedded sensors that transmit information to the patient’s doctor, alerting him that the medicine has been ingested.
While some may be wary of ingesting a sensor, its size may help calm a patient’s fears, reports Nature.com. The sensor is the size of a sand-particle. The silicon chip contains trace amounts of magnesium and copper, according to the drug maker.
When swallowed, the chip generates a “slight voltage in response to digestive juices,” which sends a signal to the surface of the patient’s skin, according to the company’s information on the pill. A patch on the patient’s skin then relays the transmitted information to his doctor’s mobile phone.
The patch also monitors the patient’s heart rate, respiration and temperature, relaying real data of how he is responding to the medication. The patient can get this information sent to a mobile telephone so he knows the information their doctor is getting.
“The point is not for doctors to castigate people, but to understand how people are responding to their treatments,” says George Savage, co-founder and chief medical officer of the Proteus Biomedical as reported by Nature.com.
“This way doctors can prescribe a different dose or a different medicine if they learn that it’s not being taken appropriately.”
The chip also tracks what the patient eats and when, all of which is reported to his doctor as well. Patients with a chronic illness and the elderly will likely be top candidates for these digital pills, according to Savage.
The FDA approval is based on studies showing the pill’s safety and efficacy. But it has only passed the device as it performed while implanted in placebo pills. The manufacturer, Proteus Digital Health, hopes to get approval on the device working with drugs in the future.
“Proponents of digital medical devices predict this and future medical innovations will provide alternatives to doctor visits, blood tests, MRIs and CAT scans.”
What about some advantages of this new technology specifically for clinical research? Some applications could be:
- More accurate drug accountability
- More detailed information such as exact time of dosing
- Better safety oversight and ability to promptly contact patient if missed dose poses safety concern
- Better tracking of relationship to medication administration and adverse events
- Better tracking of relationship to medication administration and relief of symptoms
- Tracking of medication administration for special populations such as the elderly patients with dementia, vision impaired, children, etc.
- Sharing dosing information with caregivers, family and medical professionals via smart phones
The FDA has approved digestible devices for use with placebos-a first in the expanding field of… When a patient swallows it, the pill generates slight voltage which responds to digestive juices.
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The FDA recently approved digestible microchips. The chips… The Food and Drug Administration recently approved digestible microchips. …But it has only passed the device as it performed while implanted in placebo pills.
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