Tracking patients with digital pill approved
Print Edition
US regulators have approved the first drug with a sensor that alerts doctors when the medication has been taken, offering a way to monitor patients but also raises privacy concerns.
The digital pill combines two existing products: The former blockbuster psychiatric medication Abilify 鈥 long used to treat schizophrenia and bipolar disorder 鈥 with a sensor tracking system first approved in 2012. The technology is intended to help prevent dangerous emergencies that can occur when patients skip their medication, such as manic episodes experienced by those suffering from bipolar disorder.
But Otsuka Pharmaceutical Co and Proteus Digital Health will face hurdles. The pill has not yet been shown to actually improve patients鈥 medication compliance, a feature insurers are likely to insist on before paying for the pill. Additionally, patients must be willing to allow their doctors and caregivers to access the digital information.
These privacy issues are likely to crop up more often as drugmakers and medical device companies combine their products with technologies developed by Silicon Valley. The technology could be a useful tool, but it will also change how doctors relate to their patients as they鈥檙e able to see whether they are following instructions.
鈥淚t鈥檚 truth serum time,鈥 said Arthur Caplan, a medical ethicist at NYU鈥檚 Langone Medical Center. 鈥淚s the doctor going to start yelling at me? Am I going to get a big accusatory speech? How will that interaction be handled?鈥
The technology carries risks for patient privacy too if there are breaches of medical data or unauthorized use as a surveillance tool, said James Giordano, a professor of neurology at Georgetown University Medical Center.
鈥淐ould this type of device be used for real-time surveillance? The answer is of course it could,鈥 said Giordano.
The new pill, Abilify MyCite, is embedded with a digital sensor that is activated by stomach fluids, sending a signal to a patch worn by the patient and notifying a digital smartphone app that the medication has been taken.
The FDA stressed that there are limitations to monitoring patients.
鈥淎bilify MyCite should not be used to track drug ingestion in 鈥榬eal-time鈥 or during an emergency,鈥 the statement said, 鈥淏ecause detection may be delayed or may not occur.鈥
Patients can track their dosage on their smartphone and allow their doctors, family or caregivers to access the information through a website.
In a statement issued last May, at the time the FDA accepted submission of the product for review, the companies said 鈥渨ith the patient鈥檚 consent, this information could be shared with their healthcare professional team and selected family and friends, with the goal of allowing physicians to be more informed in making treatment decisions.鈥
While it鈥檚 the first time the FDA has approved such a pill, various pharmacies and hospitals in the US have previously 鈥減ackaged鈥 various drugs and sensors. But the federal endorsement increases the likelihood that insurers will eventually pay for it.
- About Us
- |
- Terms of Use
- |
-
RSS - |
- Privacy Policy
- |
- Contact Us
- |
- Shanghai Call Center: 962288
- |
- Tip-off hotline: 52920043
- 娌狪CP璇侊細娌狪CP澶05050403鍙-1
- |
- 浜掕仈缃戞柊闂讳俊鎭湇鍔¤鍙瘉锛31120180004
- |
- 缃戠粶瑙嗗惉璁稿彲璇侊細0909346
- |
- 骞挎挱鐢佃鑺傜洰鍒朵綔璁稿彲璇侊細娌瓧绗354鍙
- |
- 澧炲肩數淇′笟鍔＄粡钀ヨ鍙瘉锛氭勃B2-20120012
Copyright 漏 1999- Shanghai Daily. All rights reserved.Preferably viewed with Internet Explorer 8 or newer browsers.
