PHARMACY

Sensor necklace replaces medication diaries, helps fight noncompliance

BY Drew Buono

ATLANTA Researchers at the Georgia Institute of Technology’s School of Electrical and Computer Engineering have designed a sensor necklace that records the exact time and date when specifically designed pills are swallowed, and reminds patients if any doses are being missed.

“Forgetfulness is a huge problem, especially among the elderly, but so is taking the medication at the wrong time, stopping too early or taking the wrong dose,” said Maysam Ghovanloo, assistant professor in the school. “Studies show that drug noncompliance costs the country billions of dollars each year as a result of re-hospitalization, complications, disease progression and even death.”

The necklace, called MagneTrace, contains an array of magnetic sensors that could be used to detect when specially designed medications containing a tiny magnet passes through a person’s esophagus. And for persons who may not want to wear a necklace, MagneTrace sensors can be incorporated into a patch attached to the chest.

The date and time the user swallowed the pill can be recorded on a handheld wireless device, such as a smartphone, carried on the user’s body. The information can then be sent to the patient’s doctor, caregiver or family member over the Internet. The device can notify both the patient and the patient’s doctor if the prescribed dosage is not taken at the proper time.

This technology can also help researchers and pharmaceutical companies conduct more accurate clinical trials of new drugs. Currently, medication diaries kept by the patients determine compliance but patients are prone to fill out diaries just before meetings held to monitor their progress and they may adjust their medication to compensate for missed doses. Inaccurate data from clinical trials can affect decisions made about new drugs, potentially impacting millions of people.

“A patient cannot cheat the system by passing the pill past the necklace sensors on the outside of the neck because the signal processing algorithm is smart enough to only look for the pill’s magnetic signature while it passes through the esophagus,” said Ghovanloo.

MagneTrace was designed so that it would have no effect on the body. Multiple strong magnets in the gastrointestinal tract can potentially result in a blockage. However, the magnet used in the pill or capsule is very small—three millimeters in diameter and about one millimeter thick—and coated with a thick indigestible, insoluble polymer coating that prevents absorption of the magnet and prevents magnets from combining.

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PHARMACY

Hi-Tech Pharmacal Q3 sales down

BY Drew Buono

AMITYVILLE, N.Y. Hi-Tech Pharmacal has released the results of its third quarter, which ended on Jan. 31.

For the three-month period, the company saw its net sales for generic pharmaceuticals products decrease by 10 percent from $13.8 million during third quarter 2007 to $12.5 million for the same period in 2008.

The healthcare products division, which markets the company’s branded over-the-counter products, had net sales of $2.6 million for the quarter, a decrease of $0.8 million compared with the same period for 2007.

Research and product development costs for the three-month period increased $0.1 million to $1.4 million as compared with $1.3 million for the three-month period ended Jan. 31, 2007, as the company increased expenditures on external projects.

The company experienced a net loss for the period ended Jan. 31, 2008, of $1.5 million compared with net income of $0.7 million in the prior period.

David Seltzer, president and chief executive officer, commented, “The quarter was challenging as we experienced a milder that expected cough-and-cold season, which affected our higher margin prescription products, as well as our OTC brands. Additionally we faced increased competition on selected generic products.”

Seltzer further commented, “We are very upbeat about our generic business due to our recent approval of generic Flonase, and more recently, the approval for the generic alternative to Hycodan. Also, our Midlothian Laboratories division has performed well. To date, the Midlothian division has already launched two new generic prescription products since we announced the acquisition on Dec. 31, 2007. In the healthcare products division, we are excited about the upcoming launch of new and unique products, both in the areas of diabetes management, as well as broader nondiabetes related markets.”

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FDA names Woodcock director of CDER

BY Drew Buono

WASHINGTON Food and Drug Administration commissioner Andrew von Eschenbach has named Janet Woodcock as director of the agency’s Center for Drug Evaluation and Research.

In October 2007, while serving as the agency’s deputy commissioner and chief medical officer, where she oversaw scientific and regulatory operations, Woodcock agreed to assume the role of acting director of CDER.

Throughout her career at the FDA, Woodcock has played an integral role in advancing the health of the American public. Under her guidance, the FDA launched the Critical Path Initiative designed to close the gap between basic scientific research and the medical product development process. This initiative called for a collaborative effort to modernize the drug development process and has resulted in several prominent partnerships looking at a wide variety of scientific issues.

“Dr. Woodcock’s exemplary service since October was confirmation of her being ideally suited to lead the center during this crucial period following the passage of the Food and Drug Administration Amendments Act of 2007,” noted von Eschenbach. “The agency is fully committed to implementing the drug safety programs laid out by this act and meeting the goals set under the prescription drug user fee program, which will help ensure that CDER has the additional resources that are needed to conduct these very complex and comprehensive reviews.”

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