PHARMACY

Study finds opportunities for mobile health apps to engage patients

BY Alaric DeArment

PARSIPPANY, N.J. — The "vast majority" of available mobile apps focused on health and wellness have limited functionality or evidence of value in advancing healthcare provision and outcomes, according to a new report by IMS Health.

The report, "Patient Apps for Improved Healthcare: From Novelty to Mainstream," by the IMS Institute for Healthcare Informatics, found that most efforts in app development have been focused on such aspects of overall wellness as diet and exercise, but don’t address the needs of patients with multiple chronic conditions and who are older than 65 years.

IMS researchers surveyed the more than 43,000 health-related apps in the Apple App Store, but found that only 16,275 were directly related to patient health and treatment.

"The movement toward digital therapeutics is clear," IMS Institute executive director Murray Aitken said. "Mobile health apps have the potential to drive a disruptive shift in patient engagement and healthcare delivery. Harnessing the power of apps has become a focal point of innovation, yet barriers remain to their broad and systematic use by providers and patients."

The study found that more than 90% of the apps reviewed scored less than 40 out of 100 possible points for functionality, based on 25 screening factors. Use of the apps is also limited: More than half of the apps have been downloaded fewer than 500 times, and five apps account for 15% of all downloads in the healthcare category.

 

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Impax Labs, Tolmar receive FDA approval for generic version of Solaraze

BY Ryan Chavis

HAYWARD, Calif., and FORT COLLINS, Colo.  — Impax Labs and Tolmar announced that the Food and Drug Administration has given final approval to Tolmar’s generic version of Solaraze (diclofenac sodium) gel in the 3% strength.

Impax Labs entered into a Development, Supply and Distribution agreement with Tolmar on June 12 in which Tolmar granted Impax Labs an exclusive license to commercialize generic Solaraze in the United States. Under the terms of that agreement, Tolmar is responsible for product development and manufacturing, and Impax Labs is repsonsible for marketing and sales of the product.

Sales of Solaraze gel 3% in the United States were $78 million for the 12 months ended Sept. 2013.

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FDA report delves into personalized medicine

BY Alaric DeArment

SILVER SPRINGS, Md. — Earlier this year, the Food and Drug Administration approved a new drug for treating cystic fibrosis for patients who have a specific genetic mutation, but that also treats the underlying cause of the disease rather than the disease itself.

That drug, Vertex Pharmaceuticals’ Kalydeco (ivacaftor), along with cancer drugs for patients whose tumors have specific genetic characteristics identified by a companion diagnostic test, are examples of personalized medicine. Personalized medicine, in which medical treatments are tailored to patients’ individual characteristics, is a growing field and the subject of a new report by the FDA designed to provide a framework for regulating it.

"For the first time, it provides a compendium of FDA’s many recent efforts to advance regulatory standards, methods and tools in support of personalized medicine and to further refine critical regulatory processes and policies in order to bring about personalized medical product development," FDA commissioner Margaret Hamburg wrote in a forward to the report.

 

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