HEALTH

Wireless home-based healthcare applications, services set to grow, analysis finds

BY DSN STAFF

NEW YORK That $4.4 billion opportunity is really only the tip of the iceberg. The real opportunity, especially for pharmacists and their nurse practitioner/physician assistant partners, is in the ancillary services that will accompany the functionality behind wireless diagnostic devices — think a medication therapy management/chronic disease coaching one-two punch.

It’s not a question of if wireless diagnostic devices will realize that full $4.4 billion potential, but when. That’s primarily because cost will be a big driver behind adoption of these devices. The fact is that no matter what shape healthcare reform takes, the system will eventually go bankrupt without an emphasis on disease-management/prevention (a.k.a. MTM/chronic disease coaching).

Another driver behind widespread adoption will be how nicely wireless diagnostic device functionality will dovetail with the currently-developing electronic health records. As is evident with the current meteoric rise in popularity of iPhone and other smart phone applications, not to mention the increasing popularity of such social media sites as Facebook and Twitter, it’s more and more becoming a wired, wired world out there.

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Sanofi Pasteur submits supplemental application to FDA for flu vaccine

BY Michael Johnsen

SWIFTWATER, Pa. Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, on Friday announced the company has submitted a supplemental application for licensure of its influenza A(H1N1) 2009 monovalent vaccine to the Food and Drug Administration.

Responding to recent recommendations by the FDA, the company’s supplemental application requests the FDA’s evaluation of the influenza A(H1N1) 2009 strain change, which is expected to expedite the licensure process for the pandemic vaccine.

“Filing this application is consistent with our commitment to work collaboratively with public health officials in producing a vaccine against the influenza A(H1N1) 2009 virus,” stated Wayne Pisano, president and CEO of Sanofi Pasteur. “It is essential that we pursue the vaccine licensure pathway made available to us, while at the same time, continue the important clinical studies of our vaccine.”

The supplemental application follows recent recommendations by the FDA to evaluate the influenza A(H1N1) 2009 monovalent vaccines using the same regulatory process by which it approves new viral strains contained in the annual seasonal influenza vaccines.

While these strain change supplements are not required to be supported by new clinical data, immunogenicity and safety data will be made available through clinical studies. Sanofi Pasteur will test the immunogenicity and safety of its influenza A(H1N1) 2009 monovalent vaccine through clinical trials in the U.S., which began Aug. 6. The planned clinical trials will consist of approximately 2,000 subjects and will also evaluate the safety and potential benefits of adding an adjuvant to the pandemic vaccine.

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CDC releases updated flu guidance for back-to-school

BY Michael Johnsen

ATLANTA The Centers for Disease Control and Prevention on Friday released updated guidance for school administrators and state and local governments to help decrease the spread of flu among students and school staff during the 2009-2010 school year.

Approximately 55 million students and 7 million staff attend the more than 130,000 public and private schools in the United States each day, the CDC noted, representing about one-fifth of the country’s population.

In a nutshell, in lieu of closing schools outright at the first hint of influenza-like illness, CDC is suggesting that sick kids and teachers stay home and that children and teachers attending schools emphasize illness etiquette — i.e., washing hands, covering mouth when coughing/sneezing and proper disposal of tissues.

The CDC is suggesting that ill students and staff be quarantined in a separate room until they can be sent home. CDC also recommends that they wear a surgical mask, if possible, and that those who care for ill students and staff wear protective gear such as a mask.

Based on the severity of 2009 H1N1 flu-related illness thus far, the CDC guidance recommends that students and staff with influenza-like illness remain home until 24 hours after resolution of fever without the use of fever-reducing medications.

School staff should routinely clean areas that students and staff touch often with the cleaners they typically use. However, special cleaning with bleach and other non-detergent-based cleaners is not necessary, the CDC stated.

The guidance also provides a checklist for making decisions at the local government level, which is usually tasked with the decision around possible school closures. The decision to dismiss students should balance the goal of reducing the number of people who become seriously ill or die from influenza with the goal of minimizing social disruption and safety risks to children sometimes associated with school dismissal. Based on the experience and knowledge gained in jurisdictions that had large outbreaks in spring 2009, the potential benefits of preemptively dismissing students from school are often outweighed by negative consequences, including students being left home alone, health workers missing shifts when they must stay home with their children, students missing meals, and interruption of students’ education. CDC expects that the overall impact of 2009 H1N1 should be greater as compared to earlier this spring, and school dismissals may be in fact be warranted depending on the disease burden and other conditions.

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