FDA, AMA, Others Back New Healthcare Notification Network


By Neil Versel

March 25, 2008 | A coalition of medical societies, malpractice insurers, pharmaceutical and medical device manufacturers, health plans, and government agencies is trying to end the era of paper patient-safety alerts with the launch of an electronic network to disseminate wide-scale drug and device recalls and warnings.

“We’re talking about moving patient safety online and out of the U.S. Mail,” says Nancy Dickey, M.D., chair of the iHealth Alliance and past president of the American Medical Association. The iHealth Alliance is the governing body of the Medem network, a physician connectivity service founded by national medical societies that is providing the technology to the new Health Care Notification Network (HCNN).

The Health Care Notification Network, publicly unveiled Tuesday morning, is intended to speed up—and ultimately replace—the long-standing process of mailing drug and device warnings and recalls to healthcare providers. “This way, doctors … won’t be hearing of problems first from the media or patients who come into their office, so they won’t be blindsided,” according to Janet Woodcock, M.D., chief medical officer and director of the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA).

The FDA has indicated a preference for e-mail and other electronic forms of communication for disseminating information to the public. The agency has agreed to participate in the HCNN.

Dickey, who also is president of the Texas A&M Health Science Center (College Station, Texas), calls the network a “single, simple organized source for all product-related safety information.”

In addition to speeding up the notification process, the site adds “interactive bells and whistles” to help deliver “more robust information” to clinicians and their patients, according to Medem chief executive Edward Fotsch, M.D.

A typical HCNN screen contains the actual alert in the center column, formatted with the same fonts and colors the FDA recommends for mailed notifications. The left-hand column has links for more information on the drug or device in questions—including images—as well as a link for the user to contact the manufacturer. The right side of the screen has suggestions on how care providers can notify patients, plus a link to the FDA MedWatch reporting program.

Doctors who have Web portals through Medem can send the alerts to their sites and e-mail the information directly to patients with iHealthRecords, Medem’s personal health record (PHR) product, Fotsch says.

Alerts will be tailored to specialties so physicians are not overwhelmed with every notice for every device or drug. “Nothing will make people discard information faster than receiving a large number of irrelevant alerts,” Dickey says.

There is no charge for healthcare providers to participate. “If you can get patient safety today on a free network, you’re hard-pressed to wait two weeks [for a manufacturer to print and mail a paper alert],” Fotsch says.

Malpractice insurance carriers, through the Physician Insurance Association of America (PIAA), are supporting HCNN as an essential element of patient safety, and the Joint Commission has endorsed the effort. “I am asking our insured physicians to enroll in the HCNN and receive their FDA-related patient safety notifications online,” says David Troxel, M.D., medical director of malpractice insurer The Doctors Co.

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