FDA, AMA promote physician notification system

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The FDA, the American Medical Association (AMA), physician specialty groups, drug and device manufacturers and liability insurers are promoting a new online early-warning system that moves doctors ahead in the queue for drug and device notifications.

The system, Health Care Notification Network (HCNN), has more than 100,000 physicians enrolled as it approaches its July launch date, reported American Medical News (AMNews).

HCNN, which is free to physicians and funded by drug and device makers, is intended to convey patient safety alerts more quickly via email and is accessible from any internet-capable device. The network's developers estimate that it could cut to a day or two—from the three to four weeks it now takes—the time needed for drug and device manufacturers to draft a letter, gain FDA approval, print and mail the communication.

"This is another route to get the message out to practicing physicians that there may be a significant change in the way medicines are used or that some problem has surfaced in the way devices are used," said Edward L. Langston, MD, prior chair of the AMA board of trustees.

The need for speed in alerting physicians to possible dangers associated with drugs and devices is being called a patient safety issue—a matter of continuing focus as reports are released calling attention to preventable deaths or questioning prescription drug safety.
"Electronic warnings make sense if for no other reason than to keep yourself on the same electronic footing as patients," noted Nancy W. Dickey, MD, chair of the iHealth Alliance, a nonprofit board that governs the new service.

She added that physicians should expect more FDA communications. “Medicine will only become more complex, and we can expect that updated information from the FDA is going to increase.”

When the network was first announced in March, Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said it was a great opportunity for better protection of medical products in this country. Paper alerts will continue to be sent, she said, although the hope is that they will eventually be phased out.

Other efforts are under way to speed risk communication between the FDA and physicians, noted Langston. One, which is being conducted by the AMA and about a dozen specialty groups, involves collecting email addresses from members for use by the FDA to convey new data, reported AMNews.

Another, MedWatch, which was established by the agency in 1993, plays a similar role but critics say it inundates participants with information irrelevant to their practices. Despite its 15-year life span, only about 90,000 individuals have signed up for MedWatch.

HCNN is expected to fare better than MedWatch since it will send notifications to the physicians who need them, said Edward Fotsch, MD, the CEO of Medem, a for-profit company founded in 1999 by the AMA and six other medical societies, which will operate the network.

HCNN will disseminate the same number of alerts sent by manufacturers, but alerts will be tailored by specialty, so individual doctors will receive about one or two per month, Fotsch estimates. "For example, a recall of a pacemaker wire wouldn't go to pediatricians."

According to AMNews, the network will provide a link to MedWatch, which retains the important function of collecting reports of adverse events. Dickey said she hopes that will make it easier for physicians to send a message about a patient's possible reaction to a medication.

"If it were easy to click on an icon and send a message to the FDA, the quality of their pharmaceutical evaluations would go up, and we would know a great deal more about medication interactions and reactions than we do now based on minimal responses from a handful of physicians,” she concluded.