By Anna Edney March 25, 2008
As FDA works to sort out a tainted blood-thinner scandal that resulted in a massive recall of heparin, the nonprofit patient and provider organization iHealth Alliance and the physician communication network Medem are working with the agency to ready an e-mail notification system to alert physicians to potential treatment problems much faster than the current snail-mail system. The system, the Health Care Notification Network, will start e-mailing alerts direct from drugmakers in June, Ed Fotsch, CEO of Medem, said today. FDA's drug center Director Janet Woodcock said such a network would have been helpful during the heparin fiasco that has attracted increasing congressional attention since recent revelations raised suspicion that the medicine was deliberately contaminated in China. FDA last week determined the blood thinner's active ingredient, made in China, was contaminated with a modified chondroitin sulfate. Heparin has been linked to at least 19 deaths and hundreds of complications. Physicians will no longer learn of drug problems through the media or concerned patients due to slow paper mailings, Woodcock said.
FDA updated its guidelines in 2006 to encourage electronic dissemination of patient safety alerts. The alerts typically come from drug manufacturers, but FDA may use the system for some of its communications. The Health Care Notification Network is a free service to physicians who sign up. It will be funded by manufacturers who are expected to pay fees similar to the costs of printing and mailing the alerts, Fotsch said. The paper alerts will continue as long as necessary. Like the patient safety alerts sent through snail mail, electronic alerts are targeted to certain specialties, Nancy Dickey, chairwoman of the iHealth Alliance, said. "Nothing will make people discard everything faster than receiving a large volume of irrelevant information," Woodcock said. FDA operates an electronic alert called MedWatch, but it sends out only agency notifications and is not targeted or widely used, Fotsch said.
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