A new online service that delivers "Dear Doctor" letters from manufacturers with safety alerts via e-mail is up and running, and looking to increase its focus on devices.
The Health Care Notification Network (HCNN) was unveiled in March and sent out the first electronic patient safety notification Oct. 22. The initial alert was to update prescribing information on a class of antibiotics made by Bayer Healthcare.
HCNN is the result of a three-year-plus effort among medical industry stakeholders, including FDA and manufacturers.
"On one level, it's common sense," said Edward Fotsch, CEO of health information technology firm Medem, which provides network operations for HCNN. "At the same time, because it involves changes in FDA regulations and corralling lots of medical societies and the liability carriers ... it was a lot of moving pieces. And it's still moving."
The service is free for physicians, while manufacturers who contract with the organization must pay a fee. "They basically pay the HCNN instead of paying for the mail, so for them it's either costneutral or costsaving," Fotsch said.
Physicians not enrolled in HCNN will receive the Bayer alert in the mail "later in the month," HCNN explains. Doctors who do not open the e-mail alert within 72 hours will
also receive a notification in the mail.
Because of these potentially weeks-long delays in receiving product safety information, liability carriers are pushing doctors to enroll. HCNN now has e-mail access to "a couple hundred thousand" physicians, and hopes to enroll more than 90% of all doctors over the next 18 months, Fotsch said.
"We're now engaged with some state boards [that] are looking at making [enrollment] a requirement," he noted.
The ultimate goal is to migrate all device and drug recalls and safety alerts to HCNN's online delivery system, replacing the old paper-based mail system. FDA shares this objective as well.
To help facilitate the move away from paper, the agency issued clarifying guidance in March 2006 in support of electronically distributed health information.
Mandatory recalls of devices and human cell, tissue, and cellular and tissue-based products that are initiated by FDA are not addressed by that guidance, but "given that we don't do many of those, I don't think it will be an issue," said Jay Crowley, senior adviser for patient safety in FDA's device center.
Certainly, "the HCNN would be used for manufacturer-initiated recalls," Crowley told "The Gray Sheet."
"That's the goal, to get away from paper if we can."
CME Credits, Sample Surveying In The Works
As part of an effort to increase its device focus, HCNN plans to roll out new features next year, including sample surveying to gauge whether a single safety event is indicative of a larger trend, and other product tracking services.
Another new feature would allow physicians to receive continuing medical education (CME) credits for answering attached alert related questions.
"If you said, what kind of things should [doctors] be focused on for continued medical education credits, it's hard to find something that's more important and timely than ... recalls and warnings," Fotsch said. Drug trade group PhRMA is already a member of HCNN, and Fotsch said he would like to see the device industry group AdvaMed come on board.
HCNN is governed by the not-for-profit iHealth Alliance, a consortium of medical societies, liability insurance carriers, patient advocacy groups and others. Janet Woodcock, director of FDA's drug center, sits on the board as a liaison member.