New Service Replaces Paper-based Product Safety Alerts With E-mails

"Imagine reducing the volume of paper and mail in your office, while improving patient safety and reducing your professional liability. All at no cost to you." That's the opening of a short video posted earlier this spring on the popular video-sharing Web site YouTube. The video describes the Health Care Notification Network, or HCNN, a free new service that soon will begin delivering FDA-mandated patient safety notices -- those "Dear Doctor" letters FPs now receive via snail mail -- to physicians and other health care professionals electronically.

"We're talking about moving drug alerts and patient safety into real time and out of the U.S. mail," said FP Nancy Dickey, M.D., of College Station, Texas, during a Web conference announcing the launch of the HCNN. Dickey, vice chancellor of Texas A&M University and a past president of the AMA, chairs the not-for-profit organization iHealth Alliance, which governs the HCNN.

"It's slow, it's expensive -- often with weeks of delay between the time a notice is required and (when) it actually reaches the physician's hands," Dickey said, referring to the current paper-based notification system. "It's ineffective -- literally stacks of mail come into a physician's office, and it's not uncommon for an alert to be mistaken for marketing and simply tossed away."

Indeed, in a 2006 guidance statement, the FDA specifically addressed the potential benefits of using electronic means to convey voluntary recall communications about FDA-regulated products and important drug safety information, acknowledging the potential pitfalls of using paper notices.

"Many are now concerned that these important drug information communications sent to physicians and other health care providers are not reaching the intended audience in a timely manner or at all," the FDA statement reads. "Letters to health care providers often are screened by one or more 'gatekeepers' and may not reach the intended recipients -- the providers who need the drug information for treating patients."

A letter-based system of disseminating information "exposes physicians to additional liability, because it gets to them late -- if at all," said Edward Fotsch, M.D., in an interview with AAFP News Now. Fotsch is CEO of Medem Inc., which operates the HCNN. Medem represents a partnership of the AMA, medical specialty organizations and several state associations.

The physician liability issue is key, according to Fotsch, and is the chief driver behind the widespread support the HCNN has achieved among medical liability carriers. To date, more than three dozen medical malpractice carriers have announced their support for the network.

Also signing on to the venture are some 20 health insurers and health care organizations, nearly a dozen medical societies and physician and trade organizations, and various other health care entities.

Janet Woodcock, M.D., acting director of the FDA's Center for Drug Evaluation and Research, saluted the HCNN "for stepping up to the plate and for providing this service."

"FDA fully supports the transition to an interactive, electronic information environment for safety information both for drugs and devices and for biologicals," Woodcock said during the launch event. "We feel this way, doctors and other prescribers, health care professionals, won't be hearing of problems first from the media or from concerned patients who come into their office. So they will not be blind-sided; they will have the emerging information as soon as it's available."

That same timeliness factor is prompting negotiations between the HCNN and the CDC regarding the possibility of using the network to send alerts about national public health emergencies, such as those pertaining to a major infectious disease outbreak or bioterrorism event.

Physicians picturing their e-mail inboxes slammed by a sudden influx of unwanted e-mails can relax, according to Fotsch. "It's targeted just like the letters," he said. "If you're a neurologist, you're not getting stuff that's targeted for pediatrics." Most likely, he predicted, FPs should expect to receive only a handful of notices each month.

Other benefits of the new service include the clinician's ability to add an office manager or other staff member to the list of designated recipients and a feature that makes it easy for clinicians to send patients appropriate information from HCNN alerts using the clinicians' pre-existing practice e-mail systems.