‘Dear Doctor’ letters are going electronic, via HCNN

Multi-year effort has been undertaken to move doctor notifications out of the Post Office

Usually, when an FDA notice like a "black box warning" on a label, or even a drug recall, is announced, one assumes that medical doctors and other healthcare providers have received direct and explicit instructions from the manufacturer already. But in fact, those notices, informally known as "Dear Doctor" letters, are usually either faxed or sent through the postal system. And all too often, they are lost in other mail, or simply ignored.

At some undetermined point in the next few weeks, the first official e-mail notice of a "Dear Doctor" letter will zip through the Internet to arrive at the e-mailbox of medical doctors and other health professionals. Although it sounds like a trivial undertaking to provide this service, getting to this point has taken a lot of effort by manufacturers, healthcare IT providers and FDA—and the system is not yet fully functioning.

The effort began several years ago in discussions between medical societies, as represented by a nonprofit called the iHealth Alliance, and FDA. Traditionally—and by FDA requirement—notices of "black box warnings" on drug labels, drug recalls and other information are mailed by manufacturers to medical professionals. All too often, these notices are lost in incoming mail stacks, or simply ignored; that process can also take upwards of three weeks. Newspaper headlines might be filled with news about such recalls, but they only become effective when prescribers act on the information.

Last March, through its business subsidiary, Medem Inc. (San Francisco), iHealth opened the Health Care Notification Network (HCNN.net). Through early August, about 100,000 health care professionals have signed up for the free service, but the goal is to get all 300,000 or so prescribing physicians on board, according to Dr. Ed Fotsch, CEO of Medem. To this end, Medem is connecting with a wide range of medical societies to have their memberships sign up on the site.

The first problem HCNN had to address, says Fotsch, is that FDA rules required the mail notice and did not allow for e-mail. That changed in 2006. In the meantime, Medem set up the e-mail service and an automated means of verifying the licensing of users who signed up. When the first official notice goes out, the addresses of doctors who open the e-mail will be recorded, confirming delivery of the information. At a certain point afterwards, all other healthcare professionals who should receive the info, and doctors who did not open the e-mail, will be sent the traditional paper mailing. J. M Knipper Co. (Lakewood, NJ) is the con-tractor who will handle these mailings.

The service is free to physicians; manufacturers who are required by FDA to send Dear Doctor letters will be charged approximately $1 per opened e-mail. That cost can be substantially below the cost of a regular postal mailing, so it represents a significant potential savings to manufacturers. In addition, medical liability carriers have been supportive of the effort—since it potentially reduces medical liabilities for dispensing drugs improperly. "Participation is not mandatory by manufacturers," notes Fotsch, "but the advantages to them are real. We’ve even heard of one manufacturer who is accounting for reduced paper use as part of its ’green’ initiative."