At a time of heightened safety concerns about prescription drugs, notices from pharmaceutical companies about warnings and label changes still typically come to doctors via an antiquated method: the U.S. mail.
Besides taking too long to arrive, doctors say the notices often get buried in stacks of drug-company marketing materials or thrown out with junk mail. "They get stuck in the mailbox," says Kenneth Renney, a family physician in Houston. "Do I go to my mailbox every day? No."
Now, a nonprofit group called the iHealth Alliance is launching an online network that will email alerts to doctors who sign up. It is being operated by Medem Inc., a for-profit company founded in 1999 by the American Medical Association and six other medical societies.
To keep doctors from becoming overwhelmed by a barrage of emails, the alerts will be focused by specialty -- notices about dermatologic drugs would go to dermatologists only, for instance -- and will be limited almost exclusively to alerts that drug makers send out in what are often known as "Dear Doctor" letters: significant drug-label changes, warnings and recalls.
Until recently, drug companies felt bound by federal regulations, dating back to the pre-Internet era, that described how to send these types of communications through a paper-based system. In 2006, the FDA issued guidance saying the rules were outdated and that it was acceptable for the messages to go out by email. But many drug makers have stuck to the regular mail because it has seemed like the surest way to reach doctors.
"Physicians are now inundated with mailings and paperwork, and the concern has always been that many of these reach the circular file immediately," says Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, referring to the trash can.
The iHealth Alliance is a nonprofit group whose board includes doctors and medical-society leaders. Drug makers will pay to use the new system, which will be free for doctors and won't include any drug-company marketing materials. Doctors who don't sign up for it will continue to receive the notifications through the mail.
After receiving email notifications, doctors will get updates by going to a Web site called the Health Care Notification Network, which will archive alerts for a year, and will record that the doctors have gone to the site to see the notices. The network will provide suggested language that doctors can forward to their patients, explaining the alerts in lay terms. And doctors will be able to hit buttons that will let them send feedback to the FDA or the manufacturers about patients' reactions to drugs. The network may also be used to send doctors information on major public-health emergencies or bioterrorism alerts.
Johnson & Johnson, based in New Brunswick, N.J., is among drug makers that plan to start using the email system. Currently, the process for mailing out letters involves multiple steps that can take a few days or longer, says Christine Cote, a vice president in a J&J office involved with new technologies and ventures. "We're talking about the Dark Ages here, doing pigeon posts," Ms. Cote says.
Alan Metz, North American medical director at GlaxoSmithKline PLC, says the company, based in Britain, is also inclined to use the new system, though it hasn't made a final decision.
Medem says five major drug makers have requested contracts to start using the system, though none are official yet. Doctors can sign up at www.hcnn.net. Drug-safety alerts are expected to begin flowing through it in about two months.
For patients who want to stay on top of FDA and drug-company alerts affecting drugs they are taking, one option is to establish an online personal-health record at www.ihealthrecord.org, which is also operated by Medem. Notifications are sent about drugs that patients record they are taking.
The National Library of Medicine runs a Web site, largely oriented to doctors, called DailyMed that includes updated label information. Another option is the government site MedlinePlus, which is more oriented to consumers and includes information about drugs. Groups such as the American Diabetes Association also collect relevant health news and offer electronic news feeds to patients with those conditions.
The FDA offers an email-alert system called MedWatch that sends out notices about a variety of health-safety issues, but the iHealth Alliance hopes its system will distribute alerts that are more targeted to the individual recipients' needs.
By Sarah Rubenstein
Wall Street Journal; March 25, 2008
