FDA Approves Email Notification For Recalls
Monday, April 07, 2008
The FDA recently agreed on the use of e-mail to notify physicians of dangerous drug and medical device recalls. To date, safety alerts were issued to the media instantly, but they were sent to doctors in the mail."A lot of times I hear about products being withdrawn from my patients who've read the paper that morning and I get something in the mail two weeks later," says Dr. Paul Dillon, who is with Simpsonville Family Practice.
He said the new system is more effective. "The only surprise is that it took this long," he said.
Medem Inc., an online communications service for the health care industry, operates the Health Care Notification Network.
Here's how it works. The FDA determines a drug or medical device is potentially dangerous and mandates manufacturers notify physicians. Now, instead of sending these alerts via the postal service, they'll be sent instantly via e-mail. Manufacturers paid for the mailings previously and they will pay for this service as well, said Medem spokesman Jason Willett.
Guidance counselor Carole Phillips of Anderson, who got caught up in the Vioxx flap a couple years ago when she was taking the recalled drug for hip pain she suffered from a basketball injury, said the new system makes sense.
"It would be reassuring that you could find out quickly if you're taking a certain type of medication," she said, "to let you know the dangers and precautions."
And patient safety advocate Helen Haskell of Columbia said most people communicate electronically these days, and the faster the notification, the better.
"This is important information that needs to get to doctors quickly," said Haskell, founder of Mothers Against Medical Error.
E-mail alerts could help prevent needless injuries, said Dr. Georges Benjamin, executive director of the American Public Health Association, citing the recent heparin scare as a good example. Worldwide, patients were being injected with the popular blood thinner, but it turned out to contaminated, resulting in a number of deaths.
"A broad range of the medical community uses heparin," he said. "And you would think every physician who does give an injection would want to know about that right away."
Nonetheless, he said, many physicians aren't on the technology grid and there will still be people who "love snail mail."
And Peter Lurie of the consumer watchdog group Public Citizen said faster is better too. But he worries e-mails might get caught in spam filters or deleted without being read, and that doctors need to enroll instead of being automatically signed up.
Willett said alerts would continue to be sent via the postal service to enrolled doctors who have not opened their e-mail alerts and to doctors who have not enrolled. And Medem expects all doctors will enroll. Insurers are requiring their participating doctors to sign up, he said, and most major manufacturers have committed to using the network.
Dr. Pat Marshall, medical director of the Greenville Hospital System University Medical Group, a multi-specialty practice, endorsed the concept, saying it can also be used in the event of public health emergencies nationwide.
"I think it is a great idea," he said via e-mail. "It just means physicians will get notification as soon as it is available instead of getting a mailing that occurs well after the information is released."
HCNN officials say the system could also limit malpractice suits since fewer patients would be harmed. And it should reduce paperwork.
Once physicians get the notice, they can contact patients via e-mail or telephone, and tell them to stop taking a medication or come in for a consultation, said Dillon.
"We have the ability, since we are on electronic medical records, to do a search on all patients who are on that medication, for example, and from there, start calling them," he said. "More and more, the computer has become the norm for communication and to obtain information. It's just a shame it's taken this long for it to happen."