Do Doctors Read Drug Warning Labels?

Teaching physicians the pros and cons of the slew of new drugs that come out each year hasn't been easy. It's all about figuring out how each patient's risk factors match each drug's side effects.

Somehow doctors don't read the warning labels of prescribed drugs. The FDA has already banned four drugs that have killed patients because the doctors never read the warnings or disregarded them. Another drug will be removed this summer.

Now the FDA is prepared to overhaul hard-to-read drug labels. An easier system similar to how foods are labeled would make it easier for doctors to spot the biggest risks.

"Our interest is the clinician who has 30 seconds to make that prescribing decision," says FDA drug chief Dr. Janet Woodcock. "They need something right in front of them."

But that alone won't solve the problem. Agency scientists also are debating stricter measures such as restricting which doctors can prescribe certain risky drugs.

At a recent meeting the agency's scientific advisers showed the heightened concern:

An experimental pill for impotence called Uprima could kill some men if it's allowed on the market, the advisers said bluntly. But they called new impotence treatments necessary, so they urged strong warning labels to deter prescriptions for the men most at risk.

Yet when a top FDA official asked how to ensure those warnings would do any good, the advisers admitted they probably wouldn't.

"I don't think any of us knows what does work," responded adviser Dr. Robert Califf of Duke University. "Less than 1 percent of physicians have seen a label in the last year. So I think it's highly unlikely that putting anything in the label is going to make any difference."

That's a message the FDA "has been very slow to understand," says Dr. Jerry Avorn, medication safety chief at Boston's Brigham & Women's Hospital.

The reality of a drug label includes a bevy of instructions on mixing, the drug's chemistry and its side effects. Doctor's said they are too busy to read them so they get their drill from pharmaceutical salesmen unlikely to stress risks.

"We can't have a system that works for only the good doctors, because they're not the ones who are going to get their patients into trouble," adds Avorn.

Avorn wants the FDA to restrict marketing of risky drugs, like the agency did two years ago, ordering that doctors must be specially trained to prescribe the infamous birth defect-causing drug thalidomide. FDA officials are debating that idea.

But it's not just FDA's problem. Medical schools "do a very bad job" in teaching medication use, and no one requires that doctors prove they safely prescribe to get their medical licenses renewed, Avorn noted.

Avorn's Harvard-affiliated hospital is pioneering programs to teach doctors to prescribe better. Minutes after a prescription enters the hospital's computer system, his office can page the physician to urge safer substitution. He also counters pharmaceutical sales pitches by sending experts on 15-minute visits with doctors to explain the safest use of new drugs, a program copied in several hospitals here and abroad.

"You can change prescribing practices," he concludes. But for most doctors today, "there's nobody coming to teach them anything except the sales reps."

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