A new prescription for the drug label The FDA will soon unveil guidelines to help doctors clarify patients' treatment. We talked to some advisers who have a few points to add.

WASHINGTON -- The Food and Drug Administration and various players in the pharmaceutical industry are tackling a problem that bedevils consumers and doctors alike: how to build better drug labels.

The goal is to improve the quality and clarity of information for consumers, from the text that appears on the bottle to paperwork that accompanies prescription drug purchases.

The insert designed for doctors, for instance, is crammed with microscopic gray type that is so confusing that doctors complain they can't find what they need. The upshot: Many frustrated physicians don't read labels that are supposed to guide them in writing prescriptions. Meanwhile, side-effect warnings can scare elderly patients, who make up less than 15 percent of the nation's population but take nearly one-third of drugs prescribed.

What's at stake when drug information is fuzzy? Nearly half of doctors consult drug labels at least once a day. Shaving 15 seconds from the time it takes to find what they need on a drug label can save 525,000 hours a year, according to the FDA. Helping doctors quickly read drug labels could save $62.8 million over 10 years, assuming a $75 hourly wage for physicians. The FDA also projects better prescription drug labels could prevent serious side effects that accompany incorrect drug use, for an annual savings of $3.8 billion in hospital costs.

Within weeks, the FDA will finalize guidelines to make labels for physicians clearer with an index so doctors can quickly find what they want to know.

''We think this is critically important," said Dr. Steven Galson, acting director of FDA's Center for Drug Evaluation and Research. ''This has everything to do with how we communicate about drugs."

Nearly five years in the making, the revised labels will make their debut as the FDA attempts to make good on recent promises to speed drug risk details to consumers. Members of Congress who want to bolster drug safety have been nonplused that negotiations with Merck & Co. delayed by nearly two years the addition of heart risk warnings to the label of the painkiller Vioxx. This month, the FDA committed to adding black boxes -- its most strident warnings -- to two eczema drugs weeks after federal advisers issued the recommendation.

In a voluntary effort, drug companies and pharmacies are providing drug information -- often stapled to their prescription envelopes -- that rewrites key details from the prescriber's label in plain English. By next year, the nation's more than 57,000 retail pharmacies will distribute these leaflets to 95 percent of patients filling new prescriptions.

Even so, that effort may not be enough. Patients ignore the pamphlet or discard it. Worse, some don't understand it. That's what Duke University found during a study of patients and drug pamphlets. Patients were asked to scrutinize the one-page leaflets for drugs they were already taking and were told a quiz would follow. Some were allowed to keep their pamphlets. Still, they flubbed the equivalent of an open-book test.

''They did well on some things. They tend to know what it's for," said Ruth S. Day, director of Duke's medical cognition laboratory, where she studies the ease of consumers finding, understanding, and using medical information.

''But the risks are the ones they have most difficulty with. If you ask them 'About how many potential side effects are there?' they tend to grossly underestimate how many there are. Even though they just read it," she added.

By contrast, customers at the Kmart where pharmacist Karen Reed works in Beckley, W. Va., read drug information so intently that the pharmacy yanks the physician's drug label to avoid unnecessary panic. The pharmacy is the national chain's 16th-busiest and its customers include retired miners who suffer from a litany of chronic health problems, including obesity, diabetes, and hypertension.

''Sometimes, they read too much and they're, like, scared to death by the warnings," said Reed. ''Manufacturers are required to put that on there by the FDA. But it scares people to death."

In the near future, doctors and pharmacists will see major warnings first. The prescriber's label for prescription drugs will adopt a version of the clearly crafted highlight box currently on many over-the-counter products. Because the prescription drug label accompanies print advertising, consumers will see the new highlight boxes in newspaper and magazine drug ads.

''It's got bolded headings. And it's got short descriptions. That sort of highlight section is going to go on every prescription drug label," the FDA's Galson said. ''It's going to be much easier for physicians and patients to look quickly and get information that is complete and clear."

Dr. Michael Weber, associate dean for research at State University of New York's Downstate Medical Center, said the long, detailed label doctors see needs an executive summary. He's trying to interest federal regulators in adopting a guide that would summarize the drug's benefits, risks, and warnings in a few simple paragraphs.

''If you've got something important to say, you should be able to say it in a few crisp sentences," Weber said.

The FDA estimates the change it is recommending will cost the industry $94.5 million over 10 years, as some printed drug labels nearly double in length.

The label change, however, was slowed by other controversies.

''The industry has strong feelings about it," Galson said. ''Physicians, practitioners have strong feelings about it. And, it's been an institution at FDA to do the label a certain way."

Drug companies worried that doctors might mistake the warnings conveniently located at the top of the label as the drug's only side effects.

''If a physician only read the major side effects, and something happened to a patient that was in the minor side effects that, say, the physician wasn't aware of, would this put the drug company at increased liability?" said Alan Goldhammer, FDA liaison for the drug industry's lobbying and trade group, the Pharmaceutical Research and Manufacturers of America. ''Given the litigious nature of America, that was one of our concerns."

For its part, the pharmaceutical industry says soon it will deliver electronic versions of prescriber's labels to pharmacies. The change will speed updated labels to pharmacists within 24 hours of changes, Goldhammer said.

But some argue the big label stuck on the drug bottle itself -- which consumers see each time they take the drug -- is ripe for revision. Those labels are regulated, state by state, by individual state boards of pharmacy.

If Stacy Kaufman had his way, the amber bottle would show an image of the pill inside and would include a tab where the customer could jot down the condition the medicine treated.

''That's a value," said Kaufman, president of ScriptChek Visual Verification Systems, a Florida company that that is lobbying to replace existing labels with ones that are more consumer-friendly. ''Your medications don't tell you what they're used for."

After a pharmacist gave him the wrong drug, Kaufman said, creating a better label became a passion. He estimates he's spent $100,000 of his own money reformatting drug bottle labels to be more helpful.

A simple change has already resulted in an improved pharmacy label: Computer software can now ensure that correct stickers -- with instructions such as do not take with grapefruit juice -- accompany specific drugs.

''In the past, it was all left to the pharmacist's memory," said Michael Cohen, president of the Institute for Safe Medication Practices. ''Obviously, no one can remember everything. Important information would be left off the label."

Diedtra Henderson can be reached at dhenderson@globe.com.