Pharmacy Blog

Open your medicine cabinet, and take a close look at every prescription pill bottle you've got. Chances are, each vial is plastered with at least one colorful warning sticker that contains a bold but strangely ambiguous phrase or two accompanied, perhaps, by a cryptic drawing. You might see, for example, a red sticker depicting a gushing faucet, with a message in fine print that reads, "MEDICATION SHOULD BE TAKEN WITH PLENTY OF WATER." But, how much is plenty? Would a cup of coffee be acceptable instead?

Another common sticker urges, "DO NOT CHEW OR CRUSH, SWALLOW WHOLE," next to a diagram that looks at least as much like an arrow chasing a nickel down the throat of a bota bag as it resembles a drug tablet falling into a stomach.

These insistent little strips of paper or plastic hundreds of them are designed and manufactured by a number of well meaning companies, each according to its own format, symbology and color scheme. The warning stickers on prescription bottles have not traditionally been deemed important contributors to patient education.

Compared with the package insert prepared by the drug's manufacturer under the hot breath of the Food and Drug Administration or the one-page consumer summaries that pharmacists add, the warning stickers are just fluffy little extras.

As such, they are not standardized, regulated or even reviewed by the F.D.A. Nor are they generally tested for effectiveness before they hit the market.

But some health literacy experts worry that many patients, overwhelmed by a proliferation of paper warnings often written in turgid prose are relying instead on the stickers to tell them how to take medications.

"What I'm hearing from patients is that they don't really much use these handouts that are stapled to the bag," said Dr. Ruth Parker, an internist who treats patients at the large public hospital associated with Emory University in Atlanta. "What they will sometimes do is look at the label."

Dr. Parker recently completed two studies on the topic with Dr. Terry Davis of Louisiana State University at Shreveport and Dr. Michael Wolf of Northwestern's Feinberg School of Medicine in Chicago. The scientists said that, so far, they had not heard of anyone who was harmed by over-reliance on the little stickers as medication guides.

Still, their results, not yet published but already being talked about in health literacy circles, suggest that a risk does exist. And patients with reading skills that do not stretch beyond sixth or seventh grade seem likely to be the most vulnerable.

To explore the problem, the researchers interviewed a few hundred healthy, English-speaking adults in three states to identify a group with a broad cross section of reading skills. About a third of those enrolled in one of two studies tested below a sixth-grade reading level. Another third of the group read at a level higher than 12th grade.

The researchers showed the volunteers samples of real warning stickers, one at a time, and asked them individually to explain what action the label was urging. The high number of errors across the board was startling.

For example, when the volunteers saw the sticker with the little pill-popping bota bag, some participants in the studies inverted the meaning completely, and thought that it meant they should chew the pill and crush it before swallowing. Others thought the stomach was a bladder. Still others decided the label meant the drug was "just for your stomach."

Many people seemed to guess at a sticker's meaning instead of reading the tiny type, making leaps that often got them into trouble.

For example, common misinterpretations of a yellow label bearing an icon of the sun with a slash through it were, "Don't take medicine if you've been in the sunlight too long," "Don't leave medicine in the sun," and "Don't leave medicine in the sun, but in a cool place." The extremely fine print of that label actually read, in all capital letters: "YOU SHOULD AVOID PROLONGED OR EXCESSIVE EXPOSURE TO DIRECT AND/OR ARTIFICIAL SUNLIGHT WHILE TAKING THIS DRUG."

The "FOR EXTERNAL USE ONLY'' sticker stumped 25 percent of even those who could read every word, and misled 90 percent of the adults in the lowest literacy group.

That, Dr. Wolf said, was probably because its icon was so strange. The label depicted an oddly-stretched human shape encased in what looked like a series of ghostly shrouds. Take this pill to stop hallucinations? To start them?

"A lot of people thought that icon meant the drug was radioactive," Dr. Wolf said.

At a loss to make out the image, many people in the study seized on the red color as signaling danger or urgency. "Use extreme caution in how you take it," one person said the warning meant. Another interpreted it to mean, "Take only if you need it." Indeed.

"These labels can pose problems for all patients, not just those with low literacy skills," Dr. Wolf said. "But our research showed that those with low skills are hit harder because they are more likely to rely on a sticker's color and its icon."

Dr. Davis said she had noticed that in most cases, the label designers seemed to have chosen the colors of the stickers without any regard to content. She says she believes that is a mistake.

"There's nothing intrinsic to the shape or color of a stop sign that means stop," she said, "but we all learn really early on, long before we can read, that we're supposed to stop when we come to a red octagon with white letters, and we're to go when we see a green light."

One bright red label said, "THIS DRUG IS AVAILABLE IN A COST SAVING GENERIC," but a "NOT TO BE SWALLOWED" warning was printed on a blue sticker.

"Designers need to realize that patients are imputing meaning to the color of those labels," Dr. Davis said, "whether it was intended or not." In theory, the researchers said they thought that using crisp, pre-tested icons, intuitive colors and other innovations on the stickers could actually help curb medication mistakes by patients who do not read well or who are led by age, infirmity or more transient conditions like pregnancy, grief or exhaustion to reach for the wrong bottle.

Last spring, Target announced a redesign of the prescription bottles used in all its pharmacies to, among other things, improve the legibility of the labels. The company is in the midst of redesigning its prescription warning labels, as well.

But innovation alone is not the answer, Dr. Parker said. "The last thing we need are 400 new and improved icons, any more than we need 400 new and improved stop signs," she said. "What we need is clarity and consistency about which warnings to use when."

She added, "I believe we absolutely need some sort of regulation about this, because we need standardization." Ray Bullman, executive vice president of the National Council on Patient Information and Education in Bethesda, Md., knows firsthand that the warning labels are used inconsistently.

"When I pick up my prescription drug, the number of stickers on it depends on which pharm tech is on that night," Mr. Bullman said. "There's usually one for dizziness, a warning not to take it with grapefruit juice, and some others lined up around the bottle like those tall, thin cookies around a cake."

More are not necessarily better, he said, and added, "Sometimes it gets almost to the point that you can't read the prescription."

In Philadelphia, Jean Krause, the chief executive of the American College of Physicians Foundation, said that even within her office she had noticed inconsistency in the way the warning labels were used. Ms. Krause and two colleagues all take the same cholesterol-lowering drug, but they buy it from three different pharmacies.

"My bottle says 'Do not take with grapefruit juice or grapefruit products,' " Ms. Krause said. "But neither of my colleagues' bottles say a word about that. I have to wonder why not."

Ms. Krause is hoping that, coincidentally, the work of her foundation might soon help resolve that question. At the end of November, a team of researchers from Harvard Medical School and the RAND Corporation that is leading the foundation's Prescription Bottle Labeling Project is scheduled to report back on, among other things, the problems that have arisen in regard to warning labels and any potential solutions.

"I don't know what they're going to say, but I'm pretty sure it won't simply be, 'More research is needed.' '' Ms. Krause said. "We're ready to take action, if that is what's called for.

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