CR staffers filled prescriptions at five nearby pharmacies. Here are the surprising results.

How confident are you that you take prescription drugs correctly? The instructions on the bottle's label may not seem to be hard to follow, but more than 500,000 Americans misinterpret them every year.

We wanted to do a "spot check" and see for ourselves how different drug labels, bottle warnings, and consumer drug information leaflets compared with one another. So Consumer Reports staffers filled prescriptions for 5 milligrams of warfarin at five chain pharmacies near our offices in Yonkers, N.Y.: Costco, CVS, Target, Walgreens, and Walmart. The drug warfarin, also known by the brand-name Coumadin, is a commonly used generic blood thinner, which can cause dangerous bleeding if taken incorrectly.

Given the known dangers with this medication—it's the second most common drug linked to emergency-room visits in the U.S.—we expected fairly clear and moderately consistent warnings and instructions across all the prescriptions. Instead we found critical information that was confusing, misleading, buried, or absent.

While the findings are not nationally representative for each chain, they do provide a glimpse into common issues consumers may face. Prescription drug bottles had an array of instructions and warnings—or alarmingly, as in the case of one store, no warnings at all. (In another visit, that same store did include warnings on the bottle. A third prescription we filled at a different store in the same chain also included warnings, but valuable label space was also used to print the lunch hours when the pharmacy was closed.)

We also found additional drug-safety information stuffed or stapled into pharmacy bags that was difficult to read due to very small type, had inconsistent information about side effects, or was written in confusing medical jargon. And four of the five pharmacies failed to follow a U.S. Food and Drug Administration regulation that calls for including an FDA medication guide with many prescription drugs.

Prescription bottle labels

There are about 1.5 million preventable medication errors each year, according to a 2006 report from the Institute of Medicine. Roughly one-third of those mistakes occur outside of hospitals, where patients must rely upon their own ability to follow the instructions on their medication containers. Studies have found that half of adults in outpatient settings misunderstand at least some of the instructions on a drug's bottle labels. For example, a 2007 study in the journal Patient Education and Counseling found that one-third of patients did not realize that "two tablets by mouth twice daily" meant taking four pills in a 24-hour period.

"Health literacy is a big issue," says Allen Vaida, Pharm.D., executive vice president of the Institute for Safe Medication Practices (ISMP) in Pennsylvania. "Even college grads can have trouble when it comes to understanding terms that health-care workers use."

When your doctor scratches a few letters and numbers onto a prescription pad, a pharmacist must then translate those abbreviations into easy-to-understand instructions for you, which are typed onto the patient drug label on the bottle. If your doctor instructs you to take a drug twice a day, for example, the pharmacist can choose to write "twice a day," "every 12 hours," "once in the morning and once in the evening," or similar instructions.

But "patients do better with more specific directions," says William Shrank, M.D., an assistant professor at Harvard Medical School who studies the effectiveness of patient drug labels.

Language like, "1 tablet in the morning and 1 tablet at night, 12 hours apart" helps patients understand when they should take their medication , rather than the vague "twice a day," which isn't associated with any time frame. That can cause some people, for example, to take the drug at say, 9 a.m. and then again at 3 p.m., then wait another 18 hours until they take another dose.

Why is there so much variation on prescription drug labels?

Part of the problem is that there's no nationwide standard, unlike the Nutrition Facts labels on food packages or the Drug Facts labels on over-the-counter medication. Although the Federal Food, Drug, and Cosmetic Act requires certain details to appear on bottle labels (like the patient's name and dosage instructions), other details can vary by state. The labels aren't monitored by the Food and Drug Administration; rather, each state's board of pharmacy is responsible for their content.

Most chain pharmacies send patients home with pages of instructions and warnings about the drugs, but a 2008 FDA study suggests that this literature usually isn't helpful. Some research has found that the majority of people don't read it completely because the language is too complex. Most patients rely on the information printed directly on their medication containers, which is why having an easy-to-read label and warnings is so important.

The U.S. Pharmacopeia, the authority that sets voluntary standards for prescription medication, and the Institute for Safe Medicine Practices recently suggested that it's helpful to patients when labels contain:

• Words typed in easy-to-read 12-point type, with the patient's name, drug name, and drug instructions in the largest letters. But not all pharmacies follow this suggestion. Harvard researchers who studied dozens of patient drug labels found that the words that are often the most prominent on labels pertain to the pharmacy itself, not drug information.

• Warnings typed directly onto patient labels in a large typeface. Research has found that fewer than 10 percent of people examine their drug containers for the colorful warning stickers that sometimes appear on the bottle. And warnings that appear on the labels that are typed in very small type can be hard to read or hard to find.

• The generic and brand name of a drug. This might prevent someone from mistakenly taking a double dose of the same medication prescribed by two doctors and filled at two different pharmacies, one as the generic version and one as the brand-name drug. Filling all of your prescriptions at the same pharmacy helps you avoid accidental mix-ups like this.

• Images or physical descriptions of the pills in the container. Someone who reads that he or she should be taking round blue tablets will probably call the pharmacy if there are oval-shaped white pills in the container.

• No extra zeroes (like 5.0 mg), so patients who take 5 mg of a medication don't incorrectly remember it as "50 mg" when talking to a doctor.

• The pharmacy's information—name, address, and phone number—at the bottom of the label, so the patient's drug information is prominently displayed at the top for easy reading.

One pharmacy chain's labels stood out from the pack. Target reinvented their bottles and labels in 2005 to help reduce patient errors. It created triangular containers that stand on their caps, leaving a large area on the front and back for drug-information labels. The drug information is in large typeface, the pharmacy details are small and at the bottom of the label, and there's room for multiple warnings and instructions on the back of the bottles. Target has even incorporated a color-coding system for their drug containers so family members won't accidentally reach for the wrong bottle. The ISMP has given the chain an award for its effective labels, and researchers who study patient labels have also taken notice.

"Target should be commended for their efforts to help patients read and understand medication labels," Shrank says. "I think it represents a dramatic improvement over standard labels." 

What we found: Bottle warning labels

One benefit of Target's redesigned bottle is that it allows more space for more warnings and instructions on the back. In the case of the warfarin prescription we filled, the bottle label clearly included four horizontal warnings and one directive to "read the medication guide that comes with this medicine." Walgreens also had four warnings printed on the bottle label; CVS had three printed on the label, Costco had two warning stickers positioned sideways on the bottle, and Walmart had none. (Filling another 5 mg warfarin prescription at the same Walmart a second time did yield a bottle with three warning stickers on it, as did a third trip to another Walmart in the area, though they weren't the same three warning stickers on each bottle.)

How can there be different or missing warning labels? Drugstores use information from various software vendors, and the software sets the risk level of a medication based on scientific studies, says Carmen Catizone, executive director of the National Association of Boards of Pharmacy, which works with each state's regulatory board.

And, while each state's board of pharmacy has the ability to set guidelines for prescription bottle warnings, none of them has. "It's up to the company and pharmacist to then decide what risk levels merit what labels," says Catizone. "Some companies don't allow discretion in affixing warning labels generated by the software system, while others make the warning labels available and it's the pharmacist who decides which label to affix to the container."

from: https://www.consumerreports.org/cro/2011/06/can-you-read-this-drug-label/index.htm