Confusing Labels

Here is an interesting by Consumer Reports showing how labels and instructions on prescription medicine are often incomplete, confusing and inconsistent.

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“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.”

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