The Washington Post

A new look for prescription drug labels

If you are reading The Checkup health blog, chances are you’re sufficiently “health literate” to decipher the labels on your own prescription drug packages.

But for many people, that’s a daunting task. According to the Institute of Medicine (IOM), about 77 million Americans have limited “health literacy,” the ability to access, process and understand information related to their health care and thus to make informed decisions about their care. The IOM in 2004 outlined steps for improving health literacy. The problem is particularly acute among older people, those with poor language skills and those for whom English is not their first language, according to the U.S. Pharmacopeial Convention (USP), which on Thursday published new standards for organizing and presenting key information on Rx drug container labels.

In keeping with the IOM’s effort, the USP -- a nonprofit organization that sets quality and safety standards for medicines and foods – has crafted guidelines for making prescription drug labels clearer and easier for everyone to read. The standards, which state pharmacy boards may now elect to adopt, would make labels’ design more user friendly and offer, to the extent possible, plain-language instructions for drugs’ safe and effective use. (Other aspects of prescription drug labeling, including package inserts, are regulated by the FDA.)

The new standards call for placing the information that’s most vital to patients most prominently on the labels. That means positioning the patient’s name, the drug’s nonproprietary and brand name, its strength and clear directions for its use – expressed in the simplest possible terms – at the top of the label. Less important info, such as the pharmacy name, would be positioned less prominently.

Rather than instructing patients to “take 2 tablets twice daily,” the new standards would have labels state more specifically “take 2 tablets in the morning and 2 tablets in the evening,” for example. The standards also suggest listing the purpose for which the medication is to be taken, again using the simplest language possible. Under the standards, “hypertension” is out; “high blood pressure” is in.

The standards also address matters ranging from font size and style to providing directions in the patient’s preferred language – and ensuring that those directions have been accurately translated.

Here's an example of what a label created under the standards might look like.


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