USP Calls for Standardizing Prescription Container Labeling

Janice Simmons, May 11, 2010

To provide more consistent labeling that is easier to understand on dispensed prescription packages, the U.S. Pharmacopeial Convention (USP) has issued a new set of recommendations to standardize prescription labels through format, appearance, content, and language of prescription labels.

The labeling was created following a request from the Institute of Medicine (IOM) to address limited health literacy, which impacts more than 90 million adults nationwide. One of the components of health literacy is the ability to properly understand medication instructions and important supplemental information, such as drug interactions.

Poor health literacy can lead to non adherence and medication errors, according to IOM, which may pose significant health risks to patients. Medication misuse results in over 1 million adverse drug events annually.

USP, a nonprofit organization that sets standards addressing the identity, strength, quality, and purity of medicines across the country, formed a Health Literacy and Prescription Container Labeling Advisory Panel in 2007 to find ways to improve prescription drug container labeling.

"Patients have the right to understand health information that is necessary to safely care for themselves and their families," said Joanne Schwartzberg, MD, co chair of the advisory panel. "Confusing medication labels is one area that can be improved considerably."

The advisory panel call for provisions to:

Organize the prescription label in a patient centered manner. Information should be organized in a way to best reflect how most patients seek out and understand medication instructions. The prescription container label should feature only the most critical patient information needed for safe and effective understanding and use.

Simplify language. The language on the label should be clear, simple, concise, and standardized. Only common terms and sentences should be used. Use of unfamiliar words—including Latin terms and unclear medical jargon—should be avoided. Ambiguous terms such as "take as directed" should be avoided—unless clear and unambiguous supplemental instructions and counseling are provided.

Use explicit text to describe dosage and interval instructions. Dosage, usage, and administration instructions must clearly separate dose from interval. They must provide the explicit frequency of drug administration, such as "Take 4 tablets each day" or "take 2 tablets in the morning and 2 tablets in the evening." Use numeric rather than alphabetic characters for numbers.

Include purpose for use. While confidentiality could be a problem for including this information, USP said current evidence supports inclusion of purpose for use language in clear, simple terms such as indicating specific use for high blood pressure, rashes, or stomach cramps.

Improve readability. Critical information for patients must appear on the prescription label in an "uncondensed, simple, familiar" language in minimum 12 point, sans serif font (e.g., Arial).

Provide labeling in patient's preferred language. Whenever possible, prescription container labeling should be provided in the patient's preferred language. Translations of labels should be produced using a high quality translation process.

Include supplemental information. Auxiliary information on the prescription container should be minimized and should be limited to evidence based critical information.

Standardize directions to patients. As e-prescribing becomes more widespread, standards should be developed for prescribing directions to patients. This can lead to consistency of language and use across many healthcare professions and systems. An important element is the elimination of Latin abbreviations, which are often misunderstood and susceptible to variation in translation.

Janice Simmons Janice Simmons is a senior editor and Washington, DC, correspondent for HealthLeaders Media Online. She can be reached at
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