With medication misuse resulting in more than one million adverse drug events per year in the
United States, new standards released today by the U.S. Pharmacopeial Convention (USP) for the
first time provide a universal approach to the format, appearance, content and language of
instructions for medicines in containers dispensed by pharmacists. Wide variability in prescription
container labels exists today across individual prescriptions, pharmacies, retail chains and
states. The USP standards provide specific direction on how to organize labels in a
“patient-centered” manner that best reflects how most patients seek out and understand medication
Studies have found that 46 percent of patients misunderstood one or more dosage instructions on
prescription labels. The problem is particularly troublesome in patients with low or marginal
literacy (one study showed patients with low literacy were 34 times more likely to misinterpret
prescription warning labels), and in patients receiving multiple medications that are scheduled for
administration using unnecessarily complex, non-standardized time periods. However, even patients
with adequate literacy often misunderstand common prescription directions and warnings.
The USP effort to create these new standards developed from an Institute of Medicine (IOM)-led
initiative to improve health literacy, which is defined as the degree to which people can obtain,
process and understand the basic health information and services they need to make appropriate
health decisions. According to IOM, 77 million Americans have limited health literacy, and a
majority of Americans have difficulty understanding and using currently available health
information and services.
Elements of the new USP standards, contained in General Chapter <17> Prescription Container
Labeling, of the United States Pharmacopeia and the National Formulary, include:
•Emphasize instructions and other information important to patients.
•Give explicit instructions.
•Include purpose for use.
•Address limited English proficiency.
•Address visual impairment.
Examples of prescription container labels that comply with the new USP standard are available at