The U.S. Pharmacopeial Convention (USP) has released a new set of standards for the way information and instructions are arranged and worded on prescription drug labels to make them easier for patients to read and understand.
This is the first time USP has provided direction for a universal approach to prescription container labeling, and the recommendation comes on the heels of an Institute of Medicine (IOM) initiative to improve health literacy in the United States. According to IOM, 77 million Americans have limited health literacy meaning they are unable to acquire and comprehend basic health information, services or directives. While enforcement of USP’s new standard will be at the discretion of each state’s pharmacy board, it is believed that adoption of a universal standard for labeling will reduce medication misuse as well as the number of adverse drug events resulting from misuse.
USP-NF General Chapter <17> Prescription Container Labeling provides label manufacturers, pharmacists and prescribers with detailed specifications for creating patient-centered labels. In developing the new standards, USP studied patient thought processes and common behaviors regarding medication usage to determine exactly which information is most important in helping the patient understand how to safely adhere to a prescribed drug regimen.
In addition to focusing on the inclusion of the most pertinent information, the standards emphasize the importance of readability and explicitness. Developers also urge pharmacists to keep in mind the impact that language barriers and visual impairment have on a patient’s ability to fully comprehend medication instructions.
In addition, the Agency for Healthcare Research and Quality’s Health Literacy Pharmacy Center offers helpful tools and even more information on how pharmacists can help address health literacy issues.
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