USP Proposes Standards for Drug Labels

Jan 13, 2011

Last week, the US Pharmacopeia published proposed standards for the content, language, format, and appearance of prescription drug labels in an effort to enhance patient understanding and safety. Medication labels should “fulfill the professional obligations of the prescriber and pharmacist” because they are patient’s best, and sometimes only, source of information about the drug, according to the proposed standards. Patients commonly misunderstand dosage instructions and auxiliary warnings, regardless of their level of literacy, partly because prescribers do not phrase their instructions in the same way for the same medications. The proposed standards are intended to reduce confusion and help establish a common language for labels.

USP proposed that labels be organized in the same way that patients seek and understand instructions. The document proposes that labels omit anything but the most important information needed for understanding and safe drug use.

Instructions and other crucial information (e.g., patient name, drug name, and drug strength) should be placed prominently at the top of the label, according to the proposed standards. Less crucial information (e.g., pharmacy name, prescriber name, refill information, and expiration date) should be placed away from dosing instructions so that it does not distract the patient.

Many of the proposed standard’s recommendations address the language that the label uses. Language should be “clear, simplified, concise, and familiar” and should avoid Latin terms, unfamiliar words, and unexplained medical jargon, according to the document. Instructions should explicitly name time periods when doses must be taken (e.g., morning or evening) because patients sometimes interpret “vague instructions,” such as “twice daily,” differently than the prescriber intends, according to the document. The standard also suggests that labels contain numbers in place of the names of numbers (i.e., “2” instead of “two”). Labels also should be printed in the patient’s preferred language and be written through a “high-quality translation process,” according to the standard.

Auxiliary information that is included on a label should be crucial for patient safety and understanding (e.g., warnings and administration alerts). Icons should be used only when they are clear and when consumer testing has shown that they improve patient understanding, according to the proposed standard.

The standard also offers advice about improving the label’s legibility. Labels should be produced in high-contrast print in simple, uncondensed fonts, according to the document. The label should be punctuated and capitalized according to the rules for sentences, and important information should be printed in a large font. The document also suggests that the label contain sufficient white space between sentences and between sections for easy reading.

In November 2009, after receiving recommendations from the Health Literacy and Prescription Container Labeling Advisory Panel, USP’s Safe Medication Use Expert Committee requested that USP develop patient-centered label standards to promote patient understanding. The recommendations formed the basis of the proposed standards. USP is accepting public comments on the document through March 31, 2011.

See related PharmTech articles:
To Label or Not to Label (PharmTech)

Academia Urges More Transparency on Labels (ePT)

Changes to Vial Labels May Affect Patient Safety (PharmTech)