New Rx Label Standards: Add Your Voice

by pharmacy on March 1, 2011

The U.S. Pharmacopeia, or USP, has invited pharmacists and other medical professionals to help draft new labeling standards for prescription medicines. USP hopes to make dramatic changes to Rx labels that will include more readable font size, user-friendly language, more specific instructions and the most pertinent information at the top.

The move is designed to cut down on dosing errors caused by misunderstood directions. Instructions like “Take one pill twice a day” are inadequate. The aim of the new standards are to give the patient more information about when and how the medication should be taken without plowing through several pages of miniscule font laden with medical terms and jargon. Research has clearly shown that the current labeling standards are unusable to the average patient, a situation with potentially dangerous risks, especially for elderly patients with poor eyesight and faulty memory.

The new proposed standards would highlight the most important information, including the name and strength of the drug, the patient’s name, and instructions written in clear and understandable language and in readable font. Specifically, the proposal outlines plans to:

  • Organize the prescription label in a patient-centered manner
  • Emphasize instructions and other information important to    patients
  • Simplify language
  • Give explicit instructions
  • Include purpose for use
  • Limit auxiliary information
  • Address limited English proficiency
  • Improve readability

While most pharmacy and regulatory associations agree that there is a problem, reaction to the proposal has not been strictly positive. Critics point out that increasing the font size could lead to larger prescription bottles, and more packaging could translate to additional expense.

How You Can Get Involved

Read the Rx label proposal at the USP website. USP encourages feedback and ideas, and is accepting comment until March 31, 2011. They hope to see the new labeling standards on the shelves early as May 2012. Email your opinions to 17PrescriptionContainerLabeling@usp.org.

Once the comments are reviewed, the USP will decide whether changes to the standards are necessary. USP’s Director of Healthcare Quality Standards, Shawn Becker, MS, RN, expects to get some negative feedback addressing the feasibility of the plan, for example, “There is no room on container labels for these types of changes.” The USP hopes some creative ideas to help overcome these objections will be forthcoming.

What do you think? What can be removed from the label to make more room? Can you think of concise but clear ways to give instructions? If so, add your voice and help enact a change that could make a real difference to patients all over the United States.

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