USP wants new Rx label standards

February 1, 2011

New draft standards from the U.S. Pharmacopeial Convention could bring dramatic changes to Rx labels as early as 2012. Changes to USP Chapter 17, Prescription Container Labeling, include larger font, placement of the most important information at the top, more understandable language, and more white space.

A new prescription-drug label format is headed your way. New draft standards from the U.S. Pharmacopeial Convention could bring dramatic changes to Rx labels as early as 2012. Changes to USP Chapter 17, Prescription Container Labeling, include larger font, placement of the most important information at the top, more understandable language, and more white space.

“The label is probably the most important thing from the patient’s point of view,” said Joanne Schwartzberg, MD, co-chair of the USP Health Literacy and Prescription Container Labeling Advisory Panel that developed the proposed standards. “The label is often the only source of information that the patient has available at home. Years of research have shown that labels as currently presented are mostly unusable by patients.”

Schwartzberg is also director for aging and community health at the American Medical Association.

Nearly 40% of patients with a high school education or higher misunderstand the typical drug label, she said. Understanding is even lower for patients with lower reading levels.

“The current prescription drug label is a very unsafe situation,” Schwartzberg told Drug Topics. “Standardizing the look and content of labels is a safety issue.”

The USP proposals say that when creating Rx labels, pharmacies should:

  • Emphasize the most important information at the top, including the patient’s name, drug name, drug strength, and instructions;
  • Avoid Latin terms, use simple concise language, and make instructions explicit. Labels should say “Take 2 tablets in the morning and in the evening” instead of “Take two tablets twice daily”;
  • Use at least 12-point font printed in black on a plain white background.

Reaction to the proposals has been mixed.

The National Community Pharmacists Association (NCPA) is unconvinced.

“This is a lot of the same information we’ve seen before,” said Ronna Hauser, PharmD, vice president, Policy and Regulatory Affairs, NCPA. “Auxiliary labels can be put to good use, but if you increase the font size, we’re going to have to start using larger prescription bottles.”

The Institute for Safe Medication Practices (ISMP) backs USP’s proposals.

“We definitely think they are going in the right direction,” said Donna Horn, RPh, DPh, director of Patient Safety – Community Pharmacy, ISMP. “The label is supposed to be for the patient, but historically, it has been used for regulators and auditors. Information like the physician’s phone number, address, and DEA number or the drug packager are important, but don’t need to be on the label. It’s all readily available in the pharmacy.”

The proposals are online at http://www.usp.org/USPNF/notices/generalChapter17.html. USP is accepting public comment through March 31.