USP proposal calls for new prescription label standards

March 15, 2011

A new prescription drug label format is in the works. Draft standards from the U.S. Pharmacopeial Convention could bring dramatic changes to Rx labels in 2012.

Key Points

A new prescription drug label format is headed your way. Draft standards from the U.S. Pharmacopeial Convention could bring dramatic changes to Rx labels in 2012. Updates 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.

Most important

"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, which developed the proposed standards.

USP included multiple industry groups in discussions leading to the draft standards. Reaction has been mixed. Groups focused on patient safety generally like the proposals. Groups with an interest in the business of pharmacy are less enthusiastic.

They worry that increasing font size means larger labels, less marketing-oriented information, new computer programs, and other costly changes. Carmen Catizone, executive director of the National Association of Boards of Pharmacy (NABP), noted that opposition from independent and chain pharmacy interests has scuttled similar labeling proposals in California and elsewhere.

Seen it before

"This is a lot of the same information we've seen before," said Ronna Hauser, PharmD, vice president, Policy and Regulatory Affairs, National Community Pharmacists Association. "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."

Absolutely not, according to the Institute for Safe Medication Practices (ISMP). All it takes is a redesign that eliminates anything and everything that does not directly relate to key information such as the patient's name, drug name, instructions for use, and expiration.

A step in the right direction

Confusing and unsafe

A new label format can't come too soon for USP. Nearly 40% of patients with a high school education or higher misunderstand the typical drug label, Dr. Schwartzberg noted. Understanding is even lower for those with lower reading levels.

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

What to do

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

Catizone said NABP has repeatedly asked state boards, FDA, and pharmacy interest groups to limit Rx labels to information that is designed to help the patient. That means no ads, no audit trails, nothing that is not directly useful to the patient.

"We're pretty much in concert with USP," Catizone said. "We're asking for a common-sense approach to including only what is actually necessary for the patient on the label. State boards will probably adopt these changes with some degree of flexibility during a transition period."

Once USP standards are enacted, they become the standard of care, he noted. That leaves states, and pharmacies in those states, open to legal challenge in cases of patient harm that might be linked to labels that do not conform to the new standards.

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