Landmark Study Supports Industry Position
Frederick J. Balboni, Jr., Executive Director, Consortium for the Advancement of Patient Safety (CAPS)

Frederick J. Balboni, Jr.

These labels will have to change on Dec. 1, 2013, when the revised US Pharmacopeia (USP) General Chapter <1> Injections, Labeling of Ferrules and Cap Overseals takes effect. The revised chapter limits printing on ferrules and cap overseals to cautionary statements.

The new standard classifies printing on ferrules and cap overseals as labeling for the first time. The new chapter also requires pharmaceutical companies to provide justification to the US Food and Drug Administration for printing a cautionary statement on a vial ferrule or cap overseal. If no cautionary statement is necessary, the top of the ferrule and cap overseal must remain blank.

Members of the Consortium for the Advancement of Patient Safety (CAPS) are disappointed with USP's proposed revision. Since the revision to USP <1> was first proposed five years ago, industry has sent written comments and made presentations to USP in support of a less restrictive standard, emphasizing the crucial role of printed information in minimizing administrative errors and improving patient safety. USP contends that most vial-cap messages create a "billboard effect" and that healthcare practitioners should rely on package inserts and drug-vial labels.

CAPS representatives met with FDA in 2009 to discuss the issue. During the meeting, an FDA representative stated that no factual, independent data supported either position (i.e., that of CAPS or USP) and recommended a human factors engineering (HFE) study to examine the use of vial labels. CAPS commissioned such a study and the findings (described below) indicate that USP's revision has the potential to threaten patient safety. CAPS presented the data to USP's Nomenclature Expert Committee on May 25, 2010, to assist the organization in creating an acceptable, viable standard.

The study was led by Anthony Andre, PhD, founding principal of Interface Analysis Associates and adjunct professor of human factors and ergonomics at San Jose State University in California. Andre is a certified ergonomist and the president-elect of the Human Factors and Ergonomics Society, an international organization with chapters in the US, Canada, and Europe.

The study consisted of three phases carried out between January and March 2010: a literature review, a web-based survey of more than 300 healthcare practitioners across the United States, and an HFE analysis. The data points to these overall conclusions:

• No medication-error data could be found that pointed to the ferrule or cap overseal as a source or cause of incidents or accidents.
• When presented with the idea of certain ferrule or cap overseal messages being prohibited, an overwhelming majority of respondents (74%) stated that "it would be harmful to eliminate most of these messages."
• Less information is not necessarily more effective, meaning that limiting messages to crucial information does not make such information more visible.