Landmark Study Supports Industry Position
Frederick J. Balboni, Jr., Executive Director, Consortium for the Advancement of Patient Safety (CAPS)
For decades, pharmaceutical companies have printed messages on the ferrules and cap overseals of injectable-drug vials to
help ensure safe delivery and administration. Messages include dosing and storage instructions as well as brand names and
logos aimed at combating drug counterfeiting.
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.
USP released its most recent proposed revision to General Chapter <1> on Aug. 4, 2010. The text will be published in USP 34–National Formulary (NF) 29 in November, with the implementation date set for December 2013. The most recent USP revision replaces the chapter revision
published in the Pharmacopeial Forum's January–February 2011 issue, which had an implementation date of May 2011. USP's first proposed revision of General Chapter
<1> was published in early 2005.
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
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.
The survey showed that the majority of respondents value cap messages that would be prohibited by the USP revision. Eighty
percent of survey respondents said they foresee an increase in medication errors if many of the currently allowed cap messages
are prohibited, and 69% disagree with USP's approach to making crucial warnings more salient to those who handle drug vials.