In developing this standard, the USP Nomenclature Expert Committee recognized that the situations in which injectable products
are often administered can be extremely busy, including in emergency rooms or in ICUs. Reports—including the aforementioned
from IOM—as well as from the National Coordinating Council for Medication Error Reporting and Prevention and the Institute
for Safe Medication Practices have indicated that labeling of injectable products may be linked to medication errors in the
administration of these products. Patient-safety data from US hospitals collected through the USP MEDMARX program (1998–2006)
indicated that the most severe medication errors for injectable products were predominantly related to human performance deficits,
occurring most often at the time of administration, with environmental distractions as the major contributing factor. The
goal of the standard is to minimize opportunities for this type of error.
The new standard
Changes to USP General Chapter <1> have been considered by four USP expert committees during the past decade. These committees
are made up of independent, outside experts. The committees evaluated evolving scientific literature, reviewed data from medication-error
reporting databases, facilitated stakeholder meetings, and routinely consulted with the US Food and Drug Administration regarding
the labeling of injectable products.
Over the years, expert committees have implemented changes to many labeling standards to reduce the likelihood of serious
medication errors arising from misadministration of medicines. These changes affected potassium chloride for injection concentrate,
neuromuscular blocking agents, and vincristine-sulfate injectable products. Although these medication-specific revisions were
needed to address dangerous situations, the USP Nomenclature Expert Committee decided it was also necessary to address the
problem of misadministration systematically across all injectable pharmaceuticals. In June 2010, USP's 2005–2010 Nomenclature
Expert Committee voted to adopt changes to the ferrules and cap overseals section of the chapter in the interest of patient
The revised section of the standard states that only cautionary statements may appear on the top (circle) surface of the ferrule
or cap overseal of a vial containing an injectable product. The cautionary statement should appear on both the ferrule and
cap overseal but may appear solely on the ferrule if the cap overseal is transparent and the cautionary statement beneath
the cap is readily legible. Products that do not require cautionary statements should be free of information on this surface,
so continued from page 97
that those with cautionary statements are immediately apparent. This systematic approach to the labeling of injectable products
will help ensure that cautionary statements can be easily seen by practitioners, thereby reducing the opportunity for errors
from misadministration of these products.
The standard defines a cautionary statement as one intended to prevent an imminent life-threatening situation and may include
instructional statements that may provide potency or other safety-related instructions if warranted. Cautionary statements
must be simple, concise, and devoid of inessential information. Inessential information includes company names, logos, and
The standard was revised under the direction of USP's Nomenclature Expert Committee. USP Expert Committees are composed of
outside experts that operate under strict conflict-of-interest rules to establish public standards. These volunteers have
diverse healthcare backgrounds such as pharmacy, nursing, and fields of medicine, or experience in academia, health plans,
consumer organizations, or the pharmaceutical industry. Under USP's public review process, expert committees publish proposed
new or revised standards. Comments by any party are considered by the committee for scientific merit, and standards are adjusted
based on this feedback. Standards are adopted by USP expert volunteers by a majority vote.
The CAPS position reflected alongside this column was first presented to the USP Nomenclature Expert Committee in May 2010,
as part of the public comment period. The committee considered this information along with all other comments submitted in
making its final decision on the standard.
Concerns about the proposed standard fell into two categories: first, whether important information that could affect the
safety of the patient would be restricted under the standard; and second, whether anticounterfeiting measures on product caps
would be considered usable. The Nomenclature Committee took these issues seriously. Addressing the first matter, the Expert
Committee determined that the standard is designed to help ensure the visibility of the most critical safety messages. It
is important to note that the standard will not restrict messages contained elsewhere on the injectable vial (e.g., vial skirt
or label), but only on the ferrule and cap overseal areas. With regard to the second matter, the Expert Committee recognized
the importance of anticounterfeiting activities, and concluded that there are many mechanisms for ensuring product accountability
that involve technologies and approaches other than labeling ferrules and cap overseals.