The HFE analysis studied 20 healthcare practitioners, all of whom handle drug vials and are responsible for cross-checking
against prescriptions and drug-delivery orders. Participants were asked to select the correct drug among a group of vials,
using realistic patient-prescription scenarios. Some of the vials had cap labels that would be prohibited by the USP proposal.
During the test, practitioners were able to find and select drug products with cap labels with greater speed and more accuracy
than those that did not have labels. In addition, participants rated more positively the ease-of-use and confidence they felt
when working with cap labels.
For example, one registered nurse initially selected a drug with a 100 U potency, thinking she had obtained the drug with
a potency of 10 U. She noticed her mistake only when the message "100 U" printed on the cap caught her attention. In a post-task
interview, she confirmed that without this printing, she would have left the 100-U vial on the drug cart for administration.
CAPS considers the study findings a conservative perspective on the value of cap messages because many healthcare practitioners
are not trained to notice or use cap messages in drug selection.
The results of all three phases of the study (see the full results at
http://www.caps-edu.org/) suggest that the current standard proposed by USP for General Chapter <1> will not achieve the stated objective of increased
patient safety. CAPS maintains that strategically placed messages on drug vial caps can provide an additional layer of protection
for healthcare practitioners when they determine dosage before administering injectable drugs. In addition, sophisticated
technologies may prove effective to help prevent counterfeit drugs from infiltrating the nation's drug supply.
In a commentary released on August 4, USP stated, "The Expert Committee was not persuaded that the results of the HFE evaluation
were in opposition of the proposed standard, as the experimental scenarios did not test the proposed standard" (1). The release
from USP also stated that the committee "determined there was not sufficient reason to conduct or await any studies prior
to the release of the standard (1)."
USP will accept comments on the new standard for 90 days after its November 2010 publication. In light of the CAPS study and
potential impact on patient safety, CAPS encourages industry, caregivers, and patients to contact USP regarding this important
Revised Standard Designed to Reduce Patient Death and Disability from Misadministration of Injectables
Shawn C. Becker, Director, Healthcare Quality Standards, US Pharmacopeia
The US Pharmacopeia's (USP) revised standard to USP General Chapter <1> Injections, Labeling of Ferrules and Cap Overseals section is designed to address medication errors that may be linked to misadministration of injectable products at the time of use.
Such errors have been implicated in episodes of patient death and disability. As an indicator of the importance of reducing
medication errors from all sources, not just injectables, the Institute of Medicine (IOM) has estimated that as many as 98,000
people die in any given year from medical errors that occur in hospitals. Of these, IOM estimates the intensive-care unit
(ICU) medication error rate to be as high as 6% (2). In direct-observation studies assessing medication errors with injectables,
the rate is even higher, according to IOM. Some studies demonstrate medication-error rates as high as 49%.
Shawn C. Becker
Although USP's goal in revising this standard is to assist healthcare practitioners to protect their patients from harm, the
organization recognizes the significant impact the revision will have on industry and is addressing this concern through an
extended implementation period of more than three years.