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Keep It Short No
More
When it comes to labeling, you'd better mind your p's and q's.
And u's and cc's and any other abbreviations often used to tighten
up labeling copy. Michael R. Cohen, president of the Institute of
Safe Medication Practices (ISMP; Huntingdon Valley, PA), calls such
"alphabet soup" in drug labeling "hazardous to your health." The
abbreviation "U" or "u," for instance, is often used in place of
"unit," but it can be mistaken for the numbers 0 or 4. According to
ISMP, such mistakes can cause a "10-fold overdose or greater." Also,
"u" can also be mistaken for "cc," so a dose could be "given in
volume instead of units," warns ISMP.
FDA understands the risk. The agency has partnered with ISMP to
launch a campaign against mistakes rooted in unclear
abbreviations. The campaign urges everyone in the healthcare
industry, including pharmaceutical manufacturers and those that
produce packaging and labeling, to avoid a number of abbreviations
that have been linked to medical errors in the past.
ISMP has put together a list of such risky acronyms, like the
aforementioned "u." Some of these still appear in packaging and
labeling. The danger isn't just from patient misunderstanding.
Professionals, too, who often work long shifts with short staffs,
can make mistakes when labeling abbreviations are unclear.
Cohen also advises against the use of these abbreviations in
package inserts-not just package labels-as well as in some of the
pharmaceutical advertising seen by doctors. "This helps to
perpetuate the problem," says Cohen. "FDA has recently [held] a
training session to the review division's professional staff and
asked them not to allow these in advertising and labeling."
For instance, the June 1 issue of Medication Safety Alert
recounts a pharmacist's recent discovery that a new drug's package
insert listing dosing regimens as BID, TID, and QD could lead to
errors. The manufacturer wrote BID to convey that the total daily
dose should be divided into two doses and TID to convey that the
total daily dose be divided into three doses. Most professionals,
however, would read those two abbreviations as twice-daily dosing
and three-times-daily dosing, respectively, says ISMP.
Cohen says that most hospitals and long-term-care facilities are
attempting to meet National Patient Safety Goals as established by
the Joint Commission on Accreditation of Healthcare Organization
(JCAHO). "They have to follow these guidelines to get accredited,"
says Cohen.
The commission even has its own list of banned abbreviations. Trouble is, doctors have a
hard time breaking "old habits," explains Cohen. "It isn't easy for
them because drug container labeling still occasionally uses bad
abbreviations."
Cohen urges "pharmaceutical manufacturers to review drug labeling
and packaging as well as new drug applications for use of
error-prone abbreviations." He also advises firms to "include the
ISMP list in corporate editorial style guidelines as well as into
software and medical device design."
Limited labeling real estate may be a challenge, and
abbreviations can make the most of such space. But before you print
an acronym, stay away from those listed on ISMP's and JCAHO's lists.
To ensure your message is clear, run it by a diverse team of
doctors, nurses, pharmacists, and even patients, because they are
reading inserts, too.
Daphne
Allen Editor |