A few stripes on the side of a drug bottle or packet sounds
like a simple thing to agree upon and implement. But the
Food and Drug Administration recently broke a stalemate
by ordering mandatory use of such bar codes and a standard
way to represent information about drugs in a bar code.
To the select number of nurses who've already implemented
bar coded medicine, the improved accuracy and delivery
speed of drugs has been stunning.
"It has caught errors we didn't even know we were
making," said Peg Spisak, RN, director of quality
and risk management and patient safety officer at Ohio
Valley General Hospital in McKees Rocks, Pa.
Ohio Valley's pilot use of bar coded medications went
live Sept. 18, 2001, using McKesson Corp.'s Admin-RX,
with which bedside nurses scan patient wristband and
medication bar codes into a handheld terminal that communicates
to a wireless hospital network where electronic medical
records are kept.
"Busy nurses make mistakes without realizing it,"
Spisak said. "Now, if someone tried to take this
away, we'd have a problem."
However, many nurses still rely on paper charts to
administer the "five rights" (right medication,
right patient, right dose, right route, at the right
time), as the lack of standards and concerns over the
cost of technology and training have kept many drug
companies from placing bar codes on most medicines.
A rash of stories on medication errors in the United
States prompted a call for a federal role. Department
of Health and Human Services Secretary Tommy Thompson
announced March 13 a proposed rule requiring bar codes
on drug labels, similar in appearance to the bar codes
present for years on retail products.
The proposed rule would apply to prescription drugs,
excluding physician samples, and to over-the-counter
drugs commonly used in hospitals and dispensed pursuant
to an order. The rule would apply to drug manufacturers,
repackers, relabelers and private-label distributors
of drugs. The proposal would require the bar code to
contain, at a minimum, the drug's National Drug Code
number, a unique number that identifies each drug, its
dosage form and its strength.
The nurses interviewed for this story welcomed the
FDA move.
The FDA intends to make the rule effective three years
after it publishes a final rule. However, some drugs
already have bar codes, and some firms have announced
their intention to place bar codes on their drugs sooner.
Health care providers are under no obligation to implement
systems to read and record the information contained
on the bar codes. However, hospitals such as Ohio Valley
have acted as vanguards in doing so.
Veterans Administration hospitals have adopted bar
coding for pharmaceutical products used at patients'
bedsides, according to Jerry Phillips, associate director
of the FDA's Office of Drug Safety.
"We use this as a role model," Phillips said.
Several national hospital purchasing alliances, including
Premier Inc., Novation and Amerinet, plan to preferentially
award contracts to those pharmaceutical companies that
provide bar coded medications, said Allen Vaida, executive
director of the Institute for Safe Medication Practices
in Huntingdon Valley, Pa.
"What really drives the market is what people
will buy, and the good sign is that the purchasing alliances
are on board," Vaida said.
Today, 30 percent to 35 percent of drugs already have
bar codes. However, firms use different, incompatible
standards. So even as hospitals print bar codes for
medications that don't have them, they also may have
to print bar codes to replace incompatible ones.
The FDA's mandate replaces such conflicting standards
with a unified one that permits extensions to a basic
set of information. The 90-day public comment period
that ends June 13 is also an invitation for advocates
of extended information to argue for its inclusion and
standardization. For instance, the Institute for Safe
Medication Practices wants each drug's expiration date
and lot number to be required and standardized across
all FDA-mandated drug bar codes.
Other health care providers are concerned that the
regulations will encourage pharmaceutical companies
to continue a recent trend in which some drugs are packaged
in bulk instead of single doses. Hospital pharmacies
can divide such packages into smaller containers and
apply new bar codes, which adds to drug costs.
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