FDA Issues Bar Code Regulation
February 25, 2004
Today's Action
In an effort to improve patient safety in the hospital setting
by reducing medication errors, the Food and Drug Administration
(FDA) has published a final rule titled, Bar Code Label
Requirements for Human Drug Products and Biological
Products.
The Final Rule
FDA is issuing a final rule that requires "bar codes" on most
prescription drugs and on certain over-the-counter drugs. Bar codes
are symbols consisting of horizontal lines and spaces and are
commonly seen on most consumer goods. In retail settings, bar codes
identify the specific product and allow software to link the
product to price and other sales- and inventory-related
information. FDA's bar code rule uses bar codes to address an
important public health concern -- medication errors associated
with drug products.
How Would It Work
The final rule requires linear bar codes on most prescription
drugs and on over-the-counter drugs commonly used in hospitals and
dispensed pursuant to an order. The bar code must, at a minimum,
contain the drug's National Drug Code (NDC) number, which uniquely
identifies the drug.
For blood and blood components intended for transfusion, the
final rule requires the use of machine-readable information in a
format approved for use by FDA. The machine-readable information
must include, at a minimum, the facility identifier, the lot number
relating to the donor, the product code, and the donor's ABO and
Rh.
Bar codes on drugs would help prevent medication errors when
used with a bar code scanning system and computerized database.
This system would work as follows:
- A patient is admitted to the hospital. The hospital gives the
patient a bar-coded identification bracelet to link the patient to
his or her computerized medical record.
- As required by the rule, most prescription drugs and certain
over-the-counter drugs would have a bar code on their labels. The
bar code would reflect the drug's NDC number.
- The hospital would have bar code scanners or readers that are
linked to the hospital's computer system of electronic medical
records.
- Before a healthcare worker administers a drug to the patient,
the healthcare worker scans the patient's bar code. This allows the
computer to pull up the patient's computerized medical record.
- The healthcare worker then scans the drug(s) that the hospital
pharmacy has provided to be administered to the patient. This scan
informs the computer which drug is being administered.
- The computer then compares the patient's medical record to the
drug(s) being administered to ensure that they match. If there is a
problem, the computer sends an error message, and the healthcare
worker investigates the problem.
- The problem could be one of many things:
- Wrong patient
- Wrong dose of drug
- Wrong drug
- Wrong time to administer the drug
- The patient's chart has been updated and the prescribed
medication has changed
So, for example, a bar code system could prevent a child from
receiving an adult dosage of a drug and prevent a patient from
mistakenly receiving a duplicate dose of a drug he or she had
already received. A bar code system can also allow the computer to
record the time that the patient receives the drug, ensuring more
accurate medical records.
Improving Patient Safety
The Institute of Medicine and other expert bodies have concluded
that medical errors have substantial costs in lives, injuries, and
wasted health care resources, and that drug-related adverse events
are a major component of those errors.
FDA estimates that the bar code rule, once implemented, will
result in more than 500,000 fewer adverse events over the next 20
years. Thus, FDA estimates a 50% reduction in medication errors
that would otherwise occur when drugs are dispensed or
administered, even though some hospitals that currently have bar
code systems in place report a higher error reduction from bar code
usage.
Other Benefits
Patients would avoid pain, suffering, and extensions of hospital
stays with an estimated value of $93 billion over the next 20
years. In addition, hospitals are expected to avoid litigation
associated with preventable adverse events, reduce malpractice
liability insurance premiums, and increase receipts from more
accurate billing procedures.
Also, the bar coding system could help with inventory control
for drug manufacturers, wholesalers and pharmacists, as well as
efficiencies in ordering and billing.
