Medication Errors Associated with Packaging and Labeling of IV Bags
Hazard [Health Devices Nov 1997;26(11):440-2]
A member hospital reported an incident in which
800 cc of sterile water, instead of saline solution, was accidentally administered to
a patient during surgery. The infusion of water caused the patient's blood to hemolyze.
(The subsequent condition of the patient was not reported.) In this incident, a 1,000 mL
bulk pharmacy intravenous (IV) bag containing sterile water had been mistaken for a
similar-looking 1,000 mL IV bag containing 0.9% sodium chloride (i.e., saline) solution.
At the same hospital, a similar incident, involving 500 mL bags of these solutions, was
averted when the error was recognized before the solution was administered.
ECRI receives numerous reports of medication errors—some of which
result in patient injury or death. In a number of these reports, a medication was
mistakenly administered either because the drug container (e.g., IV bag, ampule, prefilled
syringe, bottle) was similar in appearance to the intended medication's container or
because the packages had similar labeling. Obviously, the severity of such errors depends
largely on the type of medication administered.
A number of factors can contribute to the mistaking of one medication for
another. Failure to read the labels on the packaging is one cause; if a medication is
stored in the wrong location or if clinicians select the medication based solely on the
appearance of its package, mistakes are more likely to result. Also, confusion can occur
between medications with names that look alike or sound alike or between premixed
medications packaged in similar-looking containers. Another potential source for confusion
with premixed medications is the presence of different concentrations of the same
medication in a particular location (e.g., a package with a 100 mg/mL concentration of a
drug could be mistaken for one with a 10 mg/mL concentration).
In the reported incident, the similar appearance of the two different brands of IV
bags contributed to the medication error. However, the 1,000 mL sterile water bags, which
are supposed to be limited to the pharmacy, are labeled with a boxed area stating
"Pharmacy Bulk Package—Not For Direct Infusion." And, as noted by the
manufacturer, users should be responsible for reading drug labels before dispensing and
As this incident illustrates, many medication errors can be avoided if
clinicians carefully read the labeling when selecting or administering a medication.
However, drug manufacturers, hospital pharmacy staff, prescribing physicians, other
healthcare workers, and even patients can also play a role in minimizing the occurrence of
medication errors. Below, we present recommendations for avoiding these types of errors.
ECRI will continue to monitor reports of errors associated with packaging and labeling and
will report on such incidents in the future.
- Avoid storing medications with similar packaging in
the same location or in close proximity.
- Follow the American Society of Health-System Pharmacists
(ASHP) guidelines for preventing hospital medication errors.(1) These
guidelines include specific recommendations for organizations and
departments, prescribing physicians, pharmacists, and patients. ASHP's
recommendations include the following:
- Fully document all medication prescriptions and deliveries,
and instruct staff that any discrepancy or misunderstanding about prescription or patient
information should be verified with the prescribing physician. Staff members should be
told that all caregivers (regardless of level) have the duty to
question the prescribing physician (regardless of the
physician's relative position in the hospital hierarchy) if they
have concerns about a drug, dose, or patient.
- Periodically train staff in practices
that will help avoid medication errors.
- Ensure that medication storage and distribution to hospital
locations outside the pharmacy are supervised by hospital
pharmacy staff only. Nonpharmacists should not be allowed to
enter the pharmacy if it is closed.
- Perform failure mode and effects analysis. This is
a technique used to identify all medication errors that could occur,
determine how they could occur, and estimate what their consequences would
be. Steps are then taken to prevent errors from occurring, when possible,
and to minimize the effects of any errors that do occur.
- Report any information relating to medication errors
to the Medication Errors Reporting Program operated by the United States
Pharmacopeial Convention (USP) and the Institute for Safe Medication
Practices (ISMP). This program shares information on medication errors with
healthcare professionals (while keeping the identity of the reporting
institution confidential) to prevent similar errors from recurring. ISMP
publishes reports in professional journals and newsletters and on electronic
bulletin boards. A confidential report is also sent to the U.S. Food and
Drug Administration (FDA), as well as to the supplier of the reported
product. The Medication Errors Reporting Program can be reached by
telephone: (800) 233-7767 (24 hours a day),
or by mail: 12601 Twinbrook Parkway, Rockville MD
20852. All reports are confidential.
- U.S. hospitals should report incidents in which a
device caused or helped cause a medication error to FDA as required by the
Safe Medical Devices Act. Errors clearly attributable to clinicians need not
- Urge suppliers to provide clear and unique labels
and packages for their various individual medications.
- American Society of Health-System Pharmacists (ASHP). ASHP guidelines on
preventing medication errors in hospitals [ASHP report]. Am J Hosp Pham
Intravenous Fluid Containers [12-172]
Cause of Device-Related Incident
Device factor: Design/labeling error
User error: Incorrect clinical use
Support system failures: Failure to train
and/or credential; Improper storage; Lack of competent accident investigation
Mechanism of Injury or Death
Anaphylaxis; Hemolysis; Overdose; Underdose; Wrong drug