| Drug
administration errors appear to be a major source
of iatrogenic harm to hospitalized patients. A recent
study estimated that drug-related errors occur in
one out of five doses given to patients in hospitals.1
Administration errors were found to account for
38 percent of drug-related errors,2
and the annual cost of drug-related errors was estimated
to be approximately $2.8 million for a 700-bed teaching
hospital.3 While there
is relatively little information about drug administration
errors made by anesthesiologists, the available
data suggest that anesthesia-related drug administration
errors are relatively common. In a survey of anesthesiologists
in New Zealand, 12.5 percent of anesthesiologists
responding to the survey reported having harmed
patients by a drug administration error.4
A subsequent prospective study of 7,794 anesthetic
procedures in New Zealand found an overall incidence
of drug administration error of 0.75 percent, based
upon self-reporting by anesthesiologists.5
In order to obtain additional information about
drug administration errors in the anesthesia care
setting, we reviewed the cases of drug administration
error contained in the ASA Closed Claims Project
database. There were 205 drug errors, representing
about 4 percent of the total database of 5,803 cases.
The proportion of the database composed of drug
errors has been roughly constant, standing at 4
percent for the 1980s and 1990s.
For the purposes of this article, we have classified
the drug errors into the following categories (after
Webster, et al.5):
| • Omission — drug not given |
| • Repetition — extra dose of an
intended drug |
| • Substitution — incorrect drug
instead of the desired drug; a swap |
| • Insertion — a drug that was
not intended to be given at a particular time
or at any time |
| • Incorrect dose — wrong dose
of an intended drug |
| • Incorrect route — wrong route
of an intended drug |
| • Other — usually
a more complex event not fitting the categories
above |
Out of 205 claims for drug errors, there were only
two cases of “omission,” four cases
of “incorrect route” and no cases of
“repetition.” There were 50 cases of
“substitution” (24 percent), 35 cases
of “insertion” (17 percent), 64 cases
of “incorrect dose” (31 percent) and
50 cases of “other” (24 percent) [Figure
1]. The “other” cases were generally
complex, with drug administration error usually
being one of several issues. Drug infusions were
involved in 30 cases (15 percent).
Errors involving drug infusions were diverse in
nature. Of the 30 cases of error related to drug
infusions, 14 involved succinylcholine. Although
the use of succinylcholine infusions may be less
common since the advent of shorter-acting, nondepolarizing
muscle relaxants, there is a relatively recent claim
(from 1995) related to succinylcholine infusion.
There were two cases of protamine infusions administered
inadvertently while patients were on cardiopulmonary
bypass that resulted in death or major morbidity.
Drug administration errors frequently resulted in
serious problems. There were immediate and major
physiologic effects associated with the drug administration
error in 97 cases (47 percent) [Figure 1]. There
were 50 deaths (24 percent) and 70 cases (34 percent)
with major morbidity (serious, long-lasting or permanent
injury), similar to other types of claims within
the ASA Closed Claims database.
A wide variety of drugs were involved in errors
[Figure 2]. Two drugs in particular were most commonly
involved. Succinylcholine was involved in 35 cases
(17 percent), and epinephrine was involved in 17
cases (8 percent).
Twelve of the 35 cases involving succinylcholine
resulted in patients being awake while paralyzed,
due to succinylcholine boluses given prior to induction
agents, or succinylcholine infusions that were started
inadvertently in awake patients. Succinylcholine
was administered to five patients with a previous
history of definite or probable pseudocholinesterase
deficiency, resulting in prolonged neuromuscular
blockade. Hyperkalemic cardiac arrest occurred in
two paraplegic patients and a patient with Guillain-Barré
syndrome who received succinylcholine. Succinylcholine
infusions were involved in 14 of the 35 succinylcholine-related
cases.
Drug administration errors involving epinephrine
were particularly dangerous, with death or major
morbidity resulting in 11 of the 17 epinephrine-related
cases. Six of the 17 cases involving epinephrine
were caused by ampoule swaps where epinephrine ampoules
were confused with ampoules of the intended drugs.
Drugs that were interchanged with epinephrine were
ephedrine (two cases), pitocin (three cases) and
hydralazine (one case). An informative case report
describing the nearly fatal results of inadvertent
epinephrine administration due to an ampoule swap
has been published.6
There were 19 cases of intraoperative awareness
(9 percent). Of the 19 cases of intraoperative awareness,
14 involved inadvertent administration of a muscle
relaxant to an awake patient. In 12 cases, the muscle
relaxant was succinylcholine; in two cases, it was
vecuronium. A patient who received vecuronium instead
of cefazolin developed post-traumatic stress disorder
as a result of being paralyzed while awake. The
remaining five cases of awareness not related to
inadvertent administration of a muscle relaxant
were either unexplained (one case), related to omission
of an induction agent (one case) or were apparently
related to inadequate doses of general anesthetic
agents (three cases).
ASA Closed Claims Project reviewers judged the care
to be “less than appropriate” in 84
percent of the drug error claims, a substantially
higher percentage than for the nondrug error claims
in the database. Care was judged to be “less
than appropriate” in only 35 percent of the
nondrug error claims. Payments were made to plaintiffs
in 72 percent of the drug error claims compared
to 52 percent of the nondrug error claims.
Bar coding of anesthesia-related drugs in the operating
room has been described recently,7
and there are commercially available products that
link bar code readers to computerized information
systems designed for anesthesiologists. Whether
these systems are effective in preventing drug administration
errors is unknown at the current time. A recent
proposal by the Food and Drug Administration (FDA)
<www.fda.gov/oc/initiatives/barcode-sadr/fs-barcode.html>
to require standardized bar codes on all prescription
drugs could facilitate bar coding at the point of
care. It would appear essential to include drug
infusion as well as bolus administration in any
anesthesia point-of-care computerized drug administration
system as 15 percent of drug error cases in the
ASA Closed Claims Project involved drug infusion.
In summary, claims related to drug errors from the
ASA Closed Claims Project database were classified
according to mechanism. The most common distinct
mechanisms were substitution, insertion and incorrect
dose. Drug errors also were a factor in claims that
involved multiple problems in patient management
(classified as “other”). A wide variety
of drugs was involved, but succinylcholine and epinephrine
were the most significant individual drugs.
| References: |
| 1. Barker KN, Flynn EA, Pepper GA, Bates DW,
Mikeal RL. Medication errors observed in 36
health care facilities. Arch Intern Med.
2002; 162:1897-1903. |
| 2. Leape LL, Bates DW, Cullen DJ, et al. Systems
analysis of adverse drug events. ADE Prevention
Study Group. JAMA. 1995; 274:35-43. |
| 3. Bates DW, Spell N, Cullen DJ, et al. The
costs of adverse drug events in hospitalized
patients. Adverse Drug Events Prevention Study
Group. JAMA. 1997; 277:307-311. |
| 4. Merry AF, Peck DJ. Anaesthetists, errors
in drug administration and the law. N Z
Med J. 1995; 24:185-187. |
| 5. Webster CS, Merry AF, Larsson L, McGrath
KA, Weller J. The frequency and nature of drug
administration error during anaesthesia.
Anaesth Intensive Care. 2001; 29:494-500. |
| 6. Orser BA, Oxorn DC. An anaesthetic drug
error: Minimizing the risk. Can J Anaesth.
1994; 41:120-124. |
| 7. Merry AF, Webster CS, Mathew DJ. A new,
safety-oriented drug administration and automated
anesthesia record system. Anesth Analg.
2001; 93:385-390. |
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T. Andrew Bowdle, M.D., Ph.D., is Professor
of Anesthesiology and Pharmaceutics (Adjunct)
and Chief of Cardiothoracic Anesthesiology,
University of Washington, Seattle, Washington.
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