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Background: Medication errors are a national con- Clinical significance was judged by an expert panel of
cern. physicians.
Objective: To identify the prevalence of medication er- Main Outcome Measure: Medication errors reach-
rors (doses administered differently than ordered). ing patients.
Design: A prospective cohort study. Results: In the 36 institutions, 19% of the doses (605/
3216) were in error. The most frequent errors by cat-
Setting: Hospitals accredited by the Joint Commission egory were wrong time (43%), omission (30%), wrong
on Accreditation of Healthcare Organizations, nonac- dose (17%), and unauthorized drug (4%). Seven per-
credited hospitals, and skilled nursing facilities in Geor- cent of the errors were judged potential adverse drug
gia and Colorado. events. There was no significant difference between er-
ror rates in the 3 settings (P=.82) or by size (P=.39). Er-
Participants: A stratified random sample of 36 insti- ror rates were higher in Colorado than in Georgia (P=.04).
tutions. Twenty-six declined, with random replace-
ment. Medication doses given (or omitted) during at least Conclusions: Medication errors were common (nearly
1 medication pass during a 1- to 4-day period by nurses 1 of every 5 doses in the typical hospital and skilled nurs-
on high medication–volume nursing units. The target ing facility). The percentage of errors rated potentially
sample was 50 day-shift doses per nursing unit or until harmful was 7%, or more than 40 per day in a typical 300-
all doses for that medication pass were administered. patient facility. The problem of defective medication ad-
ministration systems, although varied, is widespread.
Methods: Medication errors were witnessed by obser-
vation, and verified by a research pharmacist (E.A.F.). Arch Intern Med. 2002;162:1897-1903
T
HE 1999 Institute of Medi- searchers. They found that 56% of the
cine report1 on the quality events they detected were due to prescrib-
of care, entitled To Err Is ing errors and 44% involved administra-
Human: Building a Safer tion. Obviously, drug therapy cannot be
Health System, has drawn successful unless prescribing and deliv-
From the Center for Pharmacy
national attention to the occurrence, clini- ery and administration are performed cor-
Operations and Designs, School
of Pharmacy, Auburn cal consequences, and cost of adverse drug rectly.
University, Auburn, Ala events (ADEs) in hospitals. The report calls A key variable in assessing the medi-
(Drs Barker and Flynn); the for more systematic approaches to the pre- cation system in health care facilities is
School of Nursing, University of vention of injuries due to medical care. whether the patient receives the pre-
Colorado Health Sciences Many of these ADEs are viewed as origi- scribed medication. A medication error was
Center, Denver (Dr Pepper); nating from systems problems (ie, prob- defined for this study as a discrepancy be-
the Division of General Internal lems with the processes of the medica- tween the dose ordered and the dose re-
Medicine and Primary Care, tion use system). We divide those ceived. This definition takes a systems view
Brigham and Women’s processes into (1) prescribing and (2) de- of medication error, because the focus is
Hospital, and the Center for
livery and administration. The focus of this on the system outcome rather than on the
Applied Medical Information
Systems, Partners Healthcare article is on the latter. actions of individual health care work-
and Harvard Medical School, Leape and associates2 studied ADEs ers. Medication error is operationalized as
Boston, Mass (Dr Bates); and involving medications using methods that an easily understood rate that is simply cal-
DACE Co, West Monroe, La included solicited self-report and daily culated: (doses in error/total doses given
(Dr Mikeal). medical record review by clinical nurse re- or omitted) ⫻ 100. This measure of medi-
A medication error was defined in general as a dose adminis- The overall medication error rates (with and without wrong
tered differently than as ordered on the patient’s medical rec- time errors) for each site were compared between states, facil-
ord. Such medication errors were viewed as system defects (ie, ity types, accreditation status, and facility size categories us-
outcomes different from those the system was designed to de- ing an analysis of variance. The Tukey test was used to deter-
liver and administer to the patients). Categories of medication mine the means between which significant differences existed
errors were defined as follows. in the comparison of facility types. Computer software (SAS
1. Unauthorized drug: the administration of a dose of medi- statistical software for Windows, version 6.12; SAS Institute Inc,
cation that had never been ordered for that patient. Cary, NC) was used. The ␣ level was set at .05.
2. Extra dose: any dose given in excess of the total number
of times ordered by the physician, such as a dose given based on ASSESSMENT OF POTENTIAL FOR HARM
the expired order, after a drug had been discontinued, or after a
drug had been put on hold. A potential ADE was defined in general as a medication error
3. Wrong dose: any dose of preformed dosage units (such that had the potential to cause a patient discomfort or jeopar-
as tablets) that contained the wrong strength or number; if an dize the patient’s health and safety. In this study, the opera-
injectable product, then any dose that was ±10% or more dif- tional definition was the expert judgment (and majority deci-
ferent from the correct dosage; if any other dosage form, then sion) of a 3-physician advisory panel, each experienced in
any dose that was ±17% or more of the correct dose in the judg- making such judgments, who evaluated the same descriptive
ment of the observer. In judging dosage, measuring devices and information for each medication error detected. Health Care
graduations were those provided for routine use by the insti- Financing Administration guidelines (available from the au-
tution: graduations on the syringe for injections, graduations thors) for judging significance were provided to the panel.
on medicine cups for oral liquids, and drops for the dropper The information sent to the physicians’ panel (at
provided. Wrong dose errors were counted for ointments, topi- Brigham and Women’s Hospital) included a description of
cal solutions, and similar medications only when the dose was each individual error, the drug involved, and the error cat-
specified quantitatively by the prescriber (eg, in inches of egory. The information excluded the data collection method
ointment). used and the data collector type so as to blind the panel to
4. Omission: failure to give an ordered dose. If no at- these factors. Information sent about each patient’s condition
tempt was made to administer the dose, an omission error was included sex, age, allergies, disease states, selected laboratory
counted. If the patient refused the medication, an opportunity data if associated with a medication, red flag drugs ordered,
for error was not counted provided the nurse responsible for and physician or nurse progress notes when deemed notewor-
administering the dose tried to give it. Doses withheld accord- thy by the research pharmacist reviewing the patient’s medi-
ing to policies calling for the withholding of medication doses, cal record.
such as nothing by mouth before surgery, were not counted as An institutional review board application was submitted
errors or opportunities for errors. Omissions were detected by and approved by Auburn University and the Colorado Mul-
comparing the medications administered at a given time with tiple Institutional Review Board.
doses that should have been given at that time based on the
physician’s written order and protocols. RESULTS
5. Wrong route: medication administered to a patient us-
ing a different route than ordered (eg, oral administration of a Overall percentage agreement on the Drug Pass Exami-
drug ordered intramuscularly). Included in this category were
doses given in the wrong site, such as the right eye instead of
nation was 96%, with the range of agreement on each in-
the left eye. dividual question between 89% and 100%, indicating in-
6. Wrong form: the administration of a dose in a differ- terrater reliability. The result of the repeated-measures
ent form than ordered by the physician. If enteric-coated as- analysis of variance test found that the split-halves test
pirin was ordered, but plain aspirin was administered, a wrong scores were not significantly different within subjects, in-
form error was counted. dicating intrarater reliability (F1,8 =2.26, P = .0541).
Facility Type
Error Category Overall Accredited Hospitals Nonaccredited Hospitals Skilled Nursing Facilities
Omission 183 (6) 73 (5) 8 (3) 102 (7)
Wrong dose 103 (3) 46 (3) 12 (4) 45 (3)
Unauthorized drug 22 (1) 12 (1) 2 (1) 8 (1)
Wrong form 20 (1) 10 (1) 2 (1) 8 (1)
Extra dose 10 (0) 7 (0) 0 (0) 3 (0)
Wrong route 6 (0) 1 (0) 1 (0) 4 (0)
Wrong technique 2 (0) 0 (0) 0 (0) 2 (0)
Wrong time 259 (8) 85 (6) 31 (11) 143 (10)
Total errors 605 (19) 234 (16) 56 (20) 315 (22)
No error 2611 (81) 1247 (84) 228 (80) 1136 (78)
Total Doses 3216 (100) 1481 (100) 284 (100) 1451 (100)
*Data are given as number (percentage) of doses for each facility type. Percentages are rounded to the nearest whole number.
The mean error rate detected in the 36 sites in At- The 3-physician panel rated 7% of the errors de-
lanta and Denver was 19% (605 of 3216 doses). Exclud- tected (48 of 675 errors assessed) as potential ADEs. When
ing wrong time errors, the error rate was 10%. The range wrong time errors are excluded, 10% of the errors were
was 0% to 67%, with a 95% confidence interval of ±4.5%. considered potential ADEs (45 of 448 errors). Table 4
All data were collected during 81 observation days from lists examples of those errors rated as potential ADEs.
May 4 to November 11, 1999. The error rates by cat- Table 5 shows the potential clinical significance for each
egory (Table 1) demonstrate that the most frequent er- error type.
rors were wrong time (8%), omission (6%), and wrong
dose (3%); as a percentage of all errors, the results in-
cluded wrong time (43%), omission (30%), wrong dose COMMENT
(17%), and unauthorized drug (4%).
The distribution of error rates by error category was The results show that medication errors were common,
similar between accredited and nonaccredited hospitals and occurring in 19% or nearly 1 of every 5 doses in the typi-
skilled nursing facilities (Table 1). When rate by site was cal site. Assuming 10 doses per patient day, this would
compared (Table 2), however, substantial variation be- mean the typical patient was subject to about 2 errors
tween sites was found, with error rates ranging from 0% every day. There was substantial variation by site and re-
at one site to 66.7% at another. To help maintain ano- gion, however; therefore, the results can only be de-
nymity of the sites, size was categorized as large (⬎100) scribed for the sample observed.
and small (ⱕ100) based on number of certified beds.
There was no significant difference in error rates by POTENTIAL FOR HARM
type or size of facility. The statistics comparing the 3 types
of sites were as follows: F2,33 = 0.20, P = .82; and exclud- A panel of 3 physicians, experienced with such judg-
ing wrong time errors, F2,33 = 0.39, P= .68. The 17 large ments, rated 7% of these errors as potential ADEs (10%
sites had a mean ± 95% confidence interval error rate of if wrong time errors are excluded). This is comparable
16.5%±5.8% (excluding wrong time errors, 9.7%±2.9%), to the 8% of all errors found in the teaching hospital
and the 19 small sites had a mean ± 95% confidence in- study by Bates et al.12 (The methods and definitions
terval error rate of 20.5% ± 6.9% (excluding wrong time used, although not identical, were similar.) For 300 in-
errors, 10.2%±3.0%), resulting in F1,34 =0.75, P=.39 (ex- patients, assuming 10 doses per patient on 1 day, this
cluding wrong time errors: F1,34 = 0.06, P = .80). would be almost 40 potential ADEs per day in that fa-
The one teaching hospital had a low error rate of cility. Many drugs could have the potential for harm in
4.7% (8.2% including wrong time errors). The error rates some patients, but were judged safe herein because
for the accredited and nonaccredited facilities are shown these particular patients were not susceptible. For ex-
by error category in Table 1. There was no significant dif- ample, enteric coated aspirin, 325 mg, was adminis-
ference in error rates by accreditation status, with tered to a patient without an order. This unauthorized
(F1,22 =0.30, P= .59) or without (F1,22 =0, P = .95) wrong drug error was rated as not significant by the 3-physi-
time errors. This also proved true when those 5 in tran- cian panel. However, if the patient were also receiving
sition were treated as nonaccredited (F1,22 = 0.05, P =.82) warfarin sodium therapy, this could have been a clini-
(excluding wrong time errors: F1,22 =0, P = .96). cally significant error. When pharmacists in other stud-
The mean ± 95% confidence intervals error rates in ies were asked to judge the potential for harm from
the Colorado sites (Table 3), 23.4% ± 7.6% (excluding drugs involved in errors based on their pharmacological
wrong time errors, 13.0% ± 3.1%) (F1,34 = 4.75, P = .04), class alone, they found 67% of the doses threatening
were significantly greater than in the Georgia sites, harm.13-15 Systems should be designed to eliminate
13.8%±4.0% (excluding wrong time errors, 7.0%±1.9%) threats to patients for the full range of clinical condi-
(F1,34 =10.25, P = .003). tions that might be encountered.
*Large sites had more than 100 licensed beds; small sites, 100 or fewer licensed beds. Ellipses indicate data not applicable.
†These hospitals were not accredited at the start of the study, but achieved accreditation status before data collection.
ACCREDITATION BY THE JOINT COMMISSION riod) to 26.2% (also an accredited hospital). The Joint
ON ACCREDITATION OF Commission on Accreditation of Healthcare Organiza-
HEALTHCARE ORGANIZATIONS tions has identified medication errors as one of the most
frequent sentinel events.16
Statistically, accreditation by the Joint Commission on
Accreditation of Healthcare Organizations was irrel- GEOGRAPHIC LOCATION
evant for differentiating the hospitals by error rate. The
error rates, excluding wrong time errors, ranged from 0% It is unclear why the error rates for the 3 types of sites
(in 2 hospitals gaining accreditation during the study pe- were significantly higher in Colorado than in Georgia.
Facility Type
*Data are given as number (percentage) of doses for each facility type in each region. Percentages are rounded to the nearest whole number.
†This subtotal does not equal the sum of the individual percentages because of rounding.
Table 4. Examples of Errors Rated by the Physician Panel Table 5. Potential Clinical Significance
as Potential Adverse Drug Events* for Each Error Category
REFERENCES
CONCLUSIONS
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