Anda di halaman 1dari 7

Relationship between Medication Errors and

Adverse Drug Events


David W. Bates, MD, MSc, Deborah L. Boyle, BA, Martha B. Vander Vliet, RN,
James Schneider, RPh, Lucian Leape, MD

OBJECTIVE: To evaluate the f r e q u e n c y of m e d i c a t i o n errors


using a multidisciplinary approach, to classify t h e s e errors
by type, and to determine h o w often m e d i c a t i o n errors are
associated with adverse drug events (ADEs) and potential ADEs.
DESIGN: Medication errors were detected u s i n g self-report
by pharmacists, nurse review of all patient charts, and review
of all medication s h e e t s . I n c i d e n t s that w e r e t h o u g h t to represent ADEs or potential ADEs were identified through s p o n taneous reporting from nursing or p h a r m a c y p e r s o n n e l , solicited reporting from n u r s e s , and daily chart review by the
study nurse. I n c i d e n t s were s u b s e q u e n t l y classified by two
i n d e p e n d e n t reviewers as A D E s or potential A D E s .
SETTING: Three m e d i c a l units at a n urban tertiary care h o s pital.
PATIENTS: A cohort of 3 7 9 c o n s e c u t i v e a d m i s s i o n s during
a 51-day period ( 1 , 7 0 4 patient-days).
INTERVENTION: None.
MEASUREMENTS AND MAIN R E S U L T S : Over the s t u d y period, 1 0 , 0 7 0 medication orders were written, and 5 3 0 medications errors were identified (5.3 errors/100 orders), for a
m e a n of 0 . 3 medication errors per patient-day, or 1.4 per
admission. Of the m e d i c a t i o n errors, 53% involved at least
one m i s s i n g d o s e of a medication; 15% involved other d o s e
errors, 8% frequency errors, and 5% route errors. During the
same period, 2 5 ADEs and 3 5 potential ADEs were f o u n d . Of
the 2 5 ADEs, five (20% ] were a s s o c i a t e d w i t h m e d i c a t i o n
errors; all were j u d g e d preventable. T h u s , five o f 5 3 0 medication errors (0.9%) resulted in ADEs. P h y s i c i a n c o m p u t e r
order entry c o u l d have prevented 84% o f n o n - m i s s i n g d o s e
medication errors, 86% o f potential ADEs, and 60% of preventable ADEs.
CONCLUSIONS: Medication errors are c o m m o n , a l t h o u g h
relatively few result in ADEs. However, t h o s e that do are preventable, m a n y through p h y s i c i a n c o m p u t e r order entry.
K E Y WORDS: m e d i c a t i o n error; adverse drug event; c o m puter order entry.
J GEN INTERN MED 1 9 9 5 ; 1 0 : 1 9 9 - - 2 0 5 .

Received from the Division of General Medicine, Departments


of Medicine and Pharmacy. Brigham and Women's Hospital
and Harvard Medical School, Boston. Massachusetts.
Supported in part by the Risk Management Foundation. Dr.
Bates is the recipient of National Resource Service Award I
F32 HS00040-01 from the Agency for Health Care Policy and
Research.
Address correspondence and reprint requests to Dr. Bates:
Division of General Medicine, Department of Medicine. Brigham
and Women's Hospital, 75 Francis Street. Boston, MA 02115.

n j u r i e s d u e to d r u g s were the m o s t f r e q u e n t c a u s e of
adverse events i n the Harvard Medical Practice Study,
in which a b o u t 1% of all hospitalized p a t i e n t s suffered
a disabling i n j u r y related to m e d i c a t i o n s . ~O t h e r s t u d i e s
have also suggested t h a t d r u g s are a major m e d i a t o r of
iatrogenic illness.2,
A d v e r s e drug e v e n t s (ADEs}, defined as i n j u r i e s res u l t i n g from medical i n t e r v e n t i o n s related to a drug, are
common. However, s p o n t a n e o u s reporting, the u s u a l
m e a n s of ADE i d e n t i f i c a t i o n , overlooks as m a n y as 9 5 99% of ADEs t h a t are detectable by other m e t h o d s . 4-6
In addition, m o s t ADEs are d o s e - d e p e n d e n t a n d potentially predictable; a smaller n u m b e r are u n p r e d i c t a b l e ,
idiosyncratic, or allergic r e a c t i o n s to drugs. 7-9 Almost
all errors r e s u l t i n g i n ADEs are associated w i t h the first
type of ADEs, w h i c h are p a r t i c u l a r l y i m p o r t a n t b e c a u s e
they may be preventable.
M e d i c a t i o n errors are errors i n the process of ordering or delivering a m e d i c a t i o n , regardless of w h e t h e r
a n i n j u r y o c c u r r e d or t h e p o t e n t i a l for i n j u r y w a s
present. Some m e d i c a t i o n errors result i n ADEs. Medication errors c a n o c c u r at a n y stage i n the d r u g ordering, d i s p e n s i n g , a n d a d m i n i s t r a t i o n process.
A n u m b e r of s t u d i e s have evaluated the f r e q u e n c y
of m e d i c a t i o n errors, m o s t of w h i c h do n o t r e s u l t in
ADEs. lo-13 Two recent s t u d i e s of error f r e q u e n c y identified the e r r a n t orders i n t e r c e p t e d by p h a r m a c i s t s i n
pediatric hospitals, I. 1~ a n d f o u n d a rate of 3 - 5 medication errors per 1,000 orders. However, these s t u d i e s
did not d e t e r m i n e the f r e q u e n c y of m e d i c a t i o n errors
that were u n k n o w n to p h a r m a c i s t s , the n u m b e r of ADEs
resulting from m e d i c a t i o n errors, or the a m o u n t of rework t h a t m e d i c a t i o n errors c a u s e for providers. O t h e r s
have developed c o m p r e h e n s i v e r e c o m m e n d a t i o n s for error prevention, i n c l u d i n g improved e d u c a t i o n in d r u g
p r o p e r t i e s a n d s t a n d a r d i z e d d r u g l a b e l i n g , 14-17 alt h o u g h these r e c o m m e n d a t i o n s have n o t b e e n prioritized.
Because p h y s i c i a n errors in w r i t i n g orders a c c o u n t
for m a n y m e d i c a t i o n errors, one major technologic intervention t h a t a p p e a r s to have s u b s t a n t i a l p o t e n t i a l for
r e d u c i n g the n u m b e r of m e d i c a t i o n errors is p h y s i c i a n
c o m p u t e r order entry, ~8. 19 in w h i c h p h y s i c i a n s write orders directly o n the c o m p u t e r . Orders can be s t r u c t u r e d ,
r e d u c i n g dose errors a n d legibility problems, a n d the
c o m p u t e r c a n c o n d u c t checks for the p r e s e n c e of s u c h
t h i n g s as d r u g allergies a n d d r u g - d r u g i n t e r a c t i o n s .
However, the p e r c e n t a g e of m e d i c a t i o n errors t h a t m a y
be preventable u s i n g s u c h a s y s t e m is u n k n o w n .
t99

200

Bates et al., Medication Errors a n d ADEs

To develop effective strategies for i m p r o v i n g the current d r u g o r d e r i n g a n d delivery system, the frequency
a n d types of m e d i c a t i o n errors a n d their r e l a t i o n s h i p s
with ADEs m u s t be b e t t e r defined. T h u s , we u n d e r t o o k
a s t u d y to: 1 ) evaluate the f r e q u e n c y of m e d i c a t i o n errors
u s i n g a c o m p r e h e n s i v e m u l t i d i s c i p l i n a r y a p p r o a c h ; 2)
classify m e d i c a t i o n errors a c c o r d i n g to type; 3] determ i n e how often m e d i c a t i o n errors are associated with
ADEs a n d p o t e n t i a l ADEs; 4) evaluate the c o n s e q u e n c e s
of m e d i c a t i o n errors i n t e r m s of rework for providers;
a n d 5) evaluate the p r o p o r t i o n of m e d i c a t i o n errors t h a t
may be preventable u s i n g p h y s i c i a n c o m p u t e r order entry.

METHODS
Patient Population
The p a t i e n t p o p u l a t i o n c o n s i s t e d of a cohort of all
adults a d m i t t e d to three m e d i c a l u n i t s at B r i g h a m a n d
Women's Hospital d u r i n g October a n d November 1992.
Two general medical u n i t s a n d one medical i n t e n s i v e
care u n i t (ICU) were s t u d i e d over a 51-day period. T h e s e
u n i t s were selected b e c a u s e we previously f o u n d i n another s t u d y a n d s e p a r a t e d a t a collection period t h a t
medical u n i t s h a d h i g h e r rates of ADEs t h a n did surgical
units, a n d ICUs h a d h i g h e r rates of ADEs t h a n did n o n ICUs. 7 I n t e r n s order m o s t of the m e d i c a t i o n s o n these
units. The u n i t of e v a l u a t i o n was the patient-day.

Definitions
M e d i c a t i o n errors were defined as errors o c c u r r i n g
at a n y stage i n the process of o r d e r i n g or delivering a
medication. They i n c l u d e d the e n t i r e r a n g e of severity,
from trivial errors, s u c h as orders t h a t n e c e s s i t a t e d clarification or m i s s i n g doses (defined as i n s t a n c e s i n w h i c h
a d r u g was n o t available i n the m e d i c a t i o n drawer w h e n
the n u r s e went to give it), to l i f e - t h r e a t e n i n g errors, s u c h
as a p a t i e n t ' s receiving t e n t i m e s the accepted dose of a
drug with a n a r r o w t o x i c - t h e r a p e u t i c ratio. R u l e violations were orders t h a t were faulty i n some way b u t h a d
little potential for h a r m or extra work b e c a u s e they were
interpreted by n u r s i n g a n d p h a r m a c y w i t h o u t clarification, p r e s u m a b l y correctly. A n example is a n order
s u c h as "MgS04 1 a m p IV now," b e c a u s e a m p u l e s come
in several s t r e n g t h s b u t o n e s t r e n g t h is s t a n d a r d .
A d v e r s e d r u g e v e n t s ( A D E s ) were defined as i n j u r i e s
r e s u l t i n g from medical i n t e r v e n t i o n s related to a drug.
Adverse d r u g events m a y r e s u l t from m e d i c a t i o n errors
or from adverse d r u g r e a c t i o n s i n w h i c h there was n o
error. For example, s e d a t i o n from a n overdose of a b e n zoidazapine a n d a r a s h c a u s e d by a n allergic r e s p o n s e
to penicillin are b o t h ADEs. M e d i c a t i o n errors with potential for i n j u r y b u t i n w h i c h n o i n j u r y occurred were
classified as p o t e n t i a l A D E s . A n example is a n order for
penicillin for a p a t i e n t w i t h a k n o w n allergy to the d r u g
in which the order was i n t e r c e p t e d or the p a t i e n t re-

JGIM

ceived the d r u g a n d experienced n o allergic r e a c t i o n (Fig.


1). I n c i d e n t s were defined as o c c u r r e n c e s t h a t the s t u d y
n u r s e t h o u g h t m i g h t r e p r e s e n t a n ADE or a p o t e n t i a l
ADE, w h e t h e r or n o t t h e r e w a s a n error.

Case Finding
All new orders were evaluated to d e t e r m i n e w h e t h e r
they represented p o t e n t i a l m e d i c a t i o n errors. Renewal
orders were c o u n t e d b u t were excluded from the analyses, b e c a u s e we felt they would less often be associated
with m e d i c a t i o n errors. P o t e n t i a l m e d i c a t i o n errors were
detected in three ways: first, p h a r m a c i s t s reported a n y
prescribing errors identified d u r i n g the d i s p e n s i n g process; second, the s t u d y n u r s e reviewed all c h a r t s for
evidence of m e d i c a t i o n errors: a n d third, a t r a i n e d reviewer evaluated all m e d i c a t i o n s h e e t s received by the
pharmacy. The c h a r t review i n c l u d e d a careful daily
reading of the progress n o t e s i n each chart, followed by
a more detailed i n v e s t i g a t i o n if the n u r s e identified indications of a possible m e d i c a t i o n error (e.g., m a j o r
bleeding, new c o n f u s i o n , u n a n t i c i p a t e d ICU transfer,
use of a n a n t i d o t e s u c h as naloxone, or p r e s c r i p t i o n of
certain m e d i c a t i o n s s u c h as d i p h e n h y d r a m i n e ) . The
trained reviewer looked for orders t h a t n e c e s s i t a t e d clarification or change, w h i c h was also often n o t e d by the
p h a r m a c i s t s on m e d i c a t i o n sheets.
I n c i d e n t s t h a t were t h o u g h t to r e p r e s e n t ADEs or
potential ADEs were identified i n a s i m i l a r fashion, b u t
in addition reports of i n c i d e n t s were solicited from n u r s e s
t h r o u g h daily visits to the u n i t s b y the s t u d y n u r s e , a n d
by daily electronic-mail n o t e s to n u r s e s o n the u n i t s .
Providers reporting i n c i d e n t s were a s s u r e d a n o n y m i t y .
Clinical data collected from the medical record for
all p a t i e n t s involved i n a n ADE or a p o t e n t i a l ADE included the date a n d time of the i n c i d e n t , the n a m e a n d
dose of the d r u g involved, c o m p l i c a t i o n s , a n d the source
of identification of the i n c i d e n t . For m e d i c a t i o n errors
we d e t e r m i n e d w h e t h e r c o n t a c t b e t w e e n the provider
a n d the staff h a d b e e n n e c e s s a r y for t h e p r o b l e m ' s resolution; for example, w h e t h e r the p h a r m a c i s t h a d called
the p h y s i c i a n to clarify a n order. F r o m this, we e s t i m a t e d
the a m o u n t of rework (defined as a d d i t i o n a l work c a u s e d
by system m a l f u n c t i o n s ) required.

Review Process
All potential m e d i c a t i o n errors were evaluated by a
physician reviewer, who classified t h e m as m e d i c a t i o n
error, rule violation, or n o error. A 10% s a m p l e was rereviewed by a second p h y s i c i a n to d e t e r m i n e reliability.
Medication errors were classified b y type: dose error
(overdose, u n d e r d o s e , m i s s i n g dose, w r o n g dose form,
dose omitted), route error (incorrect route, w r o n g route,
route omitted), frequency error (incorrect frequency, freq u e n c y omitted), s u b s t i t u t i o n error (wrong d r u g given,
wrong p a t i e n t received drug), d r u g - d r u g i n t e r a c t i o n ,

JGIM

20t

V o l u m e 10. April 1995

inappropriate drug, illegible order, k n o w n allergy to drug,


n o n f o r m u l a r y drug, avoidable delay i n t r e a t m e n t , a n d
preparation error.
I n c i d e n t s (suspected ADEs or p o t e n t i a l ADEs) were
evaluated i n d e p e n d e n t l y by two reviewers, a n d classified
into one of four categories: ADEs: p o t e n t i a l ADEs; medication errors, w h e n a n error was p r e s e n t b u t there was
no i n j u r y or p o t e n t i a l for injury; a n d exclusions, w h e n
no error was m a d e a n d the i n j u r y was m i n o r . W h e n the
reviewers disagreed a b o u t the classification, they m e t
a n d came to a c o n s e n s u s . P r e c o n s e n s u s reliability for
j u d g m e n t s for presence of a n AIDE or a p o t e n t i a l ADE
made u s i n g this methodology was previously f o u n d to
be good, 7 with k a p p a scores of a p p r o x i m a t e l y 0.8.
The ADEs a n d p o t e n t i a l ADEs were t h e n classified
according to severity a n d preventability, as previously
reportedY Severity was classified as l i f e - t h r e a t e n i n g , serious, or significant. 1o Preventability was classified using a four-point scale a d a p t e d from D u b o i s a n d Brook. 2
For p u r p o s e s of analysis, this f o u r - p o i n t scale was collapsed into two categories: p r e v e n t a b l e a n d n o t preventable. We previously f o u n d 7 t h a t k a p p a s for j u d g m e n t s o fADEs regarding preventability a n d severity u s i n g
these scales were 0 . 6 3 - 0 . 8 9 . Medication errors were also
evaluated as to the likelihood t h a t they would be preventable, u s i n g a c o m p u t e r i z e d p h y s i c i a n order e n t r y
system. Service r e s p o n s i b l e for the i n c i d e n t was also
identified; categories were p h y s i c i a n s , n u r s i n g , p h a r macy, secretary, other, multifactorial, a n d n o n e .
Statistical Methods
Univariate a n a l y s e s were carried o u t u s i n g the chis q u a r e test for categorical variables. I n t e r r a t e r reliabilities for w h e t h e r a n ADE was p r e s e n t a n d for j u d g m e n t s
of preventability a n d severity were calculated u s i n g the
kappa statistic. 2~ D e t e r m i n a t i o n of i n t e r r a t e r reliability
for w h e t h e r a m e d i c a t i o n error, rule violation, or n e i t h e r
was p r e s e n t was m a d e u s i n g a three-way k a p p a statistic. 22 The SAS statistical package was u s e d to c o n d u c t
the analyses. 2~
RESULTS
The 51-day s t u d y period i n c l u d e d 379 a d m i s s i o n s
a n d 1,704 patient-days, d u r i n g w h i c h 10,070 medication orders were w r i t t e n o n the three medical u n i t s . In
addition, 1,532 renewal orders were w r i t t e n . T h e 10,070
orders i n c l u d e d 3,913 o r d e r i n g sets (a set is a g r o u p of

FIGURE t. The relationships between medication errors, adverse


drug events [ADEs], and potential ADEs. Only a small proportion
of medication errors represent an ADE or a potential ADE, and
while all potential ADEs are medication errors, only the minority
of ADEs are associated with a medication error.

medication orders w r i t t e n at one time). A m o n g these


10,070 orders, there were a total of 530 m e d i c a t i o n errors (5.3%), or 1.4 m e d i c a t i o n errors per a d m i s s i o n (Table
I). In addition, 128 of the 10,070 orders were j u d g e d to
be rule violations (0.08 rule v i o l a t i o n s per patient-day}.
The k a p p a b e t w e e n reviewers was 0.68 for the j u d g m e n t
of w h e t h e r a n order r e p r e s e n t e d a m e d i c a t i o n error, a
rule violation, or n e i t h e r of the above.
Medication order error rates were c o m p a r e d b y u n i t
(Table 2). Many more orders were w r i t t e n i n the ICU
(12.6 o r d e r s / p a t i e n t day) t h a n o n the two medical u n i t s
(3.8 a n d 3.9 orders/patient-day), b u t the error rates were
similar (4.5, 6.0, a n d 6.0 errors/100 orders) across the
units. However, s e r i o u s errors were 4.5 t i m e s more freq u e n t i n the first medical u n i t (0.9 s e r i o u s errors/100
orders) t h a n i n the other medical u n i t a n d the ICU (0.2
serious errors/100 orders each) (p < 0.001). T h e r e a s o n
for this difference is u n c l e a r , as the two medical u n i t s
share staffing.
Classification of m e d i c a t i o n errors showed t h a t 53%
(280) r e p r e s e n t e d m i s s i n g doses, a n d 47% (250) were
n o n - m i s s i n g dose errors. While m i s s i n g dose errors are
relatively m i n o r from the clinical perspective, they c a n
result i n s i g n i f i c a n t delays i n giving m e d i c a t i o n s to patients. C o n t a c t b e t w e e n p h a r m a c y a n d n u r s i n g p e r s o n nel was r e q u i r e d for all 280 of these errors.

Table I
Medication Order and Error Rates

Medication orders
Medication errors
Adverse drug events

n~lO0
Orders

n/l,000
Patient-days

n/Admission

I 0,070
530
25

5.3
0.25

5,910
311
14.7

26.6
1.4
0.07

202

Bates

et al., Medication

JGIM

Errors and AIDEs

Table 2
Medication Order and Error Rates by Unit

General unit 1
General unit 2
intensive care unit

Orders

Patientdays

Orders/
Patient-day

Errors/100
Orders

Serious Errors*/
100 Orders

2,498
2,496
5,076

648
653
403

3.9
3.8
12.6

6
6
4.5

0.9
0.2
0.2

*Serious errors are d e f i n e d a s t h o s e a s s o c i a t e d w i t h a d v e r s e drug e v e n t s (ADEs) a n d potential A D E s .

A m o n g t h e n o n - m i s s i n g dose e r r o r s (Table 3), dose


errors, f r e q u e n c y errors, a n d r o u t e e r r o r s were t h e m o s t
c o m m o n . However, less f r e q u e n t types of e r r o r s were
sometimes serious, for example, the 11 i n s t a n c e s in w h i c h
a m e d i c a t i o n w a s o r d e r e d for a p a t i e n t w i t h a k n o w n
allergy. P h y s i c i a n s were j u d g e d r e s p o n s i b l e for 81% of
these errors; c o m p u t e r i z e d o r d e r e n t r y could have a significant effect on r e d u c t i o n of t h e s e errors, a n d indeed,
84% of all n o n - m i s s i n g dose e r r o r s were j u d g e d preventable by c o m p u t e r i z e d o r d e r entry. Provider c o n t a c t
was r e q u i r e d for r e s o l u t i o n of t h e e r r o r in 83%.
For b o t h m i s s i n g d o s e e r r o r s a n d t h e r e m a i n d e r of
m e d i c a t i o n errors, a n t i b i o t i c s were t h e d r u g class m o s t
often involved. A n t i b i o t i c s were a s s o c i a t e d w i t h 19% of
n o n - m i s s i n g dose m e d i c a t i o n errors, followed by electrolyte c o n c e n t r a t e s (10%), c a r d i o v a s c u l a r d r u g s (8%l,
and analgesics (7%).
In all, 82% of m e d i c a t i o n e r r o r s were i d e n t i f i e d
t h r o u g h review of m e d i c a t i o n s h e e t s ; p h a r m a c y self-report yielded 9%, a n d n u r s e self-report a n d c h a r t review
yielded the r e m a i n i n g 9%. M i s s i n g dose e r r o r s were
identified a l m o s t exclusively t h r o u g h review of m e d i c a tion sheets. Even w h e n t h e s e e r r o r s were e x c l u d e d from
the analysis, review of m e d i c a t i o n s h e e t s r e m a i n e d t h e
m o s t p r o d u c t i v e s o u r c e , a n u n e x p e c t e d finding.

ADEs and Medication Errors


D u r i n g the s a m e t i m e period, 25 ADEs were identified, five of w h i c h were a s s o c i a t e d w i t h m e d i c a t i o n errors a n d were j u d g e d p r e v e n t a b l e (Table 4). Therefore,
five of 530 m e d i c a t i o n e r r o r s (0.9%) r e s u l t e d in a n ADE;
an a d d i t i o n a l 35 m e d i c a t i o n e r r o r s (6.7%) w e r e j u d g e d
to be p o t e n t i a l ADEs. No m i s s i n g dose e r r o r w a s associated w i t h a n ADE or a p o t e n t i a l ADE.
Severity of t h e p o t e n t i a l A D E s a n d ADEs w a s also
assessed (Table 4); no p a t i e n t died of a n ADE. T h e five
preventable ADEs i n c l u d e d a h y p o t e n s i v e episode, hemoptysis, g a s t r o i n t e n t i n a l b l e e d i n g , a local toxic reaction, a n d a n a s p i r a t i o n p n e u m o n i a . E r r o r s a s s o c i a t e d
with the five p r e v e n t a b l e A D E s i n c l u d e d a dose error, a
frequency error, a n i n s t a n c e in w h i c h follow-up of therapy was i n a d e q u a t e , a d r u g - d r u g i n t e r a c t i o n , a n d a
t r a n s c r i p t i o n error. P h y s i c i a n s were j u d g e d r e s p o n s i b l e
for three a n d n u r s e s for two.
Most of the p o t e n t i a l A D E s (27 of 35, 77%) were
errors t h a t were i n t e r c e p t e d before t h e m e d i c a t i o n w a s

a d m i n i s t e r e d (Table 3). In t h e r e m a i n i n g e i g h t a n adverse o u t c o m e was a v o i d e d only by c h a n c e . T h e s e e i g h t


potential ADEs i n c l u d e d t h r e e dose errors, a f r e q u e n c y
error, an i n s t a n c e in w h i c h a p a t i e n t received a d r u g
ordered for a n o t h e r p a t i e n t , a n i n a d v e r t e n t d i s c o n t i n u a t i o n of a drug, a n a v o i d a b l e delay in t r e a t m e n t , a n d
a case in w h i c h a d r u g w a s n o t given w h e n n e e d e d . Of
the 27 potential ADEs t h a t were i n t e r c e p t e d before t h e
m e d i c a t i o n r e a c h e d t h e p a t i e n t , 11 (41%) were t h e r e s u l t
of an order for a d r u g to w h i c h t h e p a t i e n t h a d a k n o w n
allergy. Physicians were j u d g e d r e s p o n s i b l e for 93% of
the i n t e r c e p t e d p o t e n t i a l ADEs, a n d verbal o r d e r s acc o u n t e d for 19%.
C o m p u t e r o r d e r e n t r y w a s j u d g e d to have the potential to p r e v e n t t h r e e p r e v e n t a b l e ADEs (60%), five
{62 %) of the n o n i n t e r c e p t e d p o t e n t i a l ADEs, a n d 25 (93 %)
of the i n t e r c e p t e d p o t e n t i a l ADEs.

DISCUSSION
We f o u n d t h a t m e d i c a t i o n e r r o r s w e r e m o r e c o m m o n
t h a n h a s been s u g g e s t e d by o t h e r reports, t h a t relatively
few resulted in a d v e r s e events, a n d t h a t they c r e a t e d a
s u b s t a n t i a l b u r d e n of p r o v i d e r rework. Most m e d i c a t i o n
errors a p p e a r e d potentially p r e v e n t a b l e by t h e u s e of
physician c o m p u t e r o r d e r entry.
The rate of m e d i c a t i o n e r r o r s t h a t we found, 53 per
1,000 orders, is s u b s t a n t i a l l y h i g h e r t h a n h a s b e e n previously reported.~-~3 24-31 Clearly, t h e r a t e of d e t e c t i o n
d e p e n d s on the i n t e n s i t y of surveillance. To m a x i m i z e
our ability to find errors, we u s e d a c o m p r e h e n s i v e approach to case detection: a c o m b i n a t i o n of p h a r m a c i s t s "
review of p r e s c r i p t i o n s , p a t i e n t h o s p i t a l r e c o r d review,
solicitation of r e p o r t s by n u r s e s , a n d d e t a i l e d review of
all medication sheets. Using m o r e limited m e t h o d s , lower
rates will be found. For example, two of t h e l a r g e s t s t u d ies of m e d i c a t i o n e r r o r s i d e n t i f i e d only t h r e e to five
errors per 1,000 orders, b u t t h e s e were r e s t r i c t e d to
o r d e r i n g errors identified a n d p r e v e n t e d by p h a r m a cists, ~o., ~ while we identified e r r o r s w h e t h e r or n o t t h e y
were prevented, a n d also d u r i n g t h e a d m i n i s t r a t i o n a n d
d i s p e n s i n g processes. O t h e r s h a v e f o u n d t h a t w h e n
p h a r m a c y error d e t e c t i o n w a s c o m b i n e d w i t h a review
of all p r e s c r i p t i o n s , 32 m e d i c a t i o n e r r o r s p e r 1,000 orders were found. 24
While the e x h a u s t i v e a p p r o a c h we u s e d w o u l d be

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203

Volume 10. April 1995

prohibitively expensive for a large-scale study or for ongoing quality measurement, this limited study provides
a n e s t i m a t e of t h e u p p e r b o u n d o f e r r o r i n t h e m e d i cation ordering, dispensing, and administration proc e s s e s . T h e r a t e of s e v e n A D E s p e r I 0 0 a d m i s s i o n s t h a t

after missing doses, dose errors were the most frequent


type of e r r o r . I n t e r e s t i n g l y , a s m a l l g r o u p of m e d i c a t i o n
errors caused a large proportion of ADEs and potential
ADEs. F o r e x a m p l e , o r d e r s for a d r u g t o w h i c h t h e p a tient had a known allergy accounted for only 2% of the
m e d i c a t i o n e r r o r s i n t h i s s t u d y , b u t 3 1 % of t h e p o t e n t i a l
ADEs. T h i s s u g g e s t s t h a t i m p r o v e m e n t s i n o r d e r i n g systems should target both high-frequency errors (such as

we d e t e c t e d d u r i n g t h i s s t u d y p e r i o d w a s s i m i l a r t o t h a t
in a previous study we conducted, 7 and to findings in a
much larger study we have recently completed on the
i n c i d e n c e a n d c a u s e s of A D E s ( u n p u b l i s h e d d a t a , 1 9 9 4 )
s o it is likely t h a t t h e r e l a t i o n s h i p o f m e d i c a t i o n e r r o r s
to i n j u r i e s h e r e d e s c r i b e d ( 1 0 0 : 1 ) i s r e p r e s e n t a t i v e .
In c l a s s i f y i n g m e d i c a t i o n e r r o r s , m a n y s t u d i e s h a v e
found that dose errors (underdose, overdose, and wrong
d o s e ) a r e t h e m o s t f r e q u e n t type. t. ~. ~3.26, 31, 32 H o w -

dose errors) and infrequent serious errors. For example,


a u t o m a t e d a l l e r g y c h e c k i n g a t t h e t i m e a n o r d e r is p l a c e d
could substantially reduce the frequency of ADEs due to
a k n o w n allergy.

ever, n o n e o f t h e s e s t u d i e s m a d e a c o n c e r t e d s e a r c h f o r
m i s s i n g d o s e s , w h i c h w e f o u n d to b e b y f a r t h e m o s t
c o m m o n t y p e of m e d i c a t i o n e r r o r . W e a l s o f o u n d t h a t

e s t i m a t e s is v e r y w i d e ; p r o p o r t i o n s f r o m 0 to 5 8 % h a v e
been reported. Moreover, these numbers are only estimates, not actual measurements. One four-year survey

Several studies have assessed the potential of medi c a t i o n e r r o r s to c a u s e A D E s , to. ~. ~a. az b u t t h e r a n g e o f

Table 3
Classification of M e d i c a t i o n Errors Other Than Missing Doses
Total M e d i c a t i o n
Errors*
(n = 250]
Error type
Dose errors
Frequency errors
Route errors
Illegible order
Known allergy to d r u g
Wrong d r u g or p a t i e n t
Other

77
43
26
16
lI
11
66

(31%)
(17%)
(I0%)
(6%)
(4%)
(4%)
(26%)

Preventable ADEst
(n = 5)
i
I

Potential ADEs:
Not Intercepted
(n = 8]

Potential ADEs:
Intercepted
(n = 27]

{20%)
(20%)
0
0
0
0
3 t60%)

3
l

(38%)
{12%)
0
0
0
I (12%)
3 (38%)

I0 (37%)
2 (7%)
3 (I I%)
0
I I (41%)
2 (7%)
0

Service responsible
Physicians
Nursing
Pharmacy
Other

203 (81%)
34 (14%)
7 (3%)
6 (2%)

3
2

(60%)
(40%}
0
0

2
6

(25%)
(75%)
0
0

25 (93%)
l (4%}
0
0

Preventable by order entry


Yes
No

209 (84%)
41 (16%)

3
2

(60%)
(40%)

5
3

(62%)
(38%)

25 193%)
2 (7%)

Order type
Verbal
Written
Unclear

41 (16%)
200 (80%)
9 (4%)

0
5(I00%)
0

7
I

0
(88%)
(12%)

5 (19%)
21 (78%)
I (4%)

*Includes m e d i c a t i o n errors t h a t w e r e A D E s or p o t e n t i a l ADEs, so t h e categories a r e not m u t u a l l y e x c l u s i v e .


'ADEs = a d v e r s e drug e v e n t s .
*Errors were: i n a d e q u a t e f o l l o w u p , d r u g - d r u g interaction, a n d a transcription error l e a d i n g to a f a i l u r e to a d m i n i s t e r t h e drug.
*Errors were: a v o i d a b l e d e l a y in t r e a t m e n t , i n a d v e r t e n t d i s c o n t i n u a t i o n o f a drug. a n d a d r u g not g i v e n w h e n n e e d e d .

Table 4
Preventability of Adverse Drug Events (ADEs] a n d Potential ADEs

Life-threatening
Serious
Significant

ADEs:
Not Preventable
(n = 20]

ADEs:
Preventable
(n = 5)

Potential ADEs:
Not Intercepted
(n = 8]

Potential ADEs:
Intercepted
[n = 27)

0
3 (15%)
17 {85%)

I (20%)
4 (80%)
0

I (12%)
5 (63%)
2 (25%)

3 (I 1%)
I2 (44%)
12 (44%)

204

JGIM

B a t e s e t al., M e d i c a t i o n Errors a n d A D E s

of d i s p e n s i n g a n d a d m i n i s t r a t i o n m e d i a t i o n errors f o u n d
that 0.21% of these errors c a u s e d a n ADE, 25 a l t h o u g h
medication errors d u e to p h y s i c i a n orders were excluded, a n d the m e d i c a t i o n h a d to reach the p a t i e n t to
be considered a n error. We f o u n d t h a t a p p r o x i m a t e l y 1%
of m e d i c a t i o n errors actually c a u s e d a n ADE (2 % if missing doses were excluded), a n d a n a d d i t i o n a l 7% represented p o t e n t i a l ADEs.
While the d e s i g n of the s t u d y did n o t p e r m i t u s to
m e a s u r e the h o u r s of rework c a u s e d by m e d i c a t i o n errors, they are clearly s u b s t a n t i a l . Ninety-two p e r c e n t of
the errors (all of the m i s s i n g doses a n d 83% of the remainder) n e c e s s i t a t e d at least a telephone call b e t w e e n
n u r s e a n d p h a r m a c i s t , n u r s e a n d p h y s i c i a n , or p h a r macist a n d p h y s i c i a n . In p r e v i o u s s t u d i e s i n this hospital we f o u n d t h a t the r e s o l u t i o n of a m i s s i n g dose
requires a n average of 8 m i n u t e s of c o m b i n e d n u r s i n g
a n d p h a r m a c y times. P u b l i s h e d reports of m i s s i n g doses
also provide a n e c d o t a l evidence t h a t m i s s i n g doses are
a major source of rework.aa-a6 T r a c k i n g d o w n p h y s i c i a n s
to correct a n order is even more t i m e - c o n s u m i n g . If the
overall average rework time is 8 m i n u t e s per error, the
total a m o u n t of t i m e w a s t e d as a result of the 530 medication errors we f o u n d w o u l d be 71 h o u r s , a n average
of a b o u t a h a l f - h o u r per u n i t each day. T i e r n e y et al.
found that the n u m b e r of t i m e s a p h a r m a c i s t called a
physician to clarify a n order was r e d u c e d by a b o u t o n e
third with p h y s i c i a n order e n t r y (Tierney W, c o m m u nication, 1994). M e d i c a t i o n errors a n d ADEs have s u b stantial costs b e y o n d those a s s o c i a t e d with rework, inc l u d i n g i n c r e a s e d l e n g t h of stay, i n j u r y to p a t i e n t s , a n d
malpractice costs. A r e c e n t e s t i m a t e of the cost to the
hospital of a n ADE w a s $ 2 , 0 0 0 . 37

Implications for Prevention


The A m e r i c a n Society of Hospital P h a r m a c i s t s h a s
recently created a set of c o m p r e h e n s i v e g u i d e l i n e s for
medication error p r e v e n t i o n , i n c l u d i n g advice for prescribers, p h a r m a c i s t s , n u r s e s , p a t i e n t s , a d m i n i s t r a tors, a n d d r u g m a n u f a c t u r e r s J 4 a n d o t h e r s have m a d e
r e c o m m e n t a t i o n s for m e d i c a t i o n error p r e v e n t i o n as
well. m. m-~7, 30. 31 However, these r e c o m m e n d a t i o n s are
so encyclopedic t h a t it w o u l d be i m p o s s i b l e to i m p l e m e n t
all of them. T h i s s t u d y h a s identified those areas m o s t
in need of a t t e n t i o n b y i d e n t i f y i n g the m o s t c o m m o n
types of m e d i c a t i o n errors a n d those a s s o c i a t e d with
ADEs.
Fortunately, relatively few m e d i c a t i o n errors have
the potential to r e s u l t i n ADEs, a n d the c u r r e n t safety
net for p r e v e n t i n g ADEs c a t c h e s m o s t s e r i o u s errors.
Most potential ADEs are p r e v e n t e d before the p a t i e n t
receives the drug. However, t h i s is a n a r e n a i n w h i c h
health care should, i n o u r view, strive for a zero defect
rate. One p e r c e n t of m e d i c a t i o n errors' r e s u l t i n g i n ADEs
is too m a n y .
P h y s i c i a n c o m p u t e r order e n t r y r e p r e s e n t s a m a j o r

system c h a n g e with great p o t e n t i a l for r e d u c i n g serious m e d i c a t i o n errors. In p h y s i c i a n order entry, physicians write orders u s i n g the c o m p u t e r , w h i c h p e r m i t s
i n t e r v e n t i o n at the time orders are written. Several s t u d ies have described the i m p l e m e n t a t i o n of order entry.iS. 19. 38--44 T a r g e t i n g the p h y s i c i a n t h r o u g h comp u t e r order e n t r y s h o u l d be h i g h l y effective i n r e d u c i n g
errors, since in the p r e s e n t s t u d y p h y s i c i a n s were responsible for 81% of the m e d i c a t i o n e r r o r s o t h e r t h a n
m i s s i n g doses. It is expected t h a t order e n t r y will decrease m e d i c a t i o n errors i n several ways. D r u g orders
will require a d r u g n a m e , dose, route, a n d frequency,
which will e l i m i n a t e errors of o m i s s i o n . All orders will
be legible, a n d t r a n s c r i p t i o n errors will be e l i m i n a t e d .
C o m p u t e r i z e d dose c h e c k i n g a n d g u i d e d - d o s e algor i t h m s s h o u l d decrease the o c c u r r e n c e of orders with
incorrect dosages. C o m p u t e r s c a n also store relevant information r e g a r d i n g d r u g - d r u g i n t e r a c t i o n s , k n o w n allergies, a n d a p p r o p r i a t e dosage s c h e d u l e s a c c o r d i n g to
the p a t i e n t s ' s characteristics. 4. 42 44
This s t u d y h a s several l i m i t a t i o n s . We s t u d i e d three
medical u n i t s i n one t e a c h i n g hospital, so o u r r e s u l t s
may not be generalizable to o t h e r settings. Also, despite
a "broad net," some m e d i c a t i o n errors a l m o s t certainly
escaped our detection. For example, o u r m e t h o d did n o t
detect cases i n w h i c h the choice of the d r u g was inappropriate given the p a t i e n t ' s c h a r a c t e r i s t i c s , a n d we u n doubtedly m i s s e d some errors i n a d m i n i s t r a t i o n , because these errors occur at the last step in the medication
delivery process a n d are the h a r d e s t to detect. A n o t h e r
potential b i a s t h a t m i g h t decrease the ADE a n d medication error rates is a H a w t h o r n e effect related to the
fact that n u r s e s a n d p h a r m a c i s t s o n the s t u d y u n i t s
were involved i n the study. Finally, o u r classification of
ADEs by severity a n d p r e v e n t a b i l i t y is a n implicit measure. However, the i n t e r r a t e r a g r e e m e n t was good, a n d
the reliability of this m e t h o d h a s b e e n confirmed by other
studies. 7
We conclude t h a t m e d i c a t i o n errors are c o m m o n ,
a n d that most s e r i o u s errors r e s u l t from errors i n prescribing by p h y s i c i a n s . However, relatively few medication errors r e s u l t s i n ADEs, e i t h e r b e c a u s e they have
little potential for i n j u r y or b e c a u s e they are i n t e r c e p t e d
by p h a r m a c i s t s a n d n u r s e s . Nonetheless, 1.4% of the
p a t i e n t s a d m i t t e d d u r i n g the s t u d y suffered a potentially
preventable ADE. Of these p r e v e n t a b l e ADEs, more t h a n
half could have b e e n p r e v e n t e d by c o m p u t e r order entry.
Medication errors have o t h e r costs t h a t m a y be s u b stantial, i n c l u d i n g m a l p r a c t i c e costs, rework for providers, a n d waste for hospitals.

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