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
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
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
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
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
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
JGIM
203
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
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 -
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
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
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%)
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
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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