ORIGINAL INVESTIGATION

Effect of an Electronic Medication Reconciliation

Application and Process Redesign on Potential
Adverse Drug Events
A Cluster-Randomized Trial
Jeffrey L. Schnipper, MD, MPH; Claus Hamann, MD, MS; Chima D. Ndumele, MPH;
Catherine L. Liang, MPH; Marcy G. Carty, MD, MPH; Andrew S. Karson, MD, MPH;
Ishir Bhan, MD; Christopher M. Coley, MD; Eric Poon, MD, MPH; Alexander Turchin, MD, MS;
Stephanie A. Labonville, PharmD, BCPS; Ellen K. Diedrichsen, PharmD; Stuart Lipsitz, ScD;
Carol A. Broverman, PhD; Patricia McCarthy, PA, MHA; Tejal K. Gandhi, MD, MPH

Background: Medication reconciliation at transitions
in care is a national patient safety goal, but its effects on
important patient outcomes require further evaluation.
We sought to measure the impact of an information tech-
nology–based medication reconciliation intervention on
medication discrepancies with potential for harm (po-
tential adverse drug events [PADEs]).
Methods: We performed a controlled trial, random-
ized by medical team, on general medical inpatient units
at 2 academic hospitals from May to June 2006. We en-
rolled 322 patients admitted to 14 medical teams, for
whom a medication history could be obtained before dis-
charge. The intervention was a computerized medica-
tion reconciliation tool and process redesign involving
physicians, nurses, and pharmacists. The main out-
come was unintentional discrepancies between pread-
mission medications and admission or discharge medi-
cations that had potential for harm (PADEs).
Results: Among 160 control patients, there were 230
PADEs (1.44 per patient), while among 162 interven-
tion patients there were 170 PADEs (1.05 per patient)
(adjusted relative risk [ARR], 0.72; 95% confidence in-
terval [CI], 0.52-0.99). A significant benefit was found
at hospital 1 (ARR, 0.60; 95% CI, 0.38-0.97) but not at
hospital 2 (ARR, 0.87; 95% CI, 0.57-1.32) (P=.32 for test
of effect modification). Hospitals differed in the extent
of integration of the medication reconciliation tool into
computerized provider order entry applications at
discharge.
Conclusions: A computerized medication reconcilia-
tion tool and process redesign were associated with a de-
crease in unintentional medication discrepancies with po-
tential for patient harm. Software integration issues are
likely important for successful implementation of com-
puterized medication reconciliation tools.
Trial Registration: clinicaltrials.gov Identifier:
NCT00296426
Arch Intern Med. 2009;169(8):771-780

Author Affiliations are listed at
the end of this article.
E
FFORTS TO IMPROVE THE
quality and safety of health
care include attention to un-
intentional medication dis-
crepancies, defined as un-
explained differences among documented
regimens across different sites of care (eg,
prior to admission compared with hospi-
tal admitting orders).1,2 Discrepancies are
highly prevalent; up to 67% of inpatients
have at least 1 unexplained discrepancy in
their prescription medication history at
admission.3
Because medication discrepancies are
an important contributor to adverse drug
events (ADEs) among hospitalized and re-
cently discharged patients,4-6 The Joint
Commission on Accreditation of Health-
care Organizations designated medica-
tion reconciliation as a “National Patient
Safety Goal” in 2005.7 Medication recon-
ciliation is “a process of identifying the
most accurate list of all medications a pa-
tient is taking . . . and using this list to pro-
vide correct medications for patients any-
where within the health care system.”8
Hospitals have undertaken diverse ap-
proaches to comply with The Joint Com-
mission’s mandate. Some studies support
medication reconciliation as a means to re-
duce medication discrepancies or ADEs9-15;
most are either pre-post studies or uncon-
trolled evaluations of the types of errors
intercepted by the process. Few rigorous
studies demonstrate that medication rec-
onciliation efforts improve important pa-

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 Hospital stage Nurse Physician Pharmacist

Confirms accuracy of PAML Takes medication history: collects

during admission assessment, sources of preadmission medication
identifies discrepancies, notifies data, interviews patient/family,
admitting physician creates and documents PAML

Chooses and documents planned

action on admission for each
Reviews PAML, planned actions on
medication in PAML
Admission admission, and admission orders,
confirms reconciliation, identifies
important discrepancies, notifies
admitting physician
Writes admission orders

Resolves discrepancies with nurse

and pharmacist, updates PAML and
inpatient orders as necessary

Gathers additional sources of
PAML information, helps resolve
uncertainties or discrepancies in
PAML, notifies responsible physician
During
hospitalization
Gathers additional sources of PAML Gathers additional sources of
information, resolves uncertainties PAML information, helps resolve
or discrepancies in PAML with help uncertainties or discrepancies in
of nurse and/or pharmacist PAML, notifies responsible physician

Updates PAML and inpatient orders

as necessary

Reviews PAML, current medications, Reviews PAML and current

and discharge orders, confirms medications, creates discharge
reconciliation orders, documents reconciliation

Discharge Reviews discharge medications

with patient/caregiver Resolves any remaining discrepancies
with nurse, updates discharge orders
as necessary, documents discharge
medications and changes from prior
Identifies discrepancies, notifies to admission
discharging physician

Figure 1. Redesigned medication reconciliation workflow. Adapted from Poon et al17 with permission. PAML indicates preadmission medication list.

tient outcomes or define the best ways to implement these
processes or identify the patients most likely to benefit.
We sought to determine the effects of a redesigned pro-
cess for medication reconciliation, supported by infor-
mation technology (IT), on potential ADEs (PADEs). We
hypothesized that our intervention would decrease PADEs
in all patients and that patients at high risk for medica-
tion discrepancies would benefit most.
METHODS
STUDY DESIGN, SETTING, AND PARTICIPANTS
The Partners Medication Reconciliation Study was a cluster-
randomized controlled trial conducted from May 1 through June
20, 2006, at 2 large academic hospitals in Boston, Massachu-
setts. The design of this study has been described.16 Eligible pa-
tients were admitted to one of several general medicine teams
and floors of each hospital, according to a rotating call cycle.
Each team (6 at hospital 1 and 8 at hospital 2) consisted of 1
attending physician, 1 junior or senior resident, 2 to 4 interns,
and 1 or 2 medical students. Patients were enrolled if study phar-
macists (generally 1 pharmacist per weekday per hospital) had
time to obtain a medication history prior to discharge. Pa-
tients admitted to 1 of 7 randomly chosen medical teams and
floors were assigned to the intervention, while patients admit-
ted to the other teams and on different floors received usual
care. Thus, patients in the 2 arms were cared for by different
physicians and nurses. Randomization was stratified by
study hospital and assigned by the principal investigator
( J.L.S.) using random number generation in Microsoft Excel
(Microsoft Corp, Redmond, Washington). Patients dis-
charged from a nonstudy team or floor, patients transferred
between a control team or floor and an intervention team or
floor, and patients discharged after June 20, 2006, were
excluded. The study was approved by the institutional
review board of Partners HealthCare, Boston; patient con-
sent was deemed unnecessary.
INTERVENTION
The intervention consisted of an IT application designed to fa-
cilitate medication reconciliation, integrated into the inter-

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 nally developed computerized provider order entry (CPOE) sys-
tems at the 2 hospitals, and process redesign involving
physicians, nurses, and pharmacists.
IT APPLICATION: THE PREADMISSION
MEDICATION LIST BUILDER
The medication reconciliation application, the Preadmission
Medication List (PAML) Builder, has been previously de-
scribed.17 It is a Web-based application that promotes the cre-
ation of a preadmission medication list from several electronic
sources (including 2 ambulatory electronic medical record sys-
tems used at Partners HealthCare and discharge orders from
the 2 study hospitals), documents a planned action on admis-
sion for each PAML medication (eg, continue on admission,
discontinue), facilitates review of a completed PAML and ad-
mission medications by a second clinician, and facilitates rec-
onciliation of the PAML with current inpatient medications when
discharge orders are written. Features of the PAML Builder ap-
plication include the following:
v Creation of the preadmission medication list
1. Displays “medications from electronic sources,” com-
prising the active medications from the 2 ambulatory
electronic medical records used at the 2 study hospi-
tals and the medications ordered at the most recent dis-
charge from the study hospitals.
2. Allows the admitting clinician to move selected medi-
cations from electronic sources into the PAML, with
or without changes in dose or frequency; to add new
medications (ie, not available in electronic sources)
based on the admission medication history; and to up-
date the PAML during the hospitalization as more ac-
curate information becomes available.
v Reconciliation of medications at admission
1. Requires one of the following planned actions on ad-
mission for every medication in the PAML as prepa-
ration for writing admission orders: continue as writ-
ten, discontinue, continue at different dose/frequency/
route, or substitute with a different medication.
2. Facilitates confirmation of reconciliation by a clinical
pharmacist.
v Reconciliation of medications at discharge
1. Displays the PAML and current inpatient medication
orders at the time discharge orders are being written.
2. Requires confirmation that reconciliation of the PAML
with discharge medications has taken place.
At study time, the PAML Builder was not fully integrated with
the CPOE system at either study hospital, so PAML medications
could not automatically become CPOE admission orders. At dis-
charge, hospital 1 displayed current inpatient medications along-
side preadmission medications with the ability to order medica-
tions from either list. At hospital 2, these 2 lists existed in separate
display windows, and preadmission medications needed to be or-
dered separately to be resumed at discharge.
PROCESS REDESIGN
To implement medication reconciliation successfully, roles and
workflows of residents, staff physicians, nurses, and pharma-
cists at the 2 hospitals were redesigned (Figure 1). Physi-
cians were given primary responsibility for taking preadmis-
sion medication histories and referring to this list when ordering
medications in the hospital and at discharge. Pharmacists were
responsible for confirming the reconciliation process at admis-
sion, while nurses were responsible for confirming reconcili-
ation at discharge. Most notably, we replaced redundant medi-
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cation history taking performed independently and without
communication with interdisciplinary collaboration to obtain
the most accurate medication history possible; we also used pur-
poseful cross-checking to increase compliance (Figure 1).
Training in process redesign and in the use of the PAML Builder
was similar at the 2 hospitals and generally consisted of 30 min-
utes to 2 hours of small-group training sessions, computer-
based training, and e-mail announcements, supplemented by edu-
cational handouts, online materials, and IT staff support. Timing
of the trial differed in relation to hospitalwide rollout of medica-
tion reconciliation at the hospitals. At hospital 1, this study was
conducted during the first phase of a phased hospitalwide roll-
out, so that clinicians were exposed to a wide range of materials
publicizing the importance of medication reconciliation (eg, an
information booth stationed in the hospital’s main hallway, group
and individual e-mails to clinicians, and presentations to hospi-
tal leadership). At hospital 2, the study was conducted prior to
an all-at-once hospitalwide rollout, with consequently less pub-
licity about medication reconciliation.
Patients in the usual care study arm received the preinterven-
tion standard of care. Residents documented medication histo-
ries in admission notes; pharmacists reviewed medication or-
ders for appropriateness. At discharge, physicians wrote discharge
orders (without facilitated access to preadmission medication his-
tories); nurses educated patients about their medications.
OUTCOMES
The main study outcome was the number of unintentional medi-
cation discrepancies with potential for causing harm (PADEs)
per patient. Defined as “incidents with potential for injury re-
lated to a drug,”18 PADEs have been used as a medication safety
measure in numerous studies,18-22 and reductions in PADEs due
to interventions tend to track with reductions in actual ADEs.23
Our process for outcome assessment has been previously
described.16 A “gold standard” preadmission medication his-
tory was taken of all study patients by 1 of 2 study pharma-
cists at each hospital, following a strict protocol but not blinded
to intervention status. The resulting preadmission medication
list was compared with the medication history taken by the medi-
cal team, with all admission medication orders, and with all
discharge orders. Discrepancies between the gold standard pread-
mission medication history and admission or discharge orders
were identified, and intentional reasons for changes were sought
from the medical record. If necessary and when possible, phar-
macists communicated directly with the medical team after dis-
charge orders were written to verify intent. Medication dis-
crepancies that were not clearly intentional were recorded.
Recorded discrepancies were shown by the study pharmacist
to rotating adjudication teams of 2 physicians (from a pool of 6)
blinded to intervention status. Each medication discrepancy and
the patient discharge summary were reviewed. Additional elec-
tronic patient information such as ordered medications and test
results were reviewed as needed. Using an expert-derived classi-
fication scheme,24 the 2 physicians recorded whether each medi-
cation discrepancy was intentional and, if unintentional, the time
(admission vs discharge) and type of discrepancy (eg, omission,
change in dose). An error in preadmission medication history was
recorded as a “history error” (eg, not including aspirin on the
preadmission medication list, thus explaining why it is not or-
dered at discharge). Conversely, an error of reconciling the medi-
cation history with medication orders was recorded as a “recon-
ciliation error” (eg, aspirin therapy not restarted at discharge despite
being on the preadmission medication list and clinically indi-
cated at discharge). Independently, the 2 reviewers judged the
potential for harm for each unintentional discrepancy and its po-
tential severity, as in previous studies.18 All disagreements were
WWW.ARCHINTERNMED.COM
 801 Patients on 14 medical teams
assessed for eligibility
322 Patients on 14 medical
teams randomized by team
162 Patients on 7 medical teams
allocated to intervention
162 Received intervention
162 Received process change
education
160 Used PAML Builder
75 Completed PAML within
24 hours
0 Did not receive intervention
0 Lost to follow-up
0 Discontinued intervention
162 Analyzed
0 Excluded from analysis
Figure 2. Trial flow diagram. PAML indicates preadmission medication list.
resolved by discussion and by a third adjudicator if necessary
(needed in 86 of 4700 adjudicated medication discrepancies
[1.8%]).
Weekly meetings were conducted to ensure consistency be-
tween sites and among study pharmacists and physician adju-
dicators. Reliability of the gold standard preadmission medi-
cation histories and physician adjudication of outcomes have
been shown to be moderate to high.16 Prespecified secondary
outcomes, based on hospital administrative data, included emer-
gency department visits and hospital readmissions within 30
days of discharge.
STATISTICAL ANALYSIS
Patient characteristics and study results were calculated using pro-
portions, means with standard deviations, and medians with in-
terquartile ranges. Poisson log-linear regression was used to de-
termine associations between the number of PADEs per patient
and study arm. To adjust for potential confounding, a weighted
propensity score approach was used in which the data for each
patient were weighted by the inverse of the probability of being
in the treatment arm given each of the potential confounding co-
variates.25 Covariates, chosen a priori on clinical grounds, in-
cluded patient age, number of outpatient visits within the previ-
ous year, inpatient admissions to index hospital within the previous
month, number of preadmission medications, number of high-
risk preadmission medications, admission source, primary care
physician (PCP) from within the hospital network, whether the
PCP was the discharging physician, family or caregiver as a source
of preadmission medication information, level of training of ad-
mitting physician, and patients’ understanding of their medica-
tions (subjectively categorized by the study pharmacist as low,
medium, or high). High-risk medication classes, based on their
risk for causing PADEs in the control group when prescribed, in-
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479 Excluded
443 Met exclusion criteria
397 Discharged prior to completion of
“gold standard” medication history
10 Discharged from nonstudy floor
12 Transferred between study arms
1 Died prior to completion of
medication history
3 Discharged after end of study
37 Did not meet inclusion criteria
37 Never admitted to study team or
floor
0 Declined to participate
9 Other reasons
160 Patients on 7 medical teams
allocated to usual care
160 Received usual care
0 Lost to follow-up
160 Analyzed
0 Excluded from analysis
cluded gout medications, muscle relaxants, hyperlipidemic medi-
cations, antidepressants, and respiratory medications.16 Health-
care utilization outcomes were compared using logistic regression
with general estimating equations clustered by admitting
physician.
Subgroup analyses explored possible effect modification; pre-
specified subgroups included study hospital, PADE risk score,
number of preadmission medications, transfers from outside
institutions, level of training of admitting physician, and pa-
tient understanding of medications. The PADE risk score, de-
rived from the control group, was calculated by assigning 2
points for patients younger than 85 years and 1 point each for
low or medium patient understanding of medications, having
16 or more preadmission medications, 4 or more high-risk pread-
mission medications (as defined in the previous paragraph),
13 or more outpatient visits in the previous year, and having a
family member or caregiver as a source of preadmission medi-
cation information.16 Interaction terms (ie, subgroup⫻study
arm) were entered into secondary models to evaluate the sta-
tistical significance of any effect modification.
Generalized estimating equations, using a robust covariance
matrix, were applied to adjust for clustering of results by the ad-
mitting physician. Model fit for the propensity score model of the
primary outcome was assessed based on aggregates of residu-
als26 using the ASSESS statement in SAS statistical software (SAS
Institute Inc, Cary, North Carolina), with a P value computed based
on 10 000 simulated paths (P=.60, suggesting good model fit).
Analyses were intention to treat. P⬍.05 (2 sided) was consid-
ered significant. Analyses were implemented with SAS statistical
software, version 9.1 (SAS Institute Inc).
Our target sample comprised 460 patients, which was es-
timated to provide a 90% power to detect a 60% relative de-
crease (based on studies of paper-based medication reconcili-
ation9,10) in the presence of any PADE (from 27%5,6,11 to 11%
WWW.ARCHINTERNMED.COM
 Table 1. Baseline Characteristics of Study Population

Total Population Hospital 1 Hospital 2

Intervention Control Intervention Control Intervention Control

Characteristic (n=162) (n=160) (n=84) (n=86) (n=78) (n=74)
Age, y
⬍50 35 (22) 35 (22) 17 (20) 15 (17) 18 (23) 20 (27)
50-59 27 (17) 25 (15) 15 (18) 18 (21) 12 (15) 7 (9)
60-74 49 (30) 35 (22) 26 (31) 16 (19) 23 (30) 19 (26)
75-84 34 (21) 48 (30) 17 (20) 29 (34) 17 (22) 19 (26)
ⱖ85 17 (10) 17 (11) 9 (11) 8 (9) 8 (10) 9 (12)
Female 84 (52) 92 (57) 37 (44) 46 (54) 47 (60) 46 (62)
Median income by zip code, $
ⱕ39 000 37 (23) 31 (19) 19 (23) 12 (14) 18 (23) 19 (26)
39 001-47 000 40 (25) 43 (27) 21 (25) 25 (29) 19 (24) 18 (24)
47 001-63 000 48 (29) 36 (23) 23 (27) 19 (22) 25 (32) 17 (23)
⬎63 000 37 (23) 50 (31) 21 (25) 30 (35) 16 (21) 20 (27)
Insurance
Private 50 (31) 43 (27) 19 (23) 25 (29) 31 (40) 18 (24)
Medicare only 4 (3) 7 (5) 3 (4) 2 (2) 1 (1) 5 (7)
Medicare with secondary 76 (47) 79 (49) 45 (54) 44 (51) 31 (40) 35 (47)
Free care/Medicaid 25 (15) 26 (16) 15 (17) 13 (16) 10 (13) 13 (18)
Other/self-pay 7 (4) 5 (3) 2 (2) 2 (2) 5 (6) 3 (4)
Medicare under age 65 y 18 (11) 11 (7) 13 (15) 8 (9) 5 (6) 3 (4)
PCP within Partners 81 (50) 98 (61) 48 (57) 53 (62) 33 (42) 45 (61)
HealthCare network a,b
Preadmission source
Emergency department 106 (65) 96 (60) 57 (68) 49 (57) 49 (63) 47 (63)
Transfer from other service 17 (10) 15 (9) 0 (0) 0 (0) 17 (22) 15 (20)
Transfer from outside 16 (10) 23 (14) 6 (7) 14 (16) 10 (13) 9 (12)
institution
Scheduled from home 9 (6) 11 (7) 8 (10) 9 (11) 1 (1) 2 (3)
Day procedure 14 (9) 15 (9) 13 (15) 14 (16) 1 (1) 1 (1)
Admission DRG weight, c median 0.99 (0.76-1.27) 1.03 (0.83-1.28) 0.99 (0.77-1.24) 1.02 (0.83-1.22) 1.01 (0.73-1.26) 1.03 (0.82-1.44)
(IQR)
Charlson Comorbidity Scored
0-1 54 (34) 46 (29) 21 (26) 21 (26) 33 (43) 25 (34)
2-3 49 (31) 53 (34) 28 (35) 24 (29) 21 (27) 29 (39)
4-5 25 (16) 21 (13) 13 (16) 10 (12) 12 (15) 11 (15)
ⱖ6 31 (19) 36 (23) 19 (23) 27 (33) 12 (15) 9 (12)

(continued)

of patients), assuming an ␣ level of .05, 5 patients per admit-
ting physician, and an intraclass correlation coefficient by phy-
sician of 0.10 (we did not adjust for additional correlation at
the team level). The study was not powered to detect a differ-
ence in health care utilization.
RESULTS
DESCRIPTION OF STUDY SAMPLE
Of 801 patients originally identified as potentially eli-
gible for the study, 322 were enrolled and were cared for
by each of the 14 randomized medical teams and by 117
different admitting physicians. The most common rea-
son for patient exclusion was lack of time of the study
pharmacist to obtain a medication history before dis-
charge. Compared with enrolled patients, unenrolled pa-
tients had shorter lengths of stay (a table of the charac-
teristics of the study sample and the excluded subjects
is available from the corresponding author).
Of 162 patients assigned to the intervention arm, the
PAML Builder application was used in 160 patients (99%).
A PAML was “completed” (planned actions on admis-
sion assigned for all medications and the list signed off
as “ready for review” by a pharmacist) within 24 hours
of admission for 75 patients (46%), including 42 of 84
patients (50%) at hospital 1 and 33 of 78 patients (42%)
at hospital 2 (P=.35 for comparison). A PAML was com-
pleted prior to discharge in 121 patients (75%). The pri-
mary outcome could be evaluated in all 322 patients.
Figure 2 shows the study flow. Patient characteristics
in the 2 study arms were similar, except for a signifi-
cantly lower proportion of PCPs within the Partners
HealthCare network and a higher proportion of non-
medicine interns in the intervention group (Table 1).
Some differences were also noted by study hospital (a table
of the site differences in baseline patient characteristics
is available from the corresponding author).
EFFECT OF THE INTERVENTION ON PADEs
Among the 162 patients assigned to the intervention, there
were 170 unintentional medication discrepancies with
potential for patient harm (1.05 PADEs per patient) vs

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 Table 1. Baseline Characteristics of Study Population (continued)

Total Population Hospital 1 Hospital 2

Intervention Control Intervention Control Intervention Control

Characteristic (n=162) (n=160) (n=84) (n=86) (n=78) (n=74)
Total No. of preadmission medications b,e
Quartile 1 (1-8) 45 (28) 42 (26) 23 (27) 27 (31) 22 (28) 15 (21)
Quartile 2 (9-12) 54 (33) 38 (24) 28 (33) 20 (23) 26 (33) 18 (24)
Quartile 3 (13-17) 37 (23) 38 (24) 19 (23) 18 (22) 18 (23) 20 (27)
Quartile 4 (18-33) 26 (16) 42 (26) 14 (17) 21 (24) 12 (16) 21 (28)
No. of high-risk preadmission medications f
Quartile 1 (0-1) 37 (23) 43 (27) 15 (18) 27 (31) 22 (28) 16 (21)
Quartile 2 (2-3) 42 (26) 34 (21) 25 (30) 15 (17) 17 (22) 19 (26)
Quartile 3 (4-5) 44 (27) 42 (26) 22 (26) 22 (26) 22 (28) 20 (27)
Quartile 4 (ⱖ6) 39 (24) 41 (26) 22 (26) 22 (26) 17 (22) 19 (26)
Medical student involvement in patient care 18 (11) 12 (8) 8 (10) 6 (7) 8 (10) 6 (8)
Experience level of admitting physician a,b,g
Medicine intern 124 (77) 104 (65) 70 (84) 64 (75) 54 (69) 40 (55)
Medicine resident 13 (8) 32 (20) 11 (13) 8 (9) 2 (3) 24 (32)
Attending/fellow physician 4 (2) 8 (5) 1 (1) 5 (6) 3 (4) 3 (4)
ED/Ob-Gyn intern 18 (11) 1 (1) 0 (0) 0 (0) 18 (23) 1 (1)
Unknown 3 (2) 15 (9) 2 (2) 9 (10) 1 (1) 6 (8)
Patient understanding of preadmission medications h
High 51 (32) 55 (35) 36 (43) 35 (41) 15 (20) 20 (27)
Medium 79 (50) 71 (44) 32 (39) 35 (18) 47 (18) 36 (49)
Low 29 (18) 33 (21) 15 (18) 16 (41) 14 (62) 17 (24)
Previous hospitalization in the last 31 d 33 (20) 30 (19) 17 (20) 20 (23) 16 (21) 10 (14)
No. of outpatient visits in the last 12 mo
0 40 (25) 36 (22) 15 (18) 14 (16) 25 (32) 22 (30)
1-4 52 (32) 37 (23) 28 (33) 21 (24) 24 (31) 16 (22)
5-11 40 (25) 41 (26) 24 (29) 24 (28) 16 (20) 17 (23)
⬎11 30 (18) 46 (29) 17 (20) 27 (32) 13 (17) 19 (25)

Abbreviations: DRG, diagnosis-related group; ED, emergency department; IQR, interquartile range; Ob-Gyn, obstetrics/gynecology; PCP, primary care physician.
a P⬍.05 for comparison between intervention and control groups (total population).
b P⬍.05 for comparison between intervention and control groups at hospital 2.
c Based on Medicare 2006 weights (version 23).27
d Based on administrative billing codes.28
e Excluding “as needed” medications and topical agents.
f In 5 medication classes most likely to cause potential adverse drug events when prescribed: gout medications, muscle relaxants, hyperlipidemic agents,
antidepressants, and respiratory medications.16
g P⬍.05 for comparison between intervention and control groups at hospital 1.
h Based on pharmacist assessment.

230 (1.44 PADEs per patient) among the 160 patients
assigned to usual care, an adjusted 28% relative risk re-
duction (Table 2). Ninety-eight PADEs were consid-
ered serious, ie, to have potential to cause serious harm
such as rehospitalization or persistent alteration in health
function, including 43 PADEs in the intervention arm
(0.27 per patient) and 55 PADEs in those assigned to usual
care (0.34 per patient). The intervention was associated
with a significant reduction in PADEs at discharge but
not at admission (Table 2). Table 3 gives examples of
different types of PADEs identified during the study.
No significant differences were found in health care uti-
lization. The rate of hospital readmission or emergency de-
partment visit within 30 days was 20% in the intervention
arm and 24% in the usual care arm (clustered odds ratio,
0.76; 95% confidence interval [CI], 0.43-1.35).
In subgroup analyses, we found effect modification by
PADE risk score and a suggestion of an effect modifica-
tion by hospital. The effect of the intervention was greater
in the 167 patients with a PADE risk score of 4 or higher
(adjusted and clustered relative risk, 0.62; 95% CI, 0.41-
0.93) than in the 155 patients with a risk score of 3 or
lower (adjusted and clustered relative risk, 1.09; 95% CI,
0.49-2.44) (P value for interaction, .02). The interven-
tion was associated with a significant reduction in PADEs
at hospital 1 but not at hospital 2 (P value for interac-
tion, .32) (Table 4). Differences between hospitals were
qualitatively similar for the adjusted effect of the inter-
vention on PADEs due to history errors, those due to rec-
onciliation errors, PADEs at admission, and those at dis-
charge (Table 4). No other subgroup differences were
found in the effect of the intervention.
COMMENT
In this 2-hospital cluster-randomized controlled trial, we
found that a medication reconciliation intervention con-
sisting of novel IT and process redesign involving phy-
sicians, nurses, and pharmacists was associated with a
28% relative risk reduction in unintentional medication
discrepancies with potential for harm, a type of PADE.
The absolute risk reduction between the 2 arms was 0.39
PADE per patient or a number needed to treat 2.6 pa-

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 Table 2. Incidence and Relative Rates of Potential Adverse Drug Events Due to Unintentional Medication Discrepancies

PADEs, No. (per Patient) PADEs, No. (per Patient)

in the Control Arm in the Intervention Arm Unadjusted RR Adjusted and Clustered RR
Outcome (n=160) (n = 162) (95% CI) (95% CI) a,b
All PADEs 230 (1.44) 170 (1.05) 0.74 (0.60-0.89) 0.72 (0.52-0.99)
PADEs by type of error c
History errors 153 (0.96) 125 (0.77) 0.81 (0.64-1.02) 0.80 (0.55-1.15)
Reconciliation errors 80 (0.50) 52 (0.32) 0.64 (0.45-0.91) 0.62 (0.29-1.34)
PADEs by time of occurrence
PADEs at admission 49 (0.31) 44 (0.27) 0.89 (0.59-1.33) 0.87 (0.51-1.52)
PADEs at discharge 181 (1.13) 126 (0.78) 0.69 (0.55-0.86) 0.67 (0.49-0.98)

Abbreviations: CI, confidence interval; RR, relative risk.

a Adjusted for clustering by admitting physician using general estimating equations.
b Propensity score–adjusted model. Propensity score based on patient age, number of outpatient visits within the previous year, inpatient admissions to the
index hospital within the previous month, number of preadmission medications, number of high-risk preadmission medications, admission source, primary care
physician from within the hospital network, whether the primary care physician was the discharging physician, family or caregiver as a source of preadmission
medication information, level of training of the physician documenting the medication history, and patient understanding of their medications. Except for patient
understanding of their medications, which was dichotomized as high vs medium or low, all other variables were categorized as in Table 1.
c Three PADEs in the control arm and 7 PADEs in the intervention arms were attributed to both history error and reconciliation error.

tients to prevent 1 PADE. The intervention was more suc-
cessful in patients at high risk for medication discrep-
ancies and possibly more successful at hospital 1 than at
hospital 2. To our knowledge, this is the first random-
ized controlled trial of an IT-based medication recon-
ciliation intervention.
We believe our intervention was successful because
it combined effective process redesign with IT. The new
reconciliation process encouraged interdisciplinary com-
munication and cross-checks. The PAML Builder
application facilitated accurate medication histories
by presenting several sources of available medication in-
formation, and it displayed the PAML with current in-
patient medications during the discharge ordering
process.
However, our intervention was far from perfect in
eliminating potentially harmful medication discrepan-
cies (1.05 PADEs per patient in the intervention arm).
Possible reasons include incomplete and inaccurate elec-
tronic sources of ambulatory medications, lack of pa-
tient and caregiver knowledge of preadmission medica-
tion regimens, lack of clinician adherence with the
reconciliation process, and software usability issues (such
as ease of adding new medications to the PAML and lack
of integration with the admission ordering process).
Our intervention was more successful in patients at
high risk for medication discrepancies, based on a risk
score derived from the control group. If prospectively vali-
dated in other populations, this score could prove use-
ful in prioritizing those most in need of intensive recon-
ciliation efforts, ie, above the minimum Joint Commission
standard.7
The intervention reduced PADEs at discharge but not
at admission. This result was likely because of the fol-
lowing circumstances: (1) PADEs in general were more
common at discharge than at admission16; (2) most er-
rors of reconciliation occurred at discharge, and the PAML
Builder may have been particularly effective at reducing
these kinds of errors; and (3) delays in completing a PAML
would also have attenuated the effectiveness of the in-
tervention at admission but not at discharge.
A significant reduction in PADEs with the interven-
tion at hospital 1 but not at hospital 2 could have been
due to chance, since the study was not powered to de-
tect a difference in PADEs at each hospital individually.
Alternatively, part of the answer may be the phased hos-
pitalwide rollout of the intervention at hospital 1, which
led to more publicity about medication reconciliation,
possibly resulting in greater compliance with the new pro-
cesses. Hospital differences related to reducing “medi-
cation history errors” may be due in part to greater in-
volvement of nurses at admission at hospital 1. Based on
informal, unblinded interviews with clinical personnel
conducted after study completion, nurses at hospital 1
more consistently confirmed PAML accuracy at admis-
sion compared with hospital 2. Hospital differences in
reducing “reconciliation errors” were likely due to dif-
ferences in discharge medication computer screens de-
veloped at the 2 hospitals—a hypothesis we generated a
priori. At hospital 1, it was easier to view inpatient and
preadmission medications simultaneously and to order
medications from either list at discharge.
Regarding other studies of medication reconcilia-
tion, 2 recent pre-post studies of paper-based interven-
tions evaluated effects on actual ADEs based on retro-
spective review of a random selection of medical records,
demonstrating a 43% to 84% relative risk reduction.9,10
A recent randomized controlled trial of a pharmacist-
run “medication reconciliation and seamless care ser-
vice” found that 56.3% of 119 control patients had a drug
therapy inconsistency or omission at discharge on ret-
rospective medical record review compared with 3.6%
of intervention patients (based on an independent re-
view of 17% of intervention patients’ medical records by
a second pharmacist).29 Mostly descriptive studies of IT-
based medication reconciliation tools are also begin-
ning to be published,30-34 and commercial vendors are
starting to provide medication reconciliation modules in
their applications.30,35
We believe IT-based medication reconciliation inter-
ventions have several advantages over paper-based so-
lutions, including the ability to use existing electronic

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 Table 3. Examples of Potential Adverse Drug Events a

History Timing of Error Type of Error Reason for Error Potential Severity
A patient with multiple cardiac risk factors was admitted for Admission Omission Reconciliation error Serious
atypical chest pain. At home he was taking atenolol,
100 mg by mouth daily. The medical team accurately
documented this medication in the preadmission
medication list but did not prescribe it (or any other
␤-blocker) on admission or any time during the
hospitalization. No medical reason could be found for
withholding it, and notes document a plan to continue
optimal medical management of possible coronary
disease. The patient was discharged on his home dose of
atenolol.
A patient with a seizure disorder was admitted for peripheral Admission Frequency History error Serious
edema and COPD exacerbation. At home the patient was
taking carbamazepine, 100 mg by mouth twice daily, but
the medical team incorrectly documented 100 mg by
mouth 3 times a day in the preadmission medication list
and then prescribed that frequency on admission. No
blood levels of the medication were drawn during the
hospitalization.
A patient with a history of asthma was admitted for an Discharge Omission Reconciliation error Serious
asthma exacerbation. At home, the patient was using an
albuterol inhaler, 2 puffs every 4 hours as needed for
shortness of breath. The team accurately documented the
medication in the preadmission medication list. During the
hospitalization the patient was given albuterol by
nebulizer. At discharge, no albuterol (or any other
short-acting bronchodilator) was prescribed.
A patient with gastroesophageal reflux disease was admitted Discharge Omission History error Significant
with nausea and vomiting and was found to have
hyponatremia. At home, the patient was taking
omeprazole 20 mg by mouth daily, but the medical team
did not document this medication in the preadmission
medication list. During hospitalization, the patient was
prescribed esomeprazole for stress ulcer prophylaxis. At
discharge, no proton pump inhibitor or other antireflux
medication was prescribed.
A patient with a history of myocardial infarction and Discharge Dose History error Serious
hypertension was admitted for a gastrointestinal bleed. At
home the patient was taking lisinopril, 10 mg by mouth
daily, but the medical team incorrectly documented 25 mg
by mouth daily in the preadmission medication list.
During the hospitalization the patient was hypertensive,
and the team appropriately ordered captopril instead of
lisinopril to manage his blood pressure. At discharge, with
a normal blood pressure, the team ordered what they
thought was his home dose of lisinopril, 25 mg by mouth
daily.

Abbreviation: COPD, chronic obstructive pulmonary disease.

a In all cases, errors were corrected prior to finalization of the discharge orders.

sources of ambulatory medication information, better in-
tegration into workflow in hospitals with CPOE, easier
sharing of reconciliation information across providers,
automatic production of documentation for discharge
summaries, comparisons of medication lists to facilitate
reconciliation and patient education, provision of alerts
and reminders to ensure compliance, and ability to track
compliance to inform further process improvement.
This study has several limitations. First, because it was
conducted on general medical services at academic hos-
pitals, results may not be generalizable to other settings.
Patients with very short lengths of stay may have been
disproportionately discharged before enrollment, lead-
ing to selection of a sicker patient population; the re-
sults may not be generalizable to less sick patients or those
taking fewer medications. Second, the study measured
potential and not actual ADEs, and while we analyzed
health care utilization, the study was not powered to de-
tect a reduction in this outcome. Third, full use of the
PAML Builder was not achieved: only 46% of patients had
a completed PAML within 24 hours of admission (al-
though 75% were complete by discharge), thus limiting
the ability of the intervention to benefit patients. Based
on an analysis of clinician attitudes and patterns of use
of the application, we attribute this nonadherence to the
lack of integration of the application with CPOE at ad-
mission.36 This problem has since been remedied; cur-
rently 80% to 90% of PAMLs are complete within 24 hours
of admission. Fourth, we cannot exclude the possibility
of unmeasured provider characteristics confounding the

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Table 4. Differences in Effect of Intervention by Study Site
Hospital 1
Adjusted and
Clustered RR
Outcome (95% CI)
PADEs per patient 0.60 (0.38-0.97)
PADEs per patient due to history 0.66 (0.36-1.20)
errors
PADEs per patient due to 0.56 (0.18-1.70)
reconciliation errors
PADEs per patient at admission 0.57 (0.18-1.76)
PADEs per patient at discharge 0.61 (0.35-1.04)
Abbreviations: CI, confidence interval; PADEs, potential adverse drug events;
RR, relative risk.
results, but the factors we adjusted for had no effects on
study findings. Finally, hypotheses about the effects of
the intervention’s rollout or the involvement of nurses
in the medication history process at the 2 hospitals were
generated post hoc and may be biased.
In conclusion, an interdisciplinary medication recon-
ciliation intervention comprising novel IT and process
redesign was associated with a significant reduction in
unintentional medication discrepancies with potential for
harm. Institutions should strongly consider adopting elec-
tronic medication reconciliation tools as availability in-
creases. Site-specific differences suggest that electronic
medication reconciliation tools should facilitate com-
parisons of medication lists at transition points and use
of these lists to order medications for the next care set-
ting. Provider education on taking complete medica-
tion histories and purposeful “independent redundan-
cies”12 in the reconciliation process (eg, nurses verifying
the accuracy of physician-produced medication histo-
ries) are also likely important to the success of any medi-
cation reconciliation effort. Future research should be di-
rected at more rigorous evaluations of the environments,
medication reconciliation interventions, and implemen-
tation characteristics that best improve outcomes and at
further development and evaluation of commercially avail-
able electronic medication reconciliation tools. Ideally,
multicenter studies using methods such as randomized
controlled trials or interrupted time series analyses should
be conducted using more downstream health outcomes
(such as total ADEs and hospital readmissions). More
work is needed to eliminate serious medication recon-
ciliation errors and make transitions in care as safe as
possible.
Accepted for Publication: December 6, 2008.
Author Affiliations: Brigham and Women’s Academic
Hospitalist Service (Drs Schnipper and Carty), Division
of General Medicine (Drs Schnipper, Carty, Poon, Lip-
sitz, and Gandhi and Mr Ndumele and Ms Liang), Cen-
ter for Clinical Excellence (Drs Carty and Gandhi), and
Pharmacy Services (Dr Labonville), Brigham and Wom-
en’s Hospital, Boston, Massachusetts; Department of Medi-
cine (Dr Hamann, Karson, Bhan, and Coley), Geriatric
Medicine Unit (Dr Hamann), Center for Quality and Safety
(Dr Karson and Ms McCarthy), and Pharmacy Services
(REPRINTED) ARCH INTERN MED/ VOL 169 (NO. 8), APR 27, 2009
©2009 American Medical Association. All rights reserved.
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(Dr Diedrichsen), Massachusetts General Hospital, Boston;
Partners Information Systems Clinical Informatics
Research and Development, Boston (Drs Poon, Turchin,
Hospital 2 and Broverman); and Harvard Medical School, Boston
Adjusted and
Clustered RR
(Drs Schnipper, Hamann, Carty, Karson, Bhan, Coley,
(95% CI) Poon, Turchin, Lipsitz, and Gandhi).
0.87 (0.57-1.32)
Correspondence: Jeffrey L. Schnipper, MD, MPH, Divi-
0.94 (0.59-1.48) sion of General Medicine, Brigham and Women’s Hos-
pital, 1620 Tremont St, Boston, MA 02120-1613
0.75 (0.36-1.58) (jschnipper@partners.org).
Author Contributions: Dr Schnipper had full access to
1.18 (0.58-2.41)
all the data in the study and takes responsibility for the
0.77 (0.49-1.20)
integrity of the data and the accuracy of the data analy-
sis. Study concept and design: Schnipper, Carty, Karson,
Poon, Broverman, and Gandhi. Acquisition of data:
Schnipper, Hamann, Carty, Karson, Bhan, Labonville, Die-
drichsen, and Gandhi. Analysis and interpretation of data:
Schnipper, Hamann, Ndumele, Liang, Coley, Poon, Tur-
chin, Lipsitz, McCarthy, and Gandhi. Drafting of the manu-
script: Schnipper. Critical revision of the manuscript for
important intellectual content: Hamann, Ndumele, Li-
ang, Carty, Karson, Bhan, Coley, Poon, Turchin, Labon-
ville, Diedrichsen, Lipsitz, Broverman, McCarthy, and
Gandhi. Statistical analysis: Schnipper, Ndumele, and Lip-
sitz. Obtained funding: Schnipper, Coley, Broverman, and
Gandhi. Administrative, technical, and material support:
Liang, Karson, Coley, and McCarthy. Study supervision:
Broverman.
Financial Disclosure: None reported.
Funding/Support: This study was funded in part by an
investigator-initiated grant from the Harvard Risk Man-
agement Foundation, including compensation for Elisa-
beth Burdick, MS, Amy Bloom, MPH, and Emily Barsky,
BA, as well as internal funding from Brigham and Wom-
en’s Hospital (BWH), Massachusetts General Hospital,
and Partners HealthCare. Dr Schnipper was supported
by a mentored clinical scientist award from the Na-
tional Heart, Lung, and Blood Institute (K08 HL072806).
Role of the Sponsors: The funding organizations had no
role in the design and conduct of the study; collection,
management, analysis, and interpretation of the data; and
preparation, review, or approval of the manuscript.
Previous Presentations: Portions of this work were
presented as a poster at the Summer Meeting of the
American Society of Health–System Pharmacists; June
25, 2007; San Francisco, California; and was presented
orally as an abstract at the Society of General Internal
Medicine Annual Meeting; April 10, 2008; Pittsburgh,
Pennsylvania.
Additional Contributions: The following Partners In-
formation Systems personnel were involved in develop-
ing this intervention: Barry Blumenfeld, MD, Cheryl Van
Putten, PMP, John Poikonen, BA, Eric Godlewski, BA,
Linda Moroni, MBA, Michael McNamara, BA, Sandra
Smith, BA, Marilyn Paterno, MBI, Daniel Fuchs, BS, Ol-
iver James, BS, and Greg Rath, BA. The BWH medica-
tion reconciliation implementation team included Erin
Graydon-Baker, MS, RRT, Christine McCormack, BA,
Christina Pelletier, BA, Emily Maher, MD, Ellen Bergeron,
RN, MSN, Jennifer Kuzemchak, BA, Michael Cotugno,
RPh, and Andrea Giannattasio, BA). The Massachusetts
General Hospital medication reconciliation implemen-
WWW.ARCHINTERNMED.COM
779
 tation team included George Baker, MD, Sally Millar, RN,
and Margaret Clapp, BA. Bonnie Greenwood, Pharm D,
and Trisha LaPointe, Pharm D, BCPS, assisted in phar-
macist data collection; and BWH personnel John Orav,
PhD, provided for biostatistical assistance, Elisabeth Bur-
dick, MS, assisted in statistical programming, Amy Bloom,
MPH, assisted in project management, and Emily Bar-
sky, BA, Eric Tomasini, BA, and Emily Dattwyler, BA, pro-
vided research assistance. Jaylyn Olivo and Jeanne Zim-
merman at BWH provided editorial assistance.
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