Int J Clin Pharm (2012) 34:382–388
DOI 10.1007/s11096-012-9623-5
RESEARCH ARTICLE
Handling drug-related problems in rehabilitation patients:
a randomized study
Karin Willoch • Hege Salvesen Blix •
Anne Marit Pedersen-Bjergaard • Anne Kathrine Eek
Aasmund Reikvam
•
Received: 15 May 2011 / Accepted: 17 February 2012 / Published online: 3 March 2012
Springer Science+Business Media B.V. 2012
Abstract Background Drug-related problems (DRPs)
have been found to be associated with increased morbidity,
mortality, and health costs. Objective To investigate whether
the inclusion of pharmacists in a rehabilitation team influences the handling of DRPs in the ward and whether an
intervention in hospital affects drug use after discharge.
Setting The rehabilitation ward of a general hospital in Oslo,
Norway. Methods Patients were randomized into an intervention group (IG) or a usual care group (CG). The IG
patients were followed prospectively by a pharmacist, who
reviewed the patients’ drug therapies using information
from their medical records and patient interviews. The
pharmacist identified DRPs and suggested solutions during
multidisciplinary team meetings. The IG patients received
targeted drug counselling from the pharmacist before discharge. The drug therapy in the CG, for the period from
study randomization to discharge, was assessed retrospectively by the pharmacist, who identified DRPs and recorded
how they were acted upon. Three months after discharge,
pharmacists who were blinded to the patient randomization,
K. Willoch (&) H. S. Blix A. M. Pedersen-Bjergaard A. K. Eek
Lovisenberg Diakonale Hospital Pharmacy,
Lovisenberggate 17, 0440 Oslo, Norway
e-mail: karin.willoch@apotek.no
H. S. Blix
Department of Pharmacoepidemiology,
Norwegian Institute of Public Health,
Oslo, Norway
A. Reikvam
Department of Pharmacology/Department of Clinical Medicine,
Faculty of Medicine, University of Oslo, Oslo, Norway
123
visited the patients at home and interviewed them about their
medication. Main outcome measures: Types and frequencies
of DRPs in the IG and CG were compared at hospital
admission, at discharge, and 3 months after discharge.
Results Of the 77 patients included, 40 belonged to the IG
and 37 to the CG. Patient characteristics (IG vs CG) were as
follows: age 73.5 versus 76.8 years; female 58 versus 68%;
mean number of drugs at admission 8.3 versus 7.8; and mean
number of drugs at discharge 8.5 versus 7.7. At admission,
4.4 DRPs per patient were recorded in the IG and 4.2 in the
CG. Significantly more DRPs were acted upon and resolved
in the IG; at discharge, the IG had 1.2 DRPs per patient and
the CG had 4.0 (P \ 0.01). At the home visit, a significant
difference between the groups was found: 1.63 versus 2.62
DRPs (P = 0.02) for the IG and the CG, respectively.
Conclusion Involvement of a pharmacist in drug-therapy
management, including participation in multidisciplinary
team discussions, markedly improved the identification and
resolution of DRPs during a hospital stay. The benefit persisted after discharge.
Keywords Clinical pharmacy Drug-related problem Medication review Norway Randomised trial Rehabilitation ward
Impact of findings on practice
•
•
•
The participation of pharmacists in hospital multidisciplinary teams markedly improves the identification
and resolution of DRPs during hospital stays.
This benefit—reduced number of DRPs—persists after
discharge.
Changes in patients’ medication in hospital frequently
generate compliance problems after discharge.
Int J Clin Pharm (2012) 34:382–388
Introduction
Drug-related problems (DRPs) have been found to be associated with increased morbidity, mortality, and health costs
[1–3]. Many hospital admissions are the results of adverse
drug reactions, and a sizeable proportion of these are regarded as preventable [4–6]. Therefore, reducing DRPs should
benefit both patients and society. Strategies to optimize drug
therapy in hospitals have been developed and the results of a
multidisciplinary approach, involving the expertise of clinical pharmacists, have been promising [7].
During hospitalization, patients’ drug therapies are frequently changed [8, 9]. New drugs are added, doses are
adjusted, and existing drugs are discontinued. This is
challenging for the patient, and, once at home, the patient
might be confused about which drugs and doses are still
applicable. Pharmacist counselling during and after hospitalization may reduce DRPs and mortality [10, 11]. In
general, few randomized controlled studies have assessed
the inclusion of clinical pharmacists in hospital care teams.
The few that have been undertaken predominantly investigated patients admitted to acute care wards, such as
intensive care units and acute medical clinics, etc. [7, 12].
On rehabilitation wards, patients are beyond the acute stage
of illness and there is time to optimize and stabilize their
therapies. Furthermore, at this time, patients are in a phase
that is well suited to supervision. Whether clinical pharmacists could contribute to the optimization of the drug
therapies of rehabilitation patients has not yet been
investigated.
383
for training and rehabilitation to a rehabilitation ward at
Lovisenberg Diakonale Hospital, a general hospital in Oslo,
Norway, were eligible for the study. The patients were
admitted for either medical or surgical rehabilitation. Study
participants were included if they used at least three drugs on
a daily basis and were clinically judged to have adequate
cognitive function. Patients were excluded if there were
plans to discharge them to a nursing home or if they had
professional help to take their medication at home. The
study was carried out between November 2005 and February
2008. The usual length of stay in the rehabilitation department is 3 weeks, so it provides a convenient setting for
health-care professionals to evaluate and adjust patients’
medicine regimens.
A clinical pharmacist enrolled the patients into the study
(Fig. 1). At admission, all eligible patients underwent a general interview, based on a standardized questionnaire designed
for this purpose. The questionnaire included open questions
about actual drug use and the patient’s knowledge of his/her
own medications, as well as whether he/she had experienced
any adverse drug reactions or insufficient efficacy of the drug
therapy.
The patients were then randomized into either the
intervention group (IG) or the usual care group (controls,
CG). The IG patients were followed prospectively during
their hospital stays by a clinical pharmacist, who reviewed
the patients’ drug therapies using information available in
Aim of the study
We used a prospective randomized controlled methodology
to investigate whether pharmacists, as part of a multidisciplinary care team, improve drug therapy and prevent inhospital DRPs in rehabilitation patients, and assessed
whether this intervention would affect drug use after
discharge.
Methods
Patients and study design
A prospective randomized controlled trial was designed.
Hospitalized patients receiving usual care were compared
with patients receiving care from a multidisciplinary team
that included a clinical pharmacist, who was involved in the
patients’ medical treatment from immediately after randomization (see below) until discharge. Patients admitted
Fig. 1 Study design (flow chart)
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384
the hospital medical records, laboratory data, and the
standardized interview form (see above). If there were any
discrepancy between the hospital medical records and the
drug use reported by the patient, the patient’s general
practitioner (GP) was contacted. During this advanced
medication review and during the patients’ stay in hospital,
the clinical pharmacist identified any DRPs, and most of
these were discussed in the meetings of the medical multidisciplinary team led by physicians. Moreover, through a
patient counselling talk before discharge, the pharmacist
systematically informed the IG patients about their medications, particularly about any changes in their drug therapies. In this way, the entire intervention undertaken was
the inclusion of the clinical pharmacist in the multidisciplinary care team.
The CG patients were given usual care, insofar as a
pharmacist was not part of their treatment teams. No
pharmacist counselling was given at discharge. In both
groups, counselling by physicians was part of the usual
clinical routine. After discharge, the CG patients were
reviewed retrospectively by the same clinical pharmacist
who followed the IG patients. For the CG, DRPs at
admission and at discharge were identified using information from hospital medical records, laboratory data, and the
standardized interview undertaken at admission, i.e., before
randomization. For example, identification of adverse drug
reactions in the CG at discharge was based on information
from the medical records.
For both the IG and CG patients, a follow-up home visit
by pharmacists was carried out 3 months after discharge, an
interval that was regarded as appropriate for the evaluation
of any possible post-discharge effects of the intervention
undertaken in hospital. At home, the patients went through
the same type of interview as the admission interview, and
the same standardized questionnaire was used. However, the
pharmacist who conducted the home interview did not have
access to the patient’s medical records or laboratory data.
This was because of privacy protection. Only members of
the multidisciplinary care team who were involved in the
patient’s treatment, were allowed access to the medical
records. For this reason, no information on diagnoses or risk
factors was available. However, the patient’s discharge
medication list (information routinely given to all patients)
was used as background information when the pharmacist
was preparing for the home visit.
The power estimation of the study showed that with 40
patients in each group and an estimated average of two
DRPs per patient, it would be possible to identify a difference of 0.31 DRPs between the groups with a power of
80% and a significance level of 5%.
The study protocol was approved by the Regional
Committees for Medical and Health Research Ethics and
the study participants gave their written informed consent.
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Int J Clin Pharm (2012) 34:382–388
Randomization and blinding
After enrolment in the study, the participants were randomized to either the IG or the CG. Block randomization
was applied, with blocks of 20 patients. The clinical
pharmacist who carried out the intervention knew whether
the patients belonged to the IG or CG, but the physicians
and nurses in the department were blinded to the group
assignments. The pharmacists who visited the patients at
home were blinded to whether the patients belonged to the
IG or CG.
Data collection
During the hospital stay, the following data were recorded
from the medical chart of each patient: age, sex, presenting
complaints, medications (brand name, formulation, strength,
dose), changes in drug therapy during the hospital stay, relevant medical history, and the results of laboratory tests.
Specific factors that are assumed to increase the risk of DRPs
were also recorded. These, which by nature are a composition of pharmacological, clinical, and patient-related factors,
here called ‘clinical/pharmacological risk factors’ were the
following: polypharmacy (defined as[5 drugs at admission),
reduced renal function [glomerular filtration rate (GFR)
below 60 mL/min, as calculated with the Modification of
Diet in Renal Disease (MDRD) formula], reduced liver
function (aspartate aminotransferase or alanine aminotransferase three times above the normal value), confirmed
diabetes mellitus, cardiac failure, history of allergy or
adverse reactions to drugs, non-compliance reported in the
medical record, and the use of drugs with narrow therapeutic
index. We also recorded abuse of alcohol, centrally acting
psychostimulants, and benzodiazepines or opioids when
these were reported in the medical record.
From the patients’ interviews at admission, the following data were collected: medication used before hospital
admission, patient’s knowledge of his/her own drugs
(name, formulation, strength, dose, administration, and
indication), possible adverse effects, and insufficient drug
effects, if experienced.
At the home visit, the patient’s ongoing medications
were recorded, together with the same type of information
obtained in the admission interview.
Drug-related problems
‘‘DRPs’’ were defined in accordance with the definition of
the Pharmaceutical Care Network Europe: a drug-related
problem is an event or circumstance involving drug therapy
that actually or potentially interferes with desired health
outcomes [13]. In this study, a classification system containing six main classes (drug choice, dosing, adverse drug
Int J Clin Pharm (2012) 34:382–388
reactions, interactions, drug use, and others) was used to
categorize the DRPs [14]. This is a validated classification
system used in clinical practice in hospitals, nursing
homes, and ambulatory care in Norway. The data collectors
had been using the system in their daily work as clinical
pharmacists, so the system was well suited for the classification of the DRPs in a standardized way. Drug interactions were only recorded when they were clinically
relevant to the individual patient. The subdivision of the
main DRP classes appears in Table 2.
The DRPs noted at admission and discharge were
recorded either prospectively (IG) or retrospectively (CG).
The DRPs experienced by patients at home were recorded
if they were related to the medications the patients were
taking at the time of discharge and still used at the time of
the home visit. If the DRPs had been resolved by the
patient’s GP or if a DRP was related to changes to the
patient’s drugs/medication made after hospital discharge,
they were not included.
Statistical analysis
A database was established. The data were analysed using
SPSS 17.0 for Windows. Descriptive statistics are shown as
means and frequencies with standard deviations. P values
less than 0.05 (P \ 0.05) were deemed to be statistically
significant. To test the differences between groups, an
independent-samples t test was used for continuous variables and a Chi-square test was used for categorical
variables.
Results
A total of 77 patients were included, 40 in the IG and 37 in
the CG; three patients, all belonging to a total of 40 in the
CG group, were lost to follow-up immediately after
the randomization and data on these were not included in
the result analyses. Table 1 presents the patient characteristics and shows that the two groups were well balanced
before the intervention. Of the 77 enrolled patients, 59
were visited at home 3 months after discharge, 30 in the IG
and 29 in the CG. The reasons that the other home visits
were not made were: five patients had moved to nursing
homes; six did not want or were unable to have home
visits; no contact could be made with five patients; and two
patients had died.
At admission, 176 DRPs were identified in the IG (4.4
DRPs per patient) and 155 DRPs in the CG (4.2 DRPs per
patient). The corresponding figures in the two groups at
discharge were 49 DRPs (1.23 DRPs per patient) in the IG
and 148 DRPs (4.0 DRPs per patient) in the CG, implying a
385
reduction of 72% in the IG patients and of 5% in the CG
patients.
Table 2 shows the DRPs for the IG and CG at hospital
admission and at discharge. The most common DRP in
both groups was medication chart error, mainly related to
imperfect or insufficient information about the patient’s
medication before hospital admission. This DRP occurred
so frequently that it was taken out of the category others
and specified separately. The structured patient interview
performed at admission identified 30% of all DRPs at
admission, so these DRPs would have remained undetected
if the patients had not been interviewed by the pharmacist.
Medication chart errors, compliance problems and adverse
drug reactions were most often only detected in patient
interviews. The remaining DRPs identified at admission
were detected by the pharmacist through the use of medical
records and laboratory data.
Table 3 shows the types and frequencies of the DRPs
recorded 3 months after discharge. At the home visits, the
most frequent DRP identified in both groups was patient
compliance problems (category drug use). Fifty-four of the
125 DRPs registered at home belonged to this category.
Half of the compliance problems (27/54) were directly
related to changes made in medication during the hospital
stay. In the IG, 11% of patients (3/30) did not use their
medication appropriately (i.e., they were non-compliant)
because of misunderstanding, compared with 38% (11/29)
of the patients in the CG (P = 0.015). The types of noncompliance were: continued use of drugs that had been
discontinued in hospital; non-use of hospital-prescribed
drugs; and misunderstandings about the new dosage
regimens.
Three months after hospital discharge, 11 of 40 patients
in the IG and 10 of 37 in the CG had been readmitted to
hospital, and one patient in each group had died.
Discussion
In this randomized study, we demonstrated that the participation of a pharmacist in a hospital multidisciplinary team
substantially reduced the number of DRPs observed in
rehabilitation patients. Other researchers have reported
benefits from pharmacists’ participation in the identification
and handling of DRPs in other types of wards [7, 12, 15–20].
Although the inclusion of a pharmacist in the multidisciplinary team was the only intervention, the positive effects
might be partly attributable to factors other than just the
pharmacist’s practical handling of the DRPs. It is likely that
a synergistic effect was achieved with the multidisciplinary
collaboration. Communication between team members with
different skills allows a more comprehensive evaluation and
probably results in improved pharmacotherapy. Among
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386
Int J Clin Pharm (2012) 34:382–388
Table 1 Demographic characteristics, number of drugs, number of clinical/pharmacological risk factors, and number of drug-related problems
(DRPs) of the 77 study patients
Intervention group (N = 40)
Sex, female, % (no.)
57.5% (23)
Control group (N = 37)
67.6% (25)
P value
0.48
Mean (SD) [range]
Mean (SD) [range]
Age
No. drugs on admission
73.5 (12.153) [33–96]
8.25 (2.99) [4–15]
76.8 (11.71) [42–94]
7.8 (2.55) [3–13]
0.22
0.47
No. drugs at discharge
8.53 (3.54) [2–18]
7.7 (2.52) [2–13]
0.25
% (No.)
% (No.)
Clinical/pharmacological risk factors
Diabetes
20 (8)
19 (7)
0.57
Heart failure
17.5 (7)
19 (7)
0.55
Polypharmacy ([5 drugs)
75 (30)
76 (28)
0.58
Renal impairment, GFR B 60 mL/min
Reduced liver function
27.5 (11)
0.3 (1)
32 (12)
0
0.57
0.34
History of allergic reactions/ADRs
15 (6)
24 (9)
0.31
Known non-compliance
5 (2)
5 (2)
0.94
Misuse of alcohol/drugs
30 (12)
19 (7)
0.27
Use of narrow therapeutic index drugs
40 (16)
40.5 (15)
0.57
No. DRPs per patient on admission
4.40 (2.88) [0–13]
4.19 (2.78) [0–12]
No. DRPs per patient at discharge
1.23 (1.21) [0–5]
4.0 (2.24) [0–11]
Home visit (N = 59)
(N = 30)
0.74
\0.01
(N = 29)
No. drugs at home
8.93 (3.98) [1–17]
8.0 (2.58) [2–13]
0.29
No. DRPs per patient at home
1.63 (1.40) [0–5]
2.62 (1.74) [0–7]
0.02
Standard deviations (SD) are given in parentheses and ranges in square brackets
other things, the direct communication between pharmacists
and other staff members during ward rounds or in the multidisciplinary team meetings, where prescribing decisions
are made, allows the pharmacist to explain the background
of his/her recommendations.
All types of DRPs were reduced between admission and
discharge in the IG, but in particular, ‘‘medication chart
errors’’ showed the most substantial reduction. In contrast,
in the CG, the total number of DRPs and the DRP pattern
remained largely unchanged. The lower level of chart
errors in the IG at discharge was attributed to the pharmacists’ intervention, thus confirming the benefit achieved
by including a pharmacist in the drug reconciliation process. Moreover, it seems clear that unintended discrepancies between the medication regimens in hospital and at
home were a common problem. This has also been reported
by others [21, 22].
The patients’ compliance was notably improved in the
IG. Several studies have approached the problem of patient
compliance and a recent Cochrane report concluded that
drug adherence in patients with chronic health conditions is
complex and that new methods are required to improve
123
compliance [23]. Our results indicate that pharmacists are
particularly well suited to address the compliance problem.
A strength of our study is its randomized controlled
design, in contrast with similar studies, which have been
observational. In fact, to the best of our knowledge, this is
the first randomized study of DRPs in rehabilitation
patients. The pharmacists who identified the DRPs during
the home visit 3 months after hospital discharge did not
participate in the hospital part of the study and they were
blinded to whether the patients belonged to the IG or CG.
This circumvented any information bias. One limitation of
the study was the temporal difference between the two
groups in the identification of the DRPs present in hospital:
the IG was followed prospectively and the DRPs of the CG
were assessed retrospectively after discharge. This could
have led to fewer observed DRPs in the CG, because less
information was available to the pharmacist who identified
the DRPs retrospectively. Ethical considerations were
taken into account when a retrospective approach was
chosen for the CG group. The pharmacist could not passively follow the control group prospectively without
intervening if he/she became aware of potentially harmful
Int J Clin Pharm (2012) 34:382–388
Table 2 Types and numbers of
DRPs at admission and at
discharge in 77 hospitalized
patients
387
Categories of DRPs
1. Drug choice
23
52
53
17
20
Unnecessary drug
15
4
13
9
Inappropriate drug choice
20
8
22
24
23
11
24
21
6
2
6
6
11
6
6
3
8
10
3
12
4. Drug interaction
5. Drug use
Patient compliance
Administrative error by health-care professionals
6. Others
Need for monitoring
Medication chart error arising
from incorrect medical records
Others
Summary
Table 3 Types and numbers of DRPsa recorded 3 months after
discharge
No. IG DRPs
(N = 30)
No. CG DRPs
(N = 29)
5
15
Need for additional drug
1
3
Unnecessary drug
Inappropriate drug choice
0
4
3
9
8
5
Too-high dose
4
1
Too-low dose
3
1
Non-optimal drug formulation
or dosing schedule
1
3
10
19
3. Adverse drug reaction
4. Drug interaction
0
1
24
34
23
31
1
3
6. Others
2
2
Summary
49
76
5. Drug use
Patient compliance
Administrative error by healthcare professionals
IG intervention group, CG control group
a
CG at
discharge
11
3. Adverse drug reaction
2. Dosing
CG at
admission
IG at
discharge
57
Too-low dose
Non-optimal drug formulation or dosing schedule
1. Drug choice
IG at
admission
22
Too-high dose
Categories of DRPs
No. CG DRPs (N = 37)
Need for additional drug
2. Dosing
The main DRP categories and
subdivisions are given. IG
intervention group, CG control
group
No. IG DRPs (N = 40)
The method of identifying DRPs at the home visit differed somewhat from the method used in hospital because the medical records
were not available to the pharmacists
15
2
5
8
4
2
5
6
17
3
20
15
16
3
20
14
60
8
49
45
7
4
8
51
4
39
1
1
33
2
0
2
4
176
49
155
148
DRPs. It is also noteworthy that our study could not distinguish which of the different tasks of the pharmacist was
most powerful in reducing the DRPs. Our aim was to
investigate the impact of the whole role executed by the
pharmacist within the hospital care team. However, separate clinical pharmacy tasks, such as medication reconciliation and patient counselling before discharge, have been
assessed in some studies [21, 22, 24, 25].
The results of the home visits showed a significantly
lower number of DRPs in the IG than in the CG 3 months
after discharge. This difference was attributed to the fewer
DRPs in the IG at discharge, thus demonstrating that the
benefit achieved between hospital admission and discharge
was still present 3 months later. However, the DRPs could
not be assessed with the same completeness at the home
visits as in hospital because at the home visits, the pharmacists did not have access to the patients’ medical
information. Therefore, the evaluation was largely based
on the standardized questionnaire, direct patient communication, and information in the medication list provided by
the hospital at discharge. Consequently, for example, the
DRP ‘‘medication chart error’’, which was frequently
recorded in hospital, was not evaluated at the home visit.
Conversely, an obvious advantage of the home visit was
that the pharmacists could check on the medicines in the
patients’ possession in their homes.
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Int J Clin Pharm (2012) 34:382–388
In Norway, there has been growing interest in medication reviews and patient counselling by pharmacists, both
in ambulatory care and in hospital. Although no legal
regulations have been put in place, the Norwegian Ministry
of Health and Care has encouraged projects that provide
information about how to improve the use of medicines
[26].
Conclusion
In conclusion, the involvement of a pharmacist in drug
therapy management, including his/her participation in
multidisciplinary team discussions, markedly improved the
identification and resolution of DRPs during patients’
hospital stays. The benefit of the pharmacist’s involvement
persisted after the patients were discharged.
Acknowledgments We thank Jan Egil Røe and Anne Gerd Granås
for their general support during the study, and Teresa Lüdde for
database registration.
Funding We thank the Norwegian Directorate of Health for financial support.
Conflicts of interest
None to declare.
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