SCIENCE &
PRACTICE
Effect of a Training Program on
Community Pharmacists'
Detection of and Intervention in
Drug-Related Problems
by Jay D. Currie, PharmD, Elizabeth A. Chrischilles, PhD, Angela K. Kuehl, PharmD,
and Raymond A. Buser
Abstract
Objective: To develop and present a pharmaceutical
care training program for pharmacists, and to examine the
ability of these pharmacists to provide pharmaceutical care
in a community pharmacy setting.
Design: Prospective, randomized study.
Intervention: A 40-hour pharmaceutical care training
program was developed and presented to pharmacists,
and 1,078 patients were randomly assigned to receive
either (1) traditional pharmacy services or (2) pharmaceuti-
cal care, consisting of initial patient work-up and follow-up
with documentation in a patient record.
Measurements: The study period was six months.
Pharmacists documented problems identified, actions tak-
en, and time required for all patients.
Results: Pharmacists consistently identified and inter-
vened to address problems in both study groups. Patients
receiving pharmaceutical care were more than seven times
as likely to have any problems identified (odds ratio [OR]
7.5; confidence interval [Cll 4.2-13.1), more than eight
times as likely to have an intervention performed (OR 8.1 ;
CI 4.7-14.2), and more than eight times as likely to have a
drug-related problem identified (OR 8.6; CI 4.8-15.5) than
were patients receiving traditional pharmacy services only.
Time spent counseling patients was similar for the two
groups.
Conclusions: The training program proved to be an
effective way to increase the number of problems identified
and addressed by pharmacists.
journal of the American Pharmaceutical Association
Introduction
Pharmacists have long interacted with patients, but until '
recently the focus of the interaction was either the drug
product itself or the proper use of that product. Adequate
counseling about medications is an important aspect of a
pharmacist's duties to the patient, yet it does not connote the
provision of care. The new focus on pharmaceutical care
requires the pharmacist to develop a new relationship with
the patient and to take on new responsibilities. 1 ,2 In 1990
Hepler and Strand defmed pharmaceutical care as
the responsible provision of drug therapy for the purpose of
achieving specific outcomes that improve a patient's quality
of life. These outcomes are 1) cure of a disease, 2) elimina-
tion or reduction of a patient's symptomatology, 3) arresting
or slowing of a disease process, and 4) preventing a disease
or symptomatology. 3
"
This philosophy of practice involves, by ·definition , an
interdisciplinary team approach that may be more easily envi-
sioned in an institutional environment than in the communi-
ty pharmacy. However, the need for pharmaceutical care in
the ambulatory care setting is evidenced by the gro~ing
body of literature on drug-induced morbidity and mortality.
When this study was performed in 1992 through 1994, there
was little published research evaluating the benefits of p har-
maceutical care in an ambulatory setting. Yet the research
that was available clearly indicated that a significant propor-
tion of hospital admissions (from 2.9% to 7.9%) result from
adverse drug reactions. 4-6 Medication errors were found to be
especially common in patients who have recently been dis-
charged from the hospital. Patients taking multiple medica-
tions at the time of discharge and those whose drug regi-
Marchi April1997 Vol. NS37, No. 2
 ... SCIENCE
Table 1
Elements of the Pharmaceutical Care
Training Program
Part 1
Pharmaceutical Care Philosophy
Evolution of pharmacy practice
Extent of drug-related problems
Definition of pharmaceutical care
Roles and responsibilities of pharmacist in
providing care
Implementing Pharmaceutical Care
Establishing practice ideals
Identifying and addressing probable barriers to
implementation
Necessary pharmacy structural and procedural
changes
Identification of Drug-Related Problems
Necessary data collection
Categorization of drug-related problems
Process of determining problem existence
Clinical drug-related problem solving
Development of a Problem-Oriented Pharmacy Record
Concepts of a problem-oriented record
Components of a problem-oriented pharmacy record
Rationale behind structured patient care notes
Characteristics of a good patient care note
Components of a SOAP note
Communication Skills Development
Barriers to effective communication
Nonverbal communication
Open-ended questions
Empathy
Conducting a patient interview
Assertiveness
Part 2
Collecting a Patient History
Medication history
Medical hi_s tory
Relevant review of systems
Initial interview versus follow-up
Systematic Approach to Problem Solving
Completion of the Problem-Oriented Pharmacy Record
Use of problem lists
Generation of SOAP notes
Development of a Follow-Up Mechanism
Group Case Review
Individual Case Review
Videotaping of Interview Technique
Evaluation of Pharmacist Skills
SOAP = Subjective Objective Assessment Plan.
Vol. NS37, No.2 March/April1997
& PRACTICE
mens changed frequently during their hospital stay were
found to be more likely to make errors after discharge, such
as taking a discontinued medication or not complying with a
regimen change. In this study, medication counseling before
hospital discharge did not appear to affect the results.7 Non-
compliance with prescribed therapy is also an important
cause of drug-related morbidity and mortality; a meta-analysis
by Sullivan et al. found that 5.3% of hospital admissions could
be attributed to noncompliance. 8 Taken together, these data
suggest that patients would benefit from ongoing monitoring
of drug therapy. However, to accomplish this, an organized
and reproducible method needs to be developed for provid-
ing pharmaceutical care in the ambulatory setting.
Several reports have discussed the potential for community
pharmacists to add significantly to the care of patients.
McKenney et al. observed that community pharmacists were
effective in improving compliance with antihypertensive
therapy, with improved blood pressure control as a result. 9
The pharmacist training program credited for these results
was disease-specific, and only high-risk patients participated.
This study highlighted the impact that a community pharma-
cist could have in the management of a chronic disease. A
Department of Health and Human Services report published
in 1990 concluded that clinical pharmacy services add value
to patient care in both institutional and ambulatory settings
and can reduce health care costS.l0 However, the report
acknowledged that such services are not widely available in
ambulatory settings, and it identified several "barriers" that
could limit the provision of these services. Barriers included
product-based reimbursement, physician/pharmacist con-
flicts regarding professional roles, information access prob-
lems, pharmacists' lack of training to provide direct patient
care, and low desire on the part of patients for pharmaceuti-
cal care. This report acknowledged that the barriers may be
difficult to overcome, and that different solutions may be
needed for each practice setting. Penna identified additional
barriers, possibly the most significant of which is the reluc-
tance of pharmacists to accept this new responsibility. 11
At the time our study was initiated, some information on
the value of pharmacy services in community pharmacy was
beginning to appear in the literature, although, as noted
above, this information was limited. 12 Rupp et al. reported
that 2.6% of new prescription orders presented at a commu-
nity pharmacy had errors that required active pharmacist
intervention; approximately 80% of these were prescription-
based errors and omissions (incomplete or vague information
regarding the drug, strength, or directions). 13 Christensen
et al. found problems with approximately 4% of prescription
orders presented to an outpatient health maintenance organi-
zation , most commonly drug interactions and drug
underuse. 14 These studies describe problems identified by
the pharmacist, but were oriented to problems associated
with the prescription order versus global assessment of the
journal of the American Phannaceutical Association
 ... SCIENCE & PRACTICE

patient's drug therapy. tural/procedural changes in the pharmacy; (4) enrollment of

Since these studies were published, Strand et al. have iden-
tified further categories of "drug-related" problems that focus
on the patient's therapy as a whole. I5 These eight categories
are: (1) medical indication for additional drug therapy; (2)
wrong drug being taken; (3) too little of the correct drug
being taken; (4) too much of the correct drug being taken; (5)
adverse dnlg reaction present; (6) drug-drug, drug-food,
drug-laboratory interaction; (J) not receiving the prescribed
drug; and (8) no valid medical indication for drug therapy.
Identification of problems in these categories requires the
pharmacist to evaluate the safety, effectiveness, and appropri-
ateness of a particular patient's drug therapy, and to routinely
monitor the patient for progress toward therapeutic goals,
signs of drug-therapy problems, and satisfaction with care.
This focus on the patient-rather than the prescription
order-is the basis of pharmaceutical care. The need is evi-
dent for well-designed studies evaluating pharmaceutical care
in the ambulatory setting.
This study was designed to examine the ability of patient-
oriented pharmacists to provide pharmaceutical care in a
community pharmacy setting. Specific study goals were (1) to
develop an educational program that prepares community
pharmacists to collect and analyze the information needed to
identify and resolve drug-related problems; (2) to determine
whether the educational program could increase the number
of drug-related problems identified and interventions made by
community pharmacists; (3) to describe the types of prob-
lems and actions taken by the pharmacists; and (4) to
describe the information sources used by pharmacists when
resolving identified problems.
intervention patients and initiation of the intervention; and
(5) a six-month period of interventions and data collection,
Informed consent was obtained after randomization for inter. )
vention patients only, because of the passive nature and large
size of the control group. This "prerandomization" stUdy
design is described by Ellenberg. 16 )
Selection of Potential Intervention Patients
Ambulatory, noninstitutionalized patients who had had two
or more prescription orders filled at the study pharmacy duro )
ing the preceding 12 months were considered eligible stUdy
candidates. One-half of all eligible patients were randomly
selected as the study population; the other half were reserved
for use as a replacement pool in order to meet study goals for
numbers of intervention patients. Of those selected, 120
patients were then randomly selected as the intervention t
(pharmaceutical care) group and the rest (n = 1,000) became
the control group.
Although this study was originally planned as a pilot study,)
sample sizes were selected to ensure greater than 80% power
to detect a difference of no more than 6% between the con·
trol and intervention groups. Only 23 of the 91 originally
selected intervention patients eligible after exclusion were
enrolled in the study. Study pharmacists reviewed the replace·
ment pool and identified supplemental patients whom they
believed would be willing to participate. The 86 supplemen·,·
tal patients identified (before exclusions) were randomized to
intervention or control status. Intervention-eligible patients
were then invited to enroll as described below.

Table 2
Methods and
Subject Selection and Enrollment
Materials
Intervention Control

A prospective, randomized Original patients'"

study was conducted at Clax- Selected 120 1,000
ton Pharmacy, an indepen- Eligible after exclusions 91 905
dent community pharmacy Number enrolled 23 905
in Cedar Rapids, Iowa (popu- Supplemental patients t
lation approximately
Selected 43 43
100,000), from May 1992 to
Eligible after exclusions 41 41
January 1994. The order of
study events was: (1) ran- Number enrolled 14 41
dom selection of potential Total eligible after exclusions 132 946
intervention patients; (2) Total enrolled 37 946
design of a data collection
mechanism and initiation of * Original patients were those initially assigned to intervention or control groups,
tSupplemental patients were those selected later from the replacement pool because of low enrollment rates
data collection; (3) educa- among the original patients,
tional intervention and struc-

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 ~ SCIENCE & PRACTICE ~

Figure 1
three full-time pharmacists
Distribution of Drug-Related Problems by Study Group who were the principal care
providers at the pharmacy.
Each part was taught over a
Drug use without indication II Intervention period of several days from
mid-July to mid-August 1992.
Not receiving prescribed drug
D Control Content was based on the
available literature and on
Drug-drug/food interaction
contributions from pharmacy
and medical clinicians. The
Adverse drug reaction
focus was on improvement of
Lower dose needed
problem-solving and commu-
nication skills; therapeutic
Higher dose needed information was not includ-
ed. The time required by
Wrong drug being taken each pharmacist to complete
the educational portion of
Untreated indication the program was approxi-
o 10 20 30 40 50 60 70 mately 40 hours. Of this,
Percentage of all identified drug-related problems approximately 30 hours were
spent in direct contact with
the educator, with the
Documentation remaining 10 hours spent on independent study. After suc-
Before the patients were enrolled, the pharmacists began cessful completion of the program, pharmacists were
logging identified problems for all pharmacy patients on a assessed for their ability to collect and analyze patient data,
Pharmacist Intervention Report Form (pIRF), adapted from a identify problems, solve problems, develop intervention
previously published form.13 The PIRF was used for all strategies, and document patient care.
patients throughout the study period. Study pharmacists com-
pleted a PIRF each time a problem was identified and when-
ever time was spent with an intervention patient. Categorical Pharmacy Changes
I information collected on the PIRF included patient demo- Structural and procedural changes were made in the study
graphics, the type of problem identified, the action taken to pharmacy to facilitate the provision of pharmaceutical care.
resolve it, the information sources used by the pharmacist in Structural changes included limited remodeling to create a
resolving the problem, and the time spent by the pharmacist patient care area. A merchandise counter, a Post Office area
in various activities. The PIRF was used only as a data collec- located in front of the dispensing area, and a perpendicular
tion tool for the study. It was not used for patient data collec- counter with cash register were removed to allow for the cre-
tion, the provision of care, or the documentation of patient ation of an 8-by-l0-foot semi-private consultation area, separat-
care. ed from the rest of the pharmacy by 7-foot-high framed walls.
Problems were differentiated as either prescription-related This arrangement accommodated sit-down interactions with
or drug-related. Prescription-related problems included those patients, and the consultation area included a desk, table and
that involved the ability of the pharmacist to dispense the pre- chairs, computer, and space for storage of patient records.
scription order correctly (e.g., incorrect drug or dosage, omis- Adjacent to this area was a five-foot-Iong counter used for
sion of information). Drug-related problems included those stand-up interactions. Both areas were accessible from the dis-
identified by Strand et al. 15 as previously described. These pensing area and the patient waiting area. Procedural changes
allowed the pharmacist to categorize issues relating to the involved new documentation methods and allocation of
therapeutic appropriateness of the patients' regimen. All PIRF noncognitive duties to an experienced technician. Changes
data were reviewed for completeness and proper coding by were made at the discretion of the study pharmacists.
the investigators.

Enrollment of Intervention Patients/

Pharmacist Educational Program Initiation of Intervention
The two-part educational program (Table 1) was developed The study was approved by the local institutional review
and primarily taught by one of the investigators ODC) to the board. Informed consent was obtained from patients

journal of the American pharmaceutical Association

Vol. NS37, No.2 MarchiApri11997
 .. SCIENCE & PRACTICE ~

Distribution of Identified Problem Types by Study Group

Intervention Control

No. (%) Total No. of Problems No. (%) of Total No. of Problems
Problem Type Problems Identified per 100 Patients Problems Identified per 100 Patients

Total prescription- 0(0) 0 5 (15.2) 0.5

related problems
Incorrect drug/dose/form 0(0) 0 2 (6.1) 0.2
Omission on prescription 0(0) 0 1 (3.0) 0.1
Lack of patient understanding 0(0) 0 1 (3.0) 0.1
Other 0(0) 0 1 (3.0) 0.1
Total drug-related problems 76 (100) 57.6 28 (84.8) 3.0
Drug needed/untreated 9 (11.8) 6.8 1 (3.0) 0.1
indication
Wrong drug being taken 18 (23.7) 13.6 4(12.1) 0.4
Higher dose needed 3 (3.9) 2.3 1 (3.0) 0.1
Lower dose needed 4 (5.3) 3.0 4 (12.1) 0.4
Adverse drug reaction present 11 (14.5) 8.3 0(0) 0
Drug-c/rug/drug-food 16 (21.1) 12.1 17 (51.5) 1.8
interaction
Not receiving prescribed drug 5 (6.6) 3.8 0(0) 0
Drug use without indication 10 (13.2) 7.6 1 (3.0) 0.1

randomly selected for the intervention before being inter-
viewed. Recruitment and enrollment was initiated after the
educational intervention. Control patients were not infonned
about the study. For control patients, data collection occurred
over the entire period that intervention patients were
enrolled. For intervention patients, the period of data collec-
tion was six months after enrollment.
Intervention patients were interviewed by the pharmacist,
and medication and medical infonnation was collected and
documented on a modification of the Pharmacist's Workup of
Drug Therapy form described by Strand et al. 17 Phannacists
then used this information to develop a Problem-Oriented
Pharmacy Record (POPR), or patient chart, in which all of the
drug-related problems for that patient were recorded. A
patient-specific list of drug-related problems was created
using the categorization method developed by Strand et al. 15
A one-page problem list was developed as a cover sheet and
table of contents to the POPR. This sheet summarized the cur-
rent medications, as well as medical and drug-related prob-
lems. The Subjective Objective Assessment Plan (SOAP) for-
mat was used to summarize the problems identified and to
record the thoughts and actions of the pharmacists. The
PO PR served as the primary reference and documentation
source for the pharmaceutical care of intervention patients by
the phannacist.
Control patients received the standard care provided to all
patients at the pharmacy. The main source of information for
control patients was the computerized medication profile,
which was reviewed when each new or refill prescription
order was presented. Standard care at this pharmacy included I
screening for drug allergies, drug interactions, therapeutic
incompatibilities, and appropriate medication use, as well as
patient counseling; standard care did not include the collec·
tion of additional information about patients' current drug
therapy.
Statistical Analysis
Information on problem identification and resolution duro
ing each patient visit was extracted from the PIRF. Compar·
isons between the intervention and control groups for pro-
portions of patients for whom problems were identified or
actions taken were done using fisher's exact test and the
Mantel-Haenszel Chi-Square test, controlling for original ver-
sus supplemental patients. All analyses were two-sided, and
p values less than 0.05 were considered statistically Signifi-
cant. The Mante1-Haenszel test was used for comparative anal-
yses of the groups with respect to types of problems identi-
fied, types of actions taken, and types of information sources
consulted. Differences between groups in mean times
required were calculated using the Wilcoxan TWO-Sample
test.

journal of the American Phannaceutical Association March/April1997 vol. NS37, No. 2

 .. SCIENCE
Number of Patients with at Least One Problem Detected by Study Group
Study Group Number of Patients
Intervention 41
Control 41
Mante/-Haenszel
overall odds ratio
* Original patie nts w ere those initially assigned to intervention or control groups; s upplemental patients were those selected later from the replacement
pool because of low enro llment rates among the o rig inal patients.
t Fisher's exact test, p < .0001.
:j: Mantel-Haenszel Chi-Square , p < .0001 .
Results
Recruitment and Enrollment
Patient randomization and enrollment results are shown in
Table 2. Patients were excluded for the following reasons: use
of medical equipment or devices only, subsequent admission
to long-term care facilities or group homes, relocation out of
the area, inability to speak English, and death. Overall,
because of difficulties in obtaining patient consent, only 25%
of those initially selected for the intervention group (and not
subsequently excluded) actually enrolled (i.e., received the
pharmaceutical care intervention). Reasons for non-
enrollment were inability to contact patient (55%), patient
refusal (21%), patient death/relocation (11%), and unknown
(13%) (pharmacist did not record reason). All analyses (unless
otherwise specified) nevertheless include the 132 individuals
eligible for intervention, regardless of whether the patient
was ultimately enrolled.
Problem Types Identified
During the study period, 109 problems were identified in
all study patients (Table 3). Problems identified totaled 76 and
33 in the intervention and control groups, respectively. No
prescription-related problems were detected in the interven-
tion group. Approximately 85% of all problems identified in
the control group were drug-related.
Table 3 displays problems identified per 100 patients in
each study group. There were 57.6 drug-related problems
identified per 100 intervention patients, compared with 3.0
Vol. NS37, No.2 MarchiApril 1997
& PRACTICE ~
Table 4
Number (0/0) of Patients 95% Confidence
with Pro.blem Detected Odds Ratio Interval
12 (29.3) 3.S t 1.1,13.1
4 (9.8)
7.5+ 4.2,13.1
problems per 100 control patients. The most common
drug-related problem identified in the intervention group
was "wrong drug being taken " (13.6 problems per 100
patients); in the control group it was "drug-drug/drug-food
interaction" (1.8 problems per 100 patients). Percentage
distributions of types of drug-related problems identified in
both groups are shown in Figure 1. Statistical comparison
of the breakdown of drug-related problem types identified
in each group was generally nonsignificant, with wide con-
fidence intervals reflecting the small numbers for compari-
son in each separate category. However, a significantly
higher percentage of drug-related problems identified in
the control group were in the "drug-drug/drug-food inter-
action" category (p < 0.005), as compared with the inter-
vention group.
Types of Actions Taken for Problem Resolution
Figure 2 shows the distribution of actions taken for prob-
lem resolution for the two study groups. The number of
actions taken was 93 for the intervention group and 74 for
the control group. Patient counseling was the most common
action taken-66% of total actions taken for the intervention
group and 32% for the control group. Prescription-related
actions (clarifications, changes, etc.) accounted for a larger
proportion of action types in control as compared with inter-
vention patients, 40.5% versus 7.5%, respectively.
Frequency of Problem Identification
and Resolution
Table 4 shows numbers of intervention patients versus con-
trol patients in the original and supplemental groups who had
journal of the American Pharmaceutical Association
 ... SCIENCE & PRACTICE

at least one problem identified. The odds of problem identifi-
cation for intervention patients were seven and one-half times
greater than for control patients after combining original and
supplemental groups. The overall odds ratio (OR) for drug-
related problem identification was 8.6 (95% confidence inter-
val [CIl, 4.8-15.5). Likewise, the odds of taking action to
resolve problems for patients in the intervention group were
more than eight times greater than in patients in the control
group (OR 8.1 ; 95% CI, 4.7-14.2).
group was the POPR and communication with the patient;
the patient served as an information source for .a significantly
higher proportion as compared with the control group
(P < 0.0001). Pharmacists primarily consulted the prescriber
or prescriber agent, the medication profile, and the patient as
information sources for the control group. Consultation with
the prescriber or prescriber agent represented a signmcantly
higher proportion of patients in the control group (p < 0.01).

Time Requirements Discussion

Figure 3 displays the distribution of time spent with
patients in both groups. Mean time spent counseling patients
was similar in both study groups (p > 0.24). Mean counseling This study found that pharmacists can and do identify prob-
time per problem was 2.0 minutes and 2.3 minutes for the lems related to patients' drug therapy. This is especially true
intervention and control groups, respectively. Counseling when the pharmacist spends additional time with the patient
time was less than seven minutes for almost all problems. collecting a detailed medication history and medical history,
Information collection during the iilltial interview accolmt- and uses a systematic process to evaluate that information.
ed for much of the time spent with intervention patients. The distribution of types of problems identified varied
Time required for initial interviews in intervention patients between the study groups. As would be expected, a trend
decreased as the study progressed. Documentation time was found in the intervention group toward more frequent
(using the POPR) for intervention patients averaged 9.9 min- identification of drug-related problems (e.g., untreated indica· I
utes per problem in the intervention group. For the 37 tion, wrong drug being taken, adverse drug reaction present,I
enrolled patients only, a total of 114 minutes was required and drug use without indication) that would require a more
over the six-month intervention period for additional follow- detailed patient history to identify. The lack of prescription·
up encounters. In addition, pharmacists spent 23 minutes related problems in the intervention group may be explained
total over the course of the
study providing additional Figure 2
documentation of follow-up
encounters or monitoring for Percentage of Total Actions Taken for Problem Resolution
intervention patients when by Study Group
no new problems were iden-
tified. Thus, in the interven-
tion group, the majority of Prescription order dispensed as written .....- - - - ,
• Intervention
pharmacist time was spent in
the initial patient "work-up, " Prescription order clarified and dispensed
Control o
as opposed to follow-up
patient encounters. Prescription order changed

Prescription order not dispensed

Information Sources
The medication profile
Patient counseled • • • • • 1111•••••••
was the most frequently con-
Written information given
sulted information source for
problem evaluation in the

_-II-
Recommendation to physician
intervention group , and
served as an information
qther
source for a significantly
higher proportion of patients
o 10 20 30 40 50 60 70 80
than in the control group
Percentage of total actions taken
(P < 0.0001). Next in fre-
quency for the intervention

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fP.!!II March!Aprlll997 Vol. NS37. No.2 I
 .. SCIENCE & PRACTICE ~

Figure 3
patients were more than
Distribution of Time Spent with Study Patients eight times than for control
patients.
In order to conclude that
the difference seen between
groups was primarily a result
of the pharmaceutical care
Intervention
intervention, it is necessary to
consider the likelihood of
other possible explanations.
For example, the possibility
exists that the pharmacists
might somehow have altered
their care practices and docu-
II Documentation mentation for the control
Counseling patients in such a way as to
Control
II Interview/Data Collection result in underreporting for
this group. However, previ-
ous community pharmacy-
based studies have reported
o 5 10 15 20 25 30 cognitive services documen-
tation rates ranging from
Minutes
0.8% to 4.9% of prescription
orders filled. 13 ,14 ,18,19 The
lower end of this range repre-
by the fact that the ca.re being provided was often not related sents studies in which pharmacists self-reported problems
to the dispensing process itself. However, the high percent- (similar to the methods used in this study), as opposed to rely-
ages of "drug interaction" and "lower dose needed" problem ing on direct observation and documentation by a researcher.
types identified in the control patients speak favorably of the Although the percentage of documented problems in the con-
pharmacist's role in screening for problems during the dis- trol group was slightly below this range (0.4% of prescription
pensing process. orders filled), it is unlikely that underreporting was solely
The provision of pharmaceutical care to intervention responsible for such a large difference between groups. Fur-
patients resulted in impressive odds for the identification of thermore, it is unlikely that selection bias could have account-
problems in this group relative to the control patients. Specifi- ed for the large difference, because intervention patients
cally, for patients selected for the pharmaceutical care inter- were randomly selected. Had another patient selection
vention, the odds of identifying a problem were more than method been used (e.g., allocating only high-risk patients to
seven times greater than those for patients who received tra- the intervention group), there would have been a higher like-
ditional pharmacy services. Furthermore, this odds ratio is lihood of selection bias.
almost certainly an underestimation of the true effect of this In this pilot study, we believed that it was most appropriate
pharmaceutical care intervention, because all 132 randomized to randomly select patients to receive the pharmaceutical care
patients were included in the analysis and only 37 ultimately intervention, and then obtain informed consent only from
were enrolled and received the intervention. Considering those selected patients. The size of the study population
only the 37 patients who actually received the pharmaceutical made it logistically impossible to obtain informed consent
care intervention, approximately two problems were identi- from all eligible patients before randomization. An alternative
fied per patient. would have been to obtain consent from a small portion of
The number of actions taken to resolve problems in both eligible patients, then randomize them to the intervention or
stUdy groups was similar to or greater than the total number control groups. However, it was anticipated that asking phar-
of problems, indicating that pharmacists do attempt to resolve macists to provide two different levels of care to two small
identified problems. Significantly more prescription-related groups of patients would entail difficulties with logisticS and
actions were taken to resolve problems identified in the con- bias. It seemed logical that pharmacists could more easily pro-
trol group, reflecting the larger percentage of prescription- vide appropriate care if all patients not selected for the inter-
related problems identified in these patients. The odds of vention were considered to be the control group. Because
pharmacists taking problem-solving actions for intervention control patients received standard pharmacy care, and data

Journal of the American Phannaceutical Association

Vol. NS37, No.2 March/April1997
 <II SCIENCE
were collected anonymously, informed consent was not
required from these patients.
These results indicate that the educational program in phar-
maceutical care skills and the implementation of these skills
in practice successfully increased the rate of problem identifi-
cation. It is important that this study evaluated the effective-
ness of an intensive, process-based pharmacist education pro-
gram by evaluating drug-related problem rates as documented
by the pharmacists providing care. According to a study by
Kimberlin et al., there was no difference in the rate of drug-
therapy problem detection between geriatric patients whose
pharmacists did or did not receive an educational interven-
tion. 2o However, the educational intervention was less inten-
sive, fewer categories of problems were evaluated, and docu-
mentation systems for patient information and problem
identification were not reported. These authors concluded
that" .. .it is our belief.. .that an effort to successfully imple-
ment changes in community pharmacy that would lead to
comprehensive improvements in patient drug therapy
requires a restructuring of the environment or system in
which pharmacists practice. " 20 Indeed, the combination of
pharmacist education and pharmacy restructuring that was
performed in this study did lead to increased identification of
and intervention in drug therapy problems.
We did not evaluate whether the additional drug-related
problems identified may have resulted in decreased health
care expenditures for the patients. Although economic out-
comes were not directly evaluated in our study, a recent cost-
of-illness study estimated the costs associated with various
adverse outcomes of drug-related problems. 21 The authors
concluded that drug-related morbidity and mortality should
be considered one of the leading diseases in terms of
resources consumed, and that even a 10% reduction in pre-
ventable drug-related morbidity and mortality could lead to
substantial savings to the health care system. Recently pub-
lished reports further highlight the potential role of the phar-
macist in terms of having an impact on both the cost and
quality of therapy. Lesar et al. 22 described the incidence and
Significance of drug misprescribing in the inpatient setting.
Hospital pharmacists averted over 2,100 clinically significant
medication prescribing errors, 3.99 per 1,000 orders, in one
hospital over the course of one year. Other articles describe
the incidence and costs associated with adverse drug events
in hospitalized patients. Adverse events occurred at a rate of
2.43 per 100 admissions and resulted in 1.74 additional days
in hospital and a mean cost of over $2,000 per event in a
study by Classen et al. 23 Nearly 50% of the adverse events
were judged to be preventable. Bates et al. 24 found an
increased length of stay of 2.2 days with an associated cost of
over $3,200 per adverse drug event. In their study 28% of
events were deemed preventable and were projected to cost
the study hospital $2.8 million per year. Further work needs
to be done to identify the impact of community pharmacist
Journal of the American Pharmaceutical Association
& PRACTICE ~
interventions to decrease the rates of medication prescribing
errors and prevent adverse drug events, thus reducing overall
health care costs. Because identification of drug-related prob-
lems, as in our study, does not preclude adverse outcomes.
further research is needed to evaluate such outcome
measures.
Despite the difference seen in problem identification rates.
mean time spent counseling patients was similar in both
groups. This disputes the common assumption that provision
of pharmaceutical care primarily involves patient counseling.
Rather, the two activities in the intervention group that
required the most time were the initial interview and docu·
mentation of care. Once the initial work-up time was invest·
ed, the time needed to monitor and document care for the 3"7
enrolled intervention patients over the six-month period was
only slightly over two hours. No other study has measured
time requirements for providing pharmaceutical care for this
long a period. This information may provide some reassur·
ance for those who fear that providing pharmaceutical care to
large numbers of patients would involve an insurmountable
time commitment.
The pharmacists became more efficient as the study pro-
gressed, requiring less time for patient interviews and docu·
mentation toward the end of the study period. Documenta·
tion methods were revised to enable more concise and
efficient collection of information.
Some mention is warranted of the difficulties encountered
by the investigators, because it is likely that these issues will
resurface in future studies of this type. The major problem
proved to be enrollment of patients in the pharmaceutical
care (intervention) group. Patients ' reluctance to sign
informed consent documents was a major barrier. In addition.
many patients did not present for scheduled interviews or
were otherwise unwilling to commit the time necessary for
the interview. This suggests that patients did not recognize an
advantage to spending this time with the pharmacist. Yet an
informal pre-study survey indicated overwhelming support on
the part of pharmacy patients for the proposed pharmaceuti-
cal care services and a willingness to participate, should such
services be offered. Once the study was underway, however.
these same respondents often would not commit to an inter-
view. Obviously, patients have reservations about receiving
these services, which are new to them. Much of this reluc-
tance seemed to be due to fear of the unknown, even in a
pharmacy with a history of a high level of service. An organ-
ized effort to educate patients about the potential benefits of
pharmaceutical care and the types of changes to expect
would likely increase patient acceptance. Furthermore, the
routine provision of pharmaceutical care to all patients would
facilitate further study because these services would become
a familiar (and not a research-oriented) aspect of patient care.
Completing this study also proved to be challenging for the
pharmacists involved. Major changes in pharmacy layout and
MarchiApril1997 Vol. NS37, No.2
 .. SCIENCE & PRACTICE
, function were necessary. Financial commitment was involved
in making structural changes to the pharmacy and increasing
staff, and new documentation methods were introduced.
Conclusion
This prospective, randomized study founq pharmacists to
be more than seven times as likely to identify at least one
problem in patients to whom they were providing pharma-
ceutical care. The most common types of drug-related prob-
lems identified differed between the intervention and control
groups: "wrong drug being taken" was most commonly noted
in the intervention group, and "drug-drug/drug-food interac-
tion" was most commonly noted in the control group. Phar-
macists consistently took actions to resolve the problems
identified. Distribution of the information sources that phar-
macists consulted to resolve problems also differed between
the intervention group and the control group. Although total
time spent with patients was greater in the intervention
group, counseling time was similar between groups; observed
differences in total time were attributable to the initial work-
up time, documentation, and greater monitoring time for
patients in the intervention group.
Making the transition to a pharmaceutical care practice is
challenging. In addition to changes in work flow and pharma-
cy layout, such a transition involves a restructuring of the
pharmacists' behavior and thought processes. To this end,
perhaps the greatest challenge met by the study pharmacists
was their commitment to integrate the philosophies of phar-
maceutical care into their practice. After making a commit-
ment to the change in practice philosophy, a process-based
approach to pharmaceutical care education, as presented in
this study, gave the pharmacists the basic tools they neede~
to implement pharmaceutical care on a day-ta-day basis.
jay D. Currie, PharmD, is assistant professor (clinical), College
of Pharmacy, University of Iowa. Elizabeth A. Chrischilles, PhD, is
associate professor, Department of Preventive Medicine, College of
Medicine, University of Iowa. Angela K Kuehl, PharmD, is clinical
pharmacist, Department of Preventive Medicine, College of
Medicine, University of Iowa. Raymond A. Buser is president, C.R.
Pharmacy Service, Inc., Cedar Rapids, Iowa.
This research was funded by a grant from the Iowa Pharmacy
Foundation.
Acknowledgments
The investigators would like to thank the follOWing pharmacies
and pharmacists without whose efforts this study would not have
been possible: Claxton Pharmacy: Tim Starry, Melinda james, and
Jeff Reist, FASCP. Shepley Pharmacy: Al Shepley, Doug Wetrich, and
Vol. NS37, No.2 March/April1997
Donnette johnson. The investigators would like to thank RobertJ
Cipolle, PharmD (University of Minnesota), for allowing the use of
the Pharmacist's Workup of Drug Therapy worksheet in this study,
and Donald AF Nelson, MD, and Russell H Brown, PhD, for their
assistance in presenting the educational program.
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