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n estimated 3–28% of all medi-
Abstract: The effect of pharmaceutical care ing improved in all 10 domains evaluated in
cal hospitalizations are due to
on the prevention, detection, and resolu- the intervention group but worsened in 5
preventable adverse drug tion of medication-related problems in domains in the control group. There were
events (ADEs), defined as medication- high-risk patients in a rural community was no significant differences between the
related injuries.1,2 Drug-related mor- studied. groups at 12 months in health-related qual-
bidity and mortality are estimated to Adult patients who received care at clin- ity of life or medication misadventures.
cost more than $136 billion annual- ics in a medically underserved area of Ala- Medication compliance scores improved in
ly.1 Average medical costs may be bama and who were identified as being at the intervention group but not in the con-
high risk of medication-related adverse trol group. Medication knowledge in-
increased by $2000 per ADE, and av-
events were randomly assigned to a control creased in the intervention group and de-
erage hospitalizations may be length- group or an intervention group. The control creased in the control group.
ened by approximately two days.1,3 In group received standard medical care, and the Pharmaceutical care in a rural, community-
addition, patients may have unex- intervention group received pharmaceuti- based setting appeared to reduce inap-
pected or excessive drug responses cal care, including a medical record review, propriate prescribing, enhance disease
requiring discontinuation or modifi- a medication history review, pharmaco- management, and improve medication
cation of the regimen or possibly therapeutic evaluation, and patient medi- compliance and knowledge without ad-
cation education and monitoring over a versely affecting health-related quality of
hospitalization. These incidents,
one-year period. life.
which are referred to as adverse drug A total of 69 patients completed the
reactions (ADRs), can result in tem- study (33 in the intervention group and 36 Index terms: Anticoagulants; Compliance;
porary harm, disability, or death.2 in the control group). The percentage of Diabetes mellitus; Drugs, adverse reactions;
Errors in the prescribing and patients responding to hypertension, dia- Hyperlipidemia; Hypertension; Interven-
management of drug therapy are re- betes, dyslipidemia, and anticoagulation tions; Patients; Pharmaceutical care; Phar-
therapy increased significantly in the inter- maceutical services; Prescribing; Quality of
sponsible for many ADEs.4 Inappro-
vention group and declined in the control life; Rational therapy
priate prescribing is prevalent among Am J Health-Syst Pharm. 2003; 60:1123-9
group. Ratings for inappropriate prescrib-
elderly patients and is associated with
undesirable outcomes. Previous
studies suggested that up to 51% of
medications for elderly patients rors.4 Medication errors, ADEs, and sponse and is always unexpected or
might be overused and that up to ADRs are collectively defined as undesirable to the patient.”2
90% might be misused.5,6 Lack of medication misadventures, in which Most research describing ADEs,
knowledge and lack of timely access an iatrogenic incident occurs that ADRs, and medication errors has
to patient information are consid- may be attributable to “error, immu- been conducted in hospital environ-
ered root causes of prescribing er- nologic response, or idiosyncratic re- ments, not outpatient settings. 7
Therefore, factors associated with United States and is characterized by consent. Patient enrollment began in
outpatient ADEs are unclear. Addi- a low life expectancy, a low ratio of January 1999. High risk was defined
tional information is particularly physicians to residents, inadequate as presence of three or more of the
needed regarding medication misad- prenatal care, and high rates of sexu- following risk factors: five or more
ventures in rural outpatient environ- ally transmitted diseases, asthma, di- medications in the drug regimen, 12
ments. Clinical and educational abetes, dyslipidemia, and cardiovas- or more doses per day, four or more
pharmacy services in the ambulatory cular diseases. Residents routinely do medication changes in the previous
care setting have been shown to im- not seek preventive care because they year, three or more concurrent dis-
prove drug therapy documentation, lack transportation and insurance eases, a history of medication non-
prescribing, medication compliance, coverage. compliance, and the presence of
and overall health outcomes.6 These The study was begun in December drugs requiring therapeutic moni-
services are especially needed in ru- 1998 by conducting orientation ses- toring. We considered a patient to be
ral areas, where access to medical sions at each clinic to familiarize phy- noncompliant if the physician made
and pharmaceutical services is often sicians and clinic staff with the pro- that assessment in the medical
limited. tocol. Study kits consisting of data record or if the patient demonstrat-
This article describes the imple- collection forms, patient informed- ed a pattern of noncompliance in
mentation and outcomes of a rural consent forms, and pertinent surveys self-reports or the medication-refill
education and drug information were distributed. Space was estab- history. Drugs that were considered
program in a medically indigent lished at each site for various phar- to necessitate monitoring were long-
population. This was a collaborative, macist functions, including patient term medications requiring labora-
community-based, civic-engagement interviews and counseling. Mecha- tory testing to ensure safety and effi-
program that extended pharmaceuti- nisms were established for identifying cacy, such as warfarin, theophylline,
cal care services into rural areas of patients meeting inclusion criteria and and phenytoin. Patients were exclud-
Alabama. The program’s primary for patient follow-up. Investigator- ed from the study if they had signifi-
purpose was to determine the effect training sessions were conducted with cant cognitive impairment, a history
of pharmaceutical care on the pre- all involved pharmacists to review the of missed office visits, scheduling
vention, detection, and resolution of protocol and tools for documenting conflicts, or a life expectancy of less
drug-related problems in high-risk patient demographics, medication than one year.9
patients in a rural community. knowledge, compliance, prescribing Patients were identified by the
appropriateness, and satisfaction. Pa- participating pharmacists through
Methods tient education packets were devel- manual evaluation of clinic medical
Study design and program im- oped by the pharmacists conducting records and review of computerized
plementation. The local institutional the study for hypertension, diabetes medical records in physician offices.
review board approved a random- mellitus, dyslipidemia, and anticoagu- Randomization and interven-
ized controlled study designed to lation services. tion. In the study, four pharmacists
monitor patients for one year in A system was developed in which joined to provide pharmaceutical
community-based physician offices in the patient, physician, or nurse report- care at the clinics two or three after-
order to document the influence of ed suspected problems with drug ther- noons per week. Since the clinics did
pharmaceutical care services. Practice apy. Patients, nurses, and physicians not have a pharmacy, interventions
sites included three community-based were educated about the signs and were limited to clinical services and
family medicine clinics affiliated with symptoms of medication misadven- patient education and did not in-
the University of Alabama School of tures. These reports were prepared clude dispensing. However, patients
Medicine—Tuscaloosa and located on index cards and individually re- were asked to bring all their current
in the neighboring towns of Al- viewed by a pharmacist. In addition, medications on follow-up visits, and
iceville and Gordo in Pickens Coun- pharmacists noted any drug-related the pharmacists contacted local
ty, Alabama. problems detected during inspection pharmacies for dispensing informa-
Pickens County is 1 of 12 counties of prescription bottles or during pa- tion as necessary.
referred to alternatively as Alabama’s tient interviews. Patients were randomly assigned
Third World (after the region’s se- Patient selection. Adult patients to a control group or an intervention
vere poverty) or the Black Belt (after (18 years or older) who received care group. The control group received
the rich, dark soil that supported ex- at the participating clinics and were standard medical care, and the inter-
tensive cotton production in the identified as being at high risk for vention group received standard
1800s).8 This county ranks among medication-related adverse events medical care plus pharmaceutical
the poorest 13% of counties in the were enrolled after giving informed care (Table 1).
scribed. For example, if a patient tion group by using chi-square anal- intervention-group patients and 36
stated that he or she missed five dos- ysis. Since multiple pairwise compar- controls). Twelve patients were not
es of a once-daily medication during isons were conducted during this included because they were lost to
the past month, the compliance study, a Bonferroni correction was follow-up (3 intervention-group pa-
score would be 83% (25/30). Com- conducted, and the a priori α level tients and 3 controls), they died (2
pliance scores for each medication was set at 0.003. and 1), or they refused to participate
were combined to calculate the mean The baseline characteristics of the (3 and 0).
compliance score. The percentage of study groups were assessed with Stu- Clinical outcomes. Hospitaliza-
noncompliant patients was com- dent’s t test and the chi-square test or tions and ED visits. The number of
pared between groups by using chi- Fisher’s exact test. A medical record hospitalizations and ED visits de-
square analysis. The change in the review was conducted at baseline to creased in the intervention group
compliance rate from baseline was determine the number of emergency while remaining constant in the con-
evaluated with repeated-measures department (ED) visits and hospital- trol group compared with the year
ANOVA. Noncompliant patients izations for each patient that oc- preceding enrollment. Eleven hospi-
completed a brief questionnaire to curred during the preceding year. talizations were reported for the con-
explore possible reasons for the Data for the same variables were col- trol group in the year prior to the
problem. lected during the study period. Fre- study, compared with 24 in the inter-
Patient self-reports were used to quency changes were compared by vention group. During the study
assess medication knowledge during using the paired t test. year, the control group had 11 hospi-
each pharmacist–patient encounter. talizations, and the intervention
A knowledge score was determined Results group had 2 (p = 0.003). The number
by dividing the number of medica- At baseline, the intervention and of ED visits remained constant in the
tions for which a patient reported the control groups were not significantly control group at 6 and decreased in
correct name, purpose, dose, and fre- different with respect to demograph- the intervention group from 18 in
quency by the total number of medi- ic characteristics and medication use, the year before the study to 4 during
cations and multiplying by 100. The compliance, and knowledge (Table the study (p = 0.044).
results were compared between 2). The patients’ four most common Hypertension. At baseline, there
groups with Student’s t test or the diseases were hypertension (51%), was no significant difference in sys-
rank sum test. The percent change in dyslipidemia (40%), diabetes melli- tolic or diastolic blood pressure of
medication knowledge scores was tus (27%), and osteoarthritis (12%). patients with diagnosed hyperten-
evaluated with repeated-measures Over 17% of the patients had no in- sion in either group. (Table 3) Mean
ANOVA. surance coverage for prescription blood pressures at baseline were
The Medical Outcomes Study medications. above the recommended goals for
36-Item Short-Form Health Survey End-of-study interviews were hypertension treatment. However, the
(SF-36) assesses the quality of life completed for 69 (85%) of the 81 pa- percentage of patients at the targeted
in terms of physical health (physical tients who were initially enrolled (33 blood pressure was higher at baseline
functioning, physical role function,
pain, and general health) and mental
health (mental health, emotional role
function, social functioning, and en- Table 2.
ergy).13 Changes in the eight health- Comparison of Study Groups at Baseline
related quality-of-life domains were Characteristic or Intervention Control Group
assessed at study enrollment and the Variable Group (n = 33) (n = 36) p
end of the study by using repeated- Sex (% male) 36.4 27.8 0.445
measures multivariate ANOVA. Race (% white) 60.6 61.1 0.966
Mean ± S.D. age (yr) 64.4 ± 13.7 66.7 ± 12.3 0.467
Medication misadventures were Marital status (%
identified for all enrolled patients. married) 75.8 72.2 0.935
The number of patients who had at Median education, yr
(range) 12 (4–16) 12 (8–16) 0.980
least one medication misadventure Mean ± S.D. no.
was divided by the total number of medications 6.3 ± 2.2 5.7 ± 1.7 0.201
patients in each group to yield a per- Mean ± S.D. %
compliancea 84.9 ± 6.7 88.9 ± 5.8 0.728
centage. The percentage of misad- Mean ± S.D. medication
ventures in the control group was knowledge score (%) 56.3 ± 9.7 58.2 ± 10.4 0.709
compared with that in the interven- a
Percentage of patients with compliance scores of 80–100%.
in the control group (31.0%) than in in all 10 MAI domains in the inter- Of the seven patients reporting
the intervention group, although the vention group and increased in 5 do- medication misadventures, four were
difference was not significant. At 12 mains in the control group. The do- in the intervention group and three
months, intervention-group patients mains in which prescribing was most were in the control group (Table 6).
were significantly more likely than frequently inappropriate were dos- A variety of minor ADRs were re-
control patients to have targeted blood age, correctness of directions, practi- ported, including anxiety, confusion,
pressures. Furthermore, there was a cality of directions, and expense. cough, wheezing, swelling, and rash.
significant increase from baseline in
the percentage of patients at goal in the
intervention group. Table 3.
Diabetes mellitus. At baseline, the Clinical Outcomes
diabetic patient in the two groups Intervention Control
had similar hemoglobin A1c values Item Group Group p
(Table 3). The percentage of patients Hypertension
achieving the therapeutic goal in- No. pts. 24 29 …
creased from 23.1% to 100.0% in the No. (%) pts. at
goala
intervention group during the 12- Baseline 3 (12.5) 9 (31.0) 0.109
month period but decreased in the 12 mo 22 (91.7) 8 (27.6) 0.001
control group. The percentage of pa- Diabetes mellitus
No. pts. 13 16 …
tients meeting the goal at 12 months No. (%) pts. at
was significantly higher in the inter- goalb
vention group than in the control Baseline 3 (23.1) 9 (56.3) 0.071
12 mo 13 (100.0) 5 (26.7) 0.001
group. Dyslipidemia
Dyslipidemia. Baseline LDL cho- No. pts. 19 19 …
lesterol values did not differ signifi- No. (%) pts. at
goalc
cantly between the groups, and cho- Baseline 2 (10.5) 3 (15.8) 0.631
lesterol in both groups appeared to 12 mo 14 (77.8) 1 (5.9) 0.001
be poorly controlled (Table 3). The Anticoagulation
No. pts. 4 6 …
intervention group had a dramatic No. (%) pts. at
improvement in LDL cholesterol at goald
12 months, while the percentage of Baseline 1 (25.0) 3 (50.0) 0.571
12 mo 4 (100.0) 1 (16.7) 0.048
patients in the control group meet- a
The goal for hypertension treatment was a systolic blood pressure of ≤140 mm Hg and a diastolic blood
ing LDL cholesterol goals actually pressure of ≤90 mm Hg, except for patients with diabetes mellitus, in whom the goal was a systolic blood
declined. pressure of ≤135 mm Hg and a diastolic blood pressure of ≤80 mm Hg.
b
The goal for diabetes mellitus treatment was a hemoglobin A1c concentration of ≤7.5%.
Anticoagulation. Less than half of c
The goal for dyslipidemia treatment was based on the practice guidelines of Adult Cholesterol Education
patients in both groups had thera- Program Adult Treatment Panel III.
d
The goal for anticoagulation therapy was an International Normalized Ratio of 2–3.
peutic INRs at baseline (Table 3). At
12 months, all patients in the inter-
vention group had INRs within the
targeted range, but only 25% of con- Table 4.
trol patients did. Health-Related Quality-of-Life Scoresa
Quality of life. No significant dif-
ferences in health-related quality-of- Mean ± S.D. Scoreb
life scores were observed between the Intervention Group Control Group
(n = 33) (n = 36)
groups at baseline or at 12 months
(Table 4). The intervention group’s Domain Baseline 12 Months Baseline 12 Months
score improved in each category, but Physical functioning 62.0 ± 29.4 68.6 ± 24.0 61.9 ± 24.3 56.1 ± 27.5
Social functioning 70.6 ± 24.9 77.8 ± 24.3 73.3 ± 26.6 73.0 ± 28.2
not significantly. Physical role function 50.8 ± 42.2 68.2 ± 42.1 47.9 ± 42.8 52.8 ± 42.2
Prescribing appropriateness and Emotional role function 59.6 ± 44.7 82.8 ± 36.4 69.4 ± 45.3 65.8 ± 45.4
medication misadventures. Table 5 Mental health 72.0 ± 17.4 73.1 ± 21.2 69.0 ± 18.6 72.3 ± 17.1
Energy 47.0 ± 23.5 55.6 ± 20.3 46.9 ± 24.1 47.9 ± 20.2
shows the percentage of prescrip- Pain 60.0 ± 27.0 68.5 ± 22.3 65.4 ± 23.0 63.1 ± 25.8
tions that were considered inappro- General health perception 50.8 ± 19.5 57.0 ± 19.6 49.9 ± 19.8 50.1 ± 15.9
priate on the MAI. The percentage of a
On Medical Outcomes Study 36-Item Short Form.
b
inappropriate prescriptions decreased None of the differences between groups were significant.
study by Hanlon et al.6 found a 24% significant differences in some of the Pharmacists. Suggested definitions and
relationships among medication misad-
reduction in inappropriate prescrib- patient-specific outcomes and may ventures, medication errors, adverse drug
ing at 12 months among patients at a limit the generalizability of the re- events, and adverse drug reactions. Am J
Veterans Affairs medical center who sults. Although patients were random- Health-Syst Pharm. 1998; 55:165-6.
3. Bates DW, Spell N, Cullen DJ et al. The
received pharmacist interventions, ized, physicians were not because of costs of adverse drug events in hospital-
compared with only a 6% decline the small number of physicians prac- ized patients. JAMA. 1997; 277:307-11.
among control patients (p = 0.0006). ticing in the rural community. We 4. Lesar TS, Briceland L, Stein DS. Factors
related to errors in medication prescrib-
No between-group differences in did not evaluate differences between ing. JAMA. 1997; 277:312-7.
quality of life, compliance, or satis- clinic sites or physicians. The clinical 5. Brook RH, Kamberg CJ, Mayer-Oakes A
faction were noted by these authors. importance of the differences in MAI et al. Appropriateness of acute medical
care for the elderly: an analysis of the lit-
Differences in appropriateness scores scores and SF-36 results is unclear. erature. Health Policy. 1990; 14:225-42.
could have been due to the unique- The MAI is restricted to 10 elements 6. Hanlon JT, Weinberger M, Samsa GP et
ness of the environment in which the of prescribing and does not ade- al. A randomized, controlled trial of a
clinical pharmacist intervention to im-
MAI was applied. The pharmacists in quately identify underprescribing. prove inappropriate prescribing in elder-
our study were trained to use the in- While the MAI represents an inter- ly outpatients with polypharmacy. Am J
dex, and an independent reviewer mediate outcome, and the SF-36 may Med. 1996; 100:428-37.
7. Finn B, Carlstedt BC. Reporting adverse
evaluated the accuracy and consis- not adequately measure changes in drug reactions in an ambulatory care set-
tency of the determinations among quality of life influenced by pharma- ting. Am J Health-Syst Pharm. 1995; 52:
pharmacists. ceutical care, it can be concluded that 2704-6.
8. Hansen J, Archibald J. Life is short, pros-
Medication misadventures did pharmacist interventions do improve perity is long gone. http://al.com/
not differ significantly in frequency patient care. Finally, we did not docu- specialreport/birminghamnews/
between the intervention group and ment the percentage of pharmacist ?blackbelt1.html (accessed 2003 Jan 3).
9. Koecheler JA, Abramowitz PW, Swim SE
the control group. Also, patient recommendations that were imple- et al. Indicators for the selection of ambu-
knowledge about medications im- mented to evaluate whether a differ- latory patients who warrant pharmacist
proved in the intervention group, ence existed between physicians and monitoring. Am J Hosp Pharm. 1989; 46:
729-32.
but not among the controls. pharmacists with respect to recom- 10. Robertson KE. Process for preventing or
O’Connell and Johnson15 have noted mendation acceptance. It could have identifying and resolving problems in
that many factors may contribute to been possible for such differences to drug therapy. Am J Health-Syst Pharm.
1996; 53:639-50.
changes in patients’ medication inadvertently reflect differences be- 11. American Society of Health-System Phar-
knowledge and compliance, includ- tween the two groups. macists. ASHP guidelines on pharmacist-
ing lack of individualized counseling, conducted patient education and coun-
Conclusion seling. Am J Health-Syst Pharm. 1997; 54:
lack of written instructions to rein- 431-4.
force oral instructions, inability to Pharmaceutical care in a rural, 12. Samsa GP, Hanlon JT, Schmader KE et al.
recall information, and lack of com- community-based setting appeared A summated score for the medication ap-
propriateness index: development and
pliance aids. to reduce inappropriate prescribing, assessment of clinimetric properties in-
The mean number of prescribed enhance disease management, and cluding content validity. J Clin Epidemiol.
medications declined significantly in improve medication compliance and 1994; 8:891-6.
13. Ware JE, Sherbourne CD. The MOS 36-
the intervention group compared knowledge without adversely affect- Item Short-Form Health Survey (SF-36).
with the control group. It is possible ing health-related quality of life. I. Conceptual framework and item selec-
that this reduction contributed to the tion. Med Care. 1992; 30:473-83.
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increased compliance of the inter- 1. Classen DC, Pestotnik SL, Evans S et al. pharmacy services: has the agenda
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