Impact of Pharmaceutical Care On The Health-Relate
Impact of Pharmaceutical Care On The Health-Relate
Impact of Pharmaceutical Care On The Health-Relate
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Original Article
ABSTRACT: The present study was planned to assess the impact of pharmaceutical care on the
health-related quality of life (HRQoL) among hemodialysis (HD) patients. An open-label,
randomized control study was carried out at three different HD centers of teaching, government,
and corporate hospitals in South India. The patients were randomized into two groups (Usual
Care Group [UC] and Pharmaceutical Care Group [PC]) by block design method. The PC group
received the normal care along with pharmaceutical care delivered by a qualified registered
pharmacist. The assessment of the HRQoL was carried out at baseline, 6th and 12th months for the
both groups for a total of 12-month follow-up. A total number of 200 patients were recruited from
the three HD centers. At the end of the study, 153 patients were followed. Out of 153 patients, 83
were from academic hospital (UC, n = 41; PC, n = 42), 18 from government hospital (UC, n = 09;
PC, n = 09), and 52 from corporate hospital (UC, n = 25; PC, n = 27). The HRQoL scores were
significantly improved over time in the domains noticed with regard to the “physical functioning,
general health, emotional well-being, social functioning, symptom/problem list, and effects of
kidney disease” in all the three centers of PC group compared to UC group with P <0.05. The
pharmaceutical care provided by a trained pharmacist had positive impact in HRQoL of HD
patients.
Dr. Uday Venkat Mateti, End-stage renal disease (ESRD) refers to the
Department of Pharmacy Practice, stage-5 chronic kidney disease (CKD) when
Nitte Gulabi Shetty Memorial Institute of kidneys no longer function at a level needed
Pharmaceutical Sciences, Nitte University, for survival. This stage is reached when
Mangaluru- 575 018, Karnataka, India. overall renal function, measured by glomerular
E-mail: udayvenkatmateti@gmail.com filtration rate, is <15 mL/min of normal.1 It has
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been reported that globally ESRD is the 12th income. As a result, the patients invariably
highest cause of disease associated mortality depend on family income, and this has a
and annually there are 830,000 deaths.2 In negative impact on the marital status, family,
India, it is a “hidden epidemic” because there and social activities. The QoL of HD patients
is no nation-wide ESRD registry. Some epide- is found to be deteriorated compared to gene-
miological studies have revealed that millions ral population and other chronic diseases.11,13
of people suffer from CKD.3 There is a need to take stock of situation
As such, ESRD is increasing in epidemic regarding QoL and the components of social,
proportions in India and will be the third pathological, and ESRD-related morbidities.
biggest culprit of morbidity and mortality after The outcome of the inventory of above would
cancer and cardiovascular diseases. The more be able to identify the key factors and plan for
frequent complications of hemodialysis (HD) diminishing their effects on QoL of patients.
includes hypotension (20%–30%), cramps (5%– Health education is needed for patients to
20%), nausea and vomiting (5%–15%), head- assist them in self-care. In addition to self-
ache (5%), chest pain (2%–5%), back pain (2%– care, motivation plays an important role among
5%), itching (5%), and fever and chills (<1%).4 dialysis patients. Patients need updates on
The comorbidities such as cardiovascular issues of drugs, disease, and lifestyle changes
diseases, hypertension, diabetes, renal anemia, appropriate for the failed renal function.5 This
hyperphosphatemia, congestive heart failure, study was aimed to assess the impact of
peripheral vascular disease, and malnutrition Pharmaceutical Care on the HRQoL among
can cause severe consequences to the HD HD patients of teaching, government, and
patients.5,6 The review of literature suggests that corporate hospitals.
the quality of life (QoL) is compromised in
HD patients compared to general population.7 Patients and Methods
The WHO defines the health as “a state of
complete physical, mental, and social well- Study design and period
being not merely the absence of disease”. The This was an open-label, randomized control
WHO also defines QoL as “individuals” per- trial Registered under the Clinical Trial
ception of their position in life in the context Registry of India (Ref. no. CTRI/2014/
of the culture and value systems in which they 004900) was carried out for 15 months bet-
live and in relation to their goals, expectations, ween March 2014–May 2015 at three different
standards and concerns.”8 HD centers of teaching, government, and
Numerous publications have focused on corporate hospitals.
drug-related problems (DRPs) which are very
common in patients on dialysis with esti- Sample size
mation of one DRP for every 15 medicine The sample size was calculated based on the
exposures9 due to DRPs-induced morbidity primary objective and the change in QoL
and nonadherence to the medications with a scores at 0, 6, and 12 months repeated measure
high rate of 67%.10 Most of the publications at 84% power and 5% level of significance.
have revealed that there is a lack of know- The minimum sample required for the study is
ledge, attitude, and practice (KAP) regarding 76 patients per group and anticipating a
the drugs, disease, and lifestyle changes dropout rate of 20%, the required sample size
among CKD patients on HD.11,12 Poor adhe- is 76/0.8 = 95 per each group.
rence is a common problem where patient’s
myths and beliefs play an important role in Ethical approval
shaping the KAP. Health-related QoL This study was approved by the Institutional
(HRQoL) is an important measure in ESRD Ethics Committee (Ref. no. IEC/165/2013),
because long-term HD often compromises the before the initiation.
patient’s ability to earn affecting financial
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from the three HD centers. Out of 200 of the HD patients were from the lower middle
patients, 104 from academic hospital (UC, n = class, rural background who were not doing
52; PC, n = 52), 26 government hospital (UC, any job. The median vintage of HD was (UC
n = 13; PC, n = 13), and 70 corporate hospital group is 50; PC group is 53), (UC group is 26;
(UC, n = 35; PC, n = 35). At the end of the PC group is 24), and (UC group is 32; PC
study, 153 patients were followed. Out of 153 group is 36) months in academic, government,
patients, 83 were from academic hospital (UC, and corporate hospital patients, respectively.
n = 41; PC, n = 42), 18 from government The baseline demographics such as age, gender,
hospital (UC, n = 09; PC, n = 09), and 52 from education, marital status, working status, domi-
corporate hospital (UC, n = 25; PC, n = 27). ciliary status, socioeconomic status, income
There were 47 dropouts in total, out of which per month, health-care schemes, distance tra-
25 were in UC group and 22 in PC group. veled to the HD centers, HD vintage, number
of hours of HD per week, risk factors, and
Baseline characteristics of hemodialysis patients comorbidities were not significantly different
The mean age of HD patients from the aca- in the UC group vs. PC group in all the three
demic hospital (UC group is 49.40 years; PC HD centers. The detailed baseline characte-
group is 52.78 years), government hospital (UC ristics of HD patients are presented in Table 1.
group is 48 years; PC group is 49.15 years), The baseline HRQoL score of KDQoL-36
and corporate hospital (UC group is 53.77 domains such as short form-12 (SF-12) com-
years; PC group is 52.97 years); gender-wise ponents and ESRD-targeted areas were not
distribution of men from the academic hospital significantly different in the UC group vs. PC
(UC group is 76.9%; PC group is 82.7%), group in all the three HD centers. The detailed
government hospital (UC group is 76.9%; PC baseline HRQoL scores of the HD patients are
group is 84.6%), and corporate hospital (UC presented in Table 2.
group is 74.3%; PC group is 68.6%), majority
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Table 1. Baseline demographic details of HD patients from academic, government and corporate hospitals.
Academic hospital Government hospital Corporate hospital
Demographics UC PC UC PC UC PC
P P P
(n=52) (n=52) (n=13) (n=13) (n=35) (n=35)
Age, Mean±SD 49.40±12.47 52.78±10.45 0.137 48±17 49.15±12.57 0.846 53.77±11.87 52.97±15.12 0.806
Gender, n (%)
Male 40 (76.9) 43 (82.7) 0.464 10 (76.9) 11 (84.6) 1.000 26 (74.3) 24 (68.6) 0.597
Female 12 (23.1) 9 (17.3) 3 (23.1) 2 (15.4) 9 (25.7) 11 (31.4)
Education status, No.
(%)
Illiterate 10 (19.2) 9 (17.3) 0.313 3 (23.1) 3 (15.4) 0.719 2 (5.7) 7 (20) 0.059
Primary school 3 (5.8) 2 (3.8) 3 (23.1) 5 (38.5) 5 (14.2) 1 (2.9)
Middle school 6 (11.5) 6 (11.5) 1 (7.7) - 7 (20) 5 (14.3)
High school 17 (32.7) 11 (21.1) 4 (30.8) 4 (30.8) 7 (20) 9 (25.7)
Intermediate 8 (15.4) 9 (17.3) 2 (15.4) 2 (15.4) 8 (22.9) 5 (14.3)
Graduate 8 (15.4) 14 (26.9) - - 6 (17.1) 8 (22.9)
Marital status, No. (%)
Married 44 (84.6) 49 (94.2) 10 (76.9) 12 (92.3) 32 (91.4) 3 (88.6)
Unmarried 8 (15.4) 3 (5.8) 0.105 3 (23.1) 1 (7.7) 0.593 3 (8.6) 4 (11.4) 1.000
Employment status, No.
(%)
Not working 43 (82.7) 43 (82.7) 11 (84.6) 12 (92.3) 34 (97.1) 29 (82.9)
Working 9 (17.3) 9 (17.3) 1.00 2 (15.4) 1 (7.7) 1.000 1 (2.9) 6 (17.1) 0.106
1299
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Table 3. HRQOL scores for UC and PC groups of academic hospital HD patients.
Baseline HRQoL Scores# 6 Months HRQoL Scores# 12 Months HRQoL Scores#
Greenhouse-Geisser
KDQoL-36 Domains UC PC UC PC UC PC
and P
(n=41) (n=42) (n=41) (n=42) (n=41) (n=42)
12 item health survey
(SF-12)
F (1.572, 127.324) =
Physical functioning 48.17±19.67 44.64±16.02 45.12±18.72 53.57±19.57 43.29±21.32 51.19±20.19
3.944, P = 0.031*
F (1.813, 146.886) =
Role-physical 43.90±120.69 44.04±19.68 43.90±17.82 48.80±18.12 39.02±19.16 46.42±20.87
0.447, P = 0. 621
F (1.518, 122.991) =
Pain 50±18.54 52.97±17.63 43.90±16.56 48.21±13.96 40.85±16.54 47.61±19.76
0.473, P = 0. 572
F (1.815, 147.055) =
General health 37.19±14.91 34.52±13.47 35.97±12.56 42.26±17.88 34.75±15.69 41.07±18.16
3.656, P = 0. 032*
F (1.416, 114.688) =
Emotional well-being 42.92±14.92 39.76±12.32 39.26±112.32 48.33±16.66 40.24±16.04 47.14±22.22
7.882, P = 0. 002**
F (1.797, 145.533) =
Role-emotional 47.56±19.20 52.38±24.57 43.90±19.98 59.52±29.71 46.34±23.42 61.90±30.86
1.331, P = 0.226
F (1.634, 132.344) =
Social functioning 56.09±22.20 55.35±23.12 54.26±17.59 67.85±17.70 52.43±21.50 66.66±25.10
5.569, P = 0.008**
F (1.395, 113.027) =
1303
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Table 5. HRQOL Scores for UC and PC groups of Corporate Hospital HD patients.
Baseline HRQoL Scores# 6 Months HRQoL Scores# 12 Months HRQoL Scores#
Greenhouse-Geisser
KDQoL-36 Domains UC PC UC PC UC PC
and P
(n = 25) (n = 27) (n = 25) (n = 27) (n = 25) (n = 27)
12 item health survey
(SF-12)
F (1.797, 89.865) =
Physical functioning 42±21.31 44.44±16.01 36±14.57 51.85±15.38 37±19.25 48.14±22.91
3.606, P = 0.036*
F (1.744, 87.189) =
Role-physical 46±13.10 40.74±14.68 44±14.06 44.44±14.89 40±14.83 38.88±11.87
0.159, P = 0.824
F (1.498, 74.885) =
Pain 43±21.26 42.59±18.10 39±17.79 38.88±14.43 38±16.32 39.81±17.34
0.106, P = 0.842
F (1.857, 92.850) =
General health 33±17.26 31.48±11.16 30±12.50 38.88±18.77 31±16.58 42.59±20.59
3.349, P = 0.043*
F (1.290, 64.519) =
Emotional well-being 42.80±14.29 39.25±14.65 38±11.54 46.66±14.93 39.20±18.96 48.14±22.19
4.606, P = 0.027*
F (1.977, 98.874) =
Role-emotional 48±22.73 46.29±23.03 42±18.70 61.11±28.86 44±21.98 57.40±26.68
2.926, P = 0.059
F (1.547, 77.367) =
Social functioning 67±17.26 61.11±20.01 59±21.50 69.44±18.77 61±22.91 64.81±24.27
3.992, P = 0.032*
F (1.430, 71.497) =
Energy/Fatigue 38.40±15.18 42.22±17.83 36.80±14.92 41.48±14.59 37.60±16.54 44.44±18.54
The study carried out by Aghakhani et al Manipal University for providing us with the
assessed the intervention of nutritional edu- research facilities.
cation in HRQoL of HD patients in Iran. The
increase in HRQoL domains scores was Conflict of interest: None declared.
observed in diet-counseled group compared to
control group.26 The registered pharmacist- References
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