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Academic Sciences International Journal of Pharmacy and Pharmaceutical Sciences

ISSN- 0975-1491 Vol 6, Suppl 2, 2014

Research Article

MEDICATION ADHERENCE TO ANTIDIABETIC THERAPY IN PATIENTS WITH TYPE 2


DIABETES MELLITUS

MANJUSHA SAJITH*1, MADHU PANKAJ2, ATMATAM PAWAR3, AMIT MODI4, RONAK SUMARIYA4
1Department of Clinical Pharmacy, Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, 2Department of Medicine, Bharati
Medical College, Bharati Vidyapeeth Deemed University, 3Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, 4Poona
College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune. Email: manjusaji1@yahoo.com
Received: 10 Dec 2013, Revised and Accepted: 09 Feb 2014

ABSTRACT
Objective: The study is to evaluate self-reported medication adherence and to identify factors linked with poor adherence in patients with type 2
diabetes mellitus.
Methods: The prospective study was conducted over a period of six months in the department of Medicine, Bharati Hospital. A total of 105 type 2
diabetics patients who fulfilled the inclusion criteria were recruited in the study. Adherence to treatment has been assessed during a personal
interview with each patient using questionnaire. Medication adherence was assessed by using Morisky medication adherence scale (MMAS).
Results: The adherence levels were 40.95%, 37.14% and 21.90% for high, medium and poor adherence, respectively. The correlation between
patients’ socio-demographic and adherence rate to anti diabetic therapy indicated that higher prevalence of adherence among men (43.33%), the
elderly (46.81%), those with primary education (47.06%) and the unemployed patients (41.46%). We found a better percentage of adherences in
combination therapy with 43.90%. The most common reasons for non-adherence to taking medication(s) as prescribed were inadequate knowledge
about therapy (81.90%), financial problem (61.90%), patients feeling better (33.33%) and feeling worse (33.33%). Moreover, the factors for non
adherence to appointment keeping were identified as travel a lot and busy schedule of work with 33.33%, and 13.33%, respectively.
Conclusion: In conclusion, this study revealed a moderate level of adherence among the participants. Efforts are needed to increase the medication
adherence of these patients so they can realize the full benefits of prescribed therapies
Keywords: Anti-diabetic medication, Medication adherence, Glycaemia control, Type 2 diabetes mellitus.

INTRODUCTION modifications that in turn minimizes long-term complications [11,


12].
Diabetes mellitus refers to a group of common metabolic disorders
that share the phenotype of hyperglycaemia. Poor adherence to medication regimens is common, contributing to
substantial worsening of disease, death and increased health-care
The prevalence of diabetes mellitus is growing rapidly worldwide costs. Hence, practitioners should always look for poor adherence
and is reaching epidemic proportions. It is estimated that there are and can enhance adherence by emphasizing the value of a patient’s
currently 285 million people with diabetes worldwide and this regimen, making the regimen simple and customizing the regimen to
number is set to increase to 438 million by the year 2030 [1]. India the patient’s lifestyle. Therefore, the purpose of this study is to
leads the world with largest number of diabetes subjects earning the identify Drug Utilization pattern, Medication Adherence and reasons
dubious distinction of being term the “Diabetes Capital of the world” associated with Non-adherence to anti-diabetic therapy which will
[2]. The prevalence of diabetics in Indian adults was found to be help the Physicians in making decisions to reduce the same, helps in
2.4% in rural and 4‐11.6% in urban dwellers [3]. India is presently achieving glycemic targets of type 2 diabetes mellitus patients. It will
estimated to have 41 million individuals affected by this deadly undoubtedly benefit the physicians to understand the patient’s
disease, with every fifth diabetic in the world being an Indian [4]. response to the treatment provided which may help for a strict and
A key dimension of healthcare quality is adherence to prescribed successful management of this chronic illness in the future.
medications. According to the World Health Organization, non- MATERIALS AND METHODS
adherence to the medical regimen consist a major clinical problem in
the management of patients with chronic illness [5]. Rates of non A prospective observational study was carried out for the duration
adherence with any medication treatment may vary from 15% to of six months among the patients who were admitted in Bharati
93%, with an average estimated rate of 50% [6]. hospital. All the patients above 18 years of age of either sex, patients
taking diabetes medication(s) were included in the study. Pregnant
Adherence with medication usage is defined as the proportion of women and surgical reference were excluded from the study.
prescribed doses of medication actually taken by a patient over a
specified period of time [7]. Compliance, a synonymous term which For data collection and documentation Patient profile form was
was commonly used in the past, implies a passive role and simply designed which includes information on patients demographic
following the demands of a prescriber and non-compliance has been details (e.g. Patient’s Name, Age, Sex, educational status,
regarded as associated with deviant or irrational behaviour [8]. employment, date of admission and date of discharge), presenting
complaints, provisional/confirmed diagnosis, social history, past
Non-adherence or non-compliance, poverty, lack of knowledge and medical/medication history, current medications, discharge
poor follow ups are the main factors observed in poor glycaemic medications, laboratory test reports.
control [9]. Individuals with poor management of diabetes are at a
greater risk of developing long-term micro and macro-vascular Adherence to treatment has been assessed during a personal
complications that lead to the damage of end organs such as kidneys, interview with each patient using questionnaire. Medication
heart, brain and eyes, affects the direct and indirect health care costs adherence to diabetes medicines was determined using a modified
and overall quality of life [10]. Optimal glucose control can be version of the four items, self-reported Morisky medication
achieved through strict adherence to medications, diet and life style adherence scale [41]. Each item is in a yes/no format with a
Sajith et al.
Int J Pharm Pharm Sci, Vol 6, Suppl 2, 564-570

maximum possible score of four equating very poor adherence and 0 a primary education and the occupation section of the respondents
considered as good adherence. indicates that 39.05% patients were unemployed. Socio-
demographic and clinical characteristics of the participants are
RESULTS summarized in TABLE1.
A total of 105 diabetes mellitus patients were enrolled in the study, The assessment of the patients’ responses to the 4-item modified
out of which 57.14% were males and 42.86% were females. The Morisky adherence predictor scale showed that 43 (40.95%) of the
prevalence of Diabetes Mellitus in our study set up was 7.95%. Most patients had good adherence with prescribed medications, whereas
patients belonged to the middle age group 41-60 years (48.57%) 37.14% had medium adherence and 21.90 % had low adherence
followed by Elderly group > 60 years (44.76%). 32.38% patients had (Table 2).

Table 1: Socio-demographic characteristics of diabetic patients


Respondent’s characteristics No. of patients Percentage (%)
Gender
Male 60 57.14
Female 45 42.86
Age (years)
Young group (18–40) 7 6.67
Middle-age group (41–60) 51 48.57
Elderly group (>60) 47 44.76
Educational status
Primary 34 32.38
Secondary 30 28.57
Tertiary 20 19.05
Illiterate 21 20.00
Employment status
Employed 40 38.09
Unemployed 41 39.05
Disabled 3 2.86
Retired 21 20.00
Place of residence
City 70 66.67
Village 35 33.33
Social habits
Smoker 14 13.33
Alcoholic 7 6.67
Both 8 7.62
None 76 72.38
Clinical characteristics of diabetic patients
Disease related parameters No. of patients Percentage (%)
a) Duration of disease since diagnosis (years)
<5
6-10 46 43.81
> 10 30 28.57
29 27.62
b) Family history of diabetes
Yes 25 23.81
No 80 76.19
c) HbA1c (%)
Yes 50 47.62
No 55 52.38
4.5-6.3 6 12.00
6.4-8.0 15 30.00
8.0-9.0 5 10.00
9.0-14.0 24 48.00
e) Co-morbidities
Hypertension 24 22.86
Hypertension+ Ischemic heart disease 11 10.48
Hypertension + Coronary artery disease 1 0.95
Chronic renal failure 1 0.95
Ischemic heart disease 1 0.95
Others 50 47.62
No 17 16.19

Table 2: Summary of patient’s responses to the modified Morisky adherence predictor scale (n=105)
Question Yes No
Response (score coding) Number Percentage Number Percentage
(%) (%)
Do you ever forget to take your Medicine(s)? 43 40.95 62 59.05
Do you sometimes not being careful in taking your medicine (s)? 39 37.14 66 62.86
When you feel better, do you sometimes stop taking your medicine(s)? 35 33.33 70 66.67

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Int J Pharm Pharm Sci, Vol 6, Suppl 2, 564-570

Sometimes if you feel worse when you take your medication(s), do you stop taking 35 33.33 70 66.67
them?
Distribution of scores Total Percentage (%)
0 43 40.95
1 16 15.24
2 23 21.90
3 20 19.05
4 3 2.86
Percentage Category
0 43 (%)
1-2 39
3-4 23 40.95 High adherence
37.14 Medium adherence
21.90 Low adherence

Table 3: A correlation between patients’ socio-demographic characteristics and


Variables No. of Patients High Adherence Medium Adherence Low
(%) N (%) N (%) Adherence
N (%)
Gender
Male 60 (57.14) 26 (43.33) 19 (31.67) 15 (25.00)
Female 45 (42.86) 17 (37.78) 20 (44.44) 8 (17.78)
Age (years)
Young group (18–40) 7 (6.67) 3 (42.86) 2 (28.57) 2 (28.57)
Middle-age group (41–60) 51 (48.57) 17 (33.33) 25 (49.0) 9 (17.65)
Elderly group (>60) 47 (44.76) 22 (46.81) 12 (25.53) 13 (27.66)
Educational status
Primary 34 (32.38) 16 (47.06) 9 (26.47) 9 (26.47)
Secondary 30 (28.57) 10 (33.33) 16 (53.33) 4 (13.33)
Tertiary 20 (19.05) 6 (30.00) 8 (40.00) 6 (30.00)
Illiterate 21 (20.00) 10 (47.62) 6 (28.57) 5 (23.81)
Employment status
Employed 40 (38.09) 12 (30.00) 17 (42.50) 11 (27.50)
Unemployed 41 (39.05) 17 (41.46) 14 (34.15) 10 (24.39)
Disabled 3 (2.86) - 3 (2.86) -
Retired 21 (20.00) 13 (61.90) 5 (23.81) 3 (14.28)
Family Support
Present 37 (35.24) 17 (45.94) 13 (35.13) 7 (18.92)
Absent 68 (64.76) 24 (35.29) 27 (39.70) 17 (25.00)
Place of residence
City 70 (66.67) 26 (37.14) 28 (40.00) 16 (22.86)
Village 35 (33.33) 15 (42.86) 12 (34.28) 8 (22.86)

Fig. 1a: Drug adherence Fig. 1b: Dietary adherence


45.00% 3.81%
Adherence rate(%)

40.95% 37.14%
40.00%
35.00%
30.00% 21.90%
25.00%
20.00%
15.00% Yes=4
10.00% No=101
5.00%
0.00% 96.19%
High Medium Low
Drug adherence

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Int J Pharm Pharm Sci, Vol 6, Suppl 2, 564-570

Fig. 1c: Exercise adherence Fig. 1d: Appointment adherence

1.90%

Yes=36
32.29%
Yes=36 Yes=2
No=69 No=103
No=69
65.71% 98.10%

Fig 1

50.00%
45.45%
45.00% 40.54% 43.90%

40.00% 40.54%

35.00% 34.15%
% of Adherence rate

31.82%
30.00%

25.00% 21.95% 22.73% High


18.92%
20.00% Medium

15.00% Low

10.00%

5.00%

0.00%
Monotherapy=37 Combination=41 Fixed dose=22

Types of therapy

Fig. 2: Adherence by types of therapy

Table 4: Factors affecting rate of medication adherence in Type 2 diabetic patients.


Causes Number of patients Percentage (%)
Non adherence to taking anti-diabetic medications as prescribed
Social and Economic
a. Costs of medication too expensive 36 34.29
b. lack of financial resources 65 61.90
Therapy- related factors
a. Complexity of medication regimen 20 19.05
b. Number of medications/Too much medications 27 25.71
c. Frequency of dosing / Increasing number of dosing times 19 18.10
d. Side effects 1 0.95
e. Long duration of treatment period 61 58.10
Patient-related factors
a. Lack of knowledge about the disease 33 31.43
b. Inadequate knowledge regarding therapy 86 81.90
c. Forgetfulness 17 16.19
d. Decision to omit 20 19.04
e. Being busy/ busy schedule of Work 12 11.42
f. Forget fullness + Being busy 2 1.90
g. When felt better 35 33.33
h. When felt worse/bad 35 33.33

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Int J Pharm Pharm Sci, Vol 6, Suppl 2, 564-570

i. Others (pain due to injection, Hypoglycemia etc.) 14 13.33


Non-adherence to appointment keeping
Causes Number of patients Percentage (%)
Forgetfulness 17 16.50
Travel a lot 35 33.98
Long clinic wait time 16 15.53
No response 21 20.39
Nature/busy schedule of work 14 13.59

Figure 2 reveals the fact of percentages of adherence rate and blood glucose control. Of the 31 patients who had goal blood glucose
number of drugs used in T2DM patients with respect to control, 53.49% were high adherent, 20.51 % were medium
Monotherapy, Combination therapy and Fixed dose therapy. Several adherent and 13.04 % were low adherent. The blood glucose control
factors were found to have significant effects on the rate of rate was significantly higher in those that high adhere to anti-
medication adherence (Table 4). Among 105 patients, 32.38% diabetic medication when compared with non-adhering (medium
patients had good blood glucose control and 67.62% patients had no and poor adherence) patient (TABLE 5).

Table 5: Association between adherence with medication and plasma glucose control
Parameters No. of patients Plasma glucose status
Controlled (%) Uncontrolled (%)
105 34 (32.38) 71 (67.62)
Medication adherence pattern No. % No. %
Good adherence 43 23 53.49 20 46.51
Medium adherence 39 8 20.51 31 79.49
Low adherence 23 3 13.04 20 86.96
Total 105 34 32.38 71 67.62

DISCUSSION Nepal (Hypertension accounted for 70.62% of the total


complication) [22]. Our study findings are also similar to the study
Diabetes mellitus is one of the major non communicable diseases conducted in Texas medical centre that hypertension is more
which are growing very fast in this modern era. Diabetes and common complication affecting 20-60% of people with diabetes
associated complications pose a major healthcare burden worldwide [23].
and present major challenge to patients, health care systems and
national economies. Males predominated in the study population The 4-item modified Morisky adherence predictor scale used to
which is in agreement with the results of various other studies in assess medication adherence might be associated with some
India [13] and United States [14]. The reason for this might be that shortcomings since it is a self-report method; however, there is no
smoking, alcoholic habits and other lifestyle changes are seen more gold standard method for assessing adherence. The assessment of
commonly in males and these factors have hallucinating effect on the patients’ responses to the 4-item modified Morisky adherence
health including glycemic control. The higher prevalence in younger predictor scale [41] showed that 40.95% (n=43) of the patients had
age group may be due to the lifestyle of the younger population and good adherence with prescribed medications, whereas 37.14% had
also the stress factor which unmasks diabetes causing blood sugar to medium adherence and 21.90 % had low adherence. The finding is
rise [15]. The level of education and place of residence are important in line with the findings of a study carried out in France, which
determinants of how quickly a diagnosis will be made. The revealed the following adherence levels: good adherence 39%,
performance paid work, level of education and economic status can medium adherence 49%, and poor adherence 12%. The good
have a positive and negative impact on the quality of life of diabetes adherence recorded in this study is also inconsistent with the
patients, as a result, on the level of metabolic control. Satisfaction findings of some studies. However, the poor adherence level
with treatment and quality of life are positively associated with revealed by this study is consistent with the finding of a study
employment and a higher income. People with lower education level carried out in Mulago teaching hospital Uganda that recorded an
and unemployment persons, have, in general, a lower satisfaction overall prevalence of non-adherence of 28.9% [24].
with life and are less satisfied with diabetes treatment, as well as
having worse metabolic control [16]. Educational status in our study Medication adherence is a key component for patients with
was found more in primary education with higher prevalence rate of diabetes. Our results have shown that therapeutic adherence was
32.38%. In the employment status the unemployed patients had significantly affected by different patient- centered factors like age,
more prevalence with 39.05% than employed with 38.09%; family support, educational status, employment status, place of
compared with French study there was no significant difference residence. Our study has found a high rate of good adherence in
found [38]. The uses of alcohol and cigarette smoking were not male with 43.33% than females. The result is similar to that found in
significantly reported in our study [15]. another study among African Americans in which the men scored
higher than women on self care adherence [25]. The effect of gender
The duration of diabetes plays an important role in management of on the rate of adherence to medication in other research studies is
diabetes. This study showed that most of the patients (43.81 %) had contradictory. Female patients were found by some researchers to
a diabetic history of 1-5 years [17]. Patients with a long duration of have better adherence [26]. In addition, some studies could not find
diabetes are at a higher risk of developing complications [17]. a relationship between gender and adherence to medication [27].
76.19% patients were with no family history of diabetes [18]. The effect of the age factor was found in our patient population with
Achieving good glycaemic control in diabetic subjects has proven a higher rate of drug compliance in elderly patients with 46.81%
real challenge to healthcare providers. Studies have documented whereas in other study elderly age group was found with 68%
that self-care among T2DM subjects improved glycaemic control and adherence rate [28]. In another study, more adherence was found in
reduced complications [19, 20]. In the present study, only 23 (53.49 younger age group with 51.8% and lesser adherence was found in
%) of the subjects had good glycaemic control, which is different elderly and middle age group [27]. Data on age is consistent with the
from various studies [21]. A total 88 (83.81%) patients suffered literature; chronic patients' age affects adherence to drug therapy, as
from co-morbid condition. Hypertension accounted for 27.27% of lower adherence was seen among younger patients [29]. In regard to
the total complications which is lower than the study reported in schooling, more educated patients were more adherent to therapy.

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Int J Pharm Pharm Sci, Vol 6, Suppl 2, 564-570

Low schooling makes learning more difficult; as diabetes drug the reasons why some patients do not take their anti-diabetic
therapy gets more complex; patients are required to have more medications as prescribed was found to be 16.19% and forgetfulness
complex cognitive skills to be able to understand the prescribed is a widely reported factor that causes non-adherence with
drug therapy and to adhere to treatment for good glucose control. In medication or clinic appointments was found to be 13.33% which
our study, patients with primary education (47.06%) have higher are lower than the study conducted in Nigeria [18].
compliance. Several studies found that patients with higher
educational level might have higher compliance [30]. On the basis of This study has demonstrated that blood glucose control was
occupation, the unemployed patients had high medication significantly higher among patients that adhered with their anti-
adherence rate with 41.46% compared to employed patients diabetic medication compared with their non-adherent
30.00%,whereas the study conducted in Malaysia, the unemployed counterparts. The adherence rate of 40.95% in this study is lower
patients rate was more with 74.1% and employed ratio was low than adherence rate of 72.5% reported in Eastern Nigeria [39] while
[31]. Support provided by family also played a beneficial role in 60.2% reported in Ibadan, south-west Nigeria in 2009 [36] and
enhancing adherence, in our study around 45.94% was found while 51.3% reported in Ethiopia [38]. The finding of this study has
similar result with 47.7% was found in another study [27]. The demonstrated the contribution of adherence factor for blood glucose
general finding from different research articles showed that patients control among the study population. Thus, if diabetic patients
who had emotional support and help from family member, or adhere with their appropriately prescribed anti-diabetic medication,
healthcare providers were more likely to be adherent to the glycaemic outcome will be expectedly improved [40]. Clinicians
treatment. [9]. Place of residence is important determinant where attending to type 2 diabetic patients should inquire rationally for
37.14% patients of urban had shown higher rate of adherence medication adherence at every clinical encounter with diabetic
compare to rural area. A study conducted in Egypt was found 41.9% patients. This will prevent the clinician from attributing lack of
in urban and 34.4% in rural adherence rate [16]. Aerobic exercise response to medications as therapeutic failure rather than
and restricted food was reported to be part of the recommended medication adherence problems. This assumption has resulted in the
non-drug management of diabetes mellitus disease. Dietary and clinical decision of increasing the dose of the medications, changing
exercise self-care behaviours are similar which are the most time- the medication or adding another anti-diabetic drug. The magnitude
consuming aspects of the daily regimen and are also the behaviours of this practice is better imagined than seen and will not favour
requiring the greatest alteration in life-style. In our study, it was attainment of clinically therapeutic outcome among type 2 diabetic
noted that 3.81%, 32.29% and 1.90% respectively of all patients patients.
were belonging to dietary, exercise adherence and to the
appointment for regular follow up. As for noncompliance with CONCLUSION
individual measures, the dietary noncompliance was found in this It is concluded that the participants in the area of study were
study (96.19%) which is more than the Canadian study with 73% moderately adherent to their anti-diabetic medications. Various
[32], the U.S. study with 65% [33], and the Mexican study with 62% factors of medication non-adherence were identified and evaluated.
[34]. In our study, good exercise adherence was found to be 32.29% Therefore, we recommend interventions that will address these
which is higher than the studies [27] and [34]. We found a better factors of non-adherence in order to improve adherence the more.
percentage of adherence in combination therapy with 43.90% and Some of such interventions include the physicians and pharmacists
lower percentage of adherence in monotherapy with 18.92% as improving on the areas of patient education and medication
compared to study conducted in Italy [35]. counselling, communication between them and patients,
The high costs of medication agreed to by majority of the patients as encouraging patients to monitor their blood glucose level regularly,
the most important reason preventing optimal adherence had been simplifying drug regimen with decreasing the number of drug taken,
supported by previous studies where financial constraint was medication selection bearing in mind cost and intolerable side
identified as the major hindrance to medication adherence among effects of the medications. Physicians and Pharmacists should also
type 2 diabetes populations. In our study, the cost of expensive adopt interventions that are designed to help patients remember to
medication was found to be 34.29% which is similar, whereas the keep their clinic appointments and to take their anti-diabetic
other factor for non adherence i.e. complexity of dosage regimen was medications as prescribed.
found to be 19.05% which is noted significantly higher than the ACKNOWLEDGEMENT
study performed in South-western Nigeria [36]. India is a resource
limited setting where the majority of the people estimated to live This study would not have been possible without the guidance and
below poverty levels so the economic access to anti diabetic the help of several individual who in one way or another contributed
medication appeared restricted. In this study, the main external and extended their valuable assistance in the preparation and
challenge of adherence is financial problem (61.90%). This is in completion of this study.We extend our immense thanks to our Co-
agreement with study done in Nigeria [37] in which around 2/3 and guide for his guidance and help that provided a good basis for our
in Ethopia 37.1% of the non-adherence is due to financial difficulty project work.We also would like to thank to all the post graduate
[38]. Side effect of drug which is considered as a factor for non- students, residents, nurses of Medicine Department, Bharati Hospital
adherence appeared with 0.95% which is significantly lower than & Research Centre, Bharati Vidyapeeth Deemed University, for
the study carried out in Ethopia [38]. Our results confirm that one of helping us in one way or the other.
the most important factors contributing to adherence to OHAs was
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