Adherence to medications among Patients with

O RI GI NA L A RT I CL E

Adherence to medications among Patients with Diabetes Mellitus Type 2 at Ballabgarh HDSS: A Community Based Study Puneet Misra1, Harshal R Salve2, Rahul Srivastava3, Shashi Kant4, Anand Krishnan5 Professor, 2Assistant Professor, 3Former Senior Resident,4Professor and Head, Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi

1,5

Abstract Introduction: Burden of diabetes mellitus in India is on rise. Adherence to treatment is essential to diabetes control and prevention of complications. Objectives: To study the adherence to treatment of diabetes mellitus and its determinants among rural population Material and methods: A cross-sectional study was conducted in a rural community of north India. From a list of all self-reported diabetics (aged ≥18 years), 400 were randomly selected. Information about drug prescription and intake, socio-demographic factors, health seeking behaviors and disease status were obtained from the participants. Height, weight and blood pressure were recorded. Blood samples were collected to measure HbA1c levels Results: Out of 371 self-reported diabetic patients, 113 (30.4%) did not take any medication since last one month of the interview. Amongst 258 patients, who were taking treatment, 146 (39.4, 95%CI: 34.5-44.4) were found to have 100% drug adherence rate. Tobacco (p=0.03) and alcohol (p=0.04) use were significantly associated with drug adherence on bi variate analysis. Drug adherence rate was higher in group with HbA1c level more than 6.4gm%. Conclusion: A high proportion of diabetic patients were not adhering to the treatment prescribed to them by their consulting doctors. There is urgent need for awareness generation about diabetes treatment adherence and developing adherence-monitoring mechanisms at community level. Diabetes Mellitus Key words: Adherence, diabetes mellitus, Rural India Introduction

Material and Methods

The number of people with diabetes mellitus in India is increasing across geographic, ethnic and administrative boundaries.1-5 The International Diabetes Federation estimates that the number of diabetic patients in India more than doubled from 19 million in 1995 to 40.9 million in 2007, projected to increase to 69.9 million by 2025.

It was a community based cross-sectional study conducted at Ballabgarh HDSS site.9 Study Population was selfreported diabetics aged > 18 years with records in Ballabgarh HMIS.

As per WHO, average rate of non-adherence in patients with chronic disease is 50% in developed countries.6Adherence is the single most important modifiable factor that can render even best treatment ineffective. Most of Indian studies on treatment adherence among diabetics’ are hospital based.7-8 Present study was conducted to know treatment adherence amongst diabetics and its association with various factors in a rural community.

Sample size of 400 was calculated taking prevalence for adherence to diabetic treatment as 35%10 with 5% absolute error and 15% refusal. Amongst 616 total diabetics in HMIS, 400 were selected randomly. All sampled adults were contacted at household. Information on was self-reported and obtained on pre-designed questionnaire. One-month treatment record was checked for the completion of the findings Drug adherence was determined by both recall and pill count method. To minimize recall bias, drug intake was asked for last one week only. In recall method, patients

Address for correspondence: Dr Puneet Misra, Professor, Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, Email id: [email protected] Received:27/11/2017, Accepted:5/7/2018

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Misra P: Adherence to medications among patients with Type 2 DM

were asked to recall individual drug intake in last one week prior to interview. Adherence to drug was calculated by dividing drug consumed with drug prescribed. Adherence was reported in the form of percentage. Patient was categorized as adhered to medication only if adherence was 100% by recall method. We have also calculated adherence by using pill count. Empty blister packs were counted for prescribed medications to estimate the drug intake. The reference period for pill count was one week. Taking no treatment despite being prescribed and missing even a single pill was considered as non-adherent. Fasting Blood sample was collected. Blood samples were analyzed for HBA1C estimation in the laboratory at Civil Hospital Ballabgarh. American Diabetic Association (ADA) Criteria was utilized for classification of HbA1C levels. Information about drug prescription and intake, socio-demographic factors, health seeking behaviors and disease status were

obtained from the participants. Height, weight and blood pressure were recorded. Data was entered in Ms Excel and analyzed using STATA. t test was used for continuous variables and Chi square test was used for categorical variables.

Table 1: Demographic Profile of the study participants

Table 2: Adherence to treatment of DM with level of BMI, Duration, HbA1C and co morbidity of Hypertension

Total (371) Category

Age Group

Sex

Presence of Health Facility

Caste

Occupation

Education Level

SubCategory

N

18-45 years

72

Results Demographic details of study participants are given in Table 1. Out of total 371 study subjects, 325 (87.6%) blood samples were collected. Amongst 371 participants, 258(69.5%) had taken treatment for diabetes in last 1 month. Prevalence of drug adherence among all diabetics with recall method was 39.4% (95% CI 34.5-44.4).

Adherence P (146) Value % 19.4

N 27

Category

% 37.5

46-60 years

142

38.3

54

>60 years

157

42.3

65

41.4

Male

194

52.3

68

35.1

Female

177

47.7

78

44.1

Primary Health Centre

127

34.2

51

Sub Centre

129

34.8

51

No Health Facility

115

31.0

44

General

138

37.2

48

34.8

Backward

180

48.5

80

44.4

SC/ST

53

14.3

18

34.0

Dependent

141

38.0

59

41.8

Housewife

130

35.0

55

42.3

Currently working

100

27.0

32

Illiterate

154

41.5

64

41.6

Primary

58

15.6

18

31.0

Secondary

133

35.8

56

42.1

7.0

8

38.0

39.5

0.08

Duration of DM 0.23 HbA1c** (n=325) 0.21

0.36

30.8

148

39.9 48

32.4

0.03

Alcohol Consumption

59

15.9

27.1

0.04

Total (371)

Adherence (146) P Value

N

%

N

%

35

9.4

14

40.0

Normal 190 (18.5 – 24.9)

51.2 73

38.4

Overweight (25 – 29.9)

101

27.2 40

39.6

Obese (>=30)

45

12.1 19

42.2

5 years

125

33.7 57

45.6

6.4

237

72.9 100 42.2

Normal

42

11.3 19

45.2

107

28.8 42

39.3

124

33.4 51

41.1

98

26.4 34

34.7

Pre-HyperHyperten- tensive sion*** Stage1 HTN

32.0

Tobacco Consumption

16

BMI Category

0.95

38.3

Subcategory

Underweight (< 18.5)

0.78

40.2

Graduate & 26 above

Ethical clearance for the study was obtained from ethical committee of All India Institute of Medical Sciences, New Delhi.

Stage 2 HTN

0.97

0.02

0.64

*DM – Diabetes Mellitus, BMI – Body Mass Index, ** HbA1C categorization was done using American Diabetic Association (ADA) Criteria. *** JNC 7 Criteria was used for classification of Hypertension

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Misra P: Adherence to medications among patients with Type 2 DM

Figure 1: Flow of study participants

Amongst 258 study participants, who had taken any treatment for diabetes in last 1 month, 146 (56.6%, 95% CI: 50.5-62.5) had 100% adherence to the prescribed medicines for last seven days. The prevalence of drug adherence among diabetics with pill count methods was 39.2% (95% CI: 34.4-44.7).

Mean HbA1c level amongst those who had taken any treatment in last one month was 8.57 compared to 8.14 among those who were not taking any medicine. In the group who were taking treatment, mean HbA1c level was 8.57 among the drug adhered group as compared to 8.58 in non-adherence group.

Females (had a better drug adherence compared to males (44.1% Vs35.1%). Prevalence of drug adherence among tobacco and alcohol users was 32.4% and 27.1% respectively. A statistically significant association was found between tobacco consumption (p value=0.03) and alcohol use with drug adherence (p value=0.04). (Table 2)

In multivariate analysis with gender, caste, alcohol consumption, tobacco use, numbness, giddiness, polydypsia and medical prescription, none were found to be statistically significant. The R square value for the model was 0.08. Almost similar results were found during the sensitivity analysis where pill count method.

With increase in duration of DM, adherence increased and it was statistically significant (p=0.02). Highest adherence rate was observed for HbA1c level of >6.4gm% while the lowest was with HbA1c level