systematic evaluation of exclusive factors … · out of 150 patients 89(59.3%) men and 61(40.6%)...

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www.wjpps.com Vol 7, Issue 9, 2018. 1237 Bandari et al. World Journal of Pharmacy and Pharmaceutical Sciences SYSTEMATIC EVALUATION OF EXCLUSIVE FACTORS ASSOCIATED WITH NON-ADHERENCE TO TREATMENT IN IBD PATIENTS Bandari Madhuri 1 *, Mudigonda Shirisha Yadav 2 , Potharla Ajay Kumar 2 , Vishlavath Ganesh Naik 2 , Dr. Rupa Banerjee 3 and Dr. A. Srinivasa Rao 4 1,2 Internee-Pharm.D (Doctor of Pharmacy) Bhaskar Pharmacy College. 3 Senior Consultant at IBD Unit, Asian Institute of Gastroenterology, Somajiguda, Hyderabad. 4 Principal, Bhaskar Pharmacy College, Yenkapally, Moinabad. ABSTRACT Adherence to treatment is a key condition in preventing relapses in inflammatory bowel disease. This study was contrived with the aim to evaluate the exclusive factors associated with non-adherence to treatment in Inflammatory Bowel Disease. A total population of 150 patients were evaluated for this study from Asian Institute of Gastroenterology, to find out the factors causing non-adherence to treatment. A questionnaire concerning demographic, clinical, patient related, medication related, physician related, socioeconomic and psychological assessment of patients were evaluated by using Microsoft Excel 2007. Out of 150 patients 89(59.3%) men and 61(40.6%) women completed the questionnaire. Patients with Crohn’s disease 73(48.6%), indeterminate colitis 4(2%), and ulcerative colitis 73(48.6%). In patient related factors, non-adherence causing co-factors were diminished quality of life 91(60.67%), full time employment 81(54%), and lack of understanding the drug use 80(53.3%). In medication related factors, high cost 102(68%), non-availability of medication 78(52%), heavy pill burden 76(50.6%). In physician related factors, lack of explanation about side-effects 91(80.67%). In psychological assessment, health dependent on medication 97(64.66%), prefer once daily medication 96(64%), effect of medicine on future health 89(59.33%), mystery to take medication 46(30.66%). In socioeconomic factors, lack of participation in sports/activity 44(29.33%), going out socially 45(30%), worried about future income 63(42%) causing non adherence in patients. Conclusion: In this prospective observational study, socioeconomic factors were causing the WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES SJIF Impact Factor 7.421 Volume 7, Issue 9, 1237-1257 Research Article ISSN 2278 – 4357 Article Received on 21 July 2018, Revised on 11 August 2018, Accepted on 31 August 2018 DOI: 10.20959/wjpps20189-12353 *Corresponding Author Bandari Madhuri Internee-Pharm.D (Doctor of Pharmacy) Bhaskar Pharmacy College.

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Page 1: SYSTEMATIC EVALUATION OF EXCLUSIVE FACTORS … · Out of 150 patients 89(59.3%) men and 61(40.6%) women completed the questionnaire. Patients with &rohn’s disease 73(48.6%), indeterminate

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SYSTEMATIC EVALUATION OF EXCLUSIVE FACTORS

ASSOCIATED WITH NON-ADHERENCE TO TREATMENT IN IBD

PATIENTS

Bandari Madhuri1*, Mudigonda Shirisha Yadav

2, Potharla Ajay Kumar

2, Vishlavath

Ganesh Naik2, Dr. Rupa Banerjee

3 and Dr. A. Srinivasa Rao

4

1,2

Internee-Pharm.D (Doctor of Pharmacy) Bhaskar Pharmacy College.

3Senior Consultant at IBD Unit, Asian Institute of Gastroenterology, Somajiguda, Hyderabad.

4Principal, Bhaskar Pharmacy College, Yenkapally, Moinabad.

ABSTRACT

Adherence to treatment is a key condition in preventing relapses in

inflammatory bowel disease. This study was contrived with the aim to

evaluate the exclusive factors associated with non-adherence to

treatment in Inflammatory Bowel Disease. A total population of 150

patients were evaluated for this study from Asian Institute of

Gastroenterology, to find out the factors causing non-adherence to

treatment. A questionnaire concerning demographic, clinical, patient

related, medication related, physician related, socioeconomic and

psychological assessment of patients were evaluated by using

Microsoft Excel 2007. Out of 150 patients 89(59.3%) men and 61(40.6%) women completed

the questionnaire. Patients with Crohn’s disease 73(48.6%), indeterminate colitis 4(2%), and

ulcerative colitis 73(48.6%). In patient related factors, non-adherence causing co-factors were

diminished quality of life 91(60.67%), full time employment 81(54%), and lack of

understanding the drug use 80(53.3%). In medication related factors, high cost 102(68%),

non-availability of medication 78(52%), heavy pill burden 76(50.6%). In physician related

factors, lack of explanation about side-effects 91(80.67%). In psychological assessment,

health dependent on medication 97(64.66%), prefer once daily medication 96(64%), effect of

medicine on future health 89(59.33%), mystery to take medication 46(30.66%). In

socioeconomic factors, lack of participation in sports/activity 44(29.33%), going out socially

45(30%), worried about future income 63(42%) causing non adherence in patients.

Conclusion: In this prospective observational study, socioeconomic factors were causing the

WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES

SJIF Impact Factor 7.421

Volume 7, Issue 9, 1237-1257 Research Article ISSN 2278 – 4357

Article Received on

21 July 2018,

Revised on 11 August 2018,

Accepted on 31 August 2018

DOI: 10.20959/wjpps20189-12353

*Corresponding Author

Bandari Madhuri

Internee-Pharm.D (Doctor of

Pharmacy) Bhaskar

Pharmacy College.

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non-adherence to treatment due to high cost of the medication which can be overcome by

prescribing generic drugs, low cost medication. Patient counseling and patient education will

enhance the quality of life of patients.

KEYWORDS: Adherence, Non-adherence, Ulcerative Colitis, Crohn’s disease, Medication,

Treatment.

INTRODUCTION

Inflammatory bowel disease (IBD) covers a group of disorders in which intestine become

inflamed (red and swollen), probably as result of an immune reaction of the body against its

own intestinal tissue. Three types of IBD are Ulcerative colitis, Crohn’s disease and

Indeterminate colitis. As the name suggests, Ulcerative colitis is a chronic or long lasting

disease that causes inflammation, irritation or swelling and sores called ulcers on the inner

lining of the large intestine. Crohn’s disease can involve any part of the GIT from mouth to

the anus, it mostly affects the small intestine or the colon.[1]

The exact cause of ulcerative

colitis is unknown. Researchers believe the following factors may play a role in causing

ulcerative colitis, overactive intestinal immune system, genes and environment. The exact

cause of Crohn's disease remains unknown. Previously, diet and stress were suspected. A

number of factors, such as heredity and a malfunctioning immune system, likely play a role

in its development.[11]

IBD treatment usually involves either drug therapy or surgery. Anti-inflammatory drugs

include corticosteroids and aminosalicylates, Immunosuppressant drugs include azathioprine,

mercaptopurine, cyclosporine and methotrexate. One class of drugs called tumor necrosis

factor (TNF)-alpha inhibitors, or biologics, works by neutralizing a protein produced by the

immune system. Examples include infliximab, adalimumab andgolimumab. Other biologic

therapies that may be used are natalizumab, vedolizumab and ustekinumab. Other

medications and supplements likeAnti-diarrheal medications, Pain relievers, Iron

supplements, calcium andvitamin –D supplements.[1,4]

Adherence is defined as “the extent to which a person’s behavior (in terms of taking

medications, following diets, or excuting life style changes) coincides with medical or health

advice. Medication adherence is one of the most important factors that determine therapeutic

outcomes, especially in patients suffering from chronic illnesses. There are many situations in

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clinical practice where adherence is extremely important for better therapeutic outcomes.

These include chronic diseases such as Diabetis, Hypertension and IBD.

Improving adherence to prescribed medical treatments remains an almost universally agreed-

upon challenge in health care. Medication non-adherence can be defined as either the

intentional or unwitting failure to take medications as prescribed. By not following the

prescriber’s orders correctly, the patient will experience decreased effectiveness of treatment

which can lead to the worsening of their condition. Patient non-adherence is one of the best

documented but least understood health related behaviors. Factors pertaining to disease,

treatment, patient, clinician, lower socioeconomic status, psychologic, limited family support,

shorter duration of illness, co-morbid illness have been identified as the determinants or risk

factors for non-adherence. Both internal and external factors seem to influence whether a

patient follows health care advice. Internal factors include patient characteristics such as age,

culture, social background, values, attitudes, and emotions caused by the disease. External

factors include the relationship between the patient and the physician or the nurse; support

from family, health care personnel, and friends; and the impact of health education. Internal

and external factors have a powerful influence on patient decision making and behavior

change.[10]

MATERIALS AND METHODS

Methodology

This study was prospective and observational (non-interventional) and was conducted for 6

months (i.e.., from september 2017 to February 2018) at Asian Institute of Gastroenterology,

Somajiguda, Hyderabad. The study included a total of 150 patients. Patients diagnosed of

ulcerative colitis or crohn’s disease were included in the study for evaluation of factors

causing non-adherence by using questionnaire in IBD patients. Patient visiting outpatient

department of AIG Hospital were reviewed. Those subjects who met the study criteria were

enrolled. The enrolled patients were reviewed for the medication use; demographic details,

social habits, diagnosis, past medical history, familial history, co-morbid conditions, extra

intestinal manifestations, number of disease relapses, present disease condition(active or

remission), side effects experienced in the data collection form. Their Adherence rate in

patients was assessed by MMAS-8 scale and patiaents were counseled about their disease,

medications, side-effects, management of disease, importance of medication adherence.

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AIMS AND OBJECTIVES

The main aim is to evaluate the patient, medication, physician, socioeconomic and

psychological factors associated with non-adherence to treatment in IBD patients.

Objectives

To evaluate the patient, medication, physician related, socioeconomic and psychological

factors causing non-adherence in IBD patients.

To evaluate the adherence rate in the IBD patients.

To provide patient counseling and educate patients regarding their disease, possible

symptoms, importance of adherence to treatment, side-effects, and their management so

as to improve quality of life of patients.

RESULTS AND DISCUSSION

Results

In our current observational study, a total of 150 patients attending the OPD of AIG were

assessed. The patients included were diagnosed either ulcerative colitis or crohn’s disease and

indeterminate. The factors causing non-adherence in IBD patients, adherence rate in IBD

patients were assessed.

1. Distribution Based On Sex

Table: 1

Sex Frequency Percentage

MALE 89 59.3

FEMALE 61 40.6

TOTAL 150 100

Figure: 1

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2. Distribution Based On Age

Table 2:

Age Group Frequency Percentage

Early adulthood (18-35) 75 50

Adulthood (36-50) 50 33.4

Late adulthood (51-65) 21 14

Young old (66-74) 3 2

Old (75-84) 1 0.6

Total 150 100

Figure: 2

3. Distribution Based On Disease

Table 3:

Disease Wise Distribution Frequency Percentage

Ulcerative colitis 73 48.6

Crohn’s disease 73 48.6

Indeterminate 4 2.6

Total 150 100

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Figure: 3

4. Disease Distribution Based On Gender

Table 4:

Disease Distribution Based On Gender Frquency Percentage

UC (male) 46 30.6

UC (female) 27 18

CD (male) 41 27.3

CD (female) 32 21.3

INDETERMINATE (male) 2 1.3

INDETERMINATE (female) 2 1.3

Total 150 100

Figure: 4

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Evaluation of Factors Causing Non-Adhernce

1. Patient Related Factors

Table 5:

S.NO Patient related factors (n=150) Adherence(0) Percentage Non adherence(1) Percentage

A1 Forgetfulness 104 69.33 46 30.67

A2 Lack of understanding the drug use 70 46.67 80 53.33

A3 No effect of medication 112 74.67 38 25.33

A4 Increased rates of relapse 99 66 51 34

A5 Worried about side effects 86 57.33 64 42.67

A6 Symptomatic remission (felt better) 123 82 27 18

A7 Diminished quality of life 59 39.33 91 60.67

A8

Co-morbidities or underlying disease.

(depression is a significant predictor of

poor adherence)

80 53.33 70 46.67

A9 Confusing medicines there by missing

the doses 133 88.67 17 11.33

A10 Using NSAIDS 121 80.67 29 19.33

A11 Full time employment 69 46 81 54

A12 No improvement symptomatically 127 84.67 23 15.33

A13 Family influence 130 86.67 20 13.33

Figure: 5

A1-Forgetfulness A9 - Confusing medicines there by missing doses

A2 - Lack of understanding the drug use A10 - Using NSAIDS

A3 - No effect of medication A11 - Full time employment

A4 - Increased rates of relapse A12 - No improvement symptomatically

A5 - Worried about side effects A13 - Family influence

A6 - Symptomatic remission (felt better)

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2. Medication Related Factors

Table 6:

S.NO Medication related factors Adherence(0) Percentage Non adherence(1) Percentage

B14 High cost of medication 48 32 102 68

B15 Large number of concomitant

medication 83 55.33 67 44.67

B16 Alternative medication (taking

alternative treatment

simultaneously) 100 66.67 50 33.33

B17 Non availability of medication 72 48 78 52

B18 Heavy pill burden 74 49.33 76 50.67

B19 High frequency of dosing 92 61.33 58 38.67

B20 Side effects 87 58 63 42

Figure: 6

B14 - High cost of medication B18 - Non availability of medication

B15 - Large number of concomitant medication B19 - High frequency of dosing

B16 - Alternative medication B20 - Side effects

B17 - Non availability of medication

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3. Physician Related Factors

Table 7:

S.NO Physician related factors Adherence(0) Percentage Non adherence(1) Percentage

C21 Were you told about your

disease? 143 95.33 7 4.67

C22 Were you told about effects,

dose, schedule of the drug? 117 78 33 39.33

C23 Were you told regarding side

effects? 59 39.33 91 80.67

C24 Were you told about the plan of

management? 121 80.67 29 19.33

C25 Were you told about the

importance to adhere to drug? 95 63.33 55 36.67

Figure: 7

C21- Were you told about your disease?

C22 - Were you told about effects, dose, schedule of the drug?

C23 - Were you told regarding side effects?

C24 - Were you told about the plan of management?

C25 - Were you told about the importance to adhere to drug?

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4. Psychological Assessment

Table 8:

S.NO Psychological Assessment Adherent(0) % Moderate Non-

Adherent(1) %

Highly Non-

adherent(2) %

PA1 Are you using more than

advised? 140 93.33 10 6.6 0 0

PA2 Would you prefer once daily

medication? 49 32.6 96 64 5 3.3

PA3 Do you feel like this medicine

disrupts your life? 78 52 66 44 6 4

PA4 Do you feel this medicines

mystery to you? 82 54.66 22 14.66 46 30.66

PA5 Do you think your health

depends on this medicine? 48 32 97 64.66 5 3.33

PA6 Do you think your disease get

worse? 83 55.33 59 39.33 9 6

PA7 Do you think this medicine

protects you from worsening? 131 87.33 15 10 4 2.66

PA8 Do you think this medicine will

affect your future health? 52 34.66 89 59.33 9 6

PA9 Are you worrying about

becoming dependent on this

medicine?

61 40.66 86 57.33 3 2

PA10 Have you felt mentally disturbed

due to this medication? 82 54.66 66 44 2 1.33

PA11 How do you feel your health is

now? 129 86 20 13.33 1 0.66

PA12 Have you felt depressed or upset

due to this medication? 71 47.33 79 52.66 0 0

PA13 How much you are satisfied,

happy, pleased with this drug? 124 82.66 24 16 2 1.33

PA14 Do you know non adherence

with medication increase the risk

of clinical relapse? 121 80.66 17 11.33 12 8

PA15 Do you think it is helping in

maintaining the healthy state? 136 90.66 9 6 5 3.3

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Figure: 8

E. Socioeconomic Factors

Table 9:

S.NO Socioeconomic Factors Adherent(0) % LowNon-

adherent(1) %

Moderate non-

adherent(2) %

Highly non-

adherent(3) %

SE1 Is it harder to make

friends because of IBD? 119 79.33 17 11.33 7 4.66 7 4.66

SE2

Do other people bully you

or leave you out of things

because of IBD/its

treatment?

121 80.66 19 12.66 7 4.66 3 2

SE3

Despite IBD, can you take

part in sport or activity

you would like?

41 27.33 33 22 32 21.33 44 29.33

SE4 Does IBD make it difficult

to travel? 55 36.66 33 22 26 17.33 36 24

SE5

Do you feel there is

someone you can talk to

about your IBD condition?

78 52 25 16.66 12 8 35 23.33

SE6 Is there any impairment in

the work due to IBD? 61 40.66 52 34.66 25 16.66 12 8

SE7

Do you ever stop taking

medication due to lack of

money?

122 81.33 14 9.33 10 6.66 4 2.66

SE8 Do you think that your

family doesn't support 109 72.66 9 6 4 2.66 28 18.66

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you?

SE9

When you want to join

conversation how hesitant

do you feel about doing

so?

96 64 26 17.33 21 14 7 4.66

SE10 How often do you go out

socially? 37 24.66 29 19.33 45 30 39 26

SE11

How well your income

covers things you must

have-food, medicine,

clothing etc

63 42 51 34 18 12 18 12

SE12

Are you worried about

your future income

covering the things you

must have?

37 24.66 26 17.33 63 42 24 16

Figure: 9

Evaluation of Adherence and Non-Adherence Rates in Ibd Patients

A. Patient Related Factors

Table 10:

Adherence Score Frequency Percentage

0 – 4 90 60

5 – 13 60 40

Total 150 100

Adherence score: (0 - 4) - Adherent; (>4 - Non-adherent)

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B. Medication Related Factors

Table 11:

Adherence Score Frequency Percentage

0 – 3 80 53.4

4 – 7 70 46.66

Total 150 100

Adherence score: (0 - 3) - Adherent; (>3 - Non adherent)

C. Physician related factors

Table 12:

Adherence Score Frequency Percentage

0 – 2 120 80

3 – 5 30 20

Total 150 100

Adherence score: (0 - 2) - Adherent; (>2 – Non adherent)

D. Psychological Assessment

Table 13:

Adherence Score Frequency Percentage

0 – 10 137 91.4

11 – 30 13 8.66

Total 150 100

Adherence score: (0 – 10) - Adherent; (>10 – Non adherent)

E. Socioeconomic Factors

Table 14:

Adherence Score Frequency Percentage

0 – 9 57 38

10 – 36 93 62

Total 150 100

Adherence score: (0 – 9) - Adherent; (>9 – Non adherent)

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F. Morisky Medication Adherence Scale (MMAS–8)

Table 15:

Adherence Score Frequency Percentage

High adherence (0) 22 14.6

Moderate adherence (1-2) 70 46.66

Low adherence (3-8) 58 38.66

Total 150 100

Comparison of adherence and non-adherence percentage between the factors

Table 16: Shows that non-adherence percentage is more for socioeconomic factors.

Factors Adherence percentage Non-adherence percentage

Patient related 60 40

Medication related 53.4 46.66

Physician related 80 20

Psychological Assessment 91.4 8.66

Socioeconomic 38 62

Figure 10: Comparison of adherence and non-adherence percentage between the

factors.

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Evaluation of medication adherence in patients based on their educational qualification

Table 17: Education wise Adherence distribution.

EDUCATIONAL QUALIFICATIONS

S.NO MMAS-SCORE Illiterate Percentage SSC,

Inter Percentage UG Percentage PG Percentage

1 High Adherence(0) 0 0 7 17.5 7 11.47 8 16.6

2 Moderate

Adherence(1-2) 0 0 19 47.5 29 47.5 22 45.8

3 Low Adherence(3-8) 1 100 14 35 25 40.9 18 37.5

Evaluation of adherence in patients based on their age

Table 18: Age wise Adherence distribution.

AGE WISE DISTRIBUTION

S.NO MMAS-SCORE Early

adulthood

(18-35) %

Adult hood

(36-50) %

Late

adulthood

(51-65) %

Young old

(66-74) %

Old

(75-84) %

1 High Adherence(0) 7 9.33 9 18 6 28.57 0 0 0 0

2 Moderate Adherence

(1-2) 40 53.33 19 38 8 38.09 3 100 0 0

3 Low Adherence (3-8) 28 37.33 22 44 7 33.33 0 0 1 100

DISCUSSION

In Inflammatory bowel disease (IBD), studies have revealed medication non-adherence

prevalence rates ranging from 35%–72%. Adherence to treatment seems to be correlated with

various factors including demographic, clinical, and psychological factors. However, data

concerning the impact of socioeconomic and psychological status on adherence to treatment

in IBD are limited.

Majority of studies have shown an equal gender distribution of IBD. In this study, male

patients were 89 (59.3%) slightly predominant compared to female patients 61(40.6%).

The total population is divided into different age groups according to the WHO guidelines

i.e., early adulthood (18 – 35years), adulthood (36 – 50years), late adulthood (51 – 65years),

young old (66 – 74years), old (75 – 84years). IBD was mostly diagnosed in early adulthood

with majority of patients 75 (50%) in which age group of (18-35years) which was followed

by 50 patients (33.4%) in the age group of (36-50years). Patients of late adulthood diagnosed

with IBD were 21 (14%) and young old age and old age patients were 3 (2%) and 1 (0.6%).

The study conducted by Reenu Malhotra., et al. showed that IBD can occur at any age, but

often people are diagnosed between the ages of 15 – 35.

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Thus our study is in concordance with Reenu Malhotra’s study.[5]

Patients diagnosed with UC were 73 (48.6%) and patients diagnosed with CD were 73

(48.6%) and patients diagnosed with indeterminate are 4 (2%). The study conducted by Bhatt

J et.al.[45]

Showed that, in India the ratio of UC and CD are 8:1, thus it shows UC is more

prevalent than CD in India and also revealed that Asians have a much lower incidence of

crohn’s disease compared to ulcerative colitis.

Thus our study is in concordance with Bhatt J., et al’s study.[6]

Patients were assessed for disease distribution based on gender, where UC male patients are

46 (30.6%), UC female patients are 27 (18%), CD male patients are 41 (27.3%), CD female

patients are 32 (21.3%), and Indeterminate male patients are 2 (1.3%), female patients are 2

(1.3%) The study conducted by Laniprideaux et al. has shown an equal gender distribution

for UC and CD, although studies have reported a slight female predominance for CD and a

male predominance in UC. Our study shows that CD most predominantly occurs in male

patients 41 (27.3%) compared to female patients 32 (21.3%). UC occurs most commonly in

male patients 46 (30.6%) compared to female patients 27 (18%).

Thus our study is not in concordance with Laniprideaux’s study.[7]

A questionnaire is created to evaluate or validate the factors causing non-adherence. All the

factors were examined in total population, Patient related factors includes a set of thirteen co-

factors (questions) where each co-factor (question) is evaluated by giving score 0 – adherence

(negative) and score 1- non-adherence (positive) in our study as we are evaluating the co-

factors which are causing non-adherence in patients. Out of 150 patients, based on the score

(0 or 1) the adherence percentage and non-adherence percentage is given for each co-factor.

All the co-factors of patient related are evaluated and in which diminished quality of life

91(60.67%), full time employment 81(54%), lack of understanding the drug use 80 (53.33)

were the main factors causing non adherence in patients.

While in medication related the co-factors like high cost of medication 102(68%), non-

availability of medication 78(52%) and heavy pill burden 76(50.67) were causing non-

adherence in patients. The study conducted by EleniVangeli et al. shows that none of the

patient related factors or medication related factors were found to be consistently associated

with non-adherence.

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Thus our study is in concordance with EleniVangeli’s study.[8]

In physician related factors, lack of patient education about the side-effects of medication 91

(80.67%) is the major factor causing non adherence. In psychological assessment, co-factors

like mystery to take medication 46(30.66%) causing high non adherence in patients, while

co-factors like health dependent on medication 97(64.66%), prefer once daily medication

96(64%), effect of medicine on future health 89(59.33%) were showing moderate non

adherence in patients. The study conducted by StephaneNahon et al. states that psychological

distress and constraints related to treatment decrease adherence to treatment.

Thus our study is not in concordance with StephaneNahon’s study.[9]

In socioeconomic, co-factors like participation in sports/activity 44(29.33%) causing high

non-adherence in patients, and going out socially 45(30%), worried about future income

63(42%) were the factors causing moderate non adherence in patients.

The adherence and non-adherence rates in total population were assessed based on the

adherence score given for each patient. For patient related factors, 90 patients (60%) were

adherent i.e., under the adherence score of (0 – 4) and 60 patients (40%) were non-adherent

i.e., under the adherence score of (5 – 13) as shown in the table 10.

For medication related factors, 80 patients (53.4%) were adherent i.e., under the adherence

score of (0 – 3) and 70 patients (46.6%) were non-adherent i.e., under the adherence score of

(4 – 7) as shown in the table 11. For physician related factors, 120 patients (80%) were

adherent i.e., under the adherence score of (0 – 2) and 30 patients (20%) were non-adherent

i.e., under the adherence score of (3 – 5) as shown in the table 12.

For psychological factors, 137 patients (91.4%) were adherent i.e., under the adherence score

of (0 – 10) and 13 patients (8.6%) were non-adherent i.e., under the adherence score of (11 -

30) as shown in the table 13.

For socioeconomic factors, 57 patients (38%) were adherent i.e., under the adherence score of

(0 - 9) and 93 patients (62%) were non-adherent i.e., under the adherence score of (10 - 36) as

shown in the 14.

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The best known and most widely used scales for research adherence is the Medication

Adherence Questionnaire (MAQ) by Morisky et al. In this questionnaire a set of eight

questions were used with options No=0 or yes=1. And divided the patients into three

categories: High adherence (0), Moderate adherence (1 – 2) and Low adherence (3 – 8). Out

150 patients, 22 (14.6%) were highly adherent, 70 (46.66%) were moderately adherent, and

58 (38.66%) were low adherent to treatment. By assessing the Adherence score, most of the

patients were moderately adherent to the treatment of IBD.

By comparing the Adherence and Non-adherence percentages between the factors, all the

factors were showing more Adherence percentage than the Non-adherence percentage except

the socioeconomic factors in which non-adherence percentage is more than the adherence

percentage.

Adherence rate is also given based on the educational qualifications of the patients by using

Morisky Medication Adherence scale (MMAS-8) as shown in the table 17. The patients were

categorized into 1) Illiterate - single patient with low adherence (100%), 2) SSC & Inter -

where, 7 patients (17.5%) were high adherent, 19 patients (47.5%) were moderately adherent

and 14 patients (35%) were low adherent. 3) Under Graduate (UG) - where, 7 patients

(11.47%) were highly adherent, 29 patients (47.5%) were moderately adherent and 25

patients (40.9%) were low adherent to treatment. 4) Post Graduate (PG) - where, 8 patients

(16.6%) were highly adherent, 22 patients (45.8%) were moderately adherent and 18 patients

(37.5%) were low adherent to treatment.

Adherence rate is also given based on age groups of the patients by using Morisky scale as

shown in the table 18.The patients were categorized into 1) For Early adulthood (18 – 35):

High adherence – 7 patients (9.33%), Moderate adherence - 40 patients (53.3%), Low

adherence – 28 patients (37.3%). 2) Adulthood (36 – 50): High adherence - 9 patients (18%),

moderate adherence 19 patients (38%), Low adherence 22 patients (44%). 3) Late adulthood

(51 – 65): High adherence – 6 patients (28.57%), moderate adherence - 8 patients (38.09%),

Low adherence – 7 patients (33.33%). 4) young old (66 – 74 ): Only 3 patients (100%) with

moderate adherence. 5) Old (75 – 84): Only 1 patient (100%) with low adherence.

CONCLUSION

Socioeconomic factors are decreasing the adherence rate to treatment compared to other

factors. The present study clearly suggests that the barriers of non-adherence should be

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Bandari et al. World Journal of Pharmacy and Pharmaceutical Sciences

prevented to achieve better outcome for a disease. IBD is chronic inflammatory autoimmune

disease. As IBD is incurable it leads to long term management. It is too difficult to maintain

adherence rate in this particular condition. Subjects who are unable to afford high cost of

drugs with difficulty in handling multiple drugs at short period of time are having more rate

of non-adherence which is effecting progress of IBD.

As high cost is major reason for non-adherence, it can be overcome by using other brands of

the same medication. The drugs like Biologics are very costly (Rs75,000 – 1 lakh/-) for single

injection, as common people cannot afford to take such costly drugs the economic factors

were effecting the adherence in IBD patients. And patients who are unable to take multiple

drugs are to be explained the importance of adherence to treatment and to be counseled that,

in this condition the patient must have to take multiple drugs to prevent the relapse and

maintain remission of the disease. Patients are to be educated regarding the disease and

treatment by the physician. And the quality of life of patients is improved by patient

education.

The non-adherence caused by above co-factors can be overcome by providing patient

counseling. It is essential for healthcare providers to create a trusting, comfortable

relationship with the patients. Communication is the key to solving medication adherence

problems. An important thing is that many instances of medication non-adherence go

unreported due to patients who feel threatened by direct questioning and be unwilling to

admit errors. Furthermore, prescription refill records and pill counts may not provide an

accurate estimate of adherence rates. It is vital to keep close eye on the patients’ medication

habits.

ACKNOWLEDGEMENT

I am thankful to the Almighty for blessings in successful completion of this dissertation. The

satisfaction that accompanies the successful completion of any task would be incomplete

without mentioning the people who made it possible with constant guidance, support and

encouragement. I would like to express my appreciation for all the efforts of people who have

directly or indirectly contributed their ideas and energies in successful completion of my

project.

My deepest Gratitude is to our director, Dr. D. Nageshwar Reddy. I have been amazingly

fortunate to him as he gave us the freedom to explore on our own and at the same time

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guidance to recover when our steps faltered. His patience and support helped us overcome

many crisis situations and finish this dissertation.

I express my gratitude to Dr. A. SrinivasaRao, Principal, Bhaskar Pharmacy College for

providing me the required facilities as well as other resources to carry out my research work

successfully.

I would like to express my sincere Thanks to Dr. Rupa Banerjee teacher and mentor. She

has given her guidance and constant supervision and also providing necessary information

regarding the project and also her support in completing the project. We are also thankful to

her for reading our reports; commenting on our views and helping us understand and enrich

our ideas.

I am indebted to my esteemed HOD Dr. A.V. Kishore Babu, Associate professor,

Department of Pharmacy Practice, Bhaskar Pharmacy College for his valuable guidance,

advice and encouragement.

I am indebted to my esteemed guide Dr. K. Arun, Pharm.D Assistant professor, Department

of Pharmacy Practice, Bhaskar Pharmacy College for his valuable guidance, advice and

encouragement.

I would like to express my special Gratitude and thanks to ASIAN INSTITUTE OF

GASTROENTEROLOGY staff for giving us such attention and time for this study.

I am blessed to have such caring and loving Parents and it is to them that I dedicate this

thesis. I would like to thank my dearest friends for their immense love, help, encouragement

and support without which I might not have completed this work successfully. And I finally

thank all those who have directly or indirectly helped me getting through this project

successfully.

REFERENCES

1. Goldman L, et al., eds. Inflammatory bowel disease. In: Goldman-Cecil Medicine. 25th

ed. Philadelphia, Pa.: Saunders Elsevier; 2016. https://www.clinicalkey.com. Accessed

May 10, 2017.

2. Overview of inflammatory bowel disease. The Merck Manual for Health Care

Professionals.http://www.merckmanuals.com/professional/gastrointestinal-

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Bandari et al. World Journal of Pharmacy and Pharmaceutical Sciences

disorders/inflammatory-bowel-disease-ibd/overview-of-inflammatory-bowel-disease.

Accessed July 7, 2017.

3. Feldman M, et al. Ulcerative colitis. In: Sleisenger and Fordtran's Gastrointestinal and

Liver Disease: Pathophysiology, Diagnosis, Management. 10th

ed. Philadelphia, Pa.:

Saunders Elsevier; 2016. https://www.clinicalkey.com. Accessed June 20, 2017.

4. Complementary and alternative medicine (CAM). Crohn's & Colitis Foundation.

http://www.crohnscolitisfoundation.org/resources/complementary-alternative.html.

Accessed June 21, 2017.

5. Reenu Malhotra., et al. High prevalence of Inflammatory Bowel disease in United States,

Residents of Indian ancestry. Clinical Gastroenterology and Hepatology, 2015; 13(4):

683 – 689.

6. Bhatt J., et al. (Indian Journal of Gastroenterology) self- reported treatment adherence in

inflammatory bowel disease in Indian patients. Indian J Gastroenterol, 2009 July –

August; 28(4): 143 – 146.

7. Laniprideaux. et al. Inflammatory bowel disease in Asia: A systematic review Journal of

Gatroenterology and Hepatology, 2012 March; 19: 1266 - 1280.

8. Eleni Vangeli., et al. A systematic review of factors associated with non-adherence to

treatment for immune-mediated inflammatory diseases. Adv Ther., 2015; 32: 983 – 1028.

9. Stephane Nahon., et al. Socioeconomic and psychological factors associated with non-

adherence to treatment in inflammatory bowel disease patients: results of the isseo

survey. Inflamm Bowel dis., 2011; 17: 1270 – 1276.

10. G.Parthasaradhi. A textbook of clinical pharmacy practice. 2nd

edition ed. Universities

press (India), 2012.

11. Inflammatory Bowel Syndrome – https://googleweblight.com.