chapter ii review of literature -...

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CHAPTER – II

REVIEW OF LITERATURE

Review of literature for the present study is broadly categorized into:

1. Chronic Diseases-Overview

2. Hypertension-Meaning, classification, causes, clinical manifestations,

treatment, complications and lack of drug responsiveness and Studies related

to prevalence of hypertension

3. Diabetes Mellitus-Meaning, ethiology and pathophysiology, charecteristics of

type1 and type2 diabetes mellitus, clinical manifestations, drug, complications,

Studies related to prevalence of diabetes mellitus

4. Studies related to prevalence of hypertension and diabetes

5. Medication compliance- Meaning, Studies related to drug compliance and

related factors, Studies done with Morisky scale

6. Studies related to client education

Chronic Diseases-Overview

According to WHO Chronic diseases are diseases of long duration and generally

slow progression. Chronic diseases, such as heart disease, stroke, cancer, chronic

respiratory diseases and diabetes, are by far the leading cause of mortality in the

world, representing 60% of all deaths. Out of the 35 million people who died from

chronic disease in 2005, half were under 70 and half were women.12

Non communicable Diseases (NCDs) are assuming alarming proportions in the

South-East Asia Region (SEAR) of WHO of which India is a part. They account

the 51% of all deaths and 44% of the disease burden in the Region. Therefore

NCDs should no longer be regarded as a problem confined to the developed

countries and affluent segments of society. In fact they are clearly emerging as

a major public health challenge in developing countries of SEAR.12

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The changes in the economic, social and demographic determinants of health

and adoption of unhealthy lifestyles are contributing to observed

conversion in the disease pattern characterized by a progressive and

accelerated rise in morbidity and mortality due to NCDs in the Region. NCDs

are linked to a cluster of major risk factors such as tobacco use, unhealthy diets,

physical inactivity, obesity, high blood pressure, cholesterol and glucose

levels that are measurable and largely modifiable.

The majority of NCDs are preventable. Furthermore, the knowledge on cost-

effective interventions for NCDs and their risk factors at population, community

and individual level is available. However, the application of this knowledge is

hampered by inadequate recognition of the impact of NCDs on economic

development. Also the lack of financial support retards capacity development for

the prevention and control of NCDs in the Region. 12

The Commission on Chronic Illness in USA has defined "chronic diseases" as

"comprising all impairments or deviations from normal, which have one or more

of the following characteristics: are permanent, leave residual disability, are

caused by non-reversible pathological alteration, require special training of the

patient for rehabilitation, may be expected to require a long period of

supervision, observation or care".15

Non-communicable diseases (NCDs) include cardiovascular, renal, nervous and

mental diseases, musculooskeletal conditions such as arthritis and allied

diseases, chronic non-specific respiratory diseases (e.g., chronic bronchitis,

emphysema, asthma), permanent results of accidents, senility, blindness,

cancer, diabetes, obesity and various other metabolic and degenerative

diseases and chronic results of communicable diseases. Disorders of unknown

cause and progressive course are often labelled "degenerative".15

Chronic non-communicable diseases are assuming increasing importance

among the adult population in both developed and developing countries.

Cardiovascular diseases and cancer are at present the leading causes of death


in developed countries (e.g., North America) accounting for 70 to 75 percent of

total deaths. The prevalence of chronic disease is showing an upward trend in

most countries, and for several reasons this trend is likely to increase. For one

reason, life expectancy is increasing in most countries and a greater number of

people are living to older ages, and are at greater risk to chronic diseases of

various kinds. For another, the life-styles and behavioural patterns of people are

changing rapidly, these being favourable to the onset of chronic diseases.

Modern medical care is now enabling many with chronic diseases to survive.

The impact of chronic diseases on the lives of people is serious when measured

in terms of loss of life, disablement, family hardship and poverty, and economic

loss to the country. Developing countries are now warned to take appropriate

steps to avoid the "epidemics" of non-communicable diseases likely to come

with socio-economic and health developments.15

Based on current trends, it is expected that noncommunicablediseases (NCD)

will account for 73% of deaths and 60% of the global disease burden by 2020,

and will account for a major proportion of disease and deaths in India. These

deaths are mostly due to heart disease, strokes, diabetes mellitus, cancers and

lung diseases.16

As chronic diseases are becoming a dangerous epidemic, the present study

tried to explore about the most important of them ie hypertension and diabetes

mellitus.

HYPERTENSION

Meaning

Hypertension is a sustained elevation of Blood Pressure. In adults, hypertension

exists when systolic blood pressure (SBP) is equal to or greater than 140 mm Hg or

diastolic blood pressure (DBP) is equal to or greater than 90 mm Hg for extended

periods of time. The classification shown in table is of those not taking

antihypertensive drugs and not acutely ill. (Table1). The diagnosis of hypertension


requires that elevated readings be present on at least three occasions during several

weeks.17

Table-1 Classification of Blood Pressure for Adults Age 18 Years and Older17

BLOOD PRESSURE, MM HG

CATEGORY SYSTOLIC DIASTOLIC

Optimal <120 and <80

Normal <130 and <85

High normal 130-139 or 85-89

Hypertension (based on an average of 2 readings)

Stage 1 140-159 or 90-99

Stage 2 160-179 or 100-109

Stage 3 ≥180 or ≥110

Classification of Hypertension

The Table describes the BP classification used in the United States for people 18

years of age and older. The Joint National Commission classifies hypertension

according to stages (1to 3) with the addition of a "high normal" category. These

experts consider the person with BP in the high normal category to be at higher risk

for the development of definite hypertension and recommend more frequent

monitoring than the person with lower BP. The risk of progression from high normal

to definite hypertension is controversial. The etiology of hypertension can be

classified as either primary or secondary.17

Primary Hypertension: Primary (essential) hypertension is elevated BP without an

identified cause and accounts for 90% to 95% of all cases of hypertension. Although

the exact cause of primary hypertension is unknown, several contributing factors,

including increased SNS activity, overproduction of sodium-retaining hormones and


vasoconstrictors, increased sodium intake, greater than ideal body weight, diabetes

mellitus and excessive alcohol intake, have been identified. 17

Secondary Hypertension: Secondary hypertension is elevated BP with a specific

cause that often can be identified and corrected. This type of hypertension accounts

for 5% to 10% of hypertension in adults and more than 80% of hypertension in

children. If a person below age 20 or over age 50 suddenly develops hypertension,

especially if it is severe a secondary cause should be suspected. Clinical findings

that suggest secondary hypertension include unprovoked hypokalemia, abdominal

bruit, variable pressures with history of tachycardia, sweating and tremor, or a family

history of renal disease.

Causes of secondary hypertension include the following:

(1) coarctation or congenital narrowing of the aorta

(2) renal disease such as renal artery stenosis and parenchymal disease

(3) endocrine disorders such as pheochromocytoma. Cushing syndrome, and

hyperaldosteronism

(4) neurologic disorders such as brain tumors, quadriplegia. and head injury

(5) sleep apnea

(6) medications such as sympathetic stimulants (including cocaine), monoamine

oxidase inhibitors taken with tyramine-containing foods, estrogen replacement ther-

apy, oral contraceptive pills, and nonsteroidal antiinflammatory drugs (NSAIDs)

(7) pregnancy-induced hypertension. Treatment of secondary hypertension is

directed at eliminating the underlying cause. Secondary hypertension is a

contributing factor to hypertensive crisis.17

Clinical Manifestations

Hypertension is often called the "silent killer" because it is frequently asymptomatic

until it becomes severe and target organ disease has occurred. A patient with severe

hypertension may experience a variety of symptoms secondary to effects on blood

vessels in the various organs and tissues or to the increased workload of the heart.

These secondary symptoms include fatigue, reduced activity tolerance, dizziness,

palpitations, angina, and dyspnea. In the past, symptoms of hypertension were

thought to include headache, nosebleeds, and dizziness. However, unless BP is very


high or low these symptoms are not more frequent in people with hypertension than

in the general population.17

Complications

The most common complications of hypertension are target organ diseases (Table)

occurring in the heart (hypertensive heart disease), brain (cerebrovascular disease),

peripheral vasculature (peripheral vascular disease), kidney (nephrosclerosis), and

eyes (retinal damage).

Table-2 Manifestations of Target Organ Disease17

ORGAN MANIFESTATIONS

Cardiac

Clinical, electrocardiographic, or radiologic evidence of coronary artery diseases

Left ventricular hypertrophy or "strain" by electrocardiography or left ventricular hypertrophy by echocardiography

Left ventricular dysfunction or cardiac failure

Cerebrovascular Peripheral vascular

Transient ischemic attack or stroke Absence of one or more major pulses in the extremities (except for dorsalispedis) with or without intermittent claudication; aneurysm

Renal Serum creatinine ≥1.5 mg/dl (130 µmol L)

Proteinuria (1 ÷ or greater) Microalbuminuria

Retinopathy Hemorrhages or exudates with or without papilledema

Treatment

The goal of treatment is to prevent complications and death by achieving and

maintaining the arterial blood pressure at 140/90 mm of Hg or lower. The optimal

management plan would be one that is inexpensive and simple and causes the least

possible disruption in the patient‟s life. For patients with uncomplicated hypertension

and no specific indications for another medication, the recommended initial


medication includes diuretics, beta-blockers, or both. The table gives a list of various

pharmacologic agents that are recommended for the treatment of hypertension.17

Table-3 Drug therapy used in hypertension.17

DRUG MECHANISM OF

ACTION

SIDE EFFECTS

AND ADVERSE

EFFECTS

NURSING

CONSIDERATIONS

Diuretics

Thiazide and

Related Diuretics

bendroflumethiazide

benzthiazide

chlorthalidone

hydrochlorothiazide

metolazone

methyclothiazide

t\ichlormethiazide

Inhibit NaCI

reabsorption in

the distal

convoluted tubule;

increases

excretion of Na+

and CI Initial de-

crease in ECF;

sustained

decrease in SVR.

Lower BP

moderately in 2-4

wk.

Fluid and electrolyte

imbalances (volume

depletion, hy-

pokalemia,

hyponatremia,

hypochloremia,

hypomagnesemia,

hypercalcemia,

hyperuricemia,

metabolic alkalosis);

CNS effects (vertigo,

headache,

weakness); GI

effects (anorexia,

nausea, vomiting.

diarrhea,

constipation, pancre-

atitis); sexual

problems (impotence

and decreased

libido); blood

dyscrasias; and

dermatologic

(photosensitivity,

skin rash) effects.

Decreased glucose

Monitor for orthostatic

hypotension,

hypokalemia, and

alkalosis. Thiazides

may potentiate

cardiotoxicity of

digoxin by producing

hypokalemia. Dietary

sodium restriction re-

duces the risk of

hypokalemia. NSAIDs

can decrease diuretic

and antihypertensive

effect of thiazide

diuretics. Advise pa-

tient to supplement

with potassium-rich

foods. Current doses

are lower than previ-

ously recommended.


tolerance.

Loop Diuretics

bumetanide

ethacrynic acid

furosemide

torsemide

Inhibit NaCI

reabsorption in

the thick

ascending limb of

the loop of Henle.

Increase excretion

of Na+ and CI-.

More potent

diuretic effect than

thiazides, but

shorter duration of

action, less ef-

fective for

hypertension.

Fluid electrolyte

imbalance as with

thiazides, except no

hypercalcemia.

Ototoxicity (hearing

impairment,

deafness, vertigo)

that is usually

reversible. Metabolic

effects, including

hyperuricemia,

hyperglycemia,

increased LDL

cholesterol and

triglycerides with

decreased HDL

cholesterol.

Monitor for orthostatic

hypotension and

electrolyte abnormal-

ities. Loop diuretics

remain effective

despite renal

insufficiency. Diuretic

effect of drug

increases at higher

doses.

Potassium-Sparing

Diuretics

amiloride

triamterene

spironolactone

eplerenone

Reduce K+ and

Na+ exchange in

the distal and

collecting tubules.

Reduces

excretion of K+,

H+, Ca2+, and

Mg2+.

Inhibit the Na+

retaining and K +

excreting effects

of aldosterone in

the distal and

collecting tubules.

Hyperkalemia,

nausea, vomiting.

diarrhea, headache,

leg cramps, and

dizziness.

Same as amiloride

and triamterene;

may cause

gynecomastia,

impotence,

decreased libido,

and menstrual

irregularities.

Monitor for

orthostatichypotension

and hyperkalemia.

Potassium-sparing

diuretics are

contraindicated in

patients with renal

failure and uS6d with

caution in patients on

ACE inhibitors or

angiotensin II

blockers. Avoid

potassium

supplements.


Adrenergic

Inhibitors Central-

Acting Adrenergic

Agonists clonidine

Reduces

sympathetic

outflow from CNS.

Reduces periph-

eral sympathetic

tone, produces

vasodilation; de

creases SVR and

BP.

Dry mouth, sedation,

impotence, nausea,

dizziness, sleep

disturbance;

nightmares, restless-

ness,and

depression.

Symptomatic

bradycardia in

patients with

conduction disorder.

Sudden

discontinuation may

cause withdrawal

syndrome including

rebound tachycardia

hypertension,,

headache, tremors,

apprehension, and

sweating. Chewing

gum or hard candy

may relieve dry

mouth. Alcohol and

sedatives increase

sedation. May be

given transdermally

with fewer side effects

and better

compliance.

Guanabenz Same as

clonidine.

Same as clonidine. Same as clonidine,

but not available in

transdermal

formulation.

Guanfacine Same as

clonidine.

Same as clonidine. Same as clonidine,

but not available in

transdermal

formulation.

Methyldopa Same as

clonidine.

Sedation, fatigue,

orthostatic hy-

potension,

decreased libido,

impotence, dry

mouth, hemolytic

Instruct patient about

daytime sedation and

avoidance of

hazardous activities.

Administration of a

single daily dose at


anemia,

hepatotoxicity,

sodium and water

retent.ion, psychic

depression.

bedtime minimizes

sedative effect.

Peripheral-Acting

Adrenergic

Antagonists

Guanethidine

Prevents

peripheral release

of norepinephrine.

resulting in

vasodilation;

lowers CO and

reduces SBP

more than DBP.

Marked orthostatic

hypotension,

diarrhea, cramps,

bradycardia,

retrograde or

delayed ejaculation,

sodium and water

retention.

May cause severe

postural hypotension;

not recommended for

use in patients with

cerebrovascular or

coronary insufficiency

or in older adults;

advise patient to rise

slowly and wear

support stockings.

Hypotensive effect is

delayed for 2-3 days

and lasts 7-10 days

after withdrawal. Once

daily dosing.

Guanadrel sulfate

reserpine

Same as

guanethidine.

Depletes central

and peripheral

stores of

norepinephrine;

results in

peripheral

vasodilation

(decreases SVR

and BP).

Similar to

guanethidine.

Sedation and

inability to con-

centrate; depression;

nasal stuffiness.

Must be given twice

daily. Contraindicated

in patients with history

of depression. Monitor

mood and mental

status regularly. Advise

patient to avoid

barbiturates, alcohol

and narcotics.


α1-Adrenergic

Blockers

doxazosin

prazosin

terazosin

Block α1-

adrenergic effects

producing

peripheral va-

sodilation

(decreases SVR

and BP).

Variable amount of

postural hypotension

depending on the

plasma volume. May

see profound

orthostatic hy-

potension with

syncope within 90

minutes after initial

dose. Retention of

salt and water.

Reduced resistance to

the outflow of urine in

benign prostatic

hyperplasia. Taking

drug at bedtime

reduces risks associ-

ated with orthostatic

hypotension.

Beneficial effects on

lipid profile.

Phentolamine Blocks α1-

adrenergic recep-

tors, resulting in

peripheral

vasodilation

(decreases SVR

and BP).

Acute, prolonged

hypotension, cardiac

arrhythmias,

tachycardia,

weakness, flushing.

Abdominal pain,

nausea, and ex-

acerbation of peptic

ulcer.

Used in short-term

management of

pheochromocytoma.

Also used locally to

prevent necrosis of

skin and subcutaneous

tissue after

extravasation of an a-

adrenergic drug. No

oral formulation.

βAdrenergic

Blockers

acebutolol

atenolol

betaxolol

bisoprolol

carteolol

carvedilol

Reduce BP by

antagonizing β

adrenergic

effects. Decrease

CO and reduce

sympathetic

vasoconstrictor

tone. Decrease

rennin secretion

by kidney.

Bronchospasm,

atrioventricular

conduction block,

impaired peripheral

circulation. Night-

mares, depression,

weakness, reduced

exercise capacity.

May induce or

exacerbate heart

β-Adrenergic blockers

vary in lipid solubility,

selectivity, and

presence of partial

sympathomimetic

effect, which explains

different therapeutic

and side effect profiles

of specific agents.

Monitor pulse


metoprolol

nadolol

penbutolol

pindolol

propranolol

timolol

esmolol

Reduces BP by

antagonizing β

adrenergic

effects.

failure in susceptible

patients. Sudden

withdrawal of ,B-

adrenergic blockers

may cause rebound

hypertension and ex-

acerbate symptoms

of ischemic heart

disease.

regularly. Caution in

patients with diabetes

mellitus because drug

may mask signs of

hypoglycemia.

IV administration;

rapid onset and very

short duration of

action.

Combined α- and β

Adrenergic Blocker

labetalol

α1,β1 adrenergic

blocking

properties pro-

ducing peripheral

vasodilation and

decreased heart

rate. Reduces

CO, SVR, and BP.

Dizziness, fatigue,

nausea, vomiting,

dyspepsia,

paresthesia, nasal

stuffiness,

impotence, edema.

Hepatic toxicity.

Same as ,β-

adrenergic blockers.

IV form available for

hypertensive crisis in

hospitalized patients.

Patients must be kept

supine during IV

administration. Assess

patient tolerance of

upright position

(severe postural

hypotension) before

allowing upright

activities (e.g.,

commode).

Direct

Vasodilators

diazoxide

Reduces SVR and

BP by direct

arterial

vasodilation.

Reflex sympathetic

activation producing

increased HR, CO,

and salt and water

retention.

Hyperglycemia,

IV use only for



Administer only into

peripheral vein.


especially in patients

with type 2 diabetes.

hydralazine Reduces SVR and

BP by direct

arterial

vasodilation.

Headache, nausea,

flushing, palpitation,

tachycardia,

dizziness, and

angina. Hemolytic

anemia, vasculitis,

and rapidly progres-

sive

glomerulonephritis.

IV use for



Twicedaily oral

dosage. Not used as

monotherapy because

of side effects.

Contraindicated in pa-

tients with coronary

artery disease; used

with caution in pa-

tients over 40 years of

age.

minoxidil Reduces SVR and

BP by direct

arterial

vasoldilation.

Reflex tachycardia,

marked sodium and

fluid retention (may

require loop diuretics

for control), and

hirsuitism. May

cause ECG changes

(flattened and

inverted T waves)

not related to

ischemia.

Reserved for

treatment of severe

hypertension

associated with renal

failure and resistant to

other therapy. 'Once-

or twice daily dosage.

nitroglycerin Relaxes arterial

and venous

smooth muscle

reducing preload

and SVR. At low

dose, venous

Hypotension,

headache, vomiting,

flushing.

IV use for


hospitalized patients

with myocardial

ischemia.

Administered by


dilation pre-

dominates; at

higher dose

arterial dilation is

present

continuous IV infusion

with pump or control

device.

Use intraarterial moni-

toring of BP. Light-

resistant bags, bottles,

and administration

sets must be used;

stable for 24 hr.

Monitor thiocyanate

levels with prolonged

(2:24 to 48 hr) use.

sodium

nitroprusside

Direct arterial

vasodilation re-

duces SVR and

BP.

Acute hypotension,

nausea, vomiting.

muscle twitching.

Signs of thiocyanate

toxicity include

anorexia, nausea,

fatigue, and

disorientation.

Ganglionic Blockers

trimethaphan

Interrupts

adrenergic control

of arteries, results

in vasodilation,

and reduces SVR

and BP.

Visual disturbance,

dilated pupils, dry

mouth, urinary

hesitancy, subjective

chilliness.

IV use for initial

control of BP in

patient with dissecting

aortic aneurysm.

Administered by

continuous IV infusion

with pump or control

device.

Angiotensin

Inhibitors

Angiotensin-

Converting Enzyme

Inhibitors

benazepril

captopril

enalapril

fosinopril lisinopril moexipril

perindopril

Inhibit

angiotensin-

converting

enzyme; reduce

conversion of

angiotensin I to

angio tensin II (A-

II); prevent A-II-

mediated vasocon

striction. Inhibit

Hypotension, loss of

taste, cough,

hyperkalemia, acute

renal failure, skin

rash, angioneurotic

edema. Same as

oral forms.

Aspirin and NSAIDs

may reduce drug

effectiveness. Addition

of diuretic enhances

drug effect Should not

be used with

potassium-sparing

diuretics. Can cause

fetal morbidity or

mortality. Captopril


quinapril

ramipril

trandolapril

enalaprilat

angiotensin

converting

enzyme when oral

agents not

appropriate..

may be given orally

for hypertensive crisis.

Given IV over 5

minutes; may be given

every 6 hr.

Angiotensin II

Receptor Blockers

candesilrtan

eprosartan

irbesartan

losartan

olmesartan

telmisartan

tasosartan

valsartan

Prevent action of

angiotensin II and

produce

vasodilation and

increased salt and

water excretion.

Hyperkalemia,

decreased renal

function.

Full effect on BP may

not be seen for 3-6

wk.

Calcium Channel

Blockers

amlodipine

diltiazem

felodipine

isradipine

mibefradil

nicardipine

nifedipine

nisoldipine

verapamil

Block movement

of extracellular

calcium into cells,

causing

vasodilation and

decreased SVR.

Nausea, headache,

dizziness, peripheral

edema. Reflex

tachycardia (with

dihydropyridines).

Reflex decrease HR

(with diltiazem);

constipation (with

verapamil).

Use with caution in

patients with heart

failure.

Contraindicated in

patients with second-

or third-degree heart

block. IV nicardipine

available for hy-

pertensive crisis in


Sustained-release for-

mulations for some

drugs. Avoid

grapefruit when on

nifedipine.


Side effects and adverse effects of antihypertensive drugs may be so undesirable

that the patient may not comply with therapy. The table gives reasons for lack of

responsiveness to therapy which includes non compliance to drug.

Table-4 Causes for lack of Responsiveness to therapy

Nonadherence to therapy

Cost of medication

Instructions not clear or not given to

the patient in writing

Inadequate or no patient teaching

Lack of involvement of the patient in

the treatment plan

Side effects of medication

Dementia

Inconvenient dosing

Drug – related causes

Dosages too low

Inappropriate combinations

Rapid inactivation

Drug interactions

Nonsteroidal anti-inflammatory drugs

Oral contraceptives

Sympathomimetics

Antidepressants

Adrenal Corticosteroids

Nasal decongestants

Licrorice containing substance (eg.,

chewing tobacco)

Cocaine

Cyclosporine

Erythropoietin

Associated conditions

Increasing obesity

Alcohol intake more than 1 oz/day

Secondary Hypertension

Renal insufficiency

Renovascular hypertension

Pheochromocytoma

Primary aldosteronism

Volume overload

Inadequate diuretic therapy

Excess sodium intake

Fluid retention from reduction of

blood pressure

Progressive renal damage

Pseudohypertension


Studies related to prevalence of hypertension

In a study conducted in Northern India, it was found that there was a rising trend in

the prevalence of hypertension over the last 3 decades. The people of seven villages

in the age group of 17-70 years were interviewed. The prevalence of hypertension

was 4.5% and was higher among females than males and only 26.3% of all

hypertensive were aware of their disease and only 3.5% had regular treatment.4

In an ICMR study

in 1994 involving 5537 individuals (3050 urban residents and 2487

rural residents) demonstrated 25% and 29% prevalence of hypertension (Criteria:

>=140/90 mm of Hg) among males and females respectively in urban Delhi and 13%

and 10% in rural Haryana From south India, Kutty VR

carried out hypertension

prevalence study (criteria: >=160/95 mm of Hg) in rural Kerala during 1991 in the 20

plus age group and the prevalence was found to be 18%. Later studies in Kerala

(Criteria: JNC VI) reported 37% prevalence of hypertension among 30-64 age group

in 1998 and 55% among 40-60 age group

during 2000. A higher prevalence of 69%

and 55% was recorded among elderly populations aged sixty and above in the urban

and rural areas respectively during 2000. The Sentinel Surveillance Project,

documented 28% overall prevalence of hypertension (criteria: =JNC VI) from 10

regions of the country in the age group 20-69. 5

In a multi centric study

involving six urban cities in India (Chennai, Bangalore,

Hyderabad, Mumbai, Culcutta and New Delhi) in the country among the age group of

20 and above showed a prevalence of 14% among men and women (sample size:

5288 men; 5928 women). The Sentinel Surveillance Project, documented 10%

overall prevalence of diabetes from 10 regions of the country using the criteria (FPG

> 126 mg/dl or on treatment) in the age group 20-69. 5

A survey conducted at Assam has mentioned in their annual report that 3180 people

from 5 districts who were 30+ years were included in the study where an interview

was done followed by assessments for anthropometric measurements, blood

pressure and ECG monitor for coronary heart disease. The prevalence in the study

population was 33.3% and 22% were aware of the blood pressure.18


A study to identify the Prevalence of hypertension in coastal Karnataka was done to

estimate the prevalence and socio demographic correlates among adults above 30

years. It was a community based cross-sectional study carried out on a population of

1,239 respondents, using a two-stage stratified, probability proportional to size

sampling technique. Study variables included, socio-demographic characteristics,

physical activity, blood pressure and blood glucose measurements, anthropometric

measurements, family history of hypertension and diabetes. The study included

1,419 subjects with a response rate of 87.3%. Among the respondents 434 (35%)

were males and 805 (65%) were females. The prevalence of hypertension was found

to be 43.3%. Based on JNC VII classification, pre-hypertension was noted among

41.4% of the subjects, with 43.7% individuals being in the 30-39 year age group.

Advancing age, male gender, current diabetic status, central obesity, being

overweight and obese as defined by BMI were identified by the multivariate logistic

regression model to be associated with the presence of hypertension. 19

Diabetes Mellitus

Meaning

It is a multisystem disease related to abnormal insulin production, impaired insulin

utilization, or both. Diabetes mellitus is a serious health problem throughout the

world. 17

Etiology and Pathophysiology

Current theories link the causes of diabetes, singly or in combination, to genetic,

autoimmune, viral and environmental factors (e.g obesity, stress). Regardless of its

cause, diabetes is primarily a disorder of glucose metabolism related to absent or

insufficient insulin supplies and / or poor utilization of the insulin that is available. 17

Although the American Diabetes Association (ADA) recognize 11 different

classifications of the disease, most of these types are rarely encountered in routine

nursing practice. The two most common types of diabetes are classified as type 1 or

type 2 diabetes mellitus. Gestational diabetes and secondary diabetes are other


classifications of diabetes commonly seen in clinical practice. The table shows the

difference in charecteristics of type-1 and 2 diabetes mellitus.17

Table-5 Chacteristics of type 1 and type 2 Diabetets Mellitus 17

Factor Type 1 Diabetes

Mullitus

Type 2 Diabetes Mullitus

Age at onset More common in young

person but can occur at

any age

Usually age 35 yr or older

but can occur at any age

Incidence is increasing in

children

Type of onset Sign and symptoms

abrupt but disease

process may be present

for several years

Insidious

Prevalence Accounts for 5% - 10% of

all types of diabetes

Accounts for 90% of all

types of diabetets

Environmental factors Virus, toxins Obesity, lack of exercise

Islet cell antibodies Often present at onset Absent

Endogenous insulin Minimal or absent Possibly excessive;

adequate but delayed

secretion or reduced

utilization

Nutritional status Thin catabolic state Obese or possibly normal

Symptoms Thirst polyuria

polyphagia, fatigue

Frequently none or mild

Ketosis Prone at onset or during

insulin deficiency

Resistant except during

infection or stress

Nutritional therapy Essential Essential possibly sufficient

for glycemic control

Insulin Required for all Required for some

Oral hypoglycemic agents Not beneficial Usually beneficial

Vascular and neurologic

complications

Frequent Frequent


Clinical Manifestations

Type 1 Diabetes Mellitus: Because the onset of type 1 diabetes is rapid, the

initialmanifestations are usually acute. The classic symptoms are polyuria (frequent

urination) polydipsia (excessive thirst) and polyphagia (excessive hunger). The

osmotic effect of glucose produces the manifestations of polydipsia and polyuria.

Polyphagia is a consequence of cellular malnourishment when insulin deficiency

prevents utilization of glucose for energy. Weight loss may occur as the body cannot

get glucose and turns to other energy souces, such as fat and protein. Weakness

and fatigue may also be experienced as body cells lack needed energy from

glucose. Ketoacidosis, a complication associated with untreated type 1 diabetes, is

associated with additional clinical manifestations.17

Type 2 Diabetes Mellitus: The clinical manifestations of type 2 diabetes are often

nonspecific, although it is possible that an individual with type 2 diabetes will

experience some of the classic symptoms associated with type 1. Some of the more

common manifestations associated with type 2 diabetes include fatigue recurrent

infections prolonged wound healing and visual changes. Unfortunately the clinical

manifestations appear so gradually that before the person knows it he or she may

have complications. 17

Drug therapy

Insulin

Exogenous (injected) insulin is needed when a patient has inadequate insulin to

meet specific metabolic needs and the combination of nutritional therapy, exercise,

and Oral agents cannot maintain a satisfactory blood glucose level. The problems

with insulin therapy are hypoglycemia, allergic reactions, lipodystrophy and somogyi

effects.

Somogyi effect or chronic somogyi rebound is a rebounding high blood sugar that is

a response to low blood sugar. In context of managing the blood glucose level

manually with insulin injections this effect is counter-intuitive to insulin users who

experience high blood sugar in the morning as a result of an over abundance of

insulin at night. This controversial phenomenon was named after Dr.Michael

Somogyi. 20


Oral agents(OAs)

They are not insulin, but they work to improve the mechanisms by which insulin and

glucose are produced and used by the body. For any of the OAs to be effective, the

patient must have circulating endogenous insulin. There are currently no OAs to treat

type1 diabetes. It may be used in combination with agents from other classes or with

insulin to achieve blood glucose targets. Guidelines for assessing patients receiving

OAs are given in table below.17

Table-6 Oral agents for diabetes mellitus17

Type Mechanism of action Side effects

First generation

sulfonylureas

Tolbutamide

Acetohexamine

Tolazamide

Cholopropamide

Stimulate release of insulin from

pancreatic islets; decrease

glycogenolysis and gluconegoenesis

enhance cellular sentivity to insulin

Weight gain,

hypoglycemia

Second Genreation

sulfonylureas

Glipizide

Glyburide

Glimepiride

Stimulate release of insulin from

pancreatic islets decrease glycogenolysis

and gluconeogensis; enhance cellular

sensitivity to insulin

Weight gain

hypoglycemia

Meglitindes

Repaglinide Nateglinide

Stimulate a rapid and short lived release

of insulin from the pancreas

Weight gain

hypoglycemia

Biguanide

Metformin

Rate of hepatic glucose production

augments glucose uptake by tissues

especially muscles

Diarrehea lactic

acidosis

α-Glucosidase inhibitors

acarbose

Miglito

Delay absorption of glucose from GI tract

Gas, abdominal pain,

diarrhea


Thiazolidinediones

Pioglitazone

Rosiglitazone

Glucose up take in muscle endogenous

glucose production

Weight gain edema

Combination therapy

Glucovance

Avandmet

Metaglip

Combination of metformin and glyburide

Combination of rosiglitazone and

metformin

Combination of metformin and glipizide

Nausea, diarrhea

abdominal pain lactic

acidosis weight gain

hypoglycemia

Table-6a Injectable non-insulin drugs

S.No Name Action Side effects

1. Exenatide (Byetta)21 It is an incretin mimetic which

stimulates insulin production and

helps the person to feel full by

delaying emptying of stomach.

Hypoglycemia

2. Pramlintide(SymlinR)21 It is a synthetic version of amylin

which helps the person feel full by

delaying the emptying of stomach.

Nausea, vomitting

3. Liraglutide-r DNA

origin(Victoza R)22

Is 97% similar to the hormone

GLP_1 which signals beta cells to

release insulin hence it helps beta

cells to release insulin.

Thyroid cancer,

pancreatitis

Complications

Chronic complications of diabetes are primarily those of end organ disease that

result from damage to the large and small blood vessels from chronic hyperglycemia.

Based on studies conducted by the American Diabetes Association has given

recommendations for ongoing evaluation which is listed below.17


Table-7 Complications of diabetes mellitus and the detection methods17

Complication Type of Examination Frequency

Retinopathy Funduscopic- dilated eye

examination

Annually

Nephropathy Urinalysis for microalbuminuria Annually

Neuropathy(foot and

lower extremities)

Visual examination of foot

Comprehensive foot examination:

-visual examination

-sensory examination with

monofilament and tuning fork

-palpation(pulses, temperature,

callus formation)

Daily by patient,

every visit by health

care provider

Annually

Cardiovascular disease Blood pressure

Lipid panel

Exercise stress testing (may include

stress ECG, stress echocardiogram,

perfusion imaging)

Every visit

Annually

As needed based

on risk factors

Studies related to prevalence of diabetes

A study has reported that WHO estimates 135 million diabetic cases in 1995 and this

number would increase to 300 million by the year 2025. It also states that India will

lead the world with the largest number of diabetics in any given country.6

In a study on prevalence of diabetes in a rural area of central India observed

34(3.67%) were diabetic out of a total 122(13.20%) who had abnormal glucose

tolerance in a rural area of Nagpur district23. In this study nine hundred and twenty

four subjects aged greater than or equal to 30 were selected by systematic random

sampling of houses, and all subjects were interviewed using a standardized

proforma and screened by 75g oral glucose tolerance test based on WHO criteria.

The prevalence of diabetes found is high compared to that in the WHO report (2.4%)

for rural India. The study also found that upper socioeconomic class, family history of


diabetes, reduced physical activity, and increased BMI, were important predictors of

diabetes.

A study on “Prevalence of diagnosed diabetes in an urban area of Puducherry, India:

Time for preventive action”24 aimed to estimate the number of persons diagnosed

with diabetes in Puducherry. Diabetes was diagnosed retrospectively from all family

folders of 2667 families(population 11835) for the period 2003-06. The data was

verified by home visits. It was found 643 individuals had been diagnosed with

diabetes and the prevalence was estimated to be 5.6%(5.31% in males and 6.1% in

females), age-specific findings were 8.2% in the age group of ≥20 years and above

20% after the age of 50 years. The study also concluded that diabetes is more

prevalent after the age of 40 years.

The global prevalence of diabetes –estimates for the year 2000 and projections for

203025 predicted a prevalence rate of 4.4% in 2030 ie upto 366million. It is due to an

increase in urban population and of people > 65 years.

A Study of prevalence of diabetes mellitus and impaired fasting glucose in a rural

population was conducted with the main aim to estimate the prevalence of diabetes

mellitus and Impaired Fasting Glucose(IFG) in Suttur Village, Karnataka State26. A

cross sectional survey was carried out in this village to estimate the prevalence of

diabetes and IFG. Blood samples were collected with a minimum of eight hours

fasting. Estimation of blood sugar was done by GOD/POD method. The ADA 1997

criteria was adopted for diagnosis of impaired fasting glucose (IFG) and Diabetes

mellitus (DM) The prevalence rate (percent) of diabetes mellitus for persons above

the age of 25 years was 3.77%. The prevalence in males was 4.58% and in females

it was 2.66%. Impaired fasting glucose was 2.82% in male and 2.78 % in female.

The maximum prevalence was observed in the age group of 56 to 65 in both males

and females. There was no significant difference in the prevalence of IFG among the

three different communities; the study has highlighted the association of age, sex

and community, with prevalence of diabetes.

A study done in Karnal district, Haryana27 tried to identify the prevalence of type I

diabetes in north India as previous data were from Karnataka registry which showed


an incidence of 3.7/1lakh in boys and 4/1lakh in girls above 13 years and population

based study in urban Chennai 1996 an incidence of 10.5/1lakh and overall in India

estimates of 1.6 to 10.5/1lakh had been reported. The study used hospital based

registry to identify prevalence. The results were out of 222017 population of Karnal

diabetes prevalence was 10.2/1lakh population, in urban 26.6/1lakh, rural

4.27/1lakh.The prevalence rates of type I diabetes was 31.9/1lakh,men-

11.56/1lakh,women-8.6/1lakh 5-16years-22.22/1lakh and 0-5years-3.82/1lakh.This

study thus highlights the prevalence of type I diabetes in the various gradients of

population at Karnal.

Studies related to prevalence of hypertension and diabetes

The Karnataka state health policy 200428, states that Karnataka carries a double

burden of communicable and non-communicable diseases. The latter include, in

particular cardiovascular diseases, including hypertension, cancers and diabetes.

The prevalence/incidence of various NCDs for 1998 has also been estimated, for

India, based on various published studies from different regions. These estimates

may be relatively conservative, as suggested by the comparison with the diabetes

prevalence estimates of the World Health Organization. Even then, it is estimated

that about one-fifth of the population would have at least one of these selected NCDs

Report of National Cardiovascular Disease Database Supported by Ministry of

Health & Family Welfare, Government of India and World Health Organization has

given the prevalence studies for diabetes and hypertension.The MEDLINE, EMBASE

and INDMED databases from 1940-2005, were searched to obtain prevalence

studies on hypertension in Indian population. The search terms used were

“prevalence”, “hypertension”, “high blood pressure”, “coronary risk factors”, and

“India”. Using the above literature search techniques, fifty-two epidemiological

studies published between 1940 and 2005 were identified. All the studies identified

were cross sectional in nature. The study location (urban vs rural), age group

studied, sample size, criteria for diagnosis of hypertension, prevalence of

hypertension in the total group, men and women were classified separately. There

were marked heterogeneity among studies mostly due to the varying time periods of


data collection and differing definitions of hypertension. However, prevalence of

hypertension based on JNC V criteria was available from 22 studies across India.

The earliest study was conducted by Dubey VD (1954), documented 4% prevalence

of hypertension (criteria:>160/95) amongst industrial workers of Kanpur. Later

studies in Kerala (Criteria: JNC VI) report 37% prevalence of hypertension among

30-64 age group

in 1998 and 55% among 40-60 age group

during 2000. A higher

prevalence of 69% and 55% was recorded among elderly populations aged sixty and

above in the urban and rural areas respectively during 2000. Few studies on

prevalence on hypertension are available from eastern Indian population. In 2002,

Hazarika et al

reported 61% prevalence (criteria: =JNC VI) among man and women

aged thirty and above in Assam. The Sentinel Surveillance Project, documented

28% overall prevalence of hypertension (criteria: =JNC VI) from 10 regions of the

country in the age group 20-69. A study conducted in the urban areas of Chennai

during 2000

(age group>=40) reported a higher prevalence of hypertension (54%)

among low income group (monthly income < Rs 30000/annum and 40% prevalence

among high-income group (monthly income > Rs 60000/annum). Misra et al

reported

12% prevalence of hypertension in the slums of Delhi. 5

Prevalence studies on Diabetes were identified as using the same methodology

described previously. The search terms used were “prevalence”, “diabetes”

“hypertension”, “coronary risk factors”, “glucose abnormalities”, “dysglycaemia”,

“coronary”, “insulin and metabolic syndrome” and “India”. Using the above literature

search techniques, twenty-seven epidemiological studies published between 1950

and 2005 were found. All the studies identified were cross sectional in nature. The

study location (urban Vs rural), age group studied, sample size, criteria for diagnosis

of diabetes, prevalence of diabetes in the total group, men and women tabulated

separately. There were marked heterogeneity among studies mostly due to the

varying time periods of data collection and differing definitions of diabetes. During

1972-75, ICMR

carried out a large multicentric study in India, which documented

2.6% and 1.5% prevalence of diabetes (criteria: FBS>5.6mmol/l or Post 1-h glucose

value>=7.8mmol/l or Post 2-h glucose value>=6.7mmol/l) among men and women in

the urban areas while in rural areas had a lower prevalence: 1.8% and 1.3%

respectively. In 1994, Wander GS reported 5% prevalence of diabetes (criteria:

random venous blood glucose >180mg/dl or history) among a rural population


Ludhiana, Punjab. Further, Gupta R from Jaipur, through three epidemiological

studies carried out during 1994, 2001

and 2003

demonstrated rising trend rates of

diabetes (criteria: FBS>126mg/dl or history) 1%, 13%, and 18% respectively among

males and 1%, 11% and 14% respectively among females. In 2000, a multi centric

study

involving six urban cities in India (Chennai, Bangalore, Hyderabad, Mumbai,

Culcutta and New Delhi) in the country among the age group of 20 and above

showed a prevalence of 14% among men and women (sample size: 5288 men; 5928

women). The Sentinel Surveillance Project, documented 10% overall prevalence of

diabetes from 10 regions of the country using the criteria (FPG > 126 mg/dl or on

treatment) in the age group20-69.4. 5

A study on the Prevalence of diabetes, obesity, hypertension and hyperlipidemia in

the central area of Argentina29 had studied representative samples of the population,

based on a multistage probabilistic sampling design; samples were taken from each

of the four cities. The sample size was calculated to obtain a precision of 4% for the

prevalence assessment. The subjects included were aged 20 years and over.

Standardization of the prevalence rates used, the entire study sample as the

reference population. Age-standardised prevalence rates for the cities ranged

between 22.4% and 30.8% for obesity, 27.9% and 43.6% for hypertension, 24.2%

and 36.4% for hyperlipidemia, and 6.5% and 7.7% for diabetes mellitus. All these

prevalences increased with age. 58.1% of the obese subjects and 51.2% of the

diabetic subjects had hypertension, while 43.2% of the obese subjects and 52.8% of

the diabetic subjects had hyperlipidemia.

The report of the working group on communicable and non communicable diseases

for the 11th five year plan September 2006 by Dr.RK Srivastava30 has given the

following comments India is experiencing a rapid health transition, with a large and

rising burdens of chronic diseases, which are estimated to account for 53% of all

deaths and 44% of Disability Adjusted Living Years lost in 2005. Non-communicable

Diseases, especially diabetes mellitus, cardiovascular diseases, cancer, stroke and

chronic lung diseases have emerged as major public health problems due to an

ageing population and environmentally-driven changes in behavior. The premature

morbidity and mortality in the most productive phase of life is posing a serious

challenge to Indian society and its economy. India has the largest number of people


with diabetes in the world, with an estimated 19.3 million in 1995 and projected 57.2

million in2025. The prevalence of type-2 diabetes in urban Indian adults has been

reported to have increased from less than 3% in 1970 to about 12% in 2000. Nearly

2.7 crore CHD cases(urban-1.2 crores and rural-1.5 crores) are estimated to have

occurred in 2000 which will double to nearly 6.1 crores cases in 2015. A total of 6.4

crore cases of CVD are likely in the year 2015 of which 96% would be CHD cases

and death from this group of diseases are likely to amount to be a

staggering34lakhs.

The studies on prevalence of hypertension and diabetes gave an insight into the

magnitude of the problem. The prevalence being very high, it needs an intervention

so as to bring down the complications and the morbidity rates.

Medication Compliance

Meaning

Adherence to (or compliance with) a medication regimen is generally defined as the

extent to which patients take medications as prescribed by their health care

providers. The word “adherence” is preferred by many health care providers,

because “compliance” suggests that the patient is passively following the doctor‟s

orders and that the treatment plan is not based on a therapeutic alliance or contract

established between the patient and the physician. Both terms are imperfect and

uninformative descriptions of medication-taking behavior. Adherence rates are

typically higher among patients with acute conditions, as compared with those with

chronic conditions; persistence among patients with chronic conditions is

disappointingly low, dropping most dramatically after the first six months of therapy.2

According to International Society for pharmocoeconomics and outcomes research;

Medication compliance (synonym: adherence) refers to the act of conforming to the

recommendations made by the provider with respect to timing, dosage, and

frequency of medication taking. Therefore medication compliance may be defined as

“the extent to which a patient acts in accordance with the prescribed interval and


dose of a dosing regimen.” Compliance is measured over a period of time and

reported as a percentage.31

Compliance (or adherence) is a medical term that means the degree to which a

patient correctly follows medical advice. The most effective way for a doctor to

improve patient‟s compliance is through a positive physician-patient relationship.2

Other factors that increase compliance include:

Patient feeling ill

Limitations of patients activities due to disease state

Written instructions for taking medication

Acute illness

Simple treatment schedule

Short time spent in waiting room

Physician recommending one change at a time

Benefits of care outweigh costs

Peer support

Patients may not accurately report back to health care workers because of fear of

possible embarrassment, being chastised, or seeming to be ungrateful for a doctor's

care. Causes for poor compliance include:2

Forgetfulness

Poor rapport with physician

Few symptoms

Chronic illness

Prescription not collected or not dispensed

Purpose of treatment not clear

Perceived lack of effect

Real or perceived side-effects

Instructions for administration not clear

Physical difficulty in complying (e.g. opening medicine containers, handling

small tablets, swallowing difficulties, travel to place of treatment)

Unattractive formulation, such as unpleasant taste


Complicated regimen

Cost of drugs

Studies on drug compliance and related factors

In an article on Compliance in Hypertension states that non compliance is a

universal characteristic and can affect all patients. The major problem is that it is not

recognized in clinical practice. Good communication with the patient is essential to

prevent non compliance. Long acting drugs can also be recommended.8

In the study the multilevel compliance challenge9; it is stated that compliance is a

complex behavioural pattern strongly influenced by the environment in which the

patient lives, healthcare providers practice and health care systems delivery of care.

The health care providers including pharmacists, nurses, psychologists etc who are

involved in primary and secondary prevention play a role in enhancing compliance

by interpreting recommendations, educating and motivating patients, monitoring

responses to recommended behaviours and providing feedback. Maximum use of

these services should be made by patients to overcome non compliance to drugs.

Multilevelapproach of education and behaviour change is important like consumer

health education, provider education, etc.

In the study on Challenges in diabetes management with particular reference to

India32 states that diabetes was estimated to be responsible for 109 thousand

deaths, 1157 thousand years of life lost and for 2263 thousand disability adjusted life

years in India during 2004. The study also identifies that health systems have not

matured to manage diabetes effectively and indicate that 50-60% of diabetic patients

donot achieve glycemic target of HbA1C below 7%. It cites that the cost of treatment,

need for lifelong medication, coupled with limited availability of anti-diabetic

medications in the public sector and cost in the private sector are important issues

for treatment compliance.

In a study on Development and validation of a survey to assess barriers to drug use

in patients with chronic heart failure33 used the barriers to medication survey and


administered it to 128 consecutive patients attending an outpatient heart failure

clinic. Patients were also required to complete the Minnesota living with heart failure

questionnaire and a self reported drug scale. Patients with good adherence reported

few barriers (Pearson‟s correlation coefficient r=−0.14, p=0.14), patients who

reported few barriers also reported few MLHF scores(r=0.42, p<0.001) with a

strongest support in the social support domain(r=0.53, p<0.001).All respondents

reported having a good relationship with health care professionals and the most

common barriers to drug use were poor support networks and previous adverse

reactions.

In a study on Assessment of factors influencing Blood pressure control in a managed

care population used a retrospective analysis34 and randomly selected 502 patient

records from three primary care clinics in southeast Michigan. These patients took

fewer blood pressure drugs throughout the year (p=0.023) and had lower anti

hypertensive costs than those who had not achieved HEDIS blood pressure goals.

46% of the diabetic patients were at their blood pressure goal of below 130/85 mm of

Hg and 71.6% of them were managed with angiotensin-converting enzyme inhibitors

or angiotensin receptor blockers. Among the participants with antihypertensive

therapy 37.6% received β blockers, 50.5 % ACE inhibitors, 5.9% angiotensin

receptor blockers, 22.7% calcium channel blockers, 38.9 % diuretics, 9.5% α

blockers, <1% vasodilators 7.6% other drugs and no one was using ganglionic

blockers.

A study was done on Relationship between drug therapy noncompliance and patient

characteristics, health related quality of life, and health care costs35in which

computerized prescription records from 1054 patients at high risk for drug related

problems were studied, the compliance ratio for a 12 month period was calculated

and correlated with health care use, demographic variables, drug-related variables

and scores for health related quality of life. The difference between compliant and

noncompliant clients were found significant in several characteristics like age

(p=0.05), higher number of chronic conditions(p<0.001) and taking more

drugs(p<0.001) but logistic regression revealed that only the number of chronic

conditions was a significant factor for non compliance (0.665, CI 0.593-0.745). The


study also concludes that compliance was not a predictor of concurrent or future

hospitalizations or mortality, nor a significant predictor for health care costs.

A study was done on drug compliance among hypertensive patients in Tabuk, Saudi

Arabia36, it was a prospective study where compliance was checked by pill counting

method and the reasons were analysed. The compliance rate was 53% it was

associated positively with male sex and negatively with older age, symptoms of

illness and drug side effects. The degree of blood pressure control was worse

among noncompliant subjects. Reasons for non compliance identified included

asymptomatic nature of hypertension, shortage of drugs, side effects, forgetfulness

and lack of health education.

A survey was conducted in US by Harris Interactive online survey37 in which 2507

US adults participated between March 16 and 18 2005. It was done for The Wall

Street Journal Online‟s health Industry Edition. The results reveal that out of the 63%

(1648) adults who had prescription drugs prescribed to them to be taken regularly in

the last year nearly two thirds 64% report they had forgotten to take their medication,

with 11% stating that this had happened often or very often (2005). The other

reasons cited by the people are:

I had no symptoms or the symptoms went away 36%

I wanted to save money 35%

I didn‟t believe the drugs were effective 33%

I didn‟t think I needed to take them 31%

I had painful or frightening side effects 28%

The drugs prevented me from doing other things I wanted

to do

25%

A study on Compliance and knowledge of hypertensive patients attending PHC

centres in AL-Khobar, Saudi Arabia38 was a cross-sectional study of all hypertensive

patients (190) attending four primary health centres.The mean age was 49.9±11.7

years, the overall compliance rate was 34.2% which was lower in those aged <55

years than older patients (26.2% versus 48.5%, p< 0.001) and among educated than

illiterate (30.4%and 38.1% respectively, p<0.001). The knowledge level regarding the

disease was very minimal as 41.6% of the patients thought that hypertension could


have a permanent cure and 43.7% that medication could be stopped once control

was achieved. As to the etiology 66.3% thought as emotional stress and 1.6% as

heredity. Hence an education on hypertension is essential among these patients.

A study was done to identify the prevalence, awareness and compliance to treatment

among the Parsi community in Bombay39. It was identified that among 2879 subjects

>or = 20 years of age were randomly selected of which 2415 participated in the

study. The overall prevalence of hypertension in the community was 36.4% of which

48.5% were unaware of their hypertensive status. Among those aware 36.4% were

non compliant with their hypertensive drugs and only 13.6% had optimally controlled

hypertension.

In a study on treatment seeking behavior and compliance of diabetic patients in a

rural area of south India it is reported that out of 112 patients interviewed 72% had

some symptoms at the time of diagnosis and the majority of them were diagnosed in

government health centers; non compliance was seen in 57% of the 112 patients

interviewed and the reasons identified were lack of patient friendly, flexible health

care system. 40

In a study conducted by glycemic control and medication compliance in diabetic

patients in a pharmacist managed clinic in Hong Kong41; non compliant patients were

assessed by nurses and sent to the pharmacist. The clients had to visit the clinic

three times. During the first visit (week 0), the pharmacist used either direct pill

counts or questioning to assess the baseline compliance rate. The second visit

usually occurred at week 2 and the final visit at weeks 10-12. The reasons for the

patients' noncompliance and any problems encountered in their therapies were

documented. A 15- to 30-minute diabetes education session was arranged for each

patient. During the session, the pharmacist obtained a medication history; evaluated

drug compliance; provided drug information; educated the patient about diet,

exercise, smoking cessation, hypoglycemia, and sick-day management; and

monitored adverse drug reactions. Information on monitoring blood glucose and

hemoglobin A1c (HbA1c) levels and preventing complications was also presented.

The pharmacist gave the patient's physician therapeutic recommendations for


achieving the goal of an HbA1c concentration of less than 7%. At the end of the third

visit, patients completed a satisfaction questionnaire. Out of 95 patients, 91 gave

complete data. The compliance rate at the beginning and at the end of third visit was

41.3±25.6 and 97.8±1.6, p<0.005. The reasons for non compliance are as follows:

Forgetfulness 61.5%

Adverse effects 25.3%

Wrong belief about treatment 8.8%

Not realizing that the treatment had been changed 6.6%

Others 2.2%

An article published from the general medicine division Palo Alto and Division of

clinical pharmacology, California about the Epidemiology of medicine –taking42

behavior states the rate of adherence increases if the number of doses per day is

less ie once daily around 60-90%, twice 50-80%, four times a day 30-70%.The report

has identified the barriers to adherence as Poor provider-patient communication,

Patient‟s interaction with the health care system and physicians‟s interaction with

the health care system.

According to a study on compliance and hypertension, the approaches to

compliance are patient demographics, medication characteristics, clinical factors,

health beliefs and the quality of patient provider communication. They have also said

that clinicians can increase compliance by assessing their patients stage of behavior

change and matching the intervention to that stage.43

An article „Does a positive attitude help when your chronic illness becomes worse‟44

states that Positive attitudes towards treatment and relationships with family and

caregivers can effect the outcomes of treatments. Positive attitudes are necessary

when successfully dealing with the crisis effects of psychological issues that follow a

chronic illness. These issues include: self image, anger, control, dependency,

stigma, isolation, abandonment and death.

In a study conducted at a rural health institution, Nigeria45 during 2008-09, 240

hypertensives were surveyed on their knowledge, attitudes and practices on

hypertension and their impact on compliance with antihypertensive drugs. The


results of the study were one hundred and fourteen patients (47.5%) were men and

126 (52.5%) were women, mean age was 48.8±13.2 years, mean systolic and

diastolic BP were 156.8±25.1 mmHg and 98.4±18.7 mmHg respectively. The study

also revealed that only less than half (47.1%) showed good knowledge of their

hypertension and 141 (58.8%) possessed good knowledge of their antihypertensive

drugs. It also found that knowledge of hypertension was better in women than in men

(59.3% vs 40.7%, p=0.014), compliance to medications was good in only 77 (32.1%)

of the patients. The reasons attributed to poor compliance in the study was: poor

knowledge of the disease and ignorance of the need for long-term treatment

(95,32.6%); high cost of medications (63, 21.7%); religious practices and cultural

beliefs (37,12.5%); adverse drug reactions (19, 6.5%); inadequate access to medical

care (18, 6.2%); and use of complimentary medications (60, 20.5%).

C. Everett Koop, MD, said, “Drugs don't work in patients who don't take them.” There

is a lot of evidence that patients are not taking their medications as prescribed. Lack

of medication adherence contributes to poor patient outcomes and billions of health

care dollars spent unnecessarily. The article on Promoting Medication Adherence in

Older Adults … and the Rest of Us by Barbara Kocurek (2010), reviews medication

adherence in the United States, common reasons for lack of adherence, and

strategies for improving medication-taking in patients. The article states that several

studies have been published looking specifically at medication adherence in people

with diabetes and that a recently published systematic review reports adherence

rates to diabetes medications varied from 31 to 87% in retrospective studies and

from 53 to 98% in prospective studies, difficulty with taking medications as

prescribed can occur in anyone and that research has shown it affects both males

and females of all ages and across the spectrum of education and socioeconomic

status. It also discusses that age itself has not been identified as a risk factor for

medication nonadherence and the results of one study found that patients who were

more likely to be nonadherent were actually < 65 years of age and had fewer

comorbidities. This article gives educating the clients as a suggestion to improve

patient compliance. 1

Low adherence with antihypertensives in actual practice: the association with social

participation – a multilevel analysis was a study done to examine whether low social

http://spectrum.diabetesjournals.org/search?author1=Barbara+Kocurek&sortspec=date&submit=Submit


participation is associated with low adherence with antihypertensive medication, and

if this association is modified by the municipality of residence.The study identified

1288 users of antihypertensive medication from The Health Survey in Scania 2000,

Sweden, The outcome was low adherence with antihypertensives during the last two

weeks. Multilevel logistic regression with participants at the first level and

municipalities at the second level was used for analyses of the data. The results of

the study were low social participation was associated with low adherence with

antihypertensives during the last two weeks (OR = 2.05, 95% CI: 1.05–3.99),

independently of low educational level. However, after additional adjustment for poor

self-rated health and poor psychological health, the association between low social

participation and low adherence with antihypertensives during the last two weeks

remained but was not conclusive (OR = 1.80, 95% CI: 0.90–3.61). Furthermore, the

association between low social participation and low adherence with

antihypertensives during the last two weeks varied among municipalities in Scania

(i.e., cross-level interaction). The study concluded that low social participation seems

to be associated with low adherence with antihypertensives during the last two

weeks, and this association may be modified by the municipality of residence. Future

studies aimed at investigating health-related behaviours in general and low

adherence with medication in particular might benefit if they consider area of

residence.46

In the study done at new Delhi on Drug utilization of oral hypoglycemic agents in a

university teaching hospital in India Patients with established type 2 diabetes

(n = 218) visiting the OPD and IPD were interviewed using a structured

questionnaire during the period January–May 2006. The study aimed to determine

the drug utilization patterns in type 2 diabetic patients on oral hypoglycemic agents in

the Medicine Outpatient Department (OPD) and Inpatient Department (IPD) of

Majeedia Hospital, a teaching hospital of Hamdard University, New Delhi. They

found that a majority of the type 2 diabetic patients in this setting were treated with

multiple antidiabetic drug therapy. The most commonly prescribed antidiabetic drug

class was biguanides (metformin) followed by sulphonylureas (glimepiride),

thiazolidinediones (pioglitazone), insulin and alpha-glucosidase inhibitors (miglitol).

As monotherapy insulin was the most common choice followed by metformin. The

most prevalent multiple therapy was a three-drug combination of


glimepiride + metformin + pioglitazone. More than half of the type 2 diabetic patients

showed poor adherence (compliance) to the prescribed therapy. Clinical monitoring

of patients' adherence to prescribed treatments is recommended and measures

should be taken to improve it.47

The reviews stated had helped to identify compliance as a global problem. The

Indian scenario could be assessed only by a few studies. It also helped to identify

that there were not many studies relating to compliance and family support or

compliance and previous health status.

Studies done with Morisky scale

The study on Self-Reported Morisky Score for Identifying Nonadherence with

Cardiovascular Medications48 reports that the Morisky medication adherence scale is

a commonly used adherence screening tool. It is composed of 4 yes/no questions

about past medication use patterns and is thus quick and simple to use during drug

history interviews. Forty-nine of 377 (13%) patients were categorized as non

adherent; however, only 12 (3%) patients had Morisky scores suggesting a high

likelihood of non adherence (3 or 4). While the Morisky score was a significant

independent predictor of non adherence by multivariate analysis, there was no

threshold score or individual question that yielded concurrent high sensitivity and

positive predictive values (PPVs) for identifying nonadherent patients. The internal

consistency of the questions was low (0.32), as were item-to-total score correlations,

suggesting that the individual questions were not measuring the same attribute.

A study on Factors affecting patient compliance with antihyperlipidemic medication in

a HMO population49 used prescription profile to assess their drug compliance. The

factors identified was patient characteristics, complexity of drug regimen, health

status and patient-provider interaction. Data was collected from 772 patients, 37%

complied with their treatment.The variables which showed significant influence were

female gender OR,0.64, baseline compliance-medium OR,1.86 (assessed using

Morisky scale) , perceived health status OR-SF-36 bodily pain score 1.02, SF-36

vitality score 0.97, comorbidity OR-0.90 and number of daily doses OR-0.60.


A study on The Effects of Initial Drug Choice and Comorbidity on Antihypertensive

Therapy Compliance -Results From a Population-Based Study in the Elderly50 was

done among elderly patients 65 years and older. The study tried finding the effect of

initial drug choice and comorbidity on drug compliance. A retrospective follow up was

done of 8643 outpatients aged 65 to 99 with newly prescribed antihypertensive

therapy from 1982-88 in the New Jersey Medicaid and Medicare programs.

Compliance was measured in terms of the number of days in which AHT was

available to the patient during the 12 months following the initiation of therapy. Odds

ratios (OR) and 95% confidence intervals (CI) for the outcome of good compliance (

80%) were calculated.In a logistic regression model, good compliance ( 80%) was

significantly associated with use of newer agents such as angiotensin converting

enzyme inhibitors (OR 1.9, 95% CI 1.6 to 2.2) and calcium channel blockers (OR

1.7, 95% CI 1.5 to 2.1) as compared to thiazides, the presence of comorbid cardiac

disease (OR 1.2, 95% CI 1.1 to 1.2), and multiple physician visits (OR 2.2, 95% CI

1.8 to 2.5). Good compliance was inversely associated with use of multiple

pharmacies (OR 0.4, 95% CI 0.4 to 0.5) and number of medications prescribed

overall (OR 0.8, 95% CI 0.7 to 0.9).Drug choice, comorbidity, and health services

utilization were significantly associated with AHT compliance and represent

important considerations in the management of high blood pressure. Noncompliance

may be an important cause of treatment failure in elderly hypertensives.

A study to know the influence of patient‟s consciousness regarding high blood

pressure and patient‟s attitude in face of disease controlling medicine intake among

130 hypertensive patients. 35% had their blood pressure controlled, occupation and

duration of treatment were significantly related to controlled people. The assessment

with Morisky-Green scale has revealed that the question on neglecting the medicine

hours was associated with blood pressure control and the total score obtained by

77% of the participants was ≤3 which showed non adherence. 51

Why hypertensive patient‟s donot comply with the treatment52 was a qualitative study

and participants were identified as non-compliant based on Morisky-Green test. The

factors identified were medication, patient‟s beliefs and attitudes towards

hypertension and antihypertensives, physician, condition charecteristics. The study

was done at two primary health care centres of the Spanish National Health Service.


They had done a telephonic survey among 267 hypertensive patients identified from

clinic and computer records to know their compliance status using the Morisky-

Green scale .146 patients who got a score ≥1 (this study has taken patients with

scores 2,3 and 4 for next phase of study to identify themes) were included for the

focus group discussion. The themes identified in the study were Medication(long

term use, more than one drug, taking every 24 hours, side effects, difficulty to

understand leaflets, leaflets seem frightening), Condition characteristics (chronic

conditions, well-being feeling), Patient‟s beliefs and attitudes towards hypertension

and antihypertensive (long-term use of anti-hypertensives is damaging, herbal or

natural remedies are effective for controlled high BP, disease is cured when high BP

is controlled, low adherence about treatment, risk factors, characteristics, and

complications of hypertension, most knowledge acquired by sources other than the

physician, drug-taking contingent to symptoms) and Physician (short time

consultation, doctor-patient interaction not encouraged, little time is spent regarding

information, information is provided mostly upon request by the patient, just a few

questions are asked, information provided is too general and not talked to the

individual, difficulty to understand physician‟s language or writing, eye contact is

rarely made during consultation, clinical encounter created nervousness).

Self-reported adherence with medication and cardiovascular disease outcomes in

the Second Australian National Blood Pressure Study (ANBP2)53 tried to investigate

whether responses to a previously validated four-item medication adherence

questionnaire were associated with adverse cardiovascular events. A postal survey

of medication adherence was undertaken by them in September and October

2000 of all 6018 surviving participants of the Second Australian National Blood

Pressure Study with Morisky instrument. 4039 older people with hypertension

responded to the postal survey. 2614 subjects were identified to adhere to

medication ie 67% ; those who adhered to their medication regimen (compared with

non-adherent subjects) were significantly less likely to experience a first

cardiovascular event or a first non-fatal cardiovascular event (hazard ratio [HR] for

both, 0.81; 95% CI, 0.67–0.98; P = 0.03); a fatal other cardiovascular event (HR,

0.68; 95% CI, 0.48–0.99; P = 0.04); or a first occurrence of heart failure (HR, 0.58;

95% CI, 0.37–0.90; P = 0.02). Those who answered yes to “Did you ever forget to

take your medication?” were significantly more likely to experience a cardiovascular


event or death (HR, 1.28; 95% CI, 1.04–1.57; P = 0.02); a first cardiovascular event

or death (HR, 1.31; 95% CI, 1.07–1.60; P = 0.01); a first cardiovascular event (HR,

1.34; 95% CI, 1.09–1.65; P = 0.01); or a first non-fatal cardiovascular event (HR,

1.35; 95% CI, 1.09–1.66; P = 0.01). Those who answered yes to “Sometimes, if you

felt worse when you took your medicine, did you stop taking it?” were significantly

more likely to experience a first occurrence of heart failure (HR, 2.06; 95% CI, 1.16–

3.64; P = 0.01).

A study on Assessing Medication Adherence among Older Persons in Community

Settings states in 200554 that Medication adherence is an important public health

issue. To better understand its relevance among vulnerable populations requires the

availability of a valid, reliable and practical measurement approach. Researchers

have proposed various competing methods, including pill counts and self-report

measures. It had aimed at examining the utility of pill counts compared with self-

report measures in the assessment of medication adherence among older home

care clients. The study sample had included 319 home care clients aged 65+ years

randomly selected from urban and rural settings. They conducted the study during

in-home assessments; nurses had performed a medication review (including a pill

count), administered the Morisky self-report scale, obtained supplemental

information on medication use and completed the Resident Assessment Instrument

for Home Care (RAI-HC). Responses to the Morisky scale and an open-ended

question on nonadherence were combined to form a composite self-report measure

of adherence. The results showed that pill counts were either not feasible or

considered inaccurate for 34.7% of subjects (47.5% of all eligible drugs). For the 205

subjects with available pill counts, estimates derived from the dispense date were

found to underestimate adherence when compared with the actual start date

reported by clients. The Morisky scale showed low reliability (Cronbach‟s α=0.42)

and subjects‟ responses to the scale were often in disagreement with their

responses to the open-ended question on nonadherence. There was poor

agreement between the pill count and self-report measures.

Morisky tool was adopted in this study based on the review found above. The

description and classification given has enriched the present study also to identify

the compliance to drugs.


Studies related to client education

The scope of the study Developing a generic, individualized adhernce programme

for chronic medication users55 was to describe the background for and content of an

adherence counselling programme with a specific focus on an individualised, multi-

dimensional adherence model for patients with a potential adherence problem (a so-

called individualized systems model).

An intervention programme based on WHOs systems model for adherence was

developed for implementation in primary health care and tested in a development

project in Danish pharmacies in 2004-2005 in three pharmacies and 4 GP practices

by 27 patients. Data were collected from the participants by registration forms,

questionnaires, and focus groups. Since the programme was to support patients in

the self-management process regarding choice and implementation of medication

treatment, various strategies were used and different theoretical assumptions and

choices made prior to setting up the study. These strategies include distinguishing

between different types of non-adherence, a model for stages of change, self-

efficacy, narratives, motivating interviewing strategies and coaching techniques. The

strategies and theoretical reflections formed the platform for the creation of a

counseling programme, which was tested in two forms, a basic and an extended

version - provided by either a pharmacologist or a pharmacist. Besides, the results

include a description of how the WHO-model is transformed into an individualised

counselling model. According to WHO, non-adherence should not be viewed as an

isolated, single-factor problem, but rather as a multi-dimensional problem not

determined exclusively by patient factors, as is seen most often in adherence

research. WHOs systems model aims to analyse and provide explanations for non-

adherence on a societal and health policy level in a broader sense.


Fig-2 Five dimensions of adherence

The programme identifies potential non-adherence, analyses the character of the

problems identified, including drug-related problems, explores patient resources and

provides concordance-based follow-up sessions and individually based

interventions. The model developed and used as a template for the entire

programme was called the individualised systems model. It emerged from the

transformation of the WHO model into an individualised counselling model.

Fig-3 Individual system model


According to a paper on Resourcing issues by Juan Jose´ Gagliardino 56diabetes is a

chronic, progressive disease and achieving appropriate control of glycaemia and the

other associated cardiovascular risk factors is essential to prevent its long-term

complications. Currently, recovery and rehabilitation from the cardiovascular

complications of diabetes are the major focus of diabetes care rather than primary

and secondary prevention of diabetes and its complications. This focus, coupled with

limited funding and other resource issues, means that diabetes care and outcomes

are generally suboptimal. More efficient and effective management strategies,

primarily based upon a broad educational approach including both those with

diabetes and their care-givers will be essential in reducing the cost of diabetes and

diabetes-related complications. Continuous education of patients and providers

increases the quality of care and improves clinical and metabolic outcomes as well

as reducing the cost of care and optimising human and financial resources. Thus,

education will be a key strategy in minimising the growing burden of diabetes on

society. Making these changes will require the co-operation of patients, their families,

the community, healthcare policy makers, national governments and the

pharmaceutical industry. Medical schools must also place more emphasis on

educating doctors about chronic disease management using not only recovery and

rehabilitation, but also prevention strategies, emphasising the importance of helping

patients to participate in the control of their disease.

Patients were allocated to control(114) or intervention group(118) in the study on

Improving medicine usage through patient information leaflets in India conducted at

tertiary care public health facility in India. The patients in the intervention group got

information leaflet and the primary indicators improved significantly in the

intervention group compared with the control (15.7±7.3 versus 12.2±5.4) p<0.01.

Confounding variables ie age, sex, literacy level did not influence the patient‟s

knowledge.57

In a study on assessment of impact of medication counseling on patients‟ medication

knowledge and compliance in an outpatient clinic in South India explains that there is

an improvement in the compliance among the group of patients who were counseled

against the usual care group.(92.29±4.5 and 84.71±11.8) p value is not mentioned in


the study. Knowledge level of the counseled group also showed an improvement

(13.82±1.8604 and 11.78±3.5037).58

A study on the Effectiveness of a Hypertension Educational Program on Improving

medication compliance in Shiraz, 200459 concludes that mean score of compliance

was greater after the education program (4.16 vs 2.66, p<0.05). 150 non compliant

hypertensive patients were selected and direct educational interview on how to

handle drugs was given to them in the clinic then they were divided into 4 groups

and educated through telephone consult, telephone consult and educational booklet,

educational booklet and on education. The study concludes that direct education

based on patient‟s problems is effective in improving compliance. It also

recommends that large studies are needed to differentiate between various methods.

The Working paper no. 10460 on Prevention and control of non-communicable

Diseases: status and strategies published by Indian council for research on

international economic relations estimates the prevalence of Diabetes mellitus as 13

million ie 1.3% of total population and Heart diseases (IHD, HT, Stroke, RHD)

Prevalence 65 million ie 6.6% by 1998. It also discusses that the constraints of

limited health care provider resources may be overcome by investing in patient

education and encouraging self-care which will reduce the demands of follow-up

care. The need for promoting participatory care through patient education and the

value of promoting self-monitoring and self-care in improving outcomes have been

recently acknowledged in the developed countries. From the introduction of patient

education packages for hypertension and congestive heart failure to the outstanding

success of diabetes self-care, these practices have served to alter the provider

dominated paternalistic model of care in favour of a partnership model of patient

participation. While planning the organisation of health services, the goal should be

to shift the centre of gravity of chronic care delivery progressively towards the base

of the health care pyramid. By strengthening the capacity for care by self, family,

community, paramedic, or traditional healer and by encouraging guidelines based

practice and a rational referral-follow-up pattern which obviates the need for frequent

revisits to secondary and tertiary care providers, the responsibility for delivering

chronic care devolves downwards closer to the community and away from the more

expensive and less accessible higher health care stations. Only such a shift can


ensure a sustainable system of chronic care in India, with the promise of extended

coverage and containment of costs.

Usha Malagi, Rama Naik and Ramesh Babruwadin61 their study on Knowledge

Practices and Life Style Factors of Type - 2 Diabetics has found that the life style

factors such as foods restricted and specially included, vices prevalent, exercise

behavior and knowledge and practices of 50 type-2 diabetics were assessed using a

pretested structured questionnaire. Diabetics restricted the foods such as rice, roots

and tubers, sweets and fruits. The foods were specially included for the management

of disorder by majority of diabetics (72%). Salads, green leafy vegetables, bitter

gourd, ragi and spices such as fenugreek were specially included foods. The vices

practiced by men were smoking (14%), drinking alcohol (48%) and tobacco chewing

was seen in very few men and women. Exercise was done by half of the diabetics

(56%) and half of the exercising subjects had started exercise only about a year

back. About 30% of diabetics had poor knowledge scores and 16% diabetics had

poor diabetic practice scores. Thus, the diabetics need education to improve the

knowledge and practices for the proper management of disorder.

A study on Efficacy of a home blood pressure monitoring programme on therapeutic

compliance in hypertension: the EAPACUM-HTA study62 was conducted at 40

primary care centres in Spain, with a duration of 6 months. A total of 250 patients

with newly diagnosed or uncontrolled hypertension were included. They were given

an electronic monitor for measuring compliance (monitoring events medication

system). MEMS is an electronic device which records the date and times of bottle

cap openings as a means of assessing adherence. Compliance observed was 74%

and 92% in control group and intervention group (95% CI 81.2-94 and 80.7-

98.3;p=0.0001). The number need to treat to avoid one case of noncompliance was

5.6 patients. The programme was found effective in improving compliance in arterial

hypertension.

The cited review indicates that teaching does form an effective way to improve

compliance in the clients. It gave an insight to use both formal and non formal ways

of teaching to improve compliance which is adopted in this study.

chapter ii review of literature -...

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