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1. Introduction
A Medication Use Evaluation (MUE), or Drug Use Evaluation (DUE) program
is a planned, criteria-based systematic process for monitoring, evaluating, and
continually improving medication use, with the ultimate aim of improving
medication-related outcomes for a group of patients or consumers [1]

MUE is called by different terms namely drug utilization review, drug usage
review, drug use review, drug use evaluation, and drug utilization evaluation.
It is an important component of health care organizations quality
improvement program. The goal of MUE is to provide all patients with the
most rational, safe, and effective drug therapy through the assessment and
improvement of specific medication use processes. MUE may focus on a
specific medication, a class of medications; medications used in the
management of a specific disease state or clinical setting, medications related
to a clinical event, a specific component of the medication use process, or can
be based on specific outcomes [2].

The demand for and hence the cost of health care are increasing in all
countries as the improvement and sophistication of health technologies
increase. Medicines form a small but significant proportion of total health care
costs and one that has been growing consistently as new medicines are
marketed. Many governments are focusing their activities on promoting the
effective and economic use of resources allocated to health care [3].

Pharmacoeconomics can be defined as the measurement of both the costs

and consequences of therapeutics decision making. Pharmacoeconomics can
assist in the planning process and help assign priorities where, for example,
medicines with a worse outcome and lower cost can be compared with
medicines with higher cost and better outcomes [3]. There are number of
methods available for pharmaco-economic assessment like Cost-
effectiveness analysis, Cost of illness, each of which will be used depending
on the outcomes desired and interventions targeted.
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1.1 Diabetes Mellitus

Diabetes is a metabolic disorder characterized by hyperglycemia, which is
associated with abnormalities in carbohydrate, fat and protein metabolism,
and results in chronic complications including microvascular, macrovascular
and neuropathic disorders. As a result of an aging population, changes in
lifestyle and higher levels of obesity, diabetes affects an increasing number of
patients, and the number is expected to reach more than double, world wide,
by the year 2030 [4].

Pharmacological therapy for diabetic patients is aimed at controlling

hyperglycaemia to prevent or impede complications of diabetes. The results of
the Diabetes Control and Complications Trial (DCCT) and United Kingdom
Prospective Diabetes Study (UKPDS) have showed that intensive DM
management can reduce risk of complications. Therefore aggressive drug
therapy is necessary for diabetic patients to achieve adequate glycemic
control. Oral hypoglycemics can be used alone or in combination with other
oral antidaibetic drugs (OADs) or insulin. Until 1994, oral antidaibetic drugs
available for the treatment of type 2 diabetes mellitus was limited to some
sulphonylureas and biguanides. In the last few years, four new classes were
available for the treatment. The newer agents include an alpha-glucosidase
inhibitor, the newest sulphonylurea glimepiride (1999), meglitinides (2002),
glitazones (2000) and gliptines is released in 2008 [5-7].

Hypertension affects about 60% of patients with type 2 diabetes. Serious

cardiovascular events are more than twice as likely in patients with diabetes
and hypertension as either disease alone. Hypertension and lipid disorders in
type 2 diabetes also contribute to increased coronary risk. It may be 2.3 times
higher in men and 2.9 times higher in women with type 2 diabetes mellitus
compared to nondiabetic subjects. Type 2 diabetes mellitus commonly
associated with elevated BP and with athergenic lipid abnormalities and this
combination represents a major cause of elevated coronary risk. This has
been explicitly recognized in clinical guidelines for the management of
hypertension or hypercholesterolaemia [8].
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Appropriate use of antihypertensive agents may improve BP control and

reduce complications in patients with diabetes. Evidence also supports the
need for using multiple antihypertensive agents rather than monotherapy to
achieve target BP control and greater renoprotection. In addition, more recent
data from the antihypertensive and lipid lowering treatment to prevent heart
attack trial (ALLHAT) highlight the frequent need to use multidrug regimens to
treat BP to target levels, especially in type 2 diabetes [9].

The results of the United Kingdom Prospective Diabetes Study published in

1998 demonstrated the importance of good control of BP in reducing the
onset and progression of microvascular and macrovascular complications of
the condition. In this study, the ACE inhibitors, captopril and the beta blocker,
atenolol appeared to be of equal efficacy in the management of hypertension
in diabetes patients, but other evidence suggests that ACE inhibitors or
angiotensin receptor antagonists might reduce proteinuria or delay the onset
of nephropathy in subjects with type 2 diabetic patients [10].

The results of the HOPE study suggested that the prescription of an ACE
inhibitor (Ramipril) prevents complications of diabetes mellitus and had wider
benefits in reducing the incidence of myocardial infarction, stroke, overt
nephropathy as well as cardiovascular and all-cause mortality [11].

There is also increasing evidence of the benefits from cholesterol-lowering

therapy using statin drugs in the primary and secondary prevention of
coronary heart disease in subjects with diabetes mellitus. In the Heart
Protection Study, treatment of diabetes subjects with simvastatin led to a
reduction of about a quarter in new coronary events, revascularization and
strokes even in subjects who did not have elevated baseline cholesterol
concentrations [12].

1.2 Need for the study

There are various guidelines available for the management of type 2 diabetes
mellitus with hypertension and with raised cholesterol etc. Clinical practice
may depart from recommended standards based on the results of clinical
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trials/ experience. Surveillance of variations in clinical practice may raise

questions concerning current patterns of practice and thus help to refine
policies or inform interventions to promote change [8].

In the management of diabetes, pattern of prescription may be driven by

patient factors (e.g.: body weight, motivation to improve), physician specific
variables (eg; usual practice patterns) and /or nonclinical issues (eg; patient
out-of-pocket expense). Evidencebased guidelines for prescribing
antidiabetic drug, typically, rely on objectively measurable criteria such as
HbA1C level and weight [13].

Guidelines for the treatment of type 2 diabetes have increasingly favored

tighter glycemic control, necessitating the use of more aggressive
pharmacological therapy. However the process by which physicians choose
glucose-lowering medicines is poorly documented. There is a need for
systematic study of how the drugs are being used together, whether
monotherapy, combination therapy or insulin in combination with oral therapy
among patients with type 2 diabetes [14].

The impact of diabetes on health care expenditures has been increasingly

recognized. Number of cost of illness studies have shown a threefold
increase in the direct costs of diabetic patients compared with non-diabetic
patients in the setting of different health care systems. Recent studies have
consistently shown that people with diabetes are more likely to develop many
complications, both acute and long term. Type 2 diabetes therefore, has
increasingly become the main cause of growing costs in hospitalization and
drugs. The excess costs were largely due to an increased number of hospital
days, expensive outpatients treatments, higher costs for nursing home care
and increased drug consumption. Diabetes is closely related to other cost-
intensive chronic conditions, especially cardiovascular disease and risk
factors (e.g. hypertension, lipid disorders) [15,16].

In a study at Canada on the cost of management of diabetes, it has been

reported that cardiovascular disease was the major contributor to the direct
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costs of diabetes. Therefore it has been suggested that the prevention of

cardiovascular disease in the patient with diabetes should become an
imperative [17]. To formulate an effective health planning and resource
allocation, it is important to determine economic burden with or without the
absence of chronic complications.

1.3 Objectives
General objective:
To evaluate the prescription patterns and cost of illness of type 2 diabetic
patients.

Specific objectives:
1. To determine the trends in drug use patterns among patients with type
2 diabetes.
2. To evaluate the prescription pattern of antihypertensive medications in
type 2 diabetic patients.
3. To evaluate the pattern of lipid lowering therapy in type 2 diabetic
patients.
4. To determine the cost of illness (COI) for diabetic inpatients.