Diabetes is a syndrome that is caused by a relative or an absolute lack of insulin. It is characterized by symptomatic glucose intolerance as well as alterations in lipid and protein metabolism. Over the long term, these metabolic abnormalities, particularly hyperglycemia, contribute to the development of complications such as retinopathy, nephropathy and neuropathy. Approximately 5% to 10% of the diagnosed diabetic population has type 1 diabetes mellitus (Koda-Kimble et al., 2005). Most of the diabetic patients have type 2 diabetes mellitus, a heterogeneous disorder that is characterized by obesity, β-cell dysfunction, resistance to insulin action, and increased hepatic glucose production.
1.2 PREVALENCE OF DIABETES MELLITUS
Diabetes Mellitus is a chronic disease and is no longer an epidemic that can be ignored. It is confirmed that diabetes is increasing rapidly in every parts of the world (IDF, 2009). The prevalence of diabetes for all age-groups worldwide was estimated to be 2.8% in 2000 and 4.4% in 2030. The total number of people with diabetes is projected to rise from 171 million in 2000 to 366 million in 2030 (Wild et al., 2004). In South-East Asia region, the number of people with diabetes will reach 101.0 million by year 2030 which show an increase of 72.1% compared to 58.7 million in year 2010 (IDF, 2009). While in Western Pacific region, the number of people with diabetes will reach 112.8 million people by year 2030 compared to 76.7 million people in year 2010, which show an increase of 47.0%. WHO predicts that in Asia and Australia region the prevalence of diabetic will reach 190.5 million in year 2030 (WHO, 2004).
Similarly in Malaysia, the diabetes epidemic shows an increase trend over the years. The number of people with diabetes will increase to 2.74 million by year 2025 compared to 1.53 million in year 2007. The national prevalence of diabetes was estimated to be 12.3% in year 2025 (IDF, 2009). Approximately 1.2 million people in Malaysia have diabetes and more than half of them are not aware of it.
The third National Health and Morbidity Survey (NHMS III) shows that there was an increasing trend in prevalence with age; from 2 percent in the 18-19 years old to an alarming prevalence ranging between 20.8 to 26.2 percent among those 50-64 years old. Those with primary education or less have a higher prevalence. The national prevalence of known and newly diagnosed diabetes above 30 years old rose from 8.3 percent in NHMS II to 14.9 percent in NHMS III. This shows that the prevalence of diabetes has increased by 80 percent over a decade with an average of 8 percent per year. The diabetes in Malaysia has almost doubled in magnitude over the last decade (NHMSIII, 2006).
The main factors that contribute towards the increase in the risk of diabetes are socioeconomic influences, BMI, effects of urbanization, and familial aggregation. In socioeconomic influences, it shows that lower educational status and the lack of health care facilities in the rural areas delay the diagnosis of diabetes. More than 70% of diabetes subjects in India remain undiagnosed in rural area (Deo et al., 2006). Moreover, this study also observed that people of the lower socioeconomic status had lower BMI. Furthermore, urbanization leads to unhealthy lifestyle changes which affect the metabolic changes. The high prevalence of diabetes also found associated with increasing family history of diabetes. High prevalence of diabetes in the first degree relatives which is commonly seen in Asian Indians (Deo et al., 2006).
A comparative epidemiology study was conducted among Japanese immigrants in United States living around Hawaii and Los Angeles and among Japanese living in Hiroshima. Results showed that the Japanese who lives in United States are in higher prevalence of getting diabetes compared to the Japanese in Hiroshima due to the westernized lifestyle (Hara et al., 2004).
1.3 COMPLICATIONS OF DIABETES MELLITUS
Uncontrolled diabetes mellitus will leads to multiple complications. In Malaysia, only 6.1% among the 30 – 49 year age groups of diabetes mellitus patients were under control. This reflects the lack of concern for risks and complications among the young patients. A total of 1 in 4 diabetics in the 30-39 age group already show complications of the disease (Chua, 2006). Moreover, patients with uncontrolled diabetes mellitus, regardless of the type of diabetes, exhibit significantly increased odds of surgical and systemic complications, higher mortality and increased length of stay during hospitalization (Marchant et al., 2009).
Individuals with pre-diabetes, undiagnosed type 2 diabetes, and long-lasting type 2 diabetes are at high risk of all complications of macrovascular disease, coronary heart disease (CHD), stroke, and peripheral vascular disease (Laakso, 2010). Moreover, M Lgaakso also indicates that more than 70% of type 2 diabetes patients die of cardiovascular causes. Hence, the epidemic of type 2 diabetes followed by an epidemic of diabetes-related cardiovascular diseases (CVD).
Diabetes patients present a two to four time greater risk for coronary artery disease (CAD) than non-diabetes individuals (Protopsaltis et al., 2004). The data obtained from UKPDS 23 indicated that for each 1% increment of HbA1c there was a 1.11-fold increased risk of CAD, whereas for each 1-mmol/l increment in LDL concentration, there was a 1.57-fold increased risk.
A study carried out among African American with diabetes showed that the major risk factors such as hypercholesterolemia, hypertension and smoking are important determinants of CVD in African Americans with diabetes. Moreover, other blood markers of hemostasis or inflammatory response and elevated serum creatinine proved to be CVD risk factors in African Americans with diabetes (Adeniyi et al., 2002).
Retinopathy is the most common microvascular complication of diabetes, which results in blindness for over 10,000 people with diabetes per year (Fong et al., 2004). A study done among Australian population showed that the prevalence of retinopathy was 21.9% among known type 2 diabetes and 6.2% in those newly diagnosed type 2 diabetes. Generally, 15.3% of diabetes patients have retinopathy (Tapp et al., 2003).
A prospective cohort study showed that the presence of diabetic retinopathy was associated with a two-fold higher risk of incident CHD events and a three-fold higher risk of fatal CHD (Cheung et al., 2007). Hence, the microvascular diseases do play a role in the pathogenesis of CHD in diabetes.
Amputation is one of the major complications that should be taken into consideration among diabetes patients. Diabetes is the cause of 50 % of all the non-traumatic amputations in the United States. Among all the diabetic amputations, 24 % amputations are the toe, 5.8 % are mid foot, 38 % are below the knee, and 21.4 % are above the knee, and the remaining 10 % include the hip, pelvis, knee and other sites (Levin, 2002).
One study reported an 8 % increase in amputations from 61 of 10,000 patients with diabetes in 1990 to 66 of 10,000 patients with diabetes in 1995. After diabetic patients undergo amputation, their risk of developing a foot ulcer or of requiring a second amputation increases dramatically. A total of 50 % of patients with diabetes die within 5 years after amputation (Peters et al., 2001). In Malaysia, among 203 patients that underwent amputation, 66 % of the patients were diabetics and amputations performed were related to diabetic foot conditions. Among them, 17.2 % patients underwent above knee amputation, 32.8 % underwent below knee amputation and 50 % underwent local foot amputation. About 59 % patients underwent amputation due to diabetic complication were less than 60 years old (Yusof et al., 2007).
A study done involving Korean type 2 diabetic patients showed that the HbA1c is significantly associated with carotid plaque and peripheral arterial disease (PAD) (Choi et al., 2010). A cross sectional study was conducted, and it shows that the glycemic control was poor with 53.6% of the patients having HbA1c above 8% and 24% of them had microalbuminuria (Chan et al., 2005).
1.4 MANAGEMENT OF DIABETES MELLITUS
1.4.1 Controlling Glycemic Level
Tight control of blood glucose levels offers primary and secondary prevention for the development of diabetic kidney disease (Stanton, 2008). By lowering glycated hemoglobin value to 6.5% or less, a 10% relative reduction was observed in the combined outcome of major macrovascular and microvascular events. Moreover, there was also a 21% relative reduction in nephropathy (Patel et al., 2008).
A study carried out in the United Kingdom showed that intensive blood glucose control in type 2 diabetes patients significantly increased the cost of treatment, but the cost of complication was reduced and increased the time free of complication (Gray et al., 2000). Although good controlling on blood glucose will benefit the diabetes patients, the potential benefits of glycemic control must be balanced against factors that either preempt benefits (limited life expectancy, comorbid disease) or increase risk (severe hypoglycemia, weight gain) (Woolf et al., 2000).
1.4.2 Pharmacological Treatment
According to the Malaysian Clinical Practice Guidelines Management of Type 2 Diabetes Mellitus 4th Edition (2009), the first line therapy for oral agent is Metformin, while other oral agents are acceptable as alternatives. However, usage of Thiazolidinediones (TZDs) has been found to have greater durability in glycemic control compared to Metformin and Sulphonylurea (SU). Currently there are five classes of oral hypoglycemic agents, which include α-glucosidase inhibitors (AGIs), Biguanides, Dipeptidyl petptidase-4 (DPP-4) inhibitors, Insulin Secretagogues (Sulphonylurea and Non-Sulphonylurea / Meglitnides) and Thiazolidinediones (TZDs). Factors that are taken into consideration when selecting the treatment include the patient’s clinical characteristics, such as degree of hyperglycemia, weight and renal function (Walker and Whittlesea, 2007).
Scheen and Lefebvre (1998) suggested that the selection of oral antihyperglycemic agents as first-line drugs or combination therapy should be based on both pharmacological properties of the compound (efficacy and safety) and the clinical characteristics of the patient (stage of disease, body weight). Furthermore, each antihyperglycemic agent may also be combined with insulin therapy to improve glycemic control after secondary failure to oral treatment.
A systemic review on the effectiveness and safety of oral antihyperglycemic agents showed that most oral agents improved glycemic control to the same degree as sulfonylureas, though nateglinide and α-glucosidase inhibitors may have slightly weaker effect (Bolen et al., 2007). Other than that, this review also showed that most agents other than metformin increased body weight by 1 to 5 kg. In terms of safety, sulphonylureas and repaglinides were associated with greater risk for hypoglycemia, thiazolidinediones with greater risk for heart failure and metformin with greater risk for gastrointestinal problems. Another systemic review and meta analysis on the effect of oral hypoglycemic agents on HbA1c levels showed that most OHAs lowered HbA1c levels by 0.5 to 1.25 % whereas thiazolidinediones and sulfonylureas lowered HbA1c levels by 1.0 to 1.25 % (Sherifali et al., 2010). This review also concluded that the benefit of initiating an OHA is most apparent within the first 4 to 6 months.
A meta analysis on comparison of different drugs as add-on treatment to metformin in type 2 diabetes showed that sulphonylureas, α-glucosidase inhibitors and thiazolidinediones induced reduction of HbA1c of 0.85, 0.61 and 0.42 respectively (Monami et al., 2007). In direct comparisons, sulphonylureas induced a greater reduction of HbA1c than thiazolidinediones. For the treatment with α-glucosidase inhibitors (AGIs) acarbose, a meta-analysis showed favourable trends towards risk reduction for myocardial infarction and any cardiovascular event (Hanefeld et al., 2004). The meta-analysis also revealed that acarbose treatment also significantly improved glycemic control, triglyceride levels, body weight and systolic blood pressure.
1.4.3 Non Pharmacological Treatment
Exercise plays an important therapeutic role in the management of type 2 diabetes and usually is prescribed along with dietary therapy and pharmacologic therapy. The benefits of exercise are observed through the lowering of blood glucose concentration during and after exercise (Najim, 2008). Physical activities are able to reduce the risk of progression from impaired glucose tolerance (IGT) to type 2 diabetes mellitus by 58% (Sigal et al., 2006). There is evidence that showed the relation between the exercise and the HbA1c level, where exercise training reduced HbA1c by an amount that should decrease the risk of diabetic complications (Boule et al., 2001).
b. Dietary Control
Obesity and weight gain contributes to the development of diabetes. The impact of obesity will put the diabetic patients on risk of coronary heart disease (CHD) (Anderson et al., 2003). Hence, decreasing the weight will decrease the risk for developing diabetes. Despite that, glycemic control also will be well controlled. A meta-analysis on restricted-carbohydrate diets in type 2 diabetic patients showed that there is an improvement in HbA1c, fasting glucose, and some lipid fractions (triglycerides) with lower carbohydrate-content diets (Kirk et al., 2008). A study conducted to assess the effects of high dietary fiber intake in type 2 diabetic patient shows that high intake of dietary fiber, particularly the soluble type, improves glycemic control, decreases hyperinsulinemia and also lowers plasma lipid concentrations (Chandalia et al., 2000). The Malaysian Clinical Practice Guidelines for Management of Type 2 Diabetes Mellitus 4th Edition (2009) suggests that a balanced diet consisting of 50-60% (Carbohydrate), 15-20% (Protein) and 25-30% (Fats) are encouraged. However, these recommendations must be individualized based on glucose and lipid goals.
1.5 MANAGEMENT OF CHRONIC DISEASES IN PRIMARY HEALTH CARE
In United States, there is an estimated of 99 million Americans living with a chronic illness. This becomes one of the major challenges faced by the U.S. health care system today and in the future. However, the defining features of primary care which includes continuity, coordination and comprehensiveness, are well suited to the care of chronic illness (Rothman and Wagner, 2003).
In the WHO’s World Health Report 2008: Primary Health Care Now More Than Ever shows that the primary-care team becomes the mediator between the community and the other levels of the health system, helping people navigating through the maze of health services and mobilizing the support of other facilities by referring patients or calling on the support of specialized services (WHO, 2008). Evidence has shown that with a better primary care, especially coordination of care could reduce avoidable hospitalization rates, especially for individuals with multiple chronic conditions (Wolff et al., 2002). In Thailand, the patient satisfaction toward primary care units has improved when compared to public hospitals out-patients-department. An evolutionary change, as the patients in Thailand started to have confidence in local facilities such as primary care units for monitoring of chronic diseases (Pongsupap et al., 2005).
1.5.1 The Management of Chronic Diseases in Primary Health Care Centers in Malaysia
Chronic diseases are the major cause of death and disability in Malaysia, accounted for 71% of all deaths and 69% of the total burden of disease. Preliminary data from Malaysian Non-Communicable Disease (NCD) Surveillance 2005/06 estimated that approximately 11.6 million Malaysian adults aged 25-64 years were having at least one risk factor for chronic diseases and only about 3% did not have any risk factor. (Ramli and Taher, 2008). A study carried in an urban primary health care setting in Sarawak shows that the poor glycemic control (HbA1c > 7.5%) is about 38%. Wong and Rahimah (2004) suggested that reasonable glycemic control can be achieved in the primary health care setting in Sarawak.
A study was carried out to evaluate the status of diabetes care and prevalence of diabetic complications among the diabetic patients in primary private health care Malaysia. Majority of diabetic patients treated at the primary care level were not satisfactorily controlled and were associated with a high prevalence of complications (Mafauzy, 2005). Hence, there is a need on putting on more efforts in order to achieve clinical targets.
1.6 MEDICATION ADHERENCE
A literature review showed that the adherence rates for patients with type 2 diabetes have ranged from 65 % to 85% for OHA and 60 % to 80 % for insulin (Kenreigh and Wagner, 2005). A survey was done in the United States to assess medication adherence, knowledge of therapeutic goals and goal attainment for adult patient with diabetic. The result showed that 48 % of patients were medication non-adherent and most frequently reported reasons for non-adherence were forgetfulness (34 %) and too expensive (14 %). This study also shows that the patients at HbA1c goal were more adherent than patients not at goal (Whitley et al., 2006).
A study was carried out by Tan and Judy, on self-care practices of Malaysian adults with diabetes and sub-optimal glycaemic control. The result showed that only 53 % subjects scored below 50 % in their diabetes-related knowledge, subjects with medication non-adherence, 46 % tended to have higher fasting blood glucose levels and only 15 % of the subjects practiced SMBG (Tan and Judy, 2008). Patients which non adherent to the drug regimen was found to be at higher risk of hospitalization. The study on this showed that patients with type 2 diabetes mellitus who did not obtained at least 80% of their antihyperglycemic medications across a year were at a higher risk of hospitalization in the following year (Lau and Nau, 2004).
1.6.1 Factor Affecting Non-Adherence in Diabetes Mellitus
Drug non-adherence is a major concern in patient management, especially in individuals with diabetes, which makes the glycemic control difficult to attain. Adisa et al. (2009) stated that the commonly cited intentional nonadherence practice included dose omission, 70.2%. Almost 50 % respondents were fed up with daily ingestion of drugs and 19.8% of the respondents stated that it was inconvenient to take the medications outside. Furthermore, forgetfulness (49.6%) and high cost of medication (35.5%) were also reasons for non adherence. Another factor that influenced the non adherence were patient-related factors (96%) and health care system-related factors (79%) (Ratsep et al., 2007). Ratsep et al. stated that the patient-related factors include patients’ awareness regarding diabetes and its complications, patients’ motivation to change their lifestyle, non-compliance with medical regimen, patients’ financial problems and their non-attendance. Health care system-related factors include the lack of special diabetes education for nurses, underfunding and an inadequate number of patients’ educational materials.
1.7 PHARMACISTS’ INTERVENTION
Health coaching which relies on frequent contact and ongoing intervention has emerged in recent years as part of disease management initiatives (Melko et al., 2010). This has been promoted as an effective method for improving health outcomes and patient compliance with medication. A pilot study done by Melko et al. (2010) has shown that health coaching combined with tools do increased medication adherence.
In United States, the adherence to OHA therapy ranged from 36 to 93 % in patients remaining on treatment for 6 to 24 months. Electronic monitoring identified poor compliers for interventions that improved adherence,61 to 79 % (Cramer, 2004).
A study has shown that, HbA1c levels decreased significantly in the intervention group after the 4th month and remained lower than in the control group until the 12th month (Scain et al., 2009). Moreover, a decreased of HbA1c by 0.16% was observed with each 10% increased in drug adherence (Schectman et al., 2001). With every 1 % reduction in updated mean HbA1c was associated with reductions in risk of 21 % for any end point related to diabetes, 21 % for deaths related to diabetes, 14 % for myocardial infarction and 37 % for microvascular complications (Stratton et al., 2000).
A review of the literature on the role of pharmacists indicates that there is a potential benefit of pharmacist interventions to improve medication adherence in diabetes, especially focusing in providing patient education (Lindenmeyer et al., 2006). A study on Latino patients with uncontrolled diabetes (Hemogloblin A1c ≥ 8.0%) showed that intervention from the pharmacist and health promoter team management of uncontrolled diabetes appears to be a feasible approach in order to improve the medication management (Gerber et al., 2009).
Marcio Machado and his team found that there is a significant reduction in HbA1c levels in the pharmacists’ intervention group but not in the control group which is without pharmacists’ intervention (Machado et al., 2007). In the journal which discussed the role of pharmaceutical care in diabetes management, there were evidences suggesting that the pharmacist’s efforts in optimizing the pharmacotherapy can prove a valuable component in community-based multi disciplinary diabetes care (Davis et al., 2005).
A meta analysis carried out by Conn et al. (2009) which investigated the effectiveness of interventions to improve medication adherence in older adults suggests that interventions increase medication adherence in older adults.
The types of interventions include pill count, electronic medication -event monitoring device (MEMS), diabetes education, medication counseling, monitoring and insulin initiation and/or adjustments. In comparison of MEMS and pill count, MEMS data resulted in different numbers and types of recommendations than pill counts (Matsuyama et al., 1993). Hence, the pharmacists then could make specific recommendation regarding patient educations.
A Cochrane review stated that almost all of the interventions that were effective for long term care were complex, which include combinations of more convenient care, information, reminders, self-monitoring, reinforcement, counseling, family therapy, psychological therapy, crisis intervention, manual telephone follow-up and supportive care (Haynes et al., 2008). However, there is no conclusion about the effectiveness of the interventions that could lead to large improvement in adherence and treatment outcomes.
An earlier meta analysis of studies conducted reported that chronic disease patients including those with diabetes and hypertension, as well as cancer patients and those with mental health problems benefited from interventions such as prescription refills, pill counts and electronic monitoring (Roter et al., 1998).
1.8 RESEARCH OBJECTIVES
The primary health care settings play an important role in primary steps in order to prevent the development of chronic diseases. In Malaysia, there were a number of people who have chronic diseases that received treatment in the primary health care settings. Hence, research should be carried out in order to assess the medication adherence among diabetic patients in the primary care settings in order to achieve better therapeutic outcome.
1.8.1 General Objective
To assess the impact of pharmacist counseling on medication adherence among the diabetic patients in primary care centre
1.8.2 Specific Objectives
To assess patients’ blood glucose level and knowledge, before and after counseling.
To evaluate patients’ medication adherence, before and after intervention.
To correlate the medication adherence with counseling.