IMPACT OF TREATMENT NONCOMPLIANCE AND ITS EFFECT ON CLINICAL OUTCOME AMONG PATIENTS WITH TYPE II DIABETES BY IMPROVED COMPLIANCE

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1 Page4611 Indo American Journal of Pharmaceutical Research, 2016 ISSN NO: IMPACT OF TREATMENT NONCOMPLIANCE AND ITS EFFECT ON CLINICAL OUTCOME AMONG PATIENTS WITH TYPE II DIABETES BY IMPROVED COMPLIANCE Hrushikesh Reddy. Yerraguntla 1, Muralidhar Naidu. Chitraju 1, Javeed Baig. Moghal 1*, Prathiba. Bhaskarudu 1, Bushrah Anjum. Beparie 1, Dr. Surehswara Reddy. Mulla 2 1 P Rami Reddy Memorial College of Pharmacy, Kadapa, Andhra Pradesh, India. 2 Rajiv Gandhi Institute of Medical Sciences, Kadapa, Andhra Pradesh, India. ARTICLE INFO Article history Received 20/02/2016 Available online 31/03/2016 Keywords Compliance, HBA1C, Type II Diabetes, Morisky-8-Item Medication Adherence Questionnaire. ABSTRACT Compliance is a scope to which a person's behaviour in captivating medications, diet and executing life style changes optional with the prescriber. Foremost intend of the study is to appraise how much obedience is departure to have consequence on clinical outcomes in Type II Diabetic Patients. Diabetes mellitus is a chronic illness and progressive disease that requires progressing medical care, fragmentary patient self-management education, and compliance is compulsory to managing this conditions and reduced farther complications for this conditions. The collision of medication adherence was observed among adherent and non adherent subjects. The patients diagnosed with Type 2 DM (with or without complications) from either sex > 30 years aged were included in the study and The patients under the onset of age below 30years, prescribed with insulin therapy only, who did not refill the prescription for at least once during the study period were excluded from the study. A total of 100 patients were recruited in the study of whom 74 of them completed the study and 26 were dropped out. A total of 35% followed by 15% patients were non-adherent whereas, 65% followed by 85% patients were adherent before and after counselling respectively. Noncompliance is being increasingly recognized as one of the major limitations to improve health care outcomes and a greater understanding of the relationship between non-compliance as well as treatment practices. New pioneering methods are obligatory to support those patients who not succeed in their medication compliance. Corresponding author M. Javeed Baig Department of Clinical Pharmacy, RIMS, PRRMCP, Kadapa, India javeed.baig016@gmail.com Please cite this article in press as Hrushikesh Reddy.Yerraguntla et al. Impact of Treatment Noncompliance and its Effect on Clinical Outcome Among Patients with Type II Diabetes by Improved Compliance. Indo American Journal of Pharmaceutical Research.2016:6(03). Copy right 2016 This is an Open Access article distributed under the terms of the Indo American journal of Pharmaceutical Research, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

2 Page4612 INTRODUCTION Drugs and lifestyle changes to control type 2 diabetes and allied conditions can only be Effective through adherence to the overall prescribed treatment. The World Health Organization (WHO) has revealed that adherence to long-term therapy for chronic illnesses in developed countries averages only approximately 50% [1]. Adherence implicate are usually reduced for patients with chronic circumstances than those with acute conditions associated with the long-term nature of chronic diseases for the reason that decline in adherence is most rapid after the first 6 months of therapy [2]. Such reduced adherence not only results in deprived health outcomes but it also has a momentous impact on healthcare costs [3]. Diabetes is a challenging disease to be managed successfully. It requires recurrent self-monitoring of blood glucose, dietary modifications, administration of medications as per schedule, and exercise. So regimen adherence problems are frequent in individuals with diabetes, thus making glycaemic control difficult to attain [4] Ensuring that patients take oral anti-diabetic medications as prescribed and accomplish normal or near normal blood glucose control is surrounded by the most common challenges encountered by the physicians and other health care providers involved in the treatment of diabetes. Failure to conquer the desired therapeutic goal might be related to inadequate adherence. As an alternative of changing the prescription, increasing the drug dosage, or adding a new drug, adherence assessment to the treatment should be measured first in most patients [5, 6]. A short, validated patient questionnaire are used in the present study, the Morisky instrument10 is used to gauge adherence to anti-diabetic treatment or method was used before more frequently to measure patient compliance with drug treatment[5]. The main aim for the study to selecting, we can inspect the variability in the speed of medication adherence among Type 2 diabetic patients. This may lead to a clear understanding about poor glycemic control amid these patients as well as for a strict and successful management of this chronic illness. Associated in future complications, access to and use of medicines, patients beliefs and motivation about OHA(s), patient-health care provider relationship, regularity of monitoring of blood glucose level, number of drug taken, drug regimen, experience side effects, and direct and indirect care costs in relation to patient income[7]. RESEARCH METHODOLOGY: A prospective observational study was carried out in 100 patients with type- 2 diabetes mellitus for the period of six months in the department of General medicine, RIMS Tertiary Care Teaching Hospital, after obtaining ethical permission approval from the ICE (Rc.No. 5077/ Acad. /2014 ). All subjects of either sex above the age group of 30 years, who are diagnosed with Type 2 DM (with or without complications) were included in the study and subjects under the onset of age below 30years, subjects who are not interested to participated in the study and who are taking insulin therapy such kinds of patients were excluded in the study. Patient all necessary data were collected in specially designed data collection form, it includes information on subjects demographic details (e.g. Patient s Name, Age, Sex, educational and occupational status, date of admission and date of discharge), presenting complaints, provisional/confirmed diagnosis, social history, past medical/medication history, current medications, discharge medications, laboratory test reports (HbA1c) specifically. Medication adherence was assessed during a personal interview with each patient using structured questionnaires addressing the following aspects such as (i) Assessing the knowledge, attitude and practice of diabetes in diabetic patients by using KAP Questionnaire to know what the knowledge, attitude they have about diabetes and how they practice their lifestyle having diabetes. (ii) Determining the use, belief about medications and motivate towards anti-diabetic drugs by using BMQ Questionnaire to know what they really believe about medicinal aspects. (iii) Assessing of medication adherence to know at what extent the patients are adherent to medicines by using Morisky-8 Item Medication adherence [5]. Data management and statistical analysis was done by using Graph Pad prism was used to analyze the data obtained from the questionnaire and Chi-square test was used to analyze the significant difference of the clinical outcome parameter (HbA1c) between adherent and non adherent patients of type 2 diabetic patients. RESULTS A total of 100 patients were recruited in the study subject who are suffering with DM-II, In that 74 of them completed the study and 26 were dropped out, out of which 68.9% were males and 31.08% were females. Most patients belonged to the Elderly age group > 60 years i.e years (41.8%), followed by middle age group years (28.37%) % patients had a family history of Diabetes Mellitus % patients had an education of above 10th standard, 18.91% patients had an education below 10th standard, most of the patients (64.86%) had no formal education %of patients were unemployed of which 47.29% patients were farmers, 25.67% patients were business men, followed by16.21% were from other occupation section and only % of patients were employed % of patients were diagnosed with diabetes since more than 2 years, followed by % patients diagnosed since more than 6 years, followed by 24.32% patients diagnosed less than 2 years and 18.91% patients less than 10years. Sociodemographic and clinical characteristics of the participants are summarized in (Table1).

3 Page4613 Table 1: Demographic Characteristics of the Study Population. PARAMETRES NO. OF PATIENTS PERCENTAGE GENDER Male Female AGE FAMILY HISTORY Present Absent SOCIAL HABITS Alcohol Intake Yes No Smoking Yes No EDUCATIONAL LEVEL No formal education < 10 th Std th - 12 th Std Diploma / Degree OCCUPATION Farmer Business Employee Others YEARS SINCE DIAGNOSED <2 years years years >10 years subjects had proceeded the study, in that 28 were hypertensive, 6 were CVA, 16 were Diabetic foot, 14 were Diabetic nephropathy and 10 were Diabetic Keto-acidic patients (Figure: 1). Figure 1: Co-morbidities Associated with Type 2 DM.

4 Page4614 In this Study patients prescribed with different OHA more number of patients was treated with mono-therapy for 20 subjects, dual therapy for 40 subjects and 14 subjects are treated with more than two drugs (Figure:2). Figure: 2: Different oral hyper Glycaemic drugs prescribed in patients. The assessment of the patients responses to the Morisky 8-Item Medication adherence predictor scale showed that 34(45.94%) of the patients had low adherence with prescribed medications, whereas 37.83% had medium adherence and % had good adherence before counselling whereas, 24(32.43%) of the patients had low adherence followed by 48.64% had medium adherence and 18.91% had good adherence after counselling. Thus as a part of pharmacist, author played a major role in increasing adherence to the medication of anti-diabetics by patient counselling (Figure: 3) >2 Before After 14 Figure: 3 summaries of subjects responses to morisky-8 item medication adherence scale. The assessment of the patients responses to HbA1cpredictor scale before counselling showed that 10 % number of the patients had good glycemic control (5-6) with prescribed medications, followed by 60% patients had medium glycemia(6-8) and 30 %patients had hyperglycemia(8-10). whereas, after counselling patients responses to HbA1cpredictor scale showed that 30 % number of the patients had good glycemic control(5-6) with prescribed medications, followed by 50% patients had medium glycemia(6-8) and 20 %patients had hyperglycemia(8-10).thus as a part of pharmacist, author played a major role in maintaining good glycaemic control by patient counselling (Table: 2). Table: 2 Subjects Responses to HbA1c Values before Counselling and After Counselling. Hba1c VALUES Before Counseling After Counseling % 30% % 50% % 20%

5 Page4615 Regarding MPR, a total of 33% followed by 23% patients were non-adherent whereas, 67% followed by 87% patients were adherent before and after counselling respectively. Regarding HbA1c, a total of 35% followed by 15% patients were non-adherent whereas, 65% followed by 85% patients were adherent before and after counselling respectively. This differentiation is based on the medication possession ratio (MPR).Individual patient with MPR >80% are considered to be adherent to therapy and patient with MPR < 80% are considered to be non-adherent to therapy. Comparison of adherence and non adherence with outcome parameters HbA1c and MPR was done where it was proved that MPR > 80% i.e. 87% thus patients with diabetes were adherent with their therapy (Table: 3). Table 3:- Comparison of Adherence and Non-adherence with Outcome Parameters. PARAMETER Adherence Non-Adherence P VALUE Before After Before After HbA1c 65% 85% 35% 15% < MPR mean (SD) 67% 87% 33% 23% < DISCUSSION Diabetes mellitus is one of the fastest ever growing non communicable disease in the present scenario. 68.9% of study patients were males, most patients belonged to the Elderly age group > 50 years (50-60) years (41.8%) and about 62.16% patients had a family history of Diabetes Mellitus. Most of the patients (64.86%) had no formal education. About 31.08% of patients were diagnosed with diabetes since more than 2 years. The 8-item Morisky Medication Adherence Questionnaire scale (MMAS-8) has been validated in patients with different types of chronic illnesses and Beliefs about Medicines Questionnaire (BMQ) to measure patients beliefs about medicines. Our results showed that non-adherence was significantly associated with diabetes-related knowledge, beliefs about necessity of the anti-diabetic medications, concerns about adverse consequences of anti-diabetic medications, and beliefs that all medicines are essentially harmful. However, the majority of the glycemic control studies reported that improved adherence was associated with better glycemic control, The ability to distinguish an association between adherence and HbA1C tended to occur more frequently (77.8%) in studies that characterized adherence in terms of prescription refills than in those that used various constructs for patient-reported adherence measures (42.9% of which found an association) [8]. Healthcare Providers need to assess and educate patients about diabetes mellitus to improve the level of medication adherence and consequently therapeutic outcome. There are various confounding factors that have effect on the glycemic control. The success of therapy largely depends on the responsibility of patients [9-12]. CONCLUSION Treatment non-compliance is being increasingly recognized as one of the major limitations to improve health care outcomes & a greater understanding of the relationship between non-compliance & treatment practices will be important in guiding future care practice & medication development. Assessment of beliefs and knowledge can be used to understand variations in adherence among diabetic patients. By improving knowledge of diabetic patients about their illness can positively influence their medication adherence and therapeutic outcome. New innovative methods are needed to assist those patients who fail in their medication compliance. Measures to increase patient satisfaction and counteract a lack of adherence must be multifactorial; strategies should include a reduction in the complexity of the prescription regimen, educational initiatives, improved doctor patient communication, reminder systems and reduced costs. Conflict of Interest: There are no conflicts of interest regarding the publication of this manuscript.

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