protocol ppt
protocol ppt
“IMPACT OF TREATMENT NONCOMPLIANCE AND ITS
EFFECT ON CLINICAL OUTCOME AMONG PATIENTS
WITH TYPE II DIABETES BY IMPROVED COMPLIANCE”
DEPARTMENT OF PHARMACY PRACTICE
P.R.R.M. COLLEGE OF PHARMACY
KADAPA
A.SRAVANI B.PRATHIBHA
(Reg.No.10441T0002) (Reg.No.10441T0003)
C.MURALIDHAR NAIDU M.JAVEED BAIG
(Reg.No.10441T0007) (Reg.No.10441T0016)
BY
UNDER THE GUIDANCE OF
Dr. M. SURESWARA REDDY, Y.HRUSHIKESH REDDY
MBBS; MD (GEN) M.Pharm.
Associate Professor, Assistant Professor,
Department of General Medicine, Department of Pharmacy Practice,
RIMS, Kadapa. P. Rami Reddy Memorial College Of
Pharmacy, Kadapa.
CONTENTS
INTRODUCTION
LITERATURE REVIEW
PURPOSE OF STUDY
AIM AND OBJECTIVES
METHODOLOGY
 ANALYSIS
PLAN OF WORK
CONCLUSION
INTRODUCTION
DIABETES MELLITUS
 DM is a common health problem that has serious Economic and
Medical consequences.
 The Prevalence of diabetes among adults (20-79) was estimated
as 6.4% in 2010 and by 2030 would probably increase to 7.7%.
Between 2010 and 2030, there will be a 69% increase in numbers
of adults with diabetes in developing countries and a 20% increase
in developed countries.
The most common form of DM, over 90% of people who have
diabetes is type 2 Diabetes.
 The prevalence of non-compliance is very high and is continually
increasing health-care costs.
 Globally, compliance to the treatment for chronic illness
like diabetes is just 50%, and is far less in case of developing
countries like India.
FACTORS THAT REDUCE MEDICATION ADHERENCE IN TYPE 2 DIABETES
Low literacy level, limited intelligence.
Lack of understanding about long-term treatment, poor follow ups
and restricted access to health-care facilities.
Economic instability (cost of medication).
Forgetfulness, fearless attitude towards the consequences.
Polypharmacy, complexity of medication regimens.
Associated adverse events, including weight gain, CV problems and
hypoglycaemia.
Negative Perceptions about the efficacy and safety.
Patient-healthcare provider relationship (poor communication).
METHODS TO IMPROVE ADHERENCE IN TYPE 2 DIABETES
Reduce treatment complexity, fixed-dose combinations and
decrease frequency of administration.
Use Medications that are weight reducing, with glucose-dependent
effects leading to decreased hypoglycaemia.
Education and increase knowledge.
Ensure benefits and outweigh(more important than) costs.
Improve continuity of care, and develop communication with the
patient through websites and electronic records.
Treatment non-compliance is associated with the development of
complications, disease progression, un-avoidable hospitalisations,
premature disability and death.
LITERATURE REVIEW
 Shrestha SS, Shakya R, Karmacharya BM, (2013) have
conducted a cross-sectional observational study
entitled “Medication Adherence to Oral Hypoglycemic
Agents Among Type II Diabetic Patients and their
Clinical Outcomes.
 S.S. Chua and S.P. Chan (2011) performed a cross-
sectional study entitled as “Medication adherence and
achievement of glycaemic targets in ambulatory type
2 diabetic patients”
PURPOSE OF STUDY
 Oral hypoglycemic agents are the major treatment options for
the patients with Type 2 diabetes.
 But poor adherence to Oral hypoglycemic agents (OHAs) and
insulin therapy remains as one of the main reasons for poor
metabolic control.
 So in order to improve patient medication adherence, it is
important to understand why non-adherence occurs commonly
proposed reasons include……….
 Treatment non-compliance is associated with the development of
complications, disease progression, un-avoidable hospitalisations,
premature disability and death.
 Thus as necessity the present study is designed to determine the
the prevalance of non-adherence to anti-diabetic medications in
and its association with patients glycemic outcomes and efforts
made to improve adherence.
AIM AND OBJECTIVES
AIM:
The aim of the study is to evaluate how adherence is going to
have effect on clinical outcomes in Type II Diabetic Patients in
a tertiary care teaching hospital in Kadapa (RIMS).
OBJECTIVES:
The Study entitled “Impact of Treatment Non Compliance and Its
Effect on Clinical Outcome among Patients with Type II Diabetes by
Improved Compliance” aims at achieving the objectives of……………
 Assessing the impact of medication adherence in type II diabetic
patients.
 Assessing the complications and consequences reported by the
patients.
 Achieving control over hyperglycemia by monitoring Glycosylated
Hemoglobin (HbA1c).
METHODOLOGY
 Study design : A Prospective observational study.
 Study site : Rajiv Gandhi Institute of Medical
Sciences, Kadapa.
 Study duration : The study will be performed for 6 months.
 Sample size : Approximately 100 patients.
 Inclusion criteria : All patients of either sex above the age group of 30
years, who are diagnosed with Type 2 DM
(with or without complications).
 Exclusion criteria : Patient prescribed with insulin therapy only.
The patients who did not refill the prescription for
at least once during the study period.
Patient under the onset of age below 30years.
METHODOLOGY………
STUDY MATERIALS:
 Patient demographic data collection forms. (Annexure-I).
 Patient informed consent forms(Annexure-II).
 KAP to assess diabetes – related knowledge(Annexure-III).
 The Beliefs and Brief Medication Questionnaire
(Annexure-IV).
 Morisky 8-item Medication Adherence Questionnaire
(Annexure-V)
 Medication possession rate scale .
ANALYSIS
STATISTICAL ANALYSIS:
Data will be analyzed by using
‘chi-square’test.
DATA ANALYSIS:
The obtained data will be thoroughly
analyzed to evaluate the impact of non-
adherence towards anti-diabetic therapy
and the effect of adherence and its clinical
outcomes.
The study planned shall be carried out for 6 months.
Enrolment of patients into the study is based on inclusion and exclusion
criteria after receiving informed consent form from the patients.
Prepared protocol will be submitted to the ethical committee for approval.
Periodical monitoring and measurements of blood glucose levels will be done
for every 2 month.
The incidence and prevalence of patient condition will be assessed.
The prepared data will be analyzed, processed, formed and submitted.
Plan of Work
CONCLUSION
 DM is a chronic illness that requires continuing medical care to
prevent acute complications.
 But treatment non-compliance is regarded as one of the major
limitations in improving health care outcomes.
Thus the present study is designed to determine the
prevalence of non-adherence to anti-diabetic medications in
and its association with patient’s glycaemic outcomes and
efforts made to improve adherence.
REFERENCES:
 ShresthaSS,ShakyaR,KarmacharyaBM,Thapa P; Medication adherence
to oral hypoglycemic agents among type 2 diabetic patients and their
clinical outcomes with special reference to fasting blood glucose and
glycosalatedheamoglobin levels;2013; volume 11; 43(3); 226-236.
 Craig J Currie, Mark Peyrot,MarcEvanr ,Richard R Rubin .The impact of
treatment noncompliance on mortality on people with type 2
Diabetes.Diabetes Care.2012; volume 35:1279-1284.
 S.S Chua,S,PChan.Medication adherence and achievement of
glycaemic targets in ambulatory type 2 diabetic patients.Journal of
Applied Pharmacetical Science.2011; Volume 1(4):55-59.
 P.MichaelHo, John S Rumsfeld , Frederick A Masoudi,MSPH et al ;Effect
of medication nonadherance on hospitalization and mortality among
patients with diabetes mellitus; Arch Intern Med ;2006; Volume 16
;1836-1841.
 ManelPladevali, George Divine, L.Keoki Williams, Jennifer
ElstonLafata et al. Clinical outcomes and adherance to medications
measured by claims data in patients with diabetes.Diabetes
Care.2004;Volume 27:2800-2805.
 Dr.AmitVaibhav,Dr.O.Psingh,Dr.Anil KR Tripathi. Present scenario
of Diabetes Mellitus and its treatment possibilities; Asian journal
of Modern and Ayervedic medical science; 2001 volume1(1).
 Kathleen Fairman, Brenda Motheral; Evaluating the medication
adherence; Journal of managed care pharmacy(JMCP);Nov 2000;
volume 6(6); 499-505.
 WHO guidelines for adherence to long term therapies evidence
for action. World health organization 2003.
 Alvin C. Power; Diabetes mellitus. Harrisons; Principal of Internal
Medicine; 17th edition; volume 2.
 James H.D Keefe, David S.H. Bell, Kathleen L. Wyne; overview of
Diabetes Mellitus; Diabetes Essential; Third edition ;2007;3-11
 EAM Gale, JV Anderson; Diabetes Mellitus & other disorder of
metabolism; Kumar & Clarks clinical medicine; Seventh edition;
2009;1029-1076.
 KD Tripathi; Insulin, Oral Hypoglycemic Drugs & Glucagon.
Tripathi; Essential of Medicine Pharmacology; 7th edition; 254-
274.
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protocol ppt

  • 3. “IMPACT OF TREATMENT NONCOMPLIANCE AND ITS EFFECT ON CLINICAL OUTCOME AMONG PATIENTS WITH TYPE II DIABETES BY IMPROVED COMPLIANCE” DEPARTMENT OF PHARMACY PRACTICE P.R.R.M. COLLEGE OF PHARMACY KADAPA A.SRAVANI B.PRATHIBHA (Reg.No.10441T0002) (Reg.No.10441T0003) C.MURALIDHAR NAIDU M.JAVEED BAIG (Reg.No.10441T0007) (Reg.No.10441T0016) BY UNDER THE GUIDANCE OF Dr. M. SURESWARA REDDY, Y.HRUSHIKESH REDDY MBBS; MD (GEN) M.Pharm. Associate Professor, Assistant Professor, Department of General Medicine, Department of Pharmacy Practice, RIMS, Kadapa. P. Rami Reddy Memorial College Of Pharmacy, Kadapa.
  • 4. CONTENTS INTRODUCTION LITERATURE REVIEW PURPOSE OF STUDY AIM AND OBJECTIVES METHODOLOGY  ANALYSIS PLAN OF WORK CONCLUSION
  • 5. INTRODUCTION DIABETES MELLITUS  DM is a common health problem that has serious Economic and Medical consequences.  The Prevalence of diabetes among adults (20-79) was estimated as 6.4% in 2010 and by 2030 would probably increase to 7.7%. Between 2010 and 2030, there will be a 69% increase in numbers of adults with diabetes in developing countries and a 20% increase in developed countries. The most common form of DM, over 90% of people who have diabetes is type 2 Diabetes.
  • 6.  The prevalence of non-compliance is very high and is continually increasing health-care costs.  Globally, compliance to the treatment for chronic illness like diabetes is just 50%, and is far less in case of developing countries like India. FACTORS THAT REDUCE MEDICATION ADHERENCE IN TYPE 2 DIABETES Low literacy level, limited intelligence. Lack of understanding about long-term treatment, poor follow ups and restricted access to health-care facilities. Economic instability (cost of medication). Forgetfulness, fearless attitude towards the consequences. Polypharmacy, complexity of medication regimens. Associated adverse events, including weight gain, CV problems and hypoglycaemia. Negative Perceptions about the efficacy and safety. Patient-healthcare provider relationship (poor communication).
  • 7. METHODS TO IMPROVE ADHERENCE IN TYPE 2 DIABETES Reduce treatment complexity, fixed-dose combinations and decrease frequency of administration. Use Medications that are weight reducing, with glucose-dependent effects leading to decreased hypoglycaemia. Education and increase knowledge. Ensure benefits and outweigh(more important than) costs. Improve continuity of care, and develop communication with the patient through websites and electronic records. Treatment non-compliance is associated with the development of complications, disease progression, un-avoidable hospitalisations, premature disability and death.
  • 8. LITERATURE REVIEW  Shrestha SS, Shakya R, Karmacharya BM, (2013) have conducted a cross-sectional observational study entitled “Medication Adherence to Oral Hypoglycemic Agents Among Type II Diabetic Patients and their Clinical Outcomes.  S.S. Chua and S.P. Chan (2011) performed a cross- sectional study entitled as “Medication adherence and achievement of glycaemic targets in ambulatory type 2 diabetic patients”
  • 9. PURPOSE OF STUDY  Oral hypoglycemic agents are the major treatment options for the patients with Type 2 diabetes.  But poor adherence to Oral hypoglycemic agents (OHAs) and insulin therapy remains as one of the main reasons for poor metabolic control.  So in order to improve patient medication adherence, it is important to understand why non-adherence occurs commonly proposed reasons include……….  Treatment non-compliance is associated with the development of complications, disease progression, un-avoidable hospitalisations, premature disability and death.  Thus as necessity the present study is designed to determine the the prevalance of non-adherence to anti-diabetic medications in and its association with patients glycemic outcomes and efforts made to improve adherence.
  • 10. AIM AND OBJECTIVES AIM: The aim of the study is to evaluate how adherence is going to have effect on clinical outcomes in Type II Diabetic Patients in a tertiary care teaching hospital in Kadapa (RIMS). OBJECTIVES: The Study entitled “Impact of Treatment Non Compliance and Its Effect on Clinical Outcome among Patients with Type II Diabetes by Improved Compliance” aims at achieving the objectives of……………  Assessing the impact of medication adherence in type II diabetic patients.  Assessing the complications and consequences reported by the patients.  Achieving control over hyperglycemia by monitoring Glycosylated Hemoglobin (HbA1c).
  • 11. METHODOLOGY  Study design : A Prospective observational study.  Study site : Rajiv Gandhi Institute of Medical Sciences, Kadapa.  Study duration : The study will be performed for 6 months.  Sample size : Approximately 100 patients.  Inclusion criteria : All patients of either sex above the age group of 30 years, who are diagnosed with Type 2 DM (with or without complications).  Exclusion criteria : Patient prescribed with insulin therapy only. The patients who did not refill the prescription for at least once during the study period. Patient under the onset of age below 30years.
  • 12. METHODOLOGY……… STUDY MATERIALS:  Patient demographic data collection forms. (Annexure-I).  Patient informed consent forms(Annexure-II).  KAP to assess diabetes – related knowledge(Annexure-III).  The Beliefs and Brief Medication Questionnaire (Annexure-IV).  Morisky 8-item Medication Adherence Questionnaire (Annexure-V)  Medication possession rate scale .
  • 13. ANALYSIS STATISTICAL ANALYSIS: Data will be analyzed by using ‘chi-square’test. DATA ANALYSIS: The obtained data will be thoroughly analyzed to evaluate the impact of non- adherence towards anti-diabetic therapy and the effect of adherence and its clinical outcomes.
  • 14. The study planned shall be carried out for 6 months. Enrolment of patients into the study is based on inclusion and exclusion criteria after receiving informed consent form from the patients. Prepared protocol will be submitted to the ethical committee for approval. Periodical monitoring and measurements of blood glucose levels will be done for every 2 month. The incidence and prevalence of patient condition will be assessed. The prepared data will be analyzed, processed, formed and submitted. Plan of Work
  • 15. CONCLUSION  DM is a chronic illness that requires continuing medical care to prevent acute complications.  But treatment non-compliance is regarded as one of the major limitations in improving health care outcomes. Thus the present study is designed to determine the prevalence of non-adherence to anti-diabetic medications in and its association with patient’s glycaemic outcomes and efforts made to improve adherence.
  • 16. REFERENCES:  ShresthaSS,ShakyaR,KarmacharyaBM,Thapa P; Medication adherence to oral hypoglycemic agents among type 2 diabetic patients and their clinical outcomes with special reference to fasting blood glucose and glycosalatedheamoglobin levels;2013; volume 11; 43(3); 226-236.  Craig J Currie, Mark Peyrot,MarcEvanr ,Richard R Rubin .The impact of treatment noncompliance on mortality on people with type 2 Diabetes.Diabetes Care.2012; volume 35:1279-1284.  S.S Chua,S,PChan.Medication adherence and achievement of glycaemic targets in ambulatory type 2 diabetic patients.Journal of Applied Pharmacetical Science.2011; Volume 1(4):55-59.  P.MichaelHo, John S Rumsfeld , Frederick A Masoudi,MSPH et al ;Effect of medication nonadherance on hospitalization and mortality among patients with diabetes mellitus; Arch Intern Med ;2006; Volume 16 ;1836-1841.  ManelPladevali, George Divine, L.Keoki Williams, Jennifer ElstonLafata et al. Clinical outcomes and adherance to medications measured by claims data in patients with diabetes.Diabetes Care.2004;Volume 27:2800-2805.
  • 17.  Dr.AmitVaibhav,Dr.O.Psingh,Dr.Anil KR Tripathi. Present scenario of Diabetes Mellitus and its treatment possibilities; Asian journal of Modern and Ayervedic medical science; 2001 volume1(1).  Kathleen Fairman, Brenda Motheral; Evaluating the medication adherence; Journal of managed care pharmacy(JMCP);Nov 2000; volume 6(6); 499-505.  WHO guidelines for adherence to long term therapies evidence for action. World health organization 2003.  Alvin C. Power; Diabetes mellitus. Harrisons; Principal of Internal Medicine; 17th edition; volume 2.  James H.D Keefe, David S.H. Bell, Kathleen L. Wyne; overview of Diabetes Mellitus; Diabetes Essential; Third edition ;2007;3-11  EAM Gale, JV Anderson; Diabetes Mellitus & other disorder of metabolism; Kumar & Clarks clinical medicine; Seventh edition; 2009;1029-1076.  KD Tripathi; Insulin, Oral Hypoglycemic Drugs & Glucagon. Tripathi; Essential of Medicine Pharmacology; 7th edition; 254- 274.