A Comprehensive Prospective Analysis of Prescribing Indicators, Pharmacoeconomics, Therapeutic Adherence, Adverse Drug Reactions and Quality of Life Among Patients of Type 2 Diabetes Mellitus with Hypertension in A Tertiary Care Hospital

The study is an open-labeled, comprehensive, prospective longitudinal design that will be conducted in the Department of Pharmacology in collaboration with the Department of Medicine, Rama Medical College, Hospital & Research Centre, Mandhana, Kanpur, Uttar Pradesh. In this study. The research project will be conducted as an observational prospective study on patient prescribing indicators, Pharmacoeconomics, therapeutic adherence, adverse drug reactions, and quality of life among patients of type 2 diabetes mellitus with hypertension in a tertiary care hospital, this study will be conducted in the department of medicine in collaboration with the department of pharmacology, at Rama University, Kanpur, Uttar Pradesh after getting the ethical clearance from the Institutional Ethical Committee of Rama University. The patients of type -2 diabetes mellitus with hypertension who satisfy the inclusion criteria will be enrolled from the department of medicine at Rama University, Kanpur. Informed written consent will be obtained from each patient before proper inclusion of the study.

The patients between the age group of 18-65 years of either gender diagnosed a case of Type-2 Diabetes mellitus with hypertension will be considered for the enrollment of the present study. On the first visit (Day 0) the case record form (CRF) designed as per the study protocol will be filled according to the prescription of the patients and we will investigate the following parameters – Blood pressure, blood sugar profile (HbA1c, Fasting blood sugar, Post Prandial blood sugar) and analysis of blood reports along with blood pressure value will be noted in CRF. The detailed prescription will be noted down for the analysis of prescription patterns, WHO prescribing indicators, and pharmacoeconomic analysis. Assessment of the treatment regimens, clinical endpoints (blood pressure control, as well as glucose control) and measure the subjective quality of life using the Modified Diabetes Quality of life questionnaire (MDQoL17) will be done.

The patient will be followed up on the second (DAY 30), third (Day 90) and fourth (Day 180) visits and data will be collected at each visit to evaluate following

The prescription pattern for any change in the medications and investigation of the cost-effectiveness of different therapeutic interventions employed in the management of T2DM and hypertension, considering factors such as medication costs, and healthcare utilization from the patients and their caretakers. The cost of various drugs will be calculated from the current index of medical specialties (CIMS) and Bureau of Pharma PSUs of India (BPPI) – Janaushadhi site. On completion of the study, the data obtained from the case report regarding the prescription of drugs and economic evaluation will be assessed and evaluated using appropriate statistical tests.

The level of adherence to prescribed medications among patients with T2DM and hypertension, identifying barriers to adherence, and exploring factors influencing medication compliance will be assessed by the Morisky Medication Adherence Scale. The patient shall be asked to bring the unused drugs and container during follow-up till the completion of the study. The patient prescription will be audited on every follow-up visit for appropriateness like brand repetition and if any adverse drug reaction

Adverse drug reactions associated with pharmacological interventions including their frequency, severity, and impact on patient outcomes will be measured by the Hartwig severity assessment scale for assessing the severity of adverse drug reactions. If any adverse drug reaction is observed it shall be informed to the healthcare professional for necessary modification, and the causality of reported adverse drug reaction is assessed by the WHO-UMC causality assessment system and the ADRs will be reported through the pharmacovigilance center Rama University via Vigiflow software.

The study will also evaluate the quality of life using the Modified Diabetes Quality of Life questionnaire (MDQoL17), which will be administered through an interview at the first, second, third, and fourth follow-ups.

At the end of the study data compilation and comparison will be done applying the most suitable statistical tools