Patient Reported Adverse Outcomes on Treatment of Type-2 Diabetes Mellitus and Co-Morbidities in South India

Y. Siva Shankar Reddy*¹, B Kumar¹, Umesh Kamarthi², M. Gobinath^1
1Department of Pharmacy Practice, Ratnam Institute of Pharmacy, Nellore.
²Clinical Pharmacist, BGS Global Hospitals, Kengeri, Bangalore, Karnataka, India, Pin–524348

A B S T R A C T
To evaluate patient reported adverse outcomes in type 2 diabetes mellitus with or without co-morbidities in South India. Mainly to contact the study subjects using mobile phones, to record patient reported adverse outcomes including ADR, AE and Unresolved Condition, to ensure medication adherence and to evaluate the role of active surveillance in reporting of events. This Pharmacovigilance study was a prospective Cohort study design with 3 follow ups on active surveillance to improve the passive reports form diabetic patients who are taking medicine from BGS GLOBAL hospital. We included ADR, AE’s, unresolved problems and medication adherence in surveillance to conduct PROs. Data on 133 diabetic patients were included in the study and data were collected for first 3 months and followed by 3 active surveillance. Totally we our tem got 171 outcomes, (126) (73.68%) was through Active surveillance and (45) (26.31%) was through Passive surveillance. Active surveillance repots were received while an interventional enquiry as passive reports was received voluntarily. Many patients are interacted with us for asking counseling regarding diet, exercise and medial information in regular follow ups. They are totally 35, in which 9 diet, 6 exercise, 17 medical information and 3 other. We expected more passive reports from patients but very few are shown interest to report and share their medical information with medical staff. We can conclude that many of the patients in line of medical adherence are risk zone, can chance to exposure ADR. By the study our team says that, it’s very difficult to improve and apply PROs system in developed areas like Bangalore, Hyderabad, and Chennai. Because patients don’t bother about medical induced problems and they won’t show any interest and responsibilities in reporting. Patients need to encourage and given value added basic information and tips in process of reporting in medical induced issues. In future we are planning to provide education to patients along with leaflets to improve patients reported outcomes system for better patient’s medical improvement.
Keywords: Diabetes, Glibenclamide, patient reported outcomes, active surveillance, and passive surveillance