ABSTRACT
Background: Diabetes mellitus is an emerging non communicable, life style disease & the use of anti-diabetics has been increasing. Adverse drug reactions (ADRs) are well known to occur with any class of drugs when used in normal doses for the management of diseases. Anti-diabetic agents are no exception to this. The study of ADRs is the concern of the field known as pharmacovigilance. The objective of the present study was to analyze and describe the patterns of adverse events associated with the use of oral Anti-diabetic agentsMethods: A hospital based prospective observational study at Hi-Tech Medical College and Hospital, Bhubaneswar, Orissa. Convenience samples of 266 adult patients, prescribed with oral anti-diabetic agents from October 2016 to November 2018 were selected, out of which 74 patients developed ADRs. Data collected from available prescriptions. The severity assessment is done using the Hartwig and Siegal scale and preventability assessment using modified Schumock and Thornton is done.Results: Study suggests that female predominance in 41 (55.40%) patients with maximum cases of 43.24% in age group of 61-70 years age group. Maximum ADRs reported related to endocrine system seen in 36 (48.67%) patient population. Sulfonylureas 38 (51.35%) shows the largest numbers of ADR. The maximum ADRs reported were probable (56.73%). The severity assessment using the Hartwig and Siegal scale indicated that the majority of the ADRs were 63 (81.63%) as mild cases respectively.Conclusions: This study has provided evidence of monitoring and detecting ADRs and their management through therapeutic interventions which is beneficial in the better patient outcome.
ABSTRACT
Background: Every drug has the potentiality to cause an adverse drug reaction (ADR). ADRs are a major problem in drug therapy .The aim of this study was to assess the incidence and causality of ADRs to antihypertensive agents used for the essential hypertensive patients attending at the general medicine out patients departments of Hi-Tech Medical College and Hospital, Bhubaneswar Odisha, during the time period of November 2016 to October 2018.Methods: This prospective-observational study was carried out in general medicine outpatient department of Hi-Tech Medical College and Hospital, Bhubaneswar, Odisha.Results: Out of 254 patients, 78 (30.71%) patients were developed ADRs to antihypertensive drugs. 51 (65.38%) were female and 27 (34.62%) were male. Calcium channel blockers were the commonest therapeutic class of antihypertensive drugs associated with ADRs (n = 50, 64.10%). According to WHO causality assessment scale most of the ADRs were “probable” 41 (52.56%), followed by “possible” 21 (26.92%), unclassifiable 13 (16.67%) and unlikely 3 (3.85%).Conclusions: The results of this study concluded that antihypertensive drugs able to induce the development of adverse drug reactions, which were significant cause of increase burden on health care system and decrease the quality of life, the health care professionals should take care about the rational use of antihypertensive agents. Thus, to minimize the incidence of adverse drug reaction and to increase the quality of life.