A Pharmacovigilance Study to Analyze the Adverse Drug Reactions in Patients Treated With Antihypertensive Drug in Tertiary Care Teaching Hospitals

Introductions:- Hypertension is the most common cardiovascular disease and most important public health problem. Increased arterial pressure causes hypertrophy of the left ventricle leads to pathological changes in the vasculature. Pharmacovigilance analysis study provided an insight into the drug use pattern and rational use of drugs. The outcomes of the present study contribute to us as well as public knowledge about drugs effectiveness and theirs safety concern. Material & Methods: This Pharmacovigilance analysis study was a Prospective and observational study conducted in Department of Pharmacology, Santosh Medical College and Hospital, Santosh Deemed To be University (SDTU), Ghaziabad in Collaboration with Department of Medicine, Muzaffarnagar Medical College, Muzaffarnagar during the period of June 2019 to December 2022. The study was approved by IEC, of Santosh Deemed to be University, Ghaziabad in 2019. The study was a part of PhD thesis of corresponding author. The Individual Data for Pharmacovigilance analysis was collected for 6 months of period with the help of ―Suspected Adverse Drug Reaction Reporting Form V. 1.3 and ―Medicines Side Effect Reporting Form (For Consumers) v.1.0. Statistical analysis was done by SPSS v- 20 and Excel-Sheet. Results: A total of 242 Hypertensive patients following inclusion and exclusion criteria of both genders were observed in the study. Out of 242 patients a total 47 patients showed 25 types of ADRs were recorded and assessed for 6 months. Among 47 patients, the prevalence of ADRs was predominantly higher in the patients having higher age group, i.e., > 40 years of age (70 %.). Compared to monotherapy (15-25%), combinational therapy (using more than one medicine) was linked to a higher proportion of adverse drug reactions (27.3-36.4%). The anti-hypertensive drugs combinations most frequently linked to ADRs were ARB+CCB+DU (36.36%), followed by CCB + BB (28.57%), ARB + CCB (27.27(19.35%), ACEI(25%), ARB + DU (16.67%), BB (15.15%) and ARB (15%). Conclusion: The results of the above study would be useful for the physicians in rational selection of drug therapy for treatment of hypertensive patients. The present data suggest that the ADR monitoring needs to be done in hospital settings continuously so that untoward effect caused by different medicines can be identified and documented.