Title: A Pharamcovigilance Study on Inhaled Bronchodilators in Obstructive Lung Disease
Authors: Shweta Bhandari, Dr Ravi Dosi, Aseem Verma
DOI: https://dx.doi.org/10.18535/jmscr/v8i3.10
Abstract
Inhalational Therapy has a wide range of products which are frequently being used for the treatment of Obstructive Lung Disease which generally includes COPD & Asthma. The prevalence of death due to the disease is being found as 3 million each year which is being increasing and at present it is third leading cause of death worldwide. This pharmacovigilance study is a prospective cohort study carried out at SAIMS hospital, Indore. The study is designed to monitor factual clinical trends in the treatment of OLD and to evaluate the correlation between different therapy of inhaled bronchodilator and their outcome. A total of 100 out patients were enrolled in the study after an informed consent, out of which 58 were males and 42 females. Causality assessment was done using the Naranjo’s Scale & severity was analysed using Hatwing & Siegel Scale severity scale. 32 % of ADR were attributed in the study cohort of 100 patients. Common ADRs observed with drug treatment were diarrhoea, altered bowel habits, gastritis, tachycardia, headache & muscle cramps. The prevalence of ADR was more in GIT, CVS and other organs. CNS ADRs were less reported. The present study resulted in 60 % of ADR which were observed as mild & 40 % reported to be moderate. No severe ADRs were reported. Out of all ADRs, 37.14 % belongs to Doubtful ≤ 0 category, 25.71 % belongs to possible 1-4 category, 28.57 % belongs to probable 5-8 category and 8.57 % belongs to highly probable ≥ 9 categories. Thus, this study compliance the use of inhaled bronchodilator with no severe ADR at each category (children, adult & elderly) and urges for the use of inhalational therapy.
Keywords: Pharmacovigilance, ADR.
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