A study on adverse drug reactions in a tertiary care hospital of Northeast India

Objective: Purpose of this study was to monitor adverse drug reactions reported from various departments of a tertiary care hospital in Northeast India. Reported adverse drug reactions were analysed for causality and severity assessment. Methods: This cross sectional study was conducted in a tertiar...

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Main Authors: Ratan J. Lihite, Mangala Lahkar, Sukirti Das, Debeeka Hazarika, Murali Kotni, Mudasir Maqbool, Swapna Phukan
Format: Article
Language:English
Published: Taylor & Francis Group 2017-06-01
Series:Alexandria Journal of Medicine
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2090506816300653
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author Ratan J. Lihite
Mangala Lahkar
Sukirti Das
Debeeka Hazarika
Murali Kotni
Mudasir Maqbool
Swapna Phukan
author_facet Ratan J. Lihite
Mangala Lahkar
Sukirti Das
Debeeka Hazarika
Murali Kotni
Mudasir Maqbool
Swapna Phukan
author_sort Ratan J. Lihite
collection DOAJ
description Objective: Purpose of this study was to monitor adverse drug reactions reported from various departments of a tertiary care hospital in Northeast India. Reported adverse drug reactions were analysed for causality and severity assessment. Methods: This cross sectional study was conducted in a tertiary care hospital at Guwahati, Northeast India, for 7 months. Patients of all age and either sex were included. Adverse drug reactions were reported by the physicians of this hospital and their causality and severity assessments were performed as per Naranjo’s and Hartwig’s assessment criteria respectively. Descriptive statistics were used for data analysis. Results: Total 255 adverse drug reactions were reported from various departments of this tertiary care hospital. Most of the adverse drug reactions were observed in the age group of 21–30 year. Acne (46) was commonly reported reaction. Topical steroids, betamethasone sodium phosphate and clobetasol were reported to induce maximum number of reactions (59). Skin (227, 66.9%) was commonly affected organ system. Most of the adverse drug reactions were possible (240, 94.1%) and mild (222, 87%) in nature. Conclusions: The topical steroid (betamethasone sodium phosphate) was reported to induce adverse drug reactions in majority of the patients. The commonly reported reaction was acne.
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spelling doaj.art-c7495fbd77be45c488f0649f794e1e2c2022-12-21T17:15:22ZengTaylor & Francis GroupAlexandria Journal of Medicine2090-50682017-06-0153215115610.1016/j.ajme.2016.05.007A study on adverse drug reactions in a tertiary care hospital of Northeast IndiaRatan J. Lihite0Mangala Lahkar1Sukirti Das2Debeeka Hazarika3Murali Kotni4Mudasir Maqbool5Swapna Phukan6ADR Monitoring Centre (Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Govt of India), Department of Pharmacology, Gauhati Medical College, Guwahati, IndiaDepartment of Pharmacology, Gauhati Medical College, Guwahati, IndiaInstitute of Pharmacy, Gauhati Medical College, Guwahati, IndiaDepartment of Dermatology & STD, Gauhati Medical College, Guwahati, IndiaDepartment of Pharmacy Practice, National Institute of Pharmaceutical Education & Research (NIPER), Guwahati, IndiaDepartment of Pharmacy Practice, National Institute of Pharmaceutical Education & Research (NIPER), Guwahati, IndiaDepartment of Pharmacology, Gauhati Medical College, Guwahati, IndiaObjective: Purpose of this study was to monitor adverse drug reactions reported from various departments of a tertiary care hospital in Northeast India. Reported adverse drug reactions were analysed for causality and severity assessment. Methods: This cross sectional study was conducted in a tertiary care hospital at Guwahati, Northeast India, for 7 months. Patients of all age and either sex were included. Adverse drug reactions were reported by the physicians of this hospital and their causality and severity assessments were performed as per Naranjo’s and Hartwig’s assessment criteria respectively. Descriptive statistics were used for data analysis. Results: Total 255 adverse drug reactions were reported from various departments of this tertiary care hospital. Most of the adverse drug reactions were observed in the age group of 21–30 year. Acne (46) was commonly reported reaction. Topical steroids, betamethasone sodium phosphate and clobetasol were reported to induce maximum number of reactions (59). Skin (227, 66.9%) was commonly affected organ system. Most of the adverse drug reactions were possible (240, 94.1%) and mild (222, 87%) in nature. Conclusions: The topical steroid (betamethasone sodium phosphate) was reported to induce adverse drug reactions in majority of the patients. The commonly reported reaction was acne.http://www.sciencedirect.com/science/article/pii/S2090506816300653ADRsNortheastNaranjoHartwigPharmacovigilance
spellingShingle Ratan J. Lihite
Mangala Lahkar
Sukirti Das
Debeeka Hazarika
Murali Kotni
Mudasir Maqbool
Swapna Phukan
A study on adverse drug reactions in a tertiary care hospital of Northeast India
Alexandria Journal of Medicine
ADRs
Northeast
Naranjo
Hartwig
Pharmacovigilance
title A study on adverse drug reactions in a tertiary care hospital of Northeast India
title_full A study on adverse drug reactions in a tertiary care hospital of Northeast India
title_fullStr A study on adverse drug reactions in a tertiary care hospital of Northeast India
title_full_unstemmed A study on adverse drug reactions in a tertiary care hospital of Northeast India
title_short A study on adverse drug reactions in a tertiary care hospital of Northeast India
title_sort study on adverse drug reactions in a tertiary care hospital of northeast india
topic ADRs
Northeast
Naranjo
Hartwig
Pharmacovigilance
url http://www.sciencedirect.com/science/article/pii/S2090506816300653
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