Prospective, observational study of the spontaneous reporting patterns of adverse drug reactions in a tertiary care teaching hospital (Record no. 19478)

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Original cataloging agency AIKTC-KRRC
Transcribing agency AIKTC-KRRC
100 ## - MAIN ENTRY--PERSONAL NAME
9 (RLIN) 21012
Author Santhosh Kumar Raju
245 ## - TITLE STATEMENT
Title Prospective, observational study of the spontaneous reporting patterns of adverse drug reactions in a tertiary care teaching hospital
250 ## - EDITION STATEMENT
Volume, Issue number Vol.13(3), Sep
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Place of publication, distribution, etc. New Delhi
Name of publisher, distributor, etc. SAGE
Year 2022
300 ## - PHYSICAL DESCRIPTION
Pagination 272-277p.
520 ## - SUMMARY, ETC.
Summary, etc. Objectives:To analyse the adverse drug reactions (ADRs) reported from clinical departments of a tertiary care hospital.
Materials and Methods:A prospective, observational study to analyse the reported ADRs to the pharmacovigilance unit, Department of Pharmacology, East Point College of Medical Sciences and Research Centre, between 2019 and 2021. Institutional Ethics Committee approval was taken before doing the study. The data pertaining to various parameters were recorded in the Central Drugs Standard Control Organization (CDSCO) approved ADR reporting form and were analysed with respect to each reported data using descriptive statistics and expressed as numbers and percentages using Microsoft Excel.
Results:Overall, 114 ADRs were reported during the study duration, and ADRs were most commonly reported amongst females (69) and 31–45 years (27.2%) age group. Causality assessment was done using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, which showed 75 (66%) probable and 39 (34%) possible ADRs. The highest number of ADRs were reported by Medicine department (48.2%), emergency and intensive care unit (ICU) (16.6%) followed by Dermatology department (9.6%). The majority of them were due to antimicrobial agents (53.5%). The most commonly affected organ system was found to be dermatological (68.4%) followed by the body as a whole (15.7%) and gastrointestinal system (8.7%). The presentations of ADRs were diverse; itching and rashes (34 cases) were most commonly reported.
Conclusion:This study gives an overall understanding of the current situation and trends in ADRs and their reporting status by health professionals in a tertiary care hospital, which would help to strengthen the pharmacovigilance activities at all levels of health care.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
9 (RLIN) 4774
Topical term or geographic name entry element PHARMACOLOGY
700 ## - ADDED ENTRY--PERSONAL NAME
9 (RLIN) 21013
Co-Author Geetha, S.
773 0# - HOST ITEM ENTRY
Title Journal of pharmacology and pharmacotherapeutics
Place, publisher, and date of publication New Delhi SAGE Publications
International Standard Serial Number 0976-500X
856 ## - ELECTRONIC LOCATION AND ACCESS
URL https://journals.sagepub.com/doi/epub/10.1177/0976500X221130841
Link text Click here
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Source of classification or shelving scheme
Koha item type Articles Abstract Database
Holdings
Withdrawn status Lost status Source of classification or shelving scheme Damaged status Not for loan Permanent Location Current Location Shelving location Date acquired Barcode Date last seen Price effective from Koha item type
          School of Pharmacy School of Pharmacy Archieval Section 2023-05-30 2023-0895 2023-05-30 2023-05-30 Articles Abstract Database
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