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prevalence and causality assessment of adverse drug reaction among outpatients taking antiepileptic drugs in a tertiary care center of Nepal. (Record no. 3059)

MARC details
000 -LEADER
fixed length control field	04464nam a22002537a 4500
003 - CONTROL NUMBER IDENTIFIER
control field	OSt
005 - DATE AND TIME OF LATEST TRANSACTION
control field	20230813130758.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field	220428b \|\|\|\|\| \|\|\|\| 00\| 0 eng d
040 ## - CATALOGING SOURCE
Description conventions	NLM
060 ## - NATIONAL LIBRARY OF MEDICINE CALL NUMBER
Classification number	THS-00636
100 ## - MAIN ENTRY--PERSONAL NAME
Personal name	Guragain, Neha.
9 (RLIN)	4511
245 ## - TITLE STATEMENT
Title	prevalence and causality assessment of adverse drug reaction among outpatients taking antiepileptic drugs in a tertiary care center of Nepal.
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Date of publication, distribution, etc.	c2021.
300 ## - PHYSICAL DESCRIPTION
Extent	xiv,51p.
500 ## - GENERAL NOTE
General note	Thesis Report.
520 ## - SUMMARY, ETC.
Summary, etc.	ABSTRACT: <br/><br/> Background Adverse drug reactions (ADRs) are the rising cause of morbidity and mortality, and rank among top ten causing mortality. Antiepileptic drugs (AEDs) are frequently associated with various adverse drug reaction which carry burden and treatment challenges. Epilepsy patient have long duration of antiepileptics therapy causing many adverse effects such as cognitive behavior, metabolic, hematological disorders and also has frequent drug interactions. There are limited studies in Nepal focusing on ADRs with AEDs in outpatient settings. <br/><br/> Objective: The objective of this study was to assess the prevalence and Causality assessment of ADRs among the patients under antiepileptics drugs presenting to Neurology OPD of Tribhuvan University Teaching Hospital of Nepal <br/><br/>Methods: A prospective longitudinal observational study was conducted for one year from March 2020 to Feb 2021 in the 'Neurology out-patient Clinic under the Department of Neurology at Tribhuvan University Teaching Hospital. All new and old cases (n=130) with the diagnosis of epilepsy who were on antiepileptics therapy, and met the inclusion criteria during the study period and had given written consent were enrolled, in our study. All data were recorded in a predesigned proforma sheet and descriptive statistical analysis was done by using Statistical Package for Social Sciences (SPSS), version 20. ADR causality was assessed using the Naranjo algorithms. Chi- square test was used in contingency tables and a p-value with a significance level of <0.05 was be used. Descriptive statistics were used to calculate percentages frequencies. <br/><br/> Result: A total of 130 patients with epilepsy were included in the study period. Among them, 57.7% were male. The mean age of study population was 33.5514.41 years. Majority of the epileptic patients were affected with generalized seizure 66.2% followed by patients affected with focal seizure 33.8%. Most of the participants were being treated with an AED monotherapy 53.84%. Levetiracetam 31.53% was the most prescribed drug in monotherapy followed by Sodium Valproate 12.3%. Most prescribed AEDs combination in polytherapy was Levetiracetam and Clobazam 15.38%, followed by Sodium Valproate and Levetiracetam 7.69%. A total of 31.53% patients had 109 different ADRs. The commonest ADR affecting organ system were central nervous system (CNS) in 86.3%. Among CNS, dizziness was seen in 36.69% patients followed by somnolence in 18 (16.51%). ADRs with AEDs polytherapy were found in 58.5% patients and with monotherapy in 41.4%. There was no any significant difference in ADRs frequency between monotherapy and polytherapy (P valve =0.055). According to Naranjo causality assessment scale, 54.4% patients were grouped in possible and 45.6% in probable. <br/>Conclusion: The present study has provided data on prevalence of ADRs among outpatients taking antiepileptics patient. The current results showed different ADRs involving in organ system and with AEDs regimen. Our study shows that majority of the ADRs were from CNs manifestation. In our study higher proportion of receiving polytherapy presented with ADRs as compared to those receiving monotherapy. Majority of the ADRs were found to be possible followed by probable on Naranjo causality assessment scale remained unreported due to the lack of healthcare professionals understandings, interests or the skills needed to recognize and report them. The findings of our study highlights the importance of regular monitoring and reporting of ADRs. <br/><br/> Keywords: Adverse drug reactions, Causality, Pharmacovigilance, Polytherapy, Epilepsy
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element	Adverse drug reactions.
9 (RLIN)	2404
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element	Causality.
9 (RLIN)	4512
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element	Pharmacovigilance.
9 (RLIN)	2405
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element	Polytherapy.
9 (RLIN)	4513
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element	Epilepsy.
9 (RLIN)	3567
856 ## - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier	<a href="http://nhrc.gov.np/contact/">http://nhrc.gov.np/contact/</a>
Link text	Visit NHRC Library
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme	National Library of Medicine
Koha item type	Thesis Report

Holdings
Withdrawn status	Lost status	Source of classification or shelving scheme	Damaged status	Not for loan	Home library	Current library	Shelving location	Date acquired	Total Checkouts	Full call number	Barcode	Date last seen	Price effective from	Koha item type
		National Library of Medicine			Nepal Health Research Council	Nepal Health Research Council	Reference	04/28/2022		THS00636/GUR/2021	THS-00636	04/28/2022	04/28/2022	Thesis Report