A two-year retrospective observational study of adverse drug reactions related to intravenous drug formulations

Ramani Gade, Neeraj Sadiq, Shivaraj B Patil, Venkata Rao Y, Raghuveer B, Yamini V, Sindhu P
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Abstract

Introduction: Adverse drug reactions are the major obstacles to patient safety and drug therapy monitoring. Objectives: The present article provides information on intravenous products induced adverse drug reactions collected by spontaneous reporting method through an established pharmacovigilance wing working under NCC-PVPI in an Adverse Drug reaction monitoring center-Nalgonda, Telangana. Methods: A total number of 100 intravenous products induced ADRs were collected from different age groups by observational retrospective study for the year January 2018 to December 2019. Results: The results showed that the most affected age group was 20-29 yrs (28 %). The major contribution of the gender that exposed to ADRs was female- 73 % Most intravenous product induced ADRs were reported from the Department of OBG (46 %). Drug: Ceftriaxone-induced ADRs were (38 %). The most frequently reported ADR was fever and chills (56 %). Out of 100 ADRs, one was certain, 90 were probable/likely, and the remaining 9 were possible as per the WHO-causality scale. Conclusions: In the present work, most of the ADRs were because of intravenous antibiotics followed by anesthetic agents, antiepileptic drugs, ringer lactate, dextrose normal saline, and H2 blockers.
一项关于静脉注射药物制剂不良反应的两年回顾性观察研究
药物不良反应是影响患者安全和药物治疗监测的主要障碍。目的:本文通过NCC-PVPI在泰伦加纳纳尔贡达药物不良反应监测中心建立的药物警戒部门,通过自发报告法收集静脉注射产品引起的药物不良反应的信息。方法:采用观察性回顾性研究方法,收集2018年1月至2019年12月不同年龄段静脉注射产品引起的不良反应100例。结果:以20 ~ 29岁年龄组发病率最高(28%)。暴露于不良反应的主要性别为女性(73%),大多数静脉注射产品引起的不良反应报告来自OBG部门(46%)。药物:头孢曲松引起的不良反应为(38%)。最常见的不良反应是发热和发冷(56%)。在100种不良反应中,1种是肯定的,90种是可能的,其余9种根据世卫组织因果关系量表是可能的。结论:在本工作中,静脉注射抗生素引起的不良反应最多,其次是麻醉剂、抗癫痫药物、乳酸林格盐、葡萄糖生理盐水和H2阻滞剂。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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