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临床试验/NCT04301219
NCT04301219已完成不适用

Knowledge and Practices of Adverse Drug Reaction Reporting Among Healthcare Professionals in Low and Middle-income Countries: a Cross-sectional Survey.

Getz Pharma1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,500
试验地点
1
主要终点
Country-wise Analysis on knowledge of HCPs

研究概览

简要总结

The reported literature suggests that knowledge about pharmacovigilance is on a lower side and ADR reporting is not common in developing countries. This survey may help us to identify the common gaps in knowledge and practices about pharmacovigilance so that we can devise the strategy on the basis of outcome.

详细描述

Safety evaluation of a product in a market is like a moving ball which need re-evaluation as the data gather in its life cycle.(1) As per the definition of International society of harmonization and World Health Organization, adverse reaction is Adverse drug reaction (ADR) is defined as "A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function." (2) Adverse reaction and adverse event are interchangeable use in pharmacovigilance sector by knowing the difference is that ADR term used when drug is causing the effect (1). The frequency of ADR is getting higher due to the increasing prevalence of chronic disease with the growing trend of combination drugs (3). The non-profitable organization of pharmacovigilance is playing tremendous role in disseminating the awareness of proper usage of drug globally.(3) According to Uppsala database statistics, approximately 3 million reports were listed as suspected ADRs. (4) Nearly 6.7% of hospitalizations were due to serious ADRs (5)

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
22 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants who would like to voluntarily fill the survey form

排除标准

  • Other than Health care professionals (including but not limited to Physicians, Doctors, Nurses and/or pharmacist)

结局指标

主要结局

Country-wise Analysis on knowledge of HCPs

时间窗: 2 years

Number of HCPs had knowledge about AR in their own country

Country-wise Analysis on practices of HCPs

时间窗: 2 years

Number of HCPs practicing AR reporting in their own country

次要结局

未报告次要终点

研究者

发起方
Getz Pharma
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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