A critical comparison of pharmacovigilance reporting forms in six countries with the WHO-UMC recommendations (form of the form).

Q3 Pharmacology, Toxicology and Pharmaceutics

Journal of Basic and Clinical Physiology and Pharmacology Pub Date : 2025-07-17 DOI:10.1515/jbcpp-2025-0084

Saurav Misra, Manmeet Kaur, Jayant Kumar Kairi

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引用次数: 0

Abstract

Objectives: This study will identify strengths and weaknesses of ADR reporting forms of study countries.

Methods: This was an observational study conducted at the Department of Pharmacology at Kalpana Chawla Government Medical College, Karnal. We obtained the WHO-UMC adverse event reporting guidance document for designing the ADR form for member countries. We similarly collected and analysed ADR forms from Australia, Canada, India, South Africa, the UK, and the US. Data fields were grouped into different subgroups.

Results: An analysis of ADR reporting forms from six countries revealed a total of 70 data fields. The US-FDA's FORM 3500 has the most fields at 50 (71 %), followed by India's CDSCO with 42 fields (60 %). According to WHO-UMC recommendations, Canada and Australia have the highest number of suggested fields at 10 (83 %). All forms were one page long except for the US-FDA's, which is five pages.

Conclusions: Improving patient feedback and organisational engagement is essential to raise awareness of the reporting system. A proposed generic ADR form provides detailed information for causality assessment and could serve as a basis for a standard global reporting form.

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对6个国家的药物警戒报告表格与世卫组织-联合药检委员会的建议进行关键性比较（表格的形式）。

目的：本研究将确定研究国家不良反应报告形式的优势和劣势。方法：这是一项在卡尔帕纳·舒拉政府医学院药学系进行的观察性研究。我们获得了世卫组织- umc不良事件报告指导文件，用于为成员国设计ADR表格。我们同样收集并分析了澳大利亚、加拿大、印度、南非、英国和美国的ADR表格。数据字段被分成不同的子组。结果：对来自6个国家的药品不良反应报告表进行分析，共发现70个数据字段。美国fda的FORM 3500拥有最多的领域，为50个（71 %），其次是印度的CDSCO，有42个领域（60 %）。根据世卫组织- umc的建议，加拿大和澳大利亚建议的领域最多，为10个（83% %）。所有的表格都是一页长，除了美国食品和药物管理局的表格是五页。结论：改善患者反馈和组织参与对提高对报告系统的认识至关重要。拟议的通用ADR表为因果关系评估提供了详细信息，并可作为标准全球报告表的基础。

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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来源期刊

Journal of Basic and Clinical Physiology and Pharmacology Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

3.90

自引率

0.00%

发文量

期刊介绍： The Journal of Basic and Clinical Physiology and Pharmacology (JBCPP) is a peer-reviewed bi-monthly published journal in experimental medicine. JBCPP publishes novel research in the physiological and pharmacological sciences, including brain research; cardiovascular-pulmonary interactions; exercise; thermal control; haematology; immune response; inflammation; metabolism; oxidative stress; and phytotherapy. As the borders between physiology, pharmacology and biochemistry become increasingly blurred, we also welcome papers using cutting-edge techniques in cellular and/or molecular biology to link descriptive or behavioral studies with cellular and molecular mechanisms underlying the integrative processes. Topics: Behavior and Neuroprotection, Reproduction, Genotoxicity and Cytotoxicity, Vascular Conditions, Cardiovascular Function, Cardiovascular-Pulmonary Interactions, Oxidative Stress, Metabolism, Immune Response, Hematological Profile, Inflammation, Infection, Phytotherapy.