Global Patterns of Adverse Drug Reactions Over a Decade Analyses of Spontaneous Reports to VigiBase™
Global Patterns of Adverse Drug Reactions Over a Decade Analyses of Spontaneous Reports to VigiBase™
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DOI：
10.2165/11631940-000000000-00000
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发表时间：
2012-01-01
期刊：
影响因子：
4.2
通讯作者：
Hansen, Ebba Holme
中科院分区：
文献类型：
--
作者：
Aagaard, Lise;Strandell, Johanna;Hansen, Ebba Holme
背景资料：虽然在20世纪60年代许多国家和世界卫生组织建立了收集可疑药物不良反应（ADR）信息的系统，但很少有研究检查报告的ADR与国民收入的关系。目的：本研究的目的是描述WHO ADR数据库VigiBase（TM）报告的ADR的特征，并将数据与国民收入相关联。我们分析了2000年至2009年提交给VigiBase（TM）的ADR报告，包括报告率、患者年龄和性别、类型、严重性和药物。报告也进行了分析，就国民收入水平，按照世界银行的定义分类：低，中下，中上和high.Results：我们分析了1 359 067 ADR报告，包括3 013 074 ADR。总体而言，16%的报告为严重报告，60%为女性报告。高收入国家的药品不良反应报告率最高（范围3-613份报告/百万居民/年），低收入国家最低（范围0-21份）。各收入组的ADR在年龄组、严重性和性别方面的分布不显著。总体而言，大多数ADR报告为神经系统药物，其次为心血管药物。低收入国家报告了相对较多的抗感染药物的ADR全身使用比高收入国家，高收入国家报告了更多的ADR的抗感染药物和免疫调节剂比低收入group.Conclusion：这项研究表明，高收入国家有最高的ADR报告率和低收入国家最低，在每个组的国家之间有很大的差异。仅在“皮肤和皮下组织疾病”类型的ADR以及“全身使用的抗感染药”和“抗病毒和免疫调节剂”治疗组中发现ADR报告率的显著差异。为了提高ADR报告率，特别是在低收入国家，需要更多地研究国家药物警戒中心的组织结构和经济资源以及ADR报告实践对收入群体内ADR报告率差异的影响。
Background: Although systems to collect information about suspected adverse drug reactions (ADRs) were established in many countries and by the WHO in the 1960s, few studies have examined reported ADRs related to national income.Objective: The aim of the study was to characterize ADRs reported to the WHO-ADR database, VigiBase (TM), and to relate data to national income.Methods: We analysed ADR reports submitted to VigiBase (TM) from 2000 to 2009 with respect to reporting rate, age and sex of patient, type, seriousness and medications. Reports were also analysed with respect to national income level, classified in accordance with the World Bank definition: low, lower-middle, upper-middle and high.Results: We analysed 1 359 067 ADR reports including 3 013 074 ADRs. Overall, 16% of reports were serious and 60% were reported for females. High-income countries had the highest ADR reporting rates (range 3-613 reports/million inhabitants/year) and low-income countries the lowest (range 0-21). Distribution of ADRs across income groups with respect to age group, seriousness and sex was non-significant. Overall, the majority of ADRs were reported for nervous system medications, followed by cardiovascular medicines. Low-income countries reported relatively more ADRs for antiinfectives for systemic use than high-income countries, and high-income countries reported more ADRs for antineoplastic and immunomodulating agents than lower-income groups.Conclusion: This study showed that high-income countries had the highest ADR reporting rates and low-income countries the lowest, with large variations across countries in each group. Significant differences in ADR reporting rates were only found for ADRs of the type 'skin and subcutaneous tissue disorders' and for the therapeutic groups 'antiinfectives for systemic use' and 'antineoplastic and immunomodulation agents'. To strengthen ADR reporting rates, especially in low-income countries, more research is needed about the impact of organizational structures and economic resources of national pharmacovigilance centres and ADR reporting practices on the large variations in ADR reporting rates within income groups.