报告严重药品不良反应的系统性障碍及潜在问题
Systemic Barriers and Potential Concerns from Reporting Serious Adverse Drug Reactions.
作者信息
Taylor Matthew A, Godwin Ashley C, Hoque Shamia, Bennett Charles L
机构信息
SONAR (Southern Network on Adverse Reactions) Program, University of South Carolina Colleges of Pharmacy and Engineering, Columbia, SC, 29208, USA.
出版信息
Cancer Treat Res. 2022;184:75-85. doi: 10.1007/978-3-031-04402-1_5.
About 1-10% of all serious adverse drug reactions (sADRs) are reported to the Food and Drug Administration (FDA) ( Moore T, Bennett C. Underreporting of Hemorrhagic and Thrombotic Complications of Pharmaceuticals to the U.S. Food and Drug Administration: Empirical Findings for Warfarin, Clopidogrel, Ticlopidine, and Thalidomide from the Southern Network on Adverse Reactions (SONAR). Semin Thromb Hemost. 2012;38(08):905-907. https://doi.org/10.1055/s-0032-1328890 ). Prevailing opinion suggests that low reporting rates reflect time constraints.
据报告，向美国食品药品监督管理局（FDA）上报的严重药物不良反应（sADR）约占全部此类反应的1%至10%（摩尔·T、贝内特·C。美国食品药品监督管理局收到的药品出血和血栓并发症报告不足：南方不良反应网络（SONAR）对华法林、氯吡格雷、噻氯匹定和沙利度胺的实证研究结果。《血栓与止血学 Semin Thromb Hemost》。2012年；38(08):905 - 907。https://doi.org/10.1055/s - 0032 - 1328890）。普遍观点认为，报告率低反映了时间限制。
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