EHR Anticoagulants Pharmacovigilance

描述（由申请人提供）：及时识别心血管药物先前未知的毒性是一个重要的，未解决的问题。在美国，1975年至1999年期间引入市场的548种药物中有20%在食品和药物管理局首次批准后的25年期间被撤回或获得新的“黑匣子”警告。药物不良事件（ADE）是患者发病和死亡的重要原因，但95%的ADE未报告，导致先前未知ADE的检测延迟和已知ADE的风险被低估。众所周知，电子健康记录（EHR）记录和实验室结果包含ADE信息，生物医学自然语言处理（NLP）提供了自动化工具，有助于图表审查，从而改善患者监测和上市后药物警戒。抗凝剂的最佳使用需要从EHR中准确及时地检测ADE。该提案的目标是开发“智能”NLP方法，从EHR中提取疾病、药物和结构化ADE信息，然后评估提取的ADE，以检测已知ADE类型以及临床上未识别或新型ADE（其模式或效应先前尚未确定）。PHS 398/2590（Rev.06/09）

DESCRIPTION (provided by applicant): The timely identification of previously unknown toxicities of cardiovascular drugs is an important, unsolved problem. In the United States, 20% of the 548 drugs introduced into the market between 1975 and 1999 were either withdrawn or acquired a new "black box" warning during the 25-year period following initial approval by the Food and Drug Administration. Adverse drug events (ADEs) are an important cause of morbidity and mortality in patients, yet 95% of ADEs are unreported, leading to delays in the detection of previously unknown ADEs and underestimation of the risk to known ADEs. It is known that Electronic Health Record (EHR) notes and lab results contain ADE information and biomedical natural language processing (NLP) provides automated tools that facilitate chart review and thus improve patient surveillance and post-marketing pharmacovigilance. Optimal use of anticoagulants requires accurate and timely detection of ADEs from EHRs. The objectives for this proposal are to develop "intelligent" NLP approaches to extract disease, medication, and structured ADE information from EHRs, and then evaluate extracted ADEs for detecting known ADE types as well as clinically unrecognized or novel ADEs whose pattern or effect have not been previously identified. PHS 398/2590 (Rev. 06/09) Page Continuation Format Page