Clinical importance of drug-drug-interactions

药物相互作用的临床重要性

• 批准号: 7032605
• 负责人: Sean Hennessy
• 金额: $ 47.44万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-15 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7032605
• 关键词: Medicare /Medicaid; aging; behavioral /social science research tag; chemotherapy; clinical research; disease /disorder proneness /risk; drug adverse effect; drug interactions; geriatrics; health services research tag; human data; human morbidity; human mortality; iatrogenic disease; medical records; patient safety /medical error; pharmacokinetics; statistics /biometry

DESCRIPTION (provided by applicant): Drug-drug interactions (DDIs) are an important public health problem, especially in the elderly, who are the largest consumers of medications. Nearly all existing knowledge about the clinical importance of potential DDIs comes from pharmacokinetic studies or case reports, both of which have limited utility for identifying clinically important DDIs. As a result, there is a great deal of disagreement among standard DDI reference texts regarding the clinical importance of most potential DDIs. Systematic efforts such as drug utilization review programs and computerized physician order entry that seek to improve medication use depend entirely upon a valid set of clinical rules, and are thus severely hampered by this knowledge gap. To address these critical gaps in existing knowledge of the clinical importance of DDIs, the investigators will perform controlled epidemiologic studies of high-priority potential DDIs that have been selected based on a formal process involving consultation with an Expert Panel of clinicians and clinical pharmacologists. We will use and expand upon an existing, very large pharmacoepidemiologic database consisting of Medicaid data from five large programs, supplemented by Medicare data to ensure complete capture of outcomes in the elderly, together with the General Practice Research Database from the UK. We will examine the validity of our outcome measures using medical record review. Our research strategy will include nested case-control and case-crossover designs, and will yield relative risks, risk differences, and number needed to harm (NNH). Patient and treatment factors associated with developing the adverse outcome of interest will be studied. The results of this study will have important implications for public health, clinical care, and the elucidation of the pharmacology of DDIs, and will serve as a basis for future studies examining factors not recorded in administrative and medical records data.

描述（由申请人提供）：药物互动（DDIS）是一个重要的公共卫生问题，尤其是在老年人中，是最大的药物消费者。关于潜在DDI的临床重要性的几乎所有现有知识都来自药代动力学研究或病例报告，这两者在识别临床上重要的DDI方面的实用性有限。结果，关于大多数潜在DDI的临床重要性，标准DDI参考文本之间存在很大的分歧。系统的努力，例如药物利用审查计划和试图改善用药使用的计算机化医师订单进入完全取决于一套有效的临床规则，因此受到这种知识差距的严重阻碍。为了解决DDIS临床重要性的现有知识的这些关键差距，研究人员将根据与临床医生和临床药理学专家小组的咨询有关的正式过程进行对高优先型潜在DDI的控制流行病学研究。我们将使用和扩展由来自五个大型计划的医疗补助数据组成的现有的，非常大的药物电子学数据库，并补充了Medicare数据，以确保对老年人的成果以及来自英国的通用研究数据库的完整捕获。我们将使用病历审查来检查我们的结果指标的有效性。我们的研究策略将包括嵌套的病例对照和案例交叉设计，并产生相对风险，风险差异和损害所需的数量（NNH）。将研究与发展感兴趣的不利结果相关的患者和治疗因素。这项研究的结果将对公共卫生，临床护理以及DDIS药理学的阐明具有重要意义，并将作为未来研究的基础，研究未记录在行政和医疗记录数据中的因素。