Center for Education and Research in Therapeutics

治疗学教育与研究中心

• 批准号: 7626236
• 负责人: BRIAN LESLIE STROM
• 金额: $ 110.47万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-30 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7626236
• 关键词: Center; Education; Research; Therapeutics

DESCRIPTION (provided by applicant): Advancing pharmaceutical effectiveness and safety in the United States requires reliable information regarding patterns of pharmaceutical use. The need for better information is particularly pressing regarding pediatric inpatient pharmaceuticals and over-the-counter (OTC) products, especially acetaminophen (APAP) (RFA-HS-08-005, Topic Area 4: Characterization of Key National Drug Use Scenarios). In a joint collaboration of the Centers for Education and Research on Therapeutics at The University of Pennsylvania and the M.D. Anderson Cancer Center, we propose to a) combine detailed but under-utilized existing large datasets and b) collect new primary data, which together will advance our ability to describe, study, and understand the effectiveness and safety of pharmaceuticals received by pediatric patients in hospitals, and how to improve the safe use of OTC APAP in home settings. The work we propose is divided into 2 projects. In Project I, our specific aims are to 1) Determine the rate of use of all pharmaceuticals used during pediatric hospitalizations in 2 large pediatric hospitalization databases containing pharmacy data, specifically the Pediatric Health Information System (PHIS) and Premier datasets; 2) Describe hospital-day specific rates of use, hospital day of first exposure to a drug, and concomitant drug exposures for the most commonly used drugs; 3) Use the nationally representative H-CUP Kids Inpatient Database to assess potential bias in the estimated rates of use of drugs used during pediatric hospitalizations based on the PHIS and Premier datasets; and 4) Examine among a cohort of children hospitalized for APAP overdose the patterns of receipt of an APAP overdose antidote the dose of which is titrated depending upon the extent of liver injury, thus providing a sign of the severity of APAP toxicity. Project II will be conducted in 3 phases. First, we will use focus groups to qualitatively explore knowledge, attitudes, beliefs, and practices of 5) a broadly representative sample of adults and adolescents regarding self-administration of OTC APAP, and parental administration of OTC APAP to children, and 6) a sample of key professional informants, including physician and pharmacists, with respect to communicating information on the administration and risks of OTC APAP to consumers and patients. Second, in phase 2, we will conduct a cross-sectional split-sample experimental survey to 7) estimate frequency of use, knowledge, and practices regarding use of OTC acetaminophen, and evaluate potential determinants of misuse in community-based samples. In Phase 3, we will 8) review medical records of Emergency Room visits to ascertain which events surround APAP overdosing.

描述（由申请人提供）：在美国提高药物的有效性和安全性需要有关药物使用模式的可靠信息。对更好的信息的需求尤其是关于小儿住院药和非处方药（OTC）产品的紧迫，尤其是对乙酰氨基酚（APAP）（RFA-HS-08-005，主题区域4：主要国家药物使用方案的表征）。在宾夕法尼亚大学和M.D. Anderson癌症中心的教育与研究中心共同合作中，我们建议a）结合详细但未充分利用现有的大型数据集和b） 收集新的主要数据，这些数据将共同提高我们描述，研究和理解的能力 小儿患者在医院接受的药物的有效性和安全性，以及如何在家庭环境中改善OTC APAP的安全使用。我们建议的工作分为两个项目。在项目I中，我们的具体目的是1）确定在2个含有药房数据的大儿科住院数据库中，在儿科住院期间使用的所有药物的使用率，特别是儿科健康信息系统（PHIS）和Premier数据集； 2）描述医院特定的使用率，初次接触药物的医院日以及最常用药物的药物暴露； 3）使用全国代表性的H-CUP儿童住院数据库来评估基于PHIS和Premier数据集的小儿住院期间使用的药物使用率的潜在偏见； 4）检查因APAP过量住院的一组儿童中，接受APAP过量解毒剂的模式根据肝损伤的程度滴定剂量，从而提供了APAP毒性严重程度的迹象。项目第二阶段将分为3个阶段。首先，我们将使用焦点小组来探索5）关于OTC APAP自我管理的成年人和青少年的知识，态度，信念和实践，以及对儿童的OTC APAP的习惯，以及对沟通和危险的患者，对儿童进行OTC APAP的态度以及6）单个关键专业人士的样本。其次，在第2阶段，我们将进行横截面拆分样本实验调查，以估计有关使用OTC对乙酰氨基酚的使用频率，知识和实践的频率，并评估基于社区样本中滥用的潜在决定因素。在第3阶段，我们将8）审查急诊室就诊的医疗记录，以确定哪些事件围绕APAP过量。