Center for Education and Research in Therapeutics

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。对于儿科住院药物和非处方药（OTC）产品，尤其是对乙酰氨基酚（APAP），更好的信息需求尤为迫切（RFA-HS-08-005，主题领域4：关键国家药物使用场景的表征）。在宾夕法尼亚大学治疗学教育和研究中心与医学博士的联合合作中，安德森癌症中心，我们建议a）联合收割机结合详细但未充分利用的现有大型数据集和B） 收集新的原始数据，这些数据将共同提高我们描述、研究和理解 儿科患者在医院接受的药物的有效性和安全性，以及如何提高OTC APAP在家庭环境中的安全使用。我们提出的工作分为两个项目。在项目I中，我们的具体目标是：1）在2个包含药房数据的大型儿科住院数据库（特别是儿科健康信息系统（PHIS）和Premier数据集）中确定儿科住院期间使用的所有药物的使用率; 2）描述住院日的特定使用率、首次暴露于药物的住院日以及最常用药物的伴随药物暴露; 3）使用具有全国代表性的H-CUP儿童住院患者数据库，根据PHIS和Premier数据集评估儿科住院期间使用药物的估计使用率的潜在偏倚;和4）在因APAP过量而住院的一组儿童中检查接受APAP过量解毒剂的模式，其剂量根据肝损伤的程度进行滴定，从而提供APAP毒性严重性的标志。项目二将分三个阶段进行。首先，我们将使用焦点小组定性探索知识，态度，信念和实践5）广泛代表性的成人和青少年样本关于自我管理的OTC APAP，和父母管理OTC APAP的儿童，和6）关键的专业信息提供者的样本，包括医生和药剂师，关于向消费者和患者传达OTC APAP的管理和风险信息。第二，在第二阶段，我们将进行一项横截面分样本实验调查，以7）估计使用频率，知识，以及关于使用OTC对乙酰氨基酚的做法，并评估基于社区的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，以确定哪些事件与APAP过量有关。

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.