INVESTIGATIONAL DRUG

研究药物

基本信息

批准号：
8519351
负责人：
BRIAN G MILLER
金额：
$ 9.58万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/8519351
关键词：
Academic Medical Centers Accountability Address Adverse effects Adverse event Antiemetics Area Back Biological Products California Cancer Center Cancer Center Support Grant Caregivers Caring Center for Translational Science Activities Chemotherapy-Oncologic Procedure Clinic Clinical Clinical Protocols Clinical Research Clinical Trials Code Color Communities Community Networks Computers Consent Contracts Counseling Development Doctor of Pharmacy Dosage Forms Dose Drug Compounding Drug Costs Drug Monitoring Drug Storage Education Educational Materials Emergency Situation Enrollment Ensure Equipment Equipment and supply inventories Event Floor Goals Guidelines Health Professional Hematology Home environment Hospitals Hour Human Resources Individual Institutional Review Boards Intravenous Investigation Investigational Drugs Joint Commission on Accreditation of Healthcare Organizations Knowledge Label Laws Letters Location Malignant Neoplasms Medical center Monitor Names Notification Nurses Oral Patient Care Patients Pharmaceutical Preparations Pharmaceutical Services Pharmacists Pharmacotherapy Pharmacy Schools Pharmacy facility Phase Physicians Play Policies Premedication Preparation Prevention Procedures Process Program Development Protocols documentation Randomized Recommendation Records Refrigeration Regimen Research Research Personnel Resources Review Committee Role Roswell Park Cancer Institute Schedule Secure Security Services Shipping Ships Site Site Visit Specialist Supportive care System Telefacsimile Temperature Time Training Treatment Protocols United States Universities University Hospitals University of Pittsburgh Cancer Institute Veterans Work Writing base cancer site chemotherapy clinical research site drug resource expiration laptop meetings oncology operation phase 1 study programs protocol development quality assurance research study treatment site

项目摘要

The University of Pittsburgh Cancer Institute (UPCI) Investigational Drug Service (IDS) is directed by Brian M. Miller, PharmD who is assisted by Elizabeth A. Paul, RPh and a pharmacy technician, Kristine M. Fischl. In addition, the clinic pharmacy that works in tandem with the IDS has three full-time pharmacy technicians, four full-time pharmacists, and two part-time pharmacists. These individuals also participate in treating patients enrolled in protocol treatments mainly through order-entry, mixing chemotherapy, and dispensing provided oral medication. The IDS oversees all pharmacy procedures and processes at the UPCI central and community clinical sites and the Clinical and Translational Research Center (CTRC) where UPCI sponsored studies are implemented and most Phase I studies take place. The IDS coordinate all pharmacy procedures associated with UPCI drug-related research protocols. The goal of the IDS is to ensure that the procurement, receipt, storage, accountability, preparation, dispensing, labeling, and shipping of investigational drugs are performed in accordance with all state and federal laws, Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and the local IRB approved protocol guidelines. Clinical recommendations for drug therapy, monitoring plans for a regimen, managing adverse events, and dose calculations are made with respect to the treatment of patients. Additional responsibilities of the IDS include reviewing all approved IRB protocols, standard chemotherapy and protocol regimens, supportive care regimens (antiemetics and other premedications), and investigational drug policies and procedures. UPCI's Off-site locations require special efforts to ensure rigorous and successful implementation, coordination, and monitoring clinical protocols. Throughout the entire network of cancer sites, the IDS provides oversight and monitoring for all pharmacy related activities. IDS also implements a quality assurance program, which includes labeling drugs per protocol and placing specific labeling on each medication to ensure proper dispensing, and an education program of pharmacists and/or pharmacy technicians for new protocols and treatments, inventory control, and optimized patient care.

匹兹堡大学癌症研究所 (UPCI) 研究药物服务 (IDS) 由 Brian M. Miller 是药学博士，由注册医师 Elizabeth A. Paul 和药剂技术员 Kristine M. Fischl 协助。在此外，与IDS协同工作的诊所药房有3名全职药房技术人员，4名专职药剂师2名，兼职药剂师2名。这些人也参与治疗患者主要通过订单输入、混合化疗和配药来参与方案治疗口服药物。 IDS 监督 UPCI 中心和 UPCI 的所有药房程序和流程。 UPCI 赞助的社区临床中心和临床与转化研究中心 (CTRC) 研究已经实施，大多数第一阶段研究正在进行。 IDS 协调所有药房程序与 UPCI 药物相关研究方案相关。 IDS 的目标是确保采购、研究药物的接收、储存、责任、准备、分发、标签和运输根据所有州和联邦法律、医疗保健认证联合委员会执行组织 (JCAHO) 和当地 IRB 批准的协议指南。临床用药建议治疗、治疗方案监测计划、不良事件管理和剂量计算均通过尊重患者的治疗。 IDS 的其他职责包括审查所有批准的 IRB 方案、标准化疗和方案方案、支持治疗方案（止吐药和其他术前用药）以及研究药物政策和程序。 UPCI 的异地地点需要特殊努力确保严格和成功的实施、协调和监测临床方案。在整个癌症站点网络中，IDS 为所有药房提供监督和监控相关活动。 IDS 还实施了质量保证计划，其中包括按照药品标签方案并在每种药物上贴上特定标签以确保正确配药，并进行教育药剂师和/或药学技术人员的新方案和治疗、库存控制、并优化患者护理。