Ryan M L, Colvin C L, Tankanow R M
Am J Hosp Pharm. 1987 May;44(5):1069-74.
The development, implementation, and operation of a pharmacy-based investigational drug service (IDS) at a university medical center are described. Before the IDS was established, pharmacy participation in investigational drug research was limited to the preparation of novel dosage forms. Medication errors, improper storage and labeling, and inadequate inventories of investigational drugs were common problems. Stepped-up enforcement by FDA and the National Cancer Institute (NCI) of guidelines for investigational drug control prompted the formation of a multidisciplinary task force, which recommended that the department of pharmaceutical services expand its support of investigational drug studies to include inventory control, record keeping, and clinical services. The IDS is supported by both the hospital and the school of medicine and currently receives 36% of its funding from principal investigator grants and contracts. The IDS coordinates more than 100 study protocols and dispenses more than 4000 doses of investigational drugs annually. The IDS is staffed by 1.0 full-time equivalent (FTE) clinical pharmacist and 0.5 FTE technician. Inventory control and billing functions are performed by a departmental microcomputer system. The IDS has demonstrated a positive gross margin for each of its first two years of operation. Problems associated with the control and use of investigational drugs at this institution have been successfully corrected by the implementation of a pharmacy-based IDS.
本文描述了一所大学医学中心基于药房的研究用药物服务（IDS）的开发、实施和运营情况。在IDS建立之前，药房在研究用药物研究中的参与仅限于新型剂型的制备。用药错误、储存和标签不当以及研究用药物库存不足是常见问题。美国食品药品监督管理局（FDA）和美国国立癌症研究所（NCI）加强了对研究用药物控制指南的执行力度，促使成立了一个多学科特别工作组，该工作组建议药学服务部扩大对研究用药物研究的支持，包括库存控制、记录保存和临床服务。IDS由医院和医学院共同支持，目前其资金的36%来自主要研究者的资助和合同。IDS每年协调100多个研究方案，分发超过4000剂研究用药物。IDS配备了1.0个全职等效人员（FTE）的临床药师和0.5个FTE的技术员。库存控制和计费功能由部门微机系统执行。IDS在其运营的前两年中每年都实现了正毛利。通过实施基于药房的IDS，该机构在研究用药物控制和使用方面的问题已得到成功纠正。
