Klecker R J, Cipolle R J
Am J Hosp Pharm. 1987 May;44(5):1086-9.
The procedures for obtaining and dispensing investigational drugs for single-patient compassionate use are described, and roles for pharmacists in this process at a university medical center are identified. To obtain an investigational drug, a physician must contact a pharmaceutical-company study monitor to discuss the details of the case. Other responsibilities of the physician include obtaining institutional review board approval; completing FDA form 1572 or 1573, or both; and securing written informed consent from the patient. The responsibilities of the pharmacist are to ensure that informed consent has been obtained; inform nursing, pharmacy, and medical staffs about the use, admixture requirements, and administration of the investigational agent; provide a therapeutic drug monitoring plan; and store, handle, and prepare the medication. The pharmacist also keeps inventory of all shipped drugs and returns all unused drugs to the manufacturer. Pharmacists should be knowledgeable about the proper procedure for obtaining and dispensing investigational drugs on an emergency or treatment basis.
描述了为单患者同情用药获取和分发研究性药物的程序，并确定了大学医学中心药师在此过程中的角色。要获取研究性药物，医生必须联系制药公司的研究监测员讨论病例细节。医生的其他职责包括获得机构审查委员会的批准；填写FDA表格1572或1573，或两者都填；并获得患者的书面知情同意。药师的职责是确保已获得知情同意；向护理、药房和医务人员告知研究药物的使用、混合要求和给药方法；提供治疗药物监测计划；以及储存、处理和配制药物。药师还负责记录所有运送药物的库存，并将所有未使用的药物返还给制造商。药师应了解在紧急或治疗情况下获取和分发研究性药物的正确程序。
