Brown Jamie N, Britnell Sara R, Stivers Andrew P, Cruz Jennifer L
Durham VA Health Care System, Durham, NC.
University of North Carolina Medical Center, Chapel Hill, NC.
Yale J Biol Med. 2017 Mar 29;90(1):125-133. eCollection 2017 Mar.
Standardized safety practices for investigational drugs in clinical research protocols are limited and the vast majority of research pharmacists have concerns regarding its safety. Identified areas for medication safety risks include protocol complexity, medication ordering, and the processes for packaging, storage, and dispensing investigational medications. Inclusion of a pharmacist creates multiple mechanisms to promote safety and improve the quality of clinical research. This is accomplished through collaborating in the development of a research protocol, reviewing as a member of an advisory committee, developing mechanisms that contribute to safety, and assuring compliance with local and national regulations and standards. Ultimately, the profession of pharmacy has foundational responsibility for assuring the safe and effective use of medications, including investigational drugs in clinical research. It is through multidisciplinary collaboration that a research study will attain the highest standards for safety and maximize the quality and effectiveness of the data obtained in the clinical trial.
临床研究方案中用于研究性药物的标准化安全措施有限，绝大多数研究药剂师对其安全性表示担忧。已确定的用药安全风险领域包括方案复杂性、用药医嘱以及研究性药物的包装、储存和调配流程。药剂师的参与创造了多种促进安全和提高临床研究质量的机制。这是通过在研究方案的制定过程中进行协作、作为咨询委员会成员进行审查、开发有助于安全的机制以及确保遵守地方和国家法规及标准来实现的。最终，药学专业在确保药物（包括临床研究中的研究性药物）安全有效使用方面负有基本责任。只有通过多学科协作，研究才能达到最高的安全标准，并使临床试验中获得的数据质量和有效性最大化。
