University of Texas Southwestern Medical Center, Dallas, TX, USA.
J Oncol Pharm Pract. 2024 Oct;30(7):1200-1206. doi: 10.1177/10781552231207854. Epub 2023 Oct 17.
Investigational drug service (IDS) oversees and manages use of investigational products. There is limited data on utility of pharmacy services in clinical trial conduct and outcomes, specifically on the value of a decentralized IDS pharmacist.
This is a quasi-experimental study conducted in an oncology clinical trial infusion unit. A retrospective chart review was done to reflect current practice from January through June 2022. A decentralized IDS pharmacist was piloted in December 2022. Data collected included number and types of consults, personnel requesting the consult, and intervention performed. A satisfaction questionnaire was conducted after the pilot program.
A total of 16.3% (173 of 1062 patient visits) of pharmacy consults were completed in the centralized IDS pharmacy model, while 44.5% (81 of 182 patient visits) of pharmacy consults were completed during the decentralized IDS pharmacist pilot, < .001. Decentralized IDS pharmacist completed 77% (62/81) of the consults during the pilot period. Most common types of consults were toxicity management (20%), electronic medical record issues (17%), and tubing and drug administration issues (16%). More than 80% of respondents to the satisfaction questionnaire responded that implementation of a decentralized IDS pharmacist is acceptable, appropriate, and feasible.
This pilot study demonstrated that a decentralized IDS pharmacist in an oncology clinical trial infusion unit improved accessibility to an IDS pharmacist, increased pharmacy consults relevant to patient care and optimized centralized pharmacists medication distribution workflow. Further studies are needed to evaluate patient benefits from implementing decentralized IDS pharmacist in direct patient care activities.
研究药物服务（IDS）负责监督和管理研究产品的使用。关于药房服务在临床试验实施和结果中的效用，特别是分散式 IDS 药剂师的价值，数据有限。
这是一项在肿瘤学临床试验输注单元中进行的准实验研究。回顾性图表审查是在 2022 年 1 月至 6 月期间进行的，以反映当前的实践情况。2022 年 12 月试点了分散式 IDS 药剂师。收集的数据包括咨询的数量和类型、请求咨询的人员以及进行的干预。试点计划后进行了满意度问卷调查。
在集中式 IDS 药房模式下，16.3%（1062 次患者就诊中的 173 次）的药房咨询得到了完成，而在分散式 IDS 药剂师试点期间，44.5%（182 次患者就诊中的 81 次）的药房咨询得到了完成，<0.001。在试点期间，分散式 IDS 药剂师完成了 77%（62/81）的咨询。最常见的咨询类型是毒性管理（20%）、电子病历问题（17%）和管和药物管理问题（16%）。对满意度问卷的答复者中，超过 80%的人表示，实施分散式 IDS 药剂师是可接受的、适当的和可行的。
这项试点研究表明，在肿瘤学临床试验输注单元中，分散式 IDS 药剂师可以提高 IDS 药剂师的可及性，增加与患者护理相关的药房咨询，并优化集中式药剂师的药物分配工作流程。需要进一步的研究来评估在直接患者护理活动中实施分散式 IDS 药剂师对患者的益处。
