Villanueva Mara N, Davis Jennifer E, Sobocinski Stacey M
Pharmacy Medication Management and Analytics, University of Texas MD Anderson Cancer Center, Houston, TX.
Oncology Care & Research IS, University of Texas MD Anderson Cancer Center, Houston, TX.
Am J Health Syst Pharm. 2021 Jan 22;78(3):249-260. doi: 10.1093/ajhp/zxaa373.
The processes for formulary implementation and electronic health record (EHR) integration of biosimilar products at a comprehensive cancer center are described. Implications for research protocols are also discussed.
The existing literature focuses on practical considerations for formulary addition of biosimilar products, but there is a lack of guidance on how to implement the change, particularly within the EHR. Before building the ordering tools for biosimilars, the clinical and informatics teams should determine the role of biosimilars at the institution, identify drug-specific product characteristics that affect medication build, and characterize implications of future formulary changes or drug shortages. Leveraging an orderable record provides the ability to include logic that maps to multiple products and also allows for future implementation of changes within the medication record rather than requiring "swaps" at the treatment protocol level. The institutional review board should coordinate changes in affected research protocols and consent forms and work with principal investigators to amend protocols when necessary. Pharmacy leaders should develop processes to oversee inventory during the transition period and minimize the risk of errors.
The development of a standardized approach for evaluating and implementing biosimilar products improves efficiency and collaboration among the various team members responsible for the products' integration into existing workflows, including implications for clinical research. Implementing biosimilars for agents used to treat cancer will pose new challenges and require additional considerations. Partial implementation of biosimilars continues to pose multiple challenges in the provision of patient care.
描述在一家综合癌症中心实施生物类似药的处方集以及将其整合到电子健康记录（EHR）中的过程。还讨论了对研究方案的影响。
现有文献侧重于生物类似药纳入处方集的实际考虑因素，但缺乏关于如何实施这一变更的指导，尤其是在电子健康记录方面。在构建生物类似药的订购工具之前，临床和信息学团队应确定生物类似药在该机构中的作用，识别影响药物构建的特定药物产品特征，并描述未来处方集变更或药物短缺的影响。利用可订购记录能够包含映射到多种产品的逻辑，还允许在药物记录中未来实施变更，而不是在治疗方案层面进行“替换”。机构审查委员会应协调受影响研究方案和知情同意书的变更，并在必要时与主要研究者合作修改方案。药房负责人应制定流程，在过渡期监督库存并将错误风险降至最低。
开发一种评估和实施生物类似药的标准化方法可提高负责将产品整合到现有工作流程中的各团队成员之间的效率和协作，包括对临床研究的影响。将生物类似药用于治疗癌症的药物将带来新的挑战并需要额外考虑。生物类似药的部分实施在提供患者护理方面仍然带来多重挑战。
