Supplementary file 3_Stratification system for pharmaceutical care in cancer patients: Chinese expert consensus.docx

BackgroundChina bears one of the world’s heaviest cancer burdens, with a complex and multimodal cancer treatment environment. Currently, the absence of a standardized framework for oncology pharmaceutical care limits the quality and precision of services, highlighting an urgent need for clinical guidance.
ObjectiveThe objective of this study was to establish an evidence- and practice-informed consensus on oncology pharmaceutical care, providing a standardized framework for clinical practice.
MethodsUnder the leadership of Sichuan Cancer Hospital and in collaboration with national academic organizations, a multidisciplinary expert panel conducted a systematic literature review, nationwide surveys, and consensus meetings. The recommendations were formalized through a two-round Delphi process.
ResultsThree levels of pharmaceutical care are defined in this consensus, along with their corresponding implementation principles, including prioritization of high-risk patients, assignment of the highest applicable level when multiple criteria are met, and dynamic reassessment in response to changes in clinical status. The stratification system is established based on a comprehensive assessment across three core dimensions: 1) Pathophysiological conditions, including fertility preservation, age, body mass index, performance status, comorbid chronic diseases, concurrent infections, nutritional status and support, pain management, and hepatic or renal impairment; 2) Medication-related factors, encompassing antineoplastic agent toxicity risk and management, therapeutic drug monitoring, pharmacogenomics, clinically significant drug-drug interactions, polypharmacy, special administration routes or delivery devices, medication adherence, and complex medication issues; 3) Non-medication therapeutic interventions, such as radiotherapy, interventional therapy, surgery, and novel therapies (e.g., CAR-T therapy, tumor-infiltrating lymphocyte therapy). Specific recommendations for stratified pharmaceutical care were formulated based on these factors.
ConclusionsThis expert consensus establishes a standardized and practical framework for stratified pharmaceutical care in cancer patients, aiming to improve care quality, optimize resource allocation, and enhance patient outcomes in China. It may also serve as a reference model for international initiatives seeking to establish or refine standards for oncology pharmaceutical care.

背景 中国是全球癌症负担最为沉重的国家之一，癌症治疗环境复杂且呈现多模式特征。当前，肿瘤药学服务（oncology pharmaceutical care）缺乏标准化框架，制约了服务质量与精准性，凸显了临床指导的迫切需求。
目标 本研究旨在建立基于证据与临床实践的肿瘤药学服务共识，为临床实践提供标准化操作框架。
方法 在四川癌症医院（Sichuan Cancer Hospital）牵头、全国学术组织协作下，多学科专家小组开展了系统文献综述、全国性调研及共识会议，并通过两轮德尔菲法（Delphi process）正式形成推荐意见。
结果 本共识明确了三级药学服务及其对应的实施原则，包括高危患者优先原则、满足多项标准时选用最高适用级别的原则，以及依据临床状态变化开展动态重新评估的原则。该分层体系基于三大核心维度的综合评估构建：1）病理生理状况：涵盖生育力保护、年龄、体质量指数（body mass index）、体能状态、合并慢性疾病、合并感染、营养状况与支持、疼痛管理、肝肾功能损害；2）药物相关因素：包含抗肿瘤药物（antineoplastic agent）毒性风险与管理、治疗药物监测、药物基因组学（pharmacogenomics）、临床意义重大的药物相互作用、多重用药、特殊给药途径或给药装置、用药依从性及复杂用药问题；3）非药物治疗干预措施：例如放疗、介入治疗、手术及新型疗法（如CAR-T疗法、肿瘤浸润淋巴细胞（tumor-infiltrating lymphocyte）疗法）。基于上述因素，本共识制定了分层药学服务的具体推荐意见。
结论 本专家共识建立了针对癌症患者的分层药学服务标准化、实用化框架，旨在提升我国肿瘤药学服务质量、优化资源配置并改善患者临床结局。本共识亦可作为全球范围内拟建立或完善肿瘤药学服务标准的国际项目的参考范本。