医疗机构细胞毒性药物职业暴露风险防控指南

Guidelines for prevention and control of occupational exposure risks to cytotoxic drugs in medical institution

目的为医疗机构提供细胞毒性药物职业暴露风险防控策略,提高医务人员的防护意识,降低医务人员发生潜在的职业暴露风险。方法采用世界卫生组织指南制定手册进行细胞毒性药物职业暴露风险分级管控的防护指南的研究设计。通过系统检索,指南工作组广泛收集细胞毒性药物进入医院后的调配、使用等各环节存在的暴露风险问题,采用德尔菲法构建临床问题,采用循证研究方法形成相关证据体后,按照推荐分级的评价、制定与评估方法进行质量评价,并再次通过专家共识法对推荐意见及证据级别达成共识,最终形成《医疗机构细胞毒性药物职业暴露风险防护指南》。结果通过对143位专家进行网络调查问卷调研,采用德尔菲法对指南达成共识。将工程控制、行政控制和个人防护设备3个不同等级管理相结合,通过分级管控的方式,最终确定了37个临床问题,共形成36条推荐意见。结论本指南涵盖运输、接收、储存、脱包、调剂、成品使用、废物处理等7个环节,可为医疗机构制订细胞毒性药物相关防控措施提供参考与补充,确保细胞毒性药物进入医院后,降低医务人员发生细胞毒性药物职业暴露的可能性,保护医务人员的安全。

Objective To provide medical institutions with occupational exposure risk prevention and control strategies for cytotoxic drugs,enhance the protective awareness of medical personnel and reduce potential occupational exposure risks.Methods The World Health Organization guideline was used to develop a manual for the study and design of protective guidelines for occupational exposure risk classification and control of cytotoxic drugs.Through systematic retrieval,guide working group extensively collected the exposure risk issues in the allocate,use and other aspects of cytotoxic drugs after entering the hospital.The Delphi method was used to construct clinical issues.After forming the relevant evidence using evidence-based approach,quality evaluation was conducted in accordance with the evaluation,formulation and assessment methods of recommended grading,and consensus was again reached on the recommendation opinions and evidence levels through expert consensus method.Ultimately,the Guidelines for Prevention and Control of Occupational Exposure Risks to Cytotoxic Drugs in Medical Institution was formulated.Results Through the online questionnaire survey of 143 experts,consensus on the guidelines was achieved using the Delphi method.By combining engineering controls,administrative controls and personal protective equipment at three different levels,a graded control approach was established.A total of 37 clinical issues were identified through a hierachical control approach,resulting in 36 recommendations.Conclusion This guideline covers seven steps after cytotoxic drugs enter the hospitial,including transportation,receipt,storage,unpacking,dispensing,finished product use and waste treatment,which provide reference for medical institutions to develop cytotoxic drugs related prevention and control measures.Therefore,the possibility of occupational exposure to cytotoxic drugs can be reduced and the safety of medical personnel can be protected.