医疗机构细胞毒性药物职业暴露风险防控指南 <sup>Δ</sup>

邹林珂; 闫峻峰; 刘慧; 吕子彦

doi:null

您当前的位置：

首页 >

文章列表页 >

医疗机构细胞毒性药物职业暴露风险防控指南 ^Δ

更新时间：2025-09-25

- 医疗机构细胞毒性药物职业暴露风险防控指南 ^Δ
- Guidelines for Prevention and Control of Occupational Exposure Risks to Cytotoxic Drugs in Medical Institution
- 中国药房 2025年页码：1-11
- 作者机构：
  
  1.四川省医学科学院·四川省人民医院/电子科技大学附属医院药学部个体化药物治疗四川省重点实验室，成都 610072
  2.电子科技大学医学院，成都 610072
- 作者简介：
  
  药师，硕士。研究方向：临床药学、医院药学。电话：028-8739-4760。E-mail：zlk1028@qq.com
  主任药师。研究方向：临床药学、医院药学、药事管理。电话：028-8739-3436。E-mail：289302309@qq.com
- 基金信息：
  
  国家重点研发计划主动健康和老龄化科技应对重点专项(2020YFC2005500);2021年度个体化药物治疗四川省重点实验室开放和自拟课题资助项目(2021YB10)
- DOI：
  中图分类号： R95
- 网络出版日期：2023-08-14，
- 稿件说明：
移动端阅览
邹林珂,闫峻峰,刘慧,等.医疗机构细胞毒性药物职业暴露风险防控指南[J].中国药房,

.Guidelines for Prevention and Control of Occupational Exposure Risks to Cytotoxic Drugs in Medical Institution[J].ZHONGGUO YAOFANG,
邹林珂,闫峻峰,刘慧,等.医疗机构细胞毒性药物职业暴露风险防控指南[J].中国药房, DOI：10.6039/j.issn.1001-0408...01.

.Guidelines for Prevention and Control of Occupational Exposure Risks to Cytotoxic Drugs in Medical Institution[J].ZHONGGUO YAOFANG, DOI：10.6039/j.issn.1001-0408...01.

摘要

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，制定《医疗机构细胞毒性药物职业暴露风险防控指南》。依据世界卫生组织（WHO）指南制定手册方法，收集细胞毒性药物进入医院后的运输、接收、储存、脱包、调剂、成品使用、废物处理7个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（GRADE）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，将工程控制、行政控制和个人防护设备3个不同等级相结合，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，旨在为医疗机构制定细胞毒性药物分级防控措施提供参考与补充。

Abstract

To provide prevention and control strategies of occupational exposure risks for cytotoxic drugs in medical institutions

improve the awareness of protection among medical staff

and reduce potential occupational exposure risks

the “Guidelines for Occupational Exposure Risk Protection of Cytotoxic Drugs in Medical Institutions” was developed. Based on the World Health Organization (WHO) guidelines development manual

we collected the exposure risk issues in seven stages after the cytotoxic drugs entered the hospital

such as transportation

receipt

storage

unpacking

dispensing

used of finished products

and waste disposal. The Delphi method was used to construct identify clinical issues

and evidence-based research methods were used to develop relevant evidences. Quality evaluation was conducted using the GRADE method

and consensus was reached on the recommendation opinions and evidence levels through expert consensus method. By combining engineering controls

administrative controls and personal protective equipment at different levels

a graded control approach was established. A total of 37 clinical issues were identified

resulting 36 recommendations. This guideline provides reference and supplementation for the formulation of cytotoxic drugs prevention and control measures in medical institutions.

关键词

Keywords

references

Health and Safety Executive . Safe handling of cytotoxic drugs in the workplace [EB/OL ] . ( 2019-07-23 )[ 2023-06-02 ] . http//www.hse.gov.uk/healthservices/safe-use-cytotoxic-drugs.htm http://www.hse.gov.uk/healthservices/safe-use-cytotoxic-drugs.htm .

HIJIYA N , HUDSON M M , LENSING S , et al . Cumulative incidence of secondary neoplasms as a first event after childhood acute lymphoblastic leukemia [J ] . JAMA , 2007 , 297 ( 11 ): 1207 - 1215 .

GURUSAMY K S , BEST L M , TANGUAY C , et al . Closed-system drug-transfer devices plus safe handling of hazardous drugs versus safe handling alone for reducing exposure to infusional hazardous drugs in healthcare staff [J ] . Cochrane Database Syst Rev , 2018 , 3 ( 3 ): 1465 - 1858 .

ENSSLIN A S ， STOLL Y ， PETHRAN A ， et al . Biological monitoring of cyclophosphamide and ifosfamide in urine of hospital personnel occupationally exposed to cytostatic drugs [J ] . Occup Environ Med ， 1994 ， 51 ( 4 )： 229 - 233 .

TOUZIN K ， BUSSIERES J F ， LANGLOIS E ， et al . Evaluation of surface contamination in a hospital hematology：oncology pharmacy [J ] . J Oncol Pharm Pract ， 2009 ， 15 （ 1 ）： 53 - 61 .

MASON H J ， BLAIR S ， SAMS C ， et al . Exposure to antineoplastic drugs in two UK hospital pharmacy units [J ] . Ann Occup Hyg ， 2005 ， 49 （ 7 ）： 603 - 610 .

HALL A L ， DEMERS P A ， ASTRAKIANAKIS G ， et al . Estimating national-level exposure to antineoplastic agents in the workplace：CAREX Canada findings and future research needs [J ] . Ann Work Expo Health ， 2017 ， 61 （ 6 ）： 656 - 658 .

SOTTANI C ， PORRO B ， COMELLI M ， et al . An analysis to study trends in occupational exposure to antineoplastic drugs among health care workers [J ] . J Chromatogr B Analyt Technol Biomed Life Sci ， 2010 ， 878 ( 27 )： 2593 - 2605 .

TOUZIN K , BUSSIÈRES J F , LANGLOIS E , et al . Cyclophosphamide contamination observed on the external surfaces of drug vials and the efficacy of cleaning on vial contamination [J ] . Ann Occup Hyg , 2008 , 52 ( 8 ): 765 - 771 .

HEDMER M ， GEORGIADI A ， BREMBERG E R ， et al . Surface contamination of cyclophosphamide packaging and surface contamination with antineoplastic drugs in a hospital pharmacy in Sweden [J ] . Ann Occup Hyg ， 2005 ， 49 ( 7 )： 629 - 637 .

HAO M I ， WANG T ， ZHU J ， et al . Evaluation of external contamination on the vial surfaces of some hazardous drugs that commonly used in Chinese hospitals and comparison between environmental contamination generated during robotic compounding by IV：dispensing robot vs. manual compounding in biological safety cabinet [J ] . J Oncol Pharm Pract ， 2022 ， 28 ( 7 )： 1487 - 1498 .

National Institute for Occupational Safety and Health . NIOSH alert:preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings [EB/OL ] .[ 2023-06-02 ] . https://www.cdc.gov/niosh/docs/2004-165/ https://www.cdc.gov/niosh/docs/2004-165/ .

POWER L A , COYNE J W . ASHP guidelines on handling hazardous drugs [J ] . Am J Health Syst Pharm , 2018 , 75 ( 24 ): 1996 - 2031 .

GALLANT C ， BUSSIERES J ， PLANTE R . Guidede prévention—manipulation sécuritaire des médicaments dangereux [J ] . Montréal ， QC： ASSTSAS ， 2008 ： 1 - 158 .

NABHANI-GEBARA , SHEREEN . ISOPP standards for the safe handling of cytotoxics [J ] . J Oncol Pharm Pract ， 2022 ，28( 3 - suppl )： 1078 - 1552 .

杨克虎 . 世界卫生组织指南制定手册 [M ] . 兰州：兰州大学出版社， 2013 ： 1 - 75 .

WINKLER G C ， BARLE E L ， GALATI G ， et al . Functional differentiation of cytotoxic cancer drugs and targeted cancer therapeutics [J ] . Regul Toxicol Pharmacol ， 2014 ， 70 ( 1 )： 46 - 53 .

李正翔 , 张玉 , 张伶俐 , 等 . 医疗机构药品遴选指南 [J ] . 中国药房 , 2022 , 33 ( 7 ): 769 - 776 .

MEADE E . Avoiding accidental exposure to intravenous cytotoxic drugs [J ] . Br J Nurs , 2014 , 23 ( 16 ): S34 , S36 - S34 , S39 .

EXECUTIVE S . Control of substances hazardous to health (Fifth edition) - The Control of Substances Hazardous to Health Regulations 2002 (as amended) [M/OL ] . Health and Safety Executive , 2005 : 1- 137 ( 2005 )[ 2023-06-02 ] . http://www.cbcsd.org.cn/sjk/HSE/policies/international/20130711/download/l5.pdf http://www.cbcsd.org.cn/sjk/HSE/policies/international/20130711/download/l5.pdf .

CONNO T H ， MACKENZIE B ， DEBORD D ， et al . NIOSH list of antineoplastic and other hazardous drugs in healthcare settings [EB/OL ] .( 2010-09-01 )[ 2023-06-02 ] . http://www.cdc.gov/niosh/docs/2010-167/ http://www.cdc.gov/niosh/docs/2010-167/ .

EASTY A C , COAKLEY N , CHENG R , et al . Safe handling of cytotoxics: guideline recommendations [J ] . Curr Oncol , 2015 , 22 ( 1 ): e27 - e37 .

EDGAR-HUGHES M ， BOSS K ， COULLS S ， et al . Safe handling of cytotoxic drugs and related wastes：guidelines for South Australian health services 2012 [M/OL ] . ( 2012-03 )[ 2023-06-02 ] . https://www.researchgate.net/publication/266733922 https://www.researchgate.net/publication/266733922 .

Power L A . Safe Handling Of Hazardous Drugs: Reviewing Standards for Worker Protection . J Pharm Pract News (special edition) . 2012 : 31 - 42 .

BERNABEU-MARTÍNEZ M A , RAMOS MERINO M , SANTOS GAGO J M , et al . Guidelines for safe handling of hazardous drugs: a systematic review [J ] . PLoS One , 2018 , 13 ( 5 ): e0197172 .

INTERNATIONAL Society of Oncology Pharmacy Practicioners Standards Committee . ISOPP standards of practice. Safe handling of cytotoxics [J ] . J Oncol Pharm Pract , 2007 , 13 ( Suppl ): 1 - 81 .

National Institute for Occupaional Safety and Health . Medical surveillance for healthcare workers exposed to hazardous drugs [EB/OL ] .[ 2023-06-02 ] . https://stacks.cdc.gov/view/cdc/12110 https://stacks.cdc.gov/view/cdc/12110 .

HON C Y ， TESCHKE K ， SHEN H ， et al . Antineoplastic drug contamination in the urine of Canadian healthcare workers [J ] . Int Arch Occup Environ Health ， 2015 ， 88 ( 7 )： 933 - 941 .

GALLANT C . Prevention Guide: Safe Handling of Hazardous Drugs [M ] . Montreal : ASSTSAS , 2008 .

The United States Pharmacopeial Convention (USP) . USP General Chapter Hazardous Drugs–Handling in healthcare settings [EB/OL ] .( 2014-11-01 )[ 2023-06-02 ] . https://www.uspnf.com/es/node/2881 https://www.uspnf.com/es/node/2881 .

KIM O , LEE H , JUNG H , et al . Korean nurses' adherence to safety guidelines for chemotherapy administration [J ] . Eur J Oncol Nurs , 2019 , 40 : 98 - 103 .

LAWSON C C , JOHNSON C Y , NASSAN F L , et al . CE: original research: antineoplastic drug administration by pregnant and nonpregnant nurses: an exploration of the use of protective gloves and gowns [J ] . Am J Nurs , 2019 , 119 ( 1 ): 28 - 35 .

LABRÈCHE F ， OUELLET C ， ROBERGE B ， et al . Occupational exposure to antineoplastic drugs：what about hospital sanitation personnel? [J ] . Int Arch Occup Environ Health ， 2021 ， 94 ( 8 )： 1877 - 1888 .

国家卫生健康委 . 静脉用药调配中心建设与管理指南(试行)：国卫办医函〔2021〕 598 号[EB/OL ] .( 2021-12-10 )[ 2023-06-02 ] . http://www.gov.cn/zhengce/zhengceku/2021-12/21/ content 5663666.htm http://www.gov.cn/zhengce/zhengceku/2021-12/21/content5663666.htm .

Occupational Safety and Health Administration (OSHA) . Controlling occupational exposure to hazardous drugs [EB/OL ] .（ 2016-08-01 ）[ 2023-06-02 ] . https://compliancetrainingpartners.com/wp-content/uploads/2021/08/Hazardous-Drugs-Controlling-Occupational-Exposure.pdf https://compliancetrainingpartners.com/wp-content/uploads/2021/08/Hazardous-Drugs-Controlling-Occupational-Exposure.pdf .

ARNOLD S , KAUP H M . Assessing variability of antineoplastic drugs handling practices in clinical settings [J ] . J Occup Environ Hyg , 2019 , 16 ( 12 ): 757 - 762 .

NABHANI GEBARA S , BARTON S , APPLEFORD I , et al . Consensus recommendations for the safe handling of cytotoxic agents in cytotoxic academic research laboratories (CARL) [J ] . J Oncol Pharm Pract , 2020 , 26 ( 8 ): 1953 - 1963 .

CONNOR T H ， DEBORD D G ， PRETTY J R ， et al . Evaluation of antineoplastic drug exposure of health care workers at three university-based US cancer centers [J ] . J Occup Environ Med ， 2010 ， 52 ( 10 )： 1019 - 1027 .

BURROUGHS G E ， CONNOR T H ， MCDIARMID M A ， et al . NIOSH Alert： preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings . Washington, DC: US Department of Health and Human Services, Centers for Disease Control and Prevention[EB/OL ] .（ 2018-02-07 ）[ 2023-06-02 ] . https://www.cdc.gov/niosh/docs/2004-165/ https://www.cdc.gov/niosh/docs/2004-165/ .

ACRAMEL A , FOUQUE J , BLONDEEL-GOMES S , et al . Application of an environmental monitoring to assess the practices and control the risk of occupational exposure to cyclophosphamide in two sites of a French comprehensive cancer center [J ] . Ann Work Expo Health , 2022 , 66 ( 9 ): 1215 - 1223 .

YASUI H . Safe handling of cancer chemotherapy drugs [J ] . Gan to Kagaku Ryoho ， 2016 ， 43 ( 5 )： 503 - 508 .

National Institute for Occupational Safety and Health . NIOSH list of antineoplastic and other hazardous drugs in healthcare settings [EB/OL ] .( 2018-02-28 )[ 2023-06-02 ] . www.cdc.gov/niosh/docs/2016-161/default.html www.cdc.gov/niosh/docs/2016-161/default.html .

Pan American Health Organization . Safe handling of hazardous chemotherapy drugs in limited-resource settings [EB/OL ] . [ 2023-06-02 ] . https：//goo.gl/zUoyFkPAHO/WHO https://goo.gl/zUoyFkPAHO/WHO .

NEUSS M N , GILMORE T R , BELDERSON K M , et al . 2016 updated American society of clinical oncology/oncology nursing society chemotherapy administration safety standards, including standards for pediatric oncology [J ] . J Oncol Pract , 2016 , 12 ( 12 ): 1262 - 1271 .

NSW Goverment . Cytotoxic drugs and related waste-risk management [EB/OL ] .[ 2023-06-02 ] . https：//www.safework.nsw.gov.au https://www.safework.nsw.gov.au .

Cytotoxic drugs and related waste：a risk management guide for south Australia health services [EB/OL ] . ( 2014-12-30 ) [ 2023-06-02 ] . https://www.sahealth.sa.gov.au/wps/wcm/connect/f8aa68004b3f6cf6a340afe79043faf0/Safe+Handling+Cytotoxic+Guidelines.pdf?MOD=AJPERES https://www.sahealth.sa.gov.au/wps/wcm/connect/f8aa68004b3f6cf6a340afe79043faf0/Safe+Handling+Cytotoxic+Guidelines.pdf?MOD=AJPERES .

LIN Y , CHANG Y , LIN Y C , et al . Factors influencing nurses' use of hazardous drug safe handling precautions [J ] . Oncol Nurs Forum , 2019 , 46 ( 3 ): E86 - E97 .

CRICKMAN R ， FINNELL D . Systematic review of control measures to reduce hazardous drug exposure for health care workers [J ] . J Nurs Care Qual ， 2016 ， 31 ( 2 )： 183 - 190 .

魏诗晴，凃敏，赖晓全，等 . 我国各类医疗机构部分医疗废物分类处置现状 [J ] . 中国感染控制杂志， 2021 ， 20 ( 9 )： 782 - 787 .

HILLIQUIN D ， TANGUAY C ， BUSSIÈRES J F . External contamination of commercial containers by antineoplastic agents：a literature review [J ] . Eur J Hosp Pharm ， 2020 ， 27 ( 5 )： 313 - 314 .

吴安华 , 任南 . 医疗机构医疗废物管理技术 [J ] . 中国护理管理 , 2003 , 3 ( 5 ): 59 - 62 .

中华人民共和国国务院令 . 《医疗废物管理条例》 [J ] . 中国环保产业 , 2004 ( S1 ): 6 - 10 .

浏览量

下载量

CSCD

文章被引用时，请邮件提醒。

提交

工具集

关联资源

基于德尔菲法和层次分析法构建《药品临床综合评价主题遴选指南》研究问题及主题遴选评估指标体系 ^Δ

医疗机构细胞毒性药物职业暴露风险防控指南

临床合理用药保障实现的逻辑路径原则探析

基于文献计量分析看国内药物经济学评价研究的现状及发展

世界卫生组织、美国与欧盟复方口服避孕药使用标准和指南介绍及启示

医疗机构细胞毒性药物职业暴露风险防控指南 Δ

Guidelines for Prevention and Control of Occupational Exposure Risks to Cytotoxic Drugs in Medical Institution

DOI：

摘要

Abstract

关键词

Keywords

references

医疗机构细胞毒性药物职业暴露风险防控指南 ^Δ