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澳大利亚临床肿瘤学会立场声明:2022 年更新版医疗卫生环境中单克隆抗体安全处理

Clinical Oncology Society of Australia Position Statement: 2022 update to the safe handling of monoclonal antibodies in healthcare settings.

机构信息

Department of Pharmacy, Princess Alexandra Hospital, Brisbane, Australia.

Centre for Health Services Research, The University of Queensland, Brisbane, Australia.

出版信息

Asia Pac J Clin Oncol. 2023 Dec;19(6):723-730. doi: 10.1111/ajco.13943. Epub 2023 Mar 10.

DOI:10.1111/ajco.13943
PMID:36899469
Abstract

AIM

The aims were to (a) review the scientific literature on occupational risk, including exposure mechanisms and risk assessment, with regards to handling monoclonal antibodies (mABs) in healthcare settings; and (b) update the recommendations in the Clinical Oncology Society of Australia (COSA) safe handling of monoclonal antibodies in healthcare settings position statement, published in 2013.

METHODS

A literature search was conducted between April 24, 2022, and July 3, 2022, to identify evidence relating to occupational exposure and handling of mABs in healthcare settings. Evidence in the literature was compared to the Position Statement published in 2013, and any potential additions, deletions, or revisions were discussed by the authors, and then agreed changes were made.

RESULTS

Thirty-nine references were included in this update, comprising of the 2013 Position Statement itself and 10 of its references, as well as 28 new references. The risks to healthcare workers in the preparation and administration of mABs arise from four distinct exposure mechanisms: dermal, mucosal, inhalation, and oral. Updates included recommendations on using protective eyewear during the preparation and administration of mABs, developing a local institutional risk assessment tool and handling recommendations, considerations for using closed system transfer devices, and to have awareness of the nomenclature change from 2021 for new mABs.

CONCLUSION

Practitioners should follow the 14 recommendations to lower occupational risk when handling mABs. Another Position Statement update should occur in 5-10 years to ensure the currency of recommendations.

摘要

目的

(a)回顾有关在医疗保健环境中处理单克隆抗体(mAB)的职业风险的科学文献,包括暴露机制和风险评估;(b)更新 2013 年发表的澳大利亚临床肿瘤学会(COSA)“在医疗保健环境中安全处理单克隆抗体”立场声明中的建议。

方法

2022 年 4 月 24 日至 2022 年 7 月 3 日进行了文献检索,以确定与医疗保健环境中职业暴露和 mAB 处理相关的证据。对文献中的证据与 2013 年发表的立场声明进行了比较,作者讨论了任何潜在的添加、删除或修订,并同意进行修改。

结果

本更新纳入了 39 篇参考文献,包括 2013 年的立场声明本身及其 10 篇参考文献,以及 28 篇新参考文献。医护人员在制备和管理 mAB 时面临的风险来自四个不同的暴露机制:皮肤、黏膜、吸入和口服。更新内容包括在制备和管理 mAB 时使用防护眼镜的建议,制定当地机构风险评估工具和处理建议,考虑使用密闭式传输装置,并了解自 2021 年以来新 mAB 名称的变化。

结论

从业者在处理 mAB 时应遵循 14 项建议,以降低职业风险。应在 5-10 年内再次更新立场声明,以确保建议的时效性。

相似文献

1
Clinical Oncology Society of Australia Position Statement: 2022 update to the safe handling of monoclonal antibodies in healthcare settings.澳大利亚临床肿瘤学会立场声明:2022 年更新版医疗卫生环境中单克隆抗体安全处理
Asia Pac J Clin Oncol. 2023 Dec;19(6):723-730. doi: 10.1111/ajco.13943. Epub 2023 Mar 10.
2
Australian consensus guidelines for the safe handling of monoclonal antibodies for cancer treatment by healthcare personnel.澳大利亚医护人员安全处理用于癌症治疗的单克隆抗体的共识指南。
Intern Med J. 2014 Oct;44(10):1018-26. doi: 10.1111/imj.12564.
3
Safe handling and administration of MABS: the guidance.单克隆抗体的安全处理与给药:指南
Br J Nurs. 2015 Sep;24(16 Suppl 1):S14-20. doi: 10.12968/bjon.2015.24.sup16a.s14.
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Survey of guidelines and current practices for safe handling of antineoplastic and other hazardous drugs used in 24 countries.24个国家抗肿瘤及其他危险药物安全操作指南与现行做法调查
J Oncol Pharm Pract. 2019 Jan;25(1):148-162. doi: 10.1177/1078155217726160. Epub 2017 Aug 25.
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A review of the evidence for occupational exposure risks to novel anticancer agents - A focus on monoclonal antibodies.新型抗癌药物职业暴露风险的证据综述——聚焦单克隆抗体
J Oncol Pharm Pract. 2016 Feb;22(1):121-34. doi: 10.1177/1078155214550729. Epub 2014 Sep 16.
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Developing a flowchart to evaluate the use of Closed System Drug-Transfer Devices with monoclonal antibodies: Focus on the clinical trial setting.制定流程图以评估在临床试验环境中使用含单克隆抗体的密闭式药物传输装置。
J Oncol Pharm Pract. 2023 Dec;29(8):2014-2022. doi: 10.1177/10781552231199412. Epub 2023 Sep 8.
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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.封闭系统药物转移装置加危险药物安全操作与仅进行安全操作相比,对减少医护人员接触输注性危险药物的影响
Cochrane Database Syst Rev. 2018 Mar 27;3(3):CD012860. doi: 10.1002/14651858.CD012860.pub2.
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Safe handling of monoclonal antibodies: Too large to be hazardous?单克隆抗体的安全处理:体积过大就不会有危害吗?
J Oncol Pharm Pract. 2018 Apr;24(3):218-220. doi: 10.1177/1078155217698846. Epub 2017 Mar 16.
9
A survey of manufacturing and handling practices for monoclonal antibodies by pharmacy, nursing and medical personnel.一项针对药学、护理及医疗人员对单克隆抗体的生产与处理操作的调查。
J Oncol Pharm Pract. 2016 Apr;22(2):219-27. doi: 10.1177/1078155214559113. Epub 2014 Nov 14.
10
Use of closed-system drug transfer devices in the handling and administration of MABs.在单克隆抗体的处理和给药过程中使用封闭系统药物转移装置。
Br J Nurs. 2015 Sep;24(16 Suppl 1):S21-7. doi: 10.12968/bjon.2015.24.sup16a.s21.

引用本文的文献

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A Human Skin Explant Test as a Novel In Vitro Assay for the Detection of Skin Sensitization to Aggregated Monoclonal Antibodies.一种人体皮肤外植体试验作为检测对聚集单克隆抗体皮肤致敏性的新型体外试验方法。
Toxics. 2024 Apr 30;12(5):332. doi: 10.3390/toxics12050332.