A review of research on occupational hygiene risk assessment and management of pharmaceutical dusts

doi:10.16265/j.cnki.issn1003-3033.2023.08.0904

Abstract

Abstract:

In order to improve the prevention and control system of occupational hazards of pharmaceutical dust in China and ensure occupational health of workers and sustainable development of pharmaceutical industry, the occupational hazards were investigated by briefly reviewing the cases of occupational exposure to pharmaceutical dusts that led to adverse health effects domestic and overseas. The research history and achievements of risk assessment and risk management of pharmaceutical dust were summarized, and further advice was provided based on the current research status of China. The results show that pharmaceutical dust is toxic, allergenic, carcinogenic and reproductive toxic, but it has not been paid attention to in China. Although the pharmaceutical industry as a whole has basically established a framework for risk assessment and management of pharmaceutical dust, many details still need to be improved. The research on pharmaceutical dust in China is in the initial stage, which is not deep and comprehensive enough, and there are still many problems to be further explored together.

Key words: pharmaceutical dust, occupational health, risk assessment, risk management, occupational exposure limits(OELs)

LI Sicong, XU Tao. A review of research on occupational hygiene risk assessment and management of pharmaceutical dusts[J]. China Safety Science Journal, 2023, 33(8): 219-230.

Figures/Tables 7

Tab.1

Tab.2

Fig.1

Tab.3

AIHA exposure level

暴露等级	统计学描述	定性描述	经验描述
0	$X 0.95$ ≤1%×OEL	如果暴露存在,很少会超过 OEL的1%	暴露是完全受控的——劳动者不会处于暴露中
1	1%×OEL< $X 0.95$ ≤10%×OEL	暴露很少会超过OEL的10%	暴露是高度受控的——劳动者极少或几乎不会处于暴露中
2	10%×OEL< $X 0.95$ ≤50%×OEL	暴露很少会超过OEL的50%, 极少会超过OEL	暴露是良好受控的——劳动者大部分处于低浓度和极少的高浓度的暴露中
3	50%×OEL< $X 0.95$ ≤OEL	暴露很少会超过OEL	暴露是受控的——劳动者一般处于低浓度和很少的高浓度的暴露中
4	$X 0.95$ >OEL	暴露会经常超过OEL	暴露是不受控的——劳动者经常处于高或非常高浓度的暴露中

Tab.3

Fig.2

Fig.3

Tab.4

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发表年份	作者	研究成果
1988	MCHATTIE等^[32]	提出一种推导药物化合物OELs的思路,并列出所需考虑或审查的数据类型
1989	AGIUS^[33]	从定性效果与定量数据2个角度出发,为设置合适的OELs提出系统性策略
1992	GALER等^[34]	讨论了为化合物制定OELs时应考虑的数据类型,并在将化合物总体分为致癌与非致癌2类的基础上提出一套制定OELs的流程
1995	NAUMANN等^[35]	针对在建立活性药物成分的OELs过程中不确定因子一直取10的情况进行了改进,讨论支持降低不确定因素的科学依据,提出一个框架,可以最大限度的利用临床前与临床信息,以减少建立药物活性成分的OELs时的不确定性
2000	KU^[36]	综述了几种建立药物OELs方法,包括针对于致癌物的线性多阶段法、基准剂量法、治疗剂量法、内源性生物活性水平法等
2015	WHEELER等^[37]	从毒理学和流行病学的角度描述并对比了几种基于剂量-反应的定量评估建模方法,并通过模拟数据集证明其建立OELs的实用性
2015	KUEMPEL等^[38]	聚焦于吸入剂量测定,列举几个实际例子说明对于吸入气体和颗粒物应当如何进行剂量估计与OELs的推导

评估因素
药效强度/(mg·d^-1)	>100	10100	0.110	<0.1	<0.1
急性反应的严重程度	低	低/中	中	中/高	高
有无急性警示症状	充分	一般	一般/缺乏	缺乏	无
何时出现警示症状	立即出现	立即出现	可能延迟出现	延迟出现	无
是否需要医疗干预	不需要	不需要	可能需要	可能立即需要	立即需要
急性毒性	轻微毒性	中等毒性	高度毒性	剧毒毒性	极度毒性
致敏作用	非致敏	轻度致敏	中度致敏	强力致敏	极易致敏
慢性影响的可能性(如癌症、生殖、全身)	不可能	不可能	可能	很可能	已知可能
慢性影响的严重程度	无	无	轻度	中度	重度
累积效应	无	无	轻微	中度	高度
可逆性	可逆	可逆	可能不可逆	可能不可逆	不可逆
生活质量的改变(残疾)	否	否	否/是	是	是

呼吸防护用品类型	面罩类型	正压式	负压式
自吸过滤式	半面罩	不适用	10
自吸过滤式	全面罩	不适用	100
送风过滤式	半面罩	50	不适用
	全面罩	2001 000
	开放型面罩	25
	送气头罩	2001 000
供气式	半面罩	50	10
	全面罩	1 000	100
	开放型面罩	25	不适用
	送气头罩	1 000
携气式	半面罩	>1 000	10
携气式	全面罩	>1 000	100