Zocchetti C, Della Foglia M, Colombi A
Istituti Clinici de Perfezionamento, Clinica del Lavoro, Milano.
Med Lav. 1996 Jul-Aug;87(4):330-47.
The concept of risk, in relation to human health, is a topic of primary interest for occupational health professionals. A new legislation recently established in Italy (626/94) according to European Community directives in the field of Preventive Medicine, called attention to this topic, and in particular to risk assessment and evaluation. Motivated by this context and by the impression that the concept of risk is frequently misunderstood, the present paper has two aims: the identification of the different meanings of the term "risk" in the new Italian legislation and the critical discussion of some commonly used definitions; and the proposal of a general definition, with the specification of a mathematical expression for quantitative risk estimation. The term risk (and risk estimation, assessment, or evaluation) has mainly referred to three different contexts: hazard identification, exposure assessment, and adverse health effects occurrence. Unfortunately, there are contexts in the legislation in which it is difficult to identify the true meaning of the term. This might cause equivocal interpretations and erroneous applications of the law because hazard evaluation, exposure assessment, and adverse health effects identification are completely different topics that require integrated but distinct approaches to risk management. As far as a quantitative definition of risk is of concern, we suggest an algorithm which connects the three basic risk elements (hazard, exposure, adverse health effects) by means of their probabilities of occurrence: the probability of being exposed (to a definite dose) given that a specific hazard is present (Pr(e[symbol: see text]p)), and the probability of occurrence of an adverse health effect as a consequence of that exposure (Pr(d[symbol: see text]e)). Using these quantitative components, risk can be defined as a sequence of measurable events that starts with hazard identification and terminates with disease occurrence; therefore, the following formal definition of risk is proposed: the probability of occurrence, in a given period of time, of an adverse health effect as a consequence of the existence of an hazard. In formula: R(d[symbol: see text]p) = Pr(e[symbol: see text]p) x Pr(d[symbol: see text]e). While Pr(e[symbol: see text]p) (exposure given hazard) must be evaluated in the situation under study, two alternatives exist for the estimation of the occurrence of adverse health effects (Pr(d[symbol: see text]e)): a "direct" estimation of the damage (Pr(d[symbol: see text]e) through formal epidemiologic studies conducted in the situation under observation; and an "indirect" estimation of Pr(d[symbol: see text]e) using information taken from the scientific literature (epidemiologic evaluations, dose-response relationships, extrapolations, ...). Both conditions are presented along with their respective advantages, disadvantages, and uncertainties. The usefulness of the proposed algorithm is discussed with respect to commonly used applications of risk assessment in occupational medicine; the relevance of time for risk estimation (both in the term of duration of observation, duration of exposure, and latency of effect) is briefly explained; and how the proposed algorithm takes into account (in terms of prevention and public health) both the etiologic relevance of the exposure and the consequences of exposure removal is highlighted. As a last comment, it is suggested that the diffuse application of good work practices (technical, behavioral, organizational, ...), or the exhaustive use of check lists, can be relevant in terms of improvement of prevention efficacy, but does not represent any quantitative procedure of risk assessment which, in any circumstance, must be considered the elective approach to adverse health effect prevention.
与人类健康相关的风险概念,是职业健康专业人员主要关注的话题。意大利最近根据欧洲共同体预防医学领域的指令制定了一项新立法(626/94),该立法引起了人们对这一话题的关注,特别是对风险评估的关注。受这一背景以及风险概念经常被误解这一印象的驱使,本文有两个目的:确定意大利新立法中“风险”一词的不同含义,并对一些常用定义进行批判性讨论;提出一个通用定义,并给出定量风险估计的数学表达式。风险(以及风险估计、评估或评价)一词主要涉及三种不同的情况:危害识别、暴露评估和不良健康影响的发生。不幸的是,立法中存在一些难以确定该词真正含义的情况。这可能导致对法律的含糊解释和错误应用,因为危害评估、暴露评估和不良健康影响识别是完全不同的主题,需要综合但不同的风险管理方法。就风险的定量定义而言,我们提出一种算法,通过三个基本风险要素(危害、暴露、不良健康影响)发生的概率将它们联系起来:给定特定危害存在时暴露(于确定剂量)的概率(Pr(e|p)),以及该暴露导致不良健康影响发生的概率(Pr(d|e))。利用这些定量成分,风险可以定义为一系列可测量的事件,始于危害识别,止于疾病发生;因此,提出以下风险的正式定义:在给定时间段内,由于存在危害而导致不良健康影响发生的概率。公式为:R(d|p) = Pr(e|p)×Pr(d|e)。虽然Pr(e|p)(给定危害时的暴露)必须在所研究的情况下进行评估,但对于不良健康影响发生概率(Pr(d|e))的估计有两种选择:通过在观察到的情况下进行正式的流行病学研究对损害进行“直接”估计(Pr(d|e));以及利用从科学文献中获取的信息(流行病学评估、剂量反应关系、外推法等)对Pr(d|e)进行“间接”估计。同时介绍了这两种情况各自的优点、缺点和不确定性。针对职业医学中常用的风险评估应用,讨论了所提出算法的实用性;简要解释了风险估计中时间的相关性(包括观察持续时间、暴露持续时间和效应潜伏期);并强调了所提出的算法如何(从预防和公共卫生角度)考虑暴露的病因学相关性以及去除暴露的后果。最后指出,良好工作实践(技术、行为、组织等方面)的广泛应用或清单的详尽使用,在提高预防效果方面可能是相关的,但并不代表任何定量风险评估程序,在任何情况下,定量风险评估程序都必须被视为预防不良健康影响的首选方法。