Improving Health Risk Assessment as a Basis for Public Health Decisions in the 21st Century.

One-fifth of the way through the 21st century, a commonality of factors with those of the last 50 years may offer the opportunity to address unfinished business and current challenges. The recommendations include: (1) Resisting the tendency to oversimplify scientific assessments by reliance on single disciplines in lieu of clear weight-of-evidence expressions, and on single quantitative point estimates of health protective values for policy decisions; (2) Improving the separation of science and judgment in risk assessment through the use of clear expressions of the range of judgments that bracket protective quantitative levels for public health protection; (3) Use of comparative risk to achieve the greatest gains in health and the environment; and (4) Where applicable, reversal of the risk assessment and risk management steps to facilitate timely and substantive improvements in public health and the environment. Lessons learned and improvements in the risk assessment process are applied to the unprecedented challenges of the 21st century such as, pandemics and climate change. The beneficial application of the risk assessment and risk management paradigm to ensure timely research with consistency and transparency of assessments is presented. Institutions with mandated stability and leadership roles at the national and international levels are essential to ensure timely interdisciplinary scientific assessment at the interface with public policy as a basis for organized policy decisions, to meet time sensitive goals, and to inform the public.

The history of risk: a review.

In the USA alone, around 22 million patients annually discuss the need for surgical procedure with their surgeon. On a global scale, more than 200 million patients are exposed to the risk of undergoing a surgical procedure every year. A crucial part of the informed consent process for surgery is the understanding of risk, the probability of complications, and the predicted occurrence of adverse events. Ironically, risk quantification, risk stratification, and risk management are not necessarily part of a surgeon's core skillset, considering the lengthy surgical training curriculum towards technical excellence. The present review was designed to provide a concise historic perspective on the evolution of our current understanding of risk and probability, which represent the key underlying pillars of the shared decision-making process between surgeons and patients when discussing surgical treatment options.

Where we've been, where we are, and where we are going: A 35-year perspective on healthcare risk management.

In celebration of ASHRM's 35-year anniversary, this article will explore the journey of healthcare risk management and the professionals practicing within its discipline over time and project the future of both the discipline and the -profession.

Environmental risks and environmental justice, or how titanic risks are not so titanic after all.

Some of the best-known social scientific theories of risks are those that have been elaborated by Anthony Giddens and Ulrich Beck. Although their arguments differ greatly, they agree in seeing the technologically induced risks of today's "Risk Society" as global - so pervasive that they transcend all socioeconomic as well as geopolitical and national boundaries. Most empirical work, however, provides greater support for a theoretical tradition exemplified by Short and Erikson. In this paper, we argue that many of the technological mega-risks described by Giddens and Beck as "transcending" social boundaries are better described as "Titanic risks," referring not so much to their colossal impact as to the fact that - as was the case for the majority of the victims on the Titanic - actual risks are related to victims' socioeconomic as well as sociogeographic locations. Previous research has shown this to be the case with high-risk technologies, such as nuclear energy and weaponry, and also with localized ones, such as toxic waste disposal. This article illustrates that the same is true even for the most genuinely "global" risks of all, namely those associated with global climate disruption.

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[The history of adverse drug reactions, relief for these health damage and safety measures in Japan].

The first remarkable adverse drug reaction (ADR) reported in Japan was anaphylactic shock caused by penicillin. Although intradermal testing for antibiotics had been exercised as prediction method of anaphylactic shock for a long time, it was discontinued in 2004 because of no evidence for prediction. The malformation of limbs, etc. caused by thalidomide was a global problem, and thalidomide was withdrawn from the market. Teratogenicity testing during new drug development has been implemented since 1963. Chinoform (clioquinol)-iron chelate was detected from green tongue and green urine in patients with subacute myelo-optic neuropathy (SMON) and identified as a causal material of SMON in 1970. Chinoform was withdrawn from the market, and a fund for relief the health damage caused by ADR was established in 1979. The co-administration of sorivudine and fluorouracil anticancer agents induced fatal agranulocytosis, and sorivudine was withdrawn from the market after being on sale for one month in 1993. The guidelines for package inserts were corrected with this opportunity, and early phase pharmacovigilance of new drugs was introduced later. Since acquired immune deficiency syndrome, and hepatitis B and C were driven by virus-infected blood products, the Ministry of Health, Labor and Welfare tightened regulations regarding biological products in 2003, and a fund for relief of health damage caused by infections driven from biological products was established in 2004. The other remarkable ADRs were quadriceps contracture induced by the repeated administration of muscular injection products and Creutzfeldt-Jakob disease caused by the transplantation of human dry cranial dura matter, etc. The significance of safety measures for drugs based on experiences related to ADRs is worthy of notice. New drugs are approved based on a benefit-risk assessment, if the expected therapeutic benefits outweigh the possible risks associated with treatment. Since unexpected, rare and serious ADRs have been detected after administration to many patients in the post-marketing stage, risk management is required for product life-cycle management.

Controle de riscos à saúde em radiodiagnóstico: uma perspectiva histórica / Control of health risks in radiodiagnosis: a historic approach

Apresenta o histórico da descoberta das radiações ionizantes, seus efeitos biológicos e a conseqüente necessidade de controle dos respectivos riscos à saúde. Descreve a evolução histórica do controle de risco em radiodiagnóstico no Brasil, demonstrando que este pode não estar associado apenas à dose recebida, mas também a erros de diagnóstico e a custos para o sistema de saúde. Salienta que a legislação sanitária tem um amplo leque de co-responsabilidade social para envolver todos os atores visando à proteção da saúde. (AU)

Controle de riscos à saúde em radiodiagnóstico: uma perspectiva histórica / Control of health risks in radiodiagnosis: a historic approach

Apresenta o histórico da descoberta das radiações ionizantes, seus efeitos biológicos e a conseqüente necessidade de controle dos respectivos riscos à saúde. Descreve a evolução histórica do controle de risco em radiodiagnóstico no Brasil, demonstrando que este pode não estar associado apenas à dose recebida, mas também a erros de diagnóstico e a custos para o sistema de saúde. Salienta que a legislação sanitária tem um amplo leque de co-responsabilidade social para envolver todos os atores visando à proteção da saúde.

Evaluating emerging issues in epidemiology.

Industry and government institutions need a credible approach for evaluating and responding to emerging public health issues. Representatives of industry, government, and academia met under the auspices of the International Life Sciences Institute's Health and Environmental Sciences Institute (HESI) to develop successful strategies for dealing with emerging issues based on historical case studies. The case studies chosen for evaluation were (1) tampon use and toxic shock syndrome; (2) hazardous waste and childhood cancer risk in Toms River, New Jersey; (3) fenfluramine and phentermine use and valvular heart disease; (4) silicone breast implants and cancer and auto-immune disease; and (5) progestational drugs and birth defects. We identified eight lessons from these case studies. Foremost, we recommend that public and private institutions not defer action until an issue is scientifically resolved and stress that cooperation among issue stakeholders is critical for effective issue resolution. We suggest establishing a research program as an effective way to assure that good science is included in resolution of the issue. We further recommend frequent and timely communication with all stakeholders, and the development of research approaches to fill gaps when the scientific data on an issue are limited.

Local air quality management as a risk management process: assessing, managing and remediating the risk of exceeding an air quality objective in Great Britain.

Air quality is managed in Great Britain via an effects-based, risk management process designed to provide a dynamic solution to public health issues associated with elevated concentrations of seven specified air pollutants. This paper is concerned with an examination and evaluation of the process of Local Air Quality Management (LAQM) in Great Britain from the late 1980s to date as a risk management process. The statutory basis of LAQM process is provided by the Environment Act 1995. The Act provides a framework in which national and local actions are required to identify and remediate areas of poor air quality. Within this framework, the implementation of the process at national and local levels is considered, leading to an identification and assessment of risks in the formulation and implementation of air quality management policy and practice. Local Authorities began the process of Review and Assessment in 1999 and the first round of the process concluded in 2001. Following this, some 129 Local Authorities declared one or more Air Quality Management Areas (AQMAs). The Review and Assessment elements of the framework were subjected to an evaluation in 2001 and the essential elements of it were confirmed as fit for purpose. The evaluation led to a confirmation of the process of LAQM but also a simplification based on the experience of Round 1. Now, a two step process is required comprising of an Updating and Screening Assessment and, where a risk of exceeding an Air Quality Objective (AQO) is identified, a Detailed Assessment follows. The Government has identified a time scale for Review and Assessment through to 2010 and also introduced the requirement of a regular Progress Report in order that a Local Authority is able to address routine matters of air quality management. The risks inherent in epidemiological or scientific uncertainty are factored into the LAQM process at an early stage of the process and, by identifying the risks and subjecting them to regular review, the process provides a 'level playing field' across spatial and temporal scales. Whilst the process of LAQM described in this paper has been developed for Great Britain, the generic elements of the process are applicable to other countries challenged by air pollution problems which require both national and local action to resolve them.

Thinking beyond the risk factors.

For each risk factor for Black Death he discovered, John Graunt in 1662 made a recommendation for action, such as fleeing the night air brought to the City of London docks on foreign ships. These stopped the plague for 200 years! In this honored guest lecture, I focus on thinking beyond the risk factors to their neutralization by effective action without waiting for perfect knowledge of mechanisms. For example, the decreasing risk of repairing atrioventricular septal defect resulted from risk factors that stimulated focused research to devise a better operation. General reduction in risk reduced mortality of aortic valve replacement in patients with chronic aortic regurgitation and severe left ventricular dysfunction. Optimal timing of surgery after stabilizing patients reduced risk of the Norwood procedure. Managing intractable cardiogenic shock reduced risk-adjusted mortality in post-infarct ventricular septal defect. However, we must think beyond traditional risk factors to neutralization of those brought by patient characteristics, imponderables, treatment delivery systems, institutions delivering care to groups of patients, and society caring for its population. There are limitations to thinking beyond risk factors. First, neutralizing strategies require improving processes or introducing new ones. Yet there may be process-outcome disconnect, or even counterintuitive or contradictory relations among outcomes and what are thought to be best processes. Nevertheless, thinking beyond risk factors to their neutralization by research, innovation, and application of knowledge can be as spectacularly successful as was fleeing foul air in halting Black Death.

Historical investigations: risk management in a New Zealand hospital 1888-1904.

This article reports an historical research project in which four events within one hospital are examined from the point of view of what, today, would be termed 'risk management'. The examples involve a nurse sustaining injury in the course of her work, a fire in the hospital and two instances of patient complaints--one concerning nursing care and the other relating to a time lag between admission to hospital and receiving medical attention. All would have their counterparts in situations dealt with by today's Risk Management Departments. Analysis of the processes followed in investigating these occurrences reveals what seem to be two major differences when compared to present day practices. As well as being smaller in scale and less bureaucratic the earlier investigations were based on a culture of blame. It is argued that modern risk management approaches rather than being geared toward apportioning blame are more focused on understanding what can be learned from the incident with respect to preventing recurrence.

Lessons from the past.

This article considers errors of care in neonatology. In the 19th century errors that resulted in high infant mortality were shaped by the social environment, and in this setting the development of the incubator failed. In the early 20th century, with the emergence of the modern hospital as a technological, science-driven system, physicians had more control of patients' environments, and thus medical errors could occur from systematic care and affected larger numbers. Later in the 20th century, the development of randomized controlled trials and systematic reviews began to improve care and to decrease the risks associated with new treatment methods. Large variations in practice still exist between physicians as individuals and institutions. Considering these variations as risks has led to the use of institutional databases, benchmarking and clinical care guidelines. The efficacy and safety of these methods is unproven. Risks will never disappear from medicine. The question of what risks are 'acceptable' is, in general, unanswerable.

From Bhopal to the informating of environmentalism: risk communication in historical perspective.

This essay describes the development of information technology and culture in the environmental field since the 1980s and how this has led to new understandings of risk communication. The essay also describes how environmental information systems operate as instruments of power, in the way they configure and provide access to knowledge, in the way they manage uncertainty, and in the way they build in and project particular modes of subjectivity. The goal is to provide a brief yet compelling glimpse into the "informating of environmentalism."