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Safety Problems (safety + problem)
Selected AbstractsReview article: infliximab therapy for inflammatory bowel disease , seven years onALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 4 2006P. RUTGEERTS Summary Infliximab, the chimeric monoclonal IgG1 antibody to tumour necrosis factor, is indicated for refractory luminal and fistulizing Crohn's disease and extra-intestinal manifestations of inflammatory bowel disease. Recently, the active ulcerative colitis trials (ACT) studies have shown that infliximab is also efficacious to treat ulcerative colitis resistant to standard therapy. Induction with 5 mg/kg infliximab at weeks 0, 2 and 6 is advocated. The response to infliximab is improved when concomitant immunosuppressive therapy is given. As the majority of patients will relapse if not retreated, a long-term strategy is necessary. Although episodic therapy can be used, the optimal strategy is systematic maintenance treatment with 5 mg/kg intravenous (i.v.) every 8 weeks. Long-term maintenance therapy with infliximab results in a reduction of the rate of complications, hospitalizations and surgeries associated with Crohn's disease. Safety problems with the monoclonal antibody infliximab treatment mainly concern the formation of antibodies to infliximab, which may lead to infusion reactions, loss of response and serum sickness-like delayed infusion reactions. Latent tuberculosis needs to be screened for. The rate of other opportunistic infections is slightly increased mainly in patients treated concomitantly with immunosuppression. There is no evidence that malignancy rates in patients treated with antitumour necrosis factor strategies are increased. [source] The uses and abuses of time: globalization and time arbitrage in India's outsourcing industriesGLOBAL NETWORKS, Issue 1 2009SHEHZAD NADEEM Abstract Globalization has undoubtedly altered our conceptions and experience of time. It has sped up the pace of life and some scholars even suggest that a new temporal order is supplanting ,natural' and pre-existing cycles and rhythms. Yet time is not dissolved in the global circuits of capital. Rather, globalization has brought about a complex mixture of temporal orientations; the workplaces of ,new economy', for example, are traversed by novel and retrograde modes of work pace, rhythm and time-discipline. In this article, I explore the temporal implications of the outsourcing of information technology-based service work to India. Drawing on fieldwork and interviews with workers, managers and executives in the Indian IT and Business Processing Outsourcing industries, I address the following questions: (1) How are corporations using time arbitrage to reap the full benefits of a globally dispersed labour pool? (2) What impacts are these temporal changes having on the health and social lives of Indian workers? For corporations, time arbitrage means increased efficiency and cost-savings. But for workers, it results in long hours, an intense work pace, and temporal displacement. Night-shift employees, such as call centre workers, are particularly vulnerable to such displacement, as manifested in health and safety problems and social alienation. Globalization therefore does not entail the loosening of temporal chains, but their reconfiguration: a combination both rigid and flexible that binds even as it liberates. [source] Recall event timing: Measures of managerial performance in U.S. meat and poultry plantsAGRIBUSINESS : AN INTERNATIONAL JOURNAL, Issue 3 2005Ratapol Teratanavat This study investigates the performance of meat and poultry plant managers in discovering and responding effectively to food safety problems that lead to product recalls. Timing is used as a performance measure of managers' response to recalls of food, using survival distributions of times between production and recall, and recall case duration. The objectives are to understand how these time periods vary across plants and to determine factors explaining such variability. Survival distributions are estimated using the Kaplan-Meier and life table methods. Subgroups of the population are compared using plots of the estimated survival functions and statistically compared using log-rank and Wilcoxon tests. Managers at large plants, in multi-plant firms, and at plants with prior recall experience do not perform better. Cox regressions indicate that government agency sampling programs enhanced the speed of discovery, and that national distribution networks contributed to the risk that cases remained open for a longer period. [EconLit citations: D210, Q180.] © 2005 Wiley Periodicals, Inc. Agribusiness 21: 351,373, 2005. [source] POTENTIAL FOR BACTERIAL GROWTH ON THE FRESH CUT TROPICAL SQUASH, CALABAZA (CURCUBITA MOSCHATA), DURING STORAGEJOURNAL OF FOOD SAFETY, Issue 3 2003REBECCA MONTVILLE ABSTRACT Calabaza (Curcubita moschata) is a tropical squash which is gaining popularity as a specialty crop for agricultural producers in the Northeast United States. It is commonly marketed by being cut in half, wrapped in plastic and may be held unrefrigerated until sold. This method of display is essential for consumer acceptance, yet unrefrigerated storage means that some potential for food safety problems exists. Experiments were conducted to determine the potential for bacterial growth during storage of cut calabaza. Freshly cut calabaza contained between 1.3 and 4.7 log10CFU/g aerobic mesophiles. By 10 h, duplicate counts from some samples exceeded 4 log10 CFU/g. After 24 h of room temperature storage, total aerobic plate counts ranged from 5.2 to 7.7 log10 CFU/g. Rapid bacterial growth on cut calabaza stored at room temperature indicates that these products are highly perishable, and may be able to support the growth of pathogenic bacteria, should they be introduced during the slicing process. [source] Developing an optimal approach to global drug safetyJOURNAL OF INTERNAL MEDICINE, Issue 4 2001R. Balkrishnan Abstract.,Balkrishnan R, Furberg CD (Wake Forest University School of Medicine, Winston-Salem, NC, USA). Developing an optimal approach to global drug safety (Review). J Intern Med 2001: 250; 271,279. An increasing number of media reports on a number of marketed drugs withdrawn because of harmful effects, a scientific report on epidemic proportions of serious adverse drug reactions in hospitalized patients, and a disturbing report on medical mistakes that includes medication errors have recently all brought drug safety into intense focus and placed it under greater scrutiny. Concerted efforts are now being made to understand the causes of drug safety problems and to find ways to reduce their frequency. An international symposium, ,Developing an Optimal Approach to Drug Safety' was held at Wake Forest University in the Fall of 2000 to identify the issues and solutions to extant problems in this area. This report summarizes the resulting discussions of global postmarketing surveillance initiatives and describes efforts to reduce medication errors, and improve global communication about drug safety. [source] The Japanese toxicogenomics project: Application of toxicogenomicsMOLECULAR NUTRITION & FOOD RESEARCH (FORMERLY NAHRUNG/FOOD), Issue 2 2010Takeki Uehara Abstract Biotechnology advances have provided novel methods for the risk assessment of chemicals. The application of microarray technologies to toxicology, known as toxicogenomics, is becoming an accepted approach for identifying chemicals with potential safety problems. Gene expression profiling is expected to identify the mechanisms that underlie the potential toxicity of chemicals. This technology has also been applied to identify biomarkers of toxicity to predict potential hazardous chemicals. Ultimately, toxicogenomics is expected to aid in risk assessment. The following discussion explores potential applications and features of the Japanese Toxicogenomics Project. [source] Introducing triage logic as a new strategy for the detection of signals in the WHO Drug Monitoring Database,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 6 2004M. Ståhl Abstract Purpose An important role for the WHO Programme for International Drug Monitoring is to identify signals of international drug safety problems as early as possible. The signal detection strategy, operated at the Uppsala Monitoring Centre (UMC), gave too many drug,adverse drug reaction (ADR) combinations for individual review. Therefore additional selection strategies were needed to improve the likely signal-to-noise ratio and for the UMC to complement the efforts of national centres in an efficient way. Methods The combinations database of the first quarter of 2001 was analysed using algorithms representing different strategies for finding relevant signals using triage logic. Results The strategies that together gave a manageable number of combinations, i.e. around 600, for further consideration in a single quarter were the algorithms for ,Rapid reporting increase', ,Serious reaction and new drug' and ,Special interests'. These filters began to be used routinely on the combinations database in late 2001. Conclusions While stressing that human review is essential, triage strategies are useful when attempting analysis of large amounts of data. By definition, the use of triage strategies may exclude some potential signals from consideration, although the intention is to improve the chances of detection by focussing on areas of greatest importance. Copyright © 2004 John Wiley & Sons, Ltd. [source] Use root cause analysis to understand and improve process safety culturePROCESS SAFETY PROGRESS, Issue 4 2008Ian S. Sutton Abstract This article describes the topics of root cause analysis and company culture. An evaluation of the root causes of incidents can help identify areas where the culture requires improvement. In addition, an analysis of the nature of root cause can help companies understand their culture. Following an incident, root cause analysis can be conducted for at least four levels of management, (a) line supervision, (b) facility management, (c) executive management, and (d) professionals who write and then implement regulations and standards. This article makes a distinction between root causes for occupational losses and for major process accidents; it emphasizes the teachings that improve one does not automatically improve the other. In other words, a root cause analysis program that addresses the behaviors that correct occupational safety problems may not help correct those behaviors that cause process safety incidents. Examples of how root cause analysis can help a company understand and improve its culture are provided. For instance, companies should recognize the need for both training and education. If process risk is to be reduced, employees need to be educated as well as trained because education creates new behaviors that allow for improved root cause analysis and the aversion of major events. © 2008 American Institute of Chemical Engineers Process Saf Prog 2008 [source] Best starting point to comprehensive process safety educationPROCESS SAFETY PROGRESS, Issue 3 2007Milos Ferjencik Abstract Instruction in process safety began at the Faculty of Chemical Technology, University of Pardubice, in the nineties. In 1994, a course named the Safety Engineering was formed. We aimed to equip our students with a theory that would orientate them in safety problems during their professional lives. Similar to analogous courses at other universities, the Safety Engineering course tends to follow basic steps of the quantitative risk analysis (QRA). An accident analysis and two basic notions,a system and a hazard,were selected as starting points of the course. But after a few years of experience we felt that the Safety Engineering course did not represent exactly what the majority of our students needed. Although the concept of risk analysis represents a fundamental part of any process safety theory, there is another concept that seems to be essential for professionals involved in the process industry,safety management. We started to recognize that an introduction into comprehensive process safety education should be divided into two stages. The safety management and the risk analysis should represent focal points of the first and the second stages, respectively. Two stage arrangement of the process safety course seems to suit needs of our students better than the previous scheme. After the idea of division of the process safety course had arisen, a new starting point for the comprehensive safety education had to be found. An old approach of Kletz's on "learning from accidents" showed itself to be suitable to fulfill this role most naturally. © 2007 American Institute of Chemical Engineers Process Saf Prog 26:195,202, 2007 [source] Food Safety Regulation and the Conflict of Interest: The Case of MeatSafety and E. Coli 0157PUBLIC ADMINISTRATION, Issue 3 2000Richard Schofield The Food Standards Agency (FSA) aims to remove the longstanding conflict of interest between producers and consumers which is thought to lie at the heart of the rising number of food safety problems of recent years, to restore consumer confidence, and to protect public health. This paper sets out firstly to understand what the conflicts are, how they arise and their implications for food safety, and secondly to provide some means of evaluating the proposals for the Food Standards Agency. It does this by examining the current food safety regulatory regime as it relates to e. coli 0157, one of the problems that gave rise to the FSA and an exemplar of the problems of meat safety, and places it in its wider economic context. The results show that the financial pressures on the food industry were such that food hygiene was largely dependent upon external regulation and enforcement. But the deficiencies in the conception, design and implementation of the Food Safety Act, which was fundamentally deregulatory and privileged producer interests, permitted the food safety problems to grow. The case also, by illustrating how the interests of big business predominate in the formulation of public policy at the expense of the public, reveals how the class nature of the state affects public policy and social relations. Without addressing these issues, the problems they give rise to will remain. While the case is based on experiences in Britain, the problem of food safety and the issues raised have an international significance. [source] Effective Safety Management: a Case Study in the Chemical IndustryQUALITY AND RELIABILITY ENGINEERING INTERNATIONAL, Issue 4 2004P. J. M. Sonnemans Abstract A major non-trivial problem within the area of industrial safety management today is to analyse, next to the safety impact of the technical equipment, the safety impact of a ,business process' as currently required by regulation and safety standards. This paper describes a case study of a pesticide company struggling with the question of how to improve the safety of their operational process further and at the same time also improve the reliability of their operational process. According to the literature ,control of the business process' is the keyword to improve the safety and reliability ,performance' of a company. A formal control model is proposed together with a classification system (using maturity levels) to analyse and qualify business processes with respect to their impact on process safety. This method has been applied in a case study where it resulted in a model of a business process. Using the model it was possible to classify the business process control system used and to identify related improvement opportunities. The proposed method showed that, in contrast to the company's perception, it was not the production department that was responsible for most of the problems but the peripheral processes relating to the production department. The interaction between departments caused not only potential safety problems, but also caused system reliability problems. For the company it was demonstrated that the interdependency of the (different activities in the-) operational process is an essential element preventing further improvement if not addressed properly. Copyright © 2004 John Wiley & Sons, Ltd. [source] | ||||||||||||||||