Applying System Engineering to Pharmaceutical Safety

While engineering techniques are used in the development of medical devices and have been applied to individual healthcare processes, such as the use of checklists in surgery and ICUs, the application of system engineering techniques to larger healthcare systems is less common. System safety is the part of system engineering that uses modeling and analysis to identify hazards and to design the system to eliminate or control them. In this paper, we demonstrate how to apply a new, safety engineering static and dynamic modeling and analysis approach to healthcare systems. Pharmaceutical safety is used as the example in the paper, but the same approach is potentially applicable to other complex healthcare systems. System engineering techniques can be used in re-engineering the system as a whole to achieve the system goals, including both enhancing the safety of current drugs while, at the same time, encouraging the development of new drugs

Temperature determines the diversity and structure of N2O-reducing microbial assemblages

Micro-organisms harbouring the nosZ gene convert N O to N and play a critical role in reducing global N O emissions. As higher denitrifier diversity can result in higher denitrification rates, here we aimed to understand the diversity, composition and spatial structure of N O-reducing microbial assemblages in forest soils across a large latitudinal and temperature gradient. We sequenced nosZ gene amplicons of 126 soil samples from six forests with mean annual soil temperatures (MAST) ranging from 3.7 to 25.3°C and tested predictions of the metabolic theory of ecology (MTE) and metabolic-niche theory (MNT). As predicted, α-diversity of nosZ communities increased with increasing MAST, within-site β-diversity decreased and two (pH and soil moisture) of the three niche widths examined were larger with increasing MAST. We calculated β-nearest taxon distance and Raup–Crick metric to quantify the relative influence of the assembly processes determining nosZ assemblage structure. Environmental selection was the primary process driving assemblage structure in all six forests. Homogenizing dispersal was also important at one site, which could be explained by the site's much lower variability in soil chemistry. We used canonical correspondence analysis and multiple regression on matrices to examine relationships between nosZ communities and environmental factors, and found that temperature and spatial distance were significant predictors of nosZ assemblage structure. Overall our results support both theories (MTE and MNT) tested, showing that higher temperatures are correlated with higher local diversity, wider niche breadths and lower within-site turnover rates. A plain language summary is available for this article. 2 2 2

The catch 22 of condoms in US correctional facilities

<p>Abstract</p> <p>Background</p> <p>Despite the high prevalence of sexually transmitted infections (STIs) and HIV infection in US correctional settings, most jails and prisons in the United States prevent inmates from using condoms to prevent STIs/HIV.</p> <p>Discussion</p> <p>This article makes the following arguments to justify a scalable and feasible next step in the prevention of HIV/STIs among inmates: condoms are a basic and essential part of HIV/STI prevention, HIV/STI transmission occurs in the context of corrections, and several model programs show the feasibility of condom distribution in prisons. A lower end estimate for HIV incidence among incarcerated applied to 2,000,000 new inmates annually results in thousands of new HIV infections acquired each year in corrections that could be prevented with condoms in corrections facilities. Programs from parts of the United States, Canada, and much of Europe show how programs distributing condoms in correctional facilities can be safe and effective.</p> <p>Summary</p> <p>Public health and corrections officials must work together to ensure that condoms and broader sexual disease prevention programs are integrated into US jail and prison health systems.</p

Modern cities modelled as “super-cells” rather than multicellular organisms: Implications for industry, goods and services

The structure and “metabolism” (movement and conversion of goods and energy) of urban areas has caused cities to be identified as “super-organisms”, placed between ecosystems and the biosphere, in the hierarchy of living systems. Yet most such analogies are weak, and render the super-organism model ineffective for sustainable development of cities. Via a cluster analysis of 15 shared traits of the hierarchical living system, we found that industrialized cities are more similar to eukaryotic cells than to multicellular organisms; enclosed systems, such as factories and greenhouses, paralleling organelles in eukaryotic cells. We further developed a “super-cell” industrialized city model: a “eukarcity” with citynucleus (urban area) as a regulating centre, and organaras (enclosed systems, which provide the majority of goods and services) as the functional components, and cityplasm (natural ecosystems and farmlands) as the matrix. This model may improve the vitality and sustainability of cities through planning and management

Evolution of Antiretroviral Drug Costs in Brazil in the Context of Free and Universal Access to AIDS Treatment

Amy Nunn and colleagues analyze the cost of antiretroviral drugs in Brazil between 2001 and 2005 and discuss the implications for HIV treatment in other developing countries

Health care utilisation and problems in accessing health care of female undocumented immigrants in the Netherlands

Contains fulltext : 88419.pdf (publisher's version ) (Closed access)OBJECTIVE: To obtain information about the actual use of health care facilities by undocumented women and to identify obstacles they experience in accessing health care facilities. METHODS: A mixed methods study, with structured questionnaires and semi-structured interviews, was chosen to obtain a complete understanding. One-hundred undocumented women were recruited. Diversity was sought according to age, origin and reason for being undocumented. RESULTS: Undocumented female immigrants have unmet health care needs (56%) and low health care utilisation. Sixty-nine per cent of the women reported obstacles in accessing health care facilities. These included many personal obstacles such as shame, fear and/or lack of information. Poor language proficiency (OR 0.28;. CI 0.09-0.90) reduces utilisation of primary health care services. CONCLUSION: Health care utilisation of undocumented women is low. Undocumented women refrain from seeking health care because of personal obstacles. These women need to be identified and informed about their rights, the health care system and the duty of professional confidentiality of doctors. Finally, institutional obstacles to access care should be removed since they strengthen reluctance to seek help.1 oktober 201

Statin-Associated Muscular and Renal Adverse Events: Data Mining of the Public Version of the FDA Adverse Event Reporting System

OBJECTIVE: Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to assess the muscular and renal adverse events induced by the administration of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) and to attempt to determine the rank-order of the association. METHODS: After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving pravastatin, simvastatin, atorvastatin, or rosuvastatin were analyzed. Authorized pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Myalgia, rhabdomyolysis and an increase in creatine phosphokinase level were focused on as the muscular adverse events, and acute renal failure, non-acute renal failure, and an increase in blood creatinine level as the renal adverse events. RESULTS: Based on 1,644,220 AERs from 2004 to 2009, signals were detected for 4 statins with respect to myalgia, rhabdomyolysis, and an increase in creatine phosphokinase level, but these signals were stronger for rosuvastatin than pravastatin and atorvastatin. Signals were also detected for acute renal failure, though in the case of atorvastatin, the association was marginal, and furthermore, a signal was not detected for non-acute renal failure or for an increase in blood creatinine level. CONCLUSIONS: Data mining of the FDA's adverse event reporting system, AERS, is useful for examining statin-associated muscular and renal adverse events. The data strongly suggest the necessity of well-organized clinical studies with respect to statin-associated adverse events