Expansion of nuclear power technology to new countries – SMRs, safety culture issues, and the need for an improved international safety regime

This article reviews the status and prospects of nuclear power around the world and provides a perspective on the need to strengthen national and international safety regimes and bolster nuclear safety culture globally – one prerequisite for a sustained role of the technology in the future. It discusses the prospects in countries that have never deployed nuclear power before but have expressed an interest in adding it to their future national energy mixes. Many of these “newcomer” countries are considering small modular reactor (SMR) designs which hold promise for fitting better into their local electricity systems. Thus, the article considers the technical attributes of these designs and analyzes the advantages and disadvantages of SMRs with an emphasis on economics, grid compatibility and most importantly, safety. Attributes of a safety culture are discussed from social and cultural aspects, including topics of good governance and the presence of an independent national regulatory authority. Beyond the need for strong national safety regulations, the article also highlights the need to strengthen the international regulatory regime, if nuclear power is to succeed in achieving the highest levels of safety globally. Finally, the qualities of such a regime are discussed

HUMAN DISEASE FROM RADON EXPOSURES: THE IMPACT OF ENERGY CONSERVATION IN RESIDENTIAL BUILDINGS

The level of radon and its daughters inside conventional buildings is often higher than the ambient background level. Interest in conserving energy is motivating homeowners and builers to reduce ventilation and hence to increase the concentration of indoor generated air contaminants, including radon. It is unliekly that the current radiation levels in conventional homes and buildings from radon daughters could account for a significant portion of the lung cancer rate in non-smokers. However, it is likely that some increased lung cancer risk would result from increased radon exposures; hence, it is prudent not to allow radon concentrations to rise significantly. There are several ways to implement energy conservation measures without increasing risks

Informatic Tools and Approaches in Postmarketing Pharmacovigilance Used by FDA

The safety profile of newly approved drugs and therapeutic biologics is less well developed by pre-marketing clinical testing than is the efficacy profile. The full safety profile of an approved product is established during years of clinical use. For nearly 40 years, the FDA has relied on the voluntary reporting of adverse events by healthcare practitioners and patients to help establish the safety of marketed products. Epidemiologic studies, including case series, secular trends, case-control and cohort studies, are used to supplement the investigation of a safety signal. Ideally, active surveillance systems would supplement the identification and exploration of safety signals. The FDA has implemented a number of initiatives to help identify safety problems with drugs and continues to evaluate their efforts

Health care use and costs of adverse drug events emerging from outpatient treatment in Germany: A modelling approach

<p>Abstract</p> <p>Background</p> <p>This study's aim was to develop a first quantification of the frequency and costs of adverse drug events (ADEs) originating in ambulatory medical practice in Germany.</p> <p>Methods</p> <p>The frequencies and costs of ADEs were quantified for a base case, building on an existing cost-of-illness model for ADEs. The model originates from the U.S. health care system, its structure of treatment probabilities linked to ADEs was transferred to Germany. Sensitivity analyses based on values determined from a literature review were used to test the postulated results.</p> <p>Results</p> <p>For Germany, the base case postulated that about 2 million adults ingesting medications have will have an ADE in 2007. Health care costs related to ADEs in this base case totalled 816 million Euros, mean costs per case were 381 Euros. About 58% of costs resulted from hospitalisations, 11% from emergency department visits and 21% from long-term care. Base case estimates of frequency and costs of ADEs were lower than all estimates of the sensitivity analyses.</p> <p>Discussion</p> <p>The postulated frequency and costs of ADEs illustrate the possible size of the health problems and economic burden related to ADEs in Germany. The validity of the U.S. treatment structure used remains to be determined for Germany. The sensitivity analysis used assumptions from different studies and thus further quantified the information gap in Germany regarding ADEs.</p> <p>Conclusions</p> <p>This study found costs of ADEs in the ambulatory setting in Germany to be significant. Due to data scarcity, results are only a rough indication.</p

Adverse Drug Reactions Related Hospital Admissions in Persons Aged 60 Years and over, The Netherlands, 1981–2007: Less Rapid Increase, Different Drugs

Background: Epidemiologic information on time trends of Adverse Drug Reactions (ADR) and ADR-related hospitalizations is scarce. Over time, pharmacotherapy has become increasingly complex. Because of raised awareness of ADR, a decrease in ADR might be expected. The aim of this study was to determine trends in ADR-related hospitalizations in the older Dutch population. Methodology and Principal Findings: Secular trend analysis of ADR-related hospital admissions in patients ≥60 years between 1981 and 2007, using the National Hospital Discharge Registry of the Netherlands. Numbers, age-specific and age-adjusted incidence rates (per 10,000 persons) of ADR-related hospital admissions were used as outcome measures in each year of the study. Between 1981 and 2007, ADR-related hospital admissions in persons ≥60 years increased by 143%. The overall standardized incidence rate increased from 23.3 to 38.3 per 10,000 older persons. The increase was larger in males than in females. Since 1997, the increase in incidence rates of ADR-related hospitalizations flattened (percentage annual change 0.65%), compared to the period 1981-1996 (percentage annual change 2.56%). Conclusion/Significance: ADR-related hospital admissions in older persons have shown a rapidly increasing trend in the Netherlands over the last three decades with a temporization since 1997. Although an encouraging flattening in the increasing trend of ADR-related admissions was found around 1997, the incidence is still rising, which warrants sustained attention to this problem

Predicting hospital stay, mortality and readmission in people admitted for hypoglycaemia: prognostic models derivation and validation

Aims/hypothesis: Hospital admissions for hypoglycaemia represent a significant burden on individuals with diabetes and have a substantial economic impact on healthcare systems. To date, no prognostic models have been developed to predict outcomes following admission for hypoglycaemia. We aimed to develop and validate prediction models to estimate risk of inpatient death, 24 h discharge and one month readmission in people admitted to hospital for hypoglycaemia. Methods: We used the Hospital Episode Statistics database, which includes data on all hospital admission to National Health Service hospital trusts in England, to extract admissions for hypoglycaemia between 2010 and 2014. We developed, internally and temporally validated, and compared two prognostic risk models for each outcome. The first model included age, sex, ethnicity, region, social deprivation and Charlson score (‘base’ model). In the second model, we added to the ‘base’ model the 20 most common medical conditions and applied a stepwise backward selection of variables (‘disease’ model). We used C-index and calibration plots to assess model performance and developed a calculator to estimate probabilities of outcomes according to individual characteristics. Results: In derivation samples, 296 out of 11,136 admissions resulted in inpatient death, 1789/33,825 in one month readmission and 8396/33,803 in 24 h discharge. Corresponding values for validation samples were: 296/10,976, 1207/22,112 and 5363/22,107. The two models had similar discrimination. In derivation samples, C-indices for the base and disease models, respectively, were: 0.77 (95% CI 0.75, 0.80) and 0.78 (0.75, 0.80) for death, 0.57 (0.56, 0.59) and 0.57 (0.56, 0.58) for one month readmission, and 0.68 (0.67, 0.69) and 0.69 (0.68, 0.69) for 24 h discharge. Corresponding values in validation samples were: 0.74 (0.71, 0.76) and 0.74 (0.72, 0.77), 0.55 (0.54, 0.57) and 0.55 (0.53, 0.56), and 0.66 (0.65, 0.67) and 0.67 (0.66, 0.68). In both derivation and validation samples, calibration plots showed good agreement for the three outcomes. We developed a calculator of probabilities for inpatient death and 24 h discharge given the low performance of one month readmission models. Conclusions/interpretation: This simple and pragmatic tool to predict in-hospital death and 24 h discharge has the potential to reduce mortality and improve discharge in people admitted for hypoglycaemia

Sodium fast reactor safety and licensing research plan. Volume II.

Expert panels comprised of subject matter experts identified at the U.S. National Laboratories (SNL, ANL, INL, ORNL, LBL, and BNL), universities (University of Wisconsin and Ohio State University), international agencies (IRSN, CEA, JAEA, KAERI, and JRC-IE) and private consultation companies (Radiation Effects Consulting) were assembled to perform a gap analysis for sodium fast reactor licensing. Expert-opinion elicitation was performed to qualitatively assess the current state of sodium fast reactor technologies. Five independent gap analyses were performed resulting in the following topical reports: (1) Accident Initiators and Sequences (i.e., Initiators/Sequences Technology Gap Analysis), (2) Sodium Technology Phenomena (i.e., Advanced Burner Reactor Sodium Technology Gap Analysis), (3) Fuels and Materials (i.e., Sodium Fast Reactor Fuels and Materials: Research Needs), (4) Source Term Characterization (i.e., Advanced Sodium Fast Reactor Accident Source Terms: Research Needs), and (5) Computer Codes and Models (i.e., Sodium Fast Reactor Gaps Analysis of Computer Codes and Models for Accident Analysis and Reactor Safety). Volume II of the Sodium Research Plan consolidates the five gap analysis reports produced by each expert panel, wherein the importance of the identified phenomena and necessities of further experimental research and code development were addressed. The findings from these five reports comprised the basis for the analysis in Sodium Fast Reactor Research Plan Volume I