WorldWideScience

Sample records for generic safety issue

  1. Status of safety issues at licensed power plants: TMI Action Plan requirements; unresolved safety issues; generic safety issues; other multiplant action issues. Supplement 3

    Energy Technology Data Exchange (ETDEWEB)

    1993-12-01

    As part of ongoing US Nuclear Regulatory Commission (NRC) efforts to ensure the quality and accountability of safety issue information, the NRC established a program for publishing an annual report on the status of licensee implementation and NRC verification of safety issues in major NRC requirements areas. This information was initially compiled and reported in three NUREG-series volumes. Volume 1, published in March 1991, addressed the status of Three Mile Island (TMI) Action Plan Requirements. Volume 2, published in May 1991, addressed the status of unresolved safety issues (USIs). Volume 3, published in June 1991, addressed the implementation and verification status of generic safety issues (GSIs). The first annual supplement, which combined these volumes into a single report and presented updated information as of September 30, 1991, was published in December 1991. The second annual supplement, which provided updated information as of September 30, 1992, was published in December 1992. Supplement 2 also provided the status of licensee implementation and NRC verification of other multiplant action (MPA) issues not related to TMI Action Plan requirements, USIs, or GSIs. This third annual NUREG report, Supplement 3, presents updated information as of September 30, 1993. This report gives a comprehensive description of the implementation and verification status of TMI Action Plan requirements, safety issues designated as USIs, GSIs, and other MPAs that have been resolved and involve implementation of an action or actions by licensees. This report makes the information available to other interested parties, including the public. Additionally, this report serves as a follow-on to NUREG-0933, ``A Prioritization of Generic Safety Issues,`` which tracks safety issues until requirements are approved for imposition at licensed plants or until the NRC issues a request for action by licensees.

  2. A prioritization of generic safety issues. Supplement 21, Revision insertion instructions

    Energy Technology Data Exchange (ETDEWEB)

    None, None

    1996-12-31

    The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative.

  3. A prioritization of generic safety issues. Supplement 19, Revision insertion instructions

    Energy Technology Data Exchange (ETDEWEB)

    None

    1995-11-01

    The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative. This document provides revisions and amendments to the report.

  4. Generic safety documentation model

    Energy Technology Data Exchange (ETDEWEB)

    Mahn, J.A.

    1994-04-01

    This document is intended to be a resource for preparers of safety documentation for Sandia National Laboratories, New Mexico facilities. It provides standardized discussions of some topics that are generic to most, if not all, Sandia/NM facilities safety documents. The material provides a ``core`` upon which to develop facility-specific safety documentation. The use of the information in this document will reduce the cost of safety document preparation and improve consistency of information.

  5. Regulatory analysis for the resolution of Generic Safety Issue 29: Bolting degradation or failure in nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Chang, T.Y.

    1991-09-01

    Generic Safety Issue (GSI)-29 deals with staff concerns about public risk due to degradation or failure of safety-related bolting in nuclear power plants. The issue was initiated in November 1982. Value-impact studies of a mandatory program on safety-related bolting for operating plants were inconclusive: therefore, additional regulatory requirements for operating plants could not be justified in accordance with provisions of 10 CFR 50.109. In addition, based on operating experience with bolting in both nuclear and conventional power plants, the actions already taken through bulletins, generic letters, and information notices, and the industry-proposed actions, the staff concluded that a sufficient technical basis exists for the resolution of GSI-29. The staff further concluded that leakage of bolted pressure joints is possible but catastrophic failure of a reactor coolant pressure boundary joint that will lead to significant accident sequences is highly unlikely. For future plants, it was concluded that a new Standard Review Plant section should be developed to codify existing bolting requirements and industry-developed initiatives. 9 refs., 1 tab.

  6. Data quality objectives for generic in-tank health and safety vapor issue resolution. Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    Osborne, J.W.

    1995-04-28

    Data Quality Objectives (DQOs) for generic waste storage tank vapor and gas sampling were developed in facilitated meetings and a stakeholder review session, using the most recent US EPA DQO guidelines. These meetings elicited DQOs for two major vapor problem areas: flammability and toxicity. This is a summary of the outputs of the planning team for each of the 7 steps of the DQO process.

  7. Hanford Generic Interim Safety Basis

    Energy Technology Data Exchange (ETDEWEB)

    Lavender, J.C.

    1994-09-09

    The purpose of this document is to identify WHC programs and requirements that are an integral part of the authorization basis for nuclear facilities that are generic to all WHC-managed facilities. The purpose of these programs is to implement the DOE Orders, as WHC becomes contractually obligated to implement them. The Hanford Generic ISB focuses on the institutional controls and safety requirements identified in DOE Order 5480.23, Nuclear Safety Analysis Reports.

  8. Generic Safety Issue (GSI) 171 -- Engineered Safety Feature (ESF) failure from a loop subsequent to LOCA: Assessment of plant vulnerability and CDF contributions

    Energy Technology Data Exchange (ETDEWEB)

    Martinez-Guridi, G.; Samanta, P.; Chu, L.; Yang, J. [Brookhaven National Lab., Upton, NY (United States)

    1998-03-01

    Generic Safety Issue 171 (GSI-171), Engineered Safety Feature (ESF) from a Loss Of Offsite Power (LOOP) subsequent to a Loss Of Coolant Accident (LOCA), deals with an accident sequence in which a LOCA is followed by a LOOP. This issue was later broadened to include a LOOP followed by a LOCA. Plants are designed to handle a simultaneous LOCA and LOOP. In this paper, the authors address the unique issues that are involved i LOCA with delayed LOOP (LOCA/LOOP) and LOOP with delayed LOCA (LOOP/LOCA) accident sequences. LOCA/LOOP accidents are analyzed further by developing event-tree/fault-tree models to quantify their contributions to core-damage frequency (CDF) in a pressurized water reactor and a boiling water reactor (PWR and a BWR). Engineering evaluation and judgments are used during quantification to estimate the unique conditions that arise in a LOCA/LOOP accident. The results show that the CDF contribution of such an accident can be a dominant contributor to plant risk, although BWRs are less vulnerable than PWRs.

  9. Enhancing Safety through Generic Competencies

    Directory of Open Access Journals (Sweden)

    S. Mockel

    2014-03-01

    Full Text Available This article provides insights into proactive safety management and mitigation. An analysis of accident reports reveals categories of supervening causes of accidents which can be directly linked to the concept of generic competencies (information management, communication and coordination, problem solving, and effect control. These findings strongly suggest adding the human element as another safety-constituting pillar to the concept of ship safety next to technology and regulation. We argue that the human element has unique abilities in dealing with critical and highly dynamic situations which can contribute to the system's recovery from non-routine or critical situations. By educating seafarers in generic competencies we claim to enable the people onboard to successfully deal with critical situations.

  10. A study for the domestic application plan of the Generic Safety Issue(GSI) for the Pressurized Heavy Water Reactor

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Un Chul; Jang, Jin Wook; Lee, Sang Kyung; Lee, Doo Yong; Park, Chang Hwan [Seoul National Univ., Seoul (Korea, Republic of)

    2002-03-15

    In this study, a base work to construct the database of the domestic and foreign GSls were done through performing the deviation of GSls for the PHWR by investigating the development trend of international joint studies and the GSls of 4 countries as the PHWR state and examined the IAEA acceptance of GSls classification for the GSls of Canada, Korea Republic of, Argentina and India. We evaluated the possibility of application of the safety Issue for PHWR by investigating causes, contents and follow-up measures of each items. To evaluate the domestic application validity of the safety issue, We made the investigation matrix for the safety issue of each countries and also are reflecting new results in investigation matrix by examining IAEA PHWR GSI development trend. We intended to derive the GSls which are most appropriate in our PHWR by examining every issues. the derived GSls are divided into the design parts and the operation parts. And they have to be solved as soon as possible.

  11. Generic medicines: issues and relevance for global health.

    Science.gov (United States)

    Rana, Proteesh; Roy, Vandana

    2015-12-01

    Generic medicine is a pharmaceutical product which is bioequivalent to the innovator product in terms of dosage form, strength, route of administration, quality, safety, performance characteristics, and intended use. Generic medicines are a cornerstone for providing affordable medicines to patients. The major generic markets in the world include United States of America followed by European Union, Canada, Japan, and Australia. The major suppliers of generic medicines China and India are showing tremendous growth in the generic medicine sector. There are many legal and regulatory issues along with quality concerns associated with the use of the generic products. Lately, bilateral international agreements called free trade agreements, delaying tactics by originator companies like strategic patenting and litigations on generic manufacturers, have been a major setback for the generic medicine industry. These issues need to be addressed to optimize the use of generic medicines. The sustainability of generic medicine sector is crucial for improving access to essential medicines for the worldwide. © 2015 Société Française de Pharmacologie et de Thérapeutique.

  12. [Generic drugs: quality, efficacy, safety and interchangeability].

    Science.gov (United States)

    Tschabitscher, Doris; Platzer, Peter; Baumgärtel, Christoph; Müllner, Marcus

    2008-01-01

    Since the introduction of generic drugs to the pharmaceutical market a sometimes emotional debate exists whether they are well-investigated and of high quality. There is some uncertainty about whether evidence of bioequivalence is enough to guarantee efficacy and safety of generic drugs. Some physicians ask the question if competent authorities are able to ascertain that the pharmaceutical quality of generics is acceptable. Doctors and patients sometimes are ill at ease about the interchangeability of innovator and generic products. This article describes how the European Union legislation ensures that a generic drug is only approved if its risk-benefit relationship is favourable and that it is essentially similar to the innovator product. In this context pharmacokinetic parameters are accepted as surrogates for clinical results because bioequivalence means therapeutic equivalence as well. For most drugs, current bioequivalence testing generally enables clinicians to routinely substitute generic for innovator products. Published findings, however, suggest that particular drugs may not be ideally suited for generic substitution when a patient is already on that drug. These are the so called critical dose medicinal products (drugs with a narrow therapeutic range). When starting a new therapy with any generic drug, however, its similarity to the innovator drug in terms of efficacy, safety and quality is guaranteed.

  13. Current safety issues of CANDU licensing

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Y. [University of Ottawa, Ottawa (Canada); Natalizio, A. [ENSAC Associates, Ontario (Canada)

    1994-01-15

    As requested by Korea Institute of Nuclear Safety(KINS), the status of five generic licensing issues has been examined and their potential impact on a new plant that would be constructed in Canada has been evaluated. The results and conclusions of this evaluation are summarized as follows: steam explosion in calandria, hydrogen explosion in containment, use of PSA in reactor licensing, human factors, safety critical software.

  14. Generic substitution: issues for problematic drugs.

    Science.gov (United States)

    Henderson, J D; Esham, R H

    2001-01-01

    The methodology and criteria for bioequivalence testing have been firmly established by the Food and Drug Administration (FDA). For certain drugs with a narrow therapeutic index (e.g., digoxin, levothyroxine, warfarin), generic substitution may not be advisable or even allowable, depending on the substitution laws of individual states. Digoxin and levothyroxine tablets are examples of drugs for which no New Drug Applications (NDAs) currently exist. However, commercially available generic products for both of these drugs have not been determined by the FDA to be therapeutically equivalent to the innovator products. Generic versions of warfarin have been approved by the FDA as being therapeutically equivalent to the innovator products, as have generic versions of the rescue inhaler albuterol. Yet, misinformation and myths persist regarding the adequacy and proven reliability of the FDA's determination of bioequivalence for these products.

  15. Status of generic actions items and safety analysis system of PHWR

    Energy Technology Data Exchange (ETDEWEB)

    Park, Joo Hwan; Min, Byung Joo

    2001-05-01

    This report described the review results of a GAIs(Generic Action Item) currently issued on safety analysis of PHWR(Pressurized Heavy Water Reactor) and the research activities and positions to solve the GAIs in each country which possess PHWRs. eviewing the Final Safety Analysis Report for Wolsong-2/3/4 Units, the safety analysis methodology, classification for accident scenarios, safety analysis codes, their interface, etc.. were described. From the present review report, it is intended to establish the CANDU safety analysis system by providing the better understandings and development plans for the safety analysis of PHWR. esults.

  16. A generic operational strategy to qualify translational safety biomarkers.

    Science.gov (United States)

    Matheis, Katja; Laurie, David; Andriamandroso, Christiane; Arber, Nadir; Badimon, Lina; Benain, Xavier; Bendjama, Kaïdre; Clavier, Isabelle; Colman, Peter; Firat, Hüseyin; Goepfert, Jens; Hall, Steve; Joos, Thomas; Kraus, Sarah; Kretschmer, Axel; Merz, Michael; Padro, Teresa; Planatscher, Hannes; Rossi, Annamaria; Schneiderhan-Marra, Nicole; Schuppe-Koistinen, Ina; Thomann, Peter; Vidal, Jean-Marc; Molac, Béatrice

    2011-07-01

    The importance of using translational safety biomarkers that can predict, detect and monitor drug-induced toxicity during human trials is becoming increasingly recognized. However, suitable processes to qualify biomarkers in clinical studies have not yet been established. There is a need to define clear scientific guidelines to link biomarkers to clinical processes and clinical endpoints. To help define the operational approach for the qualification of safety biomarkers the IMI SAFE-T consortium has established a generic qualification strategy for new translational safety biomarkers that will allow early identification, assessment and management of drug-induced injuries throughout R&D. Copyright © 2011 Elsevier Ltd. All rights reserved.

  17. Economic issues on food safety

    Directory of Open Access Journals (Sweden)

    Felice Adinolfi

    2016-03-01

    Full Text Available A globalised food trade, with a huge increase of the exchanged volume, extensive production and complex supply chains are contributing towards an increased number of microbiological food safety outbreaks. All of these factors are putting pressure on the stakeholders, either public or private, in terms of rule and control. In fact, this scenario could force manufacturers to be lenient towards food safety control intentionally, or unintentionally, and result in a major foodborne outbreak that causes health problems and economic loss. As a response to emerging calls for the adoption of a systemic approach to food safety, we try to identify and discuss the several related economics issue in this field. Based on an extensive analysis of academic and policy literatures on the economic effects of global environmental change at different stages of the food system, we highlight the main issues involving economists in the field of food safety. In the first part, we assessed the several approaches and problems related to the evaluation of food safety improvements, followed by an overview of drivers of food safety demand in the second part. The third section is devoted to discussing changes occurred at the institutional level in building and managing food safety policies. The last section summarises the main considerations aroused from the work.

  18. Economic Issues on Food Safety

    Science.gov (United States)

    Adinolfi, Felice; Capitanio, Fabian

    2016-01-01

    A globalised food trade, with a huge increase of the exchanged volume, extensive production and complex supply chains are contributing towards an increased number of microbiological food safety outbreaks. All of these factors are putting pressure on the stakeholders, either public or private, in terms of rule and control. In fact, this scenario could force manufacturers to be lenient towards food safety control intentionally, or unintentionally, and result in a major foodborne outbreak that causes health problems and economic loss. As a response to emerging calls for the adoption of a systemic approach to food safety, we try to identify and discuss the several related economics issue in this field. Based on an extensive analysis of academic and policy literatures on the economic effects of global environmental change at different stages of the food system, we highlight the main issues involving economists in the field of food safety. In the first part, we assessed the several approaches and problems related to the evaluation of food safety improvements, followed by an overview of drivers of food safety demand in the second part. The third section is devoted to discussing changes occurred at the institutional level in building and managing food safety policies. The last section summarises the main considerations aroused from the work. PMID:27800432

  19. Economic Issues on Food Safety.

    Science.gov (United States)

    Adinolfi, Felice; Di Pasquale, Jorgelina; Capitanio, Fabian

    2016-01-18

    A globalised food trade, with a huge increase of the exchanged volume, extensive production and complex supply chains are contributing towards an increased number of microbiological food safety outbreaks. All of these factors are putting pressure on the stakeholders, either public or private, in terms of rule and control. In fact, this scenario could force manufacturers to be lenient towards food safety control intentionally, or unintentionally, and result in a major foodborne outbreak that causes health problems and economic loss. As a response to emerging calls for the adoption of a systemic approach to food safety, we try to identify and discuss the several related economics issue in this field. Based on an extensive analysis of academic and policy literatures on the economic effects of global environmental change at different stages of the food system, we highlight the main issues involving economists in the field of food safety. In the first part, we assessed the several approaches and problems related to the evaluation of food safety improvements, followed by an overview of drivers of food safety demand in the second part. The third section is devoted to discussing changes occurred at the institutional level in building and managing food safety policies. The last section summarises the main considerations aroused from the work.

  20. ISSUES OF FETUS DRUG SAFETY

    Directory of Open Access Journals (Sweden)

    A.V. Ostrovskaya

    2010-01-01

    Full Text Available The article is focused on the issue of fetus drug safety. Development of a child’s health depends both on hereditary information and environment factors. The reason for deviation from the process of normal prenatal development could be any xenobiotics, physical factors and some medications having a pathogenic effect during pregnancy on the embryo and fetus. Due to that, the physician’s preventive work based on the knowledge of embryogenesis processes and critical development periods. Key words: teratogenic action, medications, prenatal development, congenital malformation, newborns, children.(Pediatric Pharmacology. – 2010; 7(1:25-28

  1. Guidelines for nuclear power plant safety issue prioritization information development. Supplement 5

    Energy Technology Data Exchange (ETDEWEB)

    Daling, P.M.; Lavender, J.C. [Pacific Northwest National Lab., Richland, WA (United States)

    1996-07-01

    This is the sixth in a series of reports to document the development and use of a methodology developed by the Pacific Northwest Laboratory (PNL) to calculate, for prioritization purposes, the risk, dose, and cost impacts of implementing potential resolutions to reactor safety issues (see NUREG/CR-2800, Andrews, et al., 1983). This report contains the results of issue-specific analyses for 34 generic issues. Each issue was considered within the constraints of available information at the time the issues were examined and approximately 2 staff-weeks of labor. The results are referenced as one consideration in NUREG-0933, A Prioritization of Generic Safety Issues (Emrit, et al., 1983).

  2. Generic medicine pricing in Europe: current issues and future perspective.

    Science.gov (United States)

    Simoens, Steven

    2008-01-01

    This editorial discusses a number of trends affecting the pricing of generic medicines in Europe. With respect to pricing, recent evidence has emerged that European generic medicine manufacturers face competition from Indian manufacturers; that the price level of generic medicines varies substantially between European countries; and that generic medicine manufacturers engage in competition by discount rather than price competition in France, The Netherlands and the UK. These trends suggest that there may be scope for further reducing the prices of generic medicines in several countries. In relation to reference pricing, most European countries have incorporated market incentives within reference pricing systems with a view to promoting price competition. The European experience indicates that the generic medicines industry delivers competitive prices under a reference pricing system if demand-side policies are in place that stimulate physicians, pharmacists and patients to use generic medicines. Finally, caution needs to be exercised when focusing on the drivers of generic medicine pricing as these drivers not only vary between countries, but may also vary within a country. Manufacturers of originator and generic medicines do not take a single pricing approach following patent expiry, but vary their pricing strategy from molecule to molecule.

  3. Maintenance as a safety issue.

    Science.gov (United States)

    White, Jim

    2008-11-01

    Because safety is related to electrical power systems maintenance, it seems reasonable to assume there could be legal issues if maintenance is not performed. OSHA has not yet taken the stand that not performing maintenance as required by the manufacturer, NFPA 70B, or ANSI/NETA MTS-07 constitutes a willful violation. OSHA defines a willful citation as one where: "the employer knowingly commits with plain indifference to the law. The employer either knows that what he or she is doing constitutes a violation, or is aware that a hazardous condition existed and made no reasonable effort to eliminate it". However, NFPA 70E 2009 requires this maintenance, and OSHA has stated on its Web site that NFPA 70E is "a guide for meeting the requirements of the OSHA electrical regulations". In addition, federal courts have found that NFPA 70E is "standard industry practice." Once a company receives and accepts a willful citation, especially if received as the result of an accident investigation, its worker's compensation protection no longer shields it. One definition given by a trial attorney for a willful citation was that it is equal to negligent behavior. Be smart: Maintain that equipment and save yourself major problems, including unscheduled shutdowns and possible litigation.

  4. Guidelines for nuclear power plant safety issue prioritization information development. Supplement 4

    Energy Technology Data Exchange (ETDEWEB)

    Tabatabai, A.S.; Fecht, B.A.; Powers, T.B.; Bickford, W.E.; Andrews, W.B.; Gallucci, R.H.V.; Bian, S.H.; Daling, P.M.; Eschbach, E.J.; Allen, C.H.

    1986-07-01

    This is the fifth in a series of reports to document the use of a methodology developed by the Pacific Northwest Laboratory to calculate, for prioritization purposes, the risk, dose and cost impacts of implementing resolutions to reactor safety issues (NUREG/CR-2800, Andrews et al. 1983). This report contains results of issue-specific analyses for 23 issues. Each issue was considered within the constraints of available information as of winter 1986, and two staff-weeks of labor. The results are referenced, as one consideration in setting priorities for reactor safety issues, in NUREG-0933, ''A Prioritization of Generic Safety Issues.''

  5. Guidelines for nuclear power plant safety issue prioritization information development. Supplement 2

    Energy Technology Data Exchange (ETDEWEB)

    Andrews, W.B.; Gallucci, R.H.V.; Konzek, G.J.; Heaberlin, S.W.; Fecht, B.A.; Allen, C.H.; Allen, R.D.; Bickford, W.E., Carbaugh, E.H.; Lewis, J.R.

    1983-12-01

    This is the third in a series of reports to document the use of a methodology developed by the Pacific Northwest Laboratory to calculate, for prioritization purposes, the risk, dose and cost impacts of implementing resolutions to reactor safety issues (NUREG/CR-2800, Andrews et al. 1983). This report contains results of issue-specific analyses for 31 issues. Each issue was considered within the constraints of available information as of summer 1983, and two staff-weeks of labor. The results are referenced, as one consideration in setting priorities for reactor safety issues, in NUREG-0933, A Prioritization of Generic Safety Issues.

  6. Regulatory Analysis for the resolution of Generic Issue 142: Leakage through electrical isolators in instrumentation circuits

    Energy Technology Data Exchange (ETDEWEB)

    Rourk, C.J.

    1993-09-01

    Generic Issue (GI) 142 deals with staff concerns about the design of isolation devices used to ensure separation between Class 1E and non-Class 1E electrical control and instrumentation circuits. This issue was initiated in June 1987. Staff reviews of the implementation of the Safety Parameter Display System (SPDS) requirement indicated that some isolation devices used to provide an interface between the non-Class 1E SPDS and the Class 1E safety systems would allow signal leakage if electrically challenged. It was unknown if the amount of leakage posed a hazard to safe operation of the Class 1E system. A review of failure records does not reveal any incidents of system damage caused by isolation device challenge. Furthermore, a review of existing PRA data indicates that the safety significance of ID challenge is low, at the expected challenge event frequency. However, based upon the potential design variations in future control systems resulting from application of computer technology, additional design and qualification test requirements for future plants are recommended.

  7. Newest generic OC manufacturer issues recall after packaging snafu.

    Science.gov (United States)

    1987-04-01

    Due to a packaging error that left white placebo pills in place of active pills, Gynex Inc. has had to recall 325,000 packages of generic oral contraceptives (OC), a mistake that the company insists has not affected consumers. Company vice president Stephen M. Simes says that although the majority of the defective packages remain in the possession of wholesalers and chain store warehouses, some had been shipped to pharmacies. But presently, it seems that none have reached consumers. Recently entering the generic OC market, the company's packaging error involved its first shipment of Gynex 1/35E and Gynex 0.5/35 in 28-day packs. These two generics are copy products on ON 1/35, made by Ortho Pharmaceutical, Modicon/Brevicon, made by Ortho Pharmaceutical and Syntex Laboratories--two widely used OCs. While the company is still investigating the incident, Simes explains that the company is enacting changes in the packaging procedures and is considering alterations in machinery and in quality control. The error will probably represent a financial loss for the company, and it will delay Gynex's entry into the contraceptive market. But the California-based company plans to press ahead, having already filed marketing applications for 5 additional low-dose OC formulations.

  8. Editorial safety science special issue road safety management.

    NARCIS (Netherlands)

    Wegman, F.C.M. & Hagezieker, M.P.

    2014-01-01

    The articles presented in this Special Issue on Road Safety Management represent an illustration of the growing interest in policy-related research in the area of road safety. The complex nature of this type of research combined with the observation that scientific journals pay limited attention to

  9. Road safety issues for bus transport management.

    Science.gov (United States)

    Cafiso, Salvatore; Di Graziano, Alessandro; Pappalardo, Giuseppina

    2013-11-01

    Because of the low percentage of crashes involving buses and the assumption that public transport improves road safety by reducing vehicular traffic, public interest in bus safety is not as great as that in the safety of other types of vehicles. It is possible that less attention is paid to the significance of crashes involving buses because the safety level of bus systems is considered to be adequate. The purpose of this study was to evaluate the knowledge and perceptions of bus managers with respect to safety issues and the potential effectiveness of various technologies in achieving higher safety standards. Bus managers were asked to give their opinions on safety issues related to drivers (training, skills, performance evaluation and behaviour), vehicles (maintenance and advanced devices) and roads (road and traffic safety issues) in response to a research survey. Kendall's algorithm was used to evaluate the level of concordance. The results showed that the majority of the proposed items were considered to have great potential for improving bus safety. The data indicated that in the experience of the participants, passenger unloading and pedestrians crossing near bus stops are the most dangerous actions with respect to vulnerable users. The final results of the investigation showed that start inhibition, automatic door opening, and the materials and internal architecture of buses were considered the items most strongly related to bus passenger safety. Brake assistance and vehicle monitoring systems were also considered to be very effective. With the exception of driver assistance systems for passenger and pedestrian safety, the perceptions of the importance of other driver assistance systems for vehicle monitoring and bus safety were not unanimous among the bus company managers who participated in this survey. The study results showed that the introduction of new technologies is perceived as an important factor in improving bus safety, but a better understanding

  10. The safety issues of medical robotics

    Energy Technology Data Exchange (ETDEWEB)

    Fei Baowei; Ng, W.S.; Chauhan, Sunita; Kwoh, Chee Keong

    2001-08-01

    In this paper, we put forward a systematic method to analyze, control and evaluate the safety issues of medical robotics. We created a safety model that consists of three axes to analyze safety factors. Software and hardware are the two material axes. The third axis is the policy that controls all phases of design, production, testing and application of the robot system. The policy was defined as hazard identification and safety insurance control (HISIC) that includes seven principles: definitions and requirements, hazard identification, safety insurance control, safety critical limits, monitoring and control, verification and validation, system log and documentation. HISIC was implemented in the development of a robot for urological applications that was known as URObot. The URObot is a universal robot with different modules adaptable for 3D ultrasound image-guided interstitial laser coagulation, radiation seed implantation, laser resection, and electrical resection of the prostate. Safety was always the key issue in the building of the robot. The HISIC strategies were adopted for safety enhancement in mechanical, electrical and software design. The initial test on URObot showed that HISIC had the potential ability to improve the safety of the system. Further safety experiments are being conducted in our laboratory.

  11. MIIT Issued Industrial Key Generic Technology Development Guidelines (2011)

    Institute of Scientific and Technical Information of China (English)

    2011-01-01

    In order to make full use of social resources, guide conducts of market subject, lead the developing direction of industrial key generic technology, promote industrial technology advance and realize transformation, upgrading and structural optimization of industry and communications industry, on July 1, the Ministry of Industry and Information Technology (MIIT) issued Industrial Key Generic Technology Development Guidelines (2011) (Gong Xin Bu Ke [2011] No.320),

  12. Generic frames and tonality: Mapping a polarizing issue in a multifaceted context

    OpenAIRE

    Gündüz, Ali Asker; Schedler, Kuno; Ciocan, Dumitru

    2016-01-01

    This study explores the feasibility and usefulness of five generic frames (conflict, responsibility, economic consequences, human interest and morality) in analysing framing practices in a multifaceted journalistic field over time. We show that supplementing generic frames through the tonality expressed in news stories enhances analytical quality. Mapping Swiss media outlets by how they frame a highly polarizing policy, we identify different framing practices in covering the issue. Using mult...

  13. Value impact analysis of Generic Issue 143, Availability of Heating, Ventilation, Air Conditioning (HVAC) and Chilled Water Systems

    Energy Technology Data Exchange (ETDEWEB)

    Daling, P.M.; Marler, J.E.; Vo, T.V.; Phan, H.; Friley, J.R. [Pacific Northwest Lab., Richland, WA (United States)

    1993-11-01

    This study evaluates the values (benefits) and impacts (costs) associated with potential resolutions to Generic Issue 143, ``Availability of HVAC and Chilled Water Systems.`` The study identifies vulnerabilities related to failures of HVAC, chilled water, and room cooling systems; develops estimates of room heatup rates and safety-related equipment vulnerabilities following losses of HVAC/room cooler systems; develops estimates of the core damage frequencies and public risks associated with failures of these systems; develops three proposed resolution strategies to this generic issue; and performs a value/impact analysis of the proposed resolutions. Existing probabilistic risk assessments for four representative plants, including one plant from each vendor, form the basis for the core damage frequency and public risk calculations. Both internal and external events were considered. It was concluded that all three proposed resolution strategies exceed the $1,000/person-rem cost-effectiveness ratio. Additional evaluations were performed to develop ``generic`` insights on potential design-related and configuration-related vulnerabilities and potential high-frequency ({approximately}1E-04/RY) accident sequences that involve failures of HVAC/room cooling functions. It was concluded that, although high-frequency accident sequences may exist at some plants, these high-frequency sequences are plant-specific in nature or have been resolved through hardware and/or operational changes. The plant-specific Individual Plant Examinations are an effective vehicle for identification and resolution of these plant-specific anomalies and hardware configurations.

  14. Safety and efficacy of generic drugs with respect to brand formulation.

    Science.gov (United States)

    Gallelli, Luca; Palleria, Caterina; De Vuono, Antonio; Mumoli, Laura; Vasapollo, Piero; Piro, Brunella; Russo, Emilio

    2013-12-01

    Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations. In conclusion, the use of generic drugs could be related with an increased days of disease (time to relapse) or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side-effects.

  15. Safety and efficacy of generic drugs with respect to brand formulation

    Directory of Open Access Journals (Sweden)

    Luca Gallelli

    2013-01-01

    Full Text Available Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations. In conclusion, the use of generic drugs could be related with an increased days of disease (time to relapse or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side-effects.

  16. Analysis of high burnup fuel safety issues

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Chan Bock; Kim, D. H.; Bang, J. G.; Kim, Y. M.; Yang, Y. S.; Jung, Y. H.; Jeong, Y. H.; Nam, C.; Baik, J. H.; Song, K. W.; Kim, K. S

    2000-12-01

    Safety issues in steady state and transient behavior of high burnup LWR fuel above 50 - 60 MWD/kgU were analyzed. Effects of burnup extension upon fuel performance parameters was reviewed, and validity of both the fuel safety criteria and the performance analysis models which were based upon the lower burnup fuel test results was analyzed. It was found that further tests would be necessary in such areas as fuel failure and dispersion for RIA, and high temperature cladding corrosion and mechanical deformation for LOCA. Since domestic fuels have been irradiated in PWR up to burnup higher than 55 MWD/kgU-rod. avg., it can be said that Korea is in the same situation as the other countries in the high burnup fuel safety issues. Therefore, necessary research areas to be performed in Korea were derived. Considering that post-irradiation examination(PIE) for the domestic fuel of burnup higher than 30 MWD/kgU has not been done so far at all, it is primarily necessary to perform PIE for high burnup fuel, and then simulation tests for RIA and LOCA could be performed by using high burnup fuel specimens. For the areas which can not be performed in Korea, international cooperation will be helpful to obtain the test results. With those data base, safety of high burnup domestic fuels will be confirmed, current fuel safety criteria will be re-evaluated, and finally transient high burnup fuel behavior analysis technology will be developed through the fuel performance analysis code development.

  17. Qualified Presumption of Safety (QPS) is a generic risk assessment approach applied by the European Food Safety Authority (EFSA)

    DEFF Research Database (Denmark)

    Leuschner, R. G. K.; Robinson, T. P.; Hugas, M.;

    2010-01-01

    Qualified Presumption of Safety (QPS) is a generic risk assessment approach applied by the European Food Safety Authority (EFSA) to notified biological agents aiming at simplifying risk assessments across different scientific Panels and Units. The aim of this review is to outline the implementation...... and value of the QPS assessment for EFSA and to explain its principles such as the unambiguous identity of a taxonomic unit, the body of knowledge including potential safety concerns and how these considerations lead to a list of biological agents recommended for QPS which EFSA keeps updated through...

  18. Efficacy and safety of innovator versus generic drugs in patients with epilepsy: a systematic review.

    Science.gov (United States)

    Talati, Ripple; Scholle, Jennifer M; Phung, Olivia P; Baker, Erika L; Baker, William L; Ashaye, Ajibade; Kluger, Jeffrey; Coleman, Craig I; White, C Michael

    2012-04-01

    Generic antiepileptic drugs achieve blood concentrations similar to those of innovator drugs in healthy volunteers, but their comparative effectiveness has not been well evaluated. Thus, we assessed the efficacy, tolerability, and safety of innovator versus generic antiepileptic drugs. We searched the MEDLINE database, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Web of Science for studies that evaluated innovator and generic antiepileptic drugs in patients with epilepsy and reported data on prespecified outcomes. We extracted data on study design, interventions, quality criteria, study population, baseline characteristics, and outcomes. Compared with initiation of innovator antiepileptic drugs, initiation of generic antiepileptic drugs did not significantly alter seizure occurrence (relative risk [RR] 0.87, 95% confidence interval [CI] 0.64-1.18; strength of evidence: low) or frequency (standardized mean difference 0.03, 95% CI -0.08-0.14; strength of evidence: low), withdrawals due to lack of efficacy (RR 1.02, 95% CI 0.41-2.54; strength of evidence: low) or adverse events (RR 0.79, 95% CI 0.28-2.20; strength of evidence: low), pharmacokinetic concentrations (maximum, minimum, or area under the curve [strength of evidence: low]), or a myriad of adverse events (strength of evidence: low or insufficient) in clinical trials. In qualitatively evaluated observational studies, switching between forms of antiepileptic drug (innovator to generic, generic to generic) may increase the risk of hospitalization (strength of evidence: low), hospital stay duration (strength of evidence: low), and a composite end point of medical service utilization (strength of evidence: insufficient) but may not increase outpatient service utilization (strength of evidence: low). Data are limited predominantly to carbamazepine, phenytoin, and valproic acid. Clinical trials are limited by small sample size, short-term nature, and lack of

  19. Dust Combustion Safety Issues for Fusion Applications

    Energy Technology Data Exchange (ETDEWEB)

    L. C. Cadwallader

    2003-05-01

    This report summarizes the results of a safety research task to identify the safety issues and phenomenology of metallic dust fires and explosions that are postulated for fusion experiments. There are a variety of metal dusts that are created by plasma erosion and disruptions within the plasma chamber, as well as normal industrial dusts generated in the more conventional equipment in the balance of plant. For fusion, in-vessel dusts are generally mixtures of several elements; that is, the constituent elements in alloys and the variety of elements used for in-vessel materials. For example, in-vessel dust could be composed of beryllium from a first wall coating, tungsten from a divertor plate, copper from a plasma heating antenna or diagnostic, and perhaps some iron and chromium from the steel vessel wall or titanium and vanadium from the vessel wall. Each of these elements has its own unique combustion characteristics, and mixtures of elements must be evaluated for the mixture’s combustion properties. Issues of particle size, dust temperature, and presence of other combustible materials (i.e., deuterium and tritium) also affect combustion in air. Combustion in other gases has also been investigated to determine if there are safety concerns with “inert” atmospheres, such as nitrogen. Several coolants have also been reviewed to determine if coolant breach into the plasma chamber would enhance the combustion threat; for example, in-vessel steam from a water coolant breach will react with metal dust. The results of this review are presented here.

  20. Prescribing Generic Medication in Chronic Musculoskeletal Pain Patients: An Issue of Representations, Trust, and Experience in a Swiss Cohort.

    Science.gov (United States)

    Piguet, Valérie; D'Incau, Stéphanie; Besson, Marie; Desmeules, Jules; Cedraschi, Christine

    2015-01-01

    Parallel to an ever stronger advocacy for the use of generics, various sources of information report concerns regarding substitution. The literature indicates that information regarding substitution is not univocal. The aim of this qualitative study was to explore patients' representations regarding generics in patients suffering from non-specific disabling chronic musculoskeletal pain, as these patients are confronted with the issue of the prescription and/or substitution of original formulations with generics. Qualitative methods were selected because the aim was to access the range of patients' representations and to consider their conceptions. Standardized face-to-face semi-structured interviews were used, and transcripts were submitted to content analysis. Patients' representations suggest that they might be confident in taking a generic medication: when he/she has an understanding of generics as resulting from a development process that has become part of the public domain; the generic medication is prescribed by the physician; each prescription is discussed, i.e., the patient is prescribed the generic version of a given medication and not a generic medication. Economic arguments are not sufficient to justify substitution, and may even raise issues calling upon cognitive dissonance. Even in non-life-threatening diseases, negative cues require attention and need be de-emphasized - in particular lower price as an indication of lower quality, and generic status as contradictory with advocating individualization of medication.

  1. Prescribing Generic Medication in Chronic Musculoskeletal Pain Patients: An Issue of Representations, Trust, and Experience in a Swiss Cohort.

    Directory of Open Access Journals (Sweden)

    Valérie Piguet

    Full Text Available Parallel to an ever stronger advocacy for the use of generics, various sources of information report concerns regarding substitution. The literature indicates that information regarding substitution is not univocal. The aim of this qualitative study was to explore patients' representations regarding generics in patients suffering from non-specific disabling chronic musculoskeletal pain, as these patients are confronted with the issue of the prescription and/or substitution of original formulations with generics.Qualitative methods were selected because the aim was to access the range of patients' representations and to consider their conceptions. Standardized face-to-face semi-structured interviews were used, and transcripts were submitted to content analysis.Patients' representations suggest that they might be confident in taking a generic medication: when he/she has an understanding of generics as resulting from a development process that has become part of the public domain; the generic medication is prescribed by the physician; each prescription is discussed, i.e., the patient is prescribed the generic version of a given medication and not a generic medication.Economic arguments are not sufficient to justify substitution, and may even raise issues calling upon cognitive dissonance. Even in non-life-threatening diseases, negative cues require attention and need be de-emphasized - in particular lower price as an indication of lower quality, and generic status as contradictory with advocating individualization of medication.

  2. COMPARATIVE EFFICACY AND SAFETY OF HYPOLIPIDEMIC THERAPY WITH GENERIC AND ORIGINAL MEDICINAL PRODUCTS OF SIMVASTATIN

    Directory of Open Access Journals (Sweden)

    E. I. Tarlovskaya

    2011-01-01

    Full Text Available Aim. To compare efficacy , safety and pharmacoeconomical characteristics of generic and original medicinal products of simvastatin in achievement of cholesterol and low density lipoprotein target levels. Material and methods. 38 patients with arterial hypertension accompanied by type 2 diabetes with dyslipidemia were included into the study. They had no clinically obvious ischemic heart disease and did not receive hypolipidemic pharmacotherapy for a month before the study start. The patients were randomized into group A or group B. Patients of group A (n=18 received original simvastatin, patients of group B (n=20 received generic simvastatin. Initial simvastatin dose was 20 mg daily. Lipid plasma profile, liver enzymes, creatine phosphokinase were evaluated every 4 weeks. Cost-effectiveness ratio was calculated. Results. 11 patients (61% in group A and only 5 patients (25% in group B (χ2=5.05; р<0.05 achieved cholesterol target level with simvastatin in dose of 20 mg daily in 3 months of the treatment. Creatine phosphokinase blood level did not increase significantly. Achievement of cholesterol target level cost 814 and 952 RUB per patient in groups A and B, respectively , in 1 month of simvastatin treatment. These costs were 643 and 417 RUB per patient in groups A and B, respectively , in 3 months of treatment. Conclusion. The original simvastatin in comparison with generic one has advantages in hypolipidemic effect. Safety profile is similar for both medications. Original simvastatin therapy has lower cost than this for generic simvastatin therapy in achievement of cholesterol target level in 1 month of treatment. In 3 months the cost of treatment per patient is 227 RUB higher for original medication in comparison with this for generic medication.

  3. Emerging food safety issues: An EU perspective.

    Science.gov (United States)

    McEvoy, John D G

    2016-05-01

    Safe food is the right of every citizen of the European Union (EU). A comprehensive and dynamic framework of food and feed safety legislation has been put in place and the EU's executive arm - the European Commission - is responsible for ensuring that the EU member states apply food law consistently. Similarly, the Commission plays an important role in ensuring that imported food meets the EU's stringent food safety standards. Consumer perceptions of unsafe food tend to focus on acute outbreaks of bacterial or viral origin. In recent years there have been a number of diverse food crises associated with fraudulent activity which may (e.g. melamine in dairy products in China) or may not (e.g. the horse meat scandal in the EU) represent a genuine food safety risk. Well publicized incidents of chronic exposure to chemical contamination in the EU (e.g. dioxins in meat and mycotoxins in nuts) have required robust coordinated policy responses from the Commission. Despite the decreasing incidence of non-compliant residues of veterinary medicinal products and banned substances in animal products, EU consumers are increasingly concerned about the use of such products in food-producing animals, including in the context of the build-up of antimicrobial resistance in animals and transfer to humans. The Commission plays a key role in coordination of the EU member states' responses to such incidents, in risk management, and in preparation for emerging issues. This paper focuses on how the EU as a whole has dealt with a number of food crises, and what can be learned from past incidents. Copyright © 2016 John Wiley & Sons, Ltd.

  4. Responding to safety issues in frontotemporal dementias.

    Science.gov (United States)

    Talerico, K A; Evans, L K

    2001-06-01

    As frontotemporal dementia progresses in individuals, safety issues related to behaviors and injury become a paramount concern. In addition to self-care deficits, frontotemporal dementias are often characterized by behavioral manifestations that include aggression and disinhibition. These behaviors may place the patient and caregivers at risk of injury, stress, and social embarrassment, and frequently lead to institutionalization. Additionally, motor disturbances associated with frontotemporal dementias may contribute to risk of injury from falls. The authors present an integrated biopsychosocial model to guide assessment of needs that may be expressed through behavior. Environmental, behavioral, and psychosocial strategies to assist caregivers in preventing and responding to behaviors and risks are discussed, with the goal of promoting maximum function and quality of life and minimizing caregiver strain. The authors discuss the dangers of physical restraints, which are commonly suggested as a response to fall risk and behavioral symptoms without an awareness of research-based data regarding their lack of efficacy. Benefits and risks of a variety of need-based interventions are presented in a practical, clinically relevant manner. The discussion of diverse safety-enhancing interventions is intended to enable clinicians and caregivers to identify individualized care strategies for patients with frontotemporal dementia.

  5. Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984

    OpenAIRE

    Garth Boehm; Lixin Yao; Liang Han; Qiang Zheng

    2013-01-01

    The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed, including the process of approval for generic drugs, bioequivalence issues including “switchability”, bioequivalence for complicated dosage forms, patent extension, generic drug safety, generic substitution and low-cost generics. The backlog in generic review, generic drug user fees, and “quality by design” for generic drugs is also discussed. The evolution of the ...

  6. Generic safety questions. evaluation of investigations, studies and expertises of other states for the knowledge base GeSi; Generische Sicherheitsfragen. Auswertung von Untersuchungen, Studien und Gutachten anderer Staaten fuer die Wissensbasis GeSi

    Energy Technology Data Exchange (ETDEWEB)

    Boenigke, Guenther; Eismar, Shanna

    2016-03-15

    For the non-profit-making expert organization Gesellschaft fuer Anlagen- und Reaktorsicherheit (GRS) gGmbH, maintaining know-how and broadening its knowledge in the field of nuclear safety is of fundamental relevance. One important approach to achieving this goal is to collect and assess national and international findings and events in the field of nuclear safety e.g. in connection with generic issues - i.e. issues that are not specific to a particular plant. The GeSi/GeSi International database and its subsystems serves for reflecting the current state of the art in science and technology in the field of generic issues and also as a tool in the area of knowledge management. Within the framework of Project 3611 I 01500 sponsored by the BMUB, information on these issues was compiled systematically. The aim of the project was to examine the safety issues that are cur-rently discussed at national and international level with regard to their relevance for the conditions prevailing in Germany and to follow up in detail those issues that are of relevance for national safety practice. Similar knowledge databases also exist in other major nuclear-power-plant-operating countries such as the US, Canada, and France. At present (September 2014), there are 303 issues in the overall database, of which 23 are assessed to be of ''high'' significance for German plants. Of these, 16 issues belong to the sub-database for generic safety issues (GSI) and seven belong to the sub-database for generic research issues (GFO). The database GSI currently contains 138 issues that need to be further addressed and 101 issues that are considered as solved. 43 issues from the database GFO require further investigation, while 21 issues are considered as solved.

  7. EFFICIENCY AND SAFETY ASSESSMENT OF GENERIC ATORVASTATINE IN PATIENTS WITH HYPERLIPIDEMIA

    Directory of Open Access Journals (Sweden)

    J. E. Semyonova

    2015-12-01

    Full Text Available Aim. To assess in a short-term study efficiency and safety of hypolipidemic therapy with atorvastatine generic, Tulip, in comparison with simvastatine generic, Vasilip, in hyperlipidemic patients.Material and methods. Open, randomized, comparative, cross over study included 87 patients with hyperlipidemia, who didn’t receive hypolipidemic drugs within 6 weeks, or followed hypolipidemic diet for 4 weeks. Each patient received therapy with one of the studied drugs within 6 weeks. Then after 4-week wash-out period the second therapy with the other drug was held. Consequence of courses with each drug was set by randomization. Initial dose of both drugs was 10 mg daily. Dose was adjusted after 3 weeks. The dose was increased to 20 mg daily if cholesterol of low density lipoproteid (CLDL hadn’t reached target level (< 115 mg/dl. of Treatment safety was assessed on the basis of clinical data, hepatic enzymes activity and creatine phosphokinase levels.Results. It is shown, that to reach target figures of plasma lipid spectrum, Vasilip dose was increased significantly more often, than Tulip dose. Average Tulip dose after titration was 14,8 mg daily, Vasilip dose – 15,6 mg daily. Patients with initially higher level of triglycerides (TG > 170 mg/dl after 6 weeks with Tulip treatment showed TG reduction by 38% and with Vasilip treatment – by 20%. Both drugs showed good tolerance, no significant differences in number of side-effects were observed.Conclusion. 6-week treatment with atorvastatine generic Tulip shows significant hypolipidemic effect, which appears in significant reduction of CLDL, total cholesterol, TG compared to the initial levels. Degree of total cholesterol reduction is significantly higher with Tulip treatment compared to Vasilip treatment. Analyses shown that target levels of the assessed figures were reached in more patients, treated with Tulip. Side-effects in Tulip treatment were not severe.

  8. China Launches Great Initiatives against Food Safety Issue

    Institute of Scientific and Technical Information of China (English)

    Xinhua News Agency

    2011-01-01

    @@ China is launching its greatest initiative against the recurrent food safety issue, one of the most determined efforts China has exercised in dealing with the public concerned food safety issue ever.Li Keqiang, vice premier of the State Council, raised his hope that people from all walks of life could be actively engaged into this initiative and create with joint efforts a good environment for concerning about, supporting and maintaining the food safety.

  9. Safety issues with bisphosphonate therapy for osteoporosis

    DEFF Research Database (Denmark)

    Suresh, Ernest; Pazianas, Michael; Abrahamsen, Bo

    2014-01-01

    this to guide clinicians. Osteonecrosis of the jaw from low-dose BP used for osteoporosis is very rare, and mainly a complication with high-dose i.v. BP used in oncology. The risk of atrial fibrillation too is negligible, and a definite link cannot be established between BP and oesophageal cancer. BP should...... be avoided in patients with severe renal impairment and during pregnancy and lactation because of limited safety data. Further epidemiological and clinical data are required to establish safety of BP in long-term users (>5 years) and provide evidence-based management....

  10. Nuclear power plant safety related pump issues

    Energy Technology Data Exchange (ETDEWEB)

    Colaccino, J.

    1996-12-01

    This paper summarizes of a number of pump issues raised since the Third NRC/ASME Symposium on Valve and Pump Testing in 1994. General issues discussed include revision of NRC Inspection Procedure 73756, issuance of NRC Information Notice 95-08 on ultrasonic flow meter uncertainties, relief requests for tests that are determined by the licensee to be impractical, and items in the ASME OM-1995 Code, Subsection ISTB, for pumps. The paper also discusses current pump vibration issues encountered in relief requests and plant inspections - which include smooth running pumps, absolute vibration limits, and vertical centrifugal pump vibration measurement requirements. Two pump scope issues involving boiling water reactor waterlog and reactor core isolation cooling pumps are also discussed. Where appropriate, NRC guidance is discussed.

  11. Safety Issues with Hydrogen as a Vehicle Fuel

    Energy Technology Data Exchange (ETDEWEB)

    L. C. Cadwallader; J. S. Herring

    1999-09-01

    This report is an initial effort to identify and evaluate safety issues associated with the use of hydrogen as a vehicle fuel in automobiles. Several forms of hydrogen have been considered: gas, liquid, slush, and hydrides. The safety issues have been discussed, beginning with properties of hydrogen and the phenomenology of hydrogen combustion. Safety-related operating experiences with hydrogen vehicles have been summarized to identify concerns that must be addressed in future design activities and to support probabilistic risk assessment. Also, applicable codes, standards, and regulations pertaining to hydrogen usage and refueling have been identified and are briefly discussed. This report serves as a safety foundation for any future hydrogen safety work, such as a safety analysis or a probabilistic risk assessment.

  12. Safety Issues with Hydrogen as a Vehicle Fuel

    Energy Technology Data Exchange (ETDEWEB)

    Cadwallader, Lee Charles; Herring, James Stephen

    1999-10-01

    This report is an initial effort to identify and evaluate safety issues associated with the use of hydrogen as a vehicle fuel in automobiles. Several forms of hydrogen have been considered: gas, liquid, slush, and hydrides. The safety issues have been discussed, beginning with properties of hydrogen and the phenomenology of hydrogen combustion. Safety-related operating experiences with hydrogen vehicles have been summarized to identify concerns that must be addressed in future design activities and to support probabilistic risk assessment. Also, applicable codes, standards, and regulations pertaining to hydrogen usage and refueling have been identified and are briefly discussed. This report serves as a safety foundation for any future hydrogen safety work, such as a safety analysis or a probabilistic risk assessment.

  13. Health, safety and environmental issues in thin film manufacturing

    NARCIS (Netherlands)

    Alsema, E.A.; Baumann, A.E.; Hill, R.; Patterson, M.H.

    1997-01-01

    An investigation is made of Health, Safety and Environmental (HSE) aspects for the manufacturing, use and decommissioning of CdTe, CIS and a-Si modules. Issues regarding energy requirements, resource availability, emissions of toxic materials, occupational health and safety and module waste

  14. Health, safety and environmental issues in thin film manufacturing

    NARCIS (Netherlands)

    Alsema, E.A.; Baumann, A.E.; Hill, R.; Patterson, M.H.

    2006-01-01

    An investigation is made of Health, Safety and Environmental (HSE) aspects for the manufacturing, use and decommissioning of CdTe, CIS and a-Si modules. Issues regarding energy requirements, resource availability, emissions of toxic materials, occupational health and safety and module waste treatmen

  15. Slowdown, safety, main issues for rig movers

    Energy Technology Data Exchange (ETDEWEB)

    Budd, G.

    2001-12-01

    The nature of the transportation service segment of the oil and gas industry is discussed with emphasis of how companies in this field adapt to downturns and demand spikes of the industry. The role played by the safety revolution that has swept the oil patch in the last decade, such as restrictions on the number of hours of service that truckers can perform daily, mandatory logbooks and the variety of certification required of trucking crews are described. The influence of technology, such as satellite and Internet technology, satellite cellphones, satellite tracking and dispatching of vehicles, and more specialized and bigger and heavier equipment that has to be moved, are highlighted.

  16. Gender issues on occupational safety and health.

    Science.gov (United States)

    Sorrentino, Eugenio; Vona, Rosa; Monterosso, Davide; Giammarioli, Anna Maria

    2016-01-01

    The increasing proportion of women in the workforce raises a range of gender-related questions about the different effects of work-related risks on men and women. Few studies have characterized gender differences across occupations and industries, although at this time, the gender sensitive approach is starting to acquire relevance in the field of human preventive medicine. The European Agency for Safety and Health at Work has encouraged a policy of gender equality in all European member states. Italy has adopted European provisions with new specific legislation that integrates the previous laws and introduces the gender differences into the workplace. Despite the fact that gender equal legislation opportunities have been enacted in Italy, their application is delayed by some difficulties. This review examines some of these critical aspects.

  17. Safety Issues Concerning the Medical Use of Cannabis and Cannabinoids

    Directory of Open Access Journals (Sweden)

    Mark A Ware

    2005-01-01

    Full Text Available Safety issues are a major barrier to the use of cannabis and cannabinoid medications for clinical purposes. Information on the safety of herbal cannabis may be derived from studies of recreational cannabis use, but cannabis exposure and effects may differ widely between medical and recreational cannabis users. Standardized, quality-controlled cannabinoid products are available in Canada, and safety profiles of approved medications are available through the Canadian formulary. In the present article, the evidence behind major safety issues related to cannabis use is summarized, with the aim of promoting informed dialogue between physicians and patients in whom cannabinoid therapy is being considered. Caution is advised in interpreting these data, because clinical experience with cannabinoid use is in the early stages. There is a need for long-term safety monitoring of patients using cannabinoids for a wide variety of conditions, to further guide therapeutic decisions and public policy.

  18. Modern Issues in Food Safety-A Perspective

    Institute of Scientific and Technical Information of China (English)

    James N Seiber

    2012-01-01

    INTRODUCTION There is much current interest worldwide in food safety.This results in large part from well publicized outbreaks due to foodborne pathogens,chemical food safety related to pesticides,and from persistent organic pollutants and other synthetic contaminants.Additionally,the melamine adulteration issue,acrylamide and other processing-induced toxicants in foods,petroleum hydrocarbons associated with oil spills in the oceans and seafood safety,mycotoxins and other natural contaminants in a variety of foods,and the perceived risks associated with foods improved by genetic modification or those protected by irradiation contribute to concerns over the safety of the food supply.

  19. Staying silent about safety issues: Conceptualizing and measuring safety silence motives.

    Science.gov (United States)

    Manapragada, Archana; Bruk-Lee, Valentina

    2016-06-01

    Communication between employees and supervisors about safety-related issues is an important component of a safe workplace. When supervisors receive information from employees about safety issues, they may gain otherwise-missed opportunities to correct these issues and/or prevent negative safety outcomes. A series of three studies were conducted to identify various safety silence motives, which describe the reasons that employees do not speak up to supervisors about safety-related issues witnessed in the workplace, and to develop a tool to assess these motives. Results suggest that employees stay silent about safety issues based on perceptions of altering relationships with others (relationship-based), perceptions of the organizational climate (climate-based), the assessment of the safety issue (issue-based), or characteristics of the job (job-based). We developed a 17-item measure to assess these four motives, and initial evidence was found for the construct and incremental validity of the safety silence motives measure in a sample of nurses.

  20. Safety Issues for HIFU Transducer Design

    Science.gov (United States)

    Fleury, Gérard; Berriet, Rémi; Chapelon, Jean Yves; ter Haar, Gail; Lafon, Cyril; Le Baron, Olivier; Chupin, Laurent; Pichonnat, Fabrice; Lenormand, Jérôme

    2005-03-01

    In contrast with most ultrasound modalities for medical applications, (especially ultrasound imaging), High Intensity Focused Ultrasound (HIFU) involves technologies and procedures which may present risk to the patient. These risks, resulting from the high power levels required for effective therapy, should be taken into account at the earliest stages in the design of a system dedicated to HIFU treatment. An understanding of these risks must thus be shared amongst the many players in the field of therapy using high power ultrasound. Moreover, since the number of applications of HIFU has increased appreciably over recent years and the technology is ready to move from the research to the industrial level, it is worth now considering solutions that should be put in place to guarantee the safety of the patient during HIFU treatment. This paper reports thoughts on this, identifies some risks to the patient that must be taken into consideration in the design of HIFU transducers, and proposes some solutions that could prevent the deleterious consequences of transducer misuse or failure. For the main risks identified, such as exceeding the desired acoustic power or poor control of tissue targeting, a description of transducer performance that could potentially result in problems is systematically sought. This allows proposals for precautions to be taken during operation to be made. Parameters which should be monitored to ensure safe use are also suggested. This type of approach, which should be undertaken for the different components of a therapeutic system, highlights the challenges that must be faced in the immediate future for the development and safe exploitation of HIFU systems. The necessity for standard definitions of the parameters to be checked or monitored during HIFU treatments is crucial in this approach, as is the availability of reliable dedicated measurement devices. Co-ordinated action on these topics in the HIFU community would contribute to the

  1. Arsenic trioxide: safety issues and their management

    Institute of Scientific and Technical Information of China (English)

    Wing-Yan AU; Yok-Lam KWONG

    2008-01-01

    Arsenic trioxide (As2O3) has been used medicinally for thousands of years.Its therapeutic use in leukaemia was described a century ago.Recent rekindling in the interest of As2O3 is due to its high efficacy in acute promyelocytic leukaemia (APL).As2O3 has also been tested clinically in other blood and solid cancers.Most studies have used intravenous As2O3,although an oral As2O3 is equally efficacious.Side effects of As2O3 are usually minor,including skin reactions,gastrointestinal upset,and hepatitis.These respond to symptomatic treatment or temporary drug cessation,and do not compromise subsequent treatment with As2O3.During induction therapy in APL,a leucocytosis may occasionally occur,which can be associated with fluid accumulation and pulmonary infiltration.The condition is similar to the APL differentiation syndrome during treatment with all-trans retinoic acid,and responds to cytoreductive treatment and corticosteroids.Intravenous As2O3 treatment leads to QT prolongation.In the presence of under-lying cardiopulmonary diseases or electrolyte disturbances,particularly hypokalaemia and hypomagnesaemia,serious arrhythmias may develop,with torsades du pointes reported in 1% of cases.This may be related to a dose-dependent arsenic-mediated inhibition of potassium ion channels that compro-mises cardiac repolarization.Because of slow intestinal absorption,oral-As2O3 gives a lower plasma arsenic concentration,which is associated with lesser QT prolongation and hence a more favorable cardiac safety profile.As2O3 does not appear to enter the central nervous system.However,if the blood brain barrier is breached,elemental arsenic may enter the cerebrospinal fluid.As2O3 is predomi-nantly excreted in the kidneys,and dose adjustment is required when renal func-tion is impaired.

  2. Resolution of thermal-hydraulic safety and licensing issues for the system 80+{sup {trademark}} design

    Energy Technology Data Exchange (ETDEWEB)

    Carpentino, S.E.; Ritterbusch, S.E.; Schneider, R.E. [ABB-Combustion Engineering, Windsor, CT (United States)] [and others

    1995-09-01

    The System 80+{sup {trademark}} Standard Design is an evolutionary Advanced Light Water Reactor (ALWR) with a generating capacity of 3931 MWt (1350 MWe). The Final Design Approval (FDA) for this design was issued by the Nuclear Regulatory Commission (NRC) in July 1994. The design certification by the NRC is anticipated by the end of 1995 or early 1996. NRC review of the System 80+ design has involved several new safety issues never before addressed in a regulatory atmosphere. In addition, conformance with the Electric Power Research Institute (EPRI) ALWR Utility Requirements Document (URD) required that the System 80+ plant address nuclear industry concerns with regard to design, construction, operation and maintenance of nuclear power plants. A large number of these issues/concerns deals with previously unresolved generic thermal-hydraulic safety issues and severe accident prevention and mitigation. This paper discusses the thermal-hydraulic analyses and evaluations performed for the System 80+ design to resolve safety and licensing issues relevant to both the Nuclear Stream Supply System (NSSS) and containment designs. For the NSSS design, the Safety Depressurization System mitigation capability and resolution of the boron dilution concern are described. Examples of containment design issues dealing with containment shell strength, robustness of the reactor cavity walls and hydrogen mixing under severe accident conditions are also provided. Finally, the overall approach used in the application of NRC`s new (NUREG-1465) radiological source term for System 80+ evaluation is described. The robustness of the System 80+ containment design to withstand severe accident consequences was demonstrated through detailed thermal-hydraulic analyses and evaluations. This advanced design to shown to meet NRC severe accident policy goals and ALWR URD requirements without any special design features and unnecessary costs.

  3. Nuclear Plant/Hydrogen Plant Safety: Issues and Approaches

    Energy Technology Data Exchange (ETDEWEB)

    Steven R. Sherman

    2007-06-01

    The U.S. Department of Energy, through its agents the Next Generation Nuclear Plant Project and the Nuclear Hydrogen Initiative, is working on developing the technologies to enable the large scale production of hydrogen using nuclear power. A very important consideration in the design of a co-located and connected nuclear plant/hydrogen plant facility is safety. This study provides an overview of the safety issues associated with a combined plant and discusses approaches for categorizing, quantifying, and addressing the safety risks.

  4. Comparison of the long-term efficacy and safety of generic Tacrobell with original tacrolimus (Prograf) in kidney transplant recipients

    Science.gov (United States)

    Son, Seung Yeon; Jang, Hye Ryoun; Lee, Jung Eun; Yoo, Heejin; Kim, Kyunga; Park, Jae Berm; Kim, Sung Joo; Oh, Ha Young; Huh, Wooseong

    2017-01-01

    This study aimed to evaluate the long-term efficacy and safety of a generic tacrolimus (Tacrobell [TCB]) compared to the original tacrolimus (Prograf [PGF]) in kidney transplant recipients. In this retrospective observational study, we analyzed the data from 444 patients who took TCB as a first-line immunosuppressive drug and 245 patients who took PGF. The 5-year graft survival rate was 92% for patients in the PGF group and 97% for patients in the TCB group, respectively. Cox proportional hazards for a one-sided, noninferiority model showed noninferiority (upper confidence interval [CI] limit of the hazard ratio [HR]drug. Producers of generics should support further study of their products after approval to assure physicians of their efficacy and safety. PMID:28138224

  5. Food supply and food safety issues in China.

    Science.gov (United States)

    Lam, Hon-Ming; Remais, Justin; Fung, Ming-Chiu; Xu, Liqing; Sun, Samuel Sai-Ming

    2013-06-08

    Food supply and food safety are major global public health issues, and are particularly important in heavily populated countries such as China. Rapid industrialisation and modernisation in China are having profound effects on food supply and food safety. In this Review, we identified important factors limiting agricultural production in China, including conversion of agricultural land to other uses, freshwater deficits, and soil quality issues. Additionally, increased demand for some agricultural products is examined, particularly those needed to satisfy the increased consumption of animal products in the Chinese diet, which threatens to drive production towards crops used as animal feed. Major sources of food poisoning in China include pathogenic microorganisms, toxic animals and plants entering the food supply, and chemical contamination. Meanwhile, two growing food safety issues are illegal additives and contamination of the food supply by toxic industrial waste. China's connections to global agricultural markets are also having important effects on food supply and food safety within the country. Although the Chinese Government has shown determination to reform laws, establish monitoring systems, and strengthen food safety regulation, weak links in implementation remain.

  6. Occupational safety and health issues associated with green building

    NARCIS (Netherlands)

    Terwoert, J.; Ustailieva, E.

    2013-01-01

    This e-fact provides information on the work-related risk factors and the occupational safety and health (OSH) issues associated the planning and construction of green buildings, their maintenance, renovation (retrofitting), demolition, on-site waste collection. Some of these OSH risks are new compa

  7. At Issue: Classroom Management and Safety, an Annotated Bibliography

    Science.gov (United States)

    Pricer, Wayne F.

    2008-01-01

    In the wake of the horrific shootings at Virginia Tech and Northern Illinois University, many colleges and universities have begun to reexamine and reevaluate classroom management strategies and practices. Several institutions have taken additional steps to try to deal with the issue of physical safety in the classroom. This article presents an…

  8. Characterization strategy report for the organic safety issues

    Energy Technology Data Exchange (ETDEWEB)

    Goheen, S.C.; Campbell, J.A.; Fryxell, G.E. [and others

    1997-08-01

    This report describes a logical approach to resolving potential safety issues resulting from the presence of organic components in hanford tank wastes. The approach uses a structured logic diagram (SLD) to provide a pathway for quantifying organic safety issue risk. The scope of the report is limited to selected organics (i.e., solvents and complexants) that were added to the tanks and their degradation products. The greatest concern is the potential exothermic reactions that can occur between these components and oxidants, such as sodium nitrate, that are present in the waste tanks. The organic safety issue is described in a conceptual model that depicts key modes of failure-event reaction processes in tank systems and phase domains (domains are regions of the tank that have similar contents) that are depicted with the SLD. Applying this approach to quantify risk requires knowing the composition and distribution of the organic and inorganic components to determine (1) how much energy the waste would release in the various domains, (2) the toxicity of the region associated with a disruptive event, and (3) the probability of an initiating reaction. Five different characterization options are described, each providing a different level of quality in calculating the risks involved with organic safety issues. Recommendations include processing existing data through the SLD to estimate risk, developing models needed to link more complex characterization information for the purpose of estimating risk, and examining correlations between the characterization approaches for optimizing information quality while minimizing cost in estimating risk.

  9. Characterization strategy report for the organic safety issues

    Energy Technology Data Exchange (ETDEWEB)

    Goheen, S.C.; Campbell, J.A.; Fryxell, G.E. [and others

    1997-08-01

    This report describes a logical approach to resolving potential safety issues resulting from the presence of organic components in hanford tank wastes. The approach uses a structured logic diagram (SLD) to provide a pathway for quantifying organic safety issue risk. The scope of the report is limited to selected organics (i.e., solvents and complexants) that were added to the tanks and their degradation products. The greatest concern is the potential exothermic reactions that can occur between these components and oxidants, such as sodium nitrate, that are present in the waste tanks. The organic safety issue is described in a conceptual model that depicts key modes of failure-event reaction processes in tank systems and phase domains (domains are regions of the tank that have similar contents) that are depicted with the SLD. Applying this approach to quantify risk requires knowing the composition and distribution of the organic and inorganic components to determine (1) how much energy the waste would release in the various domains, (2) the toxicity of the region associated with a disruptive event, and (3) the probability of an initiating reaction. Five different characterization options are described, each providing a different level of quality in calculating the risks involved with organic safety issues. Recommendations include processing existing data through the SLD to estimate risk, developing models needed to link more complex characterization information for the purpose of estimating risk, and examining correlations between the characterization approaches for optimizing information quality while minimizing cost in estimating risk.

  10. Internet Safety Issues for Adolescents and Adults with Intellectual Disabilities

    Science.gov (United States)

    Buijs, Petra C. M.; Boot, Erik; Shugar, Andrea; Fung, Wai Lun Alan; Bassett, Anne S.

    2017-01-01

    Background: Research on Internet safety for adolescents has identified several important issues including unwanted exposure to sexual material and sexual solicitation. Methods: Although individuals with intellectual disabilities often have poor insight and judgment, and may therefore be at risk for Internet dangers, there is surprisingly little…

  11. Food Safety. Nourishing News. Volume 3, Issue 10

    Science.gov (United States)

    Idaho State Department of Education, 2009

    2009-01-01

    Serving safe food is a critical responsibility for maintaining quality foodservice programs and healthy environments at schools and child care facilities. Child Nutrition Programs hopes you find this newsletter of assistance when reviewing the food safety program you have at each serving site. The articles contained in this issue are: (1) A…

  12. Internet Safety Issues for Adolescents and Adults with Intellectual Disabilities

    Science.gov (United States)

    Buijs, Petra C. M.; Boot, Erik; Shugar, Andrea; Fung, Wai Lun Alan; Bassett, Anne S.

    2017-01-01

    Background: Research on Internet safety for adolescents has identified several important issues including unwanted exposure to sexual material and sexual solicitation. Methods: Although individuals with intellectual disabilities often have poor insight and judgment, and may therefore be at risk for Internet dangers, there is surprisingly little…

  13. Ecological Issues Related to Children's Health and Safety

    Science.gov (United States)

    Aldridge, Jerry; Kohler, Maxie

    2009-01-01

    Issues concerning the health and safety of children and youth occur at multiple levels. Bronfenbrenner (1995) proposed an ecological systems approach in which multiple systems interact to enhance or diminish children's development. The same systems are at work in health promotion. The authors present and review articles that reflect the multiple…

  14. Selected Issues in Persistent Asynchronous Adaptive Specialization for Generic Functional Array Programming

    NARCIS (Netherlands)

    C. Grelck; H. Wiesinger

    2014-01-01

    Asynchronous adaptive specialization of rank- and shape-generic code for processing immutable (purely functional) multi-dimensional arrays has proven to be an effective technique to reconcile the desire for abstract specifications with the need to achieve reasonably high performance in sequential as

  15. Generics Substitution, Bioequivalence Standards, and International Oversight: Complex Issues Facing the FDA.

    Science.gov (United States)

    Bate, Roger; Mathur, Aparna; Lever, Harry M; Thakur, Dinesh; Graedon, Joe; Cooperman, Tod; Mason, Preston; Fox, Erin R

    2016-03-01

    The regulations for assessing the quality of generic drugs and their bioequivalence to innovator products are outdated and need to be substantially modernized. There are multiple reasons why these changes are needed, including: (i) the regulations remain largely unchanged since the passage of the Hatch-Waxman Act in 1984; (ii) medication therapies have become substantially more complex over the three decades since the passage of the Act; (iii) a switch from an innovator drug to a generic drug, or switching from one generic to another, is not a benign process - there is substantial clinical professional judgment involved and in some instances these decisions should be better informed; and (iv) pharmaceutical ingredients for finished products, whether innovator or generic, are from multiple sources of supply, adding variability in their production, and which may not be accounted for in specification tolerances. When these elements are viewed together, they clearly suggest that more transparency of responsible manufacturers in product labels and updated standards for bioequivalence are required.

  16. Iraqi Nurses’ Perspectives on Safety Issues in Maternity Services

    Directory of Open Access Journals (Sweden)

    Jamil Piro

    2015-09-01

    Full Text Available Background Studies introduce maternal and neonatal safety phenomena as important challenges to the public health, particularly in low-income countries. However, few researches are conducted on the identification of safety issues in maternity hospitals in Iraq. It was the first study on nurses’ perspectives on safety issues in Kurdistan, Iraq. Objectives The current study aimed to describe nurses’ perspectives on what constitutes a safe maternity service in Kurdistan, Iraq. Patients and Methods A qualitative design, based on a content analysis approach, was used. Ten Kurdish nurses who worked in the delivery room of Kurdistan, Iraq maternity hospital were recruited through purposive sampling. Semi-structured interviews were performed to collect data. All interviews were audiotaped and transcribed verbatim. Sampling continued to the level of data saturation. Data analysis was performed based on the steps suggested by Graneheim and Lundman. Results Thematic analysis led to the identification of six main categories including stressful job, lack of schedule and job description, providing care with limited resources, professional unaccountability, regional sociopolitical factors, and inadequate training. Conclusions Iraqi nurses identified factors such as limited health resources, lack of job description, and professional unaccountability as major safety issues in maternity services. These findings alarm the need to ensure the provision of females and neonates with appropriate care. This, however, would require coordination between Iraqi Kurdistan health authorities to provide midwifery care facilities, high-quality and relevant staff training, and an effective healthcare system in the maternity units.

  17. [GENERIC DRUGS: IS BIOEQUIVALENCE SUFFICIENT TO ENSURE QUALITY, EFFICACY AND SAFETY?].

    Science.gov (United States)

    Carrillo Norte, Juan Antonio; Postigo Mota, Salvador

    2015-05-01

    This article is focusing on the current debate that prescription of generic drugs is producing among patients and healthcare professionals. Following European Medicine Agency (EMA) recommendations, a number of generic medicines have recently been withdrawn from the market in Spain. The authorization for these generic drugs was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India. The EMA inspection of GVK revealed data manipulation of electrocardiograms during the development of some studies of generic medicines. These manipulations had taken place over a period of at least five years. The article is also dealing with the consideration that bioavailability and bioequivalence studies receive as a cornerstone to approve generic drugs, and the discrepancies between the national regulatory agencies of medicines to implement guidelines of approval. Likewise, in the last few years, the rapid expansion of clinical trial activity regarding generic medicines and other drugs in emerging markets, is often leading to doubt on the integrity of the way trials were performed and on the reliability of data obtained from these studies.

  18. Editorial: emerging issues in sociotechnical systems thinking and workplace safety.

    Science.gov (United States)

    Noy, Y Ian; Hettinger, Lawrence J; Dainoff, Marvin J; Carayon, Pascale; Leveson, Nancy G; Robertson, Michelle M; Courtney, Theodore K

    2015-01-01

    The burden of on-the-job accidents and fatalities and the harm of associated human suffering continue to present an important challenge for safety researchers and practitioners. While significant improvements have been achieved in recent decades, the workplace accident rate remains unacceptably high. This has spurred interest in the development of novel research approaches, with particular interest in the systemic influences of social/organisational and technological factors. In response, the Hopkinton Conference on Sociotechnical Systems and Safety was organised to assess the current state of knowledge in the area and to identify research priorities. Over the course of several months prior to the conference, leading international experts drafted collaborative, state-of-the-art reviews covering various aspects of sociotechnical systems and safety. These papers, presented in this special issue, cover topics ranging from the identification of key concepts and definitions to sociotechnical characteristics of safe and unsafe organisations. This paper provides an overview of the conference and introduces key themes and topics. Sociotechnical approaches to workplace safety are intended to draw practitioners' attention to the critical influence that systemic social/organisational and technological factors exert on safety-relevant outcomes. This paper introduces major themes addressed in the Hopkinton Conference within the context of current workplace safety research and practice challenges.

  19. Ethical issues in patient safety: Implications for nursing management.

    Science.gov (United States)

    Kangasniemi, Mari; Vaismoradi, Mojtaba; Jasper, Melanie; Turunen, Hannele

    2013-12-01

    The purpose of this article is to discuss the ethical issues impacting the phenomenon of patient safety and to present implications for nursing management. Previous knowledge of this perspective is fragmented. In this discussion, the main drivers are identified and formulated in 'the ethical imperative' of patient safety. Underlying values and principles are considered, with the aim of increasing their visibility for nurse managers' decision-making. The contradictory nature of individual and utilitarian safety is identified as a challenge in nurse management practice, together with the context of shared responsibility and identification of future challenges. As a conclusion, nurse managers play a strategic role in patient safety. Their role is to incorporate ethical values of patient safety into decision-making at all levels in an organization, and also to encourage clinical nurses to consider values in the provision of care to patients. Patient safety that is sensitive to ethics provides sustainable practice where the humanity and dignity of all stakeholders are respected.

  20. Occupational safety and health issues associated with green building

    OpenAIRE

    Terwoert, J.; Ustailieva, E.

    2013-01-01

    This e-fact provides information on the work-related risk factors and the occupational safety and health (OSH) issues associated the planning and construction of green buildings, their maintenance, renovation (retrofitting), demolition, on-site waste collection. Some of these OSH risks are new compared with traditional construction sites and are associated with new green materials, technologies or design. Other risks are well-known to the construction sector but they arise in new situations o...

  1. Contrast media. Safety issues and ESUR guidelines. 2. rev. ed.

    Energy Technology Data Exchange (ETDEWEB)

    Thomsen, Henrik S. [Copenhagen University Hospital, Herlev (Denmark). Dept. of Diagnostic Radiology; Copenhagen Univ., Herlev (Denmark). Dept. of Diagnostic Sciences; Webb, Judith A.W. (eds.) [St. Bartholomew' s Hospital London Univ. (United Kingdom). Dept. of Radiology

    2009-07-01

    In 1994 the European Society of Urogenital Radiology (ESUR) set up a committee to consider the safety of contrast media used for diagnostic imaging. Subsequently the committee questioned members, reviewed the literature, proposed guidelines and discussed these proposals with participants at the annual symposia of the society. The end result of this work was the successful first edition of this book, published in 2006. This second edition not only updates the previous edition, but also contains some completely new chapters, for example on gadolinium-based contrast agents, meta-analyses in contrast media research and various regulatory issues. Comprehensive consideration is given to the many different safety issues relating to iodinated, MR, ultrasound and barium contrast media. The text includes chapters on both acute and delayed non-renal adverse reactions and on renal adverse reactions. All those questions frequently raised in radiological practice are addressed, and the well-known ESUR guidelines on contrast media are included. This book, presented in a handy, easy to use format, provides an invaluable, unique and unparalleled source of information on the safety issues relating to contrast media. (orig.)

  2. Hydrogen energy demonstration plant in Patagonia: Description and safety issues

    Energy Technology Data Exchange (ETDEWEB)

    Aprea, Jose Luis [CNEA (Argentine Atomic Energy Commission), AAH, IRAM, Comahue University, CC 805, 8300 Neuquen (Argentina)

    2009-05-15

    Hydrogen safety issues and especially hydrogen hazard's address are key points to remove any safety-related barrier in the implementation process of hydrogen energy systems. Demonstrative systems based on hydrogen technologies represent a clear contribution to the task of showing the feasibility of the new technologies and their beneficial capabilities among the public. In this paper, the safety features of the first hydrogen energy demonstrative plant conceived in Latin America are analyzed. The facilities, located in the village of Pico Truncado, Patagonia, Argentina, serve to gain day-to-day experience in the production, storage, distribution, conversion and use of hydrogen in several applications. The plant uses electrolysis to generate pure hydrogen from renewable primary sources, taking advantage of the installed wind power capacity that is continually growing in the region. The installations were designed to accomplish with two primary objectives: total safety assurance and minimization of human errors. Some details of the plant, including a general layout, are presented here, in addition with design criteria, hydrogen hazards, structural precautions, gas monitoring system, existing regulations and safety requirements. (author)

  3. Complement activation as a bioequivalence issue relevant to the development of generic liposomes and other nanoparticulate drugs

    Energy Technology Data Exchange (ETDEWEB)

    Szebeni, Janos, E-mail: jszebeni2@gmail.com [Nanomedicine Research and Education Center, Semmelweis University, Budapest & SeroScience Ltd, Budapest (Hungary); Storm, Gert [Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht (Netherlands)

    2015-12-18

    Liposomes are known to activate the complement (C) system, which can lead in vivo to a hypersensitivity syndrome called C activation-related pseudoallergy (CARPA). CARPA has been getting increasing attention as a safety risk of i.v. therapy with liposomes, whose testing is now recommended in bioequivalence evaluations of generic liposomal drug candidates. This review highlights the adverse consequences of C activation, the unique symptoms of CARPA triggered by essentially all i.v. administered liposomal drugs, and the various features of vesicles influencing this adverse immune effect. For the case of Doxil, we also address the mechanism of C activation and the opsonization vs. long circulation (stealth) paradox. In reviewing the methods of assessing C activation and CARPA, we delineate the most sensitive porcine model and an algorithm for stepwise evaluation of the CARPA risk of i.v. liposomes, which are proposed for standardization for preclinical toxicology evaluation of liposomal and other nanoparticulate drug candidates. - Highlights: • Outlining of difficulties in generic development of liposomal drugs. • New regulatory requirements to evaluate CARPA in preclinical studies. • Review of complement activation by liposomes and its adverse consequences (CARPA). • Assays of C activation in vitro and CARPA in vivo, with the porcine test in focus. • Decision tree how to handle the risk of CARPA assessed by a battery of tests.

  4. ISSUES AND RECENT TRENDS IN VEHICLE SAFETY COMMUNICATION SYSTEMS

    Directory of Open Access Journals (Sweden)

    Sadayuki TSUGAWA

    2005-01-01

    Full Text Available This paper surveys the research on the applications of inter-vehicle communications, the issues of the deployment and technology, and the current status of inter-vehicle communications projects in Europe, the United States and Japan. The inter-vehicle communications, defined here as communications between on-board ITS computers, improve road traffic safety and efficiency by expanding the horizon of the drivers and on-board sensors. One of the earliest studies on inter-vehicle communications began in Japan in the early 1980s. The inter-vehicle communications play an essential role in automated platooning and cooperative driving systems developed since the 1990's by enabling vehicles to obtain data that would be difficult or impossible to measure with on-board sensors. During these years, interest in applications for inter-vehicle communications increased in the EU, the US and Japan, resulting in many national vehicle safety communications projects such as CarTALK2000 in the EU and VSCC in the US. The technological issues include protocol and communications media. Experiments employ various kinds of protocols and typically use infrared, microwave or millimeter wave media. The situation is ready for standardization. The deployment strategy is another issue. To be feasible, deployment should begin with multiple rather than single services that would work even at a low penetration rate of the communication equipment. In addition, non-technological, legal and institutional issues remained unsolved. Although inter-vehicle communications involve many issues, such applications should be promoted because they will lead to safer and more efficient automobile traffic.

  5. Use of thiopurines in inflammatory bowel disease: Safety issues

    Institute of Scientific and Technical Information of China (English)

    Anastasia; Konidari; Wael; El; Matary

    2014-01-01

    Thiopurines are widely used for maintenance treatment of inflammatory bowel disease. Interindividual variability in clinical response to thiopurines may be attributed to several factors including genetic polymorphisms, severity and chronicity of disease, comorbidities, duration of administration, compliance issues and use of concomitant medication, environmental factors and clinician and patient preferences. The purpose of this review is to summarise the current evidence on thiopurine safety and toxicity, to describe adverse drug events and emphasise the significance of drug interactions, and to discuss the relative safety of thiopurine use in adults, elderly patients, children and pregnant women. Thiopurines are safe to use and well tolerated, however dose adjustment or discontinuation of treatment must be considered in cases of non-response, poor compliance or toxicity. Drug safety, clinical response to treatment and short to long term risks and benefits must be balanced throughout treatment duration for different categories of patients. Treatment should be individualised and stratified according to patient requirements. Enzymatic testing prior to treatment commencement is advised. Surveillance with regular clinic follow-up and monitoring of laboratory markers is important. Data on long term efficacy, safety of thiopurine use and interaction with other disease modifying drugs are lacking, especially in paediatric inflammatory bowel disease. High quality, collaborative clinical research is required so as to inform clinical practice in the future.

  6. Safety issues of tooth whitening using peroxide-based materials.

    Science.gov (United States)

    Li, Y; Greenwall, L

    2013-07-01

    In-office tooth whitening using hydrogen peroxide (H₂O₂) has been practised in dentistry without significant safety concerns for more than a century. While few disputes exist regarding the efficacy of peroxide-based at-home whitening since its first introduction in 1989, its safety has been the cause of controversy and concern. This article reviews and discusses safety issues of tooth whitening using peroxide-based materials, including biological properties and toxicology of H₂O₂, use of chlorine dioxide, safety studies on tooth whitening, and clinical considerations of its use. Data accumulated during the last two decades demonstrate that, when used properly, peroxide-based tooth whitening is safe and effective. The most commonly seen side effects are tooth sensitivity and gingival irritation, which are usually mild to moderate and transient. So far there is no evidence of significant health risks associated with tooth whitening; however, potential adverse effects can occur with inappropriate application, abuse, or the use of inappropriate whitening products. With the knowledge on peroxide-based whitening materials and the recognition of potential adverse effects associated with the procedure, dental professionals are able to formulate an effective and safe tooth whitening regimen for individual patients to achieve maximal benefits while minimising potential risks.

  7. GEOTECHNICAL SAFETY ISSUES IN THE CITIES OF POLAR REGIONS

    Directory of Open Access Journals (Sweden)

    Valery Grebenets

    2012-01-01

    Full Text Available Arctic settlements built on permafrostface rather unique set of geotechnical challenges. On urbanized areas, technogenic transformation of natural landscapes due toconstruction of various types of infrastructure leads to changes in heat exchange in permafrost-atmosphere system. The spatial distribution and intensity of dangerous cryogenic processes in urbanized areas is substantially different from natural background settings found prior to construction. Climate change, especially pronounced in the Arctic, exacerbated these changes. Combination of technogenic pressure and climate change resulted in potentially hazardous situation in respect to operational safety of the buildings and structures built on permafrost. This paper is focused on geotechnical safety issues faced by the Arctic urban centers built on permafrost. Common types of technogenic impacts characteristic for urban settlements wereevaluated based on field observations and modeling techniques. The basic principles of development of deformations are discussed in respect to changing permafrost conditions and operational mode of the structures built on permafrost.

  8. Plasma concentrations of generic lopinavir/ritonavir in HIV type-1-infected individuals.

    NARCIS (Netherlands)

    Lugt, J. van der; Lange, J.; Avihingsanon, A.; Ananworanich, J.; Sealoo, S.; Burger, D.M.; Gorowara, M.; Phanuphak, P.; Ruxrungtham, K.

    2009-01-01

    BACKGROUND: Generic drugs can contribute to access to treatment for HIV-infected patients. However quality and safety remains an issue of concern. Therefore, we evaluated minimal plasma concentrations and short-term safety of a generic lopinavir/ritonavir 200/50 mg tablet formulation. METHODS: In a

  9. HTGR Dust Safety Issues and Needs for Research and Development

    Energy Technology Data Exchange (ETDEWEB)

    Paul W. Humrickhouse

    2011-06-01

    This report presents a summary of high temperature gas-cooled reactor dust safety issues. It draws upon a literature review and the proceedings of the Very High Temperature Reactor Dust Assessment Meeting held in Rockville, MD in March 2011 to identify and prioritize the phenomena and issues that characterize the effect of carbonaceous dust on high temperature reactor safety. It reflects the work and input of approximately 40 participants from the U.S. Department of Energy and its National Labs, the U.S. Nuclear Regulatory Commission, industry, academia, and international nuclear research organizations on the topics of dust generation and characterization, transport, fission product interactions, and chemical reactions. The meeting was organized by the Idaho National Laboratory under the auspices of the Next Generation Nuclear Plant Project, with support from the U.S. Nuclear Regulatory Commission. Information gleaned from the report and related meetings will be used to enhance the fuel, graphite, and methods technical program plans that guide research and development under the Next Generation Nuclear Plant Project. Based on meeting discussions and presentations, major research and development needs include: generating adsorption isotherms for fission products that display an affinity for dust, investigating the formation and properties of carbonaceous crust on the inside of high temperature reactor coolant pipes, and confirming the predominant source of dust as abrasion between fuel spheres and the fuel handling system.

  10. Contrast media. Safety issues and ESUR guidelines. 3. ed.

    Energy Technology Data Exchange (ETDEWEB)

    Thomsen, Henrik S. [Copenhagen University Hospital, Herlev (Denmark). Dept. of Diagnostic Radiology; Webb, Judith A.W. (ed.) [St. Bartholomew' s Hospital, London (United Kingdom). Dept. of Radiology

    2014-06-01

    Fully updates the previous edition and includes new chapters on various complex topics. Represents a unique and unparalleled source of information on the many safety issues relating to different contrast media. Includes chapters on acute and delayed non-renal adverse reactions and on renal adverse reactions. Presented in a handy, easy-to-use format. In 1994 the European Society of Urogenital Radiology (ESUR) set up a committee to consider the safety of contrast media used for diagnostic imaging. Subsequently the committee questioned ESUR members, reviewed the literature, proposed guidelines, and discussed these proposals with participants at the annual symposia of the society. The end result of this work was the successful first edition of this book, published in 2006, which was followed by an equally successful second edition in 2009. This third edition not only fully updates the previous edition, but also includes new chapters on complex topics such as use of contrast media in children and practical aspects of off-label contrast media use. The authorship includes members, past members, and non-members of the Contrast Media Safety Committee.

  11. Generic Selection Criteria for Safety and Patient Benefit [IV] - Physicochemical and pharmaceutical properties of brand-name and generic ketoprofen tapes.

    Science.gov (United States)

    Wada, Yuko; Kihara, Maki; Nozawa, Mitsuru; Shimokawa, Ken-Ichi; Ishii, Fumiyoshi

    2015-06-01

    The physicochemical and pharmaceutical properties (pH, peel force, water-vapor permeability, and stretchability) of brand-name and generic ketoprofen products were evaluated and compared. The pHs of Mohrus as a brand-name product and Teikoku as a generic product were low (about 4). Among the other generic products, Patell and Nichi-Iko had a pH of about 4.3 while Frestol, Raynanon, BMD, and Touchron showed a pH of 4.6-5.2, which was in the pH range of normal healthy skin (4.5-6.5). The adhesive force was high (≥ 1.38) for Mohrus as a brand-name product as well as for Teikoku and Patell as generic products, but it was low (≤ 0.57) for the other 5 generic products. The water-vapor permeabilities of Mohrus as a brand-name product and Teikoku and Patell as generic products were low, being less than 1/6 of those for the other 5 generic products. Among the 5 generic products, BMD showed the highest water-vapor permeability (1,330 g/m²), and the other products also showed a value ≥ 1,100 g/m². The elongatedness of Mohrus was the lowest (15.5 cm), and that of Raynanon was the highest (24.5 cm); the difference was 9 cm. In this study, the physiochemical and pharmaceutical properties of ketoprofen tapes were clarified, which will allow pharmacists to provide products according to the needs of each patient when a brand-name product is changed to a generic one.

  12. Safety and Regulatory Issues of the Thorium Fuel Cycle

    Energy Technology Data Exchange (ETDEWEB)

    Ade, Brian [ORNL; Worrall, Andrew [ORNL; Powers, Jeffrey [ORNL; Bowman, Steve [ORNL; Flanagan, George [ORNL; Gehin, Jess [ORNL

    2014-02-01

    Thorium has been widely considered an alternative to uranium fuel because of its relatively large natural abundance and its ability to breed fissile fuel (233U) from natural thorium (232Th). Possible scenarios for using thorium in the nuclear fuel cycle include use in different nuclear reactor types (light water, high temperature gas cooled, fast spectrum sodium, molten salt, etc.), advanced accelerator-driven systems, or even fission-fusion hybrid systems. The most likely near-term application of thorium in the United States is in currently operating light water reactors (LWRs). This use is primarily based on concepts that mix thorium with uranium (UO2 + ThO2), add fertile thorium (ThO2) fuel pins to LWR fuel assemblies, or use mixed plutonium and thorium (PuO2 + ThO2) fuel assemblies. The addition of thorium to currently operating LWRs would result in a number of different phenomenological impacts on the nuclear fuel. Thorium and its irradiation products have nuclear characteristics that are different from those of uranium. In addition, ThO2, alone or mixed with UO2 fuel, leads to different chemical and physical properties of the fuel. These aspects are key to reactor safety-related issues. The primary objectives of this report are to summarize historical, current, and proposed uses of thorium in nuclear reactors; provide some important properties of thorium fuel; perform qualitative and quantitative evaluations of both in-reactor and out-of-reactor safety issues and requirements specific to a thorium-based fuel cycle for current LWR reactor designs; and identify key knowledge gaps and technical issues that need to be addressed for the licensing of thorium LWR fuel in the United States.

  13. Safety in GPR prospecting: a rarely-considered issue

    Science.gov (United States)

    Persico, Raffaele; Pajewski, Lara; Trela, Christiane; Carrick Utsi, Erica

    2016-04-01

    Safety issues (of people first of all, but also of the equipment and environment) are rarely considered in Ground-Penetrating Radar (GPR) prospecting and, more in general, in near-surface geophysical prospecting. As is right and fully understandable, the scientific community devotes greatest attention first of all to the theoretical and practical aspects of GPR technique, affecting the quality of attainable results, secondly to the efforts and costs needed to achieve them [1-2]. However, the (luckily) growing GPR market and range of applications make it worth giving serious consideration to safety issues, too. The existing manuals dealing with safety in geophysics are mainly concerned with applications requiring "deep" geophysical prospecting, for example the search for oilfields and other hydrocarbon resources [3]. Near-surface geophysics involves less dangers than deep geophysics, of course. Nevertheless, several accidents have already happened during GPR experimental campaigns. We have personally had critical experiences and collected reliable testimonies concerning occurred problems as mountain sicks, fractures of legs, stomach problems, allergic reactions, encounters with potentially-dangerous animals, and more. We have also noticed that much more attention is usually paid to safety issues during indoor experimental activities (in laboratory), rather than during outdoor fieldworks. For example, the Italian National research Council is conventioned with safety experts who hold periodical seminaries about safety aspects. Having taken part to some of them, to our experience we have never heard a "lecture" devoted to outdoor prospecting. Nowadays, any aspects associated to the use of the technologies should be considered. The increasing sensibility and sense of responsibility towards environmental matters impose GPR end-users to be careful not to damage the environment and also the cultural heritage. Near-surface prospecting should not compromise the flora and

  14. Nanotechnology in Drug Delivery: Safety and Toxicity Issues.

    Science.gov (United States)

    Jain, Keerti; Mehra, Neelesh Kumar; Jain, Narendra K

    2015-01-01

    Nanotoxicology deals with the new perception regarding nanotechnology i.e. risk and hazards associated with nanoscale materials. Although, nanotechnology is playing significant role in modern advancements from cell phones to medicines, yet it is necessary to consider their negative part as well that could be dangerous if not given proper attention. It is not certain that nanotechnology will essentially exert toxic effects since at present only few reports are available on their toxic effects and most of them are controversial. In this review we have summarized the advances in nanotechnology, their applications and, most importantly their safety issues that are often overlooked. However combined efforts are advocated to develop promising regulatory and ethical guidelines to control production, use and disposal of nanomaterials that will be safe to human health, environment and other living organisms.

  15. Regulatory Issues Associated with Preharvest Food Safety: European Union Perspective.

    Science.gov (United States)

    Alban, Lis

    2016-10-01

    Free movement of safe and wholesome food is an essential aspect of any society. This article contains an updated description of the regulatory issues associated with preharvest food safety within the European Union. Salmonella, Campylobacter, Trichinella, antimicrobial resistance, and bovine spongiform encephalopathy are dealt with in detail. Moreover, Cysticercus bovis/Taenia saginata, Toxoplasma, Yersinia, verotoxigenic/shigatoxigenic Escherichia coli, Listeria, and foodborne viruses are briefly covered. The article describes how the focus in the European Union is changing to involve a supply chain view with a focus on cost-effectiveness. The precautionary principle-as well as the use of private standards as an instrument to ensure compliance-is dealt with. In addition, actions in the pipeline are presented and discussed.

  16. Generic Issues on Broad-Scale Soil Monitoring Schemes: A Review

    Institute of Scientific and Technical Information of China (English)

    D. ARROUAYS; B. P. MARCHANT; N. P. A. SABY; J. MEERSMANS; T. G. ORTON; M. P. MARTIN; P. H. BELLAMY; R. M. LARK; M. KIBBLEWHITE

    2012-01-01

    Numerous scientific challenges arise when designing a soil monitoring network (SMN),especially when assessing large areas and several properties that are driven by numerous controlling factors of various origins and scales.Different broad approaches to the establishment of SMNs are distinguished.It is essential to establish an adequate sampling protocol that can be applied rigorously at each sampling location and time.We make recommendations regarding the within-site sampling of soil.Different statistical methods should be associated with the different types of sampling design.We review new statistical methods that account for different sources of uncertainty.Except for those parameters for which a consensus exists,the question of testing method harmonisation remains a very difficult issue.The establishment of benchmark sites devoted to harmonisation and inter-calibration is advocated as a technical solution.However,to our present knowledge,no study has addressed crucial scientific issues such as how many calibration sites are necessary and how to locate them.

  17. A generic systematic to support bibliometric research illustrated for the performance evaluation of sustainable development issues

    Directory of Open Access Journals (Sweden)

    Fabrício Kurman Merlin

    2013-03-01

    Full Text Available The question that arises in this work is how to select a theoretical structure scientifically justified to a research. Thus, this exploratory and descriptive study aims to present and illustrate a structured process (ProKnow-C for selecting papers on performance evaluation oriented to issues concerning sustainable development. From the proposed process, it was mentioned the following results: identification of seven key words for search, identification of four databases of abstracts and full texts aligned with the research theme, selection of 9123 articles dealing with the theme; structured filtering of the 9123 selected articles from the databases in 13 scientific articles, which resulted in the theoretical underpinning for research on performance appraisal oriented to sustainable development issues. Subsequently, it was identified the bibliometric profile of the bibliography portfolio selected, highlighting the keywords, authors, journal articles and the articles of the portfolio and the portfolio of bibliographic references for the last three. Considering the results, it was argued that the proposed process was robust, since it achieved the goal of identifying and selecting relevant publications for the study, to gather scientific content aligned to the subject that the research sought to address.

  18. A comparative study of the efficacy and safety of the original and generic orlistat in obese patients in the PROFIL register

    Directory of Open Access Journals (Sweden)

    A. V. Zakharova

    2016-01-01

    Full Text Available Aim. To study the efficacy and safety of generic orlistat in comparison with the original drug in obese patients.Material and methods. Patients with obesity degree 1-3 (n=60; 11.7% men and 88.3% women were included into the open comparative randomized controlled study in parallel groups. After randomization 40 patients received of generic orlistat and 20 – the original orlistat. The duration of follow-up was 12 weeks. Changes in body weight, body mass index, and waist circumference were assessed, as well as the proportion of patients with a weight loss of 5-10% or more from baseline.Results. Weight loss >5% was observed in 28 and 25% of patients in the groups of generic and original orlistat, respectively, and weight loss >10% - in 7.7% of patients only in the group of generic drug. No significant changes in blood pressure and heart rate were found. A significant reduction in total cholesterol and low density lipoprotein cholesterol was revealed. 11 (27.5% adverse events were observed in the group of generic orlistat and 5 (25% – in the group of original orlistat.Conclusion. Generic orlistat 120 mg in capsules showed clinical equivalence to the original drug. Safety and tolerability of treatment with both drugs were comparable.

  19. Collegiate Aviation Research and Education Solutions to Critical Safety Issues. UNO Aviation Monograph Series. UNOAI Report.

    Science.gov (United States)

    Bowen, Brent, Ed.

    This document contains four papers concerning collegiate aviation research and education solutions to critical safety issues. "Panel Proposal Titled Collegiate Aviation Research and Education Solutions to Critical Safety Issues for the Tim Forte Collegiate Aviation Safety Symposium" (Brent Bowen) presents proposals for panels on the…

  20. 75 FR 14243 - Pipeline Safety: Girth Weld Quality Issues Due to Improper Transitioning, Misalignment, and...

    Science.gov (United States)

    2010-03-24

    ... Pipeline and Hazardous Materials Safety Administration Pipeline Safety: Girth Weld Quality Issues Due to... and Hazardous Materials Safety Administration (PHMSA); DOT. ACTION: Notice; issuance of advisory... girth weld failures due to welding quality issues. Misalignment during welding of large diameter line...

  1. Chemical effects head-loss research in support of generic safety issue 191.

    Energy Technology Data Exchange (ETDEWEB)

    Park, J. H.; Kasza, K.; Fisher, B.; Oras, J.; Natesan, K.; Shack, W. J.; Nuclear Engineering Division

    2006-10-31

    This summary report describes studies conducted at Argonne National Laboratory on the potential for chemical effects on head loss across sump screens. Three different buffering solutions were used for these tests: trisodium phosphate (TSP), sodium hydroxide, and sodium tetraborate. These pH control agents used following a LOCA at a nuclear power plant show various degrees of interaction with the insulating materials Cal-Sil and NUKON. Results for Cal-Sil dissolution tests in TSP solutions, settling rate tests of calcium phosphate precipitates, and benchmark tests in chemically inactive environments are also presented. The dissolution tests were intended to identify important environmental variables governing both calcium dissolution and subsequent calcium phosphate formation over a range of simulated sump pool conditions. The results from the dissolution testing were used to inform both the head loss and settling test series. The objective of the head loss tests was to assess the head loss produced by debris beds created by Cal-Sil, fibrous debris, and calcium phosphate precipitates. The effects of both the relative arrival time of the precipitates and insulation debris and the calcium phosphate formation process were specifically evaluated. The debris loadings, test loop flow rates, and test temperature were chosen to be reasonably representative of those expected in plants with updated sump screen configurations, although the approach velocity of 0.1 ft/s used for most of the tests is 3-10 times that expected in plants with large screens . Other variables were selected with the intent to reasonably bound the head loss variability due to arrival time and calcium phosphate formation uncertainty. Settling tests were conducted to measure the settling rates of calcium phosphate precipitates (formed by adding dissolved Ca to boric acid and TSP solutions) in water columns having no bulk directional flow. For PWRs where NaOH and sodium tetraborate are used to control sump pH and fiberglass insulation is prevalent, relatively high concentrations of soluble aluminum can be expected. Tests in which the dissolved aluminum (Al) resulted from aluminum nitrate additions were used to investigate potential chemical effects that may lead to high head loss. Dissolved Al concentrations of 100 ppm were shown to lead to large pressure drops for the screen area to sump volume ratio and fiber debris bed studied. No chemical effects on head loss were observed in sodium tetraborate buffered solutions even for environments with high ratios of submerged Al area to sump volume. However, in tests with much higher concentrations of dissolved Al than expected in plants, large pressure drops did occur. Interaction with NUKON/Cal-Sil debris mixtures produced much lower head losses than observed in corresponding tests with TSP, although tests were not performed over the full range of Cal-Sil that might be of interest.

  2. An interagency space nuclear propulsion safety policy for SEI - Issues and discussion

    Science.gov (United States)

    Marshall, A. C.; Sawyer, J. C., Jr.

    1991-01-01

    An interagency Nuclear Safety Policy Working Group (NSPWG) was chartered to recommend nuclear safety policy, requirements, and guidelines for the Space Exploration Initiative nuclear propulsion program to facilitate the implementation of mission planning and conceptual design studies. The NSPWG developed a top level policy to provide the guiding principles for the development and implementation of the nuclear propulsion safety program and the development of Safety Functional Requirements. In addition, the NSPWG reviewed safety issues for nuclear propulsion and recommended top level safety requirements and guidelines to address these issues. Safety topics include reactor start-up, inadvertent criticality, radiological release and exposure, disposal, entry, safeguards, risk/reliability, operational safety, ground testing, and other considerations. In this paper the emphasis is placed on the safety policy and the issues and considerations that are addressed by the NSPWG recommendations.

  3. A safety and regulatory assessment of generic BWR and PWR permanently shutdown nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Travis, R.J.; Davis, R.E.; Grove, E.J.; Azarm, M.A. [Brookhaven National Lab., Upton, NY (United States)

    1997-08-01

    The long-term availability of less expensive power and the increasing plant modification and maintenance costs have caused some utilities to re-examine the economics of nuclear power. As a result, several utilities have opted to permanently shutdown their plants. Each licensee of these permanently shutdown (PSD) plants has submitted plant-specific exemption requests for those regulations that they believe are no longer applicable to their facility. This report presents a regulatory assessment for generic BWR and PWR plants that have permanently ceased operation in support of NRC rulemaking activities in this area. After the reactor vessel is defueled, the traditional accident sequences that dominate the operating plant risk are no longer applicable. The remaining source of public risk is associated with the accidents that involve the spent fuel. Previous studies have indicated that complete spent fuel pool drainage is an accident of potential concern. Certain combinations of spent fuel storage configurations and decay times, could cause freshly discharged fuel assemblies to self heat to a temperature where the self sustained oxidation of the zircaloy fuel cladding may cause cladding failure. This study has defined four spent fuel configurations which encompass all of the anticipated spent fuel characteristics and storage modes following permanent shutdown. A representative accident sequence was chosen for each configuration. Consequence analyses were performed using these sequences to estimate onsite and boundary doses, population doses and economic costs. A list of candidate regulations was identified from a screening of 10 CFR Parts 0 to 199. The continued applicability of each regulation was assessed within the context of each spent fuel storage configuration and the results of the consequence analyses.

  4. Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness.

    Science.gov (United States)

    Kesselheim, Aaron S; Gagne, Joshua J

    2015-10-01

    Generic drugs possessing the same active ingredients, dosage form, strength, route of administration, and labeling can be approved by the US Food and Drug Administration (FDA) as interchangeable with a brand-name drug without needing to repeat the formal Phase I, II, and III clinical trials conducted by the original manufacturers. In recent years, the FDA has approved several generic drugs using product-specific testing to determine therapeutic equivalence in accordance with the unique features of the particular drug. These have been used in two primary situations: (1) cases for which certain bioequivalence studies were not relevant; and (2) cases of complex molecules that may require specially tailored pharmaceutical equivalence studies. Examples include venlafaxine extended release, acarbose, vancomycin capsules, sodium ferric gluconate, salmon calcitonin nasal spray, and enoxaparin. Product-specific approaches to demonstrating therapeutic equivalence are essential to avoid delays in low-cost generic drug availability but can have important clinical implications; yet, currently, there is no formal process in place to monitor the safety and effectiveness of generic drugs approved using modified regulatory pathways. Several strategies can be used to monitor the safety and effectiveness of generic drugs approved via product-specific determinations of therapeutic equivalence.

  5. Decision making under uncertainty: An investigation into the application of formal decision-making methods to safety issue decisions

    Energy Technology Data Exchange (ETDEWEB)

    Bohn, M P [Sandia National Labs., Albuquerque, NM (United States)

    1992-12-01

    As part of the NRC-sponsored program to study the implications of Generic Issue 57, Effects of Fire Protection System Actuation on Safety-Related Equipment,'' a subtask was performed to evaluate the applicability of formal decision analysis methods to generic issues cost/benefit-type decisions and to apply these methods to the GI-57 results. In this report, the numerical results obtained from the analysis of three plants (two PWRs and one BWR) as developed in the technical resolution program for GI-57 were studied. For each plant, these results included a calculation of the person-REM averted due to various accident scenarios and various proposed modifications to mitigate the accident scenarios identified. These results were recomputed to break out the benefit in terms of contributions due to random event scenarios, fire event scenarios, and seismic event scenarios. Furthermore, the benefits associated with risk (in terms of person-REM) averted from earthquakes at three different seismic ground motion levels were separately considered. Given this data, formal decision methodologies involving decision trees, value functions, and utility functions were applied to this basic data. It is shown that the formal decision methodology can be applied at several different levels. Examples are given in which the decision between several retrofits is changed from that resulting from a simple cost/benefit-ratio criterion by virtue of the decision-makinger's expressed (and assumed) preferences.

  6. Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984

    Directory of Open Access Journals (Sweden)

    Garth Boehm

    2013-09-01

    Full Text Available The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed, including the process of approval for generic drugs, bioequivalence issues including “switchability”, bioequivalence for complicated dosage forms, patent extension, generic drug safety, generic substitution and low-cost generics. The backlog in generic review, generic drug user fees, and “quality by design” for generic drugs is also discussed. The evolution of the US generic drug industry after the Hatch-Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re-establish a domestic generic drug industry.

  7. Safety issues in cultural heritage management and critical infrastructures management

    Science.gov (United States)

    Soldovieri, Francesco; Masini, Nicola; Alvarez de Buergo, Monica; Dumoulin, Jean

    2013-12-01

    This special issue is the fourth of its kind in Journal of Geophysics and Engineering , containing studies and applications of geophysical methodologies and sensing technologies for the knowledge, conservation and security of products of human activity ranging from civil infrastructures to built and cultural heritage. The first discussed the application of novel instrumentation, surface and airborne remote sensing techniques, as well as data processing oriented to both detection and characterization of archaeological buried remains and conservation of cultural heritage (Eppelbaum et al 2010). The second stressed the importance of an integrated and multiscale approach for the study and conservation of architectural, archaeological and artistic heritage, from SAR to GPR to imaging based diagnostic techniques (Masini and Soldovieri 2011). The third enlarged the field of analysis to civil engineering structures and infrastructures, providing an overview of the effectiveness and the limitations of single diagnostic techniques, which can be overcome through the integration of different methods and technologies and/or the use of robust and novel data processing techniques (Masini et al 2012). As a whole, the special issue put in evidence the factors that affect the choice of diagnostic strategy, such as the material, the spatial characteristics of the objects or sites, the value of the objects to be investigated (cultural or not), the aim of the investigation (knowledge, conservation, restoration) and the issues to be addressed (monitoring, decay assessment). In order to complete the overview of the application fields of sensing technologies this issue has been dedicated to monitoring of cultural heritage and critical infrastructures to address safety and security issues. Particular attention has been paid to the data processing methods of different sensing techniques, from infrared thermography through GPR to SAR. Cascini et al (2013) present the effectiveness of a

  8. Guidelines for nuclear-power-plant safety-issue-prioritization information development

    Energy Technology Data Exchange (ETDEWEB)

    Andrews, W.B.; Gallucci, R.H.V.; Heaberlin, S.W.; Bickford, W.E.; Konzek, G.J.; Strenge, D.L.; Smith, R.I.; Weakley, S.A.

    1983-02-01

    Pacific Northwest Laboratory has developed a methodology, with examples, to calculate - to an approximation serviceable for prioritization purposes - the risk, dose and cost impacts of implementing resolutions to reactor safety issues. This report is an applications guide to issue-specific calculations. A description of the approach, mathematical models, worksheets and step-by-step examples are provided. Analysis using this method is intended to provide comparable results for many issues at a cost of two staff-weeks per issue. Results will be used by the NRC to support decisions related to issue priorities in allocation of resources to complete safety issue resolutions.

  9. 注册分类6化学药品立题合理性相关问题的讨论%Issues about the rationality of subject selection in chemical generic drug registration application:a discussion

    Institute of Scientific and Technical Information of China (English)

    许真玉

    2014-01-01

    注册分类6的化学药品在注册申报过程中暴露了一些立题方面的问题。作为药物研发者,必须追踪药物最新的安全有效性和质量可控性信息,为药物研究开发提供扎实的立题基础。本文结合日常药品审评工作,从化合物、剂型、规格等方面对注册分类6化学药品立题合理性相关问题进行讨论。%Some issues about the rationality of subject selection are identified in the registration applications of chemical generic drugs. It should be the sponsor's responsibility to follow the latest information about safety, efficacy and quality control of the proposed drug, and provide a sound basis for subject selection. In this article, issues about the basis of the subject selection of chemical generic drugs are discussed from the aspects of compound, formulation and strength.

  10. Safety Issues at the DOE Test and Research Reactors. A Report to the U.S. Department of Energy.

    Science.gov (United States)

    National Academy of Sciences - National Research Council, Washington, DC. Commission on Physical Sciences, Mathematics, and Resources.

    This report provides an assessment of safety issues at the Department of Energy (DOE) test and research reactors. Part A identifies six safety issues of the reactors. These issues include the safety design philosophy, the conduct of safety reviews, the performance of probabilistic risk assessments, the reliance on reactor operators, the fragmented…

  11. Validation of Generic Models for Variable Speed Operation Wind Turbines Following the Recent Guidelines Issued by IEC 61400-27

    Directory of Open Access Journals (Sweden)

    Andrés Honrubia-Escribano

    2016-12-01

    Full Text Available Considerable efforts are currently being made by several international working groups focused on the development of generic, also known as simplified or standard, wind turbine models for power system stability studies. In this sense, the first edition of International Electrotechnical Commission (IEC 61400-27-1, which defines generic dynamic simulation models for wind turbines, was published in February 2015. Nevertheless, the correlations of the IEC generic models with respect to specific wind turbine manufacturer models are required by the wind power industry to validate the accuracy and corresponding usability of these standard models. The present work conducts the validation of the two topologies of variable speed wind turbines that present not only the largest market share, but also the most technological advances. Specifically, the doubly-fed induction machine and the full-scale converter (FSC topology are modeled based on the IEC 61400-27-1 guidelines. The models are simulated for a wide range of voltage dips with different characteristics and wind turbine operating conditions. The simulated response of the IEC generic model is compared to the corresponding simplified model of a wind turbine manufacturer, showing a good correlation in most cases. Validation error sources are analyzed in detail, as well. In addition, this paper reviews in detail the previous work done in this field. Results suggest that wind turbine manufacturers are able to adjust the IEC generic models to represent the behavior of their specific wind turbines for power system stability analysis.

  12. Promoting personal safety of building service workers: issues and challenges.

    Science.gov (United States)

    Chen, Shelley I; Skillen, D Lynn

    2006-06-01

    This exploratory, descriptive study conducted at a large western Canadian university solicited perceptions of personal safety among building service workers who perform night shift work alone. Ten semi-structured interviews were conducted at approximately 10:00 p.m. or 7:00 a.m with a convenience sample of night building service workers in private or semi-private locations on the university campus. Transcribed interview data were subjected to inductive content analysis using descriptive, interpretive, and pattern coding (Miles & Huberman, 1994). Results suggest that building service night shift workers are exposed to personal safety hazards in their physical and psychosocial work environments. In addition, culturally and linguistically appropriate delivery of safety training and education about policies and procedures is required for culturally diverse building service workers. Promotion of personal safety in this heterogeneous worker population requires due diligence, assessment, and advocacy.

  13. Regulation of Generic Drugs in Japan: the Current Situation and Future Prospects.

    Science.gov (United States)

    Kuribayashi, Ryosuke; Matsuhama, Maki; Mikami, Kenichi

    2015-09-01

    Generic drugs are interchangeable with original proprietary drugs, as they have the same active pharmaceutical ingredients, dosage forms, strength, quality, indications, effects, directions, and dosage. The cost of generic drugs is lower than original drugs, because the developmental cost is lower. The expansion of medical expenses is an important issue in many countries, including Japan, the USA, and Europe, and promotion of generic drugs has been demanded to solve this issue in Japan. Generic drug approval review in Japan is conducted by the Pharmaceuticals and Medical Devices Agency (PMDA), which reviews the equivalence of the original drugs from the viewpoint of quality, efficacy, and safety, based on documentation submitted by the generic drug applicants. However, the details of the generic drug review in Japan have not been reported. In this report, we introduce the application types, the number of applications and approvals, and the review timeline of generic drugs in Japan. In addition, we discuss recent consultations and future prospects.

  14. Safety issues of botanicals and botanical preparations in functional foods.

    Science.gov (United States)

    Kroes, R; Walker, R

    2004-05-20

    Although botanicals have played a role in the marketing of health products for ages, there is an increased interest today due to their perceived health benefits. Not only do consumers increasingly take charge of their health, but the scientific information and understanding of the beneficial health effects of bioactive substances in food, functional foods and food supplements have improved. Increasing use of these products has also led to concerns about their actual safety. Recorded cases of intoxications have triggered such concerns. The safety assessment of these substances is complicated by, amongst others, the variability of composition. Furthermore, consumption of such functional products is expected to produce physiological effects, which may lead to low margins of safety as the margin between exposure of such products and the safe level of intake are likely to be small. The safety assessment of botanicals and botanical preparations in food and food supplement should at least involve: the characterisation and quality of the material, its quality control; the intended use and consequent exposure; history of use and exposure; product comparison(s); toxicological information gathering; Risk characterisation/safety assessment. As a guidance tool, a decision tree approach is proposed to assist in determining the extent of data requirements based on the nature of the such product. This guidance tool in safety assessment was developed by an expert group of the International Life Sciences Institute (ILSI), European Branch, and is currently in press. In this paper a summarised version of this tool is presented.

  15. Recent safety issues concerning steam generators in France and their analysis by IRSN

    Energy Technology Data Exchange (ETDEWEB)

    Sollier, T.; Le Calvar, M.; Balestreri, F.; Mermaz, F. [Inst. de Radioprotection ed de Surete Nucleaaire (IRSN) (France)

    2009-07-01

    In France between 2004 and 2008, there were recurrent safety issues concerning the operation of Steam Generators (SGs). Among these issues, at least three are generic to the EDF Nuclear Power Plant (NPP) fleet: In 2004, 2005 and 2006, a total of three primary to secondary leaks occurred at Cruas NPP. The root cause of these leaks was a modification of the thermal-hydraulic condition of the SG due to a heavy build-up of oxide deposits at the flow holes of the quatrefoil-shaped Tube Support Plates (TSPs). The clogging of the TSPs, meant that the water/steam flow accelerated at the U-bend location and that tubes were subjected to high cycle fatigue near the uppermost TSPs due to flow-induced vibration. For each unscheduled outage, the origin of the leaks was a circumferential fatigue crack located at the upper edge of the uppermost TSP; In 2008, a primary to secondary leak occurred at Fessenheim NPP. The source of the leak was a circumferential crack located at the edge of the uppermost TSP at approximately the same location where cracks were found on Cruas Units. However, the SGs of Fessenheim Unit 2 have circular flow holes without significant flow section reduction due to oxide deposits. The root cause of the event was determined to be fluid-elastic instability in the U-Bend for a tube not supported by an Anti-Vibration Bar (AVB). The AVB position in the tube bundle deviated from the manufacturing design, something which affects a large number of SGs in France; In 2008, a plug failure was observed at Saint Alban NPP. A plug was propelled from the hot to the cold leg during the primary coolant circuit hydrotest. The plugging operation had been performed before the hydrotest. In this paper, IRSN presents its technical analysis of these events. It includes the SG secondary side water conditioning operation, the non-destructive testing methods in relation to the clogging-rate evaluation and tube integrity assessment, and the mechanical issues due to tube vibration

  16. Ethical issues in engineering design safety and sustainability

    NARCIS (Netherlands)

    Van Gorp, A.C.

    2005-01-01

    The goal of this research is to obtain insight in how engineers deal with ethical issues in daily engineering design practice. It is reasonable to assume that ethical issues and the way engineers deal with them depend on characteristics of the design process. I have made use of Vincentis dimensions

  17. Consumer confidence in the safety of food and newspaper coverage of food safety issues: a longitudinal perspective.

    Science.gov (United States)

    de Jonge, Janneke; Van Trijp, Hans; Renes, Reint Jan; Frewer, Lynn J

    2010-01-01

    This study develops a longitudinal perspective on consumer confidence in the safety of food to explore if, how, and why consumer confidence changes over time. In the first study, a theory-based monitoring instrument for consumer confidence in the safety of food was developed and validated. The monitoring instrument assesses consumer confidence together with its determinants. Model and measurement invariance were validated rigorously before developments in consumer confidence in the safety of food and its determinants were investigated over time. The results from the longitudinal analysis show that across four waves of annual data collection (2003-2006), the framework was stable and that the relative importance of the determinants of confidence was, generally, constant over time. Some changes were observed regarding the mean ratings on the latent constructs. The second study explored how newspaper coverage of food safety related issues affects consumer confidence in the safety of food through subjective consumer recall of food safety incidents. The results show that the newspaper coverage on food safety issues is positively associated with consumer recall of food safety incidents, both in terms of intensity and recency of media coverage.

  18. Generic Site Safety Report

    CERN Document Server

    International Atomic Energy Agency. Vienna. ITER Joint Central Team

    2001-01-01

    The ITER Engineering Design Activities (EDA) are being conducted jointly by Euratom, Japan, and the Russian Federation, as Parties to the ITER EDA Agreement signed on 21 July 1992 and subsequently extended until July 20th 2001. (The United States of America was an ITER Party until September 30th 1999). The activities are conducted under the auspices of the IAEA by the ITER Joint Central Team and by the Home Teams (HT). The JCT is composed of qualified persons made available by each of the Parties in approximately equal numbers. The JCT members are located at the ITER Joint Work Sites (JWS) in Naka (Japan), Garching (Germany), and formerly in San Diego (USA). The Home Teams are established and organized by each Party for performing the tasks of the work programme for the EDA, assigned to them in approximately equal shares. Home Teams in each of the Parties perform specific design tasks, and perform research and development in technology (physics R&D is contributed voluntarily). The Home Team Leaders (HTL) ...

  19. Pholcodine-containing cough medicines.(Safety and Efficacy Issues)

    National Research Council Canada - National Science Library

    2012-01-01

    ... taken pholcodine-containing cough medicines. Following a thorough review of all available data on the safety and efficacy of pholcodine-containing cough medicines, the Committee found no firm evidence to substantiate the hypothesis of cross-sensitization between pholcodine and NMBAs and a subsequent increased risk of anaphylactic reactions during s...

  20. Methodological issues and pitfalls of short safety culture questionnaires

    NARCIS (Netherlands)

    Jagtman, H.M.; Koornneef, F.; Akselsson, R.; Stewart, S.

    2013-01-01

    Safety culture surveys have been fielded in many different sectors of industrial activities. Many of these surveys consist of a long list of questions which is time consuming for the respondents. As part of the FP6 HILAS project a shorter survey has been developed, which aimed at getting a high resp

  1. Gender issues in safety and health at work : a review

    NARCIS (Netherlands)

    Houtman, I.L.D.; Kauppinen, K.; Kumpulainen, R.; Goudswaard, A.

    2003-01-01

    This report explores the gender differences in occupational safety and health. There is strong segregation of women and men into different jobs and tasks at work. Both men and women face significant risks. In general, men suffer more accidents and injuries at work than women do, whereas women report

  2. U.S. Food System Working Conditions as an Issue of Food Safety.

    Science.gov (United States)

    Clayton, Megan L; Smith, Katherine C; Pollack, Keshia M; Neff, Roni A; Rutkow, Lainie

    2017-02-01

    Food workers' health and hygiene are common pathways to foodborne disease outbreaks. Improving food system jobs is important to food safety because working conditions impact workers' health, hygiene, and safe food handling. Stakeholders from key industries have advanced working conditions as an issue of public safety in the United States. Yet, for the food industry, stakeholder engagement with this topic is seemingly limited. To understand this lack of action, we interviewed key informants from organizations recognized for their agenda-setting role on food-worker issues. Findings suggest that participants recognize the work standards/food safety connection, yet perceived barriers limit adoption of a food safety frame, including more pressing priorities (e.g., occupational safety); poor fit with organizational strategies and mission; and questionable utility, including potential negative consequences. Using these findings, we consider how public health advocates may connect food working conditions to food and public safety and elevate it to the public policy agenda.

  3. International and NASA SSA and Safety of Flight Issues

    Science.gov (United States)

    Johnson, Nicholas K,

    2010-01-01

    This presentation reviews the international and NASA interests in Space Situational Awareness (SSA) and space debris as it affects space flight safety. The international interesrt has increased since the collision of the Iridium and Cosmos satellites in 2009. The United Nations Committee on the Peaceful Uses of Outer Space (UN COPUOS) has commenced a multi-year effort to review the long-term sustainability of outer space activities.

  4. Legislation for the countermeasures on special issues of nuclear safety regulations

    Energy Technology Data Exchange (ETDEWEB)

    Cho, Byung Sun; Lee, Mo Sung; Chung, Gum Chun; Kim, Heon Jin; Oh, Ho Chul [Chongju Univ., Cheongju (Korea, Republic of)

    2004-02-15

    Since the present nuclear safety regulation has some legal problems that refer to special issues and contents of regulatory provisions, this report has preformed research on the legal basic theory of nuclear safety regulation to solve the problems. In addition, this report analyzed the problems of each provisions and suggested the revision drafts on the basis of analyzing problems and the undergoing theory of nuclear safety regulation.

  5. Safety, Efficacy, and Legal Issues Related to Dietary Supplements

    Science.gov (United States)

    Powers, Michael

    2004-01-01

    This article focuses on the effects of dietary supplements on collegiate and adult populations. Anabolic steroids, amphetamines, and other drugs have been used for decades to improve athletic performance. However, the legal issues and dangers associated with these drugs have resulted in reluctance by many athletes to use them. Because dietary…

  6. SHELFS: A Proactive Method for Managing Safety Issues

    Science.gov (United States)

    2001-01-01

    contrary, well established and sound methods like HazOp (Kletz, 1993), OARU (Kjellen, & Larrson, 1981) or MORT (Johnson, 1980) require large initial...interactive system with special regard to human factors issues. SHEL is the acronym for Software , Hardware, Environment, and Liveware: Software represents...by a specific combination of Hardware, Software and Liveware resources which mediate the execution of human activity. The relationship between the

  7. Containment-emergency-sump performance. Technical findings related to Unresolved Safety Issue A-43. [PWR

    Energy Technology Data Exchange (ETDEWEB)

    1983-04-01

    This report summarizes key technical findings related to the Unresolved Safety Issue A-43, Containment Emergency Sump Performance, and provides recommendations for resolution of attendant safety issues. The key safety questions relate to: (a) effects of insulation debris on sump performance; (b) sump hydraulic performance as determined by design features, submergence, and plant induced effects, and (c) recirculation pump performance wherein air and/or particulate ingestion can occur. The technical findings presented in this report provide information relevant to the design and performance evaluation of the containment emergency sump.

  8. An update on environmental, health and safety issues of interest to the photovoltaic industry

    Energy Technology Data Exchange (ETDEWEB)

    Moskowitz, P.D.; Viren, J.; Fthenakis, V.M.

    1992-08-01

    There is growing interest in the environmental, health, and safety issues related to new photovoltaic technologies as they approach commercialization. Such issues include potential toxicity of II--VI compounds; the impacts of new environmental regulations on module manufacturers; and, the need for recycling of spent modules and manufacturing wastes. This paper will review these topics. 20 refs.

  9. An update on environmental, health and safety issues of interest to the photovoltaic industry

    Energy Technology Data Exchange (ETDEWEB)

    Moskowitz, P.D.; Viren, J.; Fthenakis, V.M.

    1992-01-01

    There is growing interest in the environmental, health, and safety issues related to new photovoltaic technologies as they approach commercialization. Such issues include potential toxicity of II--VI compounds; the impacts of new environmental regulations on module manufacturers; and, the need for recycling of spent modules and manufacturing wastes. This paper will review these topics. 20 refs.

  10. Use of feedback control to address flight safety issues

    Science.gov (United States)

    Ganguli, Subhabrata

    This thesis addresses three control problems related to flight safety. The first problem relates to the scope of improvement in performance of conventional flight control laws. In particular, aircraft longitudinal axis control based on the Total Energy Control System (TECS) is studied. The research draws attention to a potentially sluggish and undesirable aircraft response when the engine dynamics is slow (typically the case). The proposed design method uses a theoretically well-developed modern design method based on Hinfinity optimization to improve the aircraft dynamic behavior in spite of slow engine characteristics. At the same time, the proposed design method achieves other desirable performance goals such as insensitivity to sensor noise and wind gust rejection: all addressed in one unified framework. The second problem is based on a system level analysis of control structure hierarchy for aircraft flight control. The objective of the analysis problem is to translate outer-loop stability and performance specifications into a comprehensive inner-loop metric. The prime motivation is to make the flight control design process more systematic and the system-integration reliable and independent of design methodology. The analysis problem is posed within the robust control analysis framework. Structured singular value techniques and free controller parameterization ideas are used to impose a hierarchical structure for flight control architecture. The third problem involves development and demonstration of a new reconfiguration strategy in the flight control architecture that has the potential of improving flight safety while keeping cost and complexity low. This research proposes a fault tolerant feature based on active robust reconfiguration. The fault tolerant control problem is formulated in the Linear Parameter Varying (LPV) design framework. A prime advantage of this approach is that the synthesis results in a single nonlinear controller (as opposed to a bank

  11. Food safety issues and information needs: an online survey of public health inspectors.

    Science.gov (United States)

    Pham, Mai T; Jones, Andria Q; Dewey, Catherine E; Sargeant, Jan M; Marshall, Barbara J

    2012-06-01

    In the study described in this article, the authors investigated the perceptions and needs of public health inspectors (PHIs) in the province of Ontario, Canada, with regard to food safety issues and information resources. A cross-sectional online survey of 239 Ontario PHIs was conducted between April and June 2009. Questions pertained to their perceptions of key food safety issues and foodborne pathogens, knowledge confidence, available resources, and resource needs. All respondents rated time-temperature abuse, inadequate hand washing, and cross contamination as important food safety issues. Salmonella, Campylobacter, and E. coli O157:H7 were pathogens reported to be of concern to 95% of respondents (221/233). Most respondents indicated that they were confident in their knowledge of food safety issues and foodborne pathogens, but wanted a central, online resource for food safety information and ongoing food safety education training for PHIs. The data from the authors' study can be used in the development of information resources targeted to the needs of PHIs involved in food safety.

  12. Patients' attitude about generics –Bulgarian perspective

    Directory of Open Access Journals (Sweden)

    Hristina Lebanova

    2012-01-01

    Full Text Available OBJECTIVE: The aim of the present study is to investigate (1 what is the patients' attitude towards and (2 preferences to use generic medicines in Bulgaria and (3 which are the main factors influencing their opinion.METHODS: Using pseudo-randomization we select a sample of 225 participants, men and women from general population, patients in community pharmacies. For our survey we used a standardized self-questionnaire of ten points. The influence of sex, age, education, medical history, knowledge of generic drugs and experience with generic substitution and medicines was examined through Chi-square tests.RESULTS: The results show that 74% of the participants seemed not to be informed on generic drugs and 26% received valuable and relevant information from their general practitioner or pharmacist. 94% believed that generic medicines are inferior to brand medicines on quality, safety and efficacy.CONCLUSIONS: The main reason for almost all the participants (94% to prefer original medicines, over generics is the insufficient information, they have. The core factors forming patients' opinion and expectations for generic drugs are medical professionals' recommendation and previous experience. The main advantages of the generics according to the participants in the study are the lower price and better accessibility. The results raise the issue of the awareness and level knowledge about generic medicines and the rational drug use in the general population.

  13. Economic grand rounds: experience with mandated use of generic medications for patients covered by the mental health safety net.

    Science.gov (United States)

    Amirsadri, Alireza; Chapman, Timothy; Breen, Michael; Drake, William; Arfken, Cynthia L

    2014-07-01

    Reducing pharmacy costs without increasing adverse outcomes would relieve some pressure on mental health budgets. This column describes the experience of a publicly funded provider network in a Michigan county that mandated generic use of psychotropic medications to address financial challenges. The percentage of brand-name medications and cost per prescription declined with the policy change, resulting in lower total pharmacy expenditures. No increase was noted in prescriptions per patient or psychiatric hospitalizations. Changes were sustained after the initial implementation period. Mandating generic use may be feasible as a tool for constraining pharmacy costs in mental health budgets.

  14. Assessment of policy issues in nuclear safety regulation according to circumstantial changes

    Energy Technology Data Exchange (ETDEWEB)

    Chang, Soon Heung; Lee, Byong Ho; Baek, Won Pil; Lee, Kwang Gu; Huh, Gyun Young; Hahn, Young Tae [Korea Advanced Institute of Science and Technology, Taejon (Korea, Republic of)

    2000-03-15

    The objective of the work is to assess various issues in nuclear safety regulation in consideration of circumstantial changes. Emphasis is given to the safety of operating NPPs. It is concluded that the Periodic Safety Review (PSR) should be implemented in Korea as soon as possible, in harmonization with the regulation for life extension of NPPs. The IAEA guidelines, including 10 year intervals and 11 safety factors, should be used as the basic guidelines. The approach to improve regulatory effectiveness is also reviewed and a transition to 'knowledge-based regulation' is suggested.

  15. [HERA-QUEST: HTA evaluation of generic pharmaceutical products to improve quality, economic efficiency, patient safety and transparency in drug product changes in hospitals].

    Science.gov (United States)

    Gyalrong-Steur, Miriam; Kellermann, Anita; Bernard, Rudolf; Berndt, Georg; Bindemann, Meike; Nusser-Rothermundt, Elfriede; Amann, Steffen; Brakebusch, Myga; Brüggmann, Jörg; Tydecks, Eva; Müller, Markus; Dörje, Frank; Kochs, Eberhard; Riedel, Rainer

    2017-04-01

    In view of the rising cost pressure and an increasing number of drug shortages, switches between generic drug preparations have become a daily routine in hospitals. To ensure consistently high treatment quality and best possible patient safety, the equivalence of the new and the previous drug preparation must be ensured before any change in the purchase of pharmaceutical products takes place. So far, no easily usable, transparent and standardized instrument for this kind of comparison between generic drug products has been available. A group of pharmaceutical experts has developed the drug HTA (health technology assessment) model "HERA" (HTA Evaluation of geneRic phArmaceutical products) through a multi-step process. The instrument is designed to perform both a qualitative and economic comparison of equivalent drug preparations ("aut idem" substitution) before switching products. The economic evaluation does not only consider unit prices and consumption quantity, but also the processing costs associated with a product change process. The qualitative comparison is based on the evaluation of 34 quality criteria belonging to six evaluation fields (e.g., approval status, practical handling, packaging design). The objective evaluation of the quality criteria is complemented by an assessment of special features of the individual hospital for complex drug switches, including the feedback of the physicians utilizing the drug preparation. Thus potentially problematic switches of pharmaceutical products can be avoided at the best possible rate, contributing to the improvement of patient safety. The novel drug HTA model HERA is a tool used in clinical practice that can add to an increase in quality, therapeutic safety and transparency of drug use while simultaneously contributing to the economic optimization of drug procurement in hospitals. Combining these two is essential for hospitals facing the tension between rising cost pressure and at the same time increasing demands

  16. Health and safety issues pertaining to genetically modified foods.

    Science.gov (United States)

    Goodyear-Smith, F

    2001-08-01

    Genetic modification involves the insertion of genes from other organisms (within or between species) into host cells to select for desirable qualities. Potential benefits of GM foods include increased nutritional value; reduced allergenicity; pest and disease-resistance; and enhanced processing value. Possible detrimental outcomes include producing foods with novel toxins, allergens or reduced nutritional value, and development of antibiotic resistance or herbicide-resistant weeds. Benefits to individuals or populations need to be weighed against adverse health and environmental risks, and may differ between developing and Westernised countries. Whether testing and monitoring should exceed requirements for conventional foods is under debate. While not necessarily scientifically justifiable, consumer concerns have resulted in Australian and New Zealand requirements to label foods containing GM-produced proteins. Dissatisfied consumer advocacy groups are calling for all foods involving GM technology to be labelled, irrelevant of whether the final product contains novel protein. Goals to improve the quantity, quality and safety of foods are laudable; however, the primary aim of the bio-food industry is financial gain. GM foods may be as safe as conventional foods but public distrust runs high. It is important that discussion is informed by science and that claims of both benefits and risks are evidence-based, to ensure that the process is driven neither by the vested interest of the bio-technical multinational companies on the one hand, nor ill-informed public fears on the other.

  17. Illustrative assessment of human health issues arising from the potential release of chemotoxic substances from a generic geological disposal facility for radioactive waste.

    Science.gov (United States)

    Wilson, James C; Thorne, Michael C; Towler, George; Norris, Simon

    2011-12-01

    Many countries have a programme for developing an underground geological disposal facility for radioactive waste. A case study is provided herein on the illustrative assessment of human health issues arising from the potential release of chemotoxic and radioactive substances from a generic geological disposal facility (GDF) for radioactive waste. The illustrative assessment uses a source-pathway-receptor methodology and considers a number of human exposure pathways. Estimated exposures are compared with authoritative toxicological assessment criteria. The possibility of additive and synergistic effects resulting from exposures to mixtures of chemical contaminants or a combination of radiotoxic and chemotoxic substances is considered. The case study provides an illustration of how to assess human health issues arising from chemotoxic species released from a GDF for radioactive waste and highlights potential difficulties associated with a lack of data being available with which to assess synergistic effects. It also highlights how such difficulties can be addressed.

  18. Safety And Reduce In Pollution Issues For Inland Waterway Transportation

    Directory of Open Access Journals (Sweden)

    Van Huong Dong

    2015-08-01

    Full Text Available According to the Ministry of Transport inland water transport is one of the five modes of transport in our country play a very important role. Inland waterway transport not only plays a major role in transporting large volumes of goods and passengers but also creates millions of jobs contributing to ensuring social security and national defense and security. However there are still many inadequacies in waterway transportation such as unequal waterway traffic The phenomenon of exploitation of river resources as planned or Process technology is not as planned exploitation of sand gravel etc. are common in most rivers and canals in the country. The signaling system is not synchronized between the signal of the inland waterway management unit and the signal of the owner The handling of domestic goods transportation and inland port management is inadequate The force of the means of development is fast uneven but concentrated in some urban areas and industrial parks. Therefore the Ministry of Transport has proposed a scheme to facilitate the development of a synchronized inland waterway infrastructure linking with other modes of transport To improve the capacity of the crew and the inland waterway transport crews. To create favorable conditions for inland waterway transportation business with reasonable transportation costs Improve the quality of water transport services Ensure safety and environmental friendliness Make a distinct advantage over other modes of transport. Specifically will develop promulgate mechanisms The policy is to facilitate the development of inland waterway infrastructure Build and promulgate mechanism The policy of supporting the development of the fleet has a reasonable structure with a fleet of about 30 self-propelled ships accounting for about 70 of the total number of inland waterway vessels To prioritize the development of the container fleet Inland waterway transportation and training retraining of human resources for

  19. Critical issues of alcohol safety in the region

    Directory of Open Access Journals (Sweden)

    Svetlana Vasil’evna Aksyutina

    2015-03-01

    Full Text Available The paper presents results of the research into the economic and socio-demographic indicators associated with the production and consumption of alcoholic beverages. It discloses the analysis of the alcoholic beverage market structure in the Vologda Oblast. The authors have identified the threshold of the safe alcohol production volume in the region taking into account the World Health Organization standards of alcohol consumption and the share of illegally produced goods. The article states that the increased alcohol production contributes to the rise in tax revenues, but the state fiscal policy to regulate the alcoholic beverage market leads to an increase in the share of shadow turnover. The authors have calculated the economic loss connected with the illegal production of alcoholic beverages in the Vologda Oblast. The alcohol consumption is a destructive socio-demographic process and one of the threats to the health of the nation. Excessive alcohol consumption leads to alcohol dependence, regression of the society and increases the threat to national and economic security. The study reveals a direct correlation between the consumption of alcoholic beverages per capita and mortality rates in men and women of working age from the causes related to the consumption of alcoholic beverages. The study of the international experience to regulate alcohol consumption has showed the need to tighten state control in the sphere of production and turnover of alcoholic products. The conduct of the unified state alcohol policy substantiates the selection of the alcohol industry in the all-Russian classifier of economic activity types. The authors have elaborated the concept and conditions of alcoholic security from the point of view of economic growth and social development. The article substantiates the necessity to monitor alcohol safety indicators when considering the regional development. It presents the complex system of socio-economic and demographic

  20. Refugee settlement workers' perspectives on home safety issues for people from refugee backgrounds.

    Science.gov (United States)

    Campbell, Emma Jean; Turpin, Merrill June

    2010-12-01

    Refugees experience higher levels of emotional, psychological and physical distress than the general migrant population during settlement in a new country. Safety in the home can be a major concern and is an issue of which occupational therapists should be aware. Occupational therapists working with refugees in many contexts feel unprepared and overwhelmed. As refugee settlement workers attend to home safety of refugees during the settlement process, this study aimed to develop an in-depth understanding of their perceptions of this issue. Such information can contribute to occupational therapists' knowledge and practice when working with refugees. An exploratory qualitative case study approach used 16 semi-structured interviews and observation of a settlement worker assisting newly arrived refugees. Participants were settlement service staff (an occupational therapist, case coordinators and cultural support workers). Three themes are reported: considerations for safety in the homes of refugees; factors influencing home safety for refugees; and sensitivity to culture. Participants described tailoring home safety-related services to each individual based on factors that influence home safety and sensitivity to culture. Awareness of home safety issues can increase cultural competence and inform practice and policy. © 2010 The Authors. Australian Occupational Therapy Journal © 2010 Australian Association of Occupational Therapists.

  1. Radiation Safety Issues in High Altitude Commercial Aircraft

    Science.gov (United States)

    Wilson, John W.; Cucinotta, Francis A.; Shinn, Judy L.

    1995-01-01

    The development of a global economy makes the outlook for high speed commercial intercontinental flight feasible, and the development of various configurations operating from 20 to 30 km have been proposed. In addition to the still unresolved issues relating to current commercial operations (12-16 km), the higher dose rates associated with the higher operating altitudes makes il imperative that the uncertainties in the atmospheric radiation environment and the associated health risks be re-examined. Atmospheric radiation associated with the galactic cosmic rays forms a background level which may, under some circumstances, exceed newly recommended allowable exposure limits proposed on the basis of recent evaluations of the A -bomb survivor data (due to increased risk coefficients). These larger risk coefficients, within the context of the methodology for estimating exposure limits, are resulting in exceedingly low estimated allowable exposure limits which may impact even present day flight operations and was the reason for the CEC workshop in Luxembourg (1990). At higher operating altitudes, solar particles events can produce exposures many orders of magnitude above background levels and pose significant health risks to the most sensitive individuals (such as during pregnancy). In this case the appropriate quality factors are undefined, and some evidence exists which indicates that the quality factor for stochastic effects is a substantial underestimate.

  2. Bioequivalence of generic drugs.

    Science.gov (United States)

    Andrade, Chittaranjan

    2015-09-01

    Generic drugs are bioequivalent to the original brand; this is a prerequisite for marketing approval. It is theoretically possible that one generic drug may overestimate the pharmacokinetic (PK) parameters of the original and another generic may underestimate these PK parameters; in consequence, these 2 generics may not be bioequivalent between themselves. The result could be loss of efficacy or development of drug-related adverse effects if these generics are interchanged in stable patients. In a recent study involving 292 indirect comparisons of generic formulations of 9 different drugs, mathematical modeling showed that in most cases (87.0% for maximum concentration, 90.1% for area under the curve, and 80.5% for both) generic drugs are bioequivalent to each other. These reassuring findings notwithstanding, prudence dictates that, in stable patients, generic drugs should be interchanged only if there is a good reason for it. This is because bioequivalent brands of drugs may differ in their excipient content, and this can result in variations in safety profiles.

  3. Pesticide Exposure, Safety Issues, and Risk Assessment Indicators

    Directory of Open Access Journals (Sweden)

    Christos A. Damalas

    2011-05-01

    of the already approved pesticides and the approval of the new compounds in the near future. Thus, new tools or techniques with greater reliability than those already existing are needed to predict the potential hazards of pesticides and thus contribute to reduction of the adverse effects on human health and the environment. On the other hand, the implementation of alternative cropping systems that are less dependent on pesticides, the development of new pesticides with novel modes of action and improved safety profiles, and the improvement of the already used pesticide formulations towards safer formulations (e.g., microcapsule suspensions could reduce the adverse effects of farming and particularly the toxic effects of pesticides. In addition, the use of appropriate and well-maintained spraying equipment along with taking all precautions that are required in all stages of pesticide handling could minimize human exposure to pesticides and their potential adverse effects on the environment.

  4. Impacts on non-human biota from a generic geological disposal facility for radioactive waste: some key assessment issues

    Energy Technology Data Exchange (ETDEWEB)

    Robinson, C A; Smith, K L [Enviros Consulting Limited, 61 The Shore, Leith, Edinburgh EH6 6RA (United Kingdom); Norris, S, E-mail: carol.robinson@enviros.co [Nuclear Decommissioning Authority, Radioactive Waste Management Directorate, Harwell Science and Innovation Campus, Curie Avenue, Harwell, Didcot OX11 0RH (United Kingdom)

    2010-06-15

    This paper provides an overview of key issues associated with the application of currently available biota dose assessment methods to consideration of potential environmental impacts from geological disposal facilities. It explores philosophical, methodological and practical assessment issues and reviews the implications of test assessment results in the context of recent and on-going challenges and debates.

  5. A study on the regulatory approach of safety issues for Korean next generation reactor

    Energy Technology Data Exchange (ETDEWEB)

    Chang, Keun Seon; Choi, Jeong Tae; Kim, In Joon [Sunmoon Univ., Asan (Korea, Republic of); Lee, Sang Hoon [Korea Association of Nuclear Technology, Taejon (Korea, Republic of); Kang, Gee Sik [Korea Power Engineering Co., Inc., Seoul (Korea, Republic of); Kim, Han Gon [Korea Electric Power Corporation, Seoul (Korea, Republic of); Park, Jae Uk; Kim, Yun Il; Yang, Soo Hyeong [Korea Advanced Institute of Science and Technology, Taejon (Korea, Republic of)

    1997-10-15

    The project aims to provide the regulatory direction of major technical issues related to the quantitative criteria for probabilistic risk analysis, establishment of containment performance criteria, design of additional water source for long-term corium cooling of core debris, protection against common mode failure of digital I and C system, criteria for safety-related operator action, quantitative reliability targets, classification of plant conditions and acceptance criteria and development of graded QA. These issues are parts of major technical issues resulted from the safety regulation R and D on the next generation reactor. Regulatory directions to be applied to the Korea Next Generation Reactors in this study are developed by analyzing the state-of-the-art of the development of local and foreign regulatory requirements, research trends, and the design features and safety goals of advanced reactors.

  6. Statistical issues in the design, conduct and analysis of two large safety studies.

    Science.gov (United States)

    Gaffney, Michael

    2016-10-01

    The emergence, post approval, of serious medical events, which may be associated with the use of a particular drug or class of drugs, is an important public health and regulatory issue. The best method to address this issue is through a large, rigorously designed safety study. Therefore, it is important to elucidate the statistical issues involved in these large safety studies. Two such studies are PRECISION and EAGLES. PRECISION is the primary focus of this article. PRECISION is a non-inferiority design with a clinically relevant non-inferiority margin. Statistical issues in the design, conduct and analysis of PRECISION are discussed. Quantitative and clinical aspects of the selection of the composite primary endpoint, the determination and role of the non-inferiority margin in a large safety study and the intent-to-treat and modified intent-to-treat analyses in a non-inferiority safety study are shown. Protocol changes that were necessary during the conduct of PRECISION are discussed from a statistical perspective. Issues regarding the complex analysis and interpretation of the results of PRECISION are outlined. EAGLES is presented as a large, rigorously designed safety study when a non-inferiority margin was not able to be determined by a strong clinical/scientific method. In general, when a non-inferiority margin is not able to be determined, the width of the 95% confidence interval is a way to size the study and to assess the cost-benefit of relative trial size. A non-inferiority margin, when able to be determined by a strong scientific method, should be included in a large safety study. Although these studies could not be called "pragmatic," they are examples of best real-world designs to address safety and regulatory concerns. © The Author(s) 2016.

  7. Tools and Equipment in Nontraditional Spaces: Safety and Liability Issues. Safety Spotlight

    Science.gov (United States)

    Love, Tyler S.; Roy, Ken R.

    2017-01-01

    "Safety Spotlight" encourages the submission of questions from Technology and Engineering (T&E) Educators, and this month's question involves the risks of placing hazardous equipment (e.g., 3D printer, laser cutter, CNC router, etc.) in a non-technology & engineering lab under the supervision of teachers not certified to teach…

  8. Complement activation as a bioequivalence issue relevant to the development of generic liposomes and other nanoparticulate drugs

    NARCIS (Netherlands)

    Szebeni, Janos; Storm, G

    2015-01-01

    Liposomes are known to activate the complement (C) system, which can lead in vivo to a hypersensitivity syndrome called C activation-related pseudoallergy (CARPA). CARPA has been getting increasing attention as a safety risk of i.v. therapy with liposomes, whose testing is now recommended in bioequi

  9. An Evaluation Methodology Development and Application Process for Severe Accident Safety Issue Resolution

    Directory of Open Access Journals (Sweden)

    Robert P. Martin

    2012-01-01

    Full Text Available A general evaluation methodology development and application process (EMDAP paradigm is described for the resolution of severe accident safety issues. For the broader objective of complete and comprehensive design validation, severe accident safety issues are resolved by demonstrating comprehensive severe-accident-related engineering through applicable testing programs, process studies demonstrating certain deterministic elements, probabilistic risk assessment, and severe accident management guidelines. The basic framework described in this paper extends the top-down, bottom-up strategy described in the U.S Nuclear Regulatory Commission Regulatory Guide 1.203 to severe accident evaluations addressing U.S. NRC expectation for plant design certification applications.

  10. Prisoner reentry: a public health or public safety issue for social work practice?

    Science.gov (United States)

    Patterson, George T

    2013-01-01

    A significant literature identifies the policy, economic, health, and social challenges that confront released prisoners. This literature also describes the public health and public safety risks associated with prisoner reentry, provides recommendations for improving the reentry process, and describes the effectiveness of prison-based programs on recidivism rates. Public health and public safety risks are particularly significant in communities where large numbers of prisoners are released and few evidence-based services exist. The purpose of this article is to describe the public health and public safety risks that released prisoners experience when they reenter communities, and to discuss the social justice issues relevant for social work practice.

  11. Climate and climate-related issues for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Naeslund, Jens-Ove (comp.)

    2006-11-15

    The purpose of this report is to document current scientific knowledge of the climate-related conditions and processes relevant to the long-term safety of a KBS-3 repository to a level required for an adequate treatment in the safety assessment SR-Can. The report also includes a concise background description of the climate system. The report includes three main chapters: A description of the climate system (Chapter 2); Identification and discussion of climate-related issues (Chapter 3); and, A description of the evolution of climate-related conditions for the safety assessment (Chapter 4). Chapter 2 includes an overview of present knowledge of the Earth climate system and the climate conditions that can be expected to occur in Sweden on a 100,000 year time perspective. Based on this, climate-related issues relevant for the long-term safety of a KBS-3 repository are identified. These are documented in Chapter 3 'Climate-related issues' to a level required for an adequate treatment in the safety assessment. Finally, in Chapter 4, 'Evolution of climate-related conditions for the safety assessment' an evolution for a 120,000 year period is presented, including discussions of identified climate-related issues of importance for repository safety. The documentation is from a scientific point of view not exhaustive, since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of a safety assessment. As further described in the SR-Can Main Report and in the Features Events and Processes report, the content of the present report has been audited by comparison with FEP databases compiled in other assessment projects. This report follows as far as possible the template for documentation of processes regarded as internal to the repository system. However, the term processes is not used in this report, instead the term issue has been used. Each issue includes a set of processes together resulting in the

  12. Patient safety culture in a district hospital in South Africa: An issue of quality.

    Science.gov (United States)

    Mayeng, Lorraine M; Wolvaardt, Jacqueline E

    2015-11-05

    The Nursing Act 33 of 2005 holds nurse practitioners responsible for all acts and omissions in the delivery of quality patient care. But quality patient care is influenced by a number of factors beyond the control of nurse practitioners. Patient safety culture is one such factor and is seldom explored in hospitals in developing countries. This article describes the patient safety culture of a district hospital in South Africa. The study identified and analysed the factors that influence the patient safety culture by using the Manchester Patient Safety Framework at the National District Hospital, Bloemfontein, Free State Province. A descriptive cross-sectional study was conducted and included the total population of permanent staff; community service health professionals; temporarily employed health professionals and volunteers. The standard Manchester Patient Safety Framework questionnaire was distributed with a response rate of 61%. Less than half of the respondents (42.4%; n = 61) graded their units as acceptable. Several quality dimensions were statistically significant for the employment profile: overall commitment to quality (p = 0.001); investigating patient incidents (p = 0.031); organisational learning following incidents (p < 0.001); communication around safety issues (p = 0.001); and team working around safety issues (p = 0.005). These same quality dimensions were also statistically significant for the professional profiles. Medical doctors had negative perceptions of all the safety dimensions. The research measured and described patient safety culture (PSC) amongst the staff at the National District Hospital (NDH). This research has identified the perceived inadequacies with PSC and gives nurse managers a clear mandate to implement change to ensure a PSC that fosters quality patient care.

  13. Patient safety culture in a district hospital in South Africa: An issue of quality

    Directory of Open Access Journals (Sweden)

    Lorraine M. Mayeng

    2015-02-01

    Full Text Available Background: The Nursing Act 33 of 2005 holds nurse practitioners responsible for all acts and omissions in the delivery of quality patient care. But quality patient care is influenced by a number of factors beyond the control of nurse practitioners. Patient safety culture is one such factor and is seldom explored in hospitals in developing countries. This article describes the patient safety culture of a district hospital in South Africa.Objectives: The study identified and analysed the factors that influence the patient safety culture by using the Manchester Patient Safety Framework at the National District Hospital, Bloemfontein, Free State Province.Method: A descriptive cross-sectional study was conducted and included the total population of permanent staff; community service health professionals; temporarily employed health professionals and volunteers. The standard Manchester Patient Safety Framework questionnaire was distributed with a response rate of 61%.Results: Less than half of the respondents (42.4%; n = 61 graded their units as acceptable. Several quality dimensions were statistically significant for the employment profile: overall commitment to quality (p = 0.001; investigating patient incidents (p = 0.031; organisational learning following incidents (p < 0.001; communication around safety issues (p = 0.001; and team working around safety issues (p = 0.005. These same quality dimensions were also statistically significant for the professional profiles. Medical doctors had negative perceptions of all the safety dimensions.Conclusion: The research measured and described patient safety culture (PSC amongst the staff at the National District Hospital (NDH. This research has identified the perceived inadequacies with PSC and gives nurse managers a clear mandate to implement change to ensure a PSC that fosters quality patient care.

  14. Perceptions and patterns of use of generic drugs among Italian family pediatricians: first round results of a web survey.

    Science.gov (United States)

    Fabiano, Valentina; Mameli, Chiara; Cattaneo, Dario; Delle Fave, Antonella; Preziosa, Alessandra; Mele, Giuseppe; Clementi, Emilio; Zuccotti, Gian Vincenzo

    2012-03-01

    Prescription of generic medicines represents an efficacious healthcare cost containment strategy. In some European countries and in the US, generic medicines are largely prescribed. In Italy, generic drugs prescription rate is lower. General Practitioners and Family Pediatricians may be less confident in prescribing generic equivalents instead of "branded" medicines. There are currently no data about Italian Family Pediatricians' perceptions and patterns of use of generic drugs. This is a first nationwide web survey conducted with the aim to evaluate generic medicines knowledge and prescribing habits of Italian Family Pediatricians. 303 Family Pediatricians completed the online questionnaire. 37.2% and 32.6% of them declared to have a sufficient or fairly good knowledge of generic medicines, respectively, and the majority of them believed that efficacy of generic medicines was sufficient (33.6%) or good (45.2%). Nevertheless, Italian Family Pediatricians are still prone to prescribe trade medicines more frequently, since only 13.5% of them declared that more than a half of their patients were treated with generic medicines. Major issues related with generic medicines prescriptions by Italian Family Pediatricians seem to be represented by diffuse scepticism about reliability of bioequivalence tests and safety of switchability from branded to generic equivalents. More information about generic drugs and more research in the field of pediatric pharmacology are needed for increasing generic medicines prescription rate among Italian Family Pediatricians.

  15. Japan's regulatory and safety issues regarding nuclear materials transport

    Energy Technology Data Exchange (ETDEWEB)

    Saito, T. [Nuclear and Industrial Safety Agency, Ministry of Economy, Trade and Industry, Government of Japan, Tokyo (Japan); Yamanaka, T. [Japan Nuclear Energy Safety Organization, Government of Japan, Tokyo (Japan)

    2004-07-01

    This paper focuses on the regulatory and safety issues on nuclear materials transport which the Government of Japan (GOJ) faces and needs to well handle. Background information about the status of nuclear power plants (NPP) and nuclear fuel cycle (NFC) facilities in Japan will promote a better understanding of what this paper addresses.

  16. State Legislative Developments on Campus Sexual Violence: Issues in the Context of Safety

    Science.gov (United States)

    Morse, Andrew; Sponsler, Brian A.; Fulton, Mary

    2015-01-01

    NASPA--Student Affairs Administrators in Higher Education and Education Commission of the States (ECS) have partnered to address legislative developments and offer considerations for leaders in higher education and policy on two top-level safety issues facing the higher education community: campus sexual violence and guns on campus. The first in a…

  17. Fire and worker health and safety: an introduction to the special issue.

    Science.gov (United States)

    Campbell, Richard; Levenstein, Charles

    2015-02-01

    One century ago, the landmark fire at the Triangle Shirtwaist Factory in New York City claimed the lives of 146 garment workers and helped spur the adoption of fire safety measures and laws targeting dangerous working conditions. Since that time, continuing advances have been made to address the threat of fire-in workplace fire safety practices and regulations, in training and safety requirements for firefighters and first responders, and in hazard communication laws that enhance disaster planning and response. Recent high profile events, including the West, Texas fertilizer plant explosion, derailments of fuel cargo trains, and garment factory fires in Bangladesh, have brought renewed attention to fire as a workplace health and safety issue and to the unevenness of safety standards and regulatory enforcement, in the United States as well as internationally. In this article, we provide an overview of fire as a workplace health and safety hazard and an introduction to the essays included in this special issue of New Solutions on fire and work.

  18. Materials-related issues in the safety and licensing of nuclear fusion facilities

    Science.gov (United States)

    Taylor, N.; Merrill, B.; Cadwallader, L.; Di Pace, L.; El-Guebaly, L.; Humrickhouse, P.; Panayotov, D.; Pinna, T.; Porfiri, M.-T.; Reyes, S.; Shimada, M.; Willms, S.

    2017-09-01

    Fusion power holds the promise of electricity production with a high degree of safety and low environmental impact. Favourable characteristics of fusion as an energy source provide the potential for this very good safety and environmental performance. But to fully realize the potential, attention must be paid in the design of a demonstration fusion power plant (DEMO) or a commercial power plant to minimize the radiological hazards. These hazards arise principally from the inventory of tritium and from materials that become activated by neutrons from the plasma. The confinement of these radioactive substances, and prevention of radiation exposure, are the primary goals of the safety approach for fusion, in order to minimize the potential for harm to personnel, the public, and the environment. The safety functions that are implemented in the design to achieve these goals are dependent on the performance of a range of materials. Degradation of the properties of materials can lead to challenges to key safety functions such as confinement. In this paper the principal types of material that have some role in safety are recalled. These either represent a potential source of hazard or contribute to the amelioration of hazards; in each case the related issues are reviewed. The resolution of these issues lead, in some instances, to requirements on materials specifications or to limits on their performance.

  19. Current Status of Health and Safety Issues of Sodium/Metal Chloride (Zebra) Batteries

    Energy Technology Data Exchange (ETDEWEB)

    Trickett, D.

    1998-12-15

    This report addresses environmental, health, and safety (EH&S) issues associated with sodium/ metal chloride batteries, in general, although most references to specific cell or battery types refer to units developed or being developed under the Zebra trademark. The report focuses on issues pertinent to sodium/metal chloride batteries and their constituent components; however, the fact that some ''issues'' arise from interaction between electric vehicle (EV) and battery design compels occasional discussion amid the context of EV vehicle design and operation. This approach has been chosen to provide a reasonably comprehensive account of the topic from a cell technology perspective and an applications perspective.

  20. Emergency medical and health providers' perceptions of key issues in prehospital patient safety.

    Science.gov (United States)

    Atack, Lynda; Maher, Janet

    2010-01-01

    To date, most patient safety studies have been conducted in relation to the hospital rather than the prehospital setting and data regarding emergency medical services (EMS)-related errors are limited. To address this gap, a study was conducted to gain an in-depth understanding of the views of highly experienced EMS practitioners, educators, administrators, and physicians on major issues pertaining to EMS patient safety. The intent of the study was to identify key issues to give direction to the development of best practices in education, policy, and fieldwork. A qualitative study was conducted using processes described by Lincoln and Guba (1985) to enhance the quality and credibility of data and analysis. Purposive sampling was used to identify informants with knowledge and expertise regarding policy, practice, and research who could speak to the issue of patient safety. Sixteen participants, the majority of whom were Canadian, participated in in-depth interviews. Two major themes were identified under the category of key issues: clinical decision making and EMS's focus and relationship with health care. An education gap has developed in EMS, and there is tension between the traditional stabilize-and-transport role and the increasingly complex role that has come about through "scope creep." If, as expected, EMS aligns increasingly with the health sector, then change is needed in the EMS educational structure and process to develop stronger clinical decision-making skills. The results of this study indicate that many individual organizations and health regions are addressing issues related to patient safety in EMS, and there are important lessons to be learned from these groups. The broader issues identified, however, are system-wide and best addressed through policy change from health regions and government.

  1. Generic variation?

    DEFF Research Database (Denmark)

    Jensen, Torben Juel

    2009-01-01

    Abstract In modern Danish, a handful of pronouns may be used to refer to a generic referent. In recent decades, the second person singular pronoun du has gained ground, apparently in parallel to similar recent developments in other languages. Even though generic du may not be as old as the tradit...

  2. Inherent safety advantages of carbide fuel systems and technical issues regarding natural convection in LMRs

    Energy Technology Data Exchange (ETDEWEB)

    Barthold, W.P. [Barthold and Associates, Inc., Albuquerque, NM (United States)

    1984-08-01

    The scope of work is to summarize inherent safety advantages that are unique to the use of a carbide based fuel system and to summarize the technical issues regarding natural convection flow in LMFBR cores. As discussed in this report, carbide fuel provides the designer with far greater flexibility than oxide fuel. Carbide fuel systems can be designed to eliminate major accident initiators. They turn quantitative advantages into a qualitative advantage. The author proposed to LANL a series of core design and component concepts that would greatly enhance the safety of carbide over oxide systems. This report cites a series of safety advantages which potentially exist for a carbide fuel system. Natural convection issues have not been given much attention in the past. Only during the last few years has this issue been addressed in some detail. Despite claims to the contrary by some of the LMR contractors, the author does not think that the natural convection phenomena is fully understood. Some of the approximations made in natural convection transient analyses have probably a greater impact on calculated transient temperatures than the effects under investigation. Only integral in-pile experimental data and single assembly out-of-pile detailed data are available for comparisons with analytical models and correlations. Especially for derated cores, the natural convection capability of a LMR should be far superior to that of a LWR. The author ranks the natural convection capability of the LMR as the most important inherent safety feature.

  3. Patient safety issues in office-based surgery and anaesthesia in Switzerland: a qualitative study.

    Science.gov (United States)

    McLennan, Stuart; Schwappach, David; Harder, Yves; Staender, Sven; Elger, Bernice

    2017-08-01

    To identify the spectrum of patient safety issues in office-based surgery and anaesthesia in Switzerland. Purposive sample of 23 experts in surgery and anaesthesia and quality and regulation in Switzerland. Data were collected via individual qualitative interviews using a researcher-developed semi-structured interview guide between March 2016 and September 2016. Interviews were transcribed and analysed using conventional content analysis. Issues were categorised under the headings "structure", "process", and "outcome". Experts identified two key overarching patient safety and regulatory issues in relation to office-based surgery and anaesthesia in Switzerland. First, experts repeatedly raised the current lack of data and transparency of the setting. It is unknown how many surgeons are operating in offices, how many and what types of operations are being done, and what the outcomes are. Secondly, experts also noted the limited oversight and regulation of the setting. While some standards exists, most experts felt that more minimal safety standards are needed regarding the requirements that must be met to do office-based surgery and what can and cannot be done in the office-based setting are needed, but they advocated a self-regulatory approach. There is a lack of empirical data regarding the quantity and quality office-based surgery and anaesthesia in Switzerland. Further research is needed to address these research gaps and inform health policy in relation to patient safety in office-based surgery and anaesthesia in Switzerland. Copyright © 2017. Published by Elsevier GmbH.

  4. NASA Aerospace Flight Battery Program: Generic Safety, Handling and Qualification Guidelines for Lithium-Ion (Li-Ion) Batteries; Availability of Source Materials for Lithium-Ion (Li-Ion) Batteries; Maintaining Technical Communications Related to Aerospace Batteries (NASA Aerospace Battery Workshop). Volume 1, Part 1

    Science.gov (United States)

    Manzo, Michelle A.; Brewer, Jeffrey C.; Bugga, Ratnakumar V.; Darcy, Eric C.; Jeevarajan, Judith A.; McKissock, Barbara I.; Schmitz, Paul C.

    2010-01-01

    This NASA Aerospace Flight Battery Systems Working Group was chartered within the NASA Engineering and Safety Center (NESC). The Battery Working Group was tasked to complete tasks and to propose proactive work to address battery related, agency-wide issues on an annual basis. In its first year of operation, this proactive program addressed various aspects of the validation and verification of aerospace battery systems for NASA missions. Studies were performed, issues were discussed and in many cases, test programs were executed to generate recommendations and guidelines to reduce risk associated with various aspects of implementing battery technology in the aerospace industry. This document contains Part 1 - Volume I: Generic Safety, Handling and Qualification Guidelines for Lithium-Ion (Li-Ion) Batteries, Availability of Source Materials for Lithium-Ion (Li-Ion) Batteries, and Maintaining Technical Communications Related to Aerospace Batteries (NASA Aerospace Battery Workshop).

  5. Issues of Safety and Security: New Challenging to Malaysia Tourism Industry

    Directory of Open Access Journals (Sweden)

    Mohd Ayob Norizawati

    2014-01-01

    Full Text Available The safety and security issues nowadays become one of the forces causing changes in tourism industry in era of millennium. The main concern of this issues more focus on crime rates, terrorism, food safety, health issues and natural disaster. This topic gained the popularity in tourism research after 9/11 tragedy and since then the academicians and practitioners started seeking the best solution in ways to mitigate these negative impacts. For Malaysia, the image as safety and secure destination was tarnished a few years lately and new unfortunates incident in this year bring more damage to Malaysia image. Healthy issues, terrorism, Lahad Datu intrusion, repeated kidnapping and shooting in Sabah, twin airlines incident, riot and illegal demonstration and false reporting by international media brings new challenging to Malaysia. Although some incident may be had short-term impact to Malaysia tourism industry, but it’s still gave the big impact to Malaysia branding process. Many travellers and Malaysian itself still believe that Malaysia is a one of safer destination and country to visit and stayed in, but more outstanding efforts was require to make sure Malaysia tourism industry was capable to recover from this negative impact as soon as possible.

  6. The safety and efficacy issues of progestin-only oral contraceptives--an epidemiologic perspective.

    Science.gov (United States)

    Chi, I

    1993-01-01

    Progestogen-only oral contraceptives (POCs) are generally considered a good contraceptive choice for brestfeeding women and for women who want to use an oral form of contraception, but are not suited for, or cannot tolerate the side effects of, estrogen-containing preparations. However, a number of POCs' safety, efficacy and other related issues remain to be addressed. This paper reviews recent literature and evaluates these issues from an epidemiologic perspective. The small number of users imposes severe limitations in designing epidemiologic studies to address POCs' long-term safety issues, but available information suggests POCs are at least as safe as, if not safer than, COCs. Compared to COCs, POCs are more likely to cause menstrual disturbances which, in turn, could affect their acceptability and lead to poor compliance and hence higher pregnancy rates. POCs' efficacy has been estimated to be between 1.4 and 4.3 pregnancies per 100 woman-years of use. Lower pregnancy rates approaching those of COCs have been reported in centers with good counseling. POCs' benefits outweigh their risks. However, more studies are needed to further address POCs' safety and efficacy issues.

  7. Safety and efficacy of once-daily single generic fixed-drug combination tablet of tenofovir, lamivudine and efavirenz among HIV-infected Thais

    Directory of Open Access Journals (Sweden)

    W Maek-a-Nantawat

    2012-11-01

    Full Text Available Background: Generic fixed dose combinations (FDCs of nucleoside reverse transcriptase inhibitors (NRTIs and non-nucleoside reverse transcriptase inhibitors (NNRTIs is commonly used in resource-limited settings to increase adherence to lifelong treatment. However, the cumulative evidence of the long-term complications, particularly mitochondrial toxicity of NRTIs, especially stavudine (or zidovudine, brings about widespread use of tenofovir (TDF. This study was aimed to assess the efficacy and safety of a FDC comprising 300 mg tenofovir (TDF, 300 mg LAM and 600 mg efavirenz (EFV. Methods: A Phase II open-label clinical trial was conducted at HIV-NAT, Thai AIDS Research Center, Thai Red Cross from April 2010 to December 2011. Patients were eligible to enroll if they were either: 1 on TDF, LAM and EFV as separate tablets, for at least 6 months with an undetectable viral load (= switch arm or 2 treatment-naïve. Safety profiles, including liver and renal functions, were assessed at baseline, weeks 4, 12, 24 and 48. In switch group, mid-dose TDF plasma concentrations were measured by HPLC at baseline and week 4 after a switch to single FDC tablet. Results: A total of 100 patients were enrolled (51 naïve. Median age was 34 years and 30% were female. The median baseline CD4 cell count (IQR was 512 (395–620 cells/L and 232 (164–284 cells/L for the switch arm and ARV-naïve group, respectively. The median (IQR log10 HIV-1 RNA for ARV-naïve group was 4.9 (4.2–5.3 copies/mL. By ITT analysis, the proportion of cases with HIV RNA<50 copies/mL was 93% and 92% at week 24 and 48, respectively. Only 1 confirmed virological failure at week 12 with NNRTI-resistant mutations (A98G, K103N, V118I, E138Q, Y181C. The reported 3 SAEs (severe headache, infective endocarditis, cervical dysplasia were found and one was possibly related to the study drug. There were 49 mild to moderate efavirenz-related central nervous system events, occurring in first few days

  8. LMFBR safety. 5. Review of current issues and bibliography of literature (1975--1976)

    Energy Technology Data Exchange (ETDEWEB)

    Buchanan, J.R.; Keilholtz, G.W.

    1977-06-08

    The current status of liquid-metal fast breeder reactor (LMFBR) development and one of the principal safety issues, a hypothetical core-disruptive accident (HCDA), are discussed. Bibliographic information on worldwide LMFBRs relative to the development and safety of the breeder reactor is presented for the period 1975 through 1976. The bibliography consists of approximately 1618 abstracts covering early research and development and operating experiences leading up to the present design practices that are necessary for the licensing of breeder reactors. Keyword, author, and permuted-title indexes are included for completeness.

  9. Clinically relevant safety issues associated with St. John's wort product labels

    Directory of Open Access Journals (Sweden)

    Rutledge Jennifer C

    2008-07-01

    Full Text Available Abstract Background St. John's wort (SJW, used to treat depression, is popular in the USA, Canada, and parts of Europe. However, there are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. One source of information about these safety considerations is the product label. The aim of this study was to evaluate the clinically relevant safety information included on labeling in a nationally representative sample of SJW products from the USA. Methods Eight clinically relevant safety issues were identified: drug interactions (SJW-HIV medications, SJW-immunosupressants, SJW-oral contraceptives, and SJW-warfarin, contraindications (bipolar disorder, therapeutic duplication (antidepressants, and general considerations (phototoxicity and advice to consult a healthcare professional (HCP. A list of SJW products was identified to assess their labels. Percentages and totals were used to present findings. Results Of the seventy-four products evaluated, no product label provided information for all 8 evaluation criteria. Three products (4.1% provided information on 7 of the 8 criteria. Four products provided no safety information whatsoever. Percentage of products with label information was: SJW-HIV (8.1%, SJW-immunosupressants (5.4%, SJW-OCPs (8.1%, SJW-warfarin (5.4%, bipolar (1.4%, antidepressants (23.0%, phototoxicity (51.4%, and consult HCP (87.8%. Other safety-related information on labels included warnings about pregnancy (74.3%, lactation (64.9%, discontinue if adverse reaction (23.0%, and not for use in patients under 18 years old (13.5%. The average number of a priori safety issues included on a product label was 1.91 (range 0–8 for 23.9% completeness. Conclusion The vast majority of SJW products fail to adequately address clinically relevant safety issues on their labeling. A few products do provide an acceptable amount of information on clinically relevant safety

  10. Current status of environmental, health, and safety issues of nickel metal-hydride batteries for electric vehicles

    Energy Technology Data Exchange (ETDEWEB)

    Corbus, D; Hammel, C J; Mark, J

    1993-08-01

    This report identifies important environment, health, and safety issues associated with nickel metal-hydride (Ni-MH) batteries and assesses the need for further testing and analysis. Among the issues discussed are cell and battery safety, workplace health and safety, shipping requirements, and in-vehicle safety. The manufacture and recycling of Ni-MH batteries are also examined. This report also overviews the ``FH&S`` issues associated with other nickel-based electric vehicle batteries; it examines venting characteristics, toxicity of battery materials, and the status of spent batteries as a hazardous waste.

  11. How to bring issues of health and safety closer to young workers during their work training

    Directory of Open Access Journals (Sweden)

    Helena Mesarič

    2016-06-01

    Full Text Available The data collected by the European Community indicates that the young, economically active population, aged from 18 to 24 years, is more likely to suffer from occupational injuries and occupational diseases in comparison with the rest of the working population, due to the lack of experience and knowledge about health and safety in the workplace, and insufficient training for safe and healthy work practices. Employers must establish an adequate system to ensure workplace health and safety, with an emphasis on providing safety training for pupils and students undergoing apprenticeship and the newly-employed young people. The Ministry of Labour, Family, Social Affairs and Equal Opportunities runs a series of projects aiming to promote health and safety culture among young people in Slovenia. The goal of the national programme for introducing occupational health and safety into the education process is offering a variety of tools and devices for educators and teachers, which can be employed to introduce the issues of occupational health and safety to young people in an exciting and engaging manner.

  12. Resolving plant operational issues related to pressurizer safety relief valve piping

    Energy Technology Data Exchange (ETDEWEB)

    Bain, R.A. [Stone and Webster Engineering Corp., Boston, MA (United States). Mechanical Engineering Div.; Testa, M.F. [Duquesne Light Co., Shippingport, PA (United States). Mechanical Engineering Dept.

    1995-11-01

    Pressurizer safety and relief valve (PSARV) piping has many technical issues related to the qualification and operation of the system that have been addressed at Beaver Valley Unit 2. The PSARV piping is part of a system that must meet Code requirements while being subjected to very significant fluid transient loadings. Valve components include safety valves, power operated relief valves (PORVs), and motor operated block valves. Fluid slugs upstream of these valves can be steam or can be hot or cold water, resulting in a significant variance in possible slug densities. Problems with design options and hardware installed to decrease slug density such as heat tracing, and the susceptibility of the PORVs to leak are issues that affect plant operation, efficiency and cost effectiveness.

  13. Safety issues related to the intermediate heat storage for the EU DEMO

    Energy Technology Data Exchange (ETDEWEB)

    Carpignano, Andrea [NEMO group, Dipartimento Energia, Politecnico di Torino, C.so Duca degli Abruzzi 24, 10129 Torino (Italy); Pinna, Tonio [ENEA, 00044 Frascati (Italy); Savoldi, Laura; Sobrero, Giulia; Uggenti, Anna Chiara [NEMO group, Dipartimento Energia, Politecnico di Torino, C.so Duca degli Abruzzi 24, 10129 Torino (Italy); Zanino, Roberto, E-mail: roberto.zanino@polito.it [NEMO group, Dipartimento Energia, Politecnico di Torino, C.so Duca degli Abruzzi 24, 10129 Torino (Italy)

    2016-11-01

    Highlights: • IHS affects only the PHTS and the BoP (Balance of Plant). • PIEs list does not change but IHS influences PIEs evolution. • Additional issues to be addressed in PIEs study due to the implementation of HIS. • No safety/operational major obstacles were found for IHS concept. - Abstract: The functional deviations able to compromise system safety in the EU DEMO Primary Heat Transfer System (PHTS) with intermediate heat storage (IHS) based on molten salts are identified and compared to the deviations identified with PHTS without IHS. The resulting safety issues for the Balance of Plant (BoP) have been taken into account. Functional Failure Mode and Effects Analysis (FFMEA) is used to highlight the Postulated Initiating Events (PIE) of incident/accident sequences and to provide some safety insights during the preliminary design. The architecture of the system with IHS does not introduce new PIE with respect to the case without IHS, but it modifies some of them. In particular the two Postulated Initiating Events that are affected by the presence of IHS are the LOCA in the tubes of the HX between primary and intermediate circuit and the loss of heat sink for the first wall or the breeding zone. In fact the IHS introduces some advantages concerning the stability of the secondary circuit, but some weaknesses are associated to the physical-chemical nature of molten salts, especially oxidizing power, corrosive nature and risk of solidification. These issues can be managed in the design by the introduction of new safety functions.

  14. Road safety in a globalised and more sustainable world: current issues and future challenges.

    Science.gov (United States)

    Daniels, Stijn; Risser, Ralf

    2014-01-01

    Although many countries have had considerable success in reducing traffic injuries over recent decades, there are still some fundamental problems in this area. At the same time, there is increasing focus on road safety research and policy development in the context of globalisation, sustainability, liveability and health. This special section presents a selection of papers that were presented at the annual ICTCT workshop held on the 8th and 9th of November 2012 in Hasselt, Belgium, and accepted for publication in Accident Analysis and Prevention following the journal's reviewing procedure. The aim of the ICTCT workshop was to analyse road safety facts, data and visions for the future in the wider context of current issues and future challenges in road safety.

  15. Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or knowledge? Part 1. Pharmacological issues

    OpenAIRE

    Roberto Nardi; Marco Masina; Giorgio Cioni; Paolo Leandri; Paola Zuccheri

    2014-01-01

    Despite compelling evidence and guidelines, in Italy, generic/equivalent drugs are still underused. The failure to adopt existing generic drugs may result into a missed opportunity to further reduce healthcare costs. Equivalent drugs are approved based on data deriving from bioequivalence studies. In the first part of the article, the concepts of generic/equivalent drugs are defined, emphasizing the differences between pharmaceutical equivalence, therapeutic equivalence, bioequivalence and bi...

  16. Radiological protection, safety and security issues in the industrial and medical applications of radiation sources

    Science.gov (United States)

    Vaz, Pedro

    2015-11-01

    The use of radiation sources, namely radioactive sealed or unsealed sources and particle accelerators and beams is ubiquitous in the industrial and medical applications of ionizing radiation. Besides radiological protection of the workers, members of the public and patients in routine situations, the use of radiation sources involves several aspects associated to the mitigation of radiological or nuclear accidents and associated emergency situations. On the other hand, during the last decade security issues became burning issues due to the potential malevolent uses of radioactive sources for the perpetration of terrorist acts using RDD (Radiological Dispersal Devices), RED (Radiation Exposure Devices) or IND (Improvised Nuclear Devices). A stringent set of international legally and non-legally binding instruments, regulations, conventions and treaties regulate nowadays the use of radioactive sources. In this paper, a review of the radiological protection issues associated to the use of radiation sources in the industrial and medical applications of ionizing radiation is performed. The associated radiation safety issues and the prevention and mitigation of incidents and accidents are discussed. A comprehensive discussion of the security issues associated to the global use of radiation sources for the aforementioned applications and the inherent radiation detection requirements will be presented. Scientific, technical, legal, ethical, socio-economic issues are put forward and discussed.

  17. Opinion of the IRSN on the instruction on the continuation of the GPR assessment of the safety re-examination VD3-900 - Examination of the conclusive report of the safety re-examination of the nr 1 reactor of the Fessenheim plant after the third decennial inspection; Avis de l'IRSN sur l'instruction des suites du GPR bilan du reexamen de surete VD3-900 - Examen du rapport de conclusions du reexamen de surete du reacteur n.1 du CNPE de Fessenheim a l'issue de sa troisieme visite decennale

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-02-15

    This report first describes the context of the safety re-examination of the nr 1 reactor of the Fessenheim nuclear power station (CNPE) and assesses the generic aspects of this re-examination, assesses additional information transmitted by EDF and concerning these generic aspects (external and internal stresses, accidents and their radiological consequences, design of systems and civil engineering works), states recommendations on various topics and issues to be considered (internal explosions, probabilistic studies, severe accidents, confinement in post-accidental situation, behaviour of containment enclosures, and son on). It assesses the content of the conclusive report of the safety re-examination

  18. Environmental, health, and safety issues of sodium-sulfur batteries for electric and hybrid vehicles

    Energy Technology Data Exchange (ETDEWEB)

    Mark, J

    1992-11-01

    This report is the last of four volumes that identify and assess the environmental, health, and safety issues that may affect the commercial-scale use of sodium-sulfur (Na/S) battery technology as the energy source in electric and hybrid vehicles. The reports are intended to help the Electric and Hybrid Propulsion Division of the Office of Transportation Technologies in the US Department of Energy (DOE/EHP) determine the direction of its research, development, and demonstration (RD D) program for Na/S battery technology. The reports review the status of Na/S battery RD D and identify potential hazards and risks that may require additional research or that may affect the design and use of Na/S batteries. This volume covers the in-vehicle safety issues of electric vehicles powered by Na/S batteries. The report is based on a review of the literature and on discussions with experts at DOE, national laboratories and agencies, and private industry. It has three major goals: (1) to identify the unique hazards associated with electric vehicle (EV) use; (2) to describe the existing standards, regulations, and guidelines that are or could be applicable to these hazards; and (3) to discuss the adequacy of the existing requirements in addressing the safety concerns of EVs.

  19. Issues and challenges for pedestrian active safety systems based on real world accidents.

    Science.gov (United States)

    Hamdane, Hédi; Serre, Thierry; Masson, Catherine; Anderson, Robert

    2015-09-01

    The purpose of this study was to analyze real crashes involving pedestrians in order to evaluate the potential effectiveness of autonomous emergency braking systems (AEB) in pedestrian protection. A sample of 100 real accident cases were reconstructed providing a comprehensive set of data describing the interaction between the vehicle, the environment and the pedestrian all along the scenario of the accident. A generic AEB system based on a camera sensor for pedestrian detection was modeled in order to identify the functionality of its different attributes in the timeline of each crash scenario. These attributes were assessed to determine their impact on pedestrian safety. The influence of the detection and the activation of the AEB system were explored by varying the field of view (FOV) of the sensor and the level of deceleration. A FOV of 35° was estimated to be required to detect and react to the majority of crash scenarios. For the reaction of a system (from hazard detection to triggering the brakes), between 0.5 and 1s appears necessary.

  20. Safety and regulatory issues regarding stem cell therapies: one clinic's perspective.

    Science.gov (United States)

    Centeno, Christopher J; Bashir, Jamil

    2015-04-01

    Stem cells therapies have been in preclinical development for the past 2 decades. A rapidly evolving regulatory landscape has restrained many of these technologies from advancing from the bench to the bedside. Although the large-scale clinical safety of stem cell therapies remains to be fully tested, the total number of patients who have safely received these therapies is large and growing. Prima facie evidence would dictate that certain types of cell therapy are likely safer than others. Understanding the current regulation regarding stem cells involves a discussion of their safety profile, as the 2 issues are closely intertwined. Copyright © 2015 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

  1. Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or knowledge? Part 1. Pharmacological issues

    Directory of Open Access Journals (Sweden)

    Roberto Nardi

    2014-05-01

    Full Text Available Despite compelling evidence and guidelines, in Italy, generic/equivalent drugs are still underused. The failure to adopt existing generic drugs may result into a missed opportunity to further reduce healthcare costs. Equivalent drugs are approved based on data deriving from bioequivalence studies. In the first part of the article, the concepts of generic/equivalent drugs are defined, emphasizing the differences between pharmaceutical equivalence, therapeutic equivalence, bioequivalence and bioavailability. A summary of the methods adopted to define bioequivalence (pharmacokinetic studies; pharmacodynamic studies; comparative clinical trials; in vitro studies is also included.

  2. Current status of environmental, health, and safety issues of lithium ion electric vehicle batteries

    Energy Technology Data Exchange (ETDEWEB)

    Vimmerstedt, L.J.; Ring, S.; Hammel, C.J.

    1995-09-01

    The lithium ion system considered in this report uses lithium intercalation compounds as both positive and negative electrodes and has an organic liquid electrolyte. Oxides of nickel, cobalt, and manganese are used in the positive electrode, and carbon is used in the negative electrode. This report presents health and safety issues, environmental issues, and shipping requirements for lithium ion electric vehicle (EV) batteries. A lithium-based electrochemical system can, in theory, achieve higher energy density than systems using other elements. The lithium ion system is less reactive and more reliable than present lithium metal systems and has possible performance advantages over some lithium solid polymer electrolyte batteries. However, the possibility of electrolyte spills could be a disadvantage of a liquid electrolyte system compared to a solid electrolyte. The lithium ion system is a developing technology, so there is some uncertainty regarding which materials will be used in an EV-sized battery. This report reviews the materials presented in the open literature within the context of health and safety issues, considering intrinsic material hazards, mitigation of material hazards, and safety testing. Some possible lithium ion battery materials are toxic, carcinogenic, or could undergo chemical reactions that produce hazardous heat or gases. Toxic materials include lithium compounds, nickel compounds, arsenic compounds, and dimethoxyethane. Carcinogenic materials include nickel compounds, arsenic compounds, and (possibly) cobalt compounds, copper, and polypropylene. Lithiated negative electrode materials could be reactive. However, because information about the exact compounds that will be used in future batteries is proprietary, ongoing research will determine which specific hazards will apply.

  3. Current status of environmental, health, and safety issues of lithium ion electric vehicle batteries

    Energy Technology Data Exchange (ETDEWEB)

    Vimmerstedt, L.J.; Ring, S.; Hammel, C.J.

    1995-09-01

    The lithium ion system considered in this report uses lithium intercalation compounds as both positive and negative electrodes and has an organic liquid electrolyte. Oxides of nickel, cobalt, and manganese are used in the positive electrode, and carbon is used in the negative electrode. This report presents health and safety issues, environmental issues, and shipping requirements for lithium ion electric vehicle (EV) batteries. A lithium-based electrochemical system can, in theory, achieve higher energy density than systems using other elements. The lithium ion system is less reactive and more reliable than present lithium metal systems and has possible performance advantages over some lithium solid polymer electrolyte batteries. However, the possibility of electrolyte spills could be a disadvantage of a liquid electrolyte system compared to a solid electrolyte. The lithium ion system is a developing technology, so there is some uncertainty regarding which materials will be used in an EV-sized battery. This report reviews the materials presented in the open literature within the context of health and safety issues, considering intrinsic material hazards, mitigation of material hazards, and safety testing. Some possible lithium ion battery materials are toxic, carcinogenic, or could undergo chemical reactions that produce hazardous heat or gases. Toxic materials include lithium compounds, nickel compounds, arsenic compounds, and dimethoxyethane. Carcinogenic materials include nickel compounds, arsenic compounds, and (possibly) cobalt compounds, copper, and polypropylene. Lithiated negative electrode materials could be reactive. However, because information about the exact compounds that will be used in future batteries is proprietary, ongoing research will determine which specific hazards will apply.

  4. 对旅游安全问题的思考%Thinking of Travel Safety Issues

    Institute of Scientific and Technical Information of China (English)

    李翠微

    2012-01-01

    旅游安全在旅游产业中扮演着极其重要而特殊的角色。首先,旅游安全是旅游活动顺利进行的保障。其次,旅游安全是旅游业发展的前提。随着旅游业的迅速发展,旅游安全问题不断出现、屡见报端,旅游活动中客观存在着的安全问题已成为进行旅游安全研究的现实根源。政府、旅游企业经营者、旅游者及社会公众应对旅游安全问题予以高度关注,相关部门更应该将安全置于旅游业重中之重的地位,并能在旅游过程各个环节采取科学有效的措施,消灭一切安全隐患,将旅游安全事故降至最低,确保旅游业的健康发展。%tourism safety plays an extremely important and special role in tourism industry.First,tourism safety is to protect the smooth conduct of tourism activities.Secondly,tourism security is a prerequisite for the development of tourism.With the rapid development of tourism,tourism security issues continue to emerge,and the objective existence of the safety issue in tourism activities has become the reality root of tourism safety research.Government,tourism business operators,tourists and the public shopuld be highly concerned about tourism security issues,relevant departments should put tourism security in a top priority,and adopt a scientific and effective measures in all aspects of the tourism process to eliminate all security risks,lower tourism safety accidents to a minimum,ensure the healthy development of the tourism industry.

  5. Final Review of Safety Assessment Issues at Savannah River Site, August 2011

    Energy Technology Data Exchange (ETDEWEB)

    Napier, Bruce A.; Rishel, Jeremy P.; Bixler, Nathan E.

    2011-12-15

    At the request of Savannah River Nuclear Solutions (SRNS) management, a review team composed of experts in atmospheric transport modeling for environmental radiation dose assessment convened at the Savannah River Site (SRS) on August 29-30, 2011. Though the meeting was prompted initially by suspected issues related to the treatment of surface roughness inherent in the SRS meteorological dataset and its treatment in the MELCOR Accident Consequence Code System Version 2 (MACCS2), various topical areas were discussed that are relevant to performing safety assessments at SRS; this final report addresses these topical areas.

  6. LMFBR safety. 1. Review of current issues and bibliography of literature, 1960--1969

    Energy Technology Data Exchange (ETDEWEB)

    Buchanan, J.R.; Keilholtz, G.W.

    1976-08-16

    This report discusses the current status of liquid-metal fast breeder (LMFBR) development and one of the principal safety issues, a hypothetical core-disruptive accident (HCDA). Bibliographic information on worldwide LMFBRs relative to the development of the breeder reactor as a safe source of nuclear power is presented for the period 1960 through 1969. The bibliography consists of 1560 abstracts covering early research and development and operating experiences leading up to the present design practices that are necessary for the licensing of breeder reactors. Key-word, author, and permuted-title indexes are included for completeness.

  7. LMFBR safety. 4. Review of current issues and bibliography of literature (1974--1975)

    Energy Technology Data Exchange (ETDEWEB)

    Buchanan, J.R.; Keilholtz, G.W.

    1977-03-21

    This report discusses the current status of liquid-metal fast breeder reactor (LMFBR) development and one of the principal safety issues, a hypothetical core-disruptive accident (HCDA). Bibliographic information on worldwide LMFBRs relative to the development of the breeder reactor as a safe source of nuclear power is presented for the period 1974 through 1975. The bibliography consists of approximately 1554 abstracts covering early research and development and operating experiences leading up to the present design practices that are necessary for the licensing of breeder reactors. Key-word, author, and permuted-title indexes are included for completeness.

  8. LMFBR safety. 2. Review of current issues and bibliography of literature, 1970--1972

    Energy Technology Data Exchange (ETDEWEB)

    Buchanan, J.R.; Keilholtz, G.W.

    1976-11-22

    This report discusses the current status of liquid-metal fast breeder reactor (LMFBR) development and one of the principal safety issues, a hypothetical core-disruptive accident (HCDA). Bibliographic information on worldwide LMFBRs relative to the development of the breeder reactor as a safe source of nuclear power is presented for the period 1970 through 1972. The bibliography consists of approximately 1620 abstracts covering early research and development and operating experiences leading up to the present design practices that are necessary for the licensing of breeder reactors. Key-word, author, and permuted-title indexes are included for completeness.

  9. LMFBR safety. 3. Review of current issues and bibliography of literature (1972--1974)

    Energy Technology Data Exchange (ETDEWEB)

    Buchanan, J.R.; Keilholtz, G.W.

    1977-02-24

    The report discusses the current status of liquid-metal fast breeder reactor (LMFBR) development and one of the principal safety issues, a hypothetical core-disruptive accident (HCDA). Bibliographic information on worldwide LMFBRs relative to the development of the breeder reactor as a safe source of nuclear power is presented for the period 1972 through 1974. The bibliography consists of approximately 1380 abstracts covering research and development and operating experiences leading up to the present design practices that are necessary for the licensing of breeder reactors. Key-word, author, and permuted-title indexes are included.

  10. Safety and licensing issues that are being addressed by the Power Burst Facility test programs. [PWR; BWR

    Energy Technology Data Exchange (ETDEWEB)

    McCardell, R.K.; MacDonald, P.E.

    1980-01-01

    This paper presents an overview of the results of the experimental program being conducted in the Power Burst Facility and the relationship of these results to certain safety and licensing issues. The safety issues that were addressed by the Power-Cooling-Mismatch, Reactivity Initiated Accident, and Loss of Coolant Accident tests, which comprised the original test program in the Power Burst Facility, are discussed. The resolution of these safety issues based on the results of the thirty-six tests performed to date, is presented. The future resolution of safety issues identified in the new Power Burst Facility test program which consists of tests which simulate BWR and PWR operational transients, anticipated transients without scram, and severe fuel damage accidents, is described.

  11. Issues in understanding the impact of the Needlestick Safety and Prevention Act on hospital sharps injuries.

    Science.gov (United States)

    Phillips, Elayne Kornblatt; Conaway, Mark; Parker, Ginger; Perry, Jane; Jagger, Janine

    2013-09-01

    Measuring the effect of the Needlestick Safety and Prevention Act (NSPA) is challenging. No agreement exists on a common denominator for calculating injury rates. Does it make a difference? How are the law and safety-engineered devices related? What is the effect on injuries and costs? This study examines those issues in assessing the impact of the legislation on hospital worker percutaneous injuries. Using a historic prospective design, we analyzed injury data from 85 hospitals. Injury rates were calculated per 100 full-time equivalents, 100 staffed beds, and 100 admissions each year from 1995 to 2005. We compared changes for each denominator. We measured the proportion of the injury rate attributed to safety-engineered devices. Finally, we estimated a national change in injuries and associated costs. For all denominators, a precipitous drop in injury rates of greater than one-third ([Formula: see text]) occurred in 2001, immediately following the legislation. The decrease was sustained through 2005. Concomitant with the decrease in rates, the proportion of injuries from safety-engineered devices nearly tripled ([Formula: see text]) across all denominators. We estimated annual reductions of more than 100,000 sharps injuries at a cost savings of $69-$415 million. While the data cannot demonstrate cause and effect, the evidence suggests a reduction in hospital worker injury rates related to the NSPA, regardless of denominator. It also suggests an association between the increase in safety-engineered devices and the reduction in overall injury rates. The decreases observed translate into significant reductions in injuries and associated costs.

  12. Family Genericity

    DEFF Research Database (Denmark)

    Ernst, Erik

    2006-01-01

    Type abstraction in object-oriented languages embody two techniques, each with its own strenghts and weaknesses. The first technique is extension, yielding abstraction mechanisms with good support for gradual specification. The prime example is inheritance. The second technique is functional abst...... the result as family genericity. The presented language design has been implemented....

  13. Family Genericity

    DEFF Research Database (Denmark)

    Ernst, Erik

    2006-01-01

    Type abstraction in object-oriented languages embody two techniques, each with its own strenghts and weaknesses. The first technique is extension, yielding abstraction mechanisms with good support for gradual specification. The prime example is inheritance. The second technique is functional abst...... the result as family genericity. The presented language design has been implemented....

  14. Radio Frequency Radiation of Millimeter Wave Length: An Evaluation of Potential Occupational Safety Issues Relating to Surface Heating

    Science.gov (United States)

    2016-06-14

    Radio frequency radiation of millimeter wave length: An evaluation of potential occupational safety issues. 5a. CONTRACT NUMBER 5b. GRANT NUMBER...Paper------------------------------- RADIO FREQUENCY RADIATION OF MILLIMETER WAVE LENGTH: POTENTIAL OCCUPATIONAL...cancer. Health Phys. 78(2):170-181; 2000 Key words: cancer; radiation , nonionizing; occupational safety; radiofrequency INTRODUCTION THE RADIO

  15. Generics and the specific features of their regulation

    Directory of Open Access Journals (Sweden)

    E. A. Ushkalova

    2016-01-01

    Full Text Available The article discusses the factors that influence the efficacy and safety of generic drugs, including regular generics, biosimilars, and generic nonbiological complex drugs. It emphasizes the importance of adequate regulatory requirements to provide a comparable therapeutic efficacy and a comparable cost-effectiveness ratio for generics versus brand-name drugs.

  16. Role of text mining in early identification of potential drug safety issues.

    Science.gov (United States)

    Liu, Mei; Hu, Yong; Tang, Buzhou

    2014-01-01

    Drugs are an important part of today's medicine, designed to treat, control, and prevent diseases; however, besides their therapeutic effects, drugs may also cause adverse effects that range from cosmetic to severe morbidity and mortality. To identify these potential drug safety issues early, surveillance must be conducted for each drug throughout its life cycle, from drug development to different phases of clinical trials, and continued after market approval. A major aim of pharmacovigilance is to identify the potential drug-event associations that may be novel in nature, severity, and/or frequency. Currently, the state-of-the-art approach for signal detection is through automated procedures by analyzing vast quantities of data for clinical knowledge. There exists a variety of resources for the task, and many of them are textual data that require text analytics and natural language processing to derive high-quality information. This chapter focuses on the utilization of text mining techniques in identifying potential safety issues of drugs from textual sources such as biomedical literature, consumer posts in social media, and narrative electronic medical records.

  17. Current global and Korean issues in radiation safety of nuclear medicine procedures.

    Science.gov (United States)

    Song, H C

    2016-06-01

    In recent years, the management of patient doses in medical imaging has evolved as concern about radiation exposure has increased. Efforts and techniques to reduce radiation doses are focussed not only on the basis of patient safety, but also on the fundamentals of justification and optimisation in cooperation with international organisations such as the International Commission on Radiological Protection, the International Atomic Energy Agency, and the World Health Organization. The Image Gently campaign in children and Image Wisely campaign in adults to lower radiation doses have been initiated in the USA. The European Association of Nuclear Medicine paediatric dosage card, North American consensus guidelines, and Nuclear Medicine Global Initiative have recommended the activities of radiopharmaceuticals that should be administered in children. Diagnostic reference levels (DRLs), developed predominantly in Europe, may be an important tool to manage patient doses. In Korea, overexposure to radiation, even from the use of medical imaging, has become a public issue, particularly since the accident at the Fukushima nuclear power plant. As a result, the Korean Nuclear Safety and Security Commission revised the technical standards for radiation safety management in medical fields. In parallel, DRLs for nuclear medicine procedures have been collected on a nationwide scale. Notice of total effective dose from positron emission tomography-computed tomography for cancer screening has been mandatory since mid-November 2014.

  18. Current status of environmental, health, and safety issues of electrochemical capacitors for advanced vehicle applications

    Energy Technology Data Exchange (ETDEWEB)

    Vimmerstedt, L J; Hammel, C J

    1997-04-01

    Electrochemical capacitors are a candidate for traction power assists in hybrid electric vehicles (HEVs). Other advanced automotive applications, while not the primary focus of current development efforts, are also possible. These include load leveling high-energy batteries, power conditioning electronics, electrically hated catalysts, electric power steering, and engine starter power. Higher power and longer cycle life are expected for electrochemical capacitors than for batteries. Evaluation of environmental, health, and safety (EH and S) issues of electrochemical capacitors is an essential part of the development and commercialization of electrochemical capacitors for advanced vehicles. This report provides an initial EH and S assessment. This report presents electrochemical capacitor electrochemistry, materials selection, intrinsic material hazards, mitigation of those hazards, environmental requirements, pollution control options, and shipping requirements. Most of the information available for this assessment pertains to commercial devices intended for application outside the advanced vehicle market and to experiment or prototype devices. Electrochemical capacitors for power assists in HEVs are not produced commercially now. Therefore, materials for advanced vehicle electrochemical capacitors may change, and so would the corresponding EH and S issues. Although changes are possible, this report describes issues for likely electrochemical capacitor designs.

  19. Level of knowledge among the population of radiation safety basic issues

    Directory of Open Access Journals (Sweden)

    S. A. Zelencova

    2015-01-01

    Full Text Available The goal of research was to determine the level of knowledge among the population on issues like sources of ionising radiation, methods of ionising radiation measurement, measures of self-protection in case of threating or actual radioactive pollution in the district, and to study self-estimation by the population of their knowledge of radiation safety issues. Research was carried out using the method of questioning of population groups in three regions close to the places of previous peaceful nuclear explosions (Arkhangelsk, Murmansk and Tyumen regions, and in five Far East regions of the Russian Federation (Kamchatka, Khabarovsk, Primorsky, Magadan and South-Sakhalin regions after radiation accident in Japan at "Fukushima-1" NPP. This research included processing of 243 questionnaires from the regions close to places of previous peaceful nuclear explosions and 216 questionnaires from the Far East regions.The analysis of obtained questioning results enabled to make the following conclusions: the level of knowledge among the population about the basic concepts of radiation safety appeared to be generally low among respondents of all eight territories. Considerable number of respondents in seven groups correctly mentioned the x-ray device as a source of ionising radiation (from 71 to 88 % of answers. In Murmansk region – only 52 % of the answers. Respondents of the same seven groups often correctly answered the question on how to detect ionising radiation (only with devices – from 68 to 98 % in different groups. The smallest number of correct answers to this question (42 % is also noted among respondents from the Murmansk region.Level of knowledge on self-protection measures at threating or actual radioactive pollution of the places of residence appeared a little higher among the Far East region population, who had actual concerns regarding the threat of radioactive pollution at the present time. However, in all eight investigated groups

  20. Provider Documentation of Geriatric Issues among Older Adults Receiving Care in Safety Net

    Science.gov (United States)

    Chodos, Anna H; Pierluissi, Edgar; Patel, Kanan; Ritchie, Christine S

    2015-01-01

    Background In a safety net setting, we evaluated primary care provider (PCP) documentation of geriatric issues and whether geriatric consultation influences subsequent documentation. Methods We performed a retrospective chart review of patients referred to an outpatient geriatric consult service at San Francisco General Hospital. The geriatrics service serves two primary care clinics and provides advice through an e-consult, an e-consult with care coordination services, or a comprehensive geriatrics assessment. We queried charts for patients ≥60 years of age, referred from October 2012 to November 2013, and received care for ≥ 6 months after the consult. For two primary care visits pre- and post-consult, we recorded documentation of geriatric issues, such as cognitive impairment, falls, and symptoms prevalent in older adults. Comparisons were analyzed using descriptive statistics and paired sample t-tests. Results Among 90 patients referred, mean age was 77.9 years (7.3) and 62.2% were female. Most patients (66.7%) were non-English speaking. Patients' race included 40% Hispanic, 32.2% Asian, 15.6% African-American, and 12.2% White. Many, 78.9%, were dual-eligible. The most common conditions included diabetes (43.3%), dementia (37.8%), and mental health disorders (31.1%). Pre-consult, PCPs documented screening for falls in 54.4%, cognitive impairment in 38.9%, mental health conditions in 35.6%, and activities of daily living in 28.9%. An advance directive or goals of care were documented in 45.6% of charts. Symptoms (pain, shortness of breath, insomnia, fatigue or anorexia) were often documented pre-consult (91.1%). The only difference in a pre-post comparison was that providers documented fewer screens post-consult for cognitive impairment (38.9 vs 21.1%). Conclusion Among PCPs in safety net clinics, less than half had documentation of common geriatrics issues, other than symptoms, prior to consulting a geriatrician. The consult did not affect post

  1. [Generic drugs: we must cut pharmaceutical spending but undertaking drug quality].

    Science.gov (United States)

    Carrillo Norte, Juan Antonio; Postigo Mota, Salvador

    2012-02-01

    The World Health Organization and all drug regulatory agencies (DRA) support the commercialization of generic medicines because they control costs and are irreplaceable therapeutic options in countries lacking the innovator product. Generic drugs are widely considered to be cost-efficient substitutes for brand-name medications. They make up about 20% of the total number of prescriptions in Spain, a figure that is still far from the use of generic drugs in USA and other European countries. Despite economical interest in this issue, in this article we review the interest of generic drugs from a pharmacological and clinical perspective that must undertake drug quality to ensure drug efficacy and safety of the patients. A generic drug (generic drugs, short: generics) is defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use". Both the reference drug and the generic drug have to demonstrate previously they are therapeutically equivalent. With the exception of parenteral drugs, two products have demonstrated to be therapeutically equivalent if after administration in the same molar dose, their effects with respect to both efficacy and safety are essentially the same, as determined from bioequivalence studies in terms of comparison of appropriate pharmacokinetic parameters and bioavailability. Parenteral formulations, however, are not required to demonstrate therapeutic equivalence because it may be considered self-evident. Such assumptions have never been challenged, but there are reasons to do so for parenteral antimicrobials. It is interesting to highlight that although brand-name drugs and generic drugs are both approved by DRA and may be interchangeable with respect to their clinical effects, they can differ substantially in their appearance. Consumers of brand-name medications receive identical-appearing batches of pills with

  2. Current status of environmental, health, and safety issues of lithium polymer electric vehicle batteries

    Energy Technology Data Exchange (ETDEWEB)

    Corbus, D; Hammel, C J

    1995-02-01

    Lithium solid polymer electrolyte (SPE) batteries are being investigated by researchers worldwide as a possible energy source for future electric vehicles (EVs). One of the main reasons for interest in lithium SPE battery systems is the potential safety features they offer as compared to lithium battery systems using inorganic and organic liquid electrolytes. However, the development of lithium SPE batteries is still in its infancy, and the technology is not envisioned to be ready for commercialization for several years. Because the research and development (R&D) of lithium SPE battery technology is of a highly competitive nature, with many companies both in the United States and abroad pursuing R&D efforts, much of the information concerning specific developments of lithium SPE battery technology is proprietary. This report is based on information available only through the open literature (i.e., information available through library searches). Furthermore, whereas R&D activities for lithium SPE cells have focused on a number of different chemistries, for both electrodes and electrolytes, this report examines the general environmental, health, and safety (EH&S) issues common to many lithium SPE chemistries. However, EH&S issues for specific lithium SPE cell chemistries are discussed when sufficient information exists. Although lithium batteries that do not have a SPE are also being considered for EV applications, this report focuses only on those lithium battery technologies that utilize the SPE technology. The lithium SPE battery technologies considered in this report may contain metallic lithium or nonmetallic lithium compounds (e.g., lithium intercalated carbons) in the negative electrode.

  3. Current issues in developing safety culture while establishing wind energy power plants in India

    Energy Technology Data Exchange (ETDEWEB)

    Gowda, M.C.M.; Repaka, B.; Gowda, P. [MSRIT Research Centre, Bangalore (India); Chandrashekar, R. [SaIT, Bangalore (India)

    2012-07-01

    Safety is important to every one working in the various organizations. They want to be safe when coming to work, at the time of work and going back to home. The ultimate aim of every worker is to work for the needs/money and or satisfaction where these would get prioritized according to the individuals. People don't want accidents to happen. People don't want to get themselves injured nor their colleagues. People would like and love to work in a company which cares for them and keeps them safe. Having said this then what makes them meet with or see an accident in the wind farm? Yes it is the unsafe act and unsafe condition which causes an accident in the wind farm. The present study put forward the factors /issues that influence people behaviors as part of weakening the safety culture to perform an unsafe act or to ignore and work in an unsafe condition. (Author)

  4. Chemical food safety issues in the United States: past, present, and future.

    Science.gov (United States)

    Jackson, Lauren S

    2009-09-23

    Considerable advances have been made over the past century in the understanding of the chemical hazards in food and ways for assessing and managing these risks. At the turn of the 20th century, many Americans were exposed to foods adulterated with toxic compounds. In the 1920s the increasing use of insecticides led to concerns of chronic ingestion of heavy metals such as lead and arsenic from residues remaining on crops. By the 1930s, a variety of agrochemicals were commonly used, and food additives were becoming common in processed foods. During the 1940s and 1950s advances were made in toxicology, and more systematic approaches were adopted for evaluating the safety of chemical contaminants in food. Modern gas chromatography and liquid chromatography, both invented in the 1950s and 1960s, were responsible for progress in detecting, quantifying, and assessing the risk of food contaminants and adulterants. In recent decades, chemical food safety issues that have been the center of media attention include the presence of natural toxins, processing-produced toxins (e.g., acrylamide, heterocyclic aromatic amines, and furan), food allergens, heavy metals (e.g., lead, arsenic, mercury, cadmium), industrial chemicals (e.g., benzene, perchlorate), contaminants from packaging materials, and unconventional contaminants (melamine) in food and feed. Due to the global nature of the food supply and advances in analytical capabilities, chemical contaminants will continue to be an area of concern for regulatory agencies, the food industry, and consumers in the future.

  5. Hanford Site organic waste tanks: History, waste properties, and scientific issues. Hanford Tank Safety Project

    Energy Technology Data Exchange (ETDEWEB)

    Strachan, D.M.; Schulz, W.W.; Reynolds, D.A.

    1993-01-01

    Eight Hanford single-shell waste tanks are included on a safety watch list because they are thought to contain significant concentrations of various organic chemical. Potential dangers associated with the waste in these tanks include exothermic reaction, combustion, and release of hazardous vapors. In all eight tanks the measured waste temperatures are in the range 16 to 46{degree}C, far below the 250 to 380{degree}C temperatures necessary for onset of rapid exothermic reactions and initiation of deflagration. Investigation of the possibility of vapor release from Tank C-103 has been elevated to a top safety priority. There is a need to obtain an adequate number of truly representative vapor samples and for highly sensitive and capable methods and instruments to analyze these samples. Remaining scientific issues include: an understanding of the behavior and reaction of organic compounds in existing underground tank environments knowledge of the types and amounts of organic compounds in the tanks knowledge of selected physical and chemical properties of organic compounds source, composition, quality, and properties of the presently unidentified volatile organic compound(s) apparently evolving from Tank C-103.

  6. Consumer Confidence in the Safety of Food and Newspaper Coverage of Food Safety Issues: A Longitudinal Perspective

    NARCIS (Netherlands)

    Jonge, de J.; Trijp, van J.C.M.; Renes, R.J.; Frewer, L.J.

    2010-01-01

    This study develops a longitudinal perspective on consumer confidence in the safety of food to explore if, how, and why consumer confidence changes over time. In the first study, a theory-based monitoring instrument for consumer confidence in the safety of food was developed and validated. The monit

  7. A pilot study exploring awareness among general public toward issues related to medication safety in the state of Penang, Malaysia

    OpenAIRE

    Mohamed Azmi Hassali; Shafie, Asrul A.; Fahad Saleem; Harith Al-Qazaz; Imran Masood; Muhammad Atif; Hisham Aljadhey

    2012-01-01

    Context: A better understanding of medication safety ensures better health state among healthcare consumers. Aim: The study aims to assess general public awareness toward issues related to medication safety. Settings and Design: A cross-sectional study was conducted among general public selected conveniently in the state of Penang, Malaysia. Materials and methods: A total of 500 respondents were approached and 476 consumers participated in the survey giving a response rate of 95.2%. Statistic...

  8. Application of Solar Chimney Concept to Solve Potential Safety Issues of Nuclear Power Plants

    Energy Technology Data Exchange (ETDEWEB)

    Khasawneh, Khalid; PARK, Youn Won [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2014-10-15

    In this paper two main events and their causes have been investigated and a potential alternative supporting system will be provided. The first event to be addressed is the Station Blackout (SBO) caused by the inherent unreliability of the Emergency Diesel Generators (EDGs) and Alternative AC (AAC) power sources. Different parameters affect The EDG unreliability; for instance, mechanical, operational, maintenance and surveillance. Those parameters will be analyzed and linked to plant safety and Core Damage Frequency (CDF). Also the AACs, the SBO diesel generators, will be studied and their operational requirements similarity with the EDGs will be discussed. The second event to be addressed is the Loss of Ultimate Heat Sink (LUHS) caused by the degradation of heat exchange effectiveness, that is, the poor heat transfer to the Ultimate Heat Sink (UHS). Different causes to such case were observed; intake lines blockages due to ice and foreign biological matters formation and oil spill near the heat sink causing the oil leakage to the heat exchangers tubes. The later cause, oil spill, has been given a special attention here due its potential effects for different nuclear power plants (NPPs) around the world; for example, Finland and the United Arab Emirates (UAE). For the Finnish case, the Finnish nuclear regulator (STUK) took already countermeasures for such scenario by introducing alternative heat sink, cooling towers, for the primary used heat sink, sea water, for one of its nuclear power plants. The abundance of the solar irradiation in the UAE region provides a perfect condition for the implementation of solar power applications. Utilizing this unique characteristic of that region may provide promising alternative and diverse options for solving potential safety related issues of their NPPs. The Solar Chimney Power Plant (SCPP) could be employed to serve as a supporting system to provide emergency power, in the case of SBO, and emergency cooling, in the case of

  9. Generic medications in ophthalmology.

    Science.gov (United States)

    Zore, Matt; Harris, Alon; Tobe, Leslie Abrams; Siesky, Brent; Januleviciene, Ingrida; Behzadi, Jennifer; Amireskandari, Annahita; Egan, Patrick; Garff, Kevin; Wirostko, Barbara

    2013-03-01

    The purpose of this review is to discuss the process of genericisation of medications in the US and Europe with a focus on ophthalmic drugs. Regulatory guidelines of the US Food and Drug Administration and the European Medicines Agency will be discussed, and the advantages and concerns of genericisation will be explored. We will look at various studies concerning the safety and efficacy of generic drugs compared to their branded counterparts. In particular, the challenges of assuring bioequivalence and therapeutic equivalence in topical ophthalmic drugs will be examined.

  10. Progress and Updates of Regulatory Challenges and Safety Issues in Korea during Three Years after Fukushima Accident

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Young Eal; Kim, Kyun Tae [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2014-10-15

    Before the public fear on radiation risk caused by neighboring country's severe accident disappeared, a series of nuclear safety issues last 3 years made a few reactors shut down and the public trust much lower than before. Because of these scandals such as cover-ups, forged certificated items, corruption of manager of licensee and so on, many efforts made during three year after Fukushima accident on improving the nuclear safety were invalidated and even regulators as well as operators have been sharply criticized for its responsibility and transparency. This paper shares information on the progress and uprates achieved in Korea so far in connection with the safety issues caused during last 3 years and actions taken by the regulatory body. Before the public fear on radiation risk caused by neighboring country's severe accident disappeared, a series of nuclear safety issues last 3 years made a few reactors shut down and the public trust much lower than before. Because of these scandals such as cover-ups, forged certificated items, corruption of manager of licensee and so on, many efforts made during three year after Fukushima accident on improving the nuclear safety were invalidated and even regulators as well as operators have been sharply criticized for its responsibility and transparency.

  11. Assessment of enriched uranium storage safety issues at the Oak Ridge Y-12 Plant

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-08-01

    This document is an assessment of the technical safety issues pertaining to the storage of EU at the Oak Ridge Y-12 Plant. The purpose of the assessment is to serve as the basis for defining the technical standards for storage of EU at Y-12. A formal assessment of the Y-12 materials acceptance criteria for EU is currently being conducted by a task force cochaired by B. G. Eddy of DOE Oak Ridge Operations and S. 0. Cox of Y-12 Defense Programs. The mission of this technical assessment for storage is obviously dependent on results of the acceptance assessment. Clearly, the two efforts require coordination to avoid inconsistencies. In addition, both these Assessments must be consistent with the Environmental Assessment for EU storage at Y-12.1 Both the Storage Assessment and the Criteria for Acceptance must take cognizance of the fact that a portion of the EU to be submitted for storage in the future is expected to be derived from foreign sources and to include previously irradiated uranium containing significant levels of transuranics, radioactive daughter products, and unstable uranium isotopes that do not occur in the EU stream of the DOE weapons complex. National security considerations may dictate that these materials be accepted despite the fact that they fail to conform to the Acceptance Criteria. This document will attempt to address the complexities inherent in this situation.

  12. Knowledge and Attitudes towards Handling Eggs in the Home: An Unexplored Food Safety Issue?

    Directory of Open Access Journals (Sweden)

    Harriet Whiley

    2017-01-01

    Full Text Available Foodborne illness is a global public health issue, with food handling in the home identified as an underestimated source. In Australia, there has been a significant increase in the incidence of salmonellosis with the majority of outbreaks linked to eggs. This study investigated Australian eggs consumer attitudes, behaviours and risk perceptions associated with the handling of raw eggs in the home. It was identified that 67% of participants chose free range eggs, 11% kept poultry, 7% did not have any preference, 7% cage eggs, 4% barn eggs, 2% organic eggs and 1% pasteurized eggs. The majority of participants (91% reported they stored eggs in the fridge. It was identified that there is an underestimation of “risky behaviour” associated with the consumption of raw eggs in the home, as 84% of participants indicated that they did not consume raw eggs, but subsequently 86% indicated that they had eaten mixture/batter containing raw eggs. Participants’ responses relating to food safety were also examined in relation to their profession and gender. Safer food handling practices were identified by Environmental Health Officers (EHO and Food handlers compared to all other professions (p < 0.05. However, the gender of participants did not significantly affect (p > 0.05 their responses.

  13. Reactor safety issues resolved by the 2D/3D program

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-09-01

    The 2D/3D Program studied multidimensional thermal-hydraulics in a PWR core and primary system during the end-of-blowdown and post-blowdown phases of a large-break LOCA (LBLOCA), and during selected small-break LOCA (SBLOCA) transients. The program included tests at the Cylindrical Core Test Facility (CCTF), the Slab Core Test Facility (SCTF), and the Upper Plenum Test Facility (UPTF), and computer analyses using TRAC. Tests at CCTF investigated core thermal-hydraulics and overall system behavior while tests at SCTF concentrated on multidimensional core thermal-hydraulics. The UPTF tests investigated two-phase flow behavior in the downcomer, upper plenum, tie plate region, and primary loops. TRAC analyses evaluated thermal-hydraulic behavior throughout the primary system in tests as well as in PWRs. This report summarizes the test and analysis results in each of the main areas where improved information was obtained in the 2D/3D Program. The discussion is organized in terms of the reactor safety issues investigated. This report was prepared in a coordination among US, Germany and Japan. US and Germany have published the report as NUREG/IA-0127 and GRS-101 respectively. (author).

  14. Epistemic uncertainty in the ranking and categorization of probabilistic safety assessment model elements: issues and findings.

    Science.gov (United States)

    Borgonovo, Emanuele

    2008-08-01

    In this work, we study the effect of epistemic uncertainty in the ranking and categorization of elements of probabilistic safety assessment (PSA) models. We show that, while in a deterministic setting a PSA element belongs to a given category univocally, in the presence of epistemic uncertainty, a PSA element belongs to a given category only with a certain probability. We propose an approach to estimate these probabilities, showing that their knowledge allows to appreciate "the sensitivity of component categorizations to uncertainties in the parameter values" (U.S. NRC Regulatory Guide 1.174). We investigate the meaning and utilization of an assignment method based on the expected value of importance measures. We discuss the problem of evaluating changes in quality assurance, maintenance activities prioritization, etc. in the presence of epistemic uncertainty. We show that the inclusion of epistemic uncertainly in the evaluation makes it necessary to evaluate changes through their effect on PSA model parameters. We propose a categorization of parameters based on the Fussell-Vesely and differential importance (DIM) measures. In addition, issues in the calculation of the expected value of the joint importance measure are present when evaluating changes affecting groups of components. We illustrate that the problem can be solved using DIM. A numerical application to a case study concludes the work.

  15. A survey of safety issues in tree-climbing applications for forestry management

    Directory of Open Access Journals (Sweden)

    D. Longo

    2013-09-01

    Full Text Available Topping, trimming, consolidation, securing and felling are very common operations in arboriculture, in city park as well as in forests. In case of very large trees, these operations are often not possible from ground level using ladders or Mobile Elevating Work Platforms (MEWPs because of excessive height or uneven/inaccessible terrain. In past years, different people start applying techniques, materials and procedures normally used in mountaineering and caving, to climb trees and these techniques start to be applied to forestry management operations; these techniques are now worldwide used. Work activities at height, as tree-climbing for forestry management purpose, are regulated in Italy by Legislative Decree 81/08 about safety in the workplace, as this activity expose operators to fall from height and many other risks. Moreover, as this activity involves the use of specific tools, operators must be trained (with periodic refreshment and tools must been periodically checked by authorised operators. The objective of this work is to present and synthesise regulations and some technical aspects in order to allow operators to better understand different issues and general principles related to this activity.

  16. Knowledge and Attitudes towards Handling Eggs in the Home: An Unexplored Food Safety Issue?

    Science.gov (United States)

    Whiley, Harriet; Clarke, Beverley; Ross, Kirstin

    2017-01-01

    Foodborne illness is a global public health issue, with food handling in the home identified as an underestimated source. In Australia, there has been a significant increase in the incidence of salmonellosis with the majority of outbreaks linked to eggs. This study investigated Australian eggs consumer attitudes, behaviours and risk perceptions associated with the handling of raw eggs in the home. It was identified that 67% of participants chose free range eggs, 11% kept poultry, 7% did not have any preference, 7% cage eggs, 4% barn eggs, 2% organic eggs and 1% pasteurized eggs. The majority of participants (91%) reported they stored eggs in the fridge. It was identified that there is an underestimation of “risky behaviour” associated with the consumption of raw eggs in the home, as 84% of participants indicated that they did not consume raw eggs, but subsequently 86% indicated that they had eaten mixture/batter containing raw eggs. Participants’ responses relating to food safety were also examined in relation to their profession and gender. Safer food handling practices were identified by Environmental Health Officers (EHO) and Food handlers compared to all other professions (p 0.05) their responses. PMID:28067811

  17. Positive visual phenomena in space: A scientific case and a safety issue in space travel.

    Science.gov (United States)

    Sannita, Walter G; Narici, Livio; Picozza, Piergiorgio

    2006-07-01

    Most astronauts on Apollo, Skylab, and MIR reported 'flashes of light' occurring in different shapes and apparently moving across the visual field, in the absence of auditory, somatosensory, or olfactory abnormal percepts. A temporal correlation with heavy nuclei or protons has been documented in space and comparable phosphenes were observed by volunteers whose eyes were exposed to accelerated heavy ions at intensities below the threshold for Cerenkov visible radiation. An interaction between heavy ions and the retina was suggested. However, the biophysics of heavy ions or protons action remains undefined, the effects on photoreceptors and neuroretina have not been differentiated, and some direct action on the visual cortex never ruled out. Phosphenes are common in migraine and are known to occur also in response to the electrical stimulation of ganglion cells (in retinas without photoreceptors), optic pathways or visual cortex, with mechanisms that bypass the chemically gated channels. Intrinsic photosensitive ganglion cells exist in the retina of teleost fish and mammals. In the hypothesis of a peculiar sensitivity to subatomic particles of the visual system, phosphenes due to the activation of processes by-passing the photoreceptors would raise questions about human safety in space. The issue is particularly relevant with experiments of increasing duration being now operative in the International Space Station (ISS) and with plans of space travel outside the geomagnetic shield. Research is in progress both in the ISS and on animal models, in the framework of the NASA/ESA actions to improve the astronauts' health in space.

  18. Knowledge and Attitudes towards Handling Eggs in the Home: An Unexplored Food Safety Issue?

    Science.gov (United States)

    Whiley, Harriet; Clarke, Beverley; Ross, Kirstin

    2017-01-06

    Foodborne illness is a global public health issue, with food handling in the home identified as an underestimated source. In Australia, there has been a significant increase in the incidence of salmonellosis with the majority of outbreaks linked to eggs. This study investigated Australian eggs consumer attitudes, behaviours and risk perceptions associated with the handling of raw eggs in the home. It was identified that 67% of participants chose free range eggs, 11% kept poultry, 7% did not have any preference, 7% cage eggs, 4% barn eggs, 2% organic eggs and 1% pasteurized eggs. The majority of participants (91%) reported they stored eggs in the fridge. It was identified that there is an underestimation of "risky behaviour" associated with the consumption of raw eggs in the home, as 84% of participants indicated that they did not consume raw eggs, but subsequently 86% indicated that they had eaten mixture/batter containing raw eggs. Participants' responses relating to food safety were also examined in relation to their profession and gender. Safer food handling practices were identified by Environmental Health Officers (EHO) and Food handlers compared to all other professions (p 0.05) their responses.

  19. Generic patch inference

    DEFF Research Database (Denmark)

    Andersen, Jesper; Lawall, Julia

    2010-01-01

    A key issue in maintaining Linux device drivers is the need to keep them up to date with respect to evolutions in Linux internal libraries. Currently, there is little tool support for performing and documenting such changes. In this paper we present a tool, spdiff, that identifies common changes...... developers can use it to extract an abstract representation of the set of changes that others have made. Our experiments on recent changes in Linux show that the inferred generic patches are more concise than the corresponding patches found in commits to the Linux source tree while being safe with respect...

  20. 食品安全监管与健康问题%Food safety supervision and health issues

    Institute of Scientific and Technical Information of China (English)

    孙翠平; 张宏蕊; 张茂

    2015-01-01

    Food is the first necessity of the people. Food is the most basic material conditions for human survival and development. Food safety issues nationwide attention, whether it is China, or other countries in the world, will do a good job in food safety as a key to ensure the national public safety work, are trying to do a good job in food safety supervision. September 1st in 2004, the State Council issued the“State Council on Further Strengthening the work of food safety decision”, decided to take effective measures to further strengthen the food safety work.Based on practical tips,only food safety supervision work, in order to improve the level of food safety in our country.%民以食为天。食品是人类赖以生存和发展的最基本的物质条件。食品安全问题举国关注,不管是我国,还是世界其他国家,都将做好食品安全工作作为确保国家公共安全的重点工作,都想方设法地做好食品安全的监管工作。2004年9月1日,国务院发布了《国务院关于进一步加强食品安全工作的决定》,决定采取切实有效的措施,进一步加强了食品安全工作。实践提示,只有将食品安全监管工作做好,才能将我国食品安全水平全面地提高起来。

  1. HTGR Generic Technology Program: safety, systems and component design and development. Quarterly progress report for the period ending March 31, 1978

    Energy Technology Data Exchange (ETDEWEB)

    1978-04-01

    The work documented includes HTGR safety and safety-related studies to better understand and more accurately define safety characteristics and safety margins of GCRs under postulated accident conditions. Also included are the design, analysis, and testing of th PCRV, liner, penetrations, thermal barrier, reactor internals, steam generator, CAHE, and rotating machinery. Design studies and analysis plus experimental procedures and results are discussed and, where appropriate, the data are presented in tables, graphs, and photographs.

  2. Calculation of combustible waste fraction (CWF) estimates used in organics safety issue screening

    Energy Technology Data Exchange (ETDEWEB)

    Heasler, P.G.; Gao, F.; Toth, J.J.

    1998-08-01

    This report describes how in-tank measurements of moisture (H{sub 2}O) and total organic carbon (TOC) are used to calculate combustible waste fractions (CWF) for 138 of the 149 Hanford single shell tanks. The combustible waste fraction of a tank is defined as that proportion of waste that is capable of burning when exposed to an ignition source. These CWF estimates are used to screen tanks for the organics complexant safety issue. Tanks with a suitably low fraction of combustible waste are classified as safe. The calculations in this report determine the combustible waste fractions in tanks under two different moisture conditions: under current moisture conditions, and after complete dry out. The first fraction is called the wet combustible waste fraction (wet CWF) and the second is called the dry combustible waste fraction (dry CWF). These two fractions are used to screen tanks into three categories: if the wet CWF is too high (above 5%), the tank is categorized as unsafe; if the wet CWF is low but the dry CWF is too high (again, above 5%), the tank is categorized as conditionally safe; finally, if both the wet and dry CWF are low, the tank is categorized as safe. Section 2 describes the data that was required for these calculations. Sections 3 and 4 describe the statistical model and resulting fit for dry combustible waste fractions. Sections 5 and 6 present the statistical model used to estimate wet CWF and the resulting fit. Section 7 describes two tests that were performed on the dry combustible waste fraction ANOVA model to validate it. Finally, Section 8 presents concluding remarks. Two Appendices present results on a tank-by-tank basis.

  3. JV Task - 116 Selenium's Role in the Seafood Safety Issue

    Energy Technology Data Exchange (ETDEWEB)

    Nicholas Ralston; Laura Raymond

    2009-03-30

    Continuing studies under these three funded projects - (JV Task 77 The Health Implications of the Mercury-Selenium Interaction, JV Task 96 Investigating the Importance of the Mercury-Selenium Interaction, and JV Task 116 Selenium's Role in the Seafood Safety Issue) - were performed to determine the effects of different levels of dietary mercury and selenium on the growth and development of test animals, and related tissue analyses, to understand the protective benefits of dietary selenium in reference to low-level exposure to mercury. Maternal exposure to methylmercury from seafood has been found to cause neurodevelopmental harm in children. However, significant nutritional benefits will be lost if fish consumption is needlessly avoided. The results of these studies support the hypothesis that intracellular Se itself is the physiologically important biomolecule and that the harm of mercury toxicity arises when Hg abundance becomes great enough to bind a significant portion of intracellular Se in vulnerable tissues such as the brain. Formation of HgSe limits bioavailability of Se for synthesis of Se-dependent enzymes, particularly in brain tissues. When production of these enzymes is impaired, the loss of their numerous essential functions results in the signs and symptoms of Hg toxicity. The finding that one mole of Se protects against many moles of Hg indicates that its beneficial effect is not due to sequestration of mercury as HgSe but rather due to the biological activity of the Se. Therefore, the selenium content of seafoods must be considered along with their methylmercury contents in evaluating the effect of dietary exposure to mercury.

  4. Pantex Plant final safety analysis report, Zone 4 magazines. Staging or interim storage for nuclear weapons and components: Issue D

    Energy Technology Data Exchange (ETDEWEB)

    1993-04-01

    This Safety Analysis Report (SAR) contains a detailed description and evaluation of the significant environmental, safety, and health (ES&H) issues associated with the operations of the Pantex Plant modified-Richmond and steel arch construction (SAC) magazines in Zone 4. It provides (1) an overall description of the magazines, the Pantex Plant, and its surroundings; (2) a systematic evaluations of the hazards that could occur as a result of the operations performed in these magazines; (3) descriptions and analyses of the adequacy of the measures taken to eliminate, control, or mitigate the identified hazards; and (4) analyses of potential accidents and their associated risks.

  5. Legal issues of the environmental safety regulation in the sphere of nanotechnology in Russian Federation

    Science.gov (United States)

    Belokrylova, Ekaterina A.

    2013-04-01

    development and application of nanoproducts, inspite of fact, that these relationships have a significant financial segment. Thus, according to the Federal Act from December 13, 2010 "About federal budget for 2011 year and the period of 2012 and 2013 years" the expenses for realisation of program "The infrastructure development of nano industry in Russian Federation for 2008-2011" were 250 milliard of Russian rubbles. The profound analyses of the current legal systems has demonstrated that nowadays the main legal regulation in nano sphere consist of some range of frame documents (accentuated by the author). Thereby, one of the most dynamic and developed field of innovative activities in Russian Federation - nanotechnology - is left out of environmental and legal area of protection and that is might lead to the raising level of ecological risks at the stage of creation and application nano products to the environment and humans' health. During the analyses of annual norms of the Report OECD "Nano technologies: the Environment, health and safety" the conclusion is following - 2010 Russia has an extremely low degree of conceptual realization of the program in the sphere of forming the policy connected with nanotechnology and its impact on the environment and also a lack of implementations of norms into the national legal systems in terms of the assessment criteria of nano safety EHS (Environmental, Health and Safety) and ELSI (Ethical, Legal and Social Issues). To the great regret, there is no independent and precise legal act about the ways to creat and apply nano products with the certain definitions and principles and, more importantly, with the level of legal obligations and responsibility. This gap is not possible to fill by just altering and editing the existed legal acts due to the lack of the state Russian regulation. Thus, one of the most dynamic fields of innovative activities - nano technologies - is practically out of the regulation. It might lead to an increase of

  6. Legislation for the countermeasures on special issues of nuclear safety regulations

    Energy Technology Data Exchange (ETDEWEB)

    Cho, Byung Sun; Lee, Mo Sung; Chung, Gum Chun; Kim, Hak Man; Oh, Ho Chul [Chongju Univ., Cheongju (Korea, Republic of)

    2003-02-15

    Since the present legal system on nuclear safety regulation has some problems that refer to contents of regulatory provisions, this mid-report has preformed research on the legal basic theory of nuclear safety regulation. And then secondly this report analyzed the problems of each provisions and suggested the revision drafts on the basis of analyzing problems and the undergoing theory of nuclear safety regulation. In order to interpret easily this report finally took the cases of judicial precedents on nuclear safety regulation in USA, Germany, Japan and Korea.

  7. A working procedure for identifying emerging food safety issues at an early stage: Implications for European and international risk management practices

    NARCIS (Netherlands)

    Marvin, H.J.P.; Kleter, G.A.; Frewer, L.J.; Cope, S.F.; Wentholt, M.T.A.; Rowe, G.

    2009-01-01

    There is a need for early identification of emerging food safety issues in order to prevent them from developing into health risks. In this paper, various existing methods and procedures which can be used for early identification of safety issues are reviewed, including the monitoring of the

  8. Assessment of the food safety issues related to genetically modified foods

    NARCIS (Netherlands)

    Kuiper, H.A.; Kleter, G.A.; Noteborn, H.P.J.M.; Kok, E.J.

    2001-01-01

    International consensus has been reached on the principles regarding evaluation of the food safety of genetically modified plants. The concept of substantial equivalence has been developed as part of a safety evaluation framework, based on the idea that existing foods can serve as a basis for

  9. 浅谈护理安全问题%Talking About Nursing Safety Issues

    Institute of Scientific and Technical Information of China (English)

    崔荣琦

    2015-01-01

    护理安全是护理管理的重要内容,也是衡量护理服务的重要质量指标。护理安全管理是护理质量管理的重要组成部分。本文从护理安全和护理安全管理的定义入手,阐述我国护理安全的现状,分析影响护理安全的因素,提出护理安全管理对策,强调护理安全的重要性。%Nursing safety is an important content of nursing management, but also an important quality indicator of nursing service. Nursing safety management is an important part of nursing quality management. The from the definition of nursing safety and safety management of nursing care of described the status of nursing safety in China, analysis of factors influencing nursing safety, put forward the countermeasure of nursing safety management, emphasize the importance of nursing safety.

  10. Assessment of the food safety issues related to genetically modified foods

    NARCIS (Netherlands)

    Kuiper, H.A.; Kleter, G.A.; Noteborn, H.P.J.M.; Kok, E.J.

    2001-01-01

    International consensus has been reached on the principles regarding evaluation of the food safety of genetically modified plants. The concept of substantial equivalence has been developed as part of a safety evaluation framework, based on the idea that existing foods can serve as a basis for compar

  11. Potential methods and approaches to assess social impacts associated with food safety issues

    NARCIS (Netherlands)

    Cope, S.F.; Frewer, L.J.; Renn, R.; Dreyer, M.

    2010-01-01

    There is evidence to suggest that consumer confidence in the European food safety has declined in recent years. Consequently, the need to integrate multifaceted dimensions into food safety governance has been recognised, although a lack of established methodologies to appraise wider social impacts r

  12. Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study

    Directory of Open Access Journals (Sweden)

    Carla Pires

    Full Text Available CONTEXT AND OBJECTIVES: Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1 to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2 to identify potential safety issues for patients. DESIGN AND SETTING: Qualitative descriptive study, involving all the package leaflets of branded medicines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Pharmacoepidemiology, School of Pharmacy, University of Lisbon. METHODS: A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compulsory regulatory issues (i.e. stated dosage and descriptions of adverse reactions and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose. RESULTS: A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only addressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety. CONCLUSION: Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines.

  13. Occupational safety issues in residential construction surveyed in Wisconsin, United States.

    Science.gov (United States)

    Choi, Sang D; Carlson, Kathryn

    2014-01-01

    Residential construction is a high-risk industry in the U.S. due to the exposure to work-related safety hazards and fall injuries. This study aimed to examine the safety training and safe work practices of construction workers within the small residential construction industry. In order to achieve the study objectives, a survey was designed and sent to approximately 200 Wisconsin based residential construction contractors. About one third of the respondents stated that they did not have any form of safety programs. The study indicated that the most common types of work-related injuries in residential construction were slips/trips/falls and cuts/lacerations. The survey findings also suggested that the residential construction contractors needed to increase the utilization of fall protection safety equipment. Further education and subject matter expert training could provide benefits to improve occupational safety and health of the small business workforce in the residential construction industry.

  14. Environmental, health, and safety issues of sodium-sulfur batteries for electric and hybrid vehicles. Volume 4, In-vehicle safety

    Energy Technology Data Exchange (ETDEWEB)

    Mark, J.

    1992-11-01

    This report is the last of four volumes that identify and assess the environmental, health, and safety issues that may affect the commercial-scale use of sodium-sulfur (Na/S) battery technology as the energy source in electric and hybrid vehicles. The reports are intended to help the Electric and Hybrid Propulsion Division of the Office of Transportation Technologies in the US Department of Energy (DOE/EHP) determine the direction of its research, development, and demonstration (RD&D) program for Na/S battery technology. The reports review the status of Na/S battery RD&D and identify potential hazards and risks that may require additional research or that may affect the design and use of Na/S batteries. This volume covers the in-vehicle safety issues of electric vehicles powered by Na/S batteries. The report is based on a review of the literature and on discussions with experts at DOE, national laboratories and agencies, and private industry. It has three major goals: (1) to identify the unique hazards associated with electric vehicle (EV) use; (2) to describe the existing standards, regulations, and guidelines that are or could be applicable to these hazards; and (3) to discuss the adequacy of the existing requirements in addressing the safety concerns of EVs.

  15. GENERIC DRUG USER FEE: AN OVERVIEW

    Directory of Open Access Journals (Sweden)

    Darshit S. Patel*, Abhishek R. Patel and Narendra A. Patel

    2012-09-01

    Full Text Available The globalization of generic drug manufacturing, supply and testing, and a growing workload that has far outpaced USFDA’s resources has created new challenges. USFDA & Industry propose generic drug user fee to address the need for globalization of the inspection process, and to speed the timely review of generic product applications. The Generic Drug User Fee (GDUF proposal is agreed by generic industry & USFDA and is focused on three key aims: safety, access, and transparency. Under the program, USFDA will receive nearly $1.5 billion over five years in supplemental funding through generic industry user fees in order to help the agency expedite access to generic drugs, enhance drug quality and safety and ensure inspection parity of both foreign and domestic manufacturing sites. GDUF also will help accelerate the market entry of additional manufacturers of drugs currently in short supply and improve quality, consistency, and availability within the supply chain, further helping to mitigate drug shortages. The GDUF new legislation is a milestone for the generic giants and a major win for American health care consumers.

  16. Addressing safety issues through a joint industry programme; Traiter des problemes de securite a travers un programme industriel commun

    Energy Technology Data Exchange (ETDEWEB)

    Pool, G.; Williams, T.P. [BG Technology (United Kingdom); Jones, A.M. [Health and Safety Executive (United Kingdom)

    2000-07-01

    In an increasingly fragmented gas market, the focus for national gas safety may not rest with one major utility or gas supplier but may be spread across many companies. There will also be many new organisations in a liberalized gas industry with varying views on the needs and benefits of safety related technology development but all agree there is a need to ensure that the good safety record of gas as a domestic fuel is maintained. The number of carbon monoxide (CO) incidents is not decreasing significantly despite an increased awareness of the problem. As a consequence, a two-year joint industry programme addressing issues related to carbon monoxide has been established, co-ordinated by BG Technology and supported by gas organisations, government agencies, manufacturers and suppliers across Europe and the World. The 2-year 2 pound million programme has been constructed as twelve separate projects addressing issues such as the reporting and analysis of domestic incidents, improved service or installation practice, CO alarm reliability and information dissemination. The paper gives results and achievements of the programme, through new techniques, standards, procedures or equipment and demonstrates how the gas industry can work together to meet common safety objectives. (authors)

  17. Status and issue of coal mine safety technology development in Japan and international co-operation

    Energy Technology Data Exchange (ETDEWEB)

    Nakmura, K. [Ministry of International Trade and Industry, Tokyo (Japan). Mine Safety Division, Environmental Protection and Industrial Location Bureau

    2001-03-01

    Recent trends in coal mine accidents in Japan are reviewed and the incident of mine fire at the Ikeshima coal mine in Nagasaki Prefecture in February 2000 reported. An overview is given of safety projects underway in Japan or jointly with Australia. Cooperative projects to prevent spontaneous combustion to develop underground monitoring techniques, and to transfer safety technologies from Japan abroad are outlined. Other projects carried out by the Japan International Cooperation Agency (JICA) are listed. Japan's long-term policy for safety technology development is outlined. 4 figs., 6 tabs.

  18. Climate and climate-related issues for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    The purpose of this report is to document current scientific knowledge on climate and climate-related conditions, relevant to the long-term safety of a KBS-3 repository, to a level required for an adequate treatment in the safety assessment SR-Site. The report also presents a number of dedicated studies on climate and selected climate-related processes of relevance for the assessment of long term repository safety. Based on this information, the report presents a number of possible future climate developments for Forsmark, the site selected for building a repository for spent nuclear fuel in Sweden (Figure 1-1). The presented climate developments are used as basis for the selection and analysis of SR-Site safety assessment scenarios in the SR-Site main report /SKB 2011/. The present report is based on research conducted and published by SKB as well as on research reported in the general scientific literature

  19. Nuclear versus fossil - weighing up the safety issues (lists accidents for each energy option)

    Energy Technology Data Exchange (ETDEWEB)

    Gittus, J. (British Nuclear Forum, London (United Kingdom))

    1992-01-01

    In the public mind a large question mark still hangs over the safety of nuclear power. But compared with the fossil alternatives, nuclear power can be shown to provide the cleaner, safer option. (author).

  20. The importance of being first: evidence from Canadian generic pharmaceuticals.

    Science.gov (United States)

    Hollis, Aidan

    2002-12-01

    This paper uses pooled cross-section data on Canadian ethical drug sales to examine the effect of entry timing on sales of generic drugs. The data is for all drugs for which the first generic competitor entered during the years 1994-1997. It is found that the first generic entrant has a lasting competitive advantage: being first into the market appears to lead to an increase of around 30% in market share (among generics) over a period of at least 4 years. This finding has considerable implications for the current policy of allowing brandname drug companies to issue pseudo-generic equivalents as a preemptive strike against true generic competitors.

  1. Emerging patient safety issues under health care reform: follow-on biologics and immunogenicity

    Directory of Open Access Journals (Sweden)

    Liang BA

    2011-12-01

    Full Text Available Bryan A Liang1-3, Timothy Mackey1,41Institute of Health Law Studies, California Western School of Law, 2Department of Anesthesiology, University of California, San Diego School of Medicine, 3San Diego Center for Patient Safety, University of California, San Diego School of Medicine,4Joint Program in Global Health, University of California San Diego-San Diego State University, San Diego, CA, USAAbstract: US health care reform includes an abbreviated pathway for follow-on biologics, also known as biosimilars, in an effort to speed up access to these complex therapeutics. However, a key patient safety challenge emerges from such an abbreviated pathway: immunogenicity reactions. Yet immunogenicity is notoriously difficult to predict, and even cooperative approaches in licensing between companies have resulted in patient safety concerns, injury, and death. Because approval pathways for follow-on forms do not involve cooperative disclosure of methods and manufacturing processes by innovator companies and follow-on manufacturers, the potential for expanded immunogenicity must be taken into account from a risk management and patient safety perspective. The US Institute of Safe Medication Practices (ISMP has principles of medication safety that have been applied in the past to high-risk drugs. We propose adapting ISMP principles to follow-on biologic forms and creating systems approaches to warn, rapidly identify, and alert providers regarding this emerging patient safety risk. This type of system can be built upon and provide lessons learned as these new drug forms are developed and marketed more broadly.Keywords: biosimilars, follow-on biologics, immunogenicity, patient safety, law, health care reform

  2. Associations between generic substitution and patients' attitudes, beliefs and experience

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette; Larsen, Pia Veldt; Andersen, Morten

    2013-01-01

    Abstract Background Generic substitution has been implemented in many countries, but knowledge about patients’ attitudes, beliefs and experiences is still sparse. Aim To assess associations between generic switching and patients’ attitudes, beliefs and experiences with previous generic switching...... on generic medicine and confidence in the healthcare system. Only prescriptions issued by the general practitioners were included. For each patient we focused on one purchase of a generically substitutable drug (index drug). Patients were identified by means of a dispensing database. Results Earlier generic...... switches within the index ATC code were statistically significantly associated with experience of a generic switch (adjusted OR 5.93 95% CI 4.70; 7.49). Having had more than 5 earlier switches within other ATC codes and having negative views on generic medicines reduced the odds of experiencing a generic...

  3. Food safety issues and training methods for ready-to-eat foods in the grocery industry.

    Science.gov (United States)

    Binkley, Margaret; Ghiselli, Richard

    2005-10-01

    As Americans have become more pressed for time, the use of convenient, simplified meals become a way of life. One aspect of this trend, known as Home Meal Replacement (IIMR), has increased in sales since its inception. Between 1999 and 2001, the average annual expenditure per consumer rose 5.6 pereent, and $958 per person per year was spent in 2002. Along with this growth, food safety risks may have increased. The study reported here examined efforts being undertaken by grocery and convenience stores to control the wholesomeness of INR food items. After a convenience sample of 500 grocery store executives was identified, a 32-item questionnaire was developed and mailed to the executives. The results indicate that the industry has taken food safety seriously with only 10 pereent reporting that they have no food safety training. The executives cited employee turnover as a major concern in food safety today, along with lack of food safety knowledge of the consumer and improper holding temperatures.

  4. Workplace health and safety issues among community nurses: a study regarding the impact on providing care to rural consumers.

    Science.gov (United States)

    Terry, Daniel; Lê, Quynh; Nguyen, Uyen; Hoang, Ha

    2015-08-12

    The objective of the study was to investigate the types of workplace health and safety issues rural community nurses encounter and the impact these issues have on providing care to rural consumers. The study undertook a narrative inquiry underpinned by a phenomenological approach. Community nursing staff who worked exclusively in rural areas and employed in a permanent capacity were contacted among 13 of the 16 consenting healthcare services. All community nurses who expressed a desire to participate were interviewed. Data were collected using semistructured interviews with 15 community nurses in rural and remote communities. Thematic analysis was used to analyse interview data. The role, function and structures of community nursing services varied greatly from site to site and were developed and centred on meeting the needs of individual communities. In addition, a number of workplace health and safety challenges were identified and were centred on the geographical, physical and organisational environment that community nurses work across. The workplace health and safety challenges within these environments included driving large distances between client's homes and their office which lead to working in isolation for long periods and without adequate communication. In addition, other issues included encountering, managing and developing strategies to deal with poor client and carer behaviour; working within and negotiating working environments such as the poor condition of patient homes and clients smoking; navigating animals in the workplace; vertical and horizontal violence; and issues around workload, burnout and work-related stress. Many nurses achieved good outcomes to meet the needs of rural community health consumers. Managers were vital to ensure that service objectives were met. Despite the positive outcomes, many processes were considered unsafe by community nurses. It was identified that greater training and capacity building are required to meet the

  5. Workplace health and safety issues among community nurses: a study regarding the impact on providing care to rural consumers

    Science.gov (United States)

    Terry, Daniel; Lê, Quynh; Nguyen, Uyen; Hoang, Ha

    2015-01-01

    Objectives The objective of the study was to investigate the types of workplace health and safety issues rural community nurses encounter and the impact these issues have on providing care to rural consumers. Methods The study undertook a narrative inquiry underpinned by a phenomenological approach. Community nursing staff who worked exclusively in rural areas and employed in a permanent capacity were contacted among 13 of the 16 consenting healthcare services. All community nurses who expressed a desire to participate were interviewed. Data were collected using semistructured interviews with 15 community nurses in rural and remote communities. Thematic analysis was used to analyse interview data. Results The role, function and structures of community nursing services varied greatly from site to site and were developed and centred on meeting the needs of individual communities. In addition, a number of workplace health and safety challenges were identified and were centred on the geographical, physical and organisational environment that community nurses work across. The workplace health and safety challenges within these environments included driving large distances between client’s homes and their office which lead to working in isolation for long periods and without adequate communication. In addition, other issues included encountering, managing and developing strategies to deal with poor client and carer behaviour; working within and negotiating working environments such as the poor condition of patient homes and clients smoking; navigating animals in the workplace; vertical and horizontal violence; and issues around workload, burnout and work-related stress. Conclusions Many nurses achieved good outcomes to meet the needs of rural community health consumers. Managers were vital to ensure that service objectives were met. Despite the positive outcomes, many processes were considered unsafe by community nurses. It was identified that greater training and

  6. Systems Engineering and Safety Issues in Scientific Facilities Subject to Ionizing Radiations

    Directory of Open Access Journals (Sweden)

    Pierre Bonnal

    2013-10-01

    Full Text Available The conception and development of large- scale scientific facilities emitting ionizing radiations rely more on project management practices in use in the process industry than on systems engineering practices. This paper aims to highlight possible reasons for this present situation and to propose some ways to enhance systems engineering so that the specific radiation safety requirements are considered and integrated in the approach. To do so, we have reviewed lessons learned from the management of large-scale scientific projects and more specifically that of the Large Hadron Collider project at CERN. It is shown that project management and systems engineering practices are complementary and can beneficially be assembled in an integrated and lean managerial framework that grants the appropriate amount of focus to safety and radiation safety aspects.

  7. Systems Engineering and Safety Issues in Scientific Facilities Subject to Ionizing Radiations

    Directory of Open Access Journals (Sweden)

    Pierre Bonnal

    2013-10-01

    Full Text Available The conception and development of large-scale scientific facilities emitting ionizing radiations rely more on project management practices in use in the process industry than on systems engineering practices. This paper aims to highlight possible reasons for this present situation and to propose some ways to enhance systems engineering so that the specific radiation safety requirements are considered and integrated in the approach. To do so, we have reviewed lessons learned from the management of large-scale scientific projects and more specifically that of the Large Hadron Collider project at CERN. It is shown that project management and systems engineering practices are complementary and can beneficially be assembled in an integrated and lean managerial framework that grants the appropriate amount of focus to safety and radiation safety aspects.

  8. Criticality safety issues in the disposition of BN-350 spent fuel

    Energy Technology Data Exchange (ETDEWEB)

    Schaefer, R. W.; Klann, R. T.; Koltyshev, S. M.; Krechetov, S.

    2000-02-28

    A criticality safety analysis has been performed as part of the BN-350 spent fuel disposition project being conducted jointly by the DOE and Kazakhstan. The Kazakhstan regulations are reasonably consistent with those of the DOE. The high enrichment and severe undermoderation of this fast reactor fuel has significant criticality safety consequences. A detailed modeling approach was used that showed some configurations to be safe that otherwise would be rejected. Reasonable requirements for design and operations were needed, and with them, all operations were found to be safe.

  9. Hazard identification checklist: Occupational safety and health issues associated with green building

    NARCIS (Netherlands)

    Terwoert, J.; Ustailieva, E.

    2013-01-01

    This checklist accompanies the e-fact on the same topic and aims to help identify the potential hazards to workers’ safety and health associated with the planning and construction of green buildings, their maintenance, renovation (retrofitting), demolition, and on-site waste collection. It also give

  10. Safety improvement issues for mission aborts of future space transportation systems.

    Science.gov (United States)

    Mayrhofer, M; Wächter, M; Sachs, G

    2006-01-01

    Two-stage winged space access vehicles consisting of a carrier stage with airbreathing turbo/ram jet engines and a rocket propelled orbital stage which may significantly reduce space transport costs and have additional advantages offer a great potential for mission safety improvements. Formulating the nominal mission and abort scenarios caused by engine malfunctions as an optimal control problem allows full exploitation of safety capabilities. The shaping of the nominal mission has a significant impact on the prospective safety. For this purpose, most relevant mission aborts are considered together with the nominal mission, treating them as an optimization problem of branched trajectories where the branching point is not fixed. The applied procedure yields a safety improved nominal trajectory, showing the feasibility of the included mission aborts with minimum payload penalty. The other mission aborts can be separately treated, with the initial condition given by the state of the nominal trajectory at the time when a failure occurs. A mission abort plan is set up, covering all emergency scenarios.

  11. National Standard of "General Request on Biological Safety" Was Officially Issued

    Institute of Scientific and Technical Information of China (English)

    2004-01-01

    @@ May 28 2004, sponsored by Standardization Administration of P.R. China ( SAC ) and Certification and Accreditation Administration of P.R. China (CNCA), China National Accreditation Board For Laboratories (CNAL) organized the press conference on National Standard of "General Request on Biological Safety" in Beijing.

  12. Relational Safety and Liberating Training Spaces: An Application with a Focus on Sexual Orientation Issues

    Science.gov (United States)

    Hernandez, Pilar; Rankin, Pressley, IV

    2008-01-01

    This article describes and discusses a teaching case of a clinical training situation involving a gay marriage and family therapy student working with a same-sex affectional couple. The conceptual pillars of this teaching case, relational safety and liberating spaces, are advanced as illustrations of how the student developed his voice in the…

  13. LMFBR safety. 6. Review of current issues and bibliography of literature (1977)

    Energy Technology Data Exchange (ETDEWEB)

    Buchanan, J.R.; Keilholtz, G.W.

    1978-07-13

    This report discusses the current status of liquid-metal fast breeder reactor (LMFBR) development. Selected bibliographic information on LMFBRs relative to the development and safety of the breeder reactor is presented for the year 1977. The bibliography consists of approximately 198 abstracts covering research and development, operating experience, and design practices. Keyword, author, and permuted-title indexes are included for completeness.

  14. SAFETY

    CERN Document Server

    Niels Dupont

    2013-01-01

    CERN Safety rules and Radiation Protection at CMS The CERN Safety rules are defined by the Occupational Health & Safety and Environmental Protection Unit (HSE Unit), CERN’s institutional authority and central Safety organ attached to the Director General. In particular the Radiation Protection group (DGS-RP1) ensures that personnel on the CERN sites and the public are protected from potentially harmful effects of ionising radiation linked to CERN activities. The RP Group fulfils its mandate in collaboration with the CERN departments owning or operating sources of ionising radiation and having the responsibility for Radiation Safety of these sources. The specific responsibilities concerning "Radiation Safety" and "Radiation Protection" are delegated as follows: Radiation Safety is the responsibility of every CERN Department owning radiation sources or using radiation sources put at its disposition. These Departments are in charge of implementing the requi...

  15. Preliminary Review of Safety Assessment Issues at Savannah River Site, August 2011

    Energy Technology Data Exchange (ETDEWEB)

    Napier, Bruce A.; Rishel, Jeremy P.; Bixler, Nathan E.

    2011-09-19

    At the request of Savannah River Nuclear Solutions (SRNS) management, a review team composed of experts in atmospheric transport modeling for environmental radiation dose assessment convened at the Savannah River Site (SRS) on August 29-30, 2011. Several issues were presented at the meeting for discussion. This is a short summary that is organized in accordance with the primary issues discussed, which is not necessarily a chronological record. Issues include: SRS Meteorological Data and its Use in MACCS2; Deposition Velocities for Particles; Deposition Velocities for Tritium; MACCS2 Dispersion Coefficients; Use of Low Surface Roughness in Open Areas; Adequacy of Meteorological Tower and Instrumentation; Displacement Height; and Validity of MACCS2 Calculations at Close-in Distances. A longer report will be issued at a later date that expands upon these topics and recommendations.

  16. Preliminary Review of Safety Assessment Issues at Savannah River Site, August 2011

    Energy Technology Data Exchange (ETDEWEB)

    Napier, Bruce A.; Rishel, Jeremy P.; Bixler, Nathan E.

    2011-09-19

    At the request of Savannah River Nuclear Solutions (SRNS) management, a review team composed of experts in atmospheric transport modeling for environmental radiation dose assessment convened at the Savannah River Site (SRS) on August 29-30, 2011. Several issues were presented at the meeting for discussion. This is a short summary that is organized in accordance with the primary issues discussed, which is not necessarily a chronological record. Issues include: SRS Meteorological Data and its Use in MACCS2; Deposition Velocities for Particles; Deposition Velocities for Tritium; MACCS2 Dispersion Coefficients; Use of Low Surface Roughness in Open Areas; Adequacy of Meteorological Tower and Instrumentation; Displacement Height; and Validity of MACCS2 Calculations at Close-in Distances. A longer report will be issued at a later date that expands upon these topics and recommendations.

  17. Finding generically stable measures

    CERN Document Server

    Simon, Pierre

    2010-01-01

    We discuss two constructions for obtaining generically stable Keisler measures in an NIP theory. First, we show how to symmetrize an arbitrary invariant measure to obtain a generically stable one from it. Next, we show that suitable sigma-additive probability measures give rise to generically stable measures. Also included is a proof that generically stable measures over o-minimal theories and the p-adics are smooth.

  18. WNA's worldwide overview on front-end nuclear fuel cycle growth and health, safety and environmental issues.

    Science.gov (United States)

    Saint-Pierre, Sylvain; Kidd, Steve

    2011-01-01

    This paper presents the WNA's worldwide nuclear industry overview on the anticipated growth of the front-end nuclear fuel cycle from uranium mining to conversion and enrichment, and on the related key health, safety, and environmental (HSE) issues and challenges. It also puts an emphasis on uranium mining in new producing countries with insufficiently developed regulatory regimes that pose greater HSE concerns. It introduces the new WNA policy on uranium mining: Sustaining Global Best Practices in Uranium Mining and Processing-Principles for Managing Radiation, Health and Safety and the Environment, which is an outgrowth of an International Atomic Energy Agency (IAEA) cooperation project that closely involved industry and governmental experts in uranium mining from around the world. Copyright © 2010 Health Physics Society

  19. The generic article

    NARCIS (Netherlands)

    Farkas, D.F.; Swart, Henriëtte de

    2005-01-01

    We take a fresh look at the connection between genericity and (in)definiteness by reconsidering a long-standing puzzle concerning the relation between definiteness and genericity. We contrast English on the one hand and Romance languages and Hungarian on the other, focusing on generic sentences invo

  20. Issues to improve the safety of 18K370 steam turbine operation

    Directory of Open Access Journals (Sweden)

    Bzymek Grzegorz

    2017-01-01

    Full Text Available The paper presents the process of improving the safety and reliability of operation the 18K370 steam turbines Opole Power Plant since the first failure in 2010 [1], up to install the on-line monitoring system [2]. It shows how the units work and how to analyse the contol stage as a critical node in designing the turbine. Selected results of the analysis of the strength of CSD (Computational Solid Dynamic and the nature of the flow in different operating regimes - thanks to CFD (Computational Fluid Dynamic analysis have been included. We have also briefly discussed the way of lifecycle management of individual elements [2,3]. The presented actions could be considered satisfactory, and improve the safety of operating steam turbines of type 18K370.

  1. Safety Issues of HG and PB as IFE Target Materials: Radiological Versus Chemical Toxicity

    Energy Technology Data Exchange (ETDEWEB)

    Reyes, S; Latkowski, J F; Cadwallader, L C; Moir, R W; Rio, G. D; Sanz, J

    2002-11-11

    We have performed a safety assessment of mercury and lead as possible hohlraum materials for Inertial Fusion Energy (IFE) targets, including for the first time a comparative analysis of the radiological and toxicological consequences of an accidental release. In order to calculate accident doses to the public, we have distinguished between accidents at the target fabrication facility and accidents at other areas of the power plant. Regarding the chemical toxicity assessment, we have used the USDOE regulations to determine the maximum allowable release in order to protect the public from adverse health effects. Opposite to common belief, it has been found that the chemical safety requirements for these materials appear to be more stringent than the concentrations that would result in an acceptable radiological dose.

  2. Towards Future Broadband Public Safety Systems: Current Issues and Future Directions

    DEFF Research Database (Denmark)

    Popovska Avramova, Andrijana; Ruepp, Sarah Renée; Dittmann, Lars

    2015-01-01

    a convergence of not just new revolutionary technologies, but of the already existing, and evolving technologies as well. This paper analyses the impact of convergence and its importance to the evolution of critical communication systems, both with respect to the fundamental features of the public safety......The vision of the Fifth generation (5G) of mobile communication is that it will be an umbrella for communications for various vertical industries that have different requirements for delay, data rates, reliability, availability, and security. 5G will not be a single technology - rather...... systems and the future broadband services that are becoming an integral part of the work of the first responders. This paper presents and discusses the recent standardization and research efforts in the area of public safety communication systems and indicates the technologies required to enable future...

  3. Applications of Advanced Nondestructive Measurement Techniques to Address Safety of Flight Issues on NASA Spacecraft

    Science.gov (United States)

    Prosser, Bill

    2016-01-01

    Advanced nondestructive measurement techniques are critical for ensuring the reliability and safety of NASA spacecraft. Techniques such as infrared thermography, THz imaging, X-ray computed tomography and backscatter X-ray are used to detect indications of damage in spacecraft components and structures. Additionally, sensor and measurement systems are integrated into spacecraft to provide structural health monitoring to detect damaging events that occur during flight such as debris impacts during launch and assent or from micrometeoroid and orbital debris, or excessive loading due to anomalous flight conditions. A number of examples will be provided of how these nondestructive measurement techniques have been applied to resolve safety critical inspection concerns for the Space Shuttle, International Space Station (ISS), and a variety of launch vehicles and unmanned spacecraft.

  4. Issues in the management of acute agitation: how much current guidelines consider safety?

    Directory of Open Access Journals (Sweden)

    Bruno ePacciardi

    2013-05-01

    Full Text Available Agitated behavior constitutes up to 10% of emergency psychiatric interventions. Pharmacological tranquilization is often used as a valid treatment for agitation but a strong evidence base does not underpin it. Available literature shows different recommendations, supported by research data, theoretical considerations or clinical experience. Rapid tranquilization is mainly based on parenteral drug treatment and the few existing guidelines on this topic, when suggesting the use of first generation antipsychotics and benzodiazepines, include drugs with questionable tolerability profile such as chlorpromazine, haloperidol, midazolam and lorazepam. In order to systematically evaluate safety concerns related to the adoption of such guidelines, we reviewed them independently from principal diagnosis while examining tolerability data for suggested treatments. There is a growing evidence about safety profile of second generation antipsychotics for rapid tranquilization but further controlled studies providing definitive data in this area are urgently needed.

  5. Hazard identification checklist: Occupational safety and health issues associated with green building

    OpenAIRE

    Terwoert, J.; Ustailieva, E.

    2013-01-01

    This checklist accompanies the e-fact on the same topic and aims to help identify the potential hazards to workers’ safety and health associated with the planning and construction of green buildings, their maintenance, renovation (retrofitting), demolition, and on-site waste collection. It also gives examples of preventive measures to address these hazards. Some of these OSH hazards are new compared with traditional construction sites and are associated with new green materials, technologies ...

  6. Review of GMO safety assessment studies: glyphosate residues in Roundup Ready crops is an ignored issue

    OpenAIRE

    2015-01-01

    Published version, also available at http://dx.doi.org/10.1186/s12302-015-0052-7 Background Genetically modified glyphosate-tolerant cultivar varieties have been a commercial success widely known as Roundup Ready plants. As new glyphosate-tolerant varieties are introduced to satisfy agriculture demand, it is relevant to review the scientific evidence that documents the quality and safety of such biotechnology. Assessments of genetically modified glyphosate-tolerant plants are partly ba...

  7. Computing what the public wants: some issues in road safety cost-benefit analysis.

    Science.gov (United States)

    Hauer, Ezra

    2011-01-01

    In road safety, as in other fields, cost-benefit analysis (CBA) is used to justify the investment of public money and to establish priority between projects. It amounts to a computation by which 'few' - the CB analysts - aim to determine what the 'many' - those on behalf of which the choice is to be made - would choose. The question is whether there are grounds to believe that the tool fits the aim. I argue that the CBA tool is deficient. First, because estimates of the value of statistical life and injury on which the CBA computation rests are all over the place, inconsistent with the value of time estimates, and government guidance on the matter appears to be arbitrary. Second, because the premises of New Welfare Economics on which the CBA is founded apply only in circumstances which, in road safety, are rare. Third, because the CBA requires the computation of present values which must be questioned when the discounting is of future lives and of time. Because time savings are valued too highly when compared to life and because discounting tends to unjustifiably diminish the value of lives saved in the future, the CBA tends to bias decisions against investment in road safety.

  8. Interconnected but underprotected? Parents' methods and motivations for information seeking on digital safety issues.

    Science.gov (United States)

    Davis, Vauna

    2012-12-01

    Parents need information and skills to meet the demands of mediating connected technology in their homes. Parents' methods and motivations for learning to protect children from digital risks were reported through a survey. This study explores relationships between information seeking, parents' concerns, risks children have experienced, and access to connected devices, in addition to the use and satisfaction of various digital safety resources. Three types of information-seeking behavior were identified: (a) protective information seeking, to protect children from being confronted with harmful content; (b) problem-solving information seeking, to help children who have been negatively affected by connected technology; and (c) attentive learning, by attending to media resources passively encountered on this topic. Friends and family are the dominant source of digital safety information, followed by presentations and the Internet. Parents' top concerns for their children using connected technology were accidental exposure to pornography, and sexual content in Internet-based entertainment. Higher numbers of risks experienced by children were positively associated with parents' problem-solving information seeking and level of attentive learning. Parents who were more concerned exhibited more problem-solving information seeking; but despite the high level of concern for children's safety online, 65 percent of parents seek information on this subject less than twice per year. Children have access to a mean of five connected devices at home; a higher number of devices was correlated with increased risks experienced by children, but was not associated with increased concern or information seeking from parents.

  9. Quality and Safety in Orthopaedics: Learning and Teaching at the Same Time: AOA Critical Issues.

    Science.gov (United States)

    Black, Kevin P; Armstrong, April D; Hutzler, Lorraine; Egol, Kenneth A

    2015-11-04

    Increasing attention has been placed on providing higher quality and safer patient care. This requires the development of a new set of competencies to better understand and navigate the system and lead the orthopaedic team. While still trying to learn and develop these competencies, the academic orthopaedist is also expected to model and teach them.The orthopaedic surgeon must understand what is being measured and why, both for purposes of providing better care and to eliminate unnecessary expense in the system. Metrics currently include hospital-acquired conditions, "never events," and thirty-day readmission rates. More will undoubtedly follow.Although commitment and excellence at the individual level are essential, the orthopaedist must think at the systems level to provide the highest value of care. A work culture characterized by respect and trust is essential to improved communication, teamwork, and confidential peer review. An increasing number of resources, both in print and electronic format, are available for us to understand what we can do now to improve quality and safety.Resident education in quality and safety is a fundamental component of the systems-based practice competency, the Next Accreditation System, and the Clinical Learning Environment Review. This needs to be longitudinally integrated into the curriculum and applied parallel to the development of resident knowledge and skill, and will be best learned if resident learning is experiential and taught within a genuine culture of quality and safety. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.

  10. Safety

    CERN Multimedia

    2003-01-01

    Please note that the safety codes A9, A10 AND A11 (ex annexes of SAPOCO/42) entitled respectively "Safety responsibilities in the divisions" "The safety policy committee (SAPOCO) and safety officers' committees" and "Administrative procedure following a serious accident or incident" are available on the web at the following URLs: Code A9: http://edms.cern.ch/document/337016/LAST_RELEASED Code A10: http://edms.cern.ch/document/337019/LAST_RELEASED Code A11: http://edms.cern.ch/document/337026/LAST_RELEASED Paper copies can also be obtained from the TIS divisional secretariat, e-mail: tis.secretariat@cern.ch. TIS Secretariat

  11. Effect of Safety Issues with HIV Drugs on the Approval Process of Other Drugs in the Same Class An Analysis of European Public Assessment Reports

    NARCIS (Netherlands)

    Arnardottir, Arna H.; Haaijer-Ruskamp, Flora M.; Straus, Sabine M. J.; de Graeff, Pieter A.; Mol, Peter G. M.

    2011-01-01

    Background: Knowledge on the safety of new medicines is limited at the time of market entry. Nearly half of all drugs used to treat HIV registered in the EU required >= 1 Direct Healthcare Professional Communication (DHPC) in the past 10 years for safety issues identified post-approval. Objective: T

  12. 关于食品安全问题的几点思考%Some Thoughts about Food Safety Issues

    Institute of Scientific and Technical Information of China (English)

    董新刚

    2014-01-01

    From a social perspective, the food security is not only a public health problem, but a social issue and political issue, and even the social stability and unity issue. Therefore, the scientific governance of the food safety issue is of great significance. For the current status of governance, the author thinks it from four angles of legislation, market behavior value-oriented, law enforcement and regulatory and the media guidance, and proposes advisory suggestions.%食品安全从社会层面来看,不仅是公共卫生问题,而是社会问题、政治问题,甚至是社会安定团结问题。因此,食品安全问题科学管治意义重大。针对目前的治理现状,笔者从立法、市场行为价值取向、执法监管及媒介引导四个角度进行了思考,并对这些问题提出了建议性意见。

  13. Effect of safety issues with HIV drugs on the approval process of other drugs in the same class: an analysis of European Public Assessment Reports.

    Science.gov (United States)

    Arnardottir, Arna H; Haaijer-Ruskamp, Flora M; Straus, Sabine M J; de Graeff, Pieter A; Mol, Peter G M

    2011-11-01

    Knowledge on the safety of new medicines is limited at the time of market entry. Nearly half of all drugs used to treat HIV registered in the EU required ≥1 Direct Healthcare Professional Communication (DHPC) in the past 10 years for safety issues identified post-approval. The aim was to evaluate the extent to which regulators and industry have addressed the risk of safety issues for HIV drugs based on prior experience with other drugs in the same class and whether doing so impacts development time of these drugs. HIV drugs receiving ≥1 DHPC in the Netherlands between January 1999 and December 2008 were identified. Each drug with a DHPC ('index' drug) was paired with subsequently approved HIV drug(s) in the same class (Anatomical Therapeutic Chemical [ATC] 4th level) ['follow-on' drugs]. Characteristics of safety issues were extracted from the DHPCs of the 'index' drugs. European Public Assessment Reports (EPARs) were reviewed regarding whether the safety issues had been considered during development and approval. Consideration of previously identified safety issues in 'follow-on' drug applications was assessed regarding attention paid to adverse drug reaction (ADR) symptoms in pre-marketing studies, Summary of Product Characteristics (SmPC) and postmarketing commitments, and whether size of the safety population was in accordance with Regulatory guidelines. 'Index' drugs were also paired with drugs in the same class already on the market ('older' drugs). For 'older' drugs, we identified whether the safety issue led to appropriate changes in the current SmPC (January 2011) compared with the SmPC at the time of marketing authorization. Clinical development time was assessed using time from first patent application to market authorization as proxy, and comparison was made between 'index' and 'follow-on' drugs. For 9 (43%) of the 21 centrally authorized HIV drugs, 11 serious safety issues that required a DHPC were identified. Two drugs were excluded from our

  14. Issues and relationships among software standards for nuclear safety applications. Version 2.0

    Energy Technology Data Exchange (ETDEWEB)

    Scott, J.A.; Preckshot, G.G.; Lawrence, J.D.; Johnson, G.L.

    1996-03-26

    Lawrence Livermore National Laboratory is assisting the Nuclear Regulatory Commission with the development of draft regulatory guides for selected software engineering standards. This report describes the results of the initial task in this work. The selected software standards and a set of related software engineering standards were reviewed, and the resulting preliminary elements of the regulatory positions are identified in this report. The importance of a thorough understanding of the relationships among standards useful for developing safety-related software is emphasized. The relationship of this work to the update of the Standard Review Plan is also discussed.

  15. Waste compatibility safety issues and final results for tank 241-T-110 push mode samples

    Energy Technology Data Exchange (ETDEWEB)

    Nuzum, J.L.

    1997-05-15

    This document is the final laboratory report for Tank 241-T-110. Push mode core segments were removed from risers 2 and 6 between January 29, 1997, and February 7, 1997. Segments were received and extruded at 222-S Laboratory. Analyses were performed in accordance with Tank 241-T-110 Push Mode Core Sampling and analysis Plan (TSAP) and Safety Screening Data Quality Objective (DQO). None of the subsamples submitted for total alpha activity (AT) or differential scanning calorimetry (DSC) analyses exceeded the notification limits stated in DQO.

  16. 反式脂肪酸安全问题辨析%Discrimination of safety issues on trans fatty acids

    Institute of Scientific and Technical Information of China (English)

    金青哲; 王兴国; 曹万新; 冉萍

    2011-01-01

    针对我国反式脂肪酸安全问题宣传中存在的问题,从氢化油、植物黄油等产品的定义和发展历史出发,释义了反式脂肪酸,阐述了反式脂肪酸与人体健康的关系,并初步评估了我国民众反式脂肪酸摄入情况,旨在开展对反式脂肪酸安全问题的科学理性讨论,普及和提高公众对反式脂肪酸问题的科学理性认识,指导食品消费和生产.%In the light of the misunderstanding of the trans fatty acids issue at present, the type of hydrogenated oil, margarine and other products were defined, and the relationship between intake of trans fatty acids and the human health was described. The daily sources and intake of trans fatty acids in the Chinese population were preliminary evaluated. The scientific and rational discussion on food safety from trans fatty acids should be advocated and expanded, so as to popularize and raise public awareness on the safety issues of trans fatty acids, as well as provide guidance for food consumption and produetion.

  17. Experimental Study and Computational Simulations of Key Pebble Bed Thermo-mechanics Issues for Design and Safety

    Energy Technology Data Exchange (ETDEWEB)

    Tokuhiro, Akira; Potirniche, Gabriel; Cogliati, Joshua; Ougouag, Abderrafi

    2014-07-08

    An experimental and computational study, consisting of modeling and simulation (M&S), of key thermal-mechanical issues affecting the design and safety of pebble-bed (PB) reactors was conducted. The objective was to broaden understanding and experimentally validate thermal-mechanic phenomena of nuclear grade graphite, specifically, spheres in frictional contact as anticipated in the bed under reactor relevant pressures and temperatures. The contact generates graphite dust particulates that can subsequently be transported into the flowing gaseous coolent. Under postulated depressurization transients and with the potential for leaked fission products to be adsorbed onto graphite 'dust', there is the potential for fission products to escape from the primary volume. This is a design safety concern. Furthermore, earlier safety assessment identified the distinct possibility for the dispersed dust to combust in contact with air if sufficient conditions are met. Both of these phenomena were noted as important to design review and containing uncertainty to warrant study. The team designed and conducted two separate effects tests to study and benchmark the potential dust-generation rate, as well as study the conditions under which a dust explosion may occure in a standardized, instrumented explosion chamber.

  18. An analysis on the licensing trends of nuclear power plant and outstanding licensing issues

    Energy Technology Data Exchange (ETDEWEB)

    Han, Kyoo Sung; Nam, Seung Duk; Jang, Keun Sun; Yang, Joon Suk; Park, Tae Chul [Korea Atomic Energy Research Institute, Taejon (Korea, Republic of)

    1993-08-01

    In this paper, nuclear licensing politics, procedures and regulatory trends of the national practices of both Korea and United States are reviewed and analyzed to begin with. The resolution process and regulatory status of severe accident issues, Unresolved Safety Issues(USIs) and Generic Safety Issues(GSIs) are also traced. Subsequently, the author suggests a scheme for resolving and preparing for anticipated licensing issues for Ulchin units 3 and 4, together with the establishment of outstanding licensing issues and regulatory criteria applicable to Ulchin units 3 and 4. 10 figs., 10 tabs., 22 refs. (Author).

  19. Design of the EURISOL multi-MW target assembly radiation and safety issues

    CERN Document Server

    Felcini, Marta; Kadi, Yacine; Otto, Thomas; Tecchio, L

    2006-01-01

    The multi-MW target proposed for the EURISOL facility will be based on fission of uranium (or thorium) compounds to produce rare isotopes far from stability. A two-step process is used for the isotope production. First, neutrons are generated in a liquid mercury target, irradiated by the 1 GeV proton or deuteron beam, provided by the EURISOL linac driver. Then, the neutrons induce fission in a surrounding assembly of uranium carbide. R&D projects on several aspects of the target assembly are ongoing. Key criteria for the target design are a maximum beam power capability of 4 MW, a remote handling system with minimum downtime and maximum reliability, as well as radiation safety, minimization of hazards and the classification of the facility. In the framework of the ongoing radiation characterization and safety studies, radiation transport simulations have been performed to calculate the prompt radiation dose in the target and surrounding materials, as well as to determine shielding material and angle-depen...

  20. Design of the EURISOL multi-MW target assembly: radiation and safety issues

    CERN Document Server

    Felcini, M; Kadi, Y; Otto, T; Tecchio, L; Otto, Th.

    2006-01-01

    The multi-MW target proposed for the EURISOL facility will be based on fission of uranium (or thorium) compounds to produce rare isotopes far from stability. A two-step process is used for the isotope production. First, neutrons are generated in a liquid mercury target, irradiated by the 1 GeV proton or deuteron beam, provided by the EURISOL linac driver. Then, the neutrons induce fission in a surrounding assembly of uranium carbide. R&D projects on several aspects of the target assembly are ongoing. Key criteria for the target design are a maximum beam power capability of 4 MW, a remote handling system with minimum downtime and maximum reliability, as well as radiation safety, minimization of hazards and the classification of the facility. In the framework of the ongoing radiation characterization and safety studies, radiation transport simulations have been performed to calculate the prompt radiation dose in the target and surrounding materials, as well as to determine shielding material and angle-depen...

  1. VISITORS PERCEPTION ON VANDALISM AND SAFETY ISSUES IN A MALAYSIAN URBAN PARK

    OpenAIRE

    Nurhayati ABDUL MALEK; Manohar MARIAPAN

    2009-01-01

    The purpose of this research is to identify and understand vandalism issues that occur in the selected case study site as well as to determine characteristics of the surrounding landscape associated with vandalism hotspots, and to justify safe environments in park areas. Questionnaire survey was conducted and specifically studies an urban park in the city of Shah Alam in the state of Selangor, Malaysia. The research indicated that people perceived vandalism to occur because of the opportuniti...

  2. Knowledge and Attitudes towards Handling Eggs in the Home: An Unexplored Food Safety Issue?

    OpenAIRE

    Harriet Whiley; Beverley Clarke; Kirstin Ross

    2017-01-01

    Foodborne illness is a global public health issue, with food handling in the home identified as an underestimated source. In Australia, there has been a significant increase in the incidence of salmonellosis with the majority of outbreaks linked to eggs. This study investigated Australian eggs consumer attitudes, behaviours and risk perceptions associated with the handling of raw eggs in the home. It was identified that 67% of participants chose free range eggs, 11% kept poultry, 7% did not h...

  3. 原研和仿制氨氯地平治疗高血压有效性和安全性的Meta分析%Efficacy and Safety of Generic and Patented Amlodipine for Hypertension:A Meta-Analysis

    Institute of Scientific and Technical Information of China (English)

    余正; 王海兵; 段君军; 李洪超

    2016-01-01

    Objective:To systematically estimate the efficacy and safety of generic and patented amlodipine for hypertension.Methods:VIP,WANFANG and CNKI were searched for relevant literatures published before December 25,2014.Based on quality of literature eval-uation,we extract the literature data, using RevMan 5.3 software.Results:After retrieving and eliminating duplicate documents, we re-ceived 62 papers with 4 RCTs being reviewed eventually.Meta-analysis results show that the generic amlodipine and original amlodipine are efficient for the treatment of hypertension with RR=0.99(95%CI:0.65,1.52,P=0.97).According to the dosage and patients in-clusion criteria, we conduct subgroup analysis; Clinical studies reported a significant efficiency with the combined effect of RR=0.99 (95%CI:0.83,1.19,P=0.95).The incidence rate of adverse drug reactions is RR=1.01 (95% CI:0.51,1.99,P=0.98).The re-sults show that there is no statistically significant difference.Conclusion:The efficacy and safety of generic and patented amlodipine is e-qual.As a result, generic amlodipine is safe and effective in hypertension treatment.%目的:运用Meta分析的方法系统评价原研与仿制氨氯地平治疗高血压的有效性和安全性。方法:在维普数据库( VIP)、万方数据库( WANFANG)和中国期刊网全文数据库( CNKI)中检索2014年12月25日之前发表的相关文献。在进行文献质量评估基础上提取文献数据,采用RevMan 5.3软件进行Meta分析。结果:经过检索并剔除重复文献后共获得62篇文献,最终纳入综述文献4篇。 Meta分析结果显示,仿制氨氯地平与原研氨氯地平治疗高血压的有效率RR=0.99(95%CI:0.65,1.52,P=0.97);根据用药剂量、病例纳入标准进行亚组分析;临床研究报道了显效率,合并效应量RR=0.99(95%CI:0.83,1.19,P=0.95);不良反应发生率 RR =1.01(95%CI:0.51,1.99,P=0.98)。研究结果显示均无

  4. Occupational Health and Safety Issues in Ontario Sawmills and Veneer/Plywood Plants: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Dave K. Verma

    2010-01-01

    Full Text Available A pilot study was conducted within the Ontario sawmill and veneer/plywood manufacturing industry. Information was collected by postal questionnaire and observational walk-through surveys. Industrial hygiene walk-through surveys were conducted at 22 work sites, and measurements for wood dust, noise, and bioaerosol were taken. The aim of the study was to obtain data on the current status regarding health and safety characteristics and an estimate of wood dust, noise, and bioaerosol exposures. The occupational exposure to wood dust and noise are similar to what has been reported in this industry in Canada and elsewhere. Airborne wood dust concentration ranged between 0.001 mg/m3 and 4.87 mg/m3 as total dust and noise exposure ranged between 55 and 117 dB(A. The study indicates the need for a more comprehensive industry-wide study of wood dust, noise, and bioaersols.

  5. Qualitative Risk Assessment for an LNG Refueling Station and Review of Relevant Safety Issues

    Energy Technology Data Exchange (ETDEWEB)

    Siu, N.; Herring, J.S.; Cadwallader, L.; Reece, W.; Byers, J.

    1998-02-01

    This report is a qualitative assessment of the public and worker risk involved with the operation of a liquefied natural gas (LNG) vehicle refueling facility. This study includes facility maintenance and operations, tank truck deliveries, and end-use vehicle fueling; it does not treat the risks of LNG vehicles on roadways. Accident initiating events are identified by using a Master Logic Diagram, a Failure Modes and Effects Analysis, and historical operating experiences. The event trees were drawn to depict possible sequences of mitigating events following the initiating events. The phenomenology of LNG and other vehicle fuels is discussed to characterize the hazard posed by LNG usage. Based on the risk modeling and analysis, recommendations are given to improve the safety of LNG refueling stations in the areas of procedures and training, station design, and the dissemination of ``best practice`` information throughout the LNG community.

  6. Reentry safety for the Topaz II Space Reactor: Issues and analyses

    Energy Technology Data Exchange (ETDEWEB)

    Connell, L.W.; Trost, L.C.

    1994-03-01

    This report documents the reentry safety analyses conducted for the TOPAZ II Nuclear Electric Propulsion Space Test Program (NEPSTP). Scoping calculations were performed on the reentry aerothermal breakup and ground footprint of reactor core debris. The calculations were used to assess the risks associated with radiologically cold reentry accidents and to determine if constraints should be placed on the core configuration for such accidents. Three risk factors were considered: inadvertent criticality upon reentry impact, atmospheric dispersal of U-235 fuel, and the Special Nuclear Material Safeguards risks. Results indicate that the risks associated with cold reentry are very low regardless of the core configuration. Core configuration constraints were therefore not established for radiologically cold reentry accidents.

  7. Interim qualitative risk assessment for an LNG refueling station and review of relevant safety issues

    Energy Technology Data Exchange (ETDEWEB)

    Siu, N.; Herring, S.; Cadwallader, L.; Reece, W.; Byers, J.

    1997-07-01

    This report is a qualitative assessment of the public and worker risk involved with the operation of a liquefied natural (LNG) vehicle refueling facility. This study includes facility maintenance and operations, tanker truck delivers and end-use vehicle fueling; it does not treat the risks of LNG vehicles on roadways. Accident initiating events are identified by using a Master Logic Diagram, a Failure Modes and Effects analysis and historical operating experiences. The event trees were drawn to depict possible sequences of mitigating events following the initiating events. The phenomenology of LNG and other vehicle fuels is discussed to characterize the hazard posed by LNG usage. Based on the risk modeling and analysis, recommendations are given to improve the safety of LNG refueling stations in the areas of procedures and training, station design, and the dissemination of best practice information throughout the LNG community.

  8. Generic tacrolimus in solid organ transplantation.

    Science.gov (United States)

    Taube, D; Jones, G; O'Beirne, J; Wennberg, L; Connor, A; Rasmussen, A; Backman, L

    2014-05-01

    The availability of a wide range of immunosuppressive therapies has revolutionized the management of patients who have undergone solid organ transplantation (SOT). However, the cost of immunosuppressive drugs remains high. This situation has led to the development of generic equivalents, which are similar in quality, safety, and efficacy to their approved innovator drugs. There are data available for three generic brands, tacrolimus (Intas), tacrolimus (PharOS), and tacrolimus (Sandoz). Bioequivalence has been demonstrated for generic tacrolimus (Sandoz) within a narrow therapeutic range to its innovator tacrolimus drug (Prograf) in both healthy volunteers and kidney transplant patients. Clinical experience with this generic tacrolimus formulation has also been established in both de novo and conversion patients who have undergone kidney and liver transplantation, as well as in conversion of other SOT patients, including lung and heart recipients.

  9. A Multi-centric Bioequivalence Trial in Ph+ Chronic Myeloid Leukemia Patients to Assess Bioequivalence and Safety Evaluation of Generic Imatinib Mesylate 400 mg Tablets

    Science.gov (United States)

    Arora, Rachna; Sharma, Manju; Monif, Tausif; Iyer, Sunil

    2016-01-01

    Purpose This study was designed to characterize the pharmacokinetic profile and to assess bioequivalence of the sponsor’s test formulation (imatinib mesylate 400 mg tablets) with an innovator product (Gleevec 400 mg tablets, Novartis Pharmaceuticals) under fed conditions, in adult patients of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) stabilized on imatinib mesylate 400 mg. In addition, the aim of this study was to monitor the safety profile of investigational medicinal products (IMPs). Materials and Methods A multicenter, randomized, open label, two-period, crossover, single dose bioequivalence study was designed for conduct under fed conditions in 42 adult Ph+ CML patients already stabilized on imatinib 400 mg tablets. Pharmacokinetic parameters Tmax, Cmax, and AUC0-24 were calculated using a non-compartmental model on validated WinNonlin software. Validated SAS software was used for statistical evaluation of data. The safety profile of investigational products was monitored during the course of study by applying a clinical process for recording observed untoward effects postadministration of investigational products. Results The 90% confidence intervals for the test/reference mean ratios of the ln-transformed PK variables Cmax (99.0%) and AUC0-24 (99.2%) were within an acceptable range of 80%-125%, as per bioequivalence assumptions. Both formulations were well tolerated after oral administration of IMPs. Conclusion The test product was found to be bioequivalent and safe, and thus can be used interchangeably in clinical practice. PMID:26875198

  10. Tritium management and safety issues in ITER and DEMO breeding blankets

    Energy Technology Data Exchange (ETDEWEB)

    Bornschein, B., E-mail: beate.bornschein@kit.edu [Karlsruhe Institute of Technology (KIT), Institute for Technical Physics, Tritium Laboratory Karlsruhe, Hermann v. Helmholtz Platz 1, 76344 Eggenstein Leopoldshafen (Germany); Day, C.; Demange, D. [Karlsruhe Institute of Technology (KIT), Institute for Technical Physics, Tritium Laboratory Karlsruhe, Hermann v. Helmholtz Platz 1, 76344 Eggenstein Leopoldshafen (Germany); Pinna, T. [ENEA UTFUS-TEC, Via E. Fermi 45, 00044 Frascati, Rome (Italy)

    2013-10-15

    Highlights: • Different aspects of tritium management in breeder blankets were reviewed. • Safe and reliable tritium management faces unique technological challenges. • Tritium recovery efficiency in tritium extraction system (TES) is a vital issue. • Tritium tracking accuracy needs to be demonstrated for the whole fuel cycle. • Improved or new processes for TES and CPS are needed in case of DEMO. -- Abstract: Safe, reliable and efficient tritium management in the breeder blanket faces unique technological challenges. Beside the tritium recovery efficiency in the tritium extraction and coolant purification systems, the tritium tracking accuracy between the inner and outer fuel cycle shall also be demonstrated. Furthermore, it is self-evident that safe handling and confinement of tritium need to be stringently assured to evolve fusion as a reliable technique. The present paper gives an overview of tritium management in breeder blankets. After a short introduction into the tritium fuel cycle and blanket basics, open tritium issues are discussed, thereby focusing on tritium extraction from blanket, coolant detritiation and tritium analytics and accountancy, necessary for accurate and reliable processing as well as for book-keeping.

  11. Issues in the sphere of ecology safety and resources for their solution in the light of political ecology theory

    Directory of Open Access Journals (Sweden)

    Vladimir G. Tyminskiy

    2017-03-01

    Full Text Available Objective to analyze the world experience of forming the paradigm of political ecology in the aspect of environmental safety. Methods dialectical method of cognition detailing logical generalization. Results the article formulates conclusions about the topicality of the environmental security issues confirming in particular by the nature of the changes in consumer demand and environmentally responsible behavior of a certain part of the population. The global trends are identified in the formation and development of international institutions in the field of political ecology scientific institutes and laboratories working in this field. The analysis of world experience of forming the paradigm of political ecology has shown that currently an attempt is made to introduce nature into the economic relationship as one of their subjects emphasizing the ambiguous attitude of scientists to ecosystem services. It is revealed that in Russia and abroad the issues of environmental security are studied by a significant number of scientific educational and public organizations. The most important trends are the shift in emphasis from the natural environment to humans and the systematization and expansion of the list of threats to environmental security. The article also analyzes the main parameters of ecological safety of Russia and formulates conclusions about the poor state of most ecosystems and quotecophobicquot industrial infrastructure. Also the problems of interregional cooperation in the environmental field are defined as well as the negative impact of transnational corporations on environmental safety. The main tasks of political ecology in the framework of the national program of socioeconomic development of Russia are defined. The conclusion is made about the necessity to formulate the problem and describe the principles of a comprehensive program of environmental safety taking into account the geological security within the national security

  12. Non-Angled Intercostal Percutaneous Access Under Full Expiration: Safety Is Not an Issue Anymore.

    Science.gov (United States)

    Ajib, Khaled M; Matta, Imad F; Zgheib, Joseph T; Jabbour, Michel E

    2017-08-01

    Percutaneous nephrolithotomy (PCNL) is a well-established procedure for the management of urinary calculi and can be performed intercostally or subcostally. Favoring one approach vs the other is still debatable, and literature has been inconclusive regarding the efficacy and safety of both approaches. Hence, this study aims to assess the safety and efficacy of direct non-angled intercostal technique performed under full expiration and to compare it to the subcostal approach. PCNL was conducted among 361 patients during 2010-2015 at Saint George Hospital University Medical Center in Beirut, Lebanon. PCNL was done by one operator and by following a standard technique. After reviewing the medical records, 304 patients were included. Data analysis was conducted using Stata/IC 10.0. Bivariate analysis was conducted using Pearson's Chi-square, and logistic regression model was run. Alpha level was set at 0.05. Of the total patients, 54.6% and 45.4% underwent intercostal (Group I) and subcostal (Group II) access, respectively. Mean drop in hemoglobin in Group II was 1.9 g/dL vs 1.48 g/dL in Group I (p-value = 0.0040). The mean difference in operation time between group I (88.61 minutes) and group II (102.58 minutes) was statistically significant (p-value = 0.0064). Patients were stone free in 88.05% of the intercostal cases and 78.52% of the subcostal cases. Group II patients were twice more likely to have residual stones compared to Group I (p-value = 0.029). No statistical significance was observed in postoperative complications among both groups. In addition, no cases of pneumothorax were reported. Compared to subcostal access, intercostal approach under full expiration is a safe technique that provides optimal approach to the intrarenal collecting system and allows less angulation, less bleeding, and yields higher stone clearance with minimal complications. When performed by a well-trained urologist, intercostal access should be advocated in PCNL to

  13. Aspartame, low-calorie sweeteners and disease: regulatory safety and epidemiological issues.

    Science.gov (United States)

    Marinovich, Marina; Galli, Corrado L; Bosetti, Cristina; Gallus, Silvano; La Vecchia, Carlo

    2013-10-01

    Aspartame is a synthetic sweetener that has been used safely in food for more than 30 years. Its safety has been evaluated by various regulatory agencies in accordance with procedures internationally recognized, and decisions have been revised and updated regularly. The present review summarizes the most relevant conclusions of epidemiological studies concerning the use of low-calorie sweeteners (mainly aspartame), published between January 1990 and November 2012. In the Nurses' Health study and the Health Professionals Followup study some excess risk of Hodgkin lymphoma and multiple myeloma was found in men but not in women; no association was found with leukemia. In the NIH-AARP Diet and Health Study, there was no association between aspartame and haematopoietic neoplasms. US case-control studies of brain and haematopoietic neoplasms also showed no association. The NIH-AARP Diet and Health Study and case-control studies from California showed no association with pancreatic cancer, and a case-control study from Denmark found no relation with breast cancer risk. Italian case-control studies conducted in 1991-2008 reported no consistent association for cancers of the upper aerodigestive tract, digestive tract, breast, endometrium, ovary, prostate, and kidney. Low calorie sweeteners were not consistently related to vascular events and preterm deliveries.

  14. Is formocresol obsolete? A fresh look at the evidence concerning safety issues.

    Science.gov (United States)

    Milnes, Alan R

    2008-07-01

    Concern has been expressed about the safety of formocresol use in pediatric dentistry. Formaldehyde, a primary component in formocresol, is a hazardous substance and is considered a probable human carcinogen by the International Agency for Research on Cancer, Health Canada, the Agency for Toxic Substances and Disease Registry in the U.S. Department of Health and Human Services, and the U.S. Environmental Protection Agency. Humans inhale and ingest formaldehyde daily, however, and produce formaldehyde during cellular metabolism. The human body is physiologically equipped to handle formaldehyde through multiple conversion pathways. The resultant single carbon atom released during metabolism is deposited in the "1-carbon pool," which, in turn, is used for the biosynthesis of macromolecules including DNA and RNA. Reevaluation of earlier research that examined potential health risks associated with formaldehyde exposure has shown that this research was based on flawed assumptions, which resulted in erroneous conclusions. The purpose of this review was to examine more recent research about formaldehyde metabolism, pharmacokinetics, and carcinogenicity. These results indicated that formaldehyde is probably not a potent human carcinogen under low exposure conditions. Extrapolation of these research results to pediatric dentistry suggests an inconsequential risk associated with formaldehyde use in pediatric pulp therapy.

  15. Safety culture

    Energy Technology Data Exchange (ETDEWEB)

    Keen, L.J. [Canadian Nuclear Safety Commission, Ottawa, Ontario (Canada)

    2003-07-01

    Safety culture has become a topic of increasing interest for industry and regulators as issues are raised on safety problems around the world. The keys to safety culture are organizational effectiveness, effective communications, organizational learning, and a culture that encourages the identification and resolution of safety issues. The necessity of a strong safety culture places an onus on all of us to continually question whether the safety measures already in place are sufficient, and are being applied. (author)

  16. Bias towards publishing positive results in orthopedic and general surgery: a patient safety issue?

    Directory of Open Access Journals (Sweden)

    Ziran Bruce H

    2007-11-01

    Full Text Available Abstract Background Research articles reporting positive findings in the fields of orthopedic and general surgery appear to be represented at a considerably higher prevalence in the peer-reviewed literature, compared to published studies on negative or neutral data. This "publication bias" may alter the balance of the available evidence-based literature and may affect patient safety in surgery by depriving important information from unpublished negative studies. Methods A comprehensive review of all published articles in a defined 7-year period was performed in 12 representative journals in the fields of orthopedic and general surgery. Every article published in all volumes of these journals between January 2000 and December 2006 was reviewed and rated by three investigators. Rating of articles was performed according to a uniform, standardized algorithm. All original articles were stratified into "positive", "negative" or "neutral", depending on the reported results. All non-original papers were excluded from analysis. Results A total of 30,197 publications were reviewed over a 7-year time-period. After excluding all non-original articles, a total of 16,397 original papers were included in the final analysis. Of these, 12,251 (74% articles were found to report positive findings, 2,709 (17% reported negative results, and 1,437 (9% were neutral. A similar publication pattern was found among all years and all journals analyzed. Altogether, 91% of all original papers reported significant data (positive or negative, whereas only 9% were neutral studies that did not report any significant findings. Conclusion There is a disproportionately high number of articles reporting positive results published in the surgical literature. A bias towards publishing positive data will systematically overestimate the clinical relevance of treatment effects by disregarding important information derived from unpublished negative studies. This "publication bias

  17. Clinical safety and tolerability issues in use of triazole derivatives in management of fungal infections

    Directory of Open Access Journals (Sweden)

    Dionissios Neofytos

    2010-04-01

    Full Text Available Dionissios Neofytos1, Edina Avdic2, Anna-Pelagia Magiorakos31Transplant and Oncology Infectious Disease Program, The Johns Hopkins University School of Medicine, Division of Infectious Diseases, 2Department of Pharmacy, The Johns Hopkins Hospital, Baltimore, USA; 3Scientific Advice Unit, European Centre for Disease Prevention and Control, Stockholm, SwedenAbstract: There has been an increase in the number of patients susceptible to invasive fungal infections (IFIs leading to a greater need for effective, well tolerated, and easily administered antifungal agents. The advent of triazoles has revolutionized the care of patients requiring treatment or prophylaxis for IFIs. However, triazoles have been associated with a number of adverse events and significant drug–drug interactions. While commonly used, physicians and patients should be aware of the distinct properties of these agents in order to ensure that patients are optimally treated with the least amount of toxicity possible. Clinicians should have a full understanding of the basic pharmacokinetics, absorption, and bioavailability of triazoles. Moreover, knowledge of the drug–drug interactions and potential toxicities of each agent is critical prior to administering a triazole. Careful history taking, thorough review of the patient’s medication list, and detailed discussion with the patients and their families about the efficacy, safety, and tolerability of these agents should be performed. Clinicians treating patients with triazoles should closely follow them, monitor pertinent laboratory tests, and consider measuring drug levels as needed. This article will review the basic pharmacokinetic properties and most frequently encountered adverse events and pitfalls associated with triazoles in clinical practice. Keywords: triazoles, fluconazole, voriconazole, posaconazole, itraconazole, review, invasive fungal infections, adverse events, drug–drug interactions

  18. Development of neuroleptic agents: pharmacogenetics and current safety issues of regulatory concern.

    Science.gov (United States)

    Shah, Rashmi

    2002-12-01

    The development of safe and effective new drug treatments for schizophrenia poses a challenging task. This class of drugs is known to be associated with a wide range of serious and troublesome safety problems that include neurological, cardiac, endocrine, and metabolic side effects. Many of these drugs have a narrow therapeutic index and generate metabolites that often have their own unique pharmacological profile different from the parent compound. These features make it imperative that the optimal dose schedules for neuroleptic drugs are carefully characterized. Many of these drugs are metabolized by cytochrome P450 enzymes, which show genetic polymorphism and a bi modal distribution within the population, A significant subset of the population cannot eliminate these drugs as effectively as the majority. This brings an added dimension of complexity in characterizing the dose and individualizing therapy. Many neuroleptic agents are proarrhythmic with an adverse effect on cardiac repolarization. They are prone to prolonging the QT interval and inducing torsade de pointes. Given the potentially fatal outcome of this ventricular tachyarrhythmia, drug development programs need to ensure that the proarrhythmic potential of any new neuroleptic agent is thoroughly explored and its proarrhythmic risk characterized. The clinical use of many of these drugs is further troubled by their high potential for drug-drug interactions. These too need to be adequately investigated during development The approval and the labeling of a new neuroleptic agent require a careful regulatory assessment of its risk/benefit ratio in comparison with the available alternatives. Their safe and effective use in routine clinical practice depends on careful attention to prescribing information, especially the contraindications, precautions, and patient-monitoring requirements.

  19. Patient safety issues in magnetic resonance imaging: state of the art.

    Science.gov (United States)

    Stecco, A; Saponaro, A; Carriero, A

    2007-06-01

    The presence of a static magnetic field (Bo), a radiofrequency field (RF), a dynamic gradient which varies in time and loud noises during an MR examination could increase patient risk. Specifically, a magnetic field could interfere with ferromagnetic material leading to one of the following five dangerous interactions: 1) projectile effect, 2) twisting, 3) burning, 4) artefacts and 5) device malfunction. The projectile effect is when an object is attracted by the magnet with the risk, as reported in literature, of hitting the patient, operators and/or the instrument. Objects which typically can undergo this effect are oxygen and helium cylinders, IV stands, cleaning trolleys, chairs, lamp holders, scissors, forceps, clampers, traction weights, monitoring instruments, and especially metallic splinters within the patient. Twisting (torsion) typically occurs with cerebral vascular clamps and cochlear implants. If parts of implants are involved a malfunction may result. Burns can be caused when electrically conductive material is introduced within the magnet, for example, ECG electrodes, monitoring cables and coils which are in contact with the patient's skin, as well as tattoos and eye-liners that contain iron-oxides. Artefacts can be induced by RF emission of implanted devices which can be mistaken for noise of the receiving coil. Implanted devices can induce signal voids which mask or simulate pathologies. Electrical or mechanical malfunction of implanted devices includes pacemakers which can stimulate inappropriately or at an elevated frequency yielding a distorted ECG with altered T-waves. The risk for patients can be reduced by specific educational programs within individual radiology departments which include other specializations and external referring physicians with the aim of developing a standardized safety protocol.

  20. Pharmacy and generic substitution of antiepileptic drugs: missing in action?

    Science.gov (United States)

    Welty, Timothy E

    2007-06-01

    Generic substitution of antiepileptic drugs is an issue that is gathering a lot of attention in the neurology community but is not receiving much attention within pharmacy. Several proposals have been drafted that restrict a pharmacist's decision-making in generic substitution. These proposals highlight concerns about the pharmacy community related to generic substitution. Careful consideration needs to be given to these issues by pharmacists and pharmacy professional organizations. Unless pharmacy as a profession takes strong positions in support of a pharmacist's ability to make decisions about pharmacotherapy and addresses many of the pharmacy-related problems of generic substitution, policies that negatively impact pharmacy will be established.

  1. Investigation of flammable gas and thermal safety issues for retrieval of waste from Tank 241-AN-105

    Energy Technology Data Exchange (ETDEWEB)

    Caley, S.M.; Stewart, C.W.; Antoniak, Z.I.; Cuta, J.M.; Mahoney, L.A.; Panisko, F.E.

    1998-09-01

    The primary purpose of this report is to identify and resolve some of the flammable gas and thermal safety issues potentially associated with the retrieval of waste from Tank 241-AN-105 (AN-105), which is the first double-shell tank scheduled for waste retrieval at Hanford. The planned retrieval scenario includes the following steps in AN-105: (1) degas the tank using two submerged mixing pumps, (2) turn off the mixer pump(s) and allow any suspended solids to settle, (3) decant the supernatant to the intermediate feed staging tank(s) (IFSTs) (AP-102 and/or AP-104) using water/caustic dilution at the transfer pump inlet, (4) add the remaining dilution water/caustic to the slurry remaining in AN-105, (5) mix the tank with the mixer pump(s) until the soluble solids dissolve, (6) turn off the mixer pump(s) and let the insoluble solids settle, and (7) decant the new supernatant to the IFST(s), leaving the insoluble solids behind. Three waste retrieval safety issues are addressed in this report. They are (1) the controlled degassing of AN-105 to ensure that the headspace remains <25% of the lower flammability limit (LFL), (2) an assessment of how dissolved gas (mainly ammonia) released during the transfer of the supernatant in AN-105 to the IFSTs and the water/caustic dilution of the remaining slurry in AN-105 will affect the flammability in these tanks; and (3) an assessment of the maximum waste temperatures that might occur in AN-105 during retrieval operations.

  2. A decade of plant proteomics and mass spectrometry: translation of technical advancements to food security and safety issues.

    Science.gov (United States)

    Agrawal, Ganesh Kumar; Sarkar, Abhijit; Righetti, Pier Giorgio; Pedreschi, Romina; Carpentier, Sebastien; Wang, Tai; Barkla, Bronwyn J; Kohli, Ajay; Ndimba, Bongani Kaiser; Bykova, Natalia V; Rampitsch, Christof; Zolla, Lello; Rafudeen, Mohamed Suhail; Cramer, Rainer; Bindschedler, Laurence Veronique; Tsakirpaloglou, Nikolaos; Ndimba, Roya Janeen; Farrant, Jill M; Renaut, Jenny; Job, Dominique; Kikuchi, Shoshi; Rakwal, Randeep

    2013-01-01

    Tremendous progress in plant proteomics driven by mass spectrometry (MS) techniques has been made since 2000 when few proteomics reports were published and plant proteomics was in its infancy. These achievements include the refinement of existing techniques and the search for new techniques to address food security, safety, and health issues. It is projected that in 2050, the world's population will reach 9-12 billion people demanding a food production increase of 34-70% (FAO, 2009) from today's food production. Provision of food in a sustainable and environmentally committed manner for such a demand without threatening natural resources, requires that agricultural production increases significantly and that postharvest handling and food manufacturing systems become more efficient requiring lower energy expenditure, a decrease in postharvest losses, less waste generation and food with longer shelf life. There is also a need to look for alternative protein sources to animal based (i.e., plant based) to be able to fulfill the increase in protein demands by 2050. Thus, plant biology has a critical role to play as a science capable of addressing such challenges. In this review, we discuss proteomics especially MS, as a platform, being utilized in plant biology research for the past 10 years having the potential to expedite the process of understanding plant biology for human benefits. The increasing application of proteomics technologies in food security, analysis, and safety is emphasized in this review. But, we are aware that no unique approach/technology is capable to address the global food issues. Proteomics-generated information/resources must be integrated and correlated with other omics-based approaches, information, and conventional programs to ensure sufficient food and resources for human development now and in the future.

  3. A pilot study exploring awareness among general public toward issues related to medication safety in the state of Penang, Malaysia

    Directory of Open Access Journals (Sweden)

    Mohamed Azmi Hassali

    2012-01-01

    Full Text Available Context: A better understanding of medication safety ensures better health state among healthcare consumers. Aim: The study aims to assess general public awareness toward issues related to medication safety. Settings and Design: A cross-sectional study was conducted among general public selected conveniently in the state of Penang, Malaysia. Materials and methods: A total of 500 respondents were approached and 476 consumers participated in the survey giving a response rate of 95.2%. Statistical analysis: Data were analyzed by using SPSS version 12.0 and descriptive statistics were reported where appropriate. Results: Majority of the respondents (n=292, 61.3% stated that they were well aware of the possible side effects of their current medications. A total of 196 respondents (41.17% believed that all medicines registered in Malaysia are safe to use as these medicines have no side effects. About 40.33% (n=192 of the respondents claimed that they share their unused medicines with family and friends who are having similar illness. Majority of respondents 57.7% (n=275 were satisfied with the drug information provided by the healthcare professionals. This study also found that more than 80% of the respondents (n=409 did report that they read the labels of their medication before using. Conclusions: In this study, it was revealed that there is a moderate level of public knowledge regarding medication safety. It is evident that public underestimates the risk of their medications. There is a general lack of awareness and understanding among the public especially toward side effects.

  4. Online continuing education course enhances nutrition and health professionals' knowledge of food safety issues of high-risk populations.

    Science.gov (United States)

    Wallner, Stephanie; Kendall, Patricia; Hillers, Virginia; Bradshaw, Eva; Medeiros, Lydia C

    2007-08-01

    To develop and evaluate the efficacy of an online continuing education course for professionals who provide food safety information to high-risk populations. A 2-credit graduate-level class was converted into six web-based modules (overview of foodborne illness, immunology, pregnancy, human immunodeficiency virus, cancer and transplants, and lifecycle) and offered to nutrition and health professionals. Participants had 8 weeks to complete the modules, pre and post questionnaires, and course evaluation. Those who successfully completed the protocol received six continuing education units from one of three professional associations. Change in knowledge was measured using pre and post questionnaires. Course efficacy was evaluated using a post-course questionnaire. A convenience sample of 140 registered dietitians/dietetic technicians registered, nurses, and extension educators were recruited through professional conferences and electronic mailing lists to take the course. Analysis of variance was used to evaluate differences in knowledge scores for all groups across five main effects (attempt, module, profession, age, and education). Course evaluation responses were used to assess course effectiveness. For each module, knowledge scores increased significantly (PRisk Populations," seem to be a convenient, effective option for dietetics professionals, nurses, and extension educators seeking knowledge about food safety issues of high-risk populations. Online learning is a promising delivery approach for the continuing education of health professionals.

  5. Assessment of environmental health and safety issues associated with the commercialization of unconventional gas recovery: Devonian shale

    Energy Technology Data Exchange (ETDEWEB)

    1981-09-01

    The purpose of this study is to identify and examine potential public health and safety issues and the potential environmental impacts from recovery of natural gas from Devonian age shale. This document will serve as background data and information for planners within the government to assist in development of our new energy technologies in a timely and environmentally sound manner. This report describes the resource and the DOE eastern gas shales project in Section 2. Section 3 describes the new and developing recovery technologies associated with Devonian shale. An assessment of the environment, health and safety impacts associated with a typical fields is presented in Section 4. The typical field for this assessment occupies ten square miles and is developed on a 40-acre spacing (that is, there is a well in each 40-acre grid). This field thus has a total of 160 wells. Finally, Section 5 presents the conclusions and recommendations. A reference list is provided to give a greater plant. Based on the estimated plant cost and the various cases of operating income, an economic analysis was performed employing a profitability index criterion of discounted cash flow to determine an interest rate of return on the plant investment.

  6. Multiple BM harvests in pediatric donors for thalassemic siblings: safety, efficacy and ethical issues.

    Science.gov (United States)

    Biral, E; Chiesa, R; Cappelli, B; Roccia, T; Frugnoli, I; Noè, A; Soliman, C; Fiori, R; Cursi, L; Cattaneo, F; Evangelio, C; Miniero, R; Ciceri, F; Roncarolo, M G; Marktel, S

    2008-09-01

    Allogeneic BMT represents the only chance of cure for beta-thalassemia. Occasionally, two affected individuals from the same family share a matched healthy sibling. Moreover, a high incidence of transplant rejection is still observed in Pesaro class III patients, requiring a second BMT procedure. In these settings, one option is to perform a second BM harvest from the same donor. Although BM harvest is a safe procedure in children, ethical issues concerning this invasive practice still arise. Here, we describe our series of seven pediatric, healthy donors, who donated BM more than once in favor of their beta-thalassemic HLA-identical siblings between June 2005 and January 2008. Three donors donated BM twice to two affected siblings and four donors donated twice for the same sibling following graft rejection of the first BMT. All donors tolerated the procedures well and no relevant side effects occurred. There was no significant difference between the two harvests concerning cell yield and time to engraftment. Our experience shows that for pediatric donors, a second BM donation is safe and feasible and good cellularity can be obtained. We suggest that a second harvest of a pediatric donor can be performed when a strong indication for BMT exists.

  7. A Methodological Framework for Software Safety in Safety Critical Computer Systems

    Directory of Open Access Journals (Sweden)

    P. V. Srinivas Acharyulu

    2012-01-01

    Full Text Available Software safety must deal with the principles of safety management, safety engineering and software engineering for developing safety-critical computer systems, with the target of making the system safe, risk-free and fail-safe in addition to provide a clarified differentaition for assessing and evaluating the risk, with the principles of software risk management. Problem statement: Prevailing software quality models, standards were not subsisting in adequately addressing the software safety issues for real-time safety-critical embedded systems. At present no standard framework does exist addressing the safety management and safety engineering priniciples for the development of software safety in safety-critical computer systems. Approach: In this study we propose a methodological framework involving safety management practices, safety engineering practices and software development life cycle phases for the development of software safety. In this framework we make use of the safety management practices such as planning, defining priniciples, fixing responsibilities, creteria and targets, risk assessment, design for safety, formulating safety requirements and integrating skills and techniques to address safety issues early with a vision for assurance and so on. In this framework we have also analysed integration of applicability of generic industrial heirarchy and software development heirarchy, with derived cyclical review involving safety professionals generating a nodal point for software safety. Results: This framework is applied to safety-critical software based laboratory prototype Railroad Crossing Control System (RCCS with a limited complexity. The results have shown that all critical operations were safe and risk free. Conclusion: The development of software based on the proposed framework for RCCS have shown a clarified and improved safety-critical operations of the overall system peformance.

  8. Generic Fortran Containers (GFC)

    Energy Technology Data Exchange (ETDEWEB)

    2016-09-01

    The Fortran language does not provide a standard library that implements generic containers, like linked lists, trees, dictionaries, etc. The GFC software provides an implementation of generic Fortran containers natively written in Fortran 2003/2008 language. The following containers are either already implemented or planned: Stack (done), Linked list (done), Tree (done), Dictionary (done), Queue (planned), Priority queue (planned).

  9. Knowledge and perceptions of physicians from private medical centres towards generic medicines: a nationwide survey from Malaysia.

    Science.gov (United States)

    Kumar, Rohit; Hassali, Mohamed Azmi; Saleem, Fahad; Alrasheedy, Alian A; Kaur, Navneet; Wong, Zhi Yen; Kader, Muhamad Ali Sk Abdul

    2015-01-01

    Generic medicine prescribing has become a common practice in public hospitals. However, the trend in private medical centres seems to be different. The objective of this study was to investigate knowledge, perceptions and behavior of physicians from private medical centres in Malaysia regarding generic medicines. This study was a cross-sectional nationwide survey targeting physicians from private medical centres in Malaysia. The survey was conducted using questionnaire having (i) background and demographic data of the physicians, volume of prescription in a day, stock of generic medicines in their hospital pharmacy etc. (ii) their knowledge about bioequivalence (iii) prescribing behavior (iv) physicians' knowledge of quality, safety and efficacy of generic medicines, and their cost (v) perceptions of physicians towards issues pertaining to generic medicines utilization. A total of 263 questionnaires out of 735 were received, giving a response rate of 35.8%. Of the respondents, 214 (81.4%) were male and 49 (18.6%) were females. The majority of the participants were in the age range of 41-50 years and comprised 49.0% of the respondents. Only 2.3% of physicians were aware of the regulatory limits of bioequivalence standards in Malaysia. Of the respondents, 23.2% agreed that they 'always' write their prescriptions using originator product name whereas 50.2% do it 'usually'. A number of significant associations were found between their knowledge, perceptions about generic medicines and their demographic characteristics. The majority of the physicians from private medical centres in Malaysia had negative perceptions about safety, quality and the efficacy of generic medicines. These negative perceptions could be the cause of the limited use of generic medicines in the private medical centres. Therefore, in order to facilitate their use, it is recommended that the physicians need to be reassured and educated about the drug regulatory authority approval system of generic

  10. Are generic drugs really inferior medicines?

    Science.gov (United States)

    Moore, N; Berdaï, D; Bégaud, B

    2010-09-01

    In this issue Gagne et al. report an elegant case-crossover study of seizures in patients on antiepileptic drugs. They found that a dispensation episode approximately triples the risk of having a seizure within 21 days, but the risk is not statistically different whether the dispensation was of the same brand-name or generic drug as previously used or a switch from brand-name to a generic or from a generic to a brand name. The cause of the seizure might be a delay in taking medication or late redispensation, among others, but apparently the nature of the product dispensed is not relevant in this study; this may alleviate some of the concerns about generic drugs and epilepsy.

  11. Occupational fatigue and other health and safety issues for young Australian workers: an exploratory mixed methods study.

    Science.gov (United States)

    Paterson, Jessica Louise; Clarkson, Larissa; Rainbird, Sophia; Etherton, Hayley; Blewett, Verna

    2015-01-01

    Youth are vulnerable to sleep loss and fatigue due to biological, social and psychological factors. However, there are few studies addressing the risk that sleep loss and fatigue pose for youth in the workplace. The aim of this study was to explore work health and safety (WHS) issues for young workers and develop strategies and solutions for improved WHS outcomes, with a focus on issues related to fatigue, using a mixed-method, multi-stage approach. Participants either completed a survey (n=212) or took part in focus groups (n=115) addressing WHS for young workers, or attended a Future Inquiry Workshop (n=29) where strategies for improving youth WHS were developed. Fatigue was identified as a significant problem by the majority of young workers and was associated with unpredictable working time arrangements, precarious employment, high workload, working overtime and limited ability to self-advocate. Participants identified six key areas for action to improve WHS outcomes for young workers; 1) develop expertise, 2) give young workers a voice, 3) improve education and training, 4) build stakeholder engagement, 5) increase employer awareness of WHS responsibilities and, 6) improve processes for employers to manage and monitor WHS outcomes. The application of these directives to fatigue is discussed.

  12. Radiation safety issues in the water treatment plant - Indoor radon and gamma radiation

    Energy Technology Data Exchange (ETDEWEB)

    Jantsikene, A.; Kiisk, M.; Suursoo, S.; Koch, R. [University of Tartu, Institute of Physics (Estonia); Lumiste, L. [Tallinn University of Technology, Department of Chemical Engineering (Estonia)

    2014-07-01

    the second stage filters, classifying them as radioactive material. {sup 222}Rn activity generated in the filter columns was compared to {sup 222}Rn activity entering the plant with raw water; the latter was estimated via liquid scintillation technique. The results indicate that {sup 222}Rn inflow is insignificant compared to the {sup 222}Rn generation in the columns. The estimated difference is in six orders of magnitude. Six alpha-track detectors were placed inside the treatment plant (in filter hall and working rooms) for measuring {sup 220}Rn and {sup 222}Rn indoor air concentrations. The obtained results are above 200 Bq/m{sup 3}. According to the Estonian Standard EVS 840:2009 'Design of radon-safe buildings', the annual radon concentration in living-, rest- and workrooms should remain below 200 Bq/m{sup 3}. The implemented investigation presented in this paper reveals the importance of monitoring radiation safety of the workers of this water treatment plant. Document available in abstract form only. (authors)

  13. Understanding and perceptions of final-year Doctor of Pharmacy students about generic medicines in Karachi, Pakistan: a quantitative insight

    Directory of Open Access Journals (Sweden)

    Jamshed SQ

    2015-05-01

    the understanding of generic medicines. Pharmacy students lacked a thorough understanding of the concepts of bioequivalence. Pharmacy academia should address these issues, which will help build confidence in generic medicines and increase the generic medicine use in Pakistan. Keywords: safety, curriculum, efficacy

  14. Should Physicians be Encouraged to use Generic Names and to Prescribe Generic Drugs?

    Science.gov (United States)

    Riaz, Haris; Krasuski, Richard A

    2016-06-01

    While using the brand names seems like a trivial issue at the outset, using these names is inherently problematic. Cardiovascular drugs remain the most commonly prescribed drugs by the physicians. The junior doctors are likely to introject practices of their seniors and consequently to reciprocate from the experiences learnt from their preceptors. Using the generic names may be one way to facilitate prescription of the generic drugs who have a better cost profile and similar efficacy than the more expensive branded drugs. In this editorial, we have outlined several arguments to suggest the importance of using the generic names in academic discussions and clinical documentation.

  15. Assessing farm tractor incidents and awareness levels of operators for tractor safety issues in the Hatay province of Turkey.

    Science.gov (United States)

    Keskin, S Görücü; Keskin, M; Soysal, Y

    2012-04-01

    Studies and statistical data on safety issues related to farm tractors and machinery are very limited in developing countries, including Turkey. This study was carried out to investigate tractor-related incidents in the Hatay province, located in the mid-south of Turkey. A questionnaire was conducted with 107 tractor operators using face-to-face interviews. Data were evaluated according to the incident type, machinery involved, and mechanism of injury or fatality. A total of 101 incidents were reported by 77 of the 107 respondents. Most of the incidents were due to tractor rollovers (65.4%), 14.8% of the incidents were due to entanglement of body parts in moving machinery, and 12.9% involved crashing into other vehicles or obstacles. The leading cause of the incidents was personal mistakes (60.4%). Fatalities resulted from 25.7% of the incidents, while 45.5% of the incidents caused non-fatal injuries. Only 5.6% of the tractors had a ROPS-enclosed cab. The percentage of ROPS-equipped tractors was 19.6%, while 41.3% of the tractors had a shade cover and 33.6% had no protective structure. Only one of the respondents used a seatbelt, although 44.9% of them stated that seatbelts should be used. It was also found that only 13.5% of the operators had training in work safety, while 95.1% stated that incidents might be reduced if people were trained. Development of appropriate policies and training programs are needed for safer operation of agricultural machinery to reduce injuries and fatalities due to farm accidents.

  16. SAFETY

    CERN Multimedia

    M. Plagge, C. Schaefer and N. Dupont

    2013-01-01

    Fire Safety – Essential for a particle detector The CMS detector is a marvel of high technology, one of the most precise particle measurement devices we have built until now. Of course it has to be protected from external and internal incidents like the ones that can occur from fires. Due to the fire load, the permanent availability of oxygen and the presence of various ignition sources mostly based on electricity this has to be addressed. Starting from the beam pipe towards the magnet coil, the detector is protected by flooding it with pure gaseous nitrogen during operation. The outer shell of CMS, namely the yoke and the muon chambers are then covered by an emergency inertion system also based on nitrogen. To ensure maximum fire safety, all materials used comply with the CERN regulations IS 23 and IS 41 with only a few exceptions. Every piece of the 30-tonne polyethylene shielding is high-density material, borated, boxed within steel and coated with intumescent (a paint that creates a thick co...

  17. SAFETY

    CERN Multimedia

    C. Schaefer and N. Dupont

    2013-01-01

      “Safety is the highest priority”: this statement from CERN is endorsed by the CMS management. An interpretation of this statement may bring you to the conclusion that you should stop working in order to avoid risks. If the safety is the priority, work is not! This would be a misunderstanding and misinterpretation. One should understand that “working safely” or “operating safely” is the priority at CERN. CERN personnel are exposed to different hazards on many levels on a daily basis. However, risk analyses and assessments are done in order to limit the number and the gravity of accidents. For example, this process takes place each time you cross the road. The hazard is the moving vehicle, the stake is you and the risk might be the risk of collision between both. The same principle has to be applied during our daily work. In particular, keeping in mind the general principles of prevention defined in the late 1980s. These principles wer...

  18. Practicing the Generic (City)

    DEFF Research Database (Denmark)

    Hansen, Lone Koefoed

    2010-01-01

    Flanagan proposes that most locative media artworks neglect the particularities of spaces, their historical and political layers. Koolhaas, on the other hand, states that all urban areas are alike, that we are facing a global Generic City. The paper analyses digital media artist Esther Polak......’s NomadicMILK project in light of the generic and particular properties of space as laid out by Flanagan and Koolhaas in order to discuss the possible reconfiguring practices of locative media....

  19. Assembly plant simulation to support decision-making n Layout Design considering safety issues. A case study.

    Directory of Open Access Journals (Sweden)

    Aída Sáez Más

    2016-12-01

    Full Text Available This paper presents a simulation model that has been created to support decision-making during the layout redesign of an engine and transmission assembly plant in the automotive sector. The plant requires a new layout and supply logistic due to an increase in its complexity and daily production. Discrete event simulation has been used to validate an initial proposal and to propose different what-if scenarios of layout and operations management systems. These scenarios will be evaluated regarding materials flow generated throughout the plants. The main focus of the decision process was focused on safety issues related to the material handling. The simulation model and its description have been done according to the methodology proposed in Sáez Más, García Sabater, Morant Llorca, y Maheut (2016, where the simulation model is focus as a 4-layer architecture (network, logic, database and visual reality. The achieved model is very flexible and modular, and it allows to save modelling time because of the parameterize of different combinations in layout and operations management.

  20. The experiences of implementing generic medicine policy in eight countries: A review and recommendations for a successful promotion of generic medicine use

    Science.gov (United States)

    Hassali, Mohamed Azmi; Alrasheedy, Alian A.; McLachlan, Andrew; Nguyen, Tuan Anh; AL-Tamimi, Saleh Karamah; Ibrahim, Mohamed Izham Mohamed; Aljadhey, Hisham

    2013-01-01

    Generic medicines are clinically interchangeable with original brand medicines and have the same quality, efficacy and safety profiles. They are, nevertheless, much cheaper in price. Thus, while providing the same therapeutic outcomes, generic medicines lead to substantial savings for healthcare systems. Therefore, the quality use of generic medicines is promoted in many countries. In this paper, we reviewed the role of generic medicines in healthcare systems and the experiences of promoting the use of generic medicines in eight selected countries, namely the United States (US), the United Kingdom (UK), Sweden, Finland, Australia, Japan, Malaysia and Thailand. The review showed that there are different main policies adopted to promote generic medicines such as generic substitution in the US, generic prescribing in the UK and mandatory generic substitution in Sweden and Finland. To effectively and successfully implement the main policy, different complementary policies and initiatives were necessarily introduced. Barriers to generic medicine use varied between countries from negative perceptions about generic medicines to lack of a coherent generic medicine policy, while facilitators included availability of information about generic medicines to both healthcare professionals and patients, brand interchangeability guidelines, regulations that support generic substitution by pharmacists, and incentives to both healthcare professionals and patients. PMID:25561861

  1. Recognizing Severe Adverse Drug Reactions: Two Case Reports After Switching Therapies to the Same Generic Company.

    Science.gov (United States)

    Gallelli, Luca; Gallelli, Giuseppe; Codamo, Giuseppe; Argentieri, Angela; Michniewicz, Andzelika; Siniscalchi, Antonio; Stefanelli, Roberta; Cione, Erika; Caroleo, Maria C; Longo, Paola; De Sarro, Giovambattista

    2016-01-01

    Generic formulations represent a way to reduce the costs of brand compounds when their patent is expired. While, the bio-equivalence in generic drugs is guaranteed, some excipients as well as dyes could be different and this could reduce the drug safety. Herein, we report the development of Adverse Drug Reactions (ADRs) in two patients after the switch from brand to generic formulations. We have tested cytochrome P450 enzymes expression as well as drug serum levels. None of these markers were altered. Checking deeply into both patient's medical history, they harbored poly-sensitivity or allergy to pollen and graminacea and used different active ingredients for different health problems coming from the same generic company Almus(®). This company used different dyes and excipients compared to the branded drugs made by distinguished companies. In conclusion, we strongly suggest to both pharmacists and physicians to be careful in giving the advice to change the drug, thinking to reduce health sanitary costs without considering the personal clinical history of each one. Paradoxically this behavior is causing other health issues, bringing to an increase of the overall costs for patients as well as for National Health System.

  2. Can Chronic Pain Patients Be Adequately Treated Using Generic Pain Medications to the Exclusion of Brand-Name Ones?

    Science.gov (United States)

    Candido, Kenneth D; Chiweshe, Joseph; Anantamongkol, Utchariya; Knezevic, Nebojsa Nick

    2016-01-01

    According to the Food and Drug Administration (FDA) reports, approximately 8 in 10 prescriptions filled in the United States are for generic medications, with an expectation that this number will increase over the next few years. The impetus for this emphasis on generics is the cost disparity between them and brand-name products. The use of FDA-approved generic drugs saved 158 billion dollars in 2010 alone. In the current health care climate, there is continually increasing pressure for prescribers to write for generic alternative medications, occasionally at the expense of best clinical practices. This creates a conflict wherein both physicians and patients may find brand-name medications clinically superior but nevertheless choose generic ones. The issue of generic versus brand medications is a key component of the discussion of health payers, physicians and their patients. This review evaluates some of the important medications in the armamentarium of pain physicians that are frequently used in the management of chronic pain, and that are currently at the forefront of this issue, including Opana (oxymorphone; Endo Pharmaceuticals, Inc., Malvern, PA), Gralise (gabapentin; Depomed, Newark, CA), and Horizant (gabapentin enacarbil; XenoPort, Santa Clara, CA) that are each available in generic forms as well. We also discuss the use of Lyrica (pregabalin; Pfizer, New York, NY), which is currently unavailable as generic medication, and Cymbalta (duloxetine; Eli Lilly, Indianapolis, IN), which has been recently FDA approved to be available in a generic form. It is clear that the use of generic medications results in large financial savings for the cost of prescriptions on a national scale. However, cost-analysis is only part of the equation when treating chronic pain patients and undervalues the relationships of enhanced compliance due to single-daily dosing and stable and reliable pharmacokinetics associated with extended-duration preparations using either retentive

  3. Bioequivalence study designs for generic solid oral anticancer drug products: scientific and regulatory considerations.

    Science.gov (United States)

    Kaur, Paramjeet; Chaurasia, Chandra S; Davit, Barbara M; Conner, Dale P

    2013-12-01

    The demonstration of bioequivalence (BE) between the test and reference products is an integral part of generic drug approval process. A sound BE study design is pivotal to the successful demonstration of BE of generic drugs to their corresponding reference listed drug product. Generally, BE of systemically acting oral dosage forms is demonstrated in a crossover, single-dose in vivo study in healthy subjects. The determination of BE of solid oral anticancer drug products is associated with its own unique challenges due to the serious safety risks involved. Unlike typical BE study in healthy subjects, the safety issues often necessitate conducting BE studies in cancer patients. Such BE studies of an anticancer drug should be conducted without disturbing the patients' therapeutic dosing regimen. Attributes such as drug permeability and solubility, pharmacokinetics, dosing regimen, and approved therapeutic indication(s) are considered in the BE study design of solid anticancer drug products. To streamline the drug approval process, the Division of Bioequivalence posts the Bioequivalence Recommendations for Specific Products guidances on the FDA public website. The objective of this article is to illustrate the scientific and regulatory considerations in the design of BE studies for generic solid oral anticancer drug products through examples.

  4. Generic Airspace Survey

    Science.gov (United States)

    Mogford, Richard H.; Bridges, Wayne; Gujarl, Vimmy; Lee, Paul U.; Preston, William

    2013-01-01

    This paper reports on an extension of generic airspace research to explore the amount of memorization and specialized skills required to manage sectors with specific characteristics or factors. Fifty-five retired controllers were given an electronic survey where they rated the amount of memorization or specialized skills needed for sixteen generic airspace factors. The results suggested similarities in the pattern of ratings between different areas of the US (East, Central, and West). The average of the ratings for each area also showed some differences between regions, with ratings being generally higher in the East area. All sixteen factors were rated as moderately to highly important and may be useful for future research on generic airspace, air traffic controller workload, etc.

  5. Generic robot architecture

    Science.gov (United States)

    Bruemmer, David J [Idaho Falls, ID; Few, Douglas A [Idaho Falls, ID

    2010-09-21

    The present invention provides methods, computer readable media, and apparatuses for a generic robot architecture providing a framework that is easily portable to a variety of robot platforms and is configured to provide hardware abstractions, abstractions for generic robot attributes, environment abstractions, and robot behaviors. The generic robot architecture includes a hardware abstraction level and a robot abstraction level. The hardware abstraction level is configured for developing hardware abstractions that define, monitor, and control hardware modules available on a robot platform. The robot abstraction level is configured for defining robot attributes and provides a software framework for building robot behaviors from the robot attributes. Each of the robot attributes includes hardware information from at least one hardware abstraction. In addition, each robot attribute is configured to substantially isolate the robot behaviors from the at least one hardware abstraction.

  6. Savannah River Site generic data base development

    Energy Technology Data Exchange (ETDEWEB)

    Blanton, C.H.; Eide, S.A.

    1993-06-30

    This report describes the results of a project to improve the generic component failure data base for the Savannah River Site (SRS). A representative list of components and failure modes for SRS risk models was generated by reviewing existing safety analyses and component failure data bases and from suggestions from SRS safety analysts. Then sources of data or failure rate estimates were identified and reviewed for applicability. A major source of information was the Nuclear Computerized Library for Assessing Reactor Reliability, or NUCLARR. This source includes an extensive collection of failure data and failure rate estimates for commercial nuclear power plants. A recent Idaho National Engineering Laboratory report on failure data from the Idaho Chemical Processing Plant was also reviewed. From these and other recent sources, failure data and failure rate estimates were collected for the components and failure modes of interest. This information was aggregated to obtain a recommended generic failure rate distribution (mean and error factor) for each component failure mode.

  7. Modular HTGR Safety Basis and Approach

    Energy Technology Data Exchange (ETDEWEB)

    Thomas Hicks

    2011-08-01

    The Next Generation Nuclear Plant (NGNP) will be a licensed commercial high temperature gas-cooled reactor (HTGR) capable of producing electricity and/or high temperature process heat for industrial markets supporting a range of end-user applications. The NGNP Project has adopted the 10 CFR 52 Combined License (COL) process, as recommended in the NGNP Licensing Strategy - A Report to Congress, dated August 2008, as the foundation for the NGNP licensing strategy [DOE/NRC 2008]. Nuclear Regulatory Commission (NRC) licensing of the NGNP plant utilizing this process will demonstrate the efficacy for licensing future HTGRs for commercial industrial applications. This information paper is one in a series of submittals that address key generic issues of the priority licensing topics as part of the process for establishing HTGR regulatory requirements. This information paper provides a summary level introduction to HTGR history, public safety objectives, inherent and passive safety features, radionuclide release barriers, functional safety approach, and risk-informed safety approach. The information in this paper is intended to further the understanding of the modular HTGR safety approach with the NRC staff and public stakeholders. The NGNP project does not expect to receive comments on this information paper because other white papers are addressing key generic issues of the priority licensing topics in greater detail.

  8. An In-Depth Analysis of the Food Safety Issues%关于食品安全问题根源的深层透析

    Institute of Scientific and Technical Information of China (English)

    李薇辉

    2013-01-01

    What causes the food safety issues? This paper analyzes the food safety issues from “dual ineffective” perspec ̄tive,market ineffectiveness and government ineffectiveness,based on economic theories. Market economy is efficiency economy,but market ineffectiveness also exists in market economy. Market ineffectiveness is closely related to a series of food safety issues in recent years. Both structural and functional ineffectiveness of market will lead to food safety issues. Furthermore,food safety is ̄sues are also relevant to government ineffectiveness,and comparatively speaking,ineffectiveness of government control rules and enforcement are the deeper causes of food safety issues. This paper appeals that the whole society should work together to establish a “dual effective” market environment to eliminate the food safety risks.%  食品安全问题的根源在哪里,文章以经济学理论为基础,从“双失灵”视角出发,对这一问题的深层原因照了X光,进行透彻地剖析。市场经济是效率经济,市场经济同时存在着市场失灵。近年来发生的一系列食品安全问题,就直接与市场失灵相关,无论是结构性市场失灵还是功能性市场失灵都会引起食品安全问题;食品安全问题与政府失灵也相关,相对于市场失灵,笔者以为,政府管制规则失灵和政府管制执行失灵,是食品安全问题产生的更深层次原因。文章呼吁全社会营造“双灵”的市场环境,从根本上解决食品安全问题。

  9. Rethinking generic skills

    Directory of Open Access Journals (Sweden)

    Roy Canning

    2013-10-01

    Full Text Available The paper provides a critical analysis of the notion of generic or transversal skillscontained with European Union policy discourses. The author presents a conceptualframework that challenges the idea that generic skills are universal, transferable andautonomous. An alternative analysis is put forward that argues the case forcontextualising skills and knowledge within particular understandings and cultures thatare more collective than individualistic in nature. The arguments are framed withinwider cross-disciplinary debates in linguistics, geosemiotics and social-cultural theoryand build upon an earlier paper exploring core skills in the UK (Canning, 2007.

  10. Generic Kalman Filter Software

    Science.gov (United States)

    Lisano, Michael E., II; Crues, Edwin Z.

    2005-01-01

    The Generic Kalman Filter (GKF) software provides a standard basis for the development of application-specific Kalman-filter programs. Historically, Kalman filters have been implemented by customized programs that must be written, coded, and debugged anew for each unique application, then tested and tuned with simulated or actual measurement data. Total development times for typical Kalman-filter application programs have ranged from months to weeks. The GKF software can simplify the development process and reduce the development time by eliminating the need to re-create the fundamental implementation of the Kalman filter for each new application. The GKF software is written in the ANSI C programming language. It contains a generic Kalman-filter-development directory that, in turn, contains a code for a generic Kalman filter function; more specifically, it contains a generically designed and generically coded implementation of linear, linearized, and extended Kalman filtering algorithms, including algorithms for state- and covariance-update and -propagation functions. The mathematical theory that underlies the algorithms is well known and has been reported extensively in the open technical literature. Also contained in the directory are a header file that defines generic Kalman-filter data structures and prototype functions and template versions of application-specific subfunction and calling navigation/estimation routine code and headers. Once the user has provided a calling routine and the required application-specific subfunctions, the application-specific Kalman-filter software can be compiled and executed immediately. During execution, the generic Kalman-filter function is called from a higher-level navigation or estimation routine that preprocesses measurement data and post-processes output data. The generic Kalman-filter function uses the aforementioned data structures and five implementation- specific subfunctions, which have been developed by the user on

  11. Health and safety plan for operations performed for the Environmental Restoration Program

    Energy Technology Data Exchange (ETDEWEB)

    Trippet, W.A. II (IT Corp., (United States)); Reneau, M.; Morton, S.L. (EG and G Idaho, Inc., Idaho Falls, ID (United States))

    1992-04-01

    This document constitutes the generic health and safety plan for the Environmental Restoration Program (ERP). It addresses the health and safety requirements of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA); Occupational Safety and Health Administration (OSHA) 29 CFR 1910.120 standard; and EG G Idaho, Inc. This plan is a guide to individuals who must complete a health and safety plan for a task performed for the EPR. It contains a task specific addendum that, when completed, specifically addresses task specific health and safety issues. This health and safety plan reduces the time it takes to write a task specific health and safety plan by providing discussions of requirements, guidance on where specific information is located, and specific topics in the Addendum that must be discussed at a task level. This format encourages a complete task specific health and safety plan and a standard for all health and safety plans written for ERP.

  12. Food Safety Education Using an Interactive Multimedia Kiosk in a WIC Setting: Correlates of Client Satisfaction and Practical Issues

    Science.gov (United States)

    Trepka, Mary Jo; Newman, Frederick L.; Huffman, Fatma G.; Dixon, Zisca

    2010-01-01

    Objective: To assess acceptability of food safety education delivered by interactive multimedia (IMM) in a Supplemental Nutrition Program for Women, Infants and Children Program (WIC) clinic. Methods: Female clients or caregivers (n = 176) completed the food-handling survey; then an IMM food safety education program on a computer kiosk.…

  13. Food Safety Education Using an Interactive Multimedia Kiosk in a WIC Setting: Correlates of Client Satisfaction and Practical Issues

    Science.gov (United States)

    Trepka, Mary Jo; Newman, Frederick L.; Huffman, Fatma G.; Dixon, Zisca

    2010-01-01

    Objective: To assess acceptability of food safety education delivered by interactive multimedia (IMM) in a Supplemental Nutrition Program for Women, Infants and Children Program (WIC) clinic. Methods: Female clients or caregivers (n = 176) completed the food-handling survey; then an IMM food safety education program on a computer kiosk.…

  14. Exploring Generic Haskell

    NARCIS (Netherlands)

    Löh, A.

    2004-01-01

    This thesis is an exploration -- an exploration of a language extension of the functional programming language Haskell. The extension is called Generic Haskell, albeit the name has been used to refer to different objects over the last several years: Many papers have described different proposals, fe

  15. Generic Market Models

    NARCIS (Netherlands)

    R. Pietersz (Raoul); M. van Regenmortel

    2005-01-01

    textabstractCurrently, there are two market models for valuation and risk management of interest rate derivatives, the LIBOR and swap market models. In this paper, we introduce arbitrage-free constant maturity swap (CMS) market models and generic market models featuring forward rates that span perio

  16. Viimsi water treatment plant for Ra removal: NORM residue/waste generation, radiation safety issues, and regulatory response

    Energy Technology Data Exchange (ETDEWEB)

    Kiisk, M.; Suursoo, S.; Realo, E.; Jantsikene, A.; Lumiste, L.; Vaeaer, K.; Isakar, K.; Koch, R. [University of Tartu (Estonia)

    2014-07-01

    values established for these radionuclides. The design and construction of the plant have underestimated the importance of aspects related to NORM accumulation and their management. Therefore, the level of Ra accumulation, ingrowth of daughter radionuclides (Th-228, Pb-210) and generation of Rn-220 and Rn-222 may pose great difficulties for the operation of the plant, especially in the case when/if the filter material is classified as NORM residue/waste with elevated radiation hazard for plant workers, public and the environment. As the first large-scale water treatment plant of the kind, there are no routine legal experience or administrative practice established in Estonia. This paper presents an overview of the operation of Viimsi Vesi Ltd. water treatment plant. The legal aspects and issues associated with management of NORM waste/residues, including classification (residue vs. waste), potential management options, optimisation of the management and radiation safety of the workers are discussed. Views of both the operator and the regulatory authority will be considered. Document available in abstract form only. (authors)

  17. Nuclear safety in EU candidate countries

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-10-01

    Nuclear safety in the candidate countries to the European Union is a major issue that needs to be addressed in the framework of the enlargement process. Therefore WENRA members considered it was their duty to offer their technical assistance to their Governments and the European Union Institutions. They decided to express their collective opinion on nuclear safety in those candidate countries having at least one nuclear power plant: Bulgaria, the Czech Republic, Hungary, Lithuania, Romania, Slovakia and Slovenia. The report is structured as follows: A foreword including background information, structure of the report and the methodology used, General conclusions of WENRA members reflecting their collective opinion, For each candidate country, an executive summary, a chapter on the status of the regulatory regime and regulatory body, and a chapter on the nuclear power plant safety status. Two annexes are added to address the generic safety characteristics and safety issues for RBMK and VVER plants. The report does not cover radiation protection and decommissioning issues, while safety aspects of spent fuel and radioactive waste management are only covered as regards on-site provisions. In order to produce this report, WENRA used different means: For the chapters on the regulatory regimes and regulatory bodies, experts from WENRA did the work. For the chapters on nuclear power plant safety status, experts from WENRA and from French and German technical support organisations did the work. Taking into account the contents of these chapters, WENRA has formulated its general conclusions in this report.

  18. A Product Safety Primer

    Science.gov (United States)

    Brown, Mary Anne Symons

    1975-01-01

    The article offers an overview of the product safety issue and offers ideas for helping students develop product safety awareness. The role of the Consumer Product Safety Commission and safety legislation are discussed. (MW)

  19. Generic and biosimilar medicines: quid?

    Directory of Open Access Journals (Sweden)

    Steven Simoens

    2012-12-01

    Full Text Available Once intellectual property protection, data and marketing exclusivity of reference medicines have expired, generic medicines and biosimilar medicines can enter the off-patent market. This market entry is conditional on the approval of marketing authorization, pricing and reimbursement. Given that there tends to be confusion surrounding generic and biosimilar medicines, this Editorial introduces basic concepts related to generic and biosimilar medicines and presents the different studies and articles included in this supplement dedicated to generic and biosimilar medicines.

  20. A survey exploring the knowledge and perceptions of senior medical students in Nepal toward generic medicines

    Directory of Open Access Journals (Sweden)

    Sudesh Gyawali

    2016-08-01

    Full Text Available Background: The accurate knowledge of generic medicine issues among future prescribers will enhance the prescribing of cost-effective medicines. This study aimed to explore the knowledge and perception of senior medical students about the generic medicines. Methodology: A cross-sectional study was conducted among 237 senior medical students (final year students and interns using a validated self-administered questionnaire. The collected data were analyzed using Statistical Package for the Social Sciences version 20 for windows and comparison of difference was done using linear by linear association. A p value of less than 0.05 was taken as statistically significant. Results: The average age (standard deviation of the respondents was 23.54 (1.39 years. Almost 5% of respondents correctly answered the question regarding the regulatory limits for bioequivalence. Almost two-thirds of respondents correctly agreed that generic medicine is bioequivalent to a brand-name medicine, and 79.3% and 72.5% of respondents correctly agreed that the medicine should be present in the same dosage form and same dose, respectively, as the brand-name medicines. However, almost half of the respondents had impression that brand-name medicines are required to meet higher safety standard than generic medicines. Almost 90% of respondents felt that advertisement by the drug companies would influence the use of brand-name medicine and they need more information about generic medicine. Conclusion: This study highlights the negative perception and knowledge deficit among the respondents. The students’ responses to almost all the statements were almost similar to the respondents’ academic year (final year students and interns, gender and nationality.

  1. A survey exploring the knowledge and perceptions of senior medical students in Nepal toward generic medicines

    Science.gov (United States)

    Gyawali, Sudesh; Hassali, Mohamed Azmi; Saha, Archana

    2016-01-01

    Background: The accurate knowledge of generic medicine issues among future prescribers will enhance the prescribing of cost-effective medicines. This study aimed to explore the knowledge and perception of senior medical students about the generic medicines. Methodology: A cross-sectional study was conducted among 237 senior medical students (final year students and interns) using a validated self-administered questionnaire. The collected data were analyzed using Statistical Package for the Social Sciences version 20 for windows and comparison of difference was done using linear by linear association. A p value of less than 0.05 was taken as statistically significant. Results: The average age (standard deviation) of the respondents was 23.54 (1.39) years. Almost 5% of respondents correctly answered the question regarding the regulatory limits for bioequivalence. Almost two-thirds of respondents correctly agreed that generic medicine is bioequivalent to a brand-name medicine, and 79.3% and 72.5% of respondents correctly agreed that the medicine should be present in the same dosage form and same dose, respectively, as the brand-name medicines. However, almost half of the respondents had impression that brand-name medicines are required to meet higher safety standard than generic medicines. Almost 90% of respondents felt that advertisement by the drug companies would influence the use of brand-name medicine and they need more information about generic medicine. Conclusion: This study highlights the negative perception and knowledge deficit among the respondents. The students’ responses to almost all the statements were almost similar to the respondents’ academic year (final year students and interns), gender and nationality. PMID:27551423

  2. Assessment of environmental health and safety issues associated with the commercialization of unconventional gas recovery: methane from coal seams

    Energy Technology Data Exchange (ETDEWEB)

    Ethridge, L.J.; Cowan, C.E.; Riedel, E.F.

    1980-07-01

    Potential public health and safety problems and the potential environmental impacts from the recovery of gas from coalbeds are identified and examined. The technology of methane recovery is described and economic and legal barriers to production are discussed. (ACR)

  3. Generic medicines: Perceptions of Physicians in Basrah, Iraq

    Directory of Open Access Journals (Sweden)

    Adheed Khalid Sharrad

    2009-08-01

    Full Text Available BackgroundThe use of cheaper generic medicines is a strategy promotedin many countries to reduce rising health care costs. The aimof this study was to explore factors affecting generic medicineprescribing by physicians in Basrah, Iraq.MethodologyA purposive sample of ten physicians practicing in Basrahwas interviewed using a semi-structured interview guide.ResultsAnalysis of the interviews identified seven major themes:medicine prescribing practice, knowledge of therapeuticequivalency of generic medicine, patients’ acceptance ofgeneric medicine, counterfeit medicine, drug informationsource and effect of drug advertising on medicines choice,brand substitution practice by community pharmacists, and,finally strategies to improve generic medicine usefulness.Participants identified helpful strategies to increase genericprescribing including; physician and patient education ongeneric medicine; persuading physicians about the safety andefficacy of generic medicines; and finally educating seniormedical students on generic prescribing.ConclusionThe data suggest that participants were enthusiasticabout prescribing generic medicines. However physiciansinsist that pharmacists should not be allowed tosubstitute generic drugs without prior approval ofdoctors.

  4. The Additional Value of an E-Mail to Inform Healthcare Professionals of a Drug Safety Issue: A Randomized Controlled Trial in the Netherlands.

    Science.gov (United States)

    Piening, Sigrid; de Graeff, Pieter A; Straus, Sabine M J M; Haaijer-Ruskamp, Flora M; Mol, Peter G M

    2013-09-01

    The usefulness and the impact of Direct Healthcare Professional Communications (DHPCs, or 'Dear Doctor letters') in changing the clinical behaviour of physicians have been debated. Changes in the current risk communication methods should preferably be based on the preferences of the healthcare professionals, to optimize the uptake of the message. The aim of this study was to assess whether safety issues are communicated more effectively with an additional e-mail sent by the Dutch Medicines Evaluation Board (MEB) than with the DHPC only. A randomized controlled trial was conducted amongst ophthalmologists and hospital pharmacists in the Netherlands, who were the target group of a DHPC that was issued for pegaptanib, a drug that is administered intra-ocularly in patients with macular degeneration. The intervention group (N = 110) received the pegaptanib DHPC, as well as the MEB e-mail. The control group (N = 105) received the traditional paper-based DHPC only. Two weeks later, the study population received an invitation to fill out an online questionnaire. Questions were asked about the respondents' knowledge and attitude regarding the pegaptanib issue, and any action they had consequently taken. Additional questions were asked about their satisfaction with the DHPC and the e-mail, and their preferred source of such information. Forty respondents (18.6%) completed the questionnaire. Eighty-one percent of the respondents in the intervention group (N = 21) and 47% of the control group (N = 19) correctly indicated that a serious increase in intra-ocular pressure could be caused by pegaptanib injections (Fishers' exact test, p = 0.046). Nine respondents in the intervention group versus none of the control group respondents indicated that they had taken action in response to the pegaptanib safety issue (Fishers' exact test, p = 0.01). The majority of both the intervention group and the control group confirmed that they would like to receive an MEB e-mail with safety

  5. Issues for resolving adverse effects on the safety culture of human work underload and workload transitions in complex human-machine systems

    Energy Technology Data Exchange (ETDEWEB)

    Ryan, T.G.

    1996-08-01

    A workshop was conducted whose specific purpose was to build on earlier work of the US National Research Council, US federal government agencies, and the larger human factors community to: (1) clarify human factors issues pertaining to degraded safety performance in advanced human-machine systems(e.g., nuclear production, transportation, aerospace) due to human work underload and workload transition, and (2) develop strategies for resolving these issues. The workshop affirmed that: (1) work underload and workload transition are issues that will have to be addressed by designers of advanced human-machine systems, especially those relying on automation, if cost, performance, safety, and operator acceptability are to be optimized, (2) human machine allocation models, standards and guidelines which go beyond simple capability approaches will be needed to preclude or seriously diminish the work underload and workload transition problems, and (3) the 16 workload definition, measurement, situational awareness, and trust issues identified during the workshop, need resolution if these models, standards, and guidelines are to be achieved.

  6. Generic wormhole throats

    CERN Document Server

    Visser, M; Visser, Matt; Hochberg, David

    1997-01-01

    Wormholes and black holes have traditionally been treated a quite separate objects with relatively little overlap. The possibility of a connection arises in that wormholes, if they exist, might have profound influence on black holes, their event horizons, and their internal structure. After discussing some connections, we embark on an overview of what can generally be said about traversable wormhole throats. We discuss the violations of the energy conditions that typically occur at and near the throat of any traversable wormhole and emphasize the generic nature of this result. We discuss the original Morris-Thorne wormhole and its generalization to a spherically symmetric time-dependent wormhole, and also discuss spherically symmetric Brans-Dicke wormholes. We also discuss the relationship with the topological censorship theorem. Finally we turn to a rather general class of wormholes that permit explicit analysis: generic static traversable wormholes (without any symmetry). We define the wormhole throat in te...

  7. The Impact of Information on Doctors’ Attitudes Toward Generic Drugs

    Directory of Open Access Journals (Sweden)

    Aggeliki V. Tsaprantzi MD

    2016-03-01

    Full Text Available The objective of this study is to assess the impact of information on doctors’ attitudes and perceptions toward generics. A cross-sectional survey based on a specially designed 21-item questionnaire was conducted. The survey involved doctors of different specialties working in a public hospital in Greece. The analysis includes descriptive and inferential statistics, reliability and validity tests, as well as structural equation modeling to evaluate the causal model. Statistical analysis was accomplished by using SPSS 20 and Amos 20. A total of 134 questionnaires out of 162 were received, providing a response rate of 82.71%. A number of significant associations were found between information and perceptions about generic medicines with demographic characteristics. It seems that the provision of quality information on generic drugs influences doctors’ attitudes and prescription practices toward generic drugs. This is not a static process but a rather dynamic issue involving information provision policies for strengthening the proper doctors’ attitudes toward generic drugs.

  8. The Impact of Information on Doctors' Attitudes Toward Generic Drugs.

    Science.gov (United States)

    Tsaprantzi, Aggeliki V; Kostagiolas, Petros; Platis, Charalampos; Aggelidis, Vassilios P; Niakas, Dimitris

    2016-01-01

    The objective of this study is to assess the impact of information on doctors' attitudes and perceptions toward generics. A cross-sectional survey based on a specially designed 21-item questionnaire was conducted. The survey involved doctors of different specialties working in a public hospital in Greece. The analysis includes descriptive and inferential statistics, reliability and validity tests, as well as structural equation modeling to evaluate the causal model. Statistical analysis was accomplished by using SPSS 20 and Amos 20. A total of 134 questionnaires out of 162 were received, providing a response rate of 82.71%. A number of significant associations were found between information and perceptions about generic medicines with demographic characteristics. It seems that the provision of quality information on generic drugs influences doctors' attitudes and prescription practices toward generic drugs. This is not a static process but a rather dynamic issue involving information provision policies for strengthening the proper doctors' attitudes toward generic drugs.

  9. Generic Network Location Service

    Directory of Open Access Journals (Sweden)

    Laban Mwansa

    2010-11-01

    Full Text Available This work presents the Generic Network Location Service based on the Chord implementation utilizing data structures called distributed hash tables (DHT or structured overlay networks, which are used to build scalable self-managing distributed systems. The provided algorithms guarantee resilience in the presence of dynamism: they guarantee consistent lookup results in the presence of nodes failing and leaving. Generic Network Location Service provides a Location Service system based on DHT technology, which is storing device location records in nodes within a Chord DHT. Location records are consisting of network device identification keys as attributes, which are used to create replicas of additional location records through established Chord hashing mechanisms. Storing device location records, in places address-able (using the DHT lookup by individual location record keys provides a simple way of implementing transla¬tion functions similar to well¬ known network services (e.g. ARP, DNS, ENUM. The generic network location ser¬vice presented in the paper is not supposed to be a substitu¬tion of the existing translation techniques (e.g. ARP, DNS, ENUM, but it is considered as an overlay service that uses data available in existing systems and provides some translations currently unavailable.

  10. Regulatory Safety Issues in the Structural Design Criteria of ASME Section III Subsection NH and for Very High Temperatures for VHTR & GEN IV

    Energy Technology Data Exchange (ETDEWEB)

    William J. O’Donnell; Donald S. Griffin

    2007-05-07

    The objective of this task is to identify issues relevant to ASME Section III, Subsection NH [1], and related Code Cases that must be resolved for licensing purposes for VHTGRs (Very High Temperature Gas Reactor concepts such as those of PBMR, Areva, and GA); and to identify the material models, design criteria, and analysis methods that need to be added to the ASME Code to cover the unresolved safety issues. Subsection NH was originally developed to provide structural design criteria and limits for elevated-temperature design of Liquid Metal Fast Breeder Reactor (LMFBR) systems and some gas-cooled systems. The U.S. Nuclear Regulatory Commission (NRC) and its Advisory Committee for Reactor Safeguards (ACRS) reviewed the design limits and procedures in the process of reviewing the Clinch River Breeder Reactor (CRBR) for a construction permit in the late 1970s and early 1980s, and identified issues that needed resolution. In the years since then, the NRC and various contractors have evaluated the applicability of the ASME Code and Code Cases to high-temperature reactor designs such as the VHTGRs, and identified issues that need to be resolved to provide a regulatory basis for licensing. This Report describes: (1) NRC and ACRS safety concerns raised during the licensing process of CRBR , (2) how some of these issues are addressed by the current Subsection NH of the ASME Code; and (3) the material models, design criteria, and analysis methods that need to be added to the ASME Code and Code Cases to cover unresolved regulatory issues for very high temperature service.

  11. Safety - a Neglected Issue When Introducing Solid Biomass Fuel in Thermal Power Plants? Some Evidence of an Emerging Risk

    DEFF Research Database (Denmark)

    Hedlund, Frank Huess; Astad, John

    2013-01-01

    The paper examines recent evidence from Denmark and abroad with climate change projects that aim to reduce global carbon dioxide emissions by converting coal fired thermal power plants to solid biomass fuel. The paper argues that projects appear to be pursued narrow-mindedly with insufficient...... attention paid to safety and points to evidence of media-shifting-that the 'resolution' of a problem within the environmental domain creates a new problem in the workplace safety domain. The paper argues that biomass pellets qualify as an emerging risk for which proper control strategies have yet...

  12. Process management - critical safety issues with focus on risk management; Processtyrning - kritiska saekerhetsfraagor med inriktning paa riskhantering

    Energy Technology Data Exchange (ETDEWEB)

    Sanne, Johan M. [Linkoeping Univ. (Sweden). The Tema Inst. - Technology and Social Change

    2005-12-15

    Organizational changes focused on process orientation are taking place among Swedish nuclear power plants, aiming at improving the operation. The Swedish Nuclear Power Inspectorate has identified a need for increased knowledge within the area for its regulatory activities. In order to analyze what process orientation imply for nuclear power plant safety a number of questions must be asked: 1. How is safety in nuclear power production created currently? What significance does the functional organization play? 2. How can organizational forms be analysed? What consequences does quality management have for work and for the enterprise? 3. Why should nuclear power plants be process oriented? Who are the customers and what are their customer values? Which customers are expected to contribute from process orientation? 4. What can one learn from process orientation in other safety critical systems? What is the effect on those features that currently create safety? 5. Could customer values increase for one customer without decreasing for other customers? What is the relationship between economic and safety interests from an increased process orientation? The deregulation of the electricity market have caused an interest in increased economic efficiency, which is the motivation for the interest in process orientation. among other means. It is the nuclear power plants' owners and the distributors (often the same corporations) that have the strongest interest in process orientation. If the functional organization and associated practices are decomposed, the prerequisites of the risk management regime changes, perhaps deteriorating its functionality. When nuclear power operators consider the introduction of process orientation, the Nuclear Power Inspectorate should require that 1. The operators perform a risk analysis beforehand concerning the potential consequences that process orientation might convey: the analysis should contain a model specifying how safety is currently

  13. [The patents game. Generic and biosimilar drugs].

    Science.gov (United States)

    Villamañán, E; González, D; Armada, E; Ruano, M; Álvarez-Sala, R; Herrero, A

    2016-01-01

    The protection provided by patents on medicines has a limited duration. The expiry of patents expiration allows copies of the drugs to be released, competing with original. At first, they were identical to the original, known as generic drugs, but in recent years, due to the marketing of biological therapies and the expiry of many of their patents, biosimilar drugs have also emerged. These are not exact copies of the original, but, like generic drugs, biosimilar drugs have to demonstrate equivalence to the reference drugs in quality, safety and efficacy. Nevertheless, despite their importance and contribution to sustainability of health system, doctors are sometimes unaware of differences between them, and their impact in terms of clinical and economic effects. An attempt is made to review and clarify certain aspects often unknown by physicians, despite their involvement in their use. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

  14. Innovation strategies for generic drug companies: moving into supergenerics.

    Science.gov (United States)

    Ross, Malcolm S F

    2010-04-01

    Pharmaceutical companies that market generic products generally are not regarded as innovators, but rather as companies that produce copies of originator products to be launched at patent expiration. However, many generics companies have developed excellent scientific innovative skills in an effort to circumvent the defense patents of originator companies. More patents per product, in terms of both drug substances (process patents and polymorph patents) and formulations, are issued to generics companies than to companies that are traditionally considered to be 'innovators'. This quantity of issued patents highlights the technical knowledge and skill sets that are available in generics companies. In order to adopt a completely innovative model (ie, the development of NCEs), a generics company would require a completely new set of skills in several fields, including a sufficient knowledge base, project and risk management experience, and capability for clinical data evaluation. However, with relatively little investment, generics companies should be able to progress into the so-called 'supergeneric' drug space - an area of innovation that reflects the existing competencies of both innovative and generics companies.

  15. Granulocyte-monocyte adsorptive apheresis in pediatric inflammatory bowel disease: results, practical issues, safety, and future perspectives

    DEFF Research Database (Denmark)

    Ruuska, T; Wewer, V; Lindgren, F

    2009-01-01

    BACKGROUND: The purpose of the study was to collect data on granulocyte-monocyte adsorptive apheresis (GMA) for the treatment of corticosteroid-dependent (SD) or corticosteroid-resistant (SR) inflammatory bowel disease (IBD) in children from 3 Nordic countries to evaluate its efficacy and safety...

  16. Power Production Safety Management Issues and Coping Strategies%电力安全生产管理中问题与应对策略探析

    Institute of Scientific and Technical Information of China (English)

    池东亮

    2014-01-01

    The electrical safety management is focused on the power of enterprise management has an important influence on the development of their own electricity companies, while largely influenced the development of our national economy. However, at this stage, there is also China's power production safety management in certain business issues, limiting the safe development of power enterprises. Firstly, electrical safety problems in production management for analysis, and then propose effective measures to strengthen the safety management of electricity for the relevant officers.%电力安全管理工作是电力企业管理中的重点,对电力企业自身的发展具有重要的影响,同时在很大程度上影响了我国国民经济的发展。然而现阶段,我国电力企业安全生产管理中还存在一定的问题,制约了电力企业的安全发展。文章首先对电力安全生产管理中存在的问题进行分析,然后提出强化电力安全生产管理的有效对策,供有关人员参考。

  17. Savannah River Site generic data base development

    Energy Technology Data Exchange (ETDEWEB)

    Blanchard , A.

    2000-01-04

    This report describes the results of a project to improve the generic component failure database for the Savannah River Site (SRS). Additionally, guidelines were developed further for more advanced applications of database values. A representative list of components and failure modes for SRS risk models was generated by reviewing existing safety analyses and component failure data bases and from suggestions from SRS safety analysts. Then sources of data or failure rate estimates were identified and reviewed for applicability. A major source of information was the Nuclear Computerized Library for Assessing Reactor Reliability, or NUCLARR. This source includes an extensive collection of failure data and failure rate estimates for commercial nuclear power plants. A recent Idaho National Engineering Laboratory report on failure data from the Idaho Chemical Processing Plant was also reviewed. From these and other recent sources, failure data and failure rate estimates were collected for the components and failure modes of interest. For each component failure mode, this information was aggregated to obtain a recommended generic failure rate distribution (mean and error factor based on a lognormal distribution). Results are presented in a table in this report. A major difference between generic database and previous efforts is that this effort estimates failure rates based on actual data (failure events) rather than on existing failure rate estimates. This effort was successful in that over 75% of the results are now based on actual data. Also included is a section on guidelines for more advanced applications of failure rate data. This report describes the results of a project to improve the generic component failure database for the Savannah River site (SRS). Additionally, guidelines were developed further for more advanced applications of database values.

  18. FHR Generic Design Criteria

    Energy Technology Data Exchange (ETDEWEB)

    Flanagan, G.F.; Holcomb, D.E.; Cetiner, S.M.

    2012-06-15

    The purpose of this document is to provide an initial, focused reference to the safety characteristics of and a licensing approach for Fluoride-Salt-Cooled High-Temperature Reactors (FHRs). The document does not contain details of particular reactor designs nor does it attempt to identify or classify either design basis or beyond design basis accidents. Further, this document is an initial attempt by a small set of subject matter experts to document the safety and licensing characteristics of FHRs for a larger audience. The document is intended to help in setting the safety and licensing research, development, and demonstration path forward. Input from a wider audience, further technical developments, and additional study will be required to develop a consensus position on the safety and licensing characteristics of FHRs. This document begins with a brief overview of the attributes of FHRs and then a general description of their anticipated safety performance. Following this, an overview of the US nuclear power plant approval process is provided that includes both test and power reactors, as well as the role of safety standards in the approval process. The document next describes a General Design Criteria (GDC)–based approach to licensing an FHR and provides an initial draft set of FHR GDCs. The document concludes with a description of a path forward toward developing an FHR safety standard that can support both a test and power reactor licensing process.

  19. FHR Generic Design Criteria

    Energy Technology Data Exchange (ETDEWEB)

    Flanagan, George F [ORNL; Holcomb, David Eugene [ORNL; Cetiner, Sacit M [ORNL

    2012-06-01

    The purpose of this document is to provide an initial, focused reference to the safety characteristics of and a licensing approach for Fluoride-Salt-Cooled High-Temperature Reactors (FHRs). The document does not contain details of particular reactor designs nor does it attempt to identify or classify either design basis or beyond design basis accidents. Further, this document is an initial attempt by a small set of subject matter experts to document the safety and licensing characteristics of FHRs for a larger audience. The document is intended to help in setting the safety and licensing research, development, and demonstration path forward. Input from a wider audience, further technical developments, and additional study will be required to develop a consensus position on the safety and licensing characteristics of FHRs. This document begins with a brief overview of the attributes of FHRs and then a general description of their anticipated safety performance. Following this, an overview of the US nuclear power plant approval process is provided that includes both test and power reactors, as well as the role of safety standards in the approval process. The document next describes a General Design Criteria (GDC) - based approach to licensing an FHR and provides an initial draft set of FHR GDCs. The document concludes with a description of a path forward toward developing an FHR safety standard that can support both a test and power reactor licensing process.

  20. [What are patients' attitudes towards generic drugs? The example of metformin].

    Science.gov (United States)

    Allenet, Benoît; Golay, Alain

    2013-05-08

    The success of cost containment with generic drugs is based on consumer's willingness to accept substitution. This investigation reveals 3 major themes that can explain attitudes of patients towards generics: 1) personal beliefs and knowledge (coming from the media issues, family, friends) are fragmented and sometimes erroneous, with a background of suspicion on the quality of the generics; 2) relation with the prescriber (indirectly pharmacist) is central to build up patient's trust; suspicious professionals generate an anxious patient; 3) previous experience from the consumer with generics. Starting from patients' experiences and beliefs allows to anticipate their resistance to the generic and to adapt drug prescription choices.

  1. Generic drugs for hypertension: are they really equivalent?

    Science.gov (United States)

    Cooper-DeHoff, Rhonda M; Elliott, William J

    2013-08-01

    Many antihypertensive drugs are now available in generic formulations at fractions of the cost of their branded counterparts. In the United States, marketing approval for generic medications is usually granted by the Food and Drug Administration on the basis of two simple studies involving dissolution rates and bioavailability in 24 - 36 healthy people, without data regarding antihypertensive efficacy, safety, or long-term outcomes. This process leaves many true disciples of "Evidence-Based Medicine" in a quandary: prescribe only brand-name medications that have been demonstrated in clinical trials to both lower blood pressure and prevent cardiovascular events, or instead recommend lower-priced generic agents that are usually supported by no such data. This review summarizes the current evidence that generic antihypertensive drugs are likely to be safe and effective, may increase the probability of medication availability and adherence for many patients, but, by law, must have a different physical appearance than the original product.

  2. Review report: safety and reliability issues on digital instrumentation and control systems in nuclear power plants and United States Nuclear Regulatory Commission`s dispositions

    Energy Technology Data Exchange (ETDEWEB)

    Watanabe, Norio; Suzudo, Tomoaki [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment

    1998-09-01

    Recently, digital instrumentation and control (I and C) systems have been applied to nuclear power plants (NPPs) in various countries. Introduction of digital I and C systems, however, raises special issues on design, implementation, safety and licensing. Since FY 1997, the Japan Atomic Energy Research Institute (JAERI) has been carrying out a project, Study on Reliability of Digital I and C Systems, which includes extensive reviews of design approaches, technical standards, regulatory processes, especially, in the United States. This report summarizes the results from the study of National Research Council (NRC) and the U.S. Nuclear Regulatory Commission`s (USNRC`s) responses to the recommendations made by the NRC`s study. That study identified six technical key issues (system aspects of digital I and C technology, software quality assurance, common-mode software failure potential, safety and reliability assessment methods, human factors and man-machine interface, dedication of commercial off-the-shelf hardware and software) and two strategic key issues (case-by-case licensing process, adequacy of technical infrastructure) that arise from the introduction of digital I and C technology and then, made recommendations to the USNRC for coping with digital I and C applications. The USNRC responded to each recommendation and showed their own dispositions in which the USNRC agreed with most of the recommendations. In Japan, it is expected that introduction of digital I and C technology is inevitable in NPPs because the vendors are gradually discontinuing support and stocking of analog components. To cope with such situations, there is a need to develop and update the standards and guidelines applicable to digital I and C technology. The key issues and the USNRC`s dispositions provided in this report is believed to be useful for developing and updating them. (J.P.N.)

  3. Effect of Safety Issues with HIV Drugs on the Approval Process of Other Drugs in the Same Class An Analysis of European Public Assessment Reports : an analysis of European public assessment reports

    NARCIS (Netherlands)

    Arnardottir, Arna H.; Haaijer-Ruskamp, Flora M.; Straus, Sabine M. J.; de Graeff, Pieter A.; Mol, Peter G. M.

    2011-01-01

    Background: Knowledge on the safety of new medicines is limited at the time of market entry. Nearly half of all drugs used to treat HIV registered in the EU required >= 1 Direct Healthcare Professional Communication (DHPC) in the past 10 years for safety issues identified post-approval. Objective:

  4. Effect of Safety Issues with HIV Drugs on the Approval Process of Other Drugs in the Same Class An Analysis of European Public Assessment Reports : an analysis of European public assessment reports

    NARCIS (Netherlands)

    Arnardottir, Arna H.; Haaijer-Ruskamp, Flora M.; Straus, Sabine M. J.; de Graeff, Pieter A.; Mol, Peter G. M.

    2011-01-01

    Background: Knowledge on the safety of new medicines is limited at the time of market entry. Nearly half of all drugs used to treat HIV registered in the EU required >= 1 Direct Healthcare Professional Communication (DHPC) in the past 10 years for safety issues identified post-approval. Objective: T

  5. Does educational intervention improve doctors’ knowledge and perceptions of generic medicines and their generic prescribing rate? A study from Malaysia

    Science.gov (United States)

    Wong, Zhi Yen; Alrasheedy, Alian A.; Saleem, Fahad; Mohamad Yahaya, Abdul Haniff; Aljadhey, Hisham

    2014-01-01

    Objectives: To investigate the impact of an educational intervention on doctors’ knowledge and perceptions towards generic medicines and their generic (international non-proprietary name) prescribing practice. Methods: This is a single-cohort pre-/post-intervention pilot study. The study was conducted in a tertiary care hospital in Perak, Malaysia. All doctors from the internal medicine department were invited to participate in the educational intervention. The intervention consisted of an interactive lecture, an educational booklet and a drug list. Doctors’ knowledge and perceptions were assessed by using a validated questionnaire, while the international non-proprietary name prescribing practice was assessed by screening the prescription before and after the intervention. Results: The intervention was effective in improving doctors’ knowledge towards bioequivalence, similarity of generic medicines and safety standards required for generic medicine registration (p = 0.034, p = 0.034 and p = 0.022, respectively). In terms of perceptions towards generic medicines, no significant changes were noted (p > 0.05). Similarly, no impact on international non-proprietary name prescribing practice was observed after the intervention (p > 0.05). Conclusion: Doctors had inadequate knowledge and misconceptions about generic medicines before the intervention. Moreover, international non-proprietary name prescribing was not a common practice. However, the educational intervention was only effective in improving doctors’ knowledge of generic medicines. PMID:26770747

  6. Does educational intervention improve doctors’ knowledge and perceptions of generic medicines and their generic prescribing rate? A study from Malaysia

    Directory of Open Access Journals (Sweden)

    Mohamed Azmi Hassali

    2014-11-01

    Full Text Available Objectives: To investigate the impact of an educational intervention on doctors’ knowledge and perceptions towards generic medicines and their generic (international non-proprietary name prescribing practice. Methods: This is a single-cohort pre-/post-intervention pilot study. The study was conducted in a tertiary care hospital in Perak, Malaysia. All doctors from the internal medicine department were invited to participate in the educational intervention. The intervention consisted of an interactive lecture, an educational booklet and a drug list. Doctors’ knowledge and perceptions were assessed by using a validated questionnaire, while the international non-proprietary name prescribing practice was assessed by screening the prescription before and after the intervention. Results: The intervention was effective in improving doctors’ knowledge towards bioequivalence, similarity of generic medicines and safety standards required for generic medicine registration (p = 0.034, p = 0.034 and p = 0.022, respectively. In terms of perceptions towards generic medicines, no significant changes were noted (p > 0.05. Similarly, no impact on international non-proprietary name prescribing practice was observed after the intervention (p > 0.05. Conclusion: Doctors had inadequate knowledge and misconceptions about generic medicines before the intervention. Moreover, international non-proprietary name prescribing was not a common practice. However, the educational intervention was only effective in improving doctors’ knowledge of generic medicines.

  7. Generic Substitution of Lamotrigine Among Medicaid Patients with Diverse Indications

    Science.gov (United States)

    Hartung, Daniel M.; Middleton, Luke; Svoboda, Leanne; McGregor, Jessina C.

    2013-01-01

    Background Controversy exists about the safety of substituting generic anti-epileptic drugs (AEDs). Lamotrigine, the prototypical newer AED, is often used for psychiatric and neurological conditions other than epilepsy. The safety of generic substitution of lamotrigine in diverse populations of AED users is unclear. Objective The objective of this study was to evaluate potential associations between generic substitution of lamotrigine and adverse consequences in a population of diverse users of this drug. Study Design This study was a retrospective cohort-crossover design using state Medicaid claims data from July 2006 through June 2009. Methods Subjects were included in the cohort if they converted from brand to generic lamotrigine and had 2 years of lamotrigine use prior to conversion. The frequency of emergency department (ED) visits, hospitalizations and condition-specific ED visits or hospitalizations were recorded in the 60 days immediately following the conversion to generic lamotrigine, then compared with the incidence of the same events during a randomly selected time period indexed to one of the patient’s past refills of branded lamotrigine. Multivariate conditional logistic regression was used to quantify the association between generic conversion and health services utilization while controlling for changes in lamotrigine dose and concurrent drug use. Results Of the 616 unique subjects included in this analysis, epilepsy was the most common diagnosis (41%), followed by bipolar disorder (32%), pain (30%) and migraine (18%). Conversion to generic lamotrigine was not associated with a statistically significant increase in the odds of an ED visit (adjusted odds ratio [AOR] = 1.35; 95% confidence interval [CI] 0.92, 1.97), hospitalization (AOR = 1.21; 95% CI 0.60, 2.50) or condition-specific encounter (AOR 1.75; 95 CI 0.87, 3.51). Conclusions A statistically significant increase in ED visits, hospitalizations or condition-specific encounters was not

  8. NET 40 Generics Beginner's Guide

    CERN Document Server

    Mukherjee, Sudipta

    2012-01-01

    This is a concise, practical guide that will help you learn Generics in .NET, with lots of real world and fun-to-build examples and clear explanations. It is packed with screenshots to aid your understanding of the process. This book is aimed at beginners in Generics. It assumes some working knowledge of C# , but it isn't mandatory. The following would get the most use out of the book: Newbie C# developers struggling with Generics. Experienced C++ and Java Programmers who are migrating to C# and looking for an alternative to other generic frameworks like STL and JCF would find this book handy.

  9. Analysis of pharmacists' opinions, attitudes and experiences with generic drugs and generic substitution in the Czech Republic.

    Science.gov (United States)

    Maly, Josef; Dosedel, Martin; Kubena, Ales; Vlcek, Jiri

    2013-01-01

    Generic substitution (GS) is an integral part of drug policy in many countries. Similarly to other countries its introduction in the Czech Republic gave rise to a vibrant discussion. The aim of the study was to map and analyze pharmacists' opinions of, attitudes towards and experiences with generic drugs and GS after the first year from its legislative embodiment in the Czech Republic. All 7,665 members of the Czech Chamber of Pharmacists were addressed to participate in a questionnaire survey between November 2008 and March 2009. The questionnaire consisted of 28 questions concerning the issue of generic drugs and GS and was divided into five sections. All collected data were analyzed using descriptive statistics and correlations were tested by selected parametric and non-parametric tests. A total of 615 completed questionnaire forms were returned (a questionnaire return rate of 8.0%). The demographic characteristics of the respondents were as follows: 470 (76.4%) females, mean age of 37.5 years (SD = 10.4) and 429 (69.6%) pharmacists with a practice specialization. Altogether 345 (56.1%) respondents became aware of the issue of brand name and generic drugs during their undergraduate studies. 378 (61.5%) respondents considered generic drugs as bioequivalent and 455 (74.0%) respondents as therapeutically equivalent to the respective brand name drugs. 99 (16.1%) pharmacists believed that generic products are of lower quality than branded drugs and 69 (11.2%) respondents expected generics to cause more adverse drug reactions. GS was perceived as a positive tool by 476 (77.4%) respondents. Only 71 (11.5%) respondents showed acquaintance with all the legal rules for GS. Legislation awareness and attitude towards GS was correlated with age (p generic drugs and GS. Approaching patients on an individual basis and pharmacists' awareness can minimize adverse drug events caused by generic drugs and at the same time enhance the professional status of pharmacists.

  10. Deep sequencing of plant and animal DNA contained within traditional Chinese medicines reveals legality issues and health safety concerns.

    Directory of Open Access Journals (Sweden)

    Megan L Coghlan

    Full Text Available Traditional Chinese medicine (TCM has been practiced for thousands of years, but only within the last few decades has its use become more widespread outside of Asia. Concerns continue to be raised about the efficacy, legality, and safety of many popular complementary alternative medicines, including TCMs. Ingredients of some TCMs are known to include derivatives of endangered, trade-restricted species of plants and animals, and therefore contravene the Convention on International Trade in Endangered Species (CITES legislation. Chromatographic studies have detected the presence of heavy metals and plant toxins within some TCMs, and there are numerous cases of adverse reactions. It is in the interests of both biodiversity conservation and public safety that techniques are developed to screen medicinals like TCMs. Targeting both the p-loop region of the plastid trnL gene and the mitochondrial 16S ribosomal RNA gene, over 49,000 amplicon sequence reads were generated from 15 TCM samples presented in the form of powders, tablets, capsules, bile flakes, and herbal teas. Here we show that second-generation, high-throughput sequencing (HTS of DNA represents an effective means to genetically audit organic ingredients within complex TCMs. Comparison of DNA sequence data to reference databases revealed the presence of 68 different plant families and included genera, such as Ephedra and Asarum, that are potentially toxic. Similarly, animal families were identified that include genera that are classified as vulnerable, endangered, or critically endangered, including Asiatic black bear (Ursus thibetanus and Saiga antelope (Saiga tatarica. Bovidae, Cervidae, and Bufonidae DNA were also detected in many of the TCM samples and were rarely declared on the product packaging. This study demonstrates that deep sequencing via HTS is an efficient and cost-effective way to audit highly processed TCM products and will assist in monitoring their legality and safety

  11. Deep sequencing of plant and animal DNA contained within traditional Chinese medicines reveals legality issues and health safety concerns.

    Science.gov (United States)

    Coghlan, Megan L; Haile, James; Houston, Jayne; Murray, Dáithí C; White, Nicole E; Moolhuijzen, Paula; Bellgard, Matthew I; Bunce, Michael

    2012-01-01

    Traditional Chinese medicine (TCM) has been practiced for thousands of years, but only within the last few decades has its use become more widespread outside of Asia. Concerns continue to be raised about the efficacy, legality, and safety of many popular complementary alternative medicines, including TCMs. Ingredients of some TCMs are known to include derivatives of endangered, trade-restricted species of plants and animals, and therefore contravene the Convention on International Trade in Endangered Species (CITES) legislation. Chromatographic studies have detected the presence of heavy metals and plant toxins within some TCMs, and there are numerous cases of adverse reactions. It is in the interests of both biodiversity conservation and public safety that techniques are developed to screen medicinals like TCMs. Targeting both the p-loop region of the plastid trnL gene and the mitochondrial 16S ribosomal RNA gene, over 49,000 amplicon sequence reads were generated from 15 TCM samples presented in the form of powders, tablets, capsules, bile flakes, and herbal teas. Here we show that second-generation, high-throughput sequencing (HTS) of DNA represents an effective means to genetically audit organic ingredients within complex TCMs. Comparison of DNA sequence data to reference databases revealed the presence of 68 different plant families and included genera, such as Ephedra and Asarum, that are potentially toxic. Similarly, animal families were identified that include genera that are classified as vulnerable, endangered, or critically endangered, including Asiatic black bear (Ursus thibetanus) and Saiga antelope (Saiga tatarica). Bovidae, Cervidae, and Bufonidae DNA were also detected in many of the TCM samples and were rarely declared on the product packaging. This study demonstrates that deep sequencing via HTS is an efficient and cost-effective way to audit highly processed TCM products and will assist in monitoring their legality and safety especially when

  12. Are There Potential Safety Issues Concerning the Safe Usage of Electronic Personal Tracking Devices? The Experience of a Multi-sport Elite Club.

    Science.gov (United States)

    Medina, Daniel; Pons, Eduard; Gomez, Antonio; Guitart, Marc; Martin, Andres; Vazquez-Guerrero, Jairo; Camenforte, Ismael; Carles, Berta; Font, Roger

    2017-01-04

    Despite approval of the use of electronic personal tracking devices (EPTD) during competition by the International Football Association Board (IFAB), other team sport organizations and leagues have banned its use due to "safety concerns", with no evidence to support this assertion. The aim of the current brief report is to provide empirical evidence to support the wide-spread usage across all sports by examining safety issues concerning the use of EPTD in a multi-team sports club. A total of 5 outdoor football teams (first team, second team, under 19, under 18 and first team female) and 3 indoor multi-sport (basketball, futsal and handball) teams have been monitored; accounting for a total of 63.734 training hours and 12.748 game hours. A questionnaire was sent to all fitness coaches involved and the clinical history was reviewed for every medical issue reported. Six minor chest contusions were recorded in female football goalkeepers wearing the frontal chest trap (3,17 episodes per 1000 training hours). During training, three episodes of minor skin abrasion affecting the thoracic area due to wearing vests too tight were recorded in U-19 football team (0,21 episodes per 1000 hours) and two episodes in U-18 (0,39 per 1000 hours). It must be noted that none of these episodes resulted in lost days of training or games, neither required medical assistance. In conclusion, empirical evidence confirms EPTD is a safe technology to use across team sports.

  13. A Generic Hybrid Encryption System (HES

    Directory of Open Access Journals (Sweden)

    Ijaz Ali Shoukat

    2013-03-01

    Full Text Available This study proposes a Generic Hybrid Encryption System (HES under mutual committee of symmetric and asymmetric cryptosystems. Asymmetric (public key Cryptosystems associates several performance issues like computational incompetence, memory wastages, energy consumptions and employment limitations on bulky data sets but they are quite secure and reliable in key exchange over insecure remote communication channels. Symmetric (private key cryptosystems are 100 times out performed, having no such issues but they cannot fulfill non-repudiation, false modifications in secret key, fake modifications in cipher text and origin authentication of both parties while exchanging information. These contradictory issues can be omitted by utilizing hybrid encryption mechanisms (symmetric+asymmetric to get optimal benefits of both schemes. Several hybrid mechanisms are available with different logics but our logic differs in infrastructural design, simplicity, computational efficiency and security as compared to prior hybrid encryption schemes. Some prior schemes are either diversified in performance aspects, customer satisfaction, memory utilization or energy consumptions and some are vulnerable against forgery and password guessing (session key recovery attacks. We have done some functional and design related changes in existing Public Key Infrastructure (PKI to achieve simplicity, optimal privacy and more customer satisfaction by providing Hybrid Encryption System (HES that is able to fulfill all set of standardized security constraints. No such PKI based generic hybrid encryption scheme persists as we have provided in order to manage all these kinds of discussed issues.

  14. Generic drug names and social welfare.

    Science.gov (United States)

    Lobo, Félix; Feldman, Roger

    2013-06-01

    This article studies how well International Nonproprietary Names (INNs), the "generic" names for pharmaceuticals, address the problems of imperfect information. Left in private hands, the identification of medicines leads to confusion and errors. Developed in the 1950s by the World Health Organization, INNs are a common, global, scientific nomenclature designed to overcome this failure. Taking stock after sixty years, we argue that the contribution of INNs to social welfare is paramount. They enhance public health by reducing errors and improving patient safety. They also contribute to economic efficiency by creating transparency as the foundation of competitive generic drug markets, reducing transaction costs, and favoring trade. The law in most countries requires manufacturers to designate pharmaceuticals with INNs in labeling and advertising. Generic substitution is also permitted or mandatory in many countries. But not all the benefits of INNs are fully realized because prescribers may not use them. We advocate strong incentives or even legally binding provisions to extend the use of INNs by prescribing physicians and dispensing pharmacists, but we do not recommend replacing brand names entirely with INNs. Instead, we propose dual use of brand names and INNs in prescribing, as in drug labeling.

  15. Generic Quantum Fourier Transforms

    CERN Document Server

    Moore, Cristopher; Russell, A; Moore, Cristopher; Rockmore, Daniel; Russell, Alexander

    2003-01-01

    The quantum Fourier transform (QFT) is the principal algorithmic tool underlying most efficient quantum algorithms. We present a generic framework for the construction of efficient quantum circuits for the QFT by ``quantizing'' the separation of variables technique that has been so successful in the study of classical Fourier transform computations. Specifically, this framework applies the existence of computable Bratteli diagrams, adapted factorizations, and Gel'fand-Tsetlin bases to offer efficient quantum circuits for the QFT over a wide variety a finite Abelian and non-Abelian groups, including all group families for which efficient QFTs are currently known and many new group families. Moreover, the method gives rise to the first subexponential-size quantum circuits for the QFT over the linear groups GL_k(q), SL_k(q), and the finite groups of Lie type, for any fixed prime power q.

  16. Dimensional regularization is generic

    CERN Document Server

    Fujikawa, Kazuo

    2016-01-01

    The absence of the quadratic divergence in the Higgs sector of the Standard Model in the dimensional regularization is usually regarded to be an exceptional property of a specific regularization. To understand what is going on in the dimensional regularization, we illustrate how to reproduce the results of the dimensional regularization for the $\\lambda\\phi^{4}$ theory in the more conventional regularization such as the higher derivative regularization; the basic postulate involved is that the quadratically divergent induced mass, which is independent of the scale change of the physical mass, is kinematical and unphysical. This is consistent with the derivation of the Callan-Symanzik equation, which is a comparison of two theories with slightly different masses, for the $\\lambda\\phi^{4}$ theory without encountering the quadratic divergence. We thus suggest that the dimensional regularization is generic in a bottom-up approach starting with a successful low-energy theory. We also define a modified version of t...

  17. Multiple sclerosis. Generic glatiramer acetate--a step toward cheaper MS drugs?

    Science.gov (United States)

    Sørensen, Per Soelberg

    2016-01-01

    A randomized, double-blind, phase III trial of generic glatiramer acetate has shown equivalent efficacy and safety compared with the approved formulation, Copaxone. The impact of approval of generic glatiramer acetate, however, will mainly depend on the pricing of the drug.

  18. Generic torus canards

    Science.gov (United States)

    Vo, Theodore

    2017-10-01

    Torus canards are special solutions of fast/slow systems that alternate between attracting and repelling manifolds of limit cycles of the fast subsystem. A relatively new dynamic phenomenon, torus canards have been found in neural applications to mediate the transition from tonic spiking to bursting via amplitude-modulated spiking. In R3, torus canards are degenerate: they require one-parameter families of 2-fast/1-slow systems in order to be observed and even then, they only occur on exponentially thin parameter intervals. The addition of a second slow variable unfolds the torus canard phenomenon, making it generic and robust. That is, torus canards in fast/slow systems with (at least) two slow variables occur on open parameter sets. So far, generic torus canards have only been studied numerically, and their behaviour has been inferred based on averaging and canard theory. This approach, however, has not been rigorously justified since the averaging method breaks down near a fold of periodics, which is exactly where torus canards originate. In this work, we combine techniques from Floquet theory, averaging theory, and geometric singular perturbation theory to show that the average of a torus canard is a folded singularity canard. In so doing, we devise an analytic scheme for the identification and topological classification of torus canards in fast/slow systems with two fast variables and k slow variables, for any positive integer k. We demonstrate the predictive power of our results in a model for intracellular calcium dynamics, where we explain the mechanisms underlying a novel class of elliptic bursting rhythms, called amplitude-modulated bursting, by constructing the torus canard analogues of mixed-mode oscillations. We also make explicit the connection between our results here with prior studies of torus canards and torus canard explosion in R3, and discuss how our methods can be extended to fast/slow systems of arbitrary (finite) dimension.

  19. 9 CFR 317.5 - Generically approved labeling.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Generically approved labeling. 317.5 Section 317.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... section), or guarantees, or which is not a domestic product labeled in a foreign language; (2) Labeling...

  20. 农村生态建筑电气安全问题探研%Research of rural ecological building electrical safety issues

    Institute of Scientific and Technical Information of China (English)

    王钧

    2013-01-01

    随着我国农村人民生活水平的提高和绿色生态建筑技术的发展,农村住宅建筑逐步向着生态化、绿色化的方向发展,同时也呈现出高档化和高层化的趋势。但是我国农村的许多地区,缺乏建筑电气设计专业人才和相应的规范,使得农村建筑存在较大安全隐患,尤其是电气火灾事故频发,严重危害广大农民的生命财产安全。文章就目前我国农村生态建筑中电气安全问题的成因进行探研,并为解决相应的电气安全问题提出了一些建设性的对策。%With China's rural people's living standards improve and the development of green building technology, rural residential building gradually toward ecology, green direction, while also showing the trend of gentrification and high-level, however, in many rural areas, lack of building electrical design professionals and the corresponding specifications, so there is a big security risk rural buildings, especially frequent cause electrical fire accidents, serious harm to life and property safety to the majority of farmers. This article discusses the causes of electrical safety the current rural eco-building. Discuss the causes of electrical safety and to address the appropriate electrical safety issues put forward some constructive measures

  1. Typed combinators for generic traversal

    NARCIS (Netherlands)

    Lämmel, R.; Vonk, J.

    2001-01-01

    Lacking support for generic traversal, functional programming languages suffer from a scalability problem when applied to large-scale program transformation problems. As a solution, we introduce emph{functional strategies: typeful generic functions that not only can be applied to terms of any type,

  2. Article choice in plural generics

    NARCIS (Netherlands)

    Farkas, D.F.; Swart, Henriëtte de

    2007-01-01

    We discuss two groups of languages where article use contrasts in generic plural sentences but is otherwise essentially similar. The languages in the first group (English and Dutch) use bare plurals in the expression of kind reference (‘Dinosaurs are extinct’) and in generic generalizations (‘Dogs a

  3. Safety issues of long-term glucose load in patients on peritoneal dialysis--a 7-year cohort study.

    Directory of Open Access Journals (Sweden)

    Hon-Yen Wu

    Full Text Available BACKGROUND: Effects of long-term glucose load on peritoneal dialysis (PD patient safety and outcomes have seldom been reported. This study demonstrates the influence of long-term glucose load on patient and technique survival. METHODS: We surveyed 173 incident PD patients. Long-term glucose load was evaluated by calculating the average dialysate glucose concentration since initiation of PD. Risk factors were assessed by fitting Cox's models with repeatedly measured time-dependent covariates. RESULTS: We noted that older age, higher glucose concentration, and lower residual renal function (RRF were significantly associated with a worse patient survival. We found that female gender, absence of diabetes, lower glucose concentration, use of icodextrin, higher serum high density lipoprotein cholesterol, and higher RRF were significantly associated with a better technique survival. CONCLUSIONS: Long-term glucose load predicted mortality and technique failure in chronic PD patients. These findings emphasize the importance of minimizing glucose load in PD patients.

  4. Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives.

    Science.gov (United States)

    Venkatesh, M; Bairavi, V G; Sasikumar, K C

    2011-01-01

    Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20(th) century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today..

  5. Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

    Directory of Open Access Journals (Sweden)

    M Venkatesh

    2011-01-01

    Full Text Available Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20 th century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today.

  6. The Food Safety Issues of China in light of Bioethics%从生命伦理学角度看我国食品安全问题

    Institute of Scientific and Technical Information of China (English)

    谭海瑛

    2013-01-01

    Objective This essay is an essential study of Chinese food safety issues from the aspect of bioethics for the purpose of establishing a life-respecting food safety system. Methods By referring to both domestic and foreign documents, the author learns the speciifc phenomena of Chinese food safety issues and the essence of bioethics and points out the bioethical intension of Chinese food safety issues, which is discussed on the basis that the government, market and consumer all lack the fundamental respect towards life. In the end, the author presents a possibility of establishing a life-respecting food safety system from the aspects of government, market and consumer as solutions. Results The essence of food safety issues is to view problems appeared in the process of implementing food safety system from the aspect of morality, which concerning some bioethical concepts (life-respected right, health right, dignity, etc.) . The specific meaning is equal to the brutal exploitation of human life, specifically manifested in three aspects, namely the inhumanity of government administration, enterprises’ greed and disrespect to human life and the consumers’ disrespect to their own life. Conclusion The solutions to food safety issues can be found in three angles. The government should integrate humanity into drafting and implementing food safety system. Enterprises should establish a correct value on making proift. Consumers should raise the awareness of respecting health and life. With all these criteria matched, a sound food policy system could be established.%目的:本文旨在从生命伦理学角度,研究中国食品安全问题的内涵以及中国食品安全问题的本质,从而构建一个尊重生命的食品安全制度。方法文章通过查阅国内外文献的方法,了解中国食品安全问题的具体表现和生命伦理学的涵义,并通过理论分析,提出生命伦理学角度下的中国食品安全问题的内涵。进一步从

  7. Health and safety plan for operations performed for the Environmental Restoration Program. Task, OU 1-03 and OU 4-10 Track 2 investigations

    Energy Technology Data Exchange (ETDEWEB)

    Trippet, W.A. II [IT Corp., (United States); Reneau, M.; Morton, S.L. [EG and G Idaho, Inc., Idaho Falls, ID (United States)

    1992-04-01

    This document constitutes the generic health and safety plan for the Environmental Restoration Program (ERP). It addresses the health and safety requirements of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA); Occupational Safety and Health Administration (OSHA) 29 CFR 1910.120 standard; and EG&G Idaho, Inc. This plan is a guide to individuals who must complete a health and safety plan for a task performed for the EPR. It contains a task specific addendum that, when completed, specifically addresses task specific health and safety issues. This health and safety plan reduces the time it takes to write a task specific health and safety plan by providing discussions of requirements, guidance on where specific information is located, and specific topics in the Addendum that must be discussed at a task level. This format encourages a complete task specific health and safety plan and a standard for all health and safety plans written for ERP.

  8. Development and application of the Safe Performance Index as a risk-based methodology for identifying major hazard-related safety issues in underground coal mines

    Science.gov (United States)

    Kinilakodi, Harisha

    The underground coal mining industry has been under constant watch due to the high risk involved in its activities, and scrutiny increased because of the disasters that occurred in 2006-07. In the aftermath of the incidents, the U.S. Congress passed the Mine Improvement and New Emergency Response Act of 2006 (MINER Act), which strengthened the existing regulations and mandated new laws to address the various issues related to a safe working environment in the mines. Risk analysis in any form should be done on a regular basis to tackle the possibility of unwanted major hazard-related events such as explosions, outbursts, airbursts, inundations, spontaneous combustion, and roof fall instabilities. One of the responses by the Mine Safety and Health Administration (MSHA) in 2007 involved a new pattern of violations (POV) process to target mines with a poor safety performance, specifically to improve their safety. However, the 2010 disaster (worst in 40 years) gave an impression that the collective effort of the industry, federal/state agencies, and researchers to achieve the goal of zero fatalities and serious injuries has gone awry. The Safe Performance Index (SPI) methodology developed in this research is a straight-forward, effective, transparent, and reproducible approach that can help in identifying and addressing some of the existing issues while targeting (poor safety performance) mines which need help. It combines three injury and three citation measures that are scaled to have an equal mean (5.0) in a balanced way with proportionate weighting factors (0.05, 0.15, 0.30) and overall normalizing factor (15) into a mine safety performance evaluation tool. It can be used to assess the relative safety-related risk of mines, including by mine-size category. Using 2008 and 2009 data, comparisons were made of SPI-associated, normalized safety performance measures across mine-size categories, with emphasis on small-mine safety performance as compared to large- and

  9. 论食品安全事件中的良性媒体应对%Positive Response of Social Media in Food Safety Issues

    Institute of Scientific and Technical Information of China (English)

    陈进

    2016-01-01

    Food safety issues have been one of hot topics in recent years around world ,and they have been one important focus for social media owing to the significance of food safety ,and the public effect and media‐based attribute of food safety issues .In the development of the issues ,social media plays an important role of monitoring ,warning ,communicating and guiding public opinion ,but it also has the problem of randomly selecting perspective of reporting and lack of self‐discipline .As one part of social public resources and an important social supervising force ,social media needs to establish a set of positive response mechanisms out of professional conscience and ethics , including an effective information spreading mechanism ,a communicating and coordinating mechanism with related parties , and a self‐discipline mechanism .%食品安全事件是近年来全球公共安全问题中的热点,由于食品安全的重要性、食品安全事件的公众效应以及基于传媒的属性,媒体常将其作为关注的热点。媒体在食品安全事件中发挥着监测预警、沟通信息、舆论引导等功能,同时也存在关注视角的选择性和职业自律的松懈等不足。作为一种社会公共资源和社会监督力量,基于传媒良知和职业操守,媒体在食品安全事件中必须形成一套良性的应对机制,包括建立信息有效传播机制、建立食品安全事件相关方的沟通协调机制、建立媒体自律机制等。

  10. Comparing Generic Drug Markets in Europe and the United States: Prices, Volumes, and Spending.

    Science.gov (United States)

    Wouters, Olivier J; Kanavos, Panos G; McKEE, Martin

    2017-09-01

    solutions to address issues in Europe and the United States, such as streamlining the generic drug approval process and requiring generic prescribing and substitution where such policies are not yet in place. The history of substitution laws in the United States provides insights into the economic, political, and cultural issues influencing the adoption of generic drug policies. Governments should apply coherent supply- and demand-side policies in generic drug markets. An immediate priority is to convince more physicians, pharmacists, and patients that generic drugs are bioequivalent to branded products. Special-interest groups continue to obstruct reform in Europe and the United States. © 2017 The Authors The Milbank Quarterly published by Wiley Periodicals, Inc. on behalf of The Millbank Memorial Fund.

  11. Safety issues in PV systems: Design choices for a secure fault detection and for preventing fire risk

    Directory of Open Access Journals (Sweden)

    M.C. Falvo

    2015-05-01

    Full Text Available Photovoltaic systems have played a key role over the last decade in the evolution of the electricity sector. In terms of safety design, it’s important to consider that a PV plant constitutes a special system of generation, where the Direct Current (DC presence results in changes to the technical rules. Moreover, if certain electrical faults occur, the plant is a possible source of fire. Choices regarding the grounding of the generator and its protection devices are fundamental for a design that evaluates fire risk. The subject of the article is the analysis of the relation between electrical phenomena in PV systems and the fire risk related to ensuring appropriate fault detection by the electrical protection system. A description of a grid-connected PV system is followed firstly by a comparison of the design solutions provided by International Standards, and secondly by an analysis of electrical phenomena which may trigger a fire. A study of two existing PV systems, where electrical faults have resulted in fires, is then presented. The study highlights the importance of checking all possible failure modes in a PV system design phase, to assess fire risk in advance. Some guidelines for the mitigation of electrical faults that may result in a fire are finally provided.

  12. Generic Patch Inference

    DEFF Research Database (Denmark)

    Andersen, Jesper; Lawall, Julia Laetitia

    2008-01-01

    A key issue in maintaining Linux device drivers is the need to update drivers in response to evolutions in Linux internal libraries. Currently, there is little tool support for performing and documenting such changes. In this paper we present a tool, spfind, that identifies common changes made...... developers can use it to extract an abstract representation of the set of changes that others have made. Our experiments on recent changes in Linux show that the inferred generic patches are more concise than the corresponding patches found in commits to the Linux source tree while being safe with respect...

  13. Pharmacovigilance as a tool for safety and monitoring: a review of general issues and the specific challenges with end-stage renal failure patients

    Directory of Open Access Journals (Sweden)

    Jacob D

    2013-04-01

    Full Text Available Dalia Jacob,1 Belén Marrón,2 Jay Ehrlich,1 Peter A Rutherford3 1Baxter Healthcare Corporation, Deerfield, IL, USA; 2Baxter Healthcare Corporation, Madrid, Spain; 3Baxter Healthcare SA, Zurich, Switzerland Abstract: Pharmacovigilance is instrumental in helping to ensure patient safety for both newly released drugs and those that are well established in the market. However, while pharmacovigilance procedures are strictly regulated in the clinical trial setting, post-marketing adverse event reporting is not well implemented or enforced. As such, the underreporting of adverse events, in relation to drugs that are on the market, is estimated to be in the region of 90%. The identification of drug safety issues in patients with complex diseases and extensive comorbidities is therefore particularly challenging. Dialysis patients – those with end-stage renal disease and often other comorbidities such as diabetes, hypertension, and cardiovascular disease – are a population with significant treatment challenges. Patients receive dialysis using complex medical devices (eg, a peritoneal dialysis home cycler and also receive a range of pharmaceutical agents as part of dialysis itself (eg, peritoneal dialysis solutions. Many of the pharmaceutical agents used to treat these patients have been developed in populations without these complications and, therefore, an extensive knowledge of potential problems and contraindications in the dialysis population is lacking. It is important that the nephrology community understands the concept of pharmacovigilance – the pharmacologic science relating to the detection, assessment, understanding, and prevention of adverse effects, particularly long-term and short-term side effects, of medicines. Health care professionals (HCPs and providers, pharmaceutical companies, global regulatory agencies, and the patients themselves all play unique and critical roles in this process. This review defines the science of

  14. Encouraging generic use can yield significant savings.

    Science.gov (United States)

    Zimmerman, Christina

    2012-11-01

    Key findings. (1) Zero copayment for generic drugs is the greatest influencer of generic statin utilization. (2) Both higher copayments for generic drugs and lower copayments for competing brands are associated with a decreased probability of using generic statins. (3) Prior authorization and step therapy requirements for brand-name statins are associated with an increased use of generic drugs. (4) Greater use of generic statins should reduce costs for patients, plans, and Medicare.

  15. A Generic Dynamic Emulator

    CERN Document Server

    Albert, Carlo

    2011-01-01

    In applied sciences, we often deal with deterministic simulation models that are too slow for simulation-intensive tasks such as calibration or real-time control. In this paper, an emulator for a generic dynamic model, given by a system of ordinary non-linear differential equations, is developed. The non-linear differential equations are linearized and Gaussian white noise is added to account for the non-linearities. The resulting linear stochastic system is conditioned on a set of solutions of the non-linear equations that have been calculated prior to the emulation. A path-integral approach is used to derive the Gaussian distribution of the emulated solution. The solution reveals that most of the computational burden can be shifted to the conditioning phase of the emulator and the complexity of the actual emulation step only scales like $\\mathcal O(Nnm^2)$, where $N$ is the number of time-points at which the solution is to be emulated, $n$ the number of solutions the emulator is conditioned on and $m$ the n...

  16. Electronuclear reactors - EDF - Orientations of generic studies to be performed for the safety re-examination of 1300 MWe reactors associated to their third decennial inspection; Reacteurs electronucleaires - EDF - Orientations des etudes generiques a mener pour le reexamen de surete des reacteurs de 1300 MWe associe a leur troisieme visite decennale

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-07-01

    This report expresses the ASN's opinion on the framework and objectives of the EDF program concerning the generic studies of the safety re-examination of the 1300 MWe reactors associated with their third decennial inspection. This comprises lessons from the Fukushima accident, the improvement of the 'internal explosion' referential by using a probabilistic study, the application of the seismic margin assessment approach as soon as possible, checking the absence of any 'cliff effect' for cooling functions, a deepened re-examination of hurricane frequencies in France. Other request by the ASN concern the verification of the pertinence of release authorizations, taking the TSN law into account, taking the AP1300 project into account, the expansion of the complementary domain, the project of reactor lifetime extension. Some technical requests are discussed in appendix

  17. Overview of the Safety Issues Associated with the Compressed Natural Gas Fuel System and Electric Drive System in a Heavy Hybrid Electric Vehicle

    Energy Technology Data Exchange (ETDEWEB)

    Nelson, S.C.

    2002-11-14

    This report evaluates the hazards that are unique to a compressed-natural-gas (CNG)-fueled heavy hybrid electric vehicle (HEV) design compared with a conventional heavy vehicle. The unique design features of the heavy HEV are the CNG fuel system for the internal-combustion engine (ICE) and the electric drive system. This report addresses safety issues with the CNG fuel system and the electric drive system. Vehicles on U. S. highways have been propelled by ICEs for several decades. Heavy-duty vehicles have typically been fueled by diesel fuel, and light-duty vehicles have been fueled by gasoline. The hazards and risks posed by ICE vehicles are well understood and have been generally accepted by the public. The economy, durability, and safety of ICE vehicles have established a standard for other types of vehicles. Heavy-duty (i.e., heavy) HEVs have recently been introduced to U. S. roadways, and the hazards posed by these heavy HEVs can be compared with the hazards posed by ICE vehicles. The benefits of heavy HEV technology are based on their potential for reduced fuel consumption and lower exhaust emissions, while the disadvantages are the higher acquisition cost and the expected higher maintenance costs (i.e., battery packs). The heavy HEV is more suited for an urban drive cycle with stop-and-go driving conditions than for steady expressway speeds. With increasing highway congestion and the resulting increased idle time, the fuel consumption advantage for heavy HEVs (compared with conventional heavy vehicles) is enhanced by the HEVs' ability to shut down. Any increase in fuel cost obviously improves the economics of a heavy HEV. The propulsion system for a heavy HEV is more complex than the propulsion system for a conventional heavy vehicle. The heavy HEV evaluated in this study has in effect two propulsion systems: an ICE fueled by CNG and an electric drive system with additional complexity and failure modes. This additional equipment will result in a less

  18. Generic substitution - comparing the clinical efficacy of a generic ...

    African Journals Online (AJOL)

    1998-03-03

    Mar 3, 1998 ... Departments of Psychiatry and Biostatistics, University of the. Orange Free State ... industry has expanded rapidly during the last 2 decades! The need to contain the ... Substitution of a generic drug product for an innovator.

  19. Radiation safety issues in Y-90 microsphere selective hepatic radioembolization therapy: possible radiation exposure from the patients

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Young Chul; Kim, Yun Hwan; Uhm, Soon Ho; Seo, Yeon Seok; Park, Eun Kyung; Oh, Sun Young; Jeong, Eu Gene; Lee, Sin Ae; Choe, Jae Gol [Korea University Anam Hospital, Seoul (Korea, Republic of)

    2010-12-15

    The purpose of this study was to estimate the possible external radiation dose to other individuals from patients treated with Y-90 resin microspheres for unresectable hepatocellular carcinoma. We designed the study prospectively to estimate the possible radiation dose to other individuals from patients who had been treated with Y-90 microspheres for unresectable hepatocellular carcinoma. We estimated the total effective dose equivalent (TEDE) using two methods: 'theoretical' TEDEs according to the administered activity and 'measured' TEDE based on the 'measured' ambient radiation exposure rate. We compared the results from each method to determine when we can release patients from confinement at the earliest time complying with the patient release criteria. A total of 20 administrations of Y-90 resin microspheres were done in 18 patients. The average administered activity was 1.2{+-}0.77 (0.28-2.97) GBq. The 'theoretical' TEDEs were in the range of 0.8-10 {mu}Sv. The 'measured' TEDEs were in the range of 2.31-185 {mu}Sv. The measured TEDEs tend to be higher than the theoretical TEDEs. The values of theoretical and measured TEDE were both far less than 1 mSv, the upper limit at which the licensee can release a patient without any written documents. The effective dose equivalent caused by the Y-90 microsphere administered patient is very low. It is safe in terms of radiation safety to the other individuals when Y-90 microsphere radioembolization therapy is done with dose less than 3 GBq. Because the measured TEDE tends to be higher than the theoretical TEDE, it is recommended to use 'measured' TEDE for determining patient release

  20. Issues with monitoring the safety of psychoactive products under a legal regulated market for new psychoactive substances ('legal highs') in New Zealand.

    Science.gov (United States)

    Rychert, Marta; Wilkins, Chris; Witten, Karen

    2017-02-23

    New Zealand's Psychoactive Substances Act (2013) established the world's first regulated market for 'low risk' psychoactive products ('legal highs'). Under an interim PSA regime, 47 existing products were permitted to be continued to be sold. To explore issues with the implementation of regulatory systems to monitor the safety of products on the legal market under the interim Psychoactive Substances Act regime. Semi-structured interviews with 30 key stakeholders, including industry, government agency, health and drug service professionals were conducted, transcribed and analysed thematically. In retrospect stakeholders questioned the decision to approve strong synthetic cannabinoid smoking products, noting their health risks because of product formulation, inconsistent manufacturing practices and smoking as the means of administration. Industry actors claimed the decision to approve synthetic cannabinoid smokeable products prevented potentially safer products from gaining market share. The system for withdrawing approved products which were subsequently found to be harmful was criticised for the poor quality of data available, limited engagement with health professionals and the slowness of product withdrawal. Many of the problems with the regime were attributed to the urgency under which the legal market under the interim Psychoactive Substances Act was established and implemented. The selection of 'safer' products, implementation of the product monitoring system, and engagement with health professionals may have benefited from more time and resources. An incremental approach to establishing the new market may have made the regulatory management of the new regime more workable. [Rychert M, Wilkins C, Witten K. Issues with monitoring the safety of psychoactive products under a legal regulated market for new psychoactive substances ('legal highs') in New Zealand. Drug Alcohol Rev 2017;00:000-000]. © 2017 Australasian Professional Society on Alcohol and other Drugs.

  1. The US generic drug industry: lessons from the first 25 years%美国仿制药行业发展头25年的经验教训

    Institute of Scientific and Technical Information of China (English)

    Garth Boehm; 姚立新; 韩亮; 郑强

    2012-01-01

    The lessons in the development of the US generic drug industry since the enacting of Drug Price Competition and Patent Term Restoration Act ( DPC & PTR Act) that resulted in the creation of the US generic drug industry were summarized. The evolution and key events in the development of the US generic drug industry in the first 25 years, including generic drug scandal, the evolution of approval for generic drugs, bioequivalence and switchability, bioequivalence for complicated dosage forms, patent evergreening, authorized generics, generic drug safety, the issues in generic drug review, the generic drug substitution system, $4 generics, were systemically reviewed and analyzed. The history of the first 25 years of the US Generic Drug Industry has presented several lessons which are of benefit to others wishing to establish or reestablish a domestic generic drug industry.%本文回顾了自《1984年药品价格竞争与专利期补偿法案》实施、创立美国仿制药行业以来,美国仿制药行业的发展经验和教训.对仿制药丑闻、仿制药审批制度发展、生物等效性与可替代性、复杂剂型的生物等效性方法、专利常青、授权仿制药、仿制药安全性、仿制药审评、仿制药替代、4美元仿制药等美国仿制药行业发展中的关键性事件和过程进行了系统回顾与分析.美国仿制药行业在头25年发展历程中的经验教训,对其他希望建立或重新建立国内仿制药行业的国家有借鉴作用.

  2. Switching to aripiprazole in outpatients with schizophrenia experiencing insufficient efficacy and/or safety/tolerability issues with risperidone: a randomized, multicentre, open-label study.

    Science.gov (United States)

    Ryckmans, V; Kahn, J P; Modell, S; Werner, C; McQuade, R D; Kerselaers, W; Lissens, J; Sanchez, R

    2009-05-01

    This study evaluated the safety/tolerability and effectiveness of aripiprazole titrated-dose versus fixed-dose switching strategies from risperidone in patients with schizophrenia experiencing insufficient efficacy and/or safety/tolerability issues. Patients were randomized to an aripiprazole titrated-dose (starting dose 5 mg/day) or fixed-dose (dose 15 mg/day) switching strategy with risperidone down-tapering. Primary endpoint was rate of discontinuation due to adverse events (AEs) during the 12-week study. Secondary endpoints included positive and negative syndrome scale (PANSS), clinical global impressions - improvement of illness scale (CGI-I), preference of medication (POM), subjective well-being under neuroleptics (SWN-K) and GEOPTE (Grupo Español para la Optimización del Tratamiento de la Esquizofrenia) scales. Rates of discontinuations due to AEs were similar between titrated-dose and fixed-dose strategies (3.5% vs. 5.0%; p=0.448). Improvements in mean PANSS total scores were similar between aripiprazole titrated-dose and fixed-dose strategies (-14.8 vs. -17.2; LOCF), as were mean CGI-I scores (2.9 vs. 2.8; p=0.425; LOCF) and SWN-K scores (+8.6 vs.+10.3; OC,+7.8 vs.+9.8; LOCF). Switching can be effectively and safely achieved through a titrated-dose or fixed-dose switching strategy for aripiprazole, with down-titration of risperidone.

  3. Long-Term Safety Issues of iPSC-Based Cell Therapy in a Spinal Cord Injury Model: Oncogenic Transformation with Epithelial-Mesenchymal Transition

    Directory of Open Access Journals (Sweden)

    Satoshi Nori

    2015-03-01

    Full Text Available Previously, we described the safety and therapeutic potential of neurospheres (NSs derived from a human induced pluripotent stem cell (iPSC clone, 201B7, in a spinal cord injury (SCI mouse model. However, several safety issues concerning iPSC-based cell therapy remain unresolved. Here, we investigated another iPSC clone, 253G1, that we established by transducing OCT4, SOX2, and KLF4 into adult human dermal fibroblasts collected from the same donor who provided the 201B7 clone. The grafted 253G1-NSs survived, differentiated into three neural lineages, and promoted functional recovery accompanied by stimulated synapse formation 47 days after transplantation. However, long-term observation (for up to 103 days revealed deteriorated motor function accompanied by tumor formation. The tumors consisted of Nestin+ undifferentiated neural cells and exhibited activation of the OCT4 transgene. Transcriptome analysis revealed that a heightened mesenchymal transition may have contributed to the progression of tumors derived from grafted cells.

  4. Internet Takeaway Food Safety Regulatory Issues%互联网外卖食品安全监管问题

    Institute of Scientific and Technical Information of China (English)

    张舒恺; 雷欣

    2016-01-01

    近几年,“互联网+”正潜移默化地改变人们生活方式、消费方式和行为习惯。网络外卖以其实惠、便利等特点深受上班族与学生族的青睐,“懒人经济”和“快节奏生活”促进了互联网外卖行业的发展。但随着第三方平台和外卖商家爆发式的增长,这一新兴的消费热点不断暴露出问题。当前,无保障的食品安全及薄弱的资质审查机制成为了该产业健康发展的掣肘。基于此,分析互联网外卖行业监管存在的不足,并从制度层面探究其深层次的原因及解决策略。%Recent years, “the internet+” has subliminally influenced people’s live styles, consumption modes, and behavior custom to a large extent. Particularly, ordering takeaway via the Internet takes advantage in providing economical and convenient choices that are warmly welcomed by white-collars and college students. Actually, the Lazy Economy and fast-paced city lifestyle have promoted the development of internet delivery industry. However, there have been many problems surfaced in this rising industry with the explosive increment of the number of the third platforms and delivery businesses. Lack of guarantee in food safety and shortage of procedures in qualiifcation examination have become the limits of industry development. This paper aims at analyzing the absence of internet delivery monitoring and exploring the possible causes and solutions from the institutional layer.

  5. Generic interpreters and microprocessor verification

    Science.gov (United States)

    Windley, Phillip J.

    1990-01-01

    The following topics are covered in viewgraph form: (1) generic interpreters; (2) Viper microprocessors; (3) microprocessor verification; (4) determining correctness; (5) hierarchical decomposition; (6) interpreter theory; (7) AVM-1; (8) phase-level specification; and future work.

  6. Generic ISIS Transport Module Project

    Data.gov (United States)

    National Aeronautics and Space Administration — The purpose of the Generic ISIS Transport Module is to provide a means to bring living specimens to and from orbit. In addition to living specimens, the module can...

  7. Generic drugs: Review and experiences from South India.

    Science.gov (United States)

    Mathew, Philip

    2015-01-01

    The cost of pharmaceuticals, as a percentage of total healthcare spending, has been rising worldwide. This has resulted in strained national budgets and a high proportion of people without access to essential medications. Though India has become a global hub of generic drug manufacturing, the expected benefits of cheaper drugs are not translating into savings for ordinary people. This is in part due to the rise of branded generics, which are marketed at a price point close to the innovator brands. Unbranded generic medicines are not finding their way into prescriptions due to issues of confidence and perception, though they are proven to be much cheaper and comparable in efficacy to branded medicines. The drug inventory of unbranded generic manufacturers fares reasonably when reviewed using the World Health Organization-Health Action International (WHO-HAI) tool for analysing drug availability. Also, unbranded generic medicines are much cheaper when compared to the most selling brands and they can bring down the treatment costs in primary care and family practice. We share our experience in running a community pharmacy for an urban health center in the Pathanamthitta district of Kerala State, which is run solely on generic medicines. The drug availability at the community pharmacy was 73.3% when analyzed using WHO-HAI tool and the savings for the final consumers were up to 93.1%, when compared with most-selling brand of the same formulation.

  8. Medicaid payment for generic drugs: achieving savings and access.

    Science.gov (United States)

    Peters, Christie Provost

    2010-09-30

    Medicaid payment for generic prescription drugs has been a point of contention for the pharmacy industry over the past few years because of reimbursement formula changes contained in the Deficit Reduction Act (DRA) of 2005. The Patient Protection and Affordable Care Act (PPACA) includes provisions to resolve some of these issues. The DRA reduced the maximum amount the federal government would pay state Medicaid programs for generic drugs, and the Centers for Medicare & Medicaid services (CMS) final regulation, to implement the DRA provisions was met with a lawsuit from the pharmacy industry. An injunction by the federal district court, followed by a congressional moratorium, kept CMS from implementing the regulation and kept the pre-DRA formula for the generic drug payment limit in place. PPACA provisions increase maximum federal reimbursement levels for Medicaid generic drugs, but the impact on the pharmacy industry depends on CMS implementation and state policies. This paper examines Medicaid payment for generic drugs, the DRA and PPACA changes to generic drug reimbursement, the concerns of the pharmacy industry, and the potential impact on access.

  9. The Generic Data Capture Facility

    Science.gov (United States)

    Connell, Edward B.; Barnes, William P.; Stallings, William H.

    The Generic Data Capture Facility, which can provide data capture support for a variety of different types of spacecraft while enabling operations costs to be carefully controlled, is discussed. The data capture functions, data protection, isolation of users from data acquisition problems, data reconstruction, and quality and accounting are addressed. The TDM and packet data formats utilized by the system are described, and the development of generic facilities is considered.

  10. Knowledge Development Generic Framework Concept

    Science.gov (United States)

    2008-12-18

    Branch This is the final MNE 5 document on Knowledge Development. Contact ZTransfBw Abt II CDE@bundeswehr.org for inquiries regarding...subsequent updates beyond MNE 5 efforts. VERSION 1.30 18. December 2008 Knowledge Development Generic Framework Concept Draft Report...2. REPORT TYPE Final 3. DATES COVERED - 4. TITLE AND SUBTITLE Knowledge Development Generic Framework Concept 5a. CONTRACT NUMBER 5b

  11. Experimental facility for containment sump reliability studies (Generic Task A-43). [PWR; BWR

    Energy Technology Data Exchange (ETDEWEB)

    Durgin, W. W.; Padmanabhan, M.; Janik, C. R.

    1980-12-01

    On July 3, 1979, Sandia National Laboratories (Sandia) contracted the Alden Research Laboratory (ARL) to conduct tests on unresolved safety issues associated with containment sump performance during the recirculation mode (Generic Task A-43). This report describes the test facility constructed and completed under Phase I, Task III of the contract. Sump performance is determined through the observation of vortex formation in the main tank and the measurement of swirl, pressure gradient, and entrained air in the suction pipes. The use of electrically operated valves and a sophisticated data acquisition system, with computer interface, allows the test flow parameters to be set and test data to be taken (with the exception of vortex observations) from a single central office.

  12. GOoDA: The Generic Optimization Data Analyzer

    CERN Document Server

    CERN. Geneva

    2012-01-01

    To address this issue, a generic decomposition of how a microprocessor is using the consumed cycles allows code developers to quickly understand which of the myriad of microarchitectural complexities they are battling, without requiring a detailed knowledge of the microarchitecture. When this approach is intrinsically integrated into a performance data analysis tool,...

  13. ASSESSMENT OF QUALITY OF GENERICS IN CARDIOLOGY: REALITY AND POSSIBILITIES

    Directory of Open Access Journals (Sweden)

    V. V. Yakusevich

    2005-01-01

    Full Text Available Wide presence of original drugs’ copies, the so-called “generics”, on the pharmaceutical market is analyzed. The positive side of this expansion is connected with the lower price of generics, which makes it possible to decrease the costs of treatment. From the other side with the advent of big number of copies of the original drugs it becomes more difficult to assess the quality of each particular generic. Russian legislation in the field of registration allows selling in the country almost all drugs, which have at least minimal similarity to the original. The problem of pre-registration studies of bioequivalency of original and analogue drugs, therapeutical equivalency is widely observed. Concrete proposals of how to prevent the overflow of the Russian market with the generics with the unproved efficacy and safety are considered.

  14. 开展仿制药质量一致性评价的探讨%Discussion on developing generics quality consistency evaluation

    Institute of Scientific and Technical Information of China (English)

    郁庆华; 谢冉行

    2014-01-01

    It is required to carry out generics quality consistency evaluation in the notice of the Twelfth Five-Year Plan of the national drug safety issued by the State Council on Jan 20, 2012. In this paper, we summarized the existing problems and causes of generic drug quality in China, and proposed that the key point of quality consistency evaluation is the consistency of multiple dissolution proifle between generics and brand-name drugs so as to provide some suggestions for further developing a work of generics quality consistency evaluation.%2012年1月20日,国务院下发的《关于印发国家药品安全“十二五”规划的通知》中要求开展仿制药一致性评价工作。本文概述我国仿制药质量存在的问题及其原因,提出开展一致性评价重点在于多条溶出曲线都要与原研药一致,旨在为进一步开展仿制药一致性评价工作提供建议。

  15. Health and Safety Plan for Operations Performed for the Environmental Restoration Program: Task, Characterization of Potential Waste Sources at Auxiliary Reactor Area-1 Operable Unit 5--07 site ARA-02

    Energy Technology Data Exchange (ETDEWEB)

    Pickett, S.L.; Morton, S.L.

    1992-06-01

    This document constitutes the generic health and safety plan for the Environmental Restoration Program (ERP). It addresses the health and safety requirements of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA); Occupational Safety and Health Administration (OSHA) 29 CFR 1910.120 standard; and EG G Idaho, Inc. This plan is a guide to individuals who must complete a health and safety plan for a task performed for the ERP. It contains a task specific addendum that, when completed, specifically addresses task specific health and safety issues. This health and safety plan reduces the time it takes to write a task specific health and safety plan by providing discussions of requirements, guidance on where specific information is located, and specific topics in the Addendum that must be discussed at a task level. This format encourages a complete task specific health and safety plan and a standard for all health and safety plans written for ERP.

  16. Health and Safety Plan for Operations Performed for the Environmental Restoration Program: Task, Characterization of Potential Waste Sources at Auxiliary Reactor Area-1 Operable Unit 5--07 site ARA-02

    Energy Technology Data Exchange (ETDEWEB)

    Pickett, S.L.; Morton, S.L.

    1992-06-01

    This document constitutes the generic health and safety plan for the Environmental Restoration Program (ERP). It addresses the health and safety requirements of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA); Occupational Safety and Health Administration (OSHA) 29 CFR 1910.120 standard; and EG&G Idaho, Inc. This plan is a guide to individuals who must complete a health and safety plan for a task performed for the ERP. It contains a task specific addendum that, when completed, specifically addresses task specific health and safety issues. This health and safety plan reduces the time it takes to write a task specific health and safety plan by providing discussions of requirements, guidance on where specific information is located, and specific topics in the Addendum that must be discussed at a task level. This format encourages a complete task specific health and safety plan and a standard for all health and safety plans written for ERP.

  17. Generic small modular reactor plant design.

    Energy Technology Data Exchange (ETDEWEB)

    Lewis, Tom Goslee,; Cipiti, Benjamin B.; Jordan, Sabina Erteza; Baum, Gregory A.

    2012-12-01

    This report gives an overview of expected design characteristics, concepts, and procedures for small modular reactors. The purpose of this report is to provide those who are interested in reducing the cost and improving the safety of advanced nuclear power plants with a generic design that possesses enough detail in a non-sensitive manner to give merit to their conclusions. The report is focused on light water reactor technology, but does add details on what could be different in a more advanced design (see Appendix). Numerous reactor and facility concepts were used for inspiration (documented in the bibliography). The final design described here is conceptual and does not reflect any proposed concept or sub-systems, thus any details given here are only relevant within this report. This report does not include any design or engineering calculations.

  18. Pharmaceutical quality of nine generic orlistat products compared with Xenical(r).

    Science.gov (United States)

    Taylor, Peter W; Arnet, Isabelle; Fischer, Anton; Simpson, Iain N

    2010-08-01

    To compare the pharmaceutical quality of Xenical (chemically produced orlistat) with nine generic products, each produced by fermentation processes. Xenical 120 mg capsules (Roche, Basel, Switzerland) were used as reference material. Generic products were from India, Malaysia, Argentina, Philippines, Uruguay, and Taiwan. Colour, melting temperature, crystalline form, particle size, capsule fill mass, active pharmaceutical ingredient content, amount of impurities, and dissolution were compared. Standard physical and chemical laboratory tests were those developed by Roche for Xenical. All nine generic products failed the Xenical specifications in four or more tests, and two generic products failed in seven tests. A failure common to all generic products was the amount of impurities present, mostly due to different by-products, including side-chain homologues not present in Xenical. Some impurities were unidentified. Two generic products tested failed the dissolution test, one product formed a capsule-shaped agglomerate on storage and resulted in poor (generic products were powder formulations. All tested generic orlistat products were pharmaceutically inferior to Xenical. The high levels of impurities in generic orlistat products are a major safety and tolerability concern. Copyright © 2010 S. Karger AG, Basel.

  19. Rural Schools and Safety Issues.

    Science.gov (United States)

    Grady, Marilyn L.

    This paper reviews the literature on violence and crime in schools and on prevention strategies and programs. A section on demographics examines incidence of crime and victimization in school, age of students involved, and types of violent behaviors. Underlying causes and conditions include family breakdown, substance abuse, poverty, and fear.…

  20. Safety Issue of Hip Resurfacing

    Directory of Open Access Journals (Sweden)

    Timothy McTighe

    2015-10-01

    Full Text Available Hip Resurfacing (HR development of the 1970s was an attempt to address the failures of conventional cemented stems. Those early HR designs failed because problems with maintaining bone under the resurfaced femoral head, and loosening of the socket with substantial acetabular bone loss. However technology, knowledge and surgical techniques have evolved over the past 45 years. The more recent designs like the Birmingham Hip Resurfacing (BHR focused on metal to metal bearing surfaces. These devices are under attack and maybe they should be. However, lets not ignore the significant amount of information and potential improvements in both design technology and surgical techniques that have come about over the past few years.

  1. 我国食品安全问题频发的原因及对策%Causes of Frequent Occurrences of Food Safety Issues in China and Its Countermeasures

    Institute of Scientific and Technical Information of China (English)

    陈冠林; 高永清

    2012-01-01

    Food is the material base for human survival and development, while food safety is closely related to public health and people's livelihood. At present, food safety problems occur frequently at home and abroad and food safety situation is not optimistic. This pa- per discussed causes of frequent occurences of food safety issues in our country and put forward some suggestions.%食品是人类赖以生存和发展的物质基础,而食品安全更是与公众健康和国计民生密切相关。当前,国内外食品安全问题频发,形势不容乐观。本文就国内食品安全问题频发的原因进行探讨并提出一些建议性对策。

  2. Safety analysis of autonomous excavator functionality

    Energy Technology Data Exchange (ETDEWEB)

    Seward, D.; Pace, C.; Morrey, R.; Sommerville, I

    2000-10-01

    This paper presents an account of carrying out a hazard analysis to define the safety requirements for an autonomous robotic excavator. The work is also relevant to the growing generic class of heavy automated mobile machinery. An overview of the excavator design is provided and the concept of a safety manager is introduced. The safety manager is an autonomous module responsible for all aspects of system operational safety, and is central to the control system's architecture. Each stage of the hazard analysis is described, i.e. system model creation, hazard definition and hazard analysis. Analysis at an early stage of the design process, and on a system that interfaces directly to an unstructured environment, exposes certain issues relevant to the application of current hazard analysis methods. The approach taken in the analysis is described. Finally, it is explained how the results of the hazard analysis have influenced system design, in particular, safety manager specifications. Conclusions are then drawn about the applicability of hazard analysis of requirements in general, and suggestions are made as to how the approach can be taken further.

  3. Rectification of two generic names

    NARCIS (Netherlands)

    Büttikofer, J.

    1896-01-01

    I am sorry to say that amongst the new generic names, occurring in my recent paper on the genus Pycnonotus and some allied Genera (N. L. M. XVII), Centrolophus and Gymnocrotaphus are already preoccupied among the Fishes, the first being used by Lacépède, the second by Günther. I propose, therefore,

  4. GENERIC model for multiphase systems

    NARCIS (Netherlands)

    Sagis, L.M.C.

    2010-01-01

    GENERIC is a nonequilibrium thermodynamic formalism in which the dynamic behavior of a system is described by a single compact equation involving two types of brackets: a Poisson bracket and a dissipative bracket. This formalism has proved to be a very powerful instrument to model the dynamic behavi

  5. Generic Hurricane Extreme Seas State

    DEFF Research Database (Denmark)

    Wehmeyer, Christof; Skourup, Jesper; Frigaard, Peter

    2012-01-01

    the US east coast and the Gulf of Mexico (1851 - 2009) and Japanese east coast (1951 -2009) form the basis for Weibull extreme value analyses to determine return period respective maximum wind speeds. Unidirectional generic sea state spectra are obtained by application of the empirical models...

  6. Generic Software Architecture for Launchers

    Science.gov (United States)

    Carre, Emilien; Gast, Philippe; Hiron, Emmanuel; Leblanc, Alain; Lesens, David; Mescam, Emmanuelle; Moro, Pierre

    2015-09-01

    The definition and reuse of generic software architecture for launchers is not so usual for several reasons: the number of European launcher families is very small (Ariane 5 and Vega for these last decades); the real time constraints (reactivity and determinism needs) are very hard; low levels of versatility are required (implying often an ad hoc development of the launcher mission). In comparison, satellites are often built on a generic platform made up of reusable hardware building blocks (processors, star-trackers, gyroscopes, etc.) and reusable software building blocks (middleware, TM/TC, On Board Control Procedure, etc.). If some of these reasons are still valid (e.g. the limited number of development), the increase of the available CPU power makes today an approach based on a generic time triggered middleware (ensuring the full determinism of the system) and a centralised mission and vehicle management (offering more flexibility in the design and facilitating the long term maintenance) achievable. This paper presents an example of generic software architecture which could be envisaged for future launchers, based on the previously described principles and supported by model driven engineering and automatic code generation.

  7. High levels of incorrect use of car seat belts and child restraints in Fife--an important and under-recognised road safety issue.

    Science.gov (United States)

    Campbell, H; Macdonald, S; Richardson, P

    1997-03-01

    considered include raising public awareness of this problem, improving information and instruction given to those who purchase child restraints, and encouraging increased collaboration between manufacturers of cars and child restraints, in considering safety issues.

  8. Crystallization Kinetics within a Generic Modeling Framework

    DEFF Research Database (Denmark)

    Meisler, Kresten Troelstrup; von Solms, Nicolas; Gernaey, Krist V.

    2014-01-01

    to the modeling of various kinetic phenomena like nucleation, growth, agglomeration, and breakage are discussed in terms of model forms, model parameters, their availability and/or estimation, and their selection and application for specific crystallization operational scenarios under study. The advantages......A new and extended version of a generic modeling framework for analysis and design of crystallization operations is presented. The new features of this framework are described, with focus on development, implementation, identification, and analysis of crystallization kinetic models. Issues related...... of employing a well-structured model library for storage, use/reuse, and analysis of the kinetic models are highlighted. Examples illustrating the application of the modeling framework for kinetic model discrimination related to simulation of specific crystallization scenarios and for kinetic model parameter...

  9. Efficacy and safety of generic escitalopram versus Lexapro in the treatment of major depression: a multicenter double-blinded randomized controlled trial%国产草酸依地普仑片与来士普治疗抑郁症有效性和安全性:随机双盲、对照、多中心临床研究

    Institute of Scientific and Technical Information of China (English)

    余一旻; 李华芳; 王飚; 栗克清; 许秀峰; 师建国; 高成阁; 谭庆荣

    2013-01-01

    imported antidepressant medications.Aim:Compare the efficacy and safety of the generic form of the selective serotonin re-uptake inhibitory (SSRI) antidepressant escitalopram to the proprietary form of escitalopram (Lexapro)in the treatment of major depression.Methods:A multicenter double-blinded randomized controlled trial enrolled 260 patients with depression and randomly assigned them to receive eight weeks of treatment with either generic escitalopram (n=130) or Lexapro (n=130).Efficacy was assessed by the Hamilton rating scale for depression (HAMD-17).Safety was assessed by evaluating adverse events reported by patients,regularly recording vital signs,and conducting laboratory tests and electrocardiograms.Results:There were 35 (27%) dropouts during the 8 weeks of treatment in the generic escitalopram group and 32 (25%) in the Lexapro group.In the intention-to-treat analysis (i.e.,including all patients) the mean (s.d.) drop in the HAMD total score at the end of the 8th week of treatment was 13.9 (8.2) in the generic escitalopram group and 14.3 (8.1) in the Lexapro group (t=0.44,p=0.664).The proportions of patients responsive to treatment (i.e.,>50% drop in total HAMD score) were 69% and 67% in the generic escitalopram group and Lexapro group,respectively (x2=0.16,df=1,p=0.690; and the proportions that achieved remission (i.e.,final HAMD <7) were 51% and 49% (x2=0.06,df=1,p=0.804).The most frequently reported adverse events were dry mouth (12.3%),nausea (9.2 %) and dizziness (6.2%) in the generic escitalopram group and nausea (10.8%),fainting (7.7%) and drowsiness (6.9%) in the Lexapro group.During the first 35 days of treatment,one suicide and two suicide attempts occurred in the generic escitalopram group and one suicide occurred in the Lexapro group (Fisher exact test,p=0.314).Conclusion:Generic escitalopram is as effective and safe as Lexapro in the initial treatment of patients with moderate to severe episodes of major depression who

  10. Generic products of antiepileptic drugs: a perspective on bioequivalence and interchangeability.

    Science.gov (United States)

    Bialer, Meir; Midha, Kamal K

    2010-06-01

    Most antiepileptic drugs (AEDs) are currently available as generic products, yet neurologists and patients are reluctant to switch to generics. Generic AEDs are regarded as bioequivalent to brand AEDs after meeting the average bioequivalence criteria; consequently, they are considered to be interchangeable with their respective brands without loss of efficacy and safety. According to the U.S. Food and Drug Administration (FDA) the present bioequivalence requirements are already so rigorous and constrained that there is little possibility that generics that meet regulatory bioequivalence criteria could lead to therapeutic problems. So is there a scientific rationale for the concerns about switching patients with epilepsy to bioequivalent generics? Herein we discuss the assessment of bioequivalence and propose a scaled-average bioequivalence approach where scaling of bioequivalence is carried out based on brand lot-to-lot variance as an alternative to the conventional bioequivalence test as a means to determine whether switching patients to generic formulations, or vice versa, is a safe and effective therapeutic option. Meeting the proposed scaled-average bioequivalence requirements will ensure that when an individual patient is switched, he or she has fluctuations in plasma levels similar to those from lot-to-lot of the brand reference levels and thus should make these generic products safely switchable without change in efficacy and safety outcomes.

  11. Mylan to Offer Generic EpiPen

    Science.gov (United States)

    ... news/fullstory_160669.html Mylan to Offer Generic EpiPen Manufacturer responds to mounting criticism about price hikes ... cheaper generic version of the emergency allergy treatment EpiPen will be made available within the next few ...

  12. Generic substitution of antiepileptic drugs: a systematic review of prospective and retrospective studies.

    Science.gov (United States)

    Yamada, Mikiko; Welty, Timothy E

    2011-11-01

    To systematically review the literature on generic antiepileptic drugs (AEDs), evaluate the efficacy and safety of generic AED substitution, and perform pharmacokinetic (PK) analysis using the American Academy of Neurology (AAN) scheme to classify evidence. PubMed and Cumulative Index to Nursing and Allied Health Literature searches from January 1, 1980, to October 15, 2010, were performed using the search terms anticonvulsant, antiepileptic drug, carbamazepine, divalproex, ethosuximide, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pheno-barbital, phenytoin, primidone, topiramate, valproate, valproic acid, and zonisamide; bioavailability, bioequivalence, bioequivalency, bioequivalent, and substitution; and generic. Retrospective and prospective controlled studies of generic substitution of AEDs were included in the review. Non-English-language articles and uncontrolled clinical studies were excluded. Published articles were categorized using the AAN criteria for systematic reviews. We identified 156 articles. Of these, 20 met our inclusion criteria; 7 were retrospective studies, 6 were prospective studies in patients with epilepsy, and 7 were prospective studies in healthy subjects. All articles were rated Class I to Class III, using AAN criteria. The retrospective studies were categorized as Class III and showed a significant relationship between generic substitution and increased use of health care resources because of seizures or AED toxicity. Prospective studies were categorized as Class I, II, and III. Prospective studies in patients showed no differences between brand and generic drugs in PK parameters of bioequivalence. Three prospective studies in healthy subjects reported significant differences in maximum drug concentrations. Comparison of brand and generic drugs revealed no significant difference in seizure frequency; however, some prospective studies showed significant differences in PK parameters, primarily those not used for bioequivalence

  13. Compositional Design of a Generic Design Agent

    NARCIS (Netherlands)

    Brazier, F.M.T.; Jonker, C.M.; Treur, J.; Wijngaards, N.J.E.

    2001-01-01

    This paper presents a generic architecture for a design agent, to be used in an Internet environment. The design agent is based on an existing generic agent model, and includes a refinement of a generic model for design, in which strategic reasoning

  14. Comparing approaches to generic programming in Haskell

    NARCIS (Netherlands)

    Hinze, R.; Jeuring, J.T.; Löh, A.

    2007-01-01

    The last decade has seen a number of approaches to data- type-generic programming: PolyP, Functorial ML, `Scrap Your Boiler- plate', Generic Haskell, `Generics for the Masses', etc. The approaches vary in sophistication and target audience: some propose full-blown pro- gramming languages, some sugge

  15. Formal Safety versus Real Safety: Quantitative and Qualitative Approaches to Safety Culture – Evidence from Estonia

    Directory of Open Access Journals (Sweden)

    Järvis Marina

    2016-10-01

    Full Text Available This paper examines differences between formal safety and real safety in Estonian small and medium-sized enterprises. The results reveal key issues in safety culture assessment. Statistical analysis of safety culture questionnaires showed many organisations with an outstanding safety culture and positive safety attitudes. However, qualitative data indicated some important safety weaknesses and aspects that should be included in the process of evaluation of safety culture in organisations.

  16. Software and System Warranty Issues and Generic Warranty Clause.

    Science.gov (United States)

    1987-06-01

    34 :- ’.-’".,:., ",’., . .’.’ . ’ -.’ -. ., .- . 0;/ .’.. ,; .’ ’.’...’. • . .. . * Phose A - Devekpment Test and Evaluation conducted at a test facility. * Phaie - Devopment Test and

  17. Efficient Generation of Generic Entanglement

    CERN Document Server

    Oliveira, R; Plenio, M B

    2006-01-01

    We find that generic entanglement is physical, in the sense that it can be generated in polynomial time from two-qubit gates picked at random. We prove as the main result that such a process generates the average entanglement of the uniform (Haar) measure in at most $O(N^3)$ steps for $N$ qubits. This is despite an exponentially growing number of such gates being necessary for generating that measure fully on the state space. Numerics furthermore show a variation cut-off allowing one to associate a specific time with the achievement of the uniform measure entanglement distribution. Various extensions of this work are discussed. The results are relevant to entanglement theory and to protocols that assume generic entanglement can be achieved efficiently.

  18. [Users sceptical about generic drugs: an anthropological approach].

    Science.gov (United States)

    Sarradon-Eck, A; Blanc, M-A; Faure, M

    2007-06-01

    Since the enactment of the 2002 legislative measures favoring the prescription of generic drugs, various quantitative studies have shown that approval by prescribers and users has risen in France. Nevertheless, scepticism remains as well as distrust towards these drugs focusing on their effectiveness compared with brand-name drugs, on potential dangers, and on the interruption they cause in prescription and consumption habits. Using a comprehensive approach, this article analyzes the social and cultural logic behind the negative image of generic drugs. The materials issued from an ethnographic study on the prescription of drugs for high blood pressure. Sixty-eight interviews were undertaken between April 2002 and October 2004 with people (39 women and 29 men, between the age of 40 and 95, 52 over the age of 60) treated for over a year for high blood pressure in rural areas in the Southeast of France. Thirteen people provided unsolicited opinions about generic drugs. Analysis of the information collected shows that users have various representations of generic drugs, including the idea of counterfeited and foreign drugs. These representations interfere with the adjustment process and the development of consumer loyalty. They are part of a set of social representations about drugs which form and express the user's reality. In these representations, the drug is an ambivalent object, carrier of both biological effectiveness and toxicity; it is also the metonymical extension of the prescriber, bestowing upon the prescription a symbolic value. By placing the generic drug in its network of symbolic and social meaning, this study highlights the coherence of the scepticism towards generic drugs by consumers (and prescribers) with a system of common opinion in which drugs are everyday things, personalized and compatible with users, symbolic exchange carriers in the physician-patient relationship, and in which confidence in the drug is also that given to the health care

  19. Issue Management Risk Ranking Systems

    Energy Technology Data Exchange (ETDEWEB)

    Novack, Steven David; Marshall, Frances Mc Clellan; Stromberg, Howard Merion; Grant, Gary Michael

    1999-06-01

    Thousands of safety issues have been collected on-line at the Idaho National Engineering and Environmental Laboratory (INEEL) as part of the Issue Management Plan. However, there has been no established approach to prioritize collected and future issues. The authors developed a methodology, based on hazards assessment, to identify and risk rank over 5000 safety issues collected at INEEL. This approach required that it was easily applied and understandable for site adaptation and commensurate with the Integrated Safety Plan. High-risk issues were investigated and mitigative/preventive measures were suggested and ranked based on a cost-benefit scheme to provide risk-informed safety measures. This methodology was consistent with other integrated safety management goals and tasks providing a site-wide risk informed decision tool to reduce hazardous conditions and focus resources on high-risk safety issues. As part of the issue management plan, this methodology was incorporated at the issue collection level and training was provided to management to better familiarize decision-makers with concepts of safety and risk. This prioritization methodology and issue dissemination procedure will be discussed. Results of issue prioritization and training efforts will be summarized. Difficulties and advantages of the process will be reported. Development and incorporation of this process into INEELs lessons learned reporting and the site-wide integrated safety management program will be shown with an emphasis on establishing self reliance and ownership of safety issues.

  20. Issue Management Risk Ranking Systems

    Energy Technology Data Exchange (ETDEWEB)

    F. M. Marshall; G. M. Grant; H. M. Stromberg; S. D. Novack

    1999-06-01

    Thousands of safety issues have been collected on-line at the Idaho National Engineering and Environmental Laboratory (INEEL) as part of the Issue Management Plan. However, there has been no established approach to prioritize collected and future issues. The authors developed a methodology, based on hazards assessment, to identify and risk rank over 5000 safety issues collected at INEEL. This approach required that it was easily applied and understandable for site adaptation and commensurate with the Integrated Safety Plan. High-risk issues were investigated and mitigative/preventive measures were suggested and ranked based on a cost-benefit scheme to provide risk-informed safety measures. This methodology was consistent with other integrated safety management goals and tasks providing a site-wide risk-informed decision tool to reduce hazardous conditions and focus resources on high-risk safety issues. As part of the issue management plan, this methodology was incorporated at the issue collection level and training was provided to management to better familiarize decision-makers with concepts of safety and risk. This prioritization methodology and issue dissemination procedure will be discussed. Results of issue prioritization and training efforts will be summarized. Difficulties and advantages of the process will be reported. Development and incorporation of this process into INEEL's lessons learned reporting and the site-wide integrated safety management program will be shown with an emphasis on establishing self reliance and ownership of safety issues.

  1. NASA Aerospace Flight Battery Program: Generic Safety, Handling and Qualification Guidelines for Lithium-Ion (Li-Ion) Batteries; Availability of Source Materials for Lithium-Ion (Li-Ion) Batteries; Maintaining Technical Communications Related to Aerospace Batteries (NASA Aerospace Battery Workshop). Volume 2, Part 1

    Science.gov (United States)

    Manzo, Michelle A.; Brewer, Jeffrey C.; Bugga, Ratnakumar V.; Darcy, Eric C.; Jeevarajan, Judith A.; McKissock, Barbara I.; Schmitz, Paul C.

    2010-01-01

    This NASA Aerospace Flight Battery Systems Working Group was chartered within the NASA Engineering and Safety Center (NESC). The Battery Working Group was tasked to complete tasks and to propose proactive work to address battery related, agency-wide issues on an annual basis. In its first year of operation, this proactive program addressed various aspects of the validation and verification of aerospace battery systems for NASA missions. Studies were performed, issues were discussed and in many cases, test programs were executed to generate recommendations and guidelines to reduce risk associated with various aspects of implementing battery technology in the aerospace industry. This report contains the Appendices to the findings from the first year of the program's operations.

  2. Generic drugs in dermatology: part II.

    Science.gov (United States)

    Payette, Michael; Grant-Kels, Jane M

    2012-03-01

    In part I, we discussed new drug development, reviewed the history of the generic drug industry, described how generic drugs are approved by the US Food and Drug Administration, and defined the concepts of bioequivalence and therapeutic equivalence. Herein, we explore various factors impacting generic drug use across the different parties involved: the prescriber, the pharmacist, the patient, and the payer. We also include original cost analysis of dermatologic brand name and generic drugs and show the potential cost savings that can be achieved through generic substitution. We conclude with a review of the data addressing potential differences in the effectiveness of brand name versus generic drugs in dermatology. The cost of brand name and generic medications is highly variable by pharmacy, state, and payer. We used one source (www.drugstore.com) as an example and for consistency across all medications discussed herein. Prices included here may not reflect actual retail prices across the United States.

  3. Handbook for cost estimating. A method for developing estimates of costs for generic actions for nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Ball, J.R.; Cohen, S.; Ziegler, E.Z.

    1984-10-01

    This document provides overall guidance to assist the NRC in preparing the types of cost estimates required by the Regulatory Analysis Guidelines and to assist in the assignment of priorities in resolving generic safety issues. The Handbook presents an overall cost model that allows the cost analyst to develop a chronological series of activities needed to implement a specific regulatory requirement throughout all applicable commercial LWR power plants and to identify the significant cost elements for each activity. References to available cost data are provided along with rules of thumb and cost factors to assist in evaluating each cost element. A suitable code-of-accounts data base is presented to assist in organizing and aggregating costs. Rudimentary cost analysis methods are described to allow the analyst to produce a constant-dollar, lifetime cost for the requirement. A step-by-step example cost estimate is included to demonstrate the overall use of the Handbook.

  4. Generic Graph Grammar: A Simple Grammar for Generic Procedural Modelling

    DEFF Research Database (Denmark)

    Christiansen, Asger Nyman; Bærentzen, Jakob Andreas

    2012-01-01

    in a directed cyclic graph. Furthermore, the basic productions are chosen such that Generic Graph Grammar seamlessly combines the capabilities of L-systems to imitate biological growth (to model trees, animals, etc.) and those of split grammars to design structured objects (chairs, houses, etc.). This results......Methods for procedural modelling tend to be designed either for organic objects, which are described well by skeletal structures, or for man-made objects, which are described well by surface primitives. Procedural methods, which allow for modelling of both kinds of objects, are few and usually...

  5. Generic Reliability-Based Inspection Planning for Fatigue Sensitive Details

    DEFF Research Database (Denmark)

    Sørensen, John Dalsgaard; Straub, Daniel; Faber, Michael Havbro

    2005-01-01

    of fatigue sensitive details in fixed offshore steel jacket platforms and FPSO ship structures. Inspection and maintenance activities are planned such that code based requirements to the safety of personnel and environment for the considered structure are fulfilled and at the same time such that the overall......The generic approach for planning of in-service NDT inspections is extended to cover the case where the fatigue load is modified during the design lifetime of the structure. Generic reliability-based inspection planning has been developed as a practical approach to perform inspection planning...... expected costs for design, inspections, repairs and failures are minimized. The method is based on the assumption of “no-finds” of cracks during inspections. Each fatigue sensitive detail is categorized according to their type of details (SN curves), FDF values, RSR values, inspection, repair and failure...

  6. Scientific considerations for generic synthetic salmon calcitonin nasal spray products.

    Science.gov (United States)

    Lee, Sau L; Yu, Lawrence X; Cai, Bing; Johnsons, Gibbes R; Rosenberg, Amy S; Cherney, Barry W; Guo, Wei; Raw, Andre S

    2011-03-01

    Under the Abbreviated New Drug Application pathway, a proposed generic salmon calcitonin nasal spray is required to demonstrate pharmaceutical equivalence and bioequivalence to the brand-name counterpart or the reference listed drug. This review discusses two important aspects of pharmaceutical equivalence for this synthetic peptide nasal spray product. The first aspect is drug substance sameness, in which a proposed generic salmon calcitonin product is required to demonstrate that it contains the same active ingredient as that in the brand-name counterpart. The second aspect is comparability in product- and process-related factors that may influence immunogenicity (i.e., peptide-related impurities, aggregates, formulation, and leachates from the container/closure system). The comparability of these factors helps to ensure the product safety, particularly with respect to immunogenicity. This review also highlights the key features of in vitro and/or in vivo studies for establishing bioequivalence for a solution nasal spray containing a systemically acting salmon calcitonin.

  7. [Beer-Fick criteria and generic drugs in Brazil].

    Science.gov (United States)

    Gorzoni, Milton Luiz; Fabbri, Renato Moraes Alves; Pires, Sueli Luciano

    2008-01-01

    Determine, according to the Beer-Fick criteria, the prevalence of drugs potentially inappropriate for the elderly available as generic medication in Brazil. Analysis of the list of generic medications issued by " Diário Oficial da União" on July/12/2004 and of the page of the National Agency for Sanitary Surveillance (ANVISA) - www.anvisa.gov.br, using the Beers-Fick criteria. From the list of 299 products 20 (6.7% of the total) included in the Beers-Fick criteria were analyzed, mainly in the categories of anxiolytics, platelet antiaggregants, antiallergics, anti-angina and vasodilators, antiarrythmics, antidepressants, antispasmodics, anti-hypertensive's, non steroid antinflammatories, antiulceratives and cardiac glycosides. These criteria do not include drugs such as cough suppressants, cinnarizine, diltiazem, piracetam, quinolones, xanthines, creams, ointments and ophthalmic solutions which are also present in the list of generic medication. The Beers-Fick criteria may prevent use of drugs potentially inappropriate for the elderly, however, it should be stressed that these criteria are not complete for Brazilian generic medications.

  8. Deep Borehole Disposal Safety Analysis.

    Energy Technology Data Exchange (ETDEWEB)

    Freeze, Geoffrey A. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Stein, Emily [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Price, Laura L. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); MacKinnon, Robert J. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Tillman, Jack Bruce [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States)

    2016-10-01

    This report presents a preliminary safety analysis for the deep borehole disposal (DBD) concept, using a safety case framework. A safety case is an integrated collection of qualitative and quantitative arguments, evidence, and analyses that substantiate the safety, and the level of confidence in the safety, of a geologic repository. This safety case framework for DBD follows the outline of the elements of a safety case, and identifies the types of information that will be required to satisfy these elements. At this very preliminary phase of development, the DBD safety case focuses on the generic feasibility of the DBD concept. It is based on potential system designs, waste forms, engineering, and geologic conditions; however, no specific site or regulatory framework exists. It will progress to a site-specific safety case as the DBD concept advances into a site-specific phase, progressing through consent-based site selection and site investigation and characterization.

  9. Handling of safety issues in the senior management group at the nuclear power plants; Behandling av saekerhetsrelaterade fraagor i kaernkraftverkens ledningsgrupper

    Energy Technology Data Exchange (ETDEWEB)

    Wahlstroem, B. [VTT Automation, Esbo (Finland)

    2001-02-01

    The report describes the results from a series of interviews, which were made in the preparation of an application for a reserach project to the Nuclear Fission Safety Programme of EU. The project application 'Learning organisations for nuclear safety - LearnSafe' collected a consortium of 5 partners and 9 associated partneres and has been assigned the reference number FIS5-2001-00066 by the European Commission. (au)

  10. Generic Crystalline Disposal Reference Case

    Energy Technology Data Exchange (ETDEWEB)

    Painter, Scott Leroy [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Chu, Shaoping [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Harp, Dylan Robert [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Perry, Frank Vinton [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Wang, Yifeng [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2015-02-20

    A generic reference case for disposal of spent nuclear fuel and high-level radioactive waste in crystalline rock is outlined. The generic cases are intended to support development of disposal system modeling capability by establishing relevant baseline conditions and parameters. Establishment of a generic reference case requires that the emplacement concept, waste inventory, waste form, waste package, backfill/buffer properties, EBS failure scenarios, host rock properties, and biosphere be specified. The focus in this report is on those elements that are unique to crystalline disposal, especially the geosphere representation. Three emplacement concepts are suggested for further analyses: a waste packages containing 4 PWR assemblies emplaced in boreholes in the floors of tunnels (KBS-3 concept), a 12-assembly waste package emplaced in tunnels, and a 32-assembly dual purpose canister emplaced in tunnels. In addition, three failure scenarios were suggested for future use: a nominal scenario involving corrosion of the waste package in the tunnel emplacement concepts, a manufacturing defect scenario applicable to the KBS-3 concept, and a disruptive glaciation scenario applicable to both emplacement concepts. The computational approaches required to analyze EBS failure and transport processes in a crystalline rock repository are similar to those of argillite/shale, with the most significant difference being that the EBS in a crystalline rock repository will likely experience highly heterogeneous flow rates, which should be represented in the model. The computational approaches required to analyze radionuclide transport in the natural system are very different because of the highly channelized nature of fracture flow. Computational workflows tailored to crystalline rock based on discrete transport pathways extracted from discrete fracture network models are recommended.

  11. Generic behaviours in impact fragmentation

    Energy Technology Data Exchange (ETDEWEB)

    Sator, N.; Mechkov, S.; Sausset, F. [Paris-6 Univ. Pierre et Marie Curie, Lab. de Physique Theorique de la Matiere Condensee, UMR CNRS 7600, 75 - Paris (France); Mechkov, S. [Ecole Normale Superieure, Lab. de Physique Statistique, 75 - Paris (France)

    2008-02-15

    From atomic nuclei to supernovae, including plates and rocks, every cohesive system can be broken into fragments, provided that the deposited energy is sufficiently large compared to its cohesive energy. We present a simple numerical model for investigating the general properties of fragmentation. By use of molecular dynamics simulations, we study the impact fragmentation of a solid disk of interacting particles with a wall. Regardless of the particular form of the interaction potential, the fragment size distribution exhibits a power law behaviour with an exponent that increases logarithmically with the energy deposited in the system, in agreement with experiments. We expect this behaviour to be generic in fragmentation phenomena. (authors)

  12. Generic maximum likely scale selection

    DEFF Research Database (Denmark)

    Pedersen, Kim Steenstrup; Loog, Marco; Markussen, Bo

    2007-01-01

    The fundamental problem of local scale selection is addressed by means of a novel principle, which is based on maximum likelihood estimation. The principle is generally applicable to a broad variety of image models and descriptors, and provides a generic scale estimation methodology. The focus...... on second order moments of multiple measurements outputs at a fixed location. These measurements, which reflect local image structure, consist in the cases considered here of Gaussian derivatives taken at several scales and/or having different derivative orders....

  13. Exploring factors underlying the attitude of community pharmacists to generic substitution: a nationwide study from Poland.

    Science.gov (United States)

    Drozdowska, Aleksandra; Hermanowski, Tomasz

    2016-02-01

    important to address all concerns pharmacists may have over generics, for example by implementing comprehensive awareness-raising campaigns. Also, pharmacotherapy monitoring systems (i.e. provided in a framework of pharmaceutical care) could be considered to identify any safety or quality concerns that may arise.

  14. Patient knowledge, perceptions, and acceptance of generic medicines: a comprehensive review of the current literature

    Directory of Open Access Journals (Sweden)

    Alrasheedy AA

    2014-04-01

    Full Text Available Alian A Alrasheedy,1 Mohamed Azmi Hassali,1 Kay Stewart,2 David CM Kong,2 Hisham Aljadhey,3 Mohamed Izham Mohamed Ibrahim,4 Saleh Karamah Al-Tamimi1 1Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia; 2Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, VIC, Australia; 3Medication Safety Research Chair, Clinical Pharmacy Department, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia; 4College of Pharmacy, Qatar University, Doha, Qatar Background: Generic medicines have the same quality, safety, and efficacy as their counterpart original brand medicines. Generic medicines provide the same therapeutic outcomes but at a much cheaper cost, so are promoted in many countries to contain pharmaceutical expenditure and sustain the health care system. Thus, the perspective of patients and medicine consumers as end users of these medicines is an important factor to enhance the use and utilization of generic medicines. The objective of this paper is to review patients’ and consumers’ knowledge, perceptions, acceptance, and views of generic medicines in the current literature. Methods: An extensive literature search was performed in several databases, namely Scopus, PubMed, ISI Web of Knowledge, Proquest, and the Wiley online library, to identify relevant studies published in the English literature for the period 1990–2013. Results: A total of 53 studies were included in the review, comprising 24 studies from Europe, ten from North America, six from Asia, five from Australia and New Zealand, five from the Middle East, one from Africa, one from Latin America, and one from the Caribbean region. A large body of literature has reported misconceptions and negative perceptions about generic medicines on the part of patients and medicine consumers. Moreover, although it is reported in almost all countries, the percentage of consumers who had

  15. Comparing the biological impact of glatiramer acetate with the biological impact of a generic.

    Directory of Open Access Journals (Sweden)

    Fadi Towfic

    Full Text Available For decades, policies regarding generic medicines have sought to provide patients with economical access to safe and effective drugs, while encouraging the development of new therapies. This balance is becoming more challenging for physicians and regulators as biologics and non-biological complex drugs (NBCDs such as glatiramer acetate demonstrate remarkable efficacy, because generics for these medicines are more difficult to assess. We sought to develop computational methods that use transcriptional profiles to compare branded medicines to generics, robustly characterizing differences in biological impact. We combined multiple computational methods to determine whether differentially expressed genes result from random variation, or point to consistent differences in biological impact of the generic compared to the branded medicine. We applied these methods to analyze gene expression data from mouse splenocytes exposed to either branded glatiramer acetate or a generic. The computational methods identified extensive evidence that branded glatiramer acetate has a more consistent biological impact across batches than the generic, and has a distinct impact on regulatory T cells and myeloid lineage cells. In summary, we developed a computational pipeline that integrates multiple methods to compare two medicines in an innovative way. This pipeline, and the specific findings distinguishing branded glatiramer acetate from a generic, can help physicians and regulators take appropriate steps to ensure safety and efficacy.

  16. Skin rash during treatment with generic itraconazole

    Directory of Open Access Journals (Sweden)

    Antonio De Vuono

    2014-01-01

    Full Text Available Generic drugs have the same active substance, the same pharmaceutical form, the same therapeutic indications and a similar bioequivalence with the reference medicinal product (branded. Although a similar efficacy is postulated, some cases of clinical inefficacy during treatment with generic formulations have been reported. In this case, we describe a woman with onychomycosis that developed a skin rash during treatment with a generic formulation of itraconazole. Drug administration and its re-challenge confirmed the association between itraconazole and skin rash. Both Naranjo probability scale and World Health Organization causality assessment scale documented a probable association between generic-itraconazole and skin rash. The switch from generic formulation to brand one induced an improvement of symptoms. Since we are unable to evaluate the role of each excipient in the development of skin rash, we cannot rule out their involvement. However, more data are necessary to better define the similarities or differences between branded and generic formulations.

  17. A Hazard Analysis for a Generic Insulin Infusion Pump

    Science.gov (United States)

    Zhang, Yi; Jones, Paul L.; Jetley, Raoul

    2010-01-01

    Background Researchers at the Food and Drug Administration (FDA)/Center for Device and Radiological Health/Office of Science and Engineering Laboratories have been exploring the concept of model-based engineering as a means for improving the quality of medical device software. Insulin pumps were chosen as a research subject because their design provides the desired degree of research complexity and these types of devices present an ongoing regulatory challenge. Methods Insulin pump hazards and their contributing factors are considered in the context of a highly abstract generic insulin infusion pump (GIIP) model. Hazards were identified by consulting with manufacturers, pump users, and clinicians; by reviewing national and international standards and adverse event reports collected by the FDA; and from workshops sponsored by Diabetes Technology Society. This information has been consolidated in tabular form to facilitate further community analysis and discussion. Results A generic insulin infusion pump model architecture has been established. A fairly comprehensive hazard analysis document, corresponding to the GIIP model, is presented in this article. Conclusions We believe that this work represents the genesis of an insulin pump safety reference standard upon which future insulin pump designs can be based to help ensure a basic level of safety. More interaction with the diabetes community is needed to assure the quality of this safety modeling process. PMID:20307387

  18. Toward a generic UGV autopilot

    Science.gov (United States)

    Moore, Kevin L.; Whitehorn, Mark; Weinstein, Alejandro J.; Xia, Junjun

    2009-05-01

    Much of the success of small unmanned air vehicles (UAVs) has arguably been due to the widespread availability of low-cost, portable autopilots. While the development of unmanned ground vehicles (UGVs) has led to significant achievements, as typified by recent grand challenge events, to date the UGV equivalent of the UAV autopilot is not available. In this paper we describe our recent research aimed at the development of a generic UGV autopilot. Assuming we are given a drive-by-wire vehicle that accepts as inputs steering, brake, and throttle commands, we present a system that adds sonar ranging sensors, GPS/IMU/odometry, stereo camera, and scanning laser sensors, together with a variety of interfacing and communication hardware. The system also includes a finite state machine-based software architecture as well as a graphical user interface for the operator control unit (OCU). Algorithms are presented that enable an end-to-end scenario whereby an operator can view stereo images as seen by the vehicle and can input GPS waypoints either from a map or in the vehicle's scene-view image, at which point the system uses the environmental sensors as inputs to a Kalman filter for pose estimation and then computes control actions to move through the waypoint list, while avoiding obstacles. The long-term goal of the research is a system that is generically applicable to any drive-by-wire unmanned ground vehicle.

  19. Revitalizing Nuclear Safety Research.

    Science.gov (United States)

    National Academy of Sciences - National Research Council, Washington, DC.

    This report covers the general issues involved in nuclear safety research and points out the areas needing detailed consideration. Topics included are: (1) "Principles of Nuclear Safety Research" (examining who should fund, who should conduct, and who should set the agenda for nuclear safety research); (2) "Elements of a Future…

  20. Nuclear power plant Generic Aging Lessons Learned (GALL). Appendix B

    Energy Technology Data Exchange (ETDEWEB)

    Kasza, K.E.; Diercks, D.R.; Holland, J.W.; Choi, S.U. [and others

    1996-12-01

    The purpose of this generic aging lessons learned (GALL) review is to provide a systematic review of plant aging information in order to assess materials and component aging issues related to continued operation and license renewal of operating reactors. Literature on mechanical, structural, and thermal-hydraulic components and systems reviewed consisted of 97 Nuclear Plant Aging Research (NPAR) reports, 23 NRC Generic Letters, 154 Information Notices, 29 Licensee Event Reports (LERs), 4 Bulletins, and 9 Nuclear Management and Resources Council Industry Reports (NUMARC IRs) and literature on electrical components and systems reviewed consisted of 66 NPAR reports, 8 NRC Generic Letters, 111 Information Notices, 53 LERs, 1 Bulletin, and 1 NUMARC IR. More than 550 documents were reviewed. The results of these reviews were systematized using a standardized GALL tabular format and standardized definitions of aging-related degradation mechanisms and effects. The tables are included in volume s 1 and 2 of this report. A computerized data base has also been developed for all review tables and can be used to expedite the search for desired information on structures, components, and relevant aging effects. A survey of the GALL tables reveals that all ongoing significant component aging issues are currently being addressed by the regulatory process. However, the aging of what are termed passive components has been highlighted for continued scrutiny. This report consists of Volume 2, which consists of the GALL literature review tables for the NUMARC Industry Reports reviewed for the report.

  1. New Safety rules

    CERN Multimedia

    Safety Commission

    2008-01-01

    The revision of CERN Safety rules is in progress and the following new Safety rules have been issued on 15-04-2008: Safety Procedure SP-R1 Establishing, Updating and Publishing CERN Safety rules: http://cern.ch/safety-rules/SP-R1.htm; Safety Regulation SR-S Smoking at CERN: http://cern.ch/safety-rules/SR-S.htm; Safety Regulation SR-M Mechanical Equipment: http://cern.ch/safety-rules/SR-M.htm; General Safety Instruction GSI-M1 Standard Lifting Equipment: http://cern.ch/safety-rules/GSI-M1.htm; General Safety Instruction GSI-M2 Standard Pressure Equipment: http://cern.ch/safety-rules/GSI-M2.htm; General Safety Instruction GSI-M3 Special Mechanical Equipment: http://cern.ch/safety-rules/GSI-M3.htm. These documents apply to all persons under the Director General’s authority. All Safety rules are available at the web page: http://www.cern.ch/safety-rules The Safety Commission

  2. PROBLEM OF GENERIC REPLACEMENT: ADVANTAGES AND DISADVANTAGES

    Directory of Open Access Journals (Sweden)

    S. N. Tolpygina

    2009-01-01

    Full Text Available The main differences between original and generic drugs as well as registration criteria for generics are described. Possible reasons of discrepancy in bioequivalence and therapeutic equivalence of original and generic drugs are reviewed. The examples of such a discrepancy as a result of comparative clinical trails (enalapril maleate are discussed. Approaches to planning of comparative trails on drug therapeutic equivalence are presented. 

  3. Generic domain models in software engineering

    Science.gov (United States)

    Maiden, Neil

    1992-01-01

    This paper outlines three research directions related to domain-specific software development: (1) reuse of generic models for domain-specific software development; (2) empirical evidence to determine these generic models, namely elicitation of mental knowledge schema possessed by expert software developers; and (3) exploitation of generic domain models to assist modelling of specific applications. It focuses on knowledge acquisition for domain-specific software development, with emphasis on tool support for the most important phases of software development.

  4. GENERIC COMMODITY PROMOTION AND PRODUCT DIFFERENTIATION

    OpenAIRE

    1999-01-01

    This paper considers whether generic promotion lowers the differentiation among competing brands as claimed in the 1997 Supreme Court case (Wileman et al. v. Glickman). Commodity promotion is modeled as a multi-stage game where products are vertically differentiated. Analytical results show that if the benefits of generic advertising from increased demand are outweighed by the costs from lower product differentiation then high-quality producers will not benefit from generic promotion but prod...

  5. Determinants of generic drug substitution in Switzerland

    Directory of Open Access Journals (Sweden)

    Lufkin Thomas M

    2011-01-01

    Full Text Available Abstract Background Since generic drugs have the same therapeutic effect as the original formulation but at generally lower costs, their use should be more heavily promoted. However, a considerable number of barriers to their wider use have been observed in many countries. The present study examines the influence of patients, physicians and certain characteristics of the generics' market on generic substitution in Switzerland. Methods We used reimbursement claims' data submitted to a large health insurer by insured individuals living in one of Switzerland's three linguistic regions during 2003. All dispensed drugs studied here were substitutable. The outcome (use of a generic or not was modelled by logistic regression, adjusted for patients' characteristics (gender, age, treatment complexity, substitution groups and with several variables describing reimbursement incentives (deductible, co-payments and the generics' market (prices, packaging, co-branded original, number of available generics, etc.. Results The overall generics' substitution rate for 173,212 dispensed prescriptions was 31%, though this varied considerably across cantons. Poor health status (older patients, complex treatments was associated with lower generic use. Higher rates were associated with higher out-of-pocket costs, greater price differences between the original and the generic, and with the number of generics on the market, while reformulation and repackaging were associated with lower rates. The substitution rate was 13% lower among hospital physicians. The adoption of the prescribing practices of the canton with the highest substitution rate would increase substitution in other cantons to as much as 26%. Conclusions Patient health status explained a part of the reluctance to substitute an original formulation by a generic. Economic incentives were efficient, but with a moderate global effect. The huge interregional differences indicated that prescribing behaviours and

  6. PROBLEM OF GENERIC REPLACEMENT: ADVANTAGES AND DISADVANTAGES

    Directory of Open Access Journals (Sweden)

    S. N. Tolpygina

    2016-01-01

    Full Text Available The main differences between original and generic drugs as well as registration criteria for generics are described. Possible reasons of discrepancy in bioequivalence and therapeutic equivalence of original and generic drugs are reviewed. The examples of such a discrepancy as a result of comparative clinical trails (enalapril maleate are discussed. Approaches to planning of comparative trails on drug therapeutic equivalence are presented. 

  7. Generic substitution of lamotrigine among medicaid patients with diverse indications: a cohort-crossover study.

    Science.gov (United States)

    Hartung, Daniel M; Middleton, Luke; Svoboda, Leanne; McGregor, Jessina C

    2012-08-01

    Controversy exists about the safety of substituting generic antiepileptic drugs (AEDs). Lamotrigine, the prototypical newer AED, is often used for psychiatric and neurological conditions other than epilepsy. The safety of generic substitution of lamotrigine in diverse populations of AED users is unclear. The objective of this study was to evaluate potential associations between generic substitution of lamotrigine and adverse consequences in a population of diverse users of this drug. This study was a retrospective cohort-crossover design using state Medicaid claims data from July 2006 through June 2009. Subjects were included in the cohort if they converted from brand to generic lamotrigine and had 2 years of lamotrigine use prior to conversion. The frequency of emergency department (ED) visits, hospitalizations and condition-specific ED visits or hospitalizations were recorded in the 60 days immediately following the conversion to generic lamotrigine, then compared with the incidence of the same events during a randomly selected time period indexed to one of the patient's past refills of branded lamotrigine. Multivariate conditional logistic regression was used to quantify the association between generic conversion and health services utilization while controlling for changes in lamotrigine dose and concurrent drug use. Of the 616 unique subjects included in this analysis, epilepsy was the most common diagnosis (41%), followed by bipolar disorder (32%), pain (30%) and migraine (18%). Conversion to generic lamotrigine was not associated with a statistically significant increase in the odds of an ED visit (adjusted odds ratio [AOR] = 1.35; 95% confidence interval [CI] 0.92, 1.97), hospitalization (AOR = 1.21; 95% CI 0.60, 2.50) or condition-specific encounter (AOR 1.75; 95 CI 0.87, 3.51). A statistically significant increase in ED visits, hospitalizations or condition-specific encounters was not observed following the switch from brand to generic lamotrigine

  8. Reference pricing with endogenous generic entry.

    OpenAIRE

    Kurt R. Brekke; Canta, Chiara; Straume, Odd Rune

    2015-01-01

    In this paper we study the effect of reference pricing on pharmaceutical prices and ex-penditures when generic entry is endogenously determined. We develop a Salop-type model where a brand-name producer competes with generic producers in terms of prices. In the market there are two types of consumers: (i) brand biased consumers who choose between brand-name and generic drugs, and (ii) brand neutral consumers who choose between the different generic drugs. We find that, for a given number of ...

  9. Generic modules for trivial extension algebras

    Institute of Scientific and Technical Information of China (English)

    杜先能

    1995-01-01

    Let A be a finite-dimensional algebra over an algebraically closed field. An indecomposable (right) ,4-module M is called generic provided M is infinite k-dimensional but finite length as (left) EndA(M)-module. Let R = A DA be the trivial extension algebra of A- Generic R-modules are constructed from generic A-modules using some functors between Mod A and Mod R. it is also proved that if A is a tame hereditary algebra, then R has only two generic modules.

  10. "Generic Entry and the Pricing of Pharmaceuticals"

    OpenAIRE

    Frank, Richard G.; David S. Salkever

    1995-01-01

    During the 1980s the share of prescriptions sold by retail pharmacies that was accounted for by generic products roughly doubled. The price response to generic entry of brand-name products has been a source of controversy. In this paper we estimate models of price responses to generic entry in the market for brand-name and generic drugs. We study a sample of 32 drugs that lost patent protection during the early to mid-1980s. Our results provide strong evidence that brand-name prices increase ...

  11. Thermal reactor safety

    Energy Technology Data Exchange (ETDEWEB)

    1980-06-01

    Information is presented concerning new trends in licensing; seismic considerations and system structural behavior; TMI-2 risk assessment and thermal hydraulics; statistical assessment of potential accidents and verification of computational methods; issues with respect to improved safety; human factors in nuclear power plant operation; diagnostics and activities in support of recovery; LOCA transient analysis; unresolved safety issues and other safety considerations; and fission product transport.

  12. Rational use of generic psychotropic drugs.

    Science.gov (United States)

    Carbon, Maren; Correll, Christoph U

    2013-05-01

    For economic reasons, the generic substitution of branded medications is common and welcome. These replacements are based on the concept of bioequivalence, which is considered equal to therapeutic equivalence. Regulatory standards for bioequivalence require the 90 % confidence intervals of group averages of pharmacokinetic measures of a generic and the original drug to overlap within ±20 %. However, therapeutic equivalence has been challenged for several psychotropic agents by retrospective studies and case reports. To evaluate the degree of bioequivalence and therapeutic equivalence of branded and generic psychotropic drugs, we performed an electronic search (from database inception until 24 May 2012 and without language restrictions) in PubMed/MEDLINE, Cochrane Library, and Web of Science. Search terms were "(generic) AND (psychotropic OR psychoactive OR antipsychotic OR antiepileptic OR antidepressant OR stimulant OR benzodiazepine)" or the respective individual substances. We included clinical studies, regardless of design, comparing branded with generic psychotropic drug formulations, identifying 35 such studies. We also included case reports/series reporting on outcomes after a switch between brand and generic psychotropics, identifying 145 clinical cases. Bioequivalence studies in healthy controls or animals, in-vitro studies, and health economics studies without medical information were excluded. An overview of the few randomized controlled studies supports that US FDA regulations assure clinically adequate drug delivery in the majority of patients switched from brand to generic. However, with a growing number of competing generic products for one substance, and growing economic pressure to substitute with the currently cheapest generic, frequent generic-generic switches, often unbeknownst to prescribing clinicians, raise concerns, particularly for antiepileptics/mood stabilizers. Generic-generic switches may vary by more than ±20 % from each other in

  13. Nordic perspectives on safety management in high reliability organizations: Theory and applications

    Energy Technology Data Exchange (ETDEWEB)

    Svenson, Ola; Salo, I.; Sjerve, A.B.; Reiman, T.; Oedewald, P. [Stockholm Univ. (Sweden)

    2006-04-15

    The chapters in this volume are written on a stand-alone basis meaning that the chapters can be read in any order. The first 4 chapters focus on theory and method in general with some applied examples illustrating the methods and theories. Chapters 5 and 6 are about safety management in the aviation industry with some additional information about incident reporting in the aviation industry and the health care sector. Chapters 7 through 9 cover safety management with applied examples from the nuclear power industry and with considerable validity for safety management in any industry. Chapters 10 through 12 cover generic safety issues with examples from the oil industry and chapter 13 presents issues related to organizations with different internal organizational structures. Although the many of the chapters use a specific industry to illustrate safety management, the messages in all the chapters are of importance for safety management in any high reliability industry or risky activity. The interested reader is also referred to, e.g., a document by an international NEA group (SEGHOF), who is about to publish a state of the art report on Systematic Approaches to Safety Management (cf., CSNI/NEA/SEGHOF, home page: www.nea.fr). (au)

  14. Identification of potentially emerging food safety issues by analysis of reports published by the European Community's Rapid Alert System for Food and Feed (RASFF) during a four-year period.

    Science.gov (United States)

    Kleter, G A; Prandini, A; Filippi, L; Marvin, H J P

    2009-05-01

    The SAFE FOODS project undertakes to design a new approach towards the early identification of emerging food safety hazards. This study explored the utility of notifications filed through RASFF, the European Commission's Rapid Alert System for Food and Feed, to identify emerging trends in food safety issues. RASFF information and alert notifications published in the four-year period of July 2003-June 2007 were assigned to categories of products and hazards. For chronological trend analysis, a basic time unit of three months was chosen. Data within each hazard category were analyzed for chronological trends, relationships between product and hazard categories, regions of origin, and countries filing the notifications. Conspicuous trends that were observed included a rise in the incidence of food contact substances, particularly 2-isopropyl-thioxanthone, as well as of chemical substances migrating from utensils and fraud-related issues. Temporary increases were noted in the incidences of the unauthorized dye Para Red, genetically modified organisms, the pesticide isophenfos-methyl, and herring worm, Anisakis simplex. National and European authorities themselves have signaled these conspicuous trends and taken measures. It is recommended to add complementary data to RASFF data, including safety assessments, risk management measures, background data on hazards and surveillance patterns, for a holistic approach towards early identification of emerging hazards.

  15. Normal birth and the issues of safety and risk : the perceptions of midwives in an Icelandic context [M.S. Thesis

    OpenAIRE

    Valgerður L. Sigurðardóttir

    2008-01-01

    Neðst á síðunni er hægt að nálgast ritgerðina í heild sinni með því að smella á hlekkinn View/Open Wellbeing and safety of mother and child is a guiding light in midwifery care. For the last decades medicalisation has increased in childbirth practice and more risk thinking is dominant in the childbirth environment. Physiological births have decreased and this has been of concerns in midwifery internationally where the concepts of safety and risk in relation to normal births, ha...

  16. 60-day waste compatibility safety issue and final results for 244-TX DCRT, grab samples TX-95-1, TX-95-2, and TX-95-3

    Energy Technology Data Exchange (ETDEWEB)

    Esch, R.A.

    1996-01-01

    Three grab samples (TX-95-1, TX-95-2, and TX-95-3) were taken from tank 241- TX-244 riser 8 on November 7, 1995 and received by the 222-S Laboratory on that same day. Samples TX-95-1 and TX-95-2 were designated as supernate liquids, and sample TX-95-3 was designated as a supernate/sludge. These samples were analyzed to support the waste compatibility safety program. Accuracy and precision criteria were met for all analyses. No notifications were required based on sample results. This document provides the analysis to support the waste compatibility safety program.

  17. 76 FR 54507 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

    Science.gov (United States)

    2011-09-01

    ... COMMISSION Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for... the effects of natural phenomena, including earthquakes, without losing the capability to perform... Electric Power Research Institute models to estimate earthquake ground motion and updated models...

  18. Analysis of French generic medicines retail market: why the use of generic medicines is limited.

    Science.gov (United States)

    Dylst, Pieter; Vulto, Arnold; Simoens, Steven

    2014-12-01

    The market share of generic medicines in France is low compared to other European countries. This perspective paper provides an overview of the generic medicines retail market in France and how the current policy environment may affect the long-term sustainability. Looking at the French generic medicines retail market and the surrounding regulatory framework, all conditions seem to be in place to create a healthy generic medicines market: the country has well-respected regulatory authorities, generic medicines enter the market in a timely manner and prices of generic medicines are competitive compared with other European countries. Despite the success of the demand-side policies targeted at pharmacists and patients, those targeted at physicians were less successful due to a lack of enforcement and a lack of trust in generic medicines by French physicians. Recommendations to increase the use of generic medicines in France round off this perspective paper.

  19. A survey exploring knowledge and perceptions of general practitioners towards the use of generic medicines in the northern state of Malaysia.

    Science.gov (United States)

    Chua, Gin Nie; Hassali, Mohamed Azmi; Shafie, Asrul Akmal; Awaisu, Ahmed

    2010-05-01

    The objective of this study was to evaluate the general practitioners' (GPs') knowledge and perceptions towards generic medicines in a northern state of Malaysia. A postal cross-sectional survey involving registered GPs in Penang, Malaysia was undertaken. A 23-item questionnaire was developed, validated and administered on the GPs. Eighty-seven GPs responded to the survey (response rate 26.8%). The majority of the respondents (85.1%) claimed that they actively prescribed generic medicines in their practice. On the other hand, only 4.6% of the respondents correctly identified the Malaysia's National Pharmaceutical Control Bureau's bioequivalence standard for generic products. There were misconceptions among the respondents about the concepts of "bioequivalence", "efficacy", "safety", and "manufacturing standards" of generic medicines. GPs in this survey believed that a standard guideline on brand substitution process, collaboration with pharmacists, patient education and information on safety and efficacy of generic medicines were necessary to ensure quality use of generics. Furthermore, advertisements and product bonuses offered by pharmaceutical companies, patient's socio-economic factors as well as credibility of manufacturers were factors reported to influence their choice of medicine. Although it appeared that GPs have largely accepted the use of generic medicines, they still have concerns regarding the reliability and quality of such products. GPs need to be educated and reassured about generic products approval system in Malaysia concerning bioequivalence, quality, and safety. The current findings have important implications in establishing generic medicines policy in Malaysia. Copyright (c) 2009 Elsevier Ireland Ltd. All rights reserved.

  20. 关于食品安全行政检查问题的探究%Inquiry about Food Safety Inspection of Administrative Issues

    Institute of Scientific and Technical Information of China (English)

    吕钦

    2016-01-01

    Food safety concerns the vital interests of the broad masses of the people's, in some extent, can affect the political stability and the socialist economic construction of our country. Recently, the frequent food safety incidents, which caused the attention of our country and even the world, it has become the government needs to solve an important problem in our country. Strengthen the food safety administrative inspection is one of the important ways to maintain food safety.%食品安全关乎广大人民群众的切身利益,在一些程度上可以影响到我国的政治安定和社会主义经济建设。最近食品安全事件频发,引发了我国乃至世界性的关注,其已成为我国政府需要解决的一个重要难题。而加强食品安全行政检查是维护食品安全的重要途径之一。

  1. Pharmaceutical policy regarding generic drugs in Belgium.

    Science.gov (United States)

    Simoens, Steven; De Bruyn, Kristien; Bogaert, Marc; Laekeman, Gert

    2005-01-01

    Pressure to control pharmaceutical expenditure and price competition among pharmaceutical companies are fuelling the development of generic drug markets in EU countries. However, in Belgium, the market for generic drugs is underdeveloped compared with other countries. To promote the use of generic drugs, the government introduced a reference pricing (RP) scheme in 2001. The aim of this paper is to discuss Belgian pharmaceutical policy regarding generic drugs and to analyse how the Belgian drug market has evolved following initiation of the RP scheme. The market share held by generic drugs increased following implementation of the RP scheme. Focusing on volume, average market share (by semester) for generic drugs amounted to 2.05% of the total pharmaceutical market from January 1998 to June 2001, compared with 6.11% from July 2001 to December 2003. As new generic drugs are introduced, their market share tends to increase in the first couple of months, after which it levels off. Faced with increasing generic competition, some manufacturers have launched new variants of their original drug, thereby effectively extending the period of patent protection. Strategies consisting of price reductions in return for the abolition of prescribing conditions and the launch of new dosages or formulations appear to have been successful in maintaining the market share of original drugs. Nevertheless, the introduction of the RP scheme was associated with savings amounting to 1.8% of pharmaceutical expenditure by the third-party payer in 2001 and 2.1% in 2002. The findings of this paper indicate that the RP scheme has stimulated the Belgian generic drug market. However, existing policy has largely failed to take into account the role that physicians and pharmacists can play in stimulating generic drug use. Therefore, further development of the Belgian generic drug market seems to hinge on the creation of appropriate incentives for physicians to prescribe, and for pharmacists to

  2. Consistency in the safety labeling of bioequivalent medications.

    Science.gov (United States)

    Duke, Jon; Friedlin, Jeff; Li, Xiaochun

    2013-03-01

    Bioequivalent medications are required by the Food and Drug Administration to have identical warnings on their labels. This requirement has both clinical and legal importance, yet has never been validated. We sought to determine the real-world consistency of electronic labeling for bioequivalent drugs from different manufacturers. Using natural language processing, we indexed the adverse drug reactions (ADRs) found in the Adverse Reactions and Post-Marketing sections of 9105 structured product labels. We calculated the standard deviation in ADR labeling for each bioequivalent drug and the percent deviation of each generic label from its corresponding brand. We also analyzed the performance of individual generic manufacturers. For the 25 drugs with the greatest discrepancy in labeled ADRs, we performed manual review to identify causes of inconsistency. 68% of multi-manufacturer drugs had discrepancies in ADR labeling. For a given drug, the mean deviation in number of labeled ADRs was 4.4, and the median was 0.8 (IQR 0 to 3.2). The mean range in number of labeled ADRs was 12 +/- 0.9, and the median was 2 (IQR 0 to 9). Overall, 77.9% of generic manufacturers produced labels differing from brand. Causes of inconsistency included missing tables, outdated post-marketing reports, and formatting issues. Despite FDA mandate, bioequivalent drugs often differ in their safety labeling. Physicians should be aware of such differences and regulators should consider new strategies for harmonizing bioequivalent labels. Copyright © 2012 John Wiley & Sons, Ltd.

  3. The trials and tribulations of repurposing metformin and other generic drugs for tuberculosis.

    Science.gov (United States)

    Bloom, Bruce E

    2016-01-01

    There are a number of generic drugs that might be useful in treating tuberculosis, but will they ever get to the patients who need them? They might, but not without a lot of help. There are intellectual property issues, endpoint issues, cost of research issues, economic incentive issues, preclinical validation issues, "who is in charge" issues and many more. It is clear that repurposed generic drugs have the potential to make a safe, effective, quick and affordable impact on a global disease of poverty such as tuberculosis. But without the economic incentives that are usually in place for drug development, can we muster the scientific, economic and governmental support to bring them to the patients?

  4. 78 FR 78366 - Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment

    Science.gov (United States)

    2013-12-26

    ... shortages, drug supply chain, safety, security, and drug innovation. As generic drugs account for more than... approvals, drug supply chain, and other topics related to human pharmaceuticals. The draft GDUFA IT plan... the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,...

  5. Generic Form of Bayesian Monte Carlo For Models With Partial Monotonicity

    NARCIS (Netherlands)

    Rajabalinejad, M.

    2012-01-01

    This paper presents a generic method for the safety assessments of models with partial monotonicity. For this purpose, a Bayesian interpolation method is developed and implemented in the Monte Carlo process. integrated approach is the generalization of the recently developed techniques used in safet

  6. Generic form of Bayesian Monte Carlo for models with partial monotonicity

    NARCIS (Netherlands)

    Rajabalinejad, M.; Spitas, C.

    2012-01-01

    This paper presents a generic method for the safety assessments of models with partial monotonicity. For this purpose, a Bayesian interpolation method is developed and implemented in the Monte Carlo process. integrated approach is the generalization of the recently developed techniques used in safet

  7. A comprehensive review and analysis of the research instruments for patient safety issue%病人安全文化/氛围测量工具比较分析

    Institute of Scientific and Technical Information of China (English)

    冯先琼; 王颖

    2012-01-01

    目的:系统地比较和分析病人安全文化/氛围测量工具的性能和特点,为研究者正确选择测量工具提供帮助.方法:应用系统回顾和比较研究的方法,收集近20年来发展并应用在医疗保健领域的病人安全文化/氛围测量工具,比较这些工具的测量维度和性能特点.结果:6个英文量表和1个中文量表符合研究纳入标准,被本研究纳入.这些研究量表的测量维度变异较大,从1~12个不等,但多涉及病人安全的管理和领导、安全方面的政策、沟通交流情况、安全事件的报告以及人员配置方面.这些研究工具性能的建立和检验方法不尽相同,多使用了因子分析法以及对量表信度检验的方法.研究工具性能指标也表现出差异性.结论:现有的病人安全文化/氛围测量工具有着不同的测量维度、工具性能和适用性,研究者应根据自身的研究目的,结合这些工具的特点做出恰当的选择.%Objective: To systematically review the research instruments regarding patient safety issues and to compare their similarities and differences in terms of content dimensions, psychometric properties and applicability. Methods: An extensive literature review was conducted initially to review research studies which had utilized scales on patient safety issue as their research instruments. The comparative method was employed subsequently to analyze the similarities and differences among the reviewed instruments regarding the content dimensions, psychometric properties, and applicability. Results: Six patient safety issue instruments in English and 1 in Chinese were selected based on the inclusion criteria of this study. The content dimensions of these instruments varied between 1 to 12. The common measurement dimensions of these patient safety issue instruments included the leadership and management support for patient safety, policies and procedures developed to ensure patient safety, communication

  8. Once more the generic name Passerina Vieillot

    NARCIS (Netherlands)

    Oort, van E.D.

    1910-01-01

    The note on the generic name of the Snow-bunting by Dr. E. Hartert in this part of our periodical gives me cause to revert to the subject of my note on the generic name Passerina Vieillot and to state here, that I stand to what I have said about the rejection of this name in Zoology (Notes Leyden Mu

  9. Designing Generic and Efficient Negotiation Strategies

    NARCIS (Netherlands)

    Tykhonov, D.

    2010-01-01

    The central aim of this thesis is the design of generic and efficient automated strategies for two-party negotiations in which negotiating parties do not reveal their preferences explicitly. A strategy for negotiation is the decision mechanism for determining the actions of a negotiator. Generic ref

  10. Typed generic traversals in $S_gamma^'$

    NARCIS (Netherlands)

    Lämmel, R.

    2001-01-01

    A typed model of strategic rewriting is developed. An innovation is that generic traversals are covered. To this end, we define a rewriting calculus $S'_{gamma$. The calculus offers a few strategy combinators for generic traversals. There is, for example, a combinator to apply a strategy to all imme

  11. Generic drugs in dermatology: part I.

    Science.gov (United States)

    Payette, Michael; Grant-Kels, Jane M

    2012-03-01

    The cost of health care in the United States is increasing. In order to help control these rising costs, all parties involved in the delivery of health care, including dermatologists, need to be part of the solution of ethically reducing the cost of delivery of care. One potential means of meeting this goal is to increase the use of generic medications in daily practice. Generic medications can offer equally efficacious therapy at significantly lower prices, which can translate into large scale savings for the individual patient, the payer, and the overall health care system. Herein we provide an overview of new drug development, review the history of the generic drug industry, describe how generic drugs are approved by the US Food and Drug Administration, and define the concepts of bioequivalence and therapeutic equivalence. In part II, we explore various factors impacting generic drug use, provide cost analyses of dermatologic brand name and generic drugs, and review data addressing potential differences in the effectiveness of brand name versus generic drugs in dermatology. The cost of brand name and generic medications is highly variable by pharmacy, state, and payer. We used one source (www.drugstore.com) as an example and for consistency across all medications discussed herein. Prices included here may not reflect actual retail prices across the United States.

  12. Defining Generic Skills. At a Glance.

    Science.gov (United States)

    National Centre for Vocational Education Research, Leabrook (Australia).

    Generic skills--skills that apply across a variety of jobs and life contexts--are taking on increased importance in Australia and internationally. There is a high demand for generic skills in the workplace because employers seek to ensure business success by recruiting and retaining employees who have a variety of skills and personal attributes as…

  13. The use of diacetyl (2,3-butanedione) and related flavoring substances as flavorings added to foods-Workplace safety issues.

    Science.gov (United States)

    Hallagan, John B

    2017-08-01

    In 2001, staff of the National Institute of Occupational Safety and Health (NIOSH) identified diacetyl (2,3-butanedione) as a "marker" of exposure in a microwave popcorn manufacturing facility in which workers developed severe respiratory illness. Subsequent investigations identified additional workers in food and flavor manufacturing facilities also with severe respiratory illness. The flavor industry, NIOSH, and federal and state regulators conducted significant programs to address workplace safety concerns related to the manufacture of flavors and foods containing added flavors. These programs, initiated in 2001, continue today. Key to the success of these programs is understanding what flavors added to foods are and how they are manufactured, how they are incorporated into foods, the specific characteristics of diacetyl and related flavoring substances, and what actions may be taken to assure the safest workplaces possible. Copyright © 2017 Elsevier B.V. All rights reserved.

  14. The problem of choosing between the original and of generic drugs in patients with overweight and obesity

    Directory of Open Access Journals (Sweden)

    M L Maksimov

    2013-10-01

    Full Text Available This review article discusses the similarities and differences in the research, production and use in clinical practice, original and generic drugs. Reproduced drugs (generics present on the Russian pharmaceutical market that have the bioequivalence data are not always equal in therapeutic equivalence of the original drug. The article presents evidence base of efficacy and safety of the original drug Xenical in the complex treatment of patients with overweight and obesity.

  15. Perception of the value of generic drugs in São Paulo, Brazil

    Directory of Open Access Journals (Sweden)

    Elene Paltrinieri Nardi

    2016-01-01

    Full Text Available Abstract The objective of this study was to assess the perceptions of opinion-leaders, patients and their accompanying family members or carers about generic drugs. Three groups of participants were surveyed: (i 50 customers while they were visiting commercial pharmacies located in São Paulo city, Brazil, (ii 25 patients and 25 companions while they were waiting at the university outpatient clinic, and (iii 50 healthcare opinion-leaders from government, hospitals, health plans, academia, and pharmaceutical companies. The questions explored socio-demographic characteristics and perceptions regarding value attributes of generic drugs compared to brand name drugs. Respondents had an average age of 52 years and 53% were women. Respondents believed generic drugs to be cheaper than brand name drugs (97%, and 31% thought generic drugs to be less effective than brand name drugs. Also, generic drugs were perceived by 54% of respondents to be as safe as brand name drugs and 74% would prefer brand name drugs if there was no price difference. In conclusion, multiple factors may contribute to the decision to buy generic drugs; among these, perceived effectiveness, safety and price appear to be the most important factors.

  16. Perception of the value of generic drugs in São Paulo, Brazil.

    Science.gov (United States)

    Nardi, Elene Paltrinieri; Ferraz, Marcos Bosi

    2016-02-01

    The objective of this study was to assess the perceptions of opinion-leaders, patients and their accompanying family members or carers about generic drugs. Three groups of participants were surveyed: (i) 50 customers while they were visiting commercial pharmacies located in São Paulo city, Brazil, (ii) 25 patients and 25 companions while they were waiting at the university outpatient clinic, and (iii) 50 healthcare opinion-leaders from government, hospitals, health plans, academia, and pharmaceutical companies. The questions explored socio-demographic characteristics and perceptions regarding value attributes of generic drugs compared to brand name drugs. Respondents had an average age of 52 years and 53% were women. Respondents believed generic drugs to be cheaper than brand name drugs (97%), and 31% thought generic drugs to be less effective than brand name drugs. Also, generic drugs were perceived by 54% of respondents to be as safe as brand name drugs and 74% would prefer brand name drugs if there was no price difference. In conclusion, multiple factors may contribute to the decision to buy generic drugs; among these, perceived effectiveness, safety and price appear to be the most important factors.

  17. Beam-beam issues in asymmetric colliders

    Energy Technology Data Exchange (ETDEWEB)

    Furman, M.A.

    1992-07-01

    We discuss generic beam-beam issues for proposed asymmetric e{sup +}- e{sup -} colliders. We illustrate the issues by choosing, as examples, the proposals by Cornell University (CESR-B), KEK, and SLAC/LBL/LLNL (PEP-II).

  18. A Review on the Research of Food Safety Issue in Rural Areas of China in Recent Years%近年来我国农村食品安全研究综述

    Institute of Scientific and Technical Information of China (English)

    宁德煌; 焦强

    2014-01-01

    通过对近年来国内农村食品安全研究方面的相关文献分析发现,学者们对农村食品安全的研究主要集中于问题、成因、对策三个方面。农村食品安全的主要问题包括食源污染、生产不规范、流通环节隐患三个方面;影响农村食品安全的因素主要包括农民购买力较低且缺乏食品安全意识、食品生产企业的利益驱动、政府监管不到位;解决这一问题的建议和对策主要包括增加农民收入、加大宣传力度、健全法律法规。如何通过加强政府监管、强化企业的社会责任、提高农民食品安全意识和维权意识等来解决农村食品安全问题,将是学界研究进一步努力的方向。%Researches of domestic scholars on the rural food safety issue can be categorized into three as-pects:first,the main problems of rural food safety;second,factors affecting food safety in rural areas;and third, suggestions and countermeasures for solving the problems of rural food safety.The food safety problem in rural areas mainly includes source pollution of food production,non-standardized food production and hidden trouble through food circulation.The food safety problem in rural areas mainly lies in the fact that the farmers have very lower purchasing power and lack food safety awareness,and government supervision does not work properly.The suggestions and countermeasures to solve the problem given in the paper include increasing farmers’income,in-tensifying food safety awareness advocating,and perfecting laws and regulations.These researches,however, failed to take into consideration the marketing departments of food enterprise,and fewer quantitative analyses in the study of food safety have been done so far in China.How to enhance the government supervision,strengthen the enterprise’s marketing management and integrate management,raise farmers’food safety awareness and consciousness will be some new academic research

  19. Thematic harvesting of agricultural resources from generic repositories

    Directory of Open Access Journals (Sweden)

    Devika P. Madalli

    2015-09-01

    Metadata aggregators provide end-users a single platform discovery facility to resources collected from various data providers. It is observed that aggregators such as INDUS [www.drtc.isibang/ac.in/indus] dealing with agriculture and related domains facilitate aggregating metadata from not only repositories but also other sources such as journals and enable a centralized access to full text and objects. While harvesting can be fairly simple and straight forward, it is not without its challenges. This paper intends to highlight some of the issues in harvesting metadata in agricultural domain. The particular focus is to identify agriculture related metadata from generic sets.

  20. Risks and benefits of generic antiepileptic drugs.

    Science.gov (United States)

    Gómez-Alonso, Juan; Kanner, Andrés M; Herranz, José Luis; Molins, Albert; Gil-Nagel, Antonio

    2008-11-01

    In most therapeutic areas, prescribing generic drugs seems to lower costs without sacrificing efficacy. The use of generic drugs for treating epilepsy may, however, be more controversial. A systematic review of the literature on generic antiepileptic drugs has been carried out based primarily on a bibliographical search in the Medline database. Published studies are usually of a descriptive nature and are sometimes based on generic drugs that were approved in times when regulatory agency requirements were not as strict as they are now. Experts claim that a change in pharmaceutical formulations could cause seizure recurrence in cases that had been successfully controlled in the past, with severe effects on patients. Meanwhile, several health organizations have provided inconsistent recommendations on the use of generic antiepileptic drugs. In order to obtain scientific evidence on the potential risks and benefits of interchanging branded and generic antiepileptic drugs, high methodological comparative studies are necessary. These studies could bring consensus about the role of generic drugs for treating epilepsy.