WorldWideScience

Sample records for drug safety concerns

  1. Drug Safety

    Science.gov (United States)

    ... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

  2. Food Safety Concerns

    Institute of Scientific and Technical Information of China (English)

    HUYONG

    2004-01-01

    In China, there is an old saying:food is the first necessity of humans. The main concern of the Chinese used to be the security of the food supply rather than the safety of the food itself. However,after a long time fighting food shortages,China became self-sufficient in food in 1995. At this time, the country began for the first time to regulate food safety. Yet China has still not established a legal systern efficient in ensuring this safety. Many problems are rooted in the administration regime and China's priority of economic development.

  3. Pharmaceutical quality of "party pills" raises additional safety concerns in the use of illicit recreational drugs.

    Science.gov (United States)

    Young, Simon A; Thrimawithana, Thilini R; Antia, Ushtana; Fredatovich, John D; Na, Yonky; Neale, Peter T; Roberts, Amy F; Zhou, Huanyi; Russell, Bruce

    2013-06-14

    To determine the content and release kinetics of 1-benzylpiperazine (BZP) and 1-(3-trifluoromethyl-phenyl)piperazine (TFMPP) from "party pill" formulations. From these data, the possible impact of pharmaceutical quality upon the safety of such illicit formulations may be inferred. The amount of BZP and TFMPP in party pill formulations was determined using a validated HPLC method. The in-vitro release kinetics of selected party pill brands were determined using a USP dissolution apparatus (75 rpm, 37.5 degrees Celsius). The release data were then fitted to a first order release model using PLOT software and the time taken to achieve 90% release reported. Many of the tested party pill brands contained amounts of BZP and TFMPP that varied considerably from that stated on the packaging; including considerable TFMPP content in some brands not labelled to contain this drug. Dissolution studies revealed that there was considerable variability in the release kinetics between brands; in one case 90% release required >30 minutes. Lack of quality control in party pill manufacture may have led to the toxic effects reported by users unaware of the true content and release of drug from pills. More stringent regulation in the manufacture and quality control of "new generation party pills" is essential to the harm reduction campaign.

  4. Safety concerns and hidden agenda behind HPV vaccines: another generation of drug-dependent society?

    Science.gov (United States)

    Khatami, Mahin

    2016-12-01

    Analyses of data and hidden agenda behind repeated failed outcomes of cancer research and therapy, status of American health, safety concerns for HPV vaccines and future research considerations are summarized in this commentary. A closer look at cancer science reveals that highly power structure (system) in medical establishment vs. anti-system and chaos in cancer research ('medical/scientific ponzi schemes') is potent recipe for failed therapeutics that kills patients but generates huge corporate profit. American health status ranks last among other developed nations despite the highest amount that USA invests in healthcare. This is a wake-up call to make sure that the evil part of human being does not prevent the health services that the public deserves. Otherwise, 'it does not matter how many resources you have, if you don't know, or don't want to know, how to use them, they will never be enough'. Answer to cancer and improved public health is possible only by switching the current corruptive and abusive culture of 'who you know' to a culture of 'what you know'. Policy makers and professionals in decision making roles are urged to return to common sense and logics that our Forefathers used to serve the public.

  5. Suicidality and risk of suicide--definition, drug safety concerns, and a necessary target for drug development: a brief report.

    Science.gov (United States)

    Meyer, Roger E; Salzman, Carl; Youngstrom, Eric A; Clayton, Paula J; Goodwin, Frederick K; Mann, J John; Alphs, Larry D; Broich, Karl; Goodman, Wayne K; Greden, John F; Meltzer, Herbert Y; Normand, Sharon-Lise T; Posner, Kelly; Shaffer, David; Oquendo, Maria A; Stanley, Barbara; Trivedi, Madhukar H; Turecki, Gustavo; Beasley, Charles M; Beautrais, Annette L; Bridge, Jeffrey A; Brown, Gregory K; Revicki, Dennis A; Ryan, Neal D; Sheehan, David V

    2010-08-01

    To address issues concerning potential treatment-emergent "suicidality," a consensus conference was convened March 23-24, 2009. This gathering of participants from academia, government, and industry brought together experts in suicide prevention, clinical trial design, psychometrics, pharmacoepidemiology, and genetics, as well as research psychiatrists involved in studies in studies of psychiatric disorders associated with elevated suicide risk across the life cycle. The process involved reviews of the relevant literature, and a series of 6 breakout sessions focused on specific questions of interest. Each of the participants at the meeting received references relevant to the formal presentations (as well as the slides for the presentations) for their review prior to the meeting. In addition, the assessment instruments of suicidal ideation/behavior were reviewed in relationship to standard measures of validity, reliability, and clinical utility, and these findings were discussed at length in relevant breakout groups, in the final plenary session, and in the preparation of the article. Consensus and dissenting views were noted. Discussion and questions followed each formal presentation during the plenary sessions. Approximately 6 questions per breakout group were prepared in advance by members of the Steering Committee and each breakout group chair. Consensus in the breakout groups was achieved by nominal group process. Consensus recommendations and any dissent were reviewed for each breakout group at the final plenary session. All plenary sessions were recorded and transcribed by a court stenographer. Following the transcript, with input by each of the authors, the final paper went through 14 drafts. The output of the meeting was organized into this brief report and the accompanying full article from which it is distilled. The full article was developed by the authors with feedback from all participants at the meeting and represents a consensus view. Any areas of

  6. Suicidality and risk of suicide--definition, drug safety concerns, and a necessary target for drug development: a consensus statement.

    Science.gov (United States)

    Meyer, Roger E; Salzman, Carl; Youngstrom, Eric A; Clayton, Paula J; Goodwin, Frederick K; Mann, J John; Alphs, Larry D; Broich, Karl; Goodman, Wayne K; Greden, John F; Meltzer, Herbert Y; Normand, Sharon-Lise T; Posner, Kelly; Shaffer, David; Oquendo, Maria A; Stanley, Barbara; Trivedi, Madhukar H; Turecki, Gustavo; Beasley, Charles M; Beautrais, Annette L; Bridge, Jeffrey A; Brown, Gregory K; Revicki, Dennis A; Ryan, Neal D; Sheehan, David V

    2010-08-01

    To address issues concerning potential treatment-emergent "suicidality," a consensus conference was convened March 23-24, 2009. This gathering of participants from academia, government, and industry brought together experts in suicide prevention, clinical trial design, psychometrics, pharmacoepidemiology, and genetics, as well as research psychiatrists involved in studies of major depression, bipolar disorder, schizophrenia, substance abuse/dependence, and other psychiatric disorders associated with elevated suicide risk across the life cycle. The process involved reviews of the relevant literature, and a series of 6 breakout sessions focused on specific questions of interest. Each of the participants at the meeting received references relevant to the formal presentations (as well as the slides for the presentations) for their review prior to the meeting. In addition, the assessment instruments of suicidal ideation/behavior were reviewed in relationship to standard measures of validity, reliability, and clinical utility, and these findings were discussed at length in relevant breakout groups, in the final plenary session, and in the preparation of the article. Consensus and dissenting views were noted. Discussion and questions followed each formal presentation during the plenary sessions. Approximately 6 questions per breakout group were prepared in advance by members of the Steering Committee and each breakout group chair. Consensus in the breakout groups was achieved by nominal group process. Consensus recommendations and any dissent were reviewed for each breakout group at the final plenary session. All plenary sessions were recorded and transcribed by a court stenographer. Following the transcript, with input by each of the authors, the final paper went through 14 drafts. The output of the meeting was organized into this scholarly article, which has been developed by the authors with feedback from all participants at the meeting and represents a consensus view

  7. Safety concerns us all

    CERN Multimedia

    SC/GS/S

    2004-01-01

    In spite of periodic safety inspections, risks can never be entirely excluded. The Safety Commission invites you to inform your supervisor or Territorial Safety Officer (TSO) of any hazardous situations you may be aware of. Actions to be taken following the fall of two windowpanes A few weeks ago, a windowpane fell from the third floor of an office building, causing minor damage to a car parked outside. No one was hurt in the incident. The putty holding the window in place had gradually deteriorated over time, and strong winds undoubtedly triggered the incident. A few weeks later, a sudden draft caused a window on the fifth floor of the same building to shatter and fall to the ground below. No one was hurt and there was no material damage. The incident was caused by a fan set into the opening window: as the window slammed shut, the weight of the fan caused the glass to break. What can we do to improve safety? examine the windows of our offices and workshops and report any problems or faults, such as dam...

  8. School Safety Concerns All Students.

    Science.gov (United States)

    Henderson, Megan

    1999-01-01

    Suggests that school safety is an issue that concerns all students. Discusses how the staff of the Rockwood South (Missouri) "RAMpage" covered the shootings at Columbine High School in a 14-page issue and in follow-up issues. Suggests that the student newspaper covered the controversial topic in an appropriate, tasteful manner. (RS)

  9. Nordic projects concerning nuclear safety

    International Nuclear Information System (INIS)

    Soerensen, H.C.

    1988-11-01

    The report describes the nature of the work done in the first half of 1988 within the field of nuclear safety (1985-89) under the Nordic program for 1985-89. Five programmes and their documentation, are described and complete lists of addresses and of persons involved is given. (AB)

  10. Diabetes Drugs and Cardiovascular Safety

    Directory of Open Access Journals (Sweden)

    Ji Cheol Bae

    2016-06-01

    Full Text Available Diabetes is a well-known risk factor of cardiovascular morbidity and mortality, and the beneficial effect of improved glycemic control on cardiovascular complications has been well established. However, the rosiglitazone experience aroused awareness of potential cardiovascular risk associated with diabetes drugs and prompted the U.S. Food and Drug Administration to issue new guidelines about cardiovascular risk. Through postmarketing cardiovascular safety trials, some drugs demonstrated cardiovascular benefits, while some antidiabetic drugs raised concern about a possible increased cardiovascular risk associated with drug use. With the development of new classes of drugs, treatment options became wider and the complexity of glycemic management in type 2 diabetes has increased. When choosing the appropriate treatment strategy for patients with type 2 diabetes at high cardiovascular risk, not only the glucose-lowering effects, but also overall benefits and risks for cardiovascular disease should be taken into consideration.

  11. Safety studies concerning nuclear power reactors

    International Nuclear Information System (INIS)

    Bailly, Jean; Pelce, Jacques

    1980-01-01

    The safety of nuclear installations poses different technical problems, whether concerning pressurized water reactors or fast reactors. But investigating methods are closely related and concern, on the one hand, the behavior of shields placed between fuel and outside and, on the other, analysis of accidents. The article is therefore in two parts based on the same plan. Concerning light water reactors, the programme of studies undertaken in France accounts for the research carried out in countries where collaboration agreements exist. Concerning fast reactors, France has the initiative of their studies owing to her technical advance, which explains the great importance of the programmes under way [fr

  12. Aviation safety : FAA and DOD response to similar safety concerns

    Science.gov (United States)

    2002-01-01

    Report to the Honorable Norman Y. Mineta, Secretary of Transportation, and the Honorable Donald H. Rumsfeld, Secretary of Defense. : Safety of aircraft is a paramount concern in both civilian and military aviation. The Federal Aviation Administration...

  13. Drug Safety: Managing Multiple Drugs

    Science.gov (United States)

    ... This series is produced by Consumers Union and Consumer Reports Best Buy Drugs , a public information project sup- ported by grants from the Engelberg Foundation and the National Library of Medicine of ... Consumer and Prescriber Education Grant Program which is funded ...

  14. IRSN research programs concerning reactor safety

    International Nuclear Information System (INIS)

    Bardelay, J.

    2005-01-01

    This paper is made up of 3 parts. The first part briefly presents the missions of IRSN (French research institute on nuclear safety), the second part reviews the research works currently led by IRSN in the following fields : -) the assessment of safety computer codes, -) thermohydraulics, -) reactor ageing, -) reactivity accidents, -) loss of coolant, -) reactor pool dewatering, -) core meltdown, -) vapor explosion, and -) fission product release. In the third part, IRSN is shown to give a major importance to experimental programs led on research or test reactors for collecting valid data because of the complexity of the physical processes that are involved. IRSN plans to develop a research program concerning the safety of high or very high temperature reactors. (A.C.)

  15. Aviation Safety Concerns for the Future

    Science.gov (United States)

    Smith, Brian E.; Roelen, Alfred L. C.; den Hertog, Rudi

    2016-01-01

    The Future Aviation Safety Team (FAST) is a multidisciplinary international group of aviation professionals that was established to identify possible future aviation safety hazards. The principle was adopted that future hazards are undesirable consequences of changes, and a primary activity of FAST became identification and prioritization of possible future changes affecting aviation. Since 2004, FAST has been maintaining a catalogue of "Areas of Change" (AoC) that could potentially influence aviation safety. The horizon for such changes is between 5 to 20 years. In this context, changes must be understood as broadly as possible. An AoC is a description of the change, not an identification of the hazards that result from the change. An ex-post analysis of the AoCs identified in 2004 demonstrates that changes catalogued many years previous were directly implicated in the majority of fatal aviation accidents over the past ten years. This paper presents an overview of the current content of the AoC catalogue and a subsequent discussion of aviation safety concerns related to these possible changes. Interactions among these future changes may weaken critical functions that must be maintained to ensure safe operations. Safety assessments that do not appreciate or reflect the consequences of significant interaction complexity will not be fully informative and can lead to inappropriate trade-offs and increases in other risks. The FAST strongly encourages a system-wide approach to safety risk assessment across the global aviation system, not just within the domain for which future technologies or operational concepts are being considered. The FAST advocates the use of the "Areas of Change" concept, considering that several possible future phenomena may interact with a technology or operational concept under study producing unanticipated hazards.

  16. Safety concerns in composite manufacturing and machining

    Science.gov (United States)

    Asmatulu, Eylem; Alonayni, Abdullah; Alamir, Mohammed

    2018-03-01

    Because of the superior properties, composites have been used in many industrial applications, including aerospace, wind turbines, ships, cars, fishing rods, storage tanks, swimming pool panels, and baseball bats. Each application may require different combinations of reinforcements and matrices, which make the manufacturing safety even more challenging while working on these substances. In this study, safety issues in composite manufacturing and machining were investigated in detail, and latest developments were provided for workers. The materials most frequently used in composite manufacturing, such as matrix (polyester, vinylester, phenolic, epoxies, methyl ethyl ketone peroxide, benzoil peroxide, hardeners, and solvents), and reinforcement materials (carbon, glass and Kevlar fibers, honeycomb and foams) can be highly toxic to human body. These materials can also be very toxic to the environment when dumped out uncontrollably, creating major future health and environmental concerns. Throughout the manufacturing process, workers inhale vapors of the liquid matrix, hardeners and solvents / thinners, as well as reinforcement materials (chopped fibers and particles) in airborne. Milling, cutting and machining of the composites can further increase the toxic inhalations of airborne composite particles, resulting in major rashes, irritation, skin disorders, coughing, severe eye and lung injury and other serious illnesses. The major portions of these hazardous materials can be controlled using appropriate personal protective equipment for the chemicals and materials used in composite manufacturing and machining. This study provides best possible safety practices utilized in composite manufacturing facilities for workers, engineers and other participants.

  17. Effectively managing public concerns about immunization safety

    Directory of Open Access Journals (Sweden)

    2002-01-01

    Full Text Available Los beneficios de la vacunación frente a las enfermedades prevenibles de este modo son muy superiores a sus mínimos riesgos. Con el fin de mantener o fortalecer los programas nacionales de vacunación, los trabajadores de todos los niveles de la salud pública deberían recibir formación sobre los temas relacionados con la vacunación y estar preparados para responder a las dudas planteadas por el público. Una respuesta rápida y franca a los temores del público acerca de las vacunas podría garantizar la integridad de los programas de vacunación en todo el continente americano, según el documento "Directrices para enfrentarse a los temores sobre la seguridad de las vacunaciones" (Guidelines for Managing Immunization Safety Concerns, elaborado por la División de Vacunas e Inmunización de la Organización Panamericana de la Salud (OPS y resumido aquí. Todo acontecimiento médico que se considere posiblemente relacionado con una vacuna debe ser investigado en el ámbito local. Si su distribución temporal y los síntomas respaldan la sospecha de que pueda estar relacionado con una vacuna, se debe iniciar una investigación más formal y, una vez finalizada, el acontecimiento debe ser clasificado en una de las cuatro categorías siguientes: 1 relacionado con el programa, 2 relacionado con la vacuna, 3 no relacionado, o 4 desconocido (investigación no concluyente. Dependiendo de la categoría a la que haya sido asignado el acontecimiento, las acciones posteriores pueden consistir en tranquilizar a los padres, a los cuidadores y a otros adultos; comunicarse con el público y con otros trabajadores de la salud; instaurar tratamiento; corregir los errores del programa, como pueden ser la manipulación de la vacuna, su almacenamiento, su administration o los problemas relacionados con la jeringuilla; comentar con los fabricantes problemas relacionados con la calidad y eficacia de la vacuna; retirar la vacuna del mercado, o iniciar nuevas

  18. Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns.

    Science.gov (United States)

    Tetteh, Raymond A; Yankey, Barbara A; Nartey, Edmund T; Lartey, Margaret; Leufkens, Hubert G M; Dodoo, Alexander N O

    2017-04-01

    Available evidence supports the efficacy of pre-exposure prophylaxis (PrEP) in decreasing the incidence of human immunodeficiency virus (HIV) infection among high-risk individuals, especially when used in combination with other behavioural preventive methods. Safety concerns about PrEP present challenges in the implementation and use of PrEP. The aim of this review is to discuss safety concerns observed in completed clinical trials on the use of PrEP. We performed a literature search on PrEP in PubMed, global advocacy for HIV prevention (Aids Vaccine Advocacy Coalition) database, clinical trials registry " http://www.clinicaltrials.gov " and scholar.google, using combination search terms 'pre-exposure prophylaxis', 'safety concerns in the use of pre-exposure prophylaxis', 'truvada use as PrEP', 'guidelines for PrEP use', 'HIV pre-exposure prophylaxis' and 'tenofovir' to identify clinical trials and literature on PrEP. We present findings associated with safety issues on the use of PrEP based on a review of 11 clinical trials on PrEP with results on safety and efficacy as at April 2016. We also reviewed findings from routine real-life practice reports. The pharmacological intervention for PrEP was tenofovir disoproxil fumarate/emtricitabine in a combined form as Truvada ® or tenofovir as a single entity. Both products are efficacious for PrEP and seem to have a good safety profile. Regular monitoring is recommended to prevent long-term toxic effects. The main adverse effects observed with PrEP are gastrointestinal related; basically mild to moderate nausea, vomiting and diarrhea. Other adverse drug effects worth monitoring are liver enzymes, renal function and bone mineral density. PrEP as an intervention to reduce HIV transmission appears to have a safe benefit-risk profile in clinical trials. It is recommended for widespread use but adherence monitoring and real-world safety surveillance are critical in the post-marketing phase to ensure that the benefits

  19. Regulatory considerations concerning IND radiopharmaceutical drug products

    International Nuclear Information System (INIS)

    Nissel, M.

    1985-01-01

    The Food and Drug Administration is charged by the Food, Drug, and Cosmetic Act, as presently amended, to assure that any drug introduced into interstate commerce is safe and effective for the purposes for which it is labeled. A radiopharmaceutical is, by definition, a new drug unless there is in effect an approved New Drug Application (NDA) for it. Before the data for the NDA are compiled, investigative studies have to be done. Before such studies can be performed in humans, an exemption from the Act is necessary. This exemption, technically the Claimed Exemption for an Investigational New Drug, is termed the IND. Both the scientific and the administrative requirements for an IND are discussed. For radiopharmaceutical drug products (RDP's), the radiation hazards, as well as the pharmacological ones, must be documented. Should the early studies demonstrate a potential for efficacy in a certain condition or disease state, an investigative protocol for an extended clinical trial is presented. The necessary requirements for Institutional Review Board (IRB) approval and consent forms are discussed. For certain research purposes, uniquely for radioactive drugs, an IND is not required for certain specific studies; the requirements for such a research study, conducted under the auspices of an approved radioactive drug research committee, are outlined

  20. HTGR safety research concerns at NRC

    International Nuclear Information System (INIS)

    Minogue, R.B.

    1982-01-01

    A general discussion of HTGR technical and safety-related problems is given. The broad areas of current research programs specific to the Fort St. Vrain reactor and applicable to HTGR technology are summarized

  1. Physician attitudes towards pharmacological cognitive enhancement: safety concerns are paramount.

    Directory of Open Access Journals (Sweden)

    Opeyemi C Banjo

    2010-12-01

    Full Text Available The ethical dimensions of pharmacological cognitive enhancement have been widely discussed in academic circles and the popular media, but missing from the conversation have been the perspectives of physicians - key decision makers in the adoption of new technologies into medical practice. We queried primary care physicians in major urban centers in Canada and the United States with the aim of understanding their attitudes towards cognitive enhancement. Our primary hypothesis was that physicians would be more comfortable prescribing cognitive enhancers to older patients than to young adults. Physicians were presented with a hypothetical pharmaceutical cognitive enhancer that had been approved by the regulatory authorities for use in healthy adults, and was characterized as being safe, effective, and without significant adverse side effects. Respondents overwhelmingly reported increasing comfort with prescribing cognitive enhancers as the patient age increased from 25 to 65. When asked about their comfort with prescribing extant drugs that might be considered enhancements (sildenafil, modafinil, and methylphenidate or our hypothetical cognitive enhancer to a normal, healthy 40 year old, physicians were more comfortable prescribing sildenafil than any of the other three agents. When queried as to the reasons they answered as they did, the most prominent concerns physicians expressed were issues of safety that were not offset by the benefit afforded the individual, even in the face of explicit safety claims. Moreover, many physicians indicated that they viewed safety claims with considerable skepticism. It has become routine for safety to be raised and summarily dismissed as an issue in the debate over pharmacological cognitive enhancement; the observation that physicians were so skeptical in the face of explicit safety claims suggests that such a conclusion may be premature. Thus, physician attitudes suggest that greater weight be placed upon the

  2. College Rampage Renews School Safety Concerns

    Science.gov (United States)

    Maxwell, Lesli A.

    2007-01-01

    Coming just four days before the anniversary of the Columbine school shootings, the mass slayings by a student gunman at Virginia Polytechnic Institute last week revived vexing questions and raised familiar fears for educators across the country who grapple daily with ensuring the safety of their students and staffs. The April 16 killings provoked…

  3. Chinese consumers concerns about food safety: Case of Tianjin

    NARCIS (Netherlands)

    Zhang XiaoYong, Xiaoyong

    2005-01-01

    The objective of this study is to gain an insight to Chinese consumers' knowledge and concerns over food safety from a case study in Tianjin city. The results indicate that Chinese consumers are very much concerned about food safety, particularly with regard to vegetables and dairy products. Chinese

  4. New safety valve addresses environmental concerns

    International Nuclear Information System (INIS)

    Taylor, J.; Austin, R.

    1992-01-01

    This paper reports that Conoco Pipeline is using a unique relief valve to reduce costs while improving environmental protection at its facilities. Conoco Pipeline Co. Inc. began testing new relief valves in 1987 to present over-pressuring its pipelines while enhancing the safety, environmental integrity and profitability of its pipelines. Conoco worked jointly with Rupture Pin Technology Inc., Oklahoma City, to seek a solution to a series of safety, environmental, and operational risks in the transportation of crude oil and refined products through pipelines. Several of the identified problems were traced to a single equipment source: the reliability of rupture discs used at pipeline stations to relieve pressure by diverting flow to tanks during over-pressure conditions. Conoco's corporate safety and environmental policies requires solving problems that deal with exposure to hydrocarbon vapors, chemical spills or the atmospheric release of fugitive emissions, such as during rupture disc maintenance. The company had used rupture pin valves as vent relief devices in conjunction with development by Rick Austin of inert gas methods to protect the inner casing wall and outer carrier pipeline wall in pipeline road crossings. The design relies on rupture pin valves set at 5 psi to isolate vent openings from the atmosphere prior to purging the annular space between the pipeline and casing with inert gas to prevent corrosion. Speciality Pipeline Inspection and Engineering Inc., Houston, is licensed to distribute the equipment for the new cased-crossing procedure

  5. in OECD countries concerning biological drugs

    African Journals Online (AJOL)

    Jane

    2011-08-22

    Aug 22, 2011 ... the pharmaceutical sector about biological drugs come under the umbrella of innovation system of each country. ... The cost of biotechnology R and D within public research centres and ... Existence of a suitable system to protect intellectual property ... biotechnology that provide the capital for industry and.

  6. Industrial radiography in the Philippines: safety concerns

    International Nuclear Information System (INIS)

    David, Jocelyn L.; Artificio, Thelma P.; Cerbolles, Justina S.; Caseria, Estrella S.; Agron, Inocencio A.

    2005-01-01

    Industrial radiography utilizes the highest activity (5.55 tera becquerel (TBq) to 7.4 TBq) among the various mobile application of radioisotopes. It is highly possible that radiographers exceed the annual dose limits for workers occupationally exposed to radiation (as prescribed in the Code of PNRI Regulations part 3) if they do not give cautious consideration to the factors that determine the radiation dose, namely: the gamma source dose rates, time distance and shielding. To enhance the safety culture among radiographers, various strategies are recommended to be undertaken by the Philippine Nuclear Research Institute as well as the licensed companies undertaking activities in industrial radiography. (Authors)

  7. Radiation safety concerns during interventional radiology

    International Nuclear Information System (INIS)

    Victor Raj, D.; Livingstone, Roshan Samuel

    2001-01-01

    Interventional radiological procedures are on the increase by virtue of the fact that these procedures replace highly invasive surgical and other procedures. Radiation dose to patients and hospital workers are of significance since these procedures tend to impart large dose to them. Moreover, long term risk from radiation absorbed by patients is of concern since the life expectancy of major fraction of patients is long after undergoing the procedure. This study intends to measure radiation dose imparted to patients as well as personnel- radiologists, technologists, nurses, etc. and estimate the risk factor involved

  8. Losing nuclear expertise - A safety concern

    International Nuclear Information System (INIS)

    Ziakova, M.

    2002-01-01

    Full text: Since the mid of eighties several important changes in human beings behaviour, which influence nuclear field, can be observed - the loss of interest in studying technical disciplines (namely nuclear), strong pressure of environmental movements, stagnation of electricity consumption and deregulation of electric markets. All these factors create conditions which are leading to the decrease of job positions related to the nuclear field connected particularly with research, design and engineering. Loss of interest in studying nuclear disciplines together with the decrease of number of job positions has led to the declining of university enrolments, closing of university departments and research reactors. In this manner just a very small number of appropriately educated new experts are brought In the same moment the additional internal factor - the relative ageing of the human workforce on both sites operators of nuclear facilities and research and engineering organisations can be observed. All these factors, if not addressed properly, could lead to the loss of nuclear expertise and the loss of nuclear expertise represents the direct thread to the nuclear safety. The latest studies have shown that at present NPPs cannot be replaced by other kinds of electric sources and in no case by renewable ones in an efficient manner. Therefore it is necessary to carefully manage knowledge gathered in the nuclear field during the years and to keep on the nuclear safety research, education and training to ensure and upgrade safe and reliable operation of existing and future nuclear facilities. This is responsibility of both the governments of the states using nuclear applications and owners of nuclear facilities. (author)

  9. Do Online Bicycle Routing Portals Adequately Address Prevalent Safety Concerns?

    Directory of Open Access Journals (Sweden)

    Martin Loidl

    2018-03-01

    Full Text Available Safety concerns are among the most prevalent deterrents for bicycling. The provision of adequate bicycling infrastructure is considered as one of the most efficient means to increase cycling safety. However, limited public funding does not always allow agencies to implement cycling infrastructure improvements at the desirable level. Thus, bicycle trip planners can at least partly alleviate the lack of adequate infrastructure by recommending optimal routes in terms of safety. The presented study provides a systematic review of 35 bicycle routing applications and analyses to which degree they promote safe bicycling. The results show that most trip planners lack corresponding routing options and therefore do not sufficiently address safety concerns of bicyclists. Based on these findings, we developed recommendations on how to better address bicycling safety in routing portals. We suggest employing current communication technology and analysis to consider safety concerns more explicitly.

  10. 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

  11. Aviation Safety: FAA and DOD Response to Similar Safety Concerns

    National Research Council Canada - National Science Library

    2002-01-01

    .... The Federal Aviation Administration (FAA) and the military services often face common safety issues as they oversee the operation of similar aircraft or even dissimilar aircraft that use common parts and materials...

  12. Ayurveda formulations: A roadmap to address the safety concerns

    Directory of Open Access Journals (Sweden)

    Kishor Patwardhan

    2017-10-01

    Full Text Available It is a matter of serious concern that the number of case reports pointing at a possible association between the clinical toxicity and the use of Ayurveda formulations is increasing significantly over the years in scientific medical literature. Though most of these cases are connected with the presence of heavy metals such as lead, mercury and arsenic in these formulations, there are also reports suggesting toxicity due to the presence of toxic chemicals of herbal origin. In the year 2008, the Government of India took an initiative of establishing the National Pharmacovigilance Programme for Ayurveda, Siddha and Unani drugs in a structured way. However, due to lack of sustained support, this program has now become defunct. This issue is of vital importance and needs to be addressed effectively on a priority basis. In this communication, we propose the following crucial policy interventions to be introduced at different levels: a. Amendments to Drug and Cosmetic Act, b. Issuing consumer guidelines, c. Issuing prescription guidelines, d. Issuing clinical monitoring guidelines, e. Implementation of good manufacturing guidelines, f. Promoting documentation of clinical safety, g. Identifying the sources of contamination, and, h. Provision for stringent punishment. If these policy interventions are taken up and implemented, a significant positive change in the scenario can be expected in the near future.

  13. International antiterrorist conventions concerning the safety of air transport

    Directory of Open Access Journals (Sweden)

    Jacek BARCIK

    2008-01-01

    Full Text Available In this article the international law regulations are presented concerning the civilian safety of the air transport. The history concerning air terrorism and international antiterrorist conventions was described in detail, involving The Chicago Convention, The Tokyo Convention, The Hague Convention and Montreal Convention.

  14. Safety concerns and risk management of multiple sclerosis therapies

    DEFF Research Database (Denmark)

    Soelberg Sorensen, P.

    2017-01-01

    Currently, more than ten drugs have been approved for treatment of relapsing-remitting multiple sclerosis (MS). Newer treatments may be more effective, but have less favorable safety record. Interferon-β preparations and glatiramer acetate treatment require frequent subcutaneous or intramuscular...... disease activity can choose between dimethyl fumarate and teriflunomide or the “old injectable.” Patients with very active MS may choose a more effective drug as the initial treatment. In case of side effects on one drug, switch to another drug can be tried. Suboptimal effect of the first drug indicates...... escalation to a highly efficacious drug. A favorable benefit-risk balance can be maintained by appropriate patient selection and appropriate risk management on therapy. New treatments will within the coming 1-2 years change our current treatment algorithm for relapsing-remitting MS....

  15. Safety considerations concerning light water reactors in Sweden

    International Nuclear Information System (INIS)

    Nilsson, T.

    1977-01-01

    In 1975 the Swedish Nuclear Power Inspectorate was commissioned by the Government to perform a Reactor Safety Study concerning commercial light water reactors. The study will contain an account of: - rules and regulations for reactor designs; - operation experience of the Swedish nuclear power plants with international comparisons; - the development of reactor designs during the last 10 years; - demands and conditions for inspection and inspection methods; - nuclear power plant operation organization; - training of operators; and - the results of research into nuclear safety. The study is scheduled for completion by July 1st, 1977, however, this paper gives a summary of the results of the Reactor Safety Study already available. The paper contains detailed statistics concerning safety related occurrences and reactor scrams in Sweden from July 1st, 1974 until the beginning of 1977

  16. Drug safety and the impact of drug warnings

    DEFF Research Database (Denmark)

    Hostenkamp, G.; Fischer, K. E.; Borch-Johnsen, K.

    2016-01-01

    Objective To analyse the impact of drug safety warnings from the European Medicines Agency (EMA) on drug utilisation and their interaction with information released through national reimbursement bodies. Methods Insurance claims data on anti-diabetic drug prescriptions in primary care in Germany...

  17. Pre-Exposure Prophylaxis for HIV Prevention : Safety Concerns

    NARCIS (Netherlands)

    Tetteh, Raymond A; Yankey, Barbara A; Nartey, Edmund T; Lartey, Margaret; Leufkens, Hubert G M; Dodoo, Alexander N O

    Available evidence supports the efficacy of pre-exposure prophylaxis (PrEP) in decreasing the incidence of human immunodeficiency virus (HIV) infection among high-risk individuals, especially when used in combination with other behavioural preventive methods. Safety concerns about PrEP present

  18. Cyber-pharmacies and emerging concerns on marketing drugs online

    Directory of Open Access Journals (Sweden)

    Vinod Scaria

    2003-08-01

    Full Text Available The booming e-commerce and a regulation-less environment online have led to the rise of a new generation of websites that market drugs and other products over the Internet. Some of these drugs are often herbal products or of dubious quality, often marketed with a mix of professional design and unverified/fraudulent claims. Several concerns have arisen from different corners and evidence of malpractice has emerged. But there is a lack of sufficient evidence confirming the concerns.

  19. Food safety concerns of fast food consumers in urban Ghana.

    Science.gov (United States)

    Omari, Rose; Frempong, Godfred

    2016-03-01

    In Ghana, out-of-home ready-to-eat foods including fast food generally have been associated with food safety problems. Notwithstanding, fast food production and consumption are increasing in Ghana and therefore this study sought to determine the food safety issues of importance to consumers and the extent to which they worry about them. First, through three focus group discussions on consumers' personal opinions about food safety issues, some emergent themes were obtained, which were used to construct an open-ended questionnaire administered face-to-face to 425 respondents systematically sampled from 20 fast food restaurants in Accra. Findings showed that most fast food consumers were concerned about food hazards such as pesticide residue in vegetables, excessive use of artificial flavour enhancers and colouring substances, bacterial contamination, migrated harmful substances from plastic packages, and general unhygienic conditions under which food is prepared and sold. Consumers also raised concerns about foodborne diseases such as cholera, typhoid, food poisoning, diarrhoea, bird flu and swine flu. The logistic regression model showed that being male increased the likelihood of worrying about general food safety issues and excessive use of flavour enhancers than in females while being youthful increased the likelihood of being worried about typhoid fever than in older consumers. These findings imply that consumers in urban Ghana are aware and concerned about current trends of food safety and foodborne disease challenges in the country. Therefore, efforts targeted at improving food safety and reducing incidences of foodborne diseases should not only focus on public awareness creation but should also design more comprehensive programmes to ensure the making of food safety rules and guidelines and enforcing compliance to facilitate availability and consumers' choice of safe foods. Copyright © 2015 Elsevier Ltd. All rights reserved.

  20. Predictive toxicology in drug safety

    National Research Council Canada - National Science Library

    Xu, Jinghai J; Urban, Laszlo

    2011-01-01

    .... It provides information on the present knowledge of drug side effects and their mitigation strategy during drug discovery, gives guidance for risk assessment, and promotes evidence-based toxicology...

  1. Food colors: Existing and emerging food safety concerns.

    Science.gov (United States)

    Oplatowska-Stachowiak, Michalina; Elliott, Christopher T

    2017-02-11

    Food colors are added to different types of commodities to increase their visual attractiveness or to compensate for natural color variations. The use of these additives is strictly regulated in the European Union, the United States, and many other countries worldwide. There is a growing concern about the safety of some commonly used legal food colorants and there is a trend to replace the synthetic forms with natural products. Additionally, a number of dyes with known or suspected genotoxic or carcinogenic properties have been shown to be added illegally to foods. Robust monitoring programs based on reliable detection methods are required to assure the food is free from harmful colors. The aim of this review is to present an up to date status of the various concerns arising from use of color additives in food. The most important food safety concerns in the field of food colors are lack of uniform regulation concerning legal food colors worldwide, possible link of artificial colors to hyperactive behavior, replacement of synthetic colors with natural ones, and the presence of harmful illegal dyes-both known but also new, emerging ones in food. The legal status of food color additives in the EU, United States, and worldwide is summarized. The reported negative health effects of both legal and illegal colors are presented. The European Rapid Alert System for Food and Feed notifications and US import alerts concerning food colors are analyzed and trends in fraudulent use of color additives identified. The detection methods for synthetic colors are also reviewed.

  2. Drug Safety Crises Management in Pharmacovigilance

    Directory of Open Access Journals (Sweden)

    Gloria Shalviri

    2018-05-01

    Full Text Available Background: Adverse drug events can cause serious consequences including death. A published report by Lazarou et al in 1998 showed that adverse drug events were the 4th to 6th leading cause of death in the United States. These events may lead to drug safety crises in some issues, which need to take crises management process for solving the problem and/or preventing similar events.Objectives: To evaluate nature of drug safety crises based on adverse events reported to Iranian Pharmacovigilance Center from 1999 through 2012. To mention success and failure outcomes of crises management process taken against detected crises.Methods: All adverse drug events received by Iranian Pharmacovigilance Center from 1999 through 2012 were evaluated for reports with fatal outcome. All alerting letters and manuscripts published by the Center during the same period were reviewed for detailed information on detected crises. World Health Organization definition was used for detecting drug safety crises.Results: Among 42036 registered cases in our database, 463 deaths were recorded. The most frequent suspected drug for adverse events with fatal outcome was ceftriaxone (100 cases. Ten different drug safety crises issues were detected during the study period and their successful or failure outcomes were evaluated. There were 112 issued alerting letters and 17 published manuscript during the same period which was monitored for detailed information.  Conclusion: It is necessary for national pharmacovigilance centers to have prepared programs for crises management. This could be useful for reducing drug related mortality.

  3. Shoe concerns and foot problems of wearers of safety footwear.

    Science.gov (United States)

    Marr, S J; Quine, S

    1993-05-01

    In Australia workers in many industries are required to wear safety footwear (footwear incorporating a steel toe cap). An investigation of the problems reported by 321 workers (70 per cent male) employed in a broad range of work activities and required to wear safety footwear was conducted in 1990 and 1991. Respondents were interviewed by a professionally trained podiatrist using a structured questionnaire followed by a foot examination. An extremely high percentage (91 per cent) of subjects reported one or more foot problems (which were verified by the podiatrist), and most considered that the safety footwear either caused the problem or adversely affected an existing foot condition. The main shoe concerns reported were excessive heat (65 per cent of all respondents), inflexible soles (52 per cent), weight (48 per cent) and pressure from steel toe cap (47 per cent). Certain gender differences were identified. General recommendations are made.

  4. [Legislation concerning alcohol and drug intake in the workplace].

    Science.gov (United States)

    Goszczyńiska, Eliza

    2013-01-01

    It is likely that the complex law concerning alcohol and drugs in the workplace is one of the reasons for unwillingness to resolve the problem of intake of such psychoactive substances by employees. 'Iherefore, the author made an attempt to depict Polish legislation in this field based on the review of legal acts and regulations, as well as on their extensive judiciary interpretation. Such an information can be used by employers in developing their workplace policy of diminishing the intake of psychoactive substances by employees. This information can also be helpful for the bodies supporting workplaces in solving problems derived from alcohol and drugs consumption, such as occupational medicine specialists and local governments.

  5. The safety concept of the Federal Government concerning waste management

    International Nuclear Information System (INIS)

    Pfaffelhuber, J.K.

    1976-01-01

    The safety concept of the FRG concerning waste management is based on the ultimate aim of having in operation until 1985 nuclear power plants with a capacity of approx. 45,000 MWe, i.e. 50 nuclear power plants with an annual fuel consumption of 1,500 tons. A critical survey shows that there is still a great number of questions to be solved, concerning the fuel cycle in particular in terms of industrial standards, and that various problems ought to be the subject of R and D activities. Activities in the field of waste management so far are concerned only with project studies and details of project definition studies. On the one hand, the principles of the safety concept for waste management are to make possible and to guarantee the operation of nuclear facilities, and on the other hand, they are to subject those facilities which serve the purpose of waste disposal to similar safety regulations as the nuclear power plants are subjected to. The integrated waste disposal system of the Federal government for CWRs until the mid eighties is described. R+D activities are still necessary, in particular concerning reprocessing techniques, techniques in the reprocessing of Pu, the conditioning of highly active wastes, testing final storage techniques, and in the field of retention of gaseous radioactive nuclides (iodine, krypton, tritium) and of safeguarding waste disposal parks against terrorists and sabotage. The legal basis for the protection of the citizen is the Atomic Energy Act and its ordinances, EURATOM basic standards, and ICRP recommendations, some of which were tightened up for the FRG. Some recommendations of the Strahlenschutzkommision - radiation exposure, storage and separation of 85 Kr, 129 J, 131 J, and 133 Xe - are dealt with in detail. (HPH/LN) [de

  6. Drug safety evaluation of defibrotide.

    Science.gov (United States)

    Richardson, Paul G; Corbacioglu, Selim; Ho, Vincent Trien-Vinh; Kernan, Nancy A; Lehmann, Leslie; Maguire, Craig; Maglio, Michelle; Hoyle, Margaret; Sardella, Marco; Giralt, Sergio; Holler, Ernst; Carreras, Enric; Niederwieser, Dietger; Soiffer, Robert

    2013-01-01

    Hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), is a potentially life-threatening complication of chemotherapeutic conditioning used in preparation for hematopoietic stem-cell transplantation (SCT). Defibrotide (DF) has been shown in Phase II and III trials to improve complete response in patients with severe VOD (sVOD). None of the articles, to date, provide a comprehensive review of the safety of DF in VOD and/or a range of other conditions. This article reviews current clinical findings on DF, primarily in terms of safety for use in treatment and prophylaxis of VOD, and relevant safety data for its use in other diseases. The literature review was conducted using a PubMed search with the fixed term 'defibrotide' in combination with ≥ 1 of 'safety', 'veno-occlusive disease' (with and without 'treatment', 'prevention'), 'oncology', 'myeloma', 'microangiopathy', 'anti-thrombotic' and 'peripheral vascular disorder'. Related articles from the EBMT and ASH conference websites were also included. DF was well tolerated in majority of the studies. The safety profile of DF is largely favourable with toxicities comparable to control populations in the setting of SCT complicated by sVOD.

  7. Safety and efficacy of drugs in pregnancy.

    Science.gov (United States)

    Knoppert, David

    2011-01-01

    Although most drugs are used to treat chronic or pregnancy-induced conditions during pregnancy and lactation, very few are studied in pregnant or breastfeeding women. The information we have on drugs taken during pregnancy and lactation is usually obtained after market approval through published case reports or case series and from pregnancy exposure or retrospective birth defect registries. Furthermore, generic drugs approved for use in this vulnerable population may be approved based on results from a male trial population. This disregards the changes that can occur during pregnancy which can affect the pharmacokinetics of drugs. In an effort to improve the information provided to prescribers, in 2008 the United States Food and Drug Administration proposed a change in product labelling where information from pregnancy exposure registries would be required. As of 2009, European Medicines Agency requires additional statements on use during pregnancy within drug labelling information. In Canada, it is anticipated that the efficacy and safety of drugs in pregnancy will be included under the Drug Safety and Effectiveness Network initiative, and that this will offer a unified approach for such assessments. Pregmedic, a non-profit organization for the advancement of safe and effective use of drugs in pregnancy, has presented a number of proposals and draft guidelines to Health Canada on the inclusion of pregnant women in pharmacokinetic studies and the establishment of registries for women who take drugs during pregnancy. Pregmedic advocates for ensuring that drugs indicated for women are studied in women.

  8. Questionnaire responses concerning safety issues in MR examination

    International Nuclear Information System (INIS)

    Yamaguchi-Sekino, Sachiko; Nakai, Toshiharu; Muranaka, Hiroyuki

    2011-01-01

    Recently, the rising numbers of medical implants and scanners with higher static magnetic field have increased safety concerns for magnetic resonance (MR) examination. To determine future safety focus, we distributed anonymous questionnaires to 3250 members of the Japanese Society for Magnetic Resonance in Medicine (JSMRM) and received 978 responses. Safety issues on the questionnaire concentrated on the handling of patients with implants (Q7-18, appendix), acoustic trauma due to scanning (Q19-21, appendix), and MR compatibility within the scanner room (Q22-25, appendix). Ninety-three percent of respondents indicated they had encountered cases with implants or medical materials of unknown MR compatibility; 21.7% reported heating problems and 15.0%, nerve stimulation problems, in patients with implants during MR examination. Although 88.7% of respondents recognized the term ''MR compatibility'', 68.2% indicated limited detailed understanding of the term. Eleven percent had had cases with suspected acoustic injury from MR scanner noise. Scanner noise levels were not clarified in any way in 37.4% cases, but 69.5% applied ear protection to patients. Labeling of ''MR compatibility'' of equipment brought into the MR scanner room was reported by 71.9%. More than 50% experienced MR compatibility issues related to equipment brought into the MR scanner room. With regard to safety issues on metallic objects which are implanted in MR workers, 88.1% indicated they would continue current operations even the implant is inside the body. Respondents identified lectures and seminars by professional societies, safety training by manufacturers, and information from the Internet and literature as the 3 main sources for up-dating safety information for MR examination. (author)

  9. Safety concerns for superconducting magnets of upcoming fusion experiments

    International Nuclear Information System (INIS)

    Turner, L.R.

    1983-01-01

    -Several fusion experiments being constructed (Tore Supra) or contemplated (DCT 8, Alcator DCT) feature superconducting coils. These coils introduce the following safety concerns: 1. Internally Cooled Conductor (ICC). ICC's are found to be highly stable against short heat pulses, even when the coolant is stagnant or moving at low steady-state velocity. However, a large heat pulse is certain to quench the conductor. Thus, determining the stability limits is vital. 2. Helium II Cooling. Helium II has both unique advantages as a coolant and unique safety problems. 3. Shorted Turns. In magnets with shorts from operational accidents, the current can switch back and forth between the short and the shorted turns, as those alternatively go normal and superconducting. 4. Hybrid Superconducting-Normal Conducting Coil System. The possibility of unequal currents in the different magnets and thus of unexpected forces on the superconducting magnets is much greater than for an all-superconducting system. Analysis of these problems are presented

  10. Development of safety analysis technology for integral reactor; evaluation on safety concerns of integral reactor

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Hee Chul; Kim, Woong Sik; Lee, J. H. [Korea Institute of Nuclear Safety, Taejeon (Korea)

    2002-03-01

    The Nuclear Desalination Plant (NDP) is being developed to produce electricity and fresh water, and is expected to locate near population zone. In the aspect of safety, it is required to protect the public and environment from the possible releases of fission products and to prevent the fresh water from the contamination of radioactivity. Thus, in this study, the safety characteristics of the integral reactor adopting passive and inherent safety features significantly different from existing nuclear power plants were investigated. Also, safety requirements applicable to the NDP were analyzed based on the regulatory requirements for current light water reactor and advanced reactor designs, and user requirements for small-medium size reactors. Based on these analyses, some safety concerns to be considered in the design stage have been identified and discussed. They include the use of proven technology for new safety features, systematic event classification and selection, strengthening containment function, and the safety impacts on desalination-related systems. The study presents the general safety requirements applicable to licensing of an integral reactor and suggests additional regulatory requirements, which need to be developed, based on the direction to resolution of the safety concerns. The efforts to identify and technically resolve the safety concerns in the design stage will provide the early confidence of SMART safety and the technical basis to evaluate the safety to designers and reviewers in the future. Suggestion on the development of additional regulatory requirements will contribute for the regulator to taking actions for licensing of an integral reactor. 66 refs., 5 figs., 24 tabs. (Author)

  11. Legislation concerning alcohol and drug intake in the workplace

    Directory of Open Access Journals (Sweden)

    Eliza Goszczyńska

    2013-08-01

    Full Text Available It is likely that the complex law concerning alcohol and drugs in the workplace is one of the reasons for unwillingness to resolve the problem of intake of such psychoactive substances by employees. Therefore, the author made an attempt to depict Polish legislation in this field based on the review of legal acts and regulations, as well as on their extensive judiciary interpretation. Such an information can be used by employers in developing their workplace policy of diminishing the intake of psychoactive substances by employees. This information can also be helpful for the bodies supporting workplaces in solving problems derived from alcohol and drugs consumption, such as occupational medicine specialists and local governments. Med Pr 2013;64(4:593–608

  12. Toxicophores: Investigations in drug safety

    International Nuclear Information System (INIS)

    Williams, Dominic P.

    2006-01-01

    Adverse drug reactions, such as hepatotoxicity, blood dyscrasias and hypersensitivity are a major obstacle for the use and the development of new medicines. Many forms of organ-directed toxicity can arise from the bioactivation of drugs to the so-called chemically reactive metabolites, which can modify tissue macromolecules. It is well established that the toxicities of model hepatotoxins, such as acetaminophen, furosemide, bromobenzene and methapyrilene can be correlated with the generation of chemically reactive metabolites, which can be detected by measurement of the irreversible binding of radiolabelled material to hepatic protein and/or the detection of stable phase II metabolites such as glutathione conjugates. The basic chemistry of the reaction of such metabolites with model nucleophiles is relatively well understood. A major challenge is to define how certain reactive intermediates may chemically modify critical proteins and how modification of specific amino acids may alter protein function which in turn may affect cell signalling, regulation, defence, function and viability. This in turn will determine whether or not bioactivation will result in a particular form of drug-induced injury. It is now clear that even relatively simple reactive intermediates can react in a discriminative manner with particular cellular proteins and even with specific amino acids within those proteins. Therefore, both non-covalent, as well as covalent bonds will be important determinants of the target protein for a particular reactive metabolite. Mammalian cells have evolved numerous defence systems against reactive intermediates. Sensitive redox proteins such as Nrf-2 recognise oxidative stress and electrophilic agents, through oxidation or covalent modification of thiol groups. Defence genes, such as epoxide hydrolase and glutamate cysteine ligase then become up-regulated in an attempt to reduce the oxidising environment. However, whether the liver receives mild or severe

  13. The root cause of patient safety concerns in an Internet pharmacy.

    Science.gov (United States)

    Montoya, Isaac D

    2008-07-01

    The Internet has become a revolutionary technology that affords worldwide opportunities never seen before. One such opportunity is the purchase of drugs over the Internet and the business of Internet pharmacies which has become prolific. Associated with this proliferation is the concern for patient safety. Numerous studies have shown that drugs purchased over the Internet come from pharmacies in a country other than the one where the patient resides and these pharmacies are not licensed, sometimes provide drugs without a prescription and that are not of the same composition as they should be, and do not provide adequate directions to the patient. In addition, the packaging of the drugs may be compromised resulting in altered medication. This paper examines the root cause of patient safety issues in Internet pharmacies. A review of the literature including the marketing literature was conducted. Healthcare marketing concepts guide business owners to identify patients' wants and distinguish them from their needs. Marketing principles detail aggressive marketing strategies within an organization's mission and in an ethical manner. Some Internet pharmacies misinterpret proven marketing principles and become overly aggressive in the market place focusing only on sales and profit rather than focusing on patient safety and long-term success of the Internet pharmacy.

  14. Social media in health--what are the safety concerns for health consumers?

    Science.gov (United States)

    Lau, Annie Y S; Gabarron, Elia; Fernandez-Luque, Luis; Armayones, Manuel

    Recent literature has discussed the unintended consequences of clinical information technologies (IT) on patient safety, yet there has been little discussion about the safety concerns in the area of consumer health IT. This paper presents a range of safety concerns for consumers in social media, with a case study on YouTube. We conducted a scan of abstracts on 'quality criteria' related to YouTube. Five areas regarding the safety of YouTube for consumers were identified: (a) harmful health material targeted at consumers (such as inappropriate marketing of tobacco or direct-to-consumer drug advertising); (b) public display of unhealthy behaviour (such as people displaying self-injury behaviours or hurting others); (c) tainted public health messages (i.e. the rise of negative voices against public health messages); (d) psychological impact from accessing inappropriate, offensive or biased social media content; and (e) using social media to distort policy and research funding agendas. The examples presented should contribute to a better understanding about how to promote a safe consumption and production of social media for consumers, and an evidence-based approach to designing social media interventions for health. The potential harm associated with the use of unsafe social media content on the Internet is a major concern. More empirical and theoretical studies are needed to examine how social media influences consumer health decisions, behaviours and outcomes, and devise ways to deter the dissemination of harmful influences in social media.

  15. Preventing errors in administration of parenteral drugs: the results of a four-year national patient safety program.

    NARCIS (Netherlands)

    Blok, C. de; Schilp, J.; Wagner, C.

    2013-01-01

    Objectives: To evaluate the implementation of a four-year national patient safety program concerning the parenteral drug administration process in the Netherlands. Methods: Structuring the preparation and administration process of parenteral drugs reduces the number of medication errors. A

  16. Production of neutrons in particle accelerators: a PNRI safety concern

    International Nuclear Information System (INIS)

    Garcia, Corazon M.; Cayabo, Lynette B.; Artificio, Thelma P.; Melendez, Johnylen V.; Piquero, Myrna E.; Parami, Vangeline K.

    2002-09-01

    In the safety assessment made for the first cyclotron facility in the Philippines, that is the cyclotron in the P.E.T. (Positron Emission Tomography) center of the St. Luke's Medical Center, the concern on the production of neutrons associated with the operation of particle accelerators has been identified. This takes into consideration the principles in the operation of particle accelerators and the associated production of neutrons resulting from their operation, the hazards and risks in their operation. The Bureau of Health Devices and Technology (BHDT) of the Department of Health in the Philippines regulates and controls the presently existing six (6) linear accelerators distributed in different hospitals in the country, being classified as x-ray producing devices. From the results of this study, it is evident that the production of neutrons from the operation of accelerators, produces neutrons and that activation due to neutrons can form radioactive materials. The PNRI (Philippine Nuclear Research Institute) being mandated by law to regulate and control any equipment or devices producing or utilizing radioactive materials should take the proper steps to subject all accelerator facilities and devices in the Philippines such as linear accelerators under its regulatory control in the same manner as it did with the first cyclotron in the country. (Author)

  17. Health and safety concerns of textiles with nanomaterials

    Science.gov (United States)

    Almeida, L.; Ramos, D.

    2017-10-01

    There is a growing concern related to the effects of nanomaterials in health and safety.Nanotechnologies are already present in many consumer products, including textiles. “Nanotextiles” can be considered as traditional textiles with the incorporation of nanoparticles. They present often functionalities such as antibacterial, ultraviolet radiation protection, water and dirt repellency, self-cleaning or flame retardancy. Nanoparticles can be released from the textile materials due to different effects (abrasion and other mechanical stresses, sweat, irradiation, washing, temperature changes, etc.). It is then expectable that “nanotextiles” may release individual nanoparticles, agglomerates of nanoparticles or small particles of textile with or without nanoparticles, depending on the type of integration of the nanoparticles in textiles. The most important exposure route of the human body to nanoparticles in case of textiles is skin contact. Several standards are being developed under the auspices of the European Committee for Standardization. In this paper, it is presented the development and application of a test method to evaluate the skin exposure to nanoparticles, to evaluate the transfer of the nanoparticles from the textile to the skin by the effect of abrasion and sweat.

  18. Nuclear safety. Concerns about the nuclear power reactors in Cuba

    International Nuclear Information System (INIS)

    Wells, Jim; Aloise, Gene; Flaherty, Thomas J.; Fitzgerald, Duane; Zavala, Mario; Hayward, Mary Alice

    1992-09-01

    the atmosphere, contains defective welds. Another said that reactor operator trainees have received training on inadequate reactor simulators. In contrast, a representative of the Cuban government told us that Cuba wants to build its reactor in accordance with safety standards. Also, according to information provided to us by a representative of the Russian government, Cuba's reactor has been constructed according to safety rules that take into account, among other things, the possible impacts of an earthquake. State Department, NRC, and DOE officials have expressed a number of concerns about the construction and operation of Cuba's nuclear power reactors. According to State Department officials, the United States maintains a comprehensive embargo on any U.S. transactions with Cuba and discourages other countries from providing assistance, except for safety purposes, to Cuba's nuclear power program. The United States would prefer that the construction of the reactors never be completed and wants Cuba to sign the Non-Proliferation Treaty or the Treaty of Tlatelolco, both of which bind signatories to blanket nonproliferation commitments for their entire nuclear program, before the United States considers reversing its policy of discouraging other countries from assisting Cuba with the construction of the reactors. The United States has asked Russia to cease providing any nuclear assistance until Cuba has signed either treaty. NRC officials are aware of, but could not verify, the Cuban emigres' allegations of safety deficiencies because available information was limited. They said, however, that if the allegations were true, the cited deficiencies could affect the safety of the reactors operation. In addition, they expressed concern about the ability of Cuba's industrial infrastructure to support the nuclear power reactors, the lack of a regulatory structure, the adequacy of training for reactor operators, the quality of the civil construction, and the design of the

  19. Definitive closure of nuclear power plants. Aspects concerning physical safety

    International Nuclear Information System (INIS)

    Rodriguez, C.; Puntarulo, L.; Canibano, J.

    1988-01-01

    This paper analyzes the various safety requirements that must be fulfilled by nuclear power plants for their operation without restrictions, such as safeguards, nuclear safety and physical protection. Physical protection, the subject most extensively dealt by the authors, is defined as safety measures aimed at providing protection against deliberate hostile deeds, such as robberies or non-authorized transport of radioactive materials or sabotage in nuclear facilities, performed either by individuals or by groups of individuals. (Author)

  20. Safety regulations concerning instrumentation and control systems for research reactors

    International Nuclear Information System (INIS)

    El-Shanshoury, A.I.

    2009-01-01

    A brief study on the safety and reliability issues related to instrumentation and control systems in nuclear reactor plants is performed. In response, technical and strategic issues are used to accomplish instrumentation and control systems safety. For technical issues there are ; systems aspects of digital I and C technology, software quality assurance, common-mode software, failure potential, safety and reliability assessment methods, and human factors and human machine interfaces. The strategic issues are the case-by-case licensing process and the adequacy of the technical infrastructure. The purpose of this work was to review the reliability of the safety systems related to these technical issues for research reactors

  1. Drug safety: Pregnancy rating classifications and controversies.

    Science.gov (United States)

    Wilmer, Erin; Chai, Sandy; Kroumpouzos, George

    2016-01-01

    This contribution consolidates data on international pregnancy rating classifications, including the former US Food and Drug Administration (FDA), Swedish, and Australian classification systems, as well as the evidence-based medicine system, and discusses discrepancies among them. It reviews the new Pregnancy and Lactation Labeling Rule (PLLR) that replaced the former FDA labeling system with narrative-based labeling requirements. PLLR emphasizes on human data and highlights pregnancy exposure registry information. In this context, the review discusses important data on the safety of most medications used in the management of skin disease in pregnancy. There are also discussions of controversies relevant to the safety of certain dermatologic medications during gestation. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. New Automated System Available for Reporting Safety Concerns | Poster

    Science.gov (United States)

    A new system has been developed for reporting safety issues in the workplace. The Environment, Health, and Safety’s (EHS’) Safety Inspection and Issue Management System (SIIMS) is an online resource where any employee can report a problem or issue, said Siobhan Tierney, program manager at EHS.

  3. Tolerability and safety of antifungal drugs

    Directory of Open Access Journals (Sweden)

    Francesco Scaglione

    2013-08-01

    Full Text Available When treating critically ill patients, as those with fungal infections, attention should be focused on the appropriate use of drugs, especially in terms of dose, safety, and tolerability. The fungal infection itself and the concomitant physiological disorders concur to increase the risk of mortality in these patients, therefore the use of any antifungal agent should be carefully evaluated, considering both the direct action on the target fungus and the adverse effects eventually caused. Among antifungal drugs, echinocandins have the greatest tolerability. In fact, unlike amphotericin B, showing nephrotoxicity, and azoles, which are hepatotoxic, the use of echinocandins doesn’t result in major adverse events.http://dx.doi.org/10.7175/rhc.v4i2s.873

  4. 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.

  5. Progress report concerning safety research for nuclear reactor facilities

    International Nuclear Information System (INIS)

    1978-01-01

    Examination and evaluation of safety research results for nuclear reactor facilities have been performed, as more than a year has elapsed since the plan had been initiated in April, 1976, by the special sub-committee for the safety of nuclear reactor facilities. The research is carried out by being divided roughly into 7 items, and seems to be steadily proceeding, though it does not yet reach the target. The above 7 items include researches for (1) criticality accident, (2) loss of coolant accident, (3) safety for light water reactor fuel, (4) construction safety for reactor facilities, (5) reduction of release of radioactive material, (6) safety evaluation based on the probability theory for reactor facilities, and (7) aseismatic measures for reactor facilities. With discussions on the progress and the results of the research this time, research on the behaviour on fuel in abnormal transients including in-core and out-core experiments has been added to the third item, deleting the power-cooling mismatch experiment in Nuclear Safety Research Reactor of JAERI. Also it has been decided to add two research to the seventh item, namely measured data collection, classification and analysis, and probability assessment of failures due to an earthquake. For these 7 items, the report describes the concrete contents of research to be performed in fiscal years of 1977 and 1978, by discussing on most rational and suitable contents conceivable at present. (Wakatsuki, Y.)

  6. India's power program and its concern over environmental safety

    International Nuclear Information System (INIS)

    Prasad, G.E.; Mittra, J.

    2001-01-01

    India's need of electrical power is enormous and per capita consumption of power is to be increased at least by ten times to reach the level of world average. Thermal Power generation faces two fold problems. First, there is scarcity of good quality fuel and second, increasing environmental pollution. India's self reliant, three stage, 'closed-fuel-cycle' nuclear power program is promising better solution to the above problems. To ensure Radiation Protection and Safety of Radiation Sources, Indian Nuclear Power program emphasizes upon design and engineering safety by incorporating necessary safety features in the design, operational safety through structured training program and typically through software packages to handle rare unsafe events and regulation by complying safety directives. A health survey among the radiation workers indicates that there is no extra threat to the public from nuclear power program. Based on latest technology, as available in case of nuclear power option, it is quite possible to meet high energy requirement with least impact on the environment.. (authors)

  7. India's power programs and its concern over environmental safety

    International Nuclear Information System (INIS)

    Prasad, G.E.; Mittra, J.; Sarma, M.S.R.

    2000-01-01

    India's need for electrical power is enormous and per capita consumption of power is to be increased at least by 10 times to reach the level of the world average. Thermal power generation faces two-fold problems. First, there is scarcity of good quality fuel and second, increasing environmental pollution. India 's self reliant, . three stage, 'closed-fuel-cycle' nuclear power program is promising a better solution to the above problems. To ensure Radiation Protection and Safety of Radiation Sources, the Indian Nuclear Power program emphasizes upon design and engineering safety by incorporating' necessary safety features in the design, operational safety through a structured training program and typically through software packages to handle rare unsafe events and regulation by complying safety directives. A health survey among the radiation workers indicates that there is no extra threat to the public from the nuclear power program. Based on the latest technology, as available in case of the nuclear power option, it is quite possible to meet high energy requirements with least impact on the environment. (authors)

  8. Safety concerns related to modular/prefabricated building construction.

    Science.gov (United States)

    Fard, Maryam Mirhadi; Terouhid, Seyyed Amin; Kibert, Charles J; Hakim, Hamed

    2017-03-01

    The US construction industry annually experiences a relatively high rate of fatalities and injuries; therefore, improving safety practices should be considered a top priority for this industry. Modular/prefabricated building construction is a construction strategy that involves manufacturing of the whole building or some of its components off-site. This research focuses on the safety performance of the modular/prefabricated building construction sector during both manufacturing and on-site processes. This safety evaluation can serve as the starting point for improving the safety performance of this sector. Research was conducted based on Occupational Safety and Health Administration investigated accidents. The study found 125 accidents related to modular/prefabricated building construction. The details of each accident were closely examined to identify the types of injury and underlying causes. Out of 125 accidents, there were 48 fatalities (38.4%), 63 hospitalized injuries (50.4%), and 14 non-hospitalized injuries (11.2%). It was found that, the most common type of injury in modular/prefabricated construction was 'fracture', and the most common cause of accidents was 'fall'. The most frequent cause of cause (underlying and root cause) was 'unstable structure'. In this research, the accidents were also examined in terms of corresponding location, occupation, equipment as well as activities during which the accidents occurred. For improving safety records of the modular/prefabricated construction sector, this study recommends that future research be conducted on stabilizing structures during their lifting, storing, and permanent installation, securing fall protection systems during on-site assembly of components while working from heights, and developing training programmes and standards focused on modular/prefabricated construction.

  9. Safety and proliferation concerns as constraints on nuclear power

    International Nuclear Information System (INIS)

    Gordon, L.

    1981-01-01

    Issues of safety and proliferation with respect to the nuclear option are discussed in this chapter. The basic premises underlying the author's analysis are: energy supply and use is a means to promote desired forms of development and not an end in itself; avoidance of nuclear mysticiam; avoidance of permanent discrimination; recognition of incommensurables; technological sophistication; and nuclear proliferation motivations apart from nuclear power development. A rational energy planner in a developing country will have to weigh carefully the interwoven factors of comparative costs and safety. Apart from cost considerations, the principal motivation for developing nuclear power is energy security

  10. Identifying Food Safety Concerns when Communication Barriers Exist

    Science.gov (United States)

    Neal, Jack A.; Dawson, Mary; Madera, Juan M.

    2011-01-01

    Abstract: Students must be prepared to lead a diverse workforce. The objective of this study was to establish a teaching method that helps students identify barriers to food safety while working in a simulated environment with communication barriers. This study employed a perspective taking exercise based upon the principles of social learning…

  11. Ibogaine: complex pharmacokinetics, concerns for safety, and preliminary efficacy measures.

    Science.gov (United States)

    Mash, D C; Kovera, C A; Pablo, J; Tyndale, R F; Ervin, F D; Williams, I C; Singleton, E G; Mayor, M

    2000-09-01

    Ibogaine is an indole alkaloid found in the roots of Tabernanthe Iboga (Apocynaceae family), a rain forest shrub that is native to western Africa. Ibogaine is used by indigenous peoples in low doses to combat fatigue, hunger and thirst, and in higher doses as a sacrament in religious rituals. Members of American and European addict self-help groups have claimed that ibogaine promotes long-term drug abstinence from addictive substances, including psychostimulants and opiates. Anecdotal reports attest that a single dose of ibogaine eliminates opiate withdrawal symptoms and reduces drug craving for extended periods of time. The purported efficacy of ibogaine for the treatment of drug dependence may be due in part to an active metabolite. The majority of ibogaine biotransformation proceeds via CYP2D6, including the O-demethylation of ibogaine to 12-hydroxyibogamine (noribogaine). Blood concentration-time effect profiles of ibogaine and noribogaine obtained for individual subjects after single oral dose administrations demonstrate complex pharmacokinetic profiles. Ibogaine has shown preliminary efficacy for opiate detoxification and for short-term stabilization of drug-dependent persons as they prepare to enter substance abuse treatment. We report here that ibogaine significantly decreased craving for cocaine and heroin during inpatient detoxification. Self-reports of depressive symptoms were also significantly lower after ibogaine treatment and at 30 days after program discharge. Because ibogaine is cleared rapidly from the blood, the beneficial aftereffects of the drug on craving and depressed mood may be related to the effects of noribogaine on the central nervous system.

  12. Considerations concerning the reliability of reactor safety equipment

    International Nuclear Information System (INIS)

    Furet, J.; Guyot, Ch.

    1967-01-01

    A review is made of the circumstances which favor a good collection of maintenance data at the C.E.A. The large amount of data to be treated has made necessary the use of a computer for analyzing automatically the results collected. Here, only particular aspects of the reliability from the point of view of the electronics used for nuclear reactor control will be dealt with: sale and unsafe failures; probability of survival (in the case of reactor safety); availability. The general diagrams of the safety assemblies which have been drawn up for two types of reactor (power reactor and low power experimental reactor) are given. Results are presented of reliability analysis which could be applied to the use of functional modular elements, developed industrially in France. Improvement of this reliability appears to be fairly limited by an increase in the redundancy; on the other hand it is shown how it may be very markedly improved by the use of automatic tests with different frequencies for detecting unsafe failures rates of measurements for the sub-assemblies and for the logic sub-assemblies. Finally examples are given to show the incidence of the complexity and of the use of different technologies in reactor safety equipment on the reliability. (authors) [fr

  13. University Deals with Drug Companies Raise Concerns over Autonomy, Secrecy.

    Science.gov (United States)

    Nicklin, Julie L.

    1993-01-01

    The large, exclusive research deal the Scripps Research Institute (California) made with one drug company has drawn criticism for conflict of interest. Critics fear researchers will focus more on marketing than on pure science and will protect corporate interests. Much of the deal-making is with foreign companies, sending profits overseas. (MSE)

  14. Software Reliability Issues Concerning Large and Safety Critical Software Systems

    Science.gov (United States)

    Kamel, Khaled; Brown, Barbara

    1996-01-01

    This research was undertaken to provide NASA with a survey of state-of-the-art techniques using in industrial and academia to provide safe, reliable, and maintainable software to drive large systems. Such systems must match the complexity and strict safety requirements of NASA's shuttle system. In particular, the Launch Processing System (LPS) is being considered for replacement. The LPS is responsible for monitoring and commanding the shuttle during test, repair, and launch phases. NASA built this system in the 1970's using mostly hardware techniques to provide for increased reliability, but it did so often using custom-built equipment, which has not been able to keep up with current technologies. This report surveys the major techniques used in industry and academia to ensure reliability in large and critical computer systems.

  15. 76 FR 59142 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2011-09-23

    ...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the...., [[Page 59143

  16. 'Speaking up' about patient safety concerns and unprofessional behaviour among residents: validation of two scales.

    Science.gov (United States)

    Martinez, William; Etchegaray, Jason M; Thomas, Eric J; Hickson, Gerald B; Lehmann, Lisa Soleymani; Schleyer, Anneliese M; Best, Jennifer A; Shelburne, Julia T; May, Natalie B; Bell, Sigall K

    2015-11-01

    To develop and test the psychometric properties of two new survey scales aiming to measure the extent to which the clinical environment supports speaking up about (a) patient safety concerns and (b) unprofessional behaviour. Residents from six large US academic medical centres completed an anonymous, electronic survey containing questions regarding safety culture and speaking up about safety and professionalism concerns. Confirmatory factor analysis supported two separate, one-factor speaking up climates (SUCs) among residents; one focused on patient safety concerns (SUC-Safe scale) and the other focused on unprofessional behaviour (SUC-Prof scale). Both scales had good internal consistency (Cronbach's α>0.70) and were unique from validated safety and teamwork climate measures (rspeaking up behaviour about safety and professionalism concerns (r=0.21, pspeaking up behaviour among residents. These two scales may fill an existing gap in residency and safety culture assessments by measuring the openness of communication about safety and professionalism concerns, two important aspects of safety culture that are under-represented in existing metrics. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  17. College Student Drug Use: Patterns, Concerns, Consequences, and Interest in Intervention

    Science.gov (United States)

    Palmer, Rebekka S.; McMahon, Thomas J.; Moreggi, Danielle I.; Rounsaville, Bruce J.; Ball, Samuel A.

    2012-01-01

    Although previous surveys have indicated high rates of illicit and prescription drug misuse among college students, few have assessed negative consequences, personal concerns, or interest in interventions for drug use. In a survey of 262 college students who self-reported lifetime use of an illicit drug, 69% reported at least one negative…

  18. A Study on Drug Safety Monitoring Program in India

    Science.gov (United States)

    Ahmad, A.; Patel, Isha; Sanyal, Sudeepa; Balkrishnan, R.; Mohanta, G. P.

    2014-01-01

    Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were nonsteroidal antiinflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%). Majority of drugs have been banned since 3-5 years in other countries but are still available for sale in India. The present study compares the drug safety monitoring systems in the developed countries such as the USA and UK and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. Absence of a gold standard for a drug safety surveillance system, variations in culture and clinical practice across countries makes it difficult for India to completely adopt another country's practices. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers. PMID:25425751

  19. Frequent food insecurity among injection drug users: correlates and concerns

    Directory of Open Access Journals (Sweden)

    Strike Carol

    2012-12-01

    Full Text Available Abstract Background Food insecurity and nutrition are two topics that are under-researched among injection drug users (IDUs. Our study examined the extent and correlates of food insecurity among a sample of IDUs and explored whether there is an association between food insecurity and injection-related HIV risk. Methods A cross-sectional survey was conducted using interviewer-administered questionnaires. Data were collected at a needle exchange program in London, Ontario, Canada between September 2006 and January 2007. Participants included 144 English-speaking IDUs who had injected drugs in the past 30 days. Participants were asked about their socio-demographic characteristics, HIV risk behaviours, food insecurity, and health/social service use. Results In the past 6 months, 54.5% of participants reported that on a daily/weekly basis they did not have enough to eat because of a lack of money, while 22.1% reported this type of food insecurity on a monthly basis. Moreover, 60.4% and 24.3% reported that they did not eat the quality or quantity of food they wanted on a daily/weekly or a monthly basis, respectively. Participants reported re-using someone else’s injection equipment: 21% re-used a needle, 19% re-used water, and 37.3% re-used a cooker. The odds of sharing injection equipment were increased for food insecure individuals. Conclusions Findings show that IDUs have frequent and variable experiences of food insecurity and these experiences are strongly correlated with sharing of injection-related equipment. Such behaviours may increase the likelihood of HIV and HCV transmission in this population. Addressing food-related needs among IDUs is urgently needed.

  20. Criticality safety concerns of uranium deposits in cascade equipment

    International Nuclear Information System (INIS)

    Plaster, M.J.

    1996-01-01

    The Paducah and Portsmouth Gaseous Diffusion Plants enrich uranium in the 235 U isotope by diffusing gaseous uranium hexafluoride (UF 6 ) through a porous barrier. The UF 6 gaseous diffusion cascade utilized several thousand open-quotes stagesclose quotes of barrier to produce highly enriched uranium (HEU). Historically, Portsmouth has enriched the Paducah Gaseous Diffusion Plant's product (typically 1.8 wt% 235 U) as well as natural enrichment feed stock up to 97 wt%. Due to the chemical reactivity of UF 6 , particularly with water, the formation of solid uranium deposits occur at a gaseous diffusion plant. Much of the equipment operates below atmospheric pressure, and deposits are formed when atmospheric air enters the cascade. Deposits may also be formed from UF 6 reactions with oil, UF 6 reactions with the metallic surfaces of equipment, and desublimation of UF 6 . The major deposits form as a result of moist air in leakage due to failure of compressor casing flanges, blow-off plates, seals, expansion joint convolutions, and instrument lines. This report describes criticality concerns and deposit disposition

  1. Legal requirements concerning the technical safety of nuclear installations

    International Nuclear Information System (INIS)

    Nolte, R.

    1984-01-01

    A short survey on nuclear risks and the nuclear safety conception is followed by the attempted clear definition of the semantic import of section 7, sub-section (2), No. 3 of the Atomic Energy Act. There are first beginnings of a concretization of the state-of-the-art in science and technology, i.e. all kinds of sub-legislative regulations such as the regulations of the Radiation Protection Ordinance which show scientific substance, guidelines issued by the Ministers, as well as codes for practice set up by various technical bodies and standardization associations, all of which are designed to compensate for this loop hole in the legislation. This study goes to examine to what extent administration and jurisdiction may take into account such codes of practice for the concretization of the legal requirements, and whether they are even binding on those executing the law. Only the respective regulations of the Radiation Protection Ordinance have a binding effect. All other guidelines and codes of practice are not legally binding per se, nor are they capable of being legally permitted by being referred to in terms of legal norms or by the self-commitment of those executing the law. Any attempt of using them, as the basis of a prime facie evidence or as an anticipating expertise, at least evidentarily for the concretization will have to fail owing to their evaluating character and to the fact that they may interfere in sociological conflict. An exception may be a case where a clear distinction can be made as to what extent the contents of such codes of practice is related to scientific and technological findings or to decisions based on evaluations. In such a case, a prima facil evicdence for the conformity of the regulation in question with the state-of-the-art in science and technology may be considered, which would easy the concretization of Art. 7 II Section 3 of the Atomic Law. (orig./HSCH) [de

  2. An analysis of electronic health record-related patient safety concerns

    Science.gov (United States)

    Meeks, Derek W; Smith, Michael W; Taylor, Lesley; Sittig, Dean F; Scott, Jean M; Singh, Hardeep

    2014-01-01

    Objective A recent Institute of Medicine report called for attention to safety issues related to electronic health records (EHRs). We analyzed EHR-related safety concerns reported within a large, integrated healthcare system. Methods The Informatics Patient Safety Office of the Veterans Health Administration (VA) maintains a non-punitive, voluntary reporting system to collect and investigate EHR-related safety concerns (ie, adverse events, potential events, and near misses). We analyzed completed investigations using an eight-dimension sociotechnical conceptual model that accounted for both technical and non-technical dimensions of safety. Using the framework analysis approach to qualitative data, we identified emergent and recurring safety concerns common to multiple reports. Results We extracted 100 consecutive, unique, closed investigations between August 2009 and May 2013 from 344 reported incidents. Seventy-four involved unsafe technology and 25 involved unsafe use of technology. A majority (70%) involved two or more model dimensions. Most often, non-technical dimensions such as workflow, policies, and personnel interacted in a complex fashion with technical dimensions such as software/hardware, content, and user interface to produce safety concerns. Most (94%) safety concerns related to either unmet data-display needs in the EHR (ie, displayed information available to the end user failed to reduce uncertainty or led to increased potential for patient harm), software upgrades or modifications, data transmission between components of the EHR, or ‘hidden dependencies’ within the EHR. Discussion EHR-related safety concerns involving both unsafe technology and unsafe use of technology persist long after ‘go-live’ and despite the sophisticated EHR infrastructure represented in our data source. Currently, few healthcare institutions have reporting and analysis capabilities similar to the VA. Conclusions Because EHR-related safety concerns have complex

  3. Concern about the Expanding Prescription Drug Epidemic: A Survey of Licensed Prescribers and Dispensers.

    Science.gov (United States)

    Wright, R Eric; Reed, Nia; Carnes, Neal; Kooreman, Harold E

    2016-01-01

    Prescription drug misuse and abuse has reached epidemic levels in the U.S., and stands as a leading cause of death. As the primary gatekeepers to the medications contributing to this epidemic, it is critical to understand the views of licensed health care professionals. In this study, we examine health care professionals' concern regarding prescription drug abuse in their communities and the impact their concern has had on their prescribing and dispensing practices. An online survey of licensed health care providers. Conducted in Indiana. This study was a state-wide evaluation of Indiana's prescription drug monitoring program. The questionnaire asked respondents how concerned they were about prescription drug abuse in their community. Variation in the level of concern was examined using ordinary least squares regression and information about the respondents' demographic background and clinical experience. In addition, we used logistic regression to examine whether concern was associated with changing prescribing and/or dispensing behavior. The majority of providers indicated they were "moderately" or "extremely concerned" about prescription drug abuse in their communities. The level of concern, however, varied significantly by profession, with pharmacists, physicians, nurse practitioners/physician assistants being more concerned than dentists. Additional analyses indicate that providers with higher levels of concern were those who also reported recently changing their prescribing and/or dispensing behavior. The voluntary nature and geographical focus of the study limits the generalizability of the findings. Concern about prescription drug abuse is generally high across the major health care professions; however, a significant minority of providers, particularly among dentists, expressed little or no concern about the epidemic. Increasing health care providers' general level of concern about prescription drug abuse may be an effective public health tool for

  4. Impact of biomarker development on drug safety assessment

    International Nuclear Information System (INIS)

    Marrer, Estelle; Dieterle, Frank

    2010-01-01

    Drug safety has always been a key aspect of drug development. Recently, the Vioxx case and several cases of serious adverse events being linked to high-profile products have increased the importance of drug safety, especially in the eyes of drug development companies and global regulatory agencies. Safety biomarkers are increasingly being seen as helping to provide the clarity, predictability, and certainty needed to gain confidence in decision making: early-stage projects can be stopped quicker, late-stage projects become less risky. Public and private organizations are investing heavily in terms of time, money and manpower on safety biomarker development. An illustrative and 'door opening' safety biomarker success story is the recent recognition of kidney safety biomarkers for pre-clinical and limited translational contexts by FDA and EMEA. This milestone achieved for kidney biomarkers and the 'know how' acquired is being transferred to other organ toxicities, namely liver, heart, vascular system. New technologies and molecular-based approaches, i.e., molecular pathology as a complement to the classical toolbox, allow promising discoveries in the safety biomarker field. This review will focus on the utility and use of safety biomarkers all along drug development, highlighting the present gaps and opportunities identified in organ toxicity monitoring. A last part will be dedicated to safety biomarker development in general, from identification to diagnostic tests, using the kidney safety biomarkers success as an illustrative example.

  5. List of reports from BMFT, CEA, EPRI, JSTA and USNRC concerning reactor safety research

    International Nuclear Information System (INIS)

    1982-02-01

    This list reviews reports from the Federal Republic of Germany, from France from Japan and from the United States of America concerning special problems in the field of reactor safety research. According to the cooperation in the Gesellschaft fuer Reaktorsicherheit (GRS). The list pursues the following order: Country of origin, problem area concerned, according to the Reactor Safety Research Programm of the BMFT, reporting organization. The list of reports appears quarterly. (orig.) [de

  6. Mothers' Concerns for Personal Safety and Privacy While Breastfeeding: An Unexplored Phenomenon.

    Science.gov (United States)

    Rosen-Carole, Casey; Allen, Katherine; Fagnano, Maria; Dozier, Ann; Halterman, Jill

    2018-04-01

    Preliminary qualitative research in upstate NY shows new mothers are worried about safety while breastfeeding. Little is known regarding prevalence of these concerns and their effect on breastfeeding outcomes. (1) Determine frequency of breastfeeding safety and privacy concerns; (2) Explore their association with breastfeeding outcomes. Mothers were surveyed immediately and 1-month postpartum about breastfeeding goals; both surveys addressed privacy and safety concerns at home, work, and in public. Outcome data included breastfeeding intent, exclusivity, and duration. Breastfeeding/non-breastfeeding mothers were compared using Chi-square and multivariate analyses. A total of 279 women enrolled. Of these 82.8% initiated breastfeeding; at 1-month 72% provided any breast milk, and 44% were exclusively breastfeeding. About 99% felt safe breastfeeding at home; 25% reported privacy concerns; and 5% felt "vulnerable or unsafe" while breastfeeding. At 1-month, 49% agreed there was a safe place to breastfeed/express milk at work (20% unsure). Non-breastfeeding mothers expressed more safety concerns outside home/at work: 18% breastfeeding versus 28% non-breastfeeding outside home; 27% breastfeeding versus 40% non-breastfeeding at work. Nearly 54% who reported feeling vulnerable/unsafe with breastfeeding initiated breastfeeding, compared with 86% not reporting this concern (p = 0.008). Fewer women initiating breastfeeding reported vulnerability/safety (3% breastfeeding versus 14% non-breastfeeding, p = 0.008) or privacy (22% breastfeeding versus 40% non-breastfeeding, p = 0.19) concerns. Associations held after controlling for age, race, parity, insurance, geography, and marital-status. Significant associations between initiation, privacy, and safety concerns did not extend to duration or exclusivity. Many breastfeeding women reported safety and privacy concerns, especially outside the home and at work, which may influence breastfeeding initiation. Further study

  7. Advancing Drug Safety Through Prospective Pharmacovigilance.

    Science.gov (United States)

    Pitts, Peter J; Le Louet, Hervé

    2018-01-01

    Much has changed in a relatively short period of time. There is a raging debate over the level of evidence expected to first introduce a treatment to patients based on smaller, more adaptive data sets. Some argue for less data followed by postapproval follow-up, others for more adaptive clinical trial designs and end-point modification driven by patient-focused drug development and use of real-world evidence. The transition in both the review and postmarketing regulatory framework is happening in front of our eyes in real time. To improve the ability of patients to receive high-quality, safe, effective, and timely care, better information via pharmacovigilance must be a priority as the world's many regulatory systems build the capacity to harness electronic health information to improve health, care quality, and safety. Globally, the widely variable ability of nations to build reliable regulatory systems (from precise review to robust pharmacovigilance) is a dangerous source of health care inequality. Developing validated tools and techniques for "predictive pharmacovigilance" will assist all health systems in better understanding the risks and benefits of the medicines they regulate by understanding what should be happening once a new medicine moves from risk-benefit regulatory efficacy to real-world risk-effectiveness. This will be of particular utility for smaller regulatory agencies with fewer resources. By comparing preapproval predictive pharmacovigilance data, developing regulatory authorities will be able to better understand the potential gap between what was predicted and what was actually measured (via more traditional pharmacovigilance methodologies). Predictive pharmacovigilance recognizes the value of understanding the imperfect reporting of real-world clinical use and that the absence of reporting is, in itself, an important postmarketing signal.

  8. Drug safety: withdrawn medications are only part of the picture.

    Science.gov (United States)

    Rawson, Nigel S B

    2016-02-13

    In a research article published in BMC Medicine, Onakpoya and colleagues provide a historical review of withdrawals of medications for safety reasons. However, withdrawn medications are only one part of the picture about how regulatory agencies manage drug risks. Moreover, medications introduced before the increased pre-marketing regulations and post-marketing monitoring systems instituted after the thalidomide tragedy have little relevance when considering the present drug safety picture because the circumstances under which they were introduced were completely different. To more fully understand drug safety management and regulatory agency actions, withdrawals should be evaluated within the setting and timeframe in which the medications are approved, which requires information about approvals and safety warnings. Studies are needed that provide a more comprehensive current picture of the identification and evaluation of drug safety risks as well as how regulatory agencies deal with them. Please see related research article: http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-016-0553-2.

  9. Safety concerns and suggested design approaches to the HTGR Reformer process concept

    International Nuclear Information System (INIS)

    Green, R.C.

    1981-09-01

    This report is a safety review of the High Temperature Gas-Cooled Reactor Reformer Application Study prepared by Gas-Cooled Reactor Associates (GCRA) of La Jolla, California. The objective of this review was to identify safety concerns and suggests design approaches to minimize risk in the High Temperature Gas-Cooled Reactor Reformer (HTGR-R) process concept

  10. Safety concerns and suggested design approaches to the HTGR Reformer process concept

    Energy Technology Data Exchange (ETDEWEB)

    Green, R.C.

    1981-09-01

    This report is a safety review of the High Temperature Gas-Cooled Reactor Reformer Application Study prepared by Gas-Cooled Reactor Associates (GCRA) of La Jolla, California. The objective of this review was to identify safety concerns and suggests design approaches to minimize risk in the High Temperature Gas-Cooled Reactor Reformer (HTGR-R) process concept.

  11. The health and safety concerns of immigrant women workers in the Toronto sportswear industry.

    Science.gov (United States)

    Gannagé, C M

    1999-01-01

    Immigrant women's conditions of work have worsened with new government and managerial strategies to restructure the Canadian apparel industry. Changes in occupational health and safety legislation have both given and taken away tools that immigrant women workers could use to improve the quality of their working lives. The author outlines a methodology for eliciting the health and safety concerns of immigrant women workers.

  12. Alcohol and prescription drug safety in older adults

    Directory of Open Access Journals (Sweden)

    Zanjani F

    2013-02-01

    Full Text Available Faika Zanjani,1,2 Aasha I Hoogland,1 Brian G Downer11Department of Gerontology, 2Building Interdisciplinary Research Careers in Women's Health University of Kentucky, Lexington, KY, USABackground: The objectives of this study were to investigate older adults' knowledge of prescription drug safety and interactions with alcohol, and to identify pharmacists' willingness to disseminate prescription drug safety information to older adults.Methods: The convenience sample consisted of 48 older adults aged 54–89 years who were recruited from a local pharmacy and who completed surveys addressing their alcohol consumption, understanding of alcohol and prescription drug interactions, and willingness to change habits regarding alcohol consumption and prescription drugs. To address pharmacist willingness, 90 pharmacists from local pharmacies volunteered and answered questions regarding their willingness to convey prescription drug safety information to older adults.Results: Older adults reported low knowledge of alcohol and prescription drug safety, with women tending to be slightly more knowledgeable. More importantly, those who drank in the previous few months were less willing to talk to family and friends about how alcohol can have harmful interactions with prescription drugs, or to be an advocate for safe alcohol and prescription drug use than those who had not had a drink recently. Pharmacists reported that they were willing to convey prescription drug safety information to older adults via a variety of formats, including displaying or distributing a flyer, and directly administering a brief intervention.Conclusion: In this study, older adults were found to have inadequate knowledge of prescription drug safety and interactions with alcohol, but pharmacists who regularly come in contact with older adults indicated that they were ready and willing to talk to older adults about prescription drug safety. Future research should focus on interventions

  13. Summary of Tiger Team Assessment and Technical Safety Appraisal recurring concerns in the Maintenance Area

    International Nuclear Information System (INIS)

    1993-01-01

    Tiger Team Assessments and Technical Safety Appraisals (TSA) were reviewed and evaluated for concerns in the Maintenance Area (MA). Two hundred and thirty one (231) maintenance concerns were identified by the Tiger Team Assessments and TSA reports. These recurring concerns appear below. A summary of the Noteworthy Practices that were identified and a compilation of the maintenance concerns for each performance objective that were not considered as recurring are also included. Where the Tiger Team Assessment and TSA identified the operating contractor or facility by name, the concern has been modified to remove the name while retaining the intent of the comment

  14. Statement on safety requirements concerning the long-term operation of the Muehleberg nuclear power station

    International Nuclear Information System (INIS)

    2012-12-01

    This report published by the Swiss Federal Nuclear Safety Inspectorate ENSI investigates the safety requirements with respect to the long-term operation of the Muehleberg nuclear power station in Switzerland. Relevant international requirements and Swiss legal stipulations concerning the long-term operation of the power station are stated. The management of aging processes is looked at. The regular verification of the integrity of various plant components such as containments, piping, steam generation system, etc. is looked at in detail. The state-of-the-art concerning deterministic accident analyses and refitting technology are discussed, as are automated safety systems. The applicable laws, decrees and guidelines are listed in appendices

  15. Nonsteroidal anti-inflammatory drug gastropathy: new avenues for safety

    Directory of Open Access Journals (Sweden)

    Roth SH

    2011-05-01

    Full Text Available Sanford H RothArizona Research and Education, Arthritis Laboratory, Arizona State University, Phoenix, AZ, USAAbstract: Chronic oral or systemic nonselective nonsteroidal anti-inflammatory drug (NSAID therapy, ubiquitously used by physicians to treat osteoarthritis-associated pain, is associated with a wide range of symptomatic adverse events, the most frequent and serious of which is gastropathy. Although cardiovascular and renal problems are a very real concern, they are significantly less frequent. These complications can be life-threatening in at-risk populations such as older adults, who are common users of long-term oral systemic NSAID therapy. Topical NSAID formulations deliver effective doses of analgesics directly to the affected joints, thereby limiting systemic exposure and potentially the risk of systemic adverse events, such as gastropathy and serious cardiovascular events. There are currently two topical NSAIDs approved by the US Food and Drug Administration for osteoarthritis-associated pain, as well as for the signs and symptoms of osteoarthritis. This review discusses the relative safety, and the gastrointestinal, cardiovascular, and renal risks of chronic oral or systemic NSAID therapy and topical NSAID formulations in patients with osteoarthritis.Keywords: NSAIDs, osteoarthritis, topical administration, synovial fluid, peptic ulcer, Helicobacter pylori

  16. Nonsteroidal anti-inflammatory drug gastropathy: new avenues for safety.

    Science.gov (United States)

    Roth, Sanford H

    2011-01-01

    Chronic oral or systemic nonselective nonsteroidal anti-inflammatory drug (NSAID) therapy, ubiquitously used by physicians to treat osteoarthritis-associated pain, is associated with a wide range of symptomatic adverse events, the most frequent and serious of which is gastropathy. Although cardiovascular and renal problems are a very real concern, they are significantly less frequent. These complications can be life-threatening in at-risk populations such as older adults, who are common users of long-term oral systemic NSAID therapy. Topical NSAID formulations deliver effective doses of analgesics directly to the affected joints, thereby limiting systemic exposure and potentially the risk of systemic adverse events, such as gastropathy and serious cardiovascular events. There are currently two topical NSAIDs approved by the US Food and Drug Administration for osteoarthritis-associated pain, as well as for the signs and symptoms of osteoarthritis. This review discusses the relative safety, and the gastrointestinal, cardiovascular, and renal risks of chronic oral or systemic NSAID therapy and topical NSAID formulations in patients with osteoarthritis.

  17. Safety risks with investigational drugs: Pharmacy practices and perceptions in the veterans affairs health system.

    Science.gov (United States)

    Cruz, Jennifer L; Brown, Jamie N

    2015-06-01

    Rigorous practices for safe dispensing of investigational drugs are not standardized. This investigation sought to identify error-prevention processes utilized in the provision of investigational drug services (IDS) and to characterize pharmacists' perceptions about safety risks posed by investigational drugs. An electronic questionnaire was distributed to an audience of IDS pharmacists within the Veteran Affairs Health System. Multiple facets were examined including demographics, perceptions of medication safety, and standard processes used to support investigational drug protocols. Twenty-one respondents (32.8% response rate) from the Northeast, Midwest, South, West, and Non-contiguous United States participated. The mean number of pharmacist full-time equivalents (FTEs) dedicated to the IDS was 0.77 per site with 0.2 technician FTEs. The mean number of active protocols was 22. Seventeen respondents (81%) indicated some level of concern for safety risks. Concerns related to the packaging of medications were expressed, most notably lack of product differentiation, expiration dating, barcodes, and choice of font size or color. Regarding medication safety practices, the majority of sites had specific procedures in place for storing and securing drug supply, temperature monitoring, and prescription labeling. Repackaging bulk items and proactive error-identification strategies were less common. Sixty-seven percent of respondents reported that an independent double check was not routinely performed. Medication safety concerns exist among pharmacists in an investigational drug service; however, a variety of measures have been employed to improve medication safety practices. Best practices for the safe dispensing of investigational medications should be developed in order to standardize these error-prevention strategies.

  18. Psychometrics of the AAN Caregiver Driving Safety Questionnaire and contributors to caregiver concern about driving safety in older adults.

    Science.gov (United States)

    Carvalho, Janessa O; Springate, Beth; Bernier, Rachel A; Davis, Jennifer

    2018-03-01

    ABSTRACTBackground:The American Academy of Neurology (AAN) updated their practice parameters in the evaluation of driving risk in dementia and developed a Caregiver Driving Safety Questionnaire, detailed in their original manuscript (Iverson Gronseth, Reger, Classen, Dubinsky, & Rizzo, 2010). They described four factors associated with decreased driving ability in dementia patients: history of crashes or citations, informant-reported concerns, reduced mileage, and aggressive driving. An informant-reported AAN Caregiver Driving Safety Questionnaire was designed with these elements, and the current study was the first to explore the factor structure of this questionnaire. Additionally, we examined associations between these factors and cognitive and behavioral measures in patients with mild cognitive impairment or early Alzheimer's disease and their informants. Exploratory factor analysis revealed a four-component structure, consistent with the theory behind the AAN scale composition. These four factor scores also were significantly associated with performance on cognitive screening instruments and informant reported behavioral dysfunction. Regressions revealed that behavioral dysfunction predicted caregiver concerns about driving safety beyond objective patient cognitive dysfunction. In this first known quantitative exploration of the scale, our results support continued use of this scale in office driving safety assessments. Additionally, patient behavioral changes predicted caregiver concerns about driving safety over and above cognitive status, which suggests that caregivers may benefit from psychoeducation about cognitive factors that may negatively impact driving safety.

  19. Safety assessments and public concern for genetically modified food products: the American view.

    Science.gov (United States)

    Harlander, Susan K

    2002-01-01

    In the relatively short time since their commercial introduction in 1996, genetically modified (GM) crops have been rapidly adopted in the United States GM crops are regulated through a coordinated framework developed in 1992 and administered by three agencies-the US Department of Agriculture (USDA) that ensures the products are safe to grow, the Environmental Protection Agency (EPA) that ensures the products are safe for the environment, and the Food and Drug Administration (FDA) that ensures the products are safe to eat. Rigorous food and environmental safety assessments must be completed before GM crops can be commercialized. Fifty-one products have been reviewed by the FDA, including several varieties of corn, soybeans, canola, cotton, rice, sugar beets, potatoes, tomatoes, squash, papaya, and flax. Because FDA considers these crops "substantially equivalent" to their conventional counterparts, no special labeling is required for GM crops in the United States and they are managed as commodities with no segregation or identity preservation. GM crops have thus made their way through commodity distribution channels into thousands of ingredients used in processed foods. It has been estimated that 70% to 85% of processed foods on supermarket shelves in the United States today contain one or more ingredients potentially derived from GM crops. The food industry and retail industry have been monitoring the opinions of their consumers on the GM issue for the past several years. Numerous independent groups have also surveyed consumer concerns about GM foods. The results of these surveys are shared and discussed here.

  20. 77 FR 2606 - Pipeline Safety: Random Drug Testing Rate

    Science.gov (United States)

    2012-01-18

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket ID PHMSA-2012-0004] Pipeline Safety: Random Drug Testing Rate AGENCY: Pipeline and Hazardous Materials... pipelines and operators of liquefied natural gas facilities must select and test a percentage of covered...

  1. 75 FR 9018 - Pipeline Safety: Random Drug Testing Rate

    Science.gov (United States)

    2010-02-26

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket ID PHMSA-2010-0034] Pipeline Safety: Random Drug Testing Rate AGENCY: Pipeline and Hazardous Materials... pipelines and operators of liquefied natural gas facilities must select and test a percentage of covered...

  2. Determining animal drug combinations based on efficacy and safety.

    Science.gov (United States)

    Kratzer, D D; Geng, S

    1986-08-01

    A procedure for deriving drug combinations for animal health is used to derive an optimal combination of 200 mg of novobiocin and 650,000 IU of penicillin for nonlactating cow mastitis treatment. The procedure starts with an estimated second order polynomial response surface equation. That surface is translated into a probability surface with contours called isoprobs. The isoprobs show drug amounts that have equal probability to produce maximal efficacy. Safety factors are incorporated into the probability surface via a noncentrality parameter that causes the isoprobs to expand as safety decreases, resulting in lower amounts of drug being used.

  3. LMFBR conceptual design study: an overview of environmental and safety concerns

    International Nuclear Information System (INIS)

    Brenchley, D.L.

    1981-06-01

    The US Department of Energy (DOE) initiated the Liquid Metal Fast Breeder (LMFBR) Conceptual Design Study (CDS) with the objective of maintaining a viable breeder option. The project is scheduled to be completed in FY-1981 but decisions regarding plant construction will be delayed until at least 1985. This report provides a review of the potential environmental and safety engineering concerns for the CDS and recommends specific action for the Environmental and Safety Engineering Division of DOE

  4. LMFBR conceptual design study: an overview of environmental and safety concerns

    Energy Technology Data Exchange (ETDEWEB)

    Brenchley, D.L.

    1981-06-01

    The US Department of Energy (DOE) initiated the Liquid Metal Fast Breeder (LMFBR) Conceptual Design Study (CDS) with the objective of maintaining a viable breeder option. The project is scheduled to be completed in FY-1981 but decisions regarding plant construction will be delayed until at least 1985. This report provides a review of the potential environmental and safety engineering concerns for the CDS and recommends specific action for the Environmental and Safety Engineering Division of DOE.

  5. Ordinance of 14 March 1983 concerning the Federal Commission for the Safety of Nuclear Installations

    International Nuclear Information System (INIS)

    1983-01-01

    The Frederal Council issued a new Ordinance concerning the Federal Commission for the Safety of Nuclear Installations. This Ordinance replaces an Ordinance of 13 June 1960 and takes into account the distribution of tasks decided several years ago between the Commission, which operates on a part-time basis, and the principal Division for the Safety of Nuclear Installations attached to the Federal Office of Energy. (NEA) [fr

  6. Summary of Tiger Team Assessment and Technical Safety Appraisal recurring concerns in the Operations Area

    International Nuclear Information System (INIS)

    1993-01-01

    Fourteen Tiger Team Assessment and eight Technical Safety Appraisal (TSA) final reports have been received and reviewed by the DOE Training Coordination Program during Fiscal Year 1992. These assessments and appraisals included both reactor and non-reactor nuclear facilities in their reports. The Tiger Team Assessments and TSA reports both used TSA performance objectives, and list ''concerns'' as a result of their findings. However, the TSA reports categorized concerns into the following functional areas: (1) Organization and Administration, (2) Radiation Protection, (3) Nuclear Criticality Safety, (4) Occupational Safety, (5) Engineering/Technical Support, (6) Emergency Preparedness, (7) Safety Assessments, (8) Quality Verification, (9) Fire Protection, (10) Environmental Protection, and (11) Energetic Materials Safety. Although these functional areas match most of the TSA performance objectives, not all of the TSA performance objectives are addressed. For example, the TSA reports did not include Training, Maintenance, and Operations as functional areas. Rather, they included concerns that related to these topics throughout the 11 functional areas identified above. For consistency, the Operations concerns that were identified in each of the TSA report functional areas have been included in this summary with the corresponding TSA performance objective

  7. Adverse drug reaction and concepts of drug safety in Ayurveda: An overview

    Science.gov (United States)

    Ajanal, Manjunath; Nayak, Shradda; Prasad, Buduru Sreenivasa; Kadam, Avinash

    2013-01-01

    Drug safety is a very basic and fundamental concept in medical practice. ADRs play an important role in assessing patient safety in any system of medicine. Pharmacovigilance study is thus significant to understand treatment outcomes. Current raised issue with respect to complementary and alternative system medicine (CAM) like Ayurveda is increased in number of safety reports along with report misinterpretation; this generates the negative impact on system. Although, Ayurveda which is holistic system of medicine from India has elaborated the causes and methods of drug-induced consequences along with preventive measures the available data in classical texts is scattered. The compilation and analysis along with modern concept drug safety is need of the hour. Present literature review was conducted from various compendium of Ayurveda and electronic data base with search terms of ‘Vyapad’, ‘Viruddha’, ‘Ahita’, ‘herb–herb interaction’, ‘idiosyncrasy’, ‘Prakritiviruddha’ etc. The reported information was analysed for the possible correlation on concept of ADR and Pharmacovigilance of current science. Overall review demonstrated that drug interaction, iatrogenic, over dose, administration of unsuitable drugs, reprehensive drug administration with respect to disease, complication from five procedural therapies (Panchakarma) and reprehensible preparation of mineral drug are nearer to the modern causes of ADR. Thus, concept of drug safety and ADR is not new to the Ayurveda. The concept “Drug which is not appropriate to be used as medicine”(Abheshaja) of Ayurveda sounds similar as that of modern pharmacovigilance. PMID:24563588

  8. Drug safety in pregnancy - monitoring congenital anomalies

    NARCIS (Netherlands)

    Morgan, Margery; De Jong-Van Den Berg, Lolkje T. W.; Jordan, Sue

    Aim This paper outlines research into the causes of congenital anomalies, and introduces a pan-European study. The potential roles of nurses and midwives in this area are illustrated by a case report. Background Since the thalidomide disaster, use of drugs in pregnancy has been carefully monitored

  9. 78 FR 20327 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2013-04-04

    ... Management Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice... of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management... Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee...

  10. Factors to Consider When Balancing Campus Safety Concerns with Students' Civil Rights

    Science.gov (United States)

    Ingersoll, Julia S.

    2017-01-01

    On April 16, 2007, a student at Virginia Tech University, known to be mentally ill, went on a rampage shooting 49 people on campus before taking his own life. When it was over, 32 people were dead, and the concept of a safe campus was forever changed. The incident revealed the inherent conflicts between campus safety concerns and students' civil…

  11. Application of the threshold of toxicological concern (TTC) to the safety evaluation of cosmetic ingredients

    NARCIS (Netherlands)

    Kroes, R.; Renwick, A.G.; Feron, V.; Galli, C.L.; Gibney, M.; Greim, H.; Guy, R.H.; Lhuguenot, J.C.; Sandt, J.J.M. van de

    2007-01-01

    The threshold of toxicological concern (TTC) has been used for the safety assessment of packaging migrants and flavouring agents that occur in food. The approach compares the estimated oral intake with a TTC value derived from chronic oral toxicity data for structurally-related compounds.

  12. Reporter Concerns in 300 Mode-Related Incident Reports from NASA's Aviation Safety Reporting System

    Science.gov (United States)

    McGreevy, Michael W.

    1996-01-01

    A model has been developed which represents prominent reporter concerns expressed in the narratives of 300 mode-related incident reports from NASA's Aviation Safety Reporting System (ASRS). The model objectively quantifies the structure of concerns which persist across situations and reporters. These concerns are described and illustrated using verbatim sentences from the original narratives. Report accession numbers are included with each sentence so that concerns can be traced back to the original reports. The results also include an inventory of mode names mentioned in the narratives, and a comparison of individual and joint concerns. The method is based on a proximity-weighted co-occurrence metric and object-oriented complexity reduction.

  13. Design concepts and safety concerns of the small and medium size reactors (SMR)

    International Nuclear Information System (INIS)

    Seul, Kwang Won; Lee, Jae Hun; Kim, Hho Jung

    1998-01-01

    The small and medium size reactors (SMR) and interface facilities such as desalination plant are expected to be located near the population area because of restrictions in transporting the plant products such as fresh water to long distance area. To protect the public around the plant facility from the possible release of radioactive materials, the design development of the SMR is focusing on an enhancement of the safety and reliability as well as the economics. In this study, the major safety concepts of the SMR designs significantly different from the current PWR designs are investigated and the safety concerns applicable to the integrated SMR design of Korea (called SMART), were identified. Those safety issues include the use of proven technology, application of strengthening defense in depth, event categorization and selection, simplification of emergency planning, determination of accident source terms and so on. The efforts to resolve the safety concerns in the design stage will provide an improvement of the safety of the SMART design

  14. Automated discovery of safety and efficacy concerns for joint & muscle pain relief treatments from online reviews.

    Science.gov (United States)

    Adams, David Z; Gruss, Richard; Abrahams, Alan S

    2017-04-01

    Product issues can cost companies millions in lawsuits and have devastating effects on a firm's sales, image and goodwill, especially in the era of social media. The ability for a system to detect the presence of safety and efficacy (S&E) concerns early on could not only protect consumers from injuries due to safety hazards, but could also mitigate financial damage to the manufacturer. Prior studies in the field of automated defect discovery have found industry-specific techniques appropriate to the automotive, consumer electronics, home appliance, and toy industries, but have not investigated pain relief medicines and medical devices. In this study, we focus specifically on automated discovery of S&E concerns in over-the-counter (OTC) joint and muscle pain relief remedies and devices. We select a dataset of over 32,000 records for three categories of Joint & Muscle Pain Relief treatments from Amazon's online product reviews, and train "smoke word" dictionaries which we use to score holdout reviews, for the presence of safety and efficacy issues. We also score using conventional sentiment analysis techniques. Compared to traditional sentiment analysis techniques, we found that smoke term dictionaries were better suited to detect product concerns from online consumer reviews, and significantly outperformed the sentiment analysis techniques in uncovering both efficacy and safety concerns, across all product subcategories. Our research can be applied to the healthcare and pharmaceutical industry in order to detect safety and efficacy concerns, reducing risks that consumers face using these products. These findings can be highly beneficial to improving quality assurance and management in joint and muscle pain relief. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. ED accreditation update. Physicians, medical staff may report safety concerns without fear of disciplinary action.

    Science.gov (United States)

    2007-11-01

    Educating your staff about The Joint Commission's requirements for concerns about hospital safety and quality of care requires the ED manager to set a tone of openness and cooperation, while at the same time emphasizing your department's role in addressing such concerns: * The ED should be the first place that staff members communicate quality and safety concerns. It is only when a problem is not addressed that they should take the issue to hospital administration and, if necessary, The Joint Commission. * A single event should not trigger a report to The Joint Commission, unless it is unusually serious. Otherwise, only a series of events should trigger a report. * Reassure your staff that you care about what is reported and will act quickly on it. Educate your staff about the reporting forms, and follow up with random audits to ensure compliance.

  16. Safety learning from drugs of the same class

    DEFF Research Database (Denmark)

    Stefansdottir, G; Knol, M J; Arnardottir, A H

    2012-01-01

    This study was aimed at assessing the extent of safety learning from data pertaining to other drugs of the same class. We studied drug classes for which the first and second drugs were centrally registered in the European Union from 1995 to 2008. We assessed whether adverse drug reactions (ADRs......) associated with one of the drugs also appeared in the Summary of Product Characteristics (SPC) of the other drug, either initially or during the postmarketing phase. We identified 977 ADRs from 19 drug pairs, of which 393 ADRs (40.2%) were listed in the SPCs of both drugs of a pair. Of these 393 that were...... present in both SPCs of a drug pair, 241 (61.3%) were present when the drug entered the market and 152 (30.7%) appeared in the postmarketing phase. The mention of ADRs in the SPCs of both same-class drugs in the postmarketing phase was associated with type A ADRs, marketing in the same regulator country...

  17. Driving and dementia: Efficient approach to driving safety concerns in family practice.

    Science.gov (United States)

    Lee, Linda; Molnar, Frank

    2017-01-01

    To provide primary care physicians with an approach to driving safety concerns when older persons present with memory difficulties. The approach is based on an accredited memory clinic training program developed by the Centre for Family Medicine Primary Care Collaborative Memory Clinic. One of the most challenging aspects of dementia care is the assessment of driving safety. Drivers with dementia are at higher risk of motor vehicle collisions, yet many drivers with mild dementia might be safely able to continue driving for several years. Because safe driving is dependent on multiple cognitive and functional skills, clinicians should carefully consider many factors when determining if cognitive concerns affect driving safety. Specific findings on corroborated history and office-based cognitive testing might aid in the physician's decisions to refer for comprehensive on-road driving evaluation and whether to notify transportation authorities in accordance with provincial reporting requirements. Sensitive communication and a person-centred approach are essential. Primary care physicians must consider many factors when determining if cognitive concerns might affect driving safety in older drivers. Copyright© the College of Family Physicians of Canada.

  18. Trust in the pharmaceutical sector : Analysis of drug safety controversies by means of drug life cycles

    NARCIS (Netherlands)

    Hernández, J.F.

    2015-01-01

    Before obtaining a marketing approval, the efficacy and safety profile of drugs is studied in specific populations and under well-controlled circumstances. After marketing approval, the drug is made available and used in ‘real world conditions’, which are known to deviate from the trial setting.

  19. Drug research methodology. Volume 2, The identification of drugs of interest in highway safety

    Science.gov (United States)

    1980-03-01

    This report presents findings of a workshop on the identification of drugs that should be the focus of near-term highway safety research. Drugs of interest are those that have a potential to increase the likelihood of traffic crashes and their attend...

  20. Guideline for examination concerning the evaluation of safety in light water power reactor installations

    International Nuclear Information System (INIS)

    1978-01-01

    This guideline was drawn up as the guide for examination when the safety evaluation of nuclear reactors is carried out at the time of approving the installation of light water power reactors. Accordingly in case of the examination of safety, it must be confirmed that the contents of application are in conformity with this guideline. If they are in conformity, it is judged that the safety evaluation of the policy in the basic design of a reactor facility is adequate, and also that the evaluation concerning the separation from the public in surroundings is adequate as the condition of location of the reactor facility. This guideline is concerned with light water power reactors now in use, but the basic concept may be the reference for the examination of the other types of reactors. If such a case occurs that the safety evaluation does not conform to this guideline, it is not excluded when the appropriate reason is clarified. The purpose of safety evaluation, the scope to be evaluated, the selection of the events to be evaluated, the criteria for judgement, the matters taken into consideration at the time of analysis, the concrete events of abnormal transient change and accident in operation, and the concrete events of serious accident and hypothetic accident are stipulated. The explanation and two appendices are attached. (Kako, I.)

  1. Drug discrimination: A versatile tool for characterization of CNS safety pharmacology and potential for drug abuse.

    Science.gov (United States)

    Swedberg, Michael D B

    2016-01-01

    Drug discrimination studies for assessment of psychoactive properties of drugs in safety pharmacology and drug abuse and drug dependence potential evaluation have traditionally been focused on testing novel compounds against standard drugs for which drug abuse has been documented, e.g. opioids, CNS stimulants, cannabinoids etc. (e.g. Swedberg & Giarola, 2015), and results are interpreted such that the extent to which the test drug causes discriminative effects similar to those of the standard training drug, the test drug would be further characterized as a potential drug of abuse. Regulatory guidance for preclinical assessment of abuse liability by the European Medicines Agency (EMA, 2006), the U.S. Food and Drug Administration (FDA, 2010), the International Conference of Harmonization (ICH, 2009), and the Japanese Ministry of Health Education and Welfare (MHLW, 1994) detail that compounds with central nervous system (CNS) activity, whether by design or not, need abuse and dependence liability assessment. Therefore, drugs with peripheral targets and a potential to enter the CNS, as parent or metabolite, are also within scope (see Swedberg, 2013, for a recent review and strategy). Compounds with novel mechanisms of action present a special challenge due to unknown abuse potential, and should be carefully assessed against defined risk criteria. Apart from compounds sharing mechanisms of action with known drugs of abuse, compounds intended for indications currently treated with drugs with potential for abuse and or dependence are also within scope, regardless of mechanism of action. Examples of such compounds are analgesics, anxiolytics, cognition enhancers, appetite control drugs, sleep control drugs and drugs for psychiatric indications. Recent results (Swedberg et al., 2014; Swedberg & Raboisson, 2014; Swedberg, 2015) on the metabotropic glutamate receptor type 5 (mGluR5) antagonists demonstrate that compounds causing hallucinatory effects in humans did not exhibit

  2. Perception vs. reality: an investigation of the misperceptions concerning the extent of peer novel drug use.

    Science.gov (United States)

    Sanders, Amber; Stogner, John M; Miller, Bryan Lee

    2013-01-01

    Misperceptions of peer substance use have previously been implicated as significant influences on individual use of both alcohol and illicit drugs. However, research on perceived social norms and related interventions are typically limited to binge drinking and marijuana and no empirical studies have explored misperceptions related to "novel drugs." The present study explored the extent of use and perceptions of use among a college sample (N = 2,349) for three categories of novel drugs: synthetic cannabinoids (Spice, K2, Mr. Miyagi, Pot-Pourri, etc.), synthetic cathinones (commonly known as "bath salts"), and Salvia divinorum. Results indicate that overall perceived use was significantly higher than actual reported use. The frequency of overestimation of peer use was particularly large for the emerging drugs when compared to alcohol and marijuana. This finding is concerning as these misperceptions have the potential to influence students toward experimentation with these substances and suggests that a possible target for intervention is misperceptions of emerging novel substances.

  3. 78 FR 16271 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2013-03-14

    ...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably...

  4. 76 FR 40735 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2011-07-11

    ...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... East, Adelphi, MD. The conference center telephone number is: 301 985-7300. Contact Person: Kalyani...

  5. 78 FR 2677 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2013-01-14

    ...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... before February 7, 2013. Time allotted for each presentation may be limited. If the number of registrants...

  6. 76 FR 59143 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2011-09-23

    ...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the..., Adelphi, MD. The conference center telephone number is 301-985-7300. Contact Person: Kalyani Bhatt, Center...

  7. 75 FR 10490 - Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management...

    Science.gov (United States)

    2010-03-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory... Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide...

  8. List of reports concerning reactor safety research from BMFT, CEA, EPRI, JSTA, and USNRC

    International Nuclear Information System (INIS)

    1982-12-01

    This list reviews reports from the Federal Republic of Germany, from France, from Japan and from the United States of America concerning special problems in the field of Reactor Safety Research. According to the cooperation of the Bundesminister fuer Forschung und Technologie (BMFT) with the Commissariat a l'Energie Atomique (CEA), the Japan Science and Technologie Agency (JSTA), the Electric Power Research Institute (EPRI) and the United States Nuclear Regulatory Commission, these Reports are available in the Gesellschaft fuer Reaktorsicherheit (GRS). The list pursues the following order: Country of origin, problem area concerned, according to the Reactor Safety Research Programm of the BMFT, reporting organization. The list of reports appears quarterly. (orig./HP) [de

  9. Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: myocardial and infectious adverse reactions as application cases.

    Science.gov (United States)

    Wang, Kejian; Weng, Zuquan; Sun, Liya; Sun, Jiazhi; Zhou, Shu-Feng; He, Lin

    2015-02-13

    Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure-activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. In the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. Copyright © 2015 Elsevier Inc. All rights reserved.

  10. Surveys of research projects concerning nuclear facility safety, financed by the Federal Ministry of the Interior

    International Nuclear Information System (INIS)

    1986-05-01

    Each progress report is a collection of individual reports, categorized by subject matter. They are a documentation of the contractor's progress, rendered by themselves on standardized forms, published, for the sake of general information on progress made in investigations concerning reactor safety, by the project attendance department of the GRS. The individual reports have serial numbers. Each report includes particulars of the objective, work carried out, results obtained and plans for project continuation. (orig./HP) [de

  11. Long-term criticality safety concerns associated with surplus fissile material disposition

    International Nuclear Information System (INIS)

    Choi, J.S.

    1995-01-01

    A substantial inventory of surplus fissile material would result from ongoing and planned dismantlement of US and Russian nuclear weapons. This surplus fissile material could be dispositioned by irradiation in nuclear reactors, and the resulting spent MOx fuel would be similar in radiation characteristics to regular LWR spent UO2 fuel. The surplus fissile material could also be immobilized into high-level waste forms, such as borosilicate glass, synroc, or metal-alloy matrix. The MOx spent fuel, or the immobilized waste forms, could then be directly disposed of in a geologic repository. Long-term criticality safety concerns arise because the fissile contents (i.e., Pu-239 and its decay daughter U-235) in these waste forms are higher than in LWR spent UO2 fuel. MOx spent fuel could contain 3 to 4 wt% of reactor-grade plutonium, compared to only 0.9 wt% of plutonium in LWR spent UO2 fuel. At some future time (tens of thousand of years), when the waste forms had deteriorated due to intruding groundwater, the water could mix with the long-lived fissile materials to form into a critical system. If the critical system is self-sustaining, somewhat like the natural-occurring reactor in OKLO, fission products produced could readily be available for dissolution and release out to the accessible environment, adversely affecting public health and safety. This paper will address ongoing activities to evaluate long-term criticality safety concerns associated with disposition of fissile material in a geologic setting. Issues to be addressed include the identification of a worst-case water-intrusion scenario and waste-form geometries which present the most concern for long-term criticality safety; and suggests of technical solutions for such concerns

  12. Engineering Hematopoietic Cells for Cancer Immunotherapy: Strategies to Address Safety and Toxicity Concerns.

    Science.gov (United States)

    Resetca, Diana; Neschadim, Anton; Medin, Jeffrey A

    2016-09-01

    Advances in cancer immunotherapies utilizing engineered hematopoietic cells have recently generated significant clinical successes. Of great promise are immunotherapies based on chimeric antigen receptor-engineered T (CAR-T) cells that are targeted toward malignant cells expressing defined tumor-associated antigens. CAR-T cells harness the effector function of the adaptive arm of the immune system and redirect it against cancer cells, overcoming the major challenges of immunotherapy, such as breaking tolerance to self-antigens and beating cancer immune system-evasion mechanisms. In early clinical trials, CAR-T cell-based therapies achieved complete and durable responses in a significant proportion of patients. Despite clinical successes and given the side effect profiles of immunotherapies based on engineered cells, potential concerns with the safety and toxicity of various therapeutic modalities remain. We discuss the concerns associated with the safety and stability of the gene delivery vehicles for cell engineering and with toxicities due to off-target and on-target, off-tumor effector functions of the engineered cells. We then overview the various strategies aimed at improving the safety of and resolving toxicities associated with cell-based immunotherapies. Integrating failsafe switches based on different suicide gene therapy systems into engineered cells engenders promising strategies toward ensuring the safety of cancer immunotherapies in the clinic.

  13. Exploring Machine Learning Techniques Using Patient Interactions in Online Health Forums to Classify Drug Safety

    Science.gov (United States)

    Chee, Brant Wah Kwong

    2011-01-01

    This dissertation explores the use of personal health messages collected from online message forums to predict drug safety using natural language processing and machine learning techniques. Drug safety is defined as any drug with an active safety alert from the US Food and Drug Administration (FDA). It is believed that this is the first…

  14. 77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-10-24

    ...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... Use (ETASU) before CDER's Drug Safety and Risk Management Advisory Committee (DSaRM). The Agency plans...

  15. 78 FR 30929 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-23

    ...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory...

  16. 77 FR 75176 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-12-19

    ...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug... being rescheduled due to the postponement of the October 29-30, 2012, Drug Safety and Risk Management... Committee: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...

  17. The Expected Net Present Value of Developing Weight Management Drugs in the Context of Drug Safety Litigation.

    Science.gov (United States)

    Chawla, Anita; Carls, Ginger; Deng, Edmund; Tuttle, Edward

    2015-07-01

    Following withdrawals, failures, and significant litigation settlements, drug product launches in the anti-obesity category slowed despite a large and growing unmet need. Litigation concerns, a more risk-averse regulatory policy, and the difficulty of developing a product with a compelling risk-benefit profile in this category may have limited innovators' expected return on investment and restricted investment in this therapeutic area. The objective of the study was to estimate perceived manufacturer risk associated with product safety litigation and increased development costs vs. revenue expectations on anticipated return on investment and to determine which scenarios might change a manufacturer's investment decision. Expected net present value of a weight-management drug entering pre-clinical trials was calculated for a range of scenarios representing evolving expectations of development costs, revenue, and litigation risk over the past 25 years. These three factors were based on published estimates, historical data, and analogs from other therapeutic areas. The main driver in expected net present value calculations is expected revenue, particularly if one assumes that litigation risk and demand are positively correlated. Changes in development costs associated with increased regulatory concern with potential safety issues for the past 25 years likely did not impact investment decisions. Regulatory policy and litigation risk both played a role in anti-obesity drug development; however, product revenue-reflecting efficacy at acceptable levels of safety-was by far the most important factor. To date, relatively modest sales associated with recent product introductions suggest that developing a product that is sufficiently efficacious with an acceptable level of safety continues to be the primary challenge in this market.

  18. Shelf life and safety concerns of bakery products--a review.

    Science.gov (United States)

    Smith, James P; Daifas, Daphne Phillips; El-Khoury, Wassim; Koukoutsis, John; El-Khoury, Anis

    2004-01-01

    Bakery products are an important part of a balanced diet and, today, a wide variety of such products can be found on supermarket shelves. This includes unsweetened goods (bread, rolls, buns, crumpets, muffins and bagels), sweet goods (pancakes, doughnuts, waffles and cookies) and filled goods (fruit and meat pies, sausage rolls, pastries, sandwiches, cream cakes, pizza and quiche). However, bakery products, like many processed foods, are subject to physical, chemical and microbiological spoilage. While physical and chemical spoilage limits the shelf life of low and intermediate moisture bakery products, microbiological spoilage by bacteria, yeast and molds is the concern in high moisture products i.e., products with a water activity (a(w)) > 0.85. Furthermore, several bakery products also have been implicated infoodborne illnesses involving Salmonella spp., Listeria monoctyogenes and Bacillus cereus, while Clostridium botulinum is a concern in high moisture bakery products packaged under modified atmospheres. This extensive review is divided into two parts. Part I focuses on the spoilage concerns of low, intermediate and high moisture bakery products while Part II focuses on the safety concerns of high moisture bakery products only. In both parts, traditional and novel methods of food preservation that can be used by the bakery industry to extend the shelf life and enhance the safety of products are discussed in detail.

  19. Pooling, meta-analysis, and the evaluation of drug safety

    Directory of Open Access Journals (Sweden)

    Leizorovicz Alain

    2002-03-01

    Full Text Available Abstract Background The "integrated safety report" of the drug registration files submitted to health authorities usually summarizes the rates of adverse events observed for a new drug, placebo or active control drugs by pooling the safety data across the trials. Pooling consists of adding the numbers of events observed in a given treatment group across the trials and dividing the results by the total number of patients included in this group. Because it considers treatment groups rather than studies, pooling ignores validity of the comparisons and is subject to a particular kind of bias, termed "Simpson's paradox." In contrast, meta-analysis and other stratified analyses are less susceptible to bias. Methods We use a hypothetical, but not atypical, application to demonstrate that the results of a meta-analysis can differ greatly from those obtained by pooling the same data. In our hypothetical model, a new drug is compared to 1 a placebo in 4 relatively small trials in patients at high risk for a certain adverse event and 2 an active reference drug in 2 larger trials of patients at low risk for this event. Results Using meta-analysis, the relative risk of experiencing the adverse event with the new drug was 1.78 (95% confidence interval [1.02; 3.12] compared to placebo and 2.20 [0.76; 6.32] compared to active control. By pooling the data, the results were, respectively, 1.00 [0.59; 1.70] and 5.20 [2.07; 13.08]. Conclusions Because these findings could mislead health authorities and doctors, regulatory agencies should require meta-analyses or stratified analyses of safety data in drug registration files.

  20. Occupational Safety and Health Concerns in Logging: A Cross-Sectional Assessment in Virginia

    Directory of Open Access Journals (Sweden)

    Sunwook Kim

    2017-11-01

    Full Text Available Increased logging mechanization has helped improve logging safety and health, yet related safety risks and concerns are not well understood. A cross-sectional study was completed among Virginia loggers. Participants (n = 122 completed a self-administered questionnaire focusing on aspects of safety and health related to logging equipment. Respondents were at a high risk of workplace injuries, with reported career and 12-month injury prevalences of 51% and 14%, respectively. Further, nearly all (98% respondents reported experiencing musculoskeletal symptoms. Over half (57.4% of respondents reported symptoms related to diesel exhaust exposure in their career. Few (15.6%, however, perceived their jobs to be dangerous. Based on the opinions and suggestions of respondents, three priority areas were identified for interventions: struck-by/against hazards, situational awareness (SA during logging operations, and visibility hazards. To address these hazards, and to have a broader and more substantial positive impact on safety and health, we discuss the need for proactive approaches such as incorporating proximity technologies in a logging machine or personal equipment, and enhancing logging machine design to enhance safety, ergonomics, and SA.

  1. Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: Myocardial and infectious adverse reactions as application cases

    Energy Technology Data Exchange (ETDEWEB)

    Wang, Kejian, E-mail: kejian.wang.bio@gmail.com [Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, Shanghai (China); Weng, Zuquan [Japan National Institute of Occupational Safety and Health, Kawasaki (Japan); Sun, Liya [Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, Shanghai (China); Sun, Jiazhi; Zhou, Shu-Feng [Department of Pharmaceutical Sciences, College of Pharmacy, University of South Florida, Tampa, FL (United States); He, Lin, E-mail: helin@Bio-X.com [Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, Shanghai (China)

    2015-02-13

    Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure–activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. In the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. - Highlights: • Drugs causing common toxicity lead to similar in vitro gene expression changes. • We built a model to predict drug toxicity with drug-specific expression profiles. • Drugs with FDA black box warnings were effectively identified by our model. • In vitro assay can detect severe toxicity in the early stage of drug development.

  2. Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: Myocardial and infectious adverse reactions as application cases

    International Nuclear Information System (INIS)

    Wang, Kejian; Weng, Zuquan; Sun, Liya; Sun, Jiazhi; Zhou, Shu-Feng; He, Lin

    2015-01-01

    Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure–activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. In the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. - Highlights: • Drugs causing common toxicity lead to similar in vitro gene expression changes. • We built a model to predict drug toxicity with drug-specific expression profiles. • Drugs with FDA black box warnings were effectively identified by our model. • In vitro assay can detect severe toxicity in the early stage of drug development

  3. 78 FR 36711 - Food and Drug Administration Safety and Innovation Act Title VII-Drug Supply Chain; Standards for...

    Science.gov (United States)

    2013-06-19

    ... inspections, and drive safety and quality throughout the supply chain. Implementation of these authorities... authorities granted to FDA under Title VII and their importance in ensuring drug safety, effectiveness, and.... FDA-2013-N-0683, FDA-2013-N-0684, and FDA-2013-N-0685] Food and Drug Administration Safety and...

  4. Global patient safety and antiretroviral drug-drug interactions in the resource-limited setting.

    Science.gov (United States)

    Seden, Kay; Khoo, Saye H; Back, David; Byakika-Kibwika, Pauline; Lamorde, Mohammed; Ryan, Mairin; Merry, Concepta

    2013-01-01

    Scale-up of HIV treatment services may have contributed to an increase in functional health facilities available in resource-limited settings and an increase in patient use of facilities and retention in care. As more patients are reached with medicines, monitoring patient safety is increasingly important. Limited data from resource-limited settings suggest that medication error and antiretroviral drug-drug interactions may pose a significant risk to patient safety. Commonly cited causes of medication error in the developed world include the speed and complexity of the medication use cycle combined with inadequate systems and processes. In resource-limited settings, specific factors may contribute, such as inadequate human resources and high disease burden. Management of drug-drug interactions may be complicated by limited access to alternative medicines or laboratory monitoring. Improving patient safety by addressing the issue of antiretroviral drug-drug interactions has the potential not just to improve healthcare for individuals, but also to strengthen health systems and improve vital communication among healthcare providers and with regulatory agencies.

  5. Health and safety concerns os migrant workers: the experience of tunisian workers in modena, Italy

    Directory of Open Access Journals (Sweden)

    Faïçal Daly

    2004-06-01

    Full Text Available This paper examines the relatively under-researched field of healthand safety of migrant workers, with special reference to Tunisian construction workers in the city of Modena in the Italian region of Emilia-Romagna. The empirical material comes from questionnaires and interviews with Tunisian migrants, plus smaller numbers of interviews with employers and trade union representatives in Modena. The paper starts by critically reviewing the scattered literature onthe health and safety of minority workers, most of which refers to the United States and the United Kingdom. The discussion then moves to a consideration of migrant health and safety questions in the contexts of racism, discrimination, social class, working conditions, labour market segmentation and (non- regulation. Specialattention is given to the failed role of trade unions in defending the rights of minority workers, in advanced countries generally and in Italy in particular. A case study is then made of the construction sector in Italy, enriched by personal accounts of the experiences of Tunisian migrant workers in Modena. Employer and tradeunion interviews reveal a lack of concern and ability to tackle the relevant issues. Barriers to health and safety awareness training are outlined. In the conclusion, recommendations are made for policy initiatives in this area.

  6. The U.S. commercial air tour industry: a review of aviation safety concerns.

    Science.gov (United States)

    Ballard, Sarah-Blythe

    2014-02-01

    The U.S. Title 14 Code of Federal Regulations defines commercial air tours as "flight[s] conducted for compensation or hire in an airplane or helicopter where a purpose of the flight is sightseeing." The incidence of air tour crashes in the United States is disproportionately high relative to similar commercial aviation operations, and air tours operating under Part 91 governance crash significantly more than those governed by Part 135. This paper reviews the government and industry response to four specific areas of air tour safety concern: surveillance of flight operations, pilot factors, regulatory standardization, and maintenance quality assurance. It concludes that the government and industry have successfully addressed many of these tenet issues, most notably by: advancing the operations surveillance infrastructure through implementation of en route, ground-based, and technological surveillance methods; developing Aeronautical Decision Making and cue-based training programs for air tour pilots; consolidating federal air tour regulations under Part 136; and developing public-private partnerships for raising maintenance operating standards and improving quality assurance programs. However, opportunities remain to improve air tour safety by: increasing the number and efficiency of flight surveillance programs; addressing pilot fatigue with more restrictive flight hour limitations for air tour pilots; ensuring widespread uptake of maintenance quality assurance programs, especially among high-risk operators not currently affiliated with private air tour safety programs; and eliminating the 25-mile exception allowing Part 91 operators to conduct commercial air tours without the safety oversight required of Part 135 operators.

  7. Report on the handling of safety information concerning flammable gases and ferrocyanide at the Hanford waste tanks

    International Nuclear Information System (INIS)

    1990-07-01

    This report discusses concerns safety issues, and management at Hanford Tank Farm. Concerns center on the issue of flammable gas generation which could ignite, and on possible exothermic reactions of ferrocyanide compounds which were added to single shell tanks in the 1950's. It is believed that information concerning these issues has been mis-handled and the problems poorly managed

  8. Report on the handling of safety information concerning flammable gases and ferrocyanide at the Hanford waste tanks

    Energy Technology Data Exchange (ETDEWEB)

    1990-07-01

    This report discusses concerns safety issues, and management at Hanford Tank Farm. Concerns center on the issue of flammable gas generation which could ignite, and on possible exothermic reactions of ferrocyanide compounds which were added to single shell tanks in the 1950's. It is believed that information concerning these issues has been mis-handled and the problems poorly managed. (CBS)

  9. Caffeine-based food supplements and beverages: Trends of consumption for performance purposes and safety concerns.

    Science.gov (United States)

    Bessada, Sílvia M F; Alves, Rita C; Oliveira, M Beatriz P P

    2018-07-01

    Nowadays, daily food supplementation regarding the improvement of physical and mental performance is a growing trend in sport practitioners, young students and active people. Food supplements are foodstuffs, labeled under food law and not obliged to safety assessments before their commercialization. Several products are commercialized claiming ergogenic effects as marketing strategies. Caffeine is often one of their main ingredients, as it increases both physical performance and concentration. This manuscript presents a general overview of the current caffeine-based food supplements and energy drinks available in the Portuguese market, as well as the consuming trends regarding their ergogenic effects, performance purposes, and active ingredients. Product claims, recommended daily intakes, caffeine pharmacology, and safety concerns aspects are also discussed aspects. Copyright © 2018 Elsevier Ltd. All rights reserved.

  10. Preclinical Data on Efficacy of 10 Drug-Radiation Combinations: Evaluations, Concerns, and Recommendations

    Directory of Open Access Journals (Sweden)

    Helen B. Stone

    2016-02-01

    Full Text Available BACKGROUND: Clinical testing of new therapeutic interventions requires comprehensive, high-quality preclinical data. Concerns regarding quality of preclinical data have been raised in recent reports. This report examines the data on the interaction of 10 drugs with radiation and provides recommendations for improving the quality, reproducibility, and utility of future studies. The drugs were AZD6244, bortezomib, 17-DMAG, erlotinib, gefitinib, lapatinib, oxaliplatin/Lipoxal, sunitinib (Pfizer, Corporate headquarters, New York, NY, thalidomide, and vorinostat. METHODS: In vitro and in vivo data were tabulated from 125 published papers, including methods, radiation and drug doses, schedules of administration, assays, measures of interaction, presentation and interpretation of data, dosimetry, and conclusions. RESULTS: In many instances, the studies contained inadequate or unclear information that would hamper efforts to replicate or intercompare the studies, and that weakened the evidence for designing and conducting clinical trials. The published reports on these drugs showed mixed results on enhancement of radiation response, except for sunitinib, which was ineffective. CONCLUSIONS: There is a need for improved experimental design, execution, and reporting of preclinical testing of agents that are candidates for clinical use in combination with radiation. A checklist is provided for authors and reviewers to ensure that preclinical studies of drug-radiation combinations meet standards of design, execution, and interpretation, and report necessary information to ensure high quality and reproducibility of studies. Improved design, execution, common measures of enhancement, and consistent interpretation of preclinical studies of drug-radiation interactions will provide rational guidance for prioritizing drugs for clinical radiotherapy trials and for the design of such trials.

  11. Socializing Young People to Ethics via Play Experience: Browser Games and Parental Concerns for Safety Online

    Directory of Open Access Journals (Sweden)

    Divina Meigs

    2009-01-01

    Full Text Available This paper considers an online game and its relation to safety and privacy, in order to examine social and ethical issues raised by parental concern over harmful content. To gain real insights on the responsibility of adults, it develops a hands-on approach that takes into account the major stakeholders, especially young people and the related circle of people around them. Therefore the research question that is raised is: how do browser games provide reassurance to parents about their children’s safety and privacy? The issue of safety online is explored in three parts, using an ethnographic research framework: it explores a specific online game, it provides a profile of participants, it analyses their types of actions in relation to safety and privacy, and discusses the results in terms of incidence of risk, peer-monitoring and community control. The findings show that there is a rather strong tendency to self-regulation, but that tendency is partly due to a strong presence of mediating adults and peers. The results are discussed in terms of incidence of risk, peer-monitoring and networked means of control on the one hand, and in terms of scientific contribution to socialization theory on the other hand. They lead to final considerations on the repertoire of ethical strategies set up online and its meaning for the concerns of adults towards online risk as well as the need for policies on regulation and self-regulation. They also lead to extensions on the socialization to norms and the appropriation of ethics by young people.

  12. Sports injuries, drowning and exposure to radiation concern Canada Safety Council meeting

    International Nuclear Information System (INIS)

    Oliver, Caroline.

    1979-01-01

    Hazards associated with surface sports, aquatic sports and exposure to radiation were considered at a meeting of the Canada Safety Council in late 1979. The session on radiation noted that 6 of 20000 radiation workers wearing dosimeters were exposed to a dose in excess of 5 rem, the annual limit set by the Atomic Energy Control Board. Radiographers were in the job classification receiving the highest doses of ionizing radiation. Concern was expressed for the emission of damaging radiation from broken mercury vapour lamps. Increased regulation rather than training was seen as the most effective solution. (T.I.)

  13. List of reports from the BMFT, CEA, EPRI, JSTA and USNRC concerning reactor safety research

    International Nuclear Information System (INIS)

    1981-09-01

    This list reviews reports from the Federal Republic of Germany, from France, from Japan and from the United States of America concerning special Problems in the field of Reactor Safety Research. According to the cooperation of the Bundesminister fuer Forschung und Technologie (BMFT) with the Commissariat a l'Energie Atomique (CEA) the Japan Science and Technology Agency (JSTA) the Electric Power Research Institute (EPRI) and the United States Nuclear Regulatory Commission these reports are available in the Gesellschaft fuer Reaktorsicherheit (GRS). The list pursues the following order: Country of origin, problem area concerned, according to the Reactor Saftety Research Program of the BMFT, reporting organization. The list of reports appears quarterly. (orig./HP) [de

  14. Human rights vs. Public safety -- When can you test your workers for drugs?

    Energy Technology Data Exchange (ETDEWEB)

    Kossowan, B. L.

    2002-06-01

    Legislative and regulatory aspects of drug testing of employees vs. public safety are discussed. While in Canada federal and provincial laws concerning human rights take precedence over public safety issues, laws and regulations vary from province to province, therefore there is good reason for concern about uncertainty. To compound the uncertainty, certain relevant laws of the United States are different (generally more stringent than corresponding Canadian laws), consequently there is the possibility that certain American companies might feel justified in refusing to do business with Canadian firms that do not follow their rigid standards. The conclusion is that while the situation may be clear enough in a legal situation, it does not always work equally well in practice. Unfortunately, at the present time there is not a whole lot of guidance available for companies to manage the workplace in a practical sense.

  15. Effect and Safety of Shihogyejitang for Drug Resistant Childhood Epilepsy

    Directory of Open Access Journals (Sweden)

    Jinsoo Lee

    2016-01-01

    Full Text Available Objective. Herbal medicine has been widely used to treat drug resistant epilepsy. Shihogyejitang (SGT has been commonly used to treat epilepsy. We investigated the effect and safety of SGT in children with drug resistant epilepsy. Design. We reviewed medical records of 54 patients with epilepsy, who failed to respond to at least two antiepileptic drugs and have been treated with SGT between April 2006 and June 2014 at the Department of Pediatric Neurology, I-Tomato Hospital, Korea. Effect was measured by the response rate, seizure-free rate, and retention rate at six months. We also checked adverse events, change in antiepileptic drugs use, and the variables related to the outcome. Results. Intent-to-treat analysis showed that, after six months, 44.4% showed a >50% seizure reduction, 24.1% including seizure-free, respectively, and 53.7% remained on SGT. Two adverse events were reported, mild skin rash and fever. Focal seizure type presented significantly more positive responses when compared with other seizure types at six months (p=0.0284, Fisher’s exact test. Conclusion. SGT is an effective treatment with excellent tolerability for drug resistant epilepsy patients. Our data provide evidence that SGT may be used as alternative treatment option when antiepileptic drug does not work in epilepsy children.

  16. Nonsteroidal anti-inflammatory drug gastropathy: new avenues for safety

    OpenAIRE

    Roth, Sandford

    2011-01-01

    Sanford H RothArizona Research and Education, Arthritis Laboratory, Arizona State University, Phoenix, AZ, USAAbstract: Chronic oral or systemic nonselective nonsteroidal anti-inflammatory drug (NSAID) therapy, ubiquitously used by physicians to treat osteoarthritis-associated pain, is associated with a wide range of symptomatic adverse events, the most frequent and serious of which is gastropathy. Although cardiovascular and renal problems are a very real concern, they are significantly less...

  17. FDA drug safety communications: a narrative review and clinical considerations for older adults.

    Science.gov (United States)

    Marcum, Zachary A; Vande Griend, Joseph P; Linnebur, Sunny A

    2012-08-01

    The US Food and Drug Administration (FDA) has new regulatory authorities intended to enhance drug safety monitoring in the postmarketing period. This has resulted in an increase in communication from the FDA in recent years about the safety profile of certain drugs. It is important to stay abreast of the current literature on drug risks to effectively communicate these risks to patients, other health care providers, and the general public. To summarize 4 new FDA drug safety communications by describing the evidence supporting the risks and the clinical implications for older adults. The FDA Web site was reviewed for new drug safety communications from May 2011 to April 2012 that would be relevant to older adults. Approved labeling for each drug or class was obtained from the manufacturer, and PubMed was searched for primary literature that supported the drug safety concern. FDA drug safety communications for 4 drugs were chosen because of the potential clinical importance in older adults. A warning for citalopram was made because of potential problems with QT prolongation in patients taking less than 40 mg per day. The evidence suggests minor changes in QT interval. Given the flat dose-response curve in treating depression with citalopram, the new 20-mg/d maximum dose in older adults is sensible. Another warning was made for proton pump inhibitors (PPIs) and an increased risk of Clostridium difficile infection. A dose-response relationship was found for this drug risk. With C. difficile infections on the rise in older adults, along with other safety risks of PPI therapy, PPIs should only be used in older adults indicated for therapy for the shortest duration possible. In addition, a warning about dabigatran was made. There is strong evidence from a large clinical trial, as well as case reports, of increased bleeding risk in older adults taking dabigatran, especially in older adults with decreased renal function. This medication should be used with caution in older

  18. Parental safety concerns--a barrier to sport and physical activity in children?

    Science.gov (United States)

    Boufous, Soufiane; Finch, Caroline; Bauman, Adrian

    2004-10-01

    To examine the extent to which parents and carers perceive injury and safety risks as serious enough to prevent or discourage their children, aged 5-12 years, from participating in sports/physical activity and to identify factors that influence these perceptions. An analysis of the 2001 New South Wales Child Health Survey. More than one-quarter of parents/ carers of active children aged 5-12 years reported discouraging or preventing children from playing a particular sport (34.7% for boys and 16.6% for girls) because of injury and safety concerns. In boys, the most frequently discouraged sport was rugby league (23.2%), followed by rugby union (7.5%) and Australian rules football (2.8%). Among girls, the most frequently discouraged activities were rollerblading (2.7%), rugby league (2.3%) and soccer (2.1%). Multivariate analysis shows that factors independently associated with parents' decision to prevent/discourage their child from engaging in sport/physical activity include their child's age and gender, language spoken at home, presence of disability, and the respondent's relation to the child. Efforts need to be made to modify some sports/ activities, such as football codes, in order to minimise injury and to ensure that children continue enjoying their favourite activity well into adulthood. Guidelines designed to promote physical activity among children and young adolescents need to take into account parental concerns regarding the associated risk of injury.

  19. Modulation of Brain Activity with Noninvasive Transcranial Direct Current Stimulation (tDCS): Clinical Applications and Safety Concerns

    Science.gov (United States)

    Zhao, Haichao; Qiao, Lei; Fan, Dongqiong; Zhang, Shuyue; Turel, Ofir; Li, Yonghui; Li, Jun; Xue, Gui; Chen, Antao; He, Qinghua

    2017-01-01

    Transcranial direct current stimulation (tDCS) is a widely-used tool to induce neuroplasticity and modulate cortical function by applying weak direct current over the scalp. In this review, we first introduce the underlying mechanism of action, the brief history from discovery to clinical scientific research, electrode positioning and montages, and parameter setup of tDCS. Then, we review tDCS application in clinical samples including people with drug addiction, major depression disorder, Alzheimer's disease, as well as in children. This review covers the typical characteristics and the underlying neural mechanisms of tDCS treatment in such studies. This is followed by a discussion of safety, especially when the current intensity is increased or the stimulation duration is prolonged. Given such concerns, we provide detailed suggestions regarding safety procedures for tDCS operation. Lastly, future research directions are discussed. They include foci on the development of multi-tech combination with tDCS such as with TMS and fMRI; long-term behavioral and morphological changes; possible applications in other research domains, and more animal research to deepen the understanding of the biological and physiological mechanisms of tDCS stimulation. PMID:28539894

  20. Observational Pharmacoepidemiology in the Drug Safety and Effectiveness Evaluation

    Directory of Open Access Journals (Sweden)

    José Cabrita

    2017-04-01

    Full Text Available Observational epidemiological studies have been used in the medicines context for more than 40 years, contributing to characterize drug use patterns and safety, efficacy and effectiveness profiles. Its use has been increased in recognition of the clinical trials limitations to assess the therapeutic and iatrogenic potential of the medicines after its commercialization. The evolution of the regulatory framework for pharmacovigilance, requiring post-marketing studies, post-authorization safety studies (PASS and the post-authorization efficacy studies (PAES to approve certain drugs, reinforced the importance of observational pharmacoepidemiology for the characterization of the medicines safety and effectiveness profiles. Pharmacoepidemiological research can be carried out from field studies designed to obtain the necessary information or in databases with health records of population samples that already contain the information. This 2nd option is more efficient and more and more frequent. Although, observational research from field studies continues to have its space, the increasing availability of databases allowed a new development to observational pharmacoepidemiology. Indeed, access to automated records databases with up-to-date information on medical prescriptions and global health care to representative population samples with long follow-up periods is a valuable tool for the study of drug use patterns and therapeutic and iatrogenic potential in routine clinical practice. In this context, observational pharmacoepidemiology reinforces its role as a scientific area particularly suitable for evaluating the safety and the effectiveness of the medicines in the “real world”, making a relevant contribution to overcome the gap in translating the evidence from the clinical trials for clinical practice.

  1. Study concerning the power plant control and safety equipment by integrated distributed systems

    International Nuclear Information System (INIS)

    Optea, I.; Oprea, M.; Stanescu, P.

    1995-01-01

    The paper deals with the trends existing in the field of nuclear control and safety equipment and systems, proposing a high-efficiency integrated system. In order to enhance the safety of the plant and reliability of the structure system and components, we present a concept based on the latest computer technology with an open, distributed system, connected by a local area network with high redundancy. A modern conception for the control and safety system is to integrate all the information related to the reactor protection, active engineered safeguard and auxiliary systems parameters, offering a fast flow of information between all the agencies concerned so that situations can be quickly assessed. The integrated distributed control is based on a high performance operating system for realtime applications, flexible enough for transparent networking and modular for demanding configurations. The general design considerations for nuclear reactors instrumentation reliability and testing methods for real-time functions under dynamic regime are presented. Taking into account the fast progress in information technology, we consider the replacement of the old instrumentation of Cernavoda-1 NPP by a modern integrated system as an economical and efficient solution for the next units. (Author) 20 Refs

  2. 75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-05-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...

  3. Genetically modified foods: safety, risks and public concerns-a review.

    Science.gov (United States)

    Bawa, A S; Anilakumar, K R

    2013-12-01

    Genetic modification is a special set of gene technology that alters the genetic machinery of such living organisms as animals, plants or microorganisms. Combining genes from different organisms is known as recombinant DNA technology and the resulting organism is said to be 'Genetically modified (GM)', 'Genetically engineered' or 'Transgenic'. The principal transgenic crops grown commercially in field are herbicide and insecticide resistant soybeans, corn, cotton and canola. Other crops grown commercially and/or field-tested are sweet potato resistant to a virus that could destroy most of the African harvest, rice with increased iron and vitamins that may alleviate chronic malnutrition in Asian countries and a variety of plants that are able to survive weather extremes. There are bananas that produce human vaccines against infectious diseases such as hepatitis B, fish that mature more quickly, fruit and nut trees that yield years earlier and plants that produce new plastics with unique properties. Technologies for genetically modifying foods offer dramatic promise for meeting some areas of greatest challenge for the 21st century. Like all new technologies, they also pose some risks, both known and unknown. Controversies and public concern surrounding GM foods and crops commonly focus on human and environmental safety, labelling and consumer choice, intellectual property rights, ethics, food security, poverty reduction and environmental conservation. With this new technology on gene manipulation what are the risks of "tampering with Mother Nature"?, what effects will this have on the environment?, what are the health concerns that consumers should be aware of? and is recombinant technology really beneficial? This review will also address some major concerns about the safety, environmental and ecological risks and health hazards involved with GM foods and recombinant technology.

  4. Drug research methodology. Volume 1, The alcohol-highway safety experience and its applicability to other drugs

    Science.gov (United States)

    1980-03-01

    This report presents the findings of a workshop concerning the alcohol and highway safety experience, which includes research efforts to define the drinking-driving problem and societal responses to reduce the increased highway safety risk attributab...

  5. Cardiovascular safety of non-steroidal anti-inflammatory drugs among healthy individuals

    DEFF Research Database (Denmark)

    Fosbøl, Emil Loldrup; Køber, Lars; Torp-Pedersen, Christian

    2010-01-01

    Studies have raised concern on the cardiovascular safety of NSAIDs. We studied safety of NSAID therapy in a nationwide cohort of healthy individuals.......Studies have raised concern on the cardiovascular safety of NSAIDs. We studied safety of NSAID therapy in a nationwide cohort of healthy individuals....

  6. Analyzing research trends on drug safety using topic modeling.

    Science.gov (United States)

    Zou, Chen

    2018-04-06

    Published drug safety data has evolved in the past decade due to scientific and technological advances in the relevant research fields. Considering that a vast amount of scientific literature has been published in this area, it is not easy to identify the key information. Topic modeling has emerged as a powerful tool to extract meaningful information from a large volume of unstructured texts. Areas covered: We analyzed the titles and abstracts of 4347 articles in four journals dedicated to drug safety from 2007 to 2016. We applied Latent Dirichlet allocation (LDA) model to extract 50 main topics, and conducted trend analysis to explore the temporal popularity of these topics over years. Expert Opinion/Commentary: We found that 'benefit-risk assessment and communication', 'diabetes' and 'biologic therapy for autoimmune diseases' are the top 3 most published topics. The topics relevant to the use of electronic health records/observational data for safety surveillance are becoming increasingly popular over time. Meanwhile, there is a slight decrease in research on signal detection based on spontaneous reporting, although spontaneous reporting still plays an important role in benefit-risk assessment. The topics related to medical conditions and treatment showed highly dynamic patterns over time.

  7. Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

    Science.gov (United States)

    2010-09-29

    The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

  8. ENSI’s synopsis concerning the enhancement of safety margins; Zusammenfassung des ENSI zur Erhöhung der Sicherheitsmargen

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2015-06-15

    This press release issued by the Swiss Federal Nuclear Safety Inspectorate ENSI discusses the results of its probabilistic safety analysis on the safety margins for Swiss nuclear power stations that was made after the Fukushima nuclear accident. External incidents such as earthquakes and flooding and their impact on the power stations are analysed by the ERSIM project concerning the enhancement of safety margins. Three shut-down scenarios are discussed. The safety margins with respect to earthquakes and flooding for all four nuclear power station sites are discussed in detail.

  9. Holes in the safety net: a case study of access to prescription drugs and specialty care.

    Science.gov (United States)

    Stanley, Ava; Cantor, Joel C; Guarnaccia, Peter

    2008-07-01

    The health care safety net in the United States is intended to fill gaps in health care services for uninsured and other vulnerable populations. This paper presents a case study of New Brunswick, NJ, a small city rich in safety net resources, to examine the adequacy of the American model of safety net care. We find substantial gaps in access to care despite the presence of a medical school, an abundance of primary care and specialty physicians, two major teaching hospitals, a large federally qualified health center and other safety net resources in this community of about 50,000 residents. Using a blend of random-digit-dial and area probability sampling, a survey of 595 households was conducted in 2001 generating detailed information about the health, access to care, demographic and other characteristics of 1,572 individuals. Confirming the great depth of the New Brunswick health care safety net, the survey showed that more than one quarter of local residents reported a hospital or community clinic as their usual source of care. Still, barriers to prescription drugs were reported for 11.0% of the area population and more than two in five (42.8%) local residents who perceived a need for specialty care reported difficulty getting those services. Bivariate analyses show significantly elevated risk of access problems among Hispanic and black residents, those in poor health, those relying on hospital and community clinics or with no usual source of care, and those living at or below poverty. In multivariate analysis, lack of health insurance was the greatest risk factor associated with both prescription drug and specialty access problems. Few local areas can claim the depth of safety net resources as New Brunswick, NJ, raising serious concerns about the adequacy of the American safety net model, especially for people with complex and chronic health care needs.

  10. Safety of diabetes drugs in patients with heart failure.

    Science.gov (United States)

    Carrasco-Sánchez, F J; Ostos-Ruiz, A I; Soto-Martín, M

    2018-03-01

    Heart failure (HF) and diabetes mellitus are 2 clinical conditions that often coexist, particularly in patients older than 65 years. Diabetes mellitus promotes the development of HF and confers a poorer prognosis. Hypoglycaemic agents (either by their mechanism of action, hypoglycaemic action or adverse effects) can be potentially dangerous for patients with HF. In this study, we performed a review of the available evidence on the safety of diabetes drugs in HF, focused on the main observational and experimental studies. Recent studies on cardiovascular safety have evaluated, although as a secondary objective, the impact of new hypoglycaemic agents on HF, helping us understand the neutrality, risks and potential benefits of these agents. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  11. Patient Drug Safety Reporting: Diabetes Patients' Perceptions of Drug Safety and How to Improve Reporting of Adverse Events and Product Complaints.

    Science.gov (United States)

    Patel, Puja; Spears, David; Eriksen, Betina Østergaard; Lollike, Karsten; Sacco, Michael

    2018-03-01

    Global health care manufacturer Novo Nordisk commissioned research regarding awareness of drug safety department activities and potential to increase patient feedback. Objectives were to examine patients' knowledge of pharmaceutical manufacturers' responsibilities and efforts regarding drug safety, their perceptions and experiences related to these efforts, and how these factors influence their thoughts and behaviors. Data were collected before and after respondents read a description of a drug safety department and its practices. We conducted quantitative survey research across 608 health care consumers receiving treatment for diabetes in the United States, Germany, United Kingdom, and Italy. This research validated initial, exploratory qualitative research (across 40 comparable consumers from the same countries) which served to guide design of the larger study. Before reading a drug safety department description, 55% of respondents were unaware these departments collect safety information on products and patients. After reading the description, 34% reported the department does more than they expected to ensure drug safety, and 56% reported "more confidence" in the industry as a whole. Further, 66% reported themselves more likely to report an adverse event or product complaint, and 60% reported that they were more likely to contact a drug safety department with questions. The most preferred communication methods were websites/online forums (39%), email (27%), and telephone (25%). Learning about drug safety departments elevates consumers' confidence in manufacturers' safety efforts and establishes potential for patients to engage in increased self-monitoring and reporting. Study results reveal potentially actionable insights for the industry across patient and physician programs and communications.

  12. A decade of e-cigarettes: Limited research & unresolved safety concerns.

    Science.gov (United States)

    Kaisar, Mohammad Abul; Prasad, Shikha; Liles, Tylor; Cucullo, Luca

    2016-07-15

    It is well known that tobacco consumption is a leading cause of preventable deaths worldwide and has been linked to major diseases ranging from cancer to chronic obstructive pulmonary disease, atherosclerosis, stroke and a host of neurological/neurodegenerative disorders. In the past decade a number of alternative vaping products have hit the market, rapidly gaining consumers especially among the younger population. Electronic nicotine delivery systems or e-cigarettes have become the sought-after product due to the belief that they are much safer than traditional cigarettes. However, inadequate research and lack of regulatory guidelines for both the manufacturing process and the content of the vaping solution of the e-cigarette has become a major concern. Highly debated and unresolved questions such as whether e-cigarettes may help smokers quit and whether e-cigarettes will promote the use of nicotine among non-smokers add to the confusion of the safety of e-cigarettes. In this review article, we summarize the current understanding (and lack thereof) of the potential health impacts of e-cigarettes. We will also highlight the most recent studies (in vivo/in vitro) which seem to conflict with the broad safety claims put forward by the manufacturers. Finally, we provide potential solutions to overcome the research gap of the short and long-term health impact of e-cigarettes. Published by Elsevier Ireland Ltd.

  13. A decade of e-cigarettes: Limited research & unresolved safety concerns

    International Nuclear Information System (INIS)

    Kaisar, Mohammad Abul; Prasad, Shikha; Liles, Tylor; Cucullo, Luca

    2016-01-01

    It is well known that tobacco consumption is a leading cause of preventable deaths worldwide and has been linked to major diseases ranging from cancer to chronic obstructive pulmonary disease, atherosclerosis, stroke and a host of neurological/neurodegenerative disorders. In the past decade a number of alternative vaping products have hit the market, rapidly gaining consumers especially among the younger population. Electronic nicotine delivery systems or e-cigarettes have become the sought-after product due to the belief that they are much safer than traditional cigarettes. However, inadequate research and lack of regulatory guidelines for both the manufacturing process and the content of the vaping solution of the e-cigarette has become a major concern. Highly debated and unresolved questions such as whether e-cigarettes may help smokers quit and whether e-cigarettes will promote the use of nicotine among non-smokers add to the confusion of the safety of e-cigarettes. In this review article, we summarize the current understanding (and lack thereof) of the potential health impacts of e-cigarettes. We will also highlight the most recent studies (in vivo/in vitro) which seem to conflict with the broad safety claims put forward by the manufacturers. Finally, we provide potential solutions to overcome the research gap of the short and long-term health impact of e-cigarettes.

  14. A Decade of e-Cigarettes: Limited Research & Unresolved Safety Concerns

    Science.gov (United States)

    Kaisar, Mohammad Abul; Prasad, Shikha; Liles, Tylor; Cucullo, Luca

    2016-01-01

    It is well known that tobacco consumption is a leading cause of preventable deaths worldwide and has been linked to major diseases ranging from cancer to chronic obstructive pulmonary disease, atherosclerosis, stroke and a host of neurological/neurodegenerative disorders. In the past decade a number of alternative vaping products have hit the market, rapidly gaining consumers especially among the younger population. Electronic nicotine delivery systems or e-cigarettes have become the sought-after product due to the belief that they are much safer than traditional cigarettes. However, inadequate research and lack of regulatory guidelines for both the manufacturing process and the content of the vaping solution of the e-cigarette has become a major concern. Highly debated and unresolved questions such as whether e-cigarettes may help smokers quit and whether e-cigarettes will promote the use of nicotine among non-smokers add to the confusion of the safety of e-cigarettes. In this review article, we summarize the current understanding (and lack thereof) of the potential health impacts of e-cigarettes. We will also highlight the most recent studies (in vivo/in vitro) which seem to conflict with the broad safety claims put forward by the manufacturers. Finally, we provide potential solutions to overcome the research gap of the short and long-term health impact of e-cigarettes. PMID:27477296

  15. Predictors of Likelihood of Speaking Up about Safety Concerns in Labour and Delivery

    Science.gov (United States)

    Lyndon, Audrey; Sexton, J. Bryan; Simpson, Kathleen Rice; Rosenstein, Alan; Lee, Kathryn A.; Wachter, Robert M.

    2011-01-01

    Background Despite widespread emphasis on promoting “assertive communication” by caregivers as essential to patient safety improvement efforts, fairly little is known about when and how clinicians speak up to address safety concerns. In this cross-sectional study we use a new measure of speaking up to begin exploring this issue in maternity care. Methods We developed a scenario-based measure of clinician’s assessment of potential harm and likelihood of speaking up in response to perceived harm. We embedded this scale in a survey with measures of safety climate, teamwork climate, disruptive behaviour, work stress, and personality traits of bravery and assertiveness. The survey was distributed to all registered nurses and obstetricians practicing in two US Labour & Delivery units. Results The response rate was 54% (125 of 230 potential respondents). Respondents were experienced clinicians (13.7 ± 11 years in specialty). Higher perception of harm, respondent role, specialty experience, and site predicted likelihood of speaking up when controlling for bravery and assertiveness. Physicians rated potential harm in common clinical scenarios lower than nurses did (7.5 vs. 8.4 on 2–10 scale; p<0.001). Some participants (12%) indicated they were unlikely to speak up despite perceiving high potential for harm in certain situations. Discussion This exploratory study found nurses and physicians differed in their harm ratings, and harm rating was a predictor of speaking up. This may partially explain persistent discrepancies between physicians and nurses in teamwork climate scores. Differing assessments of potential harms inherent in everyday practice may be a target for teamwork intervention in maternity care. PMID:22927492

  16. Exposures Resulting in Safety and Health Concerns for Child Laborers in Less Developed Countries

    Directory of Open Access Journals (Sweden)

    Derek G. Shendell

    2016-01-01

    Full Text Available Objectives. Worldwide, over 200 million children are involved in child labor, with another 20 million children subjected to forced labor, leading to acute and chronic exposures resulting in safety and health (S&H risks, plus removal from formal education and play. This review summarized S&H issues in child labor, including forced or indentured domestic labor as other sectors of child labor. Specifically, we focused on exposures leading to S&H risks. Methods. We used PubMed, Scopus, Science Direct, and Google Scholar. References were in English, published in 1990–2015, and included data focused on exposures and S&H concerns of child labor. Results. Seventy-six journal articles were identified, 67 met criteria, 57 focused on individual countries, and 10 focused on data from multiple countries (comparing 3–83 countries. Major themes of concern were physical exposures including ergonomic hazards, chemical exposure hazards, and missed education. Childhood labor, especially forced, exploitative labor, created a significant burden on child development, welfare, and S&H. Conclusions. More field researche data emphasizing longitudinal quantitative effects of exposures and S&H risks are needed. Findings warranted developing policies and educational interventions with proper monitoring and evaluation data collection, plus multiple governmental, international organization and global economic reform efforts, particularly in lower-income, less developed countries.

  17. Specialty pharmacies and other restricted drug distribution systems: financial and safety considerations for patients and health-system pharmacists.

    Science.gov (United States)

    Kirschenbaum, Bonnie E

    2009-12-15

    To discuss the role of restricted drug distribution systems in the implementation of risk evaluation and mitigation strategies (REMS), health-system pharmacists' concerns associated with the use of specialty pharmacies and other restricted drug distribution systems, reimbursement policies for high-cost specialty drugs, supply chain models for traditional and specialty drugs, and emerging trends in the management of and reimbursement for specialty pharmaceuticals. Restricted drug distribution systems established by pharmaceutical manufacturers, specialty pharmacies, or other specialty suppliers may be a component of REMS, which are required by the Food and Drug Administration for the management of known or potential serious risks from certain drugs. Concerns of health-system pharmacists using specialty suppliers include access to pharmaceuticals, operational challenges, product integrity, financial implications, continuity of care, and patient safety. An ambulatory care patient taking a specialty drug product from home to a hospital outpatient clinic or inpatient setting for administration, a practice known as "brown bagging," raises concerns about product integrity and institutional liability. An institution's finances, tolerance for liability, and ability to skillfully manage the processes involved often determine its choice between an approach that prohibits brown bagging but is costly and one that permits the practice under certain conditions and is less costly. The recent shift from a traditional supply chain model to a specialty pharmacy supply chain model for high-cost pharmaceuticals has the potential to increase pharmaceutical costs for health systems. A dialogue is needed between health-system pharmacists and group purchasing organizations to address the latter's role in mitigating the financial implications of this change and to help clarify the safety issues. Some health plans have shifted part of the cost of expensive drugs to patients by establishing a

  18. Driving safety: concerns and experiences of parents of adolescent drivers with type 1 diabetes.

    Science.gov (United States)

    Cox, Daniel J; Gonder-Frederick, Linda A; Shepard, Jaclyn A; Campbell, Laura K; Vajda, Karen A

    2012-09-01

    Driving is a dangerous activity for adolescents, perhaps being even more precarious for adolescents with type 1 diabetes due to the possibility of extreme blood glucose (BG). There is no available data on adolescent driving safety concerns and type 1 diabetes. To begin addressing this issue, we surveyed parents regarding their observations and concerns. Seventy-two parents (87.5% mothers) of adolescent drivers aged 16-19 with type 1 diabetes provided analyzable data. Females comprised 36% of their adolescents, with 74% using pump therapy. In the past year, 13 and 84% of parents reported that their adolescent had experienced severe or moderate disruptive hypoglycemia, respectively. Over half (56%) of the parents reported moderate to extreme worry about how diabetes impacted their adolescent's driving, while only 21% of parents thought their adolescents had similar concerns (p = 0.037). Almost one third (31%) of parents thought their adolescent need not treat low BG until it fell below 70 mg/dL, 13% thought their adolescent could safely drive with BG below 65 mg/dL. And, 31 and 14% of parents, respectively, reported their adolescent had been in a collision or stopped by the police in the past year, which they attributed to both hypo- and hyperglycemia. Adolescents reportedly took steps to prevent hypo- and hyperglycemia while driving, but more aggressively avoided hypoglycemia (p < 0.001). While this data is limited, lacking a non-diabetic control group and randomized sample, it does suggest that driving and adolescent type 1 diabetes deserve further attention and investigation. © 2012 John Wiley & Sons A/S.

  19. Impact of a transient instability of the ecstasy market on health concerns and drug use patterns in The Netherlands.

    Science.gov (United States)

    Brunt, Tibor M; Niesink, Raymond J M; van den Brink, Wim

    2012-03-01

    A recent decline in MDMA-like substances in ecstasy tablets has been reported by a number of countries in the European Union. This study describes the instability of the ecstasy market in The Netherlands during 2008 and 2009, and investigates whether this had any impact on drug testing or patterns of drug use. The health concerns of drug users handing in drug samples at drug testing facilities was measured using intervention time-series analysis. In addition, these ecstasy users were asked about changes in their drug use. Nationally, the unstable market situation for ecstasy has increased the number of users handing in ecstasy tablets for testing because of health concern. There was no change in the number of users handing in cocaine or gamma hydroxybutyrate (GHB). Respondents reported no major changes in their drug use resulting from the shortage of MDMA-like substances. These findings provide further insight in drug policy based on both harm reduction and use reduction. In the event of reduced ecstasy quality, ecstasy users in The Netherlands have increasingly used drug testing as a potential harm reduction tool, rather than changing their patterns of drug use. This might indicate that a transient reduction of drug quality does not serve as a good drug use reduction strategy for ecstasy users. Copyright © 2011 Elsevier B.V. All rights reserved.

  20. Drug research methodology. Volume 5, Experimentation in drugs and highway safety : the study of drug effects on skills related to driving

    Science.gov (United States)

    1980-06-01

    This report presents the findings of a workshop on experimental research in the area of drugs and highway safety. Complementing studies of drug use in different driving populations, experimentation here refers to studies performed under controlled co...

  1. Drug research methodology. Volume 4, Epidemiology in drugs and highway safety : the study of drug use among drivers and its role in traffic crashes

    Science.gov (United States)

    1980-06-01

    This report presents the findings of a workshop on epidemiology in drugs and highway safety. A cross-disciplinary panel of experts (1) identified methodological issues and constraints present in research to define the nature and magnitude of the drug...

  2. Best practices: an electronic drug alert program to improve safety in an accountable care environment.

    Science.gov (United States)

    Griesbach, Sara; Lustig, Adam; Malsin, Luanne; Carley, Blake; Westrich, Kimberly D; Dubois, Robert W

    2015-04-01

    The accountable care organization (ACO), one of the most promising and talked about new models of care, focuses on improving communication and care transitions by tying potential shared savings to specific clinical and financial benchmarks. An important factor in meeting these benchmarks is an ACO's ability to manage medications in an environment where medical and pharmacy care has been integrated. The program described in this article highlights the critical components of Marshfield Clinic's Drug Safety Alert Program (DSAP), which focuses on prioritizing and communicating safety issues related to medications with the goal of reducing potential adverse drug events. Once the medication safety concern is identified, it is reviewed to evaluate whether an alert warrants sending prescribers a communication that identifies individual patients or a general communication to all physicians describing the safety concern. Instead of basing its decisions regarding clinician notification about drug alerts on subjective criteria, the Marshfield Clinic's DSAP uses an internally developed scoring system. The scoring system includes criteria developed from previous drug alerts, such as level of evidence, size of population affected, severity of adverse event identified or targeted, litigation risk, available alternatives, and potential for duration of medication use. Each of the 6 criteria is assigned a weight and is scored based upon the content and severity of the alert received.  In its first 12 months, the program targeted 6 medication safety concerns involving the following medications: topiramate, glyburide, simvastatin, citalopram, pioglitazone, and lovastatin. Baseline and follow-up prescribing data were gathered on the targeted medications. Follow-up review of prescribing data demonstrated that the DSAP provided quality up-to-date safety information that led to changes in drug therapy and to decreases in potential adverse drug events. In aggregate, nearly 10,000 total

  3. Herbal products containing Hibiscus sabdariffa L., Crataegus spp., and Panax spp.: Labeling and safety concerns.

    Science.gov (United States)

    Nunes, Maria Antónia; Rodrigues, Francisca; Alves, Rita C; Oliveira, Maria Beatriz P P

    2017-10-01

    Herbs have been used from ancient times for infusion preparation based on their potential health effects. In particular, the consumption of Hibiscus sabdariffa L., Crataegus spp. and Panax spp. has been largely associated to cardiovascular benefits. In this work, the label information of 52 herbal products for infusion preparation containing the referred herbs was analyzed and discussed, taking into consideration the European Union regulation for herbal products, which intends to protect public health and harmonize the legal framework in Member States. Details about the cardiovascular-related statements and warning notifications about consumption were considered. Also, regulatory issues and possible herb-drug interactions were explored and discussed. A total of 14 of the 52 herbal products selected presented health claims/statements on the label. Hibiscus was present in the majority of the products and, in some cases, it was mentioned only in the ingredients list and not on the product front-of-pack. Despite the promising outcomes of these plants to modulate cardiovascular risk markers, consumers with some sort of cardiovascular dysfunction and/or under medication treatments should be aware to carefully analyze the labels and consult additional information related to these herbal products. Manufacturers have also a huge responsibility to inform consumers by presenting awareness statements. Lastly, health professionals must advise and alert their patients about possible interactions that could occur between the concomitant consumption of drugs and herbs. Overall, there is still a real need of additional studies and clinical trials to better understand herbs effects and establish a science-based guidance to assess their safety. Copyright © 2017 Elsevier Ltd. All rights reserved.

  4. Turkish Final Year Medical Students' Exposure to and Attitudes Concerning Drug Company Interactions: A Perspective from a Minimally Regulated Environment for Medical Students.

    Directory of Open Access Journals (Sweden)

    Nazim Ercument Beyhun

    Full Text Available Interactions between drug companies and medical students may affect evidence-based medical practice and patient safety. The aim of this study was to assess drug company-medical student interactions in a medical faculty where limited specific national or institutional regulations apply between drug companies and medical students. The objectives of the study were to determine the exposure and attitudes of final year medical students in terms of drug company-medical student and physician interactions, to identify factors affecting those attitudes and to provide data for policymakers working on the regulation of interactions between drug companies and medical students. This anonymous questionnaire-based study of 154 medical final year medical students at the Karadeniz Technical University Medical Faculty, Trabzon, Turkey, in April and May 2015 attracted a response rate of 92.2% (n/N, 154/164. Exposure to interaction with a pharmaceutical representative was reported by 90.3% (139/154 of students, and 68.8% (106/154 reported experiencing such interaction alongside a resident. In addition, 83.7% (128/153 of students reported an interaction during internship. Furthermore, 69.9% (107/153 of students agreed that interactions influence physicians' prescription preferences, while 33.1% (51/154 thought that a medical student should never accept a gift from a drug company and 24.7% (38/154 agreed with the proposition that "drug companies should not hold activities in medical faculties". Students with rational prescription training expressed greater agreement with the statement "I am skeptical concerning the information provided by drug companies during interactions" than those who had not received such training, and this finding was supported by logistic regression [O.R.(C.I, p -3.7(1.2-11.5, p = 0.022]. Acceptance of advertisement brochures was found to significantly reduce the level of agreement with the proposition that "A physician should not accept any

  5. Turkish Final Year Medical Students’ Exposure to and Attitudes Concerning Drug Company Interactions: A Perspective from a Minimally Regulated Environment for Medical Students

    Science.gov (United States)

    Beyhun, Nazim Ercument; Kolayli, Cevriye Ceyda; Can, Gamze; Topbas, Murat

    2016-01-01

    Interactions between drug companies and medical students may affect evidence-based medical practice and patient safety. The aim of this study was to assess drug company–medical student interactions in a medical faculty where limited specific national or institutional regulations apply between drug companies and medical students. The objectives of the study were to determine the exposure and attitudes of final year medical students in terms of drug company–medical student and physician interactions, to identify factors affecting those attitudes and to provide data for policymakers working on the regulation of interactions between drug companies and medical students. This anonymous questionnaire-based study of 154 medical final year medical students at the Karadeniz Technical University Medical Faculty, Trabzon, Turkey, in April and May 2015 attracted a response rate of 92.2% (n/N, 154/164). Exposure to interaction with a pharmaceutical representative was reported by 90.3% (139/154) of students, and 68.8% (106/154) reported experiencing such interaction alongside a resident. In addition, 83.7% (128/153) of students reported an interaction during internship. Furthermore, 69.9% (107/153) of students agreed that interactions influence physicians’ prescription preferences, while 33.1% (51/154) thought that a medical student should never accept a gift from a drug company and 24.7% (38/154) agreed with the proposition that “drug companies should not hold activities in medical faculties”. Students with rational prescription training expressed greater agreement with the statement “I am skeptical concerning the information provided by drug companies during interactions” than those who had not received such training, and this finding was supported by logistic regression [O.R.(C.I), p -3.7(1.2–11.5), p = 0.022]. Acceptance of advertisement brochures was found to significantly reduce the level of agreement with the proposition that “A physician should not

  6. Turkish Final Year Medical Students' Exposure to and Attitudes Concerning Drug Company Interactions: A Perspective from a Minimally Regulated Environment for Medical Students.

    Science.gov (United States)

    Beyhun, Nazim Ercument; Kolayli, Cevriye Ceyda; Can, Gamze; Topbas, Murat

    2016-01-01

    Interactions between drug companies and medical students may affect evidence-based medical practice and patient safety. The aim of this study was to assess drug company-medical student interactions in a medical faculty where limited specific national or institutional regulations apply between drug companies and medical students. The objectives of the study were to determine the exposure and attitudes of final year medical students in terms of drug company-medical student and physician interactions, to identify factors affecting those attitudes and to provide data for policymakers working on the regulation of interactions between drug companies and medical students. This anonymous questionnaire-based study of 154 medical final year medical students at the Karadeniz Technical University Medical Faculty, Trabzon, Turkey, in April and May 2015 attracted a response rate of 92.2% (n/N, 154/164). Exposure to interaction with a pharmaceutical representative was reported by 90.3% (139/154) of students, and 68.8% (106/154) reported experiencing such interaction alongside a resident. In addition, 83.7% (128/153) of students reported an interaction during internship. Furthermore, 69.9% (107/153) of students agreed that interactions influence physicians' prescription preferences, while 33.1% (51/154) thought that a medical student should never accept a gift from a drug company and 24.7% (38/154) agreed with the proposition that "drug companies should not hold activities in medical faculties". Students with rational prescription training expressed greater agreement with the statement "I am skeptical concerning the information provided by drug companies during interactions" than those who had not received such training, and this finding was supported by logistic regression [O.R.(C.I), p -3.7(1.2-11.5), p = 0.022]. Acceptance of advertisement brochures was found to significantly reduce the level of agreement with the proposition that "A physician should not accept any gift from a

  7. Safety report concerning Melusine (after power increase to 4 MW). Descriptive part. Volumes 1 and 2

    International Nuclear Information System (INIS)

    Baas, C.; Delcroix, V.; Jacquemain, M.; Marouby, R.; Meunier, C.; De Robien, E.; Rossillon, F.

    1967-03-01

    Construction of Melusine was started in January 1957, It first diverged on July 1, 1958. It operated at: 1 MW from March 1959; 1.4 MW from April 1960; 2 MW from September 1961; 4 MW from December 1965. Various modifications have been made since the reactor was built. They concern: - the addition of a hot cell. - the effluents: 2 reservoirs of 15 m 3 for liquid waste have been installed. The resin regeneration equipment has been completely modified. - the building: offices have been added - experimental zones have been set up in the hall - the electrical supply. - the cooling and purification circuits (installation of a second exchanger, replacement of the primary pumps, creation of a hot layer, etc... ). - the fuel elements (at the moment of the MTR type enriched to 90 per cent). - the swimming-pool (which has been partially equipped with a stainless steel coating). - the core (placing of 'stools', of a diving-board, etc...). - the ventilation: the hall has been de-pressurized during normal working in the event of an accident, the hall can be isolated and a safety circuit can be started up. A chimney has been installed. - the hall (which has been strengthened and sealed more effectively). - the control electronics (modification of the principle, and which are now entirely transistorized). So many changes have been made that the reactor now bears only a slight resemblance to the initial model. It has appeared necessary to make a brief review of these improvements in order to be able to judge more effectively the installations present safety characteristics; these latter are furthermore fairly well known as a result of the experiments carried out not only by the Thermal Transfer Service in Grenoble but also at Cadarache (Cabri) and Toulon (the work of Mr. PASCOUET). (authors) [fr

  8. Food safety concerns deriving from the use of silver based food packaging materials: a case study.

    Directory of Open Access Journals (Sweden)

    Alessandra ePezzuto

    2015-10-01

    Full Text Available The formulation of innovative packaging solutions, exerting a functional antimicrobial role in slowing down food spoilage, is expected to have a significant impact on the food industry, allowing both the maintenance of food safety criteria for longer periods and the reduction of food waste. Different materials are considered able to exert the required antimicrobial activity, among which are materials containing silver. However, challenges exist in the application of silver to food contact materials due to knowledge gaps in the production of ingredients, stability of delivery systems in food matrices and health risks caused by the same properties which also offer the benefits. Aims of the present study were to test the effectiveness and suitability of two packaging systems, one of which contained silver, for packaging and storing Stracchino cheese, a typical Italian fresh cheese, and to investigate if there was any potential for consumers to be exposed to silver, via migration from the packaging to the cheese. Results did not show any significant difference in the effectiveness of the packaging systems on packaged Stracchino cheese, excluding that the active packaging systems exerted an inhibitory effect on the growth of spoilage microorganisms. Moreover, silver migrated into the cheese matrix throughout the storage time (24 days. Silver levels in cheese finally exceeded the maximum established level for the migration of a non-authorised substance through a functional barrier (Commission Regulation (EC No. 450/2009. This result poses safety concerns and strongly suggests the need for more research aimed at better characterizing the new packaging materials in terms of their potential impacts on human health and the environment.

  9. Radiation Safety in the Neonatal Intensive Care Unit: Too Little or Too Much Concern?

    Directory of Open Access Journals (Sweden)

    Cheng-Chung Yu

    2010-12-01

    Full Text Available With rising numbers of extremely premature infants in the neonatal intensive care unit (NICU who require multiple radiologic examinations for their complex medical conditions, concerns the risk of radiation exposure become a more prevalent issue. The biological effects from cumulative doses of both primary and secondary radiation can be particularly troubling for very premature babies due to their inherent sensitivity to both iatrogenic and environmental insults. Similarly, radiologic studies performed in the NICU pose potentially significant exposure risks to caretakers and to the families of patients often present in the NICU during these examinations. The purpose of this article is to critically review the available literature regarding current exposure rates in the NICU, address the validity of radiation exposure concerns, and suggest areas for improvement. With few exceptions, studies reveal that there were only low doses of radiation derived from any single radiographic examination in standard NICUs and that the radiation dosage used was in compliance with recommendations made by the Commission of European Communities (EC and International Commission on Radiological Protection (ICRP. However, there were wide variations in the radiation dose per single examination (mean entrance skin doses ranged from 15 to 73.6 μGy and in the frequency (mean ranged from 3.2 to 31 examinations per infant of those examinations. Studies also reported low secondary exposure rates from scatter radiation to others present in the NICU during radiographic examinations. Key to limiting unnecessary radiation exposure in the NICU is the employment of proper radiation techniques and safety measures. Thus, adhering to recommendations made by the EC and ICRP can help to reduce the anxiety of patients' families and medical staff regarding their risks from the effects of ionizing radiation in the NICU.

  10. Radiation safety concerns and diagnostic reference levels for computed tomography scanners in Tamil Nadu

    International Nuclear Information System (INIS)

    Livingstone, Roshan S.; Dinakaran, Paul M.

    2011-01-01

    Radiation safety in computed tomography (CT) scanners is of concern due its widespread use in the field of radiological imaging. This study intends to evaluate radiation doses imparted to patients undergoing thorax, abdomen and pelvic CT examinations and formulate regional diagnostic reference levels (DRL) in Tamil Nadu, South India. In-site CT dose measurement was performed in 127 CT scanners in Tamil Nadu for a period of 2 years as a part of the Atomic Energy Regulatory Board (AERB)-funded project. Out of the 127 CT scanners,13 were conventional; 53 single-slice helical scanners (SSHS); 44 multislice CT (MSCT) scanners; and 17 refurbished scanners. CT dose index (CTDI) was measured using a 32-cm polymethyl methacrylate (PMMA)-body phantom in each CT scanner. Dose length product (DLP) for different anatomical regions was generated using CTDI values. The regional DRLs for thorax, abdomen and pelvis examinations were 557, 521 and 294 mGy cm, respectively. The mean effective dose was estimated using the DLP values and was found to be 8.04, 6.69 and 4.79 mSv for thorax, abdomen and pelvic CT examinations, respectively. The establishment of DRLs in this study is the first step towards optimization of CT doses in the Indian context. (author)

  11. Addiction and Women Gender Differences Concerning Drug Abuse and its Treatment

    Directory of Open Access Journals (Sweden)

    Fatemeh Safari

    2003-05-01

    Full Text Available This article focuses on the quantitative grounds for the emergence and spread of addiction among women, its medical, social and psychological problems, impediments for the treatment of addiction among women as well as gender differences concerning drug abuse and its treatment. This article is a translation of a statistical research on addiction among women and a number of other researches. Based on conclusions drawn from the said researches, women become inclined to addiction mostly by their husbands due to their cordial relationships. Moreover, the negative attitudes of peer groups can overshadow girls and women more than boys and men. From the viewpoint of psychological disorders, the relationship between disorders resulting from psychological pressure after an incident and addiction is stronger among girls and women compared to boys and men. Addiction among women in addition to certain ailments such as malnutrition, hypertension and cancer, can expose them to dangerous diseases such as Hepatitis and AIDS. There is more possibility for addicted women to be infected with AIDS and other sexually transmitted diseases compared to men and they are more exposed to female ailments compared to other women. As far as treatment impediments are concerned, women face a greater social stigma due to their addiction compared to men. Social approach considering addicted women as an indecent person is a major impediment for their treatment. Taking care of the child is also another obstacle for their treatment. There is less possibility for women to receive support from their families for quitting their addiction compared to men. Treatment programs also unwantedly may create obstacles for the treatment of women such as financial constraints, administrative bureaucracy, concentration of treatment programs for men and lack of sensitivity towards women’s addiction. The psychological impediments to treatment include internalizing the notion that addiction is a

  12. Regulatory overview report 2013 concerning nuclear safety in Swiss nuclear installations

    International Nuclear Information System (INIS)

    2014-06-01

    The Swiss Federal Nuclear Safety Inspectorate (ENSI) acting as the regulatory body of the Swiss Federation assesses and monitors nuclear facilities in Switzerland: these include five nuclear power plants, the interim storage facilities based at each plant, the Central Interim Storage Facility (ZWILAG) at Wuerenlingen together with the nuclear facilities at the Paul Scherrer Institute (PSI) and the two universities of Basel and Lausanne. Using a combination of inspections, regulatory meetings, examinations and analyses together with reports from the licensees of individual facilities, ENSI obtains the overview required concerning nuclear safety. It ensures that the facilities comply with regulations. Its regulatory responsibilities include the transport of radioactive materials from and to nuclear facilities and the preparations for a deep geological repository for nuclear waste. ENSI maintains its own emergency organisation, an integral part of the national emergency structure. It provides the public with information on particular events in nuclear facilities. This Surveillance Report describes operational experience, systems technology, radiological protection and management in all the nuclear facilities. Generic issues relevant to all facilities such as probabilistic safety analyses are described. In 2013, the five nuclear power plants in Switzerland (Beznau Units 1 and 2, Muehleberg, Goesgen and Leibstadt) were all operated safely and had complied with their approved operating conditions. The nuclear safety at all plants was rated as being good. 34 events were reported. During operation, no reactor scrams were recorded. On the INES scale, ranging from 0-7, ENSI rated all reportable events as Level 0. The ENSI safety evaluation reflects both reportable events and the results of the approximately 460 inspections conducted during 2013. ZWILAG consists of several storage halls, a conditioning plant and a plasma plant. At the end of 2013, the cask storage hall

  13. Epigenetics and cancer: implications for drug discovery and safety assessment

    International Nuclear Information System (INIS)

    Moggs, Jonathan G.; Goodman, Jay I.; Trosko, James E.; Roberts, Ruth A.

    2004-01-01

    It is necessary to determine whether chemicals or drugs have the potential to pose a threat to human health. Research conducted over the last two decades has led to the paradigm that chemicals can cause cancer either by damaging DNA or by altering cellular growth, probably via receptor-mediated changes in gene expression. However, recent evidence suggests that gene expression can be altered markedly via several diverse epigenetic mechanisms that can lead to permanent or reversible changes in cellular behavior. Key molecular events underlying these mechanisms include the alteration of DNA methylation and chromatin, and changes in the function of cell surface molecules. Thus, for example, DNA methyltransferase enzymes together with chromatin-associated proteins such as histone modifying enzymes and remodelling factors can modify the genetic code and contribute to the establishment and maintenance of altered epigenetic states. This is relevant to many types of toxicity including but not limited to cancer. In this paper, we describe the potential for interplay between genetic alteration and epigenetic changes in cell growth regulation and discuss the implications for drug discovery and safety assessment

  14. Enacting laws concerning radiation safety management for students using X-rays and electron beams under 1 MeV

    International Nuclear Information System (INIS)

    Nishizawa, Kunihide; Shibata, Michihiro; Saze, Takuya

    2004-01-01

    Laws concerning radiation safety management were analyzed from the point of view of defining precisely what is meant by radiation and what is meant by the subject. There are no laws to protect students from radiation hazards when using X-rays and electron beams under 1 MeV for research and/or education. The Law concerning Technical Standards for Preventing Radiation Hazards gives the authorities the power to enact new rules and regulations that will protect the students. The Radiation Council must take charge for enactment of all laws regarding radiation safety management. (author)

  15. A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations.

    Science.gov (United States)

    Allan, M C

    1992-01-01

    To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part I of this series provides a background for the discussion of drug safety by defining the basic terms and showing the flow of safety information through a pharmaceutical company. The customers for adverse drug event data are identified to provide a basis for providing quality service. The development of a drug product is briefly reviewed to show the evolution of safety data. Drug development and safety are defined by federal regulations. These regulations are developed by the FDA with information from pharmaceutical manufacturers. The intent of the regulations and the accompanying guidelines is described. An illustration from the news media is cited to show an alternative, positive approach to handling an adverse event report. This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text and additional readings are presented in an appendix. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction ;of the components

  16. Safety and problems in using radioactive drugs in hospitals

    International Nuclear Information System (INIS)

    Arimizu, Noboru

    1975-01-01

    The safety and the control problem of non-closed RI (radiopharmaceuticals) of which use has rapidly been increased, were studied. At present, the hospitals with an independent clinic for the nuclear medicine are very limited and many doctors, nurses and safety controllers who are working in the clinic belong to other clinics. As for the diagnosis using RI examination, the dangers of the persons who are working with radioimmunoassay, especially using Au-antigen kit were studied. Furthermore, the problems concerning the reduction of exposure dose by the use of a short half-life RI, such as sup(99m)Tc and the dangers of external exposure on the persons who use the isotope were studied. In addition, the control of RI ward for RI therapy was discussed. The author considered the specialization and fixation of doctors, nurses and technicians are becoming of necessity with the advancement of RI therapy. In addition, the necessity of training nurses for the nuclear medicine was insisted on. (Tsukamoto, Y.)

  17. Safety and problems in using radioactive drugs in hospitals

    Energy Technology Data Exchange (ETDEWEB)

    Arimizu, N [National Inst. of Radiological Sciences, Chiba (Japan)

    1975-01-01

    The safety and the control problem of non-closed RI (radiopharmaceuticals) of which use has rapidly been increased, were studied. At present, the hospitals with an independent clinic for the nuclear medicine are very limited and many doctors, nurses and safety controllers who are working in the clinic belong to other clinics. As for the diagnosis using RI examination, the dangers of the persons who are working with radioimmunoassay, especially using Au-antigen kit were studied. Furthermore, the problems concerning the reduction of exposure dose by the use of a short half-life RI, such as sup(99m)Tc and the dangers of external exposure on the persons who use the isotope were studied. In addition, the control of RI ward for RI therapy was discussed. The author considered the specialization and fixation of doctors, nurses and technicians are becoming of necessity with the advancement of RI therapy. In addition, the necessity of training nurses for the nuclear medicine was insisted on.

  18. Regulatory aspects of oncology drug safety evaluation: Past practice, current issues, and the challenge of new drugs

    International Nuclear Information System (INIS)

    Rosenfeldt, Hans; Kropp, Timothy; Benson, Kimberly; Ricci, M. Stacey; McGuinn, W. David; Verbois, S. Leigh

    2010-01-01

    The drug development of new anti-cancer agents is streamlined in response to the urgency of bringing effective drugs to market for patients with limited life expectancy. FDA's regulation of oncology drugs has evolved from the practices set forth in Arnold Lehman's seminal work published in the 1950s through the current drafting of a new International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) safety guidance for anti-cancer drug nonclinical evaluations. The ICH combines the efforts of the regulatory authorities of Europe, Japan, and the United States and the pharmaceutical industry from these three regions to streamline the scientific and technical aspects of drug development. The recent development of new oncology drug classes with novel mechanisms of action has improved survival rates for some cancers but also brings new challenges for safety evaluation. Here we present the legacy of Lehman and colleagues in the context of past and present oncology drug development practices and focus on some of the current issues at the center of an evolving harmonization process that will generate a new safety guidance for oncology drugs, ICH S9. The purpose of this new guidance will be to facilitate oncology drug development on a global scale by standardizing regional safety requirements.

  19. [The issue of harm reduction in Polish legislation concerning drug addiction. A comparative study].

    Science.gov (United States)

    Sobeyko, Justyna

    2008-01-01

    The aim of work is the assessment of legal permissibility for health and social harm reduction programmes resulting from drug use in the context of the polish legislation on narcotic drug use and drug addiction. The thesis outlines harm reduction programmes implemented worldwide, role of penal code in counteracting both narcotic drug supply and demand, attitude of United Nations and European Union to the drug problem including harm reduction programmes, solutions adopted in the selected European Union member states. The main part of the thesis presents the evolution of polish legislation regarding drug use and analysis of legal permissibility for harm reduction programmes in this context. The conclusion inferred is the statement that implementation of the harm reduction programmes requires a certain minimal depenalisation of the drug use by a legislator and the fact that restrictive legal system impedes programme realization. Thus the thesis postulates depenalisation of small drug quantities for personal use.

  20. [Post-marketing drug safety-risk management plan(RMP)].

    Science.gov (United States)

    Ezaki, Asami; Hori, Akiko

    2013-03-01

    The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.

  1. The role of the Australian Adverse Drug Reactions Advisory Committee (ADRAC) in monitoring drug safety

    International Nuclear Information System (INIS)

    Boyd, Ian W.

    2002-01-01

    The Australian adverse drug reaction reporting system is acknowledged as one of the best in the world. Despite its small population of less than 20 million people, Australia's current ADR reporting rate of over 12000 reports per year places it in the top few nations in terms of reports per capita. The ADRAC program has been in operation for over 30 years. Australia was a founding member of the WHO International Drug Monitoring Programme which commenced in 1968 and currently there are about 153000 reports in the ADRAC database. Reports from health professionals have uncovered a number of significant safety problems over the years. Of particular importance are flucloxacillin-induced hepatitis, amoxycillin/clavulanate-induced hepatitis, and the association of cystitis with tiaprofenic acid. The number and quality of the reports has allowed an understanding of the characteristics of the reactions and, using ADRAC reporters as a major source of cases, case-control studies have been completed which have identified risk factors. ADRAC's review of Australian reports has highlighted many important associations that have been disseminated through the Australian Adverse Drug Reactions Bulletin

  2. From Drug Safety to Drug Security: A Contemporary Shift in the Policing of Health.

    Science.gov (United States)

    Hornberger, Julia

    2018-01-29

    The counterfeiting of medication is increasingly seen as a major threat to health, especially in the light of both the everyday reliance on and a broadening of world-wide access to pharmaceuticals. Exaggerated or real, this threat has inaugurated, this article argues, a shift from a drug safety regime to a drug security regime that governs the flow of pharmaceuticals and brings together markets, police, and health actors in new ways. This entails a shift from soft disciplinary means aimed at incremental and continued inclusion of defaulters, to one of drastically sovereign measures of exclusion and banishment aimed at fake goods and the people associated with them, in the name of health. Through a multi-sited ethnographic study, this article shows how such new drug security efforts play themselves out especially in (South) Africa, highlighting a modus operandi of spectacular performativity and of working through suspicion and association rather than factuality, producing value less so for those in need of health than for a petty security industry itself. © 2018 by the American Anthropological Association.

  3. All-terrain vehicles (ATVs) on the road: a serious traffic safety and public health concern.

    Science.gov (United States)

    Denning, Gerene; Jennissen, Charles; Harland, Karisa; Ellis, David; Buresh, Christopher

    2013-01-01

    On-road all-terrain vehicle (ATV) crashes are frequent occurrences that disproportionately impact rural communities. These crashes occur despite most states having laws restricting on-road ATV use. A number of overall risk factors for ATV-related injuries have been identified (e.g., lack of helmet, carrying passengers). However, few studies have determined the relative contribution of these and other factors to on-road crashes and injuries. The objective of our study was to determine whether there were differences between on- and off-road ATV crashes in their demographics and/or mechanisms and outcomes of injuries. Data were derived from our statewide ATV injury surveillance database (2002-2009). Crash location and crash and injury mechanisms were coded using a modification of the Department of Transportation (DOT) coding system. Descriptive analyses and statistical comparisons (chi-square test) of variables were performed. Multivariate logistic regression analysis was used to determine relative risk. 976 records were included in the final analysis, with 38 percent of the injured individuals from on-road crashes. Demographics were similar for crashes at each location, with approximately 80 percent males, 30 percent under the age of 16, and 15 percent passengers. However, females and youths under 16 were over 4 times more likely to be passengers (P ≤ 0.0001), regardless of crash location. Compared to those off-road, on-road crash victims were approximately 10 times more likely to be involved in a vehicle-vehicle collision (P road crashes were also twice as likely to test positive for alcohol as those off-road (P road victims were only half as likely to be helmeted (P road crashes involved a collision with another vehicle, suggesting that ATVs on the road represent a potential traffic safety concern. Of note, helmets were associated with reduced risk for the number and severity of brain injuries, providing further support for the importance of helmet use. Finally

  4. 75 FR 4305 - Regulatory Guidance Concerning the Applicability of the Federal Motor Carrier Safety Regulations...

    Science.gov (United States)

    2010-01-27

    ... review of, or preparation and transmission of, typed messages via wireless phones. Because of the safety... Secretary broad power in carrying out motor carrier safety statutes and regulations to ``prescribe.... Handheld or other wireless electronic devices that are brought into a CMV are considered ``additional...

  5. Food Safety as a contributor to Food Security: global policy concerns & challenges

    Directory of Open Access Journals (Sweden)

    Vijay Kumar Chattu

    2015-12-01

    Microphysical particles such as glass and metal can be hazardous and cause serious injury to consumers. Pathogenic bacteria, viruses and toxins produced by microorganisms are all possible contaminants of food and impact food safety. Like food security, food safety is also effected by poverty and climate change. Hence Foo

  6. We have to eat, right? : food safety concerns and shopping for daily vegetables in modernizing Vietnam

    NARCIS (Netherlands)

    Wertheim-Heck, S.C.O.

    2015-01-01

    This thesis analyses how people during everyday life confront real food safety risks that are difficult to influence and come to grips with and focuses on food safety risks in modernizing Vietnam.

    Over the past 40 years Vietnam has developed from war torn country with a highly centralized

  7. Anesthetic drug wastage in the operation room: A cause for concern

    Directory of Open Access Journals (Sweden)

    Kapil Chaudhary

    2012-01-01

    Full Text Available Context: The cost of anesthetic technique has three main components, i.e., disposable supplies, equipments, and anesthetic drugs. Drug budgets are an easily identifiable area for short-term savings. Aim: To assess and estimate the amount of anesthetic drug wastage in the general surgical operation room. Also, to analyze the financial implications to the hospital due to drug wastage and suggest appropriate steps to prevent or minimize this wastage. Settings and Design: A prospective observational study conducted in the general surgical operation room of a tertiary care hospital. Materials and Methods: Drug wastage was considered as the amount of drug left unutilized in the syringes/vials after completion of a case and any ampoule or vial broken while loading. An estimation of the cost of wasted drug was made. Results: Maximal wastage was associated with adrenaline and lignocaine (100% and 93.63%, respectively. The drugs which accounted for maximum wastage due to not being used after loading into a syringe were adrenaline (95.24%, succinylcholine (92.63%, lignocaine (92.51%, mephentermine (83.80%, and atropine (81.82%. The cost of wasted drugs for the study duration was 46.57% (Rs. 16,044.01 of the total cost of drugs issued/loaded (Rs. 34,449.44. Of this, the cost of wastage of propofol was maximum being 56.27% (Rs. 9028.16 of the total wastage cost, followed by rocuronium 17.80% (Rs. 2856, vecuronium 5.23% (Rs. 840, and neostigmine 4.12% (Rs. 661.50. Conclusions: Drug wastage and the ensuing financial loss can be significant during the anesthetic management of surgical cases. Propofol, rocuronium, vecuronium, and neostigmine are the drugs which contribute maximally to the total wastage cost. Judicious use of these and other drugs and appropriate prudent measures as suggested can effectively decrease this cost.

  8. Prescription for antibiotics at drug shops and strategies to improve quality of care and patient safety

    DEFF Research Database (Denmark)

    Mbonye, Anthony K; Buregyeya, Esther; Rutebemberwa, Elizeus

    2016-01-01

    OBJECTIVES: The main objective of this study was to assess practices of antibiotic prescription at registered drug shops with a focus on upper respiratory tract infections among children in order to provide data for policy discussions aimed at improving quality of care and patient safety......-line drug for treatment of pneumonia in children according to the guidelines. CONCLUSIONS: There is urgent need to regulate drug shop practices of prescribing and selling antibiotics, for the safety of patients seeking care at these outlets....

  9. Safety profile of drugs used in the treatment of osteoporosis: a systematical review of the literature

    Directory of Open Access Journals (Sweden)

    M. Varenna

    2013-10-01

    Full Text Available The range of osteoporosis treatments is increasingly large and, like any disease, the pharmacological management of patients should involve a risk/benefit evaluation to attain the greatest reduction in risk of fracture with the lowest incidence of adverse events. The aim of this review is to critically appraise the literature about the safety issues of the main pharmacological treatments of osteoporosis. This document is the result of a consensus of experts based on a systematic review of regulatory documents, randomized controlled trials, metaanalyses, pharmacovigilance surveys and case series related to possible adverse drug reactions to osteoporosis treatment with calcium and vitamin D supplements, bisphosphonates, strontium ranelate, selective estrogen receptor modulators, denosumab, and teriparatide. As expected, randomized controlled trials showed only the most common adverse events due to the samples size and the short observation time. Case series and observational studies are able to provide data about uncommon side effects, but in some cases a sure cause-effect relationship needs still to be confirmed. Consistently with methodological limitations, the newer drugs have a tolerance profile that has not been fully explored yet. Osteoporosis treatments showed an overall good tolerance profile with rare serious adverse events that, however, must be well known by the clinician who prescribes these drugs. The concern about possible adverse events should be weighed against the reduction of morbidity and mortality associated with a significant fracture risk reduction.

  10. 77 FR 10666 - Pipeline Safety: Post Accident Drug and Alcohol Testing

    Science.gov (United States)

    2012-02-23

    ... 199 [Docket No. PHMSA-2011-0335] Pipeline Safety: Post Accident Drug and Alcohol Testing AGENCY... operators of Liquefied Natural Gas (LNG) facilities to conduct post- accident drug and alcohol tests of..., operators must drug and alcohol test each covered employee whose performance either contributed to the...

  11. Parental concern about vaccine safety in Canadian children partially immunized at age 2: a multivariable model including system level factors.

    Science.gov (United States)

    MacDonald, Shannon E; Schopflocher, Donald P; Vaudry, Wendy

    2014-01-01

    Children who begin but do not fully complete the recommended series of childhood vaccines by 2 y of age are a much larger group than those who receive no vaccines. While parents who refuse all vaccines typically express concern about vaccine safety, it is critical to determine what influences parents of 'partially' immunized children. This case-control study examined whether parental concern about vaccine safety was responsible for partial immunization, and whether other personal or system-level factors played an important role. A random sample of parents of partially and completely immunized 2 y old children were selected from a Canadian regional immunization registry and completed a postal survey assessing various personal and system-level factors. Unadjusted odds ratios (OR) and adjusted ORs (aOR) were calculated with logistic regression. While vaccine safety concern was associated with partial immunization (OR 7.338, 95% CI 4.138-13.012), other variables were more strongly associated and reduced the strength of the relationship between concern and partial immunization in multivariable analysis (aOR 2.829, 95% CI 1.151-6.957). Other important factors included perceived disease susceptibility and severity (aOR 4.629, 95% CI 2.017-10.625), residential mobility (aOR 3.908, 95% CI 2.075-7.358), daycare use (aOR 0.310, 95% CI 0.144-0.671), number of needles administered at each visit (aOR 7.734, 95% CI 2.598-23.025) and access to a regular physician (aOR 0.219, 95% CI 0.057-0.846). While concern about vaccine safety may be addressed through educational strategies, this study suggests that additional program and policy-level strategies may positively impact immunization uptake.

  12. Annual report 1996 concerning the nuclear safety and radiological protection in the Swiss nuclear installations

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-05-01

    The report presents detailed information about the nuclear safety and radiological protection in the Swiss nuclear power plants, the central interim storage at Wuerenlingen, the Paul Scherrer Institute (PSI) and other nuclear installations in Switzerland. figs., tabs., refs.

  13. Annual Report 1998 concerning the nuclear safety and radiological protection in the Swiss nuclear installations

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1999-05-01

    The report presents detailed information about the nuclear safety and radiological protection in the Swiss nuclear power plants, the central interim storage at Wuerenlingen, the Paul Scherrer Institute (PSI) and other nuclear installations in Switzerland.

  14. Annual Report 1998 concerning the nuclear safety and radiological protection in the Swiss nuclear installations

    International Nuclear Information System (INIS)

    1999-05-01

    The report presents detailed information about the nuclear safety and radiological protection in the Swiss nuclear power plants, the central interim storage at Wuerenlingen, the Paul Scherrer Institute (PSI) and other nuclear installations in Switzerland

  15. Annual Report 1999 concerning the nuclear safety and radiological protection in the Swiss nuclear installations

    International Nuclear Information System (INIS)

    2000-08-01

    The report presents detailed information about the nuclear safety and radiological protection in the Swiss nuclear power plants, the central interim storage at Wuerenlingen, the Paul Scherrer Institute (PSI) and other nuclear installations in Switzerland

  16. Annual Report 1999 concerning the nuclear safety and radiological protection in the Swiss nuclear installations

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-08-15

    The report presents detailed information about the nuclear safety and radiological protection in the Swiss nuclear power plants, the central interim storage at Wuerenlingen, the Paul Scherrer Institute (PSI) and other nuclear installations in Switzerland.

  17. Annual report 1996 concerning the nuclear safety and radiological protection in the Swiss nuclear installations

    International Nuclear Information System (INIS)

    1997-05-01

    The report presents detailed information about the nuclear safety and radiological protection in the Swiss nuclear power plants, the central interim storage at Wuerenlingen, the Paul Scherrer Institute (PSI) and other nuclear installations in Switzerland. figs., tabs., refs

  18. Health and human rights concerns of drug users in detention in Guangxi Province, China.

    Directory of Open Access Journals (Sweden)

    J Elizabeth Cohen

    2008-12-01

    Full Text Available BACKGROUND: Although confinement in drug detoxification ("detox" and re-education through labor (RTL centers is the most common form of treatment for drug dependence in China, little has been published about the experience of drug users in such settings. We conducted an assessment of the impact of detention on drug users' access to HIV prevention and treatment services and consequent threats to fundamental human rights protections. METHODS AND FINDINGS: Chinese government HIV and anti-narcotics legislation and policy documents were reviewed, and in-depth and key informant interviews were conducted with 19 injection drug users (IDUs and 20 government and nongovernmental organization officials in Nanning and Baise, Guangxi Province. Significant contradictions were found in HIV and antinarcotics policies, exemplified by the simultaneous expansion of community-based methadone maintenance therapy and the increasing number of drug users detained in detox and RTL center facilities. IDU study participants reported, on average, having used drugs for 14 y (range 8-23 y and had been confined to detox four times (range one to eight times and to RTL centers once (range zero to three times. IDUs expressed an intense fear of being recognized by the police and being detained, regardless of current drug use. Key informants and IDUs reported that routine HIV testing, without consent and without disclosure of the result, was the standard policy of detox and RTL center facilities, and that HIV-infected detainees were not routinely provided medical or drug dependency treatment, including antiretroviral therapy. IDUs received little or no information or means of HIV prevention, but reported numerous risk behaviors for HIV transmission while detained. CONCLUSIONS: Legal and policy review, and interviews with recently detained IDUs and key informants in Guangxi Province, China, found evidence of anti-narcotics policies and practices that appear to violate human rights

  19. Health and human rights concerns of drug users in detention in Guangxi Province, China.

    Science.gov (United States)

    Cohen, J Elizabeth; Amon, Joseph J

    2008-12-09

    Although confinement in drug detoxification ("detox") and re-education through labor (RTL) centers is the most common form of treatment for drug dependence in China, little has been published about the experience of drug users in such settings. We conducted an assessment of the impact of detention on drug users' access to HIV prevention and treatment services and consequent threats to fundamental human rights protections. Chinese government HIV and anti-narcotics legislation and policy documents were reviewed, and in-depth and key informant interviews were conducted with 19 injection drug users (IDUs) and 20 government and nongovernmental organization officials in Nanning and Baise, Guangxi Province. Significant contradictions were found in HIV and antinarcotics policies, exemplified by the simultaneous expansion of community-based methadone maintenance therapy and the increasing number of drug users detained in detox and RTL center facilities. IDU study participants reported, on average, having used drugs for 14 y (range 8-23 y) and had been confined to detox four times (range one to eight times) and to RTL centers once (range zero to three times). IDUs expressed an intense fear of being recognized by the police and being detained, regardless of current drug use. Key informants and IDUs reported that routine HIV testing, without consent and without disclosure of the result, was the standard policy of detox and RTL center facilities, and that HIV-infected detainees were not routinely provided medical or drug dependency treatment, including antiretroviral therapy. IDUs received little or no information or means of HIV prevention, but reported numerous risk behaviors for HIV transmission while detained. Legal and policy review, and interviews with recently detained IDUs and key informants in Guangxi Province, China, found evidence of anti-narcotics policies and practices that appear to violate human rights and imperil drug users' health.

  20. Current regulatory developments concerning the implementation of probabilistic safety analyses for external hazards in Germany

    International Nuclear Information System (INIS)

    Krauss, Matias; Berg, Heinz-Peter

    2014-01-01

    The Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU) initiated in September 2003 a comprehensive program for the revision of the national nuclear safety regulations which has been successfully completed in November 2012. These nuclear regulations take into account the current recommendations of the International Atomic Energy Agency (IAEA) and Western European Nuclear Regulators Association (WENRA). In this context, the recommendations and guidelines of the Nuclear Safety Standards Commission (KTA) and the technical documents elaborated by the respective expert group on Probabilistic Safety Analysis for Nuclear Power Plants (FAK PSA) are being updated or in the final process of completion. A main topic of the revision was the issue external hazards. As part of this process and in the light of the accident at Fukushima and the findings of the related actions resulting in safety reviews of nuclear power plants at national level in Germany and on European level, a revision of all relevant standards and documents has been made, especially the recommendations of KTA and FAK PSA. In that context, not only design issues with respect to events such as earthquakes and floods have been discussed, but also methodological issues regarding the implementation of improved probabilistic safety analyses on this topic. As a result of the revision of the KTA 2201 series 'Design of Nuclear Power Plants against Seismic Events' with their parts 1 to 6, part 1 'Principles' was published as the first standard in November 2011, followed by the revised versions of KTA 2201.2 (soil) and 2201.4 (systems and components) in 2012. The modified the standard KTA 2201.3 (structures) is expected to be issued before the end of 2013. In case of part 5 (seismic instrumentation) and part 6 (post>seismic actions) draft amendments are expected in 2013. The expert group 'Probabilistic Safety Assessments for Nuclear Power Plants' (FAK PSA) is an advisory body of the Federal

  1. Optimization method concerning target conflicts between safety aspects and occupational safety aspects in nuclear power plant operations

    International Nuclear Information System (INIS)

    Mueller, W.

    1991-01-01

    The simplified cost-benefit analysis has not been considered for applications in nuclear engineering with complex decisions between safety aspects and occupational safety aspects. The extended cost-benefit analysis encounters problems with non-monetary criteria. Solutions are in sight, however with a subjective element. A major problem in implementing the method is the psychological barrier as against an evaluation of human life. The multi-attribute utility analysis overcomes the difficulties of the extended cost-benefit analysis, however, it also creates new problems on account of the complicated construction of the utility functions. The problems are solved most elegantly with the multi-criteria outranking analysis, the only disadvantage possibly being less transparency at first sight. (orig./HP) [de

  2. Responsiveness to physicians' requests for information concerning drug interactions: a comparison of brand and generic companies.

    Science.gov (United States)

    Thomas, M; Lexchin, J

    1990-01-01

    Research-based pharmaceutical companies maintain that there are important differences between themselves and their generic competitors. Prominent among them is an alleged greater ability to provide accurate and rapid responses to requests from physicians for information about drug products. This study evaluates pharmaceutical company behavior with regard to these issues. Two drug-drug interactions were identified, along with all of the companies in Canada marketing any of the four drugs involved. Each company received a letter describing symptoms suggestive of an interaction in a patient taking its particular product and the relevant second drug. The companies were asked if they were aware of any evidence of an interaction involving the two drugs. They were also asked to provide references regarding the interaction. Responses were received from all companies contacted except one. There were no significant differences (in the hypothesized direction) between the generic and brand companies with regard to either the accuracy or promptness of the response, or the usefulness of the references cited. On the contrary, generic firms were markedly quicker to respond than were brand manufacturers. The latter were slightly more likely to acknowledge evidence of an adverse drug interaction, and to provide useful references to relevant published research.

  3. Food Safety as a contributor to Food Security: global policy concerns & challenges

    Directory of Open Access Journals (Sweden)

    Vijay Kumar Chattu

    2015-12-01

    Full Text Available The theme for World Health Day campaign for this year 2015 is “Food safety: from farm to plate, make food safe”. The day focuses on demonstrating the importance of food safety along the whole length of the food chain in a globalized world, from production and transport, to preparation and consumption (1. Everyone needs food and needs it every day either plant sources or animal sources or both. The food we eat must be nutritious and safe but we often ignore or overlook the issue of food safety. Many cases of food borne diseases either acute poisoning or chronic exposure are largely under reported. In this globalized world, though the food chain extends over thousands of miles from different continents, an error or contamination in one country can affect the health of consumers on the other part of the world. To ensure full impact, these actions must build on principles of government stewardship, engagement of civil society, (2.According to UN, access to a safe and secure food supply is a basic human right. Food safety and food security are interrelated concepts which have an impact on the health outcomes and quality of human lives. As per Food and Agricultural Organization (FAO, Food security is a situation that exists when all people, at all times, have physical, social and economic access to sufficient, safe and nutritious food that meets their dietary needs and food preferences for an active and healthy life, (3. Based on the definition of Food security, four food security dimensions can be identified: food availability, economic and physical access to food, food utilization and stability over time. Apart from that food security is also affected by Poverty and Climate change.Food safety is an umbrella term that encompasses many aspects like food items handling, preparation and storage of food to prevent illness and injury. The other important issues are chemical, microphysical and microbiological aspects of food safety, (4. Control of

  4. Probing cardiac repolarization reserve in drug safety assessment

    NARCIS (Netherlands)

    Nalos, L.

    2011-01-01

    Excessive prolongation of cardiac repolarization, manifested as QT prolongation on ECG, is common unwanted side effect of many drugs and drug candidates. Prolongation of QT interval may lead to life threatening cardiac arrhythmia – Torsade de Point (TdP). Number of drugs was withdrawn from the

  5. Regulatory oversight report 2008 concerning nuclear safety in Swiss nuclear installations

    International Nuclear Information System (INIS)

    2009-04-01

    This annual report issued by the Swiss Federal Nuclear Inspectorate (ENSI) reports on the work carried out by the Inspectorate in 2008. This report reviews the regulatory activities in the four Swiss nuclear power stations and in four further nuclear installations in various Swiss research facilities. It deals with topics such as operational details, technologies in use, radiation protection, radioactive wastes, emergency dispositions, personnel and provides an assessment of operations from the safety point of view. Also, the transportation of nuclear materials - both nuclear fuels and nuclear wastes - is reported on. General topics discussed include probabilistic safety analyses and accident management, earthquake damage analysis and agreements on nuclear safety. The underground disposal of highly-radioactive nuclear wastes and work done in the rock laboratories are discussed, as are proposals for additional nuclear power stations

  6. The TSN bill concerning transparency and safety in the nuclear sector

    International Nuclear Information System (INIS)

    Leger, M.; Lahorgue, M.B.; Strohl, P.

    2009-01-01

    This document gathers together 3 articles whose common purpose is to shed light on the 13. June 2006 French law on transparency and safety in the nuclear sector. This law is fundamental because it gave, for the first time, the legal definitions of basic concepts like nuclear safety, public information or transparency. It also gave a series of principles on which the right in nuclear activities, has to rely: the principle of precaution, the principle of prevention, the principle of remedial action, the principle of who pollutes has to pay, and the principle of public information. The law gives also a clear scheme of the roles and responsibilities in the nuclear sector: the state, the government, the nuclear safety authority, the nuclear facility operator and the land (on which the nuclear facility stands) owner. (A.C.)

  7. Description of present practice concerning the safety criteria for nuclear power plants

    International Nuclear Information System (INIS)

    1977-01-01

    In the description at hand, the authors portray how the aims defined in the safety criteria are reached, and they make proposals for improvement. Basic principles, acceptances and requirements, with which the experts of TUeV and GRS involved in licensing procedures work at the moment, are compiled. This description of present practice has to be adapted perhaps to the existing scientific knowledge at the time. In order that an optimal behaviour as regards safety is reached by the employees in nuclear power plants, criterion 2.5 requires the following measures: the places of work and the work routine in nuclear power plants are to be organized in such a way, that they offer the conditions for the optimal behaviour of employees as regards safety. (orig./HP) [de

  8. The importance of Pharmacovigilance for the drug safety: Focus on cardiovascular profile of incretin-based therapy.

    Science.gov (United States)

    Sportiello, Liberata; Rafaniello, Concetta; Scavone, Cristina; Vitale, Cristiana; Rossi, Francesco; Capuano, Annalisa

    2016-01-01

    With the recent introduction of the new European Pharmacovigilance legislation, all new drugs must be carefully monitored after admission on the European market, in order to assess the long safety profile. Currently, special attention is given to several hypoglycemic agents with recent market approval (agonists of glucagon-like peptide-1 [GLP-1] receptor and dipeptidyl peptidase 4 inhibitors [DPP-4i]), which act through the potentiation of incretin hormone signaling. Their inclusion in European additional monitoring is also due to safety problems, which seem to characterize their pharmacological class. In fact, these drugs initially showed a good tolerability profile with mainly gastrointestinal adverse events, low risk of hypoglycemia and minor effects on body weight. But, new concerns such as infections, pancreatitis, pancreatic cancer and above all cardiovascular events (especially risk of heart failure requiring hospitalization) are now arising. In this review, we highlighted aspects of the new Pharmacovigilance European dispositions, and then we investigated the tolerability profile of incretin-based therapies, in particular DPP-4 inhibitors. Notably, we focused our attention on new safety concerns, which are emerging mostly in the post-marketing period, as the cardiovascular risk profile. Evidence in literature and opinions of regulatory agencies (e.g., European Medicines Agency and Food and Drug Administration) about risks of incretin-based therapies are yet controversial, and there are many open questions in particular on cancer and cardiovascular effects. Thus, it is important to continue to monitor closely the use of these drugs in clinical practice to improve the knowledge on their long-term safety and their place in diabetes therapy. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  9. Food Safety as a contributor to Food Security: global policy concerns & challenges

    OpenAIRE

    Vijay Kumar Chattu

    2015-01-01

    The theme for World Health Day campaign for this year 2015 is “Food safety: from farm to plate, make food safe”. The day focuses on demonstrating the importance of food safety along the whole length of the food chain in a globalized world, from production and transport, to preparation and consumption (1). Everyone needs food and needs it every day either plant sources or animal sources or both. The food we eat must be nutritious and safe but we often ignore or overlook the issue of food safet...

  10. Ensuring the nuclear safety of VVER-440 reactor pressure vessels in Skoda, Concern Enterprise, Plzen

    International Nuclear Information System (INIS)

    Hrbek, Z.

    1985-01-01

    Various types of routine inspections are described of reactor pressure vessels with the aim of identifying residual lifetime and overall safety. The inspection programme includes: choice of systems and instruments, type of tests, test frequency, safety criteria, measures to be taken in case of unsatisfactory results, documentation. The criteria are given for periodical inspections and requirements listed for instruments and equipment. The main three groups of tests are: visual inspection and dimension tests, surface inspection and volumetric inspection. Briefly described is some of the equipment used. (M.D.)

  11. Online availability and safety of drugs in shortage: a descriptive study of internet vendor characteristics.

    Science.gov (United States)

    Liang, Bryan A; Mackey, Tim K

    2012-02-09

    Unprecedented drug shortages announced by the US Food and Drug Administration (FDA) have severely affected therapeutic access, patient safety, and public health. With continued shortages, patients may seek drugs online. To assess the prevalence of online marketing for current FDA shortage drugs and potential patient safety risks. We performed a descriptive study of the prevalence of online marketing for shortage drugs-that is, offers for sale of each drug, including characteristics of online drug sellers and intermediary sites marketing these drugs. Of the 72 FDA shortage-listed drugs, 68 (94%) were offered for sale online. We found 291 offers for these drugs, the vast majority (n = 207, 71.1%) by online drug sellers selling direct to consumers. Intermediary sites included data aggregators (n = 22, 8%), forum links (n = 23, 8%), and personal page data links (n = 34, 12%), as well as Flickr social media links (n = 5, 2%), all advertising drugs without a prescription. Of the 91 online drug sellers identified, 31 (34%) had more than 1 shortage drug offered for sale, representing most (n = 148, 71%) of all online drug seller sales offers. The majority of these online drug sellers (n = 21, 68%) were on the National Association of Boards of Pharmacy (NABP) Not Recommended Sites list. Finally, for shortage drugs with an online drug seller (n = 58, 85%), 53 (91%) had at least one site on the Not Recommended list and 21 (36%) had only sites on the Not Recommended list. FDA shortage drugs are widely marketed over the Internet. Suspect online drug sellers and intermediaries dominate these sales offers. As a critical risk management issue, patients, providers, and policymakers should be extremely cautious in procuring shortage drugs through Internet sourcing.

  12. Surveys of research projects concerning nuclear facility safety, financed by the Federal Ministry for the Environment, Nature Protection and Reactor Safety, 1988

    International Nuclear Information System (INIS)

    1989-11-01

    Each progress report is a collection of individual reports, categorized by subject matter. They are a documentation of the contractor's progress, rendered by themselves on standardized forms, published, for the sake of general information on progress made in investigations concerning reactor safety, by the project attendance department of the GRS. The individual reports have serial numbers. Each report includes particulars of the objective, work carried out, results obtained and plans for project continuation. (orig.) [de

  13. Surveys of research projects concerning nuclear facility safety, financed by the Federal Ministry for the Environment, Nature Protection and Reactor Safety, 1987

    International Nuclear Information System (INIS)

    1988-06-01

    Each progress report is a collection of individual reports, categorized by subject matter. They are a documentation of the contractor's progress, rendered by themselves on standardized forms, published, for the sake of general information on progress made in investigations concerning reactor safety, by the project attendance department of the GRS. The individual reports have serial numbers. Each report includes particulars of the objective, work carried out, results obtained and plans for project continuation. (orig.) [de

  14. Surveys of research projects concerning nuclear facility safety financed by the Federal Ministry for the Environment, Nature Protection and Reactor Safety, 1991

    International Nuclear Information System (INIS)

    1992-09-01

    Each progress report is a collection of individual reports, categorized by subject matter. They are a documentation of the contractor's progress, rendered by themselves on standardized forms, published, for the sake of general information on progress made in investigations concerning reactor safety, by the project attendance department of the GRS. The individual reports have serial numbers. Each report includes particulars of the objective, work carried out, results obtained and plans for project continuation. (orig.) [de

  15. Geological disposal of nuclear waste: II. From laboratory data to the safety analysis – Addressing societal concerns

    International Nuclear Information System (INIS)

    Grambow, Bernd; Bretesché, Sophie

    2014-01-01

    Highlights: • Models for repository safety can only partly be validated. • Long term risks need to be translated in the context of societal temporalities. • Social sciences need to be more strongly involved into safety assessment. - Abstract: After more than 30 years of international research and development, there is a broad technical consensus that geologic disposal of highly-radioactive waste will provide for the safety of humankind and the environment, now, and far into the future. Safety analyses have demonstrated that the risk, as measured by exposure to radiation, will be of little consequence. Still, there is not yet an operating geologic repository for highly-radioactive waste, and there remains substantial public concern about the long-term safety of geologic disposal. In these two linked papers, we argue for a stronger connection between the scientific data (paper I, Grambow et al., 2014) and the safety analysis, particularly in the context of societal expectations (paper II). In this paper (II), we assess the meaning of the technical results and derived models (paper I) for the determination of the long-term safety of a repository. We consider issues of model validity and their credibility in the context of a much broader historical, epistemological and societal context. Safety analysis is treated in its social and temporal dimensions. This perspective provides new insights into the societal dimension of scenarios and risk analysis. Surprisingly, there is certainly no direct link between increased scientific understanding and a public position for or against different strategies of nuclear waste disposal. This is not due to the public being poorly informed, but rather due to cultural cognition of expertise and historical and cultural perception of hazards to regions selected to host a geologic repository. The societal and cultural dimension does not diminish the role of science, as scientific results become even more important in distinguishing

  16. 76 FR 63929 - Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and...

    Science.gov (United States)

    2011-10-14

    ...] Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and... Administration (FDA). The meeting will be open to the public. Name of Committees: Drug Safety and Risk Management... Safe Use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On December 1...

  17. 75 FR 17417 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management...

    Science.gov (United States)

    2010-04-06

    ...] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory... Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This meeting was... Drug Safety and Risk Management Advisory Committee would be held on May 12, 2010. On page 10490, in the...

  18. Safety report concerning the reactor Pegase - volume 1 - Description of the installation - volume 2 - Safety of the installations

    International Nuclear Information System (INIS)

    Lacour, J.

    1964-01-01

    In the first volume: This report is a description of the reactor Pegase, given with a view to examine the safety of the installations. The Cadarache site at which they are situated is briefly described, in particular because of the consequences on the techniques employed for building Pegase. A description is also given of the original aspects of the reactor. The independent loops which are designed for full-scale testing of fuel elements used in natural uranium-gas-graphite reactor systems are described in this report, together with their operational and control equipment. In the second volume: In the present report are examined the accidents which could cause damage to the Pegase reactor installation. Among possible causes of accidents considered are the seismicity of the region, an excessive power excursion of the reactor and a fracture in the sealing of an independent loop. Although all possible precautions have been taken to offset the effects of such accidents, their ultimate consequences are considered here. The importance is stressed of the security action and regulations which, added to the precautions taken for the construction, ensure the safety of the installations. (authors) [fr

  19. Current statistical tools, systems and bodies concerned with safety and accident statistics.

    NARCIS (Netherlands)

    Koornstra, M.J.

    1996-01-01

    There are a wide range of differences in the methods used nationally to classify and record road accidents. The current use of road safety information systems and the few systems available for international use are discussed. Recommendations are made for a more efficient, less costly, and improved

  20. Topical points of community policy concerning nuclear safety relevant to the Internal Market

    International Nuclear Information System (INIS)

    Schroeder, M.

    1991-01-01

    Starting with the Internal Market concept, the lecture describes general and specific expectations directed to the nuclear community from a point of view of nuclear safety, and analyzes those aspects of nuclear safety, EC policy focuses on. There are the following chapters: 1. Selection of sites for nuclear installations, 2. installation and reactor safety, 3. radioactive waste management, 4. decommissioning of nuclear installations, 5. radioactive waste storage, 6. coping with nuclear accidents and other radiological emergency situations. Sophistication of public health and environmental protection within the framework of the EURATOM Treaty is seen in connection with interim and final storage as well as reprocessing of radioactive waste, and with the decommissioning of nuclear facilities on the basis of section 30 ff., and installation and reactor safety on the basis of section 203 EURATOM Treaty. Improving the protection of public health in particular is possible and necessary in order to make the EURATOM community into a proper nuclear community of law. (orig./HSCH) [de

  1. Online Availability and Safety of Drugs in Shortage: A Descriptive Study of Internet Vendor Characteristics

    Science.gov (United States)

    Mackey, Tim K

    2012-01-01

    Background Unprecedented drug shortages announced by the US Food and Drug Administration (FDA) have severely affected therapeutic access, patient safety, and public health. With continued shortages, patients may seek drugs online. Objective To assess the prevalence of online marketing for current FDA shortage drugs and potential patient safety risks. Methods We performed a descriptive study of the prevalence of online marketing for shortage drugs—that is, offers for sale of each drug, including characteristics of online drug sellers and intermediary sites marketing these drugs. Results Of the 72 FDA shortage-listed drugs, 68 (94%) were offered for sale online. We found 291 offers for these drugs, the vast majority (n = 207, 71.1%) by online drug sellers selling direct to consumers. Intermediary sites included data aggregators (n = 22, 8%), forum links (n = 23, 8%), and personal page data links (n = 34, 12%), as well as Flickr social media links (n = 5, 2%), all advertising drugs without a prescription. Of the 91 online drug sellers identified, 31 (34%) had more than 1 shortage drug offered for sale, representing most (n = 148, 71%) of all online drug seller sales offers. The majority of these online drug sellers (n = 21, 68%) were on the National Association of Boards of Pharmacy (NABP) Not Recommended Sites list. Finally, for shortage drugs with an online drug seller (n = 58, 85%), 53 (91%) had at least one site on the Not Recommended list and 21 (36%) had only sites on the Not Recommended list. Conclusions FDA shortage drugs are widely marketed over the Internet. Suspect online drug sellers and intermediaries dominate these sales offers. As a critical risk management issue, patients, providers, and policymakers should be extremely cautious in procuring shortage drugs through Internet sourcing. PMID:22321731

  2. Advice on drug safety in pregnancy: are there differences between commonly used sources of information?

    Science.gov (United States)

    Frost Widnes, Sofia K; Schjøtt, Jan

    2008-01-01

    Safety regarding use in pregnancy is not established for many drugs. Inconsistencies between sources providing drug information can give rise to confusion with possible therapeutic consequences. Therefore, it is important to measure clinically important differences between drug information sources. The objective of this study was to compare two easily accessible Norwegian sources providing advice on drug safety in pregnancy - the product monographs in the Felleskatalog (FK), published by the pharmaceutical companies, and the five regional Drug Information Centres (DICs) in Norway - in addition to assessing the frequency of questions regarding drug safety in pregnancy made to the DICs according to the Anatomical Therapeutic Chemical (ATC) classification system. Advice on drug use in pregnancy provided by the DICs in 2003 and 2005 were compared with advice in the product monographs for the respective drugs in the FK. Comparison of advice was based on categorization to one of four categories: can be used, benefit-risk assessment, should not be used, or no available information. A total of 443 drug advice were categorized. Seven out of ten of drugs frequently enquired about, according to the ATC system, were drugs acting on the nervous system (group N). For 208 (47%) of the drugs, advice differed between the DICs and FK. Advice from the FK was significantly (p drugs that were newly introduced and those that had been on the market for a longer time, advice regarding use of drugs in the first trimester and advice regarding use of drugs in the second or third trimester, or between advice provided during 2003 and during 2005. The results of this study show considerable differences between two Norwegian sources providing advice on the use of drugs in pregnancy. Based on the knowledge that healthcare providers choose sources of information in a random manner, our results may be of clinical importance. We believe that the problem with heterogeneous drug information on this

  3. Position Paper. Safety for K-12 students: United States policy concerning LGBT student safety must provide inclusion

    Directory of Open Access Journals (Sweden)

    April Sanders

    2013-07-01

    Full Text Available Students who identify as lesbian, gay, bisexual, or transgender (LGBT are at risk for harassment due to their sexual orientation or gender identification with over 85% of LGBT students in the United States (US reporting such harassment. These statistics demonstrate one aspect of the significance of this issue, but the cost of human life in some instances has revealed another layer of importance related to a need for safety policies for LGBT students. Even though a need exists for such policies, the practice of heteronormativity found in US policymaking regarding bullying does not protect victims or curb the violence. This essay highlights several recent developments in anti-bullying policy in US schools that shows the existence of heteronormativity, which is not helping to pro-tect LGBT students. By understanding the discrimination encouraged by current policy, future policy can be better shaped to protect LGBT students.

  4. [The legislation of subjects of the Russian Federation concerning prevention of alcoholism, drug addiction and toxicomania].

    Science.gov (United States)

    2011-01-01

    The article deals with analysis of the laws "On prevention of alcoholism, drug addiction and toxicomania" introduced in some subjects of the Russian Federation (Permskaya, Tomskaya, Murmanskaya oblast, the Republics of Bashkortostan, Mordovia, Buryatia, Mari El, etc.). The laws stipulate the participation of the authorities of public and municipal administration, public health, social protection, home affairs and others in the prevention activities. The integral part of this activity is the approval of corresponding regional programs with adequate financing and coordination. The laws on prevention of alcoholism, drug addiction and toxicomania, adopted in the subjects of the Russian Federation are of advance character and testify the necessity of adoption of relevant Federal law.

  5. The Swedish Nuclear Power Inspectorate's Regulations concerning Safety in connection with the Disposal of Nuclear Material and Nuclear Waste. General Recommendations concerning the Application of the Swedish Nuclear Power Inspectorate's Regulations above

    International Nuclear Information System (INIS)

    2002-06-01

    An english translation of the original Swedish regulations concerning the safety in disposal of nuclear wastes is published in this booklet, together with recommendations on how these regulations can be applied

  6. Risks of drowning and safety concerns at the beaches of Karachi--perspective from lifeguards.

    Science.gov (United States)

    Shaikh, Masood Ali

    2014-05-01

    Going to beaches is a popular pastime for many people in Karachi. Lifeguards have been deployed on many beaches for the safety and protection of beachgoers. This cross-sectional survey was conducted to study the opinions and experiences of lifeguards posted at eight beaches of Karachi. Ignorance among beachgoers about how dangerous it could be at seaside, was reported by 19 (61.3%) out of 31 lifeguards interviewed. Lifeguards had to put up with verbal and physical abuse while discharging their duties, with verbal abuse being the universal experience. Improved record keeping of drowning and near-drowning data would help make better evidence-informed beach-safety decisions in Karachi for reducing the morbidity and mortality burden owing to drowning.

  7. Regulatory oversight report 2007 concerning nuclear safety in Swiss nuclear installations

    International Nuclear Information System (INIS)

    2008-04-01

    This annual report issued by the Swiss Federal Nuclear Inspectorate (HSK) reports on the work carried out by the Inspectorate in 2007. This report reviews the regulatory activities in the four Swiss nuclear power stations and in four further nuclear installations in various Swiss research facilities. It deals with topics such as operational details, technologies in use, radiation protection, radioactive wastes, emergency dispositions and personnel and provides an assessment of operations from the point of view of safety. Also, the transportation of nuclear materials - both nuclear fuels and nuclear wastes - is reported on. General topics discussed include probabilistic safety analyses and accident management. Finally, the disposal of nuclear wastes and work done in the rock laboratories in Switzerland is commented on

  8. Safety basis for selected activities in single-shell tanks with flammable gas concerns. Revision 1

    International Nuclear Information System (INIS)

    Schlosser, R.L.

    1996-01-01

    This is full revision to Revision 0 of this report. The purpose of this report is to provide a summary of analyses done to support activities performed for single-shell tanks. These activities are encompassed by the flammable gas Unreviewed Safety Question (USQ). The basic controls required to perform these activities involve the identification, elimination and/or control of ignition sources and monitoring for flammable gases. Controls are implemented through the Interim Safety Basis (ISB), IOSRs, and OSDs. Since this report only provides a historical compendium of issues and activities, it is not to be used as a basis to perform USQ screenings and evaluations. Furthermore, these analyses and others in process will be used as the basis for developing the Flammable Gas Topical Report for the ISB Upgrade

  9. Enhancing food safety: the role of the Food and Drug Administration

    National Research Council Canada - National Science Library

    Wallace, Robert B; Oria, Maria

    2010-01-01

    .... Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources...

  10. Competition and safety as reflected in the legislation concerning technical supervision - are they incompatible

    International Nuclear Information System (INIS)

    Roth, H.A.

    1986-01-01

    The author discusses the conflicts between competition and safety in the legislation on technical supervision, the requirements on specific sectors, and the consequences of the concentration of the functions of technical supervision in the hands of the Technical Supervisory Board (TUEV). The demand to give more room for competition is found to have no legal basis in fundamental law. It therefore rests with the legislator to concert the one with the other. (orig./HP) [de

  11. Simulation experiments concerning functioning tests of technical safety devices with process computers. Pt. 2

    International Nuclear Information System (INIS)

    Hawickhorst, W.

    1976-12-01

    Computerized inspection techniques of engineered safety systems improve the diagnosis capability, relative to the presently used techniques, even if anticipated system disturbances can only be qualitatively predicted. To achieve this, the system to be inspected must be partitioned into small subsystems, which can be treated independently from each other. This report contains the formulation of a standardized inspection concept based on system decomposition. Its performance is discussed by means of simulation experiments. (orig.) [de

  12. Safety of Etoricoxib, Celecoxib, and Nonselective Nonsteroidal Antiinflammatory Drugs in Ankylosing Spondylitis and Other Spondyloarthritis Patients

    DEFF Research Database (Denmark)

    Kristensen, L E; Jakobsen, A K; Askling, J

    2015-01-01

    OBJECTIVE: Safety data regarding the use of etoricoxib and other nonsteroidal antiinflammatory drugs (NSAIDs) in ankylosing spondylitis (AS) and other spondyloarthritis (SpA) patients are rather limited. Our objective was to estimate and compare rates of gastrointestinal, renovascular, and cardio......OBJECTIVE: Safety data regarding the use of etoricoxib and other nonsteroidal antiinflammatory drugs (NSAIDs) in ankylosing spondylitis (AS) and other spondyloarthritis (SpA) patients are rather limited. Our objective was to estimate and compare rates of gastrointestinal, renovascular...

  13. Drug and alcohol crash risk : traffic safety facts : research note.

    Science.gov (United States)

    2015-02-01

    While the extent of use of alcohol by drivers and the risks posed by alcohol use have been well known for many decades, relatively little has been known about the use of other drugs by drivers and the associated risks. However, drug-impaired driving ...

  14. 75 FR 25271 - Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy Concerning...

    Science.gov (United States)

    2010-05-07

    .... One provision restricts the use of a trade or brand name of a nontobacco product as the trade or brand... . Submit written comments concerning this guidance to the Division of Dockets Management (HFA-305), Food... manufacturers may not use a trade or brand name of a nontobacco product as the trade or brand name for a...

  15. Items to be reflected to the nuclear power safety measures in Japan (concerning the examination, design and operation management) (excluding the items to be reflected to the standards)

    Energy Technology Data Exchange (ETDEWEB)

    1980-10-01

    In connection with the Three Mile Island nuclear power accident in March, 1979, in the United States, in order to introduce the lessons from it in the nuclear power safety regulations in Japan, 52 items to be reflected to the nuclear power safety measures were chosen by the Nuclear Safety Commission. Of these, 16 items were examined by the Committee on Examination of Reactor Safety. It was decided that these results would be introduced in the nuclear safety regulations, by the Nuclear Safety Commission. The following 16 items are described. For the examination, four items concerning the automatic operation of safety systems and others; for the design, five items concerning a small rupture accident, the monitoring of the state of primary coolant, control room layout and others; for the operation management, seven items concerning the inspection at the time of repair, the prevention of faulty handlings by operators and others.

  16. Items to be reflected to the nuclear power safety measures in Japan (concerning the examination, design and operation management) (excluding the items to be reflected to the standards)

    International Nuclear Information System (INIS)

    1980-01-01

    In connection with the Three Mile Island nuclear power accident in March, 1979, in the United States, in order to introduce the lessons from it in the nuclear power safety regulations in Japan, 52 items to be reflected to the nuclear power safety measures were chosen by the Nuclear Safety Commission. Of these, 16 items were examined by the Committee on Examination of Reactor Safety. It was decided that these results would be introduced in the nuclear safety regulations, by the Nuclear Safety Commission. The following 16 items are described. For the examination, four items concerning the automatic operation of safety systems and others; for the design, five items concerning a small rupture accident, the monitoring of the state of primary coolant, control room layout and others; for the operation management, seven items concerning the inspection at the time of repair, the prevention of faulty handlings by operators and others. (J.P.N.)

  17. Gender differences and demographic influences in perceived concern for driver safety and support for impaired driving countermeasures.

    Science.gov (United States)

    Butters, Jennifer; Mann, Robert E; Wickens, Christine M; Boase, Paul

    2012-12-01

    Driving safety, impaired driving, and legislation to address these concerns remain important issues. It is imperative countermeasures be targeted toward the most appropriate groups. This paper explores the potential relationship between gender and driving attitudes toward safety issues and impaired-driving countermeasures. The data are from the 2007 Impaired Driving Survey commissioned by Transport Canada and Mothers Against Drunk Driving (MADD) Canada. The survey is a, stratified by region, telephone survey of 1,514 Canadian drivers 18years of age and older with a valid driver's license who had driven within the past 30days. The findings illustrate a consistent impact of gender on these issues. Other variables were also identified as relevant factors although less consistently. Current findings suggest that strategies for building support for interventions, or for changing risk perception/concern for risky driving behaviors should be tailored by gender to maximize the potential for behavior change. This information may assist program and policy developers through the identification of more or less receptive target groups. Future research directions are also presented. Copyright © 2012 National Safety Council and Elsevier Ltd. All rights reserved.

  18. THE INFLUENCE OF MEDIA EXPOSURE, SAFETY AND HEALTH CONCERNS, AND SELF-EFFICACY ON ENVIRONMENTAL ATTITUDES TOWARDS ELECTRONIC GREEN PRODUCTS

    Directory of Open Access Journals (Sweden)

    Iman Khalid A. Qader

    2011-07-01

    Full Text Available As the high-tech industry evolves at a rapid pace, vast amounts of hazardous materials are used in fuelling its global expansion. These rapid changes in production processes are significantly depleting natural resources. With the surge of popular interest and awareness pertaining to environmental issues, organisations may be in peril if consumers' attitudes towards their products are ignored. This study intends to understand consumers' environmental attitudes towards electronic green products and to identify the effect of three factors, namely, media exposure, safety and health concerns, and self- efficacy, on this attitude. Data were collected via a self-administered questionnaire among 170 respondents in a public university. The results of the study indicated that safety and health concerns as well as self-efficacy had significant positive impacts on consumers' environmental attitudes. Surprisingly, however, media exposure did not exhibit any significant influence on consumers' environmental attitude. It is recommended that campaign and awareness projects focus on safety and health issues. Additionally, media should play a more active role in increasing environmental awareness among consumers.

  19. Concerns related to Safety Management of Engineered Nanomaterials in research environment

    International Nuclear Information System (INIS)

    Groso, A; Meyer, Th

    2013-01-01

    Since the rise of occupational safety and health research on nanomaterials a lot of progress has been made in generating health effects and exposure data. However, when detailed quantitative risk analysis is in question, more research is needed, especially quantitative measures of workers exposure and standards to categorize toxicity/hazardousness data. In the absence of dose-response relationships and quantitative exposure measurements, control banding (CB) has been widely adopted by OHS community as a pragmatic tool in implementing a risk management strategy based on a precautionary approach. Being in charge of health and safety in a Swiss university, where nanomaterials are largely used and produced, we are also faced with the challenge related to nanomaterials' occupational safety. In this work, we discuss the field application of an in-house risk management methodology similar to CB as well as some other methodologies. The challenges and issues related to the process will be discussed. Since exact data on nanomaterials hazardousness are missing for most of the situations, we deduce that the outcome of the analysis for a particular process is essentially the same with a simple methodology that determines only exposure potential and the one taking into account the hazardousness of ENPs. It is evident that when reliable data on hazardousness factors (as surface chemistry, solubility, carcinogenicity, toxicity etc.) will be available, more differentiation will be possible in determining the risk for different materials. On the protective measures side, all CB methodologies are inclined to overprotection side, only that some of them suggest comprehensive protective/preventive measures and others remain with basic advices. The implementation and control of protective measures in research environment will also be discussed.

  20. Concerns related to Safety Management of Engineered Nanomaterials in research environment

    Science.gov (United States)

    Groso, A.; Meyer, Th

    2013-04-01

    Since the rise of occupational safety and health research on nanomaterials a lot of progress has been made in generating health effects and exposure data. However, when detailed quantitative risk analysis is in question, more research is needed, especially quantitative measures of workers exposure and standards to categorize toxicity/hazardousness data. In the absence of dose-response relationships and quantitative exposure measurements, control banding (CB) has been widely adopted by OHS community as a pragmatic tool in implementing a risk management strategy based on a precautionary approach. Being in charge of health and safety in a Swiss university, where nanomaterials are largely used and produced, we are also faced with the challenge related to nanomaterials' occupational safety. In this work, we discuss the field application of an in-house risk management methodology similar to CB as well as some other methodologies. The challenges and issues related to the process will be discussed. Since exact data on nanomaterials hazardousness are missing for most of the situations, we deduce that the outcome of the analysis for a particular process is essentially the same with a simple methodology that determines only exposure potential and the one taking into account the hazardousness of ENPs. It is evident that when reliable data on hazardousness factors (as surface chemistry, solubility, carcinogenicity, toxicity etc.) will be available, more differentiation will be possible in determining the risk for different materials. On the protective measures side, all CB methodologies are inclined to overprotection side, only that some of them suggest comprehensive protective/preventive measures and others remain with basic advices. The implementation and control of protective measures in research environment will also be discussed.

  1. Safety and effectiveness of drug therapy for the acutely agitated patient (Part I

    Directory of Open Access Journals (Sweden)

    Gianluca Airoldi

    2013-04-01

    Full Text Available Acute agitation occurs in a variety of medical and psychiatric conditions, and the management of agitated, abusive, or violent patients is a common problem in the emergency department. Rapid control of potentially dangerous behaviors by physical restraint and pharmacologic tranquillization is crucial to ensure the safety of the patient and health-care personnel and to allow diagnostic procedures and treatment of the underlying condition. The purpose of this article (the first in a 2-part series is to review the extensive safety data published on the antipsychotic medications currently available for managing situations of this type, including older neuroleptics like haloperidol, chlorpromazine, and pimozide as well as a number of the newer atypical antipsychotics (olanzapine, risperidone, ziprasidone. Particular attention is focused on the ability of these drugs to lengthen the QT interval in surface electrocardiograms. This adverse effect is of major concern, especially in light of the reported relation between QT interval and the risk of sudden death. In patients with the congenital long-QT syndrome, a long QT interval is associated with a fatal paroxysmal ventricular arrhythmia knownas torsades de pointes. Therefore, careful evaluation of the QT-prolonging properties and arrhythmogenic potential of antipsychotic drugs is urgently needed. Clinical assessment of drug-induced QT-interval prolongation is strictly dependent on the quality of electrocardiographic data and the appropriateness of electrocardiographic analyses. Unfortunately, measurement imprecision and natural variability preclude a simple use of the actually measured QT interval as a surrogate marker of drug-induced proarrhythmia. Because the QT interval changes with heart rate, a rate-corrected QT interval (QTc is commonly used when evaluating a drug’s effect. In clinical settings, themost widely used formulas for rate-correction are those of Bazett (QTc=QT/RR^0.5 and Fridericia

  2. The Internet and drug safety: what are the implications for pharmacovigilance?

    Science.gov (United States)

    Cobert, B; Silvey, J

    1999-02-01

    Use of the Internet is becoming widespread throughout the world. Its use in the domain of drug safety and pharmacovigilance is spreading rapidly. Governments and industry have taken the lead in developing extensive web sites. The US Food and Drug Administration (FDA), the European Agency for the Evaluation of Medicinal Products (EMEA) and other agencies have developed sites containing enormous amounts of information both on pharmacovigilance in general and on specific drugs in particular. Under the US 'Freedom of Information Act' the FDA has put major parts of its adverse event database on line. Regulatory documents are also available from the FDA site or from hyperlinks described in the site. The US Center for Drug Evaluation and Research updates its site most days and maintains a free automated e-mail announcement service of these updates. Similarly, the EMEA updates its site frequently and publishes extensive material including regulatory documents, guidelines, European Public Assessment Reports on newly approved medications and other useful information. A free update service by e-mail is also available. Although English is the primary language used on the EMEA site, some of the information is available in other languages. Pharmaceutical companies are not using the Internet for pharmacovigilance yet. Rather, the Internet is being used for promotion of their products and for informing consumers on general information on diseases, for financial and investor data and for employment opportunities, etc. Other organisations such as lobbies, consumer groups and medical journals are also beginning to use the Internet. The electronic transmission of safety information, using the standards developed by the International Conference on Harmonization, is currently being tested for the transmission of individual patient adverse event information between companies and governments. In addition, the FDA has begun to accept adverse events from healthcare providers and consumers

  3. Problems and concerns in radiation safety management related with decommissioning of tritium facility

    International Nuclear Information System (INIS)

    Kawano, Takao

    2005-01-01

    The tritium facility at the National Institute for Fusion Science has been closed in 2002 after decommissioning procedure. A number of works have been completed including technical measures and administrative documentations to be reported to the Ministry of Education, Culture, Sport, Science and Technology. All the operations were carried out in three successive terms; 1) survey and preparations, 2) actual decommissioning works, and 3) report of all procedures to the Minister. A valuable experience we had during this project has been summarized, and some problems have also been pointed out from a viewpoint of radiation safety management. (author)

  4. Chiral Analysis of Pesticides and Drugs of Environmental Concern: Biodegradation and Enantiomeric Fraction

    Directory of Open Access Journals (Sweden)

    Alexandra S. Maia

    2017-09-01

    Full Text Available The importance of stereochemistry for medicinal chemistry and pharmacology is well recognized and the dissimilar behavior of enantiomers is fully documented. Regarding the environment, the significance is equivalent since enantiomers of chiral organic pollutants can also differ in biodegradation processes and fate, as well as in ecotoxicity. This review comprises designed biodegradation studies of several chiral drugs and pesticides followed by enantioselective analytical methodologies to accurately measure the enantiomeric fraction (EF. The enantioselective monitoring of microcosms and laboratory-scale experiments with different environmental matrices is herein reported. Thus, this review focuses on the importance of evaluating the EF variation during biodegradation studies of chiral pharmaceuticals, drugs of abuse, and agrochemicals and has implications for the understanding of the environmental fate of chiral pollutants.

  5. Legacy data sharing to improve drug safety assessment: the eTOX project

    DEFF Research Database (Denmark)

    Sanz, Ferran; Pognan, François; Steger-Hartmann, Thomas

    2017-01-01

    The sharing of legacy preclinical safety data among pharmaceutical companies and its integration with other information sources offers unprecedented opportunities to improve the early assessment of drug safety. Here, we discuss the experience of the eTOX project, which was established through...

  6. Safety, efficacy, and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis

    DEFF Research Database (Denmark)

    Egeberg, A; Ottosen, M B; Gniadecki, R

    2018-01-01

    BACKGROUND: Real-life data on newer biologic and biosimilar agents for moderate-to-severe psoriasis are lacking. OBJECTIVES: To examine safety, efficacy, and time to discontinuation (drug survival) of biologics (adalimumab, etanercept, infliximab, secukinumab, and ustekinumab) and compare origina...... the long-term safety of novel biologics for psoriasis. This article is protected by copyright. All rights reserved....

  7. Safety

    International Nuclear Information System (INIS)

    2001-01-01

    This annual report of the Senior Inspector for the Nuclear Safety, analyses the nuclear safety at EDF for the year 1999 and proposes twelve subjects of consideration to progress. Five technical documents are also provided and discussed concerning the nuclear power plants maintenance and safety (thermal fatigue, vibration fatigue, assisted control and instrumentation of the N4 bearing, 1300 MW reactors containment and time of life of power plants). (A.L.B.)

  8. Safety concerns of herbal products and traditional Chinese herbal medicines: dehydropyrrolizidine alkaloids and aristolochic acid.

    Science.gov (United States)

    Stegelmeier, Bryan L; Brown, Ammon W; Welch, Kevin D

    2015-12-01

    In many countries, including the United States, herbal supplements, tisanes and vegetable products, including traditional Chinese medicines, are largely unregulated and their content is not registered, monitored or verified. Consequently, potent plant toxins including dehydropyrrolizidine alkaloids and other potential carcinogens can contaminate these products. As herbal and food supplement producers are left to their own means to determine the safety and purity of their products prior to marketing, disturbingly often good marketing practices currently in place are ignored and content is largely undocumented. Historical examples of poisoning and health issues relating to plant material containing dehydopyrrolizidine alkaloids and aristolochic acids were used as examples to demonstrate the risk and potential toxicity of herbal products, food supplements, or traditional medicines. More work is needed to educate consumers of the potential risk and require the industry to be more responsible to verify the content and insure the safety of their products. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

  9. The Influence of Safety, Efficacy, and Medical Condition Severity on Natural versus Synthetic Drug Preference.

    Science.gov (United States)

    Meier, Brian P; Lappas, Courtney M

    2016-11-01

    Research indicates that there is a preference for natural v. synthetic products, but the influence of this preference on drug choice in the medical domain is largely unknown. We present 5 studies in which participants were asked to consider a hypothetical situation in which they had a medical issue requiring pharmacological therapy. Participants ( N = 1223) were asked to select a natural, plant-derived, or synthetic drug. In studies 1a and 1b, approximately 79% of participants selected the natural v. synthetic drug, even though the safety and efficacy of the drugs were identical. Furthermore, participants rated the natural drug as safer than the synthetic drug, and as that difference increased, the odds of choosing the natural over synthetic drug increased. In studies 2 and 3, approximately 20% of participants selected the natural drug even when they were informed that it was less safe (study 2) or less effective (study 3) than the synthetic drug. Finally, in study 4, approximately 65% of participants chose a natural over synthetic drug regardless of the severity of a specific medical condition (mild v. severe hypertension), and this choice was predicted by perceived safety and efficacy differences. Overall, these data indicate that there is a bias for natural over synthetic drugs. This bias could have implications for drug choice and usage. © The Author(s) 2015.

  10. Pancreatic Safety of Incretin-Based Drugs - FDA and EMA Assessment

    NARCIS (Netherlands)

    Egan, Amy G.; Blind, Eberhard; Dunder, Kristina; de Graeff, Pieter A.; Hummer, B. Timothy; Bourcier, Todd; Rosebraugh, Curtis

    2014-01-01

    After evaluating a safety signal regarding pancreatitis and pancreatic cancer in patients using incretin-based drugs, the Food and Drug Administration and the European Medicines Agency conclude that assertions of a causal association are inconsistent with the data. With approximately 25.8 million

  11. 78 FR 71036 - Pipeline Safety: Random Drug Testing Rate; Contractor Management Information System Reporting...

    Science.gov (United States)

    2013-11-27

    ... PHMSA-2013-0248] Pipeline Safety: Random Drug Testing Rate; Contractor Management Information System Reporting; and Obtaining Drug and Alcohol Management Information System Sign-In Information AGENCY: Pipeline... Management Information System (MIS) Data; and New Method for Operators to Obtain User Name and Password for...

  12. Drug Safety Monitoring in Children: Performance of Signal Detection Algorithms and Impact of Age Stratification

    NARCIS (Netherlands)

    O.U. Osokogu (Osemeke); C. Dodd (Caitlin); A.C. Pacurariu (Alexandra C.); F. Kaguelidou (Florentia); D.M. Weibel (Daniel); M.C.J.M. Sturkenboom (Miriam)

    2016-01-01

    textabstractIntroduction: Spontaneous reports of suspected adverse drug reactions (ADRs) can be analyzed to yield additional drug safety evidence for the pediatric population. Signal detection algorithms (SDAs) are required for these analyses; however, the performance of SDAs in the pediatric

  13. Assessment of pharmacovigilance approaches for monitoring the safety of antimalarial drugs in pregnancy

    NARCIS (Netherlands)

    Dellicour, S.O.M.C.

    2014-01-01

    Post-marketing surveillance of drugs used in pregnancy is challenging, especially in developing countries where resources for pharmacovigilance are rare. There is a need to establish simple but effective systems to monitor safety of drugs given during pregnancy in resource constrained countries.

  14. Drug safety alerts of pharmacovigilance programme of India: A scope for targeted spontaneous reporting in India

    Directory of Open Access Journals (Sweden)

    Prasad Thota

    2018-01-01

    Conclusion: In India, spontaneous reporting of ADRs existed since 1998 under passive surveillance method, but there is an urgent need to initiate TSR, which is a complementary method to spontaneous reporting on these drug safety alerts for further regulatory action by Central Drugs Standard Control Organization.

  15. Crash safety concerns for out-of-position occupant postures: A look toward safety in highly automated vehicles.

    Science.gov (United States)

    McMurry, Timothy L; Poplin, Gerald S; Shaw, Greg; Panzer, Matthew B

    2018-04-09

    Highly automated vehicle occupants will all be passengers and may be free to ride while in postures for which existing occupant safety systems such as seat belts and airbags were not originally designed. These occupants could therefore face increased risk of injury when a crash occurs. Given that current vehicles are capable of supporting a variety of occupant postures outside of the normal design position, such as reclined or turned passengers, an evaluation of current field data was performed to better understand the risks of being out of position. We investigated the frequency, demographics, and injury outcomes for out-of-position occupants using NASS-CDS. A matched analysis was performed to compare injury outcomes for out-of-position passengers with in-position drivers involved in similar crashes. Finally, case studies for out-of-position occupants were examined in the Crash Injury Research (CIREN) database. Only 0.5% of occupants in NASS-CDS with a coded posture were out of position at the time of crash. Of the out-of-position occupants, being turned or seated sideways was almost as likely as being reclined. Out-of-position occupants were younger and less likely to be belted than their in-position counterparts. Analysis of the injury data indicated a trend that being out of position was associated with an elevated risk for serious injury. However, the number of out-of-position occupants was too small to provide a definitive or statistically significant conclusion on injury outcome. Though highly automated vehicles may eventually reduce the number of crashes and traffic fatalities in the future, there will be a transition period when these vehicles remain at risk from collisions with human-driven vehicles. These crashes could cause higher than anticipated rates of injury if occupants are less likely to be belted or tend to be in positions for which restraints are not optimized. This study highlights the need for future research on occupant response and

  16. Regulatory oversight report 2012 concerning nuclear safety in Swiss nuclear installations

    International Nuclear Information System (INIS)

    2013-04-01

    The Swiss Federal Nuclear Safety Inspectorate (ENSI) assesses and monitors nuclear facilities in Switzerland. These include the five nuclear power plants, the interim storage facilities based at each plant, the Central Interim Storage Facility (ZWILAG) and the nuclear facilities at the Paul Scherrer Institute (PSI), at the Federal Institute of Technology in Lausanne (EPFL) and at the University of Basel. Using a combination of inspections, regulatory meetings, examinations and analyses together with reports from the licensees of individual facilities, ENSI obtains the required overview of nuclear safety in the relevant facilities. It ensures that the facilities comply with the regulations and operate as required by law. Its regulatory responsibilities also include the transport of radioactive materials from and to nuclear facilities and the preparations for a deep geological repository for nuclear waste. ENSI maintains its own emergency organisation. It formulates and updates its own guidelines which stipulate the criteria for evaluating the current activities and future plans of the operators of nuclear facilities. ENSI produces regular reports on its regulatory activities and nuclear safety in Swiss nuclear facilities. It fulfils its statutory obligation to provide the public with information on particular events and findings in nuclear facilities. In 2012, the five nuclear power plants in Switzerland were all operated safely. 34 events were reported; on the international INES scale of 0 to 7, ENSI rated 33 events as Level 0 and 1 as Level 1. ENSI evaluates the safety of each nuclear power plant as part of a systematic safety evaluation taking account of both reportable events and other findings, in particular the results of more than 400 inspections conducted by ENSI during 2012. ZWILAG consists of several interim storage halls, a conditioning plant and an incineration/melting plant. At the end of 2012, the cask storage hall contained 40 transport/storage casks

  17. Changes in the utilization of osteoporosis drugs after the 2010 FDA bisphosphonate drug safety communication

    Directory of Open Access Journals (Sweden)

    Bander Balkhi

    2018-02-01

    Conclusions: The 2010 FDA bisphosphonates safety communication appeared to have influenced Osteoporosis utilization in Medicaid recipients. The 2010 FDA bisphosphonates safety communication was associated with a significant reduction in the utilization of bisphosphonates in the Medicaid program.

  18. Food Safety Concerns and other Factors Affecting Iran’s Pistachio Exports to EU, Australia, and Japan

    OpenAIRE

    Ashktorab, Niloofar; Saghaian, Sayed Hossein; Shahnoushi, Naser

    2013-01-01

    In this paper, the impact of food safety concerns on Iran’s pistachio export demand was investigated. Panel data and panel cointegration analyses were used to estimate the export demand function of Iran’s pistachio nuts to the European Union (EU), Japan, and Australia for the period of 1997 to 2006 so that the relationship between factors affecting Iran’s pistachio exports can be examined. The results show the existence of long-run relationships among the variables that have a significant imp...

  19. Safety and Security Concerns of Nurses Working in the Intensive Care Unit: A Qualitative Study.

    Science.gov (United States)

    Keys, Yolanda; Stichler, Jaynelle F

    Intensive care units (ICUs) exist to serve as a safe place for critically ill patients to receive care from skilled practitioners. In this qualitative study, ICU nurses shared their perspectives on elements that promote safety and security on their units. After obtaining institutional review board approval, participants participated in telephone interviews with a nurse researcher who has experience as a bedside ICU nurse. Five categories and 14 themes were identified and then confirmed using member checking. Results indicate that participants prefer to provide care in ICUs with no more than 12 to 14 beds and provide the following: visibility of patients and coworkers; more than 1 way to exit; and can be locked in case of emergency or threat. Nearly all respondents mentioned adequate staffing as the most important attribute of a safe, secure care environment for patients and families. More research is needed to identify design features that make the most impact on providing a safe, secure ICU environment.

  20. Assessment of regulations set up under public law concerning questions of safety technology

    International Nuclear Information System (INIS)

    Steiff, A.; Althaus, W.; Dietz, B.; Gross, H.J.; Stasiczek, M.; Salzwedel, J.; Reinhardt, M.

    1992-02-01

    A goal of the preliminary study was to assess the need for a data-processing system, to analyze the goals of such a system, to conceptualize it and examine possibilities for implementing it and to do a cost-benefit analysis of it. It serves as a means of assistance for - licensing and supervisory authorities, - the manufacturers and operators of plants, - the control institutions, - the communes, the governments of the Laender and the federal government, - trade associations and professional associations, - employers' organizations and employees' organizations in their efforts to solve problems and carry out tasks regarding safety technology. Such problems arise during the planning, construction, operation, alteration, closure and removal of plants as well as during the transport and storing of materials and goods. (orig./DG) [de

  1. Raspberry ketone in food supplements – High intake, few toxicity data – A cause for safety concern?

    DEFF Research Database (Denmark)

    Bredsdorff, Lea; Wedebye, Eva Bay; Nikolov, Nikolai Georgiev

    2015-01-01

    Raspberry ketone (4-(4-hydroxyphenyl)-2-butanone) is marketed on the Internet as a food supplement. The recommended intake is between 100 and 1400 mg per day. The substance is naturally occurring in raspberries (up to 4.3 mg/kg) and is used as a flavouring substance. Toxicological studies...... on raspberry ketone are limited to acute and subchronic studies in rats. When the lowest recommended daily dose of raspberry ketone (100 mg) as a food supplement is consumed, it is 56 times the established threshold of toxicological concern (TTC) of 1800 μg/day for Class 1 substances. The margin of safety (MOS......) based on a NOAEL of 280 mg/kg bw/day for lower weight gain in rats is 165 at 100 mg and 12 at 1400 mg. The recommended doses are a concern taking into account the TTC and MOS. Investigations of raspberry ketone in quantitative structure-activity relationship (QSAR) models indicated potential cardiotoxic...

  2. Enhancement of color and clarity in topaz and diamonds by nuclear radiation, safety and security concerns

    International Nuclear Information System (INIS)

    Shamshad Ahmed

    2009-01-01

    Inducement of color and clarity in gemstone Topaz, otherwise devoid of these attributes, has been achieved by synergistic utilization of neutron irradiation, electron beam irradiation and heat. The transformation of the colorless, cheaply available topaz into desirable deep blue topaz is a significant value addition, not achievable by other contending techniques .Likewise colorless and unclear diamonds, available in trade at throw away price, have been transformed by neutron irradiation into colored diamonds, known as fancy diamonds. The enhanced gems may possess stable or unstable colors depending on the nature of the color centers produced. In the case of blue topaz and fancy diamonds the colors produced were stable and heating at elevated temperatures can only lead to fading of colors. The enhancement of gems by neutron irradiation is commercially viable provided appropriate equipment and tools are used .In the paper are described the processes of the enhancement of topaz and diamonds along with the instrumentation involved. However, in view of the radioactivity generated as a result of the exposure of gems to the neutrons, and the likelihood of undue exposure of the users, operators etc to the radioactive gems, safety aspects command serious attention. In the paper, the strategies to avoid or to mitigate the radioactivity generated have been discussed. Also documented are the methodologies and the controls to ensure that the radioactive gems are not released before ensuring that the radioactivity, if any, in the irradiated materials is not above the permissible levels in conformity with the international standards. Safety, security and safeguard of these materials are thus appropriately addressed. (Authors)

  3. Regulatory oversight report 2016 concerning nuclear safety in Swiss nuclear installations

    International Nuclear Information System (INIS)

    2017-06-01

    ENSI, the Swiss Federal Nuclear Safety Inspectorate, assesses and monitors safety in the Swiss nuclear facilities. These include the five nuclear power plants: Beznau Units 1 and 2 (KKB1 and KKB2), Muehleberg (KKM), Goesgen (KKG) and Leibstadt (KKL), the interim storage facilities based at each plant, the Central Interim Storage Facility (Zwilag) in Wuerenlingen together with the nuclear facilities at the Paul Scherrer Institute (PSI), the University of Basel (UniB) and the Federal Institute of Technology in Lausanne (EPFL). Using a combination of inspections, regulatory meetings, checks, analyses and the reporting of the operators of individual facilities, ENSI obtains the required overview of nuclear safety in these facilities. It ensures that they operate as required by law. ENSI's regulatory responsibilities also include the transport of radioactive materials from and to nuclear facilities and preparations for a deep geological repository for radioactive waste. ENSI maintains its own emergency organisation, which is an integral part of the national emergency structure that would be activated in the event of a serious incident at a nuclear facility in Switzerland. ENSI reports periodically on its supervisory activities. It informs the public about special events and findings in the nuclear installations. All five nuclear power plants in Switzerland operated safely during the past year. Nuclear safety at all plants in operation was rated as good or satisfactory. In 2016, there were 31 reportable events at the nuclear power plants. 30 events were rated Level 0 (event of no or low safety significance) on the International Nuclear and Radiological Event Scale (INES) and one was rated Level 1 (anomaly) at KKL. Zwilag consists of several interim storage buildings, a conditioning plant and a plasma plant (incineration/melting plant). At the end of 2016, the cask storage hall contained 56 transport/storage casks with spent fuel assemblies and vitrified residue

  4. A primer of drug safety surveillance: an industry perspective. Part II: Product labeling and product knowledge.

    Science.gov (United States)

    Allan, M C

    1992-01-01

    To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part II of this series discusses specific issues regarding product labeling, such as developing the labeling, changing the labeling, and the legal as well as commercial ramifications of the contents of the labeling. An adverse event report scenario is further analyzed and suggestions are offered for maintaining the product labeling as an accurate reflection of the drug safety surveillance data. This article also emphasizes the necessity of product knowledge in adverse event database management. Both scientific and proprietary knowledge are required. Acquiring product knowledge is a part of the day-to-day activities of drug safety surveillance. A knowledge of the history of the product may forestall adverse publicity, as shown in the illustration. This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction of the components of the process. Suggestions are offered

  5. Application of the Pareto principle to identify and address drug-therapy safety issues.

    Science.gov (United States)

    Müller, Fabian; Dormann, Harald; Pfistermeister, Barbara; Sonst, Anja; Patapovas, Andrius; Vogler, Renate; Hartmann, Nina; Plank-Kiegele, Bettina; Kirchner, Melanie; Bürkle, Thomas; Maas, Renke

    2014-06-01

    Adverse drug events (ADE) and medication errors (ME) are common causes of morbidity in patients presenting at emergency departments (ED). Recognition of ADE as being drug related and prevention of ME are key to enhancing pharmacotherapy safety in ED. We assessed the applicability of the Pareto principle (~80 % of effects result from 20 % of causes) to address locally relevant problems of drug therapy. In 752 cases consecutively admitted to the nontraumatic ED of a major regional hospital, ADE, ME, contributing drugs, preventability, and detection rates of ADE by ED staff were investigated. Symptoms, errors, and drugs were sorted by frequency in order to apply the Pareto principle. In total, 242 ADE were observed, and 148 (61.2 %) were assessed as preventable. ADE contributed to 110 inpatient hospitalizations. The ten most frequent symptoms were causally involved in 88 (80.0 %) inpatient hospitalizations. Only 45 (18.6 %) ADE were recognized as drug-related problems until discharge from the ED. A limited set of 33 drugs accounted for 184 (76.0 %) ADE; ME contributed to 57 ADE. Frequency-based listing of ADE, ME, and drugs involved allowed identification of the most relevant problems and development of easily to implement safety measures, such as wall and pocket charts. The Pareto principle provides a method for identifying the locally most relevant ADE, ME, and involved drugs. This permits subsequent development of interventions to increase patient safety in the ED admission process that best suit local needs.

  6. IMPACT OF HEALTH TECHNOLOGY ASSESSMENT IN LITIGATION CONCERNING ACCESS TO HIGH-COST DRUGS.

    Science.gov (United States)

    Aleman, Alicia; Perez Galan, Ana

    2017-01-01

    The impact of health technology assessment (HTA) in the judicialization of the right of health has not been deeply studied in Latin American countries. The purpose of this study is to review the process of judicialization of the access to high cost drugs in Uruguay and assess the impact HTAs have had on this process. The methodology used for this study included a comprehensive literature search in electronic databases, local journals, internal documents developed in the Ministry of Health, as well as conducting interviews with key informants. Judicialization of the access of high cost drugs has been increasing since 2010. The strategy of the Ministry of Health of Uruguay to decrease this problem included the organization of roundtables with judges and other stakeholders on the basis of HTA, the training of defense lawyers in the use and interpretation of HTA, and the participation of a professional who develops HTA in the preparation of the defense arguments. A year after the implementation of this strategy, 25 percent of writs of protection were won by the Ministry of Health. Even though the strategy implemented was effective in reducing the loss of litigations, it was not effective in reducing the growing number of writs of protection. It is essential to address this problem in a broad debate and to promote understanding between the parties.

  7. Drug-Herb Interactions in the Elderly Patient with IBD: a Growing Concern.

    Science.gov (United States)

    Rahman, Haider; Kim, Marina; Leung, Galen; Green, Jesse A; Katz, Seymour

    2017-12-01

    Inflammatory bowel disease (IBD), which includes conditions such as Crohn's disease and ulcerative colitis, is becoming more prevalent with the elderly being the fastest growing group. Parallel to this, there is an increasing interest in the use of complementary and alternative medicine (CAM). Nearly half of patients with IBD have used CAM at one time. The elderly patients, however, are burdened by comorbid conditions, polypharmacy, and altered functional status. With increasing use of complementary and alternative medicine in our elderly patients with IBD, it is vital for the provider to provide counsel on drug-herb potential interactions. CAM includes herbal products, diet, dietary supplements, acupuncture, and prayer. In this paper, we will review common CAM, specifically herbs, that are used in patients with IBD including the herb background, suggested use, evidence in IBD, and most importantly, potential interactions with IBD medications used in elderly patients. Most important evidence-based adverse events and drug-herb interactions are summarized. The herbs discussed include Triticum aestivum (wheat grass), Andrographis paniculata (chiretta), Boswellia serrata, tormentil, bilberry, curcumin (turmeric), Plantago ovata (blond psyllium), Oenothera biennis (evening primrose oil), germinated barley foodstuff, an herbal preparation of myrrh, chamomile and coffee extract, chios mastic gum, wormwood (absinthe, thujone), Cannabis sativa (marijuana, THC), tripterygium wilfordii (thunder god vine), Ulmus rubra (slippery elm bark), trigonella foenugraecum (fenugreek), Dioscorea mexicana (wild yam), Harpagophytum procumbens (devil's claw), ginger, cinnamon, licorice, and peppermint.

  8. [Drug supply chain safety in hospitals: current data and experience of the Grenoble university hospital].

    Science.gov (United States)

    Bedouch, P; Baudrant, M; Detavernier, M; Rey, C; Brudieu, E; Foroni, L; Allenet, B; Calop, J

    2009-01-01

    Drug supply chain safety has become a priority for public health which implies a collective process. This process associates all health professionals including the pharmacist who plays a major role. The objective of this present paper is to describe the several approaches proven effective in the reduction of drug-related problem in hospital, illustrated by the Grenoble University Hospital experience. The pharmacist gets involved first in the general strategy of hospital drug supply chain, second by his direct implication in clinical activities. The general strategy of drug supply chain combines risk management, coordination of the Pharmacy and Therapeutics Committee, selection and purchase of drugs and organisation of drug supply chain. Computer management of drug supply chain is a major evolution. Nominative drug delivering has to be a prior objective and its implementation modalities have to be defined: centralized or decentralized in wards, manual or automated. Also, new technologies allow the automation of overall drug distribution from central pharmacy and the implementation of automated drug dispensing systems into wards. The development of centralised drug preparation allows a safe compounding of high risk drugs, like cytotoxic drugs. The pharmacist should develop his clinical activities with patients and other health care professionals in order to optimise clinical decisions (medication review, drug order analysis) and patients follow-up (therapeutic monitoring, patient education, discharge consultation).

  9. SAFETY

    CERN Multimedia

    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...

  10. Mathematical modeling of efficacy and safety for anticancer drugs clinical development.

    Science.gov (United States)

    Lavezzi, Silvia Maria; Borella, Elisa; Carrara, Letizia; De Nicolao, Giuseppe; Magni, Paolo; Poggesi, Italo

    2018-01-01

    Drug attrition in oncology clinical development is higher than in other therapeutic areas. In this context, pharmacometric modeling represents a useful tool to explore drug efficacy in earlier phases of clinical development, anticipating overall survival using quantitative model-based metrics. Furthermore, modeling approaches can be used to characterize earlier the safety and tolerability profile of drug candidates, and, thus, the risk-benefit ratio and the therapeutic index, supporting the design of optimal treatment regimens and accelerating the whole process of clinical drug development. Areas covered: Herein, the most relevant mathematical models used in clinical anticancer drug development during the last decade are described. Less recent models were considered in the review if they represent a standard for the analysis of certain types of efficacy or safety measures. Expert opinion: Several mathematical models have been proposed to predict overall survival from earlier endpoints and validate their surrogacy in demonstrating drug efficacy in place of overall survival. An increasing number of mathematical models have also been developed to describe the safety findings. Modeling has been extensively used in anticancer drug development to individualize dosing strategies based on patient characteristics, and design optimal dosing regimens balancing efficacy and safety.

  11. Regulatory oversight report 2015 concerning nuclear safety in Swiss nuclear installations

    International Nuclear Information System (INIS)

    2016-06-01

    The Swiss Federal Nuclear Safety Inspectorate (ENSI) assesses and monitors nuclear facilities in Switzerland. These include the five nuclear power plants (Beznau Units 1 and 2, Muehleberg, Goesgen and Leibstadt), the interim storage facilities based at each plant, the Central Interim Storage Facility (Zwilag) at Wuerenlingen together with the nuclear facilities at the Paul Scherrer Institute (PSI), the University of Basel and the Federal Institute of Technology in Lausanne (EPFL), as well as the transport of radioactive materials and the preparatory work for a deep geological repository for nuclear waste. Using a combination of inspections, regulatory meetings, examinations and analyses together with reports from the licensees of individual facilities, ENSI obtains the required overview of nuclear safety in these facilities. ENSI maintains its own emergency organization. It provides the public with information on particular events and findings in nuclear facilities. ENSI publishes an annual Radiological Protection Report and a Research and Experience Report. Chapters 1 to 4 of this Surveillance Report deal with operational experience, systems technology, radiological protection and management of the 5 Swiss nuclear power plants. Chapter 5 deals with Zwilag. Chapters 6 and 7 are devoted to the nuclear facilities at PSI and the research reactor at EPFL as well as the decommissioned University of Basel’s research reactor. Chapter 8 covers the transport of radioactive materials. The subject of Chapter 9 is the deep geological storage of radioactive waste including work within the framework of the Sectoral Plan. Finally, Chapter 10 deals with generic issues relevant to all facilities such as probabilistic safety analyses. In 2015, all five nuclear power plants in Switzerland were safely operated and ENSI concluded that each had adhered to its approved operating conditions. There were 34 reportable events at the nuclear power plants; 32 events were rated at Level 0 on

  12. Regulatory overview report 2014 concerning nuclear safety in Swiss nuclear installations

    International Nuclear Information System (INIS)

    2015-06-01

    The Swiss Federal Nuclear Safety Inspectorate (ENSI), acting as the regulatory body of the Swiss Federation, assesses and monitors nuclear facilities in Switzerland: the five nuclear power plants, the interim storage facilities based at each plant, the Central Interim Storage Facility (ZWILAG) at Wuerenlingen together with the nuclear facilities at the Paul Scherrer Institute (PSI), the University of Basel (UniB) and the Federal Institute of Technology in Lausanne (EPFL). Using a combination of inspections, regulatory meetings, examinations and analyses together with reports from the licensees of individual facilities, ENSI obtains the required overview of nuclear safety. It ensures that they comply with regulations. Its regulatory responsibilities include the transport of radioactive materials from and to nuclear facilities and the preparations for a deep geological repository for nuclear waste. ENSI maintains its own emergency organisation, an integral part of the national emergency structure. It provides the public with information on particular events in nuclear facilities. This Surveillance Report describes the operational experience, systems technology, radiological protection and management in all nuclear facilities. Generic issues relevant to all facilities such as probabilistic safety analyses are described. In 2014, all five nuclear power plants in Switzerland (Beznau Units I and 2, Muehleberg, Goesgen and Leibstadt) were operated safely. The nuclear safety at all plants was rated as good. 38 events were reported. There was one reactor scram at the Leibstadt nuclear power plant. On the International Event Scale (INES), ranging from 0--7, 37 events were rated as Level 0; one event was rated as INES 1: drill holes had penetrated the steel wall of the containment to secure two hand-held fire extinguishers. ZWILAG consists of several interim storage halls, a conditioning plant and a plasma plant. At the end of 2014, the cask storage hall contained 42

  13. Infectious respiratory disease outbreaks and pregnancy: occupational health and safety concerns of Canadian nurses.

    Science.gov (United States)

    Phillips, Karen P; O'Sullivan, Tracey L; Dow, Darcie; Amaratunga, Carol A

    2011-04-01

    This paper is a report of a qualitative study of emergency and critical care nurses' perceptions of occupational response and preparedness during infectious respiratory disease outbreaks including severe acute respiratory syndrome (SARS) and influenza. Healthcare workers, predominantly female, face occupational and personal challenges in their roles as first responders/first receivers. Exposure to SARS or other respiratory pathogens during pregnancy represents additional occupational risk for healthcare workers. Perceptions of occupational reproductive risk during response to infectious respiratory disease outbreaks were assessed qualitatively by five focus groups comprised of 100 Canadian nurses conducted between 2005 and 2006. Occupational health and safety issues anticipated by Canadian nurses for future infectious respiratory disease outbreaks were grouped into four major themes: (1) apprehension about occupational risks to pregnant nurses; (2) unknown pregnancy risks of anti-infective therapy/prophylaxis; (3) occupational risk communication for pregnant nurses; and (4) human resource strategies required for pregnant nurses during outbreaks. The reproductive risk perceptions voiced by Canadian nurses generally were consistent with reported case reports of pregnant women infected with SARS or emerging influenza strains. Nurses' fears of fertility risks posed by exposure to infectious agents or anti-infective therapy and prophylaxis are not well supported by the literature, with the former not biologically plausible and the latter lacking sufficient data. Reproductive risk assessments should be performed for each infectious respiratory disease outbreak to provide female healthcare workers and in particular pregnant women with guidelines regarding infection control and use of anti-infective therapy and prophylaxis.

  14. Nanotoxicity: emerging concerns regarding nanomaterial safety and occupational hard metal (WC-Co) nanoparticle exposure.

    Science.gov (United States)

    Armstead, Andrea L; Li, Bingyun

    As the number of commercial and consumer products containing engineered nanomaterials (ENMs) continually rises, the increased use and production of these ENMs presents an important toxicological concern. Although ENMs offer a number of advantages over traditional materials, their extremely small size and associated characteristics may also greatly enhance their toxic potentials. ENM exposure can occur in various consumer and industrial settings through inhalation, ingestion, or dermal routes. Although the importance of accurate ENM characterization, effective dosage metrics, and selection of appropriate cell or animal-based models are universally agreed upon as important factors in ENM research, at present, there is no "standardized" approach used to assess ENM toxicity in the research community. Of particular interest is occupational exposure to tungsten carbide cobalt (WC-Co) "dusts," composed of nano- and micro-sized particles, in hard metal manufacturing facilities and mining and drilling industries. Inhalation of WC-Co dust is known to cause "hard metal lung disease" and an increased risk of lung cancer; however, the mechanisms underlying WC-Co toxicity, the inflammatory disease state and progression to cancer are poorly understood. Herein, a discussion of ENM toxicity is followed by a review of the known literature regarding the effects of WC-Co particle exposure. The risk of WC-Co exposure in occupational settings and the updates of in vitro and in vivo studies of both micro- and nano-WC-Co particles are discussed.

  15. Regulatory oversight report 2010 concerning nuclear safety in Swiss nuclear installations

    International Nuclear Information System (INIS)

    2011-06-01

    Acting as the regulatory body of the Swiss Confederation, the Swiss Federal Nuclear Safety Inspectorate, ENSI, assesses and monitors nuclear facilities in Switzerland. This includes the five nuclear power plants (NPPs), the plant-based interim storage facilities, the Central Interim Storage Facility (ZWILAG) at Wuerenlingen, the nuclear facilities at the Paul Scherrer Institute (PSI), the two universities of Basel and Lausanne, the transport of radioactive materials from and to nuclear facilities and the preparation for a deep geologic repository for radioactive waste. Using inspections, surveillance meetings, reviews and analyses as well as reports from plant licensees, ENSI obtains the required overview of the safety of the nuclear facilities. It maintains its own emergency organisation, which is an integral part of the national emergency structure. The legislative framework at the basis of the activity of ENSI specifies the criteria by which it evaluates the activities and plans of the operators of nuclear facilities. ENSI provides the public with information on particular events and observations relating to nuclear facilities. The five nuclear power plants in Switzerland (Beznau Units 1 und 2, Muehleberg, Goesgen and Leibstadt) were all operated safely in 2010. Last year, there were 39 notifiable events in Switzerland: 4 events affected both Beznau Units, 10 events the Goesgen NPP, 6 the Leibstadt NPP and 13 the Muehleberg NPP and 6 in other facilities. Based on the International Nuclear Event Scale (INES) of 0-7, ENSI rated 38 events as Level 0, and as INES Level 2 the event on 31 August 2010 during maintenance work at the Leibstadt NPP, where a diver was exposed to radiation in excess of the maximum annual exposure rate of 20 mSv. The ZWILAG at Wuerenlingen consists of several interim storage halls, a conditioning plant and the plasma plant (incineration/melting plant). At the end of 2010, the cask storage hall contained 34 transport/storage casks with spent

  16. Exploiting pluripotent stem cell technology for drug discovery, screening, safety, and toxicology assessments.

    Science.gov (United States)

    McGivern, Jered V; Ebert, Allison D

    2014-04-01

    In order for the pharmaceutical industry to maintain a constant flow of novel drugs and therapeutics into the clinic, compounds must be thoroughly validated for safety and efficacy in multiple biological and biochemical systems. Pluripotent stem cells, because of their ability to develop into any cell type in the body and recapitulate human disease, may be an important cellular system to add to the drug development repertoire. This review will discuss some of the benefits of using pluripotent stem cells for drug discovery and safety studies as well as some of the recent applications of stem cells in drug screening studies. We will also address some of the hurdles that need to be overcome in order to make stem cell-based approaches an efficient and effective tool in the quest to produce clinically successful drug compounds. Copyright © 2013 Elsevier B.V. All rights reserved.

  17. A safety concern related to CANDU moderator subcooling and status of KAERI moderator circulation test (MCT) experiments

    International Nuclear Information System (INIS)

    Rhee, Bo W.; Kim, Hyoung T.; Kim, Tongbeum; Im, Sunghyuk

    2015-01-01

    The flow inside the moderator tank of a CANDU-6 reactor during full power steady state operation has been suspected to be operating in the buoyancy/inertial driven mixed convection regime as illustrated in the middle figure. At some regions of the moderator tank where the buoyancy driven upward flow and the inertial momentum driven downward flows interface counter-currently, there exist some interface regions between these two flows like the middle one, and the local temperatures at these interface regions are known to oscillate with different amplitude at various fluctuation frequencies as shown. According to a numerical simulation of the moderator flow and temperature distribution at full power steady state carried out by previous researches showed that any small disturbances in the flow or temperature may initiate the system unstable and aggravate the asymmetric flow and temperature patterns. The tests at the 3-D Moderator Test Facility (MTF) that is a representative scaled-down of CANDU reactors, reproduced the expected and observed moderator behavior in the reactor as well as the local temperature fluctuations arising from the delicate balance of forced and buoyancy induced flow. This observation raised a safety concern as the local moderator temperature at some regions showed fluctuations with an amplitude that may jeopardize the safety margin, i.e. the difference between the available subcooling and the subcooling requirement. The scope of this paper is to review the basis of the safety concern related to this moderator subcooling and local temperature fluctuation and describe the current status of MCT erection and some of the experiments carried so far

  18. Why trash don't pass? pharmaceutical licensing and safety performance of drugs.

    Science.gov (United States)

    Banerjee, Tannista; Nayak, Arnab

    2017-01-01

    This paper examines how asymmetric information in pharmaceutical licensing affects the safety standards of licensed drugs. Pharmaceutical companies often license potential drug molecules at different stages of drug development from other pharmaceutical or biotechnology companies and complete the remaining of research stages before submitting the new drug application(NDA) to the food and drug administration. The asymmetric information associated with the quality of licensed molecules might result in the molecules which are less likely to succeed to be licensed out, while those with greater potential of success being held internally for development. We identify the NDAs submitted between 1993 and 2004 where new molecular entities were acquired through licensing. Controlling for other drug area specific and applicant firm specific factors, we investigate whether drugs developed with licensed molecules face higher probability of safety based recall and ultimate withdrawal from the market than drugs developed internally. Results suggest the opposite of Akerlof's (Q J Econ 84:488-500, 1970) lemons problem. Licensed molecules rather have less probability of facing safety based recalls and ultimate withdrawal from the market comparing to internally developed drug molecules. This suggests that biotechnology and small pharmaceutical firms specializing in pharmaceutical research are more efficient in developing good potential molecules because of their concentrated research. Biotechnology firms license out good potential molecules because it increases their market value and reputation. In addition, results suggest that both the number of previous approved drugs in the disease area, and also the applicant firms' total number of previous approvals in all disease areas reduce the probability that an additional approved drug in the same drug area will potentially be harmful.

  19. Nanotoxicity: emerging concerns regarding nanomaterial safety and occupational hard metal (WC-Co nanoparticle exposure

    Directory of Open Access Journals (Sweden)

    Armstead AL

    2016-12-01

    Full Text Available Andrea L Armstead,1,2 Bingyun Li1–3 1Department of Orthopaedics, School of Medicine, 2School of Pharmacy, West Virginia University, 3Mary Babb Randolph Cancer Center, Morgantown, WV, USA Abstract: As the number of commercial and consumer products containing engineered nanomaterials (ENMs continually rises, the increased use and production of these ENMs presents an important toxicological concern. Although ENMs offer a number of advantages over traditional materials, their extremely small size and associated characteristics may also greatly enhance their toxic potentials. ENM exposure can occur in various consumer and industrial settings through inhalation, ingestion, or dermal routes. Although the importance of accurate ENM characterization, effective dosage metrics, and selection of appropriate cell or animal-based models are universally agreed upon as important factors in ENM research, at present, there is no “standardized” approach used to assess ENM toxicity in the research community. Of particular interest is occupational exposure to tungsten carbide cobalt (WC-Co “dusts,” composed of nano- and micro-sized particles, in hard metal manufacturing facilities and mining and drilling industries. Inhalation of WC-Co dust is known to cause “hard metal lung disease” and an increased risk of lung cancer; however, the mechanisms underlying WC-Co toxicity, the inflammatory disease state and progression to cancer are poorly understood. Herein, a discussion of ENM toxicity is followed by a review of the known literature regarding the effects of WC-Co particle exposure. The risk of WC-Co exposure in occupational settings and the updates of in vitro and in vivo studies of both micro- and nano-WC-Co particles are discussed. Keywords: engineered nanomaterial, occupational exposure, lung disease, cancer, toxicity, particle

  20. Assessments of global drivers of vaccine hesitancy in 2014-Looking beyond safety concerns.

    Directory of Open Access Journals (Sweden)

    Melanie Marti

    Full Text Available Vaccine hesitancy has become the focus of growing attention and concern globally despite overwhelming evidence of the value of vaccines in preventing disease and saving the lives of millions of individuals every year. Measuring vaccine hesitancy and its determinants worldwide is important in order to understand the scope of the problem and for the development of evidence-based targeted strategies to reduce hesitancy. Two indicators to assess vaccine hesitancy were developed to capture its nature and scope at the national and subnational level to collect data in 2014: 1 The top 3 reasons for not accepting vaccines according to the national schedule in the past year and whether the response was opinion- or assessment-based and 2 Whether an assessment (or measurement of the level of confidence in vaccination had taken place at national or subnational level in the previous 5 years. The most frequently cited reasons for vaccine hesitancy globally related to (1 the risk-benefit of vaccines, (2 knowledge and awareness issues, (3 religious, cultural, gender or socio-economic factors. Major issues were fear of side effects, distrust in vaccination and lack of information on immunization or immunization services. The analysis revealed that 29% of all countries had done an assessment of the level of confidence in their country, suggesting that vaccine confidence was an issue of importance. Monitoring vaccine hesitancy is critical because of its influence on the success of immunization programs. To our knowledge, the proposed indicators provide the first global snapshot of reasons driving vaccine hesitancy and depicting its widespread nature, as well as the extent of assessments conducted by countries.

  1. Development of novel, 384-well high-throughput assay panels for human drug transporters: drug interaction and safety assessment in support of discovery research.

    Science.gov (United States)

    Tang, Huaping; Shen, Ding Ren; Han, Yong-Hae; Kong, Yan; Balimane, Praveen; Marino, Anthony; Gao, Mian; Wu, Sophie; Xie, Dianlin; Soars, Matthew G; O'Connell, Jonathan C; Rodrigues, A David; Zhang, Litao; Cvijic, Mary Ellen

    2013-10-01

    Transporter proteins are known to play a critical role in affecting the overall absorption, distribution, metabolism, and excretion characteristics of drug candidates. In addition to efflux transporters (P-gp, BCRP, MRP2, etc.) that limit absorption, there has been a renewed interest in influx transporters at the renal (OATs, OCTs) and hepatic (OATPs, BSEP, NTCP, etc.) organ level that can cause significant clinical drug-drug interactions (DDIs). Several of these transporters are also critical for hepatobiliary disposition of bilirubin and bile acid/salts, and their inhibition is directly implicated in hepatic toxicities. Regulatory agencies took action to address transporter-mediated DDI with the goal of ensuring drug safety in the clinic and on the market. To meet regulatory requirements, advanced bioassay technology and automation solutions were implemented for high-throughput transporter screening to provide structure-activity relationship within lead optimization. To enhance capacity, several functional assay formats were miniaturized to 384-well throughput including novel fluorescence-based uptake and efflux inhibition assays using high-content image analysis as well as cell-based radioactive uptake and vesicle-based efflux inhibition assays. This high-throughput capability enabled a paradigm shift from studying transporter-related issues in the development space to identifying and dialing out these concerns early on in discovery for enhanced mechanism-based efficacy while circumventing DDIs and transporter toxicities.

  2. Radioiodine therapy of Graves' disease - a dosimetric comparison of different strategies concerning antithyroid drugs

    International Nuclear Information System (INIS)

    Urbannek, V.; Voth, E.; Moka, D.; Schicha, H.

    2001-01-01

    Aim: Premedication with antithyroid drugs (ATD) compared to patients not pretreated with ATD causes a higher failure rate of radioiodine therapy (RITh) or demands higher therapeutical dosage of radioiodine (RI). For clinical reasons and because of accelerated iodine metabolism in hyperthyreosis a compensated thyroid metabolism is desirable. Aim of this study was to investigate the influence of ATD on the biokinetics of RI in case of Graves' disease in order to improve RITh of patients pre-treated with ATD. Methods: 385 consecutive patients who underwent RITh because of Graves' disease for the first time were included: Group A (n = 74): RITh under continuous medication with ATD; Group B (n = 111): Application of RI under continuous medication with ATD, in case of insufficient RI-uptake or shortened effective RI-half-life ATD were stopped 1-5 days after RITh; Group C (n = 200): ATD were stopped 2 days prior to RITh in all patients. We examined the influence of ATD on RI-uptake and effective RI-half-life as well as the absorbed dose achieved on the thyroid in dependence of thyroid volume and applied RI-dosage [TEQ - therapy efficiency quotient, (2)]. Results: In the RI-pretest (all patients under ATD) the RI-uptake was comparable in all three groups. During RITh-RI-uptake, effective RI-half-life and therefore the TEQ were significantly higher in Group C as compared to Groups A and B (p [de

  3. Who was concerned about radiation, food safety, and natural disasters after the great East Japan earthquake and Fukushima catastrophe? A nationwide cross-sectional survey in 2012.

    Science.gov (United States)

    Sugimoto, Takashi; Shinozaki, Tomohiro; Naruse, Takashi; Miyamoto, Yuki

    2014-01-01

    Disaster-related concerns by sub-populations have not been clarified after the great East Japan earthquake and the Fukushima nuclear power plant incidents. This paper assesses who was concerned about radiation, food safety, and natural disasters among the general population in order to buffer such concerns effectively. The hypothesis that women, parents, and family caregivers were most concerned about radiation, food safety, and natural disaster was tested using a varying-intercept multivariable logistic regression with 5809 responses from a nationwide cross-sectional survey random-sampled in March 2012. Many people were at least occasionally concerned about radiation (53.5%), food safety (47.3%), and about natural disaster (69.5%). Women were more concerned than men about radiation (OR = 1.67; 95% CI = 1.35-2.06), food safety (1.70; 1.38-2.10), and natural disasters (1.74; 1.39-2.19). Parents and family care needs were not significant. Married couples were more concerned about radiation (1.53; 1.33-1.77), food safety (1.38; 1.20-1.59), and natural disasters (1.30; 1.12-1.52). Age, child-cohabitation, college-completion, retirement status, homemaker status, and the house-damage certificate of the last disaster were also associated with at least one concern. Participants from the Kanto region were more concerned about radiation (2.08; 1.58-2.74) and food safety (1.30; 1.07-1.59), which demonstrate similar positive associations to participants from Tohoku where a disaster relief act was invoked (3.36; 2.25-5.01 about radiation, 1.49; 1.08-2.06 about food safety). Sectioning the populations by gender and other demographics will clarify prospective targets for interventions, allow for a better understanding of post-disaster concerns, and help communicate relevant information effectively.

  4. Suspected adverse drug reactions in elderly patients reported to the Committee on Safety of Medicines.

    OpenAIRE

    Castleden, C M; Pickles, H

    1988-01-01

    1. Spontaneous reports of suspected adverse drug reactions (ADRs) reported to the Committee on Safety of Medicines (CSM) have been studied in relation to patient age. 2. The proportion of reports received for the elderly increased between 1965 and 1983. 3. There was a correlation between the use of drugs and the number of ADR reports. Thus age-related prescription figures for two non-steroidal anti-inflammatory drugs (NSAI) and co-trimoxazole matched ADR reports for each drug in each age grou...

  5. Regulatory oversight report 2011 concerning nuclear safety in Swiss nuclear installations

    International Nuclear Information System (INIS)

    2012-06-01

    The Swiss Federal Nuclear Safety Inspectorate ENSI, acting as the regulatory body of the Swiss Confederation, assesses and monitors nuclear facilities in Switzerland. These include five nuclear power plants, the interim storage facilities based at each plant, the Central Interim Storage Facility (ZWILAG) at Wuerenlingen together with the nuclear facilities at the Paul Scherrer Institute (PSI) and the two universities of Basel and Lausanne. ENSI ensures that the facilities comply with regulations and operate according to the law. Its regulatory responsibilities also include the transport of radioactive materials to and from nuclear facilities and the preparations for a deep geologic repository for nuclear waste. It maintains its own emergency organisation, which is an integral part of a national emergency structure. Building on the legislative framework, ENSI also formulates and updates its own guidelines. It provides the public with information on particular events and findings in nuclear facilities. In 2011, all five nuclear power reactors in Switzerland (Beznau Units 1 and 2, Muehleberg, Goesgen and Leibstadt) were operated safely and ENSI concluded that they had complied with their approved operating conditions. There were 27 reportable events in the nuclear power plants in Switzerland: 7 at Beznau, 5 at Goesgen, 11 at Leibstadt und 4 at Muehleberg. On the international INES scale of 0 to 7, ENSI rated 26 events as Level 0. One event, at the Muehleberg nuclear power plant, was rated as INES Level 1. This related to a potential blockage of the emergency water intake system in the event of extreme flooding. The operator BKW shut down the Muehleberg plant ahead of the scheduled maintenance date and upgraded the system. ZWILAG consists of several interim storage halls, a conditioning plant and a plasma plant (incineration/melting plant). At the end of 2011, the cask storage hall contained 34 transport/storage casks with fuel assemblies and vitrified residue packages

  6. "Product on Stopper" in a Lyophilized Drug Product: Cosmetic Defect or a Product Quality Concern?

    Science.gov (United States)

    Mehta, Shyam B; Roy, Shouvik; Yang, Han-Chang Cathy

    2018-06-01

    During manufacturing of a lyophilized drug product, operator errors in product handling during loading of product filled vials onto the lyophilizer can lead to a seemingly cosmetic defect which can impact certain critical quality attributes of finished product. In this study, filling of a formulated monoclonal antibody in vials was performed using a peristaltic pump filling unit, and subsequently, the product was lyophilized. After lyophilization, upon visual inspection, around 40% of vials had cosmetic defect with residual product around stopper of the vial and were categorized as "product on stopper" vials, whereas remaining 60% vials with no cosmetic defect were called "acceptable vials." Both groups of vials from 1 single batch were tested for critical quality attributes including protein concentration (ultraviolet absorbance at 280), residual moisture (Karl Fischer), sterility (membrane filtration), and container closure integrity (CCI) (blue dye ingress). Analysis of protein quality attributes such as aggregation, protein concentration, residual moisture showed no significant difference between vials with "product on stopper" and "acceptable vials." However, CCI of the "product on stopper" vials was compromised due to the presence of product around stopper of the vial. The results from this case study demonstrate the following 2 important findings: (1) that a seemingly cosmetic defect may impact product quality, compromising the integrity of the product and (2) that CCI test method can be used as an orthogonal method to sterility testing to evaluate sterility assurance of the product. The corrective action proposed to mitigate this defect is use of a larger sized vial that can potentially minimize this defect that arises because of product handling errors. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  7. Drug safety data mining with a tree-based scan statistic.

    Science.gov (United States)

    Kulldorff, Martin; Dashevsky, Inna; Avery, Taliser R; Chan, Arnold K; Davis, Robert L; Graham, David; Platt, Richard; Andrade, Susan E; Boudreau, Denise; Gunter, Margaret J; Herrinton, Lisa J; Pawloski, Pamala A; Raebel, Marsha A; Roblin, Douglas; Brown, Jeffrey S

    2013-05-01

    In post-marketing drug safety surveillance, data mining can potentially detect rare but serious adverse events. Assessing an entire collection of drug-event pairs is traditionally performed on a predefined level of granularity. It is unknown a priori whether a drug causes a very specific or a set of related adverse events, such as mitral valve disorders, all valve disorders, or different types of heart disease. This methodological paper evaluates the tree-based scan statistic data mining method to enhance drug safety surveillance. We use a three-million-member electronic health records database from the HMO Research Network. Using the tree-based scan statistic, we assess the safety of selected antifungal and diabetes drugs, simultaneously evaluating overlapping diagnosis groups at different granularity levels, adjusting for multiple testing. Expected and observed adverse event counts were adjusted for age, sex, and health plan, producing a log likelihood ratio test statistic. Out of 732 evaluated disease groupings, 24 were statistically significant, divided among 10 non-overlapping disease categories. Five of the 10 signals are known adverse effects, four are likely due to confounding by indication, while one may warrant further investigation. The tree-based scan statistic can be successfully applied as a data mining tool in drug safety surveillance using observational data. The total number of statistical signals was modest and does not imply a causal relationship. Rather, data mining results should be used to generate candidate drug-event pairs for rigorous epidemiological studies to evaluate the individual and comparative safety profiles of drugs. Copyright © 2013 John Wiley & Sons, Ltd.

  8. Posiva's application for a decision in principle concerning a disposal facility for spent nuclear fuel. STUK's statement and preliminary safety appraisal

    International Nuclear Information System (INIS)

    Ruokola, E.

    2000-03-01

    In May 1999, Posiva Ltd submitted to the Government an application, pursuant to the Nuclear Energy Act, for a Decision in Principle on a disposal facility for spent nuclear fuel from the Finnish nuclear power plants. The Ministry of Trade and Industry requested the Radiation and Nuclear Safety Authority (STUK) to draw up a preliminary safety appraisal concerning the proposed disposal facility. In the beginning of this report, STUK's statement to the Ministry and Industry concerning the proposed disposal facility is given. In that statement, STUK concludes that the Decision in Principle is currently justified from the standpoint of safety. The statement is followed by a safety appraisal, where STUK deems, how the proposed disposal concept, site and facility comply with the safety requirements included in the Government's Decision (478/1999). STUK's preliminary safety appraisal was supported by contributions from a number of outside experts. A collective opinion by an international group of ten distinguished experts is appended to this report. (orig.)

  9. Therapeutic drug monitoring: how to improve drug dosage and patient safety in tuberculosis treatment

    Directory of Open Access Journals (Sweden)

    Giovanni Sotgiu

    2015-03-01

    Full Text Available In this article we describe the key role of tuberculosis (TB treatment, the challenges (mainly the emergence of drug resistance, and the opportunities represented by the correct approach to drug dosage, based on the existing control and elimination strategies. In this context, the role and contribution of therapeutic drug monitoring (TDM is discussed in detail. Treatment success in multidrug-resistant (MDR TB cases is low (62%, with 7% failing or relapsing and 9% dying and in extensively drug-resistant (XDR TB cases is even lower (40%, with 22% failing or relapsing and 15% dying. The treatment of drug-resistant TB is also more expensive (exceeding €50 000 for MDR-TB and €160 000 for XDR-TB and more toxic if compared to that prescribed for drug-susceptible TB. Appropriate dosing of first- and second-line anti-TB drugs can improve the patient's prognosis and lower treatment costs. TDM is based on the measurement of drug concentrations in blood samples collected at appropriate times and subsequent dose adjustment according to the target concentration. The ‘dried blood spot’ technique offers additional advantages, providing the rationale for discussions regarding a possible future network of selected, quality-controlled reference laboratories for the processing of dried blood spots of difficult-to-treat patients from reference TB clinics around the world.

  10. Cause for Concern: A Mixed-Methods Study of Campus Safety and Security Practices in United States-Mexico Border Institutions of Higher Education

    Science.gov (United States)

    Holmes, Ryan Clevis

    2014-01-01

    Campus safety has been a source of concern since the 1990s. However, in 2007, the tragedy at the Virginia Polytechnic and State University sent a sense of alarm through many institutions of higher education. Immediately following this tragedy, institutions across the country began to evaluate and question their safety and security practices. While…

  11. Lumbar epidural catheter placement in the presence of low back tattoos: a review of the safety concerns.

    Science.gov (United States)

    Welliver, Dawn; Welliver, Mark; Carroll, Tammy; James, Peggy

    2010-06-01

    Current fashion in body art includes low back tattoos of varying designs and colors, a trend that presents unique concerns for anesthesia providers. Does the placement of epidural catheters risk the introduction of tattoo pigment dyes into the epidural space through the process of coring? Are there specific risks associated with tattoo dyes and epidural needle placement? We performed a comprehensive review of the literature using multiple search databases with the intent to form guidelines for practice using a level of evidence taxonomy. The available evidence does not identify any specific risks associated with epidural catheter placement through low back tattoos, although tissue coring with tissue transport to deeper sites has been confirmed. Continued investigation is necessary before comprehensive practice guidelines regarding the practice of placing epidural needles and catheters through lumbar tattoos can be developed. We suggest avoidance of piercing tattoos when performing epidural punctures until there is sound evidence of short-term and long-term safety.

  12. Integrated safety analysis of rolapitant with coadministered drugs from phase II/III trials

    DEFF Research Database (Denmark)

    Barbour, S; Smit, T.; Wang, X

    2017-01-01

    adverse events by use versus non-use of drug substrates of CYP2D6 or BCRP. Patients and methods: Patients were randomized to receive either 180 mg oral rolapitant or placebo approximately 1-2 hours before chemotherapy in combination with a 5-hydroxytryptamine type 3 RA and dexamethasone. Data...... cytochrome P450 (CYP) 3A4, but it does inhibit CYP2D6 and breast cancer resistance protein (BCRP). To analyze potential drug-drug interactions between rolapitant and concomitant medications, this integrated safety analysis of four double-blind, randomized phase II or III studies of rolapitant examined...... for treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) during cycle 1 were pooled across the four studies and summarized in the overall population and by concomitant use/non-use of CYP2D6 or BCRP substrate drugs. Results: In the integrated safety population, 828...

  13. The Patient's Voice in Pharmacovigilance: Pragmatic Approaches to Building a Patient-Centric Drug Safety Organization.

    Science.gov (United States)

    Smith, Meredith Y; Benattia, Isma

    2016-09-01

    Patient-centeredness has become an acknowledged hallmark of not only high-quality health care but also high-quality drug development. Biopharmaceutical companies are actively seeking to be more patient-centric in drug research and development by involving patients in identifying target disease conditions, participating in the design of, and recruitment for, clinical trials, and disseminating study results. Drug safety departments within the biopharmaceutical industry are at a similar inflection point. Rising rates of per capita prescription drug use underscore the importance of having robust pharmacovigilance systems in place to detect and assess adverse drug reactions (ADRs). At the same time, the practice of pharmacovigilance is being transformed by a host of recent regulatory guidances and related initiatives which emphasize the importance of the patient's perspective in drug safety. Collectively, these initiatives impact the full range of activities that fall within the remit of pharmacovigilance, including ADR reporting, signal detection and evaluation, risk management, medication error assessment, benefit-risk assessment and risk communication. Examples include the fact that manufacturing authorization holders are now expected to monitor all digital sources under their control for potential reports of ADRs, and the emergence of new methods for collecting, analysing and reporting patient-generated ADR reports for signal detection and evaluation purposes. A drug safety department's ability to transition successfully into a more patient-centric organization will depend on three defining attributes: (1) a patient-centered culture; (2) deployment of a framework to guide patient engagement activities; and (3) demonstrated proficiency in patient-centered competencies, including patient engagement, risk communication and patient preference assessment. Whether, and to what extent, drug safety departments embrace the new patient-centric imperative, and the methods and

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

    OpenAIRE

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

    2013-01-01

    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 gener...

  15. 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

  16. Pharmacovigilance in Crisis: Drug Safety at a Crossroads.

    Science.gov (United States)

    Price, John

    2018-05-01

    Pharmacovigilance (PV) is under unprecedented stress from fundamental changes in a booming pharmaceutical industry, from the challenges of creating and maintaining an increasingly complex PV system in a globally diverse regulatory environment, and from unpredicted consequences of historical PV cost-reduction strategies. At the same time, talent availability lags demand, and many PV professionals may no longer be finding personal fulfillment in their careers. The situation creates risks for companies. Advantages and disadvantages of potential strategies to address this increasing problem at a corporate and industry level and in collaboration with regulatory agencies are discussed, as well as opportunities to adopt new technologies, including artificial intelligence and machine-learning to automate pharmacovigilance operations. These approaches would address burdensome and wasteful effort assuring regulatory compliance and free up resources to support the original mission of PV as an important public health activity and to reinvest in the development of new drugs. Copyright © 2018 Elsevier HS Journals, Inc. All rights reserved.

  17. What can nanosafety learn from drug development? The feasibility of “safety by design”

    DEFF Research Database (Denmark)

    Hjorth, Rune; van Hove, Lilian; Wickson, Fern

    2017-01-01

    Safety by design” (SbD) is an intuitively appealing concept that is on the rise within nanotoxicology and nanosafety research, as well as within nanotechnology research policy. It leans on principles established within drug discovery and development (DDD) and seeks to address safety early, as well...... as throughout product development. However, it remains unclear what the concept of SbD exactly entails for engineered nanomaterials (ENMs) or how it is envisioned to be implemented. Here, we review the concept as it is emerging in European research and compare its resemblance with the safety testing...

  18. Drug safety is a barrier to the discovery and development of new androgen receptor antagonists.

    Science.gov (United States)

    Foster, William R; Car, Bruce D; Shi, Hong; Levesque, Paul C; Obermeier, Mary T; Gan, Jinping; Arezzo, Joseph C; Powlin, Stephanie S; Dinchuk, Joseph E; Balog, Aaron; Salvati, Mark E; Attar, Ricardo M; Gottardis, Marco M

    2011-04-01

    Androgen receptor (AR) antagonists are part of the standard of care for prostate cancer. Despite the almost inevitable development of resistance in prostate tumors to AR antagonists, no new AR antagonists have been approved for over a decade. Treatment failure is due in part to mutations that increase activity of AR in response to lower ligand concentrations as well as to mutations that result in AR response to a broader range of ligands. The failure to discover new AR antagonists has occurred in the face of continued research; to enable progress, a clear understanding of the reasons for failure is required. Non-clinical drug safety studies and safety pharmacology assays were performed on previously approved AR antagonists (bicalutamide, flutamide, nilutamide), next generation antagonists in clinical testing (MDV3100, BMS-641988), and a pre-clinical drug candidate (BMS-501949). In addition, non-clinical studies with AR mutant mice, and EEG recordings in rats were performed. Non-clinical findings are compared to disclosures of clinical trial results. As a drug class, AR antagonists cause seizure in animals by an off-target mechanism and are found in vitro to inhibit GABA-A currents. Clinical trials of candidate next generation AR antagonists identify seizure as a clinical safety risk. Non-clinical drug safety profiles of the AR antagonist drug class create a significant barrier to the identification of next generation AR antagonists. GABA-A inhibition is a common off-target activity of approved and next generation AR antagonists potentially explaining some side effects and safety hazards of this class of drugs. Copyright © 2010 Wiley-Liss, Inc.

  19. Drug packaging in 2014: authorities should direct more efforts towards medication safety.

    Science.gov (United States)

    2015-05-01

    In 2014, Prescrire examined the packaging quality of about 250 drugs. A few advances stand out, mainly involving recent drugs, but on the whole, the situation is worrisome in terms of medication safety. Although pharmaceutical companies and drug regulatory agencies seem to be taking more account of the risk of accidental poisoning in children, the level of protection remains low overall in the absence of stringent measures on the part of the authorities. New drugs too often have poor-quality or even dangerous packaging at the time of their market introduction. And the packaging quality of older drugs is disturbing. Pharmaceutical companies no longer invest in the packaging of these products, and agencies often fail to take advantage of the opportunities provided by their reassessment to improve the situation. The inappropriate labelling of certain injectable drugs remains a source of medication errors, sometimes resulting in very serious consequences. In 2014, signs of progress in the packaging of several drugs show that its role in medication safety is better appreciated. But the persistence of dangers in the pharmaceuticals market, created by "unfinished", overly complex or poor-quality packaging, raises the question of the responsibility of pharmaceutical companies and agencies for past and present accidents.

  20. Potential conflict between TRIPS and GATT concerning parallel importation of drugs and possible solution to prevent undesirable market segmentation.

    Science.gov (United States)

    Lo, Chang-Fa

    2011-01-01

    From international perspective, parallel importation, especially with respect to drugs, has to do with the exhaustion principle in Article 6 of the TRIPS Agreement and the general exception in Article XX of the GATT 1994. Issues concerning the TRIPS Agreement have been constant topics of discussion. However, parallel importation in relation to the general rules of the GATT 1994 as well as to its exceptions provided in Article XX was not seriously discussed. In the view of the paper, there is a conflict between the provisions in these two agreements. The paper explains such conflict and tries to propose a method of interpretation to resolve the conflict between GATT Article XX and TRIPS Article 6 concerning parallel importation for the purpose of reducing the possible undesirable market segmentation in pharmaceutical sector. The method suggested in the paper is a proper application of good faith principle in the Vienna Convention to interpret GATT Article XX, so that there could be some flexibility for those prohibitions of parallel importation which have positive effect on international trade.

  1. Use of nonsteroidal anti-inflammatory drugs among healthy people and specific cerebrovascular safety

    DEFF Research Database (Denmark)

    Fosbøl, Emil L; Olsen, Anne-Marie Schjerning; Olesen, Jonas Bjerring

    2014-01-01

    BACKGROUND: Nonsteroidal anti-inflammatory drugs can increase bleeding and thrombosis, but little is known about the cerebrovascular safety of these drugs, especially among healthy people. AIMS: The aim of this study was to examine the risk of ischemic and hemorrhagic stroke associated with the use...... stroke). RESULTS: We selected 1,028,437 healthy individuals (median age 39 years). At least one nonsteroidal anti-inflammatory drug was claimed by 44·7% of the study population, and the drugs were generally used for a short period of time and in low doses. High-dose ibuprofen and diclofenac were......·35-3·42)]. CONCLUSIONS: In healthy individuals, use of commonly available nonsteroidal anti-inflammatory drugs such as ibuprofen, diclofenac, and naproxen was associated with increased risk of stroke....

  2. Safety pharmacology of sibutramine mesylate, an anti-obesity drug.

    Science.gov (United States)

    Kim, Eun-Joo; Park, Eun-Kyung; Suh, Kwee-Hyun

    2005-03-01

    Sibutramine mesylate is a new anti-obesity drug. It is a crystalline salt of sibutramine developed to improve the solubility of sibutramine hydrochloride. Methanesulfonic acid was used as a salt-forming acid instead of hydrochloric acid, resulting in a greatly improved solubility of 1000 mg/mL in water. Sibutramine mesylate was administered orally to ICR mice, Sprague-Dawley rats, and beagle dogs at dose levels of 1.15, 3.45, and 11.50 mg/kg to measure its effects on the central nervous system (CNS), general behaviour, cardiovascular-respiratory system and the other organ systems. Following administration of sibutramine mesylate, spontaneous locomotor activity was significantly increased from 120 min to 24 hours at 3.45 mg/kg and from 30 min to 24 hours at 11.50 mg/kg. Furthermore, there were a decrease in hexobarbital-induced sleep time, an increase in respiratory rate at 120 min, increases in intestinal transport capacity and gastric pH at 11.50 mg/kg, and decreases in gastric volume and total acidity at 3.45 and 11.50 mg/kg. However sibutramine mesylate caused no effects on general behaviour, motor coordination, body temperature, analgesia, convulsion, blood pressure, heart rate, electrocardiogram, cardiac functions of the isolated rat heart, isolated smooth muscles and renal function. Based on the above results, it was concluded that sibutramine mesylate caused effects on the spontaneous locomotor activity, hexobarbital-induced sleep time, respiration, gastrointestinal transport, and gastric secretion at a dose level of 3.45 mg/kg or greater but caused no effects on other general pharmacological reactions.

  3. The nuts and bolts of pills and portions: the functions of a drug safety working group.

    Science.gov (United States)

    Nath, Noleen S; Jones, Ellen H; Stride, Peter; Premaratne, Manuja; Thaker, Darshit; Lim, Ivan

    2011-11-01

    Hospitalised patients commonly experience adverse drug events (ADEs) and medication errors. Runciman reported that ADEs in hospitals account for 20% of reported adverse events and contribute to 27% of deaths where death followed an adverse event. Hughes recommends multidisciplinary hospital drug committees to assess performance and raise standards. The new Code of Conduct of the Medical Board of Australia recommends participation in systems for surveillance and monitoring of adverse events, and to improve patient safety. We describe the functions and role of a Drug Safety Working Group (DSWG) in a suburban hospital, which aims to audit and promote a culture of prescribing and medication administration that is prudent and cautious to minimise the risk of harm to patients. We believe that regular prescription monitoring and feedback to Resident Medical Officers (RMOs) improves medication management in our hospital.

  4. Safety of antiretroviral drugs in pregnancy and breastfeeding for mother and child

    NARCIS (Netherlands)

    Newell, Marie-Louise; Bunders, Madeleine J.

    2013-01-01

    Purpose of reviewThe introduction of combination ART to prevent mother-to-child-transmission (MTCT) has substantially decreased MTCT rates. However, there are concerns regarding safety of ART exposure for the mother, pregnancy outcome and infant. Changing MTCT prevention guidelines, with expanded

  5. Metabolic drug interactions - the impact of prescribed drug regimens on the medication safety.

    NARCIS (Netherlands)

    Fialova, D.; Vrbensky, K.; Topinkova, E.; Vlcek, J.; Soerbye, L.W.; Wagner, C.; Bernabei, R.

    2005-01-01

    Background and objective: Risk/benefit profile of prescribed drug regimens is unkown. Over 60% of commonly used medications interact on metabolic pathways (cytochrom P450 (CYP450), uridyl-glucuronyl tranferasis (UGT I, II) and P-glycoprotein (PGP) transport). Using an up-to-date knowledge on

  6. The practice of pre-marketing safety assessment in drug development.

    Science.gov (United States)

    Chuang-Stein, Christy; Xia, H Amy

    2013-01-01

    The last 15 years have seen a substantial increase in efforts devoted to safety assessment by statisticians in the pharmaceutical industry. While some of these efforts were driven by regulations and public demand for safer products, much of the motivation came from the realization that there is a strong need for a systematic approach to safety planning, evaluation, and reporting at the program level throughout the drug development life cycle. An efficient process can help us identify safety signals early and afford us the opportunity to develop effective risk minimization plan early in the development cycle. This awareness has led many pharmaceutical sponsors to set up internal systems and structures to effectively conduct safety assessment at all levels (patient, study, and program). In addition to process, tools have emerged that are designed to enhance data review and pattern recognition. In this paper, we describe advancements in the practice of safety assessment during the premarketing phase of drug development. In particular, we share examples of safety assessment practice at our respective companies, some of which are based on recommendations from industry-initiated working groups on best practice in recent years.

  7. 76 FR 64354 - Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small...

    Science.gov (United States)

    2011-10-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0529] Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business... amounts on small business, as set forth in the FDA Food Safety Modernization Act (FSMA). In particular...

  8. 76 FR 45818 - Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small...

    Science.gov (United States)

    2011-08-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0529] Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business... burden of fee amounts on small business, as set forth in the FDA Food Safety Modernization Act (FSMA...

  9. [Do residents and nurses communicate safety relevant concerns? : simulation study on the influence of the authority gradient].

    Science.gov (United States)

    St Pierre, M; Scholler, A; Strembski, D; Breuer, G

    2012-10-01

    Due to the negative impact on decision-making too steep authority gradients in teams represent a risk factor for patient safety. As residents and nursing staff may fear sanctions they may be reluctant to forward critical information to or challenge planned actions of attending physicians. In the setting of a simulation course it was investigated whether and to what extent team members would challenge decisions of familiar attending physicians. In each case where participants did not voice an opinion the underlying motives for the behavior were investigated. A total of 59 physicians and 18 nursing staff participated in the scenario. During a rapid sequence induction they were confronted with 7 critical situations created by the attending physician who had been instructed by the simulation team. Recommendations of the German Society of Anaesthesiology were ignored as well as clinical standard operating procedures (SOPs) and two potentially fatal drug administrations were ordered. An attempt was made to determine whether team members were aware of the safety threat at all and if so how they would solve the resulting conflicts. The level of verbal challenge was scored. During debriefing participants were asked to verbalize the motives which they thought might account for their silence or level of challenge. In situations where non-verbal conflict resolution was possible 65% of the participants pursued that strategy whereas 35% voiced an opinion. Situations necessitating verbal intervention were identified in 66% but 72% of the participants chose to remain silent. Team members decided to challenge the attending physician in only 28% of the situations. In 35% their statement was oblique, in 25% the problem was addressed but not further pursued and only in 40% did participants show crisp advocacy and assertiveness and initiated discussion. Asked why they had refrained from challenging the attending physician 37% had no answer, in 35% of situations participants observed a

  10. When Vacant Lots Become Urban Gardens: Characterizing the Perceived and Actual Food Safety Concerns of Urban Agriculture in Ohio.

    Science.gov (United States)

    Kaiser, Michelle L; Williams, Michele L; Basta, Nicholas; Hand, Michelle; Huber, Sarah

    2015-11-01

    This study was intended to characterize the perceived risks of urban agriculture by residents of four low-income neighborhoods in which the potential exists for further urban agriculture development and to provide data to support whether any chemical hazards and foodborne pathogens as potential food safety hazards were present. Sixty-seven residents participated in focus groups related to environmental health, food security, and urban gardening. In addition, soils from six locations were tested. Residents expressed interest in the development of urban gardens to improve access to healthy, fresh produce, but they had concerns about soil quality. Soils were contaminated with lead (Pb), zinc, cadmium (Cd), and copper, but not arsenic or chromium. Results from our study suggest paint was the main source of soil contamination. Detectable polyaromatic hydrocarbon (PAH) levels in urban soils were well below levels of concern. These urban soils will require further management to reduce Pb and possibly Cd bioavailability to decrease the potential for uptake into food crops. Although the number of locations in this study is limited, results suggest lower levels of soil contaminants at well-established gardens. Soil tillage associated with long-term gardening could have diluted the soil metal contaminants by mixing the contaminants with clean soil. Also, lower PAH levels in long-term gardening could be due to enhanced microbial activity and PAH degradation, dilution, or both due to mixing, similar to metals. No foodborne pathogen targets were detected by PCR from any of the soils. Residents expressed the need for clearness regarding soil quality and gardening practices in their neighborhoods to consume food grown in these urban areas. Results from this study suggest long-term gardening has the potential to reduce soil contaminants and their potential threat to food quality and human health and to improve access to fresh produce in low-income urban communities.

  11. Employing the arts for knowledge production and translation: Visualizing new possibilities for women speaking up about safety concerns in maternity.

    Science.gov (United States)

    Mackintosh, Nicola; Sandall, Jane; Collison, Claire; Carter, Wendy; Harris, James

    2018-06-01

    This project used animated film to translate research findings into accessible health information aimed at enabling women to speak up and secure professional help for serious safety concerns during pregnancy and after birth. We tested as proof of concept our use of the arts both as product (knowledge production) and process (enabling involvement). Emergencies during pregnancy and birth, while unusual, can develop rapidly and unexpectedly, with catastrophic consequences. Women's tacit knowledge of changes in their condition is an important resource to aid early detection, but women can worry about the legitimacy of their concerns and struggle to get these taken seriously by staff. Arts-based knowledge translation. A user group of women who had experienced complications in the perinatal period (n = 34) helped us develop and pilot test the animation. Obstetricians and midwives (15), clinical leads (3) and user group representatives (8) helped with the design and testing. The consultation process, script and storyboard enabled active interaction with the evidence, meaningful engagement with stakeholders and new understandings about securing help for perinatal complications. The method enabled us to address gender stereotypes and social norms about speaking up and embed a social script for women within the animation, to help structure their help seeking. While for some women, there was an emotional burden, the majority were glad to have been part of the animation's development and felt it had enabled their voices to be heard. This project has demonstrated the benefits of arts-science collaborations for meaningful co-production and effective translation of research evidence. © 2017 The Authors. Health Expectations published by John Wiley & Sons Ltd.

  12. Who was concerned about radiation, food safety, and natural disasters after the great East Japan earthquake and Fukushima catastrophe? A nationwide cross-sectional survey in 2012.

    Directory of Open Access Journals (Sweden)

    Takashi Sugimoto

    Full Text Available BACKGROUND: Disaster-related concerns by sub-populations have not been clarified after the great East Japan earthquake and the Fukushima nuclear power plant incidents. This paper assesses who was concerned about radiation, food safety, and natural disasters among the general population in order to buffer such concerns effectively. METHODS: The hypothesis that women, parents, and family caregivers were most concerned about radiation, food safety, and natural disaster was tested using a varying-intercept multivariable logistic regression with 5809 responses from a nationwide cross-sectional survey random-sampled in March 2012. RESULTS: Many people were at least occasionally concerned about radiation (53.5%, food safety (47.3%, and about natural disaster (69.5%. Women were more concerned than men about radiation (OR = 1.67; 95% CI = 1.35-2.06, food safety (1.70; 1.38-2.10, and natural disasters (1.74; 1.39-2.19. Parents and family care needs were not significant. Married couples were more concerned about radiation (1.53; 1.33-1.77, food safety (1.38; 1.20-1.59, and natural disasters (1.30; 1.12-1.52. Age, child-cohabitation, college-completion, retirement status, homemaker status, and the house-damage certificate of the last disaster were also associated with at least one concern. Participants from the Kanto region were more concerned about radiation (2.08; 1.58-2.74 and food safety (1.30; 1.07-1.59, which demonstrate similar positive associations to participants from Tohoku where a disaster relief act was invoked (3.36; 2.25-5.01 about radiation, 1.49; 1.08-2.06 about food safety. CONCLUSIONS: Sectioning the populations by gender and other demographics will clarify prospective targets for interventions, allow for a better understanding of post-disaster concerns, and help communicate relevant information effectively.

  13. Regulatory overview report 2013 concerning nuclear safety in Swiss nuclear installations; Aufsichtsbericht 2013 zur nuklearen Sicherheit in den schweizerischen Kernanlagen

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2014-06-15

    The Swiss Federal Nuclear Safety Inspectorate (ENSI) acting as the regulatory body of the Swiss Federation assesses and monitors nuclear facilities in Switzerland: these include five nuclear power plants, the interim storage facilities based at each plant, the Central Interim Storage Facility (ZWILAG) at Wuerenlingen together with the nuclear facilities at the Paul Scherrer Institute (PSI) and the two universities of Basel and Lausanne. Using a combination of inspections, regulatory meetings, examinations and analyses together with reports from the licensees of individual facilities, ENSI obtains the overview required concerning nuclear safety. It ensures that the facilities comply with regulations. Its regulatory responsibilities include the transport of radioactive materials from and to nuclear facilities and the preparations for a deep geological repository for nuclear waste. ENSI maintains its own emergency organisation, an integral part of the national emergency structure. It provides the public with information on particular events in nuclear facilities. This Surveillance Report describes operational experience, systems technology, radiological protection and management in all the nuclear facilities. Generic issues relevant to all facilities such as probabilistic safety analyses are described. In 2013, the five nuclear power plants in Switzerland (Beznau Units 1 and 2, Muehleberg, Goesgen and Leibstadt) were all operated safely and had complied with their approved operating conditions. The nuclear safety at all plants was rated as being good. 34 events were reported. During operation, no reactor scrams were recorded. On the INES scale, ranging from 0-7, ENSI rated all reportable events as Level 0. The ENSI safety evaluation reflects both reportable events and the results of the approximately 460 inspections conducted during 2013. ZWILAG consists of several storage halls, a conditioning plant and a plasma plant. At the end of 2013, the cask storage hall

  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. Level of Evidence Associated with FDA Safety Communications with Drug Labeling Changes: 2010-2014

    Directory of Open Access Journals (Sweden)

    Benjamin Hixon

    2017-02-01

    Full Text Available Purpose: Approximately 800,000 safety reports are submitted to the FDA annually, however, only significant issues generate drug safety communications (DSC. The purpose of this study was to determine the type of clinical evidence used to warrant a change in drug labeling for drugs with DSC between January 1, 2010 and December 31, 2014. Methods: Selected data was obtained from the FDA website. The primary endpoint of the study was the frequency of the types of clinical evidence used in FDA communications, as reported through the FDA DSC. Results were evaluated via descriptive statistics, and chi-squared for nominal data. Results: A total of 2521 drug safety labeling changes were identified and 99 (3.9% of safety communications met the inclusion criteria. The majority of the labeling changes were associated with single agents (83.8%. The three most frequently reported labeling changes were warnings (68.7%, precautions (58.6%, and patient package insert/medication guide (23.2%. Case reports resulted in the greatest number of documented literature types (n = 791, followed by randomized controlled trials (n = 76, and case control/cohort studies (n = 74. Significantly more evidence for DSCs were classified as Level of Evidence B (LOE B, 68.6%, compared to LOE A (17.1%, and LOE C (14.1% (p = 0.007. Conclusions: The majority of drug labeling change initiators was associated with LOE equivalent to B. Practitioners should evaluate data associated with labeling changes to determine how to interpret the information for their patients. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received, employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties.   Type: Original Research

  16. 76 FR 20686 - Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug...

    Science.gov (United States)

    2011-04-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0164] Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  17. 75 FR 36427 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management...

    Science.gov (United States)

    2010-06-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice...

  18. Effects of organizational safety practices and perceived safety climate on PPE usage, engineering controls, and adverse events involving liquid antineoplastic drugs among nurses.

    Science.gov (United States)

    DeJoy, David M; Smith, Todd D; Woldu, Henok; Dyal, Mari-Amanda; Steege, Andrea L; Boiano, James M

    2017-07-01

    Antineoplastic drugs pose risks to the healthcare workers who handle them. This fact notwithstanding, adherence to safe handling guidelines remains inconsistent and often poor. This study examined the effects of pertinent organizational safety practices and perceived safety climate on the use of personal protective equipment, engineering controls, and adverse events (spill/leak or skin contact) involving liquid antineoplastic drugs. Data for this study came from the 2011 National Institute for Occupational Safety and Health (NIOSH) Health and Safety Practices Survey of Healthcare Workers which included a sample of approximately 1,800 nurses who had administered liquid antineoplastic drugs during the past seven days. Regression modeling was used to examine predictors of personal protective equipment use, engineering controls, and adverse events involving antineoplastic drugs. Approximately 14% of nurses reported experiencing an adverse event while administering antineoplastic drugs during the previous week. Usage of recommended engineering controls and personal protective equipment was quite variable. Usage of both was better in non-profit and government settings, when workers were more familiar with safe handling guidelines, and when perceived management commitment to safety was higher. Usage was poorer in the absence of specific safety handling procedures. The odds of adverse events increased with number of antineoplastic drugs treatments and when antineoplastic drugs were administered more days of the week. The odds of such events were significantly lower when the use of engineering controls and personal protective equipment was greater and when more precautionary measures were in place. Greater levels of management commitment to safety and perceived risk were also related to lower odds of adverse events. These results point to the value of implementing a comprehensive health and safety program that utilizes available hazard controls and effectively communicates

  19. The impact of medicinal drugs on traffic safety: a systematic review of epidemiological studies.

    Science.gov (United States)

    Orriols, Ludivine; Salmi, Louis-Rachid; Philip, Pierre; Moore, Nicholas; Delorme, Bernard; Castot, Anne; Lagarde, Emmanuel

    2009-08-01

    To evaluate the quality of epidemiological research into effects of medicinal drugs on traffic safety and the current knowledge in this area. The bibliographic search was done in Medline electronic database using the keywords: ((accident* or crash*) and traffic and drug*) leading to 1141 references. Additional references were retrieved from the Safetylit website and the reference lists of selected studies. Original articles published in English or French, between 1 April 1979 and 31 July 2008, were considered for inclusion. We excluded descriptive studies, studies limited to alcohol or illicit drug involvement and investigations of injuries other than from traffic crashes. Studies based on laboratory tests, driving simulators or on-the-road driving tests were also excluded. Eligible studies had to evaluate the causal relationship between the use of medicinal drugs and the risk of traffic crashes. Study quality was assessed by two independent experts, according to a grid adapted from the strengthening the reporting of observational studies in epidemiology (STROBE) statement. Twenty two studies of variable methodological quality were included. Definition of drug exposure varied across studies and depended on the data sources. Potential confounding due to the interaction between the effects of the medicinal drug and disease-related symptoms was often not controlled. The risk of motor-vehicle crashes related to benzodiazepines has been amply studied and demonstrated. Results for other medicinal drugs remain controversial. There is a need for large studies, investigating the role of individual substances in the risk of road traffic crashes. Copyright 2009 John Wiley & Sons, Ltd.

  20. Using agro-industrial wastes for the cultivation of microalgae and duckweeds: Contamination risks and biomass safety concerns.

    Science.gov (United States)

    Markou, Giorgos; Wang, Liang; Ye, Jianfeng; Unc, Adrian

    2018-04-17

    Aquatic organisms, such as microalgae (Chlorella, Arthrospira (Spirulina), Tetrasselmis, Dunalliela etc.) and duckweed (Lemna spp., Wolffia spp. etc.) are a potential source for the production of protein-rich biomass and for numerous other high-value compounds (fatty acids, pigments, vitamins etc.). Their cultivation using agro-industrial wastes and wastewater (WaW) is of particular interest in the context of a circular economy, not only for recycling valuable nutrients but also for reducing the requirements for fresh water for the production of biomass. Recovery and recycling of nutrients is an unavoidable long-term approach for securing future food and feed production. Agro-industrial WaW are rich in nutrients and have been widely considered as a potential nutrient source for the cultivation of microalgae/duckweed. However, they commonly contain various hazardous contaminants, which could potentially taint the produced biomass, raising various concerns about the safety of their consumption. Herein, an overview of the most important contaminants, including heavy metals and metalloids, pathogens (bacteria, viruses, parasites etc.), and xenobiotics (hormones, antibiotics, parasiticides etc.) is given. It is concluded that pretreatment and processing of WaW is a requisite step for the removal of several contaminants. Among the various technologies, anaerobic digestion (AD) is widely used in practice and offers a technologically mature approach for WaW treatment. During AD, various organic and biological contaminants are significantly removed. Further removal of contaminants could be achieved by post-treatment and processing of digestates (solid/liquid separation, dilution etc.) to further decrease the concentration of contaminants. Moreover, during cultivation an additional removal may occur through various mechanisms, such as precipitation, degradation, and biotransformation. Since many jurisdictions regulate the presence of various contaminants in feed or food

  1. Electronic Health Record-Related Safety Concerns: A Cross-Sectional Survey of Electronic Health Record Users

    Science.gov (United States)

    Pajunen, Tuuli; Saranto, Kaija; Lehtonen, Lasse

    2016-01-01

    systematic assessments of EHR risks before harmful events occur. An EHR training program should be compulsory for all EHR users in order to address EHR safety concerns resulting from the failure to use HIT appropriately. PMID:27154599

  2. Development of the international status of science and technology concerning methods and tools for operational and long-term safety cases

    International Nuclear Information System (INIS)

    Seher, Holger; Beuth, Thomas; Bracke, Guido; Kock, Ingo; Mayer, Kim-Marisa; Moog, Helge C.; Uhlmann, Stephan; Weyand, Torben

    2016-09-01

    The project ''development of the international status of science and technology concerning methods and tools for operational and long-term safety cases'' covers the following key aspects: global aspects of the methodology for scenario assumption for the operational phase following closure, potential analysis of the derives safety cases for the project Gorleben, determination of the solid phase composition of high-level radioactive wastes using geochemical modeling calculations, search for an adequate approach for the calculation of density and viscosity of saline solutions for the future use in GRS computer codes, international approaches for an integral analysis for the host rocks clay and granite in relation to the safety requirements of BMUB.

  3. Does the Early Adopter of Drugs Exist? A Population Based Study of General Practitioners’ Prescribing of New Drugs.20 th International Conference on Pharmacoepiemiology and Risk Management. Bordeaux, France. Pharmacoepidemiology and Drug Safety, 2004;13:Sl 1:158

    DEFF Research Database (Denmark)

    Dybdahl, Torben; Andersen, Morten; Søndergaard, Jens

    2004-01-01

    20 th International Conference on Pharmacoepiemiology and Risk Management. Bordeaux, France. Pharmacoepidemiology and Drug Safety, 2004;13:Sl 1:158......20 th International Conference on Pharmacoepiemiology and Risk Management. Bordeaux, France. Pharmacoepidemiology and Drug Safety, 2004;13:Sl 1:158...

  4. Cause-specific cardiovascular risk associated with nonsteroidal antiinflammatory drugs among healthy individuals

    DEFF Research Database (Denmark)

    Fosbøl, Emil Loldrup; Folke, Fredrik; Jacobsen, Søren

    2010-01-01

    Studies have raised concern on the cardiovascular safety of nonsteroidal antiinflammatory drugs (NSAIDs). We studied safety of NSAID therapy in a nationwide cohort of healthy individuals.......Studies have raised concern on the cardiovascular safety of nonsteroidal antiinflammatory drugs (NSAIDs). We studied safety of NSAID therapy in a nationwide cohort of healthy individuals....

  5. The home electronic media environment and parental safety concerns: relationships with outdoor time after school and over the weekend among 9-11 year old children.

    Science.gov (United States)

    Wilkie, Hannah J; Standage, Martyn; Gillison, Fiona B; Cumming, Sean P; Katzmarzyk, Peter T

    2018-04-05

    Time spent outdoors is associated with higher physical activity levels among children, yet it may be threatened by parental safety concerns and the attraction of indoor sedentary pursuits. The purpose of this study was to explore the relationships between these factors and outdoor time during children's discretionary periods (i.e., after school and over the weekend). Data from 462 children aged 9-11 years old were analysed using generalised linear mixed models. The odds of spending > 1 h outdoors after school, and > 2 h outdoors on a weekend were computed, according to demographic variables, screen-based behaviours, media access, and parental safety concerns. Interactions with sex and socioeconomic status (SES) were explored. Boys, low SES participants, and children who played on their computer for  1 h outside after school than girls, high SES children and those playing on a computer for ≥2 h, respectively. Counterintuitive results were found for access to media devices and crime-related safety concerns as both of these were positively associated with time spent outdoors after school. A significant interaction for traffic-related concerns*sex was found; higher road safety concerns were associated with lower odds of outdoor time after school in boys only. Age was associated with weekend outdoor time, which interacted with sex and SES; older children were more likely to spend > 2 h outside on weekends but this was only significant among girls and high SES participants. Our results suggest that specific groups of children are less likely to spend their free time outside, and it would seem that only prolonged recreational computer use has a negative association with children's outdoor time after school. Further research is needed to explore potential underlying mechanisms, and parental safety concerns in more detail.

  6. Geochemistry and mercury contamination in receiving environments of artisanal mining wastes and identified concerns for food safety

    Energy Technology Data Exchange (ETDEWEB)

    Reichelt-Brushett, Amanda J., E-mail: amanda.reichelt-brushett@scu.edu.au [Marine Ecology Research Centre, School of Environment, Science and Engineering, Southern Cross University, PO Box 157, Lismore, NSW (Australia); School of Environment, Science and Engineering Southern Cross University, PO Box 157, Lismore, NSW (Australia); Stone, Jane [School of Environment, Science and Engineering Southern Cross University, PO Box 157, Lismore, NSW (Australia); Howe, Pelli [Marine Ecology Research Centre, School of Environment, Science and Engineering, Southern Cross University, PO Box 157, Lismore, NSW (Australia); School of Environment, Science and Engineering Southern Cross University, PO Box 157, Lismore, NSW (Australia); Thomas, Bernard [School of Environment, Science and Engineering Southern Cross University, PO Box 157, Lismore, NSW (Australia); Clark, Malcolm [Marine Ecology Research Centre, School of Environment, Science and Engineering, Southern Cross University, PO Box 157, Lismore, NSW (Australia); School of Environment, Science and Engineering Southern Cross University, PO Box 157, Lismore, NSW (Australia); Male, Yusthinus [Department of Chemistry, Faculty of Mathematics and Natural Science, Pattimura University, Ambon (Indonesia); Nanlohy, Albert [Department of Fisheries and Marine Science, Pattimura University, Ambon (Indonesia); Butcher, Paul [School of Environment, Science and Engineering Southern Cross University, PO Box 157, Lismore, NSW (Australia); NSW Department of Primary Industries, National Marine Science Centre, PO Box 4321, Coffs Harbour, NSW (Australia)

    2017-01-15

    Artisanal small-scale gold mining (ASGM) using mercury (Hg) amalgamation has been occurring on Buru Island, Indonesia since early 2012, and has caused rapid accumulation of high Hg concentrations in river, estuary and marine sediments. In this study, sediment samples were collected from several sites downstream of the Mount Botak ASGM site, as well as in the vicinity of the more recently established site at Gogrea where no sampling had previously been completed. All sediment samples had total Hg (THg) concentrations exceeding Indonesian sediment quality guidelines and were up to 82 times this limit at one estuary site. The geochemistry of sediments in receiving environments indicates the potential for Hg-methylation to form highly bioavailable Hg species. To assess the current contamination threat from consumption of local seafood, samples of fish, molluscs and crustaceans were collected from the Namlea fish market and analysed for THg concentrations. The majority of edible tissue samples had elevated THg concentrations, which raises concerns for food safety. This study shows that river, estuary and marine ecosystems downstream of ASGM operations on Buru Island are exposed to dangerously high Hg concentrations, which are impacting aquatic food chains, and fisheries resources. Considering the high dietary dependence on marine protein in the associated community and across the Mollucas Province, and the short time period since ASGM operations commenced in this region, the results warrant urgent further investigation, risk mitigation, and community education. - Highlights: • Mercury contamination of sediments and seafood due to artisanal gold mining. • Considerable risks to human and ecosystem health are identified. • Results emphasise the urgent need for risk mitigation and community education.

  7. [An investigative report concerning safety and management in the magnetic resonance environment: there are more accidents than expected].

    Science.gov (United States)

    Doi, Tsukasa; Yamatani, Yuya; Ueyama, Tsuyoshi; Nishiki, Shigeo; Ogura, Akio; Kawamitsu, Hideaki; Tsuchihashi, Toshio; Okuaki, Tomoyuki; Matsuda, Tsuyoshi; Kumashiro, Masayuki

    2011-01-01

    Using a questionnaire, we surveyed 2,500 facilities in Japan to clarify medical accidents concerning the magnetic resonance device and its environment. Data derived from 1,319 valid responses (52.8%), allowed us to analyze the situation of (or the reason for) the occurrence of the accidents and their environmental factors. Five hundred and nine facilities (39% of all facilities) had the experience of magnetically induced displacement of the large ferromagnetic material. Intravenous (I.V.) drip stands were involved the largest number of them: 31% (228 cases). Oxygen bottles had the second largest number of incidents: 20%. There were also many incidents involving various materials brought in by non-medical staff (e.g. stepladder for construction). About 20% of the accidents occurred outside of working hours. Patients in 12% of the facilities (154 facilities) experienced burns. In 39 of the cases, burns were received to the inside of the thighs. In 38 of the cases, patients received burns from an electrical cable touching the skin. There were also frequent incidents of burning regarding the boa. We received reports of burns and pain from the halo vest even though it's required to be worn for MR safety. Regarding incidents of contraindications, 280 patients with pacemakers were brought into the magnetic resonance (MR) inspection room. Twelve percent of the facilities experienced natural quench. Lack of training for the staff who introduce and operate high magnetic field devices are considered involving frequently occurring accidents of attractions and burns at hospitals with over 500 beds caused by carrying in materials.

  8. Geochemistry and mercury contamination in receiving environments of artisanal mining wastes and identified concerns for food safety

    International Nuclear Information System (INIS)

    Reichelt-Brushett, Amanda J.; Stone, Jane; Howe, Pelli; Thomas, Bernard; Clark, Malcolm; Male, Yusthinus; Nanlohy, Albert; Butcher, Paul

    2017-01-01

    Artisanal small-scale gold mining (ASGM) using mercury (Hg) amalgamation has been occurring on Buru Island, Indonesia since early 2012, and has caused rapid accumulation of high Hg concentrations in river, estuary and marine sediments. In this study, sediment samples were collected from several sites downstream of the Mount Botak ASGM site, as well as in the vicinity of the more recently established site at Gogrea where no sampling had previously been completed. All sediment samples had total Hg (THg) concentrations exceeding Indonesian sediment quality guidelines and were up to 82 times this limit at one estuary site. The geochemistry of sediments in receiving environments indicates the potential for Hg-methylation to form highly bioavailable Hg species. To assess the current contamination threat from consumption of local seafood, samples of fish, molluscs and crustaceans were collected from the Namlea fish market and analysed for THg concentrations. The majority of edible tissue samples had elevated THg concentrations, which raises concerns for food safety. This study shows that river, estuary and marine ecosystems downstream of ASGM operations on Buru Island are exposed to dangerously high Hg concentrations, which are impacting aquatic food chains, and fisheries resources. Considering the high dietary dependence on marine protein in the associated community and across the Mollucas Province, and the short time period since ASGM operations commenced in this region, the results warrant urgent further investigation, risk mitigation, and community education. - Highlights: • Mercury contamination of sediments and seafood due to artisanal gold mining. • Considerable risks to human and ecosystem health are identified. • Results emphasise the urgent need for risk mitigation and community education.

  9. Rowers’ Self-Reported Behaviors, Attitudes, and Safety Concerns Related to Exercise, Training, and Competition During Pregnancy

    Science.gov (United States)

    Mishtal, Joanna; Johnson, Teresa; Simms-Cendan, Judith

    2017-01-01

    Background The American College of Obstetrics and Gynecology notes that pregnant athletes require more supervision due to their involvement in strenuous training schedules throughout pregnancy. Currently, rowing is not mentioned in the guidelines despite its increasing popularity, high cardiovascular demands, and risk for abdominal trauma. Methods This study aimed to elicit information from competitive female rowers regarding exercise, training, and competition during pregnancy. We administered a survey consisting of 122 items to female Masters rowers in the United States, aged 21 to 49 years, from June to December 2013. Results A total of 224 recreational and elite rowers met the inclusion criteria. Pregnant rowers self-reported high levels of exercise engagement: 85.2% (n/N = 98/115) exercised during any past pregnancy; exercise adherence decreased throughout pregnancy with 51.3%, 42.4%, and 15.7% meeting and/or exceeding national guidelines during the first, second, and third trimesters, respectively. Rowers were significantly (p sport. Novel barriers to exercise in pregnancy included guilt towards the team and a mental barrier due to decreased performance. Healthcare providers are the number one information source for rowers regarding exercise during pregnancy. Conclusion Pregnant rowers are a relevant obstetrics population and have barriers and sport-specific safety concerns not previously identified in the literature. Rowers consider exercising in pregnancy to be important and struggle to meet exercise guidelines like the general population, indicating the need for healthcare providers to provide prenatal and antenatal education and interventions to support exercise during pregnancy even amongst athletes. PMID:28983443

  10. Rowers' Self-Reported Behaviors, Attitudes, and Safety Concerns Related to Exercise, Training, and Competition During Pregnancy.

    Science.gov (United States)

    Franklin, Ashley; Mishtal, Joanna; Johnson, Teresa; Simms-Cendan, Judith

    2017-08-01

    Background The American College of Obstetrics and Gynecology notes that pregnant athletes require more supervision due to their involvement in strenuous training schedules throughout pregnancy. Currently, rowing is not mentioned in the guidelines despite its increasing popularity, high cardiovascular demands, and risk for abdominal trauma. Methods This study aimed to elicit information from competitive female rowers regarding exercise, training, and competition during pregnancy. We administered a survey consisting of 122 items to female Masters rowers in the United States, aged 21 to 49 years, from June to December 2013. Results A total of 224 recreational and elite rowers met the inclusion criteria. Pregnant rowers self-reported high levels of exercise engagement: 85.2% (n/N = 98/115) exercised during any past pregnancy; exercise adherence decreased throughout pregnancy with 51.3%, 42.4%, and 15.7% meeting and/or exceeding national guidelines during the first, second, and third trimesters, respectively. Rowers were significantly (p sport. Novel barriers to exercise in pregnancy included guilt towards the team and a mental barrier due to decreased performance. Healthcare providers are the number one information source for rowers regarding exercise during pregnancy. Conclusion Pregnant rowers are a relevant obstetrics population and have barriers and sport-specific safety concerns not previously identified in the literature. Rowers consider exercising in pregnancy to be important and struggle to meet exercise guidelines like the general population, indicating the need for healthcare providers to provide prenatal and antenatal education and interventions to support exercise during pregnancy even amongst athletes.

  11. Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.

    Science.gov (United States)

    Kesselheim, A S

    2010-06-01

    In 2008 and 2009, the Supreme Court reviewed the question of whether patients injured by dangerous prescription drugs or medical devices can bring tort lawsuits against pharmaceutical and device manufacturers. The Court ruled that claims against device manufacturers were preempted while claims against pharmaceutical manufacturers were not. The threat of product liability lawsuits promotes patient safety by encouraging manufacturers to take greater responsibility in providing clear warnings about known adverse effects of their products.

  12. [Investigation of the cognition and behavior on drug safety in Beijing middle school students].

    Science.gov (United States)

    Cheng, Y C; Pan, Y P; Zhang, Y; Pan, Y T; Ding, C Y; Cao, Y; Zhuo, L; Fang, R F; Gao, A Y; Guo, J; Li, A J; Fu, Q; Ma, J; Zhan, S Y

    2017-12-18

    To understand the cognition and behavior of drug safety in Beijing middle school students and provide advice for relevant education. A cross-sectional survey using paper questionnaires was carried out on the student body of nine Beijing middle schools. Multi-stage proportionate stratified cluster sampling was adopted to enroll participants. In addition to demographic questions, the questionnaire included 17 questions assessing the cognition and behavior of safe drug use, prioritizing questions that aligned with the health education guideline for primary and secondary school students from Chinese Ministry of Education. Descriptive statistical methods were applied using the SAS 9.2 software. Of the 4 220 students investigated, 2 097(49.7%) were males and 2 123(50.3%) were females. The average age was (14.3±1.7) years. 2 030(48.1%) students were from downtown areas, 1 511(35.8%) were from urban-rural linking areas and 679(16.1%) were from rural areas. Half (51.5%) of the respondents were junior high school students, and the others were from senior high schools (34.2%) and vocational high schools (14.3%). Most of the students (89.6%) lived off campus. The awareness rate of drug safety knowledge was 74.4%, the median score of drug safety behavior was 4 points (full score was 5 points) and there was a statistically positive correlation between the two (Spearman's correlation coefficient was 0.156, Pmiddle school students is good, but problems still exist in medication adherence, the management of expired drugs and the antibiotics cognition, which need to be fixed through specific, pointed way of education. And more efforts should be made to improve the cognition in rural regions, vocational high schools and on campus students.

  13. The complications of controlling agency time discretion: FDA review deadlines and postmarket drug safety.

    Science.gov (United States)

    Carpenter, Daniel; Chattopadhyay, Jacqueline; Moffitt, Susan; Nall, Clayton

    2012-01-01

    Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses.

  14. [Evaluation of the safety of innovative drugs against viruses and infectious agents].

    Science.gov (United States)

    Kobayashi, Tetsu; Yusa, Keisuke; Kawasaki, Nana

    2013-01-01

    Recently, several novel cellular therapy products and biological drugs are being developed to treat various previously untreatable diseases. One of the most important issues regarding these innovations is how to ensure safety over infectious agents, including viruses and prions, in the earliest treatments with these products. The object of this study is a risk assessment of cases of human infectious with the agents and to present a sample risk management plan based on a collaboration among the National Institute of Health Sciences, universities, marketing authorization holders, and scientific societies. There are three subjects of study: (1) the viral safety of cellular therapy products, (2) the viral safety of biological drugs, and (3) the safety of prions. In this report, we describe the objects of the study, the project members, the study plan outline, and the ongoing plans. The results of the viral risk identification and the risk analysis of cellular therapy products will also be described, based on a review of the literature and case reports obtained during the first year of this project.

  15. Drug monitoring in child and adolescent psychiatry for improved efficacy and safety of psychopharmacotherapy

    Directory of Open Access Journals (Sweden)

    Fegert Jörg M

    2009-04-01

    Full Text Available Abstract Most psychotropic drugs used in the treatment of children and adolescents are applied "off label" with a direct risk of under- or overdosing and a delayed risk of long-term side effects. The selection of doses in paediatric psychiatric patients requires a consideration of pharmacokinetic parameters and the development of central nervous system, and warrants specific studies in children and adolescents. Because these are lacking for most of the psychotropic drugs applied in the Child and Adolescent and Psychiatry, therapeutic drug monitoring (TDM is a valid tool to optimise pharmacotherapy and to enable to adjust the dosage of drugs according to the characteristics of the individual patient. Multi-centre TDM studies enable the identification of age- and development-dependent therapeutic ranges of blood concentrations and facilitate a highly qualified standardized documentation in the child and adolescent health care system. In addition, they will provide data for future research on psychopharmacological treatment in children and adolescents, as a baseline for example for clinically relevant interactions with various co-medications. Therefore, a German-Austrian-Swiss "Competence Network on Therapeutic Drug Monitoring in Child and Adolescent Psychiatry" was founded 1 introducing a comprehensive internet data base for the collection of demographic, safety and efficacy data as well as blood concentrations of psychotropic drugs in children and adolescents.

  16. Suspected adverse drug reactions in elderly patients reported to the Committee on Safety of Medicines.

    Science.gov (United States)

    Castleden, C M; Pickles, H

    1988-10-01

    1. Spontaneous reports of suspected adverse drug reactions (ADRs) reported to the Committee on Safety of Medicines (CSM) have been studied in relation to patient age. 2. The proportion of reports received for the elderly increased between 1965 and 1983. 3. There was a correlation between the use of drugs and the number of ADR reports. Thus age-related prescription figures for two non-steroidal anti-inflammatory drugs (NSAI) and co-trimoxazole matched ADR reports for each drug in each age group. 4. The reported ADR was more likely to be serious or fatal in the elderly. 5. The commonest ADRs reported for the elderly affected the gastrointestinal (GIT) and haemopoietic systems, where more reports were received than would be expected from prescription figures. 6. The drug suspected of causing a GIT reaction was a NSAI in 75% of the reports. 7. Ninety-one per cent of fatal reports of GIT bleeds and perforations associated with NSAI drugs were in patients over 60 years of age.

  17. Safety Profile of the Newest Antiepileptic Drugs: A Curated Literature Review.

    Science.gov (United States)

    Palleria, Caterina; Cozza, Giuseppe; Khengar, Rajeshree; Libri, Vincenzo; De Sarro, Giovambattista

    2017-01-01

    Despite the introduction of new antiepileptic drugs (AEDs), the quality of life and therapeutic response for patients with epilepsy remain unsatisfactory. In addition, whilst several antiepileptic drugs (AEDs) have been approved and consequently marketed in recent years, little is known about their long-term safety and tolerability. Availability of the newest AEDs, characterized by improved pharmacokinetic profiles, has positively impacted the treatment approach for patients with partial seizures in clinical practice. However, the main cause of treatment failure is still poor patient compliance due to the occurrence of adverse drug reactions (ADRs) that lead to treatment withdrawal in about 25% of cases before achieving maximal efficacy, and is associated with increasing health care costs. In this Review, we conducted an online database search using Medline, PubMed, Embase, and the Cochrane Online Library to review the available studies highlighting the clinical relevance of side effects, pharmacological interactions, safety and tolerability of the newest AEDs: Brivaracetam (BRV), Cannabidiol (CBD), Eslicarbazepine acetate (ESL), Lacosamide (LCM), and Perampanel (PER). The principal benefit of the newest AEDs, in addition to reduced frequency and seizure severity, is the low number and severity of ADRs reported compared to more historic drugs. Early detection of ADRs could lead to an improvement in patients' quality of life, therefore it is important to monitor ADRs and to adequately perform post marketing surveillance in the clinical practice setting. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  18. Ayurpharmacoepidemiology en Route to Safeguarding Safety and Efficacy of Ayurvedic Drugs in Global Outlook

    Science.gov (United States)

    Debnath, Parikshit; Banerjee, Subhadip; Adhikari, Anjan; Debnath, Pratip K.

    2016-01-01

    Ayurpharmacoepidemiology is a new field developed by synergy of the fields of clinical pharmacology, epidemiology, and ayurveda. It will use the effects of ayurvedic medicinal products on large populations to describe and analyze the practices, evaluate the safety and efficacy, and carry out medicoeconomic evaluations. Good pharmacoepidemiology practices in ayurveda is projected to assist with issues of ayurpharmacoepidemiologic research. The embraced good pharmacoepidemiology practices guideline in this viewpoint will be able to provide valuable evidence about the health effects of ayurvedic herbs/drugs and consider different fields like pharmacovigilance, pharmacoeconomics, and drug discovery with ayurvedic reverse pharmacology approach, also pass out significant data for further basic sciences study in ayurveda biology, ayurgenomics, ayurnutrigenomics, and systems biology. Several unanswered questions about ayurvedic drug use and informed interventions or policies that can be addressed by informatics database, which will eventually demonstrate the credibility and rationality of ayurceuticals in the future. PMID:26721554

  19. Anti-Obesity Drugs: A Review about Their Effects and Safety

    Directory of Open Access Journals (Sweden)

    Jun Goo Kang

    2012-02-01

    Full Text Available The current recommendations for the treatment of obese people include increased physical activity and reduced calories intake. When the behavioral approach is not sufficient, a pharmacologic treatment is recommended. In past years, numerous drugs have been approved for the treatment of obesity; however, most of them have been withdrawn from the market because of their adverse effects. In fact, amphetamine, rimonabant and sibutramine licenses have been withdrawn due to an increased risk of psychiatric disorders and non-fatal myocardial infarction or stroke. Even if orlistat is not as effective as other drugs in reducing body weight, orlistat is presently the only available choice for the treatment of obesity because of its safety for cardiovascular events and positive effects on diabetic control. Hopefully, more effective and better tolerated anti-obesity drugs will be developed through an improved understanding of the multiple mechanisms and complex physiological systems targeting appetite.

  20. Surveys of research projects concerning nuclear facility safety, financed by the Bundesminister des Innern. 9th annual report on SR-projects 1984

    International Nuclear Information System (INIS)

    1985-06-01

    The FRG's Ministry of the Interior finances studies, expertises and investigations in the field of nuclear safety. The results of such work are meant to clarify questions left open concerning the execution of licensing procedures for nuclear facilities. The GRS (Reactor Safety Company) regularly provides information on the state of such studies, on the authority of the Ministry of the Interior. Each progress report is a collection of individual reports, categorized by subject matter. They are a documentation of the contractor's progress, rendered by themselves on standardized forms, published, for the sake of general information on progress made in investigations concerning reactor safety, by the project attendance department of the GRS. The individual reports have serial numbers. Each report includes particulars of the objective, work carried out, results obtained and plans for project continuation. (orig./HP) [de

  1. Enabling social listening for cardiac safety monitoring: Proceedings from a drug information association-cardiac safety research consortium cosponsored think tank.

    Science.gov (United States)

    Seifert, Harry A; Malik, Raleigh E; Bhattacharya, Mondira; Campbell, Kevin R; Okun, Sally; Pierce, Carrie; Terkowitz, Jeffrey; Turner, J Rick; Krucoff, Mitchell W; Powell, Gregory E

    2017-12-01

    This white paper provides a summary of the presentations and discussions from a think tank on "Enabling Social Listening for Cardiac Safety Monitoring" trials that was cosponsored by the Drug Information Association and the Cardiac Safety Research Consortium, and held at the White Oak headquarters of the US Food and Drug Administration on June 3, 2016. The meeting's goals were to explore current methods of collecting and evaluating social listening data and to consider their applicability to cardiac safety surveillance. Social listening is defined as the act of monitoring public postings on the Internet. It has several theoretical advantages for drug and device safety. First, these include the ability to detect adverse events that are "missed" by traditional sources and the ability to detect adverse events sooner than would be allowed by traditional sources, both by affording near-real-time access to data from culturally and geographically diverse sources. Social listening can also potentially introduce a novel patient voice into the conversation about drug safety, which could uniquely augment understanding of real-world medication use obtained from more traditional methodologies. Finally, it can allow for access to information about drug misuse and diversion. To date, the latter 2 of these have been realized. Although regulators from the Food and Drug Administration and the United Kingdom's Medicines and Healthcare Products Regulatory Agency participated in the think tank along with representatives from industry, academia, and patient groups, this article should not be construed to constitute regulatory guidance. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. Posiva's application for a decision in principle concerning a disposal facility for spent nuclear fuel. STUK's statement and preliminary safety appraisal

    Energy Technology Data Exchange (ETDEWEB)

    Ruokola, E. [ed.

    2000-03-01

    In May 1999, Posiva Ltd submitted to the Government an application, pursuant to the Nuclear Energy Act, for a Decision in Principle on a disposal facility for spent nuclear fuel from the Finnish nuclear power plants. The Ministry of Trade and Industry requested the Radiation and Nuclear Safety Authority (STUK) to draw up a preliminary safety appraisal concerning the proposed disposal facility. In the beginning of this report, STUK's statement to the Ministry and Industry concerning the proposed disposal facility is given. In that statement, STUK concludes that the Decision in Principle is currently justified from the standpoint of safety. The statement is followed by a safety appraisal, where STUK deems, how the proposed disposal concept, site and facility comply with the safety requirements included in the Government's Decision (478/1999). STUK's preliminary safety appraisal was supported by contributions from a number of outside experts. A collective opinion by an international group of ten distinguished experts is appended to this report. (orig.)

  3. Decree No 87-137 of 2 March 1987 concerning the High Council for nuclear safety and information

    International Nuclear Information System (INIS)

    1987-01-01

    This Decree amends the Decree of 13th March 1973 setting up a High Council for Nuclear Safety. Its purpose is to widen the terms of reference of the High Council for Nuclear Safety. In addition to its responsibilities as regards the safety of nuclear installations, it is now competent in the field of information. The Council is now charged with informing the media as well as the public not only on questions of safety proper but also on incidents and accidents occurring in nuclear installations. (NEA) [fr

  4. A survey on the factors influencing the pattern of medicine's use: Concerns on irrational use of drugs.

    Science.gov (United States)

    Soleymani, Fatemeh; Ahmadizar, Fariba; Meysamie, Alipasha; Abdollahi, Mohammad

    2013-04-01

    Pharmacists have a remarkable role in rational use of drugs by dissemination of drug information to guide patients, physicians, and policy makers. The present study was undertaken to evaluate the pharmacists' view point about the main factors affecting current drug use pattern regarding rational drug use and the most effective strategies for improving and promoting rational drug use among pharmacists. In a cross-sectional survey, pre-designed questionnaires were filled in convenient sampling by pharmacists who had attended the congress of rational drug use in Tehran, Iran. A total of 144 pharmacists with the average age of 40.78 years old were enrolled to the study. Data indicated that the most priorities in irrational use of drugs from pharmacists' view point were lack of appropriate cooperation and communication between physicians and pharmacists (39%), pharmacists' low tariff and economic issues (34%), lack of public knowledge about drug usage (45%), and lack of supervisory regulations on pharmacy practice (15.8%). In this study, lack of public knowledge and awareness about appropriate use of medicines was the most important element from pharmacists' viewpoint in occurrence of irrational drug use. Dissemination of information and compiling of diverse strategies in education, management, regulation, and finance can be very efficient due to a strong relationship between drug policies and performance of regulations and supervisions as well as drug services.

  5. Illicit Internet availability of drugs subject to recall and patient safety consequences.

    Science.gov (United States)

    Mackey, Tim K; Aung, Phyo; Liang, Bryan A

    2015-12-01

    Permanently recalled drugs are a public health concern if they remain accessible in violation of applicable regulation. Illicit online pharmacies act as an alternative form of access and have been associated with the sale to patients of counterfeit/falsified/fraudulent/substandard drugs. We wished to determine if permanently recalled and significantly restricted drugs were illegally marketed for sale online. The study was conducted in two phases with two objectives. The first phase attempted to identify drugs subject to permanent recall in certain major pharmaceutical markets as well as those listed as recalled or significantly restricted by the United Nations. We also examined the market authorization status of identified drugs in China and India. The second phase used structured searches on the Internet to determine if identified drugs were marketed for sale online. The World Wide Web. After identification of permanently recalled and restricted drugs we conducted Internet searches for illegal "no prescription" marketing events. We assessed the form of marketing, whether a site offered direct-to-patient sale, use of social media marketing, and the site's compliance status with external monitoring bodies. Number of recalled drugs marketed as available for purchase on the Internet. We identified 16 class I equivalent permanently recalled or restricted drugs, 56.3 % (n = 9) of which maintained market authorization in either China or India. Half (n = 8) were marketed for sale online without a prescription direct-to-patient. Use of social media marketing was mixed, with only 18.8 % (n = 3) of recalled drugs having a presence on Facebook, though 50.0 % (n = 8) had content on Twitter. We also found the majority (68.8 %, n = 11) were available and marketed for sale by vendors on the wholesale/business-to-business website alibaba.com primarily as active pharmaceutical ingredient. Despite efforts in several countries to restrict access to these drugs or permanently remove

  6. Safety studies of homoeopathic drugs in acute, sub-acute and chronic toxicity in rats

    Directory of Open Access Journals (Sweden)

    Surender Singh

    2017-01-01

    Full Text Available Background: Homoeopathic drugs are frequently recommended in day to day life as therapeutic agents by homoeopathic practitioners. However, safety of homoeopathic drugs remains a challenge because of the high variability of chemical components involved. Aim: The objective of the present study was to investigate the acute, subacute, and chronic oral toxicity of different homoeopathic drugs (Ferrum phosphoricum 3X, Ferrum phosphoricum 6X, Calcarea phosphoricum 6X, and Magnesium phosphoricum 6X in experimental models. Materials and Methods: In acute oral toxicity study, homoeopathic drugs were administered orally at 2000mg/kg body weight, and animals were observed for toxic symptoms till 10 days as per the OECD guidelines. For subacute and chronic toxicity study, homoeopathic drugs were administered for 28 and 180 days, respectively, as per the OECD guidelines. At the end of 28 and 180 days, the animals were sacrificed and toxicity parameters were assessed. Histopathological evaluation of different organs was also performed to assess any toxicity. Results: In acute toxicity study, no mortality was found at a dose of 2000 mg/kg which indicates that oral LD50of homoeopathic drugs were more than 2000 mg/kg. The administration of drugs at a dose of 70 mg/kg body weight for 28 and 180 days did not produce any significant change in haematological and biochemical parameters of male and female rats as compared to normal control group. No pathological changes were observed in histology of various organs of treated rats as compared to normal control animals. Conclusion: These homoeopathic drugs are safe & produce no toxicity when administered for longer duration.

  7. Social Media Impact of the Food and Drug Administration's Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis.

    Science.gov (United States)

    Sinha, Michael S; Freifeld, Clark C; Brownstein, John S; Donneyong, Macarius M; Rausch, Paula; Lappin, Brian M; Zhou, Esther H; Dal Pan, Gerald J; Pawar, Ajinkya M; Hwang, Thomas J; Avorn, Jerry; Kesselheim, Aaron S

    2018-01-05

    The Food and Drug Administration (FDA) issues drug safety communications (DSCs) to health care professionals, patients, and the public when safety issues emerge related to FDA-approved drug products. These safety messages are disseminated through social media to ensure broad uptake. The objective of this study was to assess the social media dissemination of 2 DSCs released in 2013 for the sleep aid zolpidem. We used the MedWatcher Social program and the DataSift historic query tool to aggregate Twitter and Facebook posts from October 1, 2012 through August 31, 2013, a period beginning approximately 3 months before the first DSC and ending 3 months after the second. Posts were categorized as (1) junk, (2) mention, and (3) adverse event (AE) based on a score between -0.2 (completely unrelated) to 1 (perfectly related). We also looked at Google Trends data and Wikipedia edits for the same time period. Google Trends search volume is scaled on a range of 0 to 100 and includes "Related queries" during the relevant time periods. An interrupted time series (ITS) analysis assessed the impact of DSCs on the counts of posts with specific mention of zolpidem-containing products. Chow tests for known structural breaks were conducted on data from Twitter, Facebook, and Google Trends. Finally, Wikipedia edits were pulled from the website's editorial history, which lists all revisions to a given page and the editor's identity. In total, 174,286 Twitter posts and 59,641 Facebook posts met entry criteria. Of those, 16.63% (28,989/174,286) of Twitter posts and 25.91% (15,453/59,641) of Facebook posts were labeled as junk and excluded. AEs and mentions represented 9.21% (16,051/174,286) and 74.16% (129,246/174,286) of Twitter posts and 5.11% (3,050/59,641) and 68.98% (41,138/59,641) of Facebook posts, respectively. Total daily counts of posts about zolpidem-containing products increased on Twitter and Facebook on the day of the first DSC; Google searches increased on the week of the

  8. The neuropharmacology of ADHD drugs in vivo: insights on efficacy and safety.

    Science.gov (United States)

    Heal, D J; Cheetham, S C; Smith, S L

    2009-12-01

    Results from in vivo techniques, especially intracerebral microdialysis in freely-moving rats, have provided insights into potential mechanisms responsible for the efficacy and safety of catecholaminergic drugs for ADHD treatment. The drugs reviewed come from distinct pharmacological classes: psychostimulant releasing agents, eg d-amphetamine; psychostimulant reuptake inhibitors, eg dl-threo-methylphenidate (dl-MPH), and non-stimulant reuptake inhibitors, eg atomoxetine. Psychostimulants, which currently deliver the best efficacy in treating ADHD, exhibit the following characteristics on extraneuronal catecholamine concentrations in rodent brain in vivo: 1) They enhance the efflux and function of both noradrenaline and dopamine in the central nervous system. 2) The increase of dopamine efflux that they produce is not limited to cortical regions. 3) They have a rapid onset of action with no ceiling on drug effect. d-Amphetamine has a mechanism independent of neuronal firing rate, displacing intraneuronal stores of catecholamines, delaying their reuptake and inhibiting catabolism by monoamine oxidase. dl-MPH has an enigmatic, extraneuronal action that is neuronal firing rate-dependent and reuptake transporter-mediated, yet paradoxically, almost as powerful as that of d-amphetamine. In safety terms, these powerful catecholaminergic effects also make the psychostimulants liable for abuse. Since efficacy and safety derive from the same pharmacological mechanisms, it has not yet been possible to separate these two components. However, the development of once-daily psychostimulant formulations and a prodrug, lisdexamfetamine, has improved patient compliance and markedly reduced scope for their diversion/abuse. This review will discuss the in vivo pharmacological profiles of approved catecholaminergic drugs for treatment of ADHD and implications for their clinical efficacy and abuse liability.

  9. Safety concerning the alteration in fuel material usage (new installation of the uranium enrichment pilot plant) at Ningyo Pass Mine of Power Reactor and Nuclear Fuel Development Corporation

    International Nuclear Information System (INIS)

    1978-01-01

    A report of the Committee on Examination of Nuclear Fuel Safety was presented to the Atomic Energy Commission of Japan, which is concerned with the safety in the alteration of fuel material usage (new installation of the uranium enrichment pilot plant) at the Ningyo Pass Mine. Its safety was confirmed. The alteration, i.e. installation of the uranium enrichment pilot plant, is as follows. Intended for the overall test of centrifugal uranium enrichment technology, the pilot plant includes a two-storied main building of about 9,000 m 2 floor space, containing centrifuges, UF 6 equipment, etc., a uranium storage of about 1,000 m 2 floor space, and a waste water treatment facility, two-storied with about 300 m 2 floor space. The contents of the examination are safety of the facilities, criticality control, radiation control, waste treatment, and effects of accidents on the surrounding environment. (Mori, K

  10. 24 CFR 21.225 - What actions must I take concerning employees who are convicted of drug violations in the workplace?

    Science.gov (United States)

    2010-04-01

    ... calendar days of learning about an employee's conviction, you must either— (1) Take appropriate personnel... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false What actions must I take concerning employees who are convicted of drug violations in the workplace? 21.225 Section 21.225 Housing and Urban...

  11. Decree of 22 October 1969, Stb. 474, concerning the implementation of Section 58, paragraph 4 of the Nuclear Energy Act (Duties of Food and Drugs Inspectors)

    International Nuclear Information System (INIS)

    1969-01-01

    This Decree defines the responsibilities of municipal and provincial food and drug inspectors appointed under the Nuclear Energy Act. They are required to ascertain that the provisions of the Act concerning the protection of the biological, chemical and physical human environment are observed. Their duties do not include the protection of workers. (NEA) [fr

  12. Safety aspects of protease inhibitors for chronic hepatitis C: adverse events and drug-to-drug interactions

    Directory of Open Access Journals (Sweden)

    Rosângela Teixeira

    Full Text Available The standard of care therapy of chronic hepatitis C with the combination of pegylated interferon and ribavirin for 24 or 48 weeks was a remarkable accomplishment of the past decade. However, sustained virological responses rates of about 80% (genotypes 2-3 and 50% (geno 3 type 1 were not satisfactory especially for patients infected with genotype 1. Important advances in the biology of HCV have made possible the development of the direct-acting antiviral agents boceprevir and telaprevir with substantial increase in the rates of sustained virological response with shorter duration of therapy for a large number of patients. However, the complexity of triple therapy is higher and several new side effects are expected suggesting greater expertise in the patient management. Anemia and disgeusia are frequent with boceprevir while cutaneous rash, ranging from mild to severe, is expected with telaprevir. Higher risk of drug-drug interactions demand further clinical consideration of the previous well-known adverse events of pegylated interferon and ribavirin. Identification and prompt management of these potential new problems with boceprevir and telaprevir are crucial in clinical practice for optimizing treatment and assuring safety outcomes to HCV-genotype 1 patients.

  13. Safety aspects of protease inhibitors for chronic hepatitis C: adverse events and drug-to-drug interactions

    Directory of Open Access Journals (Sweden)

    Rosângela Teixeira

    2013-04-01

    Full Text Available The standard of care therapy of chronic hepatitis C with the combination of pegylated interferon and ribavirin for 24 or 48 weeks was a remarkable accomplishment of the past decade. However, sustained virological responses rates of about 80% (genotypes 2-3 and 50% (geno 3 type 1 were not satisfactory especially for patients infected with genotype 1. Important advances in the biology of HCV have made possible the development of the direct-acting antiviral agents boceprevir and telaprevir with substantial increase in the rates of sustained virological response with shorter duration of therapy for a large number of patients. However, the complexity of triple therapy is higher and several new side effects are expected suggesting greater expertise in the patient management. Anemia and disgeusia are frequent with boceprevir while cutaneous rash, ranging from mild to severe, is expected with telaprevir. Higher risk of drug-drug interactions demand further clinical consideration of the previous well-known adverse events of pegylated interferon and ribavirin. Identification and prompt management of these potential new problems with boceprevir and telaprevir are crucial in clinical practice for optimizing treatment and assuring safety outcomes to HCV-genotype 1 patients.

  14. Thermal safety of ultrasound-enhanced ocular drug delivery: A modeling study

    International Nuclear Information System (INIS)

    Nabili, Marjan; Geist, Craig; Zderic, Vesna

    2015-01-01

    Purpose: Delivery of sufficient amounts of therapeutic drugs into the eye for treatment of various ocular diseases is often a challenging task. Ultrasound was shown to be effective in enhancing ocular drug delivery in the authors’ previous in vitro and in vivo studies. Methods: The study reported here was designed to investigate the safety of ultrasound application and its potential thermal effects in the eye using PZFlex modeling software. The safety limit in this study was set as a temperature increase of no more than 1.5 °C based on regulatory recommendations and previous experimental safety studies. Acoustic and thermal specifications of different human eye tissues were obtained from the published literature. The tissues of particular interest in this modeling safety study were cornea, lens, and the location of optic nerve in the posterior eye. Ultrasound application was modeled at frequencies of 400 kHz–1 MHz, intensities of 0.3–1 W/cm 2 , and exposure duration of 5 min, which were the parameters used in the authors’ previous drug delivery experiments. The baseline eye temperature was 37 °C. Results: The authors’ results showed that the maximal tissue temperatures after 5 min of ultrasound application were 38, 39, 39.5, and 40 °C in the cornea, 39.5, 40, 42, and 43 °C in the center of the lens, and 37.5, 38.5, and 39 °C in the back of the eye (at the optic nerve location) at frequencies of 400, 600, 800 kHz, and 1 MHz, respectively. Conclusions: The ocular temperatures reached at higher frequencies were considered unsafe based on current recommendations. At a frequency of 400 kHz and intensity of 0.8 W/cm 2 (parameters shown in the authors’ previous in vivo studies to be optimal for ocular drug delivery), the temperature increase was small enough to be considered safe inside different ocular tissues. However, the impact of orbital bone and tissue perfusion should be included in future modeling efforts to determine the safety of this

  15. Thermal safety of ultrasound-enhanced ocular drug delivery: A modeling study

    Energy Technology Data Exchange (ETDEWEB)

    Nabili, Marjan, E-mail: mnabili@gwmail.gwu.edu [Department of Electrical and Computer Engineering, The George Washington University, 800 22nd Street NW, Room 5000, Washington, DC 20052 (United States); Geist, Craig, E-mail: cgeist@mfa.gwu.edu, E-mail: zderic@gwu.edu [Department of Ophthalmology, The George Washington University, 2150 Pennsylvania Avenue NW, Floor 2A, Washington, DC 20037 (United States); Zderic, Vesna, E-mail: cgeist@mfa.gwu.edu, E-mail: zderic@gwu.edu [Department of Biomedical Engineering, The George Washington University, 800 22nd Street NW, Room 6670, Washington, DC 20052 (United States)

    2015-10-15

    Purpose: Delivery of sufficient amounts of therapeutic drugs into the eye for treatment of various ocular diseases is often a challenging task. Ultrasound was shown to be effective in enhancing ocular drug delivery in the authors’ previous in vitro and in vivo studies. Methods: The study reported here was designed to investigate the safety of ultrasound application and its potential thermal effects in the eye using PZFlex modeling software. The safety limit in this study was set as a temperature increase of no more than 1.5 °C based on regulatory recommendations and previous experimental safety studies. Acoustic and thermal specifications of different human eye tissues were obtained from the published literature. The tissues of particular interest in this modeling safety study were cornea, lens, and the location of optic nerve in the posterior eye. Ultrasound application was modeled at frequencies of 400 kHz–1 MHz, intensities of 0.3–1 W/cm{sup 2}, and exposure duration of 5 min, which were the parameters used in the authors’ previous drug delivery experiments. The baseline eye temperature was 37 °C. Results: The authors’ results showed that the maximal tissue temperatures after 5 min of ultrasound application were 38, 39, 39.5, and 40 °C in the cornea, 39.5, 40, 42, and 43 °C in the center of the lens, and 37.5, 38.5, and 39 °C in the back of the eye (at the optic nerve location) at frequencies of 400, 600, 800 kHz, and 1 MHz, respectively. Conclusions: The ocular temperatures reached at higher frequencies were considered unsafe based on current recommendations. At a frequency of 400 kHz and intensity of 0.8 W/cm{sup 2} (parameters shown in the authors’ previous in vivo studies to be optimal for ocular drug delivery), the temperature increase was small enough to be considered safe inside different ocular tissues. However, the impact of orbital bone and tissue perfusion should be included in future modeling efforts to determine the safety

  16. Safety and effectiveness of drug therapy for the acutely agitated patient (Part 2

    Directory of Open Access Journals (Sweden)

    Gianluca Airoldi

    2013-04-01

    Full Text Available Acute agitation occurs in a variety of medical and psychiatric conditions, and the management of agitated, abusive, or violent patients is a common problem in the emergency department. Rapid control of potentially dangerous behaviors by physical restraint and pharmacologic tranquillization is crucial to ensure the safety of the patient and health-care personnel and to allow diagnostic procedures and treatment of the underlying condition. The purpose of this article (the second in a 2-part series is to review published data on the efficacy and safety of antipsychotic medications currently available for managing situations of this type. Arrhythmias caused by QT-prolonging drugs occur infrequently, and multiple factors are often involved, including concomitant use of other drugs affecting the same pathway (most antipsychotic drugs prolong the QT interval by blocking potassium IKr current in HERG channels of myocardial cells, electrolyte disorders and, possibly, genetic predisposition. Judicious use of typical antipsychotics (mainly haloperidol and benzodiazepines (mainly lorazepam, given intramuscularly alone or in combination, has proved to be safe and effective for controlling acute motor agitation related to psychiatric illness; cocaine, methamphetamine, and ethanol toxicity; ethanol withdrawal; and other factors. They are still widely used and are particularly useful when limited data are available on the patient’s history of cardiovascular disease, current use of medication, and/or the likelihood of illicit drug or alcohol intoxication; when the diagnosis involves medical comorbidity or intoxication; or when there is no specific treatment (e.g., personality disorders, learning disabilities, mental retardation, organic brain damage. If rapid tranquillization is necessary before a formal diagnosis can be made and there are uncertainties regarding the patient’s medical history, lorazepam is often considered the first-line drug of choice. In

  17. Challenges and strategies to facilitate formulation development of pediatric drug products: Safety qualification of excipients.

    Science.gov (United States)

    Buckley, Lorrene A; Salunke, Smita; Thompson, Karen; Baer, Gerri; Fegley, Darren; Turner, Mark A

    2018-02-05

    A public workshop entitled "Challenges and strategies to facilitate formulation development of pediatric drug products" focused on current status and gaps as well as recommendations for risk-based strategies to support the development of pediatric age-appropriate drug products. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary, panel, and case-study breakout sessions. By enabling practical and meaningful discussion between scientists representing the diversity of involved disciplines (formulators, nonclinical scientists, clinicians, and regulators) and geographies (eg, US, EU), the Excipients Safety workshop session was successful in providing specific and key recommendations for defining paths forward. Leveraging orthogonal sources of data (eg. food industry, agro science), collaborative data sharing, and increased awareness of the existing sources such as the Safety and Toxicity of Excipients for Paediatrics (STEP) database will be important to address the gap in excipients knowledge needed for risk assessment. The importance of defining risk-based approaches to safety assessments for excipients vital to pediatric formulations was emphasized, as was the need for meaningful stakeholder (eg, patient, caregiver) engagement. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. Zero-inflated Poisson model based likelihood ratio test for drug safety signal detection.

    Science.gov (United States)

    Huang, Lan; Zheng, Dan; Zalkikar, Jyoti; Tiwari, Ram

    2017-02-01

    In recent decades, numerous methods have been developed for data mining of large drug safety databases, such as Food and Drug Administration's (FDA's) Adverse Event Reporting System, where data matrices are formed by drugs such as columns and adverse events as rows. Often, a large number of cells in these data matrices have zero cell counts and some of them are "true zeros" indicating that the drug-adverse event pairs cannot occur, and these zero counts are distinguished from the other zero counts that are modeled zero counts and simply indicate that the drug-adverse event pairs have not occurred yet or have not been reported yet. In this paper, a zero-inflated Poisson model based likelihood ratio test method is proposed to identify drug-adverse event pairs that have disproportionately high reporting rates, which are also called signals. The maximum likelihood estimates of the model parameters of zero-inflated Poisson model based likelihood ratio test are obtained using the expectation and maximization algorithm. The zero-inflated Poisson model based likelihood ratio test is also modified to handle the stratified analyses for binary and categorical covariates (e.g. gender and age) in the data. The proposed zero-inflated Poisson model based likelihood ratio test method is shown to asymptotically control the type I error and false discovery rate, and its finite sample performance for signal detection is evaluated through a simulation study. The simulation results show that the zero-inflated Poisson model based likelihood ratio test method performs similar to Poisson model based likelihood ratio test method when the estimated percentage of true zeros in the database is small. Both the zero-inflated Poisson model based likelihood ratio test and likelihood ratio test methods are applied to six selected drugs, from the 2006 to 2011 Adverse Event Reporting System database, with varying percentages of observed zero-count cells.

  19. Complicating factors in safety testing of drug metabolites: Kinetic differences between generated and preformed metabolites

    International Nuclear Information System (INIS)

    Prueksaritanont, Thomayant; Lin, Jiunn H.; Baillie, Thomas A.

    2006-01-01

    This paper aims to provide a scientifically based perspective on issues surrounding the proposed toxicology testing of synthetic drug metabolites as a means of ensuring adequate nonclinical safety evaluation of drug candidates that generate metabolites considered either to be unique to humans or are present at much higher levels in humans than in preclinical species. We put forward a number of theoretical considerations and present several specific examples where the kinetic behavior of a preformed metabolite given to animals or humans differs from that of the corresponding metabolite generated endogenously from its parent. The potential ramifications of this phenomenon are that the results of toxicity testing of the preformed metabolite may be misleading and fail to characterize the true toxicological contribution of the metabolite when formed from the parent. It is anticipated that such complications would be evident in situations where (a) differences exist in the accumulation of the preformed versus generated metabolites in specific tissues, and (b) the metabolite undergoes sequential metabolism to a downstream product that is toxic, leading to differences in tissue-specific toxicity. Owing to the complex nature of this subject, there is a need to treat drug metabolite issues in safety assessment on a case-by-case basis, in which a knowledge of metabolite kinetics is employed to validate experimental paradigms that entail administration of preformed metabolites to animal models

  20. Exploiting heterogeneous publicly available data sources for drug safety surveillance: computational framework and case studies.

    Science.gov (United States)

    Koutkias, Vassilis G; Lillo-Le Louët, Agnès; Jaulent, Marie-Christine

    2017-02-01

    Driven by the need of pharmacovigilance centres and companies to routinely collect and review all available data about adverse drug reactions (ADRs) and adverse events of interest, we introduce and validate a computational framework exploiting dominant as well as emerging publicly available data sources for drug safety surveillance. Our approach relies on appropriate query formulation for data acquisition and subsequent filtering, transformation and joint visualization of the obtained data. We acquired data from the FDA Adverse Event Reporting System (FAERS), PubMed and Twitter. In order to assess the validity and the robustness of the approach, we elaborated on two important case studies, namely, clozapine-induced cardiomyopathy/myocarditis versus haloperidol-induced cardiomyopathy/myocarditis, and apixaban-induced cerebral hemorrhage. The analysis of the obtained data provided interesting insights (identification of potential patient and health-care professional experiences regarding ADRs in Twitter, information/arguments against an ADR existence across all sources), while illustrating the benefits (complementing data from multiple sources to strengthen/confirm evidence) and the underlying challenges (selecting search terms, data presentation) of exploiting heterogeneous information sources, thereby advocating the need for the proposed framework. This work contributes in establishing a continuous learning system for drug safety surveillance by exploiting heterogeneous publicly available data sources via appropriate support tools.

  1. On the Issue of Regional Policy in the Sphere of Ecological Safety (Based on the Documents Concerning the Republic of Kalmykia

    Directory of Open Access Journals (Sweden)

    Elza I. Mantaeva

    2018-03-01

    Full Text Available The regional government should provide ecological safety in order to ensure stable social and economic development of the country. The article outlines theoretical approach and recommendations on practice concerning ecological issues, investigates state policy aiming to preserve nature and analyses sources of threat to ecological safety in the region. The modern paradigm of the country’s and region’s development is characterized by the combination of ecological and economic policy. The ecological policy providing measures for efficient use of natural resources, their protection and restoration is implemented in the economic strategy of highly developed countries and encourages stable social and economic development of the country and the region. Some researchers assert that Russia’s most regions do not possess sufficient resources necessary to implement structural shifts which can eliminate the main threats to ecological safety. The Republic of Kalmykia can be included into this list. It is rich in natural resources but they are not restored due to the lack of regulation for efficient consumption. The main concerns of the republic are water supply, desertification, and pollution of atmosphere, waste disposal, and protection of wildlife and environment, preservation of hunting ground, forest management. The republic generates no electricity so it is delivered by neighboring regions. The republic should use the renewable ways of producing energy which can contribute to the energy and ecological safety and can attract new investment funds. There is an urgent need for stricter state regulation to ensure socioeconomic development and ecological safety in Kalmykia.

  2. Safety assessment of an anti-obesity drug (sibutramine): a retrospective cohort study.

    Science.gov (United States)

    Tyczynski, Jerzy E; Oleske, Denise M; Klingman, David; Ferrufino, Cheryl P; Lee, Won Chan

    2012-08-01

    the UK [Germany: HR 0.47 (95% CI 0.17, 1.26), 0.43 (0.23, 0.81) and 0.44 (0.26, 0.75), respectively; UK: HR 0.44 (0.15, 1.31), 0.63 (0.25, 1.60) and 0.54 (0.27, 1.10), respectively]. Regardless of whether or not the model controlled for prior CV disease (CVD), the direction and statistical significance of the differences did not change. In the sensitivity analyses including only those without a history of CVD in the 365 days prior to the index date there was no increased risk of CV events in either Germany or the UK. This study offers a framework for the safety assessment of anti-obesity drugs using an observational epidemiological study design. Large electronic health databases were used to construct retrospective cohorts to examine the risk in a population using one specific anti-obesity drug. Use of sibutramine in general practice settings was not found to increase the risk of acute CV events.

  3. Projecting future drug expenditures--2009.

    Science.gov (United States)

    Hoffman, James M; Shah, Nilay D; Vermeulen, Lee C; Doloresco, Fred; Martin, Patrick K; Blake, Sharon; Matusiak, Linda; Hunkler, Robert J; Schumock, Glen T

    2009-02-01

    Drug expenditure trends in 2007 and 2008, projected drug expenditures for 2009, and factors likely to influence drug expenditures are discussed. Various factors are likely to influence drug expenditures in 2009, including drugs in development, the diffusion of new drugs, drug safety concerns, generic drugs, Medicare Part D, and changes in the drug supply chain. The increasing availability of important generic drugs and drug safety concerns continue to moderate growth in drug expenditures. The drug supply chain remains dynamic and may influence drug expenditures, particularly in specialized therapeutic areas. Initial data suggest that the Medicare Part D benefit has influenced drug expenditures, but the ultimate impact of the benefit on drug expenditures remains unclear. From 2006 to 2007, total U.S. drug expenditures increased by 4.0%, with total spending rising from $276 billion to $287 billion. Drug expenditures in clinics continue to grow more rapidly than in other settings, with a 9.9% increase from 2006 to 2007. Hospital drug expenditures increased at a moderate rate of only 1.6% from 2006 to 2007; through the first nine months of 2008, hospital drug expenditures increased by only 2.8% compared with the same period in 2007. In 2009, we project a 0-2% increase in drug expenditures in outpatient settings, a 1-3% increase in expenditures for clinic-administered drugs, and a 1-3% increase in hospital drug expenditures.

  4. Proposition of resolution tending to create an inquiry commission concerning the safety conditions of the radiotherapy practices

    International Nuclear Information System (INIS)

    2007-10-01

    Towards the number of radiotherapy acts made every year and the increase of the number of the revealed accidents, it is absolutely indispensable to have an feedback experience and an assessment of the existing means today to control the radioprotection. This work has to allow to give propositions to improve the radiotherapy quality and safety, and provide the patients safety before, during and after the ionizing radiation exposure. (N.C.)

  5. Drug development in neuropsychopharmacology.

    Science.gov (United States)

    Fritze, Jürgen

    2008-03-01

    Personalized medicine is still in its infancy concerning drug development in neuropsychopharmacology. Adequate biomarkers with clinical relevance to drug response and/or tolerability and safety largely remain to be identified. Possibly, this kind of personalized medicine will first gain clinical relevance in the dementias. The clinical relevance of the genotyping of drug-metabolizing enzymes as suggested by drug licensing authorities for the pharmacokinetic evaluation of medicinal products needs to be proven in sound clinical trials.

  6. Long-Term Safety of Drug-Eluting and Bare-Metal Stents

    DEFF Research Database (Denmark)

    Palmerini, Tullio; Benedetto, Umberto; Biondi-Zoccai, Giuseppe

    2015-01-01

    BACKGROUND: Previous meta-analyses have investigated the relative safety and efficacy profiles of different types of drug-eluting stents (DES) and bare-metal stents (BMS); however, most prior trials in these meta-analyses reported follow-up to only 1 year, and as such, the relative long-term safety....... RESULTS: Fifty-one trials that included a total of 52,158 randomized patients with follow-up duration ≥3 years were analyzed. At a median follow-up of 3.8 years, cobalt-chromium everolimus-eluting stents (EES) were associated with lower rates of mortality, definite stent thrombosis (ST), and myocardial...... infarction than BMS, paclitaxel-eluting stents (PES), and sirolimus-eluting stents (SES) and less ST than BES. Phosphorylcholine-based zotarolimus-eluting stents had lower rates of definite ST than SES and lower rates of myocardial infarction than BMS and PES. The late rates of target...

  7. Mathematical calculation skills required for drug administration in undergraduate nursing students to ensure patient safety: A descriptive study: Drug calculation skills in nursing students.

    Science.gov (United States)

    Bagnasco, Annamaria; Galaverna, Lucia; Aleo, Giuseppe; Grugnetti, Anna Maria; Rosa, Francesca; Sasso, Loredana

    2016-01-01

    In the literature we found many studies that confirmed our concerns about nursing students' poor maths skills that directly impact on their ability to correctly calculate drug dosages with very serious consequences for patient safety. The aim of our study was to explore where students had most difficulty and identify appropriate educational interventions to bridge their mathematical knowledge gaps. This was a quali-quantitative descriptive study that included a sample of 726 undergraduate nursing students. We identified exactly where students had most difficulty and identified appropriate educational interventions to bridge their mathematical knowledge gaps. We found that the undergraduate nursing students mainly had difficulty with basic maths principles. Specific learning interventions are needed to improve their basic maths skills and their dosage calculation skills. For this purpose, we identified safeMedicate and eDose (Authentic World Ltd.), only that they are only available in English. In the near future we hope to set up a partnership to work together on the Italian version of these tools. Copyright © 2015 Elsevier Ltd. All rights reserved.

  8. Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China.

    Science.gov (United States)

    Yang, Yu; Zhou, Xiaofeng; Gao, Shuangqing; Lin, Hongbo; Xie, Yanming; Feng, Yuji; Huang, Kui; Zhan, Siyan

    2018-01-01

    Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. Three major types of EHDs in China (i.e., a regional community-based database, a national claims database, and an electronic medical records [EMR] database) were selected for evaluation. Forty core variables were derived based on the US Mini-Sentinel (MS) Common Data Model (CDM) as well as the data features in China that would be desirable to support drug safety surveillance. An email survey of these core variables and eight general questions as well as follow-up inquiries on additional variables was conducted. These 40 core variables across the three EHDs and all variables in each EHD along with those in the US MS CDM and Observational Medical Outcomes Partnership (OMOP) CDM were compared for availability and labeled based on specific standards. All of the EHDs' custodians confirmed their willingness to share their databases with academic institutions after appropriate approval was obtained. The regional community-based database contained 1.19 million people in 2015 with 85% of core variables. Resampled annually nationwide, the national claims database included 5.4 million people in 2014 with 55% of core variables, and the EMR database included 3 million inpatients from 60 hospitals in 2015 with 80% of core variables. Compared with MS CDM or OMOP CDM, the proportion of variables across the three EHDs available or able to be transformed/derived from the original sources are 24-83% or 45-73%, respectively. These EHDs provide potential value to post-marketing drug safety surveillance and pharmacoepidemiology in China. Future research is warranted to assess the quality and completeness of these EHDs or additional data sources in China.

  9. Protocol between the Nuclear Protection and Safety Bureau of Portugal and the Nuclear Energy Commission of Spain on Technical Information concerning Nuclear Installations in Border Areas

    International Nuclear Information System (INIS)

    1980-01-01

    This Protocol was concluded under the Agreement of the same date on the safety of nuclear installations in border areas. Its purpose is to prescribe the type of information referred to in the Agreement. It lays down in detail all the documents to be supplied concerning the siting, construction, operation and decommissioning of nuclear installations, including the geological, seismological, meteorological, hydrological and ecological aspects of the sites concerned, for purposes of environmental protection; the characteristics of the projected installations and emergency plans must also be provided. Similarly to the Agreement, this Protocol will remain in force for a period of ten years. (NEA) [fr

  10. Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis.

    Science.gov (United States)

    Trelle, Sven; Reichenbach, Stephan; Wandel, Simon; Hildebrand, Pius; Tschannen, Beatrice; Villiger, Peter M; Egger, Matthias; Jüni, Peter

    2011-01-11

    To analyse the available evidence on cardiovascular safety of non-steroidal anti-inflammatory drugs. Network meta-analysis. Bibliographic databases, conference proceedings, study registers, the Food and Drug Administration website, reference lists of relevant articles, and reports citing relevant articles through the Science Citation Index (last update July 2009). Manufacturers of celecoxib and lumiracoxib provided additional data. All large scale randomised controlled trials comparing any non-steroidal anti-inflammatory drug with other non-steroidal anti-inflammatory drugs or placebo. Two investigators independently assessed eligibility. The primary outcome was myocardial infarction. Secondary outcomes included stroke, death from cardiovascular disease, and death from any cause. Two investigators independently extracted data. 31 trials in 116 429 patients with more than 115 000 patient years of follow-up were included. Patients were allocated to naproxen, ibuprofen, diclofenac, celecoxib, etoricoxib, rofecoxib, lumiracoxib, or placebo. Compared with placebo, rofecoxib was associated with the highest risk of myocardial infarction (rate ratio 2.12, 95% credibility interval 1.26 to 3.56), followed by lumiracoxib (2.00, 0.71 to 6.21). Ibuprofen was associated with the highest risk of stroke (3.36, 1.00 to 11.6), followed by diclofenac (2.86, 1.09 to 8.36). Etoricoxib (4.07, 1.23 to 15.7) and diclofenac (3.98, 1.48 to 12.7) were associated with the highest risk of cardiovascular death. Although uncertainty remains, little evidence exists to suggest that any of the investigated drugs are safe in cardiovascular terms. Naproxen seemed least harmful. Cardiovascular risk needs to be taken into account when prescribing any non-steroidal anti-inflammatory drug.

  11. Ethical considerations and proposed guidelines for the use of radio frequency identification: especially concerning its use for promoting public safety and national security.

    Science.gov (United States)

    Anderson, Amber McKee; Labay, Vladimir

    2006-04-01

    Radio Frequency Identification (RFID) is quickly growing in its applications. A variety of uses for the technology are beginning to be developed, including chips which can be used in identification cards, in individual items, and for human applications, allowing a chip to be embedded under the skin. Such chips could provide numerous benefits ranging from day-to-day convenience to the increased ability of the federal government to adequately ensure the safety of its citizens. However, there are also valid concerns about the potential of this technology to infringe on privacy, creating fears of a surveillance society. These are concerns that must be addressed quickly, with sensitivity to individual interests and societal welfare, allowing humanity to reap the benefits of convenience and safety without paying an unacceptable price in the loss of privacy.

  12. Brief report: Associations between in-person and electronic bullying victimization and missing school because of safety concerns among U.S. high school students.

    Science.gov (United States)

    Steiner, Riley J; Rasberry, Catherine N

    2015-08-01

    Although associations between bullying and health risk behaviors are well-documented, research on bullying and education-related outcomes, including school attendance, is limited. This study examines associations between bullying victimization (in-person and electronic) and missing school because of safety concerns among a nationally representative sample of U.S. high school students. We used logistic regression analyses to analyze data from the 2013 national Youth Risk Behavior Survey of students in grades 9-12. In-person and electronic victimization were each associated with increased odds of missing school due to safety concerns compared to no bullying victimization. Having been bullied both in-person and electronically was associated with greater odds of missing school compared to electronic bullying only for female students and in-person bullying only for male students. Collaborations between health professionals and educators to prevent bullying may improve school attendance. Published by Elsevier Ltd.

  13. Pharmacovigilance and drug safety in Calabria (Italy): 2012 adverse events analysis.

    Science.gov (United States)

    Giofrè, Chiara; Scicchitano, Francesca; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; Leporini, Christian; Ventrice, Pasquale; Carbone, Claudia; Saullo, Francesca; Rende, Pierandrea; Menniti, Michele; Mumoli, Laura; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

    2013-12-01

    Pharmacovigilance (PV) is designed to monitor drugs continuously after their commercialization, assessing and improving their safety profile. The main objective is to increase the spontaneous reporting of adverse drug reactions (ADRs), in order to have a wide variety of information. The Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) is financing several projects to increase reporting. In Calabria, a PV information center has been created in 2010. We obtained data using the database of the National Health Information System AIFA relatively to Italy and Calabria in the year 2012. Descriptive statistics were performed to analyze the ADRs. A total number of 461 ADRs have been reported in the year 2012 with an increase of 234% compared with 2011 (138 reports). Hospital doctors are the main source of this reporting (51.62%). Sorafenib (Nexavar(®)), the combination of amoxicillin/clavulanic acid and ketoprofen represent the drugs most frequently reported causing adverse reactions. Adverse events in female patients (61.83%) were more frequently reported, whereas the age groups "41-65" (39.07%) and "over 65" (27.9%) were the most affected. Calabria has had a positive increase in the number of ADRs reported, although it has not yet reached the gold standard set by World Health Organization (about 600 reports), the data have shown that PV culture is making inroads in this region and that PV projects stimulating and increasing PV knowledge are needed.

  14. Pharmacovigilance and drug safety 2011 in Calabria (Italy: Adverse events analysis

    Directory of Open Access Journals (Sweden)

    Francesca Scicchitano

    2012-01-01

    Full Text Available Background : Pharmacovigilance assesses the safety profile of drugs. Its main aim is the increase of spontaneous reporting of adverse drug reactions (ADRs. The Italian Drug Agency (AIFA; Agenzia Italiana del Farmaco is financing several projects to the aim of increasing reporting, and in Calabria a Pharmacovigilance Information Centre has been created. Materials and Methods: We analyzed the AIFA database relatively to Calabria in the year 2011 and we have analyzed ADRs using descriptive statistics. We have also collected a questionnaire-based interview in order to describe the background knowledge in the field. Results : Regarding the number of AIFA reported ADRs from Calabria, a 38% increase (138 vs. 100 in comparison to 2010 was evidenced. Hospital Doctors represent the main source of signaling (71.7 %. Ketoprofene and the combination amoxicillin/clavulanic acid represent the most frequently reported drugs causing ADRs. Our questionnaires indicated that despite the health professionals have met at least once an ADR only a small percentage of them was reported to the authorities (37%. There is a very good knowledge of the ADR concept and reporting system (90% of interviewed distinguish an ADR and knows how to report it, and there is a strong interest in participating to training courses in the field (95% are interested. Conclusions : Despite Calabria has had a positive increase in the number of reported ADRs, the total number is very low and the pharmacovigilance culture is far from being achieved in this region.

  15. Pharmacovigilance and drug safety 2011 in Calabria (Italy): Adverse events analysis.

    Science.gov (United States)

    Scicchitano, Francesca; Giofrè, Chiara; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; De Fazio, Salvatore; Menniti, Michele; Curia, Rubens; Arena, Concetta; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

    2012-09-01

    Pharmacovigilance assesses the safety profile of drugs. Its main aim is the increase of spontaneous reporting of adverse drug reactions (ADRs). The Italian Drug Agency (AIFA; Agenzia Italiana del Farmaco) is financing several projects to the aim of increasing reporting, and in Calabria a Pharmacovigilance Information Centre has been created. We analyzed the AIFA database relatively to Calabria in the year 2011 and we have analyzed ADRs using descriptive statistics. We have also collected a questionnaire-based interview in order to describe the background knowledge in the field. Regarding the number of AIFA reported ADRs from Calabria, a 38% increase (138 vs. 100) in comparison to 2010 was evidenced. Hospital Doctors represent the main source of signaling (71.7 %). Ketoprofene and the combination amoxicillin/clavulanic acid represent the most frequently reported drugs causing ADRs. Our questionnaires indicated that despite the health professionals have met at least once an ADR only a small percentage of them was reported to the authorities (37%). There is a very good knowledge of the ADR concept and reporting system (90% of interviewed distinguish an ADR and knows how to report it), and there is a strong interest in participating to training courses in the field (95% are interested). Despite Calabria has had a positive increase in the number of reported ADRs, the total number is very low and the pharmacovigilance culture is far from being achieved in this region.

  16. A rural/urban comparison of privacy and confidentiality concerns associated with providing sensitive location information in epidemiologic research involving persons who use drugs.

    Science.gov (United States)

    Rudolph, Abby E; Young, April M; Havens, Jennifer R

    2017-11-01

    Analyses that link contextual factors with individual-level data can improve our understanding of the "risk environment"; however, the accuracy of information provided by participants about locations where illegal/stigmatized behaviors occur may be influenced by privacy/confidentiality concerns that may vary by setting and/or data collection approach. We recruited thirty-five persons who use drugs from a rural Appalachian town and a Mid-Atlantic city to participate in in-depth interviews. Through thematic analyses, we identified and compared privacy/confidentiality concerns associated with two survey methods that (1) collect self-reported addresses/cross-streets and (2) use an interactive web-based map to find/confirm locations in rural and urban settings. Concerns differed more by setting than between methods. For example, (1) rural participants valued interviewer rapport and protections provided by the Certificate of Confidentiality more; (2) locations considered to be sensitive differed in rural (i.e., others' homes) and urban (i.e., where drugs were used) settings; and (3) urban participants were more likely to view providing cross-streets as an acceptable alternative to providing exact addresses for sensitive locations and to prefer the web-based map approach. Rural-urban differences in privacy/confidentiality concerns reflect contextual differences (i.e., where drugs are used/purchased, population density, and prior drug-related arrests). Strategies to alleviate concerns include: (1) obtain a Certificate of Confidentiality, (2) collect geographic data at the scale necessary for proposed analyses, and (3) permit participants to provide intersections/landmarks in close proximity to actual locations rather than exact addresses or to skip questions where providing an intersection/landmark would not obfuscate the actual address. Copyright © 2017 Elsevier Ltd. All rights reserved.

  17. Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data.

    Science.gov (United States)

    Silva, Ivair R

    2018-01-15

    Type I error probability spending functions are commonly used for designing sequential analysis of binomial data in clinical trials, but it is also quickly emerging for near-continuous sequential analysis of post-market drug and vaccine safety surveillance. It is well known that, for clinical trials, when the null hypothesis is not rejected, it is still important to minimize the sample size. Unlike in post-market drug and vaccine safety surveillance, that is not important. In post-market safety surveillance, specially when the surveillance involves identification of potential signals, the meaningful statistical performance measure to be minimized is the expected sample size when the null hypothesis is rejected. The present paper shows that, instead of the convex Type I error spending shape conventionally used in clinical trials, a concave shape is more indicated for post-market drug and vaccine safety surveillance. This is shown for both, continuous and group sequential analysis. Copyright © 2017 John Wiley & Sons, Ltd.

  18. Pharmacokinetics in Drug Discovery: An Exposure-Centred Approach to Optimising and Predicting Drug Efficacy and Safety.

    Science.gov (United States)

    Reichel, Andreas; Lienau, Philip

    2016-01-01

    The role of pharmacokinetics (PK) in drug discovery is to support the optimisation of the absorption, distribution, metabolism and excretion (ADME) properties of lead compounds with the ultimate goal to attain a clinical candidate which achieves a concentration-time profile in the body that is adequate for the desired efficacy and safety profile. A thorough characterisation of the lead compounds aiming at the identification of the inherent PK liabilities also includes an early generation of PK/PD relationships linking in vitro potency and target exposure/engagement with expression of pharmacological activity (mode-of-action) and efficacy in animal studies. The chapter describes an exposure-centred approach to lead generation, lead optimisation and candidate selection and profiling that focuses on a stepwise generation of an understanding between PK/exposure and PD/efficacy relationships by capturing target exposure or surrogates thereof and cellular mode-of-action readouts in vivo. Once robust PK/PD relationship in animal PD models has been constructed, it is translated to anticipate the pharmacologically active plasma concentrations in patients and the human therapeutic dose and dosing schedule which is also based on the prediction of the PK behaviour in human as described herein. The chapter outlines how the level of confidence in the predictions increases with the level of understanding of both the PK and the PK/PD of the new chemical entities (NCE) in relation to the disease hypothesis and the ability to propose safe and efficacious doses and dosing schedules in responsive patient populations. A sound identification of potential drug metabolism and pharmacokinetics (DMPK)-related development risks allows proposing of an effective de-risking strategy for the progression of the project that is able to reduce uncertainties and to increase the probability of success during preclinical and clinical development.

  19. The programme of the Minister of the Interior for technical regulations concerning the safety of nuclear facilities

    International Nuclear Information System (INIS)

    Berg, K.H.

    1977-01-01

    The BMI is responsible for the Atomic Energy Act being implemented. A survey is presented of the BMI's programme for setting up technical safety regulations (bar the KTA) according to the following categories: the structure of objects (hardware); the functions of machinery and human behaviour (software); know-how, abilities, responsibility of humans (live-ware); environment. (HP) [de

  20. Nonclinical safety biomarkers of drug-induced vascular injury: current status and blueprint for the future.

    Science.gov (United States)

    Mikaelian, Igor; Cameron, Mark; Dalmas, Deidre A; Enerson, Bradley E; Gonzalez, Raymond J; Guionaud, Silvia; Hoffmann, Peter K; King, Nicholas M P; Lawton, Michael P; Scicchitano, Marshall S; Smith, Holly W; Thomas, Roberta A; Weaver, James L; Zabka, Tanja S

    2014-06-01

    Better biomarkers are needed to identify, characterize, and/or monitor drug-induced vascular injury (DIVI) in nonclinical species and patients. The Predictive Safety Testing Consortium (PSTC), a precompetitive collaboration of pharmaceutical companies and the U.S. Food and Drug Administration (FDA), formed the Vascular Injury Working Group (VIWG) to develop and qualify translatable biomarkers of DIVI. The VIWG focused its research on acute DIVI because early detection for clinical and nonclinical safety monitoring is desirable. The VIWG developed a strategy based on the premise that biomarkers of DIVI in rat would be translatable to humans due to the morphologic similarity of vascular injury between species regardless of mechanism. The histomorphologic lexicon for DIVI in rat defines degenerative and adaptive findings of the vascular endothelium and smooth muscles, and characterizes inflammatory components. We describe the mechanisms of these changes and their associations with candidate biomarkers for which advanced analytical method validation was completed. Further development is recommended for circulating microRNAs, endothelial microparticles, and imaging techniques. Recommendations for sample collection and processing, analytical methods, and confirmation of target localization using immunohistochemistry and in situ hybridization are described. The methods described are anticipated to aid in the identification and qualification of translational biomarkers for DIVI. © 2014 by The Author(s).

  1. Impact of regulatory guidances and drug regulation on risk minimization interventions in drug safety: a systematic review.

    Science.gov (United States)

    Nkeng, Lenhangmbong; Cloutier, Anne-Marie; Craig, Camille; Lelorier, Jacques; Moride, Yola

    2012-07-01

    Therapeutic risk management has received growing interest in recent years, particularly since the publication of regulatory guidances in 2005 and 2006, paralleled with a change in drug regulation. The characteristics of risk minimization interventions (RMIs) that have been implemented or approved remain inadequately explored. The aim of this study was to review RMIs published in the literature or posted on regulatory agency websites over the past 10 years, and to assess whether publication of regulatory guidances on risk management is associated with changes in the number and types of interventions. Sources were searched for RMIs published/posted between 1 January 2000 and 31 December 2009. For the literature search, MEDLINE and EMBASE databases were used using key words related to drug safety (i.e. 'drug toxicity') and the individual RMI names. The website review involved searches of major regulatory authority websites such as the European Medicines Agency, US FDA, Health Canada, the UK's Medicines and Healthcare products Regulatory Agency, Japan's Pharmaceutical and Medical Devices Agency and Australia's Therapeutic Goods Administration. The following eligibility criteria were applied for inclusion in the review: published/posted between the years 2000 and 2009, inclusive; involving drug products; use in humans; and involving RMIs, or tools used to increase the reporting of adverse events (AEs). Natural healthcare products, devices, diagnostic chemicals, pregnancy registries without follow-up, medication errors and products not used as therapy for illness were not retained. For each source, the following characteristics were extracted: nature of the intervention, target population, therapeutic area, AE(s) of special interest, country/regulatory agency and year of publication. A total of 119 unique interventions were identified in the literature (54 published in 2000-4 and 65 published in 2005-9). Interventions included educational material (n = 37; 31%), black

  2. An Op-Ed concerning steroids and the law: how the Internet has changed illegal drug trade and its prosecution.

    Science.gov (United States)

    Adams, Jill U

    2010-06-01

    Athletes take anabolic steroids to increase strength, build muscle, and improve performance, even though the practice is banned by many athletic organizations and can cause serious adverse effects. State and federal laws regulate the sale and distribution of anabolic steroids to restrict their use, and yet, the Internet has become a world-flattening promoter of easy access to the drugs. While scientists continue to study the potential therapeutic and toxic effects of steroid drugs, prosecutors endeavor to uphold the laws in the slippery online environment. Here's the story of Albany County District Attorney's Office efforts to prosecute illegal online drug sales in 2000s. The discoveries of prosecutors and scientists alike should help inform policy makers of how best to manage the problem that anabolic steroids present to society. Copyright 2010 Elsevier Inc. All rights reserved.

  3. Addressing conflicts of interest in nanotechnology oversight: lessons learned from drug and pesticide safety testing

    Energy Technology Data Exchange (ETDEWEB)

    Elliott, Kevin C., E-mail: ke@sc.edu [University of South Carolina, Department of Philosophy, USC NanoCenter (United States); Volz, David C. [University of South Carolina, Department of Environmental Health Sciences, Arnold School of Public Health (United States)

    2012-01-15

    Financial conflicts of interest raise significant challenges for those working to develop an effective, transparent, and trustworthy oversight system for assessing and managing the potential human health and ecological hazards of nanotechnology. A recent paper in this journal by Ramachandran et al., J Nanopart Res, 13:1345-1371 (2011) proposed a two-pronged approach for addressing conflicts of interest: (1) developing standardized protocols and procedures to guide safety testing; and (2) vetting safety data under a coordinating agency. Based on past experiences with standardized test guidelines developed by the international Organization for Economic Cooperation and Development (OECD) and implemented by national regulatory agencies such as the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA), we argue that this approach still runs the risk of allowing conflicts of interest to influence toxicity tests, and it has the potential to commit regulatory agencies to outdated procedures. We suggest an alternative approach that further distances the design and interpretation of safety studies from those funding the research. In case the two-pronged approach is regarded as a more politically feasible solution, we also suggest three lessons for implementing this strategy in a more dynamic and effective manner.

  4. Addressing conflicts of interest in nanotechnology oversight: lessons learned from drug and pesticide safety testing

    International Nuclear Information System (INIS)

    Elliott, Kevin C.; Volz, David C.

    2012-01-01

    Financial conflicts of interest raise significant challenges for those working to develop an effective, transparent, and trustworthy oversight system for assessing and managing the potential human health and ecological hazards of nanotechnology. A recent paper in this journal by Ramachandran et al., J Nanopart Res, 13:1345–1371 (2011) proposed a two-pronged approach for addressing conflicts of interest: (1) developing standardized protocols and procedures to guide safety testing; and (2) vetting safety data under a coordinating agency. Based on past experiences with standardized test guidelines developed by the international Organization for Economic Cooperation and Development (OECD) and implemented by national regulatory agencies such as the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA), we argue that this approach still runs the risk of allowing conflicts of interest to influence toxicity tests, and it has the potential to commit regulatory agencies to outdated procedures. We suggest an alternative approach that further distances the design and interpretation of safety studies from those funding the research. In case the two-pronged approach is regarded as a more politically feasible solution, we also suggest three lessons for implementing this strategy in a more dynamic and effective manner.

  5. Preclinical safety and efficacy of a new recombinant FIX drug product for treatment of hemophilia B.

    Science.gov (United States)

    Dietrich, Barbara; Schiviz, Alexandra; Hoellriegl, Werner; Horling, Frank; Benamara, Karima; Rottensteiner, Hanspeter; Turecek, Peter L; Schwarz, Hans Peter; Scheiflinger, Friedrich; Muchitsch, Eva-Maria

    2013-11-01

    Baxter has developed a new recombinant factor IX (rFIX) drug product (BAX326) for treating patients with hemophilia B, or congenital FIX deficiency. An extensive preclinical program evaluated the pharmacokinetics, efficacy, and safety of BAX326 in different species. The efficacy of BAX326 was tested in three mouse models of primary pharmacodynamics: tail-tip bleeding, carotid occlusion, and thrombelastography. The pharmacokinetics was evaluated after a single intravenous bolus injection in mice, rats, and macaques. Toxicity was assessed in rats and macaques, safety pharmacology in rabbits and macaques, and immunogenicity in mice. BAX326 was shown to be efficacious in all three primary pharmacodynamic studies (P ≤ 0.0076). Hemostatic efficacy was dose related and similar for the three lots tested. Pharmacokinetic results showed that rFIX activity and rFIX antigen concentrations declined in a bi-phasic manner, similar to a previously licensed rFIX product. BAX326 was well tolerated in rabbits and macaques at all dose levels; no thrombogenic events and no adverse clinical, respiratory, or cardiovascular effects occurred. BAX326 was also shown to have a similar immunogenicity profile to the comparator rFIX product in mice. These results demonstrate that BAX326 has a favorable preclinical safety and efficacy profile, predictive of a comparable effect to that of the previously licensed rFIX in humans.

  6. Considerations for the nonclinical safety evaluation of antibody drug conjugates for oncology.

    Science.gov (United States)

    Roberts, Stanley A; Andrews, Paul A; Blanset, Diann; Flagella, Kelly M; Gorovits, Boris; Lynch, Carmel M; Martin, Pauline L; Kramer-Stickland, Kimberly; Thibault, Stephane; Warner, Garvin

    2013-12-01

    Antibody drug conjugates (ADCs) include monoclonal antibodies that are linked to cytotoxic small molecules. A number of these agents are currently being developed as anti-cancer agents designed to improve the therapeutic index of the cytotoxin (i.e., cytotoxic small molecule or cytotoxic agent) by specifically delivering it to tumor cells. This paper presents primary considerations for the nonclinical safety evaluation of ADCs and includes strategies for the evaluation of the entire ADC or the various individual components (i.e., antibody, linker or the cytotoxin). Considerations are presented on how to design a nonclinical safety assessment program to identify the on- and off-target toxicities to enable first-in-human (FIH) studies. Specific discussions are also included that provide details as to the need and how to conduct the studies for evaluating ADCs in genetic toxicology, tissue cross-reactivity, safety pharmacology, carcinogenicity, developmental and reproductive toxicology, biotransformation, toxicokinetic monitoring, bioanalytical assays, immunogenicity testing, test article stability and the selection of the FIH dose. Given the complexity of these molecules and our evolving understanding of their properties, there is no single all-encompassing nonclinical strategy. Instead, each ADC should be evaluated on a case-by-case scientifically-based approach that is consistent with ICH and animal research guidelines. Copyright © 2013 Elsevier Inc. All rights reserved.

  7. Addressing conflicts of interest in nanotechnology oversight: lessons learned from drug and pesticide safety testing

    Science.gov (United States)

    Elliott, Kevin C.; Volz, David C.

    2012-01-01

    Financial conflicts of interest raise significant challenges for those working to develop an effective, transparent, and trustworthy oversight system for assessing and managing the potential human health and ecological hazards of nanotechnology. A recent paper in this journal by Ramachandran et al., J Nanopart Res, 13:1345-1371 (2011) proposed a two-pronged approach for addressing conflicts of interest: (1) developing standardized protocols and procedures to guide safety testing; and (2) vetting safety data under a coordinating agency. Based on past experiences with standardized test guidelines developed by the international Organization for Economic Cooperation and Development (OECD) and implemented by national regulatory agencies such as the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA), we argue that this approach still runs the risk of allowing conflicts of interest to influence toxicity tests, and it has the potential to commit regulatory agencies to outdated procedures. We suggest an alternative approach that further distances the design and interpretation of safety studies from those funding the research. In case the two-pronged approach is regarded as a more politically feasible solution, we also suggest three lessons for implementing this strategy in a more dynamic and effective manner.

  8. A Decade in the MIST: Learnings from Investigations of Drug Metabolites in Drug Development under the "Metabolites in Safety Testing" Regulatory Guidance.

    Science.gov (United States)

    Schadt, Simone; Bister, Bojan; Chowdhury, Swapan K; Funk, Christoph; Hop, Cornelis E C A; Humphreys, W Griffith; Igarashi, Fumihiko; James, Alexander D; Kagan, Mark; Khojasteh, S Cyrus; Nedderman, Angus N R; Prakash, Chandra; Runge, Frank; Scheible, Holger; Spracklin, Douglas K; Swart, Piet; Tse, Susanna; Yuan, Josh; Obach, R Scott

    2018-06-01

    Since the introduction of metabolites in safety testing (MIST) guidance by the Food and Drug Administration in 2008, major changes have occurred in the experimental methods for the identification and quantification of metabolites, ways to evaluate coverage of metabolites, and the timing of critical clinical and nonclinical studies to generate this information. In this cross-industry review, we discuss how the increased focus on human drug metabolites and their potential contribution to safety and drug-drug interactions has influenced the approaches taken by industry for the identification and quantitation of human drug metabolites. Before the MIST guidance was issued, the method of choice for generating comprehensive metabolite profile was radio chromatography. The MIST guidance increased the focus on human drug metabolites and their potential contribution to safety and drug-drug interactions and led to changes in the practices of drug metabolism scientists. In addition, the guidance suggested that human metabolism studies should also be accelerated, which has led to more frequent determination of human metabolite profiles from multiple ascending-dose clinical studies. Generating a comprehensive and quantitative profile of human metabolites has become a more urgent task. Together with technological advances, these events have led to a general shift of focus toward earlier human metabolism studies using high-resolution mass spectrometry and to a reduction in animal radiolabel absorption/distribution/metabolism/excretion studies. The changes induced by the MIST guidance are highlighted by six case studies included herein, reflecting different stages of implementation of the MIST guidance within the pharmaceutical industry. Copyright © 2018 by The American Society for Pharmacology and Experimental Therapeutics.

  9. Safety of Therapeutic Fever Induction in Cancer Patients Using Approved PAMP Drugs

    Directory of Open Access Journals (Sweden)

    Uwe Rudolf Max Reuter

    2018-04-01

    Full Text Available William Coley, between 1895 and 1936, treated hundreds of cancer patients using infusions of fever inducing bacerial extracts. Similar experiments were done by Klyuyeva and co-workers in the 1940ies in Russia using trypanosoma extracts. Many remissions and cures were reported. We have conjectured that pathogen associated molecular pattern substances (PAMP are the molecular explanation for the beneficial treatments in both groups. We could show that a combination of PAMP can eradicate solid tumours in cancer mice if applied several times. Accordingly, we suggested to combine PAMP containing approved drugs to treat cancer patients using a protocol similar to the old fever induction regimen. In this retrospective phase-1 study we report on the fever induction capacity and safety of applications of bacterial extracts, combinations of bacterial extracts with approved drugs, and combinations of approved drugs in 131 mainly cancer patients. Adverse reactions were those which can be expected during a feverish infection and mild. Over 523 fever inductions, no severe adverse reaction was observed.

  10. A safety and tolerability study of differently-charged nanoparticles for local pulmonary drug delivery

    International Nuclear Information System (INIS)

    Harush-Frenkel, Oshrat; Bivas-Benita, Maytal; Nassar, Taher; Springer, Chaim; Sherman, Yoav; Avital, Avraham; Altschuler, Yoram; Borlak, Jurgen; Benita, Simon

    2010-01-01

    Nanoparticle (NP) based drug delivery systems provide promising opportunities in the treatment of lung diseases. Here we examined the safety and tolerability of pulmonary delivered NPs consisting of PEG-PLA as a function of particle surface charge. The rationale for such a comparison should be attributed to the differential pulmonary toxicity of positively and negatively charged PEG-PLA NP. Thus, the local and systemic effects of pulmonary administered NPs were investigated following 5 days of daily endotracheal instillation to BALB/c mice that were euthanized on the eighth or nineteenth day of the experiment. We collected bronchoalveolar lavages and studied hematological as well as histochemistry parameters. Notably, the cationic stearylamine based PEG-PLA NPs elicited increased local and systemic toxic effects both on the eighth and nineteenth day. In contrast, anionic NPs of similar size were much better tolerated with local inflammatory effects observed only on the eighth experimental day after pulmonary instillation. No systemic toxicity effect was observed although a moderate change was noted in the platelet count that was not considered to be of clinical significance. No pathological observations were detected in the internal organs following instillation of anionic NPs. Overall these observations suggest that anionic PEG-PLA NPs are useful pulmonary drug carriers that should be considered as a promising therapeutic drug delivery system.

  11. Early safety outcome following transcatheter aortic valve implantation: is the amount of contrast media used a matter of concern?

    Science.gov (United States)

    Vontobel, Jan; Possner, Mathias; Schütz, Philipp; Müller, Beat; Taramasso, Maurizio; Binder, Roland K; Haueis, Sabine; Attinger-Toller, Adrian; Maisano, Francesco; Nietlispach, Fabian

    2015-01-01

    The study objective was to evaluate the impact of the amount of contrast medium used for transcatheter aortic valve implantation (TAVI) on short-term outcome. Patients undergoing TAVI are exposed to repeat contrast medium application both for preprocedural screening and during the TAVI procedure itself. Whether the amount of contrast media is associated with worse outcome is unclear. A total of 257 patients were included (median age 82.7 years) and divided into two groups with preserved and reduced kidney function (glomerular filtration rate contrast media administered during and within 5 days prior to TAVI was analysed. A combined early safety endpoint at 30 days was evaluated. The early safety endpoint was reached by 31 patients and acute kidney injury occurred in 22 patients. The median total volume of contrast media administered was 144 ml (interquartile range 81-225 ml). The amount of contrast did not independently predict the early safety endpoint in the overall population (odds ratio [OR] 0.93, 95% confidence interval [CI] 0.56 to 1.53, p = 0.774) and in subgroups with preserved and reduced kidney function. Change in creatinine was an independent strong predictor of the early safety endpoint in the overall population (OR 18.13, 95% CI 4.70 to 69.99, p contrast did not predict a change in creatinine within 72 hours following TAVI (r = 0.02, 95% CI -0.02 to 0.07, p = 0.368). Decreased kidney function after TAVI influences outcome. When rather small amounts of contrast media are used for screening and the TAVI procedure itself, the amount of contrast media seems not to be an independent predictor of outcome, further suggesting that decreased kidney function after TAVI is multifactorial.

  12. A Model Proposal and Implementation Concerning Occupational Health and Safety within the Framework of World Class Manufacturing

    OpenAIRE

    GÜMÜŞOĞLU, Şevkinaz; TEPEKULE, Esin Tuba

    2017-01-01

    The approach, which aims atbecoming the best in every application and operation realizing every strategythat it has at a perfect level, has been referred to as World ClassManufacturing (WCM).  The synergic effectof WCM inherent in application and strategies will be helpful in takingbusinesses’ strength to the desired level in the current competitiveenvironment. For businesses in applications of Occupational Health and Safety(OHS) to perform at the top level will contribute to become the best,...

  13. RESPONSIBILITIES OF FOOD BUSINESS OPERATORS RELATED TO FOOD SAFETY: CONCERNS RELATED TO HACCP IN MICRO-BUSINESSES FOOD COMPANIES

    OpenAIRE

    T. Civera; D. Nucera; A. Bellio; M. Botosso; M. Mora; R. Goi; B. Griglio

    2012-01-01

    The research was aimed at collecting information on food safety knowledge by operators of small and less developed food businesses. This will allow to reveal what are the real drawbacks in HACCP application in these realities. Fifty meat producing plants located in Piedmont region were involved. In all the plants a questionnaire with questions on HACCP system was submitted. The analysis of the collected answers, evidenced that 42% of the operators needed to perform structural modifications in...

  14. Comparison of the safety information on drug labels in three developed countries: The USA, UK and Canada

    Directory of Open Access Journals (Sweden)

    Thamir M. Alshammari

    2017-12-01

    Full Text Available The safety information on drug labels of a company marketing the same drugs in different countries is sometimes different. The aim of the present study is to understand the differences in the volume and content of safety information on the drug labels from the same manufacturers in three developed countries: the United States of America (USA, the United Kingdom (UK and Canada. This study involved the calculation of the proportion of total safety information (PSI and of contraindications (PCI in comparison to all information on the label and the percentage of boxed warnings (PBW among the 100 labels studied from each country. The PSI on the labels of different countries is different with USA labels bearing lesser value PSI and UK labels bearing higher value PSI. The qualitative information provided on these drug labels from each country in ‘contraindications’ sections, ‘boxed/serious warnings’ and ‘overdosage’ sections presented differences in the information provided on most of the labels. We have found distinct differences between the safety information available on drug labels in terms of volume and content. We conclude that the safety information for the same products should be standardised across all countries.

  15. The impact of assay technology as applied to safety assessment in reducing compound attrition in drug discovery.

    Science.gov (United States)

    Thomas, Craig E; Will, Yvonne

    2012-02-01

    Attrition in the drug industry due to safety findings remains high and requires a shift in the current safety testing paradigm. Many companies are now positioning safety assessment at each stage of the drug development process, including discovery, where an early perspective on potential safety issues is sought, often at chemical scaffold level, using a variety of emerging technologies. Given the lengthy development time frames of drugs in the pharmaceutical industry, the authors believe that the impact of new technologies on attrition is best measured as a function of the quality and timeliness of candidate compounds entering development. The authors provide an overview of in silico and in vitro models, as well as more complex approaches such as 'omics,' and where they are best positioned within the drug discovery process. It is important to take away that not all technologies should be applied to all projects. Technologies vary widely in their validation state, throughput and cost. A thoughtful combination of validated and emerging technologies is crucial in identifying the most promising candidates to move to proof-of-concept testing in humans. In spite of the challenges inherent in applying new technologies to drug discovery, the successes and recognition that we cannot continue to rely on safety assessment practices used for decades have led to rather dramatic strategy shifts and fostered partnerships across government agencies and industry. We are optimistic that these efforts will ultimately benefit patients by delivering effective and safe medications in a timely fashion.

  16. The principle of safety evaluation in medicinal drug - how can toxicology contribute to drug discovery and development as a multidisciplinary science?

    Science.gov (United States)

    Horii, Ikuo

    2016-01-01

    Pharmaceutical (drug) safety assessment covers a diverse science-field in the drug discovery and development including the post-approval and post-marketing phases in order to evaluate safety and risk management. The principle in toxicological science is to be placed on both of pure and applied sciences that are derived from past/present scientific knowledge and coming new science and technology. In general, adverse drug reactions are presented as "biological responses to foreign substances." This is the basic concept of thinking about the manifestation of adverse drug reactions. Whether or not toxic expressions are extensions of the pharmacological effect, adverse drug reactions as seen from molecular targets are captured in the category of "on-target" or "off-target", and are normally expressed as a biological defense reaction. Accordingly, reactions induced by pharmaceuticals can be broadly said to be defensive reactions. Recent molecular biological conception is in line with the new, remarkable scientific and technological developments in the medical and pharmaceutical areas, and the viewpoints in the field of toxicology have shown that they are approaching toward the same direction as well. This paper refers to the basic concept of pharmaceutical toxicology, the differences for safety assessment in each stage of drug discovery and development, regulatory submission, and the concept of scientific considerations for risk assessment and management from the viewpoint of "how can multidisciplinary toxicology contribute to innovative drug discovery and development?" And also realistic translational research from preclinical to clinical application is required to have a significant risk management in post market by utilizing whole scientific data derived from basic and applied scientific research works. In addition, the significance for employing the systems toxicology based on AOP (Adverse Outcome Pathway) analysis is introduced, and coming challenges on precision

  17. Educational audit on drug dose calculation learning in a Tanzanian ...

    African Journals Online (AJOL)

    Background: Patient safety is a key concern for nurses; ability to calculate drug ... Specific objectives were to assess learning from targeted teaching, to identify problem areas in perfor- .... this could result in reduced risk of drug dose error in.

  18. Nuclear criticality safety: general. 4. The CASTOR X/32S Method of Covering mis-loading Concerns

    International Nuclear Information System (INIS)

    Lancaster, Dale B.; Rombough, Charles T.; Diersch, Rudolf; Spilker, Harry

    2001-01-01

    In the United States, most cask licenses do not directly consider mis-loading. If the enrichment limit for a shipping cask is high and the reactivity control is inherent in the cask, the reactivity effect of a mis-load is small. However, in large-capacity casks, such as the CASTOR X/32S, the effect can be much larger. The U.S. Department of Energy Topical Report on Actinide- Only Burnup Credit takes the position that a fuel assembly mis-load does need to be analyzed since there are multiple independent checks, and thus, the double-contingency principle is met. Unfortunately, 11 assemblies were mis-loaded at Palisades. This event has caused the U.S. Nuclear Regulatory Commission (NRC) to ask for more detail on prevention of mis-loading. In the summer of 1999, Palisades loaded 11 assemblies, which did not comply with the loading requirements for their VSC-24 cask. The cask requires 5 yr of cooling, and these 11 assemblies had just a little more than 4 yr of cooling. The mis-loading did not result in an unsafe condition but in an un-reviewed condition. This mis-loading was not identified until November 2000 during a review related to an NRC information notice. The loading plan for the cask was incorrect. The engineering review of the loading plan missed the error. The operators had loaded the cask consistent with the loading plan. The cask loading was then confirmed by comparing to the loading plan. The loading plan was in error since the engineer assumed that the entire region of fuel was discharged at the same time. The 11 assemblies of concern were reinserted in the reactor, and the engineer and the reviewer did not check for this. The reactor records for all the assemblies were correct but apparently were not checked by the engineer who created the loading plan. To prevent a mis-load criticality event, the following steps will be required for the CASTOR X/32S storage and transport cask: 1. A loading plan will be prepared for each cask loaded. This plan will be

  19. Depression longitudinally mediates the association of appearance concerns to ART non-adherence in HIV-infected individuals with a history of injection drug use.

    Science.gov (United States)

    Blashill, Aaron J; Gordon, Janna R; Safren, Steven A

    2014-02-01

    Appearance concerns are common among HIV-infected individuals, and previous cross-sectional and longitudinal data indicate that these concerns are associated with antiretroviral therapy (ART) non-adherence. However, to date, no known prospective data have explored the mechanism behind this relationship. Thus, the aim of the current study was to test depression severity as a prospective mediator of the relationship between appearance concerns and ART non-adherence in HIV-infected individuals with a history of injection drug use (IDU). Participants were 89 HIV-infected individuals with a history of IDU who participated in a prospective, randomized controlled trial of cognitive behavioral therapy for depression and medication adherence. Clinician-administered measures of depression severity and appearance concerns, along with electronic monitoring of ART non-adherence were included. Data were analyzed using longitudinal linear mixed-level modeling, and mediation was tested via the Monte Carlo Method of Assessing Mediation. Appearance concerns were predictive of depression severity, γ = .31, SE = .076, 95 % CI [.16, .46], t = 4.1, p = .0001, and depression severity was predictive of ART non-adherence, γ = 3.3, SE = 1.3, 95 % CI [.8, 5.8], t = 2.6, p = .01. The effect of appearance concerns on ART non-adherence, however, was significantly mediated by depression severity, γ = 1.02, 95 % CI [.21, 2.1]. Appearance concerns are associated with depression severity, which in turn is associated with ART non-adherence. Integrative interventions addressing appearance concerns, depression and ART adherence are needed, as this is one potential pathway towards worse health outcomes in HIV-infected individuals.

  20. RESPONSIBILITIES OF FOOD BUSINESS OPERATORS RELATED TO FOOD SAFETY: CONCERNS RELATED TO HACCP IN MICRO-BUSINESSES FOOD COMPANIES

    Directory of Open Access Journals (Sweden)

    T. Civera

    2012-08-01

    Full Text Available The research was aimed at collecting information on food safety knowledge by operators of small and less developed food businesses. This will allow to reveal what are the real drawbacks in HACCP application in these realities. Fifty meat producing plants located in Piedmont region were involved. In all the plants a questionnaire with questions on HACCP system was submitted. The analysis of the collected answers, evidenced that 42% of the operators needed to perform structural modifications in order to address the HACCP measures, whereas 40% applied modifications in working procedures. The most frequent shortcoming (44% of the answers of the HACCP system was represented by the applicability of Good Manufacturing Practices, and the most difficult control measure to be applied was the prevention of the cross-contaminations (40% of the answers. The information gathered within this project allowed to evidence the real needs of the micro businesses in the application of HACCP plan. These results can be useful for the institutions, which could elaborate HACCP alternative systems, able to better fulfil food safety requirements and Food Business Operator needs.

  1. Spillover Effects of Drug Safety Warnings on Preventive Health Care Use

    DEFF Research Database (Denmark)

    Daysal, N. Meltem; Orsini, Chiara

    2015-01-01

    We examine how new medical information on drug safety impacts preventive health care use. We exploit the release of the findings of the Women’s Health Initiative Study (WHIS) – the largest randomized controlled trial of women’s health – which demonstrated in 2002 the health risks associated...... with the long-term use of hormone replacement therapy (HRT). We first show that, after the release of the WHIS findings, HRT use dropped sharply among post-menopausal women. We then estimate the spillover effects of the WHIS findings on preventive care by means of a difference-in-differences methodology...... comparing changes in preventive care use among 60 to 69 year-old women (who have high rates of HRT use) with the change among women aged 75 and above (who have much lower rates of HRT use). Using data from the Behavioral Risk Factor Surveillance System for the period 1998–2007, we find that women aged 60...

  2. Open-label extension studies: do they provide meaningful information on the safety of new drugs?

    Science.gov (United States)

    Day, Richard O; Williams, Kenneth M

    2007-01-01

    The number of open-label extension studies being performed has increased enormously in recent years. Often it is difficult to differentiate between these extension studies and the double-blind, controlled studies that preceded them. If undertaken primarily to gather more patient-years of exposure to the new drug in order to understand and gain confidence in its safety profile, open-label extension studies can play a useful and legitimate role in drug development and therapeutics. However, this can only occur if the open-label extension study is designed, executed, analysed and reported competently. Most of the value accrued in open-label extension studies is gained from a refinement in the perception of the expected incidence of adverse effects that have most likely already been identified as part of the preclinical and clinical trial programme. We still have to rely heavily on post-marketing safety surveillance systems to alert us to type B (unpredictable) adverse reactions because open-label extension studies are unlikely to provide useful information about these types of often serious and relatively rare adverse reactions. Random allocation into test and control groups is needed to produce precise incidence data on pharmacologically expected, or type A, adverse effects. Some increased confidence about incidence rates might result from the open-label extension study; however, as these studies are essentially uncontrolled and biased, the data are not of great value. Other benefits have been proposed to be gained from open-label extension studies. These include ongoing access to an effective but otherwise unobtainable medicine by the volunteers who participated in the phase III pivotal trials. However, there are unappreciated ethical issues about the appropriateness of enrolling patients whose response to previous treatment is uncertain, largely because treatment allocation in the preceding randomised, double-blind, controlled trial has not been revealed at the

  3. Surveys of research projects concerning nuclear facility safety, financed by the Federal Ministry for the Environment, Nature Protection and Reactor Safety, 1989. (14. annual report on SR-projects)

    International Nuclear Information System (INIS)

    1990-11-01

    Each progress report is a collection of individual reports, categorized by subject matter. They are a documentation of the contractor's progress, rendered by themselves on standardized forms, published, for the sake of general information on progress made in investigations concerning reactor safety, by the project attendance department of the GRS. The individual reports have serial numbers. Each report includes particulars of the objective, work carried out, results obtained and plans for project continuation. (orig.) [de

  4. Study on safety of a nuclear ship having an integral marine water reactor. Intelligent information database program concerned with thermal-hydraulic characteristics

    International Nuclear Information System (INIS)

    Inasaka, Fujio; Nariai, Hideki; Kobayashi, Michiyuki; Murata, Hiroyuki; Aya, Izuo

    2001-01-01

    As a high economical marine reactor with sufficient safety functions, an integrated type marine water reactor has been considered most promising. At the National Maritime Research Institute, a series of the experimental studies on the thermal-hydraulic characteristics of an integrated/passive-safety type marine water reactor such as the flow boiling of a helical-coil type steam generator, natural circulation of primary water under a ship rolling motion and flashing-condensation oscillation phenomena in pool water has been conducted. This current study aims at making use of the safety analysis or evaluation of a future marine water reactor by developing an intelligent information database program concerned with the thermal-hydraulic characteristics of an integral/passive-safety reactor on the basis of the above-mentioned valuable experimental knowledge. Since the program was created as a Windows application using the Visual Basic, it is available to the public and can be easily installed in the operating system. Main functions of the program are as follows: (1) steady state flow boiling analysis and determination of stability limit for any helical-coil type once-through steam generator design. (2) analysis and comparison with the flow boiling data, (3) reference and graphic display of the experimental data, (4) indication of the knowledge information such as analysis method and results of the study. The program will be useful for the design of not only the future integrated type marine water reactor but also the small sized water reactor. (author)

  5. Regulatory oversight report 2012 concerning nuclear safety in Swiss nuclear installations; Aufsichtsbericht 2012 zur nuklearen Sicherheit in den schweizerischen Kernanlagen

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-04-15

    The Swiss Federal Nuclear Safety Inspectorate (ENSI) assesses and monitors nuclear facilities in Switzerland. These include the five nuclear power plants, the interim storage facilities based at each plant, the Central Interim Storage Facility (ZWILAG) and the nuclear facilities at the Paul Scherrer Institute (PSI), at the Federal Institute of Technology in Lausanne (EPFL) and at the University of Basel. Using a combination of inspections, regulatory meetings, examinations and analyses together with reports from the licensees of individual facilities, ENSI obtains the required overview of nuclear safety in the relevant facilities. It ensures that the facilities comply with the regulations and operate as required by law. Its regulatory responsibilities also include the transport of radioactive materials from and to nuclear facilities and the preparations for a deep geological repository for nuclear waste. ENSI maintains its own emergency organisation. It formulates and updates its own guidelines which stipulate the criteria for evaluating the current activities and future plans of the operators of nuclear facilities. ENSI produces regular reports on its regulatory activities and nuclear safety in Swiss nuclear facilities. It fulfils its statutory obligation to provide the public with information on particular events and findings in nuclear facilities. In 2012, the five nuclear power plants in Switzerland were all operated safely. 34 events were reported; on the international INES scale of 0 to 7, ENSI rated 33 events as Level 0 and 1 as Level 1. ENSI evaluates the safety of each nuclear power plant as part of a systematic safety evaluation taking account of both reportable events and other findings, in particular the results of more than 400 inspections conducted by ENSI during 2012. ZWILAG consists of several interim storage halls, a conditioning plant and an incineration/melting plant. At the end of 2012, the cask storage hall contained 40 transport/storage casks

  6. Drug Repositioning of Proton Pump Inhibitors for Enhanced Efficacy and Safety of Cancer Chemotherapy

    Directory of Open Access Journals (Sweden)

    Kenji Ikemura

    2017-12-01

    Full Text Available Proton pump inhibitors (PPIs, H+/K+-ATPase inhibitors, are the most commonly prescribed drugs for the treatment of gastroesophageal reflux and peptic ulcer diseases; they are highly safe and tolerable. Since PPIs are frequently used in cancer patients, studies investigating interactions between PPIs and anticancer agents are of particular importance to achieving effective and safe cancer chemotherapy. Several studies have revealed that PPIs inhibit not only the H+/K+-ATPase in gastric parietal cells, but also the vacuolar H+-ATPase (V-ATPase overexpressed in tumor cells, as well as the renal basolateral organic cation transporter 2 (OCT2 associated with pharmacokinetics and/or renal accumulation of various drugs, including anticancer agents. In this mini-review, we summarize the current knowledge regarding the impact of PPIs on the efficacy and safety of cancer chemotherapeutics via inhibition of targets other than the H+/K+-ATPase. Co-administration of clinical doses of PPIs protected kidney function in patients receiving cisplatin and fluorouracil, presumably by decreasing accumulation of cisplatin in the kidney via OCT2 inhibition. In addition, co-administration or pretreatment with PPIs could inhibit H+ transport via the V-ATPase in tumor cells, resulting in lower extracellular acidification and intracellular acidic vesicles to enhance the sensitivity of the tumor cells to the anticancer agents. In the present mini-review, we suggest that PPIs enhance the efficacy and safety of anticancer agents via off-target inhibition (e.g., of OCT2 and V-ATPase, rather than on-target inhibition of the H+/K+-ATPase. The present findings should provide important information to establish novel supportive therapy with PPIs during cancer chemotherapy.

  7. Considerations concerning the reliability of reactor safety equipment; Considerations sur la fiabilite des ensembles de securite de reacteurs

    Energy Technology Data Exchange (ETDEWEB)

    Furet, J; Guyot, Ch [Commissariat a l' Energie Atomique, Saclay (France). Centre d' Etudes Nucleaires

    1967-07-01

    A review is made of the circumstances which favor a good collection of maintenance data at the C.E.A. The large amount of data to be treated has made necessary the use of a computer for analyzing automatically the results collected. Here, only particular aspects of the reliability from the point of view of the electronics used for nuclear reactor control will be dealt with: sale and unsafe failures; probability of survival (in the case of reactor safety); availability. The general diagrams of the safety assemblies which have been drawn up for two types of reactor (power reactor and low power experimental reactor) are given. Results are presented of reliability analysis which could be applied to the use of functional modular elements, developed industrially in France. Improvement of this reliability appears to be fairly limited by an increase in the redundancy; on the other hand it is shown how it may be very markedly improved by the use of automatic tests with different frequencies for detecting unsafe failures rates of measurements for the sub-assemblies and for the logic sub-assemblies. Finally examples are given to show the incidence of the complexity and of the use of different technologies in reactor safety equipment on the reliability. (authors) [French] On rappelle les circonstances qui favorisent au C.E.A. la collecte d'une information valable des resultats de la maintenance. L'importance des donnees a traiter a rendu necessaire l'utilisation d'une calculatrice poux l'analyse automatique des resultats recueillis. On se limitera ici aux aspects particuliers de la fiabilite du point de vue de l'electronique pour le controle et la commande de reacteurs nucleaires: pannes sures et pannes non sures; probabilite de survie dans le cas de la securite des reacteurs; facteur de disponibilite. Les schemas de principe des ensembles de securite definis pour deux types de reacteurs (reacteur de puissance et reacteur experimental de faible puissance) sont indiques. On

  8. Comparing Safety and Efficacy of "Third-Generation" Antiepileptic Drugs: Long-Term Extension and Post-marketing Treatment.

    Science.gov (United States)

    Kwok, Charlotte S; Johnson, Emily L; Krauss, Gregory L

    2017-11-01

    Four "third-generation" antiepileptic drugs (AEDs) were approved for adjunctive treatment of refractory focal onset seizures during the past 10 years. Long-term efficacy and safety of the drugs were demonstrated in large extension studies and in reports of subgroups of patients not studied in pivotal trials. Reviewing extension study and post-marketing outcome series for the four newer AEDs-lacosamide, perampanel, eslicarbazepine acetate and brivaracetam-can guide clinicians in treating and monitoring patients. AED extension studies evaluate treatment retention, drug tolerability, and drug safety during individualized treatment with flexible dosing and thus provide information not available in rigid pivotal trials. Patient retention in the studies ranged from 75 to 80% at 1 year and from 36 to 68% at 2-year treatment intervals. Safety findings were generally similar to those of pivotal trials, with no major safety risks identified and with several specific adverse drug effects, such as hyponatremia, reported. The third-generation AEDs, some through new mechanisms and others with improved tolerability compared to related AEDs, provide new options in efficacy and tolerability.

  9. 31 March 1992 - Royal Order amending Section 133(1) of the General Regulation on safety at Work concerning protection of workers against the hazards of ionizing radiation

    International Nuclear Information System (INIS)

    1992-01-01

    A Royal Order of 31 March 1992 amends certain provisions of the Regulations on safety at work with respect to protection of workers against the hazards of ionizing radiation, amended in 1990. The purpose of the amendment is to avoid that certain international and national civil servants be hindered in their control duties. The following inspectors are concerned: the International Atomic Energy Agency inspectors; the persons designated as responsible for surveillance under the Euratom Treaty and the Act of 1955 on State security in the nuclear field; the inspectors designated by the Act of 1972 on inspections at work. (NEA)

  10. The U.S. weapon-grade plutonium shipment. Safety and security concern for the ''Eurofab'' operation in France

    International Nuclear Information System (INIS)

    Marignac, Y.; Coeytaux, X.

    2004-09-01

    The present report is a comprehensive update based on a briefing published by W.I.S.E.-Paris in July 2003 on the US plan-also known as Eurofab- to have M.O.X. lead test assemblies fabricated in the French plant of ATPu, Cadarache. Based on recent developments, it discussed the specific risks raised by the unprecedented operation, in particular at the transport and fabrication stages. This analysis includes a joint assessment, by W.I.S.E.-Paris and Large and Associates, in response to the French Institute of radiation protection and nuclear safety (I.R.S.N.) criticism over the independent reports they previously published on this issue. (author)

  11. The safety regime concerning transboundary movement of radioactive waste and its compatibility with the trade regime of the WTO

    International Nuclear Information System (INIS)

    Strack, L.

    2004-01-01

    There is now extensive international law which regulates or prohibits the transboundary movement of radioactive waste. It seems likely that the trade restrictive provisions of the safety regime could be justified under the scope of Article X XI or X X GATT(general agreement on tariffs and trade). If a legitimate non proliferation issue were involved it is likely that any WTO (world trade organization) dispute settlement organ would allow governments the use of exceptions. Thus, the emerging international radioactive waste regime seems reconcilable under the WTO system. However, further clarification by the political, not the dispute settlement, institutions of the WTO would remove any remaining uncertainty by reaffirming the requirements of current law. Achieving sustainable development requires a coherent framework of global environment and economic governance. (N.C.)

  12. Decree of the President of the Republic of 31 July 1980 concerning the Higher Institute for Safety at Work (Section 23 of Act N0 833 of 1978)

    International Nuclear Information System (INIS)

    1980-01-01

    This Decree is important as respects nuclear energy insofar as the tasks of the Institute which are mainly of an advisory nature, also concern radiation protection and safety in connection with nuclear activities. It provides for an advisory role to be played by the Institute as regards health protection in the field of nuclear power generation and radioactive materials, including use of and trade in such materials. On the other hand, it does not affect the regulations governing the use of nuclear energy, in particular as concerns Act N 0 1240 of 1971 reorganising the CNEN, Act N 0 1860 of 1962 on the peaceful uses of nuclear energy, Presidential Decree N 0 185 of 1964 on radiation protection and the decrees implementing these tests (NEA) [fr

  13. Regulatory oversight report 2016 concerning nuclear safety in Swiss nuclear installations; Aufsichtsbericht 2016 zur nuklearen Sicherheit in den schweizerischen Kernanlagen

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2017-06-15

    ENSI, the Swiss Federal Nuclear Safety Inspectorate, assesses and monitors safety in the Swiss nuclear facilities. These include the five nuclear power plants: Beznau Units 1 and 2 (KKB1 and KKB2), Muehleberg (KKM), Goesgen (KKG) and Leibstadt (KKL), the interim storage facilities based at each plant, the Central Interim Storage Facility (Zwilag) in Wuerenlingen together with the nuclear facilities at the Paul Scherrer Institute (PSI), the University of Basel (UniB) and the Federal Institute of Technology in Lausanne (EPFL). Using a combination of inspections, regulatory meetings, checks, analyses and the reporting of the operators of individual facilities, ENSI obtains the required overview of nuclear safety in these facilities. It ensures that they operate as required by law. ENSI's regulatory responsibilities also include the transport of radioactive materials from and to nuclear facilities and preparations for a deep geological repository for radioactive waste. ENSI maintains its own emergency organisation, which is an integral part of the national emergency structure that would be activated in the event of a serious incident at a nuclear facility in Switzerland. ENSI reports periodically on its supervisory activities. It informs the public about special events and findings in the nuclear installations. All five nuclear power plants in Switzerland operated safely during the past year. Nuclear safety at all plants in operation was rated as good or satisfactory. In 2016, there were 31 reportable events at the nuclear power plants. 30 events were rated Level 0 (event of no or low safety significance) on the International Nuclear and Radiological Event Scale (INES) and one was rated Level 1 (anomaly) at KKL. Zwilag consists of several interim storage buildings, a conditioning plant and a plasma plant (incineration/melting plant). At the end of 2016, the cask storage hall contained 56 transport/storage casks with spent fuel assemblies and vitrified residue

  14. “Is it still safe to eat traditional food?” Addressing traditional food safety concerns in aboriginal communities

    Energy Technology Data Exchange (ETDEWEB)

    Bordeleau, Serge, E-mail: Serge.Bordeleau@uqat.ca [Chaire de Recherche du Canada en Foresterie Autochtone, Université du Québec en Abitibi-Témiscamingue, 445 boul. de l' Université, Rouyn-Noranda, Québec J9X 5E4 (Canada); Chaire Industrielle CRSNG-UQAT-UQÀM en Aménagement Forestier Durable, Université du Québec en Abitibi-Témiscamingue, 445 boul. de l' Université, Rouyn-Noranda, Québec J9X 5E4 (Canada); Asselin, Hugo, E-mail: Hugo.Asselin@uqat.ca [Chaire de Recherche du Canada en Foresterie Autochtone, Université du Québec en Abitibi-Témiscamingue, 445 boul. de l' Université, Rouyn-Noranda, Québec J9X 5E4 (Canada); Chaire Industrielle CRSNG-UQAT-UQÀM en Aménagement Forestier Durable, Université du Québec en Abitibi-Témiscamingue, 445 boul. de l' Université, Rouyn-Noranda, Québec J9X 5E4 (Canada); and others

    2016-09-15

    Food insecurity is a growing concern for indigenous communities worldwide. While the risk of heavy metal contamination associated to wild food consumption has been extensively studied in the Arctic, data are scarce for the Boreal zone. This study addressed the concerns over possible heavy metal exposure through consumption of traditional food in four Anishnaabeg communities living in the Eastern North American boreal forest. Liver and meat samples were obtained from 196 snowshoe hares (Lepus americanus) trapped during winter 2012 across the traditional lands of the participating communities and within 56–156 km of a copper smelter. Interviews were conducted with 78 household heads to assess traditional food habits, focusing on snowshoe hare consumption. Concentrations in most meat and liver samples were below the detection limit for As, Co, Cr, Ni and Pb. Very few meat samples had detectable Cd and Hg concentrations, but liver samples had mean dry weight concentrations of 3.79 mg/kg and 0.15 mg/kg respectively. Distance and orientation from the smelter did not explain the variability between samples, but percent deciduous and mixed forest cover had a marginal negative effect on liver Cd, Cu and Zn concentrations. The estimated exposition risk from snowshoe hare consumption was low, although heavy consumers could slightly exceed recommended Hg doses. In accordance with the holistic perspective commonly adopted by indigenous people, the nutritional and sociocultural importance of traditional food must be considered in risk assessment. Traditional food plays a significant role in reducing and preventing serious health issues disproportionately affecting First Nations, such as obesity, diabetes, and cardiovascular diseases. Traditional consumption of snowshoe hare (Lepus americanus) entails low risk of heavy metal exposure if animals are tapped > 50 km from a point emission source (such as a copper smelter in the present study), if risk-increasing behaviours are

  15. “Is it still safe to eat traditional food?” Addressing traditional food safety concerns in aboriginal communities

    International Nuclear Information System (INIS)

    Bordeleau, Serge; Asselin, Hugo

    2016-01-01

    Food insecurity is a growing concern for indigenous communities worldwide. While the risk of heavy metal contamination associated to wild food consumption has been extensively studied in the Arctic, data are scarce for the Boreal zone. This study addressed the concerns over possible heavy metal exposure through consumption of traditional food in four Anishnaabeg communities living in the Eastern North American boreal forest. Liver and meat samples were obtained from 196 snowshoe hares (Lepus americanus) trapped during winter 2012 across the traditional lands of the participating communities and within 56–156 km of a copper smelter. Interviews were conducted with 78 household heads to assess traditional food habits, focusing on snowshoe hare consumption. Concentrations in most meat and liver samples were below the detection limit for As, Co, Cr, Ni and Pb. Very few meat samples had detectable Cd and Hg concentrations, but liver samples had mean dry weight concentrations of 3.79 mg/kg and 0.15 mg/kg respectively. Distance and orientation from the smelter did not explain the variability between samples, but percent deciduous and mixed forest cover had a marginal negative effect on liver Cd, Cu and Zn concentrations. The estimated exposition risk from snowshoe hare consumption was low, although heavy consumers could slightly exceed recommended Hg doses. In accordance with the holistic perspective commonly adopted by indigenous people, the nutritional and sociocultural importance of traditional food must be considered in risk assessment. Traditional food plays a significant role in reducing and preventing serious health issues disproportionately affecting First Nations, such as obesity, diabetes, and cardiovascular diseases. Traditional consumption of snowshoe hare (Lepus americanus) entails low risk of heavy metal exposure if animals are tapped > 50 km from a point emission source (such as a copper smelter in the present study), if risk-increasing behaviours are

  16. Predicting Drug Safety and Communicating Risk: Benefits of a Bayesian Approach.

    Science.gov (United States)

    Lazic, Stanley E; Edmunds, Nicholas; Pollard, Christopher E

    2018-03-01

    Drug toxicity is a major source of attrition in drug discovery and development. Pharmaceutical companies routinely use preclinical data to predict clinical outcomes and continue to invest in new assays to improve predictions. However, there are many open questions about how to make the best use of available data, combine diverse data, quantify risk, and communicate risk and uncertainty to enable good decisions. The costs of suboptimal decisions are clear: resources are wasted and patients may be put at risk. We argue that Bayesian methods provide answers to all of these problems and use hERG-mediated QT prolongation as a case study. Benefits of Bayesian machine learning models include intuitive probabilistic statements of risk that incorporate all sources of uncertainty, the option to include diverse data and external information, and visualizations that have a clear link between the output from a statistical model and what this means for risk. Furthermore, Bayesian methods are easy to use with modern software, making their adoption for safety screening straightforward. We include R and Python code to encourage the adoption of these methods.

  17. Toxicological study on the safety of DTPA as a drug, (1)

    International Nuclear Information System (INIS)

    Fukuda, Satoshi; Iida, Haruzo

    1983-01-01

    In order to clarify the safety of Ca-DTPA and Zn-DTPA recommended to use as drugs in the therapeutic removal of incorporated radionuclides from the human body, the teratological study on these two agents was carried out in rats as one of a series of the toxicological tests. The teratological effects of DTPA were observed because the fetus is highly susceptible to any drug. The pregnant females of Wistar rat were injected subcutaneously daily on days 9-13 of gestation with 1, 6, 12, 24 and 36 H.D. (H.D. = human dose, 1 H.D. = 30μmol/kg body weight) of Ca-DTPA or Zn-DTPA, respectively. In the dams, no toxic effects were observed. In the fetuses, the decrease of the survival rate was observed in only the group injected daily with 36 H.D. of Ca-DTPA. Some cases of gross defects of fetuses: the exencephaly, microphthalmia, anophthalmia and fusion of ribs were observed in the groups injected daily with 12, 24 and 36 H.D. of Ca-DTPA. The results obtained show that Ca-DTPA should not be given to a pregnant woman. However, no toxic effects of either Ca-DTPA or Zn-DTPA observed in the dams ana of Zn-DTPA even in the fetuses indicate that these agents can be used by a radiation worker who usually is an adult man. (author)

  18. Toxicological study on the safety of DTPA as a drug, (1). Teratological study in the rat

    Energy Technology Data Exchange (ETDEWEB)

    Fukuda, Satoshi; Iida, Haruzo (National Inst. of Radiological Sciences, Chiba (Japan))

    1983-03-01

    In order to clarify the safety of Ca-DTPA and Zn-DTPA recommended to use as drugs in the therapeutic removal of incorporated radionuclides from the human body, the teratological study on these two agents was carried out in rats as one of a series of the toxicological tests. The teratological effects of DTPA were observed because the fetus is highly susceptible to any drug. The pregnant females of Wistar rat were injected subcutaneously daily on days 9-13 of gestation with 1, 6, 12, 24 and 36 H.D. (H.D. = human dose, 1 H.D. = 30..mu..mol/kg body weight) of Ca-DTPA or Zn-DTPA, respectively. In the dams, no toxic effects were observed. In the fetuses, the decrease of the survival rate was observed in only the group injected daily with 36 H.D. of Ca-DTPA. Some cases of gross defects of fetuses: the exencephaly, microphthalmia, anophthalmia and fusion of ribs were observed in the groups injected daily with 12, 24 and 36 H.D. of Ca-DTPA. The results obtained show that Ca-DTPA should not be given to a pregnant woman. However, no toxic effects of either Ca-DTPA or Zn-DTPA observed in the dams or of Zn-DTPA even in the fetuses indicate that these agents can be used by a radiation worker who usually is an adult man.

  19. Efficacy and safety of immunomodulatory drugs in patients with anterior uveitis

    Science.gov (United States)

    Gómez-Gómez, Alejandro; Loza, Estíbaliz; Rosario, Maria Piedad; Espinosa, Gerard; de Morales, José M. García Ruiz; Herreras, Jose M.; Muñoz-Fernández, Santiago; Cordero-Coma, Miguel

    2017-01-01

    Abstract Background: To assess the efficacy and safety of immunomodulatory drugs in patients with noninfectious anterior uveitis (AU). Methods: Systematic review of studies were retrieved from Medline (1961 to March 2016), Embase (1961 to March 2016), and Cochrane Library (up to March 2016), and a complementary hand search was also performed. The selection criteria were as follows: (population) noninfectious AU patients, adults; (intervention) immunomodulatory drugs (any dose, regimen, route of administration, duration of treatment); (outcome) control of inflammation, steroid-sparing effect, AU flares, adverse events, and so on; (study design) systematic literature reviews, randomized controlled trials, and observational studies. The study quality was assessed using the Jadad scale and according to The Oxford Centre for Evidence-based Medicine (update 2009). Results: We included 13 studies of moderate-poor quality, with a mean duration from 5 months to 20 years, and number of AU patients ranging from 9 to 274. Patient's demographic and clinical characteristics were very heterogeneous. In most cases, uveitis anatomic classification criteria and outcomes definitions were unclear. Some of the studies only included AU patients with a systemic disease associated, mostly spondyloarthritis, others, mixed populations (idiopathic and systemic disease associated patients), and in some articles this data is not described. We found that methotrexate, cyclosporine A, azathioprine, adalimumab, and golimumab might prevent AU flares, improve ocular inflammation and visual acuity, and decrease systemic steroids doses. Conclusions: Although there is a lack of robust evidence, methotrexate, cyclosporine A, azathioprine, adalimumab, and golimumab might be effective in AU patients. PMID:29049193

  20. Efficacy and safety of immunomodulatory drugs in patients with anterior uveitis: A systematic literature review.

    Science.gov (United States)

    Gómez-Gómez, Alejandro; Loza, Estíbaliz; Rosario, Maria Piedad; Espinosa, Gerard; Morales, José M García Ruiz de; Herreras, Jose M; Muñoz-Fernández, Santiago; Cordero-Coma, Miguel

    2017-10-01

    To assess the efficacy and safety of immunomodulatory drugs in patients with noninfectious anterior uveitis (AU). Systematic review of studies were retrieved from Medline (1961 to March 2016), Embase (1961 to March 2016), and Cochrane Library (up to March 2016), and a complementary hand search was also performed. The selection criteria were as follows: (population) noninfectious AU patients, adults; (intervention) immunomodulatory drugs (any dose, regimen, route of administration, duration of treatment); (outcome) control of inflammation, steroid-sparing effect, AU flares, adverse events, and so on; (study design) systematic literature reviews, randomized controlled trials, and observational studies. The study quality was assessed using the Jadad scale and according to The Oxford Centre for Evidence-based Medicine (update 2009). We included 13 studies of moderate-poor quality, with a mean duration from 5 months to 20 years, and number of AU patients ranging from 9 to 274. Patient's demographic and clinical characteristics were very heterogeneous. In most cases, uveitis anatomic classification criteria and outcomes definitions were unclear. Some of the studies only included AU patients with a systemic disease associated, mostly spondyloarthritis, others, mixed populations (idiopathic and systemic disease associated patients), and in some articles this data is not described. We found that methotrexate, cyclosporine A, azathioprine, adalimumab, and golimumab might prevent AU flares, improve ocular inflammation and visual acuity, and decrease systemic steroids doses. Although there is a lack of robust evidence, methotrexate, cyclosporine A, azathioprine, adalimumab, and golimumab might be effective in AU patients.

  1. An update discussion on the current assessment of the safety of veterinary antimicrobial drug residues in food with regard to their impact on the human intestinal microbiome.

    Science.gov (United States)

    Cerniglia, Carl E; Pineiro, Silvia A; Kotarski, Susan F

    2016-05-01

    The human gastrointestinal tract ecosystem consists of complex and diverse microbial communities that have now been collectively termed the intestinal microbiome. Recent scientific breakthroughs and research endeavours have increased our understanding of the important role the intestinal microbiome plays in human health and disease. The use of antimicrobial new animal drugs in food-producing animals may result in the presence of low levels of drug residues in edible foodstuffs. There is concern that antimicrobial new animal drugs in or on animal-derived food products at residue-level concentrations could disrupt the colonization barrier and/or modify the antimicrobial resistance profile of human intestinal bacteria. Therapeutic doses of antimicrobial drugs have been shown to promote shifts in the intestinal microbiome, and these disruptions promote the emergence of antimicrobial-resistant bacteria. To assess the effects of antimicrobial new animal drug residues in food on human intestinal bacteria, many national regulatory agencies and international committees follow a harmonized process, VICH GL36(R), which was issued by a trilateral organization of the European Union, the USA, and Japan called the International Cooperation on Harmonization of Technical Requirements for Veterinary Medicinal Products (VICH). The guidance describes a general approach currently used by national regulatory agencies and international committees to assess the effects of antimicrobial new animal drug residues in animal-derived food on human intestinal bacteria. The purpose of this review is to provide an overview of this current approach as part of the antimicrobial new animal drug approval process in participating countries, give insights on the microbiological endpoints used in this safety evaluation, and discuss the availability of new information. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  2. Prospective drug safety monitoring using the UK primary-care General Practice Research Database: theoretical framework, feasibility analysis and extrapolation to future scenarios.

    Science.gov (United States)

    Johansson, Saga; Wallander, Mari-Ann; de Abajo, Francisco J; García Rodríguez, Luis Alberto

    2010-03-01

    recruitment and 12 months for data management and case validation). To reach the estimated target exposure necessary to raise or rule out a signal of concern to public health, we determined that a recruitment period 2-3 times longer than that used in this study would be required. Based on the real market uptake of six commonly used medicinal products launched between 2001 and 2006 in the UK (budesonide/eformoterol [fixed-dose combination], duloxetine, ezetimibe, metformin/rosiglitazone [fixed-dose combination], tiotropium bromide and tadalafil) the target exposure would not have been reached until the fifth year of marketing using a single database. It is feasible to set up a system that actively monitors drug safety using a healthcare database and an independent endpoint adjudication committee. However, future successful implementation will require multiple databases to be queried so that larger study populations are included. This requires further development and harmonization of international healthcare databases.

  3. Radiation safety concerns for pregnant or breast feeding patients. The positions of the NCRP and the ICRP

    International Nuclear Information System (INIS)

    Meinhold, C.B.

    1997-01-01

    For many years, protecting the fetus has been a concern of the National Council on Radiation Protection and Measurements (NCRP) and the International Commission on Radiological Protection (ICRP). Early recommendations focused on the possibility of a wide variety of detrimental developmental effects while later recommendations focused on the potential for severe mental retardation and/or reduction in the intelligence quotient (I.Q.). The latest recommendations also note that the risk of cancer for the fetus is probably two to three times greater per Sv than in the adult. For all these reasons, the NCRP and the ICRP have provided guidance to physicians on taking all reasonable steps to ascertain whether any woman requiring a radiological or nuclear medicine procedure is pregnant or nursing a child. The NCRP and the ICRP also advise the clinician to postpone such procedures until after delivery or cessation of nursing, if possible

  4. Radiation safety concerns for pregnant or breast feeding patients. The positions of the NCRP and the ICRP

    Energy Technology Data Exchange (ETDEWEB)

    Meinhold, C.B. [Brookhaven National Lab., Upton, NY (United States)

    1997-01-01

    For many years, protecting the fetus has been a concern of the National Council on Radiation Protection and Measurements (NCRP) and the International Commission on Radiological Protection (ICRP). Early recommendations focused on the possibility of a wide variety of detrimental developmental effects while later recommendations focused on the potential for severe mental retardation and/or reduction in the intelligence quotient (I.Q.). The latest recommendations also note that the risk of cancer for the fetus is probably two to three times greater per Sv than in the adult. For all these reasons, the NCRP and the ICRP have provided guidance to physicians on taking all reasonable steps to ascertain whether any woman requiring a radiological or nuclear medicine procedure is pregnant or nursing a child. The NCRP and the ICRP also advise the clinician to postpone such procedures until after delivery or cessation of nursing, if possible.

  5. Efficacy, safety and tolerability of sildenafil in Brazilian hypertensive patients on multiple antihypertensive drugs

    Directory of Open Access Journals (Sweden)

    Denilson C. Albuquerque

    2005-08-01

    Full Text Available OBJECTIVE: To evaluate the efficacy, safety and tolerability of sildenafil among Brazilian patients with hypertension treated with combinations of anti-hypertensive drugs. MATERIALS AND METHODS: One hundred twenty hypertensive men aged 30 to 81 years old under treatment with 2 or more anti-hypertensive drugs and with erectile dysfunction (ED lasting for at least 6 months were enrolled at 7 research centers in Brazil. Patients were randomized to receive treatment with either sildenafil or placebo taken 1 hour before sexual intercourse (initial dose of 50 mg, adjusted to 25 mg or 100 mg according to efficacy and toxicity. During the following 8 weeks, patients were evaluated regarding vital signs, adverse events, therapeutic efficacy, satisfaction with treatment and use of concurrent medications. RESULTS: The primary evaluation of efficacy, which was based on responses to questions 3 and 4 of the International Index of Erectile Function, showed significant differences regarding treatment with sildenafil (p = 0.0002 and p < 0.0001, respectively. In the assessment of global efficacy, 87% of the patients treated with sildenafil reported improved erections, as compared with 37% of patients given placebos (p < 0.0001. The other secondary evaluations supported the results favoring sildenafil. The most frequent adverse events among patients treated with sildenafil were headaches (11.4%, vasodilation (11.4% and dyspepsia (6.5%. There were no significant changes in blood pressure measurements in both groups. CONCLUSION: Sildenafil is efficacious and safe for the treatment of hypertensive patients with ED who receive concurrent combinations of anti-hypertensive drugs.

  6. Bioconjugated nano-bactericidal complex for potent activity against human and phytopathogens with concern of global drug resistant crisis.

    Science.gov (United States)

    Syed, Baker; Nagendra Prasad, M N; Mohan Kumar, K; Satish, S

    2018-05-09

    The present study emphasizes the need for novel antimicrobial agents to combat the global drug resistant crisis. The development of novel nanomaterials is reported to be of the alternative tool to combat drug resistant pathogens. In present investigation, bioconjugated nano-complex was developed from secondary metabolite secreted from endosymbiont. The endosymbiont capable of secreting antimicrobial metabolite was subjected to fermentation and the culture supernatant was assessed for purification of antimicrobial metabolite via bio-assay guided fraction techniques such as thin layer chromatography (TLC), high performance liquid chromatography (HPLC) and column chromatography. The metabolite was characterized as 2,4-Diacetylphloroglucinol (2,4 DAPG) which was used to develop bioconjugated nano-complex by treating with 1 mM silver nitrate under optimized conditions. The purified metabolite 2,4 DAPG reduced silver nitrate to form bioconjugated nano-complex to form association with silver nanoparticles. The oxidized form of DAPG consists of four hard ligands that can conjugate on to the surface of silver nanoparticles cluster. The bioconjugation was confirmed with UV-visible spectroscopy which displayed the shift and shoulder peak in the absorbance spectra. This biomolecular interaction was further determined by the Fourier-transform spectroscopy (FTIR) and nuclear magnetic resonance (NMR) analyses which displayed different signals ascertaining the molecular binding of 2,4,DAPG with silver nanoparticles. The transmission electron microscopy (TEM) analysis revealed the cluster formation due to bioconjugation. The XRD analysis revealed the crystalline nature of nano-complex with the characteristic peaks indexed to Bragg's reflection occurring at 2θ angle which indicated the (111), (200), (220) and (311) planes. The activity of bioconjugated nano-complex was tested against 12 significant human and phytopathogens. Among all the test pathogens, Shigella flexneri (MTCC

  7. Safety

    International Nuclear Information System (INIS)

    1998-01-01

    A brief account of activities carried out by the Nuclear power plants Jaslovske Bohunice in 1997 is presented. These activities are reported under the headings: (1) Nuclear safety; (2) Industrial and health safety; (3) Radiation safety; and Fire protection

  8. Regulatory oversight report 2015 concerning nuclear safety in Swiss nuclear installations; Aufsichtsbericht 2015 zur nuklearen Sicherheit in den schweizerischen Kernanlagen

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2016-06-15

    The Swiss Federal Nuclear Safety Inspectorate (ENSI) assesses and monitors nuclear facilities in Switzerland. These include the five nuclear power plants (Beznau Units 1 and 2, Muehleberg, Goesgen and Leibstadt), the interim storage facilities based at each plant, the Central Interim Storage Facility (Zwilag) at Wuerenlingen together with the nuclear facilities at the Paul Scherrer Institute (PSI), the University of Basel and the Federal Institute of Technology in Lausanne (EPFL), as well as the transport of radioactive materials and the preparatory work for a deep geological repository for nuclear waste. Using a combination of inspections, regulatory meetings, examinations and analyses together with reports from the licensees of individual facilities, ENSI obtains the required overview of nuclear safety in these facilities. ENSI maintains its own emergency organization. It provides the public with information on particular events and findings in nuclear facilities. ENSI publishes an annual Radiological Protection Report and a Research and Experience Report. Chapters 1 to 4 of this Surveillance Report deal with operational experience, systems technology, radiological protection and management of the 5 Swiss nuclear power plants. Chapter 5 deals with Zwilag. Chapters 6 and 7 are devoted to the nuclear facilities at PSI and the research reactor at EPFL as well as the decommissioned University of Basel’s research reactor. Chapter 8 covers the transport of radioactive materials. The subject of Chapter 9 is the deep geological storage of radioactive waste including work within the framework of the Sectoral Plan. Finally, Chapter 10 deals with generic issues relevant to all facilities such as probabilistic safety analyses. In 2015, all five nuclear power plants in Switzerland were safely operated and ENSI concluded that each had adhered to its approved operating conditions. There were 34 reportable events at the nuclear power plants; 32 events were rated at Level 0 on

  9. Regulatory overview report 2014 concerning nuclear safety in Swiss nuclear installations; Aufsichtsbericht 2014 zur nuklearen Sicherheit in den schweizerischen Kernanlagen

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2015-06-15

    The Swiss Federal Nuclear Safety Inspectorate (ENSI), acting as the regulatory body of the Swiss Federation, assesses and monitors nuclear facilities in Switzerland: the five nuclear power plants, the interim storage facilities based at each plant, the Central Interim Storage Facility (ZWILAG) at Wuerenlingen together with the nuclear facilities at the Paul Scherrer Institute (PSI), the University of Basel (UniB) and the Federal Institute of Technology in Lausanne (EPFL). Using a combination of inspections, regulatory meetings, examinations and analyses together with reports from the licensees of individual facilities, ENSI obtains the required overview of nuclear safety. It ensures that they comply with regulations. Its regulatory responsibilities include the transport of radioactive materials from and to nuclear facilities and the preparations for a deep geological repository for nuclear waste. ENSI maintains its own emergency organisation, an integral part of the national emergency structure. It provides the public with information on particular events in nuclear facilities. This Surveillance Report describes the operational experience, systems technology, radiological protection and management in all nuclear facilities. Generic issues relevant to all facilities such as probabilistic safety analyses are described. In 2014, all five nuclear power plants in Switzerland (Beznau Units I and 2, Muehleberg, Goesgen and Leibstadt) were operated safely. The nuclear safety at all plants was rated as good. 38 events were reported. There was one reactor scram at the Leibstadt nuclear power plant. On the International Event Scale (INES), ranging from 0--7, 37 events were rated as Level 0; one event was rated as INES 1: drill holes had penetrated the steel wall of the containment to secure two hand-held fire extinguishers. ZWILAG consists of several interim storage halls, a conditioning plant and a plasma plant. At the end of 2014, the cask storage hall contained 42

  10. Common Health, Safety and Environmental Concerns in Upstream Oil and Gas Sector: Implications for HSE Management in Ghana

    Directory of Open Access Journals (Sweden)

    Seth Oppong

    2014-01-01

    Full Text Available This paper explores the literature to identify common occupational injuries, diseases, and psychological wellbeing on oil rigs as well as the negative environmental impacts of the upstream oil and gas sector. It ends by making recommendations for effective health, safety, and environmental (HSE management. Review of the literature showed that contusion (bruise, cuts, and laceration are the commonest occupational injuries that workers on the oil rig suffer and that the injuries mostly affect the hand and finger, leg, and eyes of the offshore workers. These injuries were found to be caused mostly by direct stroke, jamming and overstrain. Similarly, accidental poisoning, musculoskeletal disorders, respiratory disorders and diseases of the digestive system were also documented as the commonest occupational diseases among offshore workers. The literature also shows that working offshore is associated with poorer psychological wellbeing or health; this is to say that offshore workers tend to experience higher levels of stress, burnout, anxiety, depression, low job satisfaction (particularly with the environmental conditions associated with their work, and sleep disorders. Finally, the literature review indicated that land-use problems, air pollution, acid rain, climate change, habitat disruption, environmental degradation, oil spills and leakages are some of environmental impacts of upstream oil production. This review was concluded by recommending some measures for the management of the HSE hazards associated with the oil and gas sector.

  11. The potential of the European network of congenital anomaly registers (EUROCAT) for drug safety surveillance: a descriptive study.

    Science.gov (United States)

    Meijer, Willemijn M; Cornel, Martina C; Dolk, Helen; de Walle, Hermien E K; Armstrong, Nicola C; de Jong-van den Berg, Lolkje T W

    2006-09-01

    European Surveillance of Congenital Anomalies (EUROCAT) is a network of population-based congenital anomaly registries in Europe surveying more than 1 million births per year, or 25% of the births in the European Union. This paper describes the potential of the EUROCAT collaboration for pharmacoepidemiology and drug safety surveillance. The 34 full members and 6 associate members of the EUROCAT network were sent a questionnaire about their data sources on drug exposure and on drug coding. Available data on drug exposure during the first trimester available in the central EUROCAT database for the years 1996-2000 was summarised for 15 out of 25 responding full members. Of the 40 registries, 29 returned questionnaires (25 full and 4 associate members). Four of these registries do not collect data on maternal drug use. Of the full members, 15 registries use the EUROCAT drug code, 4 use the international ATC drug code, 3 registries use another coding system and 7 use a combination of these coding systems. Obstetric records are the most frequently used sources of drug information for the registries, followed by interviews with the mother. Only one registry uses pharmacy data. Percentages of cases with drug exposure (excluding vitamins/minerals) varied from 4.4% to 26.0% among different registries. The categories of drugs recorded varied widely between registries. Practices vary widely between registries regarding recording drug exposure information. EUROCAT has the potential to be an effective collaborative framework to contribute to post-marketing drug surveillance in relation to teratogenic effects, but work is needed to implement ATC drug coding more widely, and to diversify the sources of information used to determine drug exposure in each registry.

  12. Pre-Departure Clearance (PDC): An Analysis of Aviation Safety Reporting System Reports Concerning PDC Related Errors

    Science.gov (United States)

    Montalyo, Michael L.; Lebacqz, J. Victor (Technical Monitor)

    1994-01-01

    Airlines operating in the United States are required to operate under instrument flight rules (EFR). Typically, a clearance is issued via voice transmission from clearance delivery at the departing airport. In 1990, the Federal Aviation Administration (FAA) began deployment of the Pre-Departure Clearance (PDC) system at 30 U.S. airports. The PDC system utilizes aeronautical datalink and Aircraft Communication and Reporting System (ACARS) to transmit departure clearances directly to the pilot. An objective of the PDC system is to provide an immediate reduction in voice congestion over the clearance delivery frequency. Participating airports report that this objective has been met. However, preliminary analysis of 42 Aviation Safety Reporting System (ASRS) reports has revealed problems in PDC procedures and formatting which have caused errors in the proper execution of the clearance. It must be acknowledged that this technology, along with other advancements on the flightdeck, is adding more responsibility to the crew and increasing the opportunity for error. The present study uses these findings as a basis for further coding and analysis of an additional 82 reports obtained from an ASRS database search. These reports indicate that clearances are often amended or exceptions are added in order to accommodate local ATC facilities. However, the onboard ACARS is limited in its ability to emphasize or highlight these changes which has resulted in altitude and heading deviations along with increases in ATC workload. Furthermore, few participating airports require any type of PDC receipt confirmation. In fact, 35% of all ASRS reports dealing with PDC's include failure to acquire the PDC at all. Consequently, this study examines pilots' suggestions contained in ASRS reports in order to develop recommendations to airlines and ATC facilities to help reduce the amount of incidents that occur.

  13. Concerns of Quality and Safety in Public Domain Surgical Education Videos: An Assessment of the Critical View of Safety in Frequently Used Laparoscopic Cholecystectomy Videos.

    Science.gov (United States)

    Deal, Shanley B; Alseidi, Adnan A

    2017-12-01

    Online videos are among the most common resources for case preparation. Using crowd sourcing, we evaluated the relationship between operative quality and viewing characteristics of online laparoscopic cholecystectomy videos. We edited 160 online videos of laparoscopic cholecystectomy to 60 seconds or less. Crowd workers (CW) rated videos using Global Objective Assessment of Laparoscopic Skills (GOALS), the critical view of safety (CVS) criteria, and assigned overall pass/fail ratings if CVS was achieved; linear mixed effects models derived average ratings. Views, likes, dislikes, subscribers, and country were recorded for subset analysis of YouTube videos. Spearman correlation coefficient (SCC) assessed correlation between performance measures. One video (0.06%) achieved a passing CVS score of ≥5; 23%, ≥4; 44%, ≥3; 79%, ≥2; and 100% ≥1. Pass/fail ratings correlated to CVS, SCC 0.95 (p quality. The average CVS and GOALS scores were no different for videos with >20,000 views (22%) compared with those with online surgical videos of LC. Favorable characteristics, such as number of views or likes, do not translate to higher quality. Copyright © 2017 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  14. Regulatory oversight report 2010 concerning nuclear safety in Swiss nuclear installations; Aufsichtsbericht 2010 zur nuklearen Sicherheit in den schweizerischen Kernanlagen

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-06-15

    Acting as the regulatory body of the Swiss Confederation, the Swiss Federal Nuclear Safety Inspectorate, ENSI, assesses and monitors nuclear facilities in Switzerland. This includes the five nuclear power plants (NPPs), the plant-based interim storage facilities, the Central Interim Storage Facility (ZWILAG) at Wuerenlingen, the nuclear facilities at the Paul Scherrer Institute (PSI), the two universities of Basel and Lausanne, the transport of radioactive materials from and to nuclear facilities and the preparation for a deep geologic repository for radioactive waste. Using inspections, surveillance meetings, reviews and analyses as well as reports from plant licensees, ENSI obtains the required overview of the safety of the nuclear facilities. It maintains its own emergency organisation, which is an integral part of the national emergency structure. The legislative framework at the basis of the activity of ENSI specifies the criteria by which it evaluates the activities and plans of the operators of nuclear facilities. ENSI provides the public with information on particular events and observations relating to nuclear facilities. The five nuclear power plants in Switzerland (Beznau Units 1 und 2, Muehleberg, Goesgen and Leibstadt) were all operated safely in 2010. Last year, there were 39 notifiable events in Switzerland: 4 events affected both Beznau Units, 10 events the Goesgen NPP, 6 the Leibstadt NPP and 13 the Muehleberg NPP and 6 in other facilities. Based on the International Nuclear Event Scale (INES) of 0-7, ENSI rated 38 events as Level 0, and as INES Level 2 the event on 31 August 2010 during maintenance work at the Leibstadt NPP, where a diver was exposed to radiation in excess of the maximum annual exposure rate of 20 mSv. The ZWILAG at Wuerenlingen consists of several interim storage halls, a conditioning plant and the plasma plant (incineration/melting plant). At the end of 2010, the cask storage hall contained 34 transport/storage casks with spent

  15. A comprehensive review of assay methods to determine drugs in breast milk and the safety of breastfeeding when taking drugs.

    Science.gov (United States)

    Fríguls, Bibiana; Joya, Xavier; García-Algar, Oscar; Pallás, C R; Vall, Oriol; Pichini, Simona

    2010-06-01

    Most of the licit and illicit drugs consumed by the breastfeeding woman pass into the milk and can modify the production, volume and composition of the milk, as well as hypothetically have short- and long-term harmful effects on the infant. There is much confusion in the scientific community regarding this issue: should a woman breastfeed her baby while continuing to use prescription drugs and/or drugs of abuse? There are many case reports of clinically significant toxicity in breast-fed infants from some substances used by mothers (such as irritability, vomiting, sedation, respiratory depression, shock), but there are too few data on studies conducted in breastfeeding women and their infants to make a realistic risk assessment. The objective measurement of a drug and/or metabolites in maternal milk is the first step when investigating the amount of drug excreted in milk and subsequently calculating the daily dose administered to the breast-fed infant. The present review reports the analytical methods developed to detect different drugs in the breast milk, listing the principal characteristics and validation parameters, advantages and disadvantages. Furthermore, the mechanisms of drug transfer into breast milk are discussed, the correlation between the concentration of the drug in breast milk and potential adverse outcomes on the infant are described for each drug, and suggested harm minimization strategies and approved breastfeeding recommendations are indicated.

  16. The algorithmic performance of J-Tpeak for drug safety clinical trial.

    Science.gov (United States)

    Chien, Simon C; Gregg, Richard E

    The interval from J-point to T-wave peak (JTp) in ECG is a new biomarker able to identify drugs that prolong the QT interval but have different ion channel effects. If JTp is not prolonged, the prolonged QT may be associated with multi ion channel block that may have low torsade de pointes risk. From the automatic ECG measurement perspective, accurate and repeatable measurement of JTp involves different challenges than QT. We evaluated algorithm performance and JTp challenges using the Philips DXL diagnostic 12/16/18-lead algorithm. Measurement of JTp represents a different use model. Standard use of corrected QT interval is clinical risk assessment on patients with cardiac disease or suspicion of heart disease. Drug safety trials involve a very different population - young healthy subjects - who commonly have J-waves, notches and slurs. Drug effects include difficult and unusual morphology such as flat T-waves, gentle notches, and multiple T-wave peaks. The JTp initiative study provided ECGs collected from 22 young subjects (11 males and females) in randomized testing of dofetilide, quinidine, ranolazine, verapamil and placebo. We compare the JTp intervals between DXL algorithm and the FDA published measurements. The lead wise, vector-magnitude (VM), root-mean-square (RMS) and principal-component-analysis (PCA) representative beats were used to measure JTp and QT intervals. We also implemented four different methods for T peak detection for comparison. We found that JTp measurements were closer to the reference for combined leads RMS and PCA than individual leads. Differences in J-point location led to part of the JTp measurement difference because of the high prevalence of J-waves, notches and slurs. Larger differences were noted for drug effect causing multiple distinct T-wave peaks (Tp). The automated algorithm chooses the later peak while the reference was the earlier peak. Choosing among different algorithmic strategies in T peak measurement results in the

  17. Detecting drug-induced prolongation of the QRS complex: New insights for cardiac safety assessment

    Energy Technology Data Exchange (ETDEWEB)

    Cros, C., E-mail: caroline.cros@hotmail.co.uk [Safety Pharmacology, Global Safety Assessment, Safety Assessment UK, AstraZeneca R and D, Alderley Park, Macclesfield, SK10 4TG (United Kingdom); Skinner, M., E-mail: Matthew.Skinner@astrazeneca.com [Safety Pharmacology, Global Safety Assessment, Safety Assessment UK, AstraZeneca R and D, Alderley Park, Macclesfield, SK10 4TG (United Kingdom); Moors, J. [Safety Pharmacology, Global Safety Assessment, Safety Assessment UK, AstraZeneca R and D, Alderley Park, Macclesfield, SK10 4TG (United Kingdom); Lainee, P. [Sanofi-Aventis R and D, 371, rue du Pr Joseph Blayac, 34184 Montpellier Cedex 04 (France); Valentin, J.P. [Safety Pharmacology, Global Safety Assessment, Safety Assessment UK, AstraZeneca R and D, Alderley Park, Macclesfield, SK10 4TG (United Kingdom)

    2012-12-01

    Background: Drugs slowing the conduction of the cardiac action potential and prolonging QRS complex duration by blocking the sodium current (I{sub Na}) may carry pro-arrhythmic risks. Due to the frequency-dependent block of I{sub Na}, this study assesses whether activity-related spontaneous increases in heart rate (HR) occurring during standard dog telemetry studies can be used to optimise the detection of class I antiarrhythmic-induced QRS prolongation. Methods: Telemetered dogs were orally dosed with quinidine (class Ia), mexiletine (class Ib) or flecainide (class Ic). QRS duration was determined standardly (5 beats averaged at rest) but also prior to and at the plateau of each acute increase in HR (3 beats averaged at steady state), and averaged over 1 h period from 1 h pre-dose to 5 h post-dose. Results: Compared to time-matched vehicle, at rest, only quinidine and flecainide induced increases in QRS duration (E{sub max} 13% and 20% respectively, P < 0.01–0.001) whereas mexiletine had no effect. Importantly, the increase in QRS duration was enhanced at peak HR with an additional effect of + 0.7 ± 0.5 ms (quinidine, NS), + 1.8 ± 0.8 ms (mexiletine, P < 0.05) and + 2.8 ± 0.8 ms (flecainide, P < 0.01) (calculated as QRS at basal HR-QRS at high HR). Conclusion: Electrocardiogram recordings during elevated HR, not considered during routine analysis optimised for detecting QT prolongation, can be used to sensitise the detection of QRS prolongation. This could prove useful when borderline QRS effects are detected. Analysing during acute increases in HR could also be useful for detecting drug-induced effects on other aspects of cardiac function. -- Highlights: ► We aimed to improve detection of drug-induced QRS prolongation in safety screening. ► We used telemetered dogs to test class I antiarrhythmics at low and high heart rate. ► At low heart rate only quinidine and flecainide induced an increase in QRS duration. ► At high heart rate the effects of two

  18. Detecting drug-induced prolongation of the QRS complex: New insights for cardiac safety assessment

    International Nuclear Information System (INIS)

    Cros, C.; Skinner, M.; Moors, J.; Lainee, P.; Valentin, J.P.

    2012-01-01

    Background: Drugs slowing the conduction of the cardiac action potential and prolonging QRS complex duration by blocking the sodium current (I Na ) may carry pro-arrhythmic risks. Due to the frequency-dependent block of I Na , this study assesses whether activity-related spontaneous increases in heart rate (HR) occurring during standard dog telemetry studies can be used to optimise the detection of class I antiarrhythmic-induced QRS prolongation. Methods: Telemetered dogs were orally dosed with quinidine (class Ia), mexiletine (class Ib) or flecainide (class Ic). QRS duration was determined standardly (5 beats averaged at rest) but also prior to and at the plateau of each acute increase in HR (3 beats averaged at steady state), and averaged over 1 h period from 1 h pre-dose to 5 h post-dose. Results: Compared to time-matched vehicle, at rest, only quinidine and flecainide induced increases in QRS duration (E max 13% and 20% respectively, P < 0.01–0.001) whereas mexiletine had no effect. Importantly, the increase in QRS duration was enhanced at peak HR with an additional effect of + 0.7 ± 0.5 ms (quinidine, NS), + 1.8 ± 0.8 ms (mexiletine, P < 0.05) and + 2.8 ± 0.8 ms (flecainide, P < 0.01) (calculated as QRS at basal HR-QRS at high HR). Conclusion: Electrocardiogram recordings during elevated HR, not considered during routine analysis optimised for detecting QT prolongation, can be used to sensitise the detection of QRS prolongation. This could prove useful when borderline QRS effects are detected. Analysing during acute increases in HR could also be useful for detecting drug-induced effects on other aspects of cardiac function. -- Highlights: ► We aimed to improve detection of drug-induced QRS prolongation in safety screening. ► We used telemetered dogs to test class I antiarrhythmics at low and high heart rate. ► At low heart rate only quinidine and flecainide induced an increase in QRS duration. ► At high heart rate the effects of two out of three

  19. 77 FR 44256 - Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510...

    Science.gov (United States)

    2012-07-27

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510(k... serious and sometimes fatal consequences to patients. This guidance provides recommendations to 510(k... unintended connections between enteral and nonenteral devices. This draft guidance is not final nor is it in...

  20. Data-driven drug safety signal detection methods in pharmacovigilance using electronic primary care records: A population based study

    Directory of Open Access Journals (Sweden)

    Shang-Ming Zhou

    2017-04-01

    Data-driven analytic methods are a valuable aid to signal detection of ADEs from large electronic health records for drug safety monitoring. This study finds the methods can detect known ADE and so could potentially be used to detect unknown ADE.

  1. Direct-to-consumer advertising (DTCA) for prescription drugs: consumers' attitudes and preferences concerning its regulation in South Korea.

    Science.gov (United States)

    Suh, Hae Sun; Lee, Donghyun; Kim, Sang Yong; Chee, Dong Hyun; Kang, Hye-Young

    2011-08-01

    To examine consumers' attitudes toward direct-to-consumer advertising (DTCA) for prescription drugs in Korea. We conducted a survey of 350 patients visiting community pharmacies to fill their prescriptions. Consumers' attitudes toward DTCA were assessed in terms of whether they felt DTCA was necessary, their trust in the information provided by DTCA, and their intention to use the information provided by DTCA. We examined consumers' preferences regarding the regulation of DTCA and their expectations of the effects of DTCA. About 60% of the respondents responded that DTCA is necessary and that they intended to use the information from DTCA. Less than half of the respondents reported that they would trust DTCA information. About 70% of the participants expressed the need for prior vetting of the DTCA content. Respondents had the highest expectation on the effect of DTCA as an information source for patients. Positive consumer expectations regarding the effects of DTCA were significantly associated with positive consumer attitudes toward DTCA (odds ratio=4.70, 95% confidence interval: 2.25-9.82). This study provides evidence that consumers in South Korea generally have positive attitudes toward DTCA. However, most of the respondents wanted a prior examination system of DTCA content to ensure that the information conveyed to them via DTCA was trustworthy. Policy-makers should be cautious and well-prepared if they decide to introduce DTCA in Korea. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  2. Regulatory oversight report 2011 concerning nuclear safety in Swiss nuclear installations; Aufsichtsbericht 2011 zur nuklearen Sicherheit in den schweizerischen Kernanlagen

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2012-06-15

    The Swiss Federal Nuclear Safety Inspectorate ENSI, acting as the regulatory body of the Swiss Confederation, assesses and monitors nuclear facilities in Switzerland. These include five nuclear power plants, the interim storage facilities based at each plant, the Central Interim Storage Facility (ZWILAG) at Wuerenlingen together with the nuclear facilities at the Paul Scherrer Institute (PSI) and the two universities of Basel and Lausanne. ENSI ensures that the facilities comply with regulations and operate according to the law. Its regulatory responsibilities also include the transport of radioactive materials to and from nuclear facilities and the preparations for a deep geologic repository for nuclear waste. It maintains its own emergency organisation, which is an integral part of a national emergency structure. Building on the legislative framework, ENSI also formulates and updates its own guidelines. It provides the public with information on particular events and findings in nuclear facilities. In 2011, all five nuclear power reactors in Switzerland (Beznau Units 1 and 2, Muehleberg, Goesgen and Leibstadt) were operated safely and ENSI concluded that they had complied with their approved operating conditions. There were 27 reportable events in the nuclear power plants in Switzerland: 7 at Beznau, 5 at Goesgen, 11 at Leibstadt und 4 at Muehleberg. On the international INES scale of 0 to 7, ENSI rated 26 events as Level 0. One event, at the Muehleberg nuclear power plant, was rated as INES Level 1. This related to a potential blockage of the emergency water intake system in the event of extreme flooding. The operator BKW shut down the Muehleberg plant ahead of the scheduled maintenance date and upgraded the system. ZWILAG consists of several interim storage halls, a conditioning plant and a plasma plant (incineration/melting plant). At the end of 2011, the cask storage hall contained 34 transport/storage casks with fuel assemblies and vitrified residue packages

  3. Patient centric drug product design in modern drug delivery as an opportunity to increase safety and effectiveness.

    Science.gov (United States)

    Stegemann, Sven

    2018-06-01

    The advances in drug delivery technologies have enabled pharmaceutical scientists to deliver a drug through various administration routes and optimize the drug release and absorption. The wide range of drug delivery systems and dosage forms represent a toolbox of technology for the development of pharmaceutical drug products but might also be a source of medication errors and nonadherence. Patient centric drug product development is being suggested as an important factor to increase therapeutic outcomes. Areas covered: Patients have impaired health and potentially disabilities and they are not medical or pharmaceutical experts but are requested to manage complex therapeutic regimens. As such the application of technology should also serve to reduce complexity, build on patients' intuition and ease of use. Patients form distinct populations based on the targeted disease, disease cluster or age group with specific characteristics or therapeutic contexts. Expert opinion: Establishing a target product and patient profile is essential to guide drug product design development. Including the targeted patient populations in the process is a prerequisite to achieve patient-centric pharmaceutical drug product design. Addressing the needs early on in the product design process, will create more universal design, avoiding the necessity for multiple product presentations to cover the different patient populations.

  4. How do pharmaceutical companies handle consumer adverse drug reaction reports? An overview based on a survey of French drug safety managers and officers.

    Science.gov (United States)

    Fleuranceau-Morel, P

    2002-01-01

    It is surprising to see how consumer Adverse Drug Reaction (ADR) reports have been continuously increasing for the last few years in Europe. This probably results from the influence of United States (US) market where the patients feels justified in telephoning the pharmaceutical companies directly with queries regarding their treatment. The growing number of alternative sources of information (e.g. health and popular magazines, spots on radio and TV etc.) to which a consumer is exposed has added to this growth too. The changing relationship between patients and doctors may also contribute to this phenomenon. It is then interesting to evaluate the way pharmaceutical companies currently deal with consumer ADR reports. The management of consumer ADR reporting was investigated by means of a questionnaire sent to 46 French drug safety managers and drug safety officers (DSOs) of multinational pharmaceutical companies. The analysis of the survey stressed the fact that pharmaceutical companies should be prepared to face up to an increase in the number of consumer ADR reports. It clearly appears that the consumers who telephone to register side-effects should be forwarded to a trained DSO with medical or pharmaceutical background and the communication skills acquired through specific training. This person should also be able to release adequate product information validated by his/her own company. The influence of the US market seems to be changing the way pharmaceutical companies deal with consumer ADR reports. Nowadays, these reports are entered into a drug safety database by most of the companies without previously having contacted the patient's general practitioner (GP) or specialist for medical confirmation. Lastly, the drug safety managers and DSOs consulted have divided opinions about the usefulness of call centres and e-mails as tools for ADR reporting. But both tools are globally rejected by the pharmaceutical companies as a reliable means of reporting. As stated

  5. Identification of UV-absorbing extractables from rubber closures used in containers of injectable powder and safety assessment of leachables in the drug.

    Science.gov (United States)

    Wei, Yulei; Wu, Ying; Zhu, Tingli; Li, Zhiyan; Zhang, Yilan

    2017-05-10

    Rubber closures have been of great concern to regulatory authorities on account of their potential safety risks to patients. The aim of our work is to provide part of data about the compatibility of the injectable powder and its packaging materials for the drug registration. In this report, methodologies were established to study the system of the preparation. Firstly, three major extractables were isolated by semi-preparative HPLC method combined with silica gel-based chromatographic methods. NMR spectra including 1D NMR ( 1 H, 13 C, DEPT135) and 2D NMR (COSY, HSQC, HMBC) were introduced to identify the extractables, besides HPLC, GC-MS, ESI-MS/MS and HRMS. The extractables were determined to be N-(2-(2,2,4,4-tetramethylcyclohexyl)allyl) benzo[d]thiazol-2-amine (1), 2,6-Di-tert-butyl-4-methylphenol (2) and sulfur (3) respectively. Then, to address safety concerns, approaches including QSAR analysis, the TTC and comprehensive literature evaluation methods to toxicological safety evaluation of the target compounds were established, where the safety threshold such as TTC and PDE values were developed. Finally, the migration testing of the extractables were performed to assess the leaching behavior of the rubber closures. An optimized analysis method was proposed using SPE and HPLC with an ultraviolet detector, which demonstrated good linearity, acceptable accuracy and precision. The levels of the target compounds in the powder were measured and the calculated worst case exposure of extractable 2 exceeded the TTC limit of 1.5μg/day, indicating that the products may possess potential health risks to patients. In contrast to previous studies, various NMR techniques, which were rarely applied to identify unknown extractables from rubber closures in the literature, were discussed for the structural elucidation of rubber closures extractables. Among the target compounds, extractable 1 was a new compound, whose isolation and structural elucidation were first reported here

  6. Review of the Safety Concern Related to CANDU Moderator Temperature Distribution and Status of KAERI Moderator Circulation Test (MCT) Experiments

    Energy Technology Data Exchange (ETDEWEB)

    Rhee, Bo W.; Kim, Hyoung T. [Severe Accident and PHWR Safety Research Division, Daejeon (Korea, Republic of); Kim, Tongbeum [University of the Witwatersrand, Johannesburg (South Africa); Im, Sunghyuk [KAIST, Daejeon (Korea, Republic of)

    2015-10-15

    threshold temperature and no further deformation is expected. Consequently, a sufficient condition to ensure fuel channel integrity following a large LOCA, is the avoidance of sustained calandria tubes dryout. If the moderator available subcooling at the onset of a large LOCA is greater than the subcooling requirements, a sustained calandria tube dryout is avoided. The temperature oscillations observed in reactor and in test measurements such as MTF need to be characterized and quantified to show that it does not jeopardize the currently available safety margins. Because of the importance of an accurate prediction of moderator temperature distributions and the related moderator subcooling, a 1/4 scaled-down moderator tank of a CANDU-6 reactor, called Moderator Circulation Test (MCT), was erected at KAERI and the current status of MCT experiment progress is described and further experiments are expected to be carried out to generate the experimental data necessary to validate the computer codes that will be used to analyze the accident analysis of operating CANDU-6 plants.

  7. Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials

    Science.gov (United States)

    Perez, Raymond; Archdeacon, Patrick; Roach, Nancy; Goodwin, Robert; Jarow, Jonathan; Stuccio, Nina; Forrest, Annemarie

    2017-01-01

    Background/aims: The Food and Drug Administration’s final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes. Clinical Trials Transformation Initiative investigated remaining barriers and potential solutions to full implementation of the final rule by polling and interviewing investigators, clinical research staff, and sponsors. Methods: In an opinion-gathering effort, two discrete online surveys designed to assess challenges and motivations related to management of expedited (7- to 15-day) investigational new drug safety reporting processes in oncology trials were developed and distributed to two populations: investigators/clinical research staff and sponsors. Data were collected for approximately 1 year. Twenty-hour-long interviews were also conducted with Clinical Trials Transformation Initiative–nominated interview participants who were considered as having extensive knowledge of and experience with the topic. Interviewees included 13 principal investigators/study managers/research team members and 7 directors/vice presidents of pharmacovigilance operations from 5 large global pharmaceutical companies. Results: The investigative site’s responses indicate that too many individual reports are still being submitted, which are time-consuming to process and provide little value for patient safety assessments or for informing actionable changes. Fewer but higher quality reports would be more useful, and the investigator and staff would benefit from sponsors’“filtering” of

  8. Sponsors' and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials.

    Science.gov (United States)

    Perez, Raymond; Archdeacon, Patrick; Roach, Nancy; Goodwin, Robert; Jarow, Jonathan; Stuccio, Nina; Forrest, Annemarie

    2017-06-01

    The Food and Drug Administration's final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes. Clinical Trials Transformation Initiative investigated remaining barriers and potential solutions to full implementation of the final rule by polling and interviewing investigators, clinical research staff, and sponsors. In an opinion-gathering effort, two discrete online surveys designed to assess challenges and motivations related to management of expedited (7- to 15-day) investigational new drug safety reporting processes in oncology trials were developed and distributed to two populations: investigators/clinical research staff and sponsors. Data were collected for approximately 1 year. Twenty-hour-long interviews were also conducted with Clinical Trials Transformation Initiative-nominated interview participants who were considered as having extensive knowledge of and experience with the topic. Interviewees included 13 principal investigators/study managers/research team members and 7 directors/vice presidents of pharmacovigilance operations from 5 large global pharmaceutical companies. The investigative site's responses indicate that too many individual reports are still being submitted, which are time-consuming to process and provide little value for patient safety assessments or for informing actionable changes. Fewer but higher quality reports would be more useful, and the investigator and staff would benefit from sponsors'"filtering" of reports and increased sponsor communication. Sponsors

  9. Use of toxicogenomics in drug safety evaluation: Current status and an industry perspective.

    Science.gov (United States)

    Vahle, John L; Anderson, Ulf; Blomme, Eric A G; Hoflack, Jean-Christophe; Stiehl, Daniel P

    2018-04-18

    Toxicogenomics held great promise as an approach to enable early detection of toxicities induced by xenobiotics; however, there remain questions regarding the impact of the discipline on pharmaceutical nonclinical safety assessment. To understand the current state of toxicogenomics in the sector, an industry group surveyed companies to determine the frequency of toxicogenomics use in in vivo studies at various stages of drug discovery and development and to assess how toxicogenomics use has evolved over time. Survey data were compiled during 2016 from thirteen pharmaceutical companies. Toxicogenomic analyses were infrequently conducted in the development phase and when performed were done to address specific mechanistic questions. Prior to development, toxicogenomics use was more frequent; however, there were significant differences in approaches among companies. Across all phases, gaining mechanistic insight was the most frequent reason cited for pursing toxicogenomics with few companies using toxicogenomics to predict toxicities. These data were consistent with the commentary submitted in response to survey questions asking companies to describe the evolution of their toxicogenomics strategy. Overall, these survey data indicate that toxicogenomics is not widely used as a predictive tool in the pharmaceutical industry but is used regularly by some companies and serves a broader role in mechanistic investigations and as a complement to other technologies. Copyright © 2018. Published by Elsevier Inc.

  10. Residues of carcinogenic animal drugs in food: difficulties in evaluation of human safety.

    Science.gov (United States)

    Somogyi, A

    1979-01-01

    The indisputable need to intensify animal production in order to provide an adequate food supply for the world population involves the use of substances that are highly potent pharmacologically and toxicologically. The history of regulatory action with regard to such additives is similar to that for other substances: first, no regulation; next, an over-reaction; and now decisions based on judicious evaluation of scientific facts. One factor that differentiates the chemicals used in animal production from other food additives is that both the parent compounds and their metabolites appear in edible products, posing problems both for the analytical detection and safety evaluation of such residues. It would be unrealistic to propose 'zero' tolerances for these additives, even if they are carcinogenic. The benefits gained from drugs that cure and prevent infections and parasitic diseases in food-producing animals, and the fact that analytical methods can now detect very small quantities make the presence of low levels of these substances in food unobjectionable.

  11. 78 FR 22270 - Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety...

    Science.gov (United States)

    2013-04-15

    ..., indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes... Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, for new drug...

  12. Determination of safety margins for whole blood concentrations of alcohol and nineteen drugs in driving under the influence cases.

    Science.gov (United States)

    Kristoffersen, Lena; Strand, Dag Helge; Liane, Veronica Horpestad; Vindenes, Vigdis; Tvete, Ingunn Fride; Aldrin, Magne

    2016-02-01

    Legislative limits for driving under the influence of 20 non-alcohol drugs were introduced in Norway in February 2012. Per se limits corresponding to blood alcohol concentrations (BAC) of 0.2g/kg were established for 20 psychoactive drugs, and limits for graded sanctions corresponding to BACs of 0.5 and 1.2g/kg were determined for 13 of these drugs. This new legislation made it possible for the courts to make sentences based on the analytical results, similar to the situation for alcohol. To ensure that the reported concentration is as least as high as the true concentration, with a 99% safety level, safety margins had to be calculated for each of the substances. Diazepam, tetrahydrocannabinol (THC) and alcohol were used as model substances to establish a new model for estimating the safety margins. The model was compared with a previous used model established several years ago, by a similar yet much simpler model, and they were found to be in agreement. The measurement uncertainties depend on the standard batch used, the work list and the measurements' replicate. A Bayesian modelling approach was used to determine the parameters in the model, using a dataset of 4700 diazepam positive specimens and 5400 THC positive specimens. Different safety margins were considered for low and high concentration levels of diazepam (≤2μM (0.6mg/L) and >2μM) and THC (≤0.01μM (0.003mg/L) and >0.01μM). The safety margins were for diazepam 19.5% (≤2μM) and 34% (>2μM), for THC 19.5% (≤0.01μM) and 24.9% (>0.01μM). Concentration dependent safety margins for BAC were based on a dataset of 29500 alcohol positive specimens, and were in the range 10.4% (0.1g/kg) to 4.0% (4.0g/kg) at a 99% safety level. A simplified approach was used to establish safety margins for the compounds amphetamine, MDMA, methamphetamine, alprazolam, phenazepam, flunitrazepam, clonazepam, nitrazepam, oxazepam, buprenorphine, GHB, methadone, ketamine, cocaine, morphine, zolpidem and zopiclone. The

  13. Ptaquiloside, the major carcinogen of bracken fern, in the pooled raw milk of healthy sheep and goats: an underestimated, global concern of food safety.

    Science.gov (United States)

    Virgilio, Antonella; Sinisi, Annamaria; Russo, Valeria; Gerardo, Salvatore; Santoro, Adriano; Galeone, Aldo; Taglialatela-Scafati, Orazio; Roperto, Franco

    2015-05-20

    Bracken fern (Pteridium aquilinum) is a worldwide plant containing toxic substances, which represent an important chemical hazard for animals, including humans. Ptaquiloside, 1, a norsesquiterpenoid glucoside, is the major carcinogen of bracken detected in the food chain, particularly in the milk from farm animals. To date, ptaquiloside has been shown in the milk of cows feeding on a diet containing bracken fern. This is the first study that shows the systematic detection of ptaquiloside, 1, and reports its direct quantitation in pooled raw milk of healthy sheep and goats grazing on bracken. Ptaquiloside, 1, was detected by a sensitive method based on the chemical conversion of ptaquiloside, 1, into bromopterosine, 4, following gas chromatography-mass spectrometry (GC-MS) analysis. The presence of ptaquiloside, 1, possibly carcinogenic to humans, in the milk of healthy animals is an unknown potential health risk, thus representing a harmful and potential global concern of food safety.

  14. The safety, efficacy and regulatory triangle in drug development: Impact for animal models and the use of animals.

    Science.gov (United States)

    van Meer, Peter J K; Graham, Melanie L; Schuurman, Henk-Jan

    2015-07-15

    Nonclinical studies in animals are conducted to demonstrate proof-of-concept, mechanism of action and safety of new drugs. For a large part, in particular safety assessment, studies are done in compliance with international regulatory guidance. However, animal models supporting the initiation of clinical trials have their limitations, related to uncertainty regarding the predictive value for a clinical condition. The 3Rs principles (refinement, reduction and replacement) are better applied nowadays, with a more comprehensive application with respect to the original definition. This regards also regulatory guidance, so that opportunities exist to revise or reduce regulatory guidance with the perspective that the optimal balance between scientifically relevant data and animal wellbeing or a reduction in animal use can be achieved. In this manuscript we review the connections in the triangle between nonclinical efficacy/safety studies and regulatory aspects, with focus on in vivo testing of drugs. These connections differ for different drugs (chemistry-based low molecular weight compounds, recombinant proteins, cell therapy or gene therapy products). Regarding animal models and their translational value we focus on regulatory aspects and indications where scientific outcomes warrant changes, reduction or replacement, like for, e.g., biosimilar evaluation and safety testing of monoclonal antibodies. On the other hand, we present applications where translational value has been clearly demonstrated, e.g., immunosuppressives in transplantation. Especially for drugs of more recent date like recombinant proteins, cell therapy products and gene therapy products, a regulatory approach that allows the possibility to conduct combined efficacy/safety testing in validated animal models should strengthen scientific outcomes and improve translational value, while reducing the numbers of animals necessary. Copyright © 2015 Elsevier B.V. All rights reserved.

  15. Working towards consensus on methods used to elicit participant-reported safety data in uncomplicated malaria clinical drug studies: a Delphi technique study.

    Science.gov (United States)

    Mandimika, Nyaradzo; Barnes, Karen I; Chandler, Clare I R; Pace, Cheryl; Allen, Elizabeth N

    2017-01-28

    Eliciting adverse event (AE) and non-study medication data reports from clinical research participants is integral to evaluating drug safety. However, using different methods to question participants yields inconsistent results, compromising the interpretation, comparison and pooling of data across studies. This is particularly important given the widespread use of anti-malarials in vulnerable populations, and their increasing use in healthy, but at-risk individuals, as preventive treatment or to reduce malaria transmission. Experienced and knowledgeable anti-malarial drug clinical researchers were invited to participate in a Delphi technique study, to facilitate consensus on what are considered optimal (relevant, important and feasible) methods, tools, and approaches for detecting participant-reported AE and non-study medication data in uncomplicated malaria treatment studies. Of 72 invited, 25, 16 and 10 panellists responded to the first, second and third rounds of the Delphi, respectively. Overall, 68% (68/100) of all questioning items presented for rating achieved consensus. When asking general questions about health, panellists agreed on the utility of a question/concept about any change in health, taking care to ensure that such questions/concepts do not imply causality. Eighty-nine percent (39/44) of specific signs and symptoms questions were rated as optimal. For non-study medications, a general question and most structured questioning items were considered an optimal approach. The use of mobile phones, patient diaries, rating scales as well as openly engaging with participants to discuss concerns were also considered optimal complementary data-elicitation tools. This study succeeded in reaching consensus within a section of the anti-malarial drug clinical research community about using a general question concept, and structured questions for eliciting data about AEs and non-study medication reports. The concepts and items considered in this Delphi to be

  16. Five-year follow-up of survival and relapse in patients who received cryotherapy during high-dose chemotherapy for stem cell transplantation shows no safety concerns.

    Science.gov (United States)

    Svanberg, A; Ohrn, K; Birgegård, G

    2012-11-01

    We have previously published a randomised controlled study of the efficacy of cryotherapy in preventing acute oral mucositis after high-dose chemotherapy for stem cell transplantation. The present study is a 5-year follow-up safety study of survival in these patients. In the previously published study oral cryotherapy (cooling of the oral cavity) during high-dose chemotherapy significantly reduced mucositis grade and opiate use in the treated group. All patients were followed up for at least 5 years with regard to relapse and death rates. Baseline data, transplant complications and mucositis data were compared. Significantly more patients (25/39) who received oral cryotherapy were alive after 5 years compared to 15/39 in the control group (P= 0.025). Relapse rates were similar. The only baseline difference was a lower proportion of patients in complete remission at transplantation in the control group (6 vs. 13, P= 0.047). This 5-year follow-up study gave no support for safety concerns with cryotherapy. © 2012 Blackwell Publishing Ltd.

  17. 75 FR 2926 - Pipeline Safety: Reporting Drug and Alcohol Test Results for Contractors and Multiple Operator...

    Science.gov (United States)

    2010-01-19

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No... Operator Identification Numbers AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT... liquid, and carbon dioxide pipelines and liquefied natural gas facilities that the Pipeline and Hazardous...

  18. Post-marketing safety and effectiveness evaluation of the intravenous anti-influenza neuraminidase inhibitor peramivir. II: a pediatric drug use investigation.

    Science.gov (United States)

    Komeda, Takuji; Ishii, Shingo; Itoh, Yumiko; Ariyasu, Yasuyuki; Sanekata, Masaki; Yoshikawa, Takayoshi; Shimada, Jingoro

    2015-03-01

    Peramivir is the only intravenous formulation among anti-influenza neuraminidase inhibitors currently available. Peramivir was approved for manufacturing and marketing in Japan in January 2010. In October 2010, an additional indication for pediatric use was approved. We conducted a pediatric drug use investigation of peramivir from October 2010 to February 2012 and evaluated its real-world safety and effectiveness in pediatric patients. We collected the data of 1254 peramivir-treated pediatric patients from 161 facilities across Japan and examined the safety in 1199 patients and effectiveness in 1188 patients. In total, 245 adverse events were observed with an incidence rate of 14.01% (168/1199). Of these, 115 events were adverse drug reactions (ADRs) with an incidence rate of 7.67% (92/1199). Common ADRs were diarrhea and abnormal behavior, with incidence rates of 2.50% (30/1199) and 2.25% (27/1199), respectively. Fourteen serious ADRs were observed in 12 patients (1.00%), including 5 cases each of abnormal behavior and neutrophil count decreased. While 87.0% (100 events) of ADRs occurred within 3 days after the initiation of peramivir administration, 87.8% (101 events) resolved or improved within 7 days after onset. Multivariate analyses indicated that the presence or absence of underlying diseases/complications was significantly related to ADR incidence. With regard to effectiveness, the median time to alleviation of both influenza symptoms and fever was 3 days, including the first day of administration. Thus, this study confirms the pediatric safety of peramivir without any concerns about effectiveness under routine clinical settings. Copyright © 2014 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  19. Applicability and safety of dual-frequency ultrasonic treatment for the transdermal delivery of drugs

    Science.gov (United States)

    Schoellhammer, Carl M.; Srinivasan, Sharanya; Barman, Ross; Mo, Stacy H.; Polat, Baris E.; Langer, Robert; Blankschtein, Daniel

    2016-01-01

    Low-frequency ultrasound presents an attractive method for transdermal drug delivery. The controlled, yet nonspecific nature of enhancement broadens the range of therapeutics that can be delivered, while minimizing necessary reformulation efforts for differing compounds. Long and inconsistent treatment times, however, have partially limited the attractiveness of this method. Building on recent advances made in this area, the simultaneous use of low- and high-frequency ultrasound is explored in a physiologically relevant experimental setup to enable the translation of this treatment to testing in vivo. Dual-frequency ultrasound, utilizing 20 kHz and 1 MHz wavelengths simultaneously, was found to significantly enhance the size of localized transport regions (LTRs) in both in vitro and in vivo models while decreasing the necessary treatment time compared to 20 kHz alone. Additionally, LTRs generated by treatment with 20 kHz + 1 MHz were found to be more permeable than those generated with 20 kHz alone. This was further corroborated with pore-size estimates utilizing hindered-transport theory, in which the pores in skin treated with 20 kHz + 1 MHz were calculated to be significantly larger than the pores in skin treated with 20 kHz alone. This demonstrates for the first time that LTRs generated with 20 kHz + 1 MHz are also more permeable than those generated with 20 kHz alone, which could broaden the range of therapeutics and doses administered transdermally. With regard to safety, treatment with 20 kHz + 1 MHz both in vitro and in vivo appeared to result in no greater skin disruption than that observed in skin treated with 20 kHz alone, an FDA-approved modality. This study demonstrates that dual-frequency ultrasound is more efficient and effective than single-frequency ultrasound and is well-tolerated in vivo. PMID:25662228

  20. The Utility of Infliximab Therapeutic Drug Monitoring among Patients with Inflammatory Bowel Disease and Concerns for Loss of Response: A Retrospective Analysis of a Real-World Experience

    Directory of Open Access Journals (Sweden)

    Robert A. Mitchell

    2016-01-01

    Full Text Available Background. Infliximab (IFX therapeutic drug monitoring (TDM allows for objective decision making in patients with inflammatory bowel disease (IBD and loss of response. Questions remain about whether IFX TDM improves outcomes. Methods. Patients with IBD who had IFX TDM due to concerns for loss of response were considered for inclusion. Serum IFX trough concentration and anti-drug antibody (ADA concentrations were measured. Patients were grouped by TDM results: group 1, low IFX/high ADA; group 2, low IFX/low ADA; group 3, therapeutic IFX. Changes in management were analyzed according to groupings; remission rates were assessed at 6 months. Results. 71 patients were included of whom 37% underwent an appropriate change in therapy. Groups 1 (67% and 2 (83% had high adherence compared to only 9% in group 3. At 6 months, 57% had achieved remission. More patients who underwent an appropriate change in therapy achieved remission, though this did not reach statistical significance (69% versus 49%; P=0.098. Conclusions. A trend towards increased remission rates was associated with appropriate changes in management following TDM results. Many patients with therapeutic IFX concentrations did not undergo an appropriate change in management, potentially reflecting a lack of available out-of-class options at the time of TDM or due to uncertainty of the meaning of the reported therapeutic range.

  1. Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project.

    Science.gov (United States)

    Perez, Raymond P; Finnigan, Shanda; Patel, Krupa; Whitney, Shanell; Forrest, Annemarie

    2016-12-15

    Use of electronic clinical trial portals has increased in recent years to assist with sponsor-investigator communication, safety reporting, and clinical trial management. Electronic portals can help reduce time and costs associated with processing paperwork and add security measures; however, there is a lack of information on clinical trial investigative staff's perceived challenges and benefits of using portals. The Clinical Trials Transformation Initiative (CTTI) sought to (1) identify challenges to investigator receipt and management of investigational new drug (IND) safety reports at oncologic investigative sites and coordinating centers and (2) facilitate adoption of best practices for communicating and managing IND safety reports using electronic portals. CTTI, a public-private partnership to improve the conduct of clinical trials, distributed surveys and conducted interviews in an opinion-gathering effort to record investigator and research staff views on electronic portals in the context of the new safety reporting requirements described in the US Food and Drug Administration's final rule (Code of Federal Regulations Title 21 Section 312). The project focused on receipt, management, and review of safety reports as opposed to the reporting of adverse events. The top challenge investigators and staff identified in using individual sponsor portals was remembering several complex individual passwords to access each site. Also, certain tasks are time-consuming (eg, downloading reports) due to slow sites or difficulties associated with particular operating systems or software. To improve user experiences, respondents suggested that portals function independently of browsers and operating systems, have intuitive interfaces with easy navigation, and incorporate additional features that would allow users to filter, search, and batch safety reports. Results indicate that an ideal system for sharing expedited IND safety information is through a central portal used by

  2. Efficacy and safety of rabeprazole in non-steroidal anti-inflammatory drug-induced ulcer in Japan.

    Science.gov (United States)

    Mizokami, Yuji

    2009-10-28

    To investigate the efficacy and safety of rabeprazole under continuous non-steroidal anti-inflammatory drug (NSAID) administration for NSAID-induced ulcer in Japan. Subjects comprised patients undergoing NSAID treatment in whom upper gastrointestinal endoscopy revealed an ulcerous lesion (open ulcer) with diameter > or = 3 mm, who required continuous NSAID treatment. Endoscopies were performed at the start of treatment, during the treatment period, and at the conclusion (or discontinuation) of treatment. Findings were evaluated as size (maximum diameter) and stage based on the Sakita-Miwa classification. An ulcer was regarded as cured when the "white coating" was seen to have disappeared under endoscopy. As criteria for evaluating safety, all medically untoward symptoms and signs (adverse events, laboratory abnormalities, accidental symptoms, etc.) occurring after the start of rabeprazole treatment were handled as adverse events. Endoscopic cure rate in 38 patients in the efficacy analysis (endoscopic evaluation) was 71.1% (27/38). Among those 38 patients, 35 had gastric ulcer with a cure rate of 71.4% (25/35), and 3 had duodenal ulcer with a cure rate of 66.7% (2/3). Three adverse drug reactions were reported from 64 patients in the safety analysis (interstitial pneumonia, low white blood cell count and pruritus); thus, the incidence rate for adverse drug reactions was 4.7% (3/64). The treatment efficacy of rabeprazole for NSAID-induced ulcer under continuous NSAID administration was confirmed.

  3. 78 FR 10107 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules To Establish Standards...

    Science.gov (United States)

    2013-02-13

    ... AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public meeting. SUMMARY: The Food and Drug Administration (FDA) is providing public meeting registration information for two FSMA related... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 16, 106, 110...

  4. The role of the anaesthetised guinea-pig in the preclinical cardiac safety evaluation of drug candidate compounds

    Energy Technology Data Exchange (ETDEWEB)

    Marks, Louise, E-mail: louise.marks@astrazeneca.com [Safety Assessment UK, AstraZeneca, Mereside, Alderley Park, Macclesfield, Cheshire, SK10 4TG (United Kingdom); Borland, Samantha; Philp, Karen; Ewart, Lorna; Lainée, Pierre; Skinner, Matthew [Safety Assessment UK, AstraZeneca, Mereside, Alderley Park, Macclesfield, Cheshire, SK10 4TG (United Kingdom); Kirk, Sarah [Innovative Medicines, Discovery Sciences, AstraZeneca, Alderley Park, Macclesfield, Cheshire, SK10 4TG (United Kingdom); Valentin, Jean-Pierre [Safety Assessment UK, AstraZeneca, Mereside, Alderley Park, Macclesfield, Cheshire, SK10 4TG (United Kingdom)

    2012-09-01

    Despite rigorous preclinical and clinical safety evaluation, adverse cardiac effects remain a leading cause of drug attrition and post-approval drug withdrawal. A number of cardiovascular screens exist within preclinical development. These screens do not, however, provide a thorough cardiac liability profile and, in many cases, are not preventing the progression of high risk compounds. We evaluated the suitability of the anaesthetised guinea-pig for the assessment of drug-induced changes in cardiovascular parameters. Sodium pentobarbitone anaesthetised male guinea-pigs received three 15 minute intravenous infusions of ascending doses of amoxicillin, atenolol, clonidine, dobutamine, dofetilide, flecainide, isoprenaline, levosimendan, milrinone, moxifloxacin, nifedipine, paracetamol, verapamil or vehicle, followed by a 30 minute washout. Dose levels were targeted to cover clinical exposure and above, with plasma samples obtained to evaluate effect/exposure relationships. Arterial blood pressure, heart rate, contractility function (left ventricular dP/dt{sub max} and QA interval) and lead II electrocardiogram were recorded throughout. In general, the expected reference compound induced effects on haemodynamic, contractility and electrocardiographic parameters were detected confirming that all three endpoints can be measured accurately and simultaneously in one small animal. Plasma exposures obtained were within, or close to the expected clinical range of therapeutic plasma levels. Concentration–effect curves were produced which allowed a more complete understanding of the margins for effects at different plasma exposures. This single in vivo screen provides a significant amount of information pertaining to the cardiovascular risk of drug candidates, ultimately strengthening strategies addressing cardiovascular-mediated compound attrition and drug withdrawal. -- Highlights: ► Evaluation of the anaesthetised guinea-pig to determine cardiac liability.

  5. The role of the anaesthetised guinea-pig in the preclinical cardiac safety evaluation of drug candidate compounds

    International Nuclear Information System (INIS)

    Marks, Louise; Borland, Samantha; Philp, Karen; Ewart, Lorna; Lainée, Pierre; Skinner, Matthew; Kirk, Sarah; Valentin, Jean-Pierre

    2012-01-01

    Despite rigorous preclinical and clinical safety evaluation, adverse cardiac effects remain a leading cause of drug attrition and post-approval drug withdrawal. A number of cardiovascular screens exist within preclinical development. These screens do not, however, provide a thorough cardiac liability profile and, in many cases, are not preventing the progression of high risk compounds. We evaluated the suitability of the anaesthetised guinea-pig for the assessment of drug-induced changes in cardiovascular parameters. Sodium pentobarbitone anaesthetised male guinea-pigs received three 15 minute intravenous infusions of ascending doses of amoxicillin, atenolol, clonidine, dobutamine, dofetilide, flecainide, isoprenaline, levosimendan, milrinone, moxifloxacin, nifedipine, paracetamol, verapamil or vehicle, followed by a 30 minute washout. Dose levels were targeted to cover clinical exposure and above, with plasma samples obtained to evaluate effect/exposure relationships. Arterial blood pressure, heart rate, contractility function (left ventricular dP/dt max and QA interval) and lead II electrocardiogram were recorded throughout. In general, the expected reference compound induced effects on haemodynamic, contractility and electrocardiographic parameters were detected confirming that all three endpoints can be measured accurately and simultaneously in one small animal. Plasma exposures obtained were within, or close to the expected clinical range of therapeutic plasma levels. Concentration–effect curves were produced which allowed a more complete understanding of the margins for effects at different plasma exposures. This single in vivo screen provides a significant amount of information pertaining to the cardiovascular risk of drug candidates, ultimately strengthening strategies addressing cardiovascular-mediated compound attrition and drug withdrawal. -- Highlights: ► Evaluation of the anaesthetised guinea-pig to determine cardiac liability. ► Haemodynamic

  6. Decree of 16 October 1969, Stb. 472, concerning the implementation of Sections 27 and 58, paragraph 5 of the Nuclear Energy Act (Registration of Radioactive Materials and Food and Drugs Inspectorate Charges)

    International Nuclear Information System (INIS)

    1969-01-01

    Under the Nuclear Energy Act, any person who prepares, transports, uses or dumps radioactive materials must keep a register concerning the materials and theses operations. This Decree stipulates that the register must be kept in such a way as to show clearly which radioactive materials subject to registration are present within the area under the jurisdiction of the food and drug inspectorates concerned. It also lays down rules concerning provision of information from the register and financing the cost of the food and drug inspectorates. (NEA) [fr

  7. Strategies for the early detection of drug-induced hepatic steatosis in preclinical drug safety evaluation studies

    International Nuclear Information System (INIS)

    Amacher, David E.

    2011-01-01

    Hepatic steatosis is characterized by the accumulation of lipid droplets in the liver. Although relatively benign, simple steatosis can eventually lead to the development of steatohepatitis, a more serious condition characterized by fibrosis, cirrhosis, and eventual liver failure if the underlying cause is not eliminated. According to the 'two hit' theory of steatohepatitis, the initial hit involves fat accumulation in the liver, and a second hit leads to inflammation and subsequent tissue injury. Because some xenobiotics target liver fatty acid metabolism, especially mitochondrial β-oxidation, it is important to avoid potential drug candidates that can contribute to either the initiation of liver steatosis or progression to the more injurious steatohepatitis. The gold standard for the detection of these types of hepatic effects is histopathological examination of liver tissue. In animal studies, these examinations are slow, restricted to a single sampling time, and limited tissue sections. Recent literature suggests that rapid in vitro screening methods can be used early in the drug R and D process to identify compounds with steatotic potential. Further, progress in the identification of potential serum or plasma protein biomarkers for these liver changes may provide additional in vivo tools to the preclinical study toxicologist. This review summarizes recent developments for in vitro screening and in vivo biomarker detection for steatotic drug candidates.

  8. Influence of companion diagnostics on efficacy and safety of targeted anti-cancer drugs: systematic review and meta-analyses.

    Science.gov (United States)

    Ocana, Alberto; Ethier, Josee-Lyne; Díez-González, Laura; Corrale