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Sample records for sipuleucel-t pharmacovigilance issues

  1. Immune Response to Sipuleucel-T in Prostate Cancer

    Directory of Open Access Journals (Sweden)

    David I. Quinn

    2012-04-01

    Full Text Available Historically, chemotherapy has remained the most commonly utilized therapy in patients with metastatic cancers. In prostate cancer, chemotherapy has been reserved for patients whose metastatic disease becomes resistant to first line castration or androgen deprivation. While chemotherapy palliates, decreases serum prostate specific antigen and improves survival, it is associated with significant side effects and is only suitable for approximately 60% of patients with castrate-resistant prostate cancer. On that basis, exploration of other therapeutic options such as active secondary hormone therapy, bone targeted treatments and immunotherapy are important. Until recently, immunotherapy has had no role in the treatment of solid malignancies aside from renal cancer and melanoma. The FDA-approved autologous cellular immunotherapy sipuleucel-T has demonstrated efficacy in improving overall survival in patients with metastatic castrate-resistant prostate cancer in randomized clinical trials. The proposed mechanism of action is reliant on activating the patients’ own antigen presenting cells (APCs to prostatic acid phosphatase (PAP fused with granulocyte-macrophage colony stimulating factor (GM-CSF and subsequent triggered T-cell response to PAP on the surface of prostate cancer cells in the patients body. Despite significant prolongation of survival in Phase III trials, the challenge to health care providers remains the dissociation between objective changes in serum PSA or on imaging studies after sipleucel-T and survival benefit. On that basis there is an unmet need for markers of outcome and a quest to identify immunologic or clinical surrogates to fill this role. This review focuses on the impact of sipuleucel-T on the immune system, the T and B cells, and their responses to relevant antigens and prostate cancer. Other therapeutic modalities such as chemotherapy, corticosteroids and GM-CSF and host factors can also affect immune response. The

  2. Sipuleucel-T: Autologous Cellular Immunotherapy for Men with Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer

    Directory of Open Access Journals (Sweden)

    Robert B. Sims

    2011-01-01

    Full Text Available Sipuleucel T is an autologous cellular immunotherapy designed to stimulate an immune response in men diagnosed with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory prostate cancer. Sipuleucel T improves overall survival and provides an additional treatment option for this patient population.

  3. Interdisciplinary critique of sipuleucel-T as immunotherapy in castration-resistant prostate cancer

    DEFF Research Database (Denmark)

    Huber, Marie L; Haynes, Laura; Parker, Chris

    2012-01-01

    -thirds of the cells harvested from placebo patients, but not from the sipuleucel-T arm, were frozen and not reinfused, a detrimental effect of this large repeated cell loss provides a potential alternative explanation for the survival "benefit." Patient safety depends on adequately addressing this alternative...

  4. Management Options in Advanced Prostate Cancer: What is the Role for Sipuleucel-T?

    OpenAIRE

    Bitting, Rhonda L.; Armstrong, Andrew J.; George, Daniel J.

    2011-01-01

    Most prostate cancer-related deaths occur in patients with castration-resistant prostate cancer (CRPC). Until recently, only therapy with docetaxel and prednisone has been shown to prolong survival in men with metastatic CRPC. With the United States Food and Drug Administration (US FDA) approvals of sipuleucel-T, cabazitaxel, and abiraterone acetate, all based on improvement in overall survival, the landscape for management of men with metastatic CRPC has dramatically changed. In this review ...

  5. An analysis of leukapheresis and central venous catheter use in the randomized, placebo controlled, phase 3 IMPACT trial of Sipuleucel-T for metastatic castrate resistant prostate cancer.

    Science.gov (United States)

    Flanigan, Robert C; Polcari, Anthony J; Shore, Neil D; Price, Thomas H; Sims, Robert B; Maher, Johnathan C; Whitmore, James B; Corman, John M

    2013-02-01

    Sipuleucel-T is an autologous cellular immunotherapy. We review the safety of the leukapheresis procedure required for sipuleucel-T preparation and complications related to venous catheter use in the randomized, placebo controlled phase 3 IMPACT (IMmunotherapy for ProstAte Cancer Trial) study (NCT 00065442). A total of 512 patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer were enrolled in the study. All patients were scheduled to undergo 3 standard 1.5 to 2.0 blood volume leukapheresis procedures at 2-week intervals. Leukapheresis related adverse events and those related to venous catheter use were reviewed. Immune cell counts were examined throughout the treatment course. Of 512 enrolled patients 506 underwent 1 or more leukapheresis procedures and were included in this analysis. Adverse events were comparable between the sipuleucel-T and control arms. Leukapheresis related adverse events were primarily associated with transient hypocalcemia (39.3%). Most leukapheresis related adverse events (97%) were of mild/moderate intensity. Median white blood cell count and absolute monocyte and lymphocyte counts were stable and within normal ranges throughout the treatment course. Of all patients 23.3% had a central venous catheter placed primarily for leukapheresis. Patients with vs without a central venous catheter had a higher risk of infection potentially related to catheter use (11.9% vs 1.3%, p nervous system (5.9% vs 2.1%, p = 0.06). Adverse events related to leukapheresis are manageable and quickly reversible. The majority of patients can undergo leukapheresis without a central venous catheter. Central venous catheters are associated with an increased risk of infections and venous vascular events. Peripheral intravenous access should be used when feasible. Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  6. Linked health data for pharmacovigilance in children: perceived legal and ethical issues for stakeholders and data guardians.

    Science.gov (United States)

    Hopf, Yvonne Marina; Bond, Christine B; Francis, Jill J; Haughney, John; Helms, Peter J

    2014-02-12

    The inclusion of the Community Health Index in the recording of National Health Service (NHS) contacts in Scotland facilitates national linkage of data such as prescribing and healthcare utilisation. This linkage could be the basis for identification of adverse drug reactions. The aim of this article is to report the views of healthcare professionals on data sharing, ownership and the legal and other applicable frameworks relevant to linkage of routinely collected paediatric healthcare data. Qualitative study using semistructured face-to-face interviews addressing the study aims. Purposive sample of professional stakeholders (n=25) including experts on ethics, data protection, pharmacovigilance, data linkage, legal issues and prescribing. Interviews were audio-recorded, transcribed and thematically analysed using a framework approach. Participants identified existing data sharing systems in the UK. Access to healthcare data should be approved by the data owners. The definition of data ownership and associated legal responsibilities for linked healthcare data were seen as important factors to ensure accountability for the use of linked data. Yet data owners were seen as facilitators of the proposed data linkage. Twelve frameworks (legal, regulatory and governance) applicable to the linkage of healthcare data were identified. A large number of potentially relevant legal and regulatory frameworks were identified. Ownership of the linked data was seen as an extension of responsibility for, or guardianship of, the source datasets. The consensus emerging from the present study was that clarity is required on the definition of data sharing, data ownership and responsibilities of data owners.

  7. [Pharmacovigilance of major parmaceutical innovation].

    Science.gov (United States)

    Xiang, Yongyang; Xie, Yanming; Yi, Danhui

    2011-10-01

    With the continuous improvement of international "pharmacovigilance" technology and methods,it becomes the key part of the post-marketing evaluation. This issue is based on this research background, and also means to find out the Chinese medicine safety monitor which consistents with the reality. A common problem is that those who choose a career in pharmacovigilance know how the complex data presented to us are a source of both fascination and frustration. In the 70's, for the first time data mining technology in the international pharmacovigilance turn up, we try to establish new signal detection method to make contributes to post-marketing evaluation of Chinese medicine and establishment of registration. Building the national adverse reaction reporting database is widely used in western country. Nature of the problem is that pharmacovigilance issues can come through a lot of assumptions into the statistical problems, different assumptions are for different statistical tests. Through the traditional imbalance between the proportion of fourfold table for other assumptions, few countries use in practice, this does not involve evidence, but this issue provides the introduce of the principle. Methods include the ratio of the report of the Netherlands (ROR), the proportion of reports than the UK ratio (PRR),WHO's information points (IC), the U.S. Food and Drug Administration empirical Bayes (EBS), etc. Because there is no international gold standard of the signal detection method, at first we use the simulation comparing these four methods of data mining, From the point of specificity, the sample size demand, this issue views the advantages and disadvantages of four methods and application conditions,and from a technical point of view and try to propose a new signal detection method, for example, Hierarchical Bayesian.

  8. Pharmacovigilance in developing countries (part I): importance and challenges.

    Science.gov (United States)

    Elshafie, Shaimaa; Zaghloul, Iman; Roberti, Anne Marie

    2017-12-16

    The thalidomide disaster was the significant historical event that acted as a catalyst for pharmacovigilance activity. Following this event developed countries initiated drug monitoring systems that evolved and now extend their scope to broader drug-related safety issues; however, this was not the case in developing countries. Pharmacovigilance is still a relatively new concept with low priority in developing countries although various issues are raising concerns that magnify the need for systems to monitor post marketing drug safety in these countries. This article analyzes the barriers to introducing robust pharmacovigilance systems in developing countries.

  9. Pharmacovigilance: Empowering healthcare professionals

    Directory of Open Access Journals (Sweden)

    Mugoša Snežana S.

    2015-01-01

    Full Text Available Introduction: Spontaneous reporting of adverse reactions is of greatest importance for obtaining information about adverse drug reactions (ADRs after granting the marketing authorization. The most important role and also the greatest responsibility belong to healthcare professionals. Their active participation is a prerequisite for the existence of an effective national drug safety monitoring. Methods: This paper examines the legislative framework concerning the pharmacovigilance system in Montenegro. The information was collected from scientific articles and the website of the Agency for Medicines and Medical Devices of Montenegro. Topic: Key segments of pharmacovigilance system are presented, with a special reference to the importance of spontaneous reporting of ADRs, results of spontaneous reporting of ADRs according to the latest Agency's Annual report on the results of spontaneous reporting of adverse reactions to medicines, possible reasons for underreporting ADRs, as well as the new EU regulation on pharmacovigilance. Conclusions: Spontaneous reporting of ADRs remains the cornerstone of pharmacovigilance systems. Hence, continuous education of healthcare professionals is needed, with the aim of improving their awareness of the importance of ADRs and risk factors that lead to them, in order to reduce the incidence of ADRs and to increase the number of reported suspected ADRs.

  10. [Pharmacovigilance in practice].

    Science.gov (United States)

    Spreux, A; Baldin, B; Chichmanian, R M

    1999-07-01

    Directed by the French Agency for the Safety of Health Products (AFSSAPS), the French pharmacovigilance system is in charge of the surveillance of drugs after they have been provided by AFSSAPS with official marketing authorizations that are in France either 'new drug approval certificates' (AMM) or 'temporary utilization authorizations' (ATU). About 3,700 pharmaceutical products are concerned which are used either for treatment (all drugs and remedies, inclusive plasma-derived blood products), prevention (vaccines, oral contraception), diagnosis (contrast products, ...), or to modify a physiologic function (general or local anesthetics). At the national level, the main actors of the system are AFSSAPS and its National Commission, the 31 Regional Centers of Pharmacovigilance, all the health professionnals, and the pharmaceutical laboratories. Health professionnals are held to notify any suspected serious or unexpected adverse effects as quickly as possible. The analysis of data collected by the national report bank permits alerts and inquiries about drug safety. Furthermore regional centers of pharmacovigilance are responsible for drug information. The French pharmacovigilance system works in cooperation with the European Agency for the Evaluation of Medicinal Products.

  11. 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.

  12. Heparin pharmacovigilance in Brazil.

    Science.gov (United States)

    Junqueira, Daniela Rezende Garcia; Viana, Thércia Guedes; Peixoto, Eliane R de M; Barros, Fabiana C R de; Carvalho, Maria das Graças; Perini, Edson

    2011-01-01

    To investigate the biological origin of injectable unfractioned heparin available in Brazilian market by discussing the impact of the profile of commercial products and the changes in heparin monograph on the drug safety. The Anvisa data base for the Registered Products of Pharmaceutical Companies and the Dictionary of Pharmaceutical Specialties (DEF 2008/2009) were searched. A survey with industries having an active permission for marketing the drug in Brazil was conducted. Five companies were granted a permission to market unfractioned heparin in Brazil. Three of them are porcine in origin and two of them are bovine in origin, with only one explicitly showing this information in the package insert. The effectiveness and safety of heparin studied in non-Brazilian populations may not represent the Brazilian reality, since most countries no longer produce bovine heparin. The currently marketed heparin has approximately 10% less anticoagulant activity than that previously produced and this change may have clinical implications. Evidence about the lack of dose interchangeability between bovine and porcine heparins and the unique safety profile of these drugs indicates the need to follow the treatment and the patients' response. Events threatening the patient's safety must be reported to the pharmacovigilance system in each particular country.

  13. Specific features of medicines safety and pharmacovigilance in Africa

    Science.gov (United States)

    Pal, Shanthi N.; Olsson, Sten; Dodoo, Alexander; Bencheikh, Rachida Soulayami

    2012-01-01

    The thalidomide tragedy in the late 1950s and early 1960s served as a wakeup call and raised questions about the safety of medicinal products. The developed countries rose to the challenge putting in place systems to ensure the safety of medicines. However, this was not the case for low-resource settings because of prevailing factors inherent in them. This paper reviews some of these features and the current status of pharmacovigilance in Africa. The health systems in most of the 54 countries of Africa are essentially weak, lacking in basic infrastructure, personnel, equipment and facilities. The recent mass deployment of medicines to address diseases of public health significance in Africa poses additional challenges to the health system with notable safety concerns. Other safety issues of note include substandard and counterfeit medicines, medication errors and quality of medicinal products. The first national pharmacovigilance centres established in Africa with membership of the World Health Organization (WHO) international drug monitoring programme were in Morocco and South Africa in 1992. Of the 104 full member countries in the programme, there are now 24 African countries with a further nine countries as associate members. The pharmacovigilance systems operational in African countries are based essentially on spontaneous reporting facilitated by the introduction of the new tool Vigiflow. The individual case safety reports committed to the WHO global database (Vigibase) attest to the growth of pharmacovigilance in Africa with the number of reports rising from 2695 in 2000 to over 25,000 in 2010. There is need to engage the various identified challenges of the weak pharmacovigilance systems in the African setting and to focus efforts on how to provide resources, infrastructure and expertise. Raising the level of awareness among healthcare providers, developing training curricula for healthcare professionals, provisions for paediatric and geriatric

  14. From Pharmacovigilance to Clinical Care Optimization.

    Science.gov (United States)

    Celi, Leo Anthony; Moseley, Edward; Moses, Christopher; Ryan, Padhraig; Somai, Melek; Stone, David; Tang, Kai-Ou

    2014-09-01

    In order to ensure the continued, safe administration of pharmaceuticals, particularly those agents that have been recently introduced into the market, there is a need for improved surveillance after product release. This is particularly so because drugs are used by a variety of patients whose particular characteristics may not have been fully captured in the original market approval studies. Even well-conducted, randomized controlled trials are likely to have excluded a large proportion of individuals because of any number of issues. The digitization of medical care, which yields rich and accessible drug data amenable to analytic techniques, provides an opportunity to capture the required information via observational studies. We propose the development of an open, accessible database containing properly de-identified data, to provide the substrate for the required improvement in pharmacovigilance. A range of stakeholders could use this to identify delayed and low-frequency adverse events. Moreover, its power as a research tool could extend to the detection of complex interactions, potential novel uses, and subtle subpopulation effects. This far-reaching potential is demonstrated by our experience with the open Multi-parameter Intelligent Monitoring in Intensive Care (MIMIC) intensive care unit database. The new database could also inform the development of objective, robust clinical practice guidelines. Careful systematization and deliberate standardization of a fully digitized pharmacovigilance process is likely to save both time and resources for healthcare in general.

  15. Pharmacovigilance in pharmaceutical companies: An overview

    OpenAIRE

    Maria Mammì; Rita Citraro; Giovanni Torcasio; Gennaro Cusato; Caterina Palleria; Eugenio Donato di Paola

    2013-01-01

    Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use. Regulation (EU) No 1235/2010 and Directive 2010/84/EU introduced new legislatio...

  16. A situational analysis of pharmacovigilance plans in the Global Fund Malaria and U.S. President's Malaria Initiative proposals.

    Science.gov (United States)

    Stergachis, Andy; Bartlein, Rebecca J K; Dodoo, Alexander; Nwokike, Jude; Kachur, S Patrick

    2010-05-30

    Pharmacovigilance programmes can monitor and help ensure the safe use of medicines that are critical to the success of global public health programmes. The widespread deployment of artemisinin-based combination therapy (ACT) by national malaria control programmes as part of the overall Global Malaria Action Plan for malaria control to elimination and eradication makes ACT an excellent candidate for pharmacovigilance activities. In 2008, The Roll Back Malaria partnership issued guidelines for inclusion of pharmacovigilance in Global Fund and other related proposals. In light of this recommendation and the rapid scale-up of ACT worldwide, an analysis of Global Fund Round 8 proposals and the President's Malaria Initiative (PMI) 2009 Malaria Operational Plans was conducted to assess if and how pharmacovigilance has been incorporated into countries' national malaria plans and donor budget requests. The Global Fund-Malaria Round 8 proposals for the 26 countries and the PMI Malaria Operational Plans (MOPs) for fiscal year 2009 for the 15 countries that were approved and received funding from either the Global Fund-Malaria Round 8 or PMI were accessed through the programme websites. The analysis consisted of conducting word counts and key word in context analyses of each proposal and plan. Twelve out of 26 (46%) of the Global Fund proposals mentioned that established pharmacovigilance systems were present in their countries. Four of the fifteen PMI MOPs (27%) mentioned that established pharmacovigilance systems were present in their countries. Only seven of the 26 (27%) Global Fund proposals included a request for funding for new or current pharmacovigilance activities. Seven of 15 (47%) MOPs included a request for funding for pharmacovigilance activities. There were relatively few requests for funding for pharmacovigilance activities, demonstrating a lack of emphasis placed on pharmacovigilance systems in recipient countries. The findings stress the need for more active

  17. Pharmacovigilance: the devastating consequences of not thinking ...

    African Journals Online (AJOL)

    Pharmacovigilance: the devastating consequences of not thinking about adverse drug reactions: The burden of adverse drug reactions (ADRs) on patient care has been found to be high globally and is particularly high in South Africa.

  18. Patient-centered pharmacovigilance: A review

    African Journals Online (AJOL)

    centered pharmacovigilance ... (DOAJ), African Journal Online, Bioline International, Open-J-Gate and Pharmacy Abstracts .... claimed a relationship between duration of drug usage and ..... prescribed physicians were completely safe, and.

  19. [Hospital pharmacists' perception of pharmacovigilance in Quebec].

    Science.gov (United States)

    Cerruti, L; Lebel, D; Bussières, J-F

    2016-03-01

    To assess the pharmacovigilance perception of Quebec's hospital pharmacists. Cross-sectional study. A questionnaire with 16 questions was developed in order to assess respondents' perception of their ability to practice pharmacovigilance, factors that can influence adverse drug reactions reporting and measures to increase reporting rate. The online questionnaire was sent to hospital pharmacist from Quebec in April 2014. The results were presented in the form of descriptive data. A total of 179/252 (71%) hospital pharmacists responded. More than 90% of respondents considered that they were able to practice all activities related to pharmacovigilance. During one year of practice, 98% of respondents faced at least one serious or unexpected adverse drug reaction and 77% notified at least one adverse drug reaction to Health Canada. The factors encouraging more than 89% of respondents to notify were: the severity, the rapidity of onset, the visibility of the reaction, the fact that the adverse drug reaction was unexpected or due to a recent marketed drug. More than 69% of respondents considered the overwork as the principal obstacle to the notification. The majority of respondents supported the implementation of 13/14 measures in order to increase reporting rate. Hospital pharmacists from Quebec presented a favorable ability to practice pharmacovigilance. Analysis of their perception of pharmacovigilance helped to identify improvements, such as the implementation of a pharmacovigilance coordinator in the health center. Copyright © 2015 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

  20. Contribution of Latin America to pharmacovigilance.

    Science.gov (United States)

    González, Juan Camilo; Arango, Victoria E; Einarson, Thomas R

    2006-01-01

    Pharmacovigilance activities have been ongoing for 4 decades. However, little is known (especially outside of the area) about the contribution of Latin America to this field. To review and quantify the published literature on pharmacovigilance in Latin American countries. We searched electronic databases including MEDLINE (1966-2004), EMBASE (1980-2004), International Pharmaceutical Abstracts (1970-2004), Toxline (1992-2004), Literatura Latino-Americana e do Caribe em Ciências da Saúde (1982-2004), Sistema de Información Esencial en Terapéutica y Salud (1980-2004), and the Pan American Health Organization Web site (1970-2004) for articles on pharmacovigilance or adverse drug reactions in any of the 19 major Latin American countries. Papers were retrieved and categorized according to content and country of origin by 2 independent reviewers. There were 195 usable articles from 13 countries. Fifty-one of the papers retrieved dealt with pharmacovigilance centers (15 national centers, 10 hospitals, 26 other), 55 covered pharmacovigilance itself (21 theoretical papers, 9 with description of models, 25 educational papers), and 89 were pharmacoepidemiologic studies of adverse drug reactions (69 case reports, 13 observational cohorts, 2 cohort studies, 1 randomized clinical trial, 4 clinical papers on adverse reaction management). Studies have increased exponentially since 1980. Five countries (Argentina, Brazil, Chile, Costa Rica, Venezuela) published reports from national centers. No studies were found from 6 countries: Dominican Republic, El Salvador, Honduras, Nicaragua, Paraguay, or Uruguay. Most studied categories were antiinfectives and drugs affecting the central nervous system, cardiovascular system, and musculoskeletal system. Contributions of Latin American countries to the field of pharmacovigilence have been remarkable, considering the constraints on these countries. A need exists for an increased number of formal pharmacovigilance studies and research

  1. Pharmacovigilance in pharmaceutical companies: An overview.

    Science.gov (United States)

    Mammì, Maria; Citraro, Rita; Torcasio, Giovanni; Cusato, Gennaro; Palleria, Caterina; di Paola, Eugenio Donato

    2013-12-01

    Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use. Regulation (EU) No 1235/2010 and Directive 2010/84/EU introduced new legislation on pharmacovigilance. The marketing authorization holder should be responsible for continuously monitoring the safety of its medicinal products for human use, for informing the authorities of any changes that might have an impact on the marketing authorization, and for ensuring that the product information is kept up-to-date. Marketing authorization holders (MAH) record all suspected adverse reactions occurring in the European Union or in the third countries, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of post-authorization study. For all medicinal products is mandatory to maintain a pharmacovigilance system master file (PSMF). According to the Legislative Decree 219/2006 the MAH must submit to the competent authorities the information on suspected adverse reactions of a medicinal product, in form of a periodic safety update reports (PSURs).

  2. Risk management plans as a tool for proactive pharmacovigilance

    DEFF Research Database (Denmark)

    Vermeer, N S; Duijnhoven, R G; Straus, S M J M

    2014-01-01

    Risk Management Plans (RMPs) have become a cornerstone in the pharmacovigilance of new drugs in Europe. The RMP was introduced in 2005 to support a proactive approach in gaining knowledge on safety concerns through early planning of pharmacovigilance activities. However, the rate at which...... of uncertainties, suggests that opportunities for optimization exist while ensuring feasible and risk-proportionate pharmacovigilance planning....

  3. Past, Present and Future of Pharmacovigilance

    Directory of Open Access Journals (Sweden)

    Derya Kaya

    2016-06-01

    Full Text Available Pharmacovigilance, is a scientific study related to follow-up problems in drug administrations and identify, record, announce and take due precautions for these problems. Pharmacovigilance works on to increase safety and effectiveness of drugs and minimize the risks associated with drug use. It is significantly developed and continues to improve to satisfy the recent needs. While information spreads like wildfire in the world, there is a need for strategic planning which adopts an integrated approach to go through difficulties caused by increased transmission between borders, easy acceptance of medical product diversity and increased safety expectation of public. We will need dynamic improvement and continuation of pharmacovigilance in all its parts to improve public health and safety. [Archives Medical Review Journal 2016; 25(2.000: 129-139

  4. 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.

  5. Training in post-authorization pharmacovigilance

    Directory of Open Access Journals (Sweden)

    Vivek Ahuja

    2010-01-01

    Full Text Available Post-authorization pharmacovigilance refers to all the activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems, from the time a product gets the authorization to be marketed in a territory. The ultimate objective of pharmacovigilance is patient safety. To ensure this, any responsible pharmaceutical company will readily vouch for the importance of all these activities, each requiring specific training for efficient and effective execution. Having a well planned job specific training curriculum can help the organization realize its goals and objectives by covering the gaps between current and desired job performance levels and existing competencies of its employees. Apart from this, trainings can help in problem solving, increasing productivity and prepare for and respond to future changes in the organization or job duties. As the pharmaceutical business continues to grow, increasing numbers of skilled people are required to manage resultant increase in pharmacovigilance activities to remain compliant. Thus, the need for training qualified resources to develop into highly skilled pharmacovigilance professionals is the need of the hour. Currently, the supply-demand situation for skilled manpower is highly skewed in favor of the demand, as this field is relatively new in India and elsewhere. It is interesting to note that not many resources, be it internet, literature or books, are available specifically addressing the need of the industry to guide them on training requirements to set up and maintain a competent pharmacovigilance department. This article aims to present a comprehensive perspective on the trainings required in the post authorization scenario pertaining to pharmacovigilance activities and suggest ways to manage these in an efficient way so as to be compliant with the global norms and best practices.

  6. Pharmacovigilance activities in ASEAN countries.

    Science.gov (United States)

    Suwankesawong, Wimon; Dhippayom, Teerapon; Tan-Koi, Wei-Chuen; Kongkaew, Chuenjid

    2016-09-01

    This study aimed to explore the current landscape and identify challenges of pharmacovigilance (PV) among Association of Southeast Asian Nations (ASEAN) countries. This cross-sectional survey collected data from May 2014 to December 2015. Questionnaires seeking to collect information on resources, processes, roles and responsibility, and functions of PV systems were sent to relevant persons in the ASEAN countries. Functions of PV centers were measured using the minimum World Health Organization requirements for a functional national PV system. Performances of PV centers were measured by the following: (1) the indicators related to the average number of individual case safety reports (ICSR); (2) presence of signal detection activities and subsequent action; and (3) contribution to the global vigilance database. Cambodia, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand, and Vietnam completed the survey. PV systems in four surveyed countries (Indonesia, Malaysia, Singapore, and Thailand) achieved all aspects of the World Health Organization minimum requirement for a functional national PV system; the remaining countries were deemed to have unclear communication strategies and/or no official advisory committee. Average numbers of recent ICSR national returns ranged from 7 to 3817 reports/year/million population; three countries (Malaysia, Singapore, and Thailand) demonstrated good performance in reporting system and reported signal detection activities and subsequent actions. All participating countries had submitted ICSRs to the Uppsala Monitoring Center during the survey period (2013-2015). Four participating countries had functional PV systems. PV capacity, functionality, and legislative framework varied depending on local healthcare ecosystem networks. Implementing effective communication strategies and/or technical assistance from the advisory committee are needed to strengthen PV in ASEAN. Copyright © 2016 John Wiley & Sons, Ltd. Copyright

  7. Vaccine Pharmacovigilance: Adverse Effects Reported and the ...

    African Journals Online (AJOL)

    Routine utilization of vaccines during immunization in children is a tool in the reduction of childhood morbidity and mortality of infectious disease globally. This requires pharmacovigilance to ensure safety among the category of patients. Due to the exposure of new born to vaccine at birth, it became necessary to assess the ...

  8. Pharmacovigilance: Tiens Slimming Tea Causes Increased Blood ...

    African Journals Online (AJOL)

    ... possible link between the constituents of the slimming tea and increased blood pressure and also provide evidence of other possible harmful effects that may occur with the use of the slimming tea. Keywords: Pharmacovigilance, hypertension, slimming tea. West African Journal of Pharmacology and Drug Research Vol.

  9. Pharmacovigilance Mobile Tool Design in the Field of Arhroplasty.

    Science.gov (United States)

    Åserød, Hanne; Babic, Ankica

    2017-01-01

    Pharmacovigilance is an important part of the patient safety and it has a great appeal to physicians. It is concerned with the safety of medical devices and treatments in the light of understanding the risks and dangers based on the already reported safety issues. Internet resources such as the Manufacturer And User Facility Device Experience (MAUDE) web-site are often retrieved due to the lack of internal, local safety databases. The research looked at how Human Computer Interaction could improve user experience. We have designed data entry for safety reporting and pharmacovigilance based on the web-bases system called WebBISS (Web-based implant search system). The expectation is not only to improve usability, but also to stimulate physicians to enter their safety data and become also contributors, and not only users of information. The expert evaluation has been generally positive and encouraged stronger help and error reporting functions. The high fidelity design has given a good impression of the future mobile solution.

  10. A day in the life of a pharmacovigilance case processor.

    Science.gov (United States)

    Bhangale, Ritesh; Vaity, Sayali; Kulkarni, Niranjan

    2017-01-01

    Pharmacovigilance (PV) has grown significantly in India in the last couple of decades. The etymological roots for the word "pharmacovigilance" are "Pharmakon" (Greek for drug) and "Vigilare" (Latin for to keep watch). It relies on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The PV data processing cycle starts with data collection in computerized systems followed by complete data entry which includes adverse event coding, drug coding, causality and expectedness assessment, narrative writing, quality control, and report submissions followed by data storage and maintenance. A case processor plays an important role in conducting these various tasks. The case processor should also manage drug safety information, possess updated knowledge about global drug safety regulations, summarize clinical safety data, participate in meetings, write narratives with medical input from a physician, report serious adverse events to the regulatory authorities, participate in the training of operational staff on drug safety issues, quality control work of other staff in the department, and take on any other task as assigned by the manager or medical director within the capabilities of the drug safety associate. There can be challenges while handling all these tasks at a time, hence the associate will have to maintain a balance to overcome them and keep on updating their knowledge on drug safety regulations, which in turn, would help in increasing their learning curve.

  11. Managing the interface with marketing to improve delivery of pharmacovigilance within the pharmaceutical industry.

    Science.gov (United States)

    Edwards, Brian

    2004-01-01

    The pharmaceutical industry is under pressure to improve the scientific quality of its decisions concerning the benefit and risks of its products while ensuring compliance with acceptable standards of marketing. All those in a pharmaceutical company who currently work within pharmacovigilance should be encouraged to lead from the front to examine ongoing marketing activities to see how they can be adapted more towards pharmacovigilance and risk management. The current irony is that the personnel who have the greatest influence on benefit-risk decisions of a product are not necessarily those who acknowledge that they are performing pharmacovigilance. Indeed, for all concerned, whether their orientation is scientific and commercial, effective communication with prescribers and consumers usually underpins product success. Also, a substantial 'marketing' budget is culturally acceptable for the pharmaceutical industry so it is logical to assume that resource for postmarketing activity is often made available. Given these realities, I suggest we should strive for an integrated marketing and risk-management plan based on the best available evidence and that being fully aware and in control of the safety issues for your products is the best way to commercialise them successfully. This approach can still be consistent with other corporate responsibilities such as trying to reduce the financial burden of product development. If this article stimulates further debate about how the pharmaceutical industry can more effectively organise resources and operations to support pharmacovigilance, risk management, and marketing, then it will have achieved its purpose.

  12. Barriers to the success of an electronic pharmacovigilance reporting system in Kenya: an evaluation three years post implementation.

    Science.gov (United States)

    Agoro, Oscar O; Kibira, Sarah W; Freeman, Jenny V; Fraser, Hamish S F

    2018-06-01

    Electronic pharmacovigilance reporting systems are being implemented in many developing countries in an effort to improve reporting rates. This study sought to establish the factors that acted as barriers to the success of an electronic pharmacovigilance reporting system in Kenya 3 years after its implementation. Factors that could act as barriers to using electronic reporting systems were identified in a review of literature and then used to develop a survey questionnaire that was administered to pharmacists working in government hospitals in 6 counties in Kenya. The survey was completed by 103 out of the 115 targeted pharmacists (89.5%) and included free-text comments. The key factors identified as barriers were: unavailable, unreliable, or expensive Internet access; challenges associated with a hybrid system of paper and electronic reporting tools; and system usability issues. Coordination challenges at the national pharmacovigilance center and changes in the structure of health management in the country also had an impact on the success of the electronic reporting system. Different personal, organizational, infrastructural, and reporting system factors affect the success of electronic reporting systems in different ways, depending on the context. Context-specific formative evaluations are useful in establishing the performance of electronic reporting systems to identify problems and ensure that they achieve the desired objectives. While several factors hindered the optimal use of the electronic pharmacovigilance reporting system in Kenya, all were considered modifiable. Effort should be directed toward tackling the identified issues in order to facilitate use and improve pharmacovigilance reporting rates.

  13. Are we pharmacovigilant enough in ophthalmic practice?

    Directory of Open Access Journals (Sweden)

    Ashok Dubey

    2013-01-01

    Full Text Available No drug is absolutely safe. Pharmacovigilance is the science related to detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. The ocular medications and devices can cause localized and systemic adverse effects. Not all adverse effects are known when a drug or device is launched in market because of limitations of clinical trials. Many adverse effects are recognized due to the spontaneous reporting of the vigilant doctors who observe and report such events encountered in their practice. Despite a large ophthalmic patient population base, India does not have robust adverse drug reaction (ADR database because of lack of reporting culture. Government of India recently launched the Pharmacovigilance Programme of India (PvPI to monitor ADRs and create awareness among the healthcare professionals about the importance of ADRs. Suspecting and reporting a possible drug reaction is very important in developing a safe and rational ophthalmic practice.

  14. A review of the National pharmacovigilance system in Malta - implementing and operating a pharmacovigilance management system.

    Science.gov (United States)

    Tanti, Amy; Micallef, Benjamin; Serracino-Inglott, Anthony; Borg, John-Joseph

    2017-01-01

    Regulatory authorities have a legal mandate to implement and maintain a Pharmacovigilance System designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. Areas covered: This review maps the implementation of pharmacovigilance activities in Malta since accession in the EU in mid 2004 and discusses the challenges the Maltese Regulator encountered while setting up adequate and effective systems to fulfil its legal mandate. Areas reviewed are those around ADR reporting, promotion and safety communications including rapid alerts and recalls, direct healthcare professional communications, risk minimisation measures and safety circulars and quality systems. Expert opinion: Within a ten year period, 3 EU directives on pharmacovigilance were implemented by our agency. Despite limitations to resources, based on a prioritised implementation, the legislation provisions are now fully operational with a good level of sustainability. Lessons learnt from this process are discussed in this review. The coming years will involve strengthening and consolidation of existing processes.

  15. Pharmacovigilance in Intensive Care Unit - An Overview

    Directory of Open Access Journals (Sweden)

    Bimla Sharma

    2008-01-01

    Full Text Available The drug related complications are on the rise warranting special attention towards patient safety in Intensive Care Unit (ICU setup. Pharmacovigilance is the science about the detection, assessment and prevention of drug related problems. This review is aimed to highlight significant problems arising from medication errors with emphasis on special drugs used in ICU (oxygen, antibiotics, sedatives, analgesics and neuromuscular blocking drugs and their risk reduction strategies in ICU utilizing practice of pharmacovigilance. Human error, lack of communication among various health providers, inadequate knowledge about drugs, failure to follow protocols or recommended guidelines are important causes of drug related problems in ICU. It is imperative that ICU administrators and medical directors of hospitals consider adverse drug events (ADEs as system failures. Pharmacovigilance, an observational science is the need of the hour for patients admitted in ICUs. We need to give more emphasis on prevention rather than treating the potentially fatal complications arising from ADEs. Eternal vigilance is the key. Protocol based management, improvement of medication system, frequent audits, improved communication, good team work, a blame free environ-ment, inclusion of a pharmacist, leadership involvement and use of information technology in the ICU are possible solutions.

  16. Patient-Reported Safety Information : A Renaissance of Pharmacovigilance?

    NARCIS (Netherlands)

    Härmark, Linda; Raine, June; Leufkens, Bert|info:eu-repo/dai/nl/075255049; Edwards, I Ralph; Moretti, Ugo; Sarinic, Viola Macolic; Kant, Agnes

    2016-01-01

    The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years

  17. Pharmacoenvironmentology – a component of pharmacovigilance

    Directory of Open Access Journals (Sweden)

    Gupta Varun

    2007-07-01

    Full Text Available Abstract According to WHO, Pharmacovigilance activities are done to monitor detection, assessment, understanding and prevention of any obnoxious adverse reactions to drugs at therapeutic concentration on animal and human beings. However, there is also a growing focus among scientists and environmentalists about the impact of drugs on environment and surroundings. The existing term 'Ecopharmacology' is too broad and not even defined in a clear manner. The term 'Pharmacoenvironmentology' seeks to deal with the environmental impact of drugs given to humans and animals at therapeutic doses.

  18. Pharmacovigilance in resource-limited countries.

    Science.gov (United States)

    Olsson, Sten; Pal, Shanthi N; Dodoo, Alex

    2015-01-01

    In the past 20 years, many low- and middle-income countries have created national pharmacovigilance (PV) systems and joined the WHO's global PV network. However, very few of them have fully functional systems. Scientific evidence on the local burden of medicine-related harm and their preventability is missing. Legislation and regulatory framework as well as financial support to build sustainable PV systems are needed. Public health programs need to integrate PV to monitor new vaccines and medicines introduced through these programs. Signal analysis should focus on high-burden preventable adverse drug problems. Increased involvement of healthcare professionals from public and private sectors, pharmaceutical companies, academic institutions and the public at large is necessary to assure a safe environment for drug therapy. WHO has a major role in supporting and coordinating these developments.

  19. Pharmacovigilance in China: current situation, successes and challenges.

    Science.gov (United States)

    Zhang, Li; Wong, Lisa Y L; He, Ying; Wong, Ian C K

    2014-10-01

    With the integration of the global pharmaceutical economy and the gradual transformation of the healthcare insurance system in China, the legislative framework for a comprehensive regulatory system monitoring the whole process including drug development, manufacture, distribution and use has been established by the China Food and Drug Administration (CFDA) to ensure the safety and effectiveness of medication use. China has established a relatively comprehensive pharmacovigilance system covering regulation, organisation and technology from 1989 to 2014. As of 2013, one national centre, 34 provincial centres and more than 400 municipal centres for adverse drug reaction (ADR) monitoring were included in the four-level pharmacovigilance network (national, provincial, municipal and county) with more than 200,000 grassroot organisation users. The China Adverse Drug Reaction Monitoring System (CADRMS) is an online spontaneous reporting system which connects the four-level pharmacovigilance network. By 2013, CADRMS had received over 6.6 million ADR case reports. After integrating and analysing pharmacovigilance data, the National Centre for ADR Monitoring (NCADRM) publishes medication safety information by releasing ADR bulletins, National ADR Annual Reports and International Pharmacovigilance Newsletters. The NCADRM also routinely provides CADRMS data feedback to manufacturers. The CFDA implemented risk management through several approaches, including arranging 'manufacturer communication meetings', modification of medication package inserts, and restriction, suspension or withdrawal of marketing authorisations. Seamless information exchange with overseas regulatory authorities and organisations remains an area for improvement. Further development of the China pharmacovigilance system in terms of signal generation, post-marketing pharmacoepidemiology research and education is also needed.

  20. Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

    Science.gov (United States)

    Härmark, Linda; Raine, June; Leufkens, Hubert; Edwards, I Ralph; Moretti, Ugo; Sarinic, Viola Macolic; Kant, Agnes

    2016-10-01

    The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years have passed since the legislation was introduced and the key question is: does pharmacovigilance yet make optimal use of patient-reported safety information? Independent research has shown beyond doubt that patients make an important contribution to pharmacovigilance signal detection. Patient reports provide first-hand information about the suspected ADR and the circumstances under which it occurred, including medication errors, quality failures, and 'near misses'. Patient-reported safety information leads to a better understanding of the patient's experiences of the ADR. Patients are better at explaining the nature, personal significance and consequences of ADRs than healthcare professionals' reports on similar associations and they give more detailed information regarding quality of life including psychological effects and effects on everyday tasks. Current methods used in pharmacovigilance need to optimise use of the information reported from patients. To make the most of information from patients, the systems we use for collecting, coding and recording patient-reported information and the methodologies applied for signal detection and assessment need to be further developed, such as a patient-specific form, development of a severity grading and evolution of the database structure and the signal detection methods applied. It is time for a renaissance of pharmacovigilance.

  1. Pharmacovigilance: Boon for the safety and efficacy of Ayuvedic formulations

    Science.gov (United States)

    Chaudhary, Anand; Singh, Neetu; Kumar, Neeraj

    2010-01-01

    Pharmacovigilance is a corrective process originating in pharmaco-epidemiology. The 1997 Erice Declaration, presented at the World Health Organisation, became the basis on which the concept was implemented internationally for conventional systems of medicine. The increasing international acceptance of Ayurveda, led regulators to implement a similar program for Ayurveda, particularly as some medical professionals, scientists and members of the public reported adverse reactions after taking Ayurvedic formulations. The World Health Organisation therefore persuaded the Department of AYUSH, Ministry of Health and Family Welfare, Government of India, to implement a pharmacovigilance program for Ayurveda, as a means to ensuring the safety and efficacy of Ayurvedic medicines. After a year of due diligence, the pharmacovigilance program was launched nationally on 29 September 2008. Since that time, Ayurveda, Siddha and Unani medicines have been monitored according to the provisions of a protocol prepared by the National Pharmacovigilance Resource Centre, IPGTRA, Jamnagar, and approved by Department of AYUSH. The program was reviewed, first, on 21st January 2009 by the National Pharmaco-vigilance Consultative Committee for ASU drugs (NPCC-ASU), and again, on 15 Feburary, 2010, when an evaluation meeting effectively rubber stamped the program. Among the outcomes of these meetings were several suggestions of measures to improve the program’s efficiency. Recent developments include the constitution of pharmacovigilance centers at all Ayurveda Teaching institutes and research centers. PMID:21731371

  2. False-positive results in pharmacoepidemiology and pharmacovigilance.

    Science.gov (United States)

    Bezin, Julien; Bosco-Levy, Pauline; Pariente, Antoine

    2017-09-01

    False-positive constitute an important issue in scientific research. In the domain of drug evaluation, it affects all phases of drug development and assessment, from the very early preclinical studies to the late post-marketing evaluations. The core concern associated with this false-positive is the lack of replicability of the results. Aside from fraud or misconducts, false-positive is often envisioned from the statistical angle, which considers them as a price to pay for type I error in statistical testing, and its inflation in the context of multiple testing. If envisioning this problematic in the context of pharmacoepidemiology and pharmacovigilance however, that both evaluate drugs in an observational settings, information brought by statistical testing and the significance of such should only be considered as additional to the estimates provided and their confidence interval, in a context where differences have to be a clinically meaningful upon everything, and the results appear robust to the biases likely to have affected the studies. In the following article, we consequently illustrate these biases and their consequences in generating false-positive results, through studies and associations between drug use and health outcomes that have been widely disputed. Copyright © 2017 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  3. A day in the life of a pharmacovigilance case processor

    Directory of Open Access Journals (Sweden)

    Ritesh Bhangale

    2017-01-01

    Full Text Available Pharmacovigilance (PV has grown significantly in India in the last couple of decades. The etymological roots for the word “pharmacovigilance” are “Pharmakon” (Greek for drug and “Vigilare” (Latin for to keep watch. It relies on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The PV data processing cycle starts with data collection in computerized systems followed by complete data entry which includes adverse event coding, drug coding, causality and expectedness assessment, narrative writing, quality control, and report submissions followed by data storage and maintenance. A case processor plays an important role in conducting these various tasks. The case processor should also manage drug safety information, possess updated knowledge about global drug safety regulations, summarize clinical safety data, participate in meetings, write narratives with medical input from a physician, report serious adverse events to the regulatory authorities, participate in the training of operational staff on drug safety issues, quality control work of other staff in the department, and take on any other task as assigned by the manager or medical director within the capabilities of the drug safety associate. There can be challenges while handling all these tasks at a time, hence the associate will have to maintain a balance to overcome them and keep on updating their knowledge on drug safety regulations, which in turn, would help in increasing their learning curve.

  4. 75 FR 65293 - Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for...

    Science.gov (United States)

    2010-10-22

    ...] Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for... Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled ``Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data...

  5. Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives

    Directory of Open Access Journals (Sweden)

    Zhengwu Lu

    2009-10-01

    Full Text Available Zhengwu LuClinical Research Department, Abbott Vascular, Santa Clara, CA, USAAbstract: Risk assessment during clinical product development needs to be conducted in a thorough and rigorous manner. However, it is impossible to identify all safety concerns during controlled clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with comorbid conditions and those being treated with concomitant medications. Therefore, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product’s risk profile and for making informed decisions on risk minimization. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The availability of a publicly accessible global safety database updated on a frequent basis would further enhance detection and communication about safety issues. Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.Keywords: information technology, pharmacovigilance, safety, standard, risk management, adverse event

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

    Science.gov (United States)

    Cobert, B; Silvey, J

    1999-02-01

    directly on line using an electronic version of its MedWatch form. It is expected that these developments will change the nature of the way pharmacovigilance is carried out. Significant issues will arise from this including privacy concerns. The European Union's 1995 directive on 'the protection of individuals with regard to the processing of personal data and on the free movement of such data (95/46/EC)' went into effect in October 1998. The enabling legislation now being passed by the member states will produce significant changes in the way companies and governments handle individual patient data in order to assure the privacy and protection of individuals.

  7. Consumer adverse drug reaction reporting - A new step in pharmacovigilance?

    NARCIS (Netherlands)

    van Grootheest, K; de Graaf, L; de Jong-van den Berg, LTW

    2003-01-01

    The direct reporting of adverse drug reactions by patients is becoming an increasingly important topic for discussion in the world of pharmacovigilance. At this time, few countries accept consumer reports. We present an overview of experiences with consumer reporting in various countries of the

  8. Sequence symmetry analysis in pharmacovigilance and pharmacoepidemiologic studies

    DEFF Research Database (Denmark)

    Lai, Edward Chia Cheng; Pratt, Nicole; Hsieh, Cheng Yang

    2017-01-01

    Sequence symmetry analysis (SSA) is a method for detecting adverse drug events by utilizing computerized claims data. The method has been increasingly used to investigate safety concerns of medications and as a pharmacovigilance tool to identify unsuspected side effects. Validation studies have i...

  9. Role of Pharmacovigilance in India: An overview.

    Science.gov (United States)

    Suke, Sanvidhan G; Kosta, Prabhat; Negi, Harsh

    2015-01-01

    Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Thus, for safety medication ADRs monitoring required for each medicine throughout its life cycle, during development of drug such as pre-marketing including early stages of drug design, clinical trials, and post-marketing surveillance. PV is concerns with the detection, assessment, understanding and prevention of ADRs. Pharmacogenetics and pharmacogenomics are an indispensable part of the clinical research. Variation in the human genome is a cause of variable response to drugs and susceptibility to diseases are determined, which is important for early drug discovery to PV. Moreover, PV has traditionally involved in mining spontaneous reports submitted to national surveillance systems. The research focus is shifting toward the use of data generated from platforms outside the conventional framework such as electronic medical records, biomedical literature, and patient-reported data in health forums. The emerging trend in PV is to link premarketing data with human safety information observed in the post-marketing phase. The PV system team obtains valuable additional information, building up the scientific data contained in the original report and making it more informative. This necessitates an utmost requirement for effective regulations of the drug approval process and conscious pre and post approval vigilance of the undesired effects, especially in India. Adverse events reported by PV system potentially benefit to the community due to their proximity to both population and public health practitioners, in terms of language and knowledge, enables easy contact with reporters by electronically. Hence, PV

  10. [Pharmacovigilance center --internal medicine interactions: A useful diagnostic tool].

    Science.gov (United States)

    Rochoy, M; Gautier, S; Bordet, R; Caron, J; Launay, D; Hachulla, E; Hatron, P-Y; Lambert, M

    2015-08-01

    Patients hospitalized in internal medicine often have unexplained clinical symptoms for which a drug origin can be considered. The prevalence of patients hospitalized for iatrogenic is estimated between 4-22%. We wanted to evaluate the diagnostic value of the regional center of pharmacovigilance to identify or confirm an iatrogenic disease in the department of internal medicine of Lille and characterize factors associated with drug-related side effect. This is a single-center prospective diagnostic study. We included all subsequent requests from the department of internal medicine with the Nord-Pas-de-Calais regional pharmacovigilance center between 2010 and 2012. The opinion of the regional pharmacovigilance centre was held on the record of the adverse drug reaction in the national pharmacovigilance database and analyzed according to the conclusion of iatrogenic used by clinicians in internal medicine (reference diagnosis) with a follow-up to June 2013. The variables relating to the patient, medication and adverse events were analyzed by binary logistic regression. We analyzed 160 contacts: 118 concordant cases, 38 false-positives (drug-related side effect retained by the regional pharmacovigilance center only), 4 false negatives. Registration in the national pharmacovigilance database had a sensitivity of 96% (95% CI [0.92 to 0.99]), a specificity of 46% (95% CI [0.38 to 0.53]), a value positive predictive of 69% (95% CI [0.62 to 0.76]), a negative predictive value of 89% (95% CI [0.84 to 0.94]) and a negative likelihood ratio of 0.1. False-positive had chronological and semiological accountabilities questionable (adjusted RR=2.1, 95% CI [1.2 to 2.8]). In our study, the regional pharmacovigilance center confirms the clinician's suspicion of drug-related side effects and helps to exclude drug-induced with a high negative predictive value. Copyright © 2015 Société nationale française de médecine interne (SNFMI). Published by Elsevier SAS. All rights reserved.

  11. Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives.

    Science.gov (United States)

    Lu, Zhengwu

    2009-01-01

    Risk assessment during clinical product development needs to be conducted in a thorough and rigorous manner. However, it is impossible to identify all safety concerns during controlled clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with comorbid conditions and those being treated with concomitant medications. Therefore, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product's risk profile and for making informed decisions on risk minimization. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The availability of a publicly accessible global safety database updated on a frequent basis would further enhance detection and communication about safety issues. Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.

  12. 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.

  13. A global view of undergraduate education in pharmacovigilance.

    Science.gov (United States)

    Hartman, Jenny; Härmark, Linda; van Puijenbroek, Eugène

    2017-07-01

    The aim of this study was to gain insight in current pharmacovigilance educational activities and to gather information on which topics should be included in the undergraduate pharmacovigilance core curriculum. A web-based questionnaire was carried out containing 45 questions divided over four sections between 28 October 2014 and 31 January 2015. Potential participants working in pharmacovigilance and/or providing training in this field were invited via email and a widespread web link and snowball sampling was used to recruit additional participants. The questionnaire was filled out by 307 respondents from 88 different countries with a response rate of 29.3% for the email invitation and an unknown rate for the web link. Respondents were mainly pharmacists and physicians. Currently, lectures are the largest proportion of educational activities and all healthcare profession curricula have a mode of 2 h as number of contact hours per course. Respondents rated clinical aspects as the most important subdomain to be included in the core curriculum with prevention of adverse drug reactions as the most important subtopic. This was followed by communication aspects between parties, with communication between regulatory authorities and healthcare professionals, methodological aspects with causality assessment, and regulatory aspects with benefit-risk assessment. This is similar to subjects addressed in current educational activities with little difference between medical and pharmacy curricula. This study gave a good general impression in current educational activities and the respondents' needs and wishes for future activities worldwide, which both will be used for the development of the undergraduate pharmacovigilance core curriculum.

  14. Linking NHS data for pediatric pharmacovigilance: Results of a Delphi survey.

    Science.gov (United States)

    Hopf, Y M; Francis, J; Helms, P J; Haughney, J; Bond, C

    2016-01-01

    be acceptable to stakeholders to introduce a data linkage system for pharmacovigilance as long as identified concerns are addressed. Concerns included adherence to current professional, legal and ethical standards, as well resolving practical issues. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  15. Developing a Crowdsourcing Approach and Tool for Pharmacovigilance Education Material Delivery.

    Science.gov (United States)

    Bate, Andrew; Beckmann, Jürgen; Dodoo, Alexander; Härmark, Linda; Hartigan-Go, Kenneth; Hegerius, Anna; Lindquist, Marie; van Puijenbroek, Eugène; Tuccori, Marco; Hagemann, Ulrich

    2017-03-01

    The number of pharmacovigilance professionals worldwide is increasing with a high staff turnover. There is a constant stream of new colleagues with an interest or need to learn about the discipline. Consequently, there is an increasing need for training in pharmacovigilance. An important step towards this has been made through developing and publishing the World Health Organization (WHO)-International Society of Pharmacovigilance (ISoP) Pharmacovigilance Curriculum. Using the Pharmacovigilance Curriculum effectively, it should be supplemented by providing comprehensive training material from various sources, and making the Pharmacovigilance Curriculum attractive and a high-utility product. We describe a pilot of the development and initial evaluation of a crowdsourcing tool for the provision of pharmacovigilance education material. Pharmacovigilance experts shared links to their material to sections of relevance in the hierarchy and a small group of organisations conducted an initial testing. In this pilot, we have shown the usability of such a web-based tool. The strengths of this approach include the potential for a routine 'democratic' approach to sharing educational material to a wider community and an openness for access.

  16. The EU-ADR Web Platform: delivering advanced pharmacovigilance tools.

    Science.gov (United States)

    Oliveira, José Luis; Lopes, Pedro; Nunes, Tiago; Campos, David; Boyer, Scott; Ahlberg, Ernst; van Mulligen, Erik M; Kors, Jan A; Singh, Bharat; Furlong, Laura I; Sanz, Ferran; Bauer-Mehren, Anna; Carrascosa, Maria C; Mestres, Jordi; Avillach, Paul; Diallo, Gayo; Díaz Acedo, Carlos; van der Lei, Johan

    2013-05-01

    Pharmacovigilance methods have advanced greatly during the last decades, making post-market drug assessment an essential drug evaluation component. These methods mainly rely on the use of spontaneous reporting systems and health information databases to collect expertise from huge amounts of real-world reports. The EU-ADR Web Platform was built to further facilitate accessing, monitoring and exploring these data, enabling an in-depth analysis of adverse drug reactions risks. The EU-ADR Web Platform exploits the wealth of data collected within a large-scale European initiative, the EU-ADR project. Millions of electronic health records, provided by national health agencies, are mined for specific drug events, which are correlated with literature, protein and pathway data, resulting in a rich drug-event dataset. Next, advanced distributed computing methods are tailored to coordinate the execution of data-mining and statistical analysis tasks. This permits obtaining a ranked drug-event list, removing spurious entries and highlighting relationships with high risk potential. The EU-ADR Web Platform is an open workspace for the integrated analysis of pharmacovigilance datasets. Using this software, researchers can access a variety of tools provided by distinct partners in a single centralized environment. Besides performing standalone drug-event assessments, they can also control the pipeline for an improved batch analysis of custom datasets. Drug-event pairs can be substantiated and statistically analysed within the platform's innovative working environment. A pioneering workspace that helps in explaining the biological path of adverse drug reactions was developed within the EU-ADR project consortium. This tool, targeted at the pharmacovigilance community, is available online at https://bioinformatics.ua.pt/euadr/. Copyright © 2012 John Wiley & Sons, Ltd.

  17. Veterinary pharmacovigilance in India: A need of hour.

    Science.gov (United States)

    Kumar, Rishi; Kalaiselvan, Vivekanandan; Verma, Ravendra; Kaur, Ismeet; Kumar, Pranay; Singh, G N

    2017-01-01

    Veterinary pharmacovigilance (PV) is important for the Medicine which are used for treating disease in animals. It becomes more important when these animals are further used for producing food. Adverse drug reactions (ADRs) have a direct impact on animals and indirect impact on human beings, for example, through milk products, other animal producing food products. Currently, PV program of India is playing a vital role in assessing the safety of medicines in Indian Population. The safety of medicine in animals can be assessed by veterinary PV. The research institutes involved in animal research and veterinary hospitals can be considered as ADR monitoring centers to assess the safety of medicines on animals.

  18. An analysis of Vigimed, a global e-mail system for the exchange of pharmacovigilance information.

    Science.gov (United States)

    Johansson, Kristina; Olsson, Sten; Hellman, Björn; Meyboom, Ronald H B

    2007-01-01

    The Internet provides novel ways for communication and data exchange between national regulators. One innovation was the introduction of Vigimed, an e-mail discussion forum for national pharmacovigilance centres (NPCs). We reviewed a sample of Vigimed messages to learn more about this new tool and about the problems encountered in everyday pharmacovigilance and how these are handled. We analysed the contents of 100 subsequent questions and the corresponding responses as stored in the Vigimed datafile. To the 100 questions circulated through Vigimed, 575 answers were received; mean number of answers per question 6, range 0-20. Fifty-five (77%) of the 71 collaborating countries and 88 (43%) of the 204 individuals who had access in the study period had submitted at least one question or answer. These countries were in all parts of the world and in various phases of development. A total of 38% of the questions concerned the regulatory status of a drug; 30% safety issues; 13% regulatory actions under consideration; and 10% drug use-related problems (more than one category possible). Of the questions, 89% concerned established drugs; 11% were classified as new. A total of 90% of the questions concerned specific active substances or drug groups. Of the drugs, 73% were classified as 'orthodox' and 9% as herbal; 4% were vaccines and 4% excipients. Emerging drug groups (anatomical therapeutic chemical codes) were NSAIDs and analgesics (M01, N02), antibacterials (J01), antiobesity drugs (A08), psychotropic drugs (N05) and antihistamines (R06). NPCs operate in a restricted environment and there is little published information about the daily practices and experiences at NPCs. Our study concerned a sample in a limited period in time. In the meantime, the use of Vigimed has greatly expanded. The data in the Vigimed records are subjected to confidentiality in regard to the identities of countries, staff members, drug products and pharmaceutical companies, which limits the

  19. Advances in pharmacovigilance initiatives surrounding antimicrobial resistance-Indian perspective.

    Science.gov (United States)

    Bairy, Laxminarayana Kurady; Nayak, Veena; A, Avinash; Kunder, Sushil Kiran

    2016-08-01

    In recent years the development of antimicrobial resistance has been accelerating, the discovery of new antimicrobial agents has slowed substantially in past decades. This review mainly focuses on the problem of antimicrobial resistance(AMR); the various contributor mechanisms, consequences and future of AMR. The review also highlights the irrational use of antimicrobials, improving their usage and problems associated with pharmacovigilance of antimicrobial resistance. Pharmacovigilance in the form of surveillance of antibiotic use is being done in 90% of the countries worldwide through the WHONET program developed by WHO. However, the data comes from a limited area of the globe. Data from every part of the world is required, so that there is geographical representation of every region. A major hurdle in quantifying the extent of antimicrobial resistance is the fact that there are several known microbes, that may turn out to be resistant to one or more of the several known antimicrobial agents. The global action plan initiated by WHO, if implemented successfully will definitely reduce AMR and will help in evaluating treatment interventions.

  20. A qualitative exploration of the major challenges facing pharmacovigilance in Saudi Arabia.

    Science.gov (United States)

    Aljadhey, Hisham; Mahmoud, Mansour A; Alshammari, Thamir M; Al-Dhaeefi, Mohammed; Le Louet, Herve; Perez-Gutthann, Susana; Pitts, Peter J

    2015-09-01

    To explore the challenges facing pharmacovigilance in Saudi Arabia and formulate recommendations to improve it from the perspective of healthcare professionals in Saudi Arabia. This was a qualitative study of 4 focus group discussions with pharmacists, physicians, and academicians held under the auspices of the King Saud University School of Pharmacy and the Center for Medicine in the Public Interest, Riyadh, Saudi Arabia. A total of 29 eligible healthcare professionals were invited to participate in the discussion. The predefined themes of the study were the current practice and major challenges facing pharmacovigilance in regulatory bodies, hospitals, the community, and academia, as well as recommendations to improve pharmacovigilance practice.  Of the 29 participants invited, 27 attended the discussion. Challenges facing regulatory bodies included complicated adverse drug reactions (ADR) reporting forms, lack of feedback on ADRs submitted to the Saudi Food and Drug Authority, lack of decisions from the local authority to withdraw medications, and lack of data on pharmacovigilance. The challenges to pharmacovigilance in hospitals included the lack of knowledge of the significance of ADR reporting, workload, blaming culture, and lack of collaboration between regulatory bodies and hospitals. However, challenges facing pharmaceutical industries included the lack of drug manufacturers in Saudi Arabia and lack of interest in pharmacovigilance. Recommendations to improve pharmacovigilance included the need for communication, stronger regulatory requirements, the need for research, the need for unified ADRs reporting, and continuous education and training.  The study has identified the challenges facing pharmacovigilance in Saudi Arabia and made certain recommendations to overcome them. These recommendations might be helpful for regulatory bodies to enhance spontaneous reporting and promote pharmacovigilance.

  1. Modern Approaches to Continuous Audit in the Pharmacovigilance System Vinnytsia region: the Results of 2016

    Directory of Open Access Journals (Sweden)

    Fedir Hladkykh

    2017-12-01

    Full Text Available The results of the pharmacovigilance system operation in Vinnytsia region during 2016 are presented based on the data of the electronic online system "Pharmacovigilance-2016", which was first introduced by us on the basis of the table editor Microsoft Excel of the file-hosting system Google Drive. The formula for calculating the efficiency of the pharmacovigilance implementation as an integral assessment of the safety oversight of medical devices in their use in Vinnytsia region during 2016 is proposed, taking into account the capacity of health facilities at the local level.

  2. Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works.

    Science.gov (United States)

    Santoro, Aniello; Genov, Georgy; Spooner, Almath; Raine, June; Arlett, Peter

    2017-10-01

    This article provides an overview of the European Union pharmacovigilance system resulting from the rationalisation and strengthening delivered through the implementation of the revised pharmacovigilance legislation. It outlines the system aims, underlying principles, components and drivers for future change. At its core, the Pharmacovigilance Risk Assessment Committee is responsible for assessing all aspects of the risk management of medicinal products, thus ensuring that medicines approved for the European Union market are optimally used by maximising their benefits and minimising risks. The main objectives of the system are to promote and protect public health by supporting the availability of medicines including those that fulfil previously unmet medical needs, and reducing the burden of adverse drug reactions. These are achieved through a proactive, risk proportionate and patient-centred approach, with high levels of transparency and engagement of civil society. In the European Union, pharmacovigilance is now fully integrated into the life cycle of medicinal products, with the planning of pharmacovigilance activities commencing before a medicine is placed on the market, and companies encouraged to start planning very early in development for high-innovation products. After authorisation, information on the safety of medicines continues to be obtained through a variety of sources, including spontaneous reports of adverse drug reactions or monitoring real-world data. Finally, the measurement of the impact of pharmacovigilance activities, auditing and inspections, as well as capacity building ensure that the system undergoes continuous improvement and can always rely on the best methodologies to safeguard public health.

  3. A Pharmacovigilance Study in First Episode of Psychosis: Psychopharmacological Interventions and Safety Profiles in the PEPs Project.

    Science.gov (United States)

    Bioque, Miquel; Llerena, Adrián; Cabrera, Bibiana; Mezquida, Gisela; Lobo, Antonio; González-Pinto, Ana; Díaz-Caneja, Covadonga M; Corripio, Iluminada; Aguilar, Eduardo J; Bulbena, Antoni; Castro-Fornieles, Josefina; Vieta, Eduard; Lafuente, Amàlia; Mas, Sergi; Parellada, Mara; Saiz-Ruiz, Jerónimo; Cuesta, Manuel J; Bernardo, Miguel

    2016-04-01

    The characterization of the first episode of psychosis and how it should be treated are principal issues in actual research. Realistic, naturalistic studies are necessary to represent the entire population of first episode of psychosis attended in daily practice. Sixteen participating centers from the PEPs project recruited 335 first episode of psychosis patients, aged 7 to 35 years. This article describes and discusses the psychopharmacological interventions and safety profiles at baseline and during a 60-day pharmacovigilance period. The majority of first episode of psychosis patients received a second-generation antipsychotic (96.3%), orally (95%), and in adjusted doses according to the product specifications (87.2%). A total of 24% were receiving an antipsychotic polytherapy pattern at baseline, frequently associated with lower or higher doses of antipsychotics than the recommended ones. Eight patients were taking clozapine, all in monotherapy. Males received higher doses of antipsychotic (P=.043). A total of 5.2% of the patients were being treated with long-acting injectable antipsychotics; 12.2% of the patients received anticholinergic drugs, 12.2% antidepressants, and 13.7% mood stabilizers, while almost 40% received benzodiazepines; and 35.52% reported at least one adverse drug reaction during the pharmacovigilance period, more frequently associated with higher antipsychotic doses and antipsychotic polytherapy (85.2% vs 45.5%, Psecurity issues, support future research of determinate pharmacological strategies for the treatment of early phases of psychosis, such as the role of clozapine, long-acting injectable antipsychotics, antipsychotic combination, and the use of benzodiazepines. © The Author 2015. Published by Oxford University Press on behalf of CINP.

  4. Hospital medication errors in a pharmacovigilance system in Colombia

    Directory of Open Access Journals (Sweden)

    Jorge Enrique Machado-Alba

    2015-11-01

    Full Text Available Objective: this study analyzes the medication errors reported to a pharmacovigilance system by 26 hospitals for patients in the healthcare system of Colombia. Methods: this retrospective study analyzed the medication errors reported to a systematized database between 1 January 2008 and 12 September 2013. The medication is dispensed by the company Audifarma S.A. to hospitals and clinics around Colombia. Data were classified according to the taxonomy of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP. The data analysis was performed using SPSS 22.0 for Windows, considering p-values < 0.05 significant. Results: there were 9 062 medication errors in 45 hospital pharmacies. Real errors accounted for 51.9% (n = 4 707, of which 12.0% (n = 567 reached the patient (Categories C to I and caused harm (Categories E to I to 17 subjects (0.36%. The main process involved in errors that occurred (categories B to I was prescription (n = 1 758, 37.3%, followed by dispensation (n = 1 737, 36.9%, transcription (n = 970, 20.6% and administration (n = 242, 5.1%. The errors in the administration process were 45.2 times more likely to reach the patient (CI 95%: 20.2–100.9. Conclusions: medication error reporting systems and prevention strategies should be widespread in hospital settings, prioritizing efforts to address the administration process.

  5. Pharmacovigilance in oncology: evaluation of current practice and future perspectives.

    Science.gov (United States)

    Baldo, Paolo; De Paoli, Paolo

    2014-10-01

    Pharmacovigilance (PV), or drug safety monitoring, aims to improve patient safety through the detection and management of drug-related adverse reactions. It is implemented both by spontaneous reporting of adverse drug reactions (ADRs) and by careful detection of signals suggestive of drug toxicity. PV is an important clinical topic in clinical practice and pharmacotherapy, assuring the maintenance of a safe risk/benefit ratio throughout the commercial life cycle of a drug. We conducted a structured literature search on PubMed, Scopus, Cinahl and the Cochrane Library. We also performed manual searches in international databases of ADR individual reports to outline a structured profile on the topic. Our goal was to review key elements that affect safety monitoring of cancer drugs and their appropriate use, highlighting the strengths and weaknesses of PV in oncology. This paper provides an understanding of the methodologies used by PV in current clinical practice and particularly in cancer drug therapy; a focus upon reporting of ADRs by health professionals and patients; and a focus upon methods used by PV to detect new signals of risk/harm related to medicines utilization. To our knowledge, few articles focus upon the importance of PV and post-marketing surveillance of cancer drug therapies. Structured management of spontaneous reports of ADRs and data collection is essential to monitoring the safe use of drugs in this field in which pharmacotherapy is affected by high incidence of drug-related complications and by a narrow benefit/risk ratio. © 2014 John Wiley & Sons, Ltd.

  6. Gentamicin nephrotoxicity: Animal experimental correlate with human pharmacovigilance outcome

    Directory of Open Access Journals (Sweden)

    Olufunsho Awodele

    2015-04-01

    Full Text Available Background: National Agency for Food and Drugs Administration and Control (NAFDAC, which is responsible for pharmacovigilance activity in Nigeria, recently withdrew injection gentamicin 280 mg, used in the management of life-threatening and multidrug-resistant infections from circulation, due to reported toxicity. Thus, this study aimed to investigate the toxicity profile of the commonly used strengths (80 mg and 280 mg of gentamicin on kidney using animal models. Methods: Animals were divided into five groups of 16 rats each. For rats of groups 1 and 2, gentamicin (1.14 mg/kg each group was administered intramuscularly twice daily for 7 and 14 days, respectively, after which eight of them were sacrificed by cervical dislocation. Blood was collected via cardiac puncture and the kidneys were carefully removed and weighed immediately. The remaining eight animals were kept for reversibility study for another 7 and 14 days, respectively. For groups 3 and 4, gentamicin (4 mg/kg each group was administered as a single daily dose for 7 and 14 days, respectively, and eight animals from the groups were subjected to reversibility study for 7 and 14 days, respectively. Group 5, the control group animals, were given 10 ml/kg distilled water for 14 days. Histopathology of the kidneys, serum creatinine levels, and antioxidant enzyme activities were investigated. Results: Significant increase (p ≤ 0.001 in the level of creatinine of rats administered 4.0 mg/kg for 14 days was observed compared with all other groups. Significant (p ≤ 0.001 elevations in the lipid peroxidation in all gentamicin-administered animals and acute tubular necrosis in most of the gentamicin-administered animals were observed. Conclusion: Toxicity profile of gentamicin on the kidneys is dependent on both dose and duration of administration. The findings justify the decision made by NAFDAC to ban the use of high-dose inj. gentamicin 280 mg in Nigeria.

  7. Pharmacovigilance study of Ayurvedic medicine in Ayurvedic Teaching Hospital: A prospective survey study.

    Science.gov (United States)

    Ajanal, Manjunath N; Nayak, Shradda U; Kadam, Avinash P; Prasad, B S

    2015-01-01

    Though Ayurveda is practiced in the Indian subcontinent since centuries, there is a paucity of systematic documentation related to the occurrence of adverse drug reactions (ADR) and other issues regarding the safety of Ayurveda medicines. To monitor and analyze the pattern and frequency of ADR to Ayurvedic medicines in an Ayurvedic hospital setup. In this prospective study, ADR monitoring was done in KLE Ayurveda Secondary Care Hospital, Belgaum, Karnataka, India by spontaneous and intensive monitoring technique for a span of 1-year (June 2010 to May 2011). Data pertaining to patient demography, drug and reaction characteristics, organ system involved and reaction outcomes were collected and evaluated. The reaction severity and predisposing factors were also assessed. In a span of one year, 84 adverse drug events were reported out of which 52 confirmed as ADR. The overall incidence of ADR in the patient population was 1.14%, out of which 23 (44.23%) were related to Panchakarma (detoxification process), 13 (25.00%) related to the herbal formulations and 06 (11.53%) were of Rasa Aushadhi (mineral or herbo-mineral formulations). The commonly affected organ systems were gastrointestinal system 24 (46.15%) and skin 15 (28.84%). The majority of the reactions were moderate 30 (57.69%) to mild 20 (38.46%) in severity. Most patients recovered from the incidence. The present work has documented the incidence and characteristic of ADR to Ayurvedic medicine in a typical Ayurveda hospital setup. This will help in developing various strategies for boosting pharmacovigilance in Ayurveda, thereby ensuring safer use of Ayurveda medicines.

  8. Pharmacist's knowledge, practice and attitudes toward pharmacovigilance and adverse drug reactions reporting process.

    Science.gov (United States)

    Suyagh, Maysa; Farah, Doaa; Abu Farha, Rana

    2015-04-01

    Adverse drug reactions (ADRs) are a major cause of drug related morbidity and mortality. Pharmacovigilance is the science that plays an essential role in the reduction of ADRs, thus the evolution and growth of this science are critical for effective and safe clinical practice. This study is considered the first study in the region to evaluate pharmacist's knowledge, practice and attitudes toward ADRs reporting after establishing the national ADRs reporting center in Jordan. A cross sectional study was used to evaluate pharmacist knowledge and attitude toward ADRs reporting. A structured validated questionnaire was developed for this purpose and a total of 208 pharmacists were recruited to participate in this study. The majority of pharmacists have insufficient awareness and lack of knowledge about pharmacovigilance and ADRs reporting. Also the rate of reporting of ADRs was extremely poor. Several factors were found to discourage pharmacists from reporting ADRs, which include inadequate information available from the patient, unavailability of pharmacist ADRs form when needed, unawareness of the existence of the national ADRs reporting system. Also pharmacists think that ADRs are unimportant or they did not know how to report them. The results of this study suggest that pharmacists have insufficient knowledge about the concept of pharmacovigilance and spontaneous ADRs reporting. On the other hand, pharmacists had positive attitudes toward pharmacovigilance, despite their little experience with ADRs reporting. Educational programs are needed to increase pharmacist's role in the reporting process, and thus to have a positive impact on the overall patient caring process.

  9. Quality management system as a tool for improvement of the dutch pharmacovigilance system

    NARCIS (Netherlands)

    Zweers, P.G.M.A.; Van Puijenbroek, E.P.; Van Grootheest, A.C.

    2009-01-01

    Introduction: The Netherlands Pharmacovigilance centre Lareb started as a regional organization in 1985. In 1995 it was appointed by the Health Authorities as the national centre for collection and analysis for reports of adverse drug reactions. Since then, Lareb has become a solid, professional

  10. Pharmacovigilance training for specialist oncology nurses-a two way evaluation

    NARCIS (Netherlands)

    Schutte, T.; Van Eekeren, R.; Richir, M.; Van Staveren, J.; Van Puijenbroek, E.P.; Tichelaar, J.; Van Agtmael, M.A.

    2017-01-01

    Background: In a new prescribing qualifcation course for specialist oncology nurses, we thought it important to emphasize pharma-covigilance and adverse drug reaction (ADR)-reporting. To this end, our aim was to develop and evaluate an ADR reporting assignment for specialist oncology nurses.

  11. 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.

  12. Utilizing social media data for pharmacovigilance: A review.

    Science.gov (United States)

    Sarker, Abeed; Ginn, Rachel; Nikfarjam, Azadeh; O'Connor, Karen; Smith, Karen; Jayaraman, Swetha; Upadhaya, Tejaswi; Gonzalez, Graciela

    2015-04-01

    Automatic monitoring of Adverse Drug Reactions (ADRs), defined as adverse patient outcomes caused by medications, is a challenging research problem that is currently receiving significant attention from the medical informatics community. In recent years, user-posted data on social media, primarily due to its sheer volume, has become a useful resource for ADR monitoring. Research using social media data has progressed using various data sources and techniques, making it difficult to compare distinct systems and their performances. In this paper, we perform a methodical review to characterize the different approaches to ADR detection/extraction from social media, and their applicability to pharmacovigilance. In addition, we present a potential systematic pathway to ADR monitoring from social media. We identified studies describing approaches for ADR detection from social media from the Medline, Embase, Scopus and Web of Science databases, and the Google Scholar search engine. Studies that met our inclusion criteria were those that attempted to extract ADR information posted by users on any publicly available social media platform. We categorized the studies according to different characteristics such as primary ADR detection approach, size of corpus, data source(s), availability, and evaluation criteria. Twenty-two studies met our inclusion criteria, with fifteen (68%) published within the last two years. However, publicly available annotated data is still scarce, and we found only six studies that made the annotations used publicly available, making system performance comparisons difficult. In terms of algorithms, supervised classification techniques to detect posts containing ADR mentions, and lexicon-based approaches for extraction of ADR mentions from texts have been the most popular. Our review suggests that interest in the utilization of the vast amounts of available social media data for ADR monitoring is increasing. In terms of sources, both health

  13. Utilizing Social Media Data for Pharmacovigilance: A Review

    Science.gov (United States)

    Sarker, Abeed; Ginn, Rachel; Nikfarjam, Azadeh; O’Connor, Karen; Smith, Karen; Jayaraman, Swetha; Upadhaya, Tejaswi; Gonzalez, Graciela

    2015-01-01

    Objective Automatic monitoring of Adverse Drug Reactions (ADRs), defined as adverse patient outcomes caused by medications, is a challenging research problem that is currently receiving significant attention from the medical informatics community. In recent years, user-posted data on social media, primarily due to its sheer volume, has become a useful resource for ADR monitoring. Research using social media data has progressed using various data sources and techniques, making it difficult to compare distinct systems and their performances. In this paper, we perform a methodical review to characterize the different approaches to ADR detection/extraction from social media, and their applicability to pharmacovigilance. In addition, we present a potential systematic pathway to ADR monitoring from social media. Methods We identified studies, describing approaches for ADR detection from social media from the Medline, Embase, Scopus and Web of Science databases, and the Google Scholar search engine. Studies that met our inclusion criteria were those that attempted to utilize ADR information posted by users on any publicly available social media platform. We categorized the studies into various dimensions such as primary ADR detection approach, size of data, source(s), availability, evaluation criteria, and so on. Results Twenty-two studies met our inclusion criteria, with fifteen (68.2%) published within the last two years. The survey revealed a clear trend towards the usage of annotated data with eleven of the fifteen (73.3%) studies published in the last two years relying on expert annotations. However, publicly available annotated data is still scarce, and we found only six (27.3%) studies that made the annotations used publicly available, making system performance comparisons difficult. In terms of algorithms, supervised classification techniques to detect posts containing ADR mentions, and lexicon-based approaches for extraction of ADR mentions from texts have been

  14. Knowledge and attitude of health-care professionals in hospitals towards pharmacovigilance in Saudi Arabia.

    Science.gov (United States)

    Alshammari, Thamir M; Alamri, Khaled K; Ghawa, Yazeed A; Alohali, Noura F; Abualkol, Shaza A; Aljadhey, Hisham S

    2015-12-01

    Drug safety has major implications for patients' lives. However, this concept is still considered new to some healthcare professionals. This study aims to investigate the knowledge and awareness of Saudi healthcare professionals to pharmacovigilance (PV). Setting Governmental and private hospitals at three main cities in Saudi Arabia (Riyadh, Jeddah, and Dammam). A cross-sectional survey among healthcare professionals (pharmacists, physicians, and nurses) within 12 Saudi hospitals was conducted between November and December 2012. The questionnaire consisted of 18 questions assessing the knowledge, awareness, and attitude of healthcare professionals (HCPs) towards science and the concept of PV. Descriptive statistics were used to analyze the data. The data were analyzed using Statistical Analysis Software (SAS 9.3). Main outcome measure Knowledge, attitude and practice of HCPs toward pharmacovigilance. Three-hundred and thirty-two healthcare professionals completed the survey (response rate 72 %), 110 (34 %) physicians, 106 (33 %) pharmacists, and 104 (32 %) nurses. More than half of the participants (55 %) did not know the correct definition of PV. Two-thirds of the respondents, 207 (65.5 %), had knowledge of the aim of post-marketing surveillance, yet only 113 (36.9 %) were aware that the National Pharmacovigilance and Drug Safety Center is the official body for monitoring adverse drug reaction in Saudi Arabia. In addition, 34.7 % agreed that lack of time could be a major barrier for reporting. The majority of the respondents (78.4 %) believed that reporting was a professional obligation and hospitals should have a drug safety department. There was a limited knowledge of pharmacovigilance that could have affected reporting incidence. Educational intervention and a practical training program need to be applied by the drug regulatory body as well as health authorities to enhance the pharmacovigilance and drug safety culture in Saudi Arabia.

  15. Effectiveness of Pharmacovigilance Training of General Practitioners A Retrospective Cohort Study in the Netherlands Comparing Two Methods

    NARCIS (Netherlands)

    Gerritsen, Roald; Faddegon, Hans; Dijkers, Fred; van Grootheest, Kees; van Puijenbroek, Eugene

    2011-01-01

    Background: Spontaneous reporting is a cornerstone of pharmacovigilance. Unfamiliarity with the reporting of suspected adverse drug reactions (ADRs) is a major factor leading to not reporting these events. Medical education may promote more effective reporting. Numerous changes have been implemented

  16. Detecting medication errors in the New Zealand pharmacovigilance database: a retrospective analysis.

    Science.gov (United States)

    Kunac, Desireé L; Tatley, Michael V

    2011-01-01

    Despite the traditional focus being adverse drug reactions (ADRs), pharmacovigilance centres have recently been identified as a potentially rich and important source of medication error data. To identify medication errors in the New Zealand Pharmacovigilance database (Centre for Adverse Reactions Monitoring [CARM]), and to describe the frequency and characteristics of these events. A retrospective analysis of the CARM pharmacovigilance database operated by the New Zealand Pharmacovigilance Centre was undertaken for the year 1 January-31 December 2007. All reports, excluding those relating to vaccines, clinical trials and pharmaceutical company reports, underwent a preventability assessment using predetermined criteria. Those events deemed preventable were subsequently classified to identify the degree of patient harm, type of error, stage of medication use process where the error occurred and origin of the error. A total of 1412 reports met the inclusion criteria and were reviewed, of which 4.3% (61/1412) were deemed preventable. Not all errors resulted in patient harm: 29.5% (18/61) were 'no harm' errors but 65.5% (40/61) of errors were deemed to have been associated with some degree of patient harm (preventable adverse drug events [ADEs]). For 5.0% (3/61) of events, the degree of patient harm was unable to be determined as the patient outcome was unknown. The majority of preventable ADEs (62.5% [25/40]) occurred in adults aged 65 years and older. The medication classes most involved in preventable ADEs were antibacterials for systemic use and anti-inflammatory agents, with gastrointestinal and respiratory system disorders the most common adverse events reported. For both preventable ADEs and 'no harm' events, most errors were incorrect dose and drug therapy monitoring problems consisting of failures in detection of significant drug interactions, past allergies or lack of necessary clinical monitoring. Preventable events were mostly related to the prescribing and

  17. Early detection of pharmacovigilance signals with automated methods based on false discovery rates: a comparative study.

    Science.gov (United States)

    Ahmed, Ismaïl; Thiessard, Frantz; Miremont-Salamé, Ghada; Haramburu, Françoise; Kreft-Jais, Carmen; Bégaud, Bernard; Tubert-Bitter, Pascale

    2012-06-01

    Improving the detection of drug safety signals has led several pharmacovigilance regulatory agencies to incorporate automated quantitative methods into their spontaneous reporting management systems. The three largest worldwide pharmacovigilance databases are routinely screened by the lower bound of the 95% confidence interval of proportional reporting ratio (PRR₀₂.₅), the 2.5% quantile of the Information Component (IC₀₂.₅) or the 5% quantile of the Gamma Poisson Shrinker (GPS₀₅). More recently, Bayesian and non-Bayesian False Discovery Rate (FDR)-based methods were proposed that address the arbitrariness of thresholds and allow for a built-in estimate of the FDR. These methods were also shown through simulation studies to be interesting alternatives to the currently used methods. The objective of this work was twofold. Based on an extensive retrospective study, we compared PRR₀₂.₅, GPS₀₅ and IC₀₂.₅ with two FDR-based methods derived from the Fisher's exact test and the GPS model (GPS(pH0) [posterior probability of the null hypothesis H₀ calculated from the Gamma Poisson Shrinker model]). Secondly, restricting the analysis to GPS(pH0), we aimed to evaluate the added value of using automated signal detection tools compared with 'traditional' methods, i.e. non-automated surveillance operated by pharmacovigilance experts. The analysis was performed sequentially, i.e. every month, and retrospectively on the whole French pharmacovigilance database over the period 1 January 1996-1 July 2002. Evaluation was based on a list of 243 reference signals (RSs) corresponding to investigations launched by the French Pharmacovigilance Technical Committee (PhVTC) during the same period. The comparison of detection methods was made on the basis of the number of RSs detected as well as the time to detection. Results comparing the five automated quantitative methods were in favour of GPS(pH0) in terms of both number of detections of true signals and

  18. The Adverse Drug Reactions from Patient Reports in Social Media Project: Five Major Challenges to Overcome to Operationalize Analysis and Efficiently Support Pharmacovigilance Process.

    Science.gov (United States)

    Bousquet, Cedric; Dahamna, Badisse; Guillemin-Lanne, Sylvie; Darmoni, Stefan J; Faviez, Carole; Huot, Charles; Katsahian, Sandrine; Leroux, Vincent; Pereira, Suzanne; Richard, Christophe; Schück, Stéphane; Souvignet, Julien; Lillo-Le Louët, Agnès; Texier, Nathalie

    2017-09-21

    Adverse drug reactions (ADRs) are an important cause of morbidity and mortality. Classical Pharmacovigilance process is limited by underreporting which justifies the current interest in new knowledge sources such as social media. The Adverse Drug Reactions from Patient Reports in Social Media (ADR-PRISM) project aims to extract ADRs reported by patients in these media. We identified 5 major challenges to overcome to operationalize the analysis of patient posts: (1) variable quality of information on social media, (2) guarantee of data privacy, (3) response to pharmacovigilance expert expectations, (4) identification of relevant information within Web pages, and (5) robust and evolutive architecture. This article aims to describe the current state of advancement of the ADR-PRISM project by focusing on the solutions we have chosen to address these 5 major challenges. In this article, we propose methods and describe the advancement of this project on several aspects: (1) a quality driven approach for selecting relevant social media for the extraction of knowledge on potential ADRs, (2) an assessment of ethical issues and French regulation for the analysis of data on social media, (3) an analysis of pharmacovigilance expert requirements when reviewing patient posts on the Internet, (4) an extraction method based on natural language processing, pattern based matching, and selection of relevant medical concepts in reference terminologies, and (5) specifications of a component-based architecture for the monitoring system. Considering the 5 major challenges, we (1) selected a set of 21 validated criteria for selecting social media to support the extraction of potential ADRs, (2) proposed solutions to guarantee data privacy of patients posting on Internet, (3) took into account pharmacovigilance expert requirements with use case diagrams and scenarios, (4) built domain-specific knowledge resources embeding a lexicon, morphological rules, context rules, semantic rules

  19. Investigating patient narratives posted on Internet and their informativeness level for pharmacovigilance purpose: The example of comments about statins.

    Science.gov (United States)

    Kheloufi, Farid; Default, Anne; Blin, Olivier; Micallef, Joelle

    2017-09-01

    Health-related networks like patient health forums may be considered as potential sources of information to early detect pharmacovigilance issues or complete data on drug safety. However, the clinical and pharmacological relevancy of such a source has not been clearly explored. We aimed to describe the characteristics and the informativeness level of Internet narratives posted by patients and mentioning adverse drug reactions (ADRs) related to statins. A retrospective cross-sectional study was conducted on an Internet website dedicated to share experience on medicines. One day of December 2012, postings about simvastatin, rosuvastatin and atorvastatin publicly available on the website were collected. Their informativeness according to 16 key elements of information (including drug start and stop date, duration of treatment, time to onset and duration of the ADR, outcome, medical history, concomitant medication) was assessed. General information about reported ADRs was also investigated. Among the 96 postings related to statins, 72 (40 women, 32 men; mean age: 59 [40-78]) mentioned at least one ADR accounting for a total of 176 ADRs. Musculoskeletal and connective tissue disorders (42.6%) and nervous system disorders (15.3%) were the main represented ADRs. Only 2 patients mentioned ADRs that could be considered as serious but 24 patients mentioned they stopped or switched their treatment toward another lipid modifying agent because of the ADR. Mean number of available key elements of information per narrative was 6/16. Time to onset and duration of the ADR were respectively available in only 31% and 3% of the narratives. Medical history and concomitant medication were respectively lacking in 87% and 86% of the narratives. Outcome was found only in 39% of the narratives. Patient narratives posted on Internet include mainly non-serious expected ADR. However, their informativeness level is very incomplete and makes difficult their assessment and use for

  20. The value of patient reporting to the pharmacovigilance system: a systematic review.

    Science.gov (United States)

    Inácio, Pedro; Cavaco, Afonso; Airaksinen, Marja

    2017-02-01

    Current trends in pharmacovigilance systems are veering towards patient involvement in spontaneous reporting of adverse drug reactions (ADRs). The aim of the current systematic review was to identify what is known and what remains unknown with respect to patient reporting to pharmacovigilance systems. A systematic literature search was conducted in PubMed, CINAHL, Journals@Ovid and the Cochrane Library. Studies were included if they contained: (i) reviews about patient reporting; (ii) evaluation of patient reports to national or supranational pharmacovigilance authorities; (iii) a comparison between patient and healthcare professional (HCP) reports submitted to pharmacovigilance authorities; and (iv) surveys of patient experiences, opinions and awareness about reporting ADRs. The methodological quality of the studies was assessed according to principles of Grading of Recommendations, Assessment, Development and Evaluations (GRADE). A total of thirty four studies were included. Five of the studies were reviews (two of which systematic reviews), fourteen retrospective observational studies, nine surveys and six applied mixed research methods. Patient reporting has the advantages of bringing novel information about ADRs. It provides a more detailed description of ADRs, and reports about different drugs and system organ classes when compared with HCP reporting. In addition, patients describe the severity and impact of ADRs on daily life, complementing information derived from HCPs. Patient reporting is relatively rare in most countries. Patient reporting adds new information, and perspective about ADRs in a way otherwise unavailable. This can contribute to better decision-making processes in regulatory activities. The present review identified gaps in knowledge that should be addressed to improve our understanding of the full potential and drawbacks of patient reporting. © 2016 The British Pharmacological Society.

  1. Social media and pharmacovigilance: A review of the opportunities and challenges.

    Science.gov (United States)

    Sloane, Richard; Osanlou, Orod; Lewis, David; Bollegala, Danushka; Maskell, Simon; Pirmohamed, Munir

    2015-10-01

    Adverse drug reactions come at a considerable cost on society. Social media are a potentially invaluable reservoir of information for pharmacovigilance, yet their true value remains to be fully understood. In order to realize the benefits social media holds, a number of technical, regulatory and ethical challenges remain to be addressed. We outline these key challenges identifying relevant current research and present possible solutions. © 2015 The British Pharmacological Society.

  2. The nature of the scientific evidence leading to drug withdrawals for pharmacovigilance reasons in France.

    Science.gov (United States)

    Olivier, Pascale; Montastruc, Jean-Louis

    2006-11-01

    Because of design, objectives and number of included subjects, clinical studies are insufficient to assess the safety of new drugs. Sometimes, serious adverse drug reactions (ADRs) led to withdrawal of the drug from the market after their approval. The objective of our study was to determine the scientific evidences leading to drug withdrawal for pharmacovigilance reasons in France. Data coming from French Health Products Safety Agency, literature and Toulouse Pharmacovigilance Center allowed to identify all drugs withdrawn from the French market for pharmacovigilance reasons from 1998 to 2004. We classified data according to their study design (Randomized Clinical Trial [RCT], case serie or case report, case-control study, cohort study, observational study, animal study), the organ/system affected and the type of ADR. A total of 21 drugs were withdrawn for safety reasons between 1998 and 2004 in France. The most frequent ADRs were hepatic (n = 7), cardiovascular (n = 4) or neurological (n = 3) ones. Eleven withdrawals were due to type-B ('unexpected') reactions (52%). For 19 out of 21 drugs, scientific evidence leading to drug withdrawal came from spontaneous case reports (or case series). Among these, case reports were the sole evidence in 12 cases. Withdrawals were based on evidence from case reports in combination with case-control or cohort study in four cases, in combination with observational study in two cases or in combination with animal study in two other cases. In only one case, a RCT supported the decision. This study underlines the importance of spontaneous case reports in detecting signals and supporting withdrawal of drug for pharmacovigilance reasons in France. Health authorities suffer from lack of comparative data resource. In this perspective, a pharmaco-epidemiological population-based database could represent a helpful tool to both generate and test safety hypotheses.

  3. 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.

  4. 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.

  5. The importance of intra-hospital pharmacovigilance in the detection of medication errors

    Science.gov (United States)

    Villegas, Francisco; Figueroa-Montero, David; Barbero-Becerra, Varenka; Juárez-Hernández, Eva; Uribe, Misael; Chávez-Tapia, Norberto; González-Chon, Octavio

    2018-01-01

    Hospitalized patients are susceptible to medication errors, which represent between the fourth and the sixth cause of death. The department of intra-hospital pharmacovigilance intervenes in the entire process of medication with the purpose to prevent, repair and assess damages. To analyze medication errors reported by Mexican Fundación Clínica Médica Sur pharmacovigilance system and their impact on patients. Prospective study carried out from 2012 to 2015, where medication prescriptions given to patients were recorded. Owing to heterogeneity, data were described as absolute numbers in a logarithmic scale. 292 932 prescriptions of 56 368 patients were analyzed, and 8.9% of medication errors were identified. The treating physician was responsible of 83.32% of medication errors, residents of 6.71% and interns of 0.09%. No error caused permanent damage or death. This is the pharmacovigilance study with the largest sample size reported. Copyright: © 2018 SecretarÍa de Salud.

  6. Patient-centered pharmacovigilance: A review | Saleh | Tropical ...

    African Journals Online (AJOL)

    Tropical Journal of Pharmaceutical Research. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 17, No 1 (2018) >. Log in or Register to get access to full text downloads.

  7. Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation.

    Science.gov (United States)

    Ozcan, Gulnihal; Aykac, Emel; Kasap, Yelda; Nemutlu, Nergiz T; Sen, Ebru; Aydinkarahaliloglu, N Demet

    2016-03-01

    In Turkey, pharmacovigilance began in 1985. A fully structured adverse drug reaction (ADR)-reporting system was established with the publication of the first pharmacovigilance regulation in 2005. Subsequent regulation published in 2014 brought further improvements to the system. In this study, we aimed to analyse the ADR-reporting pattern in the context of the first pharmacovigilance legislation in Turkey. We analysed ADR reports submitted to the Turkish Pharmacovigilance Center (TUFAM) from 2005 to 2014 with respect to reporting rate (RR), patient characteristics, type of the ADRs, suspected drugs, source of the report and the profession of the reporter. The annual RR increased gradually over the study period. RRs for females were greater than those for males. RRs were highly correlated with age. Most commonly reported ADRs were skin and subcutaneous tissue disorders. Most commonly suspected drugs were antineoplastic and immunomodulating agents. There was no remarkable change in reporting pattern of ADRs, patient characteristics or classes of suspected drugs over the years. The most common source of reports was spontaneous reporting. Contribution of the reports from studies increased gradually. Most of the reports were reported by physicians. RRs by pharmacists increased substantially over the years. This study showed that the annual RR increased gradually over the 9-year study period. This increase was neither due to an increased reporting of a specific group of ADRs or drugs, nor to an increased reporting in a specific group of patients. There was a general increase in RR in parallel to pharmacovigilance activities.

  8. Awareness among tertiary care doctors about Pharmacovigilance Programme of India: Do endocrinologists differ from others?

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    Pramod Kumar Sharma

    2016-01-01

    Full Text Available Background and Objectives: Reporting adverse drug reactions (ADRs associated with drug use is an important factor in patient safety. Majority of ADRs are preventable through improved prescribing and monitoring. Endocrinologists prescribe drugs with actions on almost all organs and for relatively longer durations. ADR are expected following the use of these drugs. Pharmacovigilance is the study of drug-related adverse effects aimed at protecting patients and public from drug-related harms. The concept of pharmacovigilance is relatively new in India, and this survey is an attempt to explore awareness among doctors of an establishing institution of national importance. Materials and Methods: The survey was conducted on faculty and resident doctors by administering a written structured questionnaire in a voluntary manner. The questionnaire contained questions meant to evaluate their awareness, understanding, and misconception about ADR reporting. Identity of the responder was kept confidential. Results: A total of 106 (faculty = 56; residents = 50 participated in survey. The most common cause cited for not reporting an ADR was “do not know how to report” by 64.15%. Majority of them (64% had no information about the Pharmacovigilance Programme of India (PvPI, and only few (8.5% had actually reported or published an ADR. Interpretation and Conclusions: ADRs are major public health problem that needs to be addressed at all levels of health care. High index of clinical suspicion are crucial for their timely detection and management. Various educational interventions have shown to improve medical professionals' awareness, understanding about ADRs and in their reporting behavior. PvPI is an important initiative toward ensuring patient safety.

  9. 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

  10. [Necessity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections].

    Science.gov (United States)

    Wang, Hai-Nan; Chen, Wen; Fu, Zheng; Du, Wen-min; He, Jia

    2008-03-01

    Traditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.

  11. Drugs and dilated cardiomyopathies: A case/noncase study in the French PharmacoVigilance Database.

    Science.gov (United States)

    Montastruc, Guillaume; Favreliere, Sylvie; Sommet, Agnès; Pathak, Atul; Lapeyre-Mestre, Maryse; Perault-Pochat, Marie-Christine; Montastruc, Jean-Louis

    2010-03-01

    To evaluate putative associations between drugs and dilated cardiomyopathy. We used the case/noncase method in the French PharmacoVigilance Database (FPVD). Cases were all the observations with dilated cardiomyopathy registered into the FPVD between 1 January 1990 and 30 June 2007. Noncases were all other reports other than those studied. Anthracyclines were used as positive controls. Data were expressed as reporting odds ratio (ROR) with their 95% confidence intervals. Out of the 258 729 adverse drug reaction (ADR) reports recorded in the FPVD between 1 January 1990 and 30 June 2007, 47 (22 men, mean age 49 years) were defined as dilated cardiomyopathy. In these 47 patients, 67 drugs were 'suspect'. A significant ROR was found with cytotoxic (epirubicin, mitoxantrone, cyclophosphamide, gemcitabine, fluorouracil) and antiretroviral (lamividune, zidovudine, abacavir) but also with isotretinoin, prednisone, appetite suppressant (clobenzorex) and psychotropic [antipsychotic (clozapine, olanzapine), lithium, antidepressant (clomipramine, amitriptyline, fluvoxamine)] drugs. The present study describes an association between some drugs and reports of dilated cardiomyopathies. This relationship involves not only some already suspected drugs (anthracyclines, antiretrovirals), but also other drugs (antipsychotics, lithium, antidepressants, retinoids) less known to induce such an ADR. Despite the mandatory limits of this kind of study (underreporting, confounding factors . . .), these data represent a pharmacovigilance signal and could contribute to establish further prospective studies in order to confirm such signals.

  12. The past, present and perhaps future of pharmacovigilance: homage to Folke Sjoqvist.

    Science.gov (United States)

    Moore, Nicholas

    2013-05-01

    Over the years since 1961 and the identification of thalidomide as the common link in thousands of birth defects, daily pharmacovigilance activities and signal generation have evolved from the analysis of individual case reports and imputology, to case series and underreporting, to spontaneous report databases and disproportionality analyses, to data mining in population databases. Regulatory requirements have also changed from purely passive monitoring and reacting to alerts to a proactive approach that includes risk management plans and risk minimization, and from reporting only by healthcare professionals to patient reporting and exploration of social media. The emphasis only on risk assessment is changing towards assessment of the risk/benefit ratio and the exploration of real-life efficacy studies to complement the measure of real-life risk. The interactions between industry and regulators have been amplified and strengthened. However, most adverse reactions, including severe ones, are related to well-known and often pharmacological effects of the older drugs, possibly with genetic predispositions. Prevention is the next frontier for pharmacovigilance, beyond simply generating alerts, and it involves not only the removal of drugs from the market, but also promotion of proper drug prescribing by better trained physicians and the proper use of drugs by better informed patients.

  13. Harnessing scientific literature reports for pharmacovigilance. Prototype software analytical tool development and usability testing.

    Science.gov (United States)

    Sorbello, Alfred; Ripple, Anna; Tonning, Joseph; Munoz, Monica; Hasan, Rashedul; Ly, Thomas; Francis, Henry; Bodenreider, Olivier

    2017-03-22

    We seek to develop a prototype software analytical tool to augment FDA regulatory reviewers' capacity to harness scientific literature reports in PubMed/MEDLINE for pharmacovigilance and adverse drug event (ADE) safety signal detection. We also aim to gather feedback through usability testing to assess design, performance, and user satisfaction with the tool. A prototype, open source, web-based, software analytical tool generated statistical disproportionality data mining signal scores and dynamic visual analytics for ADE safety signal detection and management. We leveraged Medical Subject Heading (MeSH) indexing terms assigned to published citations in PubMed/MEDLINE to generate candidate drug-adverse event pairs for quantitative data mining. Six FDA regulatory reviewers participated in usability testing by employing the tool as part of their ongoing real-life pharmacovigilance activities to provide subjective feedback on its practical impact, added value, and fitness for use. All usability test participants cited the tool's ease of learning, ease of use, and generation of quantitative ADE safety signals, some of which corresponded to known established adverse drug reactions. Potential concerns included the comparability of the tool's automated literature search relative to a manual 'all fields' PubMed search, missing drugs and adverse event terms, interpretation of signal scores, and integration with existing computer-based analytical tools. Usability testing demonstrated that this novel tool can automate the detection of ADE safety signals from published literature reports. Various mitigation strategies are described to foster improvements in design, productivity, and end user satisfaction.

  14. Pharmacovigilance in oncology: pattern of spontaneous notifications, incidence of adverse drug reactions and under-reporting

    Directory of Open Access Journals (Sweden)

    Marília Berlofa Visacri

    2014-04-01

    Full Text Available The high toxicity and narrow therapeutic window of antineoplastic agents makes pharmacovigilance studies essential in oncology. The objectives of the current study were to analyze the pattern of spontaneous notifications of adverse drug reactions (ADRs in oncology patients and to analyze the incidence of ADRs reported by outpatients on antineoplastic treatment in a tertiary care teaching hospital. To compose the pattern of ADR, the notification forms of reactions in oncology patients in 2010 were reviewed, and the reactions were classified based on the drug involved, mechanism, causality, and severity. To evaluate the incidence of reactions, a questionnaire at the time of chemotherapy was included, and the severity was classified based on the Common Terminology Criteria. The profiles of the 10 responses reported to the Pharmacovigilance Sector were type B, severe, possible, and they were primarily related to platinum compounds and taxanes. When the incidence of reactions was analyzed, it was observed that nausea, alopecia, fatigue, diarrhea, and taste disturbance were the most frequently reported reactions by oncology patients, and the grade 3 and 4 reactions were not reported. Based on this analysis, it is proposed that health professionals should be trained regarding notifications and clinical pharmacists should increasingly be brought on board to reduce under-reporting of ADRs.

  15. Epistaxis and other haemorrhagic events associated with the smoking cessation medicine varenicline : a case series from two national pharmacovigilance centres

    NARCIS (Netherlands)

    Harrison-Woolrych, Mira; Harmark, Linda; Tan, Ming; Maggo, Simran; van Grootheest, Kees

    Purpose To present a case series of haemorrhagic events associated with varenicline identified from the New Zealand (NZ) and Netherlands national pharmacovigilance centres and propose a possible mechanism for these adverse events. Methods Reports of epistaxis and other haemorrhagic events (in all

  16. Pharmacovigilance of drug allergy and hypersensitivity using the ENDA-DAHD database and the GALEN platform. The Galenda project.

    Science.gov (United States)

    Bousquet, P-J; Demoly, P; Romano, A; Aberer, W; Bircher, A; Blanca, M; Brockow, K; Pichler, W; Torres, M J; Terreehorst, I; Arnoux, B; Atanaskovic-Markovic, M; Barbaud, A; Bijl, A; Bonadonna, P; Burney, P G; Caimmi, S; Canonica, G W; Cernadas, J; Dahlen, B; Daures, J-P; Fernandez, J; Gomes, E; Gueant, J-L; Kowalski, M L; Kvedariene, V; Mertes, P-M; Martins, P; Nizankowska-Mogilnicka, E; Papadopoulos, N; Ponvert, C; Pirmohamed, M; Ring, J; Salapatas, M; Sanz, M L; Szczeklik, A; Van Ganse, E; De Weck, A L; Zuberbier, T; Merk, H F; Sachs, B; Sidoroff, A

    2009-02-01

    Nonallergic hypersensitivity and allergic reactions are part of the many different types of adverse drug reactions (ADRs). Databases exist for the collection of ADRs. Spontaneous reporting makes up the core data-generating system of pharmacovigilance, but there is a large under-estimation of allergy/hypersensitivity drug reactions. A specific database is therefore required for drug allergy and hypersensitivity using standard operating procedures (SOPs), as the diagnosis of drug allergy/hypersensitivity is difficult and current pharmacovigilance algorithms are insufficient. Although difficult, the diagnosis of drug allergy/hypersensitivity has been standardized by the European Network for Drug Allergy (ENDA) under the aegis of the European Academy of Allergology and Clinical Immunology and SOPs have been published. Based on ENDA and Global Allergy and Asthma European Network (GA(2)LEN, EU Framework Programme 6) SOPs, a Drug Allergy and Hypersensitivity Database (DAHD((R))) has been established under FileMaker((R)) Pro 9. It is already available online in many different languages and can be accessed using a personal login. GA(2)LEN is a European network of 27 partners (16 countries) and 59 collaborating centres (26 countries), which can coordinate and implement the DAHD across Europe. The GA(2)LEN-ENDA-DAHD platform interacting with a pharmacovigilance network appears to be of great interest for the reporting of allergy/hypersensitivity ADRs in conjunction with other pharmacovigilance instruments.

  17. Educational Paper: Aspects of clinical pharmacology in children--pharmacovigilance and safety.

    Science.gov (United States)

    Choonara, Imti

    2013-05-01

    Adverse drug reactions (ADRs) are a significant problem in children, affecting one in ten children in hospital. Within the community, one in 500 children will experience an adverse drug reaction each year. Pharmacovigilance has been useful in detecting suspected ADRs. However, most ADRs are unreported and often not suspected. Education of health professionals in relation to drug toxicity improves the reporting rate of suspected ADRs. Clinical trials are useful to evaluate the efficacy of drugs. They are, however, not the best way of looking at ADRs where surveillance following the widespread use of a drug is more appropriate. Alongside work by the regulatory agencies, independent investigators have helped collate data. This information has been useful in developing guidelines to prevent further cases of drug toxicity. Greater awareness and understanding of drug toxicity in children should result in more rational prescribing.

  18. Semantic distance-based creation of clusters of pharmacovigilance terms and their evaluation.

    Science.gov (United States)

    Dupuch, Marie; Grabar, Natalia

    2015-04-01

    Pharmacovigilance is the activity related to the collection, analysis and prevention of adverse drug reactions (ADRs) induced by drugs or biologics. The detection of adverse drug reactions is performed using statistical algorithms and groupings of ADR terms from the MedDRA (Medical Dictionary for Drug Regulatory Activities) terminology. Standardized MedDRA Queries (SMQs) are the groupings which become a standard for assisting the retrieval and evaluation of MedDRA-coded ADR reports worldwide. Currently 84 SMQs have been created, while several important safety topics are not yet covered. Creation of SMQs is a long and tedious process performed by the experts. It relies on manual analysis of MedDRA in order to find out all the relevant terms to be included in a SMQ. Our objective is to propose an automatic method for assisting the creation of SMQs using the clustering of terms which are semantically similar. The experimental method relies on a specific semantic resource, and also on the semantic distance algorithms and clustering approaches. We perform several experiments in order to define the optimal parameters. Our results show that the proposed method can assist the creation of SMQs and make this process faster and systematic. The average performance of the method is precision 59% and recall 26%. The correlation of the results obtained is 0.72 against the medical doctors judgments and 0.78 against the medical coders judgments. These results and additional evaluation indicate that the generated clusters can be efficiently used for the detection of pharmacovigilance signals, as they provide better signal detection than the existing SMQs. Copyright © 2014. Published by Elsevier Inc.

  19. Should methods of correction for multiple comparisons be applied in pharmacovigilance?

    Directory of Open Access Journals (Sweden)

    Lorenza Scotti

    2015-12-01

    Full Text Available Purpose. In pharmacovigilance, spontaneous reporting databases are devoted to the early detection of adverse event ‘signals’ of marketed drugs. A common limitation of these systems is the wide number of concurrently investigated associations, implying a high probability of generating positive signals simply by chance. However it is not clear if the application of methods aimed to adjust for the multiple testing problems are needed when at least some of the drug-outcome relationship under study are known. To this aim we applied a robust estimation method for the FDR (rFDR particularly suitable in the pharmacovigilance context. Methods. We exploited the data available for the SAFEGUARD project to apply the rFDR estimation methods to detect potential false positive signals of adverse reactions attributable to the use of non-insulin blood glucose lowering drugs. Specifically, the number of signals generated from the conventional disproportionality measures and after the application of the rFDR adjustment method was compared. Results. Among the 311 evaluable pairs (i.e., drug-event pairs with at least one adverse event report, 106 (34% signals were considered as significant from the conventional analysis. Among them 1 resulted in false positive signals according to rFDR method. Conclusions. The results of this study seem to suggest that when a restricted number of drug-outcome pairs is considered and warnings about some of them are known, multiple comparisons methods for recognizing false positive signals are not so useful as suggested by theoretical considerations.

  20. The impact of database restriction on pharmacovigilance signal detection of selected cancer therapies.

    Science.gov (United States)

    Hauben, Manfred; Hung, Eric; Wood, Jennifer; Soitkar, Amit; Reshef, Daniel

    2017-05-01

    The aim of this study was to investigate whether database restriction can improve oncology drug pharmacovigilance signal detection performance. We used spontaneous adverse event (AE) reports in the United States (US) Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. Positive control (PC) drug medical concept (DMC) pairs were selected from safety information not included in the product's first label but subsequently added as label changes. These medical concepts (MCs) were mapped to the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs) used in FAERS to code AEs. Negative controls (NC) were MCs with circumscribed PTs not included in the corresponding US package insert (USPI). We calculated shrinkage-adjusted observed-to-expected (O/E) reporting frequencies for the aforementioned drug-PT pairs. We also formulated an adjudication framework to calculate performance at the MC level. Performance metrics [sensitivity, specificity, positive and negative predictive value (PPV, NPV), signal/noise (S/N), F and Matthews correlation coefficient (MCC)] were calculated for each analysis and compared. The PC reference set consisted of 11 drugs, 487 PTs, 27 MCs, 37 drug-MC combinations and 638 drug-event combinations (DECs). The NC reference set consisted of 11 drugs, 9 PTs, 5 MCs, 40 drug-MC combinations and 67 DECs. Most drug-event pairs were not highlighted by either analysis. A small percentage of signals of disproportionate reporting were lost, more noise than signal, with no gains. Specificity and PPV improved whereas sensitivity, NPV, F and MCC decreased, but all changes were small relative to the decrease in sensitivity. The overall S/N improved. This oncology drug restricted analysis improved the S/N ratio, removing proportionately more noise than signal, but with significant credible signal loss. Without broader experience and a calculus of costs and utilities of correct versus incorrect classifications in

  1. Knowledge, perception, practices and barriers of healthcare professionals in Bosnia and Herzegovina towards adverse drug reaction reporting and pharmacovigilance

    Directory of Open Access Journals (Sweden)

    Maša Amrain

    2014-09-01

    Full Text Available Introduction: Pharmacovigilance is an arm of patient care. No one wants to harm patients, but unfortunately any medicine will sometimes do just this. Underreporting of adverse drug reactions by healthcare professionals is a major problem in many countries. In order to determine whether our pharmacovigilance system could be improved, and identify reasons for under-reporting, a study to investigate the role of health care professionals in adverse drug reaction (ADR reporting was performed.Methods: A pretested questionnaire comprising of 20 questions was designed for assessment of knowledge, perceptions, practice and barriers toward ADR reporting on a random sample of 1000 healthcare professionals in Bosnia and Herzegovina.Results: Of the 1000 respondents, 870 (87% completed the questionnaire. The survey showed that 62.9% health care professionals would report ADR to the Agency for Medicinal Products and Medical Device of Bosnia and Herzegovina (ALMBIH. Most of surveyed respondents has a positive perception towards ADR reporting, and believes that this is part of their professional and legal obligation, and they also recognize the importance of reporting adverse drug reactions. Only small percent (15.4% of surveyed health care professionals reported adverse drug reaction.Conclusions: The knowledge of ADRs and how to report them is inadequate among health care professionals. Perception toward ADR reporting was positive, but it is not reflected in the actual practice of ADRs, probably because of little experience and knowledge regarding pharmacovigilance. Interventions such as education and training, focusing on the aims of pharmacovigilance, completing the ADR form and clarifying the reporting criteria are strongly recommended.

  2. Knowledge of Adverse Drug Reaction Reporting and the Pharmacovigilance of Biological Medicines: A Survey of Healthcare Professionals in Ireland.

    Science.gov (United States)

    O'Callaghan, J; Griffin, B T; Morris, J M; Bermingham, Margaret

    2018-06-01

    In Europe, changes to pharmacovigilance legislation, which include additional monitoring of medicines, aim to optimise adverse drug reaction (ADR) reporting systems. The legislation also makes provisions related to the traceability of biological medicines. The objective of this study was to assess (i) knowledge and general experience of ADR reporting, (ii) knowledge, behaviours, and attitudes related to the pharmacovigilance of biologicals, and (iii) awareness of additional monitoring among healthcare professionals (HCPs) in Ireland. Hospital doctors (n = 88), general practitioners (GPs) (n = 197), nurses (n = 104) and pharmacists (n = 309) completed an online questionnaire. There were differences in mean knowledge scores relating to ADR reporting and the pharmacovigilance of biologicals among the HCP groups. The majority of HCPs who use biological medicines in their practice generally record biologicals by brand name but practice behaviours relating to batch number recording differed between some professions. HCPs consider batch number recording to be valuable but also regard it as being more difficult than brand name recording. Most respondents were aware of the concept of additional monitoring but awareness rates differed between some groups. Among those who knew about additional monitoring, there was higher awareness of the inverted black triangle symbol among pharmacists (> 86.4%) compared with hospital doctors (35.1%), GPs (35.6%), and nurses (14.9%). Hospital pharmacists had more experience and knowledge of ADR reporting than other practising HCPs. This study highlights the important role hospital pharmacists play in post-marketing surveillance. There is a need to increase pharmacovigilance awareness of biological medicines and improve systems to support their batch traceability.

  3. Analysis of Patient Narratives in Disease Blogs on the Internet: An Exploratory Study of Social Pharmacovigilance.

    Science.gov (United States)

    Matsuda, Shinichi; Aoki, Kotonari; Tomizawa, Shiho; Sone, Masayoshi; Tanaka, Riwa; Kuriki, Hiroshi; Takahashi, Yoichiro

    2017-02-24

    Although several reports have suggested that patient-generated data from Internet sources could be used to improve drug safety and pharmacovigilance, few studies have identified such data sources in Japan. We introduce a unique Japanese data source: tōbyōki, which translates literally as "an account of a struggle with disease." The objective of this study was to evaluate the basic characteristics of the TOBYO database, a collection of tōbyōki blogs on the Internet, and discuss potential applications for pharmacovigilance. We analyzed the overall gender and age distribution of the patient-generated TOBYO database and compared this with other external databases generated by health care professionals. For detailed analysis, we prepared separate datasets for blogs written by patients with depression and blogs written by patients with rheumatoid arthritis (RA), because these conditions were expected to entail subjective patient symptoms such as discomfort, insomnia, and pain. Frequently appearing medical terms were counted, and their variations were compared with those in an external adverse drug reaction (ADR) reporting database. Frequently appearing words regarding patients with depression and patients with RA were visualized using word clouds and word cooccurrence networks. As of June 4, 2016, the TOBYO database comprised 54,010 blogs representing 1405 disorders. Overall, more entries were written by female bloggers (68.8%) than by male bloggers (30.8%). The most frequently observed disorders were breast cancer (4983 blogs), depression (3556), infertility (2430), RA (1118), and panic disorder (1090). Comparison of medical terms observed in tōbyōki blogs with those in an external ADR reporting database showed that subjective and symptomatic events and general terms tended to be frequently observed in tōbyōki blogs (eg, anxiety, headache, and pain), whereas events using more technical medical terms (eg, syndrome and abnormal laboratory test result) tended to be

  4. Donor support for quality assurance and pharmacovigilance of anti-malarials in malaria-endemic countries.

    Science.gov (United States)

    Kovacs, Stephanie D; Mills, Brianna M; Stergachis, Andy

    2017-07-11

    Malaria control efforts have been strengthened by funding from donor groups and government agencies. The Global Fund to Fight AIDS, Tuberculosis and the Malaria (Global Fund), the US President's Malaria Initiative (PMI) account for the majority of donor support for malaria control and prevention efforts. Pharmacovigilance (PV), which encompasses all activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem, is a necessary part of efforts to reduce drug resistance and improve treatment outcomes. This paper reports on an analysis of PV plans in the Global Fund and PMI and World Bank's grants for malaria prevention and control. All active malaria grants as of September 2015 funded by the Global Fund and World Bank, and fiscal year 2015 and 2016 PMI Malaria Operational Plans (MOP) were identified. The total amount awarded for PV-related activities and drug quality assurance was abstracted. A Key-Word-in-Context (KWIC) analysis was conducted for the content of each grant. Specific search terms consisted of pharmacovigilance, pregn*, registry, safety, adverse drug, mass drug administration, primaquine, counterfeit, sub-standard, and falsified. Grants that mentioned PV activities identified in the KWIC search, listed PV in their budgets, or included the keywords: counterfeit, sub-standard, falsified, mass drug administration, or adverse event were thematically coded using Dedoose software version 7.0. The search identified 159 active malaria grants including 107 Global Fund grants, 39 fiscal year 2015 and 2016 PMI grants and 13 World Bank grants. These grants were primarily awarded to low-income countries (57.2%) and in sub-Saharan Africa (SSA) (70.4%). Thirty-seven (23.3%) grants included a budget line for PV- or drug quality assurance-related activities, including 21 PMI grants and 16 Global Fund grants. Only 23 (14.5%) grants directly mentioned PV. The primary focus area was improving drug

  5. Sources of information on lymphoma associated with anti-tumour necrosis factor agents: comparison of published case reports and cases reported to the French pharmacovigilance system.

    Science.gov (United States)

    Théophile, Hélène; Schaeverbeke, Thierry; Miremont-Salamé, Ghada; Abouelfath, Abdelilah; Kahn, Valentine; Haramburu, Françoise; Bégaud, Bernard

    2011-07-01

    Anti-tumour necrosis factor (TNF) agents, through their intense immunoregulatory effect, have been suspected to increase the risk of malignant lymphoma. However, the classical epidemiological approaches conducted over about the last 10 years have not totally succeeded in addressing the question of a causal or artifactual association. Therefore, the analysis of a substantial set of case reports, although usually considered as poorly generalizable to the general population, could be particularly informative. Two main sources of case reports in postmarketing settings are available; publications in medical journals and reports to pharmacovigilance systems. The aim of the study was to compare the characteristics of case reports from both these sources in order to understand whether they provided the same information for the investigation of the causal link between lymphoma and anti-TNF agents. All case reports of malignant lymphoma in patients treated with an anti-TNF agent published in MEDLINE and all reports to the French pharmacovigilance system up to 1 February 2010 were identified. Cases of malignant lymphoma identified in postmarketing surveillance from both sources were compared regarding the following variables: age, sex, anti-TNF agent involved, indication for use, type of lymphoma, prior or concomitant immunosuppressive drugs and time to onset of lymphoma. A total of 81 published case reports and 61 cases reported to the French pharmacovigilance system were compared. In published reports, patients were younger (p = 0.03) and more frequently receiving a first anti-TNF treatment (p = 0.03), particularly infliximab (p = 0.03). Conversely, in the pharmacovigilance system reports, a succession of different anti-TNFs (p = 0.03) and adalimumab (p French pharmacovigilance system differed markedly for all characteristics tested, except sex and the use of prior or concomitant immunosuppressive drugs. Published case reports favoured convincing arguments

  6. Facilitating adverse drug event detection in pharmacovigilance databases using molecular structure similarity: application to rhabdomyolysis

    Science.gov (United States)

    Vilar, Santiago; Harpaz, Rave; Chase, Herbert S; Costanzi, Stefano; Rabadan, Raul

    2011-01-01

    Background Adverse drug events (ADE) cause considerable harm to patients, and consequently their detection is critical for patient safety. The US Food and Drug Administration maintains an adverse event reporting system (AERS) to facilitate the detection of ADE in drugs. Various data mining approaches have been developed that use AERS to detect signals identifying associations between drugs and ADE. The signals must then be monitored further by domain experts, which is a time-consuming task. Objective To develop a new methodology that combines existing data mining algorithms with chemical information by analysis of molecular fingerprints to enhance initial ADE signals generated from AERS, and to provide a decision support mechanism to facilitate the identification of novel adverse events. Results The method achieved a significant improvement in precision in identifying known ADE, and a more than twofold signal enhancement when applied to the ADE rhabdomyolysis. The simplicity of the method assists in highlighting the etiology of the ADE by identifying structurally similar drugs. A set of drugs with strong evidence from both AERS and molecular fingerprint-based modeling is constructed for further analysis. Conclusion The results demonstrate that the proposed methodology could be used as a pharmacovigilance decision support tool to facilitate ADE detection. PMID:21946238

  7. Safety of Factor XIII Concentrate: Analysis of More than 20 Years of Pharmacovigilance Data

    Science.gov (United States)

    Solomon, Cristina; Korte, Wolfgang; Fries, Dietmar; Pendrak, Inna; Joch, Christine; Gröner, Albrecht; Birschmann, Ingvild

    2016-01-01

    Background Plasma-derived factor XIII (FXIII) concentrate is an effective treatment for FXIII deficiency. We describe adverse drug reactions (ADRs) reported during pharmacovigilance monitoring of Fibrogammin®/Corifact® and review published safety data. Methods Postmarketing safety reports recorded by CSL Behring from June 1993 to September 2013 were analyzed. Clinical studies published during the same period were also reviewed. Results Commercial data indicated that 1,653,450,333 IU FXIII concentrate were distributed over the review period, equivalent to 1,181,036 doses for a 70 kg patient. 75 cases were reported (one/15,700 standard doses or 22,046,000 IU). Reports of special interest included 12 cases of possible hypersensitivity reactions (one/98,400 doses or 137,787,500 IU), 7 with possible thromboembolic events (one/168,700 doses or 236,207,200 IU), 5 of possible inhibitor development (one/236,200 doses or 330,690,100 IU), and 20 of possible pathogen transmission (one/59,100 doses or 82,672,500 IU). 19 pathogen transmission cases involved viral infection; 4 could not be analyzed due to insufficient data, but for all others a causal relationship to the product was assessed as unlikely. A review of published literature revealed a similar safety profile. Conclusion Assessment of ADRs demonstrated that FXIII concentrate carries a low risk of ADRs across various clinical situations, suggesting a favorable safety profile. PMID:27781024

  8. Statistical Signal Process in R Language in the Pharmacovigilance Programme of India.

    Science.gov (United States)

    Kumar, Aman; Ahuja, Jitin; Shrivastava, Tarani Prakash; Kumar, Vipin; Kalaiselvan, Vivekanandan

    2018-05-01

    The Ministry of Health & Family Welfare, Government of India, initiated the Pharmacovigilance Programme of India (PvPI) in July 2010. The purpose of the PvPI is to collect data on adverse reactions due to medications, analyze it, and use the reference to recommend informed regulatory intervention, besides communicating the risk to health care professionals and the public. The goal of the present study was to apply statistical tools to find the relationship between drugs and ADRs for signal detection by R programming. Four statistical parameters were proposed for quantitative signal detection. These 4 parameters are IC 025 , PRR and PRR lb , chi-square, and N 11 ; we calculated these 4 values using R programming. We analyzed 78,983 drug-ADR combinations, and the total count of drug-ADR combination was 4,20,060. During the calculation of the statistical parameter, we use 3 variables: (1) N 11 (number of counts), (2) N 1. (Drug margin), and (3) N .1 (ADR margin). The structure and calculation of these 4 statistical parameters in R language are easily understandable. On the basis of the IC value (IC value >0), out of the 78,983 drug-ADR combination (drug-ADR combination), we found the 8,667 combinations to be significantly associated. The calculation of statistical parameters in R language is time saving and allows to easily identify new signals in the Indian ICSR (Individual Case Safety Reports) database.

  9. Patterns of adverse drug reaction signals in NAFDAC Pharmacovigilance activities from September to November, 2014.

    Science.gov (United States)

    Awodele, Olufunsho; Ibrahim, Ali; Orhii, Paul

    2016-03-16

    Adverse drug reaction signals are reported information on possible causal relationships between an adverse event and a drug. The National Pharmacovigilance Centre (NPC) in Nigeria has over 3,000 reported adverse drug reaction cases which have been adequately entered into the ADR data bank. Data mining of ADR reports from September to November, 2014 were carried out in this present study with the intention to describe the pattern of ADRs and generate possible signals. A total of about 100 reported cases with arrays of adverse drug reactions were reported between September and November, 2014 and the data were analyzed using SPSS version 17. Efavirenz/Tenofovir/Lamivudine combination was the highest reported drugs (24.2%) while efavirenz alone was reported in 8 times (8.8%) and HIV (63.3%) was the highest reported indication of drug use. Efavirenz caused central nervous system adverse reactions as revealed in the ADRs analyses. Zidovudine/Lamivudine/Nevirapine combination in concomitant use with Cotrimoxazole were reported 8 times with generalized maculopapular rashes on the trunk with some area of hyper pigmentation with intense itching documented twice and big/swollen rashes all over the faces. Zidovudine was also reported four times to cause severe anaemia. More surveillance is advocated so as to ascertain the consistency of the observed ADRs and thereafter establish appropriate signals.

  10. 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.

  11. Therapeutic monoclonal antibodies and the need for targeted pharmacovigilance in India.

    Science.gov (United States)

    Kalaivani, M; Singh, Abhishank; Kalaiselvan, V

    2015-01-01

    A growing number of innovative mAb therapeutics are on the global market, and biosimilar versions have now also been approved, including in India. Although efficacy and safety is demonstrated prior to approval, targeted pharmacovigilance is essential for the identification and assessment of risk for any mAb products. We analyzed the ADR data related to mAbs reported to the NCC-PvPI through the spontaneous reporting system Vigiflow during April 2011 to February 2014 to identify mAbs with the highest number of ADR including fatal/serious ADR. Only 0.72% reports were related to mAbs. Although 15 mAbs are approved in the country, only 6 mAbs were reported through Vigiflow. Rituximab was highly reported, and no fatal/serious ADR related to any mAbs were reported during the study period. Our study shows that PvPI is effective and robust system in the detection and assessment of risks associated with the use of mAbs.

  12. Interstitial lung disease induced by fluoxetine: Systematic review of literature and analysis of Vigiaccess, Eudravigilance and a national pharmacovigilance database.

    Science.gov (United States)

    Deidda, Arianna; Pisanu, Claudia; Micheletto, Laura; Bocchetta, Alberto; Del Zompo, Maria; Stochino, Maria Erminia

    2017-06-01

    We investigated a pulmonary adverse drug reaction possibly induced by fluoxetine, the Interstitial Lung Disease, by performing a systematic review of published case reports on this subject, a review of the World Health Organization VigiAccess database, of the European EudraVigilance database and of a national Pharmacovigilance database (Italian Pharmacovigilance Network). The research found a total of seven cases linking fluoxetine to Interstitial Lung Disease in the literature. 36 cases of interstitial lung disease related to fluoxetine were retrieved from the VigiAccess database (updated to July 2016), and 36 reports were found in EudraVigilance database (updated to June 2016). In the Italian Pharmacovigilance database (updated to August 2016), we found only one case of Interstitial Lung Disease, codified as "pulmonary disease". Our investigation shows that fluoxetine might be considered as a possible cause of Interstitial Lung Disease. In particular, although here we do not discuss the assessment of benefits and harms of fluoxetine, since this antidepressant is widely used, our review suggests that fluoxetine-induced Interstitial Lung Disease should be considered in patients with dyspnea, associated or not with dry cough, who are treated with this drug. An early withdrawn of fluoxetine could be useful to obtain a complete remission of this adverse drug reaction and special attention should be particularly devoted to long-term therapy, and to female and elderly patients. Although the spontaneous reporting system is affected by important limitations, drug post- marketing surveillance represents an important tool to evaluate the real world effectiveness and safety of drugs. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. Effectiveness of pharmacovigilance: multifaceted educational intervention related to the knowledge, skills and attitudes of multidisciplinary hospital staff

    Directory of Open Access Journals (Sweden)

    Fabiana Rossi Varallo

    Full Text Available OBJECTIVES: Most educational interventions in pharmacovigilance are designed to encourage physicians to report adverse drug reactions. However, multidisciplinary teams may play an important role in reporting drug-related problems. This study assessed the impact of a multifaceted educational intervention in pharmacovigilance on the knowledge, skills and attitudes of hospital professionals. METHOD: This prospective, open-label, non-randomized study was performed in a medium-complexity hospital in São Paulo, Brazil. The intervention involved four activities: 1 an interactive lecture, 2 a practical class, 3 a pre-post questionnaire administered to professionals on a multidisciplinary team, and 4 educational material. The intervention’s impact on the professionals’ knowledge and skills was assessed using the World Health Organization’s definitions. The intervention’s effect on the professionals’ attitudes was analysed by the prevalence of adverse drug event reports (adverse drug reactions, medication errors, therapeutic failure and drug quality deviations and the relevance (seriousness and expectancy of the events. RESULTS: One hundred seventy-three professionals were enrolled. A 70-fold increase in the number of adverse drug event reports was observed during the 12 months post-intervention. The intervention improved the professionals’ form-completion skills (p<0.0001 and their knowledge of pharmacovigilance (p<0.0001. The intervention also contributed to detecting serious drug-induced events. The nursing staff reported medication errors, and pharmacists and physiotherapists recognized serious adverse drug reactions. Physicians communicated suspicions of therapeutic failure. CONCLUSIONS: A multidisciplinary approach to drug-safety assessments contributes to identifying new, relevant drug-related problems and improving the rate of adverse drug event reporting. This strategy may therefore be applied to improve risk communication in

  14. Adverse drug reaction monitoring of newer oral anti diabetic drugs – a pharmacovigilance perspective

    Directory of Open Access Journals (Sweden)

    Ankita Bhattacharjee

    2016-04-01

    Full Text Available Objective: To monitor and evaluate adverse drug reactions (ADRs of newer oral anti-diabetic drugs in type II diabetics by spontaneous/solicited ADR monitoring.Material and methods: Two hundred and thirty two diabetic patients on newer oral antidiabetic drugs were evaluated prospectively in a cross-sectional study over a period of eighteen months. All patients were followed up for ADRs which were evaluated for incidence, frequency, severity and causality. ADR severity was graded according to University of Virginia Health System Adverse Drug Reaction Reporting program criteria and causality assessment was done using WHO-UMC scale.Results: 190 out of 232 patients (42 patients lost to follow up were evaluated. ADRs were observed in 34 cases (17.9%. Most common ADRs were gastrointestinal (44.2% followed by musculoskeletal (17.6%, metabolic (14.7%, infections (5.9% and others (17.6%. The maximal frequency of ADRs was seen with sitagliptin (6.4% followed by vildagliptin(3.8%, saxagliptin(2.7%, saroglitazar(2.1%, linagliptin(1.6%, canagliflozin(1.6%. 25(73.5%, 8(23.5% and 1(3% ADRs were mild, moderate and severe respectively. 24(70% ADRs were classified as possible, 9(27% probable and 1(3% unlikely on causality assessment. Conclusion: Newer oral antidiabetic drugs like gliptins and SGLT-2 inhibitors have potential to cause ADRs. Gastro-intestinal, musculoskeletal, metabolic were most common ADRs. Active pharmacovigilance should be carried out for risk identification and management. 

  15. Deep learning for pharmacovigilance: recurrent neural network architectures for labeling adverse drug reactions in Twitter posts.

    Science.gov (United States)

    Cocos, Anne; Fiks, Alexander G; Masino, Aaron J

    2017-07-01

    Social media is an important pharmacovigilance data source for adverse drug reaction (ADR) identification. Human review of social media data is infeasible due to data quantity, thus natural language processing techniques are necessary. Social media includes informal vocabulary and irregular grammar, which challenge natural language processing methods. Our objective is to develop a scalable, deep-learning approach that exceeds state-of-the-art ADR detection performance in social media. We developed a recurrent neural network (RNN) model that labels words in an input sequence with ADR membership tags. The only input features are word-embedding vectors, which can be formed through task-independent pretraining or during ADR detection training. Our best-performing RNN model used pretrained word embeddings created from a large, non-domain-specific Twitter dataset. It achieved an approximate match F-measure of 0.755 for ADR identification on the dataset, compared to 0.631 for a baseline lexicon system and 0.65 for the state-of-the-art conditional random field model. Feature analysis indicated that semantic information in pretrained word embeddings boosted sensitivity and, combined with contextual awareness captured in the RNN, precision. Our model required no task-specific feature engineering, suggesting generalizability to additional sequence-labeling tasks. Learning curve analysis showed that our model reached optimal performance with fewer training examples than the other models. ADR detection performance in social media is significantly improved by using a contextually aware model and word embeddings formed from large, unlabeled datasets. The approach reduces manual data-labeling requirements and is scalable to large social media datasets. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

  16. Knowledge, Attitude, and Practices regarding Pharmacovigilance and Adverse Drug Reaction reporting among Dental Students in a Teaching Hospital, Jodhpur, India: A Cross-sectional Study.

    Science.gov (United States)

    Chhabra, Kumar G; Sharma, Ashish; Chhabra, Chaya; Reddy, J Jyothirmai; Deolia, Shravani G; Mittal, Yogesh

    2017-10-01

    This is a cross-sectional knowledge, attitude, and practices (KAPs) study on pharmacovigilance (PV) and adverse drug reaction (ADR) reporting among dental students in a teaching hospital in India. The aim of this study was to assess the KAP of dental students regarding PV, ADR reporting, and barriers toward the same. A cross-sectional survey using a self-administered, investigator-developed, close-ended questionnaire was conducted in an academic dental hospital in India. All prescribers including third year students, final year students, and house surgeons of the same institute were included for assessment of KAP regarding PV using 16, 8, and 8 items respectively. Data regarding barriers toward ADR reporting and demographics were also collected. Mann-Whitney U-test and Kruskal-Wallis test were applied followed by post hoc test. A total of 241 of 275 respondents participated in the study with a response rate of 87.5%. Overall, 64% reported that they had no idea about the term PV. Age was significantly associated with knowledge (p = 0.045) and attitude (p = 0.016). Barriers contributing to underreporting were difficulty in deciding whether or not an ADR has occurred (52.0%), concerns that the report may be wrong (37%), lack of confidence to discuss ADR with colleagues (29%), and almost no financial benefits (24%). Participants had a comparatively favorable attitude toward PV, but their knowledge and practice need considerable improvements. This study highlights the need for appropriate dental curriculum changes and further multicentric studies to shed more light on important issues of PV among dentists in India. This study explores dentists' knowledge, attitude, and behavior regarding PV, which could help to improve patient's safety and care. The favorable attitude of dentists is an indication that PV could be added in depth in the curriculum and in general practice. Information on barriers for reporting the ADRs could help to find possible solutions for removing the

  17. A Survey on Pharmacovigilance Activities in ASEAN and Selected Non-ASEAN Countries, and the Use of Quantitative Signal Detection Algorithms.

    Science.gov (United States)

    Chan, Cheng Leng; Ang, Pei San; Li, Shu Chuen

    2017-06-01

    Most Countries have pharmacovigilance (PV) systems in place to monitor the safe use of health products. The process involves the detection and assessment of safety issues from various sources of information, communicating the risk to stakeholders and taking other relevant risk minimization measures. This study aimed to assess the PV status in Association of Southeast Asian Nation (ASEAN) countries, sources for postmarket safety monitoring, methods used for signal detection and the need for a quantitative signal detection algorithm (QSDA). Comparisons were conducted with centres outside ASEAN. A questionnaire was sent to all PV centres in ASEAN countries, as well as seven other countries, from November 2015 to June 2016. The questionnaire was designed to collect information on the status of PV, with a focus on the use of a QSDA. Data were collected from nine ASEAN countries and seven other countries. PV activities were conducted in all these countries, which were at different stages of development. In terms of adverse drug reaction (ADR) reports, the average number received per year ranged from 3 to 50,000 reports for ASEAN countries and from 7000 to 1,103,200 for non-ASEAN countries. Thirty-three percent of ASEAN countries utilized statistical methods to help detect signals from ADR reports compared with 100% in the other non-ASEAN countries. Eighty percent agreed that the development of a QSDA would help in drug signal detection. The main limitation identified was the lack of knowledge and/or lack of resources. Spontaneous ADR reports from healthcare professionals remains the most frequently used source for safety monitoring. The traditional method of case-by-case review of ADR reports prevailed for signal detection in ASEAN countries. As the reports continue to grow, the development of a QSDA would be useful in helping detect safety signals.

  18. From Big Data to Smart Data for Pharmacovigilance: The Role of Healthcare Databases and Other Emerging Sources.

    Science.gov (United States)

    Trifirò, Gianluca; Sultana, Janet; Bate, Andrew

    2018-02-01

    In the last decade 'big data' has become a buzzword used in several industrial sectors, including but not limited to telephony, finance and healthcare. Despite its popularity, it is not always clear what big data refers to exactly. Big data has become a very popular topic in healthcare, where the term primarily refers to the vast and growing volumes of computerized medical information available in the form of electronic health records, administrative or health claims data, disease and drug monitoring registries and so on. This kind of data is generally collected routinely during administrative processes and clinical practice by different healthcare professionals: from doctors recording their patients' medical history, drug prescriptions or medical claims to pharmacists registering dispensed prescriptions. For a long time, this data accumulated without its value being fully recognized and leveraged. Today big data has an important place in healthcare, including in pharmacovigilance. The expanding role of big data in pharmacovigilance includes signal detection, substantiation and validation of drug or vaccine safety signals, and increasingly new sources of information such as social media are also being considered. The aim of the present paper is to discuss the uses of big data for drug safety post-marketing assessment.

  19. Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data.

    Science.gov (United States)

    Endrikat, J; Schwenke, C; Prince, M R

    2015-07-01

    To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18-64 years. Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Rates of reported ADRs were lower in elderly patients versus adults aged statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. Copyright © 2015 The Royal College of Radiologists. All rights reserved.

  20. Hearing impairment associated with oral terbinafine use : a case series and case/non-case analysis in the Netherlands Pharmacovigilance Centre Lareb database and VigiBase™

    NARCIS (Netherlands)

    Scholl, Joep H G; van Puijenbroek, Eugene P

    2012-01-01

    BACKGROUND: The Netherlands Pharmacovigilance Centre Lareb received reports of six cases of hearing impairment in association with oral terbinafine use. This study describes these cases and provides support for this association from the Lareb database for spontaneous adverse drug reaction (ADR)

  1. An International Study of the Ability and Cost-Effectiveness of Advertising Methods to Facilitate Study Participant Self-Enrolment Into a Pilot Pharmacovigilance Study During Early Pregnancy

    NARCIS (Netherlands)

    Richardson, Jonathan Luke; Stephens, Sally; Thomas, Simon Hugh Lynton; Jamry-Dziurla, Anna; Jong-van den Berg, de Lolkje; Zetstra-van der Woude, Priscilla; Laursen, Maja; Hliva, Valerie; Mt-Isa, Shahrul; Bourke, Alison; Dreyer, Nancy A; Blackburn, Stella Cf

    2016-01-01

    BACKGROUND: Knowledge of the fetal effects of maternal medication use in pregnancy is often inadequate and current pregnancy pharmacovigilance (PV) surveillance methods have important limitations. Patient self-reporting may be able to mitigate some of these limitations, providing an adequately sized

  2. Pharmacovigilance in India, Uganda and South Africa with Reference to WHO’s Minimum Requirements

    Directory of Open Access Journals (Sweden)

    Karen Maigetter

    2015-05-01

    Full Text Available Background Pharmacovigilance (PV data are crucial for ensuring safety and effectiveness of medicines after drugs have been granted marketing approval. This paper describes the PV systems of India, Uganda and South Africa based on literature and Key Informant (KI interviews and compares them with the World Health Organization’s (WHO’s minimum PV requirements for a Functional National PV System. Methods A documentary analysis of academic literature and policy reports was undertaken to assess the medicines regulatory systems and policies in the three countries. A gap analysis from the document review indicated a need for further research in PV. KI interviews covered topics on PV: structure and practices of the system; current regulatory policy; capacity limitations, staffing, funding and training; availability and reporting of data; and awareness and usage of the systems. Twenty interviews were conducted in India, 8 in Uganda and 11 in South Africa with government officials from the ministries of health, national regulatory authorities, pharmaceutical producers, Non-Governmental Organizations (NGOs, members of professional associations and academia. The findings from the literature and KI interviews were compared with WHO’s minimum requirements. Results All three countries were confronted with similar barriers: lack of sufficient funding, limited number of trained staff, inadequate training programs, unclear roles and poor coordination of activities. Although KI interviews represented viewpoints of the respondents, the findings confirmed the documentary analysis of the literature. Although South Africa has a legal requirement for PV, we found that the three countries uniformly lacked adequate capacity to monitor medicines and evaluate risks according to the minimum standards of the WHO. Conclusion A strong PV system is an important part of the overall medicine regulatory system and reflects on the stringency and competence of the regulatory

  3. Utility of social media and crowd-intelligence data for pharmacovigilance: a scoping review.

    Science.gov (United States)

    Tricco, Andrea C; Zarin, Wasifa; Lillie, Erin; Jeblee, Serena; Warren, Rachel; Khan, Paul A; Robson, Reid; Pham, Ba'; Hirst, Graeme; Straus, Sharon E

    2018-06-14

    social media conversations for pharmacovigilance is in its infancy. Although social media data has the potential to supplement data from regulatory agency databases; is able to capture less frequently reported AEs; and can identify AEs earlier than official alerts or regulatory changes, the utility and validity of the data source remains under-studied. Open Science Framework ( https://osf.io/kv9hu/ ).

  4. Pharmacovigilance of artemether-lumefantrine in pregnant women followed until delivery in Rwanda

    Directory of Open Access Journals (Sweden)

    Rulisa Stephen

    2012-07-01

    Full Text Available Abstract Background The World Health Organization presently recommends Artemisinin-based combination therapy (ACT as first-line therapy for uncomplicated P. falciparum malaria. Many malaria-endemic countries, including Rwanda, have adopted these treatment guidelines. The Artemisinin derivative Artemether, in combination with lumefantrine, is currently used in Rwanda for malaria during the second and third trimesters of pregnancy. Safety data on the use of ACT in pregnancy are still limited though and more data are needed. Methods In this pharmacovigilance study, the exposed group (pregnant women with malaria given artemether-lumefantrine, and a matched non-exposed group (pregnant women without malaria and no exposure to artemether-lumefantrine were followed until delivery. Data were collected at public health centres all over Rwanda during acute malaria, routine antenatal visits, after hospital delivery or within 48 hours after home delivery. Information gathered from patients included routine antenatal and peri-partum data, pregnancy outcomes (abortions, stillbirths, at term delivery, congenital malformations and other adverse events through history taking and physical examination of both mothers and newborns. Results The outcomes for the total sample of 2,050 women were for the treatment (n = 1,072 and control groups (n = 978 respectively: abortions: 1.3% and 0.4%; peri-natal mortality 3.7% and 2.8%; stillbirth 2.9% and 2.4%; neonatal death [less than or equal to]7 days after birth 0.5% and 0.4%; premature delivery 0.7% and 0.3%; congenital malformations 0.3% and 0.3%. A total of 129 obstetric adverse events in 127 subjects were reported (7.3% in the treatment group, 5.0% in the control group. In a multivariate regression model, obstetric complications were more frequent in the treatment group (OR (95% CI: 1.38 (0.95, 2.01, and in primigravidae (OR (95% CI 2.65 (1.71, 4.12 and at higher age (OR per year: 1.05 (1.01-1.09. Conclusions

  5. [Hydroxychloroquine-induced hearing loss: First case of positive rechallenge and analysis of the French pharmacovigilance database].

    Science.gov (United States)

    Chatelet, J-N; Auffret, M; Combret, S; Bondon-Guitton, E; Lambert, M; Gautier, S

    2017-05-01

    Several cases of hearing loss induced by hydroxychloroquine have been reported in the literature but the role of hydroxychloroquine still remains debated. We report the first case, to our knowledge, of hearing loss induced by hydroxychloroquine with a positive re challenge in a woman treated for systemic lupus. An analysis of the French pharmacovigilance database allowed to identify 23 additional cases of hearing loss in patients treated with hydroxychloroquine and, among them, 8 had systemic lupus. Despite an excellent tolerance and high efficacy-side effect ratio, this case report adds some evidence for an otoxicity of hydroxychloroquine. Copyright © 2016 Société Nationale Française de Médecine Interne (SNFMI). Published by Elsevier SAS. All rights reserved.

  6. Farmacovigilância da heparina no Brasil Heparin pharmacovigilance in Brazil

    Directory of Open Access Journals (Sweden)

    Daniela Rezende Garcia Junqueira

    2011-06-01

    in Brazil was conducted. RESULTS: Five companies were granted a permission to market unfractioned heparin in Brazil. Three of them are porcine in origin and two of them are bovine in origin, with only one explicitly showing this information in the package insert. The effectiveness and safety of heparin studied in non-Brazilian populations may not represent the Brazilian reality, since most countries no longer produce bovine heparin. The currently marketed heparin has approximately 10% less anticoagulant activity than that previously produced and this change may have clinical implications. CONCLUSIONS: Evidence about the lack of dose interchangeability between bovine and porcine heparins and the unique safety profile of these drugs indicates the need to follow the treatment and the patients' response. Events threatening the patient's safety must be reported to the pharmacovigilance system in each particular country.

  7. 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.

  8. Possibility of Database Research as a Means of Pharmacovigilance in Japan Based on a Comparison with Sertraline Postmarketing Surveillance.

    Science.gov (United States)

    Hirano, Yoko; Asami, Yuko; Kuribayashi, Kazuhiko; Kitazaki, Shigeru; Yamamoto, Yuji; Fujimoto, Yoko

    2018-05-01

    Many pharmacoepidemiologic studies using large-scale databases have recently been utilized to evaluate the safety and effectiveness of drugs in Western countries. In Japan, however, conventional methodology has been applied to postmarketing surveillance (PMS) to collect safety and effectiveness information on new drugs to meet regulatory requirements. Conventional PMS entails enormous costs and resources despite being an uncontrolled observational study method. This study is aimed at examining the possibility of database research as a more efficient pharmacovigilance approach by comparing a health care claims database and PMS with regard to the characteristics and safety profiles of sertraline-prescribed patients. The characteristics of sertraline-prescribed patients recorded in a large-scale Japanese health insurance claims database developed by MinaCare Co. Ltd. were scanned and compared with the PMS results. We also explored the possibility of detecting signals indicative of adverse reactions based on the claims database by using sequence symmetry analysis. Diabetes mellitus, hyperlipidemia, and hyperthyroidism served as exploratory events, and their detection criteria for the claims database were reported by the Pharmaceuticals and Medical Devices Agency in Japan. Most of the characteristics of sertraline-prescribed patients in the claims database did not differ markedly from those in the PMS. There was no tendency for higher risks of the exploratory events after exposure to sertraline, and this was consistent with sertraline's known safety profile. Our results support the concept of using database research as a cost-effective pharmacovigilance tool that is free of selection bias . Further investigation using database research is required to confirm our preliminary observations. Copyright © 2018. Published by Elsevier Inc.

  9. An International Study of the Ability and Cost-Effectiveness of Advertising Methods to Facilitate Study Participant Self-Enrolment Into a Pilot Pharmacovigilance Study During Early Pregnancy

    OpenAIRE

    Richardson, Jonathan Luke; Stephens, Sally; Thomas, Simon Hugh Lynton; Jamry-Dziurla, Anna; de Jong-van den Berg, Lolkje; Zetstra - van der Woude, Priscilla; Laursen, Maja; Hliva, Valerie; Mt-Isa, Shahrul; Bourke, Alison; Dreyer, Nancy A; Blackburn, Stella CF

    2016-01-01

    BACKGROUND: Knowledge of the fetal effects of maternal medication use in pregnancy is often inadequate and current pregnancy pharmacovigilance (PV) surveillance methods have important limitations. Patient self-reporting may be able to mitigate some of these limitations, providing an adequately sized study sample can be recruited. OBJECTIVE: To compare the ability and cost-effectiveness of several direct-to-participant advertising methods for the recruitment of pregnant participants into a stu...

  10. Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data

    International Nuclear Information System (INIS)

    Endrikat, J.; Schwenke, C.; Prince, M.R.

    2015-01-01

    Aim: To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18–64 years. Materials and methods: Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Results: Rates of reported ADRs were lower in elderly patients versus adults aged <65 years due to a reduced incidence of non-serious ADRs; this was statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. Conclusions: This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. -- Highlights: •First dedicated safety study of an extracellular contrast agent in the elderly. •Elderly patients experience fewer non-serious ADRs than younger adults. •Gadobutrol has a favourable safety profile in both age groups

  11. Gingival bleeding, a possible "serious" adverse drug reaction: An observational study in the French PharmacoVigilance Database.

    Science.gov (United States)

    Bondon-Guitton, Emmanuelle; Mourgues, Thibaut; Rousseau, Vanessa; Cousty, Sarah; Cottin, Judith; Drablier, Guillaume; Micallef, Joëlle; Montastruc, Jean-Louis

    2017-09-01

    Antithrombotic drugs are known to increase the risk of gingival bleeding because they affect coagulation. However, other drugs could also be involved in gingival bleeding. We performed a pharmacoepidemiological study to identify the drugs most frequently "suspected" in the occurrence of gingival bleeding. We selected reports of "gingival bleeding" from 1 January 1985 to 30 September 2014 in the French PharmacoVigilance Database. Among 523,808 reports of adverse drug reactions, we identified 454 reports of gingival bleeding (0.09%). Most of them were "serious" (58.4%) and occurred in females (54.6%). The frequency of gingival bleeding increased with age. The most frequently "suspected" drugs were antithrombotics (67.8%), particularly fluindione. Other drugs frequently involved were furosemide followed by paracetamol, amiodarone, amoxicillin, paroxetine, ketoprofen, zolpidem, enalapril and ramipril. Thirty-nine reports involved a drug-drug interaction with antithrombotics, mainly with anti-infectives. Gingival bleeding can be an adverse drug reaction, often "serious" and rarely fatal. Patients older than 50 years and women are particularly at risk. Among drugs known to increase the risk of gingival bleeding, the most frequently involved were fluindione, furosemide, paracetamol, amiodarone, amoxicillin, paroxetine or ketoprofen. We also identified signal for drugs not usually known to be involved in bleeding, like zolpidem, enalapril or ramipril. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  12. A research framework for pharmacovigilance in health social media: Identification and evaluation of patient adverse drug event reports.

    Science.gov (United States)

    Liu, Xiao; Chen, Hsinchun

    2015-12-01

    Social media offer insights of patients' medical problems such as drug side effects and treatment failures. Patient reports of adverse drug events from social media have great potential to improve current practice of pharmacovigilance. However, extracting patient adverse drug event reports from social media continues to be an important challenge for health informatics research. In this study, we develop a research framework with advanced natural language processing techniques for integrated and high-performance patient reported adverse drug event extraction. The framework consists of medical entity extraction for recognizing patient discussions of drug and events, adverse drug event extraction with shortest dependency path kernel based statistical learning method and semantic filtering with information from medical knowledge bases, and report source classification to tease out noise. To evaluate the proposed framework, a series of experiments were conducted on a test bed encompassing about postings from major diabetes and heart disease forums in the United States. The results reveal that each component of the framework significantly contributes to its overall effectiveness. Our framework significantly outperforms prior work. Published by Elsevier Inc.

  13. Adverse Effects of Cholinesterase Inhibitors in Dementia, According to the Pharmacovigilance Databases of the United-States and Canada.

    Directory of Open Access Journals (Sweden)

    Thibault B Ali

    Full Text Available This survey analyzes two national pharmacovigilance databases in order to determine the major adverse reactions observed with the use of cholinesterase inhibitors in dementia. We conducted a statistical analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS and the Canada Vigilance Adverse Reaction Database (CVARD concerning the side effects of cholinesterase inhibitors. The statistics calculated for each adverse event were the frequency and the reporting odds ratios (ROR. A total of 9877 and 2247 reports were extracted from the FAERS and CVARD databases, respectively. A disproportionately higher frequency of reports of death as an adverse event for rivastigmine, compared to the other acetylcholinesterase inhibiting drugs, was observed in both the FAERS (ROR = 3.42; CI95% = 2.94-3.98; P<0.0001 and CVARD (ROR = 3.67; CI95% = 1.92-7.00; P = 0.001 databases. While cholinesterase inhibitors remain to be an important therapeutic tool against Alzheimer's disease, the disproportionate prevalence of fatal outcomes with rivastigmine compared with alternatives should be taken into consideration.

  14. Sistema de Farmacovigilância do Ceará: um ano de experiência Ceará State Pharmacovigilance System: a year of experience

    Directory of Open Access Journals (Sweden)

    Helena Lutéscia Coêlho

    1999-09-01

    Full Text Available No presente trabalho, o relato do primeiro ano de atividade do Sistema de Farmacovigilância do Ceará (SIFACE é apresentado como estratégia para a discussão de questões práticas e metodológicas envolvendo as dificuldades na implantação de atividade dessa natureza no Brasil. O SIFACE está sendo estruturado pelo GPUIM (Grupo de Prevenção ao Uso Indevido de Medicamentos, tendo como ponto de apoio as unidades de farmácias hospitalares. Foram processadas 63 notificações (119 suspeitas de reação adversa, em sua maioria correspondentes a mulheres (55,7% e a pacientes de 0-14 anos (34,4%, sendo os antibióticos e as reações dermatológicas os medicamentos e os tipos de reações mais freqüentes, respectivamente. Em 20% dos casos houve reexposição dos pacientes a fármacos aos quais aqueles eram intolerantes, o que ressalta a importância preventiva da farmacovigilância.This paper summarizes the first year of activity of the Ceará State Pharmacovigilance System (SIFACE as a strategy to discuss practical and methodological problems related to developing pharmacovigilance in Brazil. SIFACE is being structured by the Group for the Prevention of Improper Use of Pharmaceuticals (GPUIM, based on hospital pharmacies. A total of 63 reports (119 suspected adverse drug reactions, or ADRs were processed, the majority among women (55.7% and children (34.4%. Antibiotics were the drug group most frequently involved, and the most common reactions were dermatological. In 20% of the cases, patients had been re-exposed to drugs previously reported as producing adverse reactions, thus highlighting the importance of pharmacovigilance to prevent ADRs.

  15. Long-term safety and efficacy of a pasteurized nanofiltrated prothrombin complex concentrate (Beriplex P/N): a pharmacovigilance study.

    Science.gov (United States)

    Hanke, A A; Joch, C; Görlinger, K

    2013-05-01

    The rapid reversal of the effects of vitamin K antagonists is often required in cases of emergency surgery and life-threatening bleeding, or during bleeding associated with high morbidity and mortality such as intracranial haemorrhage. Increasingly, four-factor prothrombin complex concentrates (PCCs) containing high and well-balanced concentrations of vitamin K-dependent coagulation factors are recommended for emergency oral anticoagulation reversal. Both the safety and efficacy of such products are currently in focus, and their administration is now expanding into the critical care setting for the treatment of life-threatening bleeding and coagulopathy resulting either perioperatively or in cases of acute trauma. After 15 yr of clinical use, findings of a pharmacovigilance report (February 1996-March 2012) relating to the four-factor PCC Beriplex P/N (CSL Behring, Marburg, Germany) were analysed and are presented here. Furthermore, a review of the literature with regard to the efficacy and safety of four-factor PCCs was performed. Since receiving marketing authorization (February 21, 1996), ~647 250 standard applications of Beriplex P/N have taken place. During this time, 21 thromboembolic events judged to be possibly related to Beriplex P/N administration have been reported, while no incidences of viral transmission or heparin-induced thrombocytopenia were documented. The low risk of thromboembolic events reported during the observation period (one in ~31 000) is in line with the incidence observed with other four-factor PCCs. In general, four-factor PCCs have proven to be well tolerated and highly effective in the rapid reversal of vitamin K antagonists.

  16. Pharmacovigilance from social media: mining adverse drug reaction mentions using sequence labeling with word embedding cluster features.

    Science.gov (United States)

    Nikfarjam, Azadeh; Sarker, Abeed; O'Connor, Karen; Ginn, Rachel; Gonzalez, Graciela

    2015-05-01

    Social media is becoming increasingly popular as a platform for sharing personal health-related information. This information can be utilized for public health monitoring tasks, particularly for pharmacovigilance, via the use of natural language processing (NLP) techniques. However, the language in social media is highly informal, and user-expressed medical concepts are often nontechnical, descriptive, and challenging to extract. There has been limited progress in addressing these challenges, and thus far, advanced machine learning-based NLP techniques have been underutilized. Our objective is to design a machine learning-based approach to extract mentions of adverse drug reactions (ADRs) from highly informal text in social media. We introduce ADRMine, a machine learning-based concept extraction system that uses conditional random fields (CRFs). ADRMine utilizes a variety of features, including a novel feature for modeling words' semantic similarities. The similarities are modeled by clustering words based on unsupervised, pretrained word representation vectors (embeddings) generated from unlabeled user posts in social media using a deep learning technique. ADRMine outperforms several strong baseline systems in the ADR extraction task by achieving an F-measure of 0.82. Feature analysis demonstrates that the proposed word cluster features significantly improve extraction performance. It is possible to extract complex medical concepts, with relatively high performance, from informal, user-generated content. Our approach is particularly scalable, suitable for social media mining, as it relies on large volumes of unlabeled data, thus diminishing the need for large, annotated training data sets. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association.

  17. Adverse reactions to contrast media: an analysis of spontaneous reports in the database of the pharmacovigilance programme of India.

    Science.gov (United States)

    Kalaiselvan, Vivekanandan; Sharma, Surbhi; Singh, Gyanendra Nath

    2014-09-01

    Contrast media are used widely to improve medical imaging. Like all other pharmaceuticals, these agents are not completely devoid of risk, and continuous monitoring of adverse reactions with these agents is important. Spontaneous reporting is the simplest method for understanding the safety profile of pharmaceutical products after their approval. Our objective was to identify the pattern and characteristics of adverse reactions attributed to contrast media in the Indian population reported to the National Coordination Centre for the Pharmacovigilance Programme of India (NCC-PvPI). Individual case safety reports (ICSRs) attributed to contrast media submitted spontaneously to the NCC-PvPI were extracted from the database for July 2010 to September 2013. We analysed these reports for information related to reporter's professional category, patient's age and sex, reporter's diagnosis of the reaction, seriousness of the reaction, type of contrast media exposure, system organ class (SOC) affected (as described in World Health Organization Adverse Reaction Terminology [WHO-ART]) and outcome. Of the total 59,915 ICSRs in the database, 415 (0.7%) were suspected adverse reactions to contrast media; 44 reports were serious, including three fatal cases. The most affected SOCs were skin and appendage disorders, body as a whole-general disorders, gastrointestinal system disorders and respiratory system disorders. Hypersensitivity reactions were reported in the majority of ICSRs. The contrast media with the highest number of reports were iohexol (40.7%), iomeprol (17.8%), iopamidol (12%) and diatrizoate (12%). Most of the reactions to contrast media were allergic-like, and no previously unrecognised adverse reactions were observed in the Indian population. Further data and increased awareness among healthcare professionals is required to signal and prevent the consequences of adverse reactions attributed to contrast media.

  18. Do package inserts reflect symptoms experienced in practice?: assessment using an automated phone pharmacovigilance system with varenicline and zolpidem in a primary care setting.

    Science.gov (United States)

    Haas, Jennifer S; Amato, Mary; Marinacci, Lucas; Orav, E John; Schiff, Gordon D; Bates, David W

    2012-08-01

    While the US FDA maintains a voluntary reporting system, postmarketing adverse drug events (ADEs) are underreported, and this case report-based system does not allow accurate determination of incidence. The aim of the study was to assess the usefulness of an automated phone pharmacovigilance system for ambulatory patients by comparing systematically collected, patient-reported symptoms to reflect possible ADEs with those reported on the package inserts of two drugs with postmarketing safety concerns, varenicline and zolpidem. English-speaking adults who received a prescription for zolpidem (n = 370) or varenicline (n = 107) from a primary care physician at one of 11 participating clinics, and who participated in the pharmacovigilance system during 2008-2010, were included in the study. Patients were called approximately 4 weeks following their visit and asked to complete a standard script that asked about adherence and pre-specified symptoms. The main outcome measures were elicited rates of pre-specified symptoms or possible ADEs. Compared with the package insert, patients taking zolpidem were significantly (p zolpidem were not detected. These data highlight the potential value of, and innovative ways of collecting, information about possible ADEs directly from patients.

  19. E-pharmacovigilance: development and implementation of a computable knowledge base to identify adverse drug reactions.

    Science.gov (United States)

    Neubert, Antje; Dormann, Harald; Prokosch, Hans-Ulrich; Bürkle, Thomas; Rascher, Wolfgang; Sojer, Reinhold; Brune, Kay; Criegee-Rieck, Manfred

    2013-09-01

    Computer-assisted signal generation is an important issue for the prevention of adverse drug reactions (ADRs). However, due to poor standardization of patients' medical data and a lack of computable medical drug knowledge the specificity of computerized decision support systems for early ADR detection is too low and thus those systems are not yet implemented in daily clinical practice. We report on a method to formalize knowledge about ADRs based on the Summary of Product Characteristics (SmPCs) and linking them with structured patient data to generate safety signals automatically and with high sensitivity and specificity. A computable ADR knowledge base (ADR-KB) that inherently contains standardized concepts for ADRs (WHO-ART), drugs (ATC) and laboratory test results (LOINC) was built. The system was evaluated in study populations of paediatric and internal medicine inpatients. A total of 262 different ADR concepts related to laboratory findings were linked to 212 LOINC terms. The ADR knowledge base was retrospectively applied to a study population of 970 admissions (474 internal and 496 paediatric patients), who underwent intensive ADR surveillance. The specificity increased from 7% without ADR-KB up to 73% in internal patients and from 19.6% up to 91% in paediatric inpatients, respectively. This study shows that contextual linkage of patients' medication data with laboratory test results is a useful and reasonable instrument for computer-assisted ADR detection and a valuable step towards a systematic drug safety process. The system enables automated detection of ADRs during clinical practice with a quality close to intensive chart review. © 2013 The Authors. British Journal of Clinical Pharmacology © 2013 The British Pharmacological Society.

  20. Adverse drug reactions reporting in Calabria (Southern Italy) in the four-year period 2011-2014: impact of a regional pharmacovigilance project in light of the new European Legislation.

    Science.gov (United States)

    Leporini, Christian; Marrazzo, Giuseppina; Mumoli, Laura; Esposito, Stefania; Gallelli, Luca; Mangano, Giovanna; Brancati, Giacomino; De Francesco, Emanuela Adele; Russo, Emilio; De Sarro, Giovambattista

    2017-05-01

    The number of suspected adverse drug reactions (ADRs) yearly submitted to the Italian Network of Pharmacovigilance (RNF) has progressively increased after the new European Pharmacovigilance legislation (July 2012). These results have mostly reflected the agreements between Italian Medicines Agency (AIFA) and Italian Regions, enabling the implementation of active pharmacovigilance projects. A project was funded by the AIFA in Calabria region (Southern Italy) in 2010 to increase ADRs reporting and promote a safer medicines' use. Based on this background, we investigated the trend of ADRs in Calabria in 2011-2014, trying to analyze the possible entailments of the new law. Quantitative and descriptive analysis of ADRs submitted by Calabrian healthcare professionals and patients to the RNF database between 2011 and 2014. A sharp rise in regional reporting rate was observed over study period. Calabrian Pharmacovigilance system completely fulfilled the World Health Organization gold standard for ADR reporting rate, both in 2013 and 2014. However, heterogeneity was observed regarding reporting health facilities, healthcare professionals and patients among the study years. These findings reflect the success of the project performed in Calabria. However, this initiative should go on in the next future to obtain better and more homogeneous reporting behavior.

  1. [Data-mining characteristics of adverse drug reactions and pharmacovi-gilance of Chinese patent drugs including Aconitum herbs].

    Science.gov (United States)

    Zhang, Xiao-Meng; Li, Fan; Zhang, Bing; Chen, Xiao-Fen; Piao, Jing-Zhu

    2018-01-01

    The common Aconitum herbs in clinical application mainly include Aconiti Radix(Chuanwu), Aconiti Kusnezoffii Radix(Caowu) and Aconiti Lateralis Radix Praeparaia(Fuzi), all of which have toxicity. Therefore, the safety of using Chinese patent drugs including Aconitum herbs has become an hot topic in clinical controversy. Based on the data-mining methods, this study explored the characteristics and causes of adverse drug reactions/events (ADR/ADE) of the Chinese patent drugs including Aconitum, in order to provide pharmacovigilance and rational drug use suggestions for clinical application. The detailed ADR/ADE reports about the Chinese patent drugs including Aconitum herbs were retrieved in the domestic literature databases since 1984 to now. The information extraction and data-mining were conducted based on the platforms of Microsoft office Excel 2016, Clementine 12.0 and Cytoscape 3.3.0. Finally, 78 detailed ADR/ADE reports involving a total of 30 varieties were included. 92.31% ADR/ADE were surely or likely led by the Chinese patent drugs including Aconitum, mostly involving multiple system/organ damages with good prognosis, and even 1 case of death. The incidence of included ADRs/ADEs was associated with various factors such as the patient idiosyncratic, drug toxicity, as well as clinical medication. The patient age was most closely related to ADR/ADEs, and those aged from 60 to 69 were more easily suffered from the ADRs/ADEs of Chinese patent drugs including Aconitum. The probability of ADR/ADEs for the drugs including Chuanwu or Caowu was greater than that of Fuzi, and the using beyond the instructions dose was the most important potential safety hazard in the clinical medication process. For the regular and characteristics of ADR/ADEs led by Chinese patent drugs including Aconitum, special attention shall be paid to the elder patients or with the patients with allergies; strictly control the dosage and course of treatment, strengthen the safety medication

  2. Pharmacovigilance Evaluation of the Association Between DPP-4 Inhibitors and Heart Failure: Stimulated Reporting and Moderation by Drug Interactions.

    Science.gov (United States)

    Fadini, Gian Paolo; Sarangdhar, Mayur; Avogaro, Angelo

    2018-04-01

    In the SAVOR-TIMI trial, the risk of heart failure (HF) was increased by 27% in T2D patients randomized to the dipeptidyl peptidase-4 inhibitor (DPP4i) saxagliptin. Other studies have provided inconsistent results regarding this association. Herein, we performed a pharmacovigilance analysis of the rate of HF associated with DPP4is, focusing on stimulated reporting and moderation by drug-drug interactions. We mined the FDA adverse event (AE) reporting system (FAERS) from 2004q1 to 2017q3, including a total of 9906,642 AE reports. Rates (/1000 reports) of HF within the reports for DPP4is and reports for other antidiabetic drugs were calculated for the period up to 2013q3 (date of publication of the SAVOR-TIMI trial results) and from 2013q4 to 2017q3. Analyses were refined by filtering according to therapeutic area, concomitant diseases and drugs, and competing AEs. The rate of HF among the AE reports filed for DPP4is significantly increased after 2013q3, especially for saxagliptin. When compared to non-insulin non-glitazone antidiabetic drugs, the proportional reporting ratio (PRR) of HF for DPP4is was 0.62 (95% CI 0.56-0.68) up to 2013q3 and 2.12 (95% CI 1.96-2.28) from 2013q4 to 2017q3. This stimulated reporting was consistent in subanalyses based on the presence/absence of cardiac disorders and after controlling for competing AEs. The rate of HF among AE reports for DPP4is was modestly moderated by the concomitant use of metformin (- 15%) and strongly moderated by the concomitant use of SGLT2 inhibitors (- 63%), even after excluding competing AEs. Within the FAERS, the association between HF and DPP4is was biased by stimulated reporting, implying that the publication of the SAVOR-TIMI trial and the subsequent regulatory warnings primed clinicians to report HF events in DPP4i users as drug-related AEs. The rate of HF associated with DPP4is was moderated when they were used in combination with SGLT2 inhibitors.

  3. Persistent Sexual Dysfunction and Suicidal Ideation in Young Men Treated with Low-Dose Finasteride: A Pharmacovigilance Study.

    Science.gov (United States)

    Ali, Ayad K; Heran, Balraj S; Etminan, Mahyar

    2015-07-01

    Finasteride, a 5α-reductase inhibitor, is marketed in a low dose (1 mg) as a popular therapy for androgenic alopecia in young men. As case reports and small surveys have suggested a link between persistent sexual dysfunction (SD) and suicidal ideation (SI) with low-dose finasteride, the aim of this study was to detect signals of SD and SI secondary to low-dose finasteride use in young men. Retrospective pharmacovigilance disproportionality analysis. United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. Low-dose finasteride-related adverse event reports for men aged 18-45 years that were submitted to the FAERS between 1998 and 2013 were retrieved. Multi-item Gamma Poisson Shrinker disproportionality analysis was applied to calculate the empirical Bayes geometric mean (EBGM) and corresponding 95% confidence interval (CI) as an association metric between low-dose finasteride and the events of interest. Signals were defined as associations with thresholds of a CI lower limit of 2.0 or greater. Medical Dictionary for Regulatory Activities Preferred Terms denoting to SD and SI were identified to reflect the outcome of interest. In total, of 4910 reports, 577 persistent SD and 39 SI adverse event reports (11.8% and 7.9%, respectively) were identified for young men using low-dose finasteride; 34 (87.2%) of the 39 men with SI also experienced SD. The majority of these events were serious (e.g., contributed to the patient's death, hospitalization, or disability). Low-dose finasteride was associated with more than expected reporting of SD in young men compared with reporting of these events with all other drugs within the database (EBGM 28.0, 95% CI 26.1-30.0). Disproportional reporting in SI events was noted, although it did not reach signal threshold (EBGM 1.72; 95% CI 1.31-2.23). Among serious SD events, 43% led to disability; 28% required medical intervention, including hospitalization; and 5% were life-threatening. Six fatal SD

  4. Pacific Island Pharmacovigilance

    DEFF Research Database (Denmark)

    McEwen, John; Vestergaard, Lasse S.; Sanburg, Amanda L C

    2016-01-01

    Many Pacific Island countries (PICs) are recipients of funding support from the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund). However, most of these countries cannot be expected to meet Global Fund and World Health Organization (WHO) minimum requirements for a functioning...

  5. Experience of safety monitoring in the context of a prospective observational study of artemether-lumefantrine in rural Tanzania: lessons learned for pharmacovigilance reporting

    Directory of Open Access Journals (Sweden)

    Kabanywanyi Abdunoor M

    2010-07-01

    Full Text Available Abstract Objectives To identify and implement strategies that help meet safety monitoring requirements in the context of an observational study for artemether-lumefantrine (AL administered as first-line treatment for uncomplicated malaria in rural Tanzania. Methods Pharmacovigilance procedures were developed through collaboration between the investigating bodies, the relevant regulatory authority and the manufacturer of AL. Training and refresher sessions on the pharmacovigilance system were provided for healthcare workers from local health facilities and field recorders of the Ifakara Health Demographic Surveillance System (IHDSS. Three distinct channels for identification of adverse events (AEs and serious adverse events (SAEs were identified and implemented. Passive reporting took place through IHDSS and health care facilities, starting in October 2007. The third channel was through solicited reporting that was included in the context of a survey on AL as part of the ALIVE (Artemether-Lumefantrine In Vulnerable patients: Exploring health impact study (conducted only in March-April 2008. Results Training was provided for 40 healthcare providers (with refresher training 18 months later and for six field recorders. During the period 1st September 2007 to 31st March 2010, 67 AEs were reported including 52 under AL, five under sulphadoxine-pyrimethamine, one under metakelfin, two after antibiotics; the remaining seven were due to anti-pyretic or anti-parasite medications. Twenty patients experienced SAEs; in 16 cases, a relation to AL was suspected. Six of the 20 cases were reported within 24 hours of occurrence. Discussion Safety monitoring and reporting is possible even in settings with weak health infrastructure. Reporting can be enhanced by regular and appropriate training of healthcare providers. SMS text alerts provide a practical solution to communication challenges. Conclusion Experience gained in this setting could help to improve

  6. Family Issues

    Science.gov (United States)

    ... es Autismo? Family Issues Home / Living with Autism / Family Issues Stress Siblings A child’s autism diagnosis affects every member of the family in different ways. Parents/caregivers must now place their ... may put stress on their marriage, other children, work, finances, and ...

  7. Global Issues

    Energy Technology Data Exchange (ETDEWEB)

    Seitz, J.L.

    2001-10-15

    Global Issues is an introduction to the nature and background of some of the central issues - economic, social, political, environmental - of modern times. This new edition of this text has been fully updated throughout and features expanded sections on issues such as global warming, biotechnology, and energy. Fully updated throughout and features expanded sections on issues such as global warming, biotechnology, and energy. An introduction to the nature and background of some of the central issues - economic, social, political, environmental - of modern times. Covers a range of perspectives on a variety of societies, developed and developing. Extensively illustrated with diagrams and photographs, contains guides to further reading, media, and internet resources, and includes suggestions for discussion and studying the material. (author)

  8. The role of Clinical Pharmacists in the improvement of a pharmacovigilance system: A review of the reported adverse drug reactions during 2004-2010 in Mazandaran Province of Iran

    Directory of Open Access Journals (Sweden)

    Elham Azhdari

    2013-02-01

    Full Text Available Background: Following establishment of Iranian Adverse Drug Reaction (ADR Monitoring Center in 1997, ADR committees were established in all hospitals of Mazandaran Province of Iran. Clinical pharmacists from Mazandaran University of Medical Sciences have been involved with these committees since 2007. The aim of this study was to compare the results of the pharmacovigilance system before and after active involvement of clinical pharmacists. Methods: This study included Yellow Cards filled out by healthcare providers in Mazandaran Province during 2004-2010. Frequency of Adverse Drug Reactions (ADRs, route of administration, reporters, number of reports in each years and damaged organs were focuses. Statistical analysis was performed by SPSS 16 software. P Results: A total of 793 yellow cards were completed during 2004 – 2010. Only 38 ADRs (4.8% were related to 2004-2007. Most of the reports generated by Nurses (49.3% followed by Pharmacists and Physicians (P Conclusion: Clinical pharmacists’ intervention regarding establishing ADR committees in the hospitals improved the output of the pharmacovigilance system, although under-reporting is still a major drawback of spontaneous reporting. Keywords: Pharmacovigilance, Adverse Drug Reaction, Mazandaran, Adverse Drug Reaction Reporting Systems

  9. An evaluation of knowledge, attitude, and practice of institutional ethics committee members from eastern India regarding ethics committee functioning and pharmacovigilance activities conducted during clinical trials: A pilot study

    Directory of Open Access Journals (Sweden)

    Subhrojyoti Bhowmick

    2014-01-01

    Full Text Available Purpose of study: The vital responsibility of Institutional Ethics Committee (IEC members is to ensure the safety of the subjects participating in clinical trials. Hence, it is essential for IEC members to be aware of the common pharmacovigilance strategies followed during clinical trials. However, the information about the knowledge, attitude, and practice of IEC members regarding the pharmacovigilance activities followed during clinical trials is scarce worldwide, especially in India. Hence, this cross-sectional study was designed to assess the knowledge, attitude, and practice of IEC members of 10 hospitals of Kolkata, India. Materials and Methods: A cross-sectional study using a self-administered, validated questionnaire was conducted among 10 hospitals (five government and five corporate hospitals in Kolkata conducting active clinical research and having functional Ethics Committees (ECs in the month of September-November, 2012. An IEC approval was taken for this study. Two reminders were given to all EC members through telephone/e-mail for completion and returning of the forms. The filled in forms were returned to their respective Member Secretaries, from whom authors′ collected the forms. Data were analyzed using SPSS version 16.0 software and MS-Excel 2007. Categorical data were analyzed using Chi-square test and a P < 0.05 was considered statistically significant. Results: Out of the 100 distributed questionnaires, 40 were returned of which 10 were not filled properly. Overall awareness regarding different pharmacovigilance terminologies and activities among EC members from nonmedical background (71.43% was found to be more than that of the medical members (68.75%, though the figure was not statistically significant. Majority of the members (75% felt that EC should decide compensation in case of a serious adverse event. Conclusion: The present study signifies that there is a low level of awareness in IEC members of Kolkata regarding

  10. Workforce Issues.

    Science.gov (United States)

    1996

    This document consists of four papers presented during a symposium on work force issues moderated by Jan DeJong at the 1996 conference of the Academy of Human Resource Development (AHRD). "Rethinking the Ties that Bind: An Exploratory Study of Employee Development in Utilities in Canada and the United States" (Michael Aherne, David…

  11. Sanskrit Issue.

    Science.gov (United States)

    Miller, Barbara Stoler, Ed.

    1971-01-01

    This issue of "Mahfil" is devoted to Sanskrit literature and contains a note on Sanskrit pronunciation and selections of Sanskrit literature. It also contains articles analyzing and discussing various aspects of the literature, including "Sanskrit Rhetoric and Poetic,""The Creative Role of the Goddess Vac in the…

  12. Bond Issues.

    Science.gov (United States)

    Pollack, Rachel H.

    2000-01-01

    Notes trends toward increased borrowing by colleges and universities and offers guidelines for institutions that are considering issuing bonds to raise money for capital projects. Discussion covers advantages of using bond financing, how use of bonds impacts on traditional fund raising, other cautions and concerns, and some troubling aspects of…

  13. Key pharmacovigilance stakeholders' experiences of direct patient reporting of adverse drug reactions and their prospects of future development in the European Union.

    Science.gov (United States)

    Inácio, P; Cavaco, A; Allan, E; Airaksinen, M

    2018-02-01

    In the European Union (EU), legislation allows patients to directly report adverse drug reactions (ADRs) to competent authorities. Five years after its implementation, patient reporting is not equal in all countries. This study aimed to explore key stakeholders' perceptions of patient reporting in four EU countries. Qualitative study design. Twelve representatives from national pharmacovigilance centres and/or authorities as well as national pharmaceutical industry bodies in four EU countries participated in the study. Supranational organizations were also included. Data collection was via face-semi-structured interviews. Inductive content analysis was performed thereafter, applying principles of risk management as a theoretical framework. Four themes (attitudes and beliefs, system maturation factors, regulatory improvements, and cultural shifts) emerged, conceptually interconnected. Participants from countries introducing patient reporting recently expressed a negative attitude. Participants highlighted the need for additional resources, both human and financial, to address patient reporting and associated advantages. The findings identified perceived barriers and facilitators of patient reporting. The involvement of patients, use of information, and dissemination of patient reporting are far from optimal. A better integration of the work by EU regulatory authorities is recommended. Copyright © 2017 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

  14. Healthcare professionals and pharmacovigilance of pediatric adverse drug reactions: a 5-year analysis of Adverse Events Reporting System database of the Food and Drug Administration.

    Science.gov (United States)

    Bigi, Caterina; Tuccori, Marco; Bocci, Guido

    2017-02-17

    To analyze the Adverse Events Reporting System (AERS) database of the Food and Drug Administration (FDA), investigating the characteristics of pediatric adverse drug reactions (ADRs) and describing the effective participation of healthcare professionals in the reporting activity. Reports of ADRs were obtained from the FDA website. Only ADRs in pediatric subjects (divided by age, by country and by professional category) were included into the analysis. The drugs suspected as primary cause of the ADRs in pediatric subjects and their principal anatomic group according to the Anatomical Therapeutic Chemical classification system were considered. To classify the ADRs, the Medical Dictionary for Regularity Activities terminology was adopted. Between 2008 and 2012, FDA collected 113,077 ADRs in pediatric patients. Of the total pediatric ADR reports, those performed by medical doctors were 32%, followed by consumers (26%) and healthcare professionals (25%). Most of the ADR reports were related to the adolescent group (39%). Healthcare professionals resulted the category with the highest rate of ADR reports in neonates and infants. Drugs acting on nervous system and antineoplastic/immunomodulating agents were the most involved the pediatric ADR reports. Pyrexia, convulsion, vomiting and accidental overdose were the reactions more reported both from healthcare professionals and medical doctors. The present study describes the pediatric ADR reports of the FDA database through healthcare professional's perspective, describing the various aspects of pediatric pharmacovigilance.

  15. Ontology-based Vaccine and Drug Adverse Event Representation and Theory-guided Systematic Causal Network Analysis toward Integrative Pharmacovigilance Research.

    Science.gov (United States)

    He, Yongqun

    2016-06-01

    Compared with controlled terminologies ( e.g. , MedDRA, CTCAE, and WHO-ART), the community-based Ontology of AEs (OAE) has many advantages in adverse event (AE) classifications. The OAE-derived Ontology of Vaccine AEs (OVAE) and Ontology of Drug Neuropathy AEs (ODNAE) serve as AE knowledge bases and support data integration and analysis. The Immune Response Gene Network Theory explains molecular mechanisms of vaccine-related AEs. The OneNet Theory of Life treats the whole process of a life of an organism as a single complex and dynamic network ( i.e. , OneNet). A new "OneNet effectiveness" tenet is proposed here to expand the OneNet theory. Derived from the OneNet theory, the author hypothesizes that one human uses one single genotype-rooted mechanism to respond to different vaccinations and drug treatments, and experimentally identified mechanisms are manifestations of the OneNet blueprint mechanism under specific conditions. The theories and ontologies interact together as semantic frameworks to support integrative pharmacovigilance research.

  16. Theoretical Issues

    Energy Technology Data Exchange (ETDEWEB)

    Marc Vanderhaeghen

    2007-04-01

    The theoretical issues in the interpretation of the precision measurements of the nucleon-to-Delta transition by means of electromagnetic probes are highlighted. The results of these measurements are confronted with the state-of-the-art calculations based on chiral effective-field theories (EFT), lattice QCD, large-Nc relations, perturbative QCD, and QCD-inspired models. The link of the nucleon-to-Delta form factors to generalized parton distributions (GPDs) is also discussed.

  17. Transmission issues

    International Nuclear Information System (INIS)

    Bradford, J.; Wilson, L.; Thon, S.; Millar, N.

    2005-01-01

    This session on transmission issues focused on the role that transmission plays in electricity markets and the importance of getting the market structure right in terms of generation divestiture with buy back contracts, demand side responsive programs, transmission upgrades and long term contracts. The difficulties of distinguishing between market power and scarcity were examined along with some of the complications that ensue if transmission experiences congestion, as exemplified by the August 2003 blackout in eastern North America. The presentations described the best ways to handle transmission issues, and debated whether transmission should be deregulated or follow market forces. Issues of interconnections and reliability of connections were also debated along with the attempt to integrate renewables into the grid. Some presentations identified what new transmission must be built and what must be done to ensure that transmission gets built. The challenges and business opportunities for transmission in Alberta were discussed with reference to plans to invest in new infrastructure, where it is going outside of the province and how it works with other jurisdictions. Manitoba's Conawapa Hydro Project and its 2000 MW tie line to Ontario was also discussed. Some examples of non-optimal use of interconnections in Europe were also discussed in an effort to learn from these mistakes and avoid them in Canada. tabs., figs

  18. Miscellaneous issues

    International Nuclear Information System (INIS)

    2002-01-01

    The New Brunswick Market Design Committee has examined several issues regarding the restructuring of the province's electricity sector. This report presents issues that require guidance for implementation, with particular focus on options available for their resolutions. The issues include: (1) rate principles for stranded offer service (SOS) supply, (2) the ability of contestable customers to return to SOS after having left it, (3) whether loads embedded in distribution systems are eligible to participate in the bilateral contract market, (4) whether generators or suppliers can offer capacity and energy to SOS suppliers in competition with the SOS supplier, and (5) details for the balancing market, including pricing, bidding protocols, settlements and how intermittent power sources can participate in the market. A section on pricing for SOS explains pricing principles, the use of export profits, pricing for SOS capacity, and time of use pricing. The Committee has made recommendations for the electricity system in the province to have an energy imbalance service that can move towards a market in order to develop an efficient and effective service. This report also explains pricing in the balancing market, penalties, and settlements. 7 refs

  19. SAFE USE OF DRUGS DURING PREGNANCY IN FOCUS OF INTERNATIONAL PRACTICE OF PHARMACOVIGILANCE SYSTEM AND TERATOLOGICAL INFORMATION SERVICE ORGANIZATION

    Directory of Open Access Journals (Sweden)

    K. A. Lutsevich

    2012-01-01

    Full Text Available The safe use of drugs during pregnancy is essential to optimize the health of both pregnant woman and her future child. At the same time obstetrician-gynecologists often face the lack of evidence-based information on the use of drugs and leave the issue to the woman herself — whether the treatment benefit to the mother outweighs risks to the unborn child — relying on the limited amount of scientific data. Preconception discussion of actual risks and safe treatment reduces patient fears and maximizes the emphasis on the therapy safety. At the same time, the lack of adequate information on safety for the majority of drugs used by pregnant women combined with the need to make appropriate treatment decisions and communicate drug risk information to a potentially vulnerable population is the most challenging and critical issue of pregnant women's health.

  20. Liability Issues

    International Nuclear Information System (INIS)

    O’Donoghue, K.

    2016-01-01

    Nuclear liability conventions try to provide a set of rules to govern third party liability. Not all States are parties to one of the existing liability conventions. There are a number of reasons why individual States may choose not to join one of the existing conventions. These include limits of compensation, jurisdiction issues, complexity, cost and definition of damage among others. This paper looks at the existing conventions and identifies some of the main issues in the existing conventions which prevent some States from signing them. The paper attempts to tease out some of the perceived gaps in the existing conventions and give a brief description of the reasons why non-Contracting Parties have difficulty with the provisions of the conventions. The paper recognizes that there has been work done in this area previously by the International Expert Group on Nuclear Liability (INLEX) and others to try to develop the existing frameworks to enhance global adherence by nuclear and non-nuclear States to an effective nuclear liability regime. (author)

  1. Using resources for scientific-driven pharmacovigilance: from many product safety documents to one product safety master file.

    Science.gov (United States)

    Furlan, Giovanni

    2012-08-01

    Current regulations require a description of the overall safety profile or the specific risks of a drug in multiple documents such as the Periodic and Development Safety Update Reports, Risk Management Plans (RMPs) and Signal Detection Reports. In a resource-constrained world, the need for preparing multiple documents reporting the same information results in shifting the focus from a thorough scientific and medical evaluation of the available data to maintaining compliance with regulatory timelines. Since the aim of drug safety is to understand and characterize product issues to take adequate risk minimization measures rather than to comply with bureaucratic requirements, there is the need to avoid redundancy. In order to identify core drug safety activities that need to be undertaken to protect patient safety and reduce the number of documents reporting the results of these activities, the author has reviewed the main topics included in the drug safety guidelines and templates. The topics and sources that need to be taken into account in the main regulatory documents have been found to greatly overlap and, in the future, as a result of the new Periodic Safety Update Report structure and requirements, in the author's opinion this overlap is likely to further increase. Many of the identified inter-document differences seemed to be substantially formal. The Development Safety Update Report, for example, requires separate presentation of the safety issues emerging from different sources followed by an overall evaluation of each safety issue. The RMP, instead, requires a detailed description of the safety issues without separate presentation of the evidence derived from each source. To some extent, however, the individual documents require an in-depth analysis of different aspects; the RMP, for example, requires an epidemiological description of the indication for which the drug is used and its risks. At the time of writing this article, this is not specifically

  2. Farmacovigilância em tuberculose: relato de uma experiência no Brasil | Pharmacovigilance in tuberculosis: report of an experience in Brazil

    Directory of Open Access Journals (Sweden)

    Jorge Luiz da Rocha

    2015-05-01

    Program and the National Health Surveillance Agency (ANVISA developed a partnership to implement a pilot pharmacovigilance project to encourage the reporting of adverse reactions to antitubercular agents. Training followed by monitoring visits was conducted by three reference health services for TB treatment. Among the bottlenecks identified, we found limitations in access to the information system (NOTIVISA, slow Internet connection, poor adverse event reporting in medical records, lack of multidisciplinary integration and involvement of managers, and fragility of information flows. As a consequence, technical instructional materials were developed, the NOTIVISA form was improved and shortened, indicators for monitoring notifications were proposed, and information flows were reset. We conclude that the partnership was successful and suggest a similar strategy for other programs. Integration of health teams as well as development of simplified notification tools are challenges to be overcome if pharmacovigilance actions are to be sustainable in the country.

  3. Aplicación de la minería de datos al Sistema Cubano de Farmacovigilancia Application of data mining to the Cuban Pharmacovigilance System

    Directory of Open Access Journals (Sweden)

    Omar Calzadilla Fernández de Castro

    2007-12-01

    Full Text Available En el año 1999, se crea la Unidad Nacional Coordinadora de Farmacovigilancia, la cual funciona como el órgano técnico-científico que desarrolla la política de vigilancia de seguridad de medicamentos del Ministerio de Salud Pública e integra las actividades de los centros provinciales y de otros programas concertados de farmacovigilancia en un sistema único. Entre sus funciones más relevantes se encuentran la de definir, diseñar y desarrollar los sistemas de información; administrar la base de datos nacional; depurar y validar la información contenida en ella; y realizar y coordinar estudios científicos sobre la seguridad de los medicamentos; así como elaborar informes para las autoridades sanitarias y el Sistema Nacional de Salud. En este sistema existe la necesidad de utilizar herramientas de análisis, por lo que se trazó el objetivo de definir, diseñar y desarrollar los sistemas de tratamiento de la información y administrar la base de datos nacional "VigiBaseCuba". Aplicando una serie de transformaciones, validaciones y la adecuación de la metodología CRISP-DM para la elaboración de proyectos de minería de datos, se conformó la base de datos nacional, en un sistema de gestión de bases de datos relacional con los registros de las notificaciones de sospechas de reacciones adversas a los medicamentos y un proceso de descubrimiento de conocimiento que permite gestionar eficazmente la seguridad de los medicamentos, así como desarrollar aplicaciones para la visualización de las señales de reacciones adversas y su evoluciónIn 1999, The National Coordinating Unit of Pharmacovigilance was created. It works as a scientific and technical agency that develops the drug safety surveillance policy of the Ministry of Public Health, and integrates the activities of the provincial centres and other pharmacovigilance programs in a unique system. Some of its most important functions are to define, design and develop the information

  4. Increasing Patient Engagement in Pharmacovigilance Through Online Community Outreach and Mobile Reporting Applications: An Analysis of Adverse Event Reporting for the Essure Device in the US.

    Science.gov (United States)

    Bahk, Chi Y; Goshgarian, Melanie; Donahue, Krystal; Freifeld, Clark C; Menone, Christopher M; Pierce, Carrie E; Rodriguez, Harold; Brownstein, John S; Furberg, Robert; Dasgupta, Nabarun

    salpingectomy (62), were reported by 598 women (44.3 %). Other events of interest included loss of libido ( n  = 115); allergy to metals (109), primarily nickel; and alopecia (252). VigiGrade completeness scores were high, averaging 0.80 (±0.15). Reports received via the mobile app were considered "well documented" 55.9 % of the time, compared with an international average of 13 % for all medical products. On average, there were 15 times more reports submitted per month via the app with patient community support versus traditional pharmacovigilance portals. Outreach via an online patient community, coupled with an easy-to-use app, allowed for rapid and detailed ICSRs to be submitted, with gains in efficiency. Two-way communication and public posting of narratives led to successful engagement within a Motivation-Incentive-Activation-Behavior framework, a conceptual model for successful crowdsourcing. Reports submitted by patients were considerably more complete than those submitted by physicians in routine spontaneous reports. Further research is needed to understand how biases operate differently from those of traditional pharmacovigilance.

  5. Licensing issues

    International Nuclear Information System (INIS)

    Roberts, J.P.; Desell, L.J.; Birch, M.L.; Berkowitz, L.; Bader, J.F.

    1992-01-01

    To provide guidance for the Department of Energy's (DOE) Civilian Radioactive Waste Management Program, the Nuclear Regulatory Commission (NRC) has issued a draft regulatory guide on the Format and Content for the License Application for the High-Level Waste Repository (FCRG). To facilitate the development of the FCRG, NRC suggested that DOE use the draft guide as the basis for preparing an annotated outline for a license application. DOE is doing so using an iterative process called the Annotated Outline Initiative. DOE;s use of the Initiative will assist in achieving the desired incorporation of actual experience in the FCRG, contribute to the development of shared interpretation and understanding of NRC regulations, and provide other important programmatic benefits described in this paper

  6. Atropinic burden of prescriptions forms in patients with Alzheimer disease: a cross-sectional study in a French PharmacoVigilance Database.

    Science.gov (United States)

    Montastruc, François; Rouanet, Sarah; Gardette, Virginie; Rousseau, Vanessa; Bagheri, Haleh; Montastruc, Jean-Louis

    2015-07-01

    Atropinic drugs in patients with Alzheimer disease (AD) can decrease the effects of anticholinesterase drugs and/or induce adverse drug reactions (ADRs). Several atropinic risk scales defining an atropinic burden of drugs were proposed but were little used in AD patients. All ADRs' notifications of AD patients registered in the Midi-Pyrénées PharmacoVigilance Database between 1999 and 2013 were analyzed using Anticholinergic Drug Scale (ADS) and Anticholinergic Duran's list. The primary objective was to quantify atropinic burden in AD patients and the secondary one to investigate associated factors. Among the 475 notifications, at least one atropinic drug was found in 282 notifications (59.4%) according to ADS and 214 (45.1%) according to Duran. Mean number of atropinics per notifications was 0.9 ± 0.9 (ADS) and 0.7 ± 0.9 (Duran). Mean atropinic burden per notifications was 1.2 ± 1.5 (ADS) and 0.9 ± 1.3 (Duran). Atropinic burden ≥ 3 was found in 87 notifications (18.2%) according to ADS and 50 (10.5%) according to Duran. There was no association between atropinic burden and age of patients. The number of drugs is associated to a high atropinic burden. The present work found an association between an atropinic drug and an anticholinesterase agent in around 1 out of 2 AD patients and a clinically significant atropinic burden (≥ 3) in around 1 to 2 AD patients out of 10. The benefit harm balance of atropinic drugs must be discussed before each prescription in AD patients.

  7. A Pharmacovigilance Approach for Post-Marketing in Japan Using the Japanese Adverse Drug Event Report (JADER Database and Association Analysis.

    Directory of Open Access Journals (Sweden)

    Masakazu Fujiwara

    Full Text Available Rapid dissemination of information regarding adverse drug reactions is a key aspect for improving pharmacovigilance. There is a possibility that unknown adverse drug reactions will become apparent through post-marketing administration. Currently, although there have been studies evaluating the relationships between a drug and adverse drug reactions using the JADER database which collects reported spontaneous adverse drug reactions, an efficient approach to assess the association between adverse drug reactions of drugs with the same indications as well as the influence of demographics (e.g. gender has not been proposed.We utilized the REAC and DEMO tables from the May 2015 version of JADER for patients taking antidepressant drugs (SSRI, SNRI, and NaSSA. We evaluated the associations using association analyses with an apriori algorithm. Support, confidence, lift, and conviction were used as indicators for associations. The highest score in adverse drug reactions for SSRI was obtained for "aspartate aminotransferase increased", "alanine aminotransferase increased", with values of 0.0059, 0.93, 135.5, and 13.9 for support, confidence, lift and conviction, respectively. For SNRI, "international normalized ratio increased", "drug interaction" were observed with 0.0064, 1.00, 71.9, and NA. For NaSSA, "anxiety", "irritability" were observed with 0.0058, 0.80, 49.9, and 4.9. For female taking SSRI, the highest support scores were observed in "twenties", "suicide attempt", whereas "thirties", "neuroleptic malignant syndrome" were observed for male. Second, for SNRI, "eighties", "inappropriate antidiuretic hormone secretion" were observed for female, whereas "interstitial lung disease" and "hepatitis fulminant" were for male. Finally, for NaSSA, "suicidal ideation" was for female, and "rhabdomyolysis" was for male.Different combinations of adverse drug reactions were noted between the antidepressants. In addition, the reported adverse drug reactions

  8. Seizures during antidepressant treatment in psychiatric inpatients--results from the transnational pharmacovigilance project "Arzneimittelsicherheit in der Psychiatrie" (AMSP) 1993-2008.

    Science.gov (United States)

    Köster, M; Grohmann, R; Engel, R R; Nitsche, M A; Rüther, E; Degner, D

    2013-11-01

    There is little clinical data available about seizure rates in psychiatric inpatients, and there are no studies with reference data to the frequencies of antidepressant (AD) use for this important clinical population. This study investigates seizure rates during AD treatment in psychiatric inpatient settings, drawn from the transnational pharmacovigilance programme Arzneimittelsicherheit in der Psychiatrie (AMSP) in relation to the known frequencies of ADs used in the participating clinics. Comparisons are made to former publications and their limitations. Seventy-seven cases were identified with grand mal seizures (GMS) during AD treatment between 1993 and 2008, with a total number of 142,090 inpatients under surveillance treated with ADs in the participating hospitals. The calculated overall rate of reported seizures of patients during AD treatment in this collective is 0.05 % for ADs imputed alone or in combination with other psychotropic drug groups and 0.02 % when only ADs were given and held responsible for GMS. The patients receiving tri- or tetracyclic ADs (TCAs) had a 2-fold risk to develop a seizure as compared to the overall average rate in this sample. In 11 cases, there was only one AD imputed--the majority of these cases (9/11) were TCA. Monotherapy with selective serotonin reuptake inhibitors (SSRI) or dual serotonin and noradrenaline reuptake inhibitors (SNRI) were never imputed alone in this sample. The results of the study favour the assumption that SSRIs, noradrenergic and specific serotonergic antidepressants (NaSSA) and dual SNRI might be more appropriate than TCAs for the treatment of psychiatric patients with an enhanced seizure risk.

  9. Memory disorders associated with consumption of drugs: updating through a case/noncase study in the French PharmacoVigilance Database.

    Science.gov (United States)

    Chavant, Francois; Favrelière, Sylvie; Lafay-Chebassier, Claire; Plazanet, Caroline; Pérault-Pochat, Marie-Christine

    2011-12-01

    To investigate putative associations of reports of memory disorders and suspected drugs. We used the case/noncase method in the French PharmacoVigilance Database (FPVD). Cases were reports of memory loss in the FPVD between January 2000 and December 2009. Noncases were all other reports during the same period. To assess the association between memory impairment and drug intake, we calculated an odds ratio with its 95% confidence interval. Among the 188,284 adverse drug reactions recorded, we identified 519 cases of memory loss. The sex ratio was 0.6 and the median age was 54 years (range 4-93). The maximal number of cases occurred between 40-49 and 50-59 years. Evolution was favourable in 63% of the cases. We found significant odds ratios for benzodiazepines (alprazolam, bromazepam, prazepam, clonazepam etc.), benzodiazepine-like hypnotics (zolpidem and zopiclone), antidepressants (fluoxetine, paroxetine and venlafaxine), analgesics (morphine, nefopam and tramadol), anticonvulsants (topiramate, pregabalin, levetiracetam etc.), antipsychotics (aripiprazole and lithium) and other drugs, such as trihexyphenidyl, ciclosporin and isotretinoin. Our study confirmed an association between memory disorders and some drugs, such as benzodiazepines and anticonvulsants. However, other drugs, such as benzodiazepine-like hypnotics, newer anticonvulsants, serotonin reuptake inhibitor antidepressants, isotretinoin and ciclosporin were significantly associated with memory disorders, although this was not described or poorly described in the literature. Taking account of the limits of this study in the FPVD (under-reporting, notoriety bias etc.), the case/noncase method allows assessment and detection of associations between exposure to drugs and a specific adverse drug reaction, such as memory disorders, and could thus generate signals and orientate us to further prospective studies to confirm such associations. © 2011 The Authors. British Journal of Clinical Pharmacology © 2011

  10. Transitional issues

    International Nuclear Information System (INIS)

    1998-01-01

    This discussion paper, the fifth in the series developed at the IPPSO Market Design Conference, addressed the issue of the need to prevent Ontario Hydro from taking unfair advantage of independent producers and other stakeholders through activities and investments in new power generating capacity in the transitional period leading up to deregulation. The need for controls is predicated on the assumption that the short-term actions and investments of Ontario Hydro could seriously compromise the position of independent generators, and that without such controls the level playing field essential to the operation of a competitive market, does not exist. Various actual and potential actions of Ontario Hydro were discussed, all of which point to the need for strict controls over Ontario Hydro exercising its dominant market power in an unfair way. It was recommended that as a minimum, the provincial government should no longer provide guarantees for Ontario Hydro capital projects, and that Ontario Hydro be instructed to defer any investment on new or returning generating capacity until the new market is in place. Limits could also be placed on Ontario Hydro's marketing efforts to enter into contracts during the transition period, and Ontario Hydro and municipal utilities should be required to keep separate accounts of their commercial preparation, and to settle such accounts separate from ratepayer revenue

  11. Key issues

    International Nuclear Information System (INIS)

    Cook, N.G.W.

    1980-01-01

    Successful modeling of the thermo-mechanical and hydrochemical behavior of radioactive waste repositories in hard rock is possible in principle. Because such predictions lie outside the realm of experience, their adequacy depends entirely upon a thorough understanding of three fundamental questions: an understanding of the chemical and physical processess that determine the behavior of rock and all its complexities; accurate and realistic numerical models of the geologic media within which a repository may be built; and sufficient in-situ data covering the entire geologic region affected by, or effecting the behavior of a repository. At present sufficient is known to be able to identify most of those areas which require further attention. These areas extend all the way from a complete understanding of the chemical and physical processes determining the behavior of rock through to the exploration mapping and testing that must be done during the development of any potential repository. Many of the techniques, laboratory equipment, field instrumentation, and numerical methods needed to accomplish this do not exist at present. Therefore it is necessary to accept that a major investment in scientific research is required to generate this information over the next few years. The spectrum of scientific and engineering activities is wide extending from laboratory measurements through the development of numerical models to the measurement of data in-situ, but there is every prospect that sufficient can be done to resolve these key issues. However, to do so requires overt recognition of the many gaps which exist in our knowledge and abilities today, and of the need to bridge these gaps and of the significant costs involved in doing so

  12. Hearing impairment associated with oral terbinafine use: a case series and case/non-case analysis in the Netherlands Pharmacovigilance Centre Lareb database and VigiBase™.

    Science.gov (United States)

    Scholl, Joep H G; van Puijenbroek, Eugene P

    2012-08-01

    The Netherlands Pharmacovigilance Centre Lareb received reports of six cases of hearing impairment in association with oral terbinafine use. This study describes these cases and provides support for this association from the Lareb database for spontaneous adverse drug reaction (ADR) reporting and from Vigibase™, the ADR database of the WHO Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre. The objective of the current study was to identify whether the observed association between oral terbinafine use and hearing impairment, based on cases received by Lareb, constitutes a safety signal. Cases of hearing impairment in oral terbinafine users are described. In a case/non-case analysis, the strength of the association in Vigibase™ and the Lareb database was determined (date of analysis August 2011) by calculating the reporting odds ratios (RORs), adjusted for possible confounding by age, sex and ototoxic concomitant medication. For the purpose of this study, RORs were calculated for deafness, hypoacusis and the combination of both, defined as hearing impairment. In the Lareb database, six reports concerning individuals aged 31-82 years, who developed hearing impairment after starting oral terbinafine, were present. The use of oral terbinafine was disproportionally associated with hypoacusis in both the Lareb database (adjusted ROR 3.9; 95% CI 1.7, 9.0) and in Vigibase™ (adjusted ROR 1.7; 95% CI 1.0, 2.8). Deafness was not disproportionally present in either of the databases. Based on the described cases and the statistical analyses from both databases, a causal relationship between the use of oral terbinafine and hearing impairment is possible. The mechanism by which terbinafine could cause hearing impairment has not been elucidated yet. The pharmacological action of terbinafine is based on the inhibition of squalene epoxidase, an enzyme present in both fungal and human cells. This inhibition might result in a decrease in

  13. An International Study of the Ability and Cost-Effectiveness of Advertising Methods to Facilitate Study Participant Self-Enrolment Into a Pilot Pharmacovigilance Study During Early Pregnancy.

    Science.gov (United States)

    Richardson, Jonathan Luke; Stephens, Sally; Thomas, Simon Hugh Lynton; Jamry-Dziurla, Anna; de Jong-van den Berg, Lolkje; Zetstra-van der Woude, Priscilla; Laursen, Maja; Hliva, Valerie; Mt-Isa, Shahrul; Bourke, Alison; Dreyer, Nancy A; Blackburn, Stella Cf

    2016-01-01

    Knowledge of the fetal effects of maternal medication use in pregnancy is often inadequate and current pregnancy pharmacovigilance (PV) surveillance methods have important limitations. Patient self-reporting may be able to mitigate some of these limitations, providing an adequately sized study sample can be recruited. To compare the ability and cost-effectiveness of several direct-to-participant advertising methods for the recruitment of pregnant participants into a study of self-reported gestational exposures and pregnancy outcomes. The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) pregnancy study is a non-interventional, prospective pilot study of self-reported medication use and obstetric outcomes provided by a cohort of pregnant women that was conducted in Denmark, the Netherlands, Poland, and the United Kingdom. Direct-to-participant advertisements were provided via websites, emails, leaflets, television, and social media platforms. Over a 70-week recruitment period direct-to-participant advertisements engaged 43,234 individuals with the study website or telephone system; 4.78% (2065/43,234) of which were successfully enrolled and provided study data. Of these 90.4% (1867/2065) were recruited via paid advertising methods, 23.0% (475/2065) of whom were in the first trimester of pregnancy. The overall costs per active recruited participant were lowest for email (€23.24) and website (€24.41) advertisements and highest for leaflet (€83.14) and television (€100.89). Website adverts were substantially superior in their ability to recruit participants during their first trimester of pregnancy (317/668, 47.5%) in comparison with other advertising methods (Padvertisement methods used and in their ability to recruit participants in early pregnancy. Recruitment of a pregnant cohort using direct-to-participant advertisement methods is feasible, but the total costs incurred are not insubstantial. Future research is

  14. Technical issues and conservation conditions of medicines in the primary health care of the Brazilian Unified Health System

    Science.gov (United States)

    Costa, Ediná Alves; Araújo, Patrícia Sodré; Pereira, Marcelo Tavares; Souto, Ana Cristina; Souza, Gisélia Santana; Guerra, Augusto Afonso; Acurcio, Francisco de Assis; Guibu, Ione Aquemi; Alvares, Juliana; Costa, Karen Sarmento; Karnikowski, Margô Gomes de Oliveira; Soeiro, Orlando Mario; Leite, Silvana Nair

    2017-01-01

    ABSTRACT OBJECTIVE To characterize the technical issues and conditions of medicines conservation in Primary Health Care of Brazilian regions, responsible for pharmacy/dispensing unit profile; environmental, storage, and dose fractioning conditions; inventory control and waste management; fire and electrical failure safety items; transportation problems; advertising regulation; and pharmacovigilance. METHODS This article is part of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços (National Survey on Access, Use and Promotion of Rational Use of Medicines – Services)–, a cross-sectional and exploratory study, of evaluative nature, consisting of an information survey within a representative sample of municipalities, stratified by Brazilian regions, which constitute the study domains, and a sample of Primary Health Care services. Pharmaceutical services (PS) were directly observed with photographic record and face-to-face interviews with those responsible for the dispensing of medicines and over the telephone with those responsible for pharmaceutical services. Data were processed with the SPSS® software version 21. RESULTS The investigated dimensions showed relevant deficiencies and inequalities between the regions, generally more favorable in the Southeast and Midwest regions and weaker in the Northeast and North regions. We verified non-compliance with technical requirements and conditions essential to the conservation of medicines, which may interfere with the maintenance of stability and, thus, on their quality, efficacy, and safety. The regulation of advertising/promotion of medicines is still incipient and there is some progress in the structuring of mechanisms regarding pharmacovigilance. CONCLUSIONS The sanitary situation of medicines in Brazilian Primary Health Care is alarming due to the violation of the specific sanitary legislation for dispensing establishments and due to a wide range of

  15. Research Article Special Issue

    African Journals Online (AJOL)

    2016-05-15

    May 15, 2016 ... Near-fault earthquake issue is almost a new issue in earthquake engineering. ... although those countries had advanced regulations for seismic design of ... allocating the plastic joints according to development guideline and ...

  16. Future accelerators: physics issues

    International Nuclear Information System (INIS)

    Bjorken, J.D.

    1977-11-01

    High energy physics of the future using future accelerators is discussed. The proposed machines and instruments, physics issues and opportunities including brief sketches of outstanding recent results, and the way the proposed machines address these issues are considered. 42 references

  17. Medical Issues: Orthopedics

    Science.gov (United States)

    ... Information Packets Equipment Pool Living With SMA Medical Issues Palliative Breathing Orthopedics Nutrition Equipment Daily Life At ... curesma.org > support & care > living with sma > medical issues > orthopedics Orthopedics In SMA, muscle weakness can cause ...

  18. Medical Issues: Equipment

    Science.gov (United States)

    ... Information Packets Equipment Pool Living With SMA Medical Issues Palliative Breathing Orthopedics Nutrition Equipment Daily Life At ... curesma.org > support & care > living with sma > medical issues > equipment Equipment Individuals with SMA often require a ...

  19. Health Issues and Treatments

    Science.gov (United States)

    ... About Us Information For… Media Policy Makers Health Issues & Treatments Language: English (US) Español (Spanish) Recommend on ... people with spina bifida are exactly alike. Health issues and treatments for people with spina bifida will ...

  20. Medical Issues: Breathing

    Science.gov (United States)

    ... Information Packets Equipment Pool Living With SMA Medical Issues Palliative Breathing Orthopedics Nutrition Equipment Daily Life At ... curesma.org > support & care > living with sma > medical issues > breathing Breathing Breathing problems are the most common ...

  1. Space Station Engineering Design Issues

    Science.gov (United States)

    Mcruer, Duane T.; Boehm, Barry W.; Debra, Daniel B.; Green, C. Cordell; Henry, Richard C.; Maycock, Paul D.; Mcelroy, John H.; Pierce, Chester M.; Stafford, Thomas P.; Young, Laurence R.

    1989-01-01

    Space Station Freedom topics addressed include: general design issues; issues related to utilization and operations; issues related to systems requirements and design; and management issues relevant to design.

  2. Seven Issues, Revisited

    OpenAIRE

    Whitehead, Jim; De Bra, Paul; Grønbæk, Kaj; Larsen, Deena; Legget, John; schraefel, monica m.c.

    2002-01-01

    It has been 15 years since the original presentation by Frank Halasz at Hypertext'87 on seven issues for the next generation of hypertext systems. These issues are: Search and Query Composites Virtual Structures Computation in/over hypertext network Versioning Collaborative Work Extensibility and Tailorability Since that time, these issues have formed the nucleus of multiple research agendas within the Hypertext community. Befitting this direction-setting role, the issues have been revisited ...

  3. Uranium and nuclear issues

    International Nuclear Information System (INIS)

    1983-01-01

    This seminar focussed on the major issues affecting the future of the entire nuclear fuel cycle. In particular it covered issues bearing on the formation of public policy in relation to the use of uranium as an energy source: economic risk, industrial risks, health effects, site selection, environmental issues, and public acceptance

  4. Issues in Data Labelling

    NARCIS (Netherlands)

    Cowie, Roddy; Cox, Cate; Martin, Jeam-Claude; Batliner, Anton; Heylen, Dirk K.J.; Karpouzis, Kostas; Cowie, Roddy; Pelachaud, Catherine; Petta, Paolo

    2011-01-01

    Labelling emotion databases is not a purely technical matter. It is bound up with theoretical issues. Different issues affect labelling of emotional content, labelling of the signs that convey emotion, and labelling of the relevant context. Linked to these are representational issues, involving time

  5. Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

    Energy Technology Data Exchange (ETDEWEB)

    Gamboa, Maryelle Moreira Lima; Roesch, Heveline Rayane Moura; Lemos, Vanessa Pinheiro Amaral, E-mail: maryellelg@hotmail.com [PPG BioSaude, Universidade Luterana do Brasil, Canoas, RS (Brazil); Rocha, Bruna Oliveira [Faculty of Biology, Universidade Luterana do Brasil, Canoas, RS (Brazil); Santos-Oliveira, Ralph [Institute of Radiopharmacy Research, Universidade Estadual da Zona Oeste, Rio de Janeiro, RJ (Brazil)

    2014-04-15

    Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ) or positrons emitter (β+), linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. >From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64). In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs. (author)

  6. Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

    International Nuclear Information System (INIS)

    Gamboa, Maryelle Moreira Lima; Roesch, Heveline Rayane Moura; Lemos, Vanessa Pinheiro Amaral; Rocha, Bruna Oliveira; Santos-Oliveira, Ralph

    2014-01-01

    Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ) or positrons emitter (β+), linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. >From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64). In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs. (author)

  7. Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

    Directory of Open Access Journals (Sweden)

    Maryelle Moreira Lima Gamboa

    2014-04-01

    Full Text Available Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ or positrons emitter (β+, linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64. In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs.

  8. Integration of generic issues

    International Nuclear Information System (INIS)

    Thatcher, D.

    1989-01-01

    The NRC has recognized the need to integrate generic issues (GIs). The GI process includes a number of phases, all of which should recognize the potential for overlap and conflict among related issues. In addition to the issues themselves, other related NRC and industry programs and activities need to be factored into the GI process. Integration has taken place, or is taking place, for a number of GIs. Each case of integration involves a specific set of circumstances and, as a result, the way in which integration proceeds can vary. This paper discusses the integration of issues in the generic issue process and provides a number of examples

  9. Current issues and actions

    Energy Technology Data Exchange (ETDEWEB)

    Black, D.G.

    1995-06-01

    This section of the 1994 Hanford Site Environmental Report summarizes the progress that has been made toward achieving full regulatory compliance at the Hanford Site. Ongoing compliance self-assessments, implementation of the Tri-Party Agreement, and public meetings continue to identify environmental compliance issues. These issues are discussed openly with the regulatory agencies and with the public to ensure that all environmental compliance issues are addressed.

  10. Current issues and actions

    International Nuclear Information System (INIS)

    Black, D.G.

    1995-01-01

    This section of the 1994 Hanford Site Environmental Report summarizes the progress that has been made toward achieving full regulatory compliance at the Hanford Site. Ongoing compliance self-assessments, implementation of the Tri-Party Agreement, and public meetings continue to identify environmental compliance issues. These issues are discussed openly with the regulatory agencies and with the public to ensure that all environmental compliance issues are addressed

  11. Aviation Safety Issues Database

    Science.gov (United States)

    Morello, Samuel A.; Ricks, Wendell R.

    2009-01-01

    The aviation safety issues database was instrumental in the refinement and substantiation of the National Aviation Safety Strategic Plan (NASSP). The issues database is a comprehensive set of issues from an extremely broad base of aviation functions, personnel, and vehicle categories, both nationally and internationally. Several aviation safety stakeholders such as the Commercial Aviation Safety Team (CAST) have already used the database. This broader interest was the genesis to making the database publically accessible and writing this report.

  12. Environmental issues and wastes

    International Nuclear Information System (INIS)

    Mitamura, Hisayoshi; Banba, Tsunetaka; Maeda, Toshikatsu; Ishiyama, Takashi

    1999-08-01

    All countries in the world are concerned about environmental issues because of their global effects. Developed industrial nations are also confronted with waste issues accompanied by mass production, mass consumption, and mass dump. We have reviewed books and reports to obtain a preliminary knowledge and to understand the trend of technology development before we start R and D for 'environmental monitoring, and environmental remediation and protection'. We lay great emphasis on municipal and industrial wastes in environmental issues and summarize the history of the earth, innovative environmental approaches in advanced nations, waste issues in Japan, and examples of technology development for environmental remediation and protection. (author)

  13. Navigating "Thorny" Issues

    Science.gov (United States)

    Hutchinson, Kashema; Gilbert, Aderinsola; Malyukova, Anna

    2016-01-01

    In their article "Mindfulness and discussing 'thorny' issues in the classroom" Konstantinos Alexakos et al. ("Cult Stud Sci Educ," 2016. doi: 10.1007/s11422-015-9718-0) describe "thorny" issues as "difficult topics to discuss because they are more personal to some perhaps even cause pain and violence." As…

  14. Poverty + Hunger = Global Issues.

    Science.gov (United States)

    Schwartz, Richard H.

    1983-01-01

    Geography teachers can use mathematics to teach fourth, fifth, and sixth grade students about critical global issues. Five sample problems concerning population, poverty, waste, the arms race, and hunger are presented. The global issue related to each problem is discussed, and the solution and mathematical skill are provided. (RM)

  15. Nuclear safety - Topical issues

    International Nuclear Information System (INIS)

    1995-01-01

    The following topical issues related to nuclear safety are discussed: steam generators; maintenance strategies; control rod drive nozzle cracks; core shrouds cracks; sump strainer blockage; fire protection; computer software important for safety; safety during shutdown; operational safety experience; external hazards and other site related issues. 5 figs, 5 tabs

  16. 19 (Special Issue)

    African Journals Online (AJOL)

    mwakagugu

    19 (Special Issue). Tanzania Dental Journal 2017. 1. PRESIDENTS SPEECH AT THE OPENING CEREMONY OF THE TANZANIA DENTAL. ASSOCIATION 31ST SCIENTIFIC CONFERENCE AND .... awareness on oral health issues, high tooth decay, gum diseases and predominant tooth extraction as consistently reported ...

  17. Volume 8 Issue 2

    Directory of Open Access Journals (Sweden)

    Karen Nelson

    2017-06-01

    Full Text Available This issue is our third Students, Transitions, Achievement, Retention and Success (STARS Conference special issue held in July this year in Adelaide, Australia.   As is customary, this issue of the journal publishes the top research papers selected via a peer review process and the top Emerging Initiatives selected by the Conference Committee.    We are delighted to feature in this special  issue —Reflections on Student Persistence—prepared by Advisory Board member Professor Vincent Tinto, Distinguished University Professor Emeritus at Syracuse University, USA.  Vincent is a long-time friend and supporter of STARS and its predecessor FYHE Conferences and Journal.   In his article, Vincent explores the case for motivation to be considered as a significant aspect of the tertiary student psyche by drawing on theoretical frameworks, research and practical experiences related to the issue.

  18. Design and methods for a Scandinavian pharmacovigilance study of osteonecrosis of the jaw and serious infections among cancer patients treated with antiresorptive agents for the prevention of skeletal-related events

    Directory of Open Access Journals (Sweden)

    Acquavella J

    2016-07-01

    Full Text Available John Acquavella,1 Vera Ehrenstein,1 Morten Schiødt,2 Uffe Heide-Jørgensen,1 Anders Kjellman,3,4 Svein Hansen,5 Cecilia Larsson Wexell,6,7 Bente Brokstad Herlofson,8 Sven Erik Noerholt,9 Haijun Ma,10 Katarina Öhrling,11 Rohini K Hernandez,12 Henrik Toft Sørensen1 1Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 2Department of Oral and Maxillofacial Surgery, Rigshospitalet, Copenhagen, Denmark; 3Department of Urology, Karolinska University Hospital, 4Department of Clinical Science, Intervention, and Technology, Karolinska Institutet, Stockholm, Sweden; 5Cancer Registry of Norway, Oslo University Hospital, Oslo, Norway; 6Department of Oral and Maxillofacial Surgery, Södra Älvsborg Hospital, Borås, Sweden; 7Department of Biomaterials, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; 8Department of Oral Surgery and Oral Medicine, Faculty of Dentistry, University of Oslo, Oslo, Norway; 9Department of Oral and Maxillofacial Surgery, Aarhus University Hospital, Aarhus, Denmark; 10Global Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA; 11Clinical Development, Amgen Inc., Thousand Oaks, CA, USA; 12Center for Observational Research, Amgen Inc., Thousand Oaks, CA, USA Objective: Osteonecrosis of the jaw (ONJ is a recognized complication of potent antiresorptive therapies, especially at the doses indicated to prevent skeletal complications for cancer patients with bone metastases. This paper describes the rationale and methods for a prospective, post-authorization safety study of cancer patients treated with antiresorptive therapies. Methods: As part of a comprehensive pharmacovigilance plan, developed with regulators’ input, the study will estimate incidence of ONJ and of serious infections among adult cancer patients with bone metastases treated with denosumab (120 mg subcutaneously or zoledronic acid (4 mg intravenously, adjusted for renal function

  19. Special Issue to publish

    OpenAIRE

    Kllogjeri, Pellumb

    2015-01-01

    SciencePG has offered an email poster to help collect papers for our Special Issue and I have uploaded it for you. Please visit http://www.sciencepublishinggroup.com/specialissue/149002  to see our Special Issue announcement. Now, you can do the followings to personally contribute and promote our Special Issue:1. Submit your paper related to the topics of interest 2. Upload it to your personal websites.3. Upload it to the public websites of some universities and academic institutions...

  20. Understanding Pregnancy and Birth Issues

    Science.gov (United States)

    ... Navigation Bar Home Current Issue Past Issues Understanding Pregnancy and Birth Issues Past Issues / Winter 2008 Table ... turn Javascript on. What is a High-Risk Pregnancy? All pregnancies involve a certain degree of risk ...

  1. Special issue: Plasma Conversion

    NARCIS (Netherlands)

    Nozaki, T.; Bogaerts, A.; Tu, X.; van de Sanden, M. C. M.

    2017-01-01

    With growing concern of energy and environmental issues, the combination of plasma and heterogeneous catalysts receives special attention in greenhouse gas conversion, nitrogen fixation and hydrocarbon chemistry. Plasma gas conversion driven by renewable electricity is particularly important for the

  2. Medical Issues: Nutrition

    Science.gov (United States)

    ... support & care > living with sma > medical issues > nutrition Nutrition Good nutrition is essential to health and growth. ... must make decisions based on their own needs. Nutrition Considerations Since we are still waiting for clinical ...

  3. Strategic Issues for Training.

    Science.gov (United States)

    Pollitt, David, Ed.

    1999-01-01

    Contains precis of 18 articles on strategic management issues, including management development, on-the-job training, corporate scholarship, educational technology, coaching, investing in intellectual capital, and knowledge management. (SK)

  4. Pregnancy and Reproductive Issues

    Science.gov (United States)

    ... Health Pregnancy Share this page Facebook Twitter Email Pregnancy and Reproductive Issues Tahirah Diagnosed in 2003 Pregnancy ... in control groups without the disease. Effects of pregnancy on MS Before 1950, most women with MS ...

  5. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2018-05-16

    May 16, 2018 ... This paper discusses the issues and challenges faced during .... provision of this AELF's office is costly and need permission from the university's management. .... This is to deduct weeks for the assignment and tests because ...

  6. Research Article Special Issue

    African Journals Online (AJOL)

    2017-02-15

    Feb 15, 2017 ... One of the important issues in the field of human education is the method of ... Encouragement and punishment method in Islamic management has been ... Concept of education refers to the cultivating human talent, this.

  7. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2018-03-22

    Mar 22, 2018 ... rameter of computation time and convergence rate. The two scheme have shown ... matrix and its inversion repeatedly for every iteration. This issue causes long ..... Some New Findings on Gauss-Seidel. Technique for Load ...

  8. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2018-02-01

    Feb 1, 2018 ... The main goal of this article is to analyze methodological issues in .... methodology and theory and historiology (theory of historic process) whose goal is to .... internal branches of sociology and interdisciplinary links of ...

  9. Respiratory Issues in OI

    Science.gov (United States)

    Respiratory Issues in Osteogenesis Imperfecta \\ Introduction The respiratory system’s job is to bring oxygen into the body and remove carbon dioxide, the waste product of breathing. Because oxygen is the fuel ...

  10. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2018-04-16

    Apr 16, 2018 ... The dimensions to business process strategy factors are .... Investigation pains directed at further exploring these issues are very ... relationship management, material flow management, corporate culture in SMEs' Customer.

  11. Common Mental Health Issues

    Science.gov (United States)

    Stock, Susan R.; Levine, Heidi

    2016-01-01

    This chapter provides an overview of common student mental health issues and approaches for student affairs practitioners who are working with students with mental illness, and ways to support the overall mental health of students on campus.

  12. Fusion Canada issue 11

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1990-06-01

    A short bulletin from the National Fusion Program. Included in this issue is a report on operation at Tokamak de Varennes, CRITIC irradiations at AECL, Tritium systems at TFTR, physics contribution at ITER. 4 figs.

  13. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2017-11-10

    Nov 10, 2017 ... 1Faculty of Sports Science and Coaching, Universiti Pendidikan ... face obesity issues because of several factors such as changes in diet intake, lifestyle, physical ...... and its implications for policy and intervention strategies.

  14. Fusion Canada issue 23

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1994-01-01

    A short bulletin from the National Fusion Program highlighting in this issue TdeV tokamak updates, fusion research in Korea, CCFM program review, TdeV divertor plasma, and CFFTP program review. 4 figs.

  15. Sleep Issues and Sundowning

    Science.gov (United States)

    ... Caregiving Middle-Stage Caregiving Late-Stage Caregiving Behaviors Aggression & Anger Anxiety & Agitation Depression Hallucinations Memory Loss & Confusion Repetition Sleep Issues & Sundowning Suspicion & Delusions Wandering Abuse Start Here What You Need to Know Online ...

  16. Fusion Canada issue 27

    International Nuclear Information System (INIS)

    1995-03-01

    A short bulletin from the National Fusion Program highlighting in this issue ITER reactor siting, a major upgrade for TdeV tokamak, Ceramic Breeders: new tritium mapping technique and Joint Fusion Symposium. 2 figs

  17. Research Article Special Issue

    African Journals Online (AJOL)

    2017-02-15

    Feb 15, 2017 ... Research Article. Special Issue ... In myriad studies implemented, the quality of life has been defined in different ways among which the .... service and trading users in living area. ... market, bakery, barber shop, restaurant, etc.

  18. Environmental Compliance Issue Coordination

    Science.gov (United States)

    An order to establish the Department of Energy (DOE) requirements for coordination of significant environmental compliance issues to ensure timely development and consistent application of Departmental environmental policy and guidance

  19. Fusion Canada issue 20

    International Nuclear Information System (INIS)

    1993-03-01

    Fusion Canada's publication of the National Fusion Program. Included in this issue is the CFFTP Industrial Impact Study, CCFM/TdeV Update:helium pumping, research funds, and deuterium in beryllium - high temperature behaviour. 3 figs

  20. Issues in Electronic Publishing.

    Science.gov (United States)

    Meadow, Charles T.

    1997-01-01

    Discusses issues related to electronic publishing. Topics include writing; reading; production, distribution, and commerce; copyright and ownership of intellectual property; archival storage; technical obsolescence; control of content; equality of access; and cultural changes. (Author/LRW)

  1. Research Article Special Issue

    African Journals Online (AJOL)

    2016-05-15

    May 15, 2016 ... Assistant professor, Khorasgan Branch, Islamic Azad University, Isfahan, Iran ... Discussing the issue of knowledge leads inevitably to the problem of beliefs because .... the level of definition from truth at the level of examples.

  2. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2018-03-22

    Mar 22, 2018 ... Voltage decay is an important issue in the power system community. ... of voltage profile, the total real power loss in the system is also determined to ..... Kumar A. Optimal placement of DG in radial distribution systems based.

  3. Male Fertility Issues

    Science.gov (United States)

    Fertility issues are common in boys and men getting cancer treatment. Fertility preservation options include sperm banking, testicular shielding, testicular sperm extraction (TESE), and testicular tissue freezing. Support and clinical trials are listed.

  4. Fusion Canada issue 23

    International Nuclear Information System (INIS)

    1994-01-01

    A short bulletin from the National Fusion Program highlighting in this issue TdeV tokamak updates, fusion research in Korea, CCFM program review, TdeV divertor plasma, and CFFTP program review. 4 figs

  5. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2018-02-24

    Feb 24, 2018 ... ABSTRACT. Electronic Records and Information Management (e-RIM) framework is paramount for ..... RIM issues and problems that led to information crisis. On the other .... Malaysia: A case study in one government agency”.

  6. Research Article Special Issue

    African Journals Online (AJOL)

    2016-07-16

    Jul 16, 2016 ... investigated and analyzed from various library and documentary ... It is therefore evident that applied research on issues related to ...... [29] Cutter-SL., Burton-CG., Emrich-CT., Disaster resilience indicators for benchmarking.

  7. Fusion Canada issue 10

    International Nuclear Information System (INIS)

    1990-02-01

    A short bulletin from the National Fusion Program. Included in this issue is a report on Fusion Materials Research, ITER physics research, fusion performance record at JET, and design options for reactor building. 4 figs

  8. Fusion Canada issue 6

    International Nuclear Information System (INIS)

    1989-02-01

    A short bulletin from the National Fusion Program. Included in this issue is a funding report for CFFTP, a technical update for Tokamak de Varennes and a network for university research by the National Fusion Program. 4 figs

  9. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2018-04-18

    Apr 18, 2018 ... selectivity of possible lead compounds prior to clinical trials and ... These computational algorithms had resolved previous issues and .... In similarity with the spatial space degree of the universe, these descriptors are running ...

  10. Current Issues in Tourism

    OpenAIRE

    Xu, Shi; Martinez, Larry R.; Hubert, Van Hoof; Tews, Michael; Torres, Leonardo; Farfán, Karina

    2015-01-01

    Ram (2015 Ram, Y. (2015). Hostility or hospitality? A review on violence, bullying and sexual harassment in the tourism and hospitality industry. Current Issues in Tourism. doi:10.1080/13683500.2015.1064364 [Taylor & Francis Online], [Google Scholar] . Hostility or hospitality? A review on violence, bullying and sexual harassment in the tourism and hospitality industry. Current Issues in Tourism. doi:10.1080/13683500.2015.1064364) posits that violence and harassment are areas of concern...

  11. Definition of containment issues

    International Nuclear Information System (INIS)

    Walker, D.H.

    1982-01-01

    Public Law 96-567 Nuclear Safety Research, Development and Demonstration Act of 1980, directed the US Department of Energy (DOE) to provide an accelerated and coordinated program for developing practical generic improvements that would enhance the capability for safe, reliable and economical operation of Light Water Nuclear Reactor Power Stations. The DOE approach to defining such a program will consist of two phases, (1) definition of program requirements and (2) implementation of the program plan. This paper summarizes the results of the program definition phase for the containment integrity function. The definition phase effort was carried out by two groups of knowledgeable technical experts from the nuclear industry, one of which addressed containment integrity. Tabulated in the paper are the issues identified by the working groups and their associated priorities. Also tabulated are those high priority issues for which ongoing programs do not appear to provide sufficient information to resolve the issue. The results of this review show that existing programs to a great extent address existing issues in a manner such that the issues should be resolved by the programs

  12. The railroad perspective: Issues behind the issues

    International Nuclear Information System (INIS)

    Furber, C.P.; Brobst, W.A.

    1986-01-01

    Rail transportation is a vital segment of DOE's spent fuel program. Most of the shipments from reactors to a repository or to a Monitored Retrievable Storage facility will be by rail, and essentially all of the shipments from an MRS to a repository. Casks must move economically and efficiently, while at the same time providing adequate safety to the public and transport workers, and meeting the legal/institutional constraints. Shippers are faced with the problem of procuring transportation services in a safe manner at a reasonable cost, trying to balance freight charges against cask inventory costs. Carriers are cautious about accepting potentially high hazard materials in routine service, and are worried about uninsured losses in case of accidents. Both shippers and carriers operate under different scheduling and operational criteria. Technical and institutional constraints add to the complexity of the operation. Standardization of shipping casks and rail car design will ease the resolution of the complex problems now existent. This paper discusses the economic, safety, operational, and legal issues surrounding rail transportation

  13. Regulatory and legal issues

    International Nuclear Information System (INIS)

    Raisler, K.M.; Gregory, A.M.

    1999-01-01

    This chapter focuses on the legal issues relating to the derivatives market in the USA, and analyses the Commodity Futures Trading Commission's (CFTCs) information on swaps and hybrid instruments. The law and regulation in the USA is examined and the jurisdictional reach of the Securities and Exchange Commission (SEC), CFTC, and the Commodity Exchange Act (CEA) is described. The forward contract exclusion and the case of Transnor (Bermuda) Ltd. versus BP North America Petroleum, state laws, swap policy statement issues by the CFTC, the Futures Trading Practices Act of 1992, swaps exemptions, the exemption of hybrid instruments from the CEA, and energy contract exemption are discussed. Enforceability, derivatives, and issues before regulators are considered

  14. Year 2000 commercial issues

    Energy Technology Data Exchange (ETDEWEB)

    Kratz, M.P.J.; Booth, R.T. [Bennett Jones, Calgary, AB (Canada)

    1998-12-31

    This presentation focused on commercial aspects of the Y2K including: (1) special communication issues, (2) outsourcing transactions, (3) joint ventures and the significance for the oil and gas industry, and (4) contingency planning. Communication issues involve interaction with suppliers and vendors of critical systems, liability for Y2K communications (misrepresentation, defamation, promissory estoppel, statutory liability), securities disclosure (Canadian and US SEC requirements), protected communications, protection for Year 2000 statements. Outsourcing problems highlighted include resistance of suppliers to assume responsibility for Y2K problem remediation, factors which support and negate supplier responsibility, scope of suppliers` obligation, and warranties in respect of third party software. Regarding joint ventures, questions concerning limitations on liability, supply warranties, stand-by arrangements, stockpiling inventory, indemnities, confidentiality, operator compensation versus operator risk, and insurance were raised and addressed. Among contingency planning issues the questions of Y2K legal audit, and disclosure aspects of contingency planning were the featured concerns. figs.

  15. Energy and environmental issues

    International Nuclear Information System (INIS)

    Skea, Jim

    1993-01-01

    This paper provides an overview of the current energy-environmental issues. Firstly, the environmental problems associated with energy production and use are briefly described. Secondly, the paper reviews the availability of technological solutions to environmental problems, focussing particularly on atmospheric emission control. Finally, it moves on to look at recent policy developments in some parts of the world. Since the paper is written from the perspective of an industrialized country, emerging policy issues in Europe, Japan, and North America receive the greatest attention, with a particular focus on Europe where greenhouse gases and the proposed carbon tax have received a particularly high priority. The paper concludes with a discussion of some of the issues arising from the 1992 UNCED (UN Conference on Environment and Development) and implications for the diffusion of cleaner technologies from North to South. (author). 36 refs

  16. Year 2000 commercial issues

    International Nuclear Information System (INIS)

    Kratz, M.P.J.; Booth, R.T.

    1998-01-01

    This presentation focused on commercial aspects of the Y2K including: (1) special communication issues, (2) outsourcing transactions, (3) joint ventures and the significance for the oil and gas industry, and (4) contingency planning. Communication issues involve interaction with suppliers and vendors of critical systems, liability for Y2K communications (misrepresentation, defamation, promissory estoppel, statutory liability), securities disclosure (Canadian and US SEC requirements), protected communications, protection for Year 2000 statements. Outsourcing problems highlighted include resistance of suppliers to assume responsibility for Y2K problem remediation, factors which support and negate supplier responsibility, scope of suppliers' obligation, and warranties in respect of third party software. Regarding joint ventures, questions concerning limitations on liability, supply warranties, stand-by arrangements, stockpiling inventory, indemnities, confidentiality, operator compensation versus operator risk, and insurance were raised and addressed. Among contingency planning issues the questions of Y2K legal audit, and disclosure aspects of contingency planning were the featured concerns. figs

  17. Volume 5, Issue 1

    Directory of Open Access Journals (Sweden)

    Karen Nelson

    2014-03-01

    Full Text Available The Feature in this issue is a conversation with Richard James, a highly respected Australian academic with extensive experience in research and policy development on the First Year Experience. Richard discusses the inevitability of universal participation in tertiary education and its impact on the style of participation, student diversity, the shifting focus of decision-making on standards and credentialism; and addresses the challenges posed by these and related issues for universities and the First Year Experience, along with possible solutions.

  18. Dips spacecraft integration issues

    International Nuclear Information System (INIS)

    Determan, W.R.; Harty, R.B.

    1988-01-01

    The Department of Energy, in cooperation with the Department of Defense, has recently initiated the dynamic isotope power system (DIPS) demonstration program. DIPS is designed to provide 1 to 10 kW of electrical power for future military spacecraft. One of the near-term missions considered as a potential application for DIPS was the boost surveillance and tracking system (BSTS). A brief review and summary of the reasons behind a selection of DIPS for BSTS-type missions is presented. Many of these are directly related to spacecraft integration issues; these issues will be reviewed in the areas of system safety, operations, survivability, reliability, and autonomy

  19. Legal and institutional issues

    International Nuclear Information System (INIS)

    Anon.

    1991-01-01

    Leaving aside the natural desire to avoid the difficulties imposed by the enormously complex siting and certification process, a utility might decide to forego adding new capacity because of a variety of legal and institutional disincentives. Some of these are discussed in this chapter. The addition of new lines to support a competitive generating market also raises unique institutional issues. Perhaps the most important of these is the question of who should pay for the necessary capital expenditures. This issue also is discussed in this section

  20. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2018-02-01

    Feb 1, 2018 ... the Russian philosophical and sociological thought. The thoughts of the Russian scientist ... Research Article. Special Issue. Journal of Fundamental and Applied Sciences is licensed under a Creative Commons Attribution-NonCommercial 4.0. International License. Libraries Resource Directory. We are ...

  1. Research Article Special Issue

    African Journals Online (AJOL)

    2016-05-15

    May 15, 2016 ... Research Article. Special Issue. Journal of Fundamental and Applied Sciences is licensed under a Creative Commons Attribution-NonCommercial 4.0. International License. ... innovation is defined as: accepting ideas or behaviors in the organization that are novel and unfamiliar. Innovation can be in form ...

  2. Fusion Canada issue 18

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1992-08-01

    A short bulletin from the National Fusion Program. Included in this issue is a report on the ITER agreement signed with the EDA, the robotic maintenance for NET, the CFFTP Fusion Pilot Study, the new IEA joint programs on environment, safety and economic aspects of fusion power, and a review by the CCFM advisory committee. 3 figs.

  3. PKI Scalability Issues

    OpenAIRE

    Slagell, Adam J; Bonilla, Rafael

    2004-01-01

    This report surveys different PKI technologies such as PKIX and SPKI and the issues of PKI that affect scalability. Much focus is spent on certificate revocation methodologies and status verification systems such as CRLs, Delta-CRLs, CRS, Certificate Revocation Trees, Windowed Certificate Revocation, OCSP, SCVP and DVCS.

  4. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2017-10-17

    Oct 17, 2017 ... Perak, Malaysia was observed under ral waste in powder and xtract generated optimum produce highest length of fectively improved shoot ed faster effect on C. ed positive result for the shed light on how the Z. C. nutans. This study ld application. pagation; Zea mays stem. Research Article. Special Issue ...

  5. Career Issues in Organizations.

    Science.gov (United States)

    1997

    This document contains four papers from a symposium on career issues in organizations. "Learning During Downsizing: Stories from the Survivors" (Sharon J. Confessore) describes a study to demonstrate that survivors of corporate downsizings undertake learning activities and use many resources to accomplish the learning tasks.…

  6. Fusion Canada issue 8

    International Nuclear Information System (INIS)

    1989-08-01

    A short bulletin from the National Fusion Program. Included in this issue are Canada-ITER contributions, NET Fuel Processing Loop, Bilateral Meeting for Canada-Europe, report from Tokamak de Varennes and a report from the University of Toronto on materials research for Fusion Reactors. 3 figs

  7. Fusion Canada issue 7

    International Nuclear Information System (INIS)

    1989-05-01

    A short bulletin from the National Fusion Program. Included in this issue are CFFTP highlights on the Karlsruhe Isotope Separation System, a report on ITER tritium process systems, an experimental update on Tokamak de Varennes and Canada-U.S. bilateral technical collaboration topics. 2 figs

  8. Fusion Canada issue 17

    International Nuclear Information System (INIS)

    1992-05-01

    A short bulletin from the National Fusion Program. Included in this issue is a report on increased funding for the Canadian Fusion Program, news of the compact Toroid fuelling gun, an update on Tokamak de Varennes, the Canada - U.S. fusion meeting, measurements of plasma flow velocity, and replaceable Tokamak divertors. 4 figs

  9. Fusion Canada issue 15

    International Nuclear Information System (INIS)

    1991-10-01

    A short bulletin from the National Fusion Program. Included in this issue is a report on the 1996 IAEA Fusion Conference site, operations at the Tokamak de Varennes including divertor pumping of impurities and pumping of carbon monoxide and methane, a discussion of the CFFTP and it's role. 1 fig

  10. Research Article Special Issue

    African Journals Online (AJOL)

    2018-01-15

    Jan 15, 2018 ... Journal of Fundamental and Applied Scienc. ISSN 1112-9867 ... (0.9623, 0.3857) and (0.9975, ity, temperature, CO, UVB and. 10 concentration. In by using ANN or Fit model. Research Article. Special Issue .... The EM algorithm is a simple computational implementation to find the posterior mode. Fig.

  11. Fusion Canada issue 18

    International Nuclear Information System (INIS)

    1992-08-01

    A short bulletin from the National Fusion Program. Included in this issue is a report on the ITER agreement signed with the EDA, the robotic maintenance for NET, the CFFTP Fusion Pilot Study, the new IEA joint programs on environment, safety and economic aspects of fusion power, and a review by the CCFM advisory committee. 3 figs

  12. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2018-03-07

    Mar 7, 2018 ... nology Management and Technopreneurship, Universiti Teknikal Mal .... development of SMEs which are recession, global sourcing, lack of ..... issues act as barriers to export which are product quality, logistics and shipping, ... may influenced on the supply chain of payment and the operation cost itself.

  13. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2017-10-05

    Oct 5, 2017 ... ources and Food Industry, Universiti Sultan ZainalAbidin, 22200 Besut, ... ty problem has become a major issue in Malaysia for the past two decade ... pollution can be defined as contamination of the indoor or outdoor ...

  14. Research Article Special Issue

    African Journals Online (AJOL)

    2016-05-15

    May 15, 2016 ... twice in Iran (Department of Housing and Urban Development,2008,4). Thus, in recent years, ..... For example study of 1200 schoolchildren from four education regions in Tehran Showed that after ... In this case It is expected that be ... In a communication network issue Hierarchy, access and. Sidewalks are ...

  15. Research Issues in VDSL

    Indian Academy of Sciences (India)

    First page Back Continue Last page Overview Graphics. Research Issues in VDSL. How to cancel cross-talk? How to remove alien noise? Alien Noise is the crosstalk typically from non-VDSL users, using the same bundle. How to allocate power across different tones, also called Optimal Spectrum Balancing ...

  16. Introduction: The Transparency Issue

    NARCIS (Netherlands)

    Teurlings, J.; Stauff, M.

    2014-01-01

    Besides giving an overview on the individual contributions, this introduction to the special issue on transparency delineates a conceptual context for a critical analysis of the contemporary discourse on transparency and the media mechanisms related to it. It focuses on three ambivalences inherent

  17. Automated conflict resolution issues

    Science.gov (United States)

    Wike, Jeffrey S.

    1991-01-01

    A discussion is presented of how conflicts for Space Network resources should be resolved in the ATDRSS era. The following topics are presented: a description of how resource conflicts are currently resolved; a description of issues associated with automated conflict resolution; present conflict resolution strategies; and topics for further discussion.

  18. Fusion Canada issue 21

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1993-08-01

    A short bulletin from the National Fusion Program highlighting in this issue Europe proposes Canada`s participation in ITER, tritium for JET, CCFM/TdeV-Tokamak helium pumping and TdeV update, ITER-related R and D at CFFTP, ITER Deputy Director visits Canada, NFP Director to Chair IFRC, Award for Akira Hirose. 3 figs.

  19. Fusion Canada issue 9

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1989-11-01

    A short bulletin from the National Fusion Program. Included in this issue is a report on availability of Canadian Tritium, an ITER update, a CCFM update on Tokamak and the new team organization, an international report on Fusion in Canada and a Laser Fusion Project at the University of Toronto. 3 figs.

  20. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2018-03-07

    Mar 7, 2018 ... in the development of more up-to-date urban space. ... The goal of this paper is to analyze the issues of the organization of urban environment in ... The model of transport less micro-district Nebo (ACADEMIA gallery), the ...

  1. Fusion Canada issue 22

    International Nuclear Information System (INIS)

    1993-10-01

    A short bulletin from the National Fusion Program highlighting in this issue a bi-lateral meeting between Canada and Japan, water and hydrogen detritiation, in-situ tokamak surface analysis, an update of CCFM/TdeV and tritium accounting Industry guidance in Fusion, fast probe for plasma-surface interaction. 4 figs

  2. Fusion Canada issue 15

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1991-10-01

    A short bulletin from the National Fusion Program. Included in this issue is a report on the 1996 IAEA Fusion Conference site, operations at the Tokamak de Varennes including divertor pumping of impurities and pumping of carbon monoxide and methane, a discussion of the CFFTP and it`s role. 1 fig.

  3. Accelerating News Issue 5

    CERN Document Server

    Szeberenyi, A

    2013-01-01

    In this spring issue, we look at developments towards higher luminosity and higher energy colliders. We report on the technology developed for the remote powering of the LHC magnets and studies of diagnostics based on higher order mode port signals. We also inform you about the main outcome of the TIARA survey on market needs for accelerator scientists.

  4. Fusion Canada issue 28

    International Nuclear Information System (INIS)

    1995-06-01

    A short bulletin from the National Fusion Program highlighting in this issue the Canada - US fusion meeting in Montreal, fusion breeder work in Chile, new management at CFFTP, fast electrons in tokamaks: new data from TdeV, a program review of CCFM and Velikhov to address Montreal fusion meeting. 1 fig

  5. Fusion Canada issue 16

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1992-01-01

    A short bulletin from the National Fusion Program. Included in this issue is a report on Ontario Hydro`s contract for tritium supply from Germany, a CCFM update on plasma biasing, divertor operation, radiofrequency plasma current drive and the plasma heating system for the Tokamak de Varennes, and an agreement for ITER engineering design activities. 5 figs.

  6. Fusion Canada issue 8

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1989-08-01

    A short bulletin from the National Fusion Program. Included in this issue are Canada-ITER contributions, NET Fuel Processing Loop, Bilateral Meeting for Canada-Europe, report from Tokamak de Varennes and a report from the University of Toronto on materials research for Fusion Reactors. 3 figs.

  7. Fusion Canada issue 17

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1992-05-01

    A short bulletin from the National Fusion Program. Included in this issue is a report on increased funding for the Canadian Fusion Program, news of the compact Toroid fuelling gun, an update on Tokamak de Varennes, the Canada - U.S. fusion meeting, measurements of plasma flow velocity, and replaceable Tokamak divertors. 4 figs.

  8. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2018-03-07

    Mar 7, 2018 ... technological innovations and the spread of knowledge. ... In this paper, we propose a conceptual model to search relevant scientific ... The digital libraries are becoming a source for discovering new research trends ... Text mining techniques are used to solve some particular business issues, so it is called.

  9. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2018-03-07

    Mar 7, 2018 ... ethical issues behind the retrieval of organs (commitment to ... The article reviews the practices of European countries and attitude of the EU citizens to the .... knowledge that the purchase and sale of donor organs is prohibited ...

  10. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2018-05-01

    May 1, 2018 ... stability is a very good issue of the power systems resilience to the high disturbances. In this paper, a mirror-fuzzy controller scaled by PSO has been proposed ... In many system analysis, the researchers have configured the ...

  11. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2017-11-24

    Nov 24, 2017 ... you …? and passive form of a verb. In the Tatar language the verb kuru with gerund is used. In English for strengthening the auxiliary verb do, a modal verb must, a modal construction to be to are used. 6. DISCUSSIONS. The issue touched in this research is object of steady and long interest from domestic ...

  12. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2017-10-05

    Oct 5, 2017 ... Journal of Fundamental and Applied Sciences. ISSN 1112-9867. Available online at http://www.jfas.info. Research Article. Special Issue .... of use. Three critical success factors of e-learning (instructor characteristics, student characteristics .... Total of 95 questionnaires were used for further data analysis.

  13. Research Article Special Issue

    African Journals Online (AJOL)

    2016-05-15

    May 15, 2016 ... Journal of Fundamental and Applied Sciences is licensed under a Creative ... 1. Faculty of Engineering, Civil Engineering Department, Urmia Branch, ..... Table 4. Sections of the main components of 16 stories building ..... International Journal of Engineering Science and Innovative ... Issue 1, January 2013.

  14. Fusion Canada issue 25

    International Nuclear Information System (INIS)

    1994-08-01

    A short bulletin from the National Fusion Program highlighting in this issue an economic impact study of the Canadian site for ITER, Harvey Skarsgard: fusion pioneer retires, NFP: Phillips and Holtslander exchange roles, Europe's fusion funding proposals and an update of CCFM/TdeV. 1 fig

  15. Overview of Special Issue

    NARCIS (Netherlands)

    Hiemstra, Djoerd; Harman, Donna; Allan, James; Kelly, Diane; Belkin, Nicholas J.; Bennet, Paul; Callan, Jamie; Clarke, Charles; Diaz, Fernando; Dumais, Susan; Ferro, Nicola; Harman, Donna; Ruthven, Ian; Sakai, Tetsuya; Smucker, Mark D.; Zobel, Justin

    2017-01-01

    This special issue of SIGIR Forum marks the 40th anniversary of the ACM SIGIR Conference by showcasing papers selected for the ACM SIGIR Test of Time Award from the years 1978-2001. These papers document the history and evolution of IR research and practice, and illustrate the intellectual impact

  16. Special Issue Editorial

    African Journals Online (AJOL)

    While this special issue focuses on work in the South African context, ... practice) with youth addresses the key imperatives of (un)employment, age, ... patterns of male control over sexual encounters and women's sexuality are emergent ... in the paper by Ngabaza, Bojarczuk, Masuku and Roelfse, titled, 'Empowering young.

  17. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2018-03-07

    Mar 7, 2018 ... Labor deployment issues play an important role in analyzing their use at the country or regional level .... The growth of employment in the service sector since the 50s, as a result of the rapid ... Hotels and restaurants. 23,0 ..... for the better, its number decreases and the quality of labor resources deteriorates.

  18. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2017-11-24

    Nov 24, 2017 ... FEDERAL UNIVERSITY (FROM EMOTIONAL EDUCATION TO GLOBAL. THINKING ... ANNOTATION. The article highlights the topical issues of human education of the future humanistic- ... conditions (continuous self-education, updating and integration of educational resources on the basis of the ...

  19. Fusion Canada issue 21

    International Nuclear Information System (INIS)

    1993-08-01

    A short bulletin from the National Fusion Program highlighting in this issue Europe proposes Canada's participation in ITER, tritium for JET, CCFM/TdeV-Tokamak helium pumping and TdeV update, ITER-related R and D at CFFTP, ITER Deputy Director visits Canada, NFP Director to Chair IFRC, Award for Akira Hirose. 3 figs

  20. Fusion Canada issue 7

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1989-05-01

    A short bulletin from the National Fusion Program. Included in this issue are CFFTP highlights on the Karlsruhe Isotope Separation System, a report on ITER tritium process systems, an experimental update on Tokamak de Varennes and Canada-U.S. bilateral technical collaboration topics. 2 figs.

  1. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2017-10-05

    Oct 5, 2017 ... culture of Mamak frequenting restaurants in Malaysia, several issue has risen in relation to the .... employment of one group quasi experimental design was noted to be lacked in internal ... Food safety and quality division: ... self-reported practices of food service staff regarding food hygiene in Edirne, Turkey ...

  2. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2017-08-08

    Aug 8, 2017 ... presented in the form of a matrix in which processing of vectors is conducted by a conveyor way. ... The modularity of structure of the product systemand standardization of basic operations allow to create ... Thus, the actual issue of modern CT is the organization and hardware support of parallel production.

  3. Fusion Canada issue 26

    International Nuclear Information System (INIS)

    1994-11-01

    A short bulletin from the National Fusion Program highlighting in this issue tritium supply for Japanese research, Canada to host the 1995 IAEA Conference on Tritium, studies on the tokamak divertor and edge plasma studies, a tritium field release study, erosion studies on plasma facing materials, G. Pacher returns to CCFM and an update on CCFM/TdeV

  4. Fusion Canada issue 4

    International Nuclear Information System (INIS)

    1988-05-01

    A short bulletin from the National Fusion Program. Included in this issue is a technical update on Tokamak de Varennes, a report on the Beatrix II Breeding Materials Test Program, the Tritium glovebox system for UPM, Saudi Arabia, a broad update of the Canadian Fusion Fuels Technology Project is also included. 1 fig

  5. Issues of HRD. Symposium.

    Science.gov (United States)

    2002

    This document contains three papers from a symposium on issues of human resource development (HRD). "The Complex Roots of Human Resource Development" (Monica Lee) discusses the roots of HRD within the framework of the following views of management: (1) classic (the view that managers must be able to create appropriate rules and…

  6. Career Issues in HRD.

    Science.gov (United States)

    1999

    This document contains four symposium papers on career issues in human resource development (HRD). "Are Careers What They Used To Be: A Factor Analysis of Schein's Career Orientations Inventory" (Gerri Mukri, Sharon Confessore) is a statistical analysis of Schein's Career Orientations Inventory that finds the inventory to be a…

  7. Ethical issues in neurogenetics.

    Science.gov (United States)

    Uhlmann, Wendy R; Roberts, J Scott

    2018-01-01

    Many neurogenetic conditions are inherited and therefore diagnosis of a patient will have implications for the patient's relatives and can raise ethical issues. Predictive genetic testing offers asymptomatic relatives the opportunity to determine their risk status for a neurogenetic condition, and professional guidelines emphasize patients' autonomy and informed, voluntary decision making. Beneficence and nonmaleficence both need to be considered when making decisions about disclosure and nondisclosure of genetic information and test results. There can be disclosure concerns and challenges in determining whose autonomy to prioritize when a patient makes a genetic testing decision that can reveal the genetic status of a relative (e.g., testing an adult child when the at-risk parent has not been tested). Ethical issues are prominent when genetic testing for neurogenetic conditions is requested prenatally, on minors, adoptees, adult children at 25% risk, and for individuals with psychiatric issues or cognitive impairment. Neurogenetic conditions can result in cognitive decline which can affect decisional capacity and lead to ethical challenges with decision making, informed consent, and determining the patient's ability to comprehend test results. The ethical implications of genetic testing and emerging issues, including direct-to-consumer genetic testing, disclosure of secondary findings from genomic sequencing, and use of apolipoprotein E testing in clinical and research settings, are also discussed. Resources for information about genetic testing practice guidelines, insurance laws, and directories of genetics clinics are included. Copyright © 2018 Elsevier B.V. All rights reserved.

  8. Fusion Canada issue 12

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1990-10-01

    A short bulletin from the National Fusion Program. Included in this issue is a report on Darlington`s Tritium Removal Facility, work at universities on Deuterium Diffusivity in Beryllium, Fusion Studies, confinement research and the operation of divertors at Tokamak de Varennes. 5 figs.

  9. Research Article Special Issue

    African Journals Online (AJOL)

    pc

    2018-05-01

    May 1, 2018 ... The issues of information placement are considered on the website of the educational ... At present, a considerable attention is paid to the automation of educational ... schedule from any device quickly, since the system is the WEB service, which allows ... the system adaptation for its use on mobile devices.

  10. International Issues in Education

    Science.gov (United States)

    Ruggeri, Kai; Diaz, Carmen; Kelley, Karl; Papousek, Ilona; Dempster, Martin; Hanna, Donncha

    2008-01-01

    Anxiety, negative attitudes, and attrition are all issues presented in the teaching of statistics to undergraduates in research-based degrees regardless of location. Previous works have looked at these obstacles, but none have consolidated a multilingual, multinational effort using a consistent method. Over 400 Spanish-, English-, and…

  11. Ethical issues for librarians

    Directory of Open Access Journals (Sweden)

    Francisca Rasche

    2005-04-01

    Full Text Available It approaches the librarian ethics comprehending the Librarianship constitution from a systemic view. In this way, with the objective to raise issues to discuss professional ethics, it places the librarian in the work world and points approaches between exertion and relation context of the professionals themselves with the human rights and alteration ethics.

  12. Fusion Canada issue 22

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1993-10-01

    A short bulletin from the National Fusion Program highlighting in this issue a bi-lateral meeting between Canada and Japan, water and hydrogen detritiation, in-situ tokamak surface analysis, an update of CCFM/TdeV and tritium accounting Industry guidance in Fusion, fast probe for plasma-surface interaction. 4 figs.

  13. Fusion Canada issue 4

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1988-05-01

    A short bulletin from the National Fusion Program. Included in this issue is a technical update on Tokamak de Varennes, a report on the Beatrix II Breeding Materials Test Program, the Tritium glovebox system for UPM, Saudi Arabia, a broad update of the Canadian Fusion Fuels Technology Project is also included. 1 fig.

  14. Research Article Special Issue

    African Journals Online (AJOL)

    2016-05-15

    May 15, 2016 ... ABSTRACT. In megacities, exposure to high concentrations of air pollution, as a major concern on public health, is being felt worldwide problem. The issue of particulate matter especially the PM2.5 has become extremely crucial in Tehran, due to industrialization and population growth. Therefore, it.

  15. Fusion Canada issue 19

    International Nuclear Information System (INIS)

    1992-12-01

    A short bulletin from the National Fusion Program. Included in this issue is a report on the IAEA Plasma Biasing Meeting, the new IEA program -Nuclear Technology of Fusion reactors, TFTR tritium purification system, an update by CCFM on machine additions and modifications, and news of a new compact Toroid injector at the University of Saskatchewan. 1 fig

  16. Fusion Canada issue 9

    International Nuclear Information System (INIS)

    1989-11-01

    A short bulletin from the National Fusion Program. Included in this issue is a report on availability of Canadian Tritium, an ITER update, a CCFM update on Tokamak and the new team organization, an international report on Fusion in Canada and a Laser Fusion Project at the University of Toronto. 3 figs

  17. Fusion Canada issue 14

    International Nuclear Information System (INIS)

    1991-05-01

    A short bulletin from the National Fusion Program. Included in this issue is a report on a fusion cooperation agreement between Japan and Canada, an update at Tokamak de Varennes on plasma biasing experiments and boronization tests and a collaboration between Canada and the U.S. on a compact toroid fuelling gun. 4 figs

  18. Fusion Canada issue 12

    International Nuclear Information System (INIS)

    1990-10-01

    A short bulletin from the National Fusion Program. Included in this issue is a report on Darlington's Tritium Removal Facility, work at universities on Deuterium Diffusivity in Beryllium, Fusion Studies, confinement research and the operation of divertors at Tokamak de Varennes. 5 figs

  19. Fusion Canada issue 16

    International Nuclear Information System (INIS)

    1992-01-01

    A short bulletin from the National Fusion Program. Included in this issue is a report on Ontario Hydro's contract for tritium supply from Germany, a CCFM update on plasma biasing, divertor operation, radiofrequency plasma current drive and the plasma heating system for the Tokamak de Varennes, and an agreement for ITER engineering design activities. 5 figs

  20. Fusion Canada issue 24

    International Nuclear Information System (INIS)

    1994-04-01

    A short bulletin from the National Fusion Program highlighting in this issue the opening of the Garching ITER site, a CCFM/TdeV update,a tritium release field test, measuring radial profile of plasma current density on TdeV, power supplies for TdeV, 5th International Tritium Technology conference, and 1994 basic tritium course. 4 figs

  1. Research Article Special Issue

    African Journals Online (AJOL)

    2016-06-05

    Jun 5, 2016 ... because Amir al- Mu'minin's(peace be upon him) name is related to human perfection and. Journal of Fundamental and Applied Sciences. ISSN 1112-9867. Available online at http://www.jfas.info. Research Article. Special Issue. Journal of Fundamental and Applied Sciences is licensed under a Creative ...

  2. Research Article Special Issue

    African Journals Online (AJOL)

    2017-10-05

    Oct 5, 2017 ... We are listed under Research Associations. D THAT USES A ... Clinical Engineering, Toin University of Yokohama, Yokohama, Aoba ... Special Issue ..... advisable to run the prognosis results at least one hundred times with the Euclidean and ... They are some of the topics left for future research. 5.

  3. Exposure to anti-malarial drugs and monitoring of adverse drug reactions using toll-free mobile phone calls in private retail sector in Sagamu, Nigeria: implications for pharmacovigilance

    Directory of Open Access Journals (Sweden)

    Ogunwande Isiaka A

    2011-08-01

    Full Text Available Abstract Background Adverse drug reactions (ADRs contribute to ill-health or life-threatening outcomes of therapy during management of infectious diseases. The exposure to anti-malarial and use of mobile phone technology to report ADRs following drug exposures were investigated in Sagamu - a peri-urban community in Southwest Nigeria. Methods Purchase of medicines was actively monitored for 28 days in three Community Pharmacies (CP and four Patent and Proprietary Medicine Stores (PPMS in the community. Information on experience of ADRs was obtained by telephone from 100 volunteers who purchased anti-malarials during the 28-day period. Results and Discussion A total of 12,093 purchases were recorded during the period. Antibiotics, analgesics, vitamins and anti-malarials were the most frequently purchased medicines. A total of 1,500 complete courses of anti-malarials were purchased (12.4% of total purchases; of this number, purchases of sulphadoxine-pyrimethamine (SP and chloroquine (CQ were highest (39.3 and 25.2% respectiuvely. Other anti-malarials purchased were artesunate monotherapy (AS - 16.1%, artemether-lumefantrine (AL 10.0%, amodiaquine (AQ - 6.6%, quinine (QNN - 1.9%, halofantrine (HF - 0.2% and proguanil (PR - 0.2%. CQ was the cheapest (USD 0.3 and halofantrine the most expensive (USD 7.7. AL was 15.6 times ($4.68 more expensive than CQ. The response to mobile phone monitoring of ADRs was 57% in the first 24 hours (day 1 after purchase and decreased to 33% by day 4. Participants in this monitoring exercise were mostly with low level of education (54%. Conclusion The findings from this study indicate that ineffective anti-malaria medicines including monotherapies remain widely available and are frequently purchased in the study area. Cost may be a factor in the continued use of ineffective monotherapies. Availability of a toll-free telephone line may facilitate pharmacovigilance and follow up of response to medicines in a resource

  4. PREFACE: CEWQO Topical Issue CEWQO Topical Issue

    Science.gov (United States)

    Bozic, Mirjana; Man'ko, Margarita

    2009-09-01

    This topical issue of Physica Scripta collects selected peer-reviewed contributions based on invited and contributed talks and posters presented at the 15th Central European Workshop on Quantum Optics (CEWQO) which took place in Belgrade 29 May-3 June 2008 (http://cewqo08.phy.bg.ac.yu). On behalf of the whole community took place in Belgrade 29 May-3 June 2008 (http://cewqo08.phy.bg.ac.yu, cewqo08.phy.bg.ac.yu). On behalf of the whole community of the workshop, we thank the referees for their careful reading and useful suggestions which helped to improve all of the submitted papers. A brief description of CEWQO The Central European Workshop on Quantum Optics is a series of conferences started informally in Budapest in 1992. Sometimes small events transform into important conferences, as in the case of CEWQO. Professor Jozsef Janszky, from the Research Institute of Solid State Physics and Optics, is the founder of this series. Margarita Man'ko obtained the following information from Jozsef Janszky during her visit to Budapest, within the framework of cooperation between the Russian and Hungarian Academies of Sciences in 2005. He organized a small workshop on quantum optics in Budapest in 1992 with John Klauder as a main speaker. Then, bearing in mind that a year before Janszky himself was invited by Vladimir Buzek to give a seminar on the same topic in Bratislava, he decided to assign the name 'Central European Workshop on Quantum Optics', considering the seminar in Bratislava to be the first workshop and the one in Budapest the second. The third formal workshop took place in Bratislava in 1993 organized by Vladimir Buzek, then in 1994 (Budapest, by Jozsef Janszky), 1995 and 1996 (Budmerice, Slovakia, by Vladimir Buzek), 1997 (Prague, by Igor Jex), 1999 (Olomouc, Czech Republic, by Zdenek Hradil), 2000 (Balatonfüred, Hungary, by Jozsef Janszky ), 2001 (Prague, by Igor Jex), 2002 (Szeged, Hungary, by Mihaly Benedict), 2003 (Rostock,Germany, by Werner Vogel and

  5. Canada's domestic nuclear issues

    International Nuclear Information System (INIS)

    Anon.

    1986-01-01

    The Interfaith Program for Public Awareness of Nuclear Issues (IPPANI) is a committee of representatives of religious groups in Toronto, a group of people concerned about the moral and ethical implications of the operation of Canada's nuclear industry and of its exports to other countries. The faith groups represented are the Anglican Diocese of Toronto, the Baha'i Community of Canada, the Jewish Community of Toronto, the Roman Catholic Archdiocese of Toronto and the United Church of Canada Toronto Conference. Wishing to encourage the Canadian government to enquire into this broad question, the faith groups established IPPANI and assigned to it the task of enhancing their knowledge of the nuclear industry. IPPANI was to develop an effective set of questions to be placed before governments and to promote public discussion so that governments might become more responsive to these issues

  6. Transmission issues in Alberta

    International Nuclear Information System (INIS)

    Levson, D.

    2002-01-01

    This paper outlined the major issues and concerns facing users of the transmission system in Alberta. They include congestion management issues that make investors uncertain about power generation. It is necessary to know the difference between which transmission price signals will be faced by low cost cogeneration at Fort McMurray and Cold Lake coal-fired generation near Edmonton compared to combined cycle gas generation near Calgary. Import and export policy tariffs are another concern. Most new generation opportunities in Alberta require access to export markets, but transmission facilities for export need policy support and appropriate tariffs. It was noted that the past actions of Alberta's Transmission Administrator and balancing pool may be distorting market signals for ancillary service markets, and that loss studies and calculations need upgrading

  7. Drilling contract issues

    International Nuclear Information System (INIS)

    Davison, G.B.; Worden, D.R.; Borbridge, G.K.D.

    1997-01-01

    Some selected issues which are facing both operators and contractors in drilling for oil and gas, such as the allocation of risk by contract and by statute and the implementation of new technologies, were discussed. There are three varieties of written drilling contracts used in Canada: (1) day work and meterage contracts, (2) master drilling agreements, and (3) contracts that are used in construction projects that do not specifically relate to drilling. Issues relevant to the contractual allocation of risk, to implementing new drilling technologies, to reconciling contract and statute liability, and the formation of strategic alliances for mutual benefit, and the factors contributing to the success of such alliances were explored. 12 refs

  8. Teaching nuclear issues

    International Nuclear Information System (INIS)

    Hicks, D.W.

    1986-01-01

    This paper is based on the assumption that the nuclear debate, both globally and within Britain, is one of critical importance in the late twentieth century and that it should therefore, at some juncture, be explored as part of the school curriculum. An essential part of 'good education' in a democratic society is to teach young people how to think about such an issue, but not what to think about it. This paper attempts to set out some of the key issues and dilemmas in relation to what we may call 'nuclear education'. It perhaps asks more questions than it gives answers, but they are all essential questions which teachers must ask themselves if they are to teach sensitively about these matters. Some of these questions are given as examples. (author)

  9. CULTURAL ISSUES IN ECONOMICS

    OpenAIRE

    Maciej Meyer

    2012-01-01

    This article has been written with the purpose of attracting attention to the cultural issues, or rather lack of them, in economics. This topic has not been taken frequently into theoretical considerations due to some difficulties, although its practical implications are of great importance. The meaning of institutions which are a part of cultures has been given more coverage in the literature. The following hypothesis is proposed: culture is an important but underestimated component of the e...

  10. Uruguay; 2011 Selected Issues

    OpenAIRE

    International Monetary Fund

    2011-01-01

    This 2011 Article IV Consultation—Selected Issues paper focuses on estimating potential output and the output gap and spillovers from agriculture in the case of Uruguay. It introduces additional economic information and theory to estimate potential output, shedding some light on the discussion of current monetary and fiscal policies. The objective is to take advantage of economic data to disentangle the most recent economic performance by introducing multivariate techniques. The paper also pr...

  11. Product Category Management Issues

    OpenAIRE

    Żukowska, Joanna

    2011-01-01

    The purpose of the paper is to present the issues related to category management. It includes the overview of category management definitions and the correct process of exercising it. Moreover, attention is paid to the advantages of brand management, the benefits the supplier and retailer may obtain in this way. The risk element related to this topics is also presented herein. Joanna Żukowska

  12. Malaysia; Selected Issues

    OpenAIRE

    International Monetary Fund

    1998-01-01

    This Selected Issues paper on Malaysia highlights quantitative assessment of additional measures required during the medium term to achieve fiscal targets. The authorities aim to lower the budget deficit to about 3 percent of GDP by 2015, down from 4.0 percent in 2013, and to balance the budget by 2020. It suggests that ranking fiscal instruments under different fiscal policy goals can help policymakers identify the composition of fiscal adjustment based on their preferences. By combining ran...

  13. Medico legal issues.

    Science.gov (United States)

    Mackenzie, Geraldine; Carter, Hugh

    2010-01-01

    This chapter gives an educational overview of: * An awareness of the legal issues involved in health informatics * The need for the privacy and security of the patient record * The legal consequences of a breach of the security of the patient record * The concept of privacy law and what precautions ought to be taken to minimize legal liability for a breach of privacy and/or confidentiality.

  14. Nanotechnology and accounting issues

    OpenAIRE

    Abedalqader Rababah

    2017-01-01

    Nanotechnology is a new advanced technology used in the industry. This study conducted an investigation on the literature and highlighted the accounting issues which related to the implement of nanotechnology, especially the change of cost structure and expected solutions for the increasing of indirect costs which need more accurate allocation to the unit of products. Also, this study investigated on the future expected accounting risks for using nanotechnology. Finally, this study will open ...

  15. Introduction to pricing issues

    International Nuclear Information System (INIS)

    Anon.

    1991-01-01

    This chapter provides an overview of pricing issues the proper pricing of transmission services is essential to efficient operation of the grid. Wheeling rights have little meaning if capacity on existing lines is scarce and there is no incentive to build new lines. Depending on the type of transmission pricing policies FERC adopts, the Commission may be able to encourage more voluntary wheeling service, and to influence decisions to build or upgrade the supply of facilities

  16. Wireless ATM : handover issues

    OpenAIRE

    Jiang, Fan; Käkölä, Timo

    1998-01-01

    Basic aspects of cellular systems and the ATM transmission technology are introduced. Wireless ATM is presented as a combination of radio ATM and mobile ATM. Radio ATM is a wireless extension of an ATM connection while mobile ATM contains the necessary extensions to ATM to support mobility. Because the current ATM technology does not support mobility, handover becomes one of the most important research issues for wireless ATM. Wireless ATM handover requirements are thus analysed. A handover s...

  17. Gender issues in translation

    OpenAIRE

    ERGASHEVA G.I.

    2015-01-01

    The following research is done regarding gender in translation dealing specifically with the issue of the translators’ gender identity and its effect on their translations, as well as on how gender itself is translated and produced. We will try to clarify what gender is, how gender manifests itself in the system of language, and what problems translators encounter when translating or producing gender-related materials

  18. Accelerating News Issue 3

    CERN Document Server

    Kahle, K; Tanguy, C; Wildner, E

    2012-01-01

    This summer saw CERN announce to a worldwide audience the discovery of a Higgs-like boson, so this issue takes a look at the machine behind the discovery, the LHC, as well as future plans for a possible Higgs factory in the form of LEP3. Looking ahead too are European strategies for particle physics and accelerator-based neutrino physics. In addition, taking stock of the work so far, HiLumi LHC and EuCARD showcase their latest results.

  19. JPRS Report, Environmental Issues.

    Science.gov (United States)

    1990-12-06

    Fusion Technology Applied in Pollution Control [XINHUA 15 NovJ 27 Pollution-Free Chemical Fertilizer Enterprise Built [XINHUA 19 NovJ 27 EAST...INTER-AMERICAN AFFAIRS Nicaraguans Discover Illegal Lumbering by Costa Rican Companies [Managua LA PRENSA 31 Oct] 44 ARGENTINA Rally Protests...Nov] 74 New Rules for Operating Nuclear Plants Issued [Moscow Radio 14 Nov] 74 Expansion, Saftey of Bilibino Nuclear Power Station Discussed

  20. New Zealand; Selected Issues

    OpenAIRE

    International Monetary Fund

    2009-01-01

    This Selected Issues paper conducts a comparative analysis of the main determinants of GDP per capita growth in New Zealand and in other OECD countries to assess the relative importance of macroeconomic factors, institutional settings, and geographical location in New Zealand’s growth performance during the last 30 years. The estimation results find strong support for the view that geographical isolation has significantly hampered growth in New Zealand. The paper also reviews the internationa...

  1. Norway; Selected Issues

    OpenAIRE

    International Monetary Fund

    2005-01-01

    This Selected Issues paper analyzes inflation in Norway with a view to shedding light on this surprising development and the possible near-term course of inflation, using statistical and econometric analyses. The paper reviews recent developments of monetary policy and inflation in Norway, applies statistical and econometric tools to identify factors influencing inflation, and describes the implications of the analysis for policymaking. Using data for six advanced small open economies explici...

  2. Fusion Canada issue 13

    International Nuclear Information System (INIS)

    1991-01-01

    A short bulletin from the National Fusion Program. Included in this issue is a report on Canada's plans to participate in the Engineering Design Activities (EDA), bilateral meetings with Canada and the U.S., committee meeting with Canada-Europe, an update at Tokamak de Varennes on Plasma Biasing experiments and boronized graphite tests, fusion materials research at the University of Toronto using a dual beam accelerator and a review of the CFFTP and the CCFM. 2 figs

  3. Issues in waste combustion

    Energy Technology Data Exchange (ETDEWEB)

    Gustavsson, Lennart; Robertson, Kerstin; Tullin, Claes [Swedish National Testing and Research Inst., Boraas (Sweden); Sundquist, Lena; Wrangensten, Lars [AaF-Energikonsult AB, Stockholm (Sweden); Blom, Elisabet [AaF-Processdesign AB, Stockholm (Sweden)

    2003-05-01

    The main purpose of this review is to provide an overview of the state-of-the-art on research and development issues related to waste combustion with relevance for Swedish conditions. The review focuses on co-combustion in grate and fluidised bed furnaces. It is primarily literature searches in relevant databases of scientific publications with to material published after 1995. As a complement, findings published in different report series, have also been included. Since the area covered by this report is very wide, we do not claim to cover the issues included completely and it has not been possitile to evaluate the referred studies in depth. Basic knowledge about combustion issues is not included since such information can be found elsewhere in the literature. Rather, this review should be viewed as an overview of research and development in the waste-to-energy area and as such we hope that it will inspire scientists and others to further work in relevant areas.

  4. Condições de implantação e operação da farmacovigilância na indústria farmacêutica no Estado de São Paulo, Brasil Pharmacovigilance implementation and operational conditions in the pharmaceutical industry in São Paulo State, Brazil

    Directory of Open Access Journals (Sweden)

    Márcia Sayuri Takamatsu Freitas

    2007-01-01

    Full Text Available O desenvolvimento de novos produtos farmacêuticos e as limitações dos ensaios clínicos controlados têm sido responsáveis pelo aumento das possibilidades de eventos adversos a medicamentos. A farmacovigilância é essencial para detectar e avaliar eventos adversos a medicamentos reduzindo riscos e evitando gastos excessivos em saúde pública. Este trabalho objetivou conhecer programas de farmacovigilância de indústrias farmacêuticas sediadas no Estado de São Paulo, Brasil. Os dados foram coletados utilizando-se questionário enviado eletronicamente a 105 empresas, das quais 41,9% retornaram. O motivo principal para implantação de programas foi atender exigências regulatórias e a principal justificativa para sua ausência foi produção limitada aos produtos fitoterápicos, ofici-nais e suplementos. Discutem-se as dificuldades para implantação dos programas, os recursos utilizados e características de alguns deles. Conclusões: (a a normatização é fonte de motivação para o aumento dos programas e do número de relatos mas é insuficiente sem esclarecimentos mais específicos; (b os resultados dependem de envolvimento multisetorial; (c o Serviço de Atendimento ao Consumidor é importante fonte de relatos; (d a estrutura da operação do serviço pode ser pouco dispendiosa em termos de recursos humanos e materiais.The development of new drugs and limitations of clinical trials have increased the likelihood of adverse drug events. Pharmacovigilance is essential to detect and evaluate adverse drug events, thereby reducing risks and avoiding excessive public health costs. This study focused on the pharmacovigilance programs in the pharmaceutical industry in São Paulo State, Brazil. Data were collected through questionnaires sent electronically to 105 companies, 41.9% of which responded. The main reason for implementing pharmacovigilance programs was to comply with legal requirements, while the main justification for its absence

  5. Editorial, Volume 5, Issue 1

    Directory of Open Access Journals (Sweden)

    Kristy L. Archuleta

    2014-08-01

    Full Text Available Welcome to Volume 5, Issue 1 of the Journal of Financial Therapy! In this issue, four scholarly papers are presented along with two profiles and a book review. These four papers address very important issues, such as mental health therapists’ competency in working with financial issues, financial stress of college students, parental messages about money, and financial advice media.

  6. In This Issue

    Science.gov (United States)

    1996-08-01

    Coda This issue of the Journal, the last to be produced by the editorial staff in Austin, is remarkable only in the sense that each issue of this Journal is remarkable. In it teachers of chemistry share information, advice, and ideas that encompass a range as wide as chemistry itself. The Journal has always been a venue where the only important thread of commonalty was the goal of helping teachers--providing a "living textbook of chemistry", as it was dubbed by its founders. This textbook is different, however--it is written by its own readers and it has a new "edition" each month. This month's edition typifies the range of topics and issues found important by our readers (and authors): information about new ideas and research advances, new ways to look at and present the information we have, experiments and demonstrations to give students a first-hand exposure to chemistry, computer exercises to introduce those things that cannot be (or are too dangerous to be) presented first-hand, and ideas for better teaching techniques and classroom organization. With such a purview, it is no wonder that the articles in this issue range from the second law of thermodynamics (Frohlich, page 716) to building a Tesla coil from a car coil (Hall and Battino, page 817) and touch on such consequential topics as mimicking nature (Dennison and Harrowven, page 697) and the search for a silicon-based LED (Swisher, Richmond, and Sercel, page 738). New information about research is represented by part III of the series on electrospray ionization mass spectrometry (Hop and Bakhtiar, page A162). Senozan and Devore (page 767) look at data already long known about carbon monoxide poisoning and present a more subtle and complex explanation of the process than is usually seen in introductory texts. A really new way of looking at what we already know is the unique approach that Ginebreda (page 708) takes to waste recovery, applying the formalisms of thermodynamics to economic considerations

  7. The World energy issue

    International Nuclear Information System (INIS)

    Nifenecker, Herve

    2011-01-01

    This Power Point document proposes figures and data about the current world energy consumption, the various energy sources, the share of primary energy consumption by different sectors, and the levels of energy reserves. It addresses the issue of global warming (evolution of temperature, regional anomalies, the challenge of limitation of temperature, the greenhouse gas emissions), the strategic role of electricity (energy mix, heat production with electricity), energy savings, electricity production (key data on solar, wind, solar and biomass energy, possibilities of carbon capture, nuclear energy, costs of these different energies)

  8. Reliability issues in PACS

    Science.gov (United States)

    Taira, Ricky K.; Chan, Kelby K.; Stewart, Brent K.; Weinberg, Wolfram S.

    1991-07-01

    Reliability is an increasing concern when moving PACS from the experimental laboratory to the clinical environment. Any system downtime may seriously affect patient care. The authors report on the several classes of errors encountered during the pre-clinical release of the PACS during the past several months and present the solutions implemented to handle them. The reliability issues discussed include: (1) environmental precautions, (2) database backups, (3) monitor routines of critical resources and processes, (4) hardware redundancy (networks, archives), and (5) development of a PACS quality control program.

  9. Saudi Arabia; Selected Issues

    OpenAIRE

    International Monetary Fund

    2012-01-01

    This Selected Issues paper on Saudi Arabia assesses Saudi Arabia’s role in the oil market and global economy. Saudi Arabia, the world’s largest producer and exporter of oil, has long played a systemically important role in the global oil market. Short-term fluctuations in Saudi Arabia’s oil production have partially reflected attempts to stabilize the global oil market. Saudi Arabia has on several occasions used its systemic role to raise production to fill global demand gaps created by large...

  10. Vacuum systems - thermal issues

    International Nuclear Information System (INIS)

    Howell, J.W.

    1992-01-01

    The new high-energy synchrotron light sources currently under construction and the B-factories that are still in the planning stage present new challenges in the management of synchrotron radiation thermal loading. With particle energies from 6 to 9 GeV and currents from 0.3 to 2.5 mA, the total power and the power density of the resulting synchrotron radiation each present unique problems. The design issues involved in managing these new power levels are presented, as well as a survey of some of the proposed design solutions

  11. The money issue.

    Science.gov (United States)

    Carpenter, Dave; Haugh, Richard

    2003-06-01

    Volume is rising at a healthy pact. Technology is improving patient care. Many organizations have, out of necessity, strengthened business fundamentals, controlled costs and refined their focus. Yet not-for-profit hospitals are squeezed by a cash crunch that has balance sheets under pressure and credit downgrades outpacing upgrades--the result of shrinking investment income, rising pension obligations, low government reimbursement and other threats to operational stability. N&HN looks at the challenges, including recent fallout from the most pressing issues, how some systems have responded, and the pros and cons of borrowing now.

  12. Authoring Issues beyond Tools

    Science.gov (United States)

    Spierling, Ulrike; Szilas, Nicolas

    Authoring is still considered a bottleneck in successful Interactive Storytelling and Drama. The claim for intuitive authoring tools is high, especially for tools that allow storytellers and artists to define dynamic content that can be run with an AI-based story engine. We explored two concrete authoring processes in depth, using various Interactive Storytelling prototypes, and have provided feedback from the practical steps. The result is a presentation of general issues in authoring Interactive Storytelling, rather than of particular problems with a specific system that could be overcome by 'simply' designing the right interface. Priorities for future developments are also outlined.

  13. Turbine Replacement Issue

    Science.gov (United States)

    This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  14. Maintenance simulation: Software issues

    Energy Technology Data Exchange (ETDEWEB)

    Luk, C.H.; Jette, M.A.

    1995-07-01

    The maintenance of a distributed software system in a production environment involves: (1) maintaining software integrity, (2) maintaining and database integrity, (3) adding new features, and (4) adding new systems. These issues will be discussed in general: what they are and how they are handled. This paper will present our experience with a distributed resource management system that accounts for resources consumed, in real-time, on a network of heterogenous computers. The simulated environments to maintain this system will be presented relate to the four maintenance areas.

  15. Environmental issues in China

    Energy Technology Data Exchange (ETDEWEB)

    Travis, P.S.

    1991-10-01

    Global concern about the environment is increasing, and the People's Republic of China (PRC) is not immune from such concerns. The Chinese face issues similar to those of many other developing nations. The US Department of Energy is particularly interested in national and world pollution issues, especially those that may infringe on other countries' economic growth and development. The DOE is also interested in any opportunities that might exist for US technical assistance and equipment in combating environmental problems. Our studies of articles in the China Daily, and English-language daily newspaper published by the Chinese government, show that population, pollution, and energy are major concerns of the Chinese Communist Party. Thus this report emphasizes the official Chinese government view. Supporting data were also obtained from other sources. Regardless of the severity of their various environmental problems, the Chinese will only try to remedy those problems with the greatest negative effects on its developing economy. They will be looking for foreign assistance, financial and informational, to help implement solutions. With the Chinese government seeking assistance, the United States has an opportunity to export basic technical information, especially in the areas of pollution control and monitoring, oil exploration methods, oil drilling technology, water and sewage treatment procedures, hazardous waste and nuclear waste handling techniques, and nuclear power plant safety procedures. In those areas the US has expertise and extensive technical experience, and by exporting the technologies the US would benefit both economically and politically. 59 refs., 3 figs.

  16. CLOUD COMPUTING SECURITY ISSUES

    Directory of Open Access Journals (Sweden)

    Florin OGIGAU-NEAMTIU

    2012-01-01

    Full Text Available The term “cloud computing” has been in the spotlights of IT specialists the last years because of its potential to transform this industry. The promised benefits have determined companies to invest great sums of money in researching and developing this domain and great steps have been made towards implementing this technology. Managers have traditionally viewed IT as difficult and expensive and the promise of cloud computing leads many to think that IT will now be easy and cheap. The reality is that cloud computing has simplified some technical aspects of building computer systems, but the myriad challenges facing IT environment still remain. Organizations which consider adopting cloud based services must also understand the many major problems of information policy, including issues of privacy, security, reliability, access, and regulation. The goal of this article is to identify the main security issues and to draw the attention of both decision makers and users to the potential risks of moving data into “the cloud”.

  17. Ethics issues in retrievability

    International Nuclear Information System (INIS)

    Jensen, M.; Larsson, C.M.; Norden, M.

    2000-01-01

    We can isolate some issues, which should not be unresolved for a longer period of time. Disputes over well-defined waste management options fall in this category. The concept of retrievability has a possibility to invoke a series of questions in the minds of both specialists and non-specialists. It is intrinsically vague, in that it may refer to different phases in the repository's life, and to both open and closed repositories in the long time frame. Requirements for retrievability opens a series of issues, including open-ended philosophical question, which may give the impressions that things are not properly taken care of, since the experts differ in opinion. If such disputes cannot be resolved by consulting the existing legal framework, efforts should be made to put them to trial in the proper forum, i.e. parliament and national or local government or authorities, depending on the problem. In contrast, the value of institutional controls can easily be seen as an ethical value, whether included in the regulation of not. It has the potential to deter human intrusion and to allow remedial action by carrying information about a repository. (author)

  18. Energy issues in Africa

    International Nuclear Information System (INIS)

    Farhandi, M.

    1991-01-01

    The topic of the energy sector-and the petroleum sector in particular-in sub-Saharan Africa might well be considered an insignificant issue compared with many of the energy concerns which now command international attention. However, the World Bank believes that it is important for all those in international energy not to forget about the crucial problems facing Africa. They should become informed and concerned about these problems, and, hopefully, work together to bring about a satisfactory solution for an ongoing development dilemma. Simply put, the cost of imported energy to the African economy is exorbitantly high, sapping the resources needed to produce economic growth and social progress. This paper reports that, to address this issue, the World Bank is about to undertake a major initiative-two ground-breaking studies in the field of energy for sub-Saharan Africa. Both of these proposed studies are designed to find ways to reduce the burden of the cost of energy imports, mainly petroleum products, to this continent. One study will examine the design (and, subsequently, the implementation) of a rationalization scheme for the supply and distribution of petroleum products throughout sub-Saharan Africa. The other will consider the feasibility of transporting Nigeria's natural gas to neighbors to the west, all of which presently are importers of energy

  19. Technical issues for WIPP

    International Nuclear Information System (INIS)

    Hunter, T.O.

    1979-01-01

    Emplacement of wastes in the WIPP will include experiments on various waste types which will provide essential data on waste-rock interaction and repository response. These experiments will include evolution of the synergistic effects of both heat production, radiation, and actual waste forms. While these studies will provide essential data on the validity of waste isolation in bedded salt, they will be preceded by a broad-based experimental program which will resolve many of the current technical issues providing not only an assessment of the safety of performing such experiments but also the technical basis for assurance that the appropriate experiments are performed. Data and predictive modeling techniques, which are currently available, can bound the consequences associated with these technical issues. Predictions of the impact on public safety based on these analyses indicate that safe waste disposal in WIPP salt beds is achievable; however, a major use of WIPP will be to conduct realistic experiments with HLW forms to address some of the unresolved details of these waste/salt interactions

  20. Bituminous sands : tax issues

    International Nuclear Information System (INIS)

    Patel, B.

    2004-01-01

    This paper examined some of the tax issues associated with the production of bitumen or synthetic crude oil from oil sands. The oil sands deposits in Alberta are gaining more attention as the supplies of conventional oil in Canada decline. The oil sands reserves located in the Athabasca, Cold Lake and Peace River areas contain about 2.5 trillion barrels of highly viscous hydrocarbons called bitumen, of which nearly 315 billion barrels are recoverable with current technology. The extraction method varies for each geographic area, and even within zones and reservoirs. The two most common extraction methods are surface mining and in-situ extraction such as cyclic steam stimulation (CSS); low pressure steam flood; pressure cycle steam drive; steam assisted gravity drainage (SAGD); hot water flooding; and, fire flood. This paper also discussed the following general tax issues: bituminous sands definition; bituminous sands leases and Canadian development expense versus Canadian oil and gas property expense (COGPE); Canadian exploration expense (CEE) for surface mining versus in-situ methods; additional capital cost allowance; and, scientific research and experimental development (SR and ED). 15 refs

  1. Ethical issues in neuroscience.

    Science.gov (United States)

    Fuchs, Thomas

    2006-11-01

    The study gives an overview of ethical questions raised by the progress of neuroscience in identifying and intervening in neural correlates of the mind. Ethical problems resulting from brain research have induced the emergence of a new discipline termed neuroethics. Critical questions concern issues, such as prediction of disease, psychopharmacological enhancement of attention, memory or mood, and technologies such as psychosurgery, deep-brain stimulation or brain implants. Such techniques are capable of affecting the individual's sense of privacy, autonomy and identity. Moreover, reductionist interpretations of neuroscientific results challenge notions of free will, responsibility, personhood and the self which are essential for western culture and society. They may also gradually change psychiatric concepts of mental health and illness. These tendencies call for thorough, philosophically informed analyses of research findings and critical evaluation of their underlying conceptions of humans. Advances in neuroscience raise ethical, social and legal issues in relation to the human person and the brain. Potential benefits of applying neuroimaging, psychopharmacology and neurotechnology to mentally ill and healthy persons have to be carefully weighed against their potential harm. Questions concerning underlying concepts of humans should be actively dealt with by interdisciplinary and public debate.

  2. Environmental issues in China

    International Nuclear Information System (INIS)

    Travis, P.S.

    1991-10-01

    Global concern about the environment is increasing, and the People's Republic of China (PRC) is not immune from such concerns. The Chinese face issues similar to those of many other developing nations. The US Department of Energy is particularly interested in national and world pollution issues, especially those that may infringe on other countries' economic growth and development. The DOE is also interested in any opportunities that might exist for US technical assistance and equipment in combating environmental problems. Our studies of articles in the China Daily, and English-language daily newspaper published by the Chinese government, show that population, pollution, and energy are major concerns of the Chinese Communist Party. Thus this report emphasizes the official Chinese government view. Supporting data were also obtained from other sources. Regardless of the severity of their various environmental problems, the Chinese will only try to remedy those problems with the greatest negative effects on its developing economy. They will be looking for foreign assistance, financial and informational, to help implement solutions. With the Chinese government seeking assistance, the United States has an opportunity to export basic technical information, especially in the areas of pollution control and monitoring, oil exploration methods, oil drilling technology, water and sewage treatment procedures, hazardous waste and nuclear waste handling techniques, and nuclear power plant safety procedures. In those areas the US has expertise and extensive technical experience, and by exporting the technologies the US would benefit both economically and politically. 59 refs., 3 figs

  3. Broadband network selection issues

    Science.gov (United States)

    Leimer, Michael E.

    1996-01-01

    Selecting the best network for a given cable or telephone company provider is not as obvious as it appears. The cost and performance trades between Hybrid Fiber Coax (HFC), Fiber to the Curb (FTTC) and Asymmetric Digital Subscriber Line networks lead to very different choices based on the existing plant and the expected interactive subscriber usage model. This paper presents some of the issues and trades that drive network selection. The majority of the Interactive Television trials currently underway or planned are based on HFC networks. As a throw away market trial or a short term strategic incursion into a cable market, HFC may make sense. In the long run, if interactive services see high demand, HFC costs per node and an ever shrinking neighborhood node size to service large numbers of subscribers make FTTC appear attractive. For example, thirty-three 64-QAM modulators are required to fill the 550 MHz to 750 MHz spectrum with compressed video streams in 6 MHz channels. This large amount of hardware at each node drives not only initial build-out costs, but operations and maintenance costs as well. FTTC, with its potential for digitally switching large amounts of bandwidth to an given home, offers the potential to grow with the interactive subscriber base with less downstream cost. Integrated telephony on these networks is an issue that appears to be an afterthought for most of the networks being selected at the present time. The major players seem to be videocentric and include telephony as a simple add-on later. This may be a reasonable view point for the telephone companies that plan to leave their existing phone networks untouched. However, a phone company planning a network upgrade or a cable company jumping into the telephony business needs to carefully weigh the cost and performance issues of the various network choices. Each network type provides varying capability in both upstream and downstream bandwidth for voice channels. The noise characteristics

  4. Hydrogen peroxide safety issues

    International Nuclear Information System (INIS)

    Conner, W.V.

    1993-01-01

    A literature survey was conducted to review the safety issues involved in handling hydrogen peroxide solutions. Most of the information found in the literature is not directly applicable to conditions at the Rocky Flats Plant, but one report describes experimental work conducted previously at Rocky Flats to determine decomposition reaction-rate constants for hydrogen peroxide solutions. Data from this report were used to calculate decomposition half-life times for hydrogen peroxide in solutions containing several decomposition catalysts. The information developed from this survey indicates that hydrogen peroxide will undergo both homogeneous and heterogeneous decomposition. The rate of decomposition is affected by temperature and the presence of catalytic agents. Decomposition of hydrogen peroxide is catalyzed by alkalies, strong acids, platinum group and transition metals, and dissolved salts of transition metals. Depending upon conditions, the consequence of a hydrogen peroxide decomposition can range from slow evolution of oxygen gas to a vapor, phase detonation of hydrogen peroxide vapors

  5. Current issues in asteroseismology

    Energy Technology Data Exchange (ETDEWEB)

    Bazot, Michael; Monteiro, Mario J P F G; Straka, Christian W [Centro de Astrofisica da Universidade do Porto, Rua das Estrelas, 4150-762 Porto (Portugal)

    2008-10-15

    In this contribution we briefly review some of the current issues and promises for the future by asteroseismology. We are entering a new phase in this field driven by the wealth of data that has been collected and data that will soon be available for asteroseismology across the HR Diagram. Major difficulties in the descriptions of stellar interiors that arose in the second half of the 20th century may now be in part addressed and solved (this is the expectation{exclamation_point}) by asteroseismology with unprecedented precision. In this contribution we list some of the key open questions in stellar physics, the seismic data we expect to collect in the near future, and some techniques that will provide the tools to connect data and models.

  6. Nuclear fusion: The issues

    International Nuclear Information System (INIS)

    Griffin, R.D.

    1993-01-01

    The taming of fusion energy, has proved one of the most elusive quests of modern science. For four decades, the United States has doggedly pursued energy's holy grail, pumping more than $9 billion into research and reactor prototypes. This year, the federal government is slated to spend $339 million on fusion, more than the combined amount the government will spend for research on oil, natural gas, solar power, wind power, geothermal energy, biofuels and conservation. This article summarizes the technical, political in terms of international cooperation, economic, planning, etc. issues surrounding the continued development of fusion as a possible power source for the next century. Brief descriptions of how fusion works and of the design of a tokamak fusion machine are included

  7. Emotion, philosophical issues about.

    Science.gov (United States)

    Deonna, Julien; Tappolet, Christine; Teroni, Fabrice

    2015-01-01

    We start this overview by discussing the place of emotions within the broader affective domain-how different are emotions from moods, sensations, and affective dispositions? Next, we examine the way emotions relate to their objects, emphasizing in the process their intimate relations to values. We move from this inquiry into the nature of emotion to an inquiry into their epistemology. Do they provide reasons for evaluative judgments and, more generally, do they contribute to our knowledge of values? We then address the question of the social dimension of emotions, explaining how the traditional nature versus nurture contrast applies to them. We finish by exploring the relations between emotions, motivation and action, concluding this overview with a more specific focus on how these relations bear on some central ethical issues. © 2015 John Wiley & Sons, Ltd.

  8. Utility customer issues

    International Nuclear Information System (INIS)

    Downey, W.H.

    1997-01-01

    Customer issues affected by the restructuring of the $250 billion US electric power industry were discussed. In the past the industry's vertically integrated utilities conducted their business in protected geographic markets. With deregulation and greater competition, that industry structure will change. This presentation highlighted the strategies that Unicom is using to react to the restructuring of the electric power industry. The underlying principle is for the utility to reinvent itself to change its market orientation and focus on customer services, such as reliability, responsiveness, custom tailored solutions, and guaranteed savings over time. Attempting to become total energy providers and delivering integrated solutions to meet the needs of large industrial and commercial consumers, intensive market research, improved service and installation, and sophisticated customer retention initiatives will also have to be high on the agenda

  9. Feminist issues in development.

    Science.gov (United States)

    Antrobus, P

    1987-01-01

    The United Nations Decade for the Advancement of Women, from 1975 to 1985, leaves a legacy of a deeper understanding of the issues, and the emergence of new networks with the experience and commitment to work for further changes. However, the role and status of women did not improve. There is a new commitment to struggle for the ending of all oppression, injustice and violence of all kinds at all levels. Feminism is a consciousness of all forms of women's oppression and a commitment to work against them. Feminist critiques illuminate the larger structures that oppress both women and men. New development theories embracing feminism are necessary to understand how patriarchy and economic systems propogate oppression. The production-oriented approach to rural development is flawed n failing to address women's lack of access to land, credit, training and new technologies. Overwhelming household tasks, cultural norms, and traditional attitudes limit women's involvement in training programs and other development activities. The basic needs approach to rural development provides access to vital services to meet a family's basic needs for nutrition, housing and clothing, and allows people's participation in decision making. However, women have little actual role in decision making so their needs, concerns and perspectives are not taken into account. Women are treated as instruments to achieve goals without appreciating their perspective. Project-based approached emphasize short term goals rather than laying the foundation for longterm changes. Few projects address structural issues or empower women. Projects must include education to increase personal growth and self reliance. Development planning can be enormously enhanced by taking gender differences into account and recognizing that people, specially poor women, can promote their own devleopment. Longterm strategies that challenge existing structures, address the existing economic order, and, most of all, recognize

  10. Issues in energy finance

    Science.gov (United States)

    Khokher, Zeigham Islam

    As opposed to the well developed and understood equity markets, the energy markets are still in their infancy. The explosion of contracts, of both the primary and derivative types, are testament both to the existing size and the untapped growth potential of this exciting industry. However, because of its relative youth many basic issues in the energy markets remain unresolved. This thesis introduces some interesting questions and provides insights into these issues. Thematically, the chapters of this thesis are linked by an emphasis on valuation and risk management decisions. A contribution of this thesis is to show that subtle differences between the endogenous price process in our general equilibrium setting and the exogenous processes considered in earlier papers can generate significant differences in both financial and real option values. In addition to these valuation concerns there has been much debate about the corporate risk management function. Finance theory suggests that a value maximizing corporation should either be indifferent to hedging or, in the presence of certain imperfections, it should completely hedge all exposures. Both these extremes contradict empirical evidence. We show that existing corporate hedging behaviour is best explained in light of both physical market imperfections and directional predictions on future prices. While these speculative motives may arise from corporate hubris or genuine informational advantages, we argue that it would be difficult to implement private information in the absence of noise traders. Related to the risk management decision is the existence of futures risk premia. These premia have been thought to be cause by covariance with priced factors or due to the hedging demands of consumers and producers. This thesis argues that inventories serve as a signal of available quantity, which coupled with consumers fears regarding stockouts can induce a positive relationship between premia and inventories. In

  11. Pharmacovigilance: the devastating consequences of not thinking ...

    African Journals Online (AJOL)

    safety profile of the complex drug regimens that patients with HIV/. AIDS are often ... found that the cost of managing ADRs places a significant burden on health care ... major global public health problem that needs to be addressed at all levels of health care. .... elderly, pregnant women) is often not available or incomplete ...

  12. Knowledge, perceptions and practices of pharmacovigilance ...

    African Journals Online (AJOL)

    M.C. Joubert

    b University of KwaZulu Natal, School of Health Science, Discipline of ... component of the process ensuring that the risk of drug use does not outweigh the benefit. Pharmacists are valuable in collecting PV information, but not many studies ...

  13. The contribution of pharmacogenetics to pharmacovigilance.

    Science.gov (United States)

    Bondon-Guitton, Emmanuelle; Despas, Fabien; Becquemont, Laurent

    2016-04-01

    Since the beginning of this century, information on pharmacogenetics appears in the summary of product characteristics (SPC) of drugs. Pharmacogenetic tests particularly concern the enzymes involved in the metabolism of drugs, among which P450 cytochromes. Some patients known as poor metabolisers eliminate some drugs more slowly, causing overdoses and adverse drug reactions (ADRs). The best-known examples are AVK and VKORC1-CYP2C9 or clopidogrel and CYP2C19. In the USA, the tests are recommended before the introduction of these drugs to prevent the occurrence of ADRs. Other tests are also commonly performed to address the toxicity of certain anticancer drugs (DPYD-capecitabine, UGT1A1-irinotecan, TPMT 6-mercaptopurine). Pharmacogenetic testing is also available to identify HLA loci that are very strongly associated with the occurrence of immuno-allergic reactions to a specific drug. The best-known example is HLA-B*5701, strongly associated with hypersensitivity to abacavir, and this test is now always prescribed before the instatement of this drug. Copyright © 2016 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  14. Drug Abuse on College Campuses: Emerging Issues. Issues in Prevention

    Science.gov (United States)

    Higher Education Center for Alcohol, Drug Abuse, and Violence Prevention, 2012

    2012-01-01

    This "Issues in Prevention" focuses on emerging issues concerning drug abuse on college campuses. This issue contains the following articles: (1) Drug Abuse Trends; (2) Q&A With Jim Lange; (3) Bath Salts; (4) Refuse to Abuse; (5) Related Federal Resource; and (6) Higher Education Center Resources.

  15. REGIONAL ISSUES IN ENVIRONMENTAL EDUCATION

    African Journals Online (AJOL)

    and decision-making on a broad range of environmental ... systems seek changes in awareness, knDwledge. attitudes ... "infusion method" whereby environmental issues are dealt ... teachers on energy, water and population issues that will ...

  16. Medical and Dental Patient Issues

    Science.gov (United States)

    ... A RadiationAnswers.org Ask the Experts Medical and Dental Patient Issues What's My Risk? The risks of ... developed by our topic editors for this category: Dental-Patient Issues Medical CT Reference Books and Articles ...

  17. Recent regulatory issues in Finland

    International Nuclear Information System (INIS)

    Laaksonen, J.; Tiipana, P.

    2001-01-01

    This paper presents general regulatory issues from Finland since the last WWER Regulators Forum meeting in Odessa 11-13 October 2000. More specific issues concerning Loviisa NPP are described in the Annex of this paper. (author)

  18. Stock Issues in Aristotle's Rhetoric

    Science.gov (United States)

    Harpine, Bill

    1977-01-01

    Defines "stock issue" by the manner in which they function in Aristotle's theory, reviews examples of modern theories of stock issues, examines previous investigations of the "Rhetoric," and analyzes Aristotle's approach to this aspect of argumentation. (MH)

  19. Acknowledgment - Issue 60

    Directory of Open Access Journals (Sweden)

    Executive Editor

    2015-11-01

    Full Text Available Biblios wish to acknowledge the support of the following professionals who participated in the review process of submissions for our issue 60.ReviewersAndré Ancona Lopez (Universidade de Brasília - UnB, BrasilGildenir Carolino Santos (Universidade Estadual de Campinas - UNICAMP, BrasilJacira Gil Bernardes (Universidade Federal do Rio Grande do Sul - UFRGS, BrasilRodrigo Donoso Vegas (Universidad de Chile - UCHILE, ChileSaúl Hiram Souto Fuentes (Universidad de Monterrey - UDEM, MéxicoReviewers invitedAlejandro Uribe Tirado (Universidad de Antioquia - UDEA, ColombiaFernanda Passini Moreno (Universidade de Brasília - UnB, BrasilJosé Bernal Rivas Fernández (Universidad de Costa Rica - UCR, Costa RicaMarta Lígia Pomim Valentim (Universidade Estadual Paulista - UNESP, BrasilOrlando Corzo Cauracurí (Universidad Nacional Mayor de San Marcos - UNMSM, PerúTerezinha Elisabeth da Silva (Universidade Estadual de Londrina - UEL, BrasilZaira Regina Zafalon (Universidade Federal de São Carlos - UFSCAR, BrasilIn the same way our acknowledge to University Library System (University of Pittsburgh - PITTS, USA by constant technical support and advice for our journal.

  20. Reagan issues mineral policy

    Science.gov (United States)

    The National Materials and Minerals Program plan and report that President Reagan sent to Congress on April 5 aims to ‘decrease America's minerals vulnerability’ while reducing future dependence on potentially unstable foreign sources of minerals. These goals would be accomplished by taking inventory of federal lands to determine mineral potential; by meeting the stockpile goals set by the Strategic and Critical Material Stockpiling Act; and by establishing a business and political climate that would encourage private-sector research and development on minerals.Now that the Administration has issued its plan, the Subcommittee on Mines and Mining of the House Committee on Interior and Insular Affairs will consider the National Minerals Security Act (NMSA), which was introduced 1 year ago by subcommittee chairman Jim Santini (D-Nev.) [Eos, May 19, 1981, p. 497]. The bill calls for establishing a three-member White-House-level council to coordinate the development of a national minerals policy; amending tax laws to assist the mining industry to make capital investments to locate and produce strategic materials; and creating a revolving fund for the sale and purchase of strategic minerals. In addition, the NMSA bill would allow the secretary of the interior to make previously withdrawn public lands available for mineral development. The subcommittee will hold a hearing on the Administration's plan on May 11. Interior Secretary James Watt has been invited to testify.

  1. Sex: a sensitive issue.

    Science.gov (United States)

    1997-01-01

    Health care workers and educators may need to improve their skills in discussing sensitive issues in order to elicit and understand what influences people's attitudes toward sex. While the health worker may be bent upon preventing HIV infection, advising on family planning, or teaching youth about sexual relationships, his or her audience may have other priorities. A good counselor/teacher must learn what people's concerns are and discuss sexual health within that context. It can be difficult talking about sex because sex is a private concern and many people are embarrassed discussing it. Even sex partners often find it difficult to talk to each other about sex. Appropriate communication techniques vary depending upon the situation. It depends upon whether one is addressing people on an individual basis or in groups, which people are being addressed, which organization one is representing, and what one's role is. Good communication is a two-way sharing of information. The different stages of life, common beliefs and myths, culture and religion, relationships between men and women, reasons for having sex, and sex practices are discussed.

  2. Issues of environmental (irresponsibility

    Directory of Open Access Journals (Sweden)

    Jana Dundelová

    2013-01-01

    Full Text Available In this paper the author reflects the questions of humans’ relationship to the environment and of their ecological behaviour that becomes together with the development of modern technologies increasingly relevant just as the question whether humans are able to affect fundamentally the environment on the Earth by their activities. According to some authors (e.g. Ehrlich, 1968; Gore, 2006; Wilson, 1995; Winter, Koger, 2009; Šmajs, 2005 human survival is directly connected with people’s relationship to the nature; but other influential authors have contradictory opinions or they are at least afraid of overestimation of ecological activities that can lead to neglecting of other important problems (e.g. Simon, 1981; Goklany, 2007; Lomborg, 2007; Klaus, 2007, 2009.These issues are dealt in this article mainly from the perspective of psychological theories and concepts – the Freud’s concept of unconsciousness is discussed as well as groupthink, theory of dissonance, contingency trap, Milgram’s theory of autonomous and agentic state of consciousness, group and intergroup behaviour, social dilemma – tragedy of the commons. Achieving a sustainable way of life depends on the equilibrium between consumption of individuals and regenerative abilities of the natural environment. However, people still behave as if they were separated from the nature. The linking axis of this article is the question of psychic powers causing individual and collective ecological (irresponsibility and the resulting consequences.

  3. Year 2000 disclosure issues

    Energy Technology Data Exchange (ETDEWEB)

    Bradley, N.; Kratz, M.P.J. [Bennett Jones, Calgary, AB (Canada)

    1998-12-31

    The legal dilemma that the year 2000 (Y2K) problem presents with regard to disclosure requirements is examined. In particular, this paper reviews the complexities involved for customers, suppliers and business partners to communicate about Y2K issues. The review prominently features the many levels of statutory, regulatory and legal overlay that must be considered before any communication takes place . One of the major barriers to disclosure is the threat that any statements made by one company or individual to another may give rise to various forms of liability, including limitation, defamation, misrepresentation, detrimental reliance, collateral contracts and warranties or representations. The paper also describes recent Canadian and U.S. Y2K disclosure requirements for public companies. While the legislation is intended to promote the voluntary sharing of Y2K information, it also sets out conditions limiting the extent to which Y2K statements can be used as the basis for liability. Canadian regulatory bodies also have several policies in effect that compel issuers of new securities to emphasize uncertainties which are likely to be factors in Y2K, and public companies to discuss and analyze risks, events and uncertainties within the management discussion and analysis section of their annual reports that would cause reported financial information to be not necessarily indicative of future operating results or conditions, should those uncertainties materialize. 8 refs.

  4. In This Issue

    Science.gov (United States)

    1996-07-01

    Composing the Curriculum For your summer reading pleasure this month's issue provides a wide range of subjects and activities. Our lead article is a tribute to a chemist-composer, Lejaren A. Hiller, Jr., as well as an examination of the interesting relationship between chemistry (and science) and music. Like Hiller, Wamser and Wamser (page 601) love both chemistry and music, and this comes through loud and clear in their historical perspective on Hiller's work. Much of the rest of the issue impinges on the chemistry curriculum in one form or another. Rettich, Bailey, Frank, and Frick (page 638) describe an integrated first- and second-year curriculum being developed at Illinois Wesleyan University that includes all subdisciplines of chemistry. They describe ways to teach topics such as acids and bases so that the perspectives of (for example) organic and inorganic chemistry are integrated and contemporaneous. Those contemplating a popular reform, group work or cooperative learning, will be interested in Birk and Kurtz's program (page 615) for training teaching assistants using cooperative learning. Surely TAs who have participated in cooperative groups to develop their own techniques for handling discussion and lab sessions will be able to use group learning to better advantage. Several years ago the ACS Division of Chemical Education set up a Task Force on the General Chemistry Curriculum. With support from the National Science Foundation and others, the task force has been quite active. In addition to the summative reports published here (pages 617-636) on four areas in which general chemistry teaching can be improved, they have contributed many Forum columns in earlier issues of the Journal and have published much of their work in New Directions for General Chemistry: A Resource for Curricular Change; Baird W. Lloyd, ed. Our current approach to teaching electron configurations of the atoms is largely based on quantum theory Because of the mathematics required

  5. Radioactive waste storage issues

    International Nuclear Information System (INIS)

    Kunz, D.E.

    1994-01-01

    In the United States we generate greater than 500 million tons of toxic waste per year which pose a threat to human health and the environment. Some of the most toxic of these wastes are those that are radioactively contaminated. This thesis explores the need for permanent disposal facilities to isolate radioactive waste materials that are being stored temporarily, and therefore potentially unsafely, at generating facilities. Because of current controversies involving the interstate transfer of toxic waste, more states are restricting the flow of wastes into - their borders with the resultant outcome of requiring the management (storage and disposal) of wastes generated solely within a state's boundary to remain there. The purpose of this project is to study nuclear waste storage issues and public perceptions of this important matter. Temporary storage at generating facilities is a cause for safety concerns and underscores, the need for the opening of permanent disposal sites. Political controversies and public concern are forcing states to look within their own borders to find solutions to this difficult problem. Permanent disposal or retrievable storage for radioactive waste may become a necessity in the near future in Colorado. Suitable areas that could support - a nuclear storage/disposal site need to be explored to make certain the health, safety and environment of our citizens now, and that of future generations, will be protected

  6. Year 2000 disclosure issues

    International Nuclear Information System (INIS)

    Bradley, N.; Kratz, M.P.J.

    1998-01-01

    The legal dilemma that the year 2000 (Y2K) problem presents with regard to disclosure requirements is examined. In particular, this paper reviews the complexities involved for customers, suppliers and business partners to communicate about Y2K issues. The review prominently features the many levels of statutory, regulatory and legal overlay that must be considered before any communication takes place . One of the major barriers to disclosure is the threat that any statements made by one company or individual to another may give rise to various forms of liability, including limitation, defamation, misrepresentation, detrimental reliance, collateral contracts and warranties or representations. The paper also describes recent Canadian and U.S. Y2K disclosure requirements for public companies. While the legislation is intended to promote the voluntary sharing of Y2K information, it also sets out conditions limiting the extent to which Y2K statements can be used as the basis for liability. Canadian regulatory bodies also have several policies in effect that compel issuers of new securities to emphasize uncertainties which are likely to be factors in Y2K, and public companies to discuss and analyze risks, events and uncertainties within the management discussion and analysis section of their annual reports that would cause reported financial information to be not necessarily indicative of future operating results or conditions, should those uncertainties materialize. 8 refs

  7. Issues in Forecasting CMEs

    Science.gov (United States)

    Pizzo, V. J.

    2017-12-01

    I will present my view of the current status of space weather forecasting abilities related to CMEs. This talk will address the large-scale aspects, but specifically not energetic particle phenomena. A key point is that all models, whether sophisticated numerical contraptions or quasi-empirical ones, are only as good as the data you feed them. Hence the emphasis will be on observations and analysis methods. First I will review where we stand with regard to the near-Sun quantitative data needed to drive any model, no matter how complex or simple-minded, and I will discuss technological roadblocks that suggest it may be some time before we see any meaningful improvements beyond what we have today. Then I cover issues related to characterizing CME propagation out through the corona and into interplanetary space, as well as to observational limitations in the vicinity of 1 AU. Since none of these observational constraints are likely to be resolved anytime soon, the real challenge is to make more informed use of what is available. Thus, this talk will focus on how we may identify and pursue the most profitable approaches, for both forecast and research applications. The discussion will highlight a number of promising leads, including those related to inclusion of solar backside information, joint magnetograph observations from L5 and Earth, how to use (not just run) ensembles, more rational use of HI observations, and suggestions for using cube-sats for deep space observations of CMEs and MCs.

  8. Year 2000 compliance issues.

    Science.gov (United States)

    1999-03-01

    This month, we continue our coverage of the year 2000 (Y2K) problem as it affects healthcare facilities and the professionals who work in them. We present the following articles: "Checking PCs for Y2K Compliance"--In this article, we describe the probable sources of Y2K-related errors in PCs and present simple procedures for testing the Y2K compliance of PCs and application software. "Y2K Assessment Equipment Expectations"--In this article, we review the Y2K compliance data from a small sampling of hospitals to help answer the question "What percentage of medical equipment will likely be susceptible to Y2K problems?" "Y2K Labeling of Medical Devices"--In this article, we discuss the pros and cons of instituting a program to label each medical device with its Y2K status. Also in this section, we present an updated list of organizations that support ECRI's Position Statement on the testing of medical devices for Y2K compliance, which we published in the December 1998 issue of Health Devices (27[12]). And we remind readers of the services ECRI can offer to help healthcare institutions cope with the Y2K problem.

  9. Hunger and Development [Issue Packet].

    Science.gov (United States)

    American Freedom from Hunger Foundation, Washington, DC.

    A variety of informational materials is compiled in this issue packet concentrating on hunger and development. They have been assembled to understand the issues associated with the facts of world hunger and to try to invent new forms of action and thought necessary to find the possibilities hidden in the hunger issue. Items include: (1) a fact and…

  10. Children's Literature: An Issues Approach.

    Science.gov (United States)

    Rudman, Masha Kabakow

    Meant as a reference and guide to critical evaluation of the way issues are treated in children's books, each of the nine chapters in this book can be used independently. Each chapter contains a discussion of an issue, a section that relates how particular books handle that issue, at least two suggestions for activities that teachers can use to…

  11. Education Studies: Issues & Critical Perspectives

    Science.gov (United States)

    Kassem, Derek; Mufti, Emmanuel; Robinson, John

    2006-01-01

    This major text for Education Studies students provides a critical account of key issues in education today. The text features: (1) A critical analysis of key issues in Education Studies to encourage students' thinking about education in the broadest terms; (2) Themed sections with introductions to link the issues discussed in each chapter; (3)…

  12. Fusion Canada issue 29

    International Nuclear Information System (INIS)

    1995-10-01

    A short bulletin from the National Fusion Program highlighting in this issue Canada-Europe Accords: 5 year R and D collaboration for the International Thermonuclear Experimental Reactor (ITER) AECL is designated to arrange and implement the Memorandum of Understanding (MOU) and the ITER Engineering Design Activities (EDA) while EUROTAM is responsible for operating Europe's Fusion R and D programs plus MOU and EDA. The MOU includes tokamaks, plasma physics, fusion technology, fusion fuels and other approaches to fusion energy (as alternatives to tokamaks). STOR-M Tokamak was restarted at the University of Saskatchewan following upgrades to the plasma chamber to accommodate the Compact Toroid (CT) injector. The CT injector has a flexible attachment thus allowing for injection angle adjustments. Real-time video images of a single plasma discharge on TdeV showing that as the plasma density increases, in a linear ramp divertor, the plasma contact with the horizontal plate decreases while contact increases with the oblique plate. Damage-resistant diffractive optical elements (DOE) have been developed for Inertial Confinement Fusion (ICF) research by Gentac Inc. and the National Optics Institute, laser beam homogeniser and laser harmonic separator DOE can also be made using the same technology. Studies using TdeV indicate that a divertor will be able to pump helium from the tokamak with a detached-plasma divertor but helium extraction performance must first be improved, presently the deuterium:helium retention radio-indicates that in order to pump enough helium through a fusion reactor, too much deuterium-tritium fuel would be pumped out. 2 fig

  13. Mars Surface Environmental Issues

    Science.gov (United States)

    Charles, John

    2002-01-01

    Planetary exploration by astronauts will require extended periods of habitation on a planet's surface, under the influence of environmental factors that are different from those of Earth and the spacecraft that delivered the crew to the planet. Human exploration of Mars, a possible near-term planetary objective, can be considered a challenging scenario. Mission scenarios currently under consideration call for surface habitation periods of from 1 to 18 months on even the earliest expeditions. Methods: Environmental issues associated with Mars exploration have been investigated by NASA and the National Space Biomedical Research Institute (NSBRI) as part of the Bioastronautics Critical Path Roadmap Project (see http ://criticalpath.jsc.nasa.gov). Results: Arrival on Mars will immediately expose the crew to gravity only 38% of that at Earth's surface in possibly the first prolonged exposure to gravity other than the 1G of Earth's surface and the zero G of weightless space flight, with yet unknown effects on crew physiology. The radiation at Mars' surface is not well documented, although the planet's bulk and even its thin atmosphere may moderate the influx of galactic cosmic radiation and energetic protons from solar flares. Secondary radiation from activated components of the soil must also be considered. Ultrafine and larger respirable and nonrespirable particles in Martian dust introduced into the habitat after surface excursions may induce pulmonary inflammation exacerbated by the additive reactive and oxidizing nature of the dust. Stringent decontamination cannot eliminate mechanical and corrosive effects of the dust on pressure suits and exposed machinery. The biohazard potential of putative indigenous Martian microorganisms may be assessed by comparison with analog environments on Earth. Even in their absence, human microorganisms, if not properly controlled, can be a threat to the crew's health. Conclusions: Mars' surface offers a substantial challenge to the

  14. Ethical issues in haemophilia.

    Science.gov (United States)

    DiMichele, D; Chuansumrit, A; London, A J; Thompson, A R; Cooper, C G; Killian, R M; Ross, L F; Lillicrap, D; Kimmelman, J

    2006-07-01

    Ethical issues surrounding both the lack of global access to care as well as the implementation of advancing technologies, continue to challenge the international haemophilia community. Haemophilia is not given the priority it deserves in most developing countries. Given the heavy burdens of sickness and disease and severe resource constraints, it may not be possible to provide effective treatment to all who suffer from the various 'orphan' diseases. Nevertheless, through joint efforts, some package of effective interventions can be deployed for a significant number of those who are afflicted with 'orphan' diseases. With cost-effective utilization of limited resources, a national standard of care is possible and affordable. Gene-based diagnosis carries attendant ethical concerns whether for clinical testing or for research purposes, even as the list of its potential benefits to the haemophilia community grows rapidly. As large-scale genetic sequencing becomes quicker and cheaper, moving from the research to the clinic, we will face decisions about the implementation of prenatal, neonatal and other screening programs. Such debates will require input from not just the health care professionals but from all stakeholders in the haemophilia community. Finally, long-term therapeutic success gene transfer in small and large animal models raises the question of when and in which patient population the novel therapeutic approach should first be studied in humans with haemophilia. Although gene therapy represents a worthy goal, the central question for the haemophilia community should be whether it wishes to volunteer itself as a model for a much broader set of innovations.

  15. Issues in focus.

    Science.gov (United States)

    1994-08-01

    The issues worldwide that deserve attention pertain to international migration, the education of women, family planning, missing female children, and prevention and control of AIDS cases. Migration outside country borders has been increasing due to economic and social disparities, and uncounted and unrecognized refugees are fleeing environmental disasters. The educational status of women has increased over the past 30 years. For example, female illiteracy has declined among women aged 20-24 years from 19% to 8% in Latin America, from 38% to 12% in eastern and western Asia, and from 80% to 49% in Africa. These improvements are significant, but the problem remains, where, for instance in Africa, there is still extensive illiteracy (75% of females aged under 25 years). A 1993 Population Action International Report states that low female educational levels and weak family planning and health programs are related to large family size and high child death rates. During the 1980s family planning was linked with ecological concerns. Progress has been made in the increase in contraceptive users in developing countries from 14% to 53% during 1965-70. Fertility has declined from 6.1 children per woman in the 1950s to 3.7. Kenya is a good example of a country with high fertility that reduced fertility through its emphasis on family planning. Obstacles to increased prevalence of contraception still remain. In Mexico more than 50% of public birth control services are provided to women in secret due to fear of their husband's abuse. Population pressure can result in the loss of girl children through higher mortality, better nutrition, neglect, or gender preference in the early fetal stages. The challenge of AIDS will be in caring for the sick and adjusting to social changes due to the expected increases in orphaned children.

  16. The transportation issue management system: A tool for issue resolution

    International Nuclear Information System (INIS)

    Branch, K.M.; Boryczka, M.K.

    1987-01-01

    During the last decade, issue management programs have been developed and used by a number of large corporations in the United States. These systems have generally been designed to help senior program managers identify issues, develop strategic plans, and resolve issues. These systems involve scanning and abstracting literature to create a database that is then used for 1) issue identification, 2) issue analysis, 3) priority assessment, 4) development of corporate position/strategic options, and 5) action planning and implementation. Most of the existing systems rely on staff to identify trends in the computerized output, analyze the importance of the issue to the company, and assist in developing corporate responses. The Department of Energy has recently developed an issue management system for the Office of Civilian Radioactive Waste Management's (OCRWM) transportation program. This system is designed to help DOE identify institutional issues related to radioactive waste transportation, analyze the issues, and resolve them in a manner that is responsive to interested parties. The system will contain pertinent information from DOE technical reports, other federal documents, correspondence, professional journals, popular literature, newsclips, legislation and testimony. The program is designed around a number of institutional issues including: prenotification, physical protection procedures; highway, rail, and barge routing; inspections and enforcement of shipments; emergency response; liability, cask design and testing; overweight trucks; rail service; modal mix; infrastructure improvements; training standards, and operational procedures

  17. In This Issue

    Science.gov (United States)

    1996-04-01

    Advanced Instrumentation in the Educational Laboratory The instruments that chemists use in their research have changed dramatically in the past decades. The explosion in new techniques and their instrumental counterparts has been made possible by two significant advances. The rapid propagation of computer chips and circuitry provides opportunities to collect more specialized and refined data than ever before. Computer-controlled instruments can detect events that a human researcher would never perceive and can record hundreds of data points in the time that a person could only observe one or two. Coupled with these advances in technology are advances in theory that allow more sophisticated interpretation of data. A hundred years ago a sophisticated instrument was a balance that could weigh minute quantities. Today a sophisticated instrument is one that can identify the composition of that minute sample, determine its molecular weight, or reveal a great deal about its energy states and bonding. This bonanza of new instruments is wonderful for the research chemist but a curricular headache for the chemistry teacher. It takes more time to learn how to run an NMR than to use a balance, and more sophistication on the part of the student is needed to interpret the data. And yet many courses that only a generation ago sported an expensive analytical balance as its prize instrument now require students to understand and operate a whole panoply of complex tools. Teachers faced with accommodating these curricular changes will find several articles in this issue helpful--either providing information on new techniques or descriptions of how to incorporate them into the classroom. Electrospray ionization mass spectrometry is one of the newest tools that has been added to the analytical arsenal. It is an extension of mass spectrometry that overcomes the old barrier that allowed only analysis of low molecular weight, volatile compounds. It is now possible to use MS for

  18. Prioritization of generic safety issues

    International Nuclear Information System (INIS)

    Emrit, R.; Minners, W.; VanderMolen, H.

    1983-12-01

    This report presents the priority rankings for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The report focuses on the prioritization of generic safety issues. Issues primarily concerned with the licensing process or environmental protection and not directly related to safety have been excluded from prioritization. The prioritized issues include: TMI Action Plan items under development; previously proposed issues covered by Task Action Plans, except issues designated at Unresolved Safety Issues (USIs) which had already been assigned high priority; and newly-proposed issues. Future supplements to this report will include the prioritization of additional issues. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolutions of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative

  19. Ethical issues in neuroprosthetics

    Science.gov (United States)

    Glannon, Walter

    2016-04-01

    Objective. Neuroprosthetics are artificial devices or systems designed to generate, restore or modulate a range of neurally mediated functions. These include sensorimotor, visual, auditory, cognitive affective and volitional functions that have been impaired or lost from congenital anomalies, traumatic brain injury, infection, amputation or neurodevelopmental and neurodegenerative disorders. Cochlear implants, visual prosthetics, deep brain stimulation, brain-computer interfaces, brain-to-brain interfaces and hippocampal prosthetics can bypass, replace or compensate for dysfunctional neural circuits, brain injury and limb loss. They can enable people with these conditions to gain or regain varying degrees of control of thought and behavior. These direct and indirect interventions in the brain raise general ethical questions about weighing the potential benefit of altering neural circuits against the potential harm from neurophysiological and psychological sequelae. Other ethical questions are more specific to the therapeutic goals of particular neuroprosthetics and the conditions for which they are indicated. These include informed consent, agency, autonomy (free will) and identity. Approach. This review is an analysis and discussion of these questions. It also includes consideration of social justice issues such as how to establish and implement fair selection criteria in providing access to neuroprosthetic research and balancing technological innovation with patients’ best interests. Main results. Neuroprosthetics can restore or improve motor and mental functions in bypassing areas of injury or modulating dysregulation in neural circuits. As enabling devices that integrate with these circuits, neuroprosthetics can restore varying degrees of autonomous agency for people affected by neurological and psychiatric disorders. They can also re-establish the connectedness and continuity of the psychological properties they had before injury or disease onset and thereby

  20. The hydrogen issue.

    Science.gov (United States)

    Armaroli, Nicola; Balzani, Vincenzo

    2011-01-17

    Hydrogen is often proposed as the fuel of the future, but the transformation from the present fossil fuel economy to a hydrogen economy will need the solution of numerous complex scientific and technological issues, which will require several decades to be accomplished. Hydrogen is not an alternative fuel, but an energy carrier that has to be produced by using energy, starting from hydrogen-rich compounds. Production from gasoline or natural gas does not offer any advantage over the direct use of such fuels. Production from coal by gasification techniques with capture and sequestration of CO₂ could be an interim solution. Water splitting by artificial photosynthesis, photobiological methods based on algae, and high temperatures obtained by nuclear or concentrated solar power plants are promising approaches, but still far from practical applications. In the next decades, the development of the hydrogen economy will most likely rely on water electrolysis by using enormous amounts of electric power, which in its turn has to be generated. Producing electricity by burning fossil fuels, of course, cannot be a rational solution. Hydroelectric power can give but a very modest contribution. Therefore, it will be necessary to generate large amounts of electric power by nuclear energy of by renewable energies. A hydrogen economy based on nuclear electricity would imply the construction of thousands of fission reactors, thereby magnifying all the problems related to the use of nuclear energy (e.g., safe disposal of radioactive waste, nuclear proliferation, plant decommissioning, uranium shortage). In principle, wind, photovoltaic, and concentrated solar power have the potential to produce enormous amounts of electric power, but, except for wind, such technologies are too underdeveloped and expensive to tackle such a big task in a short period of time. A full development of a hydrogen economy needs also improvement in hydrogen storage, transportation and distribution

  1. Employee Assistance Program Issues

    Science.gov (United States)

    Gettleman, Alan G.; McGuire, William

    1999-01-01

    Employee Assistance Program (EAP) officers, as well as personnel in other disciplines from eight NASA Centers, attended this breakout session. Ms. Brenda Blair, MA, CEAP, a guest speaker at the conference, also attended as a consultant. Representatives from the NASA Centers introduced themselves and spoke briefly about their programs. In a discussion related to the conference theme on benchmarking, quality control issues within the EAP community and adequate documentation of cases were addressed. Disposition and provision for quality assurance checks for EAP providers in single person offices were also discussed. Ms. Blair presented methods for consulting with other NASA personnel in single person EAP offices as a quality control measure. EAP intervention in critical incidents was discussed. The question of whether EAP assistance is an asset or a potential liability in those situations was addressed. Suggestions were made of topics for future EAP video-teleconference topics. A program on EAP ethics was planned for a September video teleconference. Each person was asked to provide intake forms they use to Mr. Gettleman or Ms. Blair. Ms. Blair said she would review the forms to ensure that adequate notification is provided to the client for confidentiality. She would also review them to ensure they have adequate limits of confidentiality--a topic for future video teleconferencing. Mr. Gettleman described the NASA initiative to reduce stresses in the workplace, and the activities of an ad-hoc EAP group that will make recommendations to NASA senior management. Alternative training methods were discussed for reaching target audiences such as employees at risk, supervisors, and others. Pfc. David A. Pendleton, Victim Assistance Coordinator, U.S. Capitol Police. U.S. House of Representatives made a special presentation. Pfc. Pendleton was on duty during the tragic shooting of two Federal guards at the U.S. Capitol. He related the events immediately after the incident. He

  2. In This Issue

    Science.gov (United States)

    1996-06-01

    Organic Chemistry--New Challenges Perhaps more than any other of the chemical subdisciplines, the scope and focus of organic chemistry has been changed by modern technology and theoretical advances, and these changes have had an equally striking effect on the undergraduate curriculum. The main challenge in organic chemistry classes has shifted, in less than a generation, from memorizing all the groups, naming conventions, and classes of reactions to understanding complex interactions at the structural and electronic orbital level. As biochemistry and polymer chemistry have grown from being the purview of a few specialists to full-blown disciplines of their own, they have also migrated from interesting, but optional, chapters at the back of the book to separate courses in the curriculum. The availability of inexpensive instrumentation means undergraduates routinely use NMR and mass spec instead of melting points to identify their products. And the changes are continuing: segments of biochemistry are metamorphizing into molecular biology and polymer chemistry is finding interconnections with materials science. In fact, as our understanding of chemical reactions at molecular and electronic levels expands, it becomes more and more difficult to decide on demarcations between the subdisciplines. Organic chemistry is an organizational construct that once was useful for segregating certain topics into a coherent two-semester introductory course. Today, it covers so much territory that no one who is an "organic chemist" can know even a small fraction of the territory and faces unique challenges when designing and teaching undergraduate courses. In a wide spectrum of articles in this issue that fall under the "organic" umbrella--from environmental chemistry to new polymer products--teachers share their specific experiences and creative solutions to these challenges, providing their colleagues with new ideas, processes, and pedagogic approaches. To start off, we can examine

  3. Issues in environmental survey design

    International Nuclear Information System (INIS)

    Iachan, R.

    1989-01-01

    Several environmental survey design issues are discussed and illustrated with surveys designed by Research Triangle Institute statisticians. Issues related to sampling and nonsampling errors are illustrated for indoor air quality surveys, radon surveys, pesticide surveys, and occupational and personal exposure surveys. Sample design issues include the use of auxiliary information (e.g. for stratification), and sampling in time. We also discuss the reduction and estimation of nonsampling errors, including nonresponse and measurement bias

  4. Strategic pricing of equity issues

    OpenAIRE

    Klaus Ritzberger; Frank Milne

    2002-01-01

    Consider a general equilibrium model where agents may behave strategically. Specifically, suppose some firm issues new shares. If the primary market price is controlled by the issuing institution and investors' expectations on future equity prices are constant in their share purchases, the share price on the primary market cannot exceed the secondary market share price. In certain cases this may imply strict underpricing of newly issued shares. If investors perceive an influence on future sha...

  5. Policy issues in modern cartography

    CERN Document Server

    Taylor, DRF

    1998-01-01

    Policy Issues in Modern Cartography contains the views of national mapping agencies, legal scholars, the library community, the private sector and academia on these and many other important issues. The book begins with perspectives from national mapping agencies in Britain, Canada and the United States followed by a survey of the situation in Asia. The next three chapters deal primarily with legal issues such as copyright and intellectual property from both North American and European perspectives. Chapter 8 presents an important perspective on the key issues by a representative of the privat

  6. Nuclear reactors safety issues

    International Nuclear Information System (INIS)

    Barre, Francois; Seiler, Nathalie

    2008-01-01

    Full text of publication follows: Since the seventies, economic incentives have led the utilities to drive a permanent evolution of the light water reactor (LWR). The evolution deals with the reactor designs as well as the way to operate them in a more flexible manner. It is for instance related to the fuel technologies and management. On the one hand, the technologies are in continuous evolution, such as the fuel pellets (MOX, Gd fuel, or Cr doped fuels..) as well as advanced cladding materials (M5 TM , MDA or ZIRLO). On the other hand, the fuel management is also subject to continuous evolution in particular in terms of increasing the level of burn-up, the reactor (core) power, the enrichment, as well as the duration of reactor cycles. For instance, in a few years in France, the burn-up has raised beyond the value of 39 GWj/t, initially authorized up to 52 GWj/t for the UO 2 fuel. In the near future, utilities foreseen to reach fuel burn-up of 60 GWj/t for MOX fuel and 70 GWj/t for UO 2 fuel. Furthermore, the future reactor of fourth generation will use new fuels of advanced conception. Furthermore with the objective of improving the safety margins, methods and calculation tools used by the utilities in the elaboration of their safety demonstrations submitted to the Safety Authority, are in movement. The margin evaluation methodologies often consist of a calculation chain of best-estimate multi-field simulations (e.g. various codes being coupled to simulate in a realistic way the evolution of the thermohydraulic, neutronic and mechanic state of the reactor). The statistical methods are more and more sophisticated and the computer codes are integrating ever-complex physical models (e.g. three-dimensional at fine scale). Following this evolution, the Institute of Radioprotection and Nuclear Safety (IRSN), whose one of the roles is to examine the safety records and to rend a technical expertise, considers the necessity of reevaluating the safety issues for advanced

  7. Current Issues in Cosmology

    Energy Technology Data Exchange (ETDEWEB)

    Barbour, J B [Department of Physics and Astronomy, University of Rochester (United States)

    2007-02-07

    These colloquium proceedings will be valuable, the blurb says, for graduate students and researchers in cosmology and theoretical astrophysics. Specifically, the book 'looks at both the strengths and weaknesses of the current big bang model in explaining certain puzzling data' and gives a 'comprehensive coverage of the expanding field of cosmology'. The reality is rather different. Conference proceedings rarely compare in value with a solid monograph or good review articles, and Current Issues in Cosmology is no exception. The colloquium was convened by the two editors, who have both long harboured doubts about the big bang, and was held in Paris in June 2004. The proceedings contain 19 presented papers and relatively brief summary comments by four panel speakers. The questions and answers at the end of each talk and a general discussion at the end were recorded and transcribed but contain little of interest. The nature of the colloquium is indicated by panellist Francesco Bertola's comment: 'While in the 1950s it was possible to speak of rival theories in cosmology, now the big-bang picture has no strong rivals. This is confirmed by the fact that out of 1500 members of the IAU Division VIII (Galaxies and the Universe) only a dozen, although bright people, devote their time to the heterodox views.' This was largely a platform for them to give their views. At least half of the dozen, all the 'usual suspects', were present: Geoffery and Margaret Burbidge, Jayant Narlikar, Halton Arp, Chandra Wickramasinghe and, in spirit only but playing a role somewhat like the ghost of Hamlet's father, the late Fred Hoyle. Doubters presented 12 of the 19 papers. Orthodoxy should certainly be challenged and the sociology of science questioned, but I found two main problems with this book. The papers putting the orthodox view are too short, even perfunctory. The most that a serious graduate student would get out of them is a reference

  8. Current Issues in Cosmology

    International Nuclear Information System (INIS)

    Barbour, J B

    2007-01-01

    These colloquium proceedings will be valuable, the blurb says, for graduate students and researchers in cosmology and theoretical astrophysics. Specifically, the book 'looks at both the strengths and weaknesses of the current big bang model in explaining certain puzzling data' and gives a 'comprehensive coverage of the expanding field of cosmology'. The reality is rather different. Conference proceedings rarely compare in value with a solid monograph or good review articles, and Current Issues in Cosmology is no exception. The colloquium was convened by the two editors, who have both long harboured doubts about the big bang, and was held in Paris in June 2004. The proceedings contain 19 presented papers and relatively brief summary comments by four panel speakers. The questions and answers at the end of each talk and a general discussion at the end were recorded and transcribed but contain little of interest. The nature of the colloquium is indicated by panellist Francesco Bertola's comment: 'While in the 1950s it was possible to speak of rival theories in cosmology, now the big-bang picture has no strong rivals. This is confirmed by the fact that out of 1500 members of the IAU Division VIII (Galaxies and the Universe) only a dozen, although bright people, devote their time to the heterodox views.' This was largely a platform for them to give their views. At least half of the dozen, all the 'usual suspects', were present: Geoffery and Margaret Burbidge, Jayant Narlikar, Halton Arp, Chandra Wickramasinghe and, in spirit only but playing a role somewhat like the ghost of Hamlet's father, the late Fred Hoyle. Doubters presented 12 of the 19 papers. Orthodoxy should certainly be challenged and the sociology of science questioned, but I found two main problems with this book. The papers putting the orthodox view are too short, even perfunctory. The most that a serious graduate student would get out of them is a reference to a far better review article or book on modern

  9. Theme Issue on Mass Communication.

    Science.gov (United States)

    Anapol, Malthon M., Ed.

    1978-01-01

    Focusing on issues in mass communication, the six articles in this journal issue cover many facets and approaches to the topics. The first article offers a review of recent developments in the field and some comments about its future. The second article reviews feminism in comedies from the 1930s and in a current film, and the third analyzes the…

  10. Research Issues in Information Access.

    Science.gov (United States)

    Molholt, Pat

    1989-01-01

    Discusses traditional library approaches to access to information and the possible impact of information technologies, library automation, and artificial intelligence. Access issues raised by these technologies are identified and a research agenda to explore these issues is outlined. (31 references) (CLB)

  11. Special Issue: Candida and Candidiasis

    Directory of Open Access Journals (Sweden)

    Jeniel E. Nett

    2018-06-01

    Full Text Available This special issue highlights emerging topics related to Candida, the most prevalent fungal pathogen in the hospital setting. The advantages and limitations of new, non-culture based diagnostic techniques are discussed. The issue reviews mammalian and non-mammalian infection models. The manuscripts present updates on several molecular mechanisms of pathogenicity, including filamentation, biofilm formation, and phospholipid production.

  12. Ethical Issues in Online Education

    Science.gov (United States)

    Anderson, Bill; Simpson, Mary

    2007-01-01

    Teaching at a distance raises ethical issues particular to the distance context. When distance teaching is also online teaching, the situation is even more complex. Online teaching environments amplify the ethical issues faced by instructors and students. Online sites support complex discourses and multiple relationships; they cross physical,…

  13. NST Quarterly. January 1996 issue

    International Nuclear Information System (INIS)

    1996-01-01

    NST Quarterly reports current development in Nuclear Science and Technology in Malaysia. In this issue it highlights MINT activities in nuclear medicine, healthcare products sterilization, industrial irradiation dosimetry and heavy metals determination in food. The Malaysian standard for food irradiation was discussed in this issue

  14. Role of Antigen Spread and Distinctive Characteristics of Immunotherapy in Cancer Treatment

    NARCIS (Netherlands)

    Gulley, J.L.; Madan, R.A.; Pachynski, R.; Mulders, P.; Sheikh, N.A.; Trager, J.; Drake, C.G.

    2017-01-01

    Immunotherapy is an important breakthrough in cancer. US Food and Drug Administration-approved immunotherapies for cancer treatment (including, but not limited to, sipuleucel-T, ipilimumab, nivolumab, pembrolizumab, and atezolizumab) substantially improve overall survival across multiple

  15. FDA Approves First Therapeutic Cancer Vaccine

    Science.gov (United States)

    Sipuleucel-T (Provenge) is a relatively nontoxic treatment option for men with hormone-resistant or castration-resistant prostate cancer. The FDA's approval of the vaccine represented the first proof of principle that immunotherapy can work in cancer.

  16. Professional Emergence on Transnational Issues

    DEFF Research Database (Denmark)

    Seabrooke, Leonard; Tsingou, Eleni

    2015-01-01

    Addressing complex transnational problems requires coordination from different professionals. The emergence of new actors and issues has been addressed by those interested in studies of organizations through concepts and methods that highlight the importance of communities, fields, and networks...... they are conceptually linked by actors and organizations. A linked ecologies approach asks us to displace locating known actors within structures and instead pays attention to professional interactions on how ‘issue distinctions’ are made, the relationship between issue distinctions and professional tasks, and who...

  17. Psychosocial Issues in Geriatric Rehabilitation.

    Science.gov (United States)

    Rodriguez, Ricardo M

    2017-11-01

    Geriatric patients present multiple age-related challenges and needs that must be taken into account during the rehabilitation process to achieve expected goals. This article examines the importance of identifying and managing psychosocial issues commonly observed in older adults and presents strategies to optimize their rehabilitation process. Depression, anxiety, fear of falling, adjustment issues, neurocognitive disorders, and caregiver support are discussed as a selection of factors that are relevant for geriatric patients undergoing rehabilitation. An argument is made for the importance of comprehensive geriatric assessment in older adults to identify salient issues that may impact rehabilitation and quality of life. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Tribal-FERST Environmental Issue Profiles

    Science.gov (United States)

    This page provides links to the 45 issue profiles for Tribal-FERST users, organized with tabs to show issues related to pollutants, environmental media, health effects, other community issues, and all issues.

  19. C-FERST Environmental Issue Profiles

    Science.gov (United States)

    This page provides links to the 45 issue profiles for C-FERST users, organized with tabs to show issues related to pollutants, environmental media, health effects, other community issues, and all issues.

  20. SAT project introduction: management issues

    International Nuclear Information System (INIS)

    Kazennov, A.Yu.

    1998-01-01

    Management issues of introducing SAT Project include main objectives and expectations; SAT goal and management; major phases of SAT implementation; project quality assurance; SAT based training system and procedures; role of the project team qualifications

  1. Special Issue: Engineering Digital Transformation

    Directory of Open Access Journals (Sweden)

    Julio J. Garcia-Sabater

    2018-04-01

    We gratefully acknowledge the authors and particularly the reviewers, whose valuable comments have improved the quality of the selected papers, which were extended (and again reviewed by pairs after the conference in order to be published in this Special Issue.

  2. NST Quarterly. July 1996 issue

    International Nuclear Information System (INIS)

    1996-01-01

    NST Quarterly reports current development in Nuclear Science and Technology in Malaysia. In this issue it highlights MINT activities in in-vitro mutagenesis of ornamental plants, soil erosion studies and animal feed production from agricultural waste

  3. Atomic physics issues in fusion

    International Nuclear Information System (INIS)

    Post, D.E.

    1982-01-01

    Atomic physics issues have played a large role in controlled fusion research. A general introduction to the present role of atomic processes in both inertial and magnetic controlled fusion work is presented. (Auth.)

  4. NST Quarterly - January 1998 issue

    International Nuclear Information System (INIS)

    1998-01-01

    NST Quarterly reports current development in Nuclear Science and Technology in Malaysia. In this issue it highlights MINT activities in proposal of national networking for biotechnology culture collection centre (NNBCCC)

  5. NST Quarterly. October 1996 issue

    International Nuclear Information System (INIS)

    1996-01-01

    NST Quarterly reports current development in Nuclear Science and Technology in Malaysia. In this issue it highlights MINT activities in latex vulcanization (first RVNRL-based rubber gloves produced in Malaysia), tank floor scanning system (TAFLOSS), incineration and radiotherapeutic agent

  6. Issues Management Process Course # 38401

    Energy Technology Data Exchange (ETDEWEB)

    Binion, Ula Marie [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2018-02-01

    The purpose of this training it to advise Issues Management Coordinators (IMCs) on the revised Contractor Assurance System (CAS) Issues Management (IM) process. Terminal Objectives: Understand the Laboratory’s IM process; Understand your role in the Laboratory’s IM process. Learning Objectives: Describe the IM process within the context of the CAS; Describe the importance of implementing an institutional IM process at LANL; Describe the process flow for the Laboratory’s IM process; Apply the definition of an issue; Use available resources to determine initial screening risk levels for issues; Describe the required major process steps for each risk level; Describe the personnel responsibilities for IM process implementation; Access available resources to support IM process implementation.

  7. Professional Issues In Software Engineering

    CERN Document Server

    Bott, Frank; Eaton, Jack; Rowland, Diane

    2000-01-01

    An comprehensive text covering all the issues that software engineers now have to take into account apart from the technical side of things. Includes information on the legal, professional and commercial context in which they work.

  8. Prescribed burning: a topical issue

    Directory of Open Access Journals (Sweden)

    Bovio G

    2013-11-01

    Full Text Available Prescribed burning is a promising technique for the prevention of forest fires in Italy. The research deepened several ecological and operative aspects. However, legal issues need to be thoroughly investigated.

  9. Issues related to geothermal development

    International Nuclear Information System (INIS)

    Lesperance, G.O.

    1990-01-01

    This paper reports on a number of potential barriers to geothermal development in Hawaii which have been overcome but some remain. Efforts continue to address issues relating to transmission, project economics, the regulatory process, resource verification, and public acceptance

  10. NST Quarterly - April 1998 issue

    International Nuclear Information System (INIS)

    1998-01-01

    NST Quarterly reports current development in Nuclear Science and Technology in Malaysia. In this issue it highlights MINT activities in ionizing radiation as an alternative method for sanitization of herbs and spices

  11. Business Ethics: Some Theoretical Issues

    OpenAIRE

    Lluka, Valon

    2010-01-01

    Ethics can be defined as a process of evaluating actions according to moral principal of values. Throughout the centuries people were trying to choose between profit and moral. Perhaps, some of them obtain both, but every time it could have roused ethical issues. Those issues concern fairness, justice, rightness or wrongness; as a result it can only be resolved according to ethical standards. Setting the ethical standards for the way of doing business in corporation is primarily task of m...

  12. Current Issues in Maritime Health

    DEFF Research Database (Denmark)

    Wagtmann, Maria Anne

    2008-01-01

     In the early part of 2008, Maria Anne Wagtmann had the opportunity to interview the former president of the International Maritime Health Association, Dr. Tim Carter, in London about a number of current maritime health issues. In this interview, Dr. Tim Carter, who is cur­rently employed...... as the Chief Medical Advisor for the British government's Department for Transport, gives his personal - and thus non-official - opinions on these issues....

  13. Gender issues of financial analysts

    OpenAIRE

    Jingwen Ge

    2013-01-01

    Increased attention has been drawn to the gender disparity in workplace. This dissertation is dedicated to provide sight to the gender issues in financial analysts. Profound literature reviews are conducted about gender issues and financial analysts, respectively in order to comprehend the existing gender concerns in the business world, and role and functions of financial analysts. Research proposals are described to answer the following question: whether women financial analysts are more lik...

  14. Editorial: Special issue on education

    OpenAIRE

    Masal Ercan; Önder İsmail; Çalışkan Hüseyin; Beşoluk Şenol; Demirhan Eda

    2017-01-01

    This special issue consists of selected proceedings presented in ERPA International Congresses on Education 2017 which was held in Budapest / Hungary, 18-21 May 2017. Studies are related to educational sciences, science and mathematics education, social sciences education, health and sports science education, music and fine arts education, computer education and instructional technology, language education and management of education. There are eighty valuable studies in this special issue. I...

  15. Editorial: Special issue on education

    Directory of Open Access Journals (Sweden)

    Masal Ercan

    2017-01-01

    Full Text Available This special issue consists of selected proceedings presented in ERPA International Congresses on Education 2017 which was held in Budapest / Hungary, 18-21 May 2017. Studies are related to educational sciences, science and mathematics education, social sciences education, health and sports science education, music and fine arts education, computer education and instructional technology, language education and management of education. There are eighty valuable studies in this special issue. In sum the results of studies will contribute to the field.

  16. Australian uranium - the environmental issues

    International Nuclear Information System (INIS)

    Saddler, H.

    1980-01-01

    The principal theme of this paper is the changing pattern of issues which have dominated the environmental debate over uranium mining in Australia. These issues include the safeguards policy, a domestic energy policy, nuclear waste, economic development, particular environmental problems of the Alligator Rivers region and the social impact of uranium mining on the Aborigines. The special administrative arrangements which the Government has established for environmental protection in the Alligator Rivers region are outlined

  17. Characterizing Sleep Issues Using Twitter.

    Science.gov (United States)

    McIver, David J; Hawkins, Jared B; Chunara, Rumi; Chatterjee, Arnaub K; Bhandari, Aman; Fitzgerald, Timothy P; Jain, Sachin H; Brownstein, John S

    2015-06-08

    Sleep issues such as insomnia affect over 50 million Americans and can lead to serious health problems, including depression and obesity, and can increase risk of injury. Social media platforms such as Twitter offer exciting potential for their use in studying and identifying both diseases and social phenomenon. Our aim was to determine whether social media can be used as a method to conduct research focusing on sleep issues. Twitter posts were collected and curated to determine whether a user exhibited signs of sleep issues based on the presence of several keywords in tweets such as insomnia, "can't sleep", Ambien, and others. Users whose tweets contain any of the keywords were designated as having self-identified sleep issues (sleep group). Users who did not have self-identified sleep issues (non-sleep group) were selected from tweets that did not contain pre-defined words or phrases used as a proxy for sleep issues. User data such as number of tweets, friends, followers, and location were collected, as well as the time and date of tweets. Additionally, the sentiment of each tweet and average sentiment of each user were determined to investigate differences between non-sleep and sleep groups. It was found that sleep group users were significantly less active on Twitter (P=.04), had fewer friends (Pcost-effective, and customizable data to be gathered.

  18. Ethical issues in exercise psychology.

    Science.gov (United States)

    Pauline, Jeffrey S; Pauline, Gina A; Johnson, Scott R; Gamble, Kelly M

    2006-01-01

    Exercise psychology encompasses the disciplines of psychiatry, clinical and counseling psychology, health promotion, and the movement sciences. This emerging field involves diverse mental health issues, theories, and general information related to physical activity and exercise. Numerous research investigations across the past 20 years have shown both physical and psychological benefits from physical activity and exercise. Exercise psychology offers many opportunities for growth while positively influencing the mental and physical health of individuals, communities, and society. However, the exercise psychology literature has not addressed ethical issues or dilemmas faced by mental health professionals providing exercise psychology services. This initial discussion of ethical issues in exercise psychology is an important step in continuing to move the field forward. Specifically, this article will address the emergence of exercise psychology and current health behaviors and offer an overview of ethics and ethical issues, education/training and professional competency, cultural and ethnic diversity, multiple-role relationships and conflicts of interest, dependency issues, confidentiality and recording keeping, and advertisement and self-promotion.

  19. Introduction to the special issue

    Directory of Open Access Journals (Sweden)

    Gorka Elordieta

    2007-06-01

    Full Text Available For the past few years there has been an intense and increasing collaboration effort between researchers working on the Iberian languages, and this is particularly true in the realm of phonetics and phonology. The 'Journal of Portuguese Linguistics 'has played a role in contributing to stimulate such a collaborative research focusing on the Iberian languages: first with a Special Issue on 'Variation and Change in the Iberian Languages: the Peninsula and Beyond', and now with a Special Issue on the 'Prosody of Ibero-Romance and Related Languages'. In fact, to broaden its scope of coverage to the Iberian languages has become an explicit goal of the journal. As guest-editors of this issue, we are very pleased to be able to contribute to this objective, which we find an extremely fruitful one.

  20. Legal issues in radon affairs

    International Nuclear Information System (INIS)

    Massuelle, M.H.

    1999-01-01

    In France, it was only recently that cases related to high radon concentrations in dwellings received substantial publicity. This irruption of radon as a public health issue came with the general progress of scientific knowledge and the availability of a research capacity in France able to develop expertise. We are interested here in the legal implications of issues that arise from the lag between the activity of experts and the regulatory activity in the domain of radon. We use the term expertise very broadly, to cover the practical application of research findings, the relation of the researchers with the community, and finally the acts by which experts provide their knowledge to the community. We first examine the course by which science developed the radon issue and the way they organized to move from research to expertise; here we try to characterize the various needs for radon expertise. We then discuss the legal difficulties associated with radon expertise

  1. Legal issues in radon affairs

    Energy Technology Data Exchange (ETDEWEB)

    Massuelle, M.H. [Inst. de Protection et de Surete Nucleaire, Fontenay aux Roses (France)

    1999-12-01

    In France, it was only recently that cases related to high radon concentrations in dwellings received substantial publicity. This irruption of radon as a public health issue came with the general progress of scientific knowledge and the availability of a research capacity in France able to develop expertise. We are interested here in the legal implications of issues that arise from the lag between the activity of expertsand the regulatory activity in the domain of radon. We use the term expertise very broadly, to cover the practical application of research findings, the relation of the researchers with the community, and finally the acts by which experts provide their knowledge to the community. We first examine the course by which science developed the radon issue and the way they organized to move from research to expertise; here we try to characterize the various needs for radon expertise. We then discuss the legal difficulties associated with radon expertise.

  2. Workplace bullying: an emergent issue.

    Science.gov (United States)

    Essen, S Donovan; Esquivel, Cynthia; Jha, Pankaj

    2014-09-01

    All companies, including dentists, rely on their staff to represent their firms in the most positive and effective manner. Today's managers face a multitude of issues, and as such, they must walk a fine line of fostering a productive, harmonious and safe working environment for their employees. Over the last several decades it is apparent that on the- job sexual harassment is no longer the leading issue of employee complaints. Rather, the organization issue which was investigated is workplace bullying, also commonly referred to as employee harassment. Risk management is no longer limited to avoiding malpractice issues but also preventing litigation created by poor organizational behavior. The primary purpose of this paper is to explore the background of workplace bullying and how it affects today's managers and their employees, customers and suppliers. In other words, the scope of this paper will feature research on past studies, results and conclusions. Since workplace bullying affects all levels of a corporation, it must be stated that the concern and focus of this paper is for today's manager to understand the background and history of workplace bullying, and what they can do to foster a safe working environment and prevent the bully from creating mental and physical harm to their employees. This paper details the history of workplace bullying and how management, employees and suppliers deal with and address the issue. Lastly, this treatise looks at risk management from a manger/dentist's perspective, the assessment/conclusion summarizes the implications for managers regarding how they must handle the issue or risk harm to the employee and/or serious legal ramifications.

  3. Census 2001: issues and perspectives.

    Science.gov (United States)

    1998-01-01

    This article discusses the Census of India for 2001 and gender issues such as the sex ratio, undercounts of girls, tribe and scheduled caste data, and the data users' conference. The April 1998 conference was attended by representatives of government planning and development departments, research institutions, and statisticians and researchers. Under consideration was a government Ministry of Welfare proposal to reintroduce, after a 60-year hiatus, data by scheduled caste and tribe. This issue is complicated by criteria that vary by state and includability. Quotas for backward classes in educational institutions, government jobs, and in decision-making bodies are the reason for designations by caste. Some groups are distressed because of lack of inclusion as backward classes. M.N. Srinivas strongly advises that counting by caste will create problems for enumerators and will result in lawsuits and violent disturbances. G. Shah argues that caste counts will not weaken the caste system nor expand their political power, but will intensify internal conflicts between the Dalit and Bahujan movements. One other issue is the reintroduction of the 1961 Household schedule which provides family composition by landholding size and household enterprise. Krishnaji advises that this data would help analyze sex ratio imbalances. In 1997, the Core Group examined gender equity issues and operational issues about increasing the scope without increasing costs. The Core Group recommended caste data at the district and sub-district level. Undercounting of the female work force is a continuing issue from the 1991 Census. Suggestions by the Core Group are indicated in brief.

  4. Reproductive issues in anorexia nervosa

    Science.gov (United States)

    Hoffman, Elizabeth R; Zerwas, Stephanie C; Bulik, Cynthia M

    2011-01-01

    Despite a high prevalence of menstrual irregularities, women with anorexia nervosa are becoming pregnant. The physical and psychological demands of pregnancy and motherhood can represent an immense challenge for women already struggling with the medical and psychological stress of an eating disorder. This article summarizes key issues related to reproduction in women with anorexia nervosa, highlighting the importance of preconception counseling, adequate gestational weight gain, and sufficient pre- and post-natal nutrition. Postpartum issues including eating disorder symptom relapse, weight loss, breastfeeding, and risk of perinatal depression and anxiety are also discussed. PMID:22003362

  5. Ethical issues in radiation protection

    International Nuclear Information System (INIS)

    Shrader-Frechette, K.; Persson, L.

    1997-01-01

    In this note the authors survey existing international radiation-protection recommendations of the ICRP, the IAEA, and the ILO. After outlining previous work on the ethics of radiation protection and risk assessment/management, the authors review ethical thinking on five key issues related to radiation protection and ethics. They formulate each of these five issues in terms of alternative ethical stances: (1) Equity vs. Efficiency, (2) Health vs. Economics, (3) Individual Rights vs. Societal Benefits, (4) Due Process vs. Necessary Sacrifice, and (5) Stakeholder Consent vs. Management Decisions (authors)

  6. Liquid metal heat transfer issues

    International Nuclear Information System (INIS)

    Hoffman, H.W.; Yoder, G.L.

    1984-01-01

    An alkali liquid metal cooled nuclear reactor coupled with an alkali metal Rankine cycle provides a practicable option for space systems/missions requiring power in the 1 to 100 MW(e) range. Thermal issues relative to the use of alkali liquid metals for this purpose are identified as these result from the nature of the alkali metal fluid itself, from uncertainties in the available heat transfer correlations, and from design and performance requirements for system components operating in the earth orbital microgravity environment. It is noted that, while these issues require further attention to achieve optimum system performance, none are of such magnitude as to invalidate this particular space power concept

  7. Issues in Canadian LLRW management

    International Nuclear Information System (INIS)

    Charlesworth, D.H.

    1988-01-01

    Some of the issues which are of concern in Canada are similar to those being discussed in the US because Canadian low-level radioactive waste (LLRW) production is similar in quantity and characteristics to that which will be handled by some state compacts. This paper gives a Canadian viewpoint of: the choice between interim storage and permanent disposal; the importance of considering inadvertent intrusion; the role of waste categorization and stability; and the concerns in assessing disposal performance. The discussion is related to Atomic Energy of Canada Limited's LLRW disposal program, and its approach to resolving these issues

  8. Environmental issues: I - Energy utilization

    International Nuclear Information System (INIS)

    Dincer, I.

    2001-01-01

    In this article, energy utilization and its major environmental impacts are discussed from the standpoint of sustainable development, including anticipated patterns of future energy use and consequent environmental issues and policies. Overall, the paper also examines several issues related to energy utilization, environment, sustainable development from both current and future perspectives, and energy use and its environmental impacts in the transportation sector. Finally, the conclusions and recommendations are presented in the form to be beneficial to energy scientists, engineers and energy policy makers. (author)

  9. Editorial Volume 6 Issue 3

    Directory of Open Access Journals (Sweden)

    Ciorstan Smark

    2012-09-01

    Full Text Available This issue of AABFJ has several finance articles related to the Australian securities market. Segara, Das and Turner (2012 report results from the use of active extension strategies in the Australian equities market. Lee (2012 examines whether individual hedge funds and funds-of-hedge funds (FOHFs exhibit risk-return trade-off patterns. Finally, Aldamen, Duncan and Khan (2012 explore the impact of corporate governance on the demand for debt in the Australian market. Pickering (2012 explores the issue of whether public (ASX listed or partnership ownership of accounting firms is the more efficient form.

  10. Emergence Issues - not so simple

    African Journals Online (AJOL)

    Anaesthetics Supplement: Emergence Issues - not so simple. S Afr Fam Pract 2014. Vol 56 No 2 Supplement 1. Introduction. Emergence from anaesthesia is by definition the process of return to baseline physiological function of all organ systems after cessation of administration of general anaesthesia and is the stage from ...

  11. Current issues in perturbative QCD

    International Nuclear Information System (INIS)

    Hinchliffe, I.

    1994-12-01

    This review talk discusses some issues of active research in perturbative QCD. The following topics are discussed: (1) current value of αs; (2) heavy quark production in hadron collisions; (3) production of Ψ and Υ in p anti p collisions; (4) prompt photon production; (5) small-x and related phenomena; and (6) particle multiplicity in heavy quark jets

  12. Low carbon development. Key issues

    Energy Technology Data Exchange (ETDEWEB)

    Urban, Frauke; Nordensvaard, Johan (eds.)

    2013-03-07

    This comprehensive textbook addresses the interface between international development and climate change in a carbon constrained world. It discusses the key conceptual, empirical and policy-related issues of low carbon development and takes an international and interdisciplinary approach to the subject by drawing on insights from across the natural sciences and social sciences whilst embedding the discussion in a global context. The first part explores the concept of low carbon development and explains the need for low carbon development in a carbon constrained world. The book then discusses the key issues of socio-economic, political and technological nature for low carbon development, exploring topics such as the political economy, social justice, financing and carbon markets, and technologies and innovation for low carbon development. This is followed by key issues for low carbon development in policy and practice, which is presented based on cross-cutting issues such as low carbon energy, forestry, agriculture and transportation. Afterwards, practical case studies are discussed from low carbon development in low income countries in Africa, middle income countries in Asia and Latin America and high income countries in Europe and North America.

  13. Current Issues and Distributive Justice.

    Science.gov (United States)

    Rosal, Lorenca Consuelo

    1992-01-01

    Provides a lesson plan on the issue of distributive justice, or fairness in the ways things are distributed among individuals and groups. Includes a student reading concerning a proposed guaranteed standard of living. Proposes an activity that calls for student discussion of a constitutional amendment that would offer such a guarantee. (SG)

  14. Materials issues in cask development

    International Nuclear Information System (INIS)

    Chapman, R.L.; Sorensen, K.B.

    1987-01-01

    This paper identifies potential new materials as a function of their use in the cask. To the extent that identified materials are not yet qualified for their intended application, this paper identifies probable technical issues and development efforts that may be required to qualify the materials for use in transportation casks. 1 tab

  15. Classroom Issues with Series Tests

    Science.gov (United States)

    Sadek, Jawad; Euler, Russell

    2005-01-01

    We find infinite series in calculus to be one of the most confusing topics our students encounter. In this note, we look at some issues that our students find difficult or ambiguous involving the Ratio Test, the Root Test, and also the Alternating Series Test. We offer some suggestions and some examples, which could be a supplement to the set of…

  16. Virtual Special Issue on Migration

    NARCIS (Netherlands)

    Jordan, Declan; Elhorst, Paul

    2016-01-01

    This editorial introduces a virtual special issue of Spatial Economic Analysis compiled to mark the keynote lecture at the 46th Annual Conference of the Regional Science Association InternationalBritish and Irish Section in Cornwall by Professor Jacques Poot of the National Institute of Demographic

  17. Scale issues in tourism development

    Science.gov (United States)

    Sinji Yang; Lori Pennington-Gray; Donald F. Holecek

    1998-01-01

    Proponents of Alternative Tourism overwhelmingly believe that alternative forms of tourism development need to be small in scale. Inasmuch as tourists' demand has great power to shape the market, the issues surrounding the tourism development scale deserve further consideration. This paper discusses the implications and effects of the tourism development scale on...

  18. Constitutional Issues: Separation of Powers.

    Science.gov (United States)

    Gray, Leslie; Burroughs, Wynell

    1987-01-01

    Using a copy of a February 1937 letter from the publisher of the Gannett newspapers as a discussion springboard, this article provides historical background and teaching suggestions for addressing the issue of the separation of powers through Franklin Roosevelt's attempt to 'pack' the Supreme Court. (JDH)

  19. Defamation Issues in Higher Education.

    Science.gov (United States)

    Bazluke, Francine Tilewick

    This monograph reviews the law applying to defamation issues, cites various judicial decisions that affect colleges and universities, and offers guidance for minimizing the risk of defamation liability. It defines the two subclasses of defamatory statements: first, libel, which is a recorded or printed statement, and second, slander, which is…

  20. CONTEMPORARY AFRICAN PHILOSOPHY: EMERGENT ISSUES ...

    African Journals Online (AJOL)

    Dean SPGS NAU

    another on meta-philosophical issues about African philosophy, their successors, in ... Key Words: African identity, hermeneutics and culture, ... Even the quest to overcome the hegemony of Western ..... African philosophers to rethink the principles, concepts, attitudes ... there is a certain openness to new possibilities at the.

  1. Ethical Issues in Media Practice

    Institute of Scientific and Technical Information of China (English)

    马慧

    2009-01-01

    Journalists are always confronted by ethical definitions on the daily basis during their media practice.In this article,some ethical issues happened in media practice are analyzed,and aspects of both news reporters and public opinion are deeply studied,and the balance between both professional and ethics is probed seriously as well.

  2. Ethical issues in animal cloning.

    Science.gov (United States)

    Fiester, Autumn

    2005-01-01

    The issue of human reproductive cloning has recently received a great deal attention in public discourse. Bioethicists, policy makers, and the media have been quick to identify the key ethical issues involved in human reproductive cloning and to argue, almost unanimously, for an international ban on such attempts. Meanwhile, scientists have proceeded with extensive research agendas in the cloning of animals. Despite this research, there has been little public discussion of the ethical issues raised by animal cloning projects. Polling data show that the public is decidedly against the cloning of animals. To understand the public's reaction and fill the void of reasoned debate about the issue, we need to review the possible objections to animal cloning and assess the merits of the anti-animal cloning stance. Some objections to animal cloning (e.g., the impact of cloning on the population of unwanted animals) can be easily addressed, while others (e.g., the health of cloned animals) require more serious attention by the public and policy makers.

  3. Preface. Current Issues in Ethics

    Directory of Open Access Journals (Sweden)

    Holy-Luczaj Magdalena

    2017-07-01

    Full Text Available This interdisciplinary volume consist of papers on various problems in contemporary ethics. It presents the following issues: equalizing the level of positive liberty, the phenomenon of human cooperation, ethical questions related to artificial intelligence, extending ethical obligations toward artifacts, and soteriological threads of alienation criticism of religion.

  4. Controversial Issues in Learning Disability.

    Science.gov (United States)

    Sapir, Selma C.

    The author discusses controversial issues in the field of learning disabilities (LD). Among topics addressed are conflicting definitions of LD and the impact of the operational definition accepted by the US Government; etiological questions concerning the separation of neurological, environmental, and emotional factors; approaches used in training…

  5. Overriding information issues. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Hein, Vibeke

    1998-04-01

    The Nordic project on overriding information issues focus on why an information project, how to inform about a difficult subject in a modern society, how to provide advance information, how to inform when the accident has occurred and how to inform about NKS and projects. (au)

  6. Issues for the 1990s.

    Science.gov (United States)

    Weiner, Edith; Brown, Arnold

    1986-01-01

    Discussed are the issues now emerging that seem likely to dominate thinking, planning, and decision-making in the United States and elsewhere during the next decade. These include campus unrest, China as a world economic force, controlling health-care, birth defects, role of the computer in education, and human language/computer language. (RM)

  7. Special issue of photosynthetic research

    NARCIS (Netherlands)

    Okamura, M.; Wraight, C.A.; van Grondelle, R.

    2014-01-01

    This Special Issue of Photosynthesis Research honors Louis M. N. Duysens, Roderick K. Clayton, and George Feher, three pioneering researchers whose work on bacterial photosynthesis laid much of the groundwork for our understanding of the role of the reaction center in photosynthetic light energy

  8. Psychosocial Issues in Pediatric Oncology

    Science.gov (United States)

    Marcus, Joel

    2012-01-01

    Psychosocial oncology, a relatively new discipline, is a multidisciplinary application of the behavioral and social sciences, and pediatric psychosocial oncology is an emerging subspecialty within the domain of psychosocial oncology. This review presents a brief overview of some of the major clinical issues surrounding pediatric psychosocial oncology. PMID:23049457

  9. Counseling Research: Ethics and Issues.

    Science.gov (United States)

    Robinson, Sharon E.; Gross, Douglas R.

    1986-01-01

    Identifies three global areas for reserach study: (a) clinical studies, (b) counselor training investigation, and (c) evaluation. Issues such as competency, informed consent, confidentiality and privacy, cooptation and manipulation, no treatment controls, validity and generalizability of results, and authorship are discussed. (Author/BL)

  10. Environmental issues affecting CCT development

    Energy Technology Data Exchange (ETDEWEB)

    Wainman, B. [U.S. House of Representatives, Washington, DC (United States)

    1997-12-31

    The author discusses her thoughts on prospects for an energy policy from this Congress. She doesn`t believe the country will see any big sweeping energy policy acts or even utility deregulation in the next two years. Education on the issues is necessary. The author discusses the impacts for clean coal technologies and recommends continued aggressive work on deployment.

  11. Issues in Coastal Zone Management.

    Science.gov (United States)

    Davis, Derrin

    1992-01-01

    Addresses the following issues relevant to coastal zone management: overcrowding, resource exploitation, pollution, agriculture, fisheries, industrial, and other uses. Describes conflicts and trade-offs in management typified by fragmented agency decision making. Discusses implications of the greenhouse effect, sustainable development, and the…

  12. Contemporary issues in evolutionary biology

    Indian Academy of Sciences (India)

    We are delighted to bring to the readers, a set of peer-reviewed papers on evolutionary biology, published as a special issue of the Journal of Genetics. These papers emanated from ruminations upon and discussions at the Foundations of. Evolutionary Theory: the Ongoing Synthesis meeting at Coorg, India, in February ...

  13. Addressing Transgender Issues in Schools

    Science.gov (United States)

    Cavanagh, Marian

    2016-01-01

    As mainstream media focus more attention on transgender issues, and as anti-discrimination laws evolve, a shift is taking place on campuses. Many schools now include gender identity and expression in their inclusivity work and seek to establish policies and procedures to support transgender students and their families. It's not an easy task. In…

  14. Editorial Volume 4 Issue 3

    Directory of Open Access Journals (Sweden)

    Ciorstan J. Smark

    2010-09-01

    Full Text Available This issue of AABFJ presents papers from a range of approaches and research topics in keeping with thejournal’s broad focus on accounting, finance and business. This issue includes the examination of microstructurefinance in the context of real estate pricing and an analysis straddling financial analysis and the roleof accounting standards in decision-making. The policing paper in accounting employs a socialconstructionist approach to the study of the New Zealand public sector. Business education is represented ina study of students undertaking internships as part of their university degree in commerce. In the last issue,the editors flagged the move to broaden the scope of the journal to include shorter articles and book reviews.This issue presents the first book review. Readers will no doubt notice that the printable Research Onlineformat has returned to A4. In an environment of resource constraints, both financially and environmentally,the editors decided that the revised format is more appropriate. As usual, electronic media is the mostprevalent mode of delivery.This

  15. Family Issues in Multigenerational Households.

    Science.gov (United States)

    Feinauer, Leslie L; And Others

    1987-01-01

    Studied issues faced by multigenerational families and their implications for family therapy. Major factors in multigenerational households included dependency, sibling relationships, depression, and demanding and egocentric behavior. Factors to consider during family therapy include respite care, age, interdependence, dignity, provision of care,…

  16. Cybernetics and Education (Special Issue)

    Science.gov (United States)

    Kopstein, Felix F., Ed.

    1977-01-01

    This is a special issue examining the potential of cybernetics in educational technology. Articles discuss: cybernetic methods, algorithms, feedback learning theory, a structural approach to behavioral objectives and criterion-referenced testing, task specifications and diagnosis, teacher-child interaction, educational development, teaching…

  17. Communication: an ophthalmic practice issue.

    Science.gov (United States)

    Whitton, S J

    1995-12-01

    In the 1990's communication becomes an ophthalmic practice issue. The present ophthalmic climate of cost containment, downsizing, budget cuts, and lack of appreciation of contributions, results in a low staff morale. Recognition of the effects of job satisfaction and productivity led one group to seek solutions. A communication task force was formed to identify problems and the appropriate interventions.

  18. Menopause: Salient Issues for Counselors.

    Science.gov (United States)

    Patterson, Marilyn M.; Lynch, Ann Q.

    1988-01-01

    Discusses issues surrounding menopause, with the idea that counselors are in an ideal position to help change attitudes toward viewing menopause as a time of positive change rather than a time of psychological distress. Reviews historical, sociological, psychological, and attitudinal factors that account for negative responses associated with…

  19. Preface. Current Issues in Ethics

    OpenAIRE

    Holy-Luczaj Magdalena

    2017-01-01

    This interdisciplinary volume consist of papers on various problems in contemporary ethics. It presents the following issues: equalizing the level of positive liberty, the phenomenon of human cooperation, ethical questions related to artificial intelligence, extending ethical obligations toward artifacts, and soteriological threads of alienation criticism of religion.

  20. Introducing to the first issue

    Directory of Open Access Journals (Sweden)

    Cesar Acleto

    2014-06-01

    Full Text Available The presentation of the first issue of the REVISTA PERUANA DE BIOLOGíA, as official organ of dissemination of ASOCIACION DE BIOLOGOS DE LA UNIVERSIDAD DE SAN MARCOS, the reverse of the COVER is included with editorial information and BACK COVER with guidelines for authors and the reverse table with the CONTENS.

  1. Conventional shell model: some issues

    International Nuclear Information System (INIS)

    Vallieres, M.; Pan, X.W.; Feng, D.H.; Novoselsky, A.

    1997-01-01

    We discuss some important issues in shell-model calculations related to the effective interactions used in different regions of the periodic table; in particular the quality of different interactions is discussed, as well as the mass dependence of the interactions. Mention is made of the recently developed Drexel University shell-model (DUSM). (orig.)

  2. NST Quarterly - issue October 2001

    International Nuclear Information System (INIS)

    2001-01-01

    NST Quarterly reports current development in Nuclear Science and Technology in Malaysia. In this issue it reviews GM technology and GMOs - genetically modified organisms. The topics discussed includes the implication of GM in practice, the controversy and the prospect of GM technology. Radioactive pig - something like a ball or plug which cleanses the inner walls of the pipeline, also briefly presented

  3. NST Quarterly - October 1997 issue

    International Nuclear Information System (INIS)

    1997-01-01

    NST Quarterly reports current development in Nuclear Science and Technology in Malaysia. In this issue it highlights MINT activities in scientific computer modelling and simulation. A report on 2-nd FAO/IAEA research coordination meeting (RCM) of the coordinated research programme (CRP) on public acceptance of the trade development in irradiated food in Asia and the Pacific (RPFI-IV) also presented

  4. Complicating Issues in Holocaust Education

    Science.gov (United States)

    Lindquist, David H.

    2010-01-01

    Confronting the Holocaust in a classroom setting involves a complex undertaking that demands careful planning as educators develop and present curricula on the subject to their students. This article explores another problematic factor involved in teaching the Shoah, that is, several issues that exist outside the content/pedagogical framework but…

  5. Resolving Ethical Issues at School

    Science.gov (United States)

    Benninga, Jacques S.

    2013-01-01

    Although ethical dilemmas are a constant in teachers' lives, the profession has offered little in the way of training to help teachers address such issues. This paper presents a framework, based on developmental theory, for resolving professional ethical dilemmas. The Four-Component Model of Moral Maturity, when used in conjunction with a…

  6. Malaysian Serials: Issues and Problems.

    Science.gov (United States)

    Bahri, Che Norma

    This paper analyzes the issues and problems while looking at the trends and developments of serials publishing in Malaysia. The first section provides background; topics addressed include the country and people of Malaysia, the history of serials publishing in Malaysia, categories and formats of serials publishing, academic publications,…

  7. Psychosocial Issues in Learning Disabilities.

    Science.gov (United States)

    Heisler, Alice B.

    1983-01-01

    Emotional development from infancy to adolescence is traced and the effects of psychosocial issues on a child with a learning disability are considered for five of E. Erikson's seven proposed stages (trust, autonomy, initiative, industry, adolescence). The need for intervention and parent counseling at each state is emphasized. (CL)

  8. Classroom Implementation. Issues in Assessment.

    Science.gov (United States)

    Malinowski, Patricia A., Ed.

    This booklet, second in a series on issues in assessment, seeks to describe an initiative supported by Finger Lakes Community College (New York) to use classroom assessment techniques (CATs) in different academic areas and to present an overview of some assessment approaches that have been used in the classroom. Papers include: (1) "Enhancing…

  9. Strategic Issues in University Management

    NARCIS (Netherlands)

    Roosendaal, Hans E.

    2005-01-01

    In this paper we will discuss developments in the field of scientific information with the aim to determine and analyse some of the pertinent strategic issues related to higher education (HE) as seen from the stakeholder perspective of the university and its management.

  10. Study of rural transportation issues.

    Science.gov (United States)

    2010-04-01

    This report is in response to Section 6206 of the Food, Conservation, and Energy Act of 2008 (PL : 110-246), which directs the Secretaries of Agriculture and Transportation jointly to conduct a : study of rural transportation issues. The report revie...

  11. Ethical issues with cognitive enhancement

    African Journals Online (AJOL)

    drugs, so this is discriminatory on the basis of economic inequality. There are other ethical issues. Methylphenidate is licensed to be prescribed for ADHD and narcolepsy. Prescribing it to improve academic performance in a normal subject is prescribing the drug “off-label” and not in the recommendations of the producers.

  12. NST Quarterly - April 2000 issue

    International Nuclear Information System (INIS)

    1999-01-01

    NST Quarterly reports current development in Nuclear Science and Technology in Malaysia. In this issue it highlights MINT activities in genetic engineering. The articles summarized the improvement of orchids and tulips through genetic engineering and generating new varieties for the floriculture industry. It also reported, MINT won gold and silver at the International Invention 2000, 12-16 April 2000, Geneva

  13. Using Online Databases in Corporate Issues Management.

    Science.gov (United States)

    Thomsen, Steven R.

    1995-01-01

    Finds that corporate public relations practitioners felt they were able, using online database and information services, to intercept issues earlier in the "issue cycle" and thus enable their organizations to develop more "proactionary" or "catalytic" issues management repose strategies. (SR)

  14. Ethical issues in radiation protection

    International Nuclear Information System (INIS)

    Persson, Lars

    2000-03-01

    Ethical theories are relevant to the current recommendations and standards for radiation protection. Radiation protection is not only a matter for science. It is also a problem of philosophy. In order for protection regulations to be respected, it must correspond to widely accepted ethical values among those who are affected by the regulations. The workshop covered the following issues: Problems in Present Protection Policy, ICRP Protection Policy - A Historical Perspective, Radiation Risk - What we know and what we believe, Present ICRP Recommendations, Ethical Values in the Context of ICRP Recommendations, Collective Responsibility for Invisible Harm, Environmental Protection - Ethical Issues, The Global Change of Values, and Procedural justice and Radiation Protection. Six workshop contributions and a workshop summary are presented in this report

  15. Editorial, Volume 7, Issue 2

    Directory of Open Access Journals (Sweden)

    Kristy L Archuleta

    2016-12-01

    Full Text Available This issue features four articles, two profiles, and one book review. Each article adds a new contribution to the field of financial therapy. First, Dr. Asebedo applies a conflict resolution framework to money arguments. Next, Drs. Rea, Zuiker, and Mendenhall explore financial management practices among emerging adult couples. In the third paper, Drs. Ann Woodyard and Cliff Robb help to add further description of financial satisfaction. Then, Dr. Russell James offers a unique theoretical analysis of mortality salience and financial decisions. This issue also features a practitioner profile of Beth Crittenden and a scholar profile of Sarah Asebedo. Finally, we conclude with a review by Neal VanZutphen about a book entitled, The Seven Principles for Making Marriage Work.

  16. Ethical issues in radiation protection

    Energy Technology Data Exchange (ETDEWEB)

    Persson, Lars (ed.)

    2000-03-15

    Ethical theories are relevant to the current recommendations and standards for radiation protection. Radiation protection is not only a matter for science. It is also a problem of philosophy. In order for protection regulations to be respected, it must correspond to widely accepted ethical values among those who are affected by the regulations. The workshop covered the following issues: Problems in Present Protection Policy, ICRP Protection Policy - A Historical Perspective, Radiation Risk - What we know and what we believe, Present ICRP Recommendations, Ethical Values in the Context of ICRP Recommendations, Collective Responsibility for Invisible Harm, Environmental Protection - Ethical Issues, The Global Change of Values, and Procedural justice and Radiation Protection. Six workshop contributions and a workshop summary are presented in this report.

  17. Accounting-related transmission issues

    International Nuclear Information System (INIS)

    Niehaus, M.; Bjorn, P.; Pate, G.

    1999-01-01

    Various initiatives have been undertaken by the Federal Energy Regulatory Commission (FERC) to deregulate wholesale electric energy markets. These initiatives have focused on restructuring the transmission systems in the US and recently have culminated in a proposal requiring formation of and participation in regional transmission organizations. The overall form of regulation selected to determine rates for transmission entities as well as underlying regulatory decisions reached on key issues will have profound implications for transmission entities. For example, traditional cost-based regulation would require one set of accounting and reporting rules, while incentive-based regulation may not be subject to those same rules. An overview of some of the major accounting and financial reporting issues that will need to be considered is presented

  18. Foreword: Biomonitoring Equivalents special issue.

    Science.gov (United States)

    Meek, M E; Sonawane, B; Becker, R A

    2008-08-01

    The challenge of interpreting results of biomonitoring for environmental chemicals in humans is highlighted in this Foreword to the Biomonitoring Equivalents (BEs) special issue of Regulatory Toxicology and Pharmacology. There is a pressing need to develop risk-based tools in order to empower scientists and health professionals to interpret and communicate the significance of human biomonitoring data. The BE approach, which integrates dosimetry and risk assessment methods, represents an important advancement on the path toward achieving this objective. The articles in this issue, developed as a result of an expert panel meeting, present guidelines for derivation of BEs, guidelines for communication using BEs and several case studies illustrating application of the BE approach for specific substances.

  19. Technical issues in fusion reactors

    International Nuclear Information System (INIS)

    Rohatgi, V.K.; Vijayan, T.

    1989-01-01

    In this paper the issues in fusion reactor technology are examined. Rapid progress in fusion technology research in recent years can be attributed to the advances in various technologies. The commercial generation of fusion power greatly depends on the evolution and improvements in these technologies. With better understanding of plasma physics, fusion reactor designs are becoming more and more realistic and comprehensive. It is now possible to compare various concepts within the framework of established technologies. The technological issues needing better understanding and solutions to problem areas are identified. Various instabilities and energy losses are major problem areas. Extensive developments in reactor-relevant advanced materials, compact and powerful superconducting magnets, high-power systems, and plasma heating drivers need to be undertaken and emphasized

  20. Reliability issues at the LHC

    CERN Multimedia

    CERN. Geneva. Audiovisual Unit; Gillies, James D

    2002-01-01

    The Lectures on reliability issues at the LHC will be focused on five main Modules on five days. Module 1: Basic Elements in Reliability Engineering Some basic terms, definitions and methods, from components up to the system and the plant, common cause failures and human factor issues. Module 2: Interrelations of Reliability & Safety (R&S) Reliability and risk informed approach, living models, risk monitoring. Module 3: The ideal R&S Process for Large Scale Systems From R&S goals via the implementation into the system to the proof of the compliance. Module 4: Some Applications of R&S on LHC Master logic, anatomy of risk, cause - consequence diagram, decomposition and aggregation of the system. Module 5: Lessons learned from R&S Application in various Technologies Success stories, pitfalls, constrains in data and methods, limitations per se, experienced in aviation, space, process, nuclear, offshore and transport systems and plants. The Lectures will reflect in summary the compromise in...

  1. YOUNG INVESTIGATOR SPECIAL ISSUE (Editorial

    Directory of Open Access Journals (Sweden)

    Eric Eils

    2004-11-01

    Full Text Available Welcome to the first Young Investigator Special Issue of the Journal of Sports Science and Medicine (JSSM. The JSSM family is proud to start this new service to the Sport Science community and to young researchers. The background in starting this issue was the observation that large amounts of high-quality research is conducted every year by students and young investigators, but often remains solely in local university libraries and never reaches the scientific community or databases. In addition, most international journals have a high threshold in accepting papers, and it is often hard to reach this level for junior scientists because of lack of experience, supervision or confidence. These are major reasons that delay or in some cases stop young researchers from publishing their valuable work. We all received help from senior colleagues in the beginning of our career. Now it is our turn to help youngsters. With this special issue, the JSSM is now serving young researchers as a channel for publishing their work. Our goal is to motivate young researchers to submit their work to JSSM, but we also aim to motivate supervisors and expert referees to be supportive and constructive towards these young scientists at the very beginning of their career. The Young Investigator Special Issue followed a normal peer-review process, except that there were no straight rejections in the first phase of review. We advised the reviewers of the Young Investigator Special Issue to proceed with constructive advice and remarks for all manuscripts. This offered a great opportunity for the Young Investigators to revise the manuscript, while at the same time contributing to the learning process. Thereafter, if the revisions were properly conducted according to the remarks from reviewers, the manuscripts were accepted for publication. We have received many manuscripts from young researchers with a lot of potential. There has been plenty of evidence of great talent

  2. Calculating utility prudency issue costs

    International Nuclear Information System (INIS)

    Nielsen, K.R.

    1985-01-01

    The nuclear industry, particularly utilities and their construction, engineering and vendor agents, is faced with a surging increase in prudency management audits. What started as primarily a nuclear project-oriented requirement has spread to encompass most significant utility capital construction projects. Such audits are often a precedent condition to commencement of rate hearings. The cost engineer, a primary major capital construction project participant, is required to develop or critique ''prudency issue'' costs as part of such audits. Although utility costs in the broadest sense are potentially at issue, this paper concentrates on the typical project/construction management costs. The costs of design, procurement and construction are all subject to the calculation process

  3. Sustainability issues in civil engineering

    CERN Document Server

    Saride, Sireesh; Basha, B

    2017-01-01

    This compilation on sustainability issues in civil engineering comprises contributions from international experts who have been working in the area of sustainability in civil engineering. Many of the contributions have been presented as keynote lectures at the International Conference on Sustainable Civil Infrastructure (ICSCI) held in Hyderabad, India. The book has been divided into core themes of Sustainable Transportation Systems, Sustainable Geosystems, Sustainable Environmental and Water Resources and Sustainable Structural Systems. Use of sustainability principles in engineering has become an important component of the process of design and in this context, design and analysis approaches in civil engineering are being reexamined to incorporate the principles of sustainable designs and construction in practice. Developing economies are on the threshold of rapid infrastructure growth and there is a need to compile the developments in various branches of civil engineering and highlight the issues. It is th...

  4. Issues in recycling galvanized scrap

    Energy Technology Data Exchange (ETDEWEB)

    Koros, P.J. [LTV Steel Co., Inc., Cleveland, OH (United States); Hellickson, D.A. [General Motors Corp., Detroit, MI (United States); Dudek, F.J. [Argonne National Lab., IL (United States)

    1995-02-10

    The quality of the steel used for most galvanizing (and tinplate) applications makes scrap derived from their production and use a premier solid charge material for steelmaking. In 1989 the AISI created a Task Force to define the issues and to recommend technologically and economically sound approaches to assure continued, unhindered recyclability of the growing volume of galvanized scrap. The AISI program addressed the treatment of full-sized industrial bales of scrap. The current, on-going MRI (US)--Argonne National Laboratory program is focused on ``loose`` scrap from industrial and post-consumer sources. Results from these programs, issues of scrap management from source to steel melting, the choices for handling zinc in iron and steelmaking and the benefits/costs for removal of zinc (and lead) from scrap prior to melting in BOF and foundry operations are reviewed in this paper.

  5. Clearing and vegetation management issues

    International Nuclear Information System (INIS)

    Anon.

    1994-01-01

    Clearing and continued management of incompatible plant species is critical to maintaining safe and reliable transmission and distribution lines at British Columbia Hydro. As part of a general review of policies regarding rights-of-way, the clearing of BC Hydro rights-of-way was studied by a task team in order to formulate a set of recommended policies and procedures to guide employees in all rights-of-way decisions, and to provide clear direction for resolution of all rights-of-way issues in a cost-effective manner. Issues reviewed were: clearing standards and line security standardization for transmission circuits; clearing rights for removal of trees or management of vegetation beyond the statutory right-of-way; clearing and vegetation management procedures; tree replacement; arboricultural techniques; periodic reviewing of clearing practices; compensation for tree removal; herbicide use; and heritage and wildlife trees. Justification for the recommendation is provided along with alternate options and costs of compliance

  6. Surrogacy: Ethical and Legal Issues

    Directory of Open Access Journals (Sweden)

    Pikee Saxena

    2012-01-01

    Full Text Available Surrogacy refers to a contract in which a woman carries a pregnancy "for"another couple. Number of infertile couples from all over the World approach India where commercial surrogacy is legal. Although this arrangement appears to be beneficial for all parties concerned,there are certain delicate issues which need to be addressed through carefully framed laws in order to protect the rights of the surrogate mother and the intended parents.

  7. Surrogacy: Ethical and Legal Issues

    Science.gov (United States)

    Saxena, Pikee; Mishra, Archana; Malik, Sonia

    2012-01-01

    Surrogacy refers to a contract in which a woman carries a pregnancy “for” another couple. Number of infertile couples from all over the World approach India where commercial surrogacy is legal. Although this arrangement appears to be beneficial for all parties concerned,there are certain delicate issues which need to be addressed through carefully framed laws in order to protect the rights of the surrogate mother and the intended parents. PMID:23293432

  8. [DEONTOLOGICAL ISSUES IN RAILWAY HYGIENE].

    Science.gov (United States)

    Kaptsov, V A

    2015-01-01

    There are presented the main ethical and deontological problems encountered in practice and research activities of the hygienist in transport. There is shown the importance of strict compliance with hygienic standards, disregard for the principle of "technical attainability", the necessity of continuous training, improvement of skills of sanitary-educational activity and readiness to solve emerging ethical issues in connection with the development of scientific and technical progress.

  9. NST Quarterly - January 1997 issue

    International Nuclear Information System (INIS)

    1997-01-01

    NST Quarterly reports current development in Nuclear Science and Technology in Malaysia. In this issue it highlights MINT activities in local heat shrinkable copolymer and electron beam technology for purification of flue gases. It announces an International Nuclear Conference themed ' a new era in nuclear science and technology - the challenge of the 21 century ' will be held in Kuala Lumpur, Malaysia from 29 to 30 Sept 1997

  10. System issues for multichip packaging

    Science.gov (United States)

    Sage, Maurice G.; Hartley, Neil

    1991-04-01

    It is now generally recognised that the performance of an electronic system is governed by the choice of packaging technology. Never before have the technical and financial implications of a packaging technology choice been more critical and never before has technology interdependence or industry globalisation made the choice more difficult. This paper is aimed at examining the choices available and the system issues resulting from the move from single chip to multichip packaging.

  11. [Ethical issues in transfusion medicine].

    Science.gov (United States)

    Tissot, J-D; Danic, B; Cabaud, J-J; Garraud, O

    2016-09-01

    Ethics is on the cross road of off values that are present along the ways of transfusion medicine. This is an important tool to afford opinions as well as debates that always emerge when discussing transfusion medicine. The wording is particularly important; this was one among several others that characterized the soul of Jean-Jacques Lefrère when he opened the doors of the ethical issues of transfusion medicine. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  12. Reproductive issues in anorexia nervosa

    OpenAIRE

    Hoffman, Elizabeth R; Zerwas, Stephanie C; Bulik, Cynthia M

    2011-01-01

    Despite a high prevalence of menstrual irregularities, women with anorexia nervosa are becoming pregnant. The physical and psychological demands of pregnancy and motherhood can represent an immense challenge for women already struggling with the medical and psychological stress of an eating disorder. This article summarizes key issues related to reproduction in women with anorexia nervosa, highlighting the importance of preconception counseling, adequate gestational weight gain, and sufficien...

  13. Key issues for passive safety

    International Nuclear Information System (INIS)

    Hayns, M.R.

    1996-01-01

    The paper represents a summary of the introductory presentation made at this Advisory Group Meeting on the Technical Feasibility and Reliability of Passive Safety Systems. It was intended as an overview of our views on what are the key issues and what are the technical problems which might dominate any future developments of passive safety systems. It is, therefore, not a ''review paper'' as such and only record the highlights. (author)

  14. Preterm birth, an unresolved issue

    OpenAIRE

    Beliz?n, Jose M; Hofmeyr, Justus; Buekens, Pierre; Salaria, Natasha

    2013-01-01

    Premature birth is the world?s leading cause of neonatal mortality with worldwide estimates indicating 11.1% of all live births were preterm in 2010. Preterm birth rates are increasing in most countries with continual differences in survival rates amongst rich and poor countries. Preterm birth is currently an important unresolved global issue with research efforts focusing on uterine quiescence and activation, the ?omics? approaches and implementation science in order to reduce the incidence ...

  15. Digital Storytelling – Special issue

    OpenAIRE

    Yngve Nordkvelle

    2010-01-01

    Since the inception of Seminar.net the phenomenon of Digital Storytelling has often been suggested as a promising genre for teaching and learning in a variety of areas. Academically, the genre has attracted interest from scholars in media studies, political science, social work, health and education. In this issue we have sought attention from a huge number of academically inclined persons who either use the genre to teach with media, for teaching and learning about media, or studying how thi...

  16. Scale issues in remote sensing

    CERN Document Server

    Weng, Qihao

    2014-01-01

    This book provides up-to-date developments, methods, and techniques in the field of GIS and remote sensing and features articles from internationally renowned authorities on three interrelated perspectives of scaling issues: scale in land surface properties, land surface patterns, and land surface processes. The book is ideal as a professional reference for practicing geographic information scientists and remote sensing engineers as well as a supplemental reading for graduate level students.

  17. Accelerator Availability and Reliability Issues

    Energy Technology Data Exchange (ETDEWEB)

    Steve Suhring

    2003-05-01

    Maintaining reliable machine operations for existing machines as well as planning for future machines' operability present significant challenges to those responsible for system performance and improvement. Changes to machine requirements and beam specifications often reduce overall machine availability in an effort to meet user needs. Accelerator reliability issues from around the world will be presented, followed by a discussion of the major factors influencing machine availability.

  18. Surrogacy: ethical and legal issues.

    Science.gov (United States)

    Saxena, Pikee; Mishra, Archana; Malik, Sonia

    2012-10-01

    Surrogacy refers to a contract in which a woman carries a pregnancy "for" another couple. Number of infertile couples from all over the World approach India where commercial surrogacy is legal. Although this arrangement appears to be beneficial for all parties concerned,there are certain delicate issues which need to be addressed through carefully framed laws in order to protect the rights of the surrogate mother and the intended parents.

  19. Environmental issues affecting CCT development

    Energy Technology Data Exchange (ETDEWEB)

    Reidy, M. [U.S. House of Representatives, Washington, DC (United States)

    1997-12-31

    While no final legislative schedule has been set for the new Congress, two issues with strong environmental ramifications which are likely to affect the coal industry seem to top the list of closely watched debates in Washington -- the Environmental Protection Agency`s proposed new ozone and particulate matter standards and utility restructuring. The paper discusses the background of the proposed standards, public comment, the Congressional review of regulations, other legislative options, and utility restructuring.

  20. Ethical Issues in Sports Medicine

    OpenAIRE

    Greenfield, Bruce H.; West, Charles Robert

    2012-01-01

    Ethical issues present a challenge for health care professionals working with athletes of sports teams. Health care professionals?including the team physician, the physical therapist, and the athletic trainer?are faced with the challenge of returning an athlete to competition as quickly as possible but as safely as possible. Conflicts of interest arise due to conflicting obligations of the team physician to the athlete and other members of the sports organization, including coaches and the te...