WorldWideScience

Sample records for cder pharmacovigilance review

  1. How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities.

    Science.gov (United States)

    Tyner, Katherine M; Zheng, Nan; Choi, Stephanie; Xu, Xiaoming; Zou, Peng; Jiang, Wenlei; Guo, Changning; Cruz, Celia N

    2017-07-01

    The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration (FDA) was established to assess the potential impact of nanotechnology on drug products. One of the working group's major initiatives has been to conduct a comprehensive risk management exercise regarding the potential impact of nanomaterial pharmaceutical ingredients and excipients on drug product quality, safety, and efficacy. This exercise concluded that current review practices and regulatory guidance are capable of detecting and managing the potential risks to quality, safety, and efficacy when a drug product incorporates a nanomaterial. However, three risk management areas were identified for continued focus during the review of drug products containing nanomaterials: (1) the understanding of how to perform the characterization of nanomaterial properties and the analytical methods used for this characterization, (2) the adequacy of in vitro tests to evaluate drug product performance for drug products containing nanomaterials, and (3) the understanding of properties arising from nanomaterials that may result in different toxicity and biodistribution profiles for drug products containing nanomaterials. CDER continues to actively track the incorporation of nanomaterials in drug products and the methodologies used to characterize them, in order to continuously improve the readiness of our science- and risk-based review approaches. In parallel to the risk management exercise, CDER has also been supporting regulatory research in the area of nanotechnology, specifically focused on characterization, safety, and equivalence (between reference and new product) considerations. This article provides a comprehensive summary of regulatory and research efforts supported by CDER in the area of drug products containing nanomaterials and other activities supporting the development of this emerging technology.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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.

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

    African Journals Online (AJOL)

    The studies were extracted from seven databases, viz, Google Scholars, Medline, Academic Search Complete “EBSCO”, Health and Medical Complete ProQuest, Science Direct- Elsevier, SCOPUS and Wiley Online Library. Results: The review revealed that although the reports by patients were of good quality, the patients' ...

  8. 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.

  9. 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

    A scoping review to characterize the literature on the use of conversations in social media as a potential source of data for detecting adverse events (AEs) related to health products. Our specific research questions were (1) What social media listening platforms exist to detect adverse events related to health products, and what are their capabilities and characteristics? (2) What is the validity and reliability of data from social media for detecting these adverse events? MEDLINE, EMBASE, Cochrane Library, and relevant websites were searched from inception to May 2016. Any type of document (e.g., manuscripts, reports) that described the use of social media data for detecting health product AEs was included. Two reviewers independently screened citations and full-texts, and one reviewer and one verifier performed data abstraction. Descriptive synthesis was conducted. After screening 3631 citations and 321 full-texts, 70 unique documents with 7 companion reports available from 2001 to 2016 were included. Forty-six documents (66%) described an automated or semi-automated information extraction system to detect health product AEs from social media conversations (in the developmental phase). Seven pre-existing information extraction systems to mine social media data were identified in eight documents. Nineteen documents compared AEs reported in social media data with validated data and found consistent AE discovery in all except two documents. None of the documents reported the validity and reliability of the overall system, but some reported on the performance of individual steps in processing the data. The validity and reliability results were found for the following steps in the data processing pipeline: data de-identification (n = 1), concept identification (n = 3), concept normalization (n = 2), and relation extraction (n = 8). The methods varied widely, and some approaches yielded better results than others. Our results suggest that the use of

  10. 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.

  11. 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

  12. 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

  13. 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.

  14. 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.

  15. [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.

  16. 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

  17. 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.

  18. 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.

  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. 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.

  1. 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

  2. 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

  3. Information about ADRs explored by pharmacovigilance approaches: a qualitative review of studies on antibiotics, SSRIs and NSAIDs

    Science.gov (United States)

    Aagaard, Lise; Hansen, Ebba Holme

    2009-01-01

    Background Despite surveillance efforts, unexpected and serious adverse drug reactions (ADRs) repeatedly occur after marketing. The aim of this article is to analyse ADRs reported by available ADR signal detection approaches and to explore which information about new and unexpected ADRs these approaches have detected. Methods We selected three therapeutic cases for the review: antibiotics for systemic use, non-steroidal anti-inflammatory medicines (NSAID) and selective serotonin re-uptake inhibitors (SSRI). These groups are widely used and represent different therapeutic classes of medicines. The ADR studies were identified through literature search in Medline and Embase. The search was conducted in July 2007. For each therapeutic case, we analysed the time of publication, the strengths of the evidence of safety in the different approaches, reported ADRs and whether the studies have produced new information about ADRs compared to the information available at the time of marketing. Results 79 studies were eligible for inclusion in the analysis: 23 antibiotics studies, 35 NSAID studies, 20 SSRI studies. Studies were mainly published from the end of the 1990s and onwards. Although the drugs were launched in different decades, both analytical and observational approaches to ADR studies were similar for all three therapeutic cases: antibiotics, NSAIDs and SSRIs. The studies primarily dealt with analyses of ADRs of the type A and B and to a lesser extent C and D, cf. Rawlins' classification system. The therapeutic cases provided similar results with regard to detecting information about new ADRs despite different time periods and organs attacked. Approaches ranging higher in the evidence hierarchy provided information about risks of already known or expected ADRs, while information about new and previously unknown ADRs was only detected by case reports, the lowest ranking approach in the evidence hierarchy. Conclusion Although the medicines were launched in different

  4. 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...

  5. [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.

  6. Dipolar Spin Ice States with a Fast Monopole Hopping Rate in CdEr2X4 (X =Se , S)

    Science.gov (United States)

    Gao, Shang; Zaharko, O.; Tsurkan, V.; Prodan, L.; Riordan, E.; Lago, J.; Fâk, B.; Wildes, A. R.; Koza, M. M.; Ritter, C.; Fouquet, P.; Keller, L.; Canévet, E.; Medarde, M.; Blomgren, J.; Johansson, C.; Giblin, S. R.; Vrtnik, S.; Luzar, J.; Loidl, A.; Rüegg, Ch.; Fennell, T.

    2018-03-01

    Excitations in a spin ice behave as magnetic monopoles, and their population and mobility control the dynamics of a spin ice at low temperature. CdEr2 Se4 is reported to have the Pauling entropy characteristic of a spin ice, but its dynamics are three orders of magnitude faster than the canonical spin ice Dy2 Ti2 O7 . In this Letter we use diffuse neutron scattering to show that both CdEr2 Se4 and CdEr2 S4 support a dipolar spin ice state—the host phase for a Coulomb gas of emergent magnetic monopoles. These Coulomb gases have similar parameters to those in Dy2 Ti2 O7 , i.e., dilute and uncorrelated, and so cannot provide three orders faster dynamics through a larger monopole population alone. We investigate the monopole dynamics using ac susceptometry and neutron spin echo spectroscopy, and verify the crystal electric field Hamiltonian of the Er3 + ions using inelastic neutron scattering. A quantitative calculation of the monopole hopping rate using our Coulomb gas and crystal electric field parameters shows that the fast dynamics in CdEr2X4 (X =Se , S) are primarily due to much faster monopole hopping. Our work suggests that CdEr2X4 offer the possibility to study alternative spin ice ground states and dynamics, with equilibration possible at much lower temperatures than the rare earth pyrochlore examples.

  7. 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.

  8. [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.

  9. 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).

  10. 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....

  11. 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.

  12. 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

  13. 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 ...

  14. 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.

  15. 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.

  16. 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

  17. 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.

  18. 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

  19. 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.

  20. 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

  1. 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.

  2. 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

  3. 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.

  4. Magnetohydrodynamics (MHD) Engineering Test Facility (ETF) 200 MWe power plant. Conceptual Design Engineering Report (CDER) supplement. Magnet system special investigations

    Science.gov (United States)

    1981-01-01

    The results of magnet system special investigations listed below are summarized: 4 Tesla Magnet Alternate Design Study; 6 Tesla Magnet Manufacturability Study. The conceptual design for a 4 Tesla superconducting magnet system for use with an alternate (supersonic) ETF power train is described, and estimated schedule and cost are identified. The magnet design is scaled from the ETF 6 T Tesla design. Results of a manufacturability study and a revised schedule and cost estimate for the ETF 6 T magnet are reported. Both investigations are extensions of the conceptual design of a 6 T magnet system performed earlier as a part of the overall MED-ETF conceptual design described in Conceptual Design Engineering Report (CDER) Vol. V, System Design Description (SDD) 503 dated September, 1981, DOE/NASA/0224-1; NASA CR-165/52.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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...

  10. 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.

  11. 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

  12. 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...

  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 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.

  15. 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.

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

    Science.gov (United States)

    Price, John

    2018-05-01

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

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Magnetohydrodynamics (MHD) Engineering Test Facility (ETF) 200 MWe power plant. Conceptual Design Engineering Report (CDER). Volume 1: Executive summary

    Science.gov (United States)

    1981-01-01

    Main elements of the design are identified and explained, and the rationale behind them was reviewed. Major systems and plant facilities are listed and discussed. Construction cost and schedule estimates are presented, and the engineering issues that should be reexamined are identified. The latest (1980-1981) information from the MHD technology program is integrated with the elements of a conventional steam power electric generating plant.

  13. Magnetohydrodynamics (MHD) Engineering Test Facility (ETF) 200 MWe power plant. Conceptual Design Engineering Report (CDER). Volume 4: Supplementary engineering data

    Science.gov (United States)

    1981-01-01

    The reference conceptual design of the Magnetohydrodynamic Engineering Test Facility (ETF), a prototype 200 MWe coal-fired electric generating plant designed to demonstrate the commercial feasibility of open cycle MHD is summarized. Main elements of the design are identified and explained, and the rationale behind them is reviewed. Major systems and plant facilities are listed and discussed. Construction cost and schedule estimates, and identification of engineering issues that should be reexamined are also given. The latest (1980-1981) information from the MHD technology program are integrated with the elements of a conventional steam power electric generating plant. Supplementary Engineering Data (Issues, Background, Performance Assurance Plan, Design Details, System Design Descriptions and Related Drawings) is presented.

  14. 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

  15. 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.

  16. 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.

  17. 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

  18. 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.

  19. 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

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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

  12. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  14. 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

  15. 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

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

    Science.gov (United States)

    Cobert, B; Silvey, J

    1999-02-01

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

  17. [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.

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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

  3. 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.

  4. 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

    Adverse drug events are a major cause of patient safety incidents. Current systems of pharmacovigilance under-report adverse drug reactions (ADRs), especially in children, leading to delays in their identification. This is of particular concern, as children especially have an increased vulnerability to ADRs. The objective was to seek consensus among healthcare professionals (HCPs) about barriers and facilitators to the linkage of routinely collected health data for pediatric pharmacovigilance in Scotland. A Delphi survey was conducted with a random sample of HCPs including nurses, pharmacists and doctors, working in primary or secondary care, in Scotland. Participants were identified from sampling frames of the target professionals such as an NHS workforce list for general practitioners and recruited by postal invitation. A total of 819 HCPs were invited to take part. Those agreeing to participate were given the option of completing the questionnaires online or as hard copy. Reminders were sent twice at a fortnightly interval. Questions content included description of professional role as well as testing for the willingness to support the proposed project and was informed by the Theoretical Domains Framework of Behavior Change (TDF) and earlier qualitative work. Three Delphi rounds were administered, including a first round for item generation. 121 of those invited agreed to take part (15%). The first round of the Delphi study included 21 open questions and generated over a 1000 individual statements from 61 participants that returned the questionnaires (50.4%). These were rationalized to 149 items for the second round in which participants rated their views on the importance (or not) of each item on a 9-point Likert scale (strongly disagree - strongly agree). After the third round, there was consensus on items that focused on professional standards, and practical requirements, overall there was support for data linkage and a multi-professional approach. It would

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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

  20. 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. 

  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. 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

  6. 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

  7. [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.

  8. 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.

  9. 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.

  10. 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.

  11. 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...

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. [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

  3. 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.

  4. 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

  5. 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.

  6. 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

    . Patients will be identified using routinely collected data combined with medical chart review in Denmark, Sweden, and Norway. Follow-up will extend from the first administration of antiresorptive treatment to the earliest of death, loss-to-follow-up, or 5 years after therapy initiation. Results will be reported for three treatment cohorts: denosumab-naïve patients, zoledronic acid-naïve patients, and patients who switch from bisphosphonate treatment to denosumab. ONJ cases will be identified in three newly established national ONJ databases and adjudicated by the committee that functioned during the XGEVA® clinical trials program. Conclusion: This study will provide a real world counterpart to the clinical trial-estimated risks for ONJ and serious infections for cancer patients initiating denosumab or zoledronic acid. The establishment of ONJ databases in the three Scandinavian countries will have potential benefits outside this study for the elucidation of ONJ risk factors and the evaluation of ONJ treatment strategies. Keywords: cohort study, osteonecrosis of the jaw, pharmacovigilance, postmarketing drug surveillance, denosumab, zoledronic acid

  7. 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...

  8. 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

  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. 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.

  11. 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.

  12. 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.

  13. Reviews

    Science.gov (United States)

    2002-11-01

    CD-ROM REVIEW (551) Essential Physics BOOK REVIEWS (551) Collins Advanced Science: Physics, 2nd edition Quarks, Leptons and the Big Bang, 2nd edition Do Brilliantly: A2 Physics IGCSE Physics Geophysics in the UK Synoptic Skills in Advanced Physics Flash! The hunt for the biggest explosions in the universe Materials Maths for Advanced Physics

  14. 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.

  15. 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

  16. 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.

  17. 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.

  18. 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

  19. 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

  20. 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.

  1. 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

  2. Reviews.

    Science.gov (United States)

    Journal of Chemical Education, 1987

    1987-01-01

    Provides a review of both the Apple and IBM versions of ENZPACK, a software package which is designed to assist in the teaching of enzyme kinetics in courses where this topic is treated in some depth. (TW)

  3. Review

    Indian Academy of Sciences (India)

    2012-03-29

    Mar 29, 2012 ... The present review documents an overview of speciation mediated through behavioural ...... The Drosophila model (New York: Oxford University Press) .... second part of his big species book written from 1856–1858. (New ...

  4. Adverse Drug Reaction Identification and Extraction in Social Media: A Scoping Review.

    Science.gov (United States)

    Lardon, Jérémy; Abdellaoui, Redhouane; Bellet, Florelle; Asfari, Hadyl; Souvignet, Julien; Texier, Nathalie; Jaulent, Marie-Christine; Beyens, Marie-Noëlle; Burgun, Anita; Bousquet, Cédric

    2015-07-10

    The underreporting of adverse drug reactions (ADRs) through traditional reporting channels is a limitation in the efficiency of the current pharmacovigilance system. Patients' experiences with drugs that they report on social media represent a new source of data that may have some value in postmarketing safety surveillance. A scoping review was undertaken to explore the breadth of evidence about the use of social media as a new source of knowledge for pharmacovigilance. Daubt et al's recommendations for scoping reviews were followed. The research questions were as follows: How can social media be used as a data source for postmarketing drug surveillance? What are the available methods for extracting data? What are the different ways to use these data? We queried PubMed, Embase, and Google Scholar to extract relevant articles that were published before June 2014 and with no lower date limit. Two pairs of reviewers independently screened the selected studies and proposed two themes of review: manual ADR identification (theme 1) and automated ADR extraction from social media (theme 2). Descriptive characteristics were collected from the publications to create a database for themes 1 and 2. Of the 1032 citations from PubMed and Embase, 11 were relevant to the research question. An additional 13 citations were added after further research on the Internet and in reference lists. Themes 1 and 2 explored 11 and 13 articles, respectively. Ways of approaching the use of social media as a pharmacovigilance data source were identified. This scoping review noted multiple methods for identifying target data, extracting them, and evaluating the quality of medical information from social media. It also showed some remaining gaps in the field. Studies related to the identification theme usually failed to accurately assess the completeness, quality, and reliability of the data that were analyzed from social media. Regarding extraction, no study proposed a generic approach to easily

  5. Review

    DEFF Research Database (Denmark)

    Van Den Hazel, H B; Kielland-Brandt, Morten; Winther, Jakob R.

    1996-01-01

    The yeast vacuole, which is equivalent to the lysosome of higher eukaryotes, is one of the best characterized degradative organelles. This review describes the biosynthesis and function of yeast vacuolar proteases. Most of these enzymes are delivered to the vacuole via the early compartments...

  6. Reviews

    NARCIS (Netherlands)

    Adema, Frits

    1995-01-01

    This is the second volume of a revision of Tabernaemontana (Apocynaceae). The volume covers the New World species (44) and the genus Stemmadenia (10 species). This part of the revision of Tabernaemontana comes up to the high standards set in the first volume [see the review by Leenhouts, Blumea 38

  7. Reviews.

    Science.gov (United States)

    Science Teacher, 1989

    1989-01-01

    Reviews a software planetarium package called "Sky Travel." Includes two audiovisuals: "Conquest of Space" and "Windows on Science: Earth Science"; and four books: "Small Energy Sources: Choices that Work,""Stonehenge Complete,""Uneasy Careers and Intimate Lives: Women in Science…

  8. REVIEW

    African Journals Online (AJOL)

    2012-03-01

    Mar 1, 2012 ... narrowing the gap between recommended treatment protocols in ... for pregnant women is complicated by the need to take into account the health and safety of both the ... meta-analysis as at July 2011 (which reviews the APR and other ... 0.82 - 3.18) and relative risk of birth defects in EFV-containing ART.

  9. Review

    Indian Academy of Sciences (India)

    Review. J. Astrophys. Astr., Vol. 36, No. 4, December 2015, pp. 623–634 ..... 4000 K ≤ T ≤ 10000 K. The processes (1b) are characterized in this paper via ..... Mihajlov, A. A., Sreckovic, V. A., Ignjatovic, L. M., Klyucharev, A. N. 2012, J. Cluster.

  10. Review

    NARCIS (Netherlands)

    Kalkman, C.; Adema, F.

    1998-01-01

    This book intends (according to the preface) to afford at once a review, a general outline of what has been accomplished, and a set of signposts for the future. It attempts to do so in three sections on Origin and Diversification of Primitive Land Plants (4 papers), Origin and Diversification of

  11. Review

    NARCIS (Netherlands)

    Wilde, de W.J.J.O.

    1994-01-01

    This review marks the appearance of Volume II, after the publication of Volume I, Pteridophytes and Gymnosperms, in 1990; several more volumes are expected in the future before completion of the Vascular plants as a whole. The present volume contains 73 families out of some 250-500 families which

  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. Reviews

    Directory of Open Access Journals (Sweden)

    Philip Barker

    1998-12-01

    Full Text Available There were two copy-editing blunders in Clive Betts's review, in ALT-J 5 (3, of Shirley Fletcher's Designing Competence-Based Training, one in paragraph 2 line 1, the other in paragraph 3 line 8. The errors (the result of the Editor, Gabriel Jacobs, trying to perform a final proof of the journal at lightning speed in order to meet the printing deadline, and not of any mistake on the part of either Philip Barker or the University of Wales Press hardly affected meaning, but the fact that they appeared in a review of a book on competence makes the embarrassment all the more telling. The Editor apologizes, and thanks eagle-eyed readers. He has decided to read the book in the hope that such errors will not recur.

  15. Reviews

    Directory of Open Access Journals (Sweden)

    Wilma D'Ambrosio

    2013-12-01

    Full Text Available In the wake of the great interest raised by Maurizio Gabrieli’s review of the book Musical Networks. Parallel Distributed Perception and Performance (various authors; edited by Niall Griffith and Peter M. Todd, MA: MIT Press, Cambridge, 1999 which appeared in our last issue of Analitica, the present review section no longer follows the format used up to now but offers a survey of texts dedicated to the relationship between music analysis and technology. This decision was also made as a result of the request for more information on the subject by many of our readers. In coming issues we plan to extend this bibliography and comment on at least some of the most interesting texts published in recent years, among which we would immediately like to draw attention to the important work by Baroni, Dalmonte and Jacoboni published in 1999 (Le regole della musica. Indagine sui meccanismi della comunicazione, Torino, I Manuali EDT/SIdM, 1999.

  16. Identification of cellular targets involved in cardiac failure caused by PKI in oncology: an approach combining pharmacovigilance and pharmacodynamics.

    Science.gov (United States)

    Patras de Campaigno, Emilie; Bondon-Guitton, Emmanuelle; Laurent, Guy; Montastruc, Francois; Montastruc, Jean-Louis; Lapeyre-Mestre, Maryse; Despas, Fabien

    2017-07-01

    The aims of the present study were to evaluate the risk of cardiac failure (CF) associated with 15 anticancer protein kinase inhibitors (PKIs) through a case/noncase analysis and to identify which PK(s) and pathways are involved in PKI-induced CF. In order to evaluate the risk of CF, adjusted reporting odds ratios (aRORs) were calculated for the 15 anticancer PKIs in the World Health Organization safety report database (VigiBase®). We realised a literature review to identify 21 protein kinases (PKs) that were possibly involved in CF caused by PKIs. Pearson correlation coefficients (r) between aRORs and affinity data of the 15 PKIs for the 21 PKs were calculated to identify the cellular target most likely to be involved in PKI-induced CF. A total of 141 601 individual case safety reports (ICSRs) were extracted from VigiBase® for the following PKIs: afatinib, axitinib, bosutinib, crizotinib, dasatinib, erlotinib, gefitinib, imatinib, lapatinib, nilotinib, pazopanib, ruxolitinib, sorafenib, sunitinib and vandetanib. Among them, 2594 ICSRs concerned CF. The disproportionality analysis revealed that, for dasatinib, imatinib, bosutinib, sunitinib and nilotinib, disproportionality for CF was significantly higher than for other PKIs, with aRORs of 2.52 [95% CI 2.26, 2.82], 1.79 (95% CI 1.57, 2.03), 1.73 (95% CI 1.18, 2.54), 1.67 (95% CI 1.51, 1.84) and 1.38 (95% CI 1.18, 1.61), respectively. Significant values for correlation coefficients between the product of dissociation constant (pKd) and aROR were observed for two non-receptor protein kinases: ABL1 (non-phosphorylated and phosphorylated forms) and ABL2 protein kinases, with values of r = 0.83 (P = 0.0001), r = 0.75 (P = 0.0014) and r = 0.78 (P = 0.0006), respectively. We observed a higher disproportionality for CF with dasatinib, imatinib, bosutinib, sunitinib and nilotinib than with other PKIs. In addition, the study highlighted the role of ABL tyrosine kinases in CF caused by anticancer PKIs. © 2017 The British

  17. 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

  18. Critical Questions Regarding Gadolinium Deposition in the Brain and Body After Injections of the Gadolinium-Based Contrast Agents, Safety, and Clinical Recommendations in Consideration of the EMA's Pharmacovigilance and Risk Assessment Committee Recommendation for Suspension of the Marketing Authorizations for 4 Linear Agents.

    Science.gov (United States)

    Runge, Val M

    2017-06-01

    For magnetic resonance, the established class of intravenous contrast media is the gadolinium-based contrast agents. In the 3 decades since initial approval, these have proven in general to be very safe for human administration. However, in 2006, a devastating late adverse reaction to administration of the less stable gadolinium-based contrast agents was identified, nephrogenic systemic fibrosis. The result of actions taken by the European Medicines Agency and the US Food and Drug Administration, stratifying the agents by risk and contraindicating specific agents in severe renal dysfunction, has led to no new cases being identified in North America or Europe. Subsequently, in 2014, long-term deposition in the brain of gadolinium was first shown, after administration of 2 nonionic linear chelates, gadodiamide, and gadopentetate dimeglumine. This has led to an intense focus on the question of in vivo distribution, possible dechelation, and subsequent deposition of gadolinium, together with substantial clarification of the phenomenon as well as stratification of the agents on this basis. This review focuses on 8 critical questions regarding gadolinium deposition in the brain and body, with the answers and discussion therein important for future regulatory decisions and clinical practice. It is now clear that dechelation of gadolinium occurs in vivo with the linear agents and is responsible for this phenomenon, with key experts in the field recommending, except where there is no suitable alternative, a shift in clinical practice from the linear to macrocyclic agents. In addition, on March 10, 2017, the Pharmacovigilance and Risk Assessment Committee of the European Medicines Agency recommended suspension of the marketing authorization for 4 linear gadolinium contrast agents-specifically Omniscan, Optimark, Magnevist, and MultiHance (gadodiamide, gadoversetamide, gadopentetate dimeglumine, and gadobenate dimeglumine)-for intravenous injection. Cited in the report was

  19. 78 FR 72091 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2013-12-02

    ..., CDER should be contacted immediately at [email protected] in adherence to existing recall... responses per Total annual Average burden Total hours respondents respondent responses per response Notify...\\ Number of Average burden Absenteeism guidance Number of records per Total annual per Total hours...

  20. 75 FR 32786 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2010-06-09

    ... follow specific procedures to submit information to FDA of any changes, in the product, production... feasible (or based on evidence of effectiveness from studies in animals). Section 601.93 provides that... an Antibiotic Drug for Human Use'' to harmonize application procedures between CBER and CDER. The...

  1. 78 FR 48175 - Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances

    Science.gov (United States)

    2013-08-07

    ... guidances (number 19 through 22), contact the Office of Pharmaceutical Science in CDER. 23. ``Qualifying for... to the pharmaceutical industry. In most cases, FDA has developed other guidances and resources to... guidances: 1. ``Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients''--issued April 1998...

  2. Magnetohydrodynamics (MHD) Engineering Test Facility (ETF) 200 MWe power plant Conceptual Design Engineering Report (CDER)

    Science.gov (United States)

    1981-01-01

    The reference conceptual design of the magnetohydrodynamic (MHD) Engineering Test Facility (ETF), a prototype 200 MWe coal-fired electric generating plant designed to demonstrate the commercial feasibility of open cycle MHD, is summarized. Main elements of the design, systems, and plant facilities are illustrated. System design descriptions are included for closed cycle cooling water, industrial gas systems, fuel oil, boiler flue gas, coal management, seed management, slag management, plant industrial waste, fire service water, oxidant supply, MHD power ventilating

  3. Causes for the underreporting of adverse drug events by health professionals: a systematic review

    Directory of Open Access Journals (Sweden)

    Fabiana Rossi Varallo

    2014-08-01

    Full Text Available Objective: Identifying the main causes for underreporting of Adverse Drug Reaction (ADR by health professionals. Method: A systematic review carried out in the following databases: LILACS, PAHO, SciELO, EMBASE and PubMed in the period between 1992 and 2012. Descriptors were used in the search for articles, and the identified causes of underreporting were analyzed according to the classification of Inman. Results: In total, were identified 149 articles, among which 29 were selected. Most studies were carried out in hospitals (24/29 for physicians (22/29, and pharmacists (10/29. The main causes related to underreporting were ignorance (24/29, insecurity (24/29 and indifference (23/29. Conclusion: The data show the eighth sin in underreporting, which is the lack of training in pharmacovigilance. Therefore, continuing education can increase adherence of professionals to the service and improve knowledge and communication of risks due to drug use.

  4. Patient Preferences in Regulatory Benefit-Risk Assessments: A US Perspective.

    Science.gov (United States)

    Johnson, F Reed; Zhou, Mo

    Demands for greater transparency in US regulatory assessments of benefits and risks, together with growing interest in engaging patients in Food and Drug Administration regulatory decision making, have resulted in several recent regulatory developments. Although Food and Drug Administration's Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) have established patient-engagement initiatives, CDRH has proposed guidelines for considering quantitative data on patients' benefit-risk perspectives, while CDER has focused on a more qualitative approach. We summarize two significant studies that were developed in collaboration and consultation with CDER and CDRH. CDER encouraged a patient advocacy group to propose draft guidance on engaging patient and caregiver stakeholders in regulatory decision making for Duchenne muscular dystrophy. CDRH sponsored a discrete-choice experiment case study to quantify obese respondents' perspectives on "meaningful benefits." CDRH and CDER issued draft guidance in May and June 2015, respectively, on including patient-preference data in regulatory submissions. Both organizations face challenges. CDER is working on integrating qualitative data into existing evidence-based review processes and is exploring options for therapeutic areas not included on a priority list. CDRH has adopted an approach that requires patient-preference data to satisfy standards of valid scientific evidence. Although that strategy could facilitate integrating patient perspectives directly with clinical data on benefits and harms, generating such data requires building capacity. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  5. 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

  6. 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

  7. 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 ...

  8. 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 ...

  9. 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.

  10. Active and passive surveillance of yellow fever vaccine 17D or 17DD-associated serious adverse events: systematic review.

    Science.gov (United States)

    Thomas, Roger E; Lorenzetti, Diane L; Spragins, Wendy; Jackson, Dave; Williamson, Tyler

    2011-06-20

    To identify the rate of serious adverse events attributable to yellow fever vaccination with 17D and 17DD strains reported in active and passive surveillance data. We conducted a systematic review of published literature on adverse events associated with yellow fever. We searched 9 electronic databases for peer reviewed and grey literature in all languages. There were no restrictions on date of publication. Reference lists of key studies were also reviewed to identify additional studies. We identified 66 relevant studies: 24 used active, 17 a combination of passive and active (15 of which were pharmacovigilance databases), and 25 passive surveillance. ACTIVE SURVEILLANCE: A total of 2,660,929 patients in general populations were followed for adverse events after vaccination, heavily weighted (97.7%) by one large Brazilian study. There were no observed cases of viscerotropic or neurotropic disease, one of anaphylaxis and 26 cases of urticaria (hypersensitivity). We also identified four studies of infants and children (n=2199), four studies of women (n=1334), and one study of 174 HIV+, and no serious adverse events were observed. PHARMACOVIGILANCE DATABASES: 10 of the 15 databases contributed data to this review, with 107,621,154 patients, heavily weighted (94%) by the Brazilian database. The estimates for Australia were low at 0/210,656 for "severe neurological disease" and 1/210,656 for YEL-AVD, and also low for Brazil with 9 hypersensitivity events, 0.23 anaphylactic shock events, 0.84 neurologic syndrome events and 0.19 viscerotropic events cases/million doses. The five analyses of partly overlapping periods for the US VAERS database provided an estimate of 6.6 YEL-AVD and YEL-AND cases per million, and estimates between 11.1 and 15.6 of overall "serious adverse events" per million. The estimates for the UK were higher at 34 "serious adverse events" and also for Switzerland with 14.6 "neurologic events" and 40 "serious events not neurological"/million doses

  11. Magnetohydrodynamics MHD Engineering Test Facility ETF 200 MWe power plant. Conceptual Design Engineering Report CDER. Volume 3: Costs and schedules

    Science.gov (United States)

    1981-01-01

    The estimated plant capital cost for a coal fired 200 MWE electric generating plant with open cycle magnetohydrodynamics is divided into principal accounts based on Federal Energy Regulatory Commision account structure. Each principal account is defined and its estimated cost subdivided into identifiable and major equipment systems. The cost data sources for compiling the estimates, cost parameters, allotments, assumptions, and contingencies, are discussed. Uncertainties associated with developing the costs are quantified to show the confidence level acquired. Guidelines established in preparing the estimated costs are included. Based on an overall milestone schedule related to conventional power plant scheduling experience and starting procurement of MHD components during the preliminary design phase there is a 6 1/2-year construction period. The duration of the project from start to commercial operation is 79 months. The engineering phase of the project is 4 1/2 years; the construction duration following the start of the man power block is 37 months.

  12. Evaluating the safety and immunogenicity of yellow fever vaccines: a systematic review

    Directory of Open Access Journals (Sweden)

    Thomas RE

    2015-04-01

    Full Text Available Roger E Thomas Department of Family Medicine, G012 Health Sciences Center, University of Calgary Medical School, Calgary, AB, Canada Purpose: To review the safety and immunogenicity of yellow fever vaccines. Literature search: The Cochrane Library (including the Cochrane CENTRAL Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and the NHS Database of Abstracts of Reviews of Effects; MEDLINE; EMBASE; BIOSIS Previews; Global Health; CAB Abstracts; and the Lilacs Database of Latin American and Caribbean literature were searched for individual studies and systematic reviews through January 1, 2015. Results: Six yellow fever vaccines are currently produced, and they are effective against all seven yellow fever virus strains. There is a 99.2% homology of the genome sequences of the six current vaccines. Four systematic reviews identified very small numbers of serious adverse events. A systematic review (updated of all published cases identified 133 serious adverse events that met the Brighton Collaboration criteria: 32 anaphylactic, 42 neurologic (one death, 57 viscerotropic (25 deaths, and two of both neurologic and viscerotropic SAEs. The Sanofi Pasteur Global Pharmacovigilance database reported 276 million doses of Stamaril™ distributed worldwide and identified 12 reports of yellow fever vaccine-associated viscerotropic disease (YEL-AVD, 24 of yellow fever vaccine-associated neurologic disease (YEL-AND, and 33 reports of anaphylaxis (many already published. The Biomanguinhos manufacturer's database reported 110 million doses distributed worldwide between 1999 and 2009, and the rate of YEL-AND was estimated at 0.084/100,000 doses distributed and YEL-AVD at 0.02/100,000 doses distributed. Conclusion: Reports of serious adverse events are mostly from travelers from developed countries, and there is likely serious underreporting for developing countries. On the basis of the published reports, the yellow fever vaccines are

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

    Directory of Open Access Journals (Sweden)

    M. Varenna

    2013-10-01

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

  14. Global shortage of neonatal and paediatric antibiotic trials: rapid review.

    Science.gov (United States)

    Thompson, Georgina; Barker, Charlotte I; Folgori, Laura; Bielicki, Julia A; Bradley, John S; Lutsar, Irja; Sharland, Mike

    2017-10-13

    There have been few clinical trials (CTs) on antibiotics that inform neonatal and paediatric drug labelling. The rate of unlicensed and off-label prescribing in paediatrics remains high. It is unclear whether the current neonatal and paediatric antibiotic research pipeline is adequate to inform optimal drug dosing. Using the ClinicalTrials.gov registry, this review aims to establish the current global status of antibiotic CTs in children up to 18 years of age. Studies were identified using key word searches of the ClinicalTrials.gov registry and were manually filtered using prespecified inclusion/exclusion criteria. 76 registered open CTs of antibiotics in children were identified globally; 23 (30%) were recruiting newborns (only 8 (11%) included preterm neonates), 52 (68%) infants and toddlers, 58 (76%) children and 54 (71%) adolescents. The majority of registered trials were late phase (10 (15%) phase 3 and 23 (35%) phase 4/pharmacovigilance). Two-thirds were sponsored by non-profit organisations, compared with pharmaceutical companies (50 (66%) vs 26 (34%), respectively). A greater proportion of non-profit funded trials were efficacy-based strategic trials (n=34, 68%), in comparison with industry-led trials, which were most often focused on safety or pharmacokinetic data (n=17, 65%). Only 2 of the 37 antibiotics listed on the May 2016 Pew Charitable Trusts antibiotic development pipeline, currently being studied in adults, appear to be currently recruiting in open paediatric CTs. This review highlights that very few paediatric antibiotic CTs are being conducted globally, especially in neonates. There is a striking disparity noted between antibiotic drug development programmes in adults and children. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  15. Nicorandil, Gastrointestinal Adverse Drug Reactions and Ulcerations: A Systematic Review.

    Science.gov (United States)

    Pisano, Umberto; Deosaran, Jordanna; Leslie, Stephen J; Rushworth, Gordon F; Stewart, Derek; Ford, Ian; Watson, Angus J M

    2016-03-01

    Nicorandil is a popular anti-anginal drug in Europe and Japan. Apart from some common adverse drug reactions (ADR), its safety is satisfactory. Several reports have suggested a link between nicorandil, gastrointestinal (GI) ulceration and fistulas. The review aims to critically appraise, synthesize and present the available evidence of all known GI ADR per anatomical location. The study complied with the PRISMA statement. Literature and pharmacovigilance databases were used to provide rate and/or calculate parameters (median age, median dose, history of symptoms, length of therapy and healing time after withdrawal of the drug). Differences in distribution of quantitative variables were analyzed via Mann-Whitney test. Correlation between quantitative variables was assessed with a Spearman's correlation coefficient. A p value <0.05 was significant. Oral ulcerations occur in 0.2% of the subjects, anal ulcerations are present between 0.07% and 0.37% of patients. Oral and distal GI involvements are the most common ADR (28-29% and 27-31% of all GI ADR, respectively). The hepatobiliary system, the pancreas and salivary glands are not affected by nicorandil exposure. The time to develop oral ulcerations is 74 weeks among people on <30 mg/day compared to only 7.5 weeks in individuals on higher regimens (p = 0.47). There is a significant correlation between dose and ulcer healing time (Spearman's 0.525, p < 0.001). Ulcerative disease is a very commonly reported GI ADR. A delayed ulcerative tendency supports the hypothesis of an ulcerogenic metabolite. Nicorandil seems to act as a cause of the ulcerations, but appears to also work in synergy with other promoting factors. Whether the action of the metabolites relies on a specific mechanism or a simple chemical ulceration is still to be established.

  16. 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

    DEFF Research Database (Denmark)

    Acquavella, John; Ehrenstein, Vera; Schiødt, Morten

    2016-01-01

    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-authoriza......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...... (120 mg subcutaneously) or zoledronic acid (4 mg intravenously, adjusted for renal function). Patients will be identified using routinely collected data combined with medical chart review in Denmark, Sweden, and Norway. Followup will extend from the first administration of antiresorptive treatment...... to the earliest of death, loss-to-follow-up, or 5 years after therapy initiation. Results will be reported for three treatment cohorts: denosumab-naïve patients, zoledronic acid-naïve patients, and patients who switch from bisphosphonate treatment to denosumab. ONJ cases will be identified in three newly...

  17. The use of cyproterone acetate/ethinyl estradiol in hyperandrogenic skin symptoms - a review.

    Science.gov (United States)

    Bitzer, J; Römer, T; Lopes da Silva Filho, A

    2017-06-01

    Hyperandrogenism affects approximately 10-20% of women of reproductive age. Hyperandrogenic skin symptoms such as hirsutism, acne, seborrhea and alopecia are associated with significant quality of life and psychological impairment. Women with abnormalities in androgen metabolism may have accompanying anovulation and/or polycystic ovary syndrome (PCOS), both of which have reproductive and metabolic implications if left untreated. Cyproterone acetate (CPA), combined with ethinylestradiol (EE), is indicated for the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhea) and/or hirsutism, in women of reproductive age. To review the data on the efficacy and safety of CPA 2 mg/EE 35 μg for the treatment of hyperandrogenic skin symptoms in women. A non-systematic narrative review based on a literature search of the PubMed database. Seventy-eight studies were identified. The majority of sufficiently powered studies show a high efficacy of CPA 2 mg/EE 35 μg in the treatment of severe acne and hirsutism. Studies show that therapeutic response in women with hirsutism requires a long-term approach and that hyperandrogenic skin symptoms in patients with PCOS are efficiently treated. Additional benefits include cycle control and, in some women, improvement in mood and perception of body image. Safety and tolerability data are summarized by the pharmacovigilance risk assessment committee (PRAC) of the European Medicine's Agency's (EMA). This review provides a comprehensive overview about the efficacy of CPA 2 mg/EE 35 μg in the treatment of hyperandrogenic skin symptoms, thus allowing both health care professionals and women to balance the risks and benefits of treatment based on evidence.

  18. Review of the Methods to Obtain Paediatric Drug Safety Information: Spontaneous Reporting and Healthcare Databases, Active Surveillance Programmes, Systematic Reviews and Meta-analyses

    Science.gov (United States)

    Gentili, Marta; Pozzi, Marco; Peeters, Gabrielle; Radice, Sonia; Carnovale, Carla

    2018-02-06

    Knowledge of drugs safety collected during the pre-marketing phase is inevitably limited because the randomized clinical trials (RCTs) are rarely designed to evaluate safety. The small and selective groups of enrolled individuals and the limited duration of trials may hamper the ability to characterize fully the safety profiles of drugs. Additionally, information about rare adverse drug reactions (ADRs) in special groups is often incomplete or not available for most of the drugs commonly used in the daily clinical practice. In the paediatric setting several highimpact safety issues have emerged. Hence, in recent years, there has been a call for improved post-marketing pharmacoepidemiological studies, in which cohorts of patients are monitored for sufficient time in order to determine the precise risk-benefit ratio. In this review, we discuss the current available strategies enhancing the post-marketing monitoring activities of the drugs in the paediatric setting and define criteria whereby they can provide valuable information to improve the management of therapy in daily clinical practice including both safety and efficacy aspects. The strategies we cover include the signal detection using international pharmacovigilance and/or healthcare databases, the promotion of active surveillance initiatives which can generate complete, informative data sets for the signal detection and systematic review/meta-analysis. Together, these methods provide a comprehensive picture of causality and risk improving the management of therapy in a paediatric setting and they should be considered as a unique tool to be integrated with post-marketing activities. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  19. The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD medications in the pediatric population: a qualitative review of empirical studies

    Directory of Open Access Journals (Sweden)

    Aagaard L

    2011-12-01

    Full Text Available Lise Aagaard1-3, Ebba Holme Hansen1-31Department of Pharmacology and Pharmacotherapy, Section for Social Pharmacy, Faculty of Pharmaceutical Sciences, University of Copenhagen, Denmark; 2FKL-Research Centre for Quality in Medicine Use, Copenhagen, Denmark; 3Danish Pharmacovigilance Research Project (DANPREP, Copenhagen, DenmarkBackground: To review empirical studies of adverse drug reactions (ADRs reported to be associated with the use of medications generally licensed for treatment of attention deficit hyperactivity disorder (ADHD symptoms in the pediatric population.Methods: PubMed, Embase, and PsycINFO® databases were searched from origin until June 2011. Studies reporting ADRs from amphetamine derivates, atomoxetine, methylphenidate, and modafinil in children from birth to age 17 were included. Information about ADR reporting rates, age and gender of the child, type, and seriousness of ADRs, setting, study design, ADR assessors, authors, and funding sources were extracted.Results: The review identified 43 studies reporting ADRs associated with medicines for treatment of ADHD in clinical studies covering approximately 7000 children, the majority of 6- to 12-year-old boys, and particularly in the United States of America (USA. The most frequently reported ADRs were decrease in appetite, gastrointestinal pain, and headache. There were wide variations in reported ADR occurrence between studies of similar design, setting, included population, and type of medication. Reported ADRs were primarily assessed by the children/their parents, and very few ADRs were rated as being serious. A large number of children dropped out of studies due to serious ADRs, and therefore, the actual number of serious ADRs from use of psychostimulants is probably higher. A large number of studies were conducted by the same groups of authors and sponsored by the pharmaceutical companies manufacturing the respective medications.Conclusion: Reported ADRs from use of

  20. Book Reviews

    OpenAIRE

    Elena Mancusi-Materi

    2002-01-01

    Book reviews: Helmore, K. and N. Singh, Sustainable Livelihoods – Building on the Wealth of the poor (reviewed by Elena Mancusi-Materi); Scoones, I (ed.), Dinamics and Diversity: Soil fertility and farming livelihoods in africa (reviewed by Elena Mancusi-Materi); Uphoff, N. (ed.), Agroecological Innovations – Increasing Food Production with Pariciatory Development (reviewed by Elena Mancusi-Materi); Marten, G.G., Human Ecology, Basic Concepts for Sustianable Development (reviewed by Siobhán K...

  1. Re-Viewing Peer Review

    Science.gov (United States)

    Flynn, Elizabeth A.

    2011-01-01

    In this article, the author revisits her essay, "Students as Readers of Their Classmates' Writing," by providing a review of the literature on peer review over the past three decades and comments on patterns she sees in waves of peer review research and theorizing. She describes her subsequent experience with peer review in her own classes, and…

  2. Book Review: Book review

    Science.gov (United States)

    Manohar, C. S.

    2015-02-01

    The subject of the theory of vibrations has carried an aesthetic appeal to generations of engineering students for its richness of ideas, and for the intellectual challenges it offers. Also, the diverse range of its applications (covering civil, mechanical, automotive, and aerospace structures) has provided obvious motivations for its study. For most students, the subject provides, perhaps, the first encounter in substantial application of mathematical tools (differential equations, calculus of variations, Fourier/Laplace transforms, and matrix algebra) to engineering problems. The intimate relationship that the subject of mechanics has with mathematics strikes home probably for the first time. While teaching this subject, the instructor is spoilt for choice in selecting a text book and so are the students who wish to pursue a self-study of the subject. Many luminaries in the field have offered their own exposition of the subject: starting from the classics of Rayleigh, Timoshenko, Den Hartog, Bishop and Johnson, and the works of more recent vintage (e.g., the books by Meirovich, Clough, and Penzien, and works with computational flavour, such as, those by Bathe and Petyt), several works easily come to one's mind. Given this milieu, it requires a distinctive conviction to write a new book on this subject. And, here we have a book, written by a practitioner, which aims to deal with fundamental aspects of vibrations of engineering systems. The scepticism that this reviewer had on the need for having one more such book vanished as he browsed through the book and read selectively a few sections. The author's gift for elegant explanations is immediately noticeable even in such a preliminary reading. After a more careful reading, the reviewer has found this book to be insightful and he considers the book to be a welcome addition to the family of books on vibration engineering. The author has struck a fine balance between physical explanations, mathematical niceties

  3. Book Reviews

    Directory of Open Access Journals (Sweden)

    Aliraza Javaid

    2014-11-01

    Full Text Available Criminal Justice: An Introduction to Philosophies, Theories and Practice Reviewed by Aliraza Javaid Canadian Policing in the 21st Century: A Frontline Officer on Challenges and Changes Reviewed by Katie Cook

  4. Book Reviews

    Directory of Open Access Journals (Sweden)

    Lise Kanckos

    2012-06-01

    Full Text Available Believing in Belonging: Belief & Social Identity in the Modern World by Abby Day is reviewed by Lise Kanckos.Religion and the New Atheism: A Critical Appraisal, edited by Amarnath Amarasingam, is reviewed by Mikko Sillfors.

  5. Research Review

    OpenAIRE

    Anonymous

    1983-01-01

    Research Reviewed: "The Adjustment of Nominal Interest Rates to Inflation: A Review of Recent Literature"; "Role of Government in a Market Economy"; "Economic Analysis and Agricultural Policy"; "Agricultural Research Policy"

  6. Book reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2011-12-01

    Full Text Available Create Dangerously: The Immigrant Artist at Work, by Edwidge Danticat (reviewed by Colin Dayan Gordon K. Lewis on Race, Class and Ideology in the Caribbean, edited by Anthony P. Maingot (reviewed by Bridget Brereton Freedom and Constraint in Caribbean Migration and Diaspora, edited by Elizabeth Thomas-Hope (reviewed by Mary Chamberlain Black Europe and the African Diaspora, edited by Darlene Clark Hine, Trica Danielle Keaton & Stephen Small (reviewed by Gert Oostindie Caribbean Middlebrow: Leisure Culture and the Middle Class, by Belinda E dmondson (reviewed by Karla Slocum Global Change and Caribbean Vulnerability: Environment, Economy and Society at Risk, edited by Duncan McGregor, David Dodman & David Barker (reviewed by Bonham C. Richardson Encountering Revolution: Haiti and the Making of the Early Republic, by Ashli White (reviewed by Matt Clavin Red and Black in Haiti: Radicalism, Conflict, and Political Change, 1934-1957, by Matthew J. Smith (reviewed by Robert Fatton Jr. Cuba in the American Imagination: Metaphor and the Imperial Ethos, by Louis A. Pérez Jr. (reviewed by Camillia Cowling Seeds of Insurrection: Domination and Resistance on Western Cuban Plantations, 1808-1848, by Manuel Barcia (reviewed by Matt D. Childs Epidemic Invasions: Yellow Fever and the Limits of Cuban Independence, 1878-1930, by Mariola Espinosa (reviewed by Cruz Maria Nazario The Cuban Connection: Drug Trafficking, Smuggling, and Gambling in Cuba from the 1920s to the Revolution, by Eduardo Sáenz Rovner (reviewed by Ivelaw Lloyd Griffith Before Fidel: The Cuba I Remember, by Francisco José Moreno, and The Boys from Dolores: Fidel Castro’s Schoolmates from Revolution to Exile, by Patrick Symmes (reviewed by Pedro Pérez Sarduy Lam, by Jacques Leenhardt & Jean-Louis Paudrat (reviewed by Sally Price Healing Dramas: Divination and Magic in Modern Puerto Rico, by Raquel Romberg (reviewed by Grant Jewell

  7. Book reviews

    Directory of Open Access Journals (Sweden)

    T. Abdel-Motey., C. Urfels., K. Rodriguez., J. Mardikian., J.A. Drobnicki., V. Diodato.

    2000-10-01

    Full Text Available Title:(1 The Library and Information Professional’s Guide to the Internet. (2 Reinvention of the Public Library for the 21st Century. (3 Public Library Collection Development in the Information Age. (4 Making Sense of Journals in the Life Science: From Specialty Origins to Contemporary Assortment. (5 The Holocaust: Memories, Research, Reference. (6 How to Index Your Local Newspaper Using WordPerfect or Microsoft Word for Windows. (7 Effective Utilization and Management of Emerging Information Technologies. (8 Information Technology and Organizations: Challenges of New Technologies. (9 Facilities Planning for School Media and Technology Centers. (10 Libraries Without Walls 2: The Delivery of Library Services to Distance Users. (11 New International Directions in HIV Prevention for Gay and Bisexual Men. (12 Soaring to Excellence Videos: Tools of Our Trade III: Books, the Internet, and Beyond.Author:(1Reviewed by Teresa Abdel-Motey. (2Review by Claire Urfels. (3Reviewed by Dr. Ketty Rodriguez. (4Reviewed by Jackie Mardikian. (5Reviewed by John A. Drobnicki.(6Reviewed by Dr. Virgil Diodato. (7Reviewed by Dr. Lisa M. Covi. (8Reviewed by Tom Zillner. (9Reviewed by Dr. W. Bernard Lukenbill. (10Reviewed by Dr. Elizabeth Buchanan. (11Reviewed by Aisha White. (12Reviewed by Phyllis Tragash

  8. Systematic review

    DEFF Research Database (Denmark)

    Momsen, Anne-Mette Hedeager; Hald, Kathrine; Nielsen, Claus Vinther

    2017-01-01

    REVIEW OBJECTIVE/QUESTION: The objective of this review is to identify the effectiveness of expanded cardiac rehabilitation (CR) in patients diagnosed with coronary heart disease (CHD). Specifically, the review question is: What is the effectiveness of expanded CR compared to standard CR in adult...

  9. Book Review: Book review

    Science.gov (United States)

    Wegener, Daan

    Writing a biography of a complex personality and mastermind like Albert Einstein is a daunting task for any historian of science. Yet the sheer temptation of writing his biography has apparently helped to overcome scholarly scruples, as biographies of Einstein have appeared quite regularly on the market. One of them is Einstein: his Life and Universe by journalist Walter Isaacson. It is a best-seller, which is one of the reasons the book deserves a critical evaluation. Isaacson is a man of considerable repute: he has been the chairman of CNN and managing editor of Time magazine. Isaacson's Einstein is written in a style that is accessible to a wide audience. Scholars who are already familiar with Einstein's physics may still enjoy the parts of the book that deal with the relation between Einstein and the press. Indeed, the breadth of its scope is the book's major merit, as it connects the personal, scientific, public and political dimensions of Einstein's life. In this review, I discuss Isaacson's treatment of these dimensions one-by-one.

  10. Critical Review

    DEFF Research Database (Denmark)

    Rosenbaum, Ralph K.; Olsen, Stig Irving

    2018-01-01

    Manipulation and mistakes in LCA studies are as old as the tool itself, and so is its critical review. Besides preventing misuse and unsupported claims, critical review may also help identifying mistakes and more justifiable assumptions as well as generally improve the quality of a study. It thus...... supports the robustness of an LCA and increases trust in its results and conclusions. The focus of this chapter is on understanding what a critical review is, how the international standards define it, what its main elements are, and what reviewer qualifications are required. It is not the objective...... of this chapter to learn how to conduct a critical review, neither from a reviewer nor from a practitioner perspective. The foundation of this chapter and the basis for any critical review of LCA studies are the International Standards ISO 14040:2006, ISO 14044:2006 and ISO TS 14071:2014....

  11. Farmacovigilância de drogas vegetais e seus derivados: uma ação necessária e já iniciada para a segurança do paciente, no contexto do uso racional de medicamentos | Pharmacovigilance of herbal drugs and their derivatives: the beginning of necessary action for patient safety in the context of rational use of drugs

    Directory of Open Access Journals (Sweden)

    Maria Aparecida Nicoletti

    2015-05-01

    a safe treatment method. The toxicity of medicines or drugs that contain plants is a matter of public health because they can trigger adverse reactions such as severe poisoning and can interact with conventional drugs. There are few data on the safety of herbal drugs, and most of them have not been subjected to clinical phase studies. Monitoring of unwanted effects through the implementation of a pharmacovigilance system that includes the medicinal plant species is required. However, in Brazil, the safety assessment of herbal drugs and their derivatives is only beginning. It is therefore necessary to take actions to ensure that an effective and robust system is structured.

  12. Using Semantic Web Technologies to Reproduce a Pharmacovigilance Case Study

    NARCIS (Netherlands)

    M. Hildebrand (Michiel); R Hoekstra; J.R. van Ossenbruggen (Jacco)

    2013-01-01

    htmlabstractWe provide a detailed report of a reproduction study of a paper published in the International Journal of Medical Sciences (IJMS). We first use the PROV-O ontology to model our reconstruction of the computational workflow of the original experiment and to systematically explicate all

  13. Pharmacovigilance of biologicals : dynamics in post-approval safety learning

    NARCIS (Netherlands)

    Vermeer, N.S.

    2015-01-01

    Regulatory decisions to allow new drugs on the market by definition have to accept a certain level of uncertainty about the full benefit-risk balance. Pre-approval studies typically provide information on a limited number of patients over a relative short follow-up period, and handle strict

  14. The need for greater opioid pharmacovigilance in COPD

    Directory of Open Access Journals (Sweden)

    Vozoris NT

    2017-01-01

    Full Text Available Nicholas T Vozoris1–3 1Division of Respirology, Department of Medicine, St Michael’s Hospital, Toronto, ON, Canada; 2Keenan Research Centre in the Li Ka Shing Knowledge Institute, St Michael’s Hospital, Toronto, ON, Canada; 3Department of Medicine, University of Toronto, Toronto, ON, Canada I read with interest the article by Ahmadi et al1 that described the use of prescription opioid drugs among Swedes with advanced COPD. The authors are to be commended for their research work on this important clinical topic. I would like to bring to the attention of your readers several points though. Read the original article by Ahmadi et al

  15. Strategies and Systems-Level Interventions to Combat or Prevent Drug Counterfeiting: A Systematic Review of Evidence Beyond Effectiveness.

    Science.gov (United States)

    Fadlallah, Racha; El-Jardali, Fadi; Annan, Farah; Azzam, Hayat; Akl, Elie A

    2016-01-01

    A recent systematic review suggested that drug registrations and onsite quality inspections may be effective in reducing the prevalence of counterfeit and substandard drugs. However, simply replicating the most effective interventions is problematic, as it denotes implementing the intervention without further adaptation. The aim was to systematically review the evidence beyond effectiveness for systems-level interventions to combat or prevent drug counterfeiting. We conducted an extensive search, including an electronic search of 14 databases. We included studies examining the efficiency, feasibility, reliability, and economic outcomes of the interventions, as well as barriers and facilitators to their implementation. Two reviewers selected eligible studies and abstracted data in duplicate and independently. We synthesized the results narratively, stratified by type of intervention. Of 10,220 captured citations, 19 met our inclusion criteria. The findings suggest that the following may strengthen regulatory measures (e.g., registration): minimizing drug diversion, enhancing lines of communications, ensuring feedback on drug quality, and promoting strict licensing criteria. There is evidence that onsite quality surveillance and inspection systems may be efficient and cost-effective for preliminary testing of large samples of drugs. Laws and legislation need to be specific to counterfeit drugs, include firm penalties, address online purchasing of drugs, and be complemented by education of judges and lawyers. Public awareness and education should rely on multiple platforms and comprehensive and dedicated content. While product authentication technologies may be efficient and reliable in detecting counterfeit drugs in the supply chain, they require a strong information system infrastructure. As for pharmacovigilance systems, it is critical to tackle the issue of underreporting, to enhance their chances of success. Several factors are critical to the successful design

  16. Pioglitazone utilization, efficacy & safety in Indian type 2 diabetic patients: A systematic review & comparison with European Medicines Agency Assessment Report.

    Science.gov (United States)

    Pai, Sarayu A; Kshirsagar, Nilima A

    2016-11-01

    With pioglitazone ban and subsequent revoking in India along with varying regulatory decisions in other countries, it was decided to carry out a systematic review on its safety, efficacy and drug utilization in patients with type 2 diabetes mellitus (T2DM) in India and compare with the data from the European Medicines Agency Assessment Report (EMA-AR). Systematic review was performed as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, searching Medline/PubMed, Google Scholar and Science Direct databases using 'pioglitazone AND India AND human' and 'pioglitazone AND India AND human AND patient' and compared with EMA-AR. Spontaneous reports in World Health Organization VigiBase from India were compared with VigiBase data from other countries. Sixty six publications, 26 (efficacy), 32 (drug utilization) and eight (safety), were retrieved. In India, pioglitazone was used at 15-30 mg/day mostly with metformin and sulphonylurea, being prescribed to 26.7 and 8.4 per cent patients in north and south, respectively. The efficacy in clinical trials (CTs) was similar to those in EMA-AR. Incidence of bladder cancer in pioglitazone exposed and non-exposed patients was not significantly different in an Indian retrospective cohort study. There were two cases and a series of eight cases of bladder cancer published but none reported in VigiBase. In India, probably due to lower dose, lower background incidence of bladder cancer and smaller sample size in epidemiological studies, association of bladder cancer with pioglitazone was not found to be significant. Reporting of CTs and adverse drug reactions to Clinical Trials Registry of India and Pharmacovigilance Programme of India, respectively, along with compliance studies with warning given in package insert and epidemiological studies with larger sample size are needed.

  17. Book reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2010-12-01

    Full Text Available The Atlantic World, 1450-2000, edited by Toyin Falola & Kevin D. Roberts (reviewed by Aaron Spencer Fogleman The Slave Ship: A Human History, by Marcus Rediker (reviewed by Justin Roberts Extending the Frontiers: Essays on the New Transatlantic Slave Trade Database, edited by David Eltis & David Richardson (reviewed by Joseph C. Miller "New Negroes from Africa": Slave Trade Abolition and Free African Settlement in the Nineteenth-Century Caribbean, by Rosanne Marion Adderley (reviewed by Nicolette Bethel Atlantic Diasporas: Jews, Conversos, and Crypto-Jews in the Age of Mercantilism, 1500-1800, edited by Richard L. Kagan & Philip D. Morgan (reviewed by Jonathan Schorsch Brother’s Keeper: The United States, Race, and Empire in the British Caribbean, 1937-1962, by Jason C. Parker (reviewed by Charlie Whitham Labour and the Multiracial Project in the Caribbean: Its History and Promise, by Sara Abraham (reviewed by Douglas Midgett Envisioning Caribbean Futures: Jamaican Perspectives, by Brian Meeks (reviewed by Gina Athena Ulysse Archibald Monteath: Igbo, Jamaican, Moravian, by Maureen Warner-Lewis (reviewed by Jon Sensbach Left of Karl Marx: The Political Life of Black Communist Claudia Jones, by Carole Boyce Davies (reviewed by Linden Lewis Displacements and Transformations in Caribbean Cultures, edited by Lizabeth Paravisini-Gebert & Ivette Romero-Cesareo (reviewed by Bill Maurer Caribbean Migration to Western Europe and the United States: Essays on Incorporation, Identity, and Citizenship, edited by Margarita Cervantes-Rodríguez, Ramón Grosfoguel & Eric Mielants (reviewed by Gert Oostindie Home Cooking in the Global Village: Caribbean Food from Buccaneers to Ecotourists, by Richard Wilk (reviewed by William H. Fisher Dead Man in Paradise: Unraveling a Murder from a Time of Revolution, by J.B. MacKinnon (reviewed by Edward Paulino Tropical Zion: General Trujillo, FDR, and the Jews of Sos

  18. Book reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2011-06-01

    Full Text Available Globalization and the Po st-Creole Imagination: Notes on Fleeing the Plantation,by Michaeline A. Crichlow with Patricia Northover (reviewed by Raquel Romberg Afro-Caribbean Religions: An Introduction to their Historical, Cultural, and Sacred Traditions, by Nathaniel Samuel Murrell (reviewed by James Houk Africas of the Americas: Beyond the Search for Origins in the Study of Afro-Atlantic Religions, edited by Stephan Palmié (reviewed by Aisha Khan Òrì?à Devotion as World Religion: The Globalization of Yorùbá Religious Culture, edited by Jacob K. Olupona & Terry Rey (reviewed by Brian Brazeal Sacred Spaces and Religious Traditions in Oriente Cuba, by Jualynne E. Dodson (reviewed by Kristina Wirtz The Coolie Speaks: Chinese Indentured Laborers and African Slaves of Cuba, by Lisa Yun (reviewed by W. Look Lai Cuba and Western Intellectuals since 1959, by Kepa Artaraz (reviewed by Anthony P. Maingot Inside El Barrio: A Bottom-Up View of Neighborhood Life in Castro’s Cuba, by Henry Louis Taylor, Jr. (reviewed by Mona Rosendahl On Location in Cuba: Street Filmmaking During Times of Transition, by Ann Marie Stock (reviewed by Cristina Venegas Cuba in The Special Period: Culture and Ideology in the 1990s, edited by Ariana Hernandez-Reguant (reviewed by Myrna García-Calderón The Cubans of Union City: Immigrants and Exiles in a New Jersey Community. Yolanda Prieto (reviewed by Jorge Duany Target Culebra: How 743 Islanders Took On the Entire U.S. Navy and Won, by Richard D. Copaken (reviewed by Jorge Rodríguez Beruff The World of the Haitian Revolution, edited by David Patrick Geggus & Norman Fiering (reviewed by Yvonne Fabella Bon Papa: Haiti’s Golden Years, by Bernard Diederich (reviewed by Robert Fatton, Jr. 1959: The Year that Inflamed the Caribbean, by Bernard Diederich (reviewed by Landon Yarrington Dominican Cultures: The Making of a Caribbean Society, edited by Bernardo Vega

  19. Efficacy and Safety Data of Subsequent Entry Biologics Pertinent to Nephrology Practice: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Judith Genevieve Marin

    2014-12-01

    Full Text Available Background: Subsequent entry biologics (SEBs may soon be a reality in Canadian nephrology practice. Understanding the worldwide experience with these agents will be valuable to Canadian clinicians. Objectives: To compare the efficacy and safety data between SEBs used in nephrology practice and their reference biologic. Design: Systematic review. Sources of information: Ovid MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Review of Effects, Cochrane Central Register of Controlled Trials. Patients: Adult patients with chronic kidney disease (CKD. Methods: Our systematic review follows the process outlined by Cochrane Reviews. For efficacy data, all randomized controlled trials (RCTs, quasi-RCTs and observational trials in nephrology practice were included. For safety data, case series, case reports, review articles in nephrology practice and pharmacovigilance programs were included as well. Results: Only epoetin SEBs trials were published in the literature. Ten studies involving three different epoetin SEBs (epoetin zeta, HX575 and epoetin theta were included. The mean epoetin dose used did not differ significantly between the SEBs and the reference product. For epoetin zeta and epoetin theta, the mean hemoglobin levels achieved in the studies were similar between the SEBs and the reference epoetin. The HX 575 studies reported a mean absolute change in hemoglobin within the predefined equivalence margin, when compared with the reference biologic. In terms of safety data, 2 cases of pure-red-cell aplasia were linked to the subcutaneous administration of HX 575. Otherwise, the rate of adverse drug reactions was similar when epoetin SEBs were compared with the reference biologic. Limitations: Our analysis is limited by the paucity of information available on SEB use in nephrology with the exception of epoetin SEBs. Methodological flaw was found in one of the epoetin zeta studies which accounted for 45% of pooled

  20. Systematic review

    DEFF Research Database (Denmark)

    Bager, Palle; Chauhan, Usha; Greveson, Kay

    2017-01-01

    of evidence is needed and the aim of this article was to systematically review the evidence of IBD advice lines. MATERIALS AND METHODS: A broad systematic literature search was performed to identify relevant studies addressing the effect of advice lines. The process of selection of the retrieved studies...... was undertaken in two phases. In phase one, all abstracts were review by two independent reviewers. In phase two, the full text of all included studies were independently reviewed by two reviewers. The included studies underwent quality assessment and data synthesis. RESULTS: Ten published studies and 10...... congress abstracts were included in the review. The studies were heterogeneous both in scientific quality and in the focus of the study. No rigorous evidence was found to support that advice lines improve disease activity in IBD and correspondingly no studies reported worsening in disease activity. Advice...

  1. Proactive Reviews

    DEFF Research Database (Denmark)

    Kolbæk, Ditte

    2014-01-01

    with solving a task. They found improved ways of doing the job and identified management challenges. They shared their experience with colleagues who did not attend the Proactive Review and addressed the management challenges to the senior management. Proactive Reviews were reported 50-100 times a year....... Valid feedback from various stakeholders improved the original design of After Action Reviews into Proactive Reviews, which is helpful for local as well as global companies to learn from experience. The educational design started with personal experience that was shared with colleagues who cooperated...

  2. Research Review

    OpenAIRE

    Anonymous

    1981-01-01

    Research Reviewed: "Global Modeling After Its First Decade"; "Monthly Food Price Forecasts"; "Costs of Marketing Slaughter Cattle: Computerized versus Conventional Auction Systems"; "Survival Strategies for Agricultural Cooperatives"

  3. Book reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2012-06-01

    Full Text Available The African Diaspora: A History Through Culture, by Patrick Manning (reviewed by Joseph C. Miller Atlas of the Transatlantic Slave Trade, by David Eltis & David Richardson (reviewed by Ted Maris-Wolf Abolition: A History of Slavery and Antislavery, by Seymour Drescher (reviewed by Gregory E. O’Malley Paths to Freedom: Manumission in the Atlantic World, edited by Rosemary Brana-Shute & Randy J. Sparks (reviewed by Matthew Mason You Are All Free: The Haitian Revolution and the Abolition of Slavery, by Jeremy D. Popkin (reviewed by Philippe R. Girard Fighting for Honor: The History of African Martial Arts in the Atlantic World, by T .J. Desch Obi (reviewed by Flávio Gomes & Antonio Liberac Cardoso Simões Pires Working the Diaspora: The Impact of African Labor on the Anglo-American World, 1650-1850, by Frederick C. Knight (reviewed by Walter Hawthorne The Akan Diaspora in the Americas, by Kwasi Konadu (reviewed by Ray Kea Tradition and the Black Atlantic: Critical Theory in the African Diaspora, by Henry Louis Gates Jr. (reviewed by Deborah A. Thomas From Africa to Jamaica: The Making of an Atlantic Slave Society, 1775-1807, by Audra A. Diptee (reviewed by D.A. Dunkley Elections, Violence and the Democratic Process in Jamaica 1944-2007, by Amanda Sives (reviewed by Douglas Midgett Caciques and Cemi Idols: The Web Spun by Taino Rulers between Hispaniola and Puerto Rico, by José R. Oliver (reviewed by Brian D. Bates The Latin American Identity and the African Diaspora: Ethnogenesis in Context, by Antonio Olliz Boyd (reviewed by Dawn F. Stinchcomb Reconstructing Racial Identity and the African Past in the Dominican Republic, by Kimberly Eison Simmons (reviewed by Ginetta E.B. Candelario Haiti and the Haitian Diaspora in the Wider Caribbean, edited by Philippe Zacaïr (reviewed by Catherine Benoît Duvalier’s Ghosts: Race, Diaspora, and U.S. Imperialism in Haitian Literatures, by Jana

  4. Book Reviews

    Directory of Open Access Journals (Sweden)

    Christien Klaufus, Book Review Editor

    2016-10-01

    Full Text Available American Crossings: Border Politics in the Western Hemisphere, edited by Maiah Jaskoski, Arturo C. Sotomayor & Harold A. Trinkunas, 2015; reviewed by Olivier Thomas Kramsch The Remittance Landscape: Spaces of Migration in Rural Mexico and Urban USA, by Sarah Lynn Lopez, 2015; reviewed by Christien Klaufus Latin America’s Emerging Middle Classes; Economic Perspectives, editado por Jeff Dayton-Johnson, 2015; reseñado por Ludolfo Paramio Cities, Business and the Politics of Urban Violence in Latin America, by Eduardo Moncada,2016; reviewed by Gerard Martin Who Counts? The Mathematics of Death and Life after Genocide, by Diane Nelson, 2015; reviewed by Finn Stepputat Owners of the Sidewalk: Security and Survival in the Informal City, by Daniel Goldstein, 2015; reviewed by Griet Steel Beyond Tradition, Beyond Invention: Cosmic Technologies and Creativity in Contemporary Afro-Cuban Religions, edited by Diana Espírito Santo and Anastasios Panagiotopoulos, 2015; reviewed by Ken Chitwood Cuba and the U.S. Empire. A Chronological History, by Jane Franklin, 2016; reviewed by Edgar Göll Haydée Santamaría, Cuban Revolutionary: She Led by Transgression, by Margaret Randall, 2015; Vilma Espín Guillois: el fuego de la libertad, by Yolanda Ferrer Gómez and Carolina Aguilar Ayerra, 2015; reviewed by Dirk Kruijt Revolutionary Ideology and Political Destiny in Mexico, 1928-1934: Lázaro Cárdenas and Adalberto Tejeda, by Eitan Ginzberg, 2015; reviewed by Heather Fowler-Salamini Political Landscapes: Forest, Conservation and Community in Mexico, by Christopher R. Boyer, 2015; reviewed by Mariel Aguilar-Støen A Sentimental Education for the Working Man. The Mexico City Penny Press, 1900-1910, por Robert M. Buffington, 2015; reseñado por Lucas Poy Pesos and Politics: Business, Elites, Foreigners and Government in Mexico, 1854-1940, by Mark Wasserman, 2015; reviewed by Benedicte Bull State Theory and Andean Politics: New Approaches to the Study

  5. Do final‐year medical students have sufficient prescribing competencies? A systematic literature review

    Science.gov (United States)

    Tichelaar, Jelle; Graaf, Sanne; Otten, René H. J.; Richir, Milan C.; van Agtmael, Michiel A.

    2018-01-01

    Aims Prescribing errors are an important cause of patient safety incidents and are frequently caused by junior doctors. This might be because the prescribing competence of final‐year medical students is poor as a result of inadequate clinical pharmacology and therapeutic (CPT) education. We reviewed the literature to investigate which prescribing competencies medical students should have acquired in order to prescribe safely and effectively, and whether these have been attained by the time they graduate. Methods PubMed, EMBASE and ERIC databases were searched from the earliest dates up to and including January 2017, using the terms ‘prescribing’, ‘competence’ and ‘medical students’ in combination. Articles describing or evaluating essential prescribing competencies of final‐year medical students were included. Results Twenty‐five articles describing, and 47 articles evaluating, the prescribing competencies of final‐year students were included. Although there seems to be some agreement, we found no clear consensus among CPT teachers on which prescribing competencies medical students should have when they graduate. Studies showed that students had a general lack of preparedness, self‐confidence, knowledge and skills, specifically regarding general and antimicrobial prescribing and pharmacovigilance. However, the results should be interpreted with caution, given the heterogeneity and methodological weaknesses of the included studies. Conclusions There is considerable evidence that final‐year students have insufficient competencies to prescribe safely and effectively, although there is a need for a greater consensus among CPT teachers on the required competencies. Changes in undergraduate CPT education are urgently required in order to improve the prescribing of future doctors. PMID:29315721

  6. Do final-year medical students have sufficient prescribing competencies? A systematic literature review.

    Science.gov (United States)

    Brinkman, David J; Tichelaar, Jelle; Graaf, Sanne; Otten, René H J; Richir, Milan C; van Agtmael, Michiel A

    2018-04-01

    Prescribing errors are an important cause of patient safety incidents and are frequently caused by junior doctors. This might be because the prescribing competence of final-year medical students is poor as a result of inadequate clinical pharmacology and therapeutic (CPT) education. We reviewed the literature to investigate which prescribing competencies medical students should have acquired in order to prescribe safely and effectively, and whether these have been attained by the time they graduate. PubMed, EMBASE and ERIC databases were searched from the earliest dates up to and including January 2017, using the terms 'prescribing', 'competence' and 'medical students' in combination. Articles describing or evaluating essential prescribing competencies of final-year medical students were included. Twenty-five articles describing, and 47 articles evaluating, the prescribing competencies of final-year students were included. Although there seems to be some agreement, we found no clear consensus among CPT teachers on which prescribing competencies medical students should have when they graduate. Studies showed that students had a general lack of preparedness, self-confidence, knowledge and skills, specifically regarding general and antimicrobial prescribing and pharmacovigilance. However, the results should be interpreted with caution, given the heterogeneity and methodological weaknesses of the included studies. There is considerable evidence that final-year students have insufficient competencies to prescribe safely and effectively, although there is a need for a greater consensus among CPT teachers on the required competencies. Changes in undergraduate CPT education are urgently required in order to improve the prescribing of future doctors. © 2018 VU University Medical Centre. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

  7. Safety and pharmacokinetics of dolutegravir in HIV-positive pregnant women: a systematic review.

    Science.gov (United States)

    Hill, Andrew; Clayden, Polly; Thorne, Claire; Christie, Rachel; Zash, Rebecca

    2018-04-01

    The integrase strand transfer inhibitor dolutegravir (DTG) is being introduced into low- and middle-income countries (LMICs) as an alternative to first-line treatment with non-nucleoside reverse transcriptase inhibitors. However, DTG is not yet widely recommended for use in pregnant women. The aim of this systematic review was to analyse all available data on birth outcomes and congenital anomalies in the infants of pregnant women treated with DTG. A PubMed and Embase search was conducted using the terms "dolutegravir" or "DTG" and "pregnancy" or "pregnant" from the earliest available date on the database to 26 July 2017. Any reports involving women who were pregnant, HIV positive and taking DTG were included. The percentage of pregnant women with adverse birth outcomes or congenital anomalies in their infants after taking dolutegravir was compared with five historical control databases. There were six databases included in the main analysis of birth outcomes and congenital anomalies, with a total of 1200 pregnant women. The percentage of pregnant women taking DTG with adverse birth outcomes and congenital abnormalities was similar to results from historical control studies of HIV-positive women. However, there was significant heterogeneity among the six databases - the percentage of infants with congenital anomalies ranged from 0.0% in Botswana (0/116 infants) to 13.3% in IMPAACT P1026S (2/15 infants). Up to 15 million people could be on treatment with DTG in LMICs within the next 5 years, of whom a substantial percentage is likely to be women of child-bearing potential. In many countries with large HIV epidemics, unplanned pregnancies are common and access to antenatal clinic facilities may be limited. Continued pharmacovigilance is essential, but it is reassuring that no clear safety signals have been detected, to date, for pregnant women treated with DTG in terms of birth outcomes or congenital anomalies.

  8. Software Reviews.

    Science.gov (United States)

    Kinnaman, Daniel E.; And Others

    1988-01-01

    Reviews four educational software packages for Apple, IBM, and Tandy computers. Includes "How the West was One + Three x Four,""Mavis Beacon Teaches Typing,""Math and Me," and "Write On." Reviews list hardware requirements, emphasis, levels, publisher, purchase agreements, and price. Discusses the strengths…

  9. Clinical review

    DEFF Research Database (Denmark)

    Groth, Kristian; Skakkebæk, Anne; Høst, Christian

    2013-01-01

    Recently, new clinically important information regarding Klinefelter syndrome (KS) has been published. We review aspects of epidemiology, endocrinology, metabolism, body composition, and neuropsychology with reference to recent genetic discoveries.......Recently, new clinically important information regarding Klinefelter syndrome (KS) has been published. We review aspects of epidemiology, endocrinology, metabolism, body composition, and neuropsychology with reference to recent genetic discoveries....

  10. Book Reviews.

    Science.gov (United States)

    Journal of Chemical Education, 1983

    1983-01-01

    Reviews two textbooks: "Principles of Biochemistry" by Albert L. Lehninger and "Inorganic Chemistry, A Modern Introduction" by Therald Moeller. Also reviews text, study guide, and laboratory manual for Morris Hein's "Foundations of College Chemistry, Fifth Edition" and text/study guide for David A. Ucko's "Basics for Chemistry." (JN)

  11. Book Reviews.

    Science.gov (United States)

    Powicke, J. C.; And Others

    1986-01-01

    Reviews of 10 recent books and one new journal ("Catalyst: A Journal of Policy Debate") are provided. Topics of the books reviewed include: economics in modern Britain, world economics, the mixed economy, Milton Friedman's thought, British industry, economic issues, and London as a financial center. (JDH)

  12. Book Reviews

    Directory of Open Access Journals (Sweden)

    Book Review Editor, Christien Klaufus

    2015-10-01

    Full Text Available Rebel Mexico: Student Unrest and Authoritarian Political Culture During the Long Sixties, by Jaime M. Pensado, 2013, and Specters of Revolution: Peasant Guerrillas in the Cold War Mexican Countryside, by Alexander Aviña, 2014; reviewed by Wil G. PanstersWe are the face of Oaxaca: Testimony and Social Movements, by Lynn Stephen, 2013; reviewed by Jaime HoogestegerMaya Exodus: Indigenous struggle for citizenship in Chiapas, by Heidi Moksnes, 2012; reviewed by Gemma van der HaarLand and Freedom: The MST, the Zapatistas and Peasant Alternatives to Neoliberalism, by Leandro Vergara-Camus, 2014; reviewed by Jonathan DeVoreIndigenous Movements and Building the Plurinational State in Bolivia: Organisation and Identity in the Trajectory of the CSUTCB and CONAMAQ, by Radosław Powęska, 2013; reviewed by Ton SalmanMovimientos estudiantiles en la historia de América Latina IV, coordinado por Renate Marsiske, 2015; reseñado por Andrés Donoso RomoEl corazón de los libros, Alzate y Bartolache: Lectores y escritores novohispanos (S. XVIII, by Mauricio Sánchez Menchero, 2012; reviewed by Helge WendtAurality: Listening and Knowledge in Nineteenth-Century Colombia, por Ana María Ochoa Gautier, 2014; reseñado por Mercedes López RodríguezThe Vanguard of the Atlantic World: Creating Modernity, Nation, and Democracy in Nineteenth-Century Latin America, by James E. Sanders, 2014; reviewed by Michiel BaudMexico’s Once and Future Revolution: Social Upheaval and the Challenge of Rule since the Late Nineteenth Century, by Gilbert M. Joseph and Jürgen Buchenau, 2013; reviewed by Dirk KruijtThe Great Depression in Latin America, coordinado por Paulo Drinot and Alan Knight, 2014; reseñado por Juan Carlos KorolEnhancing Democracy. Public Policies and Citizen Participation in Chile, by Gonzalo Delamaza, 2014; reviewed by Camila Jara IbarraCritical Interventions in Caribbean Politics and Theory, by Brian Meeks, 2014; reviewed by Hebe VerrestBlack Power in the

  13. Systematic review

    DEFF Research Database (Denmark)

    Enggaard, Helle

    Title: Systematic review a method to promote nursing students skills in Evidence Based Practice Background: Department of nursing educate students to practice Evidence Based Practice (EBP), where clinical decisions is based on the best available evidence, patient preference, clinical experience...... and resources available. In order to incorporate evidence in clinical decisions, nursing students need to learn how to transfer knowledge in order to utilize evidence in clinical decisions. The method of systematic review can be one approach to achieve this in nursing education. Method: As an associate lecturer...... I have taken a Comprehensive Systematic Review Training course provide by Center of Clinical Guidelines in Denmark and Jonna Briggs Institute (JBI) and practice in developing a systematic review on how patients with ischemic heart disease experiences peer support. This insight and experience...

  14. Proactive Review

    DEFF Research Database (Denmark)

    Kolbæk, Ditte

    2015-01-01

    This chapter will explore how to learn from working experience through the use of an educational approach called Proactive Review. From 2005 to 2012, Proactive Review was developed and implemented in a world-class IT company based in more than 40 countries across Europe, the Middle East, and Africa....... This chapter will include some of the theoretical considerations as well as the final educational design for a Proactive Review, as exemplified in a case study from the IT company. The aim of this chapter is to provide a theoretically based and proven educational design for Lessons Learned, including...... recommendations for successful Proactive Reviews. The theory section will explore theories regarding the following two topics: first, how an organization may understand the term “learning”; and second, the starting point of learning and how an organization may maintain a learning environment. The research...

  15. Software Reviews.

    Science.gov (United States)

    Dwyer, Donna; And Others

    1989-01-01

    Reviewed are seven software packages for Apple and IBM computers. Included are: "Toxicology"; "Science Corner: Space Probe"; "Alcohol and Pregnancy"; "Science Tool Kit Plus"; Computer Investigations: Plant Growth"; "Climatrolls"; and "Animal Watch: Whales." (CW)

  16. Software Reviews.

    Science.gov (United States)

    Davis, Shelly J., Ed.; Knaupp, Jon, Ed.

    1984-01-01

    Reviewed is computer software on: (1) classification of living things, a tutorial program for grades 5-10; and (2) polynomial practice using tiles, a drill-and-practice program for algebra students. (MNS)

  17. Software Reviews.

    Science.gov (United States)

    Miller, Anne, Ed.; Radziemski, Cathy, Ed.

    1988-01-01

    Three pieces of computer software are described and reviewed: HyperCard, to build and use varied applications; Iggy's Gnees, for problem solving with shapes in grades kindergarten-two; and Algebra Shop, for practicing skills and problem solving. (MNS)

  18. Film Reviews.

    Science.gov (United States)

    Lance, Larry M.; Atwater, Lynn

    1987-01-01

    Reviews four Human Sexuality films and videos. These are: "Personal Decisions" (Planned Parenthood Federation of America, 1985); "The Touch Film" (Sterling Production, 1986); "Rethinking Rape" (Film Distribution Center, 1985); "Not A Love Story" (National Film Board of Canada, 1981). (AEM)

  19. Peer Reviewer

    OpenAIRE

    Baru Mansjur, Mansjur

    2016-01-01

    - Peer Reviewer Effects Of Histomorohometric, Bone Tu Implant Contac and Asseointegration On a novel Hybrid Micro/Nano Topografhy Modfie Dental Implant in The Mandibular Canine Premolar Area Of The Mini Pigs

  20. Book Review

    African Journals Online (AJOL)

    Bernt Lindtjorn

    Book Review. Water Resources Management in Ethiopia: Implications for the Nile Basin. ... general to specific issues within the Ethiopian context. ... properly made with regard to water source, ... of those of Tanzania, Kenya, Burundi, Rwanda,.

  1. Book Reviews

    Directory of Open Access Journals (Sweden)

    Book Review Editor, Barbara Hogenboom

    2014-10-01

    Full Text Available The Economic History of the Caribbean since the Napoleonic Wars, by Victor Bulmer-Thomas (2012; reviewed by Gert OostindieSubjects or Citizens: British Caribbean Workers in Cuba, 1900-1960, by Robert Whitney and Graciela Chailloux Laffita (2013; reviewed by Rose Mary AllenDebating Civil-Military Relations in Latin America, editado por David Mares y Rafael Martínez (2014; reseñado por Raul Benitez-ManautComparative Public Policy in Latin America, editado por Jordi Díez y Susan Franceschet (2012; reseñado por Gonzalo DelamazaEntre el desarrollo y el buen vivir. Recursos naturales y conflictos en los territorios indígenas, editado por José Aylwin, Salvador Martí i Puig, Claire Wright y Nancy Yañez (2013; reviewed by Almut Schilling-VacaflorDignity for the Voiceless. Willem Assies’s Anthropological Work in Context, editado por Ton Salman, Salvador Martí i Puig, y Gemma van der Haar (2014; reseñado por Ricardo Calla OrtegaDemocracy in ‘Two Mexicos’; Political Institutions in Oaxaca and Nuevo León, by Guadelupe Correa-Cabrera (2013; reviewed by Jos BartmanWhere the River Ends, by Shaylih Muehlmann (2013; reviewed by Maria L. Cruz-TorresKnowing History in Mexico. An ethnography of Citizenship, by Trevor Stack (2012; reviewed by Raymond BuveFor God and Revolution. Priest, Peasant, and Agrarian Socialism in the Mexican Huasteca, por Mark Saad Saka( 2013; reseñado por Antonio Escobar OhmstedeWorking Women, Entrepreneurs, and the Mexican Revolution: the Coffee Culture of Córdoba, Veracruz, by Heather Fowler-Salamini (2013; reviewed by Robert F. AlegreWar by Other Means. Aftermath in Post-Genocide Guatemala, edited by Carlota McAlister and Diana Nelson (2013; reviewed by Dirk KruijtLucha revolucionaria. Perú, 1958-1967, por Jan Lust (2013; reseñado por Dirk KruijtWomen in War. The Micro-Processes of Mobilization in El Salvador, by Jocelyn Viterna (2013; reviewed by Ralph SprenkelsZero Hunger: Political Culture and Antipoverty Policy in

  2. Book Reviews

    Directory of Open Access Journals (Sweden)

    Christien Klaufus, Book Review Editor

    2016-04-01

    Full Text Available The Improbable Conquest: Sixteenth Century Letters from the Rio de la Plata, por Pablo García Loaeza y Victoria L. Garrett, 2015; reseñado por Judith Farberman Urban Space as Heritage in Late Colonial Cuba: Classicism and Dissonance on the Plaza de Armas of Havana: 1754-1828, by Paul Niell, 2015; reviewed by Joseph L. Scarpaci El Jefe Político. Un dominio negociando en el mundo rural del Estado de México. 1856-1911, por Romana Falcón, 2015; reseñado por Raymond Buve Miedo negro, poder blanco en la Cuba colonial, por Jorge Camacho, 2015; reseñado por Oleski Miranda Navarro Revolutionary Parks: Conservation, Social Justice, and Mexico’s National Parks, 1910-1940, by Emily Wakild, 2011; reviewed by Grant Burrier Sandino’s Nation: Ernesto Cardenal and Sergio Ramírez Writing Nicaragua, 1940-2012, by Stephen Henighan, 2014; reviewed by Grace A. Gomashie La cancha peronista. Fútbol y política (1946-1955, edited by Raanan Rein, 2015; reviewed by Alexis Sossa Rojas Chile y la Guerra Fría global, edited by Tanya Harmer and Alfredo Riquelme Segovia, 2014; reviewed by Ángela Vergara Challenging Social Inequality: The Landless Rural Workers Movement and Agrarian Reform in Brazil, edited by M. Carter, 2015; reviewed by Rebecca Tarlau Brazil: Reversal of Fortune, by Alfred P. Montero, 2014; reviewed by Edgar J. Marcolin Latin American Documentary Filmmaking – Major works, by David William Foster, 2013; reviewed by Leontien Cremers Telling and Being told: Storytelling and Cultural Control in Contemporary Yucatec Maya Literatures, por Paul Worley, 2013; reseñado por Ana Ugarte Bachata and Dominican Identity/La bachata y la identidad dominicana, by Julie Sellers, 2014; reviewed by Grant D. Moss Entrepreneurial Selves: Neoliberal Respectability and the Making of a Caribbean Middle Class, by Carla Freeman, 2014; reviewed by Emiel Martens

  3. Magnetohydrodynamics (MHD) Engineering Test Facility (ETF) 200 MWe power plant. Conceptual Design Engineering Report (CDER). Volume 2: Engineering. Volume 3: Costs and schedules

    Science.gov (United States)

    1981-01-01

    Engineering design details for the principal systems, system operating modes, site facilities, and structures of an engineering test facility (ETF) of a 200 MWE power plant are presented. The ETF resembles a coal-fired steam power plant in many ways. It is analogous to a conventional plant which has had the coal combustor replaced with the MHD power train. Most of the ETF components are conventional. They can, however, be sized or configured differently or perform additional functions from those in a conventional coal power plant. The boiler not only generates steam, but also performs the functions of heating the MHD oxidant, recovering seed, and controlling emissions.

  4. Magnetohydrodynamics (MHD) Engineering Test Facility (ETF) 200 MWe power plant. Conceptual Design Engineering Report (CDER). Volume 2: Engineering. Volume 3: Costs and schedules. Final Report

    International Nuclear Information System (INIS)

    1981-09-01

    Engineering design details for the principal systems, system operating modes, site facilities, and structures of an engineering test facility (ETF) of a 200 MWE power plant are presented. The ETF resembles a coal-fired steam power plant in many ways. It is analogous to a conventional plant which has had the coal combustor replaced with the MHD power train. Most of the ETF components are conventional. They can, however, be sized or configured differently or perform additional functions from those in a conventional coal power plant. The boiler not only generates steam, but also performs the functions of heating the MHD oxidant, recovering seed, and controlling emissions

  5. Saudi Vigilance Program: Challenges and lessons learned.

    Science.gov (United States)

    Alharf, Adel; Alqahtani, Nasser; Saeed, Ghazi; Alshahrani, Ali; Alshahrani, Mubarak; Aljasser, Nasser; Alquwaizani, Mohammed; Bawazir, Saleh

    2018-03-01

    Pharmacovigilance is vital to public health. Adopting a robust spontaneous reporting system for adverse drug events can counteract most hazards that arise from utilizing medicinal products. Prior to the establishment of the Saudi Food and Drug Authority (SFDA), the number of pharmacovigilance-related activities in Saudi Arabia was limited. In 2009, the SFDA established the National Pharmacovigilance and Drug Safety Center (Saudi Vigilance). The pharmacovigilance system has remarkably improved during the past few years. Several initiatives have been taken to improve the program's performance. These initiatives include initiation of pharmacovigilance guidelines, enhancement of communication and reporting tools, training sessions for concerned staff and healthcare providers, and compliance from stakeholders. This review article provides an overview of what the Saudi Vigilance program is, focusing on the scope, mission and vision, hierarchy, operational themes, and overall work processes. Additionally, we will shed light on the challenges we encountered during the early phase and on our future plans.

  6. Book reviews

    Directory of Open Access Journals (Sweden)

    Tore Ahlbäck

    2011-05-01

    Full Text Available Four book reviews are included in this issue of Approaching Religion:The Process of Buddhist-Christian Dialogue (2009 by Paul O. Ingram is reviewed by Dr Teuvo Laitila. The book deals with contemporary dialogues between Buddhists and Christians, mainly in the West, by applying a three-part perspective denoted conceptual, engaged and internal.Producing Islamic Knowledge. Transmission and Dissemination in Western Europe (2010 by Martin van Bruinessen and Stefano Allievi is reviewed by Dr Jeanette Jouili. The book investigates into Islamic knowledge production taking place in the contemporary European context, from a theoretical as well as from a richly varied empirical perspective.Grounding Religion. A Field Guide to the Study of Religion and Ecology (2011 by Whitney A. Bauman, Richard R. Bohannon II and Kevin J. O’Brien is reviewed by MA Laura Wickström. The book provides an introduction to the field of religion and ecology with special emphasis on interreligious co-operation.Mirakel, mysterier och moraliteter. Från puritanism till New Age – en religionshistorisk studie av Helen Shucman och A Course in Miracles (2010 is reviewed by Dr Tore Ahlbäck. The book is a doctoral thesis analysing the history of creation behind the highly influential spiritual guide A Course in Miracles (1965–72 and its originator Helen Shucman.

  7. Literature review

    DEFF Research Database (Denmark)

    Nissen, Nina Konstantin; Holm, Lotte

    2015-01-01

    Improved understanding of how normal weight and moderately overweight people manage their body weight and shape could be used to inform initiatives to prevent and treat obesity. This literature review offers a thorough appraisal of existing research into perceptions and management of own body size...... among normal weight and moderately overweight people. The studies reported in the 47 publications reviewed here address various themes based on different conceptualizations. The studies point out that normal weight and moderately overweight people are much concerned about their body size, but huge...

  8. Systematic review

    DEFF Research Database (Denmark)

    Lødrup, Anders Bergh; Reimer, Christina; Bytzer, Peter

    2013-01-01

    in getting off acid-suppressive medication and partly explain the increase in long-term use of PPI. A number of studies addressing this issue have been published recently. The authors aimed to systematically review the existing evidence of clinically relevant symptoms caused by acid rebound following PPI...

  9. Book Reviews

    OpenAIRE

    Matthews, Alan; Goldin, Ian; Colman, David; Bickerton, Thomas W.; Beghin, John C.; Croci-Angelini, Elisabetta

    1992-01-01

    Books reviewed include: Principles of Agricultural Economics by D. Colman and T. Young; World Agriculture: Toward 2000 by Nikos Alexandratos; Food Subsidies in Developing Countries: Costs, Benefits and Policy Options; Elasticities in International Agricultural Trade by Colin A. Carter and W. H. Gardiner; Macroeconomics, Agriculture and Exchange Rates; Government and Agriculture in Western Europe, 1880-1988 by M. Tracy

  10. Reviews, Software.

    Science.gov (United States)

    Science Teacher, 1988

    1988-01-01

    Reviews two computer software packages for use in physical science, physics, and chemistry classes. Includes "Physics of Model Rocketry" for Apple II, and "Black Box" for Apple II and IBM compatible computers. "Black Box" is designed to help students understand the concept of indirect evidence. (CW)

  11. Software Review.

    Science.gov (United States)

    McGrath, Diane, Ed.

    1989-01-01

    Reviewed is a computer software package entitled "Audubon Wildlife Adventures: Grizzly Bears" for Apple II and IBM microcomputers. Included are availability, hardware requirements, cost, and a description of the program. The murder-mystery flavor of the program is stressed in this program that focuses on illegal hunting and game…

  12. book reviews

    African Journals Online (AJOL)

    book reviews. Self-testing in ... This book is a useful tool for registrar trainees and practising psy- chiatrists alike. ... sultation service and is a Professor of Psychiatry at Harvard. Medical ... It is recommended as a study aid and provides the ideal ...

  13. Literature Reviews

    Science.gov (United States)

    Rhoades, Ellen A.

    2011-01-01

    The primary purpose of a literature review is to assist readers in understanding the whole body of available research on a topic, informing readers on the strengths and weaknesses of studies within that body. It is defined by its guiding concept or topical focus: an account of what was previously published on a specific topic. This prevents…

  14. Book Review

    African Journals Online (AJOL)

    user

    2004-12-02

    Dec 2, 2004 ... Book Review. World Health Organization 2003. Price Not Available. ISBN 9241545755. This is a paperback book updating three earlier WHO publications namely: • General Surgery at the District Hospital,. • Surgery at the District Hospital,. • Obstetric/Gynecology, Orthopedics/Traumatology, and Anesthesia ...

  15. Book review

    African Journals Online (AJOL)

    Book review. * Professor of Higher Education Studies, Centre for Higher and Adult Education, University of Stellenbosch. Email: mfourie@sun.ac.za. Worldwide, the composition of the student population in higher education has over the past two decades changed dramatically. With larger numbers of previously underserved.

  16. Invited review

    DEFF Research Database (Denmark)

    Sangild, Per Torp; Thymann, Thomas; Schmidt, Mette

    2013-01-01

    with NEC may require resection of the necrotic parts of the intestine, leading to short bowel syndrome (SBS), characterised by reduced digestive capacity, fluid loss, and dependency on parenteral nutrition. This review presents the preterm pig as a translational model in pediatric gastroenterology that has...

  17. Systematic review

    DEFF Research Database (Denmark)

    Borup, H; Kirkeskov, L; Hanskov, Dorte Jessing Agerby

    2017-01-01

    . Conclusions: This review suggests that COPD occurs more often among construction workers than among workers who are not exposed to construction dust. It is not possible to draw any conclusions on specific subgroups as most studies analysed construction workers as one united group. In addition, no potential...

  18. Concise review

    DEFF Research Database (Denmark)

    Dawson, Jonathan I; Kanczler, Janos; Tare, Rahul

    2014-01-01

    of diseases associated with an increasingly aged population. This review describes the state of the field and current steps to translate and apply skeletal stem cell biology in the clinic and the problems therein. Challenges are described along with key strategies including the isolation and ex vivo expansion...

  19. Short Review

    DEFF Research Database (Denmark)

    Lynnerup, Niels; Rühli, Frank

    2015-01-01

    modality in ancient mummy research. The aim of this short review is to address the advantages and pitfalls of this particular technique for such unique samples. We recommend that when results of X-ray examination of mummies are presented, the specific recording data should be listed, and any given finds...

  20. Systematic review

    DEFF Research Database (Denmark)

    Helgstrand, John Thomas; Berg, Kasper Drimer; Lippert, Solvej

    2016-01-01

    trials have challenged this dogma. The aim of this study was to evaluate how endocrine therapy (ET) affects survival in different clinical settings of PCa. Materials and methods A review of published phase II, III and IV studies evaluating the effect of ET on survival was performed. Results In localized...

  1. Systematic review

    DEFF Research Database (Denmark)

    Christensen, Troels Dreier; Spindler, Karen-Lise Garm; Palshof, Jesper Andreas

    2016-01-01

    to earlier diagnosis and improved survival. Method: In this paper, we describe the incidence as well as characteristics associated with BM based on a systematic review of the current literature, following the PRISMA guidelines. Results: We show that the incidence of BM in CRC patients ranges from 0.6 to 3...

  2. Clinical review

    DEFF Research Database (Denmark)

    Hjortrup, Peter Buhl; Haase, Nicolai; Wetterslev, Mik

    2013-01-01

    Neutrophil gelatinase-associated lipocalin (NGAL) may be an early marker of acute kidney injury (AKI), but elevated NGAL occurs in a wide range of systemic diseases. Because intensive care patients have high levels of comorbidity, our objective was to conduct a systematic review of the literature...

  3. Software Reviews.

    Science.gov (United States)

    Teles, Elizabeth, Ed.; And Others

    1990-01-01

    Reviewed are two computer software packages for Macintosh microcomputers including "Phase Portraits," an exploratory graphics tool for studying first-order planar systems; and "MacMath," a set of programs for exploring differential equations, linear algebra, and other mathematical topics. Features, ease of use, cost, availability, and hardware…

  4. Book Reviews.

    Science.gov (United States)

    Coates, Elizabeth; And Others

    1993-01-01

    Reviews three books: (1) "Jeux Populaires Traditionnels pour les Enfants d'aujourd'hui" (Traditional Popular Games for Today's Children) (Jacqueline Theriault and Denise Garon); "Early Childhood Education" (B. Persky and L. Golubchick, editors); and "Playing to Learn: The Young Child, Teacher and the Classroom" (Weininger and Daniel). (AC)

  5. Book Review

    African Journals Online (AJOL)

    Angela

    The book in review tells many tales of looting, rape and murder of prominent. Nuba figures as well as ordinary Nuba folk. As the government is increasing pressure on them, the Nuba are proving to be more resilient than ever to ensure their posterity. The picture that dominates the front cover may easily be overlooked by.

  6. Book review

    Directory of Open Access Journals (Sweden)

    EC Thomas

    1978-11-01

    Full Text Available This book appears to the present reviewer to be, if not the, at least a definitive volume for students of work motivation, whether organizational behaviourists or practising managers. This field has grown rapidly as the main focus of Organizational Psychology since Vroom's (1964 enunciation of a tenable theory of work motivation and satisfaction.

  7. Book review

    African Journals Online (AJOL)

    Book review. * Dr Birgit Schreiber is the Director of the Centre for Student Support Services at the University of the. Western Cape, Cape Town, South Africa. Email: bschreiber@uwc.ac.za. Manuel Castells (2001), who is regarded as one of the most influential social scientists commenting on the role of higher education in ...

  8. Courseware Review.

    Science.gov (United States)

    Risley, John S.

    1984-01-01

    Reviews software package consisting of three programs designed to give students practice on V=IR calculations for series, parallel, and network electric circuits. Indicates that the package for Apple II microcomputers is very good for individual practice and that graphics are useful in teaching students how to draw circuits. (JN)

  9. REVIEW ARTICLE

    African Journals Online (AJOL)

    User

    UDS Publishers Limited All Right Reserved 2026-6294. REVIEW ... events of life, genetics, and male gender have been reported to be the ... If left untreated, it caus- es behavioral ... development of the urinary drainage center in the brain, but ...

  10. Book review

    African Journals Online (AJOL)

    contributions to the authoritative bibliography of the scholarly writings on the literatures of the English - speaking world. As he states in the preface to the book, Abodunrin's aim in doing this is to make a compendium of reviews of. "scholarly writing on all aspects of African literature in English'' available to students, teachers ...

  11. Book Reviews.

    Science.gov (United States)

    International Journal of Early Childhood, 1994

    1994-01-01

    Reviews "La Educacion Preescolar: Desafio y Aventura" (Lavanchy Bobsien); "Working towards Better Childcare" (Peeters and Vandenbroeck, editors); "Children's Savings: A Study in the Development of Economic Behavior" (Sonuga-Barke and Webley); "Curvas de Crecimiento Estaturo-ponderal en Escolares" (Saez Crespo and others); and "Helping Bereaved…

  12. Audiovisual Review

    Science.gov (United States)

    Physiology Teacher, 1976

    1976-01-01

    Lists and reviews recent audiovisual materials in areas of medical, dental, nursing and allied health, and veterinary medicine; undergraduate, and high school studies. Each is classified as to level, type of instruction, usefulness, and source of availability. Topics include respiration, renal physiology, muscle mechanics, anatomy, evolution,…

  13. Book review

    African Journals Online (AJOL)

    The work under review is Jack Mapanje's third volume of verse after Of Chameleons ... with which the new book opens, 'The Following Dawn the Boots', talks about the first ... 'St Margaret Chitherow of York', the poet acknowledges that his host country too has ... primary audience and learn to adjust his sights accordingly.

  14. Research Review

    Science.gov (United States)

    Serig, Dan, Ed.

    2010-01-01

    This research review is dedicated to the memory of William Safire (1929-2009). A visionary leader, Safire brought other visionaries, researchers, educators, artists, and policymakers together to explore the confluence of arts education and neuroscience. He fostered the new field of neuroeducation in his work as chair of The Dana Foundation in…

  15. Research Review

    Science.gov (United States)

    Serig, Dan

    2011-01-01

    In this review, the author explores an often-used process in research--the mind map. He uses this method in his own research and artwork. He also uses this extensively with students, particularly master students when they are trying to surround issues in their thesis projects. Mind maps are closely associated with brainstorming, as brainstorming…

  16. Peer Review

    DEFF Research Database (Denmark)

    Avital, Michel

    2018-01-01

    that the community’s hunger for publication accompanies only a modest appetite for providing the necessary support to sustain the consequent increase in peer-review load. The advent of blockchain technologies and the proliferation of cryptocurrencies presents an opportunity to develop a token-based peer...

  17. REVIEW ARTICLE

    African Journals Online (AJOL)

    User

    Serum markers related to depression: A systematic review .... system proteins that play an important role in Alz- heimer's ... lated to the reduction of BDNF and its treatment ... positive action. .... involved in the physiology of emotional and psychological disorders (Gornick .... contribute fundamentally to emotional behaviors.

  18. Review Symposium.

    Science.gov (United States)

    Fink, Dean; Harris, Alma; Strain, Michael; Willmott, Rob; Gunter, Helen

    2002-01-01

    The book "Leaders and Leadership in Education," by Helen Gunter, is the topic of four separate reviews and a response by the author. Each brief essay contains references. Dean Fink describes the book as "a breathtaking survey of contemporary management and leadership literature, particularly British." (Contains 68 references.) (MLF)

  19. Book Reviews

    OpenAIRE

    Barlow, Colin; Harvey, D. R.; Lane, S.

    1988-01-01

    Books Reviewed: The Economics of Oil Palm; Agricultural Policy Formation in the European Community: The Birth of Milk Quotas and CAP Reform by M. Petit, M. de Benedictis, D. Britton, M. de Groot, W. Henrichsmeyer, and F. Lechi; Agriculture's Future: America's Food System by T. L. Wallace

  20. Book Reviews.

    Science.gov (United States)

    Joyner, Christopher C.; And Others

    1986-01-01

    Scholarly reviews of nine books are presented. Topics include nuclear deterrence, urban planning in France, human rights in the Republic of China, the United States' support of Israel, U. S. military policy, an analysis of Rousseau's social contract, political influences on the U. S. presidency, the state and political theory, and the loss of…

  1. Review Article

    African Journals Online (AJOL)

    2007-12-02

    Dec 2, 2007 ... Introduction. What prompted this review article is because of the wrong notion that the only standard abdominal incision is the midline incision. Cases have been seen in which an abdominal incision extends from the xyphoid process to the symphysis pubis just to remove a perforated appendix! The reason ...

  2. Historical review

    International Nuclear Information System (INIS)

    Zamora C, H.H.

    1989-01-01

    Short history of the ''Instituto de Asuntos Nucleares''. A short historical review about IAN is made: from 1956 when it was called Instituto Colombiano de Asuntos Nucleares, showing its scientific and technical development and the most important events that have occurred in the last 30 years. The people who had contributed to the progress of the institution are also considered, making emphasis in the important happenings that have guided the routes of the IAN

  3. Book Reviews

    OpenAIRE

    Joann Kovacich

    2013-01-01

    Annual Review of Gerontology and Geriatrics 2010-2013 Volume 30, 2010: Focus on Biobehavioral Perspectives on Health in Late Life (Keith E. Whitfield, ed.) Linda J. Keilman , Michigan State University Volume 31, 2011: Pathways Through the Transitions of Care for Older Adults. (Peggye Dilworth-Anderson and Mary H. Palmer, eds.) Rachel Sona Reed, The Pasadena Village Volume 32, 2012: Emerging Perspectives on Resilience in Adulthood and Later Life (Bert Hayslip Jr., Gregory S...

  4. Impetigo - review.

    Science.gov (United States)

    Pereira, Luciana Baptista

    2014-01-01

    Impetigo is a common cutaneous infection that is especially prevalent in children. Historically, impetigo is caused by either group A β-hemolytic streptococci or Staphylococcus aureus. Currently, the most frequently isolated pathogen is S. aureus. This article discusses the microbiologic and virulence factors of group A β-hemolytic streptococci and Staphylococcus aureus, clinical characteristics, complications, as well as the approach to diagnosis and management of impetigo. Topical agents for impetigo therapy are reviewed.

  5. Book reviews

    DEFF Research Database (Denmark)

    Jensen, Niels Rosendal

    2009-01-01

    The review consists of two sections: In the first, community education is understood as an invitation to develop transversal, transdisciplinary research on a European level and dealing with adult education in order to improve a social Europe. In the second, the European question is understood...... as a social question. An interesting trend seems to be that neo-liberalism 'demands' reframing the social. Udgivelsesdato: March 2009...

  6. Book Review:

    Science.gov (United States)

    Stewart, J. M.

    2006-02-01

    In 1952, Mme Yvonne Choquet-Bruhat published a major paper, Théorème d'existence pour certains systèmes d'équations aux dérivées partielles non linéaires (Acta Math. 88 141-225), which laid the foundation for modern studies of the Cauchy problem in general relativity. The fiftieth anniversary of this event was celebrated with an eponymous Cargèse Summer School in 2002. The proceedings of that summer school are summarized electronically (as audio, video, transparencies and lecture notes, where available) on a DVD archive included with this volume, and are also available on the internet. However the organizers decided that a separate volume describing the 'state of the art in mathematical general relativity' would be useful, and this book is the result. It includes some material not covered in the school and excludes some school material which has been covered adequately elsewhere. Unfortunately, I was unable to find, electronically, a table of contents, which every prospective purchaser would wish to see, and so this review does in fact list all the articles, ordered, roughly, by length. About one fifth of the book is devoted to a survey of Smoothness at Null Infinity and the Structure of Initial Data by Helmut Friedrich. This is a modern study of gravitational radiation, and the analysis of Einstein's equations. It is extremely helpful to survey all of this material, including some of the latest developments, using a consistent notation. This article is strongly recommended to anyone hoping to gain a foothold in this area. Note also that 47 pages of transparencies have become 84 book pages. Lars Andersson has surveyed, in The Global Existence Problem in General Relativity, some results and conjectures about the global properties of 3+1-dimensional spacetimes with a compact Cauchy surface. Again it is very useful to have essentially all of the known results presented in a consistent notation. This material is not on the DVD. Yvonne Choquet-Bruhat has

  7. Antimalarial activity of medicinal plants from the Democratic Republic of Congo: A review.

    Science.gov (United States)

    Memvanga, Patrick B; Tona, Gaston L; Mesia, Gauthier K; Lusakibanza, Mariano M; Cimanga, Richard K

    2015-07-01

    Malaria is the most prevalent parasitic disease and the foremost cause of morbidity and mortality in the Democratic Republic of Congo. For the management of this disease, a large Congolese population recourses to traditional medicinal plants. To date the efficacy and safety of many of these plants have been validated scientifically in rodent malaria models. In order to generate scientific evidence of traditional remedies used in the Democratic Republic of Congo for the management of malaria, and show the potential of Congolese plants as a major source of antimalarial drugs, this review highlights the antiplasmodial and toxicological properties of the Congolese antimalarial plants investigated during the period of 1999-2014. In doing so, a useful resource for further complementary investigations is presented. Furthermore, this review may pave the way for the research and development of several available and affordable antimalarial phytomedicines. In order to get information on the different studies, a Google Scholar and PubMed literature search was performed using keywords (malaria, Congolese, medicinal plants, antiplasmodial/antimalarial activity, and toxicity). Data from non-indexed journals, Master and Doctoral dissertations were also collected. Approximately 120 extracts and fractions obtained from Congolese medicinal plants showed pronounced or good antiplasmodial activity. A number of compounds with interesting antiplasmodial properties were also isolated and identified. Some of these compounds constituted new scaffolds for the synthesis of promising antimalarial drugs. Interestingly, most of these extracts and compounds possessed high selective activity against Plasmodium parasites compared to mammalian cells. The efficacy and safety of several plant-derived products was confirmed in mice, and a good correlation was observed between in vitro and in vivo antimalarial activity. The formulation of several plant-derived products also led to some clinical trials

  8. Barnwood review

    International Nuclear Information System (INIS)

    1985-09-01

    This review describes the work of the Generation Development and Construction Division of the [U.K.] Central Electricity Generating Board. It includes work on nuclear power plants and fossil-fuel power plants. The following activities concerned with nuclear power are described: brief summary of all nuclear power work; Dungeness B; Hartlepool/Heysham 1; Heysham 2; irradiated fuel project (engineering service in support of irradiated fuel transport operation; model validation; analysis; instrumentation; impact evaluation; transportation study; full scale crash demonstration; concluding comments); remote visual inspection service (U.K.)

  9. LLE Review

    Energy Technology Data Exchange (ETDEWEB)

    Keck, R.L. (ed.)

    1992-01-01

    This volume of the LLE Review, covering the period January--March 1992, contains articles on the use of diffraction gratings in laser applications, and the fabrication of gratings for use in these applications. there are two articles on the use of lasers to explore fundamental physics issues and an article on the use of a solid-state diode array for x-ray imaging. Finally, the activities of the National Laser Users Facility and the GDL and OMEGA laser systems are summarized.

  10. Book Reviews

    OpenAIRE

    Christien Klaufus, Book Review Editor

    2016-01-01

    The Improbable Conquest: Sixteenth Century Letters from the Rio de la Plata, por Pablo García Loaeza y Victoria L. Garrett, 2015; reseñado por Judith Farberman Urban Space as Heritage in Late Colonial Cuba: Classicism and Dissonance on the Plaza de Armas of Havana: 1754-1828, by Paul Niell, 2015; reviewed by Joseph L. Scarpaci El Jefe Político. Un dominio negociando en el mundo rural del Estado de México. 1856-1911, por Romana Falcón, 2015; reseñado por Raymond Buve Miedo negro, poder blanco ...

  11. Book Review

    Science.gov (United States)

    Smith, René J.

    2006-01-01

    Editors Note: This book is written in Spanish and the review is given in both English and Spanish. Both reviews were written by the same individual and essentially have the same content. Code of Practice for Quality Control of Treatment Planning Systems (TPS) in Radiation Therapy, by José Miguel Delgado Rodríguez, Feliciano García Vicente, Esther Millán Cebrián. Sociedad Española de Física Médica. Ramírez de Arellano Editores, S. L. 2005, Madrid, Spain; available. secretaria@sefm.es, 50ε Protocolo para Control de Calidad en Sistemas de Planificación de Terapia con Radiaciones Ionizantes, por José Miguel Delgado Rodríguez, Feliciano García Vicente, Esther Millán Cebrián. Sociedad Española de Física Médica. Ramírez de Arellano Editores, S. L. 2005, Madrid, Spain. secretaria@sefm.es, 50ε

  12. 2008 annual merit review

    Energy Technology Data Exchange (ETDEWEB)

    None, None

    2009-01-18

    The 2008 DOE Vehicle Technologies Program Annual Merit Review was held February 25-28, 2008 in Bethesda, Maryland. The review encompassed all of the work done by the Vehicle Technologies Program: a total of 280 individual activities were reviewed, by a total of just over 100 reviewers. A total of 1,908 individual review responses were received for the technical reviews, and an additional 29 individual review responses were received for the plenary session review.

  13. Exploration Review

    Science.gov (United States)

    Wilburn, D.R.; Stanley, K.A.

    2013-01-01

    This summary of international mineral exploration activities for 2012 draws upon information from industry sources, published literature and U.S. Geological Survey (USGS) specialists. The summary provides data on exploration budgets by region and mineral commodity, identifies significant mineral discoveries and areas of mineral exploration, discusses government programs affecting the mineral exploration industry and presents analyses of exploration activities performed by the mineral industry. Three sources of information are reported and analyzed in this annual review of international exploration for 2012: 1) budgetary statistics expressed in U.S. nominal dollars provided by SNL Metals Economics Group (MEG) of Halifax, Nova Scotia; 2) regional and site-specific exploration activities that took place in 2012 as compiled by the USGS and 3) regional events including economic, social and political conditions that affected exploration activities, which were derived from published sources and unpublished discussions with USGS and industry specialists.

  14. Book Review

    Directory of Open Access Journals (Sweden)

    Adrian Brown

    2012-01-01

    Full Text Available The second edition of Computational Physics by Rubin Landau, Manuel Paez and Cristian C. Bordeianu (published by Wiley hit bookshelves in 2007, and is steadily making its way into physics classrooms across the United States. Your reviewer first encountered the book at the Stanford Campus Book Store, where it is presumably being put to good use by students and faculty. The first edition was published in 1997 with Landau and Paez as authors [Computational Physics, 1st edn, Wiley, New York, 1997]. Rubin Landau is a very experienced computational physicist and staff member of the Oregon State University in Corvallis, where he directs the Computational Physics for Undergraduates course and teaches using this book. Landau is an incredibly active teacher to put it mildly – the code for the book is supplied in an accompanying DVD and he also posts applets and video lectures for his courses on his web page (http://www.physics.orst.edu/~rubin/.

  15. LLE review

    Energy Technology Data Exchange (ETDEWEB)

    Keck, R.L. (ed.)

    1991-01-01

    This volume of the LLE Review, covering the period October-December 1991, contains articles on the analysis of argon-filled target experiments, and a theoretical analysis of the impact of nonlocal heat transport in laser filamentation in plasmas. In the Advanced Technology section there is an article on mechanisms that affect thin-film conductivity, and a report on the gain characteristics of the 20-cm SSA prototype amplifier to be used in the OMEGA Upgrade. Finally, the activities of the National Laser Users Facility and the GDL and OMEGA laser facilities are summarized. Highlights of the research reported in this issue are: argon radiation from argon-filled, polymer-shell targets is used as a core-temperature diagnostic and density diagnostic of the surrounding region in a regime where the argon line radiation is strongly absorbed. A theoretical analysis of the impact of nonlocal heat transport on laser filamentation in plasmas is developed. The resulting model is compared with experimental observations and the implications for ICF are discussed. A study of thermal conductivity in thin films seeks to identify mechanisms that result in degradation of thin-film conductivity. Identifying these mechanisms can lead to changes in the thin-film manufacture that will improve their resistance to laser damage.

  16. Book Review

    Science.gov (United States)

    Kragh, Helge

    2015-11-01

    Ever since the days of William Blake there has been an underground resistance against the soulless yet triumphant science and its unholy alliance with money, technology and political power. With the nearly undisputed hegemony that science and technological innovation has attained in the post-World War II era, this kind of resistance has resulted in numerous books and articles that in different ways warn against the dark sides of science and the socio-economic system that nourishes a science in degeneration. Classical examples include Herbert Marcuse's One-Dimensional Man (1964), Jacques Ellul's The Technological Society (1965), Theodore Roszak's The Making of a Counter Culture (1968), and Paul Feyerabend's Science in a Free Society (1978). A fair part of the literature written by sociologists and philosophers is not only critical to trends in modern science, but tends to or is overtly anti-science. The book under review belongs in some respects to this heterogeneous literary tradition, but Twilight of the Scientific Age is primarily directed against the institutional system of science and its associated ideology and not against science itself. Indeed, the author is himself a practicing scientist, an astrophysicist, and he emphasizes several times that he firmly believes in science, even that he loves it. He is not a "stupid cultural relativist," he asserts (p. 11), but a critical freethinker independent of dogmatic beliefs.

  17. CPAP review.

    Science.gov (United States)

    Chowdhury, Olie; Wedderburn, Catherine J; Duffy, Donovan; Greenough, Anne

    2012-10-01

    Continuous positive airway pressure (CPAP) is widely used in neonatal units both as a primary mode of respiratory support and following extubation from mechanical ventilation. In this review, the evidence for CPAP use particularly in prematurely born infants is considered. Studies comparing methods of CPAP generation have yielded conflicting results, but meta-analysis of randomised trials has demonstrated that delivering CPAP via short nasal prongs is most effective in preventing re-intubation. At present, there is insufficient evidence to establish the safety or efficacy of high flow nasal cannulae for prematurely born infants. Observational studies highlighted that early CPAP use rather than intubation and ventilation was associated with a lower incidence of bronchopulmonary dysplasia (BPD), but this has not been confirmed in three large randomised trials. Meta-analysis of the results of randomised trials has demonstrated that use of CPAP reduces extubation failure, particularly if a CPAP level of 5 cm H2O or more is used. Nasal injury can occur and is related to the length of time CPAP is used; weaning CPAP by pressure rather than by "time-cycling" reduces the weaning time and may reduce BPD. In conclusion, further studies are required to identify the optimum mode of CPAP generation and it is important that prematurely born infants are weaned from CPAP as soon as possible.

  18. Book Reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2008-12-01

    Jon Fraenkel; The manipulation of custom; From uprising to intervention in the Solomon Islands (Jaap Timmer Clive Moore; Happy isles in crisis; The historical causes for a failing state in Solomon Islands, 1998-2004 (Jaap Timmer Peter Burns; The Leiden legacy; Concepts of law in Indonesia (Bryan S. Turner Terry Crowley; Bislama reference grammar (Kees Versteegh REVIEW ESSAY Matthew Isaac Cohen; Transnational and postcolonial gamelan Lisa Gold; Music in Bali Margaret J. Kartomi; The Gamelan Digul and the prison camp musician who built it; An Australian link with the Indonesian revolution Marc Perlman; Unplayed melodies; Javanese gamelan and the genesis of music theory Ted Solís (ed.; Performing ethnomusicology; Teaching and representation in world music ensembles Henry Spiller; Gamelan; The traditional sounds of Indonesia Andrew N. Weintraub; Power plays; Wayang golek theater of West Java REVIEW ESSAY Victor T. King; People and nature in Borneo Tim Bending; Penan histories; Contentious narratives in upriver Sarawak Rajindra K. Puri; Deadly dances in the Bornean rainforest; Hunting knowledge of the Penan Benalui, 2005 Reed L. Wadley (ed.; Histories of the Borneo environment; Economic, political and social dimensions of change and continuity In: Bijdragen tot de Taal-, Land- en Volkenkunde no. 162 (2006, no: 4, Leiden

  19. Book Reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2008-12-01

    , and way of life (Nicholas Tapp K.S. Nathan, Mohammad Hashim Kamali (eds; Islam in Southeast Asia; Political, social and strategic challenges for the 21st century (Bryan S. Turner Andrew Pawley, Robert Attenborough, Jack Golson, Robin Hide (eds; Papuan pasts; Cultural, linguistic and biological histories of Papuan-speaking peoples (Lourens de Vries Leo Howe, The changing world of Bali; Religion, society and tourism (Carol Warren Sarah Weiss; Listening to an earlier Java; Aesthetics, gender, and the music of wayang in Central Java (Andrew N. Weintraub REVIEW ESSAY Terry Crowley: Four grammars of Malakula languages Crowley, Terry (ed. by John Lynch; The Avava language of Central Malakula (Vanuatu Crowley, Terry (ed. by John Lynch; Tape: a declining language of Malakula (Vanuatu Crowley, Terry (ed. by John Lynch; Naman: a vanishing language of Malakula (Vanuatu Crowley, Terry (ed. by John Lynch; Nese: a diminishing speech variety of Northwest Malakula (Vanuatu (Alexandre Francois REVIEW ESSAY -- ‘The folly our descendants are least likely to forgive us’: the end of nature in Southeast Asia? Michael R. Dove, Percy E. Sajise, Amity A. Doolittle (eds; Conserving nature in culture; Case studies from Southeast Asia Jeyamalar Kathirithamby-Wells; Nature and nation; Forests and development in peninsular Malaysia Celia Lowe; Wild profusion; Biodiversity conservation in an Indonesian archipelago John F. McCarthy; The fourth circle; A political ecology of Sumatra’s rainforest frontier Budy P. Resosudarmo (ed.; The politics and economics of Indonesia’s natural resources Jeffrey R. Vincent, Rozali Mohamed Ali; Managing natural wealth; Environment and development in Malaysia (David Henley In: Bijdragen tot de Taal-, Land- en Volkenkunde no. 163 (2007, no: 2/3, Leiden

  20. Book reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2010-09-01

    upland Southeast Asia. (Guido Sprenger Guido Sprenger, Die Männer, die den Geldbaum fällten; Konzepte von Austausch und Gesellschaft bei den Rmeet von Takheung, Laos. (Oliver Tappe Review Essay Two books on East Timor. Carolyn Hughes, Dependent communities; Aid and politics in Cambodia and East Timor. David Mearns (ed., Democratic governance in Timor-Leste; Reconciling the local and the national. (Helene van Klinken Review Essay Two books on Islamic terror Zachary Abuza, Political Islam and violence in Indonesia. Noorhaidi Hasan, Laskar jihad; Islam, militancy, and the quest for identity in post-New Order Indonesia. (Gerry van Klinken Korte Signaleringen Janneke van Dijk, Jaap de Jonge en Nico de Klerk, J.C. Lamster, een vroege filmer in Nederlands-Indië. Griselda Molemans en Armando Ello, Zwarte huid, oranje hart; Afrikaanse KNIL-nazaten in de diaspora. Reisgids Indonesië; Oorlogsplekken 1942-1949. Hilde Janssen, Schaamte en onschuld; Het verdrongen oorlogsverleden van troostmeisjes in Indonesië. Jan Banning, Comfort women/Troostmeisjes. (Harry Poeze

  1. Book Review:

    Science.gov (United States)

    Hudson, R. P.

    1981-04-01

    In July 1976, some thirty young scientists and their lecturers were privileged to participate in a conference on "Metrology and the Fundamental Constants" at Varenna, this being the 68th course in the "Enrico Fermi International School of Physics". Now, at last, we are all privileged to share in that experience—to a large degree—with the appearance of the Proceedings, published last summer under the auspices of the Italian Physical Society. This rather massive volume (800 pages) places in one's hands a summary of the "state of the art" in the greater part of physical metrology. It is not, however, a metrology handbook, designed to assist the unskilled in making trustworthy measurements. It summarizes, via the lectures of internationally-recognized experts, the most recent attempts to realize with enhanced accuracy the basic units of measurement and, in so doing, it presents the subject of measurement science as the central (or all-pervasive) topic in physics itself. Clearly demonstrated is the progress from discovery to "understanding" of physical phenomena which is made possible through the historical alternation of observation and measurement. The volume includes informative reviews of the fundamentals of this fundamental science, namely, the concepts of quantities and units (Allisy); systems of units and the Système International, SI. (Terrien); international aspects of metrology and standards (Terrien); practical considerations in a hierarchy of standards (Terrien); materials problems affecting metrology (Ferro Milone and Sourdo) and statistical methods (Allisy). These discussions alone, being brought together in one place, are of particular usefulness. The remaining, and major, part of the book is taken up by authoritative and generally very readable discussions of measurement topics, for the most part separately focused on one of the base units. For these one cannot help noticing nor refrain from recording a measure of imbalance: some quantities (for

  2. Book Review

    Directory of Open Access Journals (Sweden)

    Adrian Brown

    2011-01-01

    Full Text Available Phillip M. Morse and Herman Feshbach, Professors of Physics at the MIT, published their biblical-sized textbook ‘Methods of Theoretical Physics’ with McGraw-Hill in May 1953. At 1978 pages and published in two books, it is an intimidating twin tome that should still be atop the reading lists or the bookshelves of every mathematical physicist. What material is covered in this book? In the most concise of terms, this book is devoted to the study of differential equations and associated boundary conditions that describe physical fields. The thirteen chapters address what circumstances warrant the use of which differential equations, and most often addresses the question of coordinate system transformations, for example, how do Green's functions for Laplace's Equation transform under different coordinate systems? Under what circumstances the solutions can be expected to be separable? Many examples are covered to illustrate these points. Why is this book relevant to Software Programmers? This book is part of the background that any scientific programmer is likely to need in dealing with physical fields. This book was written before personal computers became ubiquitous, however it is still an outstanding effort to tie the methods of solving differential equations governing fields together in one book. The book never received a second edition, however, it was reprinted to an outstanding standard by Feshbach Publishing since 2004, run by the children of Herman Feshbach. Their website is feshbachpublishing.com. The majority of this review is a mini-commentary of the book showing what is covered in a very terse fashion, which may be useful as a summary even for those who have already read the full text. I then give a brief analysis of the approach to mathematical physics taken by the book. Finally, I will discuss who will benefit from reading this magnificent treatise, nearly 60 years after it was first published.

  3. PETC Review

    Energy Technology Data Exchange (ETDEWEB)

    Santore, R.R.; Blaustein, B.D.; Friedman, S.; Reiss, J.; Brown, J.; Price, M.M. (eds.)

    1993-01-01

    This issue of the PETC Review is devoted to explaining how the private sector can do business with DOE-and with PETC in particular-and how DOE works with academia, industry, and state and local groups to accomplish objectives of mutual interest. Over the past several years, the notion of cost-sharing'' has been receiving increased attention. Indeed, cost-shared RD D is becoming the norm, not only within DOE but also among other government agencies, including the Department of Defense. It may surprise some of our readership to learn that RD D cost-sharing is not a new government policy. In fact, it has been part of the DOE Acquisition Regulations from their inception in 1977. In lay terms, cost participation, a general kind of cost-sharing, is required for RD D efforts in which the non-Federal participant's goal is commercialization or in situations for which it is reasonable to expect that economic benefits will accrue to the participant as a result of the work. The policy is quite flexible and states that the degree of non-DOEcost participation depends on a number of factors, including the nature of the work performed and the extent of the project risk. As competition for RD D funds increases, it is to be expected that cost-sharing requirements for development, and even for basic research, will increase. Nevertheless, we think that Federal support of RD D will continue to be necessary to maintain this country's leadership in science, technology, industry, and living standards.

  4. Book Review:

    Science.gov (United States)

    Barbour, J. B.

    2007-02-01

    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

  5. Book Review:

    Science.gov (United States)

    Webb, Steve

    2008-11-01

    life and is a condensed history of the development of nuclear physics, political changes and world affairs over the period. It is succinctly arranged and the reader is taken remarkably rapidly through the salient details of the above story in a most readable way. The author states that his intention for the book is to bring the story to a much wider audience than those who work in nuclear or medical physics. Indeed he hopes it will be read by those who might call themselves non-scientists and also young people who might be inspired to pursue a career in physics. Throughout the book salient physics is compartmentalised into bite-sized boxes and explained through analogy, simple diagrams and hardly an equation in sight. Thus one such box entitled 'How to make Nukes work!' should not alarm readers or anti-terror watchdogs. The barest of information is given at all stages; just enough to follow the Rotblat story. In essence the book will be of most use to those who have only the vaguest ideas of the above story. Readers expecting a definitive, well-referenced, chronological tome, backed by a substantial bibliography of primary peer-reviewed papers, will be disappointed. Kit Hill points though to such a definitive work published two years ago by the University of Liverpool. This reviewer felt that maybe the book is a little too thin and in places longed for rather more substance and detail. The author would surely, in his defence, say 'look elsewhere'. This said, it can easily be read cover to cover in one short evening sitting. In a world burgeoned with paperwork to read, that might be considered an advantage. A second disappointment is that there is virtually nothing on the productivity of Rotblat over 30 years as Professor of Medical Physics. This reviewer feels that is a lost opportunity. Kit Hill, personal friend of Jo Rotblat and co-worker with Pugwash, was himself in a similar role (though working mainly with non-ionizing ultrasound radiation) and could have made his

  6. Nuclear Posture Review

    Science.gov (United States)

    2018-02-01

    REVIEW margin for further delay in recapitalizing the physical infrastructure needed to produce strategic materials and components for U.S. nuclear... REVIEW 2018 This page left intentionally blank REVIEW NUCLEAR POSTURE REVIEW FEBRUARY 2018...OFFICE OF THE SECRETARY OF DEFENSE This page left intentionally blank REVIEW CONTENTS SECRETARY’S PREFACE

  7. Book Review:

    Science.gov (United States)

    Poisson, E.

    2006-09-01

    The motion of a charged particle interacting with its own electromagnetic field is an area of research that has a long history; this problem has never ceased to fascinate its investigators. On the one hand the theory ought to be straightforward to formulate: one has Maxwell's equations that tell the field how to behave (given the motion of the particle), and one has the Lorentz-force law that tells the particle how to move (given the field). On the other hand the theory is fundamentally ambiguous because of the field singularities that necessarily come with a point particle. While each separate sub-problem can easily be solved, to couple the field to the particle in a self-consistent treatment turns out to be tricky. I believe it is this dilemma (the theory is straightforward but tricky) that has been the main source of the endless fascination. For readers of Classical and Quantum Gravity, the fascination does not end there. For them it is also rooted in the fact that the electromagnetic self-force problem is deeply analogous to the gravitational self-force problem, which is of direct relevance to future gravitational wave observations. The motion of point particles in curved spacetime has been the topic of a recent Topical Review [1], and it was the focus of a recent Special Issue [2]. It is surprising to me that radiation reaction is a subject that continues to be poorly covered in the standard textbooks, including Jackson's bible [3]. Exceptions are Rohrlich's excellent text [4], which makes a very useful introduction to radiation reaction, and the Landau and Lifshitz classic [5], which contains what is probably the most perfect summary of the foundational ideas (presented in characteristic terseness). It is therefore with some trepidation that I received Herbert Spohn's book, which covers both the classical and quantum theories of a charged particle coupled to its own field (the presentation is limited to flat spacetime). Is this the text that graduate students

  8. Book Review:

    Science.gov (United States)

    Folacci, Antoine; Jensen, Bruce

    2003-12-01

    Thanks to its impressive success in the second half of the 20th century, both in high-energy physics and in critical phenomena, quantum field theory has enjoyed an abundant literature. We therefore greet yet another book on this subject with caution: what can a monograph on quantum field theory bring now that is new, either conceptually or pedagogically? But when it is written by a physicist such as Bryce DeWitt, who has made his own contribution to the collection of field theory books with The Global Approach to Quantum Field Theory, all suspicion is naturally abandoned. One knows in advance that this book can only lead to a genuine enrichment of the literature. DeWitt has made a formidable contribution to various areas of physics: general relativity, the interpretation of quantum mechanics, and most of all the quantization of non-Abelian gauge theories and quantum gravity. In addition, his pedagogical publications, especially the Les Houches schools of 1963 and 1983 [1, 2], have had a great impact on quantum field theory. All this makes the reader keen to pick up his new work and a deeper reading confirms the reviewer's initial enthusiasm. We must begin by alerting the potential readers of this book that it cannot be compared to any other book in the field (unless of course we are talking about references [1] and [2], of which the book under review is an extension and reworking). This uniqueness applies to both the scientific content and the way the ideas are presented. A quick description of this book and a brief explanation of its title should convince the reader of the book's unique quality. For DeWitt, a central concept of field theory is that of `space of histories'. For a field varphii defined on a given spacetime M, the set of all varphii(x) for all x in all charts of M defines its history. It is the space Phi of all possible histories (dynamically allowed or not) of the fields defined on M which is called the `space of histories' by DeWitt. If only

  9. Book Review:

    Science.gov (United States)

    Walcher, J.

    2006-10-01

    This book is a find. Mariño meets the challenge of filling in less than 200 pages the need for an accessible review of topological gauge / gravity duality. He is one of the pioneers of the subject and a clear expositor. It is no surprise that reading this book is a great pleasure. The existence of dualities between gauge theories and theories of gravity remains one of the most surprising recent discoveries in mathematical physics. While it is probably fair to say that we do not yet understand the full reach of such a relation, the impressive amount of evidence that has accumulated over the past years can be regarded as a substitute for a proof, and will certainly help to delineate the question of what is the most fundamental quantum mechanical theory. As has been the case in the past, it is in the context of Witten's 'topological' quantum theories that the mathematical framework is well enough established to firmly ground, and fully benefit from, the development of the physical theories. This book makes an important contribution to this new chapter in the math / physics interaction. There are two main instances of topological gauge/gravity duality. In the A-model, Chern Simons gauge theory on the 3-sphere is related to the closed topological string theory on the local Calabi Yau 3-fold {\\mathcal O}_{{\\mathbb P}^1}(-1) \\oplus{\\mathcal O}_{{\\mathbb P}^1} (-1), also known as the resolved conifold (Gopakumar-Vafa duality). In the B-model, certain types of matrix models are related on the gravity side to topological strings on certain cousins of the deformed conifold (Dijkgraaf-Vafa duality). In both cases, and similarly to the more physical AdS/CFT correspondence, the duality can be discovered by realizing the gauge theory as the target space theory of open strings ending on particular D-branes in a geometry closely related to the closed string background of the gravity theory. The A-branes supporting Chern Simons theory are wrapped on the Lagrangian three

  10. Book Reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2008-12-01

    John Bowden, Nikolaus Himmelmann (eds; Papers in Austronesian subgrouping and dialectology (Hein Steinhauer Sebastiaan Pompe; The Indonesian Supreme Court; A study of institutional collapse (Bryan S. Turner Gerd R. Zimmermann; Indonesien; Eine geographische Landeskunde (Robert Wessing REVIEW ESSAY Dick van der Meij; Latest editions of Indonesian classical texts A. Teeuw, R. Dumas, Muhammad Haji Salleh, R. Tol, M.J. van Yperen (eds; A merry senhor in the Malay world; Four texts of the Syair Sinyor Kosta Julian Millie; Bidasari; Jewel of Malay Muslim culture. A. Teeuw, S.O. Robson (eds; Bhom?ntaka; The death of Bhoma J. Noorduyn, A. Teeuw; Three Old Sundanese poems In: Bijdragen tot de Taal-, Land- en Volkenkunde (BKI, no. 162 (2006, no: 2/3, Leiden

  11. Book Review:

    Science.gov (United States)

    Borcherds, P.

    2005-03-01

    superb quotations to include all of them in this review, but one of Bragg's Golden Rules for newcomers to his laboratory should be on the door of every experimental laboratory: 'Never be afraid to carry on an experiment which is declared stupid by the theorists [sic] of the laboratory'. This book is, as its subtitle implies, about Bragg and about his science. Hunter has skilfully and seamlessly interwoven the two strands. At one minute you are reading about the man and at the next you realize you are reading about the science. In writing about the science, Hunter writes knowledgeably and expects the reader to make an effort to understand. In this he is following the precept of Bragg who, when advised to avoid technical terms when lecturing to a lay audience, ridiculed this attitude with a telling metaphor: 'What could be more technical than a description of a football match? To picture the scientist's plight, one must imagine the sports expert being told to describe the match using as little as possible such terms as "ball'' or "goal'', and of course avoiding the very complex ideas involved in "try'' or "offside'' '. Bragg made several major contributions to crystallography and these are described, as already mentioned. One has to concentrate quite hard to follow but the effort is worthwhile and Hunter manages not only to convey the excitement felt by Bragg and his colleagues but also to let the reader feel it too. Bragg interacted strongly with other crystallographers, not least with his father, but also with Pauling. At times there was a close race between Bragg and Pauling, which is fully discussed. Bragg succeeded Rutherford at Cambridge. The appointment was controversial. Under Rutherford the Cavendish Laboratory concentrated on nuclear physics, while Bragg was a crystallographer, with little interest in nuclear physics. However the crystallographic work Bragg encouraged on haemoglobin and DNA led to several Nobel prizes. Bragg's activities in canvassing for Nobel

  12. Book reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2010-04-01

    Nio Liem, De rechtspositie der Chinezen in Nederlands-Indië 1848-1942; Wetgevingsbeleid tussen beginsel en belang. (Mary Somers Heidhues Zhou Daguan, A record of Cambodia: the land and its people. (Un Leang REVIEW ESSAY Longitudinal studies in Javanese performing arts Benjamin Brinner, Music in Central Java; Experiencing music, expressing culture. Barbara Hatley, Javanese performances on an Indonesian stage; Contesting culture, embracing change. Felicia Hughes-Freeland, Embodied communities; Dance traditions and change in Java. (Matthew Isaac Cohen REVIEW ESSAY Development and reform in Vietnam Stéphanie Balme and Mark Stephanie (eds, Vietnam’s new order; International perspectives on the state and reform in Vietnam. Sujian Guo, The political economy of Asian transition from communism. Ian Jeffries, Vietnam: a guide to economic and political developments. Pietro Masina, Vietnam’s development strategies. (Tran Quang Anh KORTE SIGNALERINGEN Ulbe Bosma, Indiëgangers; Verhalen van Nederlanders die naar Indië trokken. Clara Brinkgreve, Met Indië verbonden; Een verhaal van vier generaties 1849-1949. Jack Botermans en Heleen Tichler, Het vergeten Indië; Stille getuigen van het dagelijks leven in het Indië van toen. Robin te Slaa en Edwin Klijn, De NSB; Ontstaan en opkomst van de Nationaal-Socialistische Beweging, 1931-1935. Mark Loderichs, Margaret Leidelmeijer, Johan van Langen en Jan Kompagnie, Verhalen in Documenten; Over het afscheid van Indië, 1940-1950. Frederik Erens en Adrienne Zuiderweg, Linggadjati, brug naar de toekomst; Soetan Sjahrir als een van de grondleggers van het vrije Indonesië. Peter Schumacher, met medewerking van Gerard de Boer, De zaak Aernout; Hardnekkige mythes rond een Indische moord ontrafeld. Cas Oorthuys, Een staat in wording; Fotoreportage van Cas Oorthuys over het Indonesië van 1947. René Kok, Erik Somers en Louis Zweers, Koloniale oorlog 1945-1949; Van Indië tot Indonesië. H.F. Veenendaal

  13. Environmental Review Records

    Data.gov (United States)

    Department of Housing and Urban Development — HUD’s Environmental Review Records page houses environmental reviews made publicly available through the HUD Environmental Review Online System (HEROS). This...

  14. Book Reviews: Volume 8

    OpenAIRE

    2016-01-01

    Chris Frost Media Ethics and Self Regulation, reviewed by Michael Foley Damien Kiberd (ed.) Media in Ireland: The Search for Ethical Journalism, reviewed by David Quin Peter Mason and Derrick Smith Magazine Law: A Practical Guide, reviewed by Eavan Murphy

  15. Book Review:

    Science.gov (United States)

    Arimondo, Ennio

    2004-07-01

    For many years the Institute of Physics has published books on hot topics based on a collection of reprints from different journals, including some remarks by the editors of each volume. The book on Optical Angular Momentum, edited by L Allen, S M Barnett and M J Padgett, is a recent addition to the series. It reproduces forty four papers originally published in different journals and in a few cases it provides direct access to works not easily accessible to a web navigator. The collection covers nearly a hundred years of progress in physics, starting from an historic 1909 paper by Poynting, and ending with a 2002 paper by Padgett, Barnett and coworkers on the measurement of the orbital angular momentum of a single photon. The field of optical angular momentum has expanded greatly, creating an interdisciplinary attraction for researchers operating in quantum optics, atomic physics, solid state physics, biophysics and quantum information theory. The development of laser optics, especially the control of single mode sources, has made possible the specific design of optical radiation modes with a high degree of control on the light angular momentum. The editors of this book are important figures in the field of angular momentum, having contributed to key progress in the area. L Allen published an historical paper in 1999, he and M J Padgett (together with M Babiker) produced few years ago a long review article which is today still the most complete basic introduction to the angular momentum of light, while S M Barnett has contributed several high quality papers to the progress of this area of physics. The editors' choice provides an excellent overview to all readers, with papers classified into eight different topics, covering the basic principles of the light and spin and orbital angular momentum, the laboratory tools for creating laser beams carrying orbital angular momentum, the optical forces and torques created by laser beams carrying angular momentum on

  16. Book reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2005-01-01

    öder-Butterfill Andrew MacIntyre, The power of institutions; Political architecture and governance (Henk Schulte Nordholt Carol Ireson-Doolittle and Geraldine Moreno-Black, The Lao; Gender, power, and livelihood (Guido Sprenger David L. Gosling (with a foreword by Ninian Smart, Religion and ecology in India and Southeast Asia (Bryan S. Turner William C. Clarke, Remembering Papua New Guinea; An eccentric ethnography (Donald Tuzin Review essay Gerben Nooteboom: Competition, collateral damage, or ‘just accidents’? Three explanations of ethnic violence in Indonesia: - Jacques Bertrand, Nationalism and ethnic conflict in Indonesia - Cristina Eghenter, Bernard Sellato, and G. Simon Devung (eds, Social science research and conservation management in the interior of Borneo; Unravelling past and present interactions of people and forests - Nancy Lee Peluso and Michael Watts (eds, Violent environments - Günther Schlee (ed., Imagined differences; Hatred and the construction of identity

  17. Book Reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2008-12-01

    Melaka and Enyan anak Usen, Iban art; Sexual selection and severed heads: weaving, sculpture, tattooing and other arts of the Iban of Borneo (Viktor T. King John Roosa; Pretext for mass murder; The September 30th Movement and Suharto’s coup d’état in Indonesia (Gerry van Klinken Vladimir Braginsky; The heritage of traditional Malay literature; A historical survey of genres, writings and literary views (Dick van der Meij Joel Robbins, Holly Wardlow (eds; The making of global and local modernities in Melanesia; Humiliation, transformation and the nature of cultural change (Toon van Meijl Kwee Hui Kian; The political economy of Java’s northeast coast c. 1740-1800; Elite synergy (Luc Nagtegaal Charles A. Coppel (ed.; Violent conflicts in Indonesia; Analysis, representation, resolution (Gerben Nooteboom Tom Therik; Wehali: the female land; Traditions of a Timorese ritual centre (Dianne van Oosterhout Patricio N. Abinales, Donna J. Amoroso; State and society in the Philippines (Portia L. Reyes Han ten Brummelhuis; King of the waters; Homan van der Heide and the origin of modern irrigation in Siam (Jeroen Rikkerink Hotze Lont; Juggling money; Financial self-help organizations and social security in Yogyakarta (Dirk Steinwand Henk Maier; We are playing relatives; A survey of Malay writing (Maya Sutedja-Liem Hjorleifur Jonsson; Mien relations; Mountain people and state control in Thailand (Nicholas Tapp Lee Hock Guan (ed.; Civil society in Southeast Asia (Bryan S. Turner Jan Mrázek; Phenomenology of a puppet theatre; Contemplations on the art of Javanese wayang kulit (Sarah Weiss Janet Steele; Wars within; The story of Tempo, an independent magazine in Soeharto’s Indonesia (Robert Wessing REVIEW ESSAY Sean Turnell; Burma today Kyaw Yin Hlaing, Robert Taylor, Tin Maung Maung Than (eds; Myanmar; Beyond politics to societal imperatives Monique Skidmore (ed.; Burma at the turn of the 21st century Mya Than; Myanmar in ASEAN

  18. Book Reviews

    Directory of Open Access Journals (Sweden)

    Ratna Saptari

    1994-07-01

    , Harold Brookfield, South-East Asia’s environmental future; The search for sustainability. Tokyo: United Nations University Press, Kuala Lumpur: Oxford University Press, 1993, xxxii + 422 pp., maps, tables, figures, index., Yvonne Byron (eds. - Antje van der Hoek, Keebet von Benda-Beckmann, De emancipatie van Molukse vrouwen in Nederland. Utrecht: Van Arkel,1992, Francy Leatemia-Toma-tala (eds. - Michael Hitchcock, Brita L. Miklouho-Maklai, Exposing Society’s Wounds; Some aspects of Indonesian Art since 1966. Adelaide: Flinders University Asian studies Monograph No.5, illustrations, 1991, iii + 125 pp - Nico Kaptein, Fred R. von der Mehden, Two Worlds of Islam; Interaction between Southeast Asia and the Middle East.Gainesville etc: University Press of Florida 1993, xiii + 128 pp - Nico Kaptein, Karel Steenbrink, Dutch Colonialism and Indonesian Islam; Contacts and Conflicts 1596-1950. Amsterdam-Atlanta, GA: Rodopi, 1993. - Harry A. Poeze, Rudolf Mrázek, Sjahrir; Politics and exile in Indonesia. Ithaca, N.Y.: Cornell University, Southeast Asia Program, 1994. - W.G.J. Remmelink, Takao Fusayama, A Japanese memoir of Sumatra 1945-1946; Love and hatred in the liberation war. Ithaca: Cornell University (Cornell Modern Indonesia Project Monograph series 71, 1993, 151 pp., maps, illustrations. - Ratna Saptari, Diana Wolf, Factory Daughters; Gender, Household Dynamics, and Rural Industrialization in Java. Berkeley: University of California Press, 1992. - Ignatius Supriyanto, Ward Keeler, Javanese Shadow Puppets. Singapore (etc.: Oxford University Press, 1992, vii + 72 pp.,bibl., ills. (Images of Asia. - Brian Z. Tamanaha,S.J.D., Juliana Flinn, Review of diplomas and thatch houses; Asserting tradition in a changing Micronesia. Ann Arbor: University of Michigan Press, 1992. - Gerard Termorshuizen, Dorothée Buur, Indische jeugdliteratuur; Geannoteerde bibliografie van jeugdboeken over Nederlands-Indië en Indonesië, 1825-1991. Leiden, KITLV Uitgeverij, 1992, 470 pp

  19. Book Reviews

    Directory of Open Access Journals (Sweden)

    J. van Baal

    1965-01-01

    Full Text Available - R.J. Mohr, Bernard J. Siegel, Biennial Review of Anthropology 1963. Stanford University Press. Stanford, California, 1963. 306 pp. - P.E. de Josselin de Jong, Jean Poirier, Guide d’enquête monographique appliquée aux sociétés malgaches. Faculté des lettres et sciences humaines de Madagascar, Tananarive 1962. - P.E. de Josselin de Jong, Jean Poirier, L’inventaire ethno-topographique. Departement des sciences humaines, Faculté des lettres et sciences humaines, Université de Madagascar, Tananarive 1963. - H.Th. Fischer, P. van Emst, Panorama der Volken, I (Volken van Amerika en Oceanië, onder redactie van P. van Emst. Romen en zonen, Roermond 1964. 515 blz., vele ills. - C. Nooteboom, W. Frölich, Völkerkundliche Forschungen, Martin Heydrich zum 70. Geburtstag überreicht von Freunden und Schülern, herausgegeben von W. Frölich (Ethnologica, Neue Folge, Band 2, Köln, 1960. 557 S., 46 Tafeln, 116 Abb. - J. van Baal, Claude Levi-Strauss, Totemism. Translated from the French by Rodney Needham. Beacon Press, Boston, 1963. 116 pp. - J.J. Fahrenfort, Luc de Heusch, Le Pouvoir et le Sacré. Annales de Centre d’ Etude des Religions I. Université de Bruxelles. Institut de Sociologie (Solvay 1962. 228 pp. - H.J.M. Claessen, Montserrat Palau Marti, Le Roi-Dieu au Bénin, Sud Togo, Dahomey, Nigeria Occidentale. Collection Mondes d’Outre-mer, Série: Nations. Berger Levrault, Paris 1964. - P.E. de Josselin de Jong, F. Sierksma, Profiel van een incarnatie. G.A. van Oorschot, Amsterdam 1964. 244 blz. - B.A.L. Cranstone, Carl A. Schmitz, Wantoat: Art and religion of the Northeast New Guinea Papuans. Translated from the German by Mrs. G.E. van Baaren-Pape. Mouton (the Hague, Paris, 1963. 159 pp. 47 plates. - A.A. Gerbrands, William Fagg, Nigerian images. Lund Humphries, London, 1963. 47 pages, 144 plates by Herbert List. - A.A. Gerbrands, Marcelle Urbain-Faublée, L’art malgache. Presses Universitaires de France, Paris, 1963. 141 pag. 100

  20. Book reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2009-05-01

    and sails the boat downstream: Malay Sufi poems of the boat (Suryadi Gilles Gravelle; Meyah: An east Bird’s Head language of Papua, Indonesia (Ian Tupper Penny Edwards; Cambodge: The cultivation of a nation, 1860-1945 (Un Leang J. Stephen Lansing; Perfect order: Recognizing complexity in Bali (Carol Warren Roxana Waterson (ed.; Southeast Asian lives: Personal narratives and historical experience (C.W. Watson Jean DeBernardi; The way that lives in the heart: Chinese popular religion and spirit mediums in Penang, Malaysia (Robert Wessing REVIEW ESSAY Environmental and archaeological perspectives on Southeast Asia Peter Boomgaard; Southeast Asia: An environmental history Peter Boomgaard (ed.; A world of water: Rain, rivers and seas in Southeast Asian histories Ian Glover and Peter Bellwood (eds; Southeast Asia: From prehistory to history Avijit Gupta (ed.; The physical geography of Southeast Asia (Eric C. Thompson

  1. Contrast media-induced nephropathy: how has Italy contributed in the past 30 years? A systematic review

    Directory of Open Access Journals (Sweden)

    Sessa M

    2017-10-01

    contrast-induced nephropathy in Italy during the last three decades. These studies covered procedures to prevent contrast-induced nephropathy or aimed to identify risk factors, biomarkers, and scores, and their related prognosis. Keywords: nephropathy, contrast media, Italy, systematic review, drug safety, adverse drug reaction, pharmacovigilance, post-marketing surveillance

  2. Efficacy and safety of tofacitinib in the treatment of rheumatoid arthritis: a systematic review and meta-analysis

    Science.gov (United States)

    2013-01-01

    Background Tofacitinib is a disease-modifying antirheumatic drug (DMARD) which was recently approved by US Food and Drug Administration (FDA). There are several randomised clinical trials (RCTs) that have investigated the efficacy and safety of tofacitinib in adult patients with rheumatoid arthritis (RA). A systematic review with a meta-analysis of RCTs was undertaken to determine the efficacy and safety of tofacitinib in treating patients with RA. Methods Electronic and clinical trials register databases were searched for published RCTs of tofacitinib between 2009 and 2013. Outcomes of interest include 20% and 50% improvement in the American College of Rheumatology Scale (ACR20 and ACR50) response rates, rates of infection, the number of immunological/haematological adverse events (AEs), deranged laboratory results (hepatic, renal, haematological tests and lipoprotein level) and the incidence of drug withdrawal. Results Eight RCTs (n = 3,791) were reviewed. Significantly greater ACR20 response rates were observed in patients receiving tofacitinib 5 and 10 mg bid (twice daily) versus placebo at week 12, with risk ratios (RR) of 2.20 (95% CI 1.58, 3.07) and 2.38 (95% CI 1.81, 3.14) respectively. The effect was maintained at week 24 for 5 mg bid (RR 1.94; 95% CI 1.55, 2.44) and 10 mg bid (RR 2.20; 95% CI 1.76, 2.75). The ACR50 response rate was also significantly higher for patients receiving tofacitinib 5 mg bid (RR 2.91; 95% CI 2.03, 4.16) and 10 mg bid (RR 3.32; 95% CI 2.33, 4.72) compared to placebo at week 12. Patients in the tofacitinib group had significantly lower mean neutrophil counts, higher serum creatinine, higher percentage change of LDL/HDL and a higher risk of ALT/AST > 1 ULN (upper limit of normal) versus placebo. There were no significant differences in AEs and withdrawal due to AEs compared to placebo. Conclusion Tofacitinib is efficacious and well tolerated in patients with MTX-resistant RA up to a period of 24 weeks. However

  3. Engineering Review Information System

    Science.gov (United States)

    Grems, III, Edward G. (Inventor); Henze, James E. (Inventor); Bixby, Jonathan A. (Inventor); Roberts, Mark (Inventor); Mann, Thomas (Inventor)

    2015-01-01

    A disciplinal engineering review computer information system and method by defining a database of disciplinal engineering review process entities for an enterprise engineering program, opening a computer supported engineering item based upon the defined disciplinal engineering review process entities, managing a review of the opened engineering item according to the defined disciplinal engineering review process entities, and closing the opened engineering item according to the opened engineering item review.

  4. A scoping review of rapid review methods.

    Science.gov (United States)

    Tricco, Andrea C; Antony, Jesmin; Zarin, Wasifa; Strifler, Lisa; Ghassemi, Marco; Ivory, John; Perrier, Laure; Hutton, Brian; Moher, David; Straus, Sharon E

    2015-09-16

    Rapid reviews are a form of knowledge synthesis in which components of the systematic review process are simplified or omitted to produce information in a timely manner. Although numerous centers are conducting rapid reviews internationally, few studies have examined the methodological characteristics of rapid reviews. We aimed to examine articles, books, and reports that evaluated, compared, used or described rapid reviews or methods through a scoping review. MEDLINE, EMBASE, the Cochrane Library, internet websites of rapid review producers, and reference lists were searched to identify articles for inclusion. Two reviewers independently screened literature search results and abstracted data from included studies. Descriptive analysis was conducted. We included 100 articles plus one companion report that were published between 1997 and 2013. The studies were categorized as 84 application papers, seven development papers, six impact papers, and four comparison papers (one was included in two categories). The rapid reviews were conducted between 1 and 12 months, predominantly in Europe (58 %) and North America (20 %). The included studies failed to report 6 % to 73 % of the specific systematic review steps examined. Fifty unique rapid review methods were identified; 16 methods occurred more than once. Streamlined methods that were used in the 82 rapid reviews included limiting the literature search to published literature (24 %) or one database (2 %), limiting inclusion criteria by date (68 %) or language (49 %), having one person screen and another verify or screen excluded studies (6 %), having one person abstract data and another verify (23 %), not conducting risk of bias/quality appraisal (7 %) or having only one reviewer conduct the quality appraisal (7 %), and presenting results as a narrative summary (78 %). Four case studies were identified that compared the results of rapid reviews to systematic reviews. Three studies found that the conclusions between

  5. Book Review:

    Science.gov (United States)

    Swenson, C. A.

    1984-01-01

    maintained a very active interest in the affairs of the CCT. The above outline of the author's background is given here to emphasize his qualifications for presuming to undertake the writing of such an extensive and comprehensive monograph, and for doing it so well, since no similar information is given in "Temperature" nor in any of the advertising. He successfully conveys the viewpoints of both the basic scientist, whose interests are in standards thermometry and forefront research, and the person whose goals are the selection and use of the most appropriate thermometer. After an historical introduction, each of the various chapters (Thermodynamic and practical temperature scales, The measurement of thermodynamic temperatures, Fixed points and comparison baths, Resistance thermometry, Thermocouples, Radiation thermometry, Mercury-in-glass thermometry) and subsections has a similar format. This includes a capsule theoretical introduction and analysis of the subject to orient the reader and to establish limitations and approximations, a description of the current state of the art, and, finally, a nuts-and-bolts presentation which, where appropriate, includes industrial applications. Numerous tables, both in the text and in the appendices, document these discussions, along with an extensive listing of citations (close to 500) to original papers, review articles and other monographs. The coverage of topics is thorough and well-balanced, and suffers only moderately (but not deleteriously) from the biases of the author. My interests in low temperature thermometry extend upwards to 0 °C, and the author's treatment of this area is comprehensive and is done with understanding. He appears to have done equally well done equally well in the sections on higher temperature and more applied thermometry. The theoretical discussions are to educate the reader about the basic physics and consequent limitations and problems in each area. This is a difficult task which is done well on the

  6. Book Reviews

    Directory of Open Access Journals (Sweden)

    Judith Nagata

    1986-04-01

    Full Text Available - Matthias Stiefel, W.F. Wertheim, Matthias Stiefel, Rejoinder to Duller’s review in BKI 142-I, with comments by H.J. Duller., W.F. Wertheim (eds. - K.A. Adelaar, James T. Collins, The historical relationship of the languages of central Maluku, Indonesia, Pacific Linguistics Series D, No. 47, 1983. - J.G. de Casparis, Antoinette M. Barrett Jones, Early tenth-century Java from the inscriptions. A study of economic, social and administrative conditions in the first quarter of the century, Verhandelingen van het Koninklijk Instituut voor Taal-, Land- en Volkenkunde No. 107, Dordrecht/Cinnaminson 1984. XI + 204 pp. - P.J. Drooglever, L. de Jong, Het Koninkrijk der Nederlanden in de Tweede Wereldoorlog, deel 11a, Nederlands-Indië I, eerste en tweede helft, Martinus Nijhoff, Leiden 1984, 1199 pp., kaarten, foto’s. - David T. Hill, Julie Southwood, Indonesia: Law, propaganda and terror, with foreword by W.F. Wertheim, Zed press, 1983, 272 pp., Patrick Flanagan (eds. - V.J.H. Houben, C.Ch. van den Haspel, Overwicht in overleg. Hervormingen van justitie, grondgebruik en bestuur in de Vorstenlanden op Java 1880-1930, VKI 111, Dordrecht: Foris publications, 1985. - Maarten Kuitenbrouwer, J. van Goor, Imperialisme in de marge. De afronding van Nederlands-Indië, Utrecht 1985. - Harry A. Poeze, Hansje Galesloot, De Nederlandse vakbondsperiodieken van het IISG; Systematisch overzicht. Amsterdam: Stichting Internationaal Instituut voor Sociale Geschiedenis, 1985, xiv + 241 pp., Tom van der Meer (eds. - Harry A. Poeze, Frits G.P. Jacquet, Sources of the history of Asia and Oceania in the Netherlands. Part II: Sources 1796-1949. München etc.: Saur, 1983, 547 pp. - Harry A. Poeze, Mies Campfens, De Nederlandse archieven van het Internationaal Instituut voor sociale geschiedenis te Amsterdam. Amsterdam: Van Gennep, 1984, 294 pp. - Harry A. Poeze, Henk Hondius, Inventaris van het archief van de Sociaal-Democratische arbeiders partij (SDAP 1894-1946. Amsterdam

  7. Book Reviews

    Directory of Open Access Journals (Sweden)

    Redactie KITLV

    2004-10-01

    Full Text Available -Johann Angerler, Achim Sibeth, Vom Kultobjekt zur Massenware; Kulturhistorische und kunstethnologische Studie zur figürlichen Holzschnitzkunst der Batak in Nordsumatra/Indonesien. Herbolzheim: Centaurus, 2003, 416 pp. [Sozialökonomische Prozesse in Asien und Afrika 8.] -Greg Bankoff, Eva-Lotta E. Hedman ,Philippine politics and society in the twentieth century; Colonial legacies, post colonial trajectories. London: Routledge, 2000, xv + 206 pp. [Politics in Asia Series.], John T. Sidel (eds -Peter Boomgard, Andrew Dalby, Dangerous tastes; The story of spices. London: British Museum Press, 2002, 184 pp. -Max de Bruijn, G.J. Schutte, Het Indisch Sion; De Gereformeerde kerk onder de Verenigde Oost-Indische Compagnie. Hilversum: Verloren, 2002, 254 pp. [Serta Historica 7.] -Laura M. Calkins, Jacqueline Aquino Siapno, Gender, Islam, nationalism and the state in Aceh; The paradox of power, co-optation and resistance. London: RoutledgeCurzon, 2002, xxi + 240 pp. -H.J.M. Claessen, Deryck Scarr, A history of the Pacific islands; Passages through tropical time. Richmond: Curzon, 2001, xviii + 323 pp. -Matthew Isaac Cohen, Sean Williams, The sound of the ancestral ship; Highland music of West Java. Oxford: Oxford University Press, 2001, xii + 276 pp. -Freek Colombijn, Raymond K.H. Chan ,Development in Southeast Asia; Review and prospects. Aldershot: Ashgate, 2002, xx + 265 pp., Kwan Kwok Leung, Raymond M.H. Ngan (eds -Heidi Dahles, Shinji Yamashita, Bali and beyond; Explorations in the anthropology of tourism. Translated and with an introduction by J.S. Eades, New York: Berghahn, 2003, xix + 175 pp. [Asian Anthropologies.] -Frank Dhont, Hans Antlöv ,Elections in Indonesia; The New Order and beyond. With contributions by Hans Antlöv, Syamsuddin Haris, Endang Turmudi, Sven Cederroth, Kaarlo Voionmaa. London: RoutledgeCurzon, 2004, xii + 164 pp. [Nordic Institute of Asian Studies Monograph Series 88.], Sven Cederroth (eds -Frank Dhont, Aris Ananta

  8. Book Review:

    Science.gov (United States)

    Chrusciel, P. T.

    2006-06-01

    Most of us sometimes have to face a student asking: 'What do I need to get started on this'. (In my case 'this' would typically be a topic in general relativity.) After thinking about it for quite a while, and consulting candidate texts again and again, a few days later I usually end up saying: read this chapter in book I (but without going too much detail), then that chapter in book II (but ignore all those comments), then the first few sections of this review paper (but do not try to work out equations NN to NNN), and then come back to see me. In the unlikely event that the student comes back without changing the topic, there follows quite a bit of explaining on a blackboard over the following weeks. From now on I will say: get acquainted with the material covered by this book. As far as Isham's book is concerned, 'this' in the student's question above can stand for any topic in theoretical physics which touches upon differential geometry (and I can only think of very few which do not). Said plainly: this book contains most of the introductory material necessary to get started in general relativity, or those branches of mathematical physics which require differential geometry. A student who has mastered the notions presented in the book will have a solid basis to continue into specialized topics. I am not aware of any other book which would be as useful as this one in terms of the spectrum of topics covered, stopping at the right place to get sufficient introductory insight. According to the publisher, these lecture notes are the content of an introductory course on differential geometry which is taken by first-year theoretical physics PhD students, or by students attending the one-year MSc course 'Quantum Fields and Fundamental Forces' at Imperial College, London. The volume is divided into six chapters: An Introduction to Topology Differential Manifolds Vector Fields and n-Forms Lie Groups Fibre Bundles Connections in a Bundle. It is a sad reflection on current

  9. Book Review:

    Science.gov (United States)

    Kiefer, C.

    2005-10-01

    but not least, the issue of quantitative and testable predictions. Whether loop quantum gravity will become a physical theory is not clear. Nor is this clear for string theory or any other approach. However, loop quantum gravity provides a fascinating line of research and has much conceptual appeal. The present volume gives both an introduction and a review of this approach, making it suitable for advanced students as well as experts. It is certainly of interest for the readers of Classical and Quantum Gravity.

  10. Reviewer Database

    Directory of Open Access Journals (Sweden)

    Chief Editor

    2016-06-01

    Full Text Available REVIEWER DATABASEA S PaddaAarati KrishnanAarti KapilAbdul JilaniAbhaya JoglekarAbhijit PakhareAbhisek MishraAbhishek ArunAbhishek GuptaAbhishek JadhavAbhishek SinghAditi SinghAdrija RoyAdwitiya MukhopadhyayAhmed MandilA SubramanianAjit SahaiAkanksha GautamAkela MohamedAkhila GopinathanAkshay KumarAlankrata JainAli AbediAlisha SyiemliehAmal BasuAmandeep KaurA ChauhanAmarnath GuptaAmar SinhaAmir M KhanAmit KaushikAmit PawaiyaAmit SinghAmrita KansalAmrita SougaijamA WadheraAnand DixtA NeelakantanAnil PurtyAnimesh JainAnisha MohanAnjali AroraAnjan DattaAnju GahlotAnkita BajpaiAnku SaikiaAnmol GoyalAnu AgrawalAnu BhardwajAnuj JangraAnupama AryaA MohokarAnurag ChaudaryA SrivastavaAr BondArnab GhoshArpan YagnikArpit PrajapatiArshad AyubArti RauthanArun SainiArun SharmaArun ShiraliArun SugumaranArun VargheseArun WanjpeArvind NathArvind SinghAsha RAshish ChauhanAshish SinhaAshish SrivastavaAshish YadavAshok BhardwajAshok SrivastavaAshu GroverAshutosh SarwaAshwani SinhaAshwini KumarAthar AnsariAtul PuthiaAustin OkpanmaAvijit DasAvijit SinghaAvinash SunthliaB P MathurB VermaBabu DilipBadri MisraBaridalyne NongkynrihBhaswati SenguptaBhavana PandeyBhavana PantBhola NathBhupinder AnandBhupinder SinghBhuwan SharmaBiju SomanBimlesh KumarBinod KumarBinod PatroBishwas AcharyaBiswajit PaulB ChakravarthyB MannaC M S RawatC P MishraC M SinghChandra PrabhaChibi RushithaChitrangada MistryD SrivastavaDaksh SharmaDaneshwar SinghDanish ImtiazDebabrata RoyDeep ShikhaDeepa NairDeepak ChopraDeepak GuptaDeepak SharmaDeepika MittalNandanwarD SharmaDevi NairDharma BhattaD GahwaiDheeraj SharmaDhiraj SrivastavaDhrubajyotiDileepanDinesh BhatnagarDipanjan DeyDivya RajaseharanEkta GuptaEmanuel CummingsEnakshi GanguliFabrice JotterandFatma KarasuFomboh RichardGagan GargGajendra GuptaGarima MittalG BandyopadhyayGeetanjali KapoorGeetu SinghGhos AhmedGirish ChavanGirjesh YadavGita NegiGmsubba RaoGnanakshiGobezie TemesgenGokul ShindeGouri PadhyKassa GideboGunjan NathH ChopraHameeda Ali

  11. Book Review:

    Science.gov (United States)

    Fulling, S. A.

    2006-05-01

    classes of systems: quantum mechanics, linear (free) fields, and interacting fields. DeWitt's characteristic tools of effective actions, heat kernels, and ghost fields are developed. Chapters 26 and 31 outline new approaches developed in collaboration with DeWitt's recent students C Molina-Paris and C Y Wang, respectively. The first of these is a ghost-free formulation of gauge theory built on ideas of G A Vilkovisky. The second is a systematic attempt (following J Schwinger, L V Keldysh, and others) to replace the in-out matrix elements by expectation values in a single (initial) state. Most of parts VI and VII consist of special topics, such as anomalies, particle creation by external fields, Unruh acceleration temperature, black holes, and Euclideanization. Chapter 30, on black holes and Hawking radiation, will be very familiar to readers of DeWitt's influential review article [4]. Chapter 28, on anomalies, makes a careful distinction (missing from many treatments) between 'critical' anomalies, which render equations of motion inconsistent in the (would-be) quantum theory, and harmless anomalies that merely invalidate predictions that would classically follow from certain symmetries. The trace anomalies in the stress tensor of matter and the axial-current anomaly in quantum electrodynamics are harmless. Examples of critical anomalies are the chiral anomaly of a spinor field coupled to a non-Abelian gauge field and the anomaly in the conservation law of the stress tensor of certain pathological theories [5]. DeWitt's chapter calculates the trace and chiral anomalies in detail. The axial anomaly is mentioned only in a one-line summary (and not defined or indexed—generally speaking, I found the book's long index surprisingly unhelpful), and the Alvarez Witten anomaly is not mentioned at all. The last two chapters of part VII treat the most important particular quantum field theories. Chapter 34 develops many of the textbook predictions of quantum eletrodynamics from De

  12. Calculus super review

    CERN Document Server

    2012-01-01

    Get all you need to know with Super Reviews! Each Super Review is packed with in-depth, student-friendly topic reviews that fully explain everything about the subject. The Calculus I Super Review includes a review of functions, limits, basic derivatives, the definite integral, combinations, and permutations. Take the Super Review quizzes to see how much you've learned - and where you need more study. Makes an excellent study aid and textbook companion. Great for self-study!DETAILS- From cover to cover, each in-depth topic review is easy-to-follow and easy-to-grasp - Perfect when preparing for

  13. Defending submission-year analyses of new drug approvals.

    Science.gov (United States)

    Carpenter, Daniel P

    2003-01-01

    In response to the critique of Mary Olsen, Daniel Carpenter, on behalf of his co-authors, addresses the issue of analysis based on the year a new drug is submitted for Food and Drug Administration (FDA) approval, not the year it is approved. Both substantive knowledge of the FDA drug review process and sound social science theory favor submission-year averaging. The history and bureaucratic mechanics of the Center for Drug Evaluation and Review (CDER) conform to the author's assumption. The statistical theory of optimal experimentation also points to the beginning of review as a locus for effects upon decisions.

  14. Pioglitazone utilization, efficacy & safety in Indian type 2 diabetic patients: A systematic review & comparison with European Medicines Agency Assessment Report

    Directory of Open Access Journals (Sweden)

    Sarayu A Pai

    2016-01-01

    Interpretation & conclusions: In India, probably due to lower dose, lower background incidence of bladder cancer and smaller sample size in epidemiological studies, association of bladder cancer with pioglitazone was not found to be significant. Reporting of CTs and adverse drug reactions to Clinical Trials Registry of India and Pharmacovigilance Programme of India, respectively, along with compliance studies with warning given in package insert and epidemiological studies with larger sample size are needed.

  15. Scientific computer simulation review

    International Nuclear Information System (INIS)

    Kaizer, Joshua S.; Heller, A. Kevin; Oberkampf, William L.

    2015-01-01

    Before the results of a scientific computer simulation are used for any purpose, it should be determined if those results can be trusted. Answering that question of trust is the domain of scientific computer simulation review. There is limited literature that focuses on simulation review, and most is specific to the review of a particular type of simulation. This work is intended to provide a foundation for a common understanding of simulation review. This is accomplished through three contributions. First, scientific computer simulation review is formally defined. This definition identifies the scope of simulation review and provides the boundaries of the review process. Second, maturity assessment theory is developed. This development clarifies the concepts of maturity criteria, maturity assessment sets, and maturity assessment frameworks, which are essential for performing simulation review. Finally, simulation review is described as the application of a maturity assessment framework. This is illustrated through evaluating a simulation review performed by the U.S. Nuclear Regulatory Commission. In making these contributions, this work provides a means for a more objective assessment of a simulation’s trustworthiness and takes the next step in establishing scientific computer simulation review as its own field. - Highlights: • We define scientific computer simulation review. • We develop maturity assessment theory. • We formally define a maturity assessment framework. • We describe simulation review as the application of a maturity framework. • We provide an example of a simulation review using a maturity framework

  16. Tools for PSA reviews

    International Nuclear Information System (INIS)

    Linden, J. von

    1998-01-01

    It is desirable to have a uniform and competent procedure for the review of PSAs which are performed within the framework of the Periodic Safety Review of German Nuclear Power Plants. Guidelines for the review process should therefore be evaluated within task A. 1 of project SR 2096. The basis for this work is the experience and knowledge within GRS derived from PSA-related work and from several review projects as well as the German PSA Guide with its appendices. Furthermore, the review processes in the USA, Switzerland and Sweden and the Guidelines for the International Peer Review Service (IPERS Guidelines) were utilized. As a result, recommendations are given for the review process, with individual recommendations concerning the organization of the review, task allocation between the reviewers, interface problems, assessment criteria, the scope and depth of the review as well as the supporting documents. An additional result are checklists for the technical elements of the PSA, which are listed to facilicate the review work. It is not the intention of this report to work out complete review guidelines. Its aims is rather more to give recommondations and support for the review in addition to what can be derived from the existing documents that should be used for the review. The recommendations reflect the view of GRS and go beyond the statements given in the German PSA Guide (Leitfaden Probabilistische Sicherheitsanalyse /PSUe97/) in some points. (orig.) [de

  17. Cadaveric simulation: a review of reviews.

    Science.gov (United States)

    Yiasemidou, M; Gkaragkani, E; Glassman, D; Biyani, C S

    2017-11-14

    Traditional surgical training, largely based on the Halstedian model "see one, do one, teach one" is not as effective in the era of working time restrictions and elaborate shift-patterns. As a result, contemporary surgeons turned to educational methods outside the operating theatre such as simulation. Cadavers are high fidelity models but their use has ethical and cost implications and their availability may be limited. In this review, we explore the role of cadaveric simulation in modern surgical education. All the Evidence-Based Medicine databases were searched for relevant reviews. The resulting studies were assessed for inclusion to this review, according to pre-determined criteria. Data extraction was performed using a custom-made spreadsheet, and the quality of included reviews was assessed using a validated scoring system (AMSTAR). The literature review yielded 33 systematic reviews; five of which matched the inclusion criteria and were included in this review of reviews. Cadaveric simulation was found to have good face (subjective assessment of usefulness) and content validity (whether a specific element adds or retracts to the educational value) while trainees improved their surgical skills after practicing on cadavers. However, concerns have been raised about ethical issues, high cost and availability. Cadavers are an effective medium for surgical teaching, and it may be appropriate for them to be used whenever surrounding conditions such cost and availability allow. Further research is required to provide evidence on whether there is equivalence between cadavers and other educational media which may not bear the same shortcomings.

  18. Country program review Myanmar

    International Nuclear Information System (INIS)

    Boussaha, A.; Naqvi, S.H.M.; Poshyachinda, M.; Con, T.T.; Nemoto, S.

    1994-03-01

    Review of the past and present IAEA technical cooperation activities in the field of repair and maintenance of nuclear instrumentation and sectoral programs and institutional review in the same field are presented

  19. BMRAT reviewer acknowledgement 2015

    OpenAIRE

    Lili Hami

    2016-01-01

    Contributing reviewers The editors of Biomedical Research and Therapy would like to thank all our reviewers who have contributed to the journal in Volume 2 (2015). [Biomed Res Ther 2016; 3(2.000): 528-532

  20. Mizan Law Review

    African Journals Online (AJOL)

    Mizan Law Review publishes peer reviewed scholarly articles that identify, ... legal and related principles, stipulations and concepts based on research findings. Mizan's ... Comment: Major Differences between the Revised 'Federal' and SNNP ...

  1. Rate Review Data

    Data.gov (United States)

    U.S. Department of Health & Human Services — As of September 1, 2011, the Affordable Care Act and rate review regulation require review of rate increases of 10 percent or more. A non-grandfathered health plan...

  2. Country program review Myanmar

    Energy Technology Data Exchange (ETDEWEB)

    Boussaha, A; Naqvi, S H.M.; Poshyachinda, M; Con, T T; Nemoto, S

    1994-03-01

    Review of the past and present IAEA technical cooperation activities in the field of repair and maintenance of nuclear instrumentation and sectoral programs and institutional review in the same field are presented.

  3. Monthly Weather Review

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Supplements to the Monthly Weather Review publication. The Weather Bureau published the Monthly weather review Supplement irregularly from 1914 to 1949. The...

  4. Marine prostanoids - a review

    Digital Repository Service at National Institute of Oceanography (India)

    Wahidullah, S.; De

    The occurrence and structure of prostaglandins including clavulones, punaglandins and claviridenones in marine organisms is reviewEd. by comparison of the spectral data reported the identity of 20-acetoxy claviridenones b and c with 20 acetoxy...

  5. Topical report review status

    International Nuclear Information System (INIS)

    1997-08-01

    This report provides industry with procedures for submitting topical reports, guidance on how the U.S. Nuclear Regulatory Commission (NRC) processes and responds to topical report submittals, and an accounting, with review schedules, of all topical reports currently accepted for review schedules, of all topical reports currently accepted for review by the NRC. This report will be published annually. Each sponsoring organization with one or more topical reports accepted for review copies

  6. Diversifying customer review rankings.

    Science.gov (United States)

    Krestel, Ralf; Dokoohaki, Nima

    2015-06-01

    E-commerce Web sites owe much of their popularity to consumer reviews accompanying product descriptions. On-line customers spend hours and hours going through heaps of textual reviews to decide which products to buy. At the same time, each popular product has thousands of user-generated reviews, making it impossible for a buyer to read everything. Current approaches to display reviews to users or recommend an individual review for a product are based on the recency or helpfulness of each review. In this paper, we present a framework to rank product reviews by optimizing the coverage of the ranking with respect to sentiment or aspects, or by summarizing all reviews with the top-K reviews in the ranking. To accomplish this, we make use of the assigned star rating for a product as an indicator for a review's sentiment polarity and compare bag-of-words (language model) with topic models (latent Dirichlet allocation) as a mean to represent aspects. Our evaluation on manually annotated review data from a commercial review Web site demonstrates the effectiveness of our approach, outperforming plain recency ranking by 30% and obtaining best results by combining language and topic model representations. Copyright © 2015 Elsevier Ltd. All rights reserved.

  7. ACHP | Unified Federal Review

    Science.gov (United States)

    Search skip specific nav links Home arrow Unified Federal Review Three logos: 1) Executive Office of the Homeland Security. Unified Federal Environmental and Historic Preservation Review Process Please visit the new location for the Unified Federal Review located here: http://www.fema.gov/environmental-historic

  8. Reviewer acknowledgement 2013

    OpenAIRE

    Stengel, Dirk; Luckmann, Annette

    2014-01-01

    Contributing reviewers The editors of the Journal of Trauma Management and Outcomes and BioMed Central would like to show our appreciation for the following reviewers for their time, hard work and support by reviewing manuscripts for the journal in 2013.

  9. Book Review | Oloyede | African Sociological Review / Revue ...

    African Journals Online (AJOL)

    African Sociological Review / Revue Africaine de Sociologie. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 12, No 1 (2008) >. Log in or Register to get access to full text downloads.

  10. Algebra & trigonometry super review

    CERN Document Server

    2012-01-01

    Get all you need to know with Super Reviews! Each Super Review is packed with in-depth, student-friendly topic reviews that fully explain everything about the subject. The Algebra and Trigonometry Super Review includes sets and set operations, number systems and fundamental algebraic laws and operations, exponents and radicals, polynomials and rational expressions, equations, linear equations and systems of linear equations, inequalities, relations and functions, quadratic equations, equations of higher order, ratios, proportions, and variations. Take the Super Review quizzes to see how much y

  11. Systematic review automation technologies

    Science.gov (United States)

    2014-01-01

    Systematic reviews, a cornerstone of evidence-based medicine, are not produced quickly enough to support clinical practice. The cost of production, availability of the requisite expertise and timeliness are often quoted as major contributors for the delay. This detailed survey of the state of the art of information systems designed to support or automate individual tasks in the systematic review, and in particular systematic reviews of randomized controlled clinical trials, reveals trends that see the convergence of several parallel research projects. We surveyed literature describing informatics systems that support or automate the processes of systematic review or each of the tasks of the systematic review. Several projects focus on automating, simplifying and/or streamlining specific tasks of the systematic review. Some tasks are already fully automated while others are still largely manual. In this review, we describe each task and the effect that its automation would have on the entire systematic review process, summarize the existing information system support for each task, and highlight where further research is needed for realizing automation for the task. Integration of the systems that automate systematic review tasks may lead to a revised systematic review workflow. We envisage the optimized workflow will lead to system in which each systematic review is described as a computer program that automatically retrieves relevant trials, appraises them, extracts and synthesizes data, evaluates the risk of bias, performs meta-analysis calculations, and produces a report in real time. PMID:25005128

  12. Reviews of recent publications

    Directory of Open Access Journals (Sweden)

    2001-06-01

    Full Text Available Alonso, Carlos J. The Burden of Modernity: The Rhetoric of Cultural Discourse in Spanish America Reviewed by Melvin S. Arrington, Jr. Kolocotroni, Vassiliki, Jane Goldman, and Olga Taxidou, eds, Modernism: An Anthology of Sources and Documents Reviewed by Gerd Bayer Motte, Warren. Small Worlds: Minimalism in Contemporary French Literature Reviewed by William Cloonan Melton, Judith M. The Face of Exile: Autobiographical Journeys Reviewed by Claude P. Desmarais Redding, Arthur. Raids on Human Consciousness: Writing, Anarchism, and Violence Reviewed by Gail Finney Chambers, Ross. Facing It: AIDS Diaries and the Death of the Author Reviewed by Melissa A. Fitch Marx-Scouras, Danielle. The Cultural Politics of Tel Quel: Literature and the Left in the Wake of Engagement Reviewed by Diane Fourny Foster, David William. Buenos Aires: Perspectives on the City and Cultural Production Reviewed by Gustavo Geirola Nelson, Ardis L., ed. Guillermo Cabrera Infante: Assays, essays, and other arts Reviewed by José Luis Martinez-Dueñas Fox, Claire F. The Fence and the River: Culture and Politics at the U.S.-Mexico Border Reviewed by Robert Neustadt

  13. NASA Product Peer Review Process

    Science.gov (United States)

    Jenks, Ken

    2009-01-01

    This viewgraph presentation describes NASA's product peer review process. The contents include: 1) Inspection/Peer Review at NASA; 2) Reasons for product peer reviews; 3) Different types of peer reviews; and 4) NASA requirements for peer reviews. This presentation also includes a demonstration of an actual product peer review.

  14. ETF interim design review

    International Nuclear Information System (INIS)

    Steiner, D.; Rutherford, P.H.

    1980-01-01

    A three-day ETF Interim Design Review was conducted on July 23-25, 1980, at the Sheraton Potomac Inn in Rockville, Maryland. The intent of the review was to provide a forum for an in-depth assessment and critique of all facets of the ETF design by members of the fusion community. The review began with an opening plenary session at which an overview of the ETF design was presented by D. Steiner, manager of the ETF Design Center, complemented by a physics overview by P.H. Rutherford, chairman of the ETF/INTOR Physics Committee. This was followed by six concurrent review sessions over the next day and a half. The review closed with a plenary session at which the Design Review Board presented its findings. This document consists of the viewgraphs for the opening plenary session and an edited version of the presentations made by Steiner and Rutherford

  15. Down With Reviews

    Energy Technology Data Exchange (ETDEWEB)

    Wiley, H. S.

    2010-04-01

    There has been a proliferation of review articles and review journals over the last decade, and it is easy to see why. Biologists find them useful to keep up with increasingly complex science and publishers find them an easy way to increase the impact factor of journals. Unfortunately, the reasons why review articles are highly cited are mostly unrelated to their educational value. Instead, it seems mostly due to their increasing use as a surrogate for the primary literature.

  16. Sscience & technology review; Science Technology Review

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-07-01

    This review is published ten times a year to communicate, to a broad audience, Lawrence Livermore National Laboratory`s scientific and technological accomplishments, particularly in the Laboratory`s core mission areas - global security, energy and the environment, and bioscience and biotechnology. This review for the month of July 1996 discusses: Frontiers of research in advanced computations, The multibeam Fabry-Perot velocimeter: Efficient measurement of high velocities, High-tech tools for the American textile industry, and Rock mechanics: can the Tuff take the stress.

  17. Ademe et Vous. International Newsletter No. 26, Sept.-Oct.-Nov. 2013. Energy efficiency: MEDENER's progress

    International Nuclear Information System (INIS)

    Martin, Valerie; Seguin-Jacques, Catherine; Tappero, Denis

    2013-09-01

    Starting on 13 February 2012 and for a period of two years, ADEME is holding the presidency of the MEDENER association. Here is a review of its main energy management actions. By helping take innovation to the market, ADEME goes beyond research and acts as a catalyzer for innovation in its various fields of expertise. For twenty years now, ADEME and its Moroccan counterparts ADEREE, which replaced CDER in 2010, have maintained constructive and privileged relations. A European institutional twinning has further enhanced this cooperation

  18. Humanities Review Journal

    African Journals Online (AJOL)

    Humanities Review Journal is published in June and December by Humanities Research Forum. The Journal publishes original, well-researched papers, review essays, interviews, resume, and commentaries, which offer new insights into the various disciplines in the Humanities. The focus is on issues about Africa.

  19. Archives: Mizan Law Review

    African Journals Online (AJOL)

    Items 1 - 21 of 21 ... Archives: Mizan Law Review. Journal Home > Archives: Mizan Law Review. Log in or Register to get access to full text downloads. Username, Password, Remember me, or Register · Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives. 1 - 21 of 21 Items. 2017. Vol 11, No 2 ...

  20. Documents preparation and review

    International Nuclear Information System (INIS)

    1999-01-01

    Ignalina Safety Analysis Group takes active role in assisting regulatory body VATESI to prepare various regulatory documents and reviewing safety reports and other documentation presented by Ignalina NPP in the process of licensing of unit 1. The list of main documents prepared and reviewed is presented

  1. 3 CFR - Regulatory Review

    Science.gov (United States)

    2010-01-01

    ... as a means of promoting regulatory goals. The fundamental principles and structures governing... review. In this time of fundamental transformation, that process—and the principles governing regulation... the Office of Management and Budget (OMB) has reviewed Federal regulations. The purposes of such...

  2. Peer review statement

    Science.gov (United States)

    2018-03-01

    All papers published in this volume of Journal of Physics: Conference Series have been peer reviewed through processes administered by the proceedings Editors. Reviews were conducted by expert referees to the professional and scientific standards expected of a proceedings journal published by IOP Publishing.

  3. Energy and technology review

    Energy Technology Data Exchange (ETDEWEB)

    1984-03-01

    The Lawrence Livermore National Laboratory publishes the Energy and Technology Review Monthly. This periodical reviews progress mode is selected programs at the laboratory. This issue includes articles on in-situ coal gasification, on chromosomal aberrations in human sperm, on high speed cell sorting and on supercomputers.

  4. Book Reviews in Periodicals.

    Science.gov (United States)

    Ettelt, Harold J.

    All recent issues of periodicals found which contain indexed book reviews are listed in this compilation from Drake Memorial Library at the New York State University at Brockport. The periodicals are listed by 29 subject headings in this informal guide designed to be used at Drake Library. The number of reviews in the periodical in a recent year…

  5. Youth Suicide: A Review

    Science.gov (United States)

    Gould, Madelyn S.; Greenberg, Ted; Velting, Drew M.; Shaffer, David

    2006-01-01

    Following a comprehensive review of the research literature on youth suicide, the authors discuss the rates and patterns of completed suicides and suicide attempts. The state of research on potential risk and protective factors is also reviewed, covering personal characteristics, family characteristics, adverse life circumstances, and…

  6. Peer Review of Teaching

    OpenAIRE

    Fernandez, Charles E.; Yu, Jenny

    2007-01-01

    This article provides an overview and description of peer review of teaching for faculty members and administrators who would like to implement a peer review program. This may include classroom and clinical settings. A brief overview, procedure, and a teaching competence evaluation rubric are provided

  7. Review of particle properties

    International Nuclear Information System (INIS)

    Trippe, T.G.; Barbaro-Galtieri, A.; Kelly, R.L.; Rittenberg, A.; Rosenfeld, A.H.; Yost, G.P.; Barash-Schmidt, N.; Bricman, C.; Hemingway, R.J.; Losty, M.J.; Roos, M.; Chaloupka, V.; Armstrong, B.

    1976-01-01

    This review of the properties of leptons, mesons, and baryons is an updating of Review of Particle Properties, Particle Data Group [Phys. Letters 50B, No.1 (1974), and Supplement, Rev. Mod. Phys. 47 (1975) 535]. Data are evaluated, listed, averaged, and summarized in tables. Numerous tables, figures, and formulae of interest to particle physicists are also included. A data booklet is available

  8. Nigerian Music Review

    African Journals Online (AJOL)

    Nigerian Music Reveiw. ... Nigerian Music Review is aimed at the scholarly review of the developments in various musical practices in Nigeria. It considers well ... Performance practice and functions of local wine and beer parlor songs in rural Yoruba Communities in Ogbomoso · EMAIL FULL TEXT EMAIL FULL TEXT

  9. Energy and technology review

    International Nuclear Information System (INIS)

    1984-03-01

    The Lawrence Livermore National Laboratory publishes the Energy and Technology Review Monthly. This periodical reviews progress mode is selected programs at the laboratory. This issue includes articles on in-situ coal gasification, on chromosomal aberrations in human sperm, on high speed cell sorting and on supercomputers

  10. LBS Management Review: Submissions

    African Journals Online (AJOL)

    Author Guidelines. The Lagos Business School Management Review is published by management professionals for practising managers, without sacrificing academic standards. The Review welcomes articles that enhance knowledge about the process of managing an organisation as well as reflect techniques, trends and ...

  11. MELCOR Peer Review

    International Nuclear Information System (INIS)

    Boyack, B.E.; Dhir, V.K.; Gieseke, J.A.; Haste, T.J.; Kenton, M.A.; Khatib-Rahbar, M.; Leonard, M.T.; Viskanta, R.

    1992-03-01

    MELCOR is a fully integrated, engineering-level computer code that models the progression of severe accidents in light water reactor nuclear power plants. The newest version of MELCOR is Version 1.8.1, July 1991. MELCOR development has reached the point that the United States Nuclear Regulatory Commission sponsored a broad technical review by recognized experts to determine or confirm the technical adequacy of the code for the serious and complex analyses it is expected to perform. For this purpose, an eight-member MELCOR Peer Review Committee was organized. The Committee has completed its review of the MELCOR code: the review process and findings of the MELCOR Peer Review Committee are documented in this report. The Committee has determined that recommendations in five areas are appropriate: (1) MELCOR numerics, (2) models missing from MELCOR Version 1.8.1, (3) existing MELCOR models needing revision, (4) the need for expanded MELCOR assessment, and (5) documentation

  12. Thanking our peer reviewers

    Directory of Open Access Journals (Sweden)

    Storey Alan

    2013-03-01

    Full Text Available Contributing reviewers As 2013 commences I would like to take a moment to reflect and recognize the peer reviewers that made the previous year possible. Listed below are those people who reviewed for Molecular Cancer last year. All are generous individuals who donated their time to assessing and improving our authors’ submissions. Your combined efforts have been invaluable to the editorial staff in maintaining the continued success of the journal in the Open Access forum. The editors of Molecular Cancer would like to thank all the reviewers who contributed to the journal in Volume 11 (2012 by participating in the review process - taking time out of your busy schedules and even to volunteer - without your critical insights, hard work and support for the journal we wouldn’t be able to do what we do.

  13. Systematising "System": One Reviewer's Analysis of the Review Process

    Science.gov (United States)

    Coniam, David

    2011-01-01

    This paper describes one reviewer's experience of reviewing for the journal "System" over an eight-year period, 2003-2011. The paper reports on the reviews produced by the single reviewer, which have been compiled into a specific purpose--an "occluded"--corpus (Swales, 1996) of 122 reviews, comprising 93,000 words. The paper first describes the…

  14. KHNP special safety review

    International Nuclear Information System (INIS)

    Lee, Tae-Ho; Lee, Bang-Jin; Lee, Soung-Hee; Park, Goon-Cherl

    2009-01-01

    Commemorating the 30 year anniversary of commercial nuclear power plant operation in KOREA, Korea Hydro and Nuclear Power Co., Ltd. (KHNP) has conducted a Special Safety Review (SSR) of its 20 operating units to understand their safety performance and to identify any areas that need improvement. The SSR reviewed all 20 operating units for 2 weeks per site. Areas that were reviewed are Safety Margins, Plant Performance, Employee Safety, Employee Performance and Performance Improvement Process. Each review team consisted of international and domestic members. The international reviewers were from IAEA, WANO and INPO. The domestic reviewers consisted of professors, Engineering Company, Research Institute and KHNP experts. The review confirmed safe and reliable operations of the 20 nuclear units. The common understanding resulted from the SSR is as follows. Firstly, KHNP corporate and its plants confirmed and shared mutual understanding on recurring areas for improvements, especially in the areas of Organizational Effectiveness, Industrial Safety, Human Performance, Configuration Management, Operations, Equipment Performance and Material Condition. Secondly, KHNP understood that plant and department level performances are directly related to the leadership and competency of the management team including supervisors. Thirdly, the strengths of individual stations that consistently have produced good results need to be shared with the other KHNP stations. Finally, KHNP learned that strong corporate leadership and support are needed to resolve most of the areas for improvement since they are common to all KHNP stations. (author)

  15. Environmental performance reviews. Slovenia

    International Nuclear Information System (INIS)

    1997-01-01

    The ECE Committee on Environmental Policy for the Environmental Performance Review of Slovenia prepared a report on the environmental performance of Slovenia before, during and after the review mission in Ljubljana in November 1996. The Slovene partners in discussion with the review team did not spare time or effort in responding to the queries and requests made. The review mission could therefore benefit from optimal cooperation with Slovene institutions. The report by the review team, including draft recommendations for the solution of existing problems in national environmental policy and management, was submitted for evaluation by the ECE Committee on Environmental Policy at its fourth annual session in Geneva, on 26 May 1997. A high-level delegation from Slovenia attended this session. It was headed by the Minister of the Environment and also included the State Secretaries for Agriculture, Forest and Food, Economic Affairs, Environment, Physical Planning, Transport and Communications, and other delegates. The evaluation by the Committee was based on the in-depth preparation by two reviewing countries, the Netherlands and Poland. At the end of its evaluation, the Committee agreed on a final set of recommendations, replacing the draft recommendations of the review team for inclusion in this publication

  16. Human Factors Review Plan

    International Nuclear Information System (INIS)

    Paramore, B.; Peterson, L.R.

    1985-12-01

    ''Human Factors'' is concerned with the incorporation of human user considerations into a system in order to maximize human reliability and reduce errors. This Review Plan is intended to assist in the assessment of human factors conditions in existing DOE facilities. In addition to specifying assessment methodologies, the plan describes techniques for improving conditions which are found to not adequately support reliable human performance. The following topics are addressed: (1) selection of areas for review describes techniques for needs assessment to assist in selecting and prioritizing areas for review; (2) human factors engineering review is concerned with optimizing the interfaces between people and equipment and people and their work environment; (3) procedures review evaluates completeness and accuracy of procedures, as well as their usability and management; (4) organizational interface review is concerned with communication and coordination between all levels of an organization; and (5) training review evaluates training program criteria such as those involving: trainee selection, qualification of training staff, content and conduct of training, requalification training, and program management

  17. Human Factors Review Plan

    Energy Technology Data Exchange (ETDEWEB)

    Paramore, B.; Peterson, L.R. (eds.)

    1985-12-01

    ''Human Factors'' is concerned with the incorporation of human user considerations into a system in order to maximize human reliability and reduce errors. This Review Plan is intended to assist in the assessment of human factors conditions in existing DOE facilities. In addition to specifying assessment methodologies, the plan describes techniques for improving conditions which are found to not adequately support reliable human performance. The following topics are addressed: (1) selection of areas for review describes techniques for needs assessment to assist in selecting and prioritizing areas for review; (2) human factors engineering review is concerned with optimizing the interfaces between people and equipment and people and their work environment; (3) procedures review evaluates completeness and accuracy of procedures, as well as their usability and management; (4) organizational interface review is concerned with communication and coordination between all levels of an organization; and (5) training review evaluates training program criteria such as those involving: trainee selection, qualification of training staff, content and conduct of training, requalification training, and program management.

  18. Swedish encapsulation station review

    International Nuclear Information System (INIS)

    Andersson, Sven Olof; Brunzell, P.; Heibel, R.; McCarthy, J.; Pennington, C.; Rusch, C.; Varley, G.

    1998-06-01

    In the Encapsulation Station (ES) Review performed by NAC International, a number of different areas have been studied. The main objectives with the review have been to: Perform an independent review of the cost estimates for the ES presented in SKB's document 'Plan 1996'. This has been made through comparisons between the ES and BNFL's Waste Encapsulation Plant (WEP) at Sellafield as well as with the CLAB facility. Review the location of the ES (at the CLAB site or at the final repository) and its interaction with other parts of the Swedish system for spent fuel management. Review the logistics and plant capacity of the ES. Identify important safety aspects of the ES as a basis for future licensing activities. Based on NAC International's experience of casks for transport and storage of spent fuel, review the basic design of the copper/steel canister and the transport cask. This review insides design, manufacturing, handling and licensing aspects. Perform an overall comparison between the ES project and the CLAB project with the objective to identify major project risks and discuss their mitigation

  19. Swedish encapsulation station review

    Energy Technology Data Exchange (ETDEWEB)

    Andersson, Sven Olof; Brunzell, P.; Heibel, R.; McCarthy, J.; Pennington, C.; Rusch, C.; Varley, G. [NAC International, Zuerich (Switzerland)

    1998-06-01

    In the Encapsulation Station (ES) Review performed by NAC International, a number of different areas have been studied. The main objectives with the review have been to: Perform an independent review of the cost estimates for the ES presented in SKB`s document `Plan 1996`. This has been made through comparisons between the ES and BNFL`s Waste Encapsulation Plant (WEP) at Sellafield as well as with the CLAB facility. Review the location of the ES (at the CLAB site or at the final repository) and its interaction with other parts of the Swedish system for spent fuel management. Review the logistics and plant capacity of the ES. Identify important safety aspects of the ES as a basis for future licensing activities. Based on NAC International`s experience of casks for transport and storage of spent fuel, review the basic design of the copper/steel canister and the transport cask. This review insides design, manufacturing, handling and licensing aspects. Perform an overall comparison between the ES project and the CLAB project with the objective to identify major project risks and discuss their mitigation 19 refs, 9 figs, 35 tabs

  20. PSA Review Handbook

    International Nuclear Information System (INIS)

    Hallman, Anders; Nyman, Ralph; Knochenhauer, Michael

    2004-05-01

    The Swedish Nuclear Power Inspectorate (SKI) expresses requirements on the performance of PSAs as well as on PSA activities in general in the the regulatory document 'Regulations Concerning Safety in Certain Nuclear Facilities', SKlFS 1998:1. The follow-up of these activities is part of the inspection tasks of the SKI. In view or this, there is a need for documented guidelines on now to perform these inspections and reviews. The SKI PSA Review Handbook is intended to be a support in the SKI inspection and control of the PSA activities or the licensees. These PSA activities include both the organisation and working procedures of the licensee, the layout and contents of the PSA, and its areas of application. Using the regulation SKIFS 1998:1 as a starting point, the review handbook presents important aspects to be considered when judging whether a licensee fulfils the requirements on PSA activities, including the performance of PSA:s or PSA applications. The handbook shall also be a guidance for the review of PSA:s. However, the intention of the PSA Review Handbook is not to be a handbook for how a PSA is performed. The PSA Review Handbook is applicable to all types or initiating events and all operating conditions, and has been structured in a way, which stresses the integrated characteristics of PSA in the creation of the risk picture of a plant. The PSA Review Handbook has been based on the requirements for PSA of nuclear power plants, as this is the most extensive application. However, the relevant parts of it are also applicable when analysing other nuclear installations. The PSA Review Handbook is published as a research report as its contents are judged to be of general interest, and the SKI welcomes comments to the handbook. An update or the PSA Review Handbook may be required as experience with the use of the handbook is acquired and if general PSA requirements change

  1. Pharmacovigilance of patients with multiple myeloma being treated with bortezomib and/or thalidomide

    Directory of Open Access Journals (Sweden)

    T.B.M. Castro

    2016-01-01

    Full Text Available In order to evaluate the main adverse effects of drug protocols using bortezomib and/or thalidomide for the treatment of multiple myeloma, we conducted a prospective study. Data were collected through interviews, clinical observation, and from hospital records. A total of 59 patients were included. There was a predominance of females, 36 (61% vs 23 (39% males, and of whites, 49 (83.1% vs 10 (16.9% blacks. Age ranged from 40 to 94 years, with a median of 65 years (SD=11.6. Regarding staging at diagnosis, 27 (45.7% patients were in stage III-A, with 12 (20.3% patients having serum creatinine ≥2 mg/dL. The main adverse effects in the bortezomib treatment group (n=40 were: neutropenia (42.5%, diarrhea (47.5%, and peripheral neuropathy in 60% of cases, with no difference between the iv (n=26 and sc (n=14 administration routes (P=0.343. In the group treated with thalidomide (n=19, 31.6% had neutropenia, 47.4% constipation, and 68.4% peripheral neuropathy. Neutropenia was associated with the use of alkylating agents (P=0.038. Of the 3 patients who received bortezomib in combination with thalidomide, only 1 presented peripheral neuropathy (33.3%. Peripheral neuropathy was the main adverse effect of the protocols that used bortezomib or thalidomide, with a higher risk of neutropenia in those using alkylating agents. Improving the identification of adverse effects is critical in multiple myeloma patient care, as the patient shows improvements during treatment, and requires a rational and safe use of medicines.

  2. Traditional Chinese medicine pharmacovigilance in signal detection: decision tree-based data classification.

    Science.gov (United States)

    Wei, Jian-Xiang; Wang, Jing; Zhu, Yun-Xia; Sun, Jun; Xu, Hou-Ming; Li, Ming

    2018-03-09

    Traditional Chinese Medicine (TCM) is a style of traditional medicine informed by modern medicine but built on a foundation of more than 2500 years of Chinese medical practice. According to statistics, TCM accounts for approximately 14% of total adverse drug reaction (ADR) spontaneous reporting data in China. Because of the complexity of the components in TCM formula, which makes it essentially different from Western medicine, it is critical to determine whether ADR reports of TCM should be analyzed independently. Reports in the Chinese spontaneous reporting database between 2010 and 2011 were selected. The dataset was processed and divided into the total sample (all data) and the subsample (including TCM data only). Four different ADR signal detection methods-PRR, ROR, MHRA and IC- currently widely used in China, were applied for signal detection on the two samples. By comparison of experimental results, three of them-PRR, MHRA and IC-were chosen to do the experiment. We designed several indicators for performance evaluation such as R (recall ratio), P (precision ratio), and D (discrepancy ratio) based on the reference database and then constructed a decision tree for data classification based on such indicators. For PRR: R 1 -R 2  = 0.72%, P 1 -P 2  = 0.16% and D = 0.92%; For MHRA: R 1 -R 2  = 0.97%, P 1 -P 2  = 0.20% and D = 1.18%; For IC: R 1 -R 2  = 1.44%, P 2 -P 1  = 4.06% and D = 4.72%. The threshold of R,Pand Dis set as 2%, 2% and 3% respectively. Based on the decision tree, the results are "separation" for PRR, MHRA and IC. In order to improve the efficiency and accuracy of signal detection, we suggest that TCM data should be separated from the total sample when conducting analyses.

  3. Development of pharmacovigilance training module for community pharmacists in Nepal: A focus group study

    Directory of Open Access Journals (Sweden)

    Subish Palaian

    2016-01-01

    Conclusions: The feedback revealed that participants find the training sessions were useful and they were interested in future sessions. Educational interventions can play an important role in improving ADR reporting.

  4. Randomized controlled trial about pain medication flupirtine ignores recent pharmacovigilance warnings

    Directory of Open Access Journals (Sweden)

    Puljak L

    2018-01-01

    Full Text Available Livia Puljak1,2 1Laboratory for Pain Research, University of Split School of Medicine, Split, Croatia; 2Department for Development, Research and Health Technology Assessment, Agency for Quality and Accreditation in Health Care and Social Welfare, Zagreb, CroatiaOn October 16, 2017 in the Journal of Pain Research, a randomized controlled trial (RCT comparing efficacy and safety of flupirtine versus piroxicam in postoperative pain in patients undergoing lower limb surgery was published.1 However, this paper fails to report important information. Author’s reply Sowmya Chinnaiyan,1 Narayana Sarala,1 Heddur Shanthappa Arun21Department of Pharmacology, 2Department of Orthopedics, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Kolar, Karnataka, India We thank Livia Puljak for the valuable insights on the article titled “A comparative study of efficacy and safety of flupirtine  versus piroxicam in postoperative pain in patients undergoing lower limb surgery” published in the Journal of Pain Research. The concerns highlighted in the Letter to the Editor have been answered.View the original paper by Chinnaiyan and colleagues. 

  5. Post Launch Monitoring of food products : what can be learned from pharmacovigilance

    NARCIS (Netherlands)

    van Puijenbroek, E P; Hepburn, P A; Herd, T M; van Grootheest, A C

    Post Launch Monitoring (PLM) is one of the new approaches that are used in assessing the safety of novel foods or ingredients. It shares a close resemblance with procedures applied in the field of medicines, where Post Marketing Surveillance (PMS) has been carried out since the beginning of the

  6. Leveraging graph topology and semantic context for pharmacovigilance through twitter-streams.

    Science.gov (United States)

    Eshleman, Ryan; Singh, Rahul

    2016-10-06

    Adverse drug events (ADEs) constitute one of the leading causes of post-therapeutic death and their identification constitutes an important challenge of modern precision medicine. Unfortunately, the onset and effects of ADEs are often underreported complicating timely intervention. At over 500 million posts per day, Twitter is a commonly used social media platform. The ubiquity of day-to-day personal information exchange on Twitter makes it a promising target for data mining for ADE identification and intervention. Three technical challenges are central to this problem: (1) identification of salient medical keywords in (noisy) tweets, (2) mapping drug-effect relationships, and (3) classification of such relationships as adverse or non-adverse. We use a bipartite graph-theoretic representation called a drug-effect graph (DEG) for modeling drug and side effect relationships by representing the drugs and side effects as vertices. We construct individual DEGs on two data sources. The first DEG is constructed from the drug-effect relationships found in FDA package inserts as recorded in the SIDER database. The second DEG is constructed by mining the history of Twitter users. We use dictionary-based information extraction to identify medically-relevant concepts in tweets. Drugs, along with co-occurring symptoms are connected with edges weighted by temporal distance and frequency. Finally, information from the SIDER DEG is integrate with the Twitter DEG and edges are classified as either adverse or non-adverse using supervised machine learning. We examine both graph-theoretic and semantic features for the classification task. The proposed approach can identify adverse drug effects with high accuracy with precision exceeding 85 % and F1 exceeding 81 %. When compared with leading methods at the state-of-the-art, which employ un-enriched graph-theoretic analysis alone, our method leads to improvements ranging between 5 and 8 % in terms of the aforementioned measures. Additionally, we employ our method to discover several ADEs which, though present in medical literature and Twitter-streams, are not represented in the SIDER databases. We present a DEG integration model as a powerful formalism for the analysis of drug-effect relationships that is general enough to accommodate diverse data sources, yet rigorous enough to provide a strong mechanism for ADE identification.

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

    NARCIS (Netherlands)

    Rulisa, Stephen; Kaligirwa, Nadine; Agaba, Steven; Karema, Corine; Mens, Petra F.; de Vries, Peter J.

    2012-01-01

    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,

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

    OpenAIRE

    Rulisa Stephen; Kaligirwa Nadine; Agaba Steven; Karema Corine; Mens Petra F; de Vries Peter J

    2012-01-01

    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 t...

  9. Specialist Cohort Event Monitoring studies: a new study method for risk management in pharmacovigilance.

    Science.gov (United States)

    Layton, Deborah; Shakir, Saad A W

    2015-02-01

    The evolving regulatory landscape has heightened the need for innovative, proactive, efficient and more meaningful solutions for 'real-world' post-authorization safety studies (PASS) that not only align with risk management objectives to gather additional safety monitoring information or assess a pattern of drug utilization, but also satisfy key regulatory requirements for marketing authorization holder risk management planning and execution needs. There is a need for data capture across the primary care and secondary care interface, or for exploring use of new medicines in secondary care to support conducting PASS. To fulfil this need, event monitoring has evolved. The Specialist Cohort Event Monitoring (SCEM) study is a new application that enables a cohort of patients prescribed a medicine in the hospital and secondary care settings to be monitored. The method also permits the inclusion of a comparator cohort of patients receiving standard care, or another counterfactual comparator group, to be monitored concurrently, depending on the study question. The approach has been developed in parallel with the new legislative requirement for pharmaceutical companies to undertake a risk management plan as part of post-authorization safety monitoring. SCEM studies recognize that the study population comprises those patients who may have treatment initiated under the care of specialist health care professionals and who are more complex in terms of underlying disease, co-morbidities and concomitant medications than the general disease population treated in primary care. The aims of this paper are to discuss the SCEM new-user study design, rationale and features that aim to address possible bias (such as selection bias) and current applications.

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

    Directory of Open Access Journals (Sweden)

    Prasad Thota

    2018-01-01

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

  11. Reviews in plasmonics 2010

    CERN Document Server

    Geddes, Chris D

    2011-01-01

    Reviews in Plasmonics 2010, the first volume of the new book serial from Springer, serves as a comprehensive collection of current trends and emerging hot topics in the field of Plasmonics and closely related disciplines. It summarizes the year's progress in surface plasmon phenomena and its applications, with authoritative analytical reviews specialized enough to be attractive to professional researchers, yet also appealing to the wider audience of scientists in related disciplines of Plasmonics. Reviews in Plasmonics offers an essential reference material for any lab working in the Plasmonic

  12. Reviews in fluorescence 2010

    CERN Document Server

    Geddes, Chris D

    2011-01-01

    ""Reviews in Fluorescence 2010"", the seventh volume of the book serial from Springer, serves as a comprehensive collection of current trends and emerging hot topics in the field of fluorescence and closely related disciplines. It summarizes the year's progress in fluorescence and its applications, with authoritative analytical reviews specialized enough to be attractive to professional researchers, yet also appealing to the wider audience of scientists in related disciplines of fluorescence. ""Reviews in Fluorescence"" offers an essential reference material for any lab working in the fluoresc

  13. Review of particle properties

    International Nuclear Information System (INIS)

    Hikasa, K.; Hagiwara, K.; Kawabata, S.; Barnett, R.M.; Groom, D.E.; Trippe, T.G.; Wohl, C.G.; Yost, G.P.; Armstrong, B. Technical Associate; Wagman, G.S. Technical Associate; Stone, J.; Porter, F.C.; Morrison, R.J.; Cutkosky, R.E.; Montanet, L.; Gieselmann, K. Technical Associate; Aguilar-Benitez, M.; Caso, C.; Crawford, R.L.; Roos, M.; Toernqvist, N.A.; Hayes, K.G.; Hoehler, G.; Manley, D.M.

    1992-01-01

    In this Review, we list, evaluate, and average measured properties of gauge bosons, leptons, quarks, mesons, and baryons. We also summarize searches for hypothetical particles such as Higgs bosons, the top quark, heavy neutrinos, monopoles, and supersymmetric particles. All the particle properties and search limits are listed in Summary Tables. We also give numerous tables, figures, formulae, and reviews of topics such as the Standard Model, particle detectors, probability, and statistics. A booklet is available containing the Summary Tables and abbreviated versions of some other sections of this full Review

  14. Safety review advisor

    International Nuclear Information System (INIS)

    Boshers, J.A.; Uhrig, R.E.; Alguindigue, I.A.; Burnett, C.G.

    1991-01-01

    The University of Tennessee's Nuclear Engineering department, in cooperation with the Tennessee Valley Authority (TVA), is evaluating the feasibility of utilizing an expert system to aid in 10CFR50.59 evaluations. This paper discusses the history of 10CFR50.59 reviews, and details the development approach used in the construction of a prototype Safety Review Advisor (SRA). The goals for this expert system prototype are to aid the engineer in the evaluation process by directing his attention to the appropriate critical issues, increase the efficiency, consistency, and thoroughness of the evaluation process, and provide a foundation of appropriate Safety Analysis Report (SAR) references for the reviewer

  15. [Iridology: a systematic review].

    Science.gov (United States)

    Salles, Léia Fortes; Silva, Maria Júlia Paes

    2008-09-01

    This study is a literature review about Iridology/Irisdiagnose in the period from 1970 to 2005. The objective was to identify the worldwide scientific publications (articles) in this field and the opinions about the method. Twenty-five articles were found, four of them from Brazilian authors. About the category, 1 was literature review, 12 research studies and 12 updates, historical reviews or editorials. The countries that have contributed more with the studies were Brazil and Russia. Fifteen of those are in favor of the method and 10 are against it. In conclusion, it is necessary to develop more studies inside the methodological rigor, once Iridology brings hope to preventive medicine.

  16. Review of particle properties

    International Nuclear Information System (INIS)

    Montanet, L.; Gieselmann, K. Technical Associate; Barnett, R.M.; Groom, D.E.; Trippe, T.G.; Wohl, C.G.; Armstrong, B. Technical Associate; Wagman, G.S. Technical Associate; Murayama, H.; Stone, J.; Hernandez, J.J.; Porter, F.C.; Morrison, R.J.; Manohar, A.; Aguilar-Benitez, M.; Caso, C.; Lantero, P. Technical Associate; Crawford, R.L.; Roos, M.; Toernqvist, N.A.; Hayes, K.G.; Hoehler, G.

    1994-01-01

    This biennial review summarizes much of Particle Physics. Using data from previous editions, plus 2300 new measurements from 700 papers, we list evaluate, and average measured properties of gauge bosons, leptons, quarks, mesons, and baryons. We also summarize searches for hypothetical particles such as Higgs bosons, heavy neutrinos, monopoles, and supersymmetric particles. All the particle properties and search limits are listed in Summary Tables. We also give numerous tables, figures, formulae, and reviews of topics such as the Standard Model, particle detectors, probability, and statistics. A booklet is available containing the Summary Tables and abbreviated versions of some of the other sections of this full Review

  17. E-commerce Review System to Detect False Reviews.

    Science.gov (United States)

    Kolhar, Manjur

    2017-08-15

    E-commerce sites have been doing profitable business since their induction in high-speed and secured networks. Moreover, they continue to influence consumers through various methods. One of the most effective methods is the e-commerce review rating system, in which consumers provide review ratings for the products used. However, almost all e-commerce review rating systems are unable to provide cumulative review ratings. Furthermore, review ratings are influenced by positive and negative malicious feedback ratings, collectively called false reviews. In this paper, we proposed an e-commerce review system framework developed using the cumulative sum method to detect and remove malicious review ratings.

  18. Computer Center: Software Review.

    Science.gov (United States)

    Duhrkopf, Richard, Ed.; Belshe, John F., Ed.

    1988-01-01

    Reviews a software package, "Mitosis-Meiosis," available for Apple II or IBM computers with colorgraphics capabilities. Describes the documentation, presentation and flexibility of the program. Rates the program based on graphics and usability in a biology classroom. (CW)

  19. Individuals Account Review

    National Research Council Canada - National Science Library

    Scott, Donald

    2004-01-01

    .... This report was commissioned by Navy Personnel Command (NPC) to: (1) review and analyze the IA to determine if current accounting methods accurately capture the number of personnel included in the IA; (2...

  20. 164 REVIEW ARTICLE

    African Journals Online (AJOL)

    boaz

    Methods: A review of laboratory records of requests and collected reports of malaria parasite, urine microscopy, culture and sensitivity, ... indicator of quality clinical laboratory services (1,4). .... Monitoring glycaemic control: is there evidence for.

  1. Reviews in fluorescence 2008

    CERN Document Server

    Geddes, Chris D

    2010-01-01

    This volume serves as a comprehensive collection of current trends and emerging hot topics in the field of fluorescence spectroscopy. It summarizes the year's progress in fluorescence and its applications as well as includes authoritative analytical reviews.

  2. Appendix A : literature review.

    Science.gov (United States)

    2013-03-01

    This appendix contains a review of the literature and other background information : germane to the experimental and analytical research presented in subsequent appendices. Table : 1 lists the sections and topics contained in this appendix and those ...

  3. Geology of Uruguay review

    International Nuclear Information System (INIS)

    Gomez Rifas, C.

    2011-01-01

    This work is about the Uruguay geology review.This country has been a devoted to breeding cattle and agriculture.The evolution of geological knowledge begun with Dr. Karl Walther who published 53 papers between 1909 and 1948.

  4. Recensione / Recension / Book review

    Directory of Open Access Journals (Sweden)

    Bravo Fabio

    2010-03-01

    Full Text Available Book review of:Sette R., Cases on Technologies for Teaching Criminology and Victimology: Methodologies and practices, IGI Global – Information Science Reference, Hershey PA, 2010

  5. Sample Book Review

    African Journals Online (AJOL)

    David Ambrose

    Book Review: Reginald M.J. Oduor's Introduction to Ethics 105 ... actions emanating from any individual or social institution affects other individuals ... moral concepts, namely, freedom and responsibility, rights and duties, equality and justice ...

  6. Reviews in fluorescence 2007

    CERN Document Server

    Lakowicz, Joseph R; Geddes, Chris D

    2009-01-01

    This fourth volume in the Springer series summarizes the year's progress in fluorescence, with authoritative analytical reviews specialized enough for professional researchers, yet also appealing to a wider audience of scientists in related fields.

  7. Topical report review status

    International Nuclear Information System (INIS)

    1982-08-01

    A Topical Report Review Status is scheduled to be published semi-annually. The primary purpose of this document is to provide periodic progress reports of on-going topical report reviews, to identify those topical reports for which the Nuclear Regulatory Commission (NRC) staff review has been completed and, to the extent practicable, to provide NRC management with sufficient information regarding the conduct of the topical report program to permit taking whatever actions deemed necessary or appropriate. This document is also intended to be a source of information to NRC Licensing Project Managers and other NRC personnel regarding the status of topical reports which may be referenced in applications for which they have responsibility. This status report is published primarily for internal NRC use in managing the topical report program, but is also used by NRC to advise the industry of report review status

  8. Topical report review status

    International Nuclear Information System (INIS)

    1983-01-01

    A Topical Report Review Status is scheduled to be published semi-annually. The primary purpose of this document is to provide periodic progress reports of on-going topical report reviews, to identify those topical reports for which the Nuclear Regulatory Commission (NRC) staff review has been completed and, to the extent practicable, to provide NRC management with sufficient information regarding the conduct of the topical report program to permit taking whatever actions deemed necessary or appropriate. This document is also intended to be a source of information to NRC Licensing Project Managers and other NRC personnel regarding the status of topical reports which may be referenced in applications for which they have responsibility. This status report is published primarily for internal NRC use in managing the topical report program, but is also used by NRC to advise the industry of report review status

  9. EERE Peer Review Guide

    Energy Technology Data Exchange (ETDEWEB)

    None

    2009-01-18

    The primary purpose of this guide is to provide managers and staff guidance in establishing formal in-progress peer review that provides intellectually fair expert evaluation of EERE RD3 and supporting business administration programs, both retrospective and prospective.

  10. Southern African Business Review

    African Journals Online (AJOL)

    The Southern African Business Review is a refereed and accredited scientific journal of the College of Economic and Management Sciences of the .... The effects of extended water supply disruptions on the operations of SMEs · EMAIL FREE ...

  11. HIA Review Synthesis Report

    Science.gov (United States)

    A systematic review of health impact assessments (HIAs) from the U.S. was conducted to obtain a clear picture of how HIAs are being implemented nationally and to identify potential areas for improving the HIA community of practice.

  12. State Program Integrity Reviews

    Data.gov (United States)

    U.S. Department of Health & Human Services — State program integrity reviews play a critical role in how CMS provides effective support and assistance to states in their efforts to combat provider fraud and...

  13. Environmental performance reviews. Estonia

    International Nuclear Information System (INIS)

    1996-01-01

    This review of Estonia is the first environmental performance review (EPR) carried out under the auspices of the ECE Committee on Environmental Policy. This pilot ECE study builds, inter alia, on the experience gained in the preparation of pilot environmental performance reviews of Poland and Bulgaria, which were carried out in 1994-1995 by OECD in cooperation with ECE. The report focuses on capacity building; air, water, waste, and nature management; the integration of environmental and economic policies both generally and more specifically within the energy sector; and cooperation of Estonia with the international community. The review examines the current situation, recent and likely future trends, pressures, policy responses and their effectiveness. The principal conclusions and recommendations for improving Estonia's environmental performance are brought together in the concluding chapter.

  14. REVIEW ARTICLE 218

    African Journals Online (AJOL)

    boaz

    1) Epidemiology/ Surveillance, 2) Case Management/ Infection Control, 3) Social mobilization, 4) Laboratory ... The strategy group reviewed and approved all of the teams work and needed .... accountability measures and success of the polio.

  15. Carbon Based Nanotechnology: Review

    Science.gov (United States)

    Srivastava, Deepak; Saini, Subhash (Technical Monitor)

    1999-01-01

    This presentation reviews publicly available information related to carbon based nanotechnology. Topics covered include nanomechanics, carbon based electronics, nanodevice/materials applications, nanotube motors, nano-lithography and H2O storage in nanotubes.

  16. USCG Security Plan Review

    Data.gov (United States)

    Department of Homeland Security — The Security Plan Review module is intended for vessel and facility operators to check on the status of their security plans submitted to the US Coast Guard. A MISLE...

  17. Southern African Business Review

    African Journals Online (AJOL)

    Southern African Business Review. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 20, No 1 (2016) >. Log in or Register to get access to full text downloads.

  18. Model Validation Status Review

    International Nuclear Information System (INIS)

    E.L. Hardin

    2001-01-01

    The primary objective for the Model Validation Status Review was to perform a one-time evaluation of model validation associated with the analysis/model reports (AMRs) containing model input to total-system performance assessment (TSPA) for the Yucca Mountain site recommendation (SR). This review was performed in response to Corrective Action Request BSC-01-C-01 (Clark 2001, Krisha 2001) pursuant to Quality Assurance review findings of an adverse trend in model validation deficiency. The review findings in this report provide the following information which defines the extent of model validation deficiency and the corrective action needed: (1) AMRs that contain or support models are identified, and conversely, for each model the supporting documentation is identified. (2) The use for each model is determined based on whether the output is used directly for TSPA-SR, or for screening (exclusion) of features, events, and processes (FEPs), and the nature of the model output. (3) Two approaches are used to evaluate the extent to which the validation for each model is compliant with AP-3.10Q (Analyses and Models). The approaches differ in regard to whether model validation is achieved within individual AMRs as originally intended, or whether model validation could be readily achieved by incorporating information from other sources. (4) Recommendations are presented for changes to the AMRs, and additional model development activities or data collection, that will remedy model validation review findings, in support of licensing activities. The Model Validation Status Review emphasized those AMRs that support TSPA-SR (CRWMS M and O 2000bl and 2000bm). A series of workshops and teleconferences was held to discuss and integrate the review findings. The review encompassed 125 AMRs (Table 1) plus certain other supporting documents and data needed to assess model validity. The AMRs were grouped in 21 model areas representing the modeling of processes affecting the natural and

  19. Model Validation Status Review

    Energy Technology Data Exchange (ETDEWEB)

    E.L. Hardin

    2001-11-28

    The primary objective for the Model Validation Status Review was to perform a one-time evaluation of model validation associated with the analysis/model reports (AMRs) containing model input to total-system performance assessment (TSPA) for the Yucca Mountain site recommendation (SR). This review was performed in response to Corrective Action Request BSC-01-C-01 (Clark 2001, Krisha 2001) pursuant to Quality Assurance review findings of an adverse trend in model validation deficiency. The review findings in this report provide the following information which defines the extent of model validation deficiency and the corrective action needed: (1) AMRs that contain or support models are identified, and conversely, for each model the supporting documentation is identified. (2) The use for each model is determined based on whether the output is used directly for TSPA-SR, or for screening (exclusion) of features, events, and processes (FEPs), and the nature of the model output. (3) Two approaches are used to evaluate the extent to which the validation for each model is compliant with AP-3.10Q (Analyses and Models). The approaches differ in regard to whether model validation is achieved within individual AMRs as originally intended, or whether model validation could be readily achieved by incorporating information from other sources. (4) Recommendations are presented for changes to the AMRs, and additional model development activities or data collection, that will remedy model validation review findings, in support of licensing activities. The Model Validation Status Review emphasized those AMRs that support TSPA-SR (CRWMS M&O 2000bl and 2000bm). A series of workshops and teleconferences was held to discuss and integrate the review findings. The review encompassed 125 AMRs (Table 1) plus certain other supporting documents and data needed to assess model validity. The AMRs were grouped in 21 model areas representing the modeling of processes affecting the natural and

  20. Review biodepyritisation of coal

    Energy Technology Data Exchange (ETDEWEB)

    Acharya, C.; Sukla, L.B.; Misra, V.N. [Regional Research Lab., Orissa (India)

    2004-01-01

    This review provides a detailed summary of the recent and past research activities in the area of biodesulfurisation of coal. It provides information about microorganisms important for biodesulfurisation of coal, with the emphasis on Thiobacillus ferrooxidans. The review presents an insight into various methods of desulfurisation of coal combining physical and biological methods. Also, there are discussions on coal structure, distribution, mechanism and kinetics of pyrite oxidation and jarosite precipitation. Finally, areas requiring further research are identified.

  1. A Year in Review

    Directory of Open Access Journals (Sweden)

    Moyez Jiwa

    2010-12-01

    Full Text Available The AMJ is two years old. It is now a registered trademark and listed on 11 databases. In 2010 we published 169 papers from ten countries. We reviewed papers within 24 days on average and published most within 45 days. We remain committed to publication free of charge and offer free on-line access to all the material we publish. In this review we highlight the most memorable moments in 2010.

  2. Regulatory Review Committee update

    Energy Technology Data Exchange (ETDEWEB)

    Steele, T. [Polishuk, Camman and Steele, London ON (Canada)

    2001-07-01

    The Committee's objectives, current membership and current issues are reviewed. Each current issue, notably the consultation process with the Ministry of Natural Resources, appeal of Ministry actions, orphan wells/security deposits, oilfield fluid disposal and labour code practices review are discussed in some detail. Dissatisfaction with the current appeals process to the Ministry is highlighted, along with a search for an all encompassing solution. The orphan well problem also received considerable attention, with similar demands for a comprehensive solution.

  3. Review on technology II

    International Nuclear Information System (INIS)

    Mroziewicz, B.

    1986-01-01

    The most important requirements for the spectral properties of photodetectors are reviewed with particular attention to the fiber optics applications. Data on a number of materials are collected and presented. Pros and cons are pointed out for each type of photodetector-photoconductor, p-i-n photodiode and APD. A review is given of the relevant papers presented in the poster session 'Technology II' of the Symposium

  4. Review of particle properties

    Energy Technology Data Exchange (ETDEWEB)

    Yost, G P; Barnett, R M; Hinchliffe, I; Lynch, G R; Rittenberg, A; Ross, R R; Suzuki, M; Trippe, T G; Wohl, C G; Armstrong, B

    1988-04-14

    This review of the properties of gauge bosons, leptons, mesons, and baryons is an updating of the Review of Particle Properties, Particle Data Group (Phys. Lett. 170B (1986)). Data are evaluated, listed, averaged, and summarized in tables. We continue the more orderly set of particle names implemented in the 1986 edition. Numerous tables, figures, and formulae of interest to particle physicists are also included. A data booklet is available.

  5. Previous ISD Program Review.

    Science.gov (United States)

    1981-03-01

    report. The detail required for such a review would be unwieldy and would comsume inordinate amounts of time. The result of the document review will...attempts have been made at writing specific behavioral objectives (SBOs). These, however, have proven to be inadequate in that they are not stated in... behavioral terms (e.g., "will understand," "will have a knowledge of," etc.). C. Development of CRO/CRTs? In nearly all cases, ISD teams are just

  6. Review of particle properties

    International Nuclear Information System (INIS)

    Bricman, C.; Dionisi, C.; Hemingway, R.J.; Mazzucato, M.; Montanet, L.; Barash-Schmidt, N.; Crawford, R.C.; Roos, M.; Barbaro-Galtieri, A.; Horne, C.P.; Kelly, R.L.; Losty, M.J.; Rittenberg, A.; Trippe, T.G.; Yost, G.P.; Armstrong, B.

    1978-01-01

    This review of the properties of leptons, mesons, and baryons is an updating of Review of Particle Properties, Particle Data Group [Rev. Mod. Phys. 48 (1976) No. 2, Part II; and Supplement, Phys. Lett. 68B (1977) 1]. Data are evaluated, listed, averaged, and summarized in tables. Numerous tables, figures, and formulae of interest to particle physicists are also included. A data booklet is available. (Auth.)

  7. Massage Therapy Research Review

    OpenAIRE

    Field, Tiffany

    2014-01-01

    Moderate pressure massage has contributed to many positive effects including increased weight gain in preterm infants, reduced pain in different syndromes including fibromyalgia and rheumatoid arthritis, enhanced attentiveness, reduced depression and enhanced immune function (increased natural killer cells and natural killer cell activity). Surprisingly, these recent studies have not been reviewed, highlighting the need for the current review. When moderate and light pressure massage have bee...

  8. Book reviews online

    Directory of Open Access Journals (Sweden)

    Philip Barker

    1997-12-01

    Full Text Available Many thousands of books are published each year, and even specialists find it difficult to keep abreast of new books in their disciplines, learning technology being no exception - indeed, in our subject-area the situation is beginning to reach saturation point. The bookreview procedure facilitates selection: a good review will capture the essential content of a book, and will comment on its quality, style, level of presentation, appropriateness, and perhaps value for money. Figure 1 shows the review process, its relationship to the production of books and learned journals, and the functional similarity between book reviews and abstracts of papers published in learned journals. Abstracts are often archived in online databases or on CD-ROM, in this way acting as an alerting and brief reference service. Book reviews can be treated in the same way. This paper discusses the use of servers (Internet or intranet as a means of making them available to a global population. It also describes how such a facility could fit into a more general infrastructure for soliciting potential reviewers and drawing their attention to publications available for review.

  9. Spondylolysis: a critical review

    Science.gov (United States)

    Standaert, C; Herring, S

    2000-01-01

    Aim—To provide an understanding of the current concepts in the natural history, pathophysiology, diagnosis, and treatment of spondylolysis based on the available medical literature. Methods—Articles were selected for review by the following methods: (a) MEDLINE searches with review of abstracts to select relevant articles; (b) review of multiple textbooks considered likely to contain information on spondylolysis; (c) review of references in articles identified by (a) and (b). Over 125 articles were ultimately reviewed fully. Publications were selected for inclusion in this article on the basis of perceived scientific and historical merit, particularly as thought to be relevant to achieving the stated purpose of this review. As no controlled clinical trials were identified, this could not be used as an inclusion criterion. Conclusions—Isthmic spondylolysis is considered to represent a fatigue fracture of the pars interarticularis of the neural arch. There is a relatively high incidence of radiographically identified spondylolysis in the general population, but the vast majority of these lesions probably occur without associated symptoms. Symptomatic pars lesions appear to be particularly a clinical problem in adolescents, especially adolescent athletes. The optimal diagnostic and treatment algorithms are not well identified in the current literature. Multiple imaging studies may have a role in the diagnosis of a pars lesion, and treatment seems likely to require at least relative rest and physical rehabilitation with consideration of bracing or, rarely, surgical intervention depending on the clinical context. Key Words: spondylolysis; spondylolisthesis; spine; back; neural arch; pars interarticularis PMID:11131228

  10. 78 FR 47016 - Submission for Review: Request for External Review

    Science.gov (United States)

    2013-08-02

    ... OFFICE OF PERSONNEL MANAGEMENT Submission for Review: Request for External Review AGENCY: U.S... External Review. As required by the Paperwork Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 35... the Multi-State Plan Program (MSPP) on March 11, 2013, 78 FR 15560, which outlined an external review...

  11. Meta-Review: Systematic Assessment of Program Review

    Science.gov (United States)

    Harlan, Brian

    2012-01-01

    Over 20 years ago, Robert J. Barak and Barbara E. Breier suggested incorporating a regular assessment of the entire program review system into the review schedule in order to ensure that the system itself is as efficient and effective as the programs under review. Barak and Breier's seminal book on the goals and processes of program review has…

  12. 6 CFR 13.5 - Review by the Reviewing Official.

    Science.gov (United States)

    2010-01-01

    ... 6 Domestic Security 1 2010-01-01 2010-01-01 false Review by the Reviewing Official. 13.5 Section 13.5 Domestic Security DEPARTMENT OF HOMELAND SECURITY, OFFICE OF THE SECRETARY PROGRAM FRAUD CIVIL REMEDIES § 13.5 Review by the Reviewing Official. (a) If, based on the report of the Investigating Official...

  13. Dendrobium micropropagation: a review.

    Science.gov (United States)

    da Silva, Jaime A Teixeira; Cardoso, Jean Carlos; Dobránszki, Judit; Zeng, Songjun

    2015-05-01

    Dendrobium is one of the largest and most important (ornamentally and medicinally) orchid genera. Tissue culture is now an established method for the effective propagation of members of this genus. This review provides a detailed overview of the Dendrobium micropropagation literature. Through a chronological analysis, aspects such as explant, basal medium, plant growth regulators, culture conditions and final organogenic outcome are chronicled in detail. This review will allow Dendrobium specialists to use the information that has been documented to establish, more efficiently, protocols for their own germplasm and to improve in vitro culture conditions based on the optimized parameters detailed in this review. Not only will this expand the use for mass propagation, but will also allow for the conservation of important germplasm. Information on the in vitro responses of Dendrobium for developing efficient protocols for breeding techniques based on tissue culture, such as polyploidization, somatic hybridization, isolation of mutants and somaclonal variants and for synthetic seed and bioreactor technology, or for genetic transformation, is discussed in this review. This is the first such review on this genus and represents half a decade of literature dedicated to Dendrobium micropropagation.

  14. Environmental performance reviews. Croatia

    International Nuclear Information System (INIS)

    1999-01-01

    The Environmental Performance Review of Croatia began with the preparatory mission in June 1998. This report was prepared on the basis of the team's review mission to Croatia in March 1999. Its draft was submitted to the ECE Committee on Environmental Policy at its annual session in Geneva on 22 September 1999. A high-level delegation from Croatia attended this evaluation, which was prepared in-depth by two reviewing countries, the Netherlands and Slovakia. At the end of its evaluation, the Committee approved the recommendations as set out in this report. The review of Croatia's environmental performance identified a number of strengths and weaknesses in the implementation of environmental policy and management. The systematic and professional preparation of environmental management measures in the State Directorate for the Protection of Nature and the Environment is often impressive. However, their implementation and enforcement suffer from a lack of institutional weight and cooperation throughout State institutions. Therefore, improving the cooperation with all key partners is an important task. Furthermore, greater involvement of the general public in environmental management might help to strengthen the overall recognition and results of environmental management. Finally, the review also found impediments to better performance with regard to remediation of the environmental consequences of the war - a problem that can be successfully dealt with only if sufficient funds are allocated for that work

  15. 2015 Peer Review Report

    Energy Technology Data Exchange (ETDEWEB)

    None, None

    2016-03-01

    In the spring and summer of 2015, the Bioenergy Technologies Office (BETO or the Office) of the U.S. Department of Energy (DOE) implemented an external peer review of the projects in its research, development and demonstration (RD&D) portfolio. The Office manages a diverse portfolio of technologies across the spectrum of applied RD&D within the dynamic context of changing budgets and Administration priorities. The Office portfolio is organized according to the biomass-to-bioenergy supply chain—from the feedstock source to the end user (see Figure 1)—with major focus on feedstock supply and biomass conversion. The 2015 Project Peer Review took place March 23-27, 2015, outside of Washington, D.C., in Alexandria, Virginia, and evaluated most of the publicly funded projects in BETO’s portfolio. The subsequent Program Management Review took place on June 25, 2015, in Washington, D.C., and provided an Office- level assessment of strategic planning and programmatic initiatives. The peer review process enables external stakeholders to provide feedback on the responsible use of taxpayer funding and develop recommendations for the most efficient and effective ways to accelerate the development of an advanced bioenergy industry. The planning and execution of these reviews was completed over the course of 10 months, and this report includes the results of both events.

  16. ATLAS Review Office

    CERN Multimedia

    Szeless, B

    The ATLAS internal reviews, be it the mandatory Production Readiness Reviews, the now newly installed Production Advancement Reviews, or the more and more requested different Design Reviews, have become a part of our ATLAS culture over the past years. The Activity Systems Status Overviews are, for the time being, a one in time event and should be held for each system as soon as possible to have some meaning. There seems to a consensus that the reviews have become a useful project tool for the ATLAS management but even more so for the sub-systems themselves making achievements as well as possible shortcomings visible. One other recognized byproduct is the increasing cross talk between the systems, a very important ingredient to make profit all the systems from the large collective knowledge we dispose of in ATLAS. In the last two months, the first two PARs were organized for the MDT End Caps and the TRT Barrel Modules, both part of the US contribution to the ATLAS Project. Furthermore several different design...

  17. Ocular candidiasis: a review.

    Science.gov (United States)

    Shah, C P; McKey, J; Spirn, M J; Maguire, J

    2008-04-01

    To review the epidemiology, diagnosis and changing treatment paradigm of ocular candidiasis, and report current prevalence rates and risk factors at one inpatient hospital. Retrospective review; systematic literature review. All Wills Eye Institute inpatient ophthalmology consultations from Thomas Jefferson University Hospital were retrospectively reviewed between June 2006 and November 2006. All consultations for candidaemia were included. The outcome variables included chorioretinitis, endophthalmitis, visual symptoms and Candida speciation. The ophthalmic literature was reviewed using PubMed. Keywords included Candida, candidaemia, chorioretinitis, vitritis and endophthalmitis. Bibliographies were manually searched. Three of the 38 consultations for candidaemia (7.9%) had chorioretinitis. There were no cases of vitritis or endophthalmitis. The presence of symptoms, or the inability to articulate symptoms, was significantly associated with risk of ocular candidiasis (p = 0.003). All three cases of chorioretinitis had positive blood cultures for Candida albicans (p = 0.089) and were treated with oral fluconazole. Various factors have led to the increasing prevalence of inpatient candidaemia. Risk factors for ocular involvement include albicans species and the presence of, or inability to articulate, visual symptoms. For those without abnormal findings on initial examination, a subsequent retinal examination should be performed in 2 weeks, particularly if new symptoms develop or if the patient is unable to relay symptoms. Patients with chorioretinitis should be treated with systemic antifungal agents. For those with vitritis or endophthalmitis, particularly if worsening on systemic therapy alone, intravitreal antifungal medications or early vitrectomy should be considered.

  18. Handbook for WATRP reviews

    International Nuclear Information System (INIS)

    1990-05-01

    The Waste Management Assessment and Technical Review Programme (WATRP) has been developed by the International Atomic Energy Agency (Agency) to serve Member States through technical assessments and peer reviews of their national policies, concepts and other tasks related to the management of radioactive wastes. The programme is directed towards Member States with established waste management programmes. Upon request of a Member State, or an organization within a Member State, the Agency undertakes the responsibility of convening an international panel of experts and of performing a peer review of terms of reference established by the customer; the mechanisms used for this purpose are a review of source materials and technical exchanges with the customer's experts. The main objective of a WATRP review is to provide the customer with individual and collective expertise and information on the best international experience in the waste management field overall, or on some particular subject area, also validating that programmes and activities are indeed sound and performing as planned. Thus, the conclusions and recommendations of the WATRP experts should be based on internationally acceptable current thinking, taking into account proven practices or, at least, the general consensus on the most viable option for solving particular tasks

  19. ReviewChain: Untampered Product Reviews on the Blockchain

    OpenAIRE

    Martens, Daniel; Maalej, Walid

    2018-01-01

    Online portals include an increasing amount of user feedback in form of ratings and reviews. Recent research highlighted the importance of this feedback and confirmed that positive feedback improves product sales figures and thus its success. However, online portals' operators act as central authorities throughout the overall review process. In the worst case, operators can exclude users from submitting reviews, modify existing reviews, and introduce fake reviews by fictional consumers. This ...

  20. Clinical review: Riedel's thyroiditis: a clinical review.

    Science.gov (United States)

    Hennessey, James V

    2011-10-01

    Riedel's thyroiditis is a rare inflammatory process involving the thyroid and surrounding cervical tissues and is associated with various forms of systemic fibrosis. Riedel's presentation is complex, including a thyroid mass associated with local symptoms, characteristic biochemical abnormalities such as hypocalcemia and hypothyroidism, as well as the involvement of a wide range of other organ systems. Diagnosis of Riedel's thyroiditis requires histopathological confirmation, but due to high complication rates, the role of surgical intervention is limited to airway decompression and diagnostic tissue retrieval. Unique among processes of the thyroid, Riedel's is commonly treated with long-term antiinflammatory medications to arrest progression and maintain a symptom-free course. Due to its rarity, Riedel's may not be immediately diagnosed, so clinicians benefit from recognizing the constellation of findings that should make prompt diagnosis possible. A review of print and electronic reviews was conducted. Source references were identified, and available literature was reviewed. A search of the PubMed database using the search term "Riedel's thyroiditis" was cross-referenced with associated clinical findings, systemic fibrosis diagnoses, and therapeutic search terms. Because most of the literature consisted of case reports and very small series, inclusion of identified articles was based on clinical descriptions of the subjects included and the criteria for diagnosis reported. More weight was attributed to series, using contemporary criteria for diagnosis. Case reports were included if the diagnosis was clear and clinical presentation was unique to illustrate the spectrum of disease. Because the majority of therapeutic intervention data were based upon case reports and very small series, an evidence-based approach was problematic, but information is presented as objectively and with as much balance as the limited quality of the data allows. Clinical awareness of the

  1. Book reviews 2016

    Directory of Open Access Journals (Sweden)

    Hilling Axel

    2016-11-01

    Full Text Available This section contains reviews of two Swedish books on international taxation. First, the book Skatteavtal och generalklausuler, Ett komparativt perspektiv (Tax Agreements and General Anti-Avoidance Regulations, A Comparative Perspective is recommended for those who study and work with international tax law. The book analyses how tax treaties’ function to limit contracting states’ taxing powers relates to national GAARs. A comparative analysis is made between Sweden and Canada. In the second review, the doctoral dissertation EU-domstolens restirktionsprövning i mal om de grundläggande frihterna och direkta skatter (The EU Court of Justice’s examination of the restriction requirement in its direct tax case law is reviewed. The dissertation systemizes relevant CJEU’s case law and analyzes the Courts reasoning in deciding whether or not certain tax regulation is in conflict with EU fundamental freedoms.

  2. Independent technical review, handbook

    International Nuclear Information System (INIS)

    1994-02-01

    Purpose Provide an independent engineering review of the major projects being funded by the Department of Energy, Office of Environmental Restoration and Waste Management. The independent engineering review will address questions of whether the engineering practice is sufficiently developed to a point where a major project can be executed without significant technical problems. The independent review will focus on questions related to: (1) Adequacy of development of the technical base of understanding; (2) Status of development and availability of technology among the various alternatives; (3) Status and availability of the industrial infrastructure to support project design, equipment fabrication, facility construction, and process and program/project operation; (4) Adequacy of the design effort to provide a sound foundation to support execution of project; (5) Ability of the organization to fully integrate the system, and direct, manage, and control the execution of a complex major project

  3. Safety review advisor

    International Nuclear Information System (INIS)

    Boshers, J.A.; Alguindigue, I.E.; Uhrig, R.E.

    1989-01-01

    The University of Tennessee's Nuclear Engineering Department, in cooperation with the Tennessee Valley Authority (TVA), is evaluating the feasibility of utilizing an expert system to aid in 10CFR50.59 evaluations. This paper discusses the history of 10CFR50.59 reviews, and details the development approach used in the construction of a prototype Safety Review Advisor (SRA). The goals for this expert system prototype are to (1) aid the engineer in the evaluation process by directing his attention to the appropriate critical issues, (2) increase the efficiency, consistency, and thoroughness of the evaluation process, and (3) provide a foundation of appropriate Safety Analysis Report (SAR) references for the reviewer. 6 refs., 2 figs

  4. Reviews in plasmonics 2016

    CERN Document Server

    2017-01-01

    Reviews in Plasmonics 2016, the third volume of the new book series from Springer, serves as a comprehensive collection of current trends and emerging hot topics in the field of Plasmonics and closely related disciplines. It summarizes the year’s progress in surface plasmon phenomena and its applications, with authoritative analytical reviews in sufficient detail to be attractive to professional researchers, yet also appealing to the wider audience of scientists in related disciplines of Plasmonics. Reviews in Plasmonics offers an essential source of reference material for any lab working in the Plasmonics field and related areas. All academics, bench scientists, and industry professionals wishing to take advantage of the latest and greatest in the continuously emerging field of Plasmonics will find it an invaluable resource.

  5. Reviews in plasmonics 2015

    CERN Document Server

    2016-01-01

    Reviews in Plasmonics 2015, the second volume of the new book series from Springer, serves as a comprehensive collection of current trends and emerging hot topics in the field of Plasmonics and closely related disciplines. It summarizes the year’s progress in surface plasmon phenomena and its applications, with authoritative analytical reviews in sufficient detail to be attractive to professional researchers, yet also appealing to the wider audience of scientists in related disciplines of Plasmonics. Reviews in Plasmonics offers an essential source of reference material for any lab working in the Plasmonics field and related areas. All academics, bench scientists, and industry professionals wishing to take advantage of the latest and greatest in the continuously emerging field of Plasmonics will find it an invaluable resource.

  6. Independent technical review, handbook

    Energy Technology Data Exchange (ETDEWEB)

    1994-02-01

    Purpose Provide an independent engineering review of the major projects being funded by the Department of Energy, Office of Environmental Restoration and Waste Management. The independent engineering review will address questions of whether the engineering practice is sufficiently developed to a point where a major project can be executed without significant technical problems. The independent review will focus on questions related to: (1) Adequacy of development of the technical base of understanding; (2) Status of development and availability of technology among the various alternatives; (3) Status and availability of the industrial infrastructure to support project design, equipment fabrication, facility construction, and process and program/project operation; (4) Adequacy of the design effort to provide a sound foundation to support execution of project; (5) Ability of the organization to fully integrate the system, and direct, manage, and control the execution of a complex major project.

  7. AN APPROACH FOR REVIEWING AND RANKING THE CUSTOMERS’ REVIEWS THROUGH QUALITY OF REVIEW (QoR

    Directory of Open Access Journals (Sweden)

    Sumit Kawate

    2017-01-01

    Full Text Available Quality is referred as the degree of excellence that means the expected product or service being considered to achieve desired requirements. Whereas, Quality of Reviews (QoR relates to the task of determining the quality, efficiency, suitability, or utility of each review by addressing Quality of Product (QoP and Quality of Service (QoS. It is an essential task of ranking, the reviews based on the quality and efficiency of the reviews given by the users. Whatever the reviews are provided to the particular product or services are from user experiences. The Quality of Reviews (QoR is one of a kind method that defines how the customer’s standpoint for the service or product that he/she experienced. The main issue while reviewing any product, the reviewer provides his/her opinion in the form of reviews and might be a few of those reviews are malicious spam entries to skew the rating of the product. Also in another case, many times customers provide the reviews which are quite common and that won’t helpful for the buyer to interpret the helpful feedback on their products because of too many formal reviews from distinct customers. Hence, we proposed novel approaches: i to statistical analyzes the customer reviews on products by Amazon to identify top most useful or helpful reviewers; ii to analyze the products and its reviews associated for malicious reviews ratings that skewed the overall product ranking. As this is one of the efficient approaches to avoid spam reviewers somehow from reviewing the products. With this, we can use this method for distinguishing between nominal users and spammers. This method helps to quest for helpful reviewers not only to make the product better from best quality reviewers, but also these quality reviewers themselves can able to review future products.

  8. Repatriation Adjustment: Literature Review

    Directory of Open Access Journals (Sweden)

    Gamze Arman

    2009-12-01

    Full Text Available Expatriation is a widely studied area of research in work and organizational psychology. After expatriates accomplish their missions in host countries, they return to their countries and this process is called repatriation. Adjustment constitutes a crucial part in repatriation research. In the present literature review, research about repatriation adjustment was reviewed with the aim of defining the whole picture in this phenomenon. Present research was classified on the basis of a theoretical model of repatriation adjustment. Basic frame consisted of antecedents, adjustment, outcomes as main variables and personal characteristics/coping strategies and organizational strategies as moderating variables.

  9. Time crystals: a review

    Science.gov (United States)

    Sacha, Krzysztof; Zakrzewski, Jakub

    2018-01-01

    Time crystals are time-periodic self-organized structures postulated by Frank Wilczek in 2012. While the original concept was strongly criticized, it stimulated at the same time an intensive research leading to propositions and experimental verifications of discrete (or Floquet) time crystals—the structures that appear in the time domain due to spontaneous breaking of discrete time translation symmetry. The struggle to observe discrete time crystals is reviewed here together with propositions that generalize this concept introducing condensed matter like physics in the time domain. We shall also revisit the original Wilczek’s idea and review strategies aimed at spontaneous breaking of continuous time translation symmetry.

  10. The world review

    International Nuclear Information System (INIS)

    Anon.

    1999-01-01

    A world-wide review of hydrocarbon processing is presented. Following a general introduction discussing issues such as the crisis in Asia, the mergers between the oil giants, the concern over carbon dioxide emissions in Europe, the expected decline in output of oil in the USA and the attraction of Latin America in terms of natural gas, the article goes on to review the situations and prospects in various parts of the world. Fifty-one countries are discussed individually in this 34-page article. The focus throughout is very much on the activities of individual companies and contracts rather than on technical details. (UK)

  11. REVIEWER LIST – 2014

    OpenAIRE

    Chief Editor

    2014-01-01

    REVIEWER LIST – 2014 The Editorial Team would like to thank all those who gave generously of their time and expertise in reviewing the papers for the Indian Journal of Community Health in 2014.AAarti Kapil, New Delhi, IndiaAbhishek SinghAmandeep Kaur, Haldwani, IndiaAmit Kaushik, Safai, IndiaAnu Bhardwaj, Ambala, IndiaAnurag Chaudary, Ludhiana, IndiaA R BondArpan YagnikArvind Kumar Singh, Gorakhpur, IndiaAshish Yadav, Meerut, IndiaAthar Ansari, Aligarh, India BBaridalyne Nongkynrih, New Delhi...

  12. FASTBUS review 1985

    International Nuclear Information System (INIS)

    Walz, H.V.; Barsotti, E.J.

    1985-09-01

    The progress of developments based on the FASTBUS Specification DOE/ER-0189 for modular high-speed data acquisition and control systems is reviewed. Available hardware components and efforts in standardized FASTBUS software are summarized. The status of FASTBUS applications at research laboratories in North America is reported. FASTBUS work in Europe and Japan is presented in other papers at this conference. Due to the highly condensed nature of this review, background information and references from reports at the 1983 and 1984 Nuclear Science Symposia may be useful. 17 refs., 4 figs

  13. Human cryptosporidiosis: a review.

    Science.gov (United States)

    Ayuo, P O

    2009-02-01

    To provide an overview of risk factors, presentation and management of human cryptosporidium infection. Literature review was obtained through PubMed search. Published articles on the taxonomy of Cryptosporidium and the epidemiology, clinical presentation and management of cryptosporidiosis were reviewed. Abstracts and complete articles relevant to the objective were selected, read and analysed to extract information for this article. Human cryptosporidiosis is a severe diarrhoeal disease in malnourished children and immuno-compromised adults in whom it confers poor prognosis. Management is mainly supportive as drug therapy remains elusive. Fortunately the prevalence in AIDS patients is declining due to the widespread use of combination antiretroviral therapy (cART).

  14. South African Gastroenterology Review

    African Journals Online (AJOL)

    IBS - the beginning and the end: clinical review. Keith Pettengell. Full Text: EMAIL FULL TEXT EMAIL FULL TEXT · DOWNLOAD FULL TEXT DOWNLOAD FULL TEXT. Article Metrics. Metrics Loading ... Metrics powered by PLOS ALM · http://dx.doi.org/10.4314/sagr.v1i1.30693 · AJOL African Journals Online. HOW TO USE ...

  15. Homework. Literature Review

    Science.gov (United States)

    Blazer, Christie

    2009-01-01

    Although homework is assigned for a variety of academic and non-academic purposes, there is disagreement within the educational community about the value of homework and the amount of homework students should be assigned. This Literature Review summarizes the benefits and drawbacks of homework and examines how much time students should and…

  16. Review on Superconducting Materials

    OpenAIRE

    Hott, Roland; Kleiner, Reinhold; Wolf, Thomas; Zwicknagl, Gertrud

    2013-01-01

    Short review of the topical comprehension of the superconductor materials classes Cuprate High-Temperature Superconductors, other oxide superconductors, Iron-based Superconductors, Heavy-Fermion Superconductors, Nitride Superconductors, Organic and other Carbon-based Superconductors and Boride and Borocarbide Superconductors, featuring their present theoretical understanding and their aspects with respect to technical applications.

  17. Reviews: The Molecular Animator.

    Science.gov (United States)

    Journal of Chemical Education, 1987

    1987-01-01

    Provided is a review of a chemical software package. The package makes possible an instructional technique that is not effective by any other means, namely the ability to view molecular shapes in three dimensions. The program can be used with either IBM or Apple hardware. (RH)

  18. Visual Complexity: A Review

    Science.gov (United States)

    Donderi, Don C.

    2006-01-01

    The idea of visual complexity, the history of its measurement, and its implications for behavior are reviewed, starting with structuralism and Gestalt psychology at the beginning of the 20th century and ending with visual complexity theory, perceptual learning theory, and neural circuit theory at the beginning of the 21st. Evidence is drawn from…

  19. Economic and Policy Review

    African Journals Online (AJOL)

    The NESG Economic and Policy Review (EPR) is a quarterly publication of the Nigerian Economic Summit Group (NESG), established to serve as an avenue for constructive analysis of economic policies and their impacts on different aspects of the business and economic environment. The EPR aims to provide unbiased, ...

  20. Swaddling: A Systematic Review

    NARCIS (Netherlands)

    van Sleuwen, Bregje E.; Engelberts, Adèle C.; Boere-Boonekamp, Magdalena M.; Kuis, Wietse; Schulpen, Tom W.J.

    2007-01-01

    Swaddling was an almost universal child-care practice before the 18th century. It is still tradition in certain parts of the Middle East and is gaining popularity in the United Kingdom, the United States, and the Netherlands to curb excessive crying. We have systematically reviewed all articles on

  1. Annual energy review, 1990

    International Nuclear Information System (INIS)

    1991-05-01

    This Review presents long-term historical energy data. US energy consumption, production, trade, and prices are included. Also covered are consumption indicators, energy resources, petroleum, natural gas, coal, electricity, nuclear energy, renewable energy, and international energy. 5 figs., 129 tabs

  2. A Review of Measles

    Science.gov (United States)

    Dardis, Melissa R.

    2012-01-01

    Measles, once a common childhood illness that many older school nurses could recognize without difficulty, needs review again after reemerging from Europe and other continents. A highly contagious disease, which has been referenced since the seventh century, the virus can cause serious illness and death, despite the fact that it is vaccine…

  3. Polish Cartographical Review

    Directory of Open Access Journals (Sweden)

    Nedjeljko Frančula

    2017-07-01

    Full Text Available The Polish Cartographical Review (PCR journal has been published in English four times a year since 2015. The journal is in open access and it is published by De Gruyter Open. It is edited by Polish scientists in collaboration with international experts.

  4. Country programme review. Mongolia

    International Nuclear Information System (INIS)

    Dolnicar, J.; Kamel, R.; Perera, O.; Tauchid, M.

    1992-08-01

    This document reviews the current nuclear program in Mongolia, identifying the peaceful uses of nuclear technology in the country and possible future technical co-operation activities. Separate brief sections deal with food and agriculture; mineral resources; nuclear chemistry, nuclear physics and instrumentation; human health; radiation protection; water resources and nuclear energy. 1 tab

  5. REVIEW ARTICLE 218

    African Journals Online (AJOL)

    boaz

    The strategy group reviewed and approved all of the teams work and needed resources. ... de cas/ Contrôle de l'infection, 3) la mobilisation sociale, 4) Les Services de laboratoire, 5) le point d'entrée et 6) Gestion / ... molecular evidence for adaptation during human to ... respond to malaria treatment and his travel from an.

  6. Overall review paper

    International Nuclear Information System (INIS)

    Curran, S.

    1981-01-01

    A review is given of the papers presented at the European Symposium on Fast Breeder Reactors in the context of the early history of nuclear energy, the concept of breeding, the safety of the breeder, terrorism and other hazards, the need for more energy, human factors and safety. (U.K.)

  7. 6. Book Reviews

    Directory of Open Access Journals (Sweden)

    Enrico Pasini

    2015-08-01

    Full Text Available Reviews of Valery Rees, From Gabriel to Lucifer: A Cultural History of Angels, London-New York 2012; G. R. Evans, First Light. A History of Creation Myths from Gilgamesh to the God Particle, London-New York 2014.

  8. PEAR code review

    International Nuclear Information System (INIS)

    De Wit, R.; Jamieson, T.; Lord, M.; Lafortune, J.F.

    1997-07-01

    As a necessary component in the continuous improvement and refinement of methodologies employed in the nuclear industry, regulatory agencies need to periodically evaluate these processes to improve confidence in results and ensure appropriate levels of safety are being achieved. The independent and objective review of industry-standard computer codes forms an essential part of this program. To this end, this work undertakes an in-depth review of the computer code PEAR (Public Exposures from Accidental Releases), developed by Atomic Energy of Canada Limited (AECL) to assess accidental releases from CANDU reactors. PEAR is based largely on the models contained in the Canadian Standards Association (CSA) N288.2-M91. This report presents the results of a detailed technical review of the PEAR code to identify any variations from the CSA standard and other supporting documentation, verify the source code, assess the quality of numerical models and results, and identify general strengths and weaknesses of the code. The version of the code employed in this review is the one which AECL intends to use for CANDU 9 safety analyses. (author)

  9. Lagos Historical Review

    African Journals Online (AJOL)

    The Lagos Historical Review is an international and interdisciplinary journal publishing papers with a historical focus. The journal generates and participates in debates to advance the discipline of history and promote its relevance to development. The journal aims to serve the academic community with a bias towards ...

  10. Resource Reviews Bronmateriaa lbesprekings

    African Journals Online (AJOL)

    buyers of the types of books under review and in this light one might bear the following general factors in mind when choosing a suitable book. e The age and abiLity of the child. Pre-school and lower primary children cannot be expected to colour within the 1 ines or to complete every picture: children often derive pleasure ...

  11. Book Reviews Boekbesprekings

    African Journals Online (AJOL)

    Book Reviews. HYPOTHALAMIC HORMONES. Hypothalamic Hypophysiotropic Hormones. Physiological and clinical studies. Proceedings of the Conference .... tricians, it certainly succeeds in its aim. 'A book is of little use if it has no pictures', thought Alice. This book has many. Of particular interest is the last chapter in ...

  12. Neutron dosimetry - A review

    Energy Technology Data Exchange (ETDEWEB)

    Baum, J W

    1955-03-29

    This review summarizes information on the following subjects: (1) physical processes of importance in neutron dosimetry; (2) biological effects of neutrons; (3) neutron sources; and (4) instruments and methods used in neutron dosimetry. Also, possible improvements in dosimetry instrumentation are outlined and discussed. (author)

  13. Lightning injury: a review.

    Science.gov (United States)

    Ritenour, Amber E; Morton, Melinda J; McManus, John G; Barillo, David J; Cancio, Leopoldo C

    2008-08-01

    Lightning is an uncommon but potentially devastating cause of injury in patients presenting to burn centers. These injuries feature unusual symptoms, high mortality, and significant long-term morbidity. This paper will review the epidemiology, physics, clinical presentation, management principles, and prevention of lightning injuries.

  14. Rotating reactors : a review

    NARCIS (Netherlands)

    Visscher, F.; Schaaf, van der J.; Nijhuis, T.A.; Schouten, J.C.

    2013-01-01

    This review-perspective paper describes the current state-of-the-art in the field of rotating reactors. The paper has a focus on rotating reactor technology with applications at lab scale, pilot scale and industrial scale. Rotating reactors are classified and discussed according to their geometry:

  15. Review of Literature.

    Science.gov (United States)

    Armstrong, Robert L.

    1992-01-01

    Offers a critical review of eight articles and two journal issues dealing with school indicators of student success or failure; state models for school improvement and accountability; teacher burnout as an outcome of paperwork burdens; the impact of reform efforts; class size; trends in educational evaluation; mastery testing; departmentalization…

  16. Haramaya Law Review

    African Journals Online (AJOL)

    The Haramaya Law Review (HLR) publishes original scientific manuscripts and disseminates scientific and information to the users in Ethiopia, Africa and elsewhere in the world. It also enhances exchange of ideas among scientists engaged in research and development activities and accepts papers from anywhere else in ...

  17. CONTAIN independent peer review

    International Nuclear Information System (INIS)

    Boyack, B.E.; Corradini, M.L.; Khatib-Rahbar, M.; Loyalka, S.K.; Smith, P.N.

    1995-01-01

    The CONTAIN code was developed by Sandia National Laboratories under the sponsorship of the US Nuclear Regulatory Commission (NRC) to provide integrated analyses of containment phenomena. It is used to predict nuclear reactor containment loads, radiological source terms, and associated physical phenomena for a range of accident conditions encompassing both design-basis and severe accidents. The code's targeted applications include support for containment-related experimental programs, light water and advanced light water reactor plant analysis, and analytical support for resolution of specific technical issues such as direct containment heating. The NRC decided that a broad technical review of the code should be performed by technical experts to determine its overall technical adequacy. For this purpose, a six-member CONTAIN Peer Review Committee was organized and a peer review as conducted. While the review was in progress, the NRC issued a draft ''Revised Severe Accident Code Strategy'' that incorporated revised design objectives and targeted applications for the CONTAIN code. The committee continued its effort to develop findings relative to the original NRC statement of design objectives and targeted applications. However, the revised CONTAIN design objectives and targeted applications. However, the revised CONTAIN design objectives and targeted applications were considered by the Committee in assigning priorities to the Committee's recommendations. The Committee determined some improvements are warranted and provided recommendations in five code-related areas: (1) documentation, (2) user guidance, (3) modeling capability, (4) code assessment, and (5) technical assessment

  18. Medication Errors - A Review

    OpenAIRE

    Vinay BC; Nikhitha MK; Patel Sunil B

    2015-01-01

    In this present review article, regarding medication errors its definition, medication error problem, types of medication errors, common causes of medication errors, monitoring medication errors, consequences of medication errors, prevention of medication error and managing medication errors have been explained neatly and legibly with proper tables which is easy to understand.

  19. 120 Hz Gun Review

    Energy Technology Data Exchange (ETDEWEB)

    Colby, E.

    2005-01-31

    The review was held at SLAC on September 11 and 12, 2001. Presentations concerning the thermal analysis, mechanical design, integration with the laser and accelerator, general beam dynamics considerations, a load lock mechanism, and symmetric power feed options comprised the review. Slides from these presentations are available elsewhere. The review committee was charged with evaluating the 120 Hz gun design including proposed load lock and power feed options and recommending improvements. Broader evaluation of the injector as a whole (including focusing and diagnostic systems that do no impact the envelope of the gun itself) is expected to be covered in a future review and will not be commented on here. In general, the long operational experience with four generations of s-band RF guns at numerous labs worldwide has led to considerable experience in design, fabrication, and operation aspects, and provides an excellent base on which to design the higher duty factor LCLS injector. While open questions remain on obtaining the design performance from these injectors, the microwave design of the gun has reached a state of relative maturity.

  20. CONTAIN independent peer review

    Energy Technology Data Exchange (ETDEWEB)

    Boyack, B.E. [Los Alamos National Lab., NM (United States); Corradini, M.L. [Univ. of Wisconsin, Madison, WI (United States). Nuclear Engineering Dept.; Denning, R.S. [Battelle Memorial Inst., Columbus, OH (United States); Khatib-Rahbar, M. [Energy Research Inc., Rockville, MD (United States); Loyalka, S.K. [Univ. of Missouri, Columbia, MO (United States); Smith, P.N. [AEA Technology, Dorchester (United Kingdom). Winfrith Technology Center

    1995-01-01

    The CONTAIN code was developed by Sandia National Laboratories under the sponsorship of the US Nuclear Regulatory Commission (NRC) to provide integrated analyses of containment phenomena. It is used to predict nuclear reactor containment loads, radiological source terms, and associated physical phenomena for a range of accident conditions encompassing both design-basis and severe accidents. The code`s targeted applications include support for containment-related experimental programs, light water and advanced light water reactor plant analysis, and analytical support for resolution of specific technical issues such as direct containment heating. The NRC decided that a broad technical review of the code should be performed by technical experts to determine its overall technical adequacy. For this purpose, a six-member CONTAIN Peer Review Committee was organized and a peer review as conducted. While the review was in progress, the NRC issued a draft ``Revised Severe Accident Code Strategy`` that incorporated revised design objectives and targeted applications for the CONTAIN code. The committee continued its effort to develop findings relative to the original NRC statement of design objectives and targeted applications. However, the revised CONTAIN design objectives and targeted applications. However, the revised CONTAIN design objectives and targeted applications were considered by the Committee in assigning priorities to the Committee`s recommendations. The Committee determined some improvements are warranted and provided recommendations in five code-related areas: (1) documentation, (2) user guidance, (3) modeling capability, (4) code assessment, and (5) technical assessment.

  1. Data Crosscutting Requirements Review

    Energy Technology Data Exchange (ETDEWEB)

    Kleese van Dam, Kerstin [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Shoshani, Arie [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Plata, Charity [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2013-04-01

    In April 2013, a diverse group of researchers from the U.S. Department of Energy (DOE) scientific community assembled to assess data requirements associated with DOE-sponsored scientific facilities and large-scale experiments. Participants in the review included facilities staff, program managers, and scientific experts from the offices of Basic Energy Sciences, Biological and Environmental Research, High Energy Physics, and Advanced Scientific Computing Research. As part of the meeting, review participants discussed key issues associated with three distinct aspects of the data challenge: 1) processing, 2) management, and 3) analysis. These discussions identified commonalities and differences among the needs of varied scientific communities. They also helped to articulate gaps between current approaches and future needs, as well as the research advances that will be required to close these gaps. Moreover, the review provided a rare opportunity for experts from across the Office of Science to learn about their collective expertise, challenges, and opportunities. The "Data Crosscutting Requirements Review" generated specific findings and recommendations for addressing large-scale data crosscutting requirements.

  2. Russia - Public Expenditure Review

    OpenAIRE

    World Bank

    2011-01-01

    The primary objective of the Public Expenditure Review (PER) is to assist the Ministry of Finance (MOF) in identifying opportunities for efficiency gains in some key categories of government expenditure. In this context, policy makers face two related fiscal dilemmas. First, how can expenditure efficiency are increased to provide public services with fewer resources? Second, how can the fi...

  3. Energy and Technology Review

    Energy Technology Data Exchange (ETDEWEB)

    1982-09-01

    This is the first of two issues commemorating the 30th anniversary of the Lawrence Livermore National Laboratory. The early history of the laboratory is reviewed, including: the LLNL-Nevada organization; project Plowshare; the chemistry and materials science department; and development of computer systems. (GHT)

  4. Nuclear Test Personnel Review

    Science.gov (United States)

    FOIA Electronic Reading Room Privacy Impact Assessment DTRA No Fear Act Reporting Nuclear Test Personnel Review NTPR Fact Sheets NTPR Radiation Dose Assessment Documents US Atmospheric Nuclear Test History Documents US Underground Nuclear Test History Reports NTPR Radiation Exposure Reports Enewetak

  5. African Research Review: Submissions

    African Journals Online (AJOL)

    The African Research Review publishes original research output in the areas of Arts, Education, Social Sciences, Pure and applied Sciences, Engineering and ... Final selection of papers for publication in the Journal will be based on paper originality, technical quality, use of language and overall contribution to knowledge.

  6. Banking crises : A review

    NARCIS (Netherlands)

    Laeven, L.

    2011-01-01

    This review surveys the theoretical and empirical literature on the causes and consequences of banking crises, and summarizes the lessons learned from policy interventions to resolve banking crises. Despite their different origins, banking crises display similar patterns. Their causes lie in

  7. 7. Book reviews

    Directory of Open Access Journals (Sweden)

    Cecilia Carnino

    2012-07-01

    Full Text Available Reviews of M. Matheus et al. (eds., Le calamità ambientali nel tardo medioevo europeo: realtà, percezioni, reazioni, Firenze University Press, 2010;S.A. Reinert, Translating Empire. Emulation and the Origins of the Political Economy, Harvard University Press, 2011; A. Nicholls and M. Liebscher (eds., Thinking the Unconscious. Nineteenth-Century German Thought, Cambridge University Press, 2010.

  8. 5. Book Reviews

    Directory of Open Access Journals (Sweden)

    André Tiran

    2013-08-01

    Full Text Available Reviews of M.L. Pesante, Come servi. Figure del lavoro salariato dal diritto naturale all’economia politica, Franco Angeli, 2013 ; Joan W. Scott, Genere, politica, storia, éd. par I. Fazio, postface de P. di Cori, Viella, 2013.

  9. Annual Energy Review, 2008

    Energy Technology Data Exchange (ETDEWEB)

    None

    2009-06-01

    The Annual Energy Review (AER) is the Energy Information Administration's (EIA) primary report of annual historical energy statistics. For many series, data begin with the year 1949. Included are statistics on total energy production, consumption, trade, and energy prices; overviews of petroleum, natural gas, coal, electricity, nuclear energy, renewable energy, and international energy; financial and environment indicators; and data unit conversions.

  10. Swaddling : A systematic review

    NARCIS (Netherlands)

    van Sleuwen, Bregje E.; Engelberts, Adele C.; Boere-Boonekamp, Magda M.; Kuis, Wietse; Schulpen, Tom W. J.; L'Hoir, Monique P.

    2007-01-01

    Swaddling was an almost universal child-care practice before the 18th century. It is still tradition in certain parts of the Middle East and is gaining popularity in the United Kingdom, the United States, and the Netherlands to curb excessive crying. We have systematically reviewed all articles on

  11. Contaminant Hazard Reviews (compilation)

    Science.gov (United States)

    Eisler, R.; Munro, R.E.; Loges, L.M.; Boone, K.; Paul, M.M.; Garrett, L.J.

    2000-01-01

    This compact disc (CD) contains the 35 reports in the Contaminant Hazard Reviews (CHR) that were published originally between 1985 and 1999 in the U.S. Department of the Interior Biological Report series. The CD was produced because printed supplies of these reviews--a total of 105,000--became exhausted and demand remained high. Each review was prepared at the request of environmental specialists of the U.S. Fish and Wildlife Service and each contained specific information on the following: mirex, cadmium, carbofuran, toxaphene, selenium, chromium, polychlorinated biphenyls, dioxins, diazinon, mercury, polycyclic aromatic hydrocarbons, arsenic, chlorpyrifos, lead, tin, index issue, pentachlorophenol, atrazine, molybdenum, boron, chlordane, paraquat, cyanide, fenvalerate, diflubenzuron, zinc, famphur, acrolein, radiation, sodium monofluoroacetate, planar PCBs, silver, copper, nickel, and a cumulative index to chemicals and species. Each report reviewed and synthesized the technical literature on a single contaminant and its effects on terrestrial plants and invertebrates, aquatic plants and animals, avian and mammalian wildlife, and other natural resources. The subtopics include contaminant sources and uses; physical, chemical, and metabolic properties; concentrations in field collections of abiotic materials and living organisms; deficiency effects, where appropriate; lethal and sublethal effects, including effects on survival, growth, reproduction, metabolism, mutagenicity, teratogenicity, and carcinogenicity; proposed criteria for the protection of human health and sensitive natural resources; and recommendations for additional research.

  12. The certainty principle (review)

    OpenAIRE

    Arbatsky, D. A.

    2006-01-01

    The certainty principle (2005) allowed to conceptualize from the more fundamental grounds both the Heisenberg uncertainty principle (1927) and the Mandelshtam-Tamm relation (1945). In this review I give detailed explanation and discussion of the certainty principle, oriented to all physicists, both theorists and experimenters.

  13. Energy and Technology Review

    International Nuclear Information System (INIS)

    1982-09-01

    This is the first of two issues commemorating the 30th anniversary of the Lawrence Livermore National Laboratory. The early history of the laboratory is reviewed, including: the LLNL-Nevada organization; project Plowshare; the chemistry and materials science department; and development of computer systems

  14. Country programme review. Ethiopia

    International Nuclear Information System (INIS)

    1991-01-01

    This document reviews the current nuclear program in Ethiopia, identifying the peaceful uses of nuclear technology in the country and possible future technical cooperation activities. Separate brief sections deal with food and agriculture; human health; water and geothermal resources; industrial applications and instrumentation; radiation protection; higher education; programming, coordination and development

  15. Contact dermatitis. A review

    DEFF Research Database (Denmark)

    Andersen, Klaus Ejner; Benezra, C; Burrows, D

    1987-01-01

    In recent years, there has been a dramatic rise in our understanding of contact dermatitis. This paper is a review of our knowledge of the mechanisms involved in contact dermatitis and related phenomena, the investigation of these events and the emergence of significant new allergens during...

  16. Acoustics Critical Readiness Review

    Science.gov (United States)

    Ballard, Kenny

    2010-01-01

    This presentation reviews the status of the acoustic equipment from the medical operations perspective. Included is information about the acoustic dosimeters, sound level meter, and headphones that are planned for use while on orbit. Finally there is information about on-orbit hearing assessments.

  17. Taste disorders: A review

    Directory of Open Access Journals (Sweden)

    Vijay Kumar Ambaldhage

    2014-01-01

    Full Text Available For maintenance of the health of an individual, taste sensation is very important. It is an important sensation that serves to assess the nutritious content of food, support oral intake, and prevent ingestion of potentially toxic substances. Disturbances in the perception of taste can lead to loss of appetite, causing malnutrition and thus distressing both the physical and psychological well-being of the patient. Oral physicians are often the first clinicians who hear complaints about alteration in taste from the patients. In spite of the effect of taste changes on health, literature on the diagnosis, pathogenesis, and precise treatment of taste disorders are less. Taste changes may lead patients to seek inappropriate dental treatments. Proper diagnosis of the etiology is the foremost step in the treatment of taste disorders. Thus, it is important that dental clinicians to be familiar with the various causes and proper management of taste changes. In this article, we have reviewed related articles focusing on taste disorders and their management, to provide a quick sketch for the clinicians. A detailed search was performed to identify the systematic reviews and research articles on taste disorders, using PUBMED and Cochrane. All the authors independently extracted data for analysis and review. Ultimately, 26 articles underwent a full text review. In conclusion, the research to date certainly offers us valid management strategies for taste disorders. Meanwhile, practical strategies with the highest success are needed for further intervention.

  18. Country programme review. Guatemala

    International Nuclear Information System (INIS)

    1992-09-01

    This document reviews the current nuclear program in Guatemala, identifying the peaceful uses of nuclear technology in the country and possible future technical co-operation activities. Separate brief sections deal with food and agriculture; human health; radiation protection; industrial applications and hydrology; nuclear analytical techniques; nuclear instrumentation and nuclear information

  19. Kaons Review and Outlook

    CERN Document Server

    Ceccucci, A

    2006-01-01

    This article presents a review of recent results and an outlook of kaon physics. After enjoying a renaissance, the discipline is now becoming and endangered species. Action will be needed to keep kaon physics at the heart of future FPCP meetings.

  20. Book Reviews Boekbesprekings

    African Journals Online (AJOL)

    and prevention. By R. C. Schneider ... A review of serious and fatal head and neck injuries suffered in American football over a 5-year period is pre- sented. Damage done to the ... At a time when nutritional diseases are every man's concern,.