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Sample records for bla pharmacovigilance plan

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

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    Nwokike Jude

    2010-05-01

    Full Text Available Abstract Background 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. Methods 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. Results 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. Conclusions There were relatively few requests for funding for pharmacovigilance activities, demonstrating a lack of emphasis placed on pharmacovigilance systems in

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

    OpenAIRE

    Nwokike Jude; Dodoo Alexander; Bartlein Rebecca JK; Stergachis Andy; Kachur S Patrick

    2010-01-01

    Abstract Background 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 is...

  3. The role of systematic reviews in pharmacovigilance planning and Clinical Trials Authorisation application: example from the SLEEPS trial.

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    Carrol Gamble

    Full Text Available BACKGROUND: Adequate sedation is crucial to the management of children requiring assisted ventilation on Paediatric Intensive Care Units (PICU. The evidence-base of randomised controlled trials (RCTs in this area is small and a trial was planned to compare midazolam and clonidine, two sedatives widely used within PICUs neither of which being licensed for that use. The application to obtain a Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA required a dossier summarising the safety profiles of each drug and the pharmacovigilance plan for the trial needed to be determined by this information. A systematic review was undertaken to identify reports relating to the safety of each drug. METHODOLOGY/PRINCIPAL FINDINGS: The Summary of Product Characteristics (SmPC were obtained for each sedative. The MHRA were requested to provide reports relating to the use of each drug as a sedative in children under the age of 16. Medline was searched to identify RCTs, controlled clinical trials, observational studies, case reports and series. 288 abstracts were identified for midazolam and 16 for clonidine with full texts obtained for 80 and 6 articles respectively. Thirty-three studies provided data for midazolam and two for clonidine. The majority of data has come from observational studies and case reports. The MHRA provided details of 10 and 3 reports of suspected adverse drug reactions. CONCLUSIONS/SIGNIFICANCE: No adverse reactions were identified in addition to those specified within the SmPC for the licensed use of the drugs. Based on this information and the wide spread use of both sedatives in routine practice the pharmacovigilance plan was restricted to adverse reactions. The Clinical Trials Authorisation was granted based on the data presented in the SmPC and the pharmacovigilance plan within the clinical trial protocol restricting collection and reporting to adverse reactions.

  4. Pharmacovigilance programme of India

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    Kalaiselvan Vivekanandan

    2012-01-01

    Full Text Available The monitoring and reporting of adverse drug reactions (ADRs through pharmacovigilance is vital to patient safety and rational prescribing. In India, Central Drugs Standard Control Organization (CDSCO initiated Pharmacovigilance Programme of India (PvPI to report ADRs through ADRs monitoring centres in India. Indian Pharmacopoeia Commission (IPC is functioning as National Coordination Centre (NCC for PvPI. The ADRs are reported to NCC through VigiFlow by various centres are evaluated and committed to Uppsala Monitoring Centre, Sweden. The potential benefit of the PvPI is aimed to reducing or eliminating a harm of medicine. Continuous efforts of the healthcare professionals and the patients are expected to make this as one of the most successful and effective programmes. The present article updates the status and future plan of PvPI.

  5. A Review of Pharmacovigilance

    OpenAIRE

    Campbell, JE; Gossell-Williams, M; Lee, MG

    2014-01-01

    Pharmacovigilance supports safe and appropriate use of drugs. Spontaneous reporting of adverse drug reactions (ADRs) is an essential component of pharmacovigilance. However, there is significant underreporting of ADRs. Adverse drug reactions have become a major problem in developing countries. Knowledge of pharmacovigilance could form the basis for interventions aimed at improving reporting rates and decreasing ADRs.

  6. Pharmacovigilance for children's sake.

    Science.gov (United States)

    Star, Kristina; Edwards, I Ralph

    2014-02-01

    Child age-specific information on efficacy and risk of medicines can be limited for healthcare professionals and patients. It is therefore very important to make the best use of a risk planned approach to the pharmacological treatment of children. This means pharmacovigilance in the broadest sense of gaining the best data from the use of medicines in clinical practice. We consider issues that complicate safe medication use in paediatric care, as well as current progress and provide suggestions for building knowledge within paediatric pharmacovigilance to be used to minimise patient harm. The continuous development in children constitutes a challenge to prescribing and administering age-suitable doses for individual children. Children are not only different from adults but differ vastly within their own age group. Physical growth during childhood is apparent to the eye, but less obvious is the ongoing maturation of organ function important for drug disposition and action. Systematic issues such as medication errors, off-label use and the lack of age-suitable formulations are considerable obstacles for safe medication use in paediatrics. The recognition of emerging adverse drug reactions could be more challenging in developing children. Initiatives to improve the situation have been made by the WHO and regulators in the USA and EU. Age-specific changes in physiology, pharmacology and psychology, as well as systematic issues specific for children need to be considered in the work of assessing spontaneous reports in children. Pharmacovigilance needs to broaden its aims considerably beyond merely capturing new associations between drugs and events, and encompass careful collection on patient characteristics and circumstances around the reported adverse drug reaction to provide essential information that will give clues on how to prevent harm to children. PMID:24446277

  7. Pharmacovigilance in Space: Stability Payload Compliance Procedures

    Science.gov (United States)

    Daniels, Vernie R.; Putcha, Lakshmi

    2007-01-01

    Pharmacovigilance is the science of, and activities relating to the detection, assessment, understanding, and prevention of drug-related problems. Over the lase decade, pharmacovigilance activities have contributed to the development of numerous technological and conventional advances focused on medication safety and regulatory intervention. The topics discussed include: 1) Proactive Pharmacovigilance; 2) A New Frontier; 3) Research Activities; 4) Project Purpose; 5) Methods; 6) Flight Stability Kit Components; 7) Experimental Conditions; 8) Research Project Logistics; 9) Research Plan; 10) Pharmaceutical Stability Research Project Pharmacovigilance Aspects; 11) Security / Control; 12) Packaging/Containment Actions; 13) Shelf-Life Assessments; 14) Stability Assessment Parameters; 15) Chemical Content Analysis; 16) Preliminary Results; 17) Temperature/Humidity; 18) Changes in PHysical and Chemical Assessment Parameters; 19) Observations; and 20) Conclusions.

  8. EU's new pharmacovigilance legislation: considerations for biosimilars.

    Science.gov (United States)

    Calvo, Begoña; Zuñiga, Leyre

    2014-01-01

    Biosimilars are biological medicines, the active substances of which are highly similar to those of biologics that have already been authorized. As for any other medicine, the applicant of the biosimilar marketing authorization must submit a risk-management plan (RMP)/pharmacovigilance plan. The pharmacovigilance plan should take into account risks identified during product development, the potential risks and how those risks will be addressed after authorization of the product.Recently, new European Pharmacovigilance legislation has been implemented, ensuring proper risk management through the recording of suspected adverse drug reactions and data collection from all stakeholders. The new regulation entails a reduction of the administrative burden on companies and regulatory agencies, as obligations of the responsible parties are clearly established and duplication of effort avoided.This article analyzes the new European Pharmacovigilance System requirements, with special focus on those medicines requiring additional monitoring, such as biosimilars, which are priorities for pharmacovigilance. Further, it provides the new obligations to marketing authorization holders, such as the continuous benefit-risk assessment. PMID:24190573

  9. PHARMACOVIGILANCE: BARRIERS AND CHALLENGES

    OpenAIRE

    Varma, S. K.; RAPELLIWAR A; S. Sutradhar; THAWARE P; Misra, A. K.

    2013-01-01

    Pharmacovigilance is a new discipline which deals with adverse drug or any drug related problems. Pharmacovigilance programme was not bed of roses but its path is laid with challenges and barriers. It is facing obstacles from deficiency from professional health personal to web-based sale of drugs, counterfeit drug to self-medication, etc. It is an integral part of the health sector and identification and reporting of adverse drug effects will have a positive impact on the public health. Impro...

  10. Pharmacovigilance in Europe: Place of the Pharmacovigilance Risk Assessment Committee (PRAC) in organisation and decisional processes.

    Science.gov (United States)

    Laroche, Marie-Laure; Batz, Arnaud; Géniaux, Hélène; Féchant, Corinne; Merle, Louis; Maison, Patrick

    2016-04-01

    The new European legislation that came into force in July 2012 reinforced the organisation of pharmacovigilance by setting up a committee in charge of risk assessment for medicines, the Pharmacovigilance Risk Assessment Committee (PRAC). The PRAC has a remit covering the assessment of all aspects of the safety and the risk management of medicinal products for human use in the European Union. It deals with issues regarding pharmacovigilance signals, the periodic evaluation of benefit/risk reports from marketing authorization holders (MAH), risk management plans, post-marketing studies, variations or renewals of marketing authorisations, management of under surveillance drugs lists, inspections for pharmacovigilance reasons and audits of pharmacovigilance systems. The PRAC works with the pharmacovigilance systems of the European Member States, which draw up evaluation reports. These evaluations are circulated and discussed by Member States so as to issue recommendations, which serve as a basis for other European medicines committees, the Committee for Medicinal Products for Human Use (CHMP) or the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) which then give their opinion. The final decision, which applies to all Member States and to the concerned MAH, lies with the European Commission (EC). This decisional procedure thus rests on coordination involving the PRAC, the CHMP, the CMDh, the EC, the Member States and the pharmaceutical companies. In the 3 years from July 2012, the PRAC has processed nearly 4500 procedures and is still facing an increasing workload. PMID:27080834

  11. Training in post-authorization pharmacovigilance

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    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: BARRIERS AND CHALLENGES

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    VARMA S. K

    2013-01-01

    Full Text Available Pharmacovigilance is a new discipline which deals with adverse drug or any drug related problems. Pharmacovigilance programme was not bed of roses but its path is laid with challenges and barriers. It is facing obstacles from deficiency from professional health personal to web-based sale of drugs, counterfeit drug to self-medication, etc. It is an integral part of the health sector and identification and reporting of adverse drug effects will have a positive impact on the public health. Improvement in knowledge in pharmacovigilance and communication from the top level to the grass-root level in the health sector will help in proper implementation of the programme. Patient should be educated to report any adverse effects after taking drug and stop relaying on acquiring information related to drugs in web. Proper detection, reporting and analysis would help to implement the programme for the betterment of society.

  13. The new pharmacovigilance legislation and impact on observational studies

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    Sinem Ezgi Gülmez

    2013-05-01

    Full Text Available BACKGROUND: After the publication of the Regulation (EU No 1235/2010 and Directive2010/84/EU on 31st of December 2010, the new legislation on pharmacovigilance came intooperation for the better protection of public health through a further strengthened EU systemfor medicines safety.REMARKS: The main changes include the new definition of adverse reactions, Eudravigilancebecoming the single receipt point for all pharmacovigilance information through theEU, the Pharmacovigilance Risk Assessment Committee, and strengthened PASS/PAES, andrequirement of a risk management planning for all new medicines. The possible increase inPA(ESS may be a concern in terms of access to appropriate data and so obtaining necessaryauthorisations without delays.CONCLUSION: The new legislation will provide good vigilance practice standards with increasedtransparency of pharmacovigilance data. The communication will improve with theinvolvement of patient and public. With better access to real-life data, better protection ofpublic health will be ensured.

  14. Pharmacovigilance in Italy: An overview

    OpenAIRE

    Carmela Mazzitello; Stefania Esposito; Adele E De Francesco; Annalisa Capuano; Emilio Russo; Giovambattista De Sarro

    2013-01-01

    Introduction: Spontaneous reporting of adverse drug reactions (ADRs) is the basis of pharmacovigilance. In fact, ADRs are associated with a high degree of morbidity and mortality. However, underreporting by all healthcare professionals remains the major problem in Italy and in the rest of the world. The dissemination of pharmacovigilance knowledge among Italian healthcare professionals, and the new pharmacovigilance regulations may promote the early detection and reporting of ADRs. This revie...

  15. Pharmacovigilance in Italy: An overview

    Directory of Open Access Journals (Sweden)

    Carmela Mazzitello

    2013-01-01

    Full Text Available Introduction: Spontaneous reporting of adverse drug reactions (ADRs is the basis of pharmacovigilance. In fact, ADRs are associated with a high degree of morbidity and mortality. However, underreporting by all healthcare professionals remains the major problem in Italy and in the rest of the world. The dissemination of pharmacovigilance knowledge among Italian healthcare professionals, and the new pharmacovigilance regulations may promote the early detection and reporting of ADRs. This review examines the legislative framework concerning the pharmacovigilance in Italy. Materials and Methods: The information was collected from scientific articles and the websites of the Italian Ministry of Health and the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA. Results: The pharmacovigilance system, both in Italy and Europe, has undergone profound changes. European legislation on pharmacovigilance has been changed in 2010 according to the EU Regulation 1235/2010 and Directive 2010/84/EU. Basically, the changes tend to increase the efficiency, speed and transparency of pharmacovigilance activities. The new Regulation (1235/2010 and the Directive (2010/84/EU aim to strengthen the system of pharmacovigilance, establish more precisely who is obliged to do what, and allow faster and easier circulation and retrieval of information about ADRs. Conclusion: A greater knowledge on what is the Italian pharmacovigilance legislation will be useful to improve the status of ADRs reporting and spread the culture of spontaneous reporting.

  16. Pharmacovigilance in Asia

    OpenAIRE

    Pipasha Biswas

    2013-01-01

    An increase in drug safety concerns in recent years with some high profile drug withdrawals have led to raising the bar by various stakeholders more importantly by the regulatory authorities. The number of Adverse Drug Reactions (ADRs) reported have also resulted in an increase in the volume of data handled and to understand pharmacovigilance a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. Proactive pharmaco...

  17. CIOMS and ICH initiatives in pharmacovigilance and risk management: overview and implications.

    Science.gov (United States)

    Tsintis, Panos; La Mache, Edith

    2004-01-01

    In this article we review the current initiatives by the Council for International Organizations of Medical Sciences (CIOMS) and the International Conference on Harmonisation (ICH) on pharmacovigilance planning that are due for general release during 2004. These initiatives could form the basis for applying concepts of risk management to medicines throughout their life cycle, from preclinical and clinical development to marketed use. The CIOMS VI Working Group (with 28 senior scientists worldwide from drug regulatory authorities and pharmaceutical companies) is currently developing scientific guidance that relates to clinical trials for medicines during development. It recommends a developmental pharmacovigilance concept - a 'living' concept that would start early in drug development supporting the science and ethics of research leading up to licensing (marketing authorisation) and continuing to post-authorisation (postmarketing) pharmacovigilance. This approach is seen as complementary to current ICH initiatives called 'Pharmacovigilance Planning'. ICH will introduce two concepts in pharmacovigilance management of medicinal products: the 'Pharmacovigilance Specification' and the 'Pharmacovigilance Plan'. The 'Pharmacovigilance Specification' will summarise important knowns and unknowns about the medicine. It will include safety risks identified at the licensing stage, potential risks and any key missing information. These elements will be essential to the formulation of pharmacovigilance plans. Dialogue and common understanding between regulators and the pharmaceutical industry will be a key factor for developing pharmacovigilance plans during the life cycle of medicines. Appropriate interaction with health professionals and patients should also be planned for the future as regulatory systems become more transparent. Where no significant issues are apparent at the licensing (marketing authorisation) stage, routine pharmacovigilance practices will be followed

  18. Essentials for starting a pediatric clinical study (4): Clinical pediatric safety planning based on preclinical toxicity studies and pediatric pharmacovigilance guidance.

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    Sheth, Neha

    2009-01-01

    Juvenile toxicology studies in animals provide useful information to guide monitoring of potential adverse effects in children especially on growth and development. In order to continue to gain knowledge and build upon these preclinical studies, recent experience has suggested that additional approaches for monitoring of safety concerns in the pediatric population may be required. Recently, pediatric guidance has become available from the health authorities which provide pharmacovigilance concepts as they specifically relate to drugs being developed for pediatric indications. Clinical trials are typically not robust enough to detect rare or delayed safety effects as the pediatric trials are relatively short-term. Furthermore, such long term or rare effects may not be detected via standard voluntary postmarketing surveillance. Safety monitoring of children with Juvenile Inflammatory Arthritis (JIA) taking nonsteroid anti-inflammatory drug (NSAID)s will be used as an example to describe a post-marketing risk management and pharmacovigilance program that serves to better evaluate safety data from various sources. The intent of this program is to identify adverse events (AE), including events with longer latency, which may be associated with NSAID use in a pediatric population. In this presentation, the 4 major components of the program are to be addressed. Such a program may serve as a model to proactively generate and monitor safety data in order to identify AEs that may be associated with new therapeutics for a pediatric population. PMID:19571487

  19. PHARMACOVIGILANCE: A WAY FOR BETTER TOMORROW

    OpenAIRE

    Arora Rashmi; Kapoor Ramit; Gill N.S; Aggarwal Amit; Rana A. C.

    2011-01-01

    Pharmacovigilance procedures are necessary for evaluation of medicines. Thus Pharmacovigilance aims at detection, assessment and prevention of adverse effects or of any possible drug related problems. Reports of suspected adverse drug reactions (ADRs) are the basis of pharmacovigilance surveillance of drugs. So there is need of method for summarising the important identified risks of a drug, important potential risks, and important missing information, including the potentially at-risk popul...

  20. Informatics applied to pharmacovigilance: Future perspectives

    OpenAIRE

    Michele Menniti; Annamaria Menniti; Marinella Patanè; Stefania Esposito; Chiara Giofrè; Rossana Aiello; Emilio Russo

    2013-01-01

    Spontaneous adverse drugs reaction (ADRs) reporting represents a precious resource for control and information about the drug's safety and pharmacovigilance. The current reporting system is mainly based on handwritten forms and later manually loaded into a national electronic database by few local pharmacovigilance centers. This reporting system is complicated for both reporters and pharmacovigilance centers which often avoid reporting ADRs for several reasons such as the lack of data on the ...

  1. [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. PMID:22292378

  2. The role of data mining in pharmacovigilance

    NARCIS (Netherlands)

    Hauben, Manfred; Madigan, David; Gerrits, Charles M; Walsh, Louisa; Van Puijenbroek, Eugene P

    2005-01-01

    A principle concern of pharmacovigilance is the timely detection of adverse drug reactions that are novel by virtue of their clinical nature, severity and/or frequency. The cornerstone of this process is the scientific acumen of the pharmacovigilance domain expert. There is understandably an interes

  3. DNA Barcoding and Pharmacovigilance of Herbal Medicines

    OpenAIRE

    de Boer, Hugo J; Ichim, Mihael C.; Newmaster, Steven G

    2015-01-01

    Pharmacovigilance of herbal medicines relies on the product label information regarding the ingredients and the adherence to good manufacturing practices along the commercialisation chain. Several studies have shown that substitution of plant species occurs in herbal medicines, and this in turn poses a challenge to herbal pharmacovigilance as adverse reactions might be due to adulterated or added ingredients. Authentication of constituents in herbal medicines using analytical chemistry method...

  4. Pharmacovigilance and the Italian Medicines Agency

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    Giuseppe Pimpinella

    2013-01-01

    Full Text Available The new European Union (EU regulations on pharmacovigilance require that the national systems are strengthened in order to fit the new requirements. The Italian Pharmacovigilance System, coordinated by the Italian Medicines Agency (AIFA, is made by local and regional structures. In 2007, a program for funding active pharmacovigilance projects in the Italian Regions was established by the National law. The AIFA is responsible for the preparation of guidelines aimed at the identification of research areas and for the approval of the projects submitted by the regions. In April 2012, the AIFA started a program of visits at the regional pharmacovigilance centers (RPCs, aimed at monitoring their performances, evaluating the quality of the activities in order to understand the main differences and discrepancies and with a view to start a program of harmonization of the procedures in place. The outcome of the visits program highlighted major differences among the quality management systems of the various centers; hence, AIFA has decided to launch an initiative to promote in the next months the harmonization of procedures. The synergy among AIFA, regional structures, RPCs, and local structure responsible for pharmacovigilance is needed in order to establish a robust pharmacovigilance system working in full compliance with the provisions of the new EU legislation.

  5. Pharmacovigilance in practice: erythropoiesis-stimulating agents

    International Nuclear Information System (INIS)

    Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or other problems related to medical products after they have been licensed for marketing. The purpose of PV is to advance the safe use of marketed medical products. Regulatory agencies and license holders collaborate to collect data reported by health care providers, patients, and the public as well as data from systematic reviews, meta-analyses, and individual clinical and nonclinical studies. They validate and analyze the data to determine whether safety signals exist, and if warranted, develop an action plan to mitigate the identified risk. Erythropoiesis-stimulating agents (ESAs) provide an example of how PV is applied in reality. Among other approved indications, ESAs may be used to treat anemia in patients with chemotherapy-induced anemia. ESAs increase hemoglobin levels and reduce the need for transfusions; they are also associated with a known increased risk of thromboembolic events. Starting in 2003, emerging data suggested that ESAs might reduce survival. As a result of PV activities by regulatory agencies and license holders, labeling for ESAs addresses these risks. Meta-analyses and individual clinical studies have confirmed that ESAs increase the risk of thromboembolic events, but when used as indicated, ESAs have not been shown to have a significant effect on survival or disease progression. Ongoing safety studies will provide additional data in the coming years to further clarify the risks and benefits of ESAs

  6. Escherichia coli of sequence type 3835 carrying bla NDM-1, bla CTX-M-15, bla CMY-42 and bla SHV-12.

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    Feng, Yu; Yang, Ping; Xie, Yi; Wang, Xiaohui; McNally, Alan; Zong, Zhiyong

    2015-01-01

    New Delhi metallo-β-lactamase (NDM) represents a serious challenge for treatment and public health. A carbapenem-resistant Escherichia coli clinical strain WCHEC13-8 was subjected to antimicrobial susceptibility tests, whole genome sequencing and conjugation experiments. It was resistant to imipenem (MIC, >256 μg/ml) and meropenem (MIC, 128 μg/ml) and belonged to ST3835. bla NDM-1 was the only carbapenemase gene detected. Strain WCHEC13-8 also had a plasmid-borne AmpC gene (bla CMY-42) and two extended-spectrum β-lactamase genes (bla CTX-M-15 and bla SHV-12). bla NDM-1 and bla SHV-12 were carried by a 54-kb IncX3 self-transmissible plasmid, which is identical to plasmid pNDM-HF727 from Enterobacter cloacae. bla CMY-42 was carried by a 64-kb IncI1 plasmid and bla CTX-M-15 was located on a 141-kb plasmid with multiple F replicons (replicon type: F36:A4:B1). bla CMY-42 was in a complicated context and the mobilisation of bla CMY-42 was due to the transposition of ISEcp1 by misidentifying its right-end boundary. Genetic context of bla NDM-1 in strain WCHEC13-8 was closely related to those on IncX3 plasmids in various Enterobacteriaceae species in China. In conclusion, a multidrug-resistant ST3835 E. coli clinical strain carrying bla NDM-1, bla CTX-M-15, bla CMY-42 and bla SHV-12 was identified. IncX3 plasmids may be making a significant contribution to the dissemination of bla NDM among Enterobacteriaceae in China. PMID:26194736

  7. Pharmacovigilance in pharmaceutical companies: An overview

    Directory of Open Access Journals (Sweden)

    Maria Mammì

    2013-01-01

    Full Text Available 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.

  8. Gathering and exploring scientific knowledge in pharmacovigilance.

    Science.gov (United States)

    Lopes, Pedro; Nunes, Tiago; Campos, David; Furlong, Laura Ines; Bauer-Mehren, Anna; Sanz, Ferran; Carrascosa, Maria Carmen; Mestres, Jordi; Kors, Jan; Singh, Bharat; van Mulligen, Erik; Van der Lei, Johan; Diallo, Gayo; Avillach, Paul; Ahlberg, Ernst; Boyer, Scott; Diaz, Carlos; Oliveira, José Luís

    2013-01-01

    Pharmacovigilance plays a key role in the healthcare domain through the assessment, monitoring and discovery of interactions amongst drugs and their effects in the human organism. However, technological advances in this field have been slowing down over the last decade due to miscellaneous legal, ethical and methodological constraints. Pharmaceutical companies started to realize that collaborative and integrative approaches boost current drug research and development processes. Hence, new strategies are required to connect researchers, datasets, biomedical knowledge and analysis algorithms, allowing them to fully exploit the true value behind state-of-the-art pharmacovigilance efforts. This manuscript introduces a new platform directed towards pharmacovigilance knowledge providers. This system, based on a service-oriented architecture, adopts a plugin-based approach to solve fundamental pharmacovigilance software challenges. With the wealth of collected clinical and pharmaceutical data, it is now possible to connect knowledge providers' analysis and exploration algorithms with real data. As a result, new strategies allow a faster identification of high-risk interactions between marketed drugs and adverse events, and enable the automated uncovering of scientific evidence behind them. With this architecture, the pharmacovigilance field has a new platform to coordinate large-scale drug evaluation efforts in a unique ecosystem, publicly available at http://bioinformatics.ua.pt/euadr/. PMID:24349421

  9. Relation between blaTEM, blaSHV and blaCTX-M genes and acute urinary tract infections

    Institute of Scientific and Technical Information of China (English)

    Sima Sadat Seyedjavadi; Mehdi Goudarzi; Fattaneh Sabzehali

    2016-01-01

    Objective: To survey the frequency of blaTEM, blaSHV and blaCTX-M genotypes in extended-spectrum b-lactamase (ESBL)-producing Escherichia coli (E. coli) isolated from hospitalized patients with urinary tract infection and the determination of their antibiotic resistance patterns. Methods: During 11-month study, 100 ESBL-producing E. coli were collected from 330 patients who met the definition of urinary tract infection. The phenotypic identification of ESBL was confirmed by double disk synergy test and combined disk diffusion test. In vitro, susceptibility to ESBL isolates than 14 antimicrobial agents was performed by Kirby-Bauer disk diffusion method. The frequency of blaTEM, blaSHV and blaCTX-M ESBL-producing E. coli was assessed by PCR method. Results: The frequency of ESBL-producing E. coli was 40.8%. In vitro, susceptibility to ESBL-producing E. coli showed that the majority of isolates were highly susceptible to amikacin (74%) and imipenem (91%). The rates of resistance to other antibiotics varied from 33% to 96%. Through 100 tested isolates, the prevalence of blaTEM, blaSHV and blaCTX-M genes was determined to be 67%, 45% and 74% respectively. In comparison with other bla genes, the frequency of blaCTX-M was strikingly high. Conclusions: Due to the increase of E. coli with multiple ESBL genes, continuous sur-veillance in order to use appropriate antibiotics and the control of infections is necessary.

  10. 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. PMID:15154832

  11. 75 FR 65293 - Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for...

    Science.gov (United States)

    2010-10-22

    ... Animal and Plant Health Inspection Service Draft Guidelines on Pharmacovigilance of Veterinary Medicinal... (VICH) has developed a draft guideline titled ``Pharmacovigilance of Veterinary Medicinal Products... guideline applies to pharmacovigilance and adverse event reporting on veterinary vaccines regulated by...

  12. The new pharmacovigilance legislation and impact on observational studies

    OpenAIRE

    Sinem Ezgi Gülmez

    2013-01-01

    ABSTRACTBACKGROUND: After the publication of the Regulation (EU) No 1235/2010 and Directive2010/84/EU on 31st of December 2010, the new legislation on pharmacovigilance came intooperation for the better protection of public health through a further strengthened EU systemfor medicines safety.REMARKS: The main changes include the new definition of adverse reactions, Eudravigilancebecoming the single receipt point for all pharmacovigilance information through theEU, the Pharmacovigilance Risk As...

  13. Pharmacovigilance in Calabria (Italy): Local experiences resonate international relevance

    OpenAIRE

    Giuseppe Pimpinella; Loriana Tartaglia

    2013-01-01

    The new European Union (EU) regulations on pharmacovigilance require that the national systems are strengthened in order to fit the new requirements. The Italian Pharmacovigilance System, coordinated by the Italian Medicines Agency (AIFA), is made by local and regional structures. In 2007, a program for funding active pharmacovigilance projects in the Italian Regions was established by the National law. The AIFA is responsible for the preparation of guidelines aimed at the identification of r...

  14. Pharmacovigilance Among Surgeons and in Surgical Wards: Overlooked or Axiomatic?

    OpenAIRE

    Rodrigues, Gabriel Sunil; Khan, Sohil Ahmed

    2010-01-01

    To review the status of pharmacovigilance system among surgeons and in surgical wards with recommendations. Literature search using MEDLINE, cross-reference of published data and review of World Health Organization—Pharmacovigilance transcripts. Pharmacovigilance system is still in its infancy among surgeons and in surgical wards. No major studies have been published addressing this issue, till date. Surgeons are professionals least likely to report adverse drug reactions. Moreover widespread...

  15. Medication errors: pharmacovigilance centres in detection and prevention

    OpenAIRE

    Bencheikh, Rachida Soulaymani; Benabdallah, Ghita

    2009-01-01

    Detecting medication errors needs collaboration between various organizations, such as patient safety institutions, pharmacovigilance centres, and poison control centres. In order to evaluate the input of pharmacovigilance centres and poison control centres in detecting and evaluating medication errors a pilot project was initiated by the World Alliance for Patient Safety in collaboration with the Uppsala Monitoring Centre; the Moroccan pharmacovigilance centre acted as project coordinator. A...

  16. 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.

  17. Record-linkage for pharmacovigilance in Scotland

    OpenAIRE

    Evans, Josie M M; MacDonald, Thomas M

    1999-01-01

    Record-linkage is the linkage of patient-specific information that is stored separately. Recent advances in computerization have meant that record-linkage techniques in medical research are increasingly being used and refined. In particular, they have made a significant contribution to pharmacovigilance, which involves linking drug exposure to outcomes data. In this article, the contribution of record-linkage in Scotland to medical research is described. The two organizations that utilize rec...

  18. 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.

  19. DNA Barcoding and Pharmacovigilance of Herbal Medicines.

    Science.gov (United States)

    de Boer, Hugo J; Ichim, Mihael C; Newmaster, Steven G

    2015-07-01

    Pharmacovigilance of herbal medicines relies on the product label information regarding the ingredients and the adherence to good manufacturing practices along the commercialisation chain. Several studies have shown that substitution of plant species occurs in herbal medicines, and this in turn poses a challenge to herbal pharmacovigilance as adverse reactions might be due to adulterated or added ingredients. Authentication of constituents in herbal medicines using analytical chemistry methods can help detect contaminants and toxins, but are often limited or incapable of detecting the source of the contamination. Recent developments in molecular plant identification using DNA sequence data enable accurate identification of plant species from herbal medicines using defined DNA markers. Identification of multiple constituent species from compound herbal medicines using amplicon metabarcoding enables verification of labelled ingredients and detection of substituted, adulterated and added species. DNA barcoding is proving to be a powerful method to assess species composition in herbal medicines and has the potential to be used as a standard method in herbal pharmacovigilance research of adverse reactions to specific products. PMID:26076652

  20. Pharmacovigilance on sexual enhancing herbal supplements.

    Science.gov (United States)

    Bhagavathula, Akshaya Srikanth; Elnour, Asim Ahmed; Shehab, Abdulla

    2016-01-01

    The use of herbal medicines continues to expand rapidly across world and many people show positive interest to use herbal products for their health. The safety of herbal supplements has become a globally major concern in national and international health authorities due to increasing adverse events and adulterations. It is difficult to analyze herbal products that cause adverse events due to lack of sufficient information and expertise. Inadequate regulatory measures, weak quality control system and uncontrolled distribution channels are some of reasons that enhance the informal pharmaceutical market. In recent years, the unfulfilled desire for sex has been a subject that has aroused increasing public interest with respect to improve sexual functions. The use of herbal medicines substantially increased due to escalated prevalence and impact of sexual problems worldwide and estimates predicting the incidence to raise over 320 million by year 2025. The various reasons to use herbal supplements in men may be due to experiencing changes in erectile dysfunction (ED) due to certain medical conditions such as diabetes and hypertension and bodily changes as a normal part of life and aging. There is a lack of adequate evidence, no impetus to evaluate and absence of any regulatory obligations to undertake rigorous testing for safety and efficacy of herbal supplements before they sold over-the-counter (OTC). Pharmacovigilance on herbal supplements is still not well established. Sexual enhancing herbals are on demand in men health but informal adulteration is growing issue of concern. Recently, increase in use of herbal supplements for erectile dysfunction has laid a path for many illegal compositions. This paper explores facts and evidences that were observed in different countries attempting to demonstrate the importance of strengthening regulatory system to strengthen the application of pharmacovigilance principles on sexual enhancing supplements. We hereby explore the

  1. Pharmacovigilance on sexual enhancing herbal supplements

    Science.gov (United States)

    Bhagavathula, Akshaya Srikanth; Elnour, Asim Ahmed; Shehab, Abdulla

    2015-01-01

    The use of herbal medicines continues to expand rapidly across world and many people show positive interest to use herbal products for their health. The safety of herbal supplements has become a globally major concern in national and international health authorities due to increasing adverse events and adulterations. It is difficult to analyze herbal products that cause adverse events due to lack of sufficient information and expertise. Inadequate regulatory measures, weak quality control system and uncontrolled distribution channels are some of reasons that enhance the informal pharmaceutical market. In recent years, the unfulfilled desire for sex has been a subject that has aroused increasing public interest with respect to improve sexual functions. The use of herbal medicines substantially increased due to escalated prevalence and impact of sexual problems worldwide and estimates predicting the incidence to raise over 320 million by year 2025. The various reasons to use herbal supplements in men may be due to experiencing changes in erectile dysfunction (ED) due to certain medical conditions such as diabetes and hypertension and bodily changes as a normal part of life and aging. There is a lack of adequate evidence, no impetus to evaluate and absence of any regulatory obligations to undertake rigorous testing for safety and efficacy of herbal supplements before they sold over-the-counter (OTC). Pharmacovigilance on herbal supplements is still not well established. Sexual enhancing herbals are on demand in men health but informal adulteration is growing issue of concern. Recently, increase in use of herbal supplements for erectile dysfunction has laid a path for many illegal compositions. This paper explores facts and evidences that were observed in different countries attempting to demonstrate the importance of strengthening regulatory system to strengthen the application of pharmacovigilance principles on sexual enhancing supplements. We hereby explore the

  2. [Interpretation of Guidelines on Good Pharmacovigilance Practices for European Union].

    Science.gov (United States)

    Xie, Yan-Ming; Tian, Feng

    2013-09-01

    Due to the limitations of pre-authorization clinical trials, the safety information obtained from them is relatively limited. Therefore, it is very necessary to carry out pharmacovigilance activities on drugs post-marketing. In order to promote the specific implementation of the new pharmacovigilance regulations, the European medicines agency (EMA) developed the Guideline on Good Pharmacovigilance Practices (GVP), as the new criteria for pharmacovigilance in the European Union (EU). Compared with the previously published, Guidelines on Pharmacovigilance for Medicinal Products for Human Use (2007), the GVP proposed more comprehensive and systematic provisions of pharmacovigilance systems, quality control systems, judgements, pharmacovigilance inspections and audits. In addition, it set more specific and comprehensive requirements on risk management systems, the management and reporting of adverse reactions to medicinal products, periodic safety update reports, post-authorization safety studies, signal management, and so on. Interpreting the basic principles, working mechanisms, key technologies and methods of the GVP provides a useful reference for us to carry out pharmacovigilance (especially regarding safety monitoring of parenterally administered Chinese medicine). PMID:24471312

  3. 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.

  4. Starting a pharmacovigilance center: Actions for implementation

    Directory of Open Access Journals (Sweden)

    Mrinmoy Chakrabarty

    2011-01-01

    Full Text Available With burgeoning reports of adverse drug reactions due to pharmacotherapy, pharmacovigilance (PV is the buzz word in health care circles. While there are experts in this rapidly expanding field, there are many health care professionals who do not fully appreciate the import of PV in the context of modern therapeutics. In view of the national directive to institutionalize a PV center in every medical college of India, there is an urgent need to inform, educate, and enlighten the readers about the constitution and dynamics of a PV center, which this article attempts to fulfill.

  5. Detection of P. aeruginosa harboring bla CTX-M-2, bla GES-1 and bla GES-5, bla IMP-1 and bla SPM-1 causing infections in Brazilian tertiary-care hospital

    Directory of Open Access Journals (Sweden)

    Polotto Milena

    2012-08-01

    Full Text Available Abstract Background Nosocomial infections caused by Pseudomonas aeruginosa presenting resistance to beta-lactam drugs are one of the most challenging targets for antimicrobial therapy, leading to substantial increase in mortality rates in hospitals worldwide. In this context, P. aeruginosa harboring acquired mechanisms of resistance, such as production of metallo-beta-lactamase (MBLs and extended-spectrum beta-lactamases (ESBLs have the highest clinical impact. Hence, this study was designed to investigate the presence of genes codifying for MBLs and ESBLs among carbapenem resistant P. aeruginosa isolated in a Brazilian 720-bed teaching tertiary care hospital. Methods Fifty-six carbapenem-resistant P. aeruginosa strains were evaluated for the presence of MBL and ESBL genes. Strains presenting MBL and/or ESBL genes were submitted to pulsed-field gel electrophoresis for genetic similarity evaluation. Results Despite the carbapenem resistance, genes for MBLs (blaSPM-1 or blaIMP-1 were detected in only 26.7% of isolates. Genes encoding ESBLs were detected in 23.2% of isolates. The blaCTX-M-2 was the most prevalent ESBL gene (19.6%, followed by blaGES-1 and blaGES-5 detected in one isolate each. In all isolates presenting MBL phenotype by double-disc synergy test (DDST, the blaSPM-1 or blaIMP-1 genes were detected. In addition, blaIMP-1 was also detected in three isolates which did not display any MBL phenotype. These isolates also presented the blaCTX-M-2 gene. The co-existence of blaCTX-M-2 with blaIMP-1 is presently reported for the first time, as like as co-existence of blaGES-1 with blaIMP-1. Conclusions In this study MBLs production was not the major mechanism of resistance to carbapenems, suggesting the occurrence of multidrug efflux pumps, reduction in porin channels and production of other beta-lactamases. The detection of blaCTX-M-2,blaGES-1 and blaGES-5 reflects the recent emergence of ESBLs among antimicrobial resistant P. aeruginosa and

  6. The Frequency of blaVIM, blaIMP, blaKPC and blaNDM Carbapenemase Genes in Clinical Isolates of Klebsiella Pneumoniae in Kermanshah Medical Centers

    Directory of Open Access Journals (Sweden)

    A Zare

    2015-11-01

    Full Text Available Background: Carbapenemase genes have been spread among strains of Klebsiella pneumoniae that make them resistant to carbapenems. Hence, the present study aimed to study the prevalence of carbapenmase genes within K. pneumoniae isolates in Kermanshah medical centers. Methods: Sixty isolates of K. pneumoniae were collected and identified using API kit. Then, antibiotic susceptibility of isolates was determined using a disk diffusion method. The carbapenems-resistant isolates were screened for carbapenemases production using the Modified Hodge Test (MHT. The carbapenemase genes of blaVIM, blaIMP, KPC and blaNDM were detected by PCR test . Results: Out of 60 isolates, 4 isolates were resistant to carbapenem antibiotics, but only one isolate was demonstrated to be positive for carbapenemases by MHT phenotypic testing. The gene of blaVIM was detected in three isolates by PCR, though other genes were not found in the isolates. Within the isolates, 6.67% and 100% were resistant to carbapenem and ampicillin, respectively. Conclusion: The study findings revealed that dissemination rate of carbapenemase genes was not reported to be high among isolates of K. pneumoniae in Kermanshah. Only blaVIM gene was probably more frequent than other tested genes. Since most isolates examined in this study were susceptible to carbapenem antibiotics, these antibiotics are still regarded as effective drugs against infections caused by K. pneumoniae.

  7. European Union pharmacovigilance capabilities: potential for the new legislation.

    Science.gov (United States)

    Borg, John Joseph; Tanti, Amy; Kouvelas, Dimitrios; Lungu, Calin; Pirozynski, Michal; Serracino-Inglott, Anthony; Aislaitner, George

    2015-08-01

    European Directives and Regulations introduced between late 2010 and 2012 have substantially overhauled pharmacovigilance processes across the European Union (EU). In this review, the implementation of the pharmacovigilance legislative framework by EU regulators is examined with the aim of mapping Directive 2010/84/EU and Regulation EC No. 1235/2010 against their aspired objectives of strengthening and rationalizing pharmacovigilance in the EU. A comprehensive review of the current state of affairs of the progress made by EU regulators is presented in this paper. Our review shows that intense efforts by regulators and industry to fulfil legislative obligations have resulted in major positive shifts in pharmacovigilance. Harmonized decision making, transparency in decision processes with patient involvement, information accessibility to the public, patient adverse drug reaction reporting, efforts in communication and enhanced cooperation between member states to maximize resource utilization and minimize duplication of efforts are observed. PMID:26301067

  8. Discovery of bla(OXA-199, a chromosome-based bla(OXA-48-like variant, in Shewanella xiamenensis.

    Directory of Open Access Journals (Sweden)

    Zhiyong Zong

    Full Text Available INTRODUCTION: bla(OXA-48 is a globally emerging carbapenemase-encoding gene. The progenitor of bla(OXA-48 appears to be a Shewanella species. The presence of the bla(OXA-48-like gene was investigated for two Shewanella xiamenensis strains. METHODS: Strain WCJ25 was recovered from post-surgical abdominal drainages, while S4 was the type strain of S. xiamenensis. Species identification for WCJ25 was established by sequencing the 16S rDNA and gyrB genes. PCR was used to screen the bla(OXA-48-like genes and to obtain their complete sequences. A phylogenetic tree of the bla(OXA-48-like genes was constructed. The genetic context of the bla(OXA-48-like gene in strain WCJ25 was investigated by inverse PCR using self-ligated AseI- or RsaI-restricted WCJ25 DNA fragments as template, while that in strain S4 was determined by PCR mapping using that in WCJ25 as template. RESULTS: A new bla(OXA-48 variant, designated bla(OXA-48b, with four silent nucleotide differences from the bla(OXA-48 (designated bla(OXA-48a found in the Enterobacteriaceae was identified in strain S4. Strain WCJ25 had a new bla(OXA-48-like variant, bla(OXA-199, with five nucleotide differences from bla(OXA-48a and bla(OXA-48b. The OXA-199 protein has three amino acid substitutions (H37Y, V44A and D153G compared with OXA-48. Both bla(OXA-48b and bla(OXA-199 were found adjacent to genes encoding a peptidase (indicated as orf, a protein of unknown function (sprT, an endonuclease I (endA, and a ribosomal RNA methyl transferase (rsmE upstream and to transcriptional regulator gene lysR and an acetyl-CoA carboxylase-encoding gene downstream. In addition, the insertion sequence ISShes2 was found inserted downstream of bla(OXA-199 but not of bla(OXA-48b. The 26 bp sequences upstream and 63 bp downstream of bla(OXA-48a, bla(OXA-48b and bla(OXA-199 were identical. CONCLUSIONS: bla(OXA-48a, bla(OXA-48b and bla(OXA-199 might have a common origin, suggesting that the bla(OXA-48a gene found in the

  9. Need for involving consumers in Nepal’s pharmacovigilance system

    OpenAIRE

    Jha, Nisha; Rathore, Devendra Singh; Shankar, P Ravi; Thapa, Bhupendra Bahadur; Bhuju, Gajendra; Alshakka, Mohammed

    2014-01-01

    In Nepal, reporting of adverse drug reactions (ADRs) occurs on a voluntary basis by doctors, pharmacists, nurses, health assistants, and other healthcare professionals. The country’s pharmacovigilance program is still in its infancy; it has limited coverage and underreporting is common. This major limitation could be reduced with consumer involvement. This report examines the necessity and benefits of consumer involvement in Nepal’s existing pharmacovigilance program, reflecting on existing e...

  10. Pharmacovigilance: A Worldwide Master Key for Drug Safety Monitoring

    OpenAIRE

    Jeetu, G; G. Anusha

    2010-01-01

    Pharmacovigilance is like a sunshade to describe the processes for monitoring and evaluating ADRs and it is a key component of effective drug regulation systems, clinical practice and public health programmes. The number of Adverse Drug Reactions (ADRs) reported resulted in an increase in the volume of data handled, and to understand the pharmacovigilance, a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. The ...

  11. Identification of blaOXA-51, blaOXA-58, blaDIM-1 and blaVIM carbapenemase genes in hospital enterobacteriaceae isolates from Sierra Leone

    Science.gov (United States)

    We describe the results of a molecular epidemiological survey of 15 carbapenemase-encoding genes from a recent collection of clinical isolates. The most salient findings revealed that (i) 60% of the isolates harbored multiple carbapenemase genes, (ii) the blaDIM-1 gene that has only been reported in...

  12. Health professionals' knowledge, attitude and practices towards pharmacovigilance in Nepal

    Directory of Open Access Journals (Sweden)

    Palaian S

    2011-12-01

    Full Text Available Pharmacovigilance can be helpful in protecting consumers from harmful effects of medicines. Healthcare professionals should consider Adverse Drug Reaction (ADR reporting as their professional obligation and should be aware of the existing pharmacovigilance mechanisms in their countries. In Nepal, pharmacovigilance activities were initiated in 2004. Objectives: The present study evaluated the knowledge, attitude and practices (KAP of the healthcare professionals towards ADRs and pharmacovigilance in Manipal Teaching Hospital (MTH, a tertiary care teaching hospital attached to the regional pharmacovigilance center in western Nepal. Methods: A cross-sectional study was carried out in 2007 using a pretested (Cronbach alpha=0.72 questionnaire having 25 questions (15 questions on knowledge, 5 on attitude and 5 on practice. The correct/positive responses were given a score of ‘2’ and the wrong/negative responses ‘1’, maximum possible score of ‘50’. Results: A total of 131 responses were obtained among which 42 were incomplete and remaining 89 [females 49 (55.1%] were analyzed. Of the 89 professionals, 29 (32.6% were doctors, 46 (51.8 nurses and 14 (15.7% pharmacists. The mean age was 28.32 (SD=8.46 years and the median (interquartile range of duration of the service 14.5 (6-36 months. The total KAP scores was 40.06 (SD=3.51 for doctors, 38.92 (SD=4.83 for pharmacists, and 35.82 (SD=3.75 for nurses. Among the 89 professionals, 59 (62.3% had not reported even a single ADR to the pharmacovigilance center. Conclusion: The healthcare professionals at the MTH had a poor KAP towards ADRs and pharmacovigilance and there is a need for educational and awareness intervention for these professionals.

  13. AWARENESS ABOUT PHARMACOVIGILANCE AMONG RESIDENT DOCTORS IN A TERTIARY CARE HOSPITAL

    OpenAIRE

    Amit A.; Zad; Sawant; Dudhal

    2015-01-01

    BACKGROUND: Monitoring and evaluation of adverse drug reactions (ADRs) through a well - organized pharmacovigilance system is vital for safe use of medicines. ADR reporting by healthcare professionals forms the backbone of pharmacovigilance system. AIM: To assess the awareness of pharmacovigilance among resident doctors in a tertiary care hospital. ...

  14. 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. PMID:25218237

  15. Pharmacovigilance Considerations for Biosimilars in the USA.

    Science.gov (United States)

    Grampp, Gustavo; Felix, Thomas

    2015-10-01

    In 2015, five or more biosimilars may be approved in the USA. Because no two biologic medicines are identical, postapproval safety monitoring will be critical to detect potential differences in safety signals between a biosimilar, its reference product, and other biosimilars. Postapproval safety monitoring in the USA uses two signal detection systems: spontaneous reporting systems (SRSs) and active surveillance (AS) systems. Both depend on accurate identification of the specific product(s) dispensed or administered to patients, which may be compromised when products from multiple manufacturers share common drug nomenclature or coding. Product identification can present challenges across different healthcare settings, including inpatient and ambulatory care. Common oral-dosage drugs are predominantly dispensed directly to patients by pharmacists, whereas most injectable drugs, including biologics, are administered to patients by healthcare professionals in outpatient clinics or hospitals. Thus, the effectiveness of SRS and AS mechanisms in both pharmacy and medical channels must be given greater consideration as biotechnology matures. In this article, we describe these systems and their limitations. We identify challenges and opportunities for product-specific safety surveillance of biologics in both the pharmacy and medical settings and provide recommendations to improve biologic safety surveillance under the current and future systems envisioned in the Drug Quality and Security Act. As biosimilars are integrated into existing pharmacovigilance systems, distinguishable nonproprietary names and codes for all biologics, as well as other opportunities to improve traceability (e.g., increased use of barcodes), must be considered to ensure patient safety and confidence in this new class of drugs. PMID:26419971

  16. Prevalence of blaTEM , blaSHV and blaCTX-M genes in clinical isolates of Escherichia coli and Klebsiella pneumoniae from Northeast India

    Directory of Open Access Journals (Sweden)

    Arijit Bora

    2014-01-01

    Full Text Available Aim: This study was carried out to determine the presence of blaTEM , blaSHV and blaCTX-M genes in extended-spectrum β-lactamase (ESBL producing Escherichia coli (E. coli and Klebsiella pneumoniae (K. pneumoniae at a tertiary care referral hospital in Northeast India. Materials and Methods: A total of 270 E. coli and 219 K. pneumoniae isolates were recovered during the period between August 2009 and July 2010. Kirby-Bauer disk diffusion method was performed to determine the antibiotic resistance pattern. Screening and phenotypic confirmatory test for ESBL production were performed using standard disc diffusion methods. Each of the initial ESBL screening test isolate was investigated for the presence of blaTEM , blaSHV and blaCTX-M genes via polymerase chain reaction (PCR using gene-specific primers. Results: Phenotypic confirmatory test able to detect ESBL production in 73.58% of E. coli and 67.24% of K. pneumoniae. However, PCR amplification showed the presence of one or more ESBL genes in each of the initial ESBL screening positive isolate. Among three ESBL genotypes, the most prevalent genotype was found to be blaCTX-M in E. coli (88.67% and blaTEM in K. pneumoniae (77.58% ESBL producing isolates. Majority of ESBL producing isolates possess more than one ESBL genes. Conclusion: This study constituted a primer report on high prevalence of blaTEM and blaCTX-M genes in ESBL producing isolates of E. coli and K. pneumoniae and denotes the need of more extensive studies on these antibiotic genes to determine the magnitude of the problem of antibiotic resistance exiting in this locality.

  17. blaCTX-M Genes in Escherichia coli Strains from Croatian Hospitals Are Located in New (blaCTX-M-3a) and Widely Spread (blaCTX-M-3a and blaCTX-M-15) Genetic Structures▿

    OpenAIRE

    Literacka, Elżbieta; Bedenic, Branka; Baraniak, Anna; Fiett, Janusz; Tonkic, Marija; Jajic-Bencic, Ines; Gniadkowski, Marek

    2009-01-01

    CTX-M-producing Escherichia coli isolates from three Croatian hospitals were analyzed. All blaCTX-M-15 genes and one blaCTX-M-3a gene resided in widely spread ISEcp1 transposition modules, but other blaCTX-M-3a genes were in a new configuration with two IS26 copies, indicating a new event of gene mobilization from a Kluyvera ascorbata genome. The study confirmed the role of the E. coli ST131 clonal group with IncFII-type plasmids in the spread of blaCTX-M-15 and of IncL/M pCTX-M3-type plasmid...

  18. Biologics and biosimilars: role in modern pharmacotherapy and importance of pharmacovigilance

    Directory of Open Access Journals (Sweden)

    Ravi R. Alamchandani

    2014-04-01

    Full Text Available Biologics are highly sensitive large molecules with complex structure, difficult to characterize and reproduce, derived from living cells; used for treatment, diagnosis or prevention of disease. Examples are therapeutic hormones, vaccines, monoclonal antibodies etc. Biologicals are beneficial in the management of several health conditions which were once upon a time difficult to manage like cancer, multiple sclerosis, Alzheimer's disease, rheumatoid arthritis, diabetes etc. Biosimilars are proteins that are similar to innovator biologics but not the same as they differ slightly in structure however with no clinically significant difference. Biosimilars are not the exact replicas of originator biologic and are therefore not generics. Biosimilars for their approval are not required to undergo intense clinical trials as innovator biologic but are required to produce data that demonstrates its similarity to an original biologic in terms of clinical efficacy and safety. However, manufactures of both the biologics and biosimilars are required to submit pharmacovigilance and risk management plans as part of their application. Marketing authorization for biosimilars was for the first time framed by EMA along with the guidelines for developing them. As biologics and biosimilars are derived proteins they have immunogenic potential and risk of adverse events which cautions their use. Pharmacovigilance is needed to ensure that adverse events are quickly detected, reported and attributed to the correct product and manufacturer. Regulations are implemented to improve identification and traceability of biologics. Automatic substitution should not be permitted for biologicals. [Int J Res Med Sci 2014; 2(2.000: 382-386

  19. 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

  20. Occurrence of co-existing bla VIM-2 and bla NDM-1 in clinical isolates of Pseudomonas aeruginosa from India

    OpenAIRE

    Paul, Deepjyoti; Dhar (Chanda), Debadatta; Maurya, Anand Prakash; MISHRA, Shweta; Sharma, Gauri Dutt; Chakravarty, Atanu; Bhattacharjee, Amitabha

    2016-01-01

    Background bla VIM-2 harboring Pseudomonas aeruginosa has been reported worldwide and considered as the most prevalent metallo-β-lactamase after NDM which are found horizontally transferable and mostly associated with integron gene cassettes. The present study investigates the genetic background, transmission dynamics as well as stability of bla VIM-2 in clinical isolates of P. aeruginosa harbor bla NDM-1 as well which were collected from October 2012 to September 2013. Methods Two P. aerugin...

  1. An evaluation of knowledge of pharmacovigilance among nurses and midwives in Turkey

    Directory of Open Access Journals (Sweden)

    Sultan Alan

    2013-01-01

    Full Text Available This study aimed to evaluate the awareness of nurse/midwives regarding pharmacovigilance as well as their knowledge and experience in identifying and reporting adverse reactions of drugs. Nurse/midwives (n = 329, working in four state hospitals, were provided a questionnaire with a view of identifying their knowledge and skills pertaining to pharmacovigilance. Around 45% of the participants claimed to have knowledge of pharmacovigilance but only 23.3% of them could define it correctly. Although 24.3% of the participants acknowledged that adverse reactions should be reported to a centre, only 1.2% of them named this centre (Turkey Pharmacovigilance Centre-TUFAM. The present study indicates that nurse/midwives have insufficient knowledge of pharmacovigilance practices. Hence, it is essential to include pharmacovigilance training in their undergraduate and graduate education programs, and to promote reporting of adverse reactions.

  2. An evaluation of knowledge of pharmacovigilance among nurses and midwives in Turkey

    OpenAIRE

    Sultan Alan; Melike Ozturk; Sule Gokyildiz; Burcu Avcibay; Yusuf Karatas

    2013-01-01

    This study aimed to evaluate the awareness of nurse/midwives regarding pharmacovigilance as well as their knowledge and experience in identifying and reporting adverse reactions of drugs. Nurse/midwives (n = 329), working in four state hospitals, were provided a questionnaire with a view of identifying their knowledge and skills pertaining to pharmacovigilance. Around 45% of the participants claimed to have knowledge of pharmacovigilance but only 23.3% of them could define it correctly. Altho...

  3. Implementing a centralised pharmacovigilance service in a non-commercial setting in the United Kingdom

    OpenAIRE

    Dinnett, E.; Kean, S.; Tolmie, E.; Ronald, E.; Gaw, A.

    2013-01-01

    The implementation of a pharmacovigilance service compliant with the legal and regulatory responsibilities of clinical trial sponsors presents particular challenges for sponsors in a non-commercial setting. In this paper we examine these challenges in detail. We identify and discuss the key steps in the development of a pharmacovigilance service within a public health service and university setting in the United Kingdom. We describe how we have established a central Pharmacovigilance Offi...

  4. Detection of bla KPC-2 in Proteus mirabilis in Brazil

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    Adriane Borges Cabral

    2015-02-01

    Full Text Available INTRODUCTION : Infections caused by Klebsiella pneumoniae carbapenemase (KPC-producing isolates pose a major worldwide public health problem today. METHODS : A carbapenem-resistant Proteus mirabilis clinical isolate was investigated for plasmid profiles and the occurrence of β-lactamase genes. RESULTS : The isolate exhibited resistance to ertapenem and imipenem and was susceptible to meropenem, polymyxin, and tigecycline. Five plasmids were identified in this isolate. DNA sequencing analysis revealed the presence of bla KPC-2 and bla TEM-1 genes. An additional PCR using plasmid DNA confirmed that bla KPC-2 was present in one of these plasmids. Conclusions: We report the detection of bla KPC-2 in P. mirabilis in Brazil for the first time. This finding highlights the continuous transfer of bla KPC between bacterial genera, which presents a serious challenge to the prevention of infection by multidrug-resistant bacteria.

  5. [Pharmacovigilance: a case of phantom ships and Russian roulette].

    Science.gov (United States)

    Stricker, B H Ch

    2002-07-01

    The medical literature is full of associations between drugs and adverse events which have not been proven by epidemiological studies, such as the 30-year-old discussion on levodopa use and the development of melanoma. The organisation of drug safety (pharmacovigilance) by marketing authorisation holders and regulatory authorities relies heavily on voluntary reporting schemes, despite the fact that such schemes suffer from substantial underreporting. Nevertheless, even though marketing authorisation holders are legally responsible for the product, regulatory authorities scarcely oblige them to perform hypothesis-testing epidemiological studies. In view of the importance of drug safety for healthcare and the need for checks and balances, pharmacovigilance should be coordinated by an organisation which is independent from the pharmaceutical industry and regulatory authorities, such as the Dutch Healthcare Inspectorate. PMID:12138668

  6. State of knowledge of Cameroonian drug prescribers on pharmacovigilance

    OpenAIRE

    Nde, Francis; Fah, Aimé Bernard Djitafo; Simo, Francis Ampère; Wouessidjewe, Denis

    2015-01-01

    Introduction The present study conducted in Cameroon from June 2013 to February 2014 aimed to estimating the level of pharmacovigilance knowledge and practice of health professionals in Cameroon. Methods We conducted a descriptive cross-sectional survey on 149 health professionals in Cameroon from June to September 2013. Data were analyzed using software IBM SPSS 20.0. We calculated proportions and odd ratio, and confident interval of their values, keeping a threshold of p of 0.05 to determin...

  7. Pharmacovigilance: Boon for the safety and efficacy of ayuvedic formulations

    OpenAIRE

    Anand Chaudhary; Neetu Singh; Neeraj Kumar

    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 Ayu...

  8. Exploitation of semantic methods to cluster pharmacovigilance terms

    OpenAIRE

    Dupuch, Marie; Dupuch, Laëtitia; Hamon, Thierry; Grabar, Natalia

    2014-01-01

    Pharmacovigilance is the activity related to the collection, analysis and prevention of adverse drug reactions (ADRs) induced by drugs. This activity is usually performed within dedicated databases (national, European, international...), in which the ADRs declared for patients are usually coded with a specific controlled terminology MedDRA (Medical Dictionary for Drug Regulatory Activities). Traditionally, the detection of adverse drug reactions is performed with data mining algorithms, while...

  9. Pharmacovigilance and Moroccan Tuberculosis Public Program: Current Situation

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    Driss Soussi Tanani

    2014-01-01

    Full Text Available The objective of this work is to demonstrate the interest of integration of pharmacovigilance in Moroccan Tuberculosis Control Program (MTCP. Design and Data Collection. The integration of pharmacovigilance in MTCP was conducted in October 2012 with the Global Fund support. We compared the reports notified before and after this integration (period 1: January 2010–October 2012; period 2: October 2012–December 2013. The detection of signals was based on the Information Component available in VigiMine. We used the SPSS version 10.0 and MedCalc version 7.3 for data analysis. Results. The average number of spontaneous reports increased from 3.6 to 37.4 cases/month (P<10-3. The average age was 40.7±17.5 years; the sex ratio was 0.8. Hepatic reactions (32.7% predominated during the first period, while skin reactions (24.1% were in the second period (P=10-4, and 40.9% of cases in the first period were serious against 15.8% in second period (P=0.003. Nine signals were generated (hepatic enzyme increase, cholestasis, jaundice, arthralgia, acne, lower limb edema, pruritus, skin rashes, and vomiting. Conclusion. The integration of pharmacovigilance in Moroccan Tuberculosis Control Program improved the management of ADRs and detected new signals of antituberculosis drugs.

  10. Genetic Features of blaNDM-1-Positive Enterobacteriaceae▿

    OpenAIRE

    Poirel, L.; Dortet, L.; Bernabeu, S.; NORDMANN, P.

    2011-01-01

    Genetic features associated with the blaNDM-1 gene were investigated in 6 Escherichia coli, 7 Klebsiella pneumoniae, 1 Citrobacter freundii, 1 Proteus mirabilis, and 1 Providencia stuartii isolate of worldwide origin. Clonal diversity was observed for both E. coli and K. pneumoniae. The blaNDM-1 gene was carried by different plasmid types (IncA/C, IncF, IncL/M, or untypeable) and was likely chromosome borne in two isolates. The blaNDM-1 plasmids coharbored a variety of resistance determinants...

  11. Risk Management Plan and Pharmacovigilance System. Biopharmaceuticals: Biosimilars

    OpenAIRE

    Calvo, Begoña; Zuñiga, Leyre

    2011-01-01

    Editor literario del libro, Giancarlo Nota - All chapters are Open Access articles distributed under the Creative Commons Non Commercial-Share Alike-Attribution 3.0 license, which permits to copy, distribute, transmit, and adapt the work in any medium, so long as the original work is properly cited.

  12. Presence of blaPER-1 and blaVEB-1 beta-lactamase genes among isolates of Pseudomonas aeruginosa from South West of Iran.

    Science.gov (United States)

    Davodian, Elham; Sadeghifard, Nourkhoda; Ghasemian, Abdolmajid; Noorbakhsh, Samileh

    2016-09-01

    Pseudomonas aeruginosa isolates have acquired resistance to antibiotics such as novel beta-lactams. The aim of this study was to investigate the blaPER-1, blaVEB-1, and blaPSE-1 genes among isolates of P. aeruginosa among intensive care unit (ICU) patients. Sixty-five isolates were collected. The antibiotic susceptibility testing and combined disk tests were performed to detect the isolates producing extended spectrum beta-lactamases (ESBLs) among ceftazidime-resistant isolates. Polymerase chain reaction (PCR) amplification of blaPER-1, blaVEB-1, and blaPSE-1 genes was conducted. Ten (15.3%) isolates were ESBL-positive, of which 40% (n=4) belonged to males and 60% (n=6) were collected from females. Moreover, two and one isolates harbored blaPER-1 and blaVEB-1 genes, respectively. PMID:26944896

  13. Pharmacovigilance amongst patent medicine vendors (PMVs) in Ekiti state, Nigeria.

    Science.gov (United States)

    Awodele, Olufunsho; Adeniran, Adeyinka; Awodele, Deborah F

    2012-01-01

    With the current population of Nigeria and the limited number of trained health care providers, PMVs are inevitable and highly needed especially in the rural areas for the supply of drugs in treating minor illnesses. Thus, pharmacovigilance (PVG) activity in Nigeria cannot exclude the roles of PMVs; therefore, this study was aimed to determine the knowledge of PMVs on PVG and adverse drug reaction reporting system. The study was a descriptive cross-sectional survey of the knowledge of Pharmacovigilance and adverse drug reaction reporting system of 96 PMVs in Ekiti state, Nigeria before the National Pharmacovigilance training in February, 2011 and after the training. The data obtained before the training showed that more than 87% of the respondents had at least secondary level of education. About half of the respondents (58.5%) knew the correct meaning of PVG and 56.6% knew how to report ADRs. But only about one third of them (35.8%) knew where to obtain ADR forms. Very few respondents 3 (5.7%) had received report/complaints of ADR from patients in the last 1 month while just 2 (3.8%) of them reported. The most commonly mentioned factors/reasons for poor reporting of ADRs/compliance with PVG guideline by the respondents were fears of indictment (61.3%), poor public knowledge (88.7%), and poor training on PMVs (92.5%). However, the results after the training showed a statistically significant (p ≤ 0.005) improvement in the proportion of respondents who were aware of PVG (from 55.8% to 89.1%), those who knew the meaning of PVG (from 49.0% to 61.7%), where to obtain ADR form (28.3% to 92.1%) and those who knew how to report ADRs (44.2% to 88.0%). PMVs are ready to practice PVG if they are properly trained. Training has been revealed to play a significant role in the knowledge of the concept of PVG amongst PMVs. It is therefore recommended that National Pharmacovigilance Centre should continue to organize periodic trainings for PMVs especially those with poor

  14. Counterfeit drugs in India: significance and impact on pharmacovigilance

    Directory of Open Access Journals (Sweden)

    Nehal A. Shah

    2015-09-01

    Full Text Available Counterfeit drugs have emerged as a major global problem. This issue has been brought to the centre of the Indian media due to the death of 15 women attending a sterilization camp in Chhattisgarh. India's pharmaceutical industry exports drugs worth 15 billion dollars, which means a high prevalence of counterfeiting in India's drug industry has global repercussions. However, accurate figures on the extent of counterfeit drugs in India are not available. The scientific literature as well as media reports often quotes figures of 10-35%, though studies done by the Indian Government dispute this. Counterfeit drug numbers have been known to be under represented by Governments due to fear of undermining their economy and health systems. On the other hand, rival companies in other countries may have an incentive to over hype India's counterfeit problem to dent India's growing status as the leading global supplier of generic medicines. Lack of clear definitions and differences between laws of countries further complicate reporting. A high prevalence of counterfeit drugs has a large impact on both health and economic indicators. Additionally, counterfeit drugs provide significant challenges to Pharmacovigilance programmes. Hence, here we discuss the significance of use of counterfeit drugs in India and challenges faced by Pharmacovigilance due to the extensive use of counterfeit drugs. [Int J Res Med Sci 2015; 3(9.000: 2156-2160

  15. Exploitation of semantic methods to cluster pharmacovigilance terms.

    Science.gov (United States)

    Dupuch, Marie; Dupuch, Laëtitia; Hamon, Thierry; Grabar, Natalia

    2014-01-01

    Pharmacovigilance is the activity related to the collection, analysis and prevention of adverse drug reactions (ADRs) induced by drugs. This activity is usually performed within dedicated databases (national, European, international...), in which the ADRs declared for patients are usually coded with a specific controlled terminology MedDRA (Medical Dictionary for Drug Regulatory Activities). Traditionally, the detection of adverse drug reactions is performed with data mining algorithms, while more recently the groupings of close ADR terms are also being exploited. The Standardized MedDRA Queries (SMQs) have become a standard in pharmacovigilance. They are created manually by international boards of experts with the objective to group together the MedDRA terms related to a given safety topic. Within the MedDRA version 13, 84 SMQs exist, although several important safety topics are not yet covered. The objective of our work is to propose an automatic method for assisting the creation of SMQs using the clustering of semantically close MedDRA terms. The experimented method relies on semantic approaches: semantic distance and similarity algorithms, terminology structuring methods and term clustering. The obtained results indicate that the proposed unsupervised methods appear to be complementary for this task, they can generate subsets of the existing SMQs and make this process systematic and less time consuming. PMID:24739596

  16. blaCTX-M-1/9/1 Hybrid Genes May Have Been Generated from blaCTX-M-15 on an IncI2 Plasmid

    OpenAIRE

    Liu, Lanping; He, Dandan; Lv, Luchao; Liu, Wuling; Chen, Xiaojie; Zeng, Zhenling; Partridge, Sally R.; Liu, Jian-Hua

    2015-01-01

    Three hybrid CTX-M β-lactamases, CTX-M-64, CTX-M-123, and CTX-M-132, with N and C termini matching CTX-M-1 group enzymes and centers matching CTX-M-9 group enzymes, have been identified. The hybrid gene sequences suggested recombination between blaCTX-M-15 and blaCTX-M-14, the two most common blaCTX-M variants worldwide. However, blaCTX-M-64 and blaCTX-M-123 are found in an ISEcp1-blaCTX-M transposition unit with a 45-bp “spacer,” rather than the 48 bp usually associated with blaCTX-M-15, and...

  17. Adverse Drug Reaction Mining in Pharmacovigilance data using Formal Concept Analysis

    OpenAIRE

    Villerd, Jean; Toussaint, Yannick; Lillo Le-Louët, Agnès

    2010-01-01

    International audience In this paper we discuss the problem of extracting and evaluating associations between drugs and adverse effects in pharmacovigilance data. Approaches proposed by the medical informatics community for mining one drug - one effect pairs perform an exhaustive search strategy that precludes from mining high-order associations. Some specificities of pharmacovigilance data prevent from applying pattern mining approaches proposed by the data mining community for similar pr...

  18. The Monitoring Medicines Project: A Multinational Pharmacovigilance and Public Health Project

    OpenAIRE

    Pal, Shanthi N.; Olsson, Sten; Brown, Elliot G.

    2015-01-01

    The Monitoring Medicines project (MM), funded by the FP-7 EU framework, was carried out between 2009 and 2013 by a consortium of 11 partners. The objectives were to support and strengthen consumer reporting of adverse drug reactions (ADRs); expand the role and scope of national pharmacovigilance centres concerning medication errors; promote improved use of pharmacovigilance data; and develop methods to complement spontaneous reporting. The work was organised into four themes: patient reportin...

  19. Un modèle statistique pour la pharmacovigilance

    OpenAIRE

    Robert, Valérie; Celeux, Gilles; Keribin, Christine

    2015-01-01

    Les effets indésirables des médicaments sont le plus souvent découverts après l'autorisation de mise sur le marché de ces médicaments. La pharmacovigilance consiste alors a détecter le plus précocement possible l'existence d'associations entre médicaments et événements indésirables. Dans cette optique, des méthodes statistiques exploratoires (IC, Bate et al., 1998 ; GPS, Dumouchel, 1999...) sont développées depuis une vingtaine d' années. Cependant, ces méthodes sont limitées par l'utilisatio...

  20. The Occurrence of blaCTX-M, blaSHV, and blaTEM Genes in Extended-Spectrum β-Lactamase-Positive Strains of Klebsiella pneumoniae, Escherichia coli, and Proteus mirabilis in Poland

    OpenAIRE

    Ojdana, Dominika; Sacha, Paweł; Wieczorek, Piotr; Czaban, Sławomir; Michalska, Anna; Jaworowska, Jadwiga; Jurczak, Anna; Poniatowski, Bogusław; Tryniszewska, Elżbieta

    2014-01-01

    Bacteria belonging to the Enterobacteriaceae family that produce extended-spectrum β-lactamase (ESBL) enzymes are important pathogens of infections. Increasing numbers of ESBL-producing bacterial strains exhibiting multidrug resistance have been observed. The aim of the study was to evaluate the prevalence of blaCTX-M, blaSHV, and blaTEM genes among ESBL-producing Klebsiella pneumoniae, Escherichia coli, and Proteus mirabilis strains and to examine susceptibility to antibiotics of tested stra...

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

    OpenAIRE

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

    2016-01-01

    Introduction 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. Objective In this study, we aimed to analyse the ADR-reporting pattern in the context of the first pharmacovigilance legislation in Turkey. Methods We analysed ADR reports submitted to the Turkish Pharmac...

  2. Impact of educational intervention on awareness of pharmacovigilance among medical undergraduates in Karnataka, India: a cross-sectional study

    OpenAIRE

    Padmanabha Thiruganahalli Shivaraju; Manu Gangadhar; Ravi Shankar Manchukonda; Chandrakantha Thippeswamy; Neha Krishnegowda

    2016-01-01

    Background: India being a part of national pharmacovigilance program (NPP), its contribution to UMC (Uppsala monitoring centre) is very little and pharmacovigilance program of India (PvPI) is still in its infancy. Lack of vibrant reporting culture necessitates bringing the awareness and importance of it. Objective of this study was to assess the level of knowledge, awareness, and the method of application of pharmacovigilance (PV) and to evaluate the impact of an educational intervention amon...

  3. Two Multiplex Real-Time PCR Assays to Detect and Differentiate Acinetobacter baumannii and Non- baumannii Acinetobacter spp. Carrying blaNDM, blaOXA-23-Like, blaOXA-40-Like, blaOXA-51-Like, and blaOXA-58-Like Genes.

    Science.gov (United States)

    Yang, Qiu; Rui, Yongyu

    2016-01-01

    Nosocomial infections caused by Acinetobacter spp. resistant to carbapenems are increasingly reported worldwide. Carbapenem-resistant Acinetobacter (CRA) is becoming a serious concern with increasing patient morbidity, mortality, and lengths of hospital stay. Therefore, the rapid detection of CRA is essential for epidemiological surveillance. Polymerase chain reaction (PCR) has been extensively used for the rapid identification of most pathogens. In this study, we have developed two multiplex real-time PCR assays to detect and differentiate A. baumannii and non-A. baumannii Acinetobacter spp, and common carbapenemase genes, including blaNDM, blaOXA-23-like, blaOXA-40-like, blaOXA-51-like, and blaOXA-58-like. We demonstrate the potential utility of these assays for the direct detection of blaNDM-, blaOXA-23-like-, blaOXA-40-like-, blaOXA-51-like-, and blaOXA-58-like-positive CRA in clinical specimens. Primers were specifically designed, and two multiplex real-time PCR assays were developed: multiplex real-time PCR assay1 for the detection of Acinetobacter baumannii 16S-23S rRNA internal transcribed spacer sequence, the Acinetobacter recA gene, and class-B-metalloenzyme-encoding gene blaNDM; and multiplex real-time PCR assay2 to detect class-D-oxacillinase-encoding genes (blaOXA-23-like, blaOXA-40-like, blaOXA-51-like,and blaOXA-58-like). The assays were performed on an ABI Prism 7500 FAST Real-Time PCR System. CRA isolates were used to compare the assays with conventional PCR and sequencing. Known amounts of CRA cells were added to sputum and fecal specimens and used to test the multiplex real-time PCR assays. The results for target and nontarget amplification showed that the multiplex real-time PCR assays were specific, the limit of detection for each target was 10 copies per 20 μL reaction volume, the assays were linear over six log dilutions of the target genes (r2 > 0.99), and the Ct values of the coefficients of variation for intra- and interassay

  4. Two Multiplex Real-Time PCR Assays to Detect and Differentiate Acinetobacter baumannii and Non- baumannii Acinetobacter spp. Carrying blaNDM, blaOXA-23-Like, blaOXA-40-Like, blaOXA-51-Like, and blaOXA-58-Like Genes.

    Directory of Open Access Journals (Sweden)

    Qiu Yang

    Full Text Available Nosocomial infections caused by Acinetobacter spp. resistant to carbapenems are increasingly reported worldwide. Carbapenem-resistant Acinetobacter (CRA is becoming a serious concern with increasing patient morbidity, mortality, and lengths of hospital stay. Therefore, the rapid detection of CRA is essential for epidemiological surveillance. Polymerase chain reaction (PCR has been extensively used for the rapid identification of most pathogens. In this study, we have developed two multiplex real-time PCR assays to detect and differentiate A. baumannii and non-A. baumannii Acinetobacter spp, and common carbapenemase genes, including blaNDM, blaOXA-23-like, blaOXA-40-like, blaOXA-51-like, and blaOXA-58-like. We demonstrate the potential utility of these assays for the direct detection of blaNDM-, blaOXA-23-like-, blaOXA-40-like-, blaOXA-51-like-, and blaOXA-58-like-positive CRA in clinical specimens. Primers were specifically designed, and two multiplex real-time PCR assays were developed: multiplex real-time PCR assay1 for the detection of Acinetobacter baumannii 16S-23S rRNA internal transcribed spacer sequence, the Acinetobacter recA gene, and class-B-metalloenzyme-encoding gene blaNDM; and multiplex real-time PCR assay2 to detect class-D-oxacillinase-encoding genes (blaOXA-23-like, blaOXA-40-like, blaOXA-51-like,and blaOXA-58-like. The assays were performed on an ABI Prism 7500 FAST Real-Time PCR System. CRA isolates were used to compare the assays with conventional PCR and sequencing. Known amounts of CRA cells were added to sputum and fecal specimens and used to test the multiplex real-time PCR assays. The results for target and nontarget amplification showed that the multiplex real-time PCR assays were specific, the limit of detection for each target was 10 copies per 20 μL reaction volume, the assays were linear over six log dilutions of the target genes (r2 > 0.99, and the Ct values of the coefficients of variation for intra- and

  5. Characteristics of β-lactamases and their genes (blaA and blaB in Yersinia intermedia and Y. frederiksenii

    Directory of Open Access Journals (Sweden)

    Sharma Sachin

    2007-04-01

    Full Text Available Abstract Background The presence of β-lactamases in Y. enterocolitica has been reported to vary with serovars, biovars and geographical origin of the isolates. An understanding of the β-lactamases in other related species is important for an overall perception of antibiotic resistance in yersiniae. The objective of this work was to study the characteristics of β-lactamases and their genes in strains of Y. intermedia and Y. frederiksenii, isolated from clinical and non-clinical sources in India. Results The enzymes, Bla-A (a constitutive class A penicillinase and Bla-B (an inducible class C cephalosporinase were found to be present in all the clinical and non-clinical strains of Y. intermedia and Y. frederiksenii by double disc diffusion method. The results showed differential expression of Bla-A as indicated by presence/absence of synergy whereas expression of Bla-B was quite consistent. The presence of these enzymes was also reflected in the high minimum inhibitory concentrations, MIC50 (126–1024 mg/L and MIC90 (256–1024 mg/L of β-lactam antibiotics against these species. Restriction fragment length polymorphism (RFLP revealed heterogeneity in both blaA and blaB genes of Y. intermedia and Y. frederiksenii. The blaA gene of Y. intermedia shared significant sequence identity (87–96% with blaA of Y. enterocolitica biovars 1A, 1B and 4. The sequence identity of blaA of Y. frederiksenii with these biovars was 77–79%. The sequence identity of blaB gene of Y. intermedia and Y. frederiksenii was more (85% with that of Y. enterocolitica biovars 1A, 1B and 2 compared to other species viz., Y. bercovieri, Y. aldovae and Y. ruckeri. Isoelectric focusing data further revealed that both Y. intermedia and Y. frederiksenii produced Bla-A (pI 8.7 and "Bla-B like" (pI 5.5–7.1 enzymes. Conclusion Both Y. intermedia and Y. frederiksenii showed presence of blaA and blaB genes and unequivocal expression of the two β-lactamases. Limited heterogeneity

  6. Dissemination of Pseudomonas aeruginosa producing blaIMP-1 and blaVIM-1 in Qazvin and Alborz educational hospitals, Iran

    Directory of Open Access Journals (Sweden)

    Amir Peymani

    2016-01-01

    Full Text Available Background and Objectives: Pseudomonas aeruginosa is a frequent opportunistic pathogen in health care associated infections that is highly resistant to the majority of β-lactams. The aims of this study were to access the antimicrobial susceptibility pattern of P. aeruginosa isolated from educational hospitals of Qazvin and Alborz provinces, to determine the prevalence of metallo-β-lactamase (MBL among carbapenem non-susceptible isolates by combined disk (CD method, and to detect the blaIMP, blaVIM, blaSIM, blaGIM, blaSPM and blaNDM-1-MBL genes.Materials and Methods: In this cross-sectional study, 300 P. aeruginosa isolates were collected from different clinical specimens in two provinces of Qazvin and Alborz hospitals, Iran. After identification of isolates by standard laboratory methods, antimicrobial susceptibility was done against 17 antibiotics according to clinical and laboratory standards institute (CLSI guideline. CD method was carried out for detection of MBLs and the presence of blaIMP, blaVIM, blaSIM, blaGIM, blaNDM-1 and blaSPM-genes was further assessed by PCR and sequencing methods.Results: In this study, 107 (35.66% isolates were non-susceptible to imipenem and/or meropenem among those 56 (52.3% isolates were metallo-β-lactamase producer. Twenty-four of 56 (42.85% MBL-positive isolates were confirmed to be positive for MBL-encoding genes in which 14 (25% and 10 (17.85% isolates carried blaIMP-1 and blaVIM-1 genes either alone or in combination. Three (5.35% isolates carried blaIMP and blaVIM genes, simultaneously.Conclusion: Considering the moderate prevalence and clinical importance of MBL-producing isolates, rapid identification and use of appropriate infection control (IC measures are necessary to prevent further spread of infections by these resistant organisms.Keywords: Pseudomonas aeruginosa, Antibiotic resistance, Metallo-β-lactamase

  7. Detection of blaIMP4 and blaNDM1 harboring Klebsiella pneumoniae isolates in a university hospital in Malaysia

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    Nurul Izzati Hamzan

    2015-03-01

    Full Text Available Background: Antibiotic resistance among Enterobacteriaceae posts a great challenge to the health care service. The emergence of carbapenem-resistant Klebsiella pneumoniae (CRKP is attracting significant attention due to its rapid and global dissemination. The infection is associated with significant morbidity and mortality, thus creating challenges for infection control and managing teams to curb the infection. In Southeast Asia, there have been limited reports and subsequent research regarding CRKP infections. Thus, the study was conducted to characterize CRKP that has been isolated in our setting. Methods: A total of 321 K. pneumoniae were included in the study. Each isolate went through an identification process using an automated identification system. Phenotypic characterization was determined using disk diffusion, modified Hodge test, Epsilometer test, and inhibitor combined disk test. Further detection of carbapenemase genes was carried out using polymerase chain reaction and confirmed by gene sequence analysis. Results: All together, 13 isolates (4.05% were CRKP and the majority of them were resistant to tested antibiotics except colistin and tigercycline. Among seven different carbapenemase genes studied (bla KPC, bla IMP, bla SME, bla NDM, bla IMI, bla VIM, and bla OXA, only two, bla IMP4 (1.87% and bla NDM1 (2.18%, were detected in our setting. Conclusion: Evidence suggests that the prevalence of CRKP in our setting is low, and knowledge of Carbapenem-resistant Enterobacteriaceae and CRKP has improved and become available among clinicians.

  8. Epidemic Plasmid Carrying bla CTX-M-15 in Klebsiella penumoniae in China

    OpenAIRE

    Zhuo, Chao; Li, Xiao-Qiang; Zong, Zhi-yong; Zhong, Nan-shan

    2013-01-01

    Objective To investigate the local epidemiology of Klebsiella penumoniae carrying bla CTX-M-15 in southern China and to characterize the genetic environment of bla CTX-M-15. Methods PCR and DNA sequencing were used to detect and characterize the genetic contexts of bla CTX-M-15. The clonal relatedness of isolates carrying bla CTX-M-15 was determined by pulse-field gel electrophoresis. Conjugative plasmids carrying bla CTX-M-15 were obtained by mating and were further subject to restriction an...

  9. A Multiagent System for Integrated Detection of Pharmacovigilance Signals.

    Science.gov (United States)

    Koutkias, Vassilis; Jaulent, Marie-Christine

    2016-02-01

    Pharmacovigilance is the scientific discipline that copes with the continuous assessment of the safety profile of marketed drugs. This assessment relies on diverse data sources, which are routinely analysed to identify the so-called "signals", i.e. potential associations between drugs and adverse effects, that are unknown or incompletely documented. Various computational methods have been proposed to support domain experts in signal detection. However, recent comparative studies illustrated that current methods exhibit high false-positive rates, significantly variable performance across different datasets used for analysis and events of interest, but also complementarity in their outcomes. In this regard, in order to reinforce accurate and timely signal detection, we elaborated through an agent-based approach towards systematic, joint exploitation of multiple heterogeneous signal detection methods, data sources and other drug-related resources under a common, integrated framework. The approach relies on a multiagent system operating based on a collaborative agent interaction protocol, aiming to implement a comprehensive workflow that comprises of method selection and execution, as well as outcomes' aggregation, filtering, ranking and annotation. This paper presents the design of the proposed multiagent system, discusses implementation issues and demonstrates the applicability of the proposed solution in an example signal detection scenario. This work constitutes a step towards large-scale, integrated and knowledge-intensive computational signal detection. PMID:26590975

  10. Rapid and Simultaneous Detection of Genes Encoding Klebsiella pneumoniae Carbapenemase (blaKPC) and New Delhi Metallo-β-Lactamase (blaNDM) in Gram-Negative Bacilli

    OpenAIRE

    Cunningham, Scott A.; Noorie, Tabassum; Meunier, Daniele; Woodford, Neil; Patel, Robin

    2013-01-01

    We present a duplex, real-time PCR assay for detection of Klebsiella pneumoniae carbapenemase (blaKPC) and New Delhi metallo-β-lactamase (blaNDM) genes. Accuracy was assessed with 158 Gram-negative bacillary isolates, including 134 carbapenemase producers. The assay had 100% sensitivity and specificity compared with reference methods and a turnaround time of 90 min.

  11. Co-Carriage of blaKPC-2 and blaNDM-1 in Clinical Isolates of Pseudomonas aeruginosa Associated with Hospital Infections from India.

    Directory of Open Access Journals (Sweden)

    Deepjyoti Paul

    Full Text Available Global spread of KPC poses to be a serious threat complicating treatment options in hospital settings. The present study investigates the genetic environment of blaKPC-2 among clinical isolates of Pseudomonas aeruginosa from a tertiary referral hospital of India. The study isolates were collected from different wards and clinics of Silchar Medical College and Hospital, India, from 2012-2013. The presence of blaKPC was confirmed by genotypic characterization followed by sequencing. Cloning of the blaKPC-2 gene was performed and the genetic environment of this gene was characterized as well. Transferability of the resistance gene was determined by transformation assay and Southern hybridization. Additionally, restriction mapping was also carried out. Two isolates of P. aeruginosa were found to harbor blaKPC-2, were resistant towards aminoglycosides, quinolone and β-lactam-β-lactamase inhibitor combination. In both the isolates, the resistance determinant was associated with class 1 integron and horizontally transferable. Both the isolates were co-harboring blaNDM-1. The first detection of this integron mediated blaKPC-2 coexisting with blaNDM-1 in P. aeruginosa from India is worrisome, and further investigation is required to track the gene cassette mediated blaKPC-2 in terms of infection control and to prevent the spread of this gene in hospitals as well as in the community.

  12. Increasing secondary bacterial infections with Enterobacteriaceae harboring blaCTX-M-15 and blaCMY-6 in patients with bronchogenic carcinoma:an emerging point of concern

    Institute of Scientific and Technical Information of China (English)

    Mohammed Shahid; Abida Malik; Rakesh Bhargava

    2011-01-01

    Objective: To look for secondary bacterial infections in bronchogenic carcinoma (BCA) with resistant organisms harboring bla genes considering the paucity of relevant studies. Methods:A total of 137 confirmed cases of BCA and 34 healthy volunteers were studied for the occurrence and prevalence of blaCTX-M and and blaAmpC harboring-enterobacteriaceae. A subset of these patients (n=69) was previously reported for the secondary infection with the Aspergillus species. Bronchoalveolar lavages (BAL) were subjected for bacterial and fungal cultures and the bacterial isolates were screened by multiplex PCRs for the presence of blaCTX-M and blaAmpC. The isolates were also screened for the association of insertion sequence (IS26) by PCR and characterized by RAPD for any clonal relatedness. Results: A total of 143 bacterial isolates were obtained from 137 BAL specimens of BCA patients. The Enterobacteriaceae-isolates were multidrug-resistant showing concomitant resistance to fluoroquinolones and aminoglycosides. Both blaCTX-M and blaAmpC of CIT family were detected in 77.4% and 27.4% isolates, respectively. Sequencing revealed the presence of blaCTX-M-15 and blaCMY-6. Twenty one percent of the isolates were simultaneously harboring blaampC and blaCTX-M-15. IS26 PCR and RAPD typing revealed the presence of diverse bacterial population but no predominant clone was identified. The present study also suggests strong association of aspergillosis with lung cancer and further strengthens the potential use of non-validated serological tests suggested earlier. Conclusions: We emphasize that all patients of bronchogenic carcinoma should also be screened for secondary bacterial infections, along with secondary fungal infections, so as to introduce early and specific antimicrobial therapy and to prevent unwanted deaths.

  13. Spread of Enterobacter cloacae carrying blaNDM-1, blaCTX-M-15, blaSHV-12 and plasmid-mediated quinolone resistance genes in a surgical intensive care unit in Croatia.

    Science.gov (United States)

    Petrosillo, N; Vranić-Ladavac, M; Feudi, C; Villa, L; Fortini, D; Barišić, N; Bedenić, B; Ladavac, R; D'Arezzo, S; Andrašević, A Tambić; Capone, A

    2016-03-01

    The objective of this study was to describe a hospital cluster of NDM-1-producing Enterobacter cloacae infections observed in the surgical intensive care unit (ICU) of a tertiary-care hospital at Pula, Croatia. NDM-1-producing E. cloacae strains isolated from clinical samples were screened by PCR for the presence of carbapenemases. Genetic relatedness of NDM-1-producing E. cloacae strains was determined by multilocus sequence typing (MLST). During the period October 2013 to April 2014, four patients, with overlapping hospital stay in the surgical ICU, developed severe infections caused by E. cloacae demonstrated to produce carbapenemases. According to MLST, all strains belonged to ST133 and were positive by PCR for the blaNDM-1 carbapenemase gene, for blaCTX-M-15 and blaSHV-12 extended-spectrum β-lactamase (ESBL) genes, and for blaTEM-1 and blaOXA-1 narrow-spectrum β-lactamase genes. They were negative for other carbapenemases genes including blaOXA-48, blaVIM and blaKPC as well as for AmpC and the armA and rmtB aminoglycoside resistance genes. All strains were positive for the HI2 replicon, suggesting that an IncHI2 plasmid is likely the plasmid carrying the blaNDM-1 gene. Infection control measures were implemented after the first case although they were not effective in avoiding spread of this organism to other patients in the surgical ICU. In conclusion, the evolving epidemiology of NDM-producing micro-organisms and the interspecies diffusion of this resistance mechanism to emerging pathogens such as E. cloacae necessitate the setting up of strong and urgent joint measures to control the spread of NDM carbapenemase especially in the ICU setting. PMID:27436392

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

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    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.

  15. Safety profile of etifoxine: A French pharmacovigilance survey.

    Science.gov (United States)

    Cottin, Judith; Gouraud, Aurore; Jean-Pastor, Marie-Josèphe; Dautriche, Anne Disson-; Boulay, Charlène; Geniaux, Hélène; Auffret, Marine; Bernard, Nathalie; Descotes, Jacques; Vial, Thierry

    2016-04-01

    Etifoxine chlorhydrate is a benzoxazine derivative approved for the treatment of psychosomatic manifestations of anxiety since 1979. Previously labeled adverse drug reactions (ADRs) only include drowsiness, benign cutaneous reactions, and acute hypersensitivity reactions. The objectives were to examine recent data on etifoxine-related ADR by reviewing Individual Case Safety Reports (ICSRs) recorded in France especially unexpected ADRs. Etifoxine-related ICSRs were extracted from the French Pharmacovigilance database from 1 January 2000 to 30 April 2012 and data from the marketing authorization holder up to 31 December 2011 were also obtained. Of the 350 cases retained for analysis, 123 (35%) were considered serious. Dermatological or acute hypersensitivity reactions were the most frequent ADRs (59%) mainly isolated cutaneous eruptions. However, there were 24 cases of severe toxidermia (DRESS in 5, erythema multiforme in 10 and Stevens-Johnson syndrome in 5) with etifoxine as the most suspected drug in 11 patients, and seven cases of vasculitis or serum sickness-like reaction. Liver disorders were reported in 34 patients of whom 25 developed acute hepatitis with a cytolytic biological pattern in 16. Other unexpected ADRs included 16 reversible cases of metrorrhagia with positive rechallenge in 5, and three cases of biopsy-proven microscopic colitis of which one recurred after etifoxine re-administration. Although etifoxine has been marketed for more than 30 years, this survey identified a number of unexpected and sometimes serious ADRs, in particularly severe toxidermia and acute cytolytic hepatitis. A recent update of the French etifoxine summary of the product characteristics (SPC) was based on these findings. PMID:26588183

  16. Clinical pharmacology: special safety considerations in drug development and pharmacovigilance.

    Science.gov (United States)

    Atuah, Kwame N; Hughes, Dyfrig; Pirmohamed, Munir

    2004-01-01

    The dose of a drug is a major determinant of its safety, and establishing a safe dose of a novel drug is a prime objective during clinical development. The design of pre-marketing clinical trials precludes the representation of important subpopulations such as children, the elderly and people with co-morbidities. Therefore, postmarketing surveillance (PMS) activities are required to monitor the safety profile of drugs in real clinical practice. Furthermore, individual variations in pharmacogenetic profiles, the immune system, drug metabolic pathways and drug-drug interactions are also important factors in the occurrence of adverse drug reactions. Thus, the safety of a drug is a major clinical consideration before and after it is marketed. A multidisciplinary approach is required to enhance the safety profile of drugs at all stages of development, including PMS activities. Clinical pharmacology encompasses a range of disciplines and forms the backbone of drug safety consideration during clinical drug development. In this review we give an overview of the clinical drug development process and consider its limitations. We present a discussion of several aspects of clinical pharmacology and their application to enhancing drug safety. Pharmacokinetic-pharmacodynamic modelling provides a method of predicting a clinically safe dose; consideration of drug pharmacokinetics in special populations may enhance safe therapeutics in a wider spectrum of patients, while pharmacogenetics provides the possibility of genotype-specific therapeutics. Pharmacovigilance activities are also discussed. Given the complex nature and unpredictability of type B reactions, PMS activities are crucial in managing the risks drugs pose to the general population. The various aspects of clinical pharmacology discussed make a strong case for this field as the backbone of optimising and promoting safe development and use of drugs. PMID:15154826

  17. Transcriptional Analysis of the blaCTX-M-2 Gene in Salmonella enterica Serovar Infantis

    OpenAIRE

    Di Conza, José A.; Gutkind, Gabriel O.; Mollerach, Marta E.; Ayala, Juan A.

    2005-01-01

    Transcriptional organization of blaCTX-M-2 present in a multiresistance plasmid of Salmonella enterica serovar Infantis suggests the presence of more than one promoter involved in the expression of the β-lactamase gene. At least two blaCTX-M-2-specific mRNAs (near to 1 kb and 5 kb) were evidenced. Two +1 signals were detected at −22 bp and −59 bp of blaCTX-M-2 defining two putative promoters.

  18. Investigation of diversity of plasmids carrying the blaTEM-52 gene

    DEFF Research Database (Denmark)

    Bielak, Eliza Maria; Bergenholtz, Rikke D.; Jørgensen, Mikael Skaanning; Sørensen, Søren J.; Hansen, Lars H.; Hasman, Henrik

    2011-01-01

    OBJECTIVES: To investigate the diversity of plasmids that carry blaTEM-52 genes among Escherichia coli and Salmonella enterica originating from animals, meat products and humans. METHODS: A collection of 22 blaTEM-52-encoding plasmids was characterized by restriction fragment length polymorphism...... demonstrated dissemination of blaTEM-52 in Denmark (imported meat from Germany), France, Belgium and the Netherlands from 2000 to 2006 by mainly two different plasmids, one encoding blaTEM-52b (IncX1A, 45 kb) and the other blaTEM-52c (IncI1, 80 kb). In addition, blaTEM-52b was also found to be located on...... various other plasmids belonging to IncA/C and IncL/M, while blaTEM-52c was found on IncN-like as well as on IncR plasmids. In the majority of cases (n = 21) the blaTEM-52 gene was located on a Tn3 transposon. Seven out of 10 blaTEM-52 plasmids tested in conjugation experiments were shown to be capable of...

  19. Complete sequencing of an IncX3 plasmid carrying blaNDM-5 allele reveals an early stage in the dissemination of the blaNDM gene

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    M Krishnaraju

    2015-01-01

    Full Text Available Purpose: The aim of the present study was to perform molecular characterisation of the blaNDM plasmids and to understand the mechanism of its spread among pathogenic bacteria. Materials and Methods: Seventy-six non-repetitive carbapenem-resistant isolates which were collected during Nov 2011 to April 2013 from four hospitals in Chennai were analyzed for the presence of the blaNDM gene by PCR. Further, the genetic context of the blaNDM gene was analyzed by PCR specific to ISAba125 and bleMBL gene. One of the blaNDM plasmid was completely sequenced in the Illumina HiSeq platform. Results: Twenty-three isolates consisting of 8 Escherichia coli, 8 Klebsiella pneumoniae, 3 Klebsiella oxytoca, 3 Acinetobacter baumanii and 1 Pseudomonas aeruginosa were found to carry the blaNDM gene. In 18 isolates the blaNDM gene was associated with a bleMBL gene and the ISAba125 element. The complete sequencing of pNDM-MGR194 revealed an IncX3 replication type plasmid, with a length of 46,253 bp, an average GC content of 47% and 59 putative ORFs. The iteron region contained the blaNDM5 gene and the bleMBL , trpF and dsbC genes downstream and an IS5 inserted within the ISAba125 element upstream. Conclusion: This is the first report where the blaNDM gene insertion in a plasmid is not accompanied by other resistance gene determinants. These observations suggest that the IncX3 plasmid pNDM-MGR194 is an early stage in the dissemination of the blaNDM .

  20. blaCTX-M,blaTEM, andblaSHV inEnterobacteriaceae from North-Indian tertiary hospital:high occurrence of combination genes

    Institute of Scientific and Technical Information of China (English)

    Mohammed Shahid; Anuradha Singh; Farrukh Sobia; Mohammad Rashid; Abida Malik; Indu Shukla; Haris Manzoor Khan

    2011-01-01

    Objective:To delineate the frequency of occurrence ofblaCTX-M,blaTEM, andblaSHV in Enterobacteriaceae from North-Indian tertiary hospital.Methods: A random collection of a subset of45Escherichia coli (E. coli) and28Klebsiella pneumoniae (K. pneumoniae) that was resistant to a third generation cephalosporin and obtained during2007-2008 was selected for detailed screening forblaCTX-M,blaTEM, andblaSHV by monoplexPCRs. The isolates demonstrating the presence of blaCTX-M alleles were characterized for the specificCTX-M-genogroup by using a multiplexPCR.Results:Resistance to cefoperazone, ceftazidime, ceftriaxone, cefotaxime, cefoxitin and piperacillin was 100% each inK. pneumoniae isolates, whereas these resistance-rates forE. coli isolates were93.1%, 83.8%, 91.9%, 93.6%, 97.3% and97.1%, respectively. Concomitant resistance to aminoglycosides, quinolones and aztreonam was also noticed. Presence of any of the bla genes (blaCTX-M,blaTEM, andblaSHV) was noticed in a total of28 (38.4%) isolates of the73isolates studied. Many isolates demonstrated occurrence of these genes in various combinations.blaCTX-M,blaTEM, andblaSHV were noticed in 28.8%,10.9% and13.7% isolates, respectively. MultiplexPCR inblaCTX-Mharboring isolates demonstrated the presence ofCTX-M-Genogroup-1 and sequencing for the specificCTX-M-type revealed presence ofCTX-M-15 type. RAPD typing showed wide diversity in isolates.Conclusions:This is amongst the premier report describing the simultaneous occurrence ofblaTEM,blaSHV, andblaampC in IndianEnterobacteriaceae and that wider dissemination of these genes, as demonstrated by diversity of isolates, raises concern and emphasizes a need for extensive search for the presence of these gene pools in Indian subcontinent.

  1. Validation of signal impact assessment tool in order to explore pharmacovigilance signals' follow-up actions

    NARCIS (Netherlands)

    Rolfes, Leàn; Kolfschoten, Judith; Van Hunsel, Florence; Van Puijenbroek, Eugene; van Grootheest, Kees

    2014-01-01

    Background: To determine which actions are advisable for signals arising from a spontaneous reporting system, the Netherlands Pharmacovigilance Centre Lareb uses a Signal Impact Assessment Tool (SIAT). It categorizes signals into one of four categories: strong/moderate signal strength and similarly

  2. 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 org

  3. Classification of Recombinant Biologics in the EU: Divergence between National Pharmacovigilance Centers

    NARCIS (Netherlands)

    Klein, Kevin; De Bruin, Marie L.; Broekmans, Andre W.; Stolk, Pieter

    2015-01-01

    Background and Objective: Biological medicinal products (biologics) are subject to specific pharmacovigilance requirements to ensure that biologics are identifiable by brand name and batch number in adverse drug reaction (ADR) reports. Since Member States collect ADR data at the national level befor

  4. Pharmacovigilance implemented by patients: A necessity in the 21st century.

    Science.gov (United States)

    Lafond, Jean

    2016-04-01

    Pharmacovigilance should become a well-thought-out reflex for each of us, for any drugs taken on prescription or by self-medication. The issue of pharmacovigilance should naturally take its place in the dialogue between patients and health professionals, through advice given before medication is taken. Patients need to be told the importance of notifying any adverse drug reactions (ADRs). Pharmacovigilance would then become a post-hoc way of protecting patients. The importance of using pharmacovigilance should be promoted by emphasizing the fact that the life of a drug really starts after its marketing. This state of mind could be reinforced by a wider advertising campaign on the possibility of notifying the relevant authorities of any ADRs. Patient associations should encourage and help their members to do this. Notifying any ADRs should become a concern for all medical and paramedical staff: those who prescribe drugs, those who dispense them (pharmacists or pharmacy assistants), those who administer them (nurses), but also the consumers (patients) whose place is becoming more and more prominent. PMID:27080846

  5. Knowledge, attitude and practice of pharmacovigilance among private healthcare professionals of Rajkot city

    Directory of Open Access Journals (Sweden)

    Bharti N. Karelia

    2014-02-01

    Conclusions: There was a great need to create awareness among the private doctors to improve the reporting of ADRs. Even though ADR reporting make compulsory by doctors unless there is no strict government rules and regulation success of pharmacovigilance programme is questionable. [Int J Basic Clin Pharmacol 2014; 3(1.000: 50-53

  6. 3D Pharmacophoric Similarity improves Multi Adverse Drug Event Identification in Pharmacovigilance

    Science.gov (United States)

    Vilar, Santiago; Tatonetti, Nicholas P.; Hripcsak, George

    2015-03-01

    Adverse drugs events (ADEs) detection constitutes a considerable concern in patient safety and public health care. For this reason, it is important to develop methods that improve ADE signal detection in pharmacovigilance databases. Our objective is to apply 3D pharmacophoric similarity models to enhance ADE recognition in Offsides, a pharmacovigilance resource with drug-ADE associations extracted from the FDA Adverse Event Reporting System (FAERS). We developed a multi-ADE predictor implementing 3D drug similarity based on a pharmacophoric approach, with an ADE reference standard extracted from the SIDER database. The results showed that the application of our 3D multi-type ADE predictor to the pharmacovigilance data in Offsides improved ADE identification and generated enriched sets of drug-ADE signals. The global ROC curve for the Offsides ADE candidates ranked with the 3D similarity score showed an area of 0.7. The 3D predictor also allows the identification of the most similar drug that causes the ADE under study, which could provide hypotheses about mechanisms of action and ADE etiology. Our method is useful in drug development, screening potential adverse effects in experimental drugs, and in drug safety, applicable to the evaluation of ADE signals selected through pharmacovigilance data mining.

  7. Knowledge, perception and practice of pharmacovigilance among community pharmacists in South India

    Directory of Open Access Journals (Sweden)

    Prakasam A

    2012-12-01

    Full Text Available Pharmacovigilance has not progressed well in India and the concept is still in its infancy. India rates below 1% in pharmacovigilance as against the world rate of 5%. Objectives: The aim of our study was to evaluate the knowledge, perception and practice of pharmacovigilance among registered community pharmacists in Hyderabad, India. Methods: This was a prospective study to find out the knowledge, perception and practice of adverse drug reaction reporting among community pharmacists. It was conducted by a face to face questionnaire and the convenience factor of the pharmacist was taken into consideration. Results: From the 650 questionnaire administered to community pharmacists, 347 (53.3% were returned completely filled questionnaires. A number of 120 (34.6% pharmacists could define the term ‘pharmacovigilance’ to an acceptable extent and 119 (34.3% knew about the National Pharmacovigilance Programme in India. 96 (27.7% had good knowledge, 36(10.4% had fair knowledge and 215(61.9% had poor knowledge about pharmacovigilance. We have found that 196 (56.5% had good perception, 94(27.1% had fair perception and 57(16.4% had poor perception. Only 41(11.8% pharmacists ever reported an ADR and the other never reported ADR. The majority of pharmacists 223(64.3% felt that the AE is very simple and non-serious and hence did not report. Pharmacists have poor knowledge, good perception and negligibly low reporting rates. Conclusions: Incorporation of ADR reporting concepts in education curriculum, training of pharmacists and voluntary participation of pharmacists in ADR reporting is very crucial in achieving the safety goals and safeguarding public health.

  8. ISEcp1B-Mediated Transposition of blaCTX-M in Escherichia coli

    OpenAIRE

    Poirel, Laurent; Lartigue, Marie-Frédérique; Decousser, Jean-Winoc; Nordmann, Patrice

    2005-01-01

    Several expanded-spectrum β-lactamase blaCTX-M genes are associated with ISEcp1-like elements in Enterobacteriaceae. We found that ISEcp1B was able to mobilize the adjacent blaCTX-M-19 gene by a transpositional mechanism in Escherichia coli by recognizing a variety of DNA sequences as right inverted repeats.

  9. ISEcp1B-Mediated Transposition of blaCTX-M in Escherichia coli

    Science.gov (United States)

    Poirel, Laurent; Lartigue, Marie-Frédérique; Decousser, Jean-Winoc; Nordmann, Patrice

    2005-01-01

    Several expanded-spectrum β-lactamase blaCTX-M genes are associated with ISEcp1-like elements in Enterobacteriaceae. We found that ISEcp1B was able to mobilize the adjacent blaCTX-M-19 gene by a transpositional mechanism in Escherichia coli by recognizing a variety of DNA sequences as right inverted repeats. PMID:15616333

  10. Uterine Perforation with the Levonorgestrel-Releasing Intrauterine Device Analysis of Reports from Four National Pharmacovigilance Centres

    NARCIS (Netherlands)

    van Grootheest, Kees; Sachs, Bernhardt; Harrison-Woolrych, Mira; Caduff-Janosa, Pia; van Puijenbroek, Eugene

    2011-01-01

    Background: Levonorgestrel-releasing intrauterine devices (LNG-IUD) are commonly used for contraception and other indications in many countries. National pharmacovigilance centres have been receiving reports from healthcare professionals and patients of uterine perforation associated with the use of

  11. Comparative Analysis of IncHI2 Plasmids Carrying blaCTX-M-2 or blaCTX-M-9 from Escherichia coli and Salmonella enterica Strains Isolated from Poultry and Humans▿

    OpenAIRE

    Fernández, Aurora García; Cloeckaert, Axel; Bertini, Alessia; Praud, Karine; Doublet, Benoît; Weill, François-Xavier; Carattoli, Alessandra

    2007-01-01

    Salmonella enterica blaCTX-M-2 and blaCTX-M-9 plasmid backbones from isolates from Belgium and France were analyzed. The blaCTX-M-2-plasmids from both human and poultry isolates were related to the IncHI2 pAPEC-O1-R plasmid, previously identified in the United States in avian Escherichia coli strains; the blaCTX-M-9 plasmids were closely related to the IncHI2 R478 plasmid.

  12. Joint medicine-information and pharmacovigilance services could improve detection and communication about drug-safety problems

    OpenAIRE

    Schjøtt, Jan Didrik

    2014-01-01

    Jan Schjøtt,1–3 Jenny Bergman3 1Section of Clinical Pharmacology, Laboratory of Clinical Biochemistry, Haukeland University Hospital, 2Institute of Clinical Science, Faculty of Medicine and Dentistry, University of Bergen, 3Regional Medicines Information and Pharmacovigilance Centre (RELIS Vest), Haukeland University Hospital, Bergen, Norway Background: RELIS is a Norwegian network of four regional medicine-information and pharmacovigilance centers where pharmacists and ...

  13. Molecular detection of metallo-β-lactamase genes, blaIMP-1, blaVIM-2 and blaSPM-1 in imipenem resistant Pseudomonas aeruginosa isolated from clinical specimens in teaching hospitals of Ahvaz, Iran

    Directory of Open Access Journals (Sweden)

    Mojtaba Moosavian

    2015-10-01

    Full Text Available Background and Objectives: Carbapenem resistant Pseudomonas aeruginosa is a serious cause of nosocomial infections.The main purpose of the study is to determine the prevalence rate of imipenem resistant Pseudomonas aeruginosa carryingmetallo- beta- lactamase (MBL genes.Material and Methods: 236 Pseudomonas aeruginosa isolates were collected from teaching hospitals of Ahvaz Universityof Medical Sciences during a period of 9 months in 2012. These strains were identified using conventional microbiologicaltests. The susceptibility of isolates to antibiotics were assessed using disk diffusion test. The IMP-EDTA combination diskphenotypic test was performed for detection of MBL producing strains. Finally, polymerase chain reaction (PCR wasperformed to detect MBL genes, blaIMP-1, blaVIM-2 and blaSPM-1 in imipenem resistant strains.Results: Out of 236 examined isolates, 122 isolates (51.4% were resistant to imipenem. The IMP-EDTA combination testshowed that among 122 imipenem resistant strains, 110 strains (90% were phenotipically MBL producers. Additionally, theresults of PCR method showed that 2 strains (1.6% and 67strains (55% of imipenem resistant Pseudomonas aeruginosaisolates contained blaVIM-2 and blaIMP-1 genes respectively. No SPM-1gene was found in the examined samples.Conclusion: Resistance of P. aeruginosa isolates to imipenem due to MBL enzymes is increasing in Ahavaz. Becauseof clinical significance of this kind of resistance, rapid detection of MBL producing strains and followed by appropriatetreatment is necessary to prevent the spreading of these organisms.

  14. A questionnaire based study to assess knowledge, attitude and practice of pharmacovigilance among undergraduate medical students in a Tertiary Care Teaching Hospital of South India

    OpenAIRE

    Bikash Ranjan Meher; N Joshua; Asha, B.; Deepali Mukherji

    2015-01-01

    Objectives: Spontaneous reporting of adverse drug reaction (ADR) is the backbone of pharmacovigilance program. Under reporting by prescribers is still exist. This study was done to assess the knowledge, attitude, and practice (KAP) of undergraduate students about pharmacovigilance. Materials and Methods: It was a questionnaire-based cross-sectional study. Study tool was a validated questionnaire containing 21 questions to evaluate KAP of pharmacovigilance among undergraduate medical students ...

  15. A comparative evaluation of different teaching aids among fourth term medical students to improve the knowledge, attitude and perceptions about pharmacovigilance: An experimental study

    OpenAIRE

    Bagewadi, Harish G; Rekha M S; Sabari Anandh JV

    2015-01-01

    Objectives: The Study was designed to assess the awareness of Pharmacovigilance and Adverse Drug Reactions (ADR’s) and to evaluate the effectiveness of different teaching aids.Materials and Methods: This was a questionnaire-based pre- and post-test on (KAP) Knowledge, Attitude, Perception about pharmacovigilance. Students were given handouts regarding pharmacovigilance and ADR reporting one week before the educational interventions. Fourth term medical students (n=72) participated in the stud...

  16. 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. PMID:26147850

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

    OpenAIRE

    2015-01-01

    Objectives: To explore the challenges facing pharmacovigilance in Saudi Arabia and formulate recommendations to improve it from the perspective of healthcare professionals in Saudi Arabia. Methods: 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 w...

  18. Correlation versus Causation? Pharmacovigilance of the Analgesic Flupirtine Exemplifies the Need for Refined Spontaneous ADR Reporting

    OpenAIRE

    Anderson, Nora; Borlak, Juergen

    2011-01-01

    Annually, adverse drug reactions result in more than 2,000,000 hospitalizations and rank among the top 10 causes of death in the United States. Consequently, there is a need to continuously monitor and to improve the safety assessment of marketed drugs. Nonetheless, pharmacovigilance practice frequently lacks causality assessment. Here, we report the case of flupirtine, a centrally acting non-opioid analgesic. We re-evaluated the plausibility and causality of 226 unselected, spontaneously rep...

  19. Combining quantitative and qualitative methods in signal detection and evaluation in pharmacovigilance.

    OpenAIRE

    Perry, Michelle Phyllis Agnes

    2013-01-01

    Background: Pharmacovigilance (PV) is the science and activities involved in monitoring and developing the safety profile of all marketed medicines. Adverse drug reaction (ADRs) for medicinal products can be identified through post-marketing studies by methods of signal detection. Traditional, qualitative methods involve clinical review of cases, and coupled with modern, quantitative methods which have evolved as PV has grown, may help surveillance of the large number of medicinal products on...

  20. Pharmacovigilance in India, Uganda and South Africa with reference to WHO’s minimum requirements

    OpenAIRE

    Karen Maigetter; Pollock, Allyson M; Abhay Kadam; Kim Ward; Weiss, Mitchell G.

    2015-01-01

    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 r...

  1. Rapid Detection of blaKPC Carbapenemase Genes by Real-Time PCR▿

    OpenAIRE

    Hindiyeh, Musa; Smollen, Gill; Grossman, Zehava; Ram, Daniela; Davidson, Yehudit; Mileguir, Fernando; Vax, Marina; Ben David, Debbie; Tal, Ilana; Rahav, Galia; Shamiss, Ari; Mendelson, Ella; Keller, Nathan

    2008-01-01

    Carbapenem resistance among Enterobacteriaceae is an emerging problem worldwide. Klebsiella pneumoniae carbapenemase (blaKPC) enzymes are among the most common β-lactamases described. In this study, we report the development and validation of a real-time PCR (q-PCR) assay for the detection of blaKPC genes using TaqMan chemistry. The q-PCR amplification of blaKPC DNA was linear over 7 log dilutions (r2 = 0.999; slope, 3.54), and the amplification efficiency was 91.6%. The q-PCR detection limit...

  2. 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.

  3. Novel variant (bla(VIM-4)) of the metallo-beta-lactamase gene bla(VIM-1) in a clinical strain of Pseudomonas aeruginosa.

    Science.gov (United States)

    Pournaras, Spyros; Tsakris, Athanassios; Maniati, Maria; Tzouvelekis, Leonidas S; Maniatis, Antonios N

    2002-12-01

    A Pseudomonas aeruginosa isolate highly resistant to carbapenems was collected from a patient with postsurgical cerebrospinal infection in Greece. The isolate carried a class 1 integron that contained as a sole cassette the gene bla(VIM-4), a novel variant of bla(VIM-1), with one nucleotide difference resulting in a Ser-to-Arg change at amino acid position 175 of the VIM-1 enzyme. This is the first detection of a VIM-1 variant after its appearance in Italy. PMID:12435718

  4. The establishment of a duplex real-time PCR assay for rapid and simultaneous detection of bla NDM and bla KPC genes in bacteria

    OpenAIRE

    Zheng, Fen; Sun, Jingjing; Cheng, Cancan; Rui, Yongyu

    2013-01-01

    The latest threat of multidrug-resistant Gram-negative bacteria corresponds to the emergence of carbapenemase New Delhi metallo-β-lactamase (NDM) and Klebsiella pneumoniae carbapenemase (KPC) producers. Rapid molecular detection is essential to limit their spread. In this study, a duplex real-time polymerase chain reaction (PCR) that was specific for the detection of bla NDM and blaKPC with the same limit of detection of ten plasmid copies was developed. The assay was linear over eight log di...

  5. Multicenter Evaluation of a New DNA Microarray for Rapid Detection of Clinically Relevant bla Genes from ? -Lactam-Resistant Gram-Negative Bacteria

    OpenAIRE

    Bogaerts, P.; Hujer, A.M.; Naas, T.; de Castro, R. R.; A. Endimiani; Nordmann, P.; Glupczynski, Y.; Bonomo, R.A.

    2011-01-01

    A new commercial low-density microarray which identifies common extended-spectrum β-lactamase plasmid-mediated cephalosporinase genes, as well as carbapenemase (blaKPC and blaNDM) genes, was evaluated. We tested 207 clinical and reference/collection isolates of the Enterobacteriaceae possessing different bla genes. Overall, the sensitivity and specificity of the microarray were 100% for the detection of the plasmid-mediated blaAmpC, blaKPC, and blaNDM genes using bla gene sequencing as the re...

  6. A descriptive study of knowledge of Pharmacovigilance and adverse drug reactions among second professional undergraduate medical students in a teaching hospital

    Directory of Open Access Journals (Sweden)

    Rehana Tabassum

    2015-10-01

    Conclusions: Our study revealed that there are gaps between knowledge regarding ADRs and Pharmacovigilance that needs to be addressed on priority basis for the success of the Pharmacovigilance program and better clinical management of patients in general. [Int J Basic Clin Pharmacol 2015; 4(5.000: 1016-1020

  7. Multilocus Sequence Types of Carbapenem-Resistant Pseudomonas aeruginosa in Singapore Carrying Metallo-β-Lactamase Genes, Including the Novel blaIMP-26 Gene▿

    OpenAIRE

    Koh, Tse Hsien; Khoo, Cheng Teng; Tan, Thuan Tong; Mohamed Arshad, Mohamed Amir Bin; Ang, Li Ping; Lau, Lee Jin; Hsu, Li-Yang; Ooi, Eng Eong

    2010-01-01

    Nine imipenem-resistant Pseudomonas aeruginosa isolates were found to contain a variety of metallo-β-lactamase genes, including blaIMP-1, blaIMP-7, blaVIM-2, blaVIM-6, and the novel blaIMP-26. Multilocus sequence typing showed a diversity of sequence types. Comparison with isolates from an earlier study showed that the epidemic clones from 2000 have not become established.

  8. 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

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

    Science.gov (United States)

    Sharma, Pramod Kumar; Singh, Surjit; Dhamija, Puneet

    2016-01-01

    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.

  10. 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.

  11. 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

  12. Pharmacovigilance: What to do if you see an adverse reaction and the consequences

    Energy Technology Data Exchange (ETDEWEB)

    Stenver, Doris I. [Danish Medicines Agency, 1 Axel Heides Gade, DK-2300 Copenhagen S (Denmark)], E-mail: dis@dkma.dk

    2008-05-15

    With outset in a recently identified safety signal - the association between gadolinium and nephrogenic systemic fibrosis - the article highlights the aim of pharmacovigilance and provides an overview of the European regulatory drug safety network. The main objective of the article is to provide appropriate information concerning the regulatory environment to health care professionals working in a clinical setting. The important role played by health care professionals in drug safety surveillance, as well as examples of how the regulatory decision making is functioning in practice, are described and exemplified by means of the gadolinium case.

  13. Pharmacovigilance: What to do if you see an adverse reaction and the consequences

    International Nuclear Information System (INIS)

    With outset in a recently identified safety signal - the association between gadolinium and nephrogenic systemic fibrosis - the article highlights the aim of pharmacovigilance and provides an overview of the European regulatory drug safety network. The main objective of the article is to provide appropriate information concerning the regulatory environment to health care professionals working in a clinical setting. The important role played by health care professionals in drug safety surveillance, as well as examples of how the regulatory decision making is functioning in practice, are described and exemplified by means of the gadolinium case

  14. High dose artesunate in combination with mefloquine: pharmacovigilance in the Venezuelan Amazon.

    Science.gov (United States)

    Metzger, W G; Magris, M; Vivas-Martínez, S; Giron, A; Brooms, J D; Villalobos, N; Cruz, L; Peña Pimentel, F N; Perez, L; España, R

    2012-03-01

    Forty-six patients in a remote health post of Amazonas, Venezuela, accidentally received artesunate in a dose of 10 mg/kg/day combined with mefloquine. This corresponds to the upper limit of the therapeutic range recommended by the WHO (2-10 mg/kg/day). Side effects were retrospectively investigated and a pharmacovigilance report was written. The main side effects were vomiting and diarrhea. Four patients developed complications with signs of dehydration. It is suggested to re-assess the therapeutic range of artesunate when given in combination with mefloquine and to establish a worldwide centralized antimalarial toxicity reporting system. PMID:22153748

  15. Incidence of blaNDM-1 gene in Escherichia coli isolates at a tertiary care referral hospital in Northeast India

    Directory of Open Access Journals (Sweden)

    A Bora

    2013-01-01

    Full Text Available Purpose: Increasing reports on New Delhi metallo-β-lactamase-1 (NDM-1 producing Escherichia coli constitute a serious threat to global health since it is found to be highly resistant to most of the currently available antibiotics including carbapenems. This study has been performed to find out the incidence blaNDM-1 in E. coli isolates recovered from the various clinical samples at a tertiary care referral hospital in Northeast India. Materials and Methods: A total of 270 non-duplicated E. coli isolates were recovered from the various clinical samples at a tertiary care referral hospital in Northeast India. All isolates with reduced susceptibility to meropenem or ertapenem (diameter of zones of inhibition, ≤21 mm were further phenotypically confirmed for carbapenemase production by modified Hodge test. All screened isolates were also subjected to the polymerase chain reaction detection of blaNDM-1 gene and additional bla genes coding for transmission electron microscopy, SHV, CTX-M, and AmpC. Results: Out of 270 E. coli isolates, 14 were screened for carbapenemase production on the basis of their reduced susceptibility to meropenem or ertapenem. All screened isolates were found to be positive for blaNDM-1 . Each of the blaNDM-1 possessing isolate was also positive for two or more additional bla genes, such as blaTEM , blaCTX-M and blaAmpC . Phylogenetic analysis showed very less variation in blaNDM-1 gene with respect to blaNDM-1 possessing E. coli isolates from other parts of India and abroad. Conclusions: Our findings highlight the incidence of blaNDM-1 in E. coli isolates with a reduced susceptibility to meropenem or ertapenem.

  16. Dominance of blaCTX-M within an Australian Extended-Spectrum β-Lactamase Gene Pool▿

    OpenAIRE

    Zong, Zhiyong; Partridge, Sally R.; Thomas, Lee; Iredell, Jonathan R.

    2008-01-01

    blaCTX-M genes, particularly blaCTX-M-15, are the dominant extended-spectrum β-lactamase (ESBL) genes among clinical isolates of Escherichia coli and Klebsiella pneumoniae in Sydney, Australia, where we also found one example of blaCTX-M-62, encoding a novel enzyme conferring ceftazidime resistance. ESBL genes were present in diverse community isolates and in a variety of associated conjugative plasmids.

  17. First report of the blaOXA-58 gene in a clinical isolate of Acinetobacter baumannii in Rio de Janeiro, Brazil

    Directory of Open Access Journals (Sweden)

    Deuseli Quaresma de Figueiredo

    2011-05-01

    Full Text Available Carbapenemase production is an important mechanism of carbapenem resistance among nonfermentative Gram-negative isolates. This study aimed to report the detection of blaOXA-58 gene in multiresistant clinical isolates of Acinetobacter baumannii recovered from inpatients in a public hospital. Polymerase chain reaction tests were performed to detect the blaOXA-23-like, blaOXA-24-like, blaOXA-58-like and blaOXA-51-like genes. The blaOXA-58 and blaOXA-23 genes were detected in one and three isolates, respectively. Sequencing of the blaOXA-58-like amplicon revealed 100% identity with the A. baumannii blaOXA-58 gene listed in the GenBank database. This is the first report of an OXA-58-producing A. baumannii isolate in Rio de Janeiro, Brazil.

  18. BlaSTorage: a fast package to parse, manage and store BLAST results

    Directory of Open Access Journals (Sweden)

    Orsini Massimiliano

    2013-01-01

    Full Text Available Abstract Background Large-scale sequence studies requiring BLAST-based analysis produce huge amounts of data to be parsed. BLAST parsers are available, but they are often missing some important features, such as keeping all information from the raw BLAST output, allowing direct access to single results, and performing logical operations over them. Findings We implemented BlaSTorage, a Python package that parses multi BLAST results and returns them in a purpose-built object-database format. Unlike other BLAST parsers, BlaSTorage retains and stores all parts of BLAST results, including alignments, without loss of information; a complete API allows access to all the data components. Conclusions BlaSTorage shows comparable speed of more basic parser written in compiled languages as C++ and can be easily integrated into web applications or software pipelines.

  19. Knowledge, attitude and practices toward pharmacovigilance and adverse drug reactions in postgraduate students of Tertiary Care Hospital in Gujarat

    Directory of Open Access Journals (Sweden)

    Het B Upadhyaya

    2015-01-01

    Full Text Available Being key health care professional, physicians, pharmacist and nurses have immense responsibility in reporting adverse drug reaction (ADR. Therefore, the study objective was to evaluate the knowledge, attitude and practices (KAP toward pharmacovigilance and ADRs of postgraduate students of our institute. A cross-sectional questionnaires based study was carried out in postgraduate students of the clinical department at tertiary care hospital attached with Govt. Medical College, Vadodara, Gujarat (India. A total of 22 questionnaires about KAP toward ADRs and pharmacovigilance were developed and peer viewed of all questionnaires by expert faculties from our institute. We were contacted directly to postgraduate students of respective clinical department; questionnaires were distributed and taken back after 30 min. The filled KAP questionnaires were analyzed in question wise and their percentage value was calculated by using Microsoft Excel spreadsheet. Postgraduate residents (n = 101 from different clinical departments were enrolled in the study. Average 34.83% correct and 64.08% incorrect knowledge about ADRs and pharmacovigilance and an average 90.76% students were agreed to reporting ADRs is necessary, mandatory and increased patient′s safety. Only 7.92% of postgraduate doctors were reported ADR at institute or ADR reporting center. We concluded that postgraduate students have a better attitude toward reporting ADRs, but have lack of knowledge and poor practices of ADRs. The majority of postgraduate students were felt ADR reporting and monitoring is very important, but few had ever reported ADRs because of lack of sensitization and knowledge of pharmacovigilance and ADR.

  20. Klebsiella pneumoniae carrying blaNDM-1 gene in orthopedic practice

    Directory of Open Access Journals (Sweden)

    Varsha Gupta

    2014-01-01

    Full Text Available Emergence and spread of carbapenemases in Enterobacteriaceae is a cause of concern worldwide, the latest threat being New Delhi metallo-β-lactamase (NDM-1. This report is of an orthopedic case with fracture femur managed with internal fixation and bone grafting, who subsequently developed secondary infection with Klebsiella pneumoniae harboring blaNDM-1 gene. Minimum inhibitory concentration (MIC of imipenem was ≥8 μg/ml by E-test, suggestive of carbapenemase production. Phenotypic and further genotypic detection confirmed the presence of blaNDM-1 gene. The isolate remained susceptible only to tigecycline, colistin, and polymyxin B.

  1. Blaženje podnebnih sprememb z uporabo geoinženiringa

    OpenAIRE

    Horvat, Sanja

    2015-01-01

    V diplomski nalogi se osredotočamo na vrednotenje dveh znanosti, znanosti o podnebnih spremembah in znanosti o geoinženiringu, katerega osnovni namen je blaženje podnebnih sprememb. Diplomska naloga je razdeljena na dva dela. V prvem delu podrobneje razglabljamo o znanosti in politiki podnebnih sprememb ter njihovem orodju (o t.i. klimatskih modelih), s katerim operiramo in napovedujemo razvoj podnebnih sprememb, na podlagi katerih se sprejemajo radikalne družbenopolitične odločitve za blažen...

  2. Goslar Blaž Demšar: prispevek za zgodovino slovenskega glasbilarstva:

    OpenAIRE

    Pokorn, Danilo

    1999-01-01

    The article is didiceted to Blaž Demšar (1903-1981), the best Slovene violin maker. He was the first in Slovenia who elevated violin making to the level of artistry and also archieved international recognition with his instruments Prispevek je posvečen Blažu Demšarju (1903-1981), najboljšemu slovenskemu goslarju. Goslarstvo je kot prvi na Slovenskem povzdignil na reven umetniškega oblikovanja in s svojimi instrumenti dosegel priznanje tudi v tujini

  3. Complete Genome Sequence of a Klebsiella pneumoniae Strain Carrying blaNDM-1 on a Multidrug Resistance Plasmid

    Science.gov (United States)

    Lau, Anna F.; Palmore, Tara N.; Frank, Karen M.; Segre, Julia A.

    2016-01-01

    Here, we report the genome sequence of a blaNDM-1-positive Klebsiella pneumoniae AATZP isolate cultured from a perirectal surveillance swab collected upon admission of a patient to the NIH Clinical Center in 2014. Genome sequencing of this isolate revealed three plasmids, including one carrying the blaNDM-1 gene encoding resistance to carbapenems. PMID:27417839

  4. US biosimilar pathway unlikely to be used: developers will opt for a traditional BLA filing.

    Science.gov (United States)

    Wiatr, Claudia

    2011-02-01

    In March 2010, the US passed the healthcare reform bill, including The Biologics Price Competition and Innovation Act of 2009, which established an abbreviated Biologic License Application (aBLA) pathway for the approval of biosimilars. The aBLA pathway may never be used. At the "Business of Biosimilars" meeting in Boston in September, developers of both innovator and generic biologics as well as representatives from the scientific, regulatory, and legal communities noted that, because of unclear requirements for clinical data and the need for public disclosure of proprietary data, manufacturers of generic biologics are unlikely to take advantage of the aBLA process, opting instead for a standard Biologic License Application (BLA). The implications of an unusable biosimilars pathway in the US dampen our already soft outlook for biosimilars. Companies will still develop follow-on biologics, but approved compounds will behave as new branded drugs. Biosimilars in the US are therefore not likely to lead to aggressive pricing, but will more likely mirror current situations where several similar biologics are available. For example, the interferon (IFN) β-1a products Avonex® and Rebif®, and Betaseron® (IFN β-1b) have all enjoyed >10% price increases for the last several years in spite of their clinical similarities. inThought reiterates its outlook for generic erosion of a typical biologic that projects a loss of revenue of 30% over 5 years compared to the 90% revenue loss for a typical branded small molecule. PMID:21222498

  5. Regulating medicines in Europe: the European Medicines Agency, marketing authorisation, transparency and pharmacovigilance.

    Science.gov (United States)

    Permanand, Govin; Mossialos, Elias; McKee, Martin

    2006-01-01

    Following a review process lasting almost four years, and culminating in several pieces of new European legislation, adjustments have been made to the European Union's (EU) regulatory framework for pharmaceuticals. The European Commission laid out its priorities for the review as: simplifying the authorisation system, ensuring a high quality of public health, completing the internal market in medicines, and preparing for the enlargement of the Union. Amongst the most important changes brought about by the new rules are those relating to the European drug approval procedures, the functions and operational transparency of the European Medicines Agency (EMEA), and the EU's pharmacovigilance system. This article provides a brief examination of key elements of these changes, and considers the extent to which they serve the goal of improved public health protection within the EU. PMID:16521363

  6. Adverse drug reactions to self-medication: a study in a pharmacovigilance database.

    Science.gov (United States)

    Berreni, Aurélia; Montastruc, François; Bondon-Guitton, Emmanuelle; Rousseau, Vanessa; Abadie, Delphine; Durrieu, Geneviève; Chebane, Leila; Giroud, Jean-Paul; Bagheri, Haleh; Montastruc, Jean-Louis

    2015-10-01

    Although self-medication is widely developed, there are few detailed data about its adverse drug reactions (ADRs). This study investigated the main characteristics of ADRs with self-medication recorded in the Midi-Pyrénées PharmacoVigilance between 2008 and 2014. Self-medication included first OTC drugs and second formerly prescribed drugs later used without medical advice (reuse of previously prescribed drugs). Among the 12 365 notifications recorded, 160 (1.3%) were related to SM with 186 drugs. Around three-forth of the ADRs were 'serious'. Mean age was 48.8 years with 56.3% females. The most frequent ADRs were gastrointestinal and neuropsychiatric and main drug classes involved NSAIDs, analgesics, and benzodiazepines. Phytotherapy-homeopathy accounted for 9.1% of drugs. PMID:26215671

  7. Knowledge, attitudes and practice of pharmacovigilance among health care professionals in Indonesia

    Directory of Open Access Journals (Sweden)

    Grace Wangge

    2016-07-01

    Abstract Background: World Health Organization (WHO defines pharmacovigilance (PV as a science and activities related to detection, assessment, understanding and prevention of adverse effect or any other drug related problem. It aims to enhance patient care and patient safety in drug use. Although Indonesia has joined WHO international drug safety monitoring program since 1970s, the implementation is not applied effectively especially in developing country and there are poor contribution of health care professionals (HCPs as an agent of the program. In this study, we assessed current knowledge, activities and practice of PV among HCPs in Indonesia. Methods: This is a preliminary survey using a questionnaire distributed among HCPs through health seminar and internet. The questionnaire consists of statement/question about knowledge(6, activities(6 and whether HCPs who encounter ADRs handle and report it correctly.  If the respondents gave 80 % suitable answers in the knowledge or attitude sections, they were categorized as having “good” knowledge or attitude. We analyzed whether knowledge, attitude and other characteristic had any influence on the respodents PV practice. Results: We included 109 questionnaires from 118 distributed questionnaires. Most of the respondents were females (90 respondents, 82.6%, medical doctors (100 respondents, 91.7%, and were working in primary health care level. Good knowledge was found in 28 (25.7 % of respondents, while good attitude towards PV were found in less than 20 % (18 of the respondents. Only 4 (3.7 % of total respondents did a good pharmacovigilance practice.  We found no significant association between level of knowledge, attitude and other factors to the poor pratice of PV. Conclusion: The knowledge, activities and practices of pharmacovigilance among HCPs in Indonesia were poor and requires a continuous socialization among HCPs in different level of care. Key Words: pharmacovigilance, health care professionals, patient

  8. 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.

  9. Colistin-Nonsusceptible Pseudomonas aeruginosa Sequence Type 654 with blaNDM-1 Arrives in North America.

    Science.gov (United States)

    Mataseje, L F; Peirano, G; Church, D L; Conly, J; Mulvey, M; Pitout, J D

    2016-01-01

    This study describes 3 different blaNDM-1 genetic platforms in 3 different species obtained from the same patient who was directly transferred to an institution in Calgary, Alberta, Canada, following a prolonged hospital stay in India. The blaNDM-1 in the Escherichia coli isolate was located on a 176-kb IncA/C plasmid contained within an ISCR1 region. The blaNDM-1 in the Providencia rettgeri isolate was located on a 117-kb IncT plasmid contained within Tn3000, while the blaNDM-1 in the Pseudomonas aeruginosa isolate was located on the chromosome within an ISCR3 region. This report highlights the plasticity of the genetic regions and environments associated with blaNDM-1. To the best of our knowledge, this is the first report of P. aeruginosa with blaNDM-1 identified in North America and the first report of blaOXA-181 in P. rettgeri. The P. aeruginosa isolate belonged to the international high-risk sequence type 654 clone and was nonsusceptible to colistin. This case emphasizes the need for the use of appropriate infection prevention and control measures and vigilant screening for carbapenem-resistant Gram-negative bacteria in patients with a history of travel to areas of endemicity, such as the Indian subcontinent. PMID:26824951

  10. Multiplex Real-Time PCR Assay for Detection and Classification of Klebsiella pneumoniae Carbapenemase Gene (blaKPC) Variants▿

    OpenAIRE

    Chen, Liang; Mediavilla, José R.; Endimiani, Andrea; Rosenthal, Marnie E.; Zhao, Yanan; Robert A Bonomo; Kreiswirth, Barry N.

    2011-01-01

    Carbapenem resistance mediated by plasmid-borne Klebsiella pneumoniae carbapenemases (KPC) is an emerging problem of significant clinical importance in Gram-negative bacteria. Multiple KPC gene variants (blaKPC) have been reported, with KPC-2 (blaKPC-2) and KPC-3 (blaKPC-3) associated with epidemic outbreaks in New York City and various international settings. Here, we describe the development of a multiplex real-time PCR assay using molecular beacons (MB-PCR) for rapid and accurate identific...

  11. Knowledge, attitude and practices toward pharmacovigilance and adverse drug reactions in postgraduate students of Tertiary Care Hospital in Gujarat

    OpenAIRE

    Het B Upadhyaya; Vora, Mukeshkumar B.; Jatin G Nagar; Patel, Pruthvish B.

    2015-01-01

    Being key health care professional, physicians, pharmacist and nurses have immense responsibility in reporting adverse drug reaction (ADR). Therefore, the study objective was to evaluate the knowledge, attitude and practices (KAP) toward pharmacovigilance and ADRs of postgraduate students of our institute. A cross-sectional questionnaires based study was carried out in postgraduate students of the clinical department at tertiary care hospital attached with Govt. Medical College, Vadodara, Guj...

  12. Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database

    OpenAIRE

    2011-01-01

    BackgroundThiazolidinediones (TZDs), rosiglitazone (RGZ) and pioglitazone (PGZ) are widely used as hypoglycemic drugs in patients with type 2 diabetes mellitus. The aim of our study was to investigate the profile of adverse drug reactions (ADRs) related to TZDs and to investigate potential risk factors of these ADRs.MethodsType 2 diabetic patients were identified from the French Database of PharmacoVigilance (FPVD) between 2002 and 2006. We investigated ADR related to TZD, focusing on 4 ADR: ...

  13. Sequence analysis of bla CTX-M-28 , an ESBL responsible for third-generation cephalosporin resistance in Enterobacteriaceae, for the first time in India

    Directory of Open Access Journals (Sweden)

    Kingsley Jemima

    2008-04-01

    Full Text Available The most common group of ESBLs not belonging to the bla TEM or bla SHV families were termed bla CTX-M , to highlight their ESBLs′ greater activity against cefotaxime than against ceftazidime. The presence of nosocomial bla CTX-M-28 -producing Enterobacteriaceae strains has not been reported earlier in Indian hospitals. The sequences of bla CTX-M-28 gene from cephalosporin-resistant Enterobacteriaceae were analyzed. The structural gene encodes a 290 amino-acid protein, which is most related to the bla CTX-M β-lactamases. The conserved K-T-G was identified in the bla CTX-M-28 protein sequence, but significantly, two point mutations (N→T and (F→S were identified in the Y-G-N- and S-T-F-K-conserved motifs respectively. These point mutations were seen in all the three sequenced isolates

  14. Isolation of Enterobacter aerogenes carrying blaTEM-1 and blaKPC-3 genes recovered from a hospital Intensive Care Unit.

    Science.gov (United States)

    Pulcrano, Giovanna; Pignanelli, Salvatore; Vollaro, Adriana; Esposito, Matilde; Iula, Vita Dora; Roscetto, Emanuela; Soriano, Amata Amy; Catania, Maria Rosaria

    2016-06-01

    Enterobacter aerogenes has recently emerged as an important hospital pathogen. In this study, we showed the emergence of E. aerogenes isolates carrying the blaKPC gene in patients colonized by carbapenem-resistant Klebsiella pneumoniae strains. Two multiresistant E. aerogenes isolates were recovered from bronchial aspirates of two patients hospitalized in the Intensive Care Unit at the "Santa Maria della Scaletta" Hospital, Imola. The antimicrobial susceptibility test showed the high resistance to carbapenems and double-disk synergy test confirmed the phenotype of KPC and AmpC production. Other investigation revealed that ESBL and blaKPC genes were carried on the conjugative pKpQIL plasmid. This is a relevant report in Italy that describes a nosocomial infection due to the production of KPC beta-lactamases by an E. aerogenes isolate in patients previously colonized by K. pneumoniae carbapenem-resistant. In conclusion, it's necessary a continuous monitoring of multidrug-resistant strains for the detection of any KPC-producing bacteria that could expand the circulation of carbapenem-resistant pathogens. PMID:27004836

  15. blaGES carrying Pseudomonas aeruginosa isolates from a public hospital in Rio de Janeiro, Brazil

    Directory of Open Access Journals (Sweden)

    Flávia L. P. C. Pellegrino

    2006-08-01

    Full Text Available Previous analysis of Pseudomonas aeruginosa class-1 integrons from Rio de Janeiro, Brazil, revealed the blaGES gene in one isolate. We screened isolates of two widespread PFGE genotypes, A and B, at a public hospital in Rio, for the presence of blaGES. The gene was detected in all seven P. aeruginosa isolates belonging to genotype B. Three of the seven genotype-B isolates were resistant to amikacin, aztreonam, ceftazidime, cefepime, ciprofloxacin, gentamicin, imipenem, meropenem, piperacillin-tazobactam and ticarcillin-clavulanic acid. The other four isolates were resistant to all these agents, except gentamicin, imipenem, meropenem and piperacillin-tazobactam. A synergistic effect between ceftazidime and imipenem or clavulanic acid suggested the production of GES-type ESBL.

  16. Diversity and evolution of blaZ from Staphylococcus aureus and coagulase-negative staphylococci

    DEFF Research Database (Denmark)

    Olsen, John E.; Christensen, Henrik; Aarestrup, Frank Møller

    2006-01-01

    NS) and Staphylococcus aureus of bovine origin. Methods: blaZ was detected in 143 strains of penicillin-resistant S. aureus and CoNS from five Danish cattle herds (n = 25/23), random CoNS isolates from Denmark (n = 37), a collection of S. aureus from six different countries (n = 52), humans in Denmark (n = 3) and beta...... types. The major types all contained strains of both human and bovine origin, and more than one Staphylococcus species, demonstrating a shared gene pool. In a comparison of S. aureus and CoNS obtained from five Danish cattle herds, the same type of blaZ was only detected in one case. Conclusions...

  17. Identification of emergent blaCMY-2-carrying Proteus mirabilis lineages by whole-genome sequencing

    OpenAIRE

    Mac Aogáin, M.; Rogers, T.R.; Crowley, B.

    2016-01-01

    Whole-genome sequencing of 24 Proteus mirabilis isolates revealed the clonal expansion of two cefoxitin-resistant strains among patients with community-onset infection. These strains harboured bla CMY-2 within a chromosomally located integrative and conjugative element and exhibited multidrug resistance phenotypes. A predominant strain, identified in 18 patients, also harboured the PGI-1 genomic island and associated resistance genes, accounting for its broader antibiotic resistance profile. ...

  18. Antibiotic sensitivity pattern in blaNDM-1-positive and carbapenemase-producing Enterobacteriaceae

    OpenAIRE

    Mulla, Summaiya; Charan, Jaykaran; Rajdev, Sangita

    2016-01-01

    Background: Some studies published in recent time revealed that many bacteria from Enterobacteriaceae group are multi-antibiotic-resistant because of the production enzymes carbapenemase particularly New Delhi metallo-beta-lactamase encoded by gene called blaNDM-1. Looking at public health importance of this issue there is a need for studies at other centers to confirm or refute published findings. Objectives: This study was designed with the aim of exploring antibiotic resistance in Enteroba...

  19. A pharmacovigilance study of antihypertensive medicines at a South Delhi hospital

    Directory of Open Access Journals (Sweden)

    Hussain A

    2009-01-01

    Full Text Available The aim of the present study was to monitor adverse drug reactions associated with antihypertensive drugs. The study was conducted in medicine out patient department of 150-bed Majeedia Hospital at Hamdard University Campus in New Delhi. The study was conducted by way of one to one patient interview by a registered pharmacist using a questionnaire-based Adverse Drug Reaction Monitoring Form drafted according to the World Health Organisation Monitoring Guidelines. A total of 34 adverse drug reactions were observed in 250 hypertensive patients during the four month study. A high percentage of adverse drug reactions occurred in middle aged and female patients. Of the 34 adverse drug reactions, 18 (52.9% were mild, 14 (41.2% moderate and only 2 (5.8% were classified as severe. Combination therapy was associated with significantly high occurrence (P < 0.05 of adverse drug reactions, with a total of 21 (61.8% as compared to monotherapy (n=13, 38.2%. Cardiovascular adverse drug reactions constituted a major component, followed by gastrointestinal and respiratory complaints. Beta-blockers were the drug category associated with majority of adverse drug reactions, followed by angiotensin-converting enzyme inhibitors and calcium channel blockers. The above pharmacovigilance study presents the adverse drug reaction profile of antihypertensive medicines prescribed in our University Teaching Hospital. It was concluded that calcium channel blockers were the most frequently prescribed drug category but beta blockers were associated with higher frequency of adverse drug reactions.

  20. Pharmacovigilance and drug safety in Calabria (Italy: 2012 adverse events analysis

    Directory of Open Access Journals (Sweden)

    Chiara Giofrè

    2013-01-01

    Full Text Available Introduction: 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. Materials and Methods: 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. Results: 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. Conclusions: 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.

  1. Additive effect of BLA GABAA receptor mechanism and (+)-MK-801 on memory retention deficit, an isobologram analysis.

    Science.gov (United States)

    Khakpoor, Mitra; Nasehi, Mohammad; Vahdati, Akbar; Hoseyni, Seyed-Ebrahim; Zarrindast, Mohammad-Reza

    2016-04-01

    There is a near correlation between N-methyl-d-aspartate (NMDA) and γ-aminobutyric acid (GABA) receptors in the modulation of learning and memory in the basolateral amygdala (BLA). In this study, we investigated the involvement of GABAA receptors in the BLA in amnesia induced by (+)-MK-801, a noncompetitive antagonist of NMDA receptors, in male Wistar rats. After guide cannulae were bilaterally placed in the BLA, animals were trained in a step-through type passive avoidance task and then tested 24h after training to measure memory retrieval and locomotor activity. Post-training intra-BLA microinjection of (+)-MK-801 (0.5μg/rat) and GABAA receptor agonists (muscimol at doses 0.05 and 0.1μg/rat) or antagonist (bicuculline at doses 0.05 and 0.1μg/rat) decreased step-through latency during retrieval but did not alter locomotor activity. Results also showed that a subthreshold dose of muscimol (0.025μg/rat) potentiated impairment induced by (+)-MK-801, whereas bicuculline (0.025μg/rat) restored it. Furthermore, the highest dose of muscimol (0.5μg/rat) increased locomotor activity induced by (+)-MK-801. Isobologram analysis showed that there was an additive but not synergistic effect between muscimol and (+)-MK-801 on memory retention deficits in the BLA. In conclusion, muscimol and bicuculline decreased retention of memory formation in the BLA, and GABAA receptors in the BLA may be involved in the additive effect on (+)-MK-801-induced memory retention deficits. PMID:26853734

  2. A comparative evaluation of different teaching aids among fourth term medical students to improve the knowledge, attitude and perceptions about pharmacovigilance: An experimental study

    Directory of Open Access Journals (Sweden)

    Harish G. Bagewadi

    2015-04-01

    Full Text Available Objectives: The Study was designed to assess the awareness of Pharmacovigilance and Adverse Drug Reactions (ADR’s and to evaluate the effectiveness of different teaching aids.Materials and Methods: This was a questionnaire-based pre- and post-test on (KAP Knowledge, Attitude, Perception about pharmacovigilance. Students were given handouts regarding pharmacovigilance and ADR reporting one week before the educational interventions. Fourth term medical students (n=72 participated in the study. They were randomly allocated into group A (n=24, group B (n=24 and group C (n=24. A pre-validated 20-point questionnaire on Pharmacovigilance and Adverse Drug Reactions (ADR’s reporting was distributed to each group of students before the educational intervention to know their awareness. The interactive educational interventions on Pharmacovigilance were given using Overhead projector (OHP and transparencies to group A students, Black board (BB method to group B students, Power point presentation (PPT method to group C students respectively. Theoretical content was the same in all the educational interventions. The chi-square test and one way ANOVA was used for statistical calculation.Results: The overall response rates were expressed as percentages, Mean±SD. The Mean Pre-KAP scores on knowledge was (7.7±0.48 but the total post- KAP scores after (OHP, (BB, and (PPT were (12.1±0.39, (17.4±0.3, (19.4±0.21 respectively. The correct response rates were found to be statistically significant (P<0.001.The feedback from the students was encouraging; handouts before the class were greatly welcomed.Conclusion: The study greatly imparted knowledge about pharmacovigilance and ADR’s reporting and students preferred power point presentations the most.

  3. Susceptibility Pattern and Distribution of Oxacillinases and blaPER-1 Genes among Multidrug Resistant Acinetobacter baumannii in a Teaching Hospital in Iran

    Directory of Open Access Journals (Sweden)

    Sareh Bagheri Josheghani

    2015-01-01

    Full Text Available Acinetobacter baumannii (A. baumannii is an important nosocomial pathogen in healthcare institutions. β-Lactamase-mediated resistance is the most common mechanism for carbapenem resistance in A. baumannii. The aim of this study was to determine the antibiotic resistance pattern, to detect OXA encoding genes, class A, blaPER-1, and to detect the presence of ISAba1. A total of 124 A. baumannii isolates were collected from hospitalized patients in a teaching hospital in Kashan, Iran. The susceptibility of isolates to different antibiotics was determined by disk-diffusion method. PCR was used to detect blaPER-1, blaOXA-23, blaOXA-24, blaOXA-51, blaOXA-58, and ISAba1 genes. All isolates were resistant to ceftazidime, ceftriaxone, and cefotaxime. All of the isolates revealed susceptibility to polymyxin B and colistin. Ninety-six percent of the isolates were extensive drug resistance (XDR, 5.6% extended spectrum beta-lactamase (ESBL, and 54.8% metallo-beta-lactamase (MBL. All isolates were positive for blaOXA-51 and ISAba1. blaOXA-23,  blaOXA-24, and blaOXA-58 were found in 79.8%, 25%, and 3.2%, respectively. The frequency rate of blaPER-1 gene was 52.4%. Multidrug resistant A. baumannii isolates are increasing in our setting and extensively limit therapeutic options. The high rate presence of class D carbapenemase-encoding genes, mainly blaOXA-23 carbapenemases, is worrying and alarming as an emerging threat in our hospital.

  4. Improving Detection of Arrhythmia Drug-Drug Interactions in Pharmacovigilance Data through the Implementation of Similarity-Based Modeling.

    Science.gov (United States)

    Vilar, Santiago; Lorberbaum, Tal; Hripcsak, George; Tatonetti, Nicholas P

    2015-01-01

    Identification of Drug-Drug Interactions (DDIs) is a significant challenge during drug development and clinical practice. DDIs are responsible for many adverse drug effects (ADEs), decreasing patient quality of life and causing higher care expenses. DDIs are not systematically evaluated in pre-clinical or clinical trials and so the FDA U. S. Food and Drug Administration relies on post-marketing surveillance to monitor patient safety. However, existing pharmacovigilance algorithms show poor performance for detecting DDIs exhibiting prohibitively high false positive rates. Alternatively, methods based on chemical structure and pharmacological similarity have shown promise in adverse drug event detection. We hypothesize that the use of chemical biology data in a post hoc analysis of pharmacovigilance results will significantly improve the detection of dangerous interactions. Our model integrates a reference standard of DDIs known to cause arrhythmias with drug similarity data. To compare similarity between drugs we used chemical structure (both 2D and 3D molecular structure), adverse drug side effects, chemogenomic targets, drug indication classes, and known drug-drug interactions. We evaluated the method on external reference standards. Our results showed an enhancement of sensitivity, specificity and precision in different top positions with the use of similarity measures to rank the candidates extracted from pharmacovigilance data. For the top 100 DDI candidates, similarity-based modeling yielded close to twofold precision enhancement compared to the proportional reporting ratio (PRR). Moreover, the method helps in the DDI decision making through the identification of the DDI in the reference standard that generated the candidate. PMID:26068584

  5. The emerge of a new superbug gene blaNDM-1

    Institute of Scientific and Technical Information of China (English)

    Wang Kaiji

    2011-01-01

    @@ NDM-- 1 in detail: NDM-1, which is the abbreviation of 'New Delhi metallo-beta-lactamase', is a recently dis-covered enzyme that is produced by some gram-negative Enterobaeteriaceae such as E coil (Esehe-riehia toll) and Klebsiella pneumonia.It is named after 'New Delhi', which is the capital of India, be-cause the first patient who was diagnosed to be colo-nized by bacteria with blaNDM-1 gene had gone toa hospital in New Delhi for cosmetic surgery not long before he was diagnosed.

  6. Identification of emergent bla CMY-2 -carrying Proteus mirabilis lineages by whole-genome sequencing.

    Science.gov (United States)

    Mac Aogáin, M; Rogers, T R; Crowley, B

    2016-01-01

    Whole-genome sequencing of 24 Proteus mirabilis isolates revealed the clonal expansion of two cefoxitin-resistant strains among patients with community-onset infection. These strains harboured bla CMY-2 within a chromosomally located integrative and conjugative element and exhibited multidrug resistance phenotypes. A predominant strain, identified in 18 patients, also harboured the PGI-1 genomic island and associated resistance genes, accounting for its broader antibiotic resistance profile. The identification of these novel multidrug-resistant strains among community-onset infections suggests that they are endemic to this region and represent emergent P. mirabilis lineages of clinical significance. PMID:26865983

  7. Characterization of a novel plasmid type and various genetic contexts of bla OXA-58 in Acinetobacter spp. from multiple cities in China.

    Directory of Open Access Journals (Sweden)

    Yiqi Fu

    Full Text Available BACKGROUND/OBJECTIVE: Several studies have described the epidemiological distribution of blaOXA-58-harboring Acinetobacter baumannii in China. However, there is limited data concerning the replicon types of blaOXA-58-carrying plasmids and the genetic context surrounding blaOXA-58 in Acinetobacter spp. in China. METHODOLOGY/PRINCIPAL FINDINGS: Twelve non-duplicated blaOXA-58-harboring Acinetobacter spp. isolates were collected from six hospitals in five different cities between 2005 and 2010. The molecular epidemiology of the isolates was carried out using PFGE and multilocus sequence typing. Carbapenemase-encoding genes and plasmid replicase genes were identified by PCR. The genetic location of blaOXA-58 was analyzed using S1-nuclease method. Plasmid conjugation and electrotransformation were performed to evaluate the transferability of blaOXA-58-harboring plasmids. The genetic structure surrounding blaOXA-58 was determined by cloning experiments. The twelve isolates included two Acinetobacter pittii isolates (belong to one pulsotype, three Acinetobacter nosocomialis isolates (belong to two pulsotypes and seven Acinetobacter baumannii isolates (belong to two pulsotypes/sequence types. A. baumannii ST91 was found to be a potential multidrug resistant risk clone carrying both blaOXA-58 and blaOXA-23. blaOXA-58 located on plasmids varied from ca. 52 kb to ca. 143 kb. All plasmids can be electrotransformed to A. baumannii recipient, but were untypeable by the current replicon typing scheme. A novel plasmid replicase named repAci10 was identified in blaOXA-58-harboring plasmids of two A. pittii isolates, three A. nosocomialis isolates and two A. baumannii isolates. Four kinds of genetic contexts of blaOXA-58 were identified. The transformants of plasmids with structure of IS6 family insertion sequence (ISOur1, IS1008 or IS15-ΔISAba3-like element-blaOXA-58 displayed carbapenem nonsusceptible, while others with structure of intact ISAba3-like element-bla

  8. Dissemination and Characterization of Plasmids Carrying oqxAB-bla CTX-M Genes in Escherichia coli Isolates from Food-Producing Animals

    OpenAIRE

    Liu, Bao-Tao; Yang, Qiu-E.; Li, Liang; Sun, Jian; Liao, Xiao-Ping; Fang, Liang-Xing; Yang, Shou-Shen; Deng, Hui; Liu, Ya-Hong

    2013-01-01

    Background The association of PMQR and ESBLs in negative-bacteria isolates has been of great concern. The present study was performed to investigate the prevalence of co-transferability of oqxAB and bla CTX-M genes among the 696 Escherichia coli ( E. coli ) isolates from food-producing animals in South China, and to characterize these plasmids. Methods The ESBL-encoding genes (bla CTX-M, bla TEM and bla SHV), and PMQR (qnrA, qnrB, qnrS, qnrC, qnrD, aac(6’)-Ib-cr, qepA, and oqxAB) of these 696...

  9. In Vitro Analysis of ISEcp1B-Mediated Mobilization of Naturally Occurring β-Lactamase Gene blaCTX-M of Kluyvera ascorbata

    OpenAIRE

    Lartigue, Marie-Frédérique; Poirel, Laurent; Aubert, Daniel; Nordmann, Patrice

    2006-01-01

    ISEcp1B has been reported to be associated with and to mobilize the emerging expanded-spectrum β-lactamase blaCTX-M genes in Enterobacteriaceae. Thus, the ability of this insertion sequence to mobilize the blaCTX-M-2 gene was tested from its progenitor, Kluyvera ascorbata. Insertions of ISEcp1B upstream of the blaCTX-M-2 gene in K. ascorbata reference strain CIP7953 were first selected with cefotaxime (0.5 and 2 μg/ml). In those cases, ISEcp1B brought promoter sequences enhancing blaCTX-M-2 e...

  10. The emergence of bla CTX-M-15-carrying Escherichia coli of ST131 and new sequence types in Western China

    OpenAIRE

    Zhang, Lei; Lü, Xiaoju; Zong, Zhiyong

    2013-01-01

    Background bla CTX-M-15, the most widely distributed gene encoding extended-spectrum β-lactamases globally, was not common in China. This study was performed to characterize bla CTX-M-15-carrying Escherichia coli in western China. Findings Out of 144 Escherichia coli isolates from 20 hospitals in western China, 8 were found carrying bla CTX-M-15. bla CTX-M-15 was carried by isolates of ST131and 5 new STs (ST3342, ST3513, ST3516, ST3517 and ST3518). The 5 new STs shared 5 identical alleles out...

  11. Correlation versus causation? Pharmacovigilance of the analgesic flupirtine exemplifies the need for refined spontaneous ADR reporting.

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    Nora Anderson

    Full Text Available Annually, adverse drug reactions result in more than 2,000,000 hospitalizations and rank among the top 10 causes of death in the United States. Consequently, there is a need to continuously monitor and to improve the safety assessment of marketed drugs. Nonetheless, pharmacovigilance practice frequently lacks causality assessment. Here, we report the case of flupirtine, a centrally acting non-opioid analgesic. We re-evaluated the plausibility and causality of 226 unselected, spontaneously reported hepatobiliary adverse drug reactions according to the adapted Bradford-Hill criteria, CIOMS score and WHO-UMC scales. Thorough re-evaluation showed that only about 20% of the reported cases were probable or likely for flupirtine treatment, suggesting an incidence of flupirtine-related liver injury of 1∶100,000 when estimated prescription data are considered, or 0.8 in 10,000 on the basis of all 226 reported adverse drug reactions. Neither daily or cumulative dose nor duration of treatment correlated with markers of liver injury. In the majority of cases (151/226, an average of 3 co-medications with drugs known for their liver liability was observed that may well be causative for adverse drug reactions, but were reported under a suspected flupirtine ADR. Our study highlights the need to improve the quality and standards of ADR reporting. This should be done with utmost care taking into account contributing factors such as concomitant medications including over-the-counter drugs, the medical history and current health conditions, in order to avoid unjustified flagging and drug warnings that may erroneously cause uncertainty among healthcare professionals and patients, and may eventually lead to unjustified safety signals of useful drugs with a reasonable risk to benefit ratio.

  12. The association of pancreatitis with antidiabetic drug use: gaining insight through the FDA pharmacovigilance database.

    Science.gov (United States)

    Raschi, E; Piccinni, C; Poluzzi, E; Marchesini, G; De Ponti, F

    2013-08-01

    In patients with diabetes, disease per se, co-morbidities and drugs, including novel agents acting on the incretin system, have all been associated with pancreatitis with controversial data. We investigated the publicly available FDA Adverse Event Reporting System (FDA_AERS) database to gain insight into the possible association between antidiabetic agents and pancreatitis. To this aim, a case/non-case method was retrospectively performed on the FDA_AERS database (2004-2009 period). Cases were defined as reports of pancreatitis according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology. All other reports associated with antidiabetics were considered non-cases. The Reporting Odds Ratio (RORs), with corresponding 95% confidential interval (CI) and Mantel-Haenszel corrected P value, was calculated as a measure of disproportionality, with subsequent time-trend analysis. We retrieved 86,938 reports related to antidiabetics, corresponding to 159,226 drug-report combinations: 2,625 cases and 156,601 non-cases. Disproportionality was found only for exenatide (number of cases, 709; ROR, 1.76; 95% CI, 1.61-1.92; P MH < 0.001) and sitagliptin (128; 1.86; 1.54-2.24; <0.001). For exenatide, significant disproportionality appeared in the first quarter of 2008 (ROR, 1.24; 95% CI, 1.10-1.40; P MH < 0.001), soon after the FDA alert; for sitagliptin in the second quarter of 2008 (1.41; 1.05-1.90; 0.021). This temporal analysis found a striking influence of relevant FDA warnings on reporting of pancreatitis (the so-called notoriety bias) and is, therefore, recommended to avoid transforming a pharmacovigilance signal of alert automatically into an alarm. The precise quantification of the risk of pancreatitis associated with antidiabetics deserves assessment through specific disease-based registries. PMID:22008948

  13. Adverse Drug Reactions to First Line Anti-Tubercular Drugs - A Pharmacovigilance Study

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    Dr. Umeshchandra C Honnaddi

    2016-02-01

    Full Text Available Introduction: Tuberculosis is one of the major health problems in India and developing countries. It is the second leading infectious cause of morbidity and mortality in the world.Objective: The present study was undertaken to study the Adverse Drug Reactions (ADRs to first line Anti-tubercular drugs (ATTs prescribed to tuberculosis patients admitted to Medicine Department, BTGH, attached to M.R. Medical College, Gulbarga.Materials and Methods: A Prospective Observational study was carried among tuberculosis patients on Directly Observed Short Course Chemotherapy (DOTS, admitted to Medicine Department, BTGH, attached to M.R. Medical College; Gulbarga.120 Patients were included during the study period of 9 months from 1st October 2014 to 30th June 2015. The data was collected in a Proforma which included questionnaire.Results: A total of 120 tuberculosis patients on DOTS were enrolled for the study. Out of 107 patients, 63 patients (58.87% developed ADRs. Out of 63 patients, 32 patients (51% developed Gastro-intestinal problems, 14 patients developed CNS problems (22%, 11 patients (18% developed Hepatitis, 4 patients (6% developed Fever and 2 patients (3% developed Pancreatitis. The most serious ADR was Hepatitis.Conclusion: Results of the study reveals that about 58.87% of patients developed ADRs during the study period. These ADRs will lead to stoppage of drugs, development of Drug resistance and Therapeutic Failure. If a proper Pharmacovigilance system is implemented in the hospital, most of the patients may report their ADRs and thereby we can improve the patient adherence and treatment outcome.

  14. Detection of extended-spectrum β-lactamases (blaCTX-M-1 and blaTEM in Escherichia coli, Salmonella spp., and Klebsiella pneumoniae isolated from poultry in North Eastern India

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    H. Lalzampuia

    2014-11-01

    Full Text Available Aim: The present study was conducted to record the association of extended spectrum β-lactamases (ESBLs producing enteric bacteria with diarrhea of poultry birds in Mizoram, India. Materials and Methods: Fecal samples were collected from poultry birds with the history of diarrhea from different parts of Mizoram. Samples were processed for isolation and identification of Escherichia coli, Salmonella, and Klebsiella pneumoniae. All the isolates were subjected to antibiotic sensitivity assays. Phenotypically, ESBLs production ability was determined by double discs synergy test (DDST method. ESBLs producing isolates were subjected to polymerase chain reaction (PCR for detection of ESBLs genes. Plasmids were cured by acridine orange. Transfer of resistance from donor to recipient strains was done by in vitro horizontal method. Results: A total of 134 enteric bacteria was isolated, of which 102 (76.12%, 21 (15.67% and 11 (8.21% were E. coli, Salmonella spp. and K. pneumoniae, respectively. By DDST 7 (5.22% isolates (6 E. coli and 1 K. pneumoniae were ESBLs producer. PCR analysis confirmed 5 (3.73% (4 E. coli and 1 K. pneumoniae isolates harboured blaCTX-M-1 gene and/or blaTEM gene. All the isolates were carrying plasmids ranging between 0.9 kb and ~30 kb. Of the 4 isolates positive for blaCTX-M-1 and/or blaTEM, 2 (1.84% were confirmed for blaCTX-M-1 gene in their plasmid. No blaTEM gene was detected from plasmid. The resistance plasmid could not be transferred to the recipient by in vitro horizontal gene transfer method. Conclusion: ESBLs producing enteric bacteria are circulating in poultry in North Eastern Region of India. As poultry is one of the most common food animals in this region, these organisms may enter in human population through them.

  15. XML Determination of Phylogenetic Group and Prevalence of blaCTX-M and blaCTX-M-15 Genes in Escherichia Coli Isolates from Intestinal and Urinary Tract Infections in under Five- Year- Old Children

    OpenAIRE

    Momeni, F. (MSc); Ghanbarpour, R. (PhD); Dolatshah, L. (MSc); Alizade, H. (MSc)

    2014-01-01

    Background and Objective: CTX-M type extended spectrum beta-lactamases is a rapidly expanding group of enzymes encountered with increasing fre‌quency, especially, in Escherichia coli (E. coli). There are a few reports on phylogenetic background of E. coli isolates from clinical sources of under five-year- old children in Iran. The purpose of this study was phylotyping of E. coli isolates having blaCTX-M and blaCTX-M-15 genes from under five-year- old children with diarrhea and urinary tract i...

  16. Virulence of Klebsiella pneumoniae isolates harboring bla KPC-2 carbapenemase gene in a Caenorhabditis elegans model.

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    Jean-Philippe Lavigne

    Full Text Available Klebsiella pneumoniae carbapenemase (KPC is a carbapenemase increasingly reported worldwide in Enterobacteriaceae. The aim of this study was to analyze the virulence of several KPC-2-producing K. pneumoniae isolates. The studied strains were (i five KPC-2 clinical strains from different geographical origins, belonging to different ST-types and possessing plasmids of different incompatibility groups; (ii seven transformants obtained after electroporation of either these natural KPC plasmids or a recombinant plasmid harboring only the bla KPC-2 gene into reference strains K. pneumoniae ATCC10031/CIP53153; and (iii five clinical strains cured of plasmids. The virulence of K. pneumoniae isolates was evaluated in the Caenorhabditis elegans model. The clinical KPC producers and transformants were significantly less virulent (LT50: 5.5 days than K. pneumoniae reference strain (LT50: 4.3 days (p<0.01. However, the worldwide spread KPC-2 positive K. pneumoniae ST258 strains and reference strains containing plasmids extracted from K. pneumoniae ST258 strains had a higher virulence than KPC-2 strains belonging to other ST types (LT50: 5 days vs. 6 days, p<0.01. The increased virulence observed in cured strains confirmed this trend. The bla KPC-2 gene itself was not associated to increased virulence.

  17. Clonal and horizontal spread of the blaOXA-232 gene among Enterobacteriaceae in a Korean hospital.

    Science.gov (United States)

    Jeong, Seok Hoon; Lee, Kyu Man; Lee, Jacob; Bae, Il Kwon; Kim, Jae-Seok; Kim, Han-Sung; Song, Wonkeun

    2015-05-01

    All 16 Klebsiella pneumoniae isolates and both Escherichia coli isolates harbored the bla(OXA-232) and bla(CTX-M-15) genes. Furthermore, all 16 K. pneumoniae isolates belonged to a unique pulsed-field gel electrophoresis clone and were assigned to an identical sequence type (ST14). The 2 E. coli isolates were identified as ST131 and ST457. The bla(OXA-232) gene underwent horizontal transfer to E. coli isolates via a conjugative ColE-type plasmid. The introduction of this K. pneumoniae ST14 strain to the Korean hospital was attributed to an index patient who was likely colonized during a prior hospitalization in India. PMID:25702524

  18. Further Spread of blaNDM-5 in Enterobacteriaceae via IncX3 Plasmids in Shanghai, China

    Science.gov (United States)

    Zhang, Fangfang; Xie, Lianyan; Wang, Xiaoli; Han, Lizhong; Guo, Xiaokui; Ni, Yuxing; Qu, Hongping; Sun, Jingyong

    2016-01-01

    One hundred and two carbapenem-resistant Enterobacteriaceae (CRE) strains were isolated in a teaching hospital in Shanghai, China from 2012 to 2015. In a follow-up study, four New Delhi metallo-β-lactamase-5 (NDM-5)-producing strains were identified after screening these CRE strains, including 1 Klebsiella pneumoniae strain (RJ01), 1 Proteus mirabilis strain (RJ02), and 2 Escherichia coli strains (RJ03 and RJ04). All K. pneumoniae and E. coli isolates were resistant to carbapenems, third-generation cephalosporins, and piperacillin-tazobactam, but were susceptible to amikacin. No epidemiological links for either E. coli isolate were found by multilocus sequence typing (MLST) and pulsed-field gel electrophoresis (PFGE). However, MLST revealed a novel sequence type, ST2250, of the K. pneumoniae RJ01 strain. Inc types and sizes of blaNDM-5-carrying plasmids differed among the four isolates, although in P. mirabilis RJ02 and E. coli RJ03, blaNDM-5 was carried by conjugative IncX3 plasmids of nearly the same size (∼40 kb). Investigation of the genetic background of sequences flanking the blaNDM-5 gene showed that all four isolates shared the same genetic content (IS3000-ΔISAba125-IS5-blaNDM-5-ble-trpF-dsbC-IS26-ΔumuD), which was identical to that of the pNDM_MGR194 plasmid circulating in India. This is the first identification of blaNDM-5 in P. mirabilis, which suggests its further spread to Enterobacteriaceae, and indicates that IncX3 plasmids may play an important role in potentiating the spread of blaNDM. PMID:27065982

  19. Further Spread of bla NDM-5 in Enterobacteriaceae via IncX3 Plasmids in Shanghai, China.

    Science.gov (United States)

    Zhang, Fangfang; Xie, Lianyan; Wang, Xiaoli; Han, Lizhong; Guo, Xiaokui; Ni, Yuxing; Qu, Hongping; Sun, Jingyong

    2016-01-01

    One hundred and two carbapenem-resistant Enterobacteriaceae (CRE) strains were isolated in a teaching hospital in Shanghai, China from 2012 to 2015. In a follow-up study, four New Delhi metallo-β-lactamase-5 (NDM-5)-producing strains were identified after screening these CRE strains, including 1 Klebsiella pneumoniae strain (RJ01), 1 Proteus mirabilis strain (RJ02), and 2 Escherichia coli strains (RJ03 and RJ04). All K. pneumoniae and E. coli isolates were resistant to carbapenems, third-generation cephalosporins, and piperacillin-tazobactam, but were susceptible to amikacin. No epidemiological links for either E. coli isolate were found by multilocus sequence typing (MLST) and pulsed-field gel electrophoresis (PFGE). However, MLST revealed a novel sequence type, ST2250, of the K. pneumoniae RJ01 strain. Inc types and sizes of bla NDM-5-carrying plasmids differed among the four isolates, although in P. mirabilis RJ02 and E. coli RJ03, bla NDM-5 was carried by conjugative IncX3 plasmids of nearly the same size (∼40 kb). Investigation of the genetic background of sequences flanking the bla NDM-5 gene showed that all four isolates shared the same genetic content (IS3000-ΔISAba125-IS5-bla NDM-5-ble-trpF-dsbC-IS26-ΔumuD), which was identical to that of the pNDM_MGR194 plasmid circulating in India. This is the first identification of bla NDM-5 in P. mirabilis, which suggests its further spread to Enterobacteriaceae, and indicates that IncX3 plasmids may play an important role in potentiating the spread of bla NDM. PMID:27065982

  20. Molecular typing and genetic environment of the blaKPC gene in Chilean isolates of Klebsiella pneumoniae.

    Science.gov (United States)

    Barría-Loaiza, Carla; Pincheira, Andrea; Quezada, Mario; Vera, Alejandra; Valenzuela, Pedro; Domínguez, Mariana; Lima, Celia A; Araya, Ingrid; Araya, Pamela; Prat, Soledad; Aguayo, Carolina; Fernández, Jorge; Hormazábal, Juan Carlos; Bello-Toledo, Helia; González-Rocha, Gerardo

    2016-03-01

    The aim of this work was to determine the genetic environment and transferability of blaKPC as well as the pulsotypes of KPC-producing Klebsiella pneumoniae strains isolated from clinical samples in Chilean hospitals. Seventeen strains, principally isolated in Santiago (the capital of Chile) during the years 2012 and 2013, were included. The genetic environment of blaKPC was elucidated by PCR mapping and sequencing. Molecular typing was performed by pulsed-field gel electrophoresis (PFGE) and multilocus sequence typing (MLST). Curing and conjugation experiments were performed with six strains of different sequence types (STs) and pulsotypes. Thirteen pulsotypes and six STs, mainly belonging to clonal complex 258, were found. In addition, seven strains belonged to a new ST assigned ST1161. The blaKPC sequence indicated that 16 strains had the KPC-2 variant; in only one strain (UC331) an amino acid change (R6P) was detected, corresponding to a new KPC variant designated KPC-24. Molecular characterisation of the blaKPC genetic environment revealed two distinct platforms, namely variant 1a and the Tn4401a isoform, with the first being the most common (11/17 strains). Mating experiments failed to produce transconjugants; however, loss of blaKPC was achieved by plasmid curing in all assayed strains. In conclusion, in Chilean strains of K. pneumoniae, blaKPC is primarily found associated with the variant 1a and is located in non-transferable plasmids. In addition, this study highlights the description of the new ST1161 and the new KPC-24 variant. PMID:27436389

  1. Dissemination of IncI2 Plasmids That Harbor the blaCTX-M Element among Clinical Salmonella Isolates.

    Science.gov (United States)

    Wong, Marcus Ho-Yin; Liu, Lizhang; Yan, Meiying; Chan, Edward Wai-Chi; Chen, Sheng

    2015-08-01

    The extended-spectrum-β-lactamase (ESBL) determinant CTX-M-55 is increasingly prevalent in Escherichia coli but remains extremely rare in Salmonella. This study reports the isolation of a plasmid harboring the blaCTX-M-55 element in a clinical Salmonella enterica serotype Typhimurium strain resistant to multiple antibiotics. This plasmid is genetically identical to several known IncI2-type elements harbored by E. coli strains recovered from animals. This finding indicates that IncI2 plasmids harboring the blaCTX-M genes may undergo cross-species migration among potential bacterial pathogens, with E. coli as the major source of such elements. PMID:26014934

  2. First Human Isolate of Salmonella enterica Serotype Enteritidis Harboring blaCTX-M-14 in South America

    OpenAIRE

    Bado, I; Garcia-Fulgueiras, V.; Cordeiro, N F; Betancor, L.; Caiata, L.; Seija, V.; Robino, L.; Algorta, G.; Chabalgoity, J. A.; Ayala, J. A.; Gutkind, G. O.; Vignoli, R

    2012-01-01

    We studied a clinical isolate of Salmonella enterica serotype Enteritidis showing resistance to oxyiminocephalosporins. PCR analysis confirmed the presence of bla CTX-M-14 linked to IS903 in a 95-kb IncI1 conjugative plasmid. Such a plasmid is maintained on account of the presence of a pndAC addiction system. Multilocus sequence typing (MLST) analysis indicated that the strain belongs to ST11. This is the first report of bla CTX-M-14 in Salmonella Enteritidis of human origin in South America....

  3. Recent Emergence of Escherichia coli with Cephalosporin Resistance Conferred by blaCTX-M on Washington State Dairy Farms

    OpenAIRE

    Davis, Margaret A.; Sischo, William M.; Jones, Lisa P.; Moore, Dale A; Ahmed, Sara; Short, Diana M.; Besser, Thomas E.

    2015-01-01

    Enterobacteriaceae-associated blaCTX-M genes have become globally widespread within the past 30 years. Among isolates from Washington State cattle, Escherichia coli strains carrying blaCTX-M (CTX-M E. coli strains) were absent from a set of 2008 isolates but present in a set of isolates from 2011. On 30 Washington State dairy farms sampled in 2012, CTX-M E. coli prevalence was significantly higher on eastern than on northwestern Washington farms, on farms with more than 3,000 adult cows, and ...

  4. 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

  5. IMPACT OF EDUCATIONAL INTERVENTION ON KNOWLEDGE, ATTITUDE AND PRACTICE OF PHARMACOVIGILANCE AMONG MEDICAL GRADUATES OF RURAL TERTIARY CARE, TEACHING HOSPITAL OF CENTRAL INDIA

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    VARMA SUSHIL KUMAR

    2013-01-01

    Full Text Available To assess the awareness of Pharmacovigilance among the medical graduates and to evaluate the need of inclusion of KAP (Knowledge, Attitude and Practice of Pharmacovigilance in Internship Training Programme as an educational intervention.Material and Methods: The present study was conducted in the Internship orientation program in a rural hospital of central India. It was a Hospital Based Cross Sectional Study in which 65 Interns (medical graduates were participated. Semi-structured, Pre-Designed, Pre-tested Questionnaire was used for data collection. Data was entered and analyzed using statistical software ‘EPI INFO 3.5.3’.Results: In our study a total of 65 medical graduates were responded and involved in the pre KAP and post KAP survey questionnaires. The overall response rate between pre intervention and post intervention was statistically significant and that shows effectiveness of educational intervention for improving awareness of Pharmacovigilance among medical graduates.Conclusion: Imparting the knowledge and awareness of Pharmacovigilance among the medical graduates by mean of continuous educational intervention would bring update of knowledge for drug safety into their everyday clinical practice and also bring the adverse drug reactions(ADRs reporting culture among them.

  6. Evaluation of the knowledge, attitude and the practice of pharmacovigilance among the interns and doctors in a tertiary level care teaching hospital in Northern India

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    Manreet Singh Sekhon

    2016-06-01

    Conclusions: There is a great need to create awareness and to promote the reporting of ADR amongst interns and doctors, which will lay a solid foundation for these healthcare professionals to be involved in quality pharmacovigilance. [Int J Basic Clin Pharmacol 2016; 5(3.000: 1068-1074

  7. Ambiente genético del Gen blaCTX-M-12 en aislamientos hospitalarios de Klebsiella pneumoniae

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    Yamile Adriana Celis Bustos

    2009-06-01

    Full Text Available The blaCTX-M-12 gene’s genetic environmnt in Klebsiella pneumoniae hospital isolates Resumen: En Colombia se han detectado genes del grupo CTX-M-1 con alta frecuencia en aislamientos de Klebsiella pneumoniae causantes de infección intrahospitalaria. El conocimiento de los factores genéticos que pueden favorecer la diseminación de estos genes entre especies bacterianas es un aspecto importante para el control de la resistencia. En este estudio se identificaron los plásmidos portadores del gen blaCTX-M-12 en 21 aislamientos clínicos de K. pneumoniae. Se evaluó por conjugación la transferencia de resistencia a antibióticos. Integrones, secuencias de inserción y otros elementos genéticos fueron detectados por amplificación del ADN plasmídico con la reacción en cadena de la polimerasa (PCR. Mediante análisis por PCR se determinó la relación entre el gen blaCTX-M-12 y los elementos genéticos detectados. En todos los aislamientos, el gen blaCTX-M-12 se encontró en plásmidos conjugativos de tamaños entre 65 y 106 kpb. La transferencia por conjugación de estos elementos móviles puede explicar la amplia diseminación de este gen entre enterobacterias causantes de infección nosocomial en hospitales de Bogotá, Colombia. El gen blaCTX-M-12 se encontró corriente abajo de ISEcp1, secuencia de inserción que se ha asociado con la movilización de determinantes genéticos de resistencia. Los promotores de ISEcp1, detectados por análisis de secuencia, pueden facilitar la expresión de la cefotaximasa codificada por este gen.Palabras clave: resistencia a antibióticos; elementos genéticos móviles; gen blaCTX-M-12; plásmidos conjugativos;  Klebsiella pneumoniae. Abstract: Genes from CTX-M-1 group have been detected with great frequency in Colombia in intrahospital infection-causing Klebsiella pneumoniae isolates. Knowledge regarding the genetic factors favouring such genes’ dissemination amongst bacterial species is an

  8. Dissemination and characterization of plasmids carrying oqxAB-bla CTX-M genes in Escherichia coli isolates from food-producing animals.

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    Bao-Tao Liu

    Full Text Available BACKGROUND: The association of PMQR and ESBLs in negative-bacteria isolates has been of great concern. The present study was performed to investigate the prevalence of co-transferability of oqxAB and bla CTX-M genes among the 696 Escherichia coli (E. coli isolates from food-producing animals in South China, and to characterize these plasmids. METHODS: The ESBL-encoding genes (bla(CTX-M, bla(TEM and bla(SHV, and PMQR (qnrA, qnrB, qnrS, qnrC, qnrD, aac(6'-Ib-cr, qepA, and oqxAB of these 696 isolates were determined by PCR and sequenced directionally. Conjugation, S1 nuclease pulsed-field gel electrophoresis (PFGE and Southern blotting experiments were performed to investigate the co-transferability and location of oqxAB and bla(CTX-M. The EcoRI digestion profiles of the plasmids with oqxAB-bla(CTX-M were also analyzed. The clonal relatedness was investigated by PFGE. RESULTS: Of the 696 isolates, 429 harbored at least one PMQR gene, with oqxAB (328 being the most common type; 191 carried bla(CTX-M, with bla(CTX-M-14 the most common. We observed a significant higher prevalence of bla(CTX-M among the oqxAB-positive isolates (38.7% than that (17.4% in the oqxAB-negative isolates. Co-transferability of oqxAB and bla(CTX-M was found in 18 of the 127 isolates carrying oqxAB-bla(CTX-M. These two genes were located on the same plasmid in all the 18 isolates, with floR being on these plasmids in 13 isolates. The co-dissemination of these genes was mainly mediated by F33:A-: B- and HI2 plasmids with highly similar EcoRI digestion profiles. Diverse PFGE patterns indicated the high prevalence of oqxAB was not caused by clonal dissemination. CONCLUSION: bla(CTX-M was highly prevalent among the oqxAB-positive isolates. The co-dissemination of oqxAB-bla(CTX-M genes in E. coli isolates from food-producing animals is mediated mainly by similar F33:A-: B- and HI2 plasmids. This is the first report of the co-existence of oqxAB, bla(CTX-M, and floR on the same

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

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    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

  10. Nurses in municipal care of the elderly act as pharmacovigilant intermediaries: a qualitative study of medication management

    Science.gov (United States)

    Johansson-Pajala, Rose-Marie; Jorsäter Blomgren, Kerstin; Bastholm-Rahmner, Pia; Fastbom, Johan; Martin, Lene

    2016-01-01

    Objective To explore registered nurses’ experience of medication management in municipal care of the elderly in Sweden, with a focus on their pharmacovigilant activities. Design A qualitative approach using focus-group discussions was chosen in order to provide in-depth information. Data were analysed by qualitative content analysis. Setting Five focus groups in five different long-term care settings in two regions in Sweden. Subject A total of 21 registered nurses (RNs), four men and 17 women, aged 27–65 years, with 4–34 years of nursing experience. Results The findings reveal that RNs in municipal long-term care settings can be regarded as “vigilant intermediaries” in the patients’ drug treatments. They continuously control the work of staff and physicians and mediate between them, and also compensate for existing shortcomings, both organizational and in the work of health care professionals. RNs depend on other health care professionals to be able to monitor drug treatments and ensure medication safety. They assume expanded responsibilities, sometimes exceeding their formal competence, and try to cover for deficiencies in competence, experience, accessibility, and responsibility-taking. Conclusion The RNs play a central but also complex role as “vigilant intermediaries” in the medication monitoring process, including the issue of responsibility. Improving RNs’ possibility to monitor their patients’ drug treatments would enable them to prevent adverse drug events in their daily practice. New strategies are justified to facilitate RNs’ pharmacovigilant activities. Key pointsThis study contributes to the understanding of registered nurses’ (RNs’) role in medication management in municipal care of the elderly (i.e. detecting, assessing, and preventing adverse drug events or any drug-related problems). RNs can be considered to be “vigilant intermediaries” in elderly patients’ drug treatments, working at a distance from staff

  11. blaCTX-M-I group extended spectrum beta lactamase-producing Salmonella typhi from hospitalized patients in Lagos, Nigeria

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    Akinyemi KO

    2015-05-01

    Full Text Available Kabiru O Akinyemi,1 Bamidele A Iwalokun,2 Olajide O Alafe,1 Sulaiman A Mudashiru,1 Christopher Fakorede,11Department of Microbiology, Lagos State University, Ojo, Lagos, Nigeria; 2Biochemistry and Nutrition Division, Nigerian Institute of Medical Research, Yaba, Lagos, NigeriaPurpose: The global spread of blaCTX-M-I extended-spectrum beta-lactamase (ESBL-producing Salmonella spp. remains a major threat to treatment and control. Evidence of emergence and spread of this marker are lacking in Nigeria. This study investigated blaCTX-M-I ESBL production among Salmonella isolates from hospitalized patients.Methods: Patients (158 total made up of two groups were evaluated. Group A was composed of 135 patients with persistent pyrexia and group B was composed of 23 gastroenteritis patients and their stool samples. Samples were cultured, and isolates were identified and were subjected to antibiotic susceptibility testing by standard methods. Isolates were further screened for ESBL production, blaCTX-M-I genes and transferability by double disk synergy test, plasmid extraction, polymerase chain reaction, and conjugation experiment.Results: Thirty-five (25.9% Salmonella isolates were identified from group A, of which 74.3% were S. typhi, 22.9% were S. paratyphi and two (5.7% were invasive non-typhoidal S. enteritidis. Nine Plasmodium falciparum infections were recorded, four of which were identified as co-infections with typhoidal Salmonella. Only two (8.7% S. enteritidis samples were obtained from group B (P>0.05. A total of 24 isolates were ESBL-positive, eliciting resistance to five to seven antibiotics, and were multiple-drug resistant. ESBL production due to the blaCTX-M-I gene cluster was detected in eleven (45.8% Salmonella isolates. Nine (81.8% of the eleven blaCTX-M-I ESBL producers were S. typhi and two (18.2% isolates were S. enteritidis. Four of nine S. typhi blaCTX-M-I ESBL-producing strains harbored 23 kb self-transmissible plasmid that was co

  12. Knowledge, Attitude and Practices towards Pharmacovigilance and Adverse Drug Reactions in health care professional of Tertiary Care Hospital, Bhavnagar

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    Dr.Mukeshkumar B Vora

    2014-11-01

    Full Text Available Purpose: Adverse drug reactions (ADRs are adverse consequences of drug therapy. ADRs are representing a major concern of health systems in terms of early recognition, proper management and prevention. Under reporting of Adverse Drug Reactions (ADRs is a common problem in Pharmacovigilance programs. Poor perceptions of doctors about ADRs and risk management have contributed to high rate of ADR under-reporting in India. Underreporting has also been attributed to lack of time to doctor, misconceptions about spontaneous reporting and lack of information on how to report, where to report and a lack of availability of report forms, and also physicians' attitudes to ADRs. The objective of our study was to evaluate the knowledge, attitude and practices (KAP of health care professional towards Pharmacovigilance and adverse drug reactions in a tertiary care hospital, Bhavnagar, Gujarat, India. Methods: A cross-sectional questionnaires based study was carried out in Post graduate students and faculties of tertiary care hospital attached with Govt. Medical College, Bhavnagar, Gujarat. Post graduate students and faculties of different clinical subjects working in the tertiary care teaching hospital, Bhavnagar, Gujarat (India were enrolled and present throughout in study. 22 questionnaires about knowledge, attitude and practices towards ADRs and Pharmacovigilance were developed and peer viewed of all questionnaires by expert faculties from Pharmacology department. We were contacted directly to post graduate students and faculties of respective clinical department, questionnaires were distributed, 30 minutes time given to filled form. Any clarification and extra time was needed, provided to them. The filled KAP questionnaires were analyzed in question wise and their percentage value was calculated by using Microsoft excel spread sheet and online statistical software. Results: In study, postgraduate residents (n=81 and faculties (n=63 from different clinical

  13. 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. PMID:26461922

  14. 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.

    2016-01-01

    Background: 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. Methods: 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. Results: 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%, P<.001). Conclusions: These data indicate that the overall pharmacologic prescription for treating a first episode of psychosis in Spain follows the clinical practice guideline recommendations, and, together with security 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. PMID:26506856

  15. Health Professionals' Knowledge, Attitudes and Practices about Pharmacovigilance in India: A Systematic Review and Meta-Analysis

    Science.gov (United States)

    Bhagavathula, Akshaya Srikanth; Elnour, Asim Ahmed; Jamshed, Shazia Qasim; Shehab, Abdulla

    2016-01-01

    Background Spontaneous or voluntary reporting of suspected adverse drug reactions (ADRs) is one of the vital roles of all health professionals. In India, under-reporting of ADRs by health professionals is recognized as one of the leading causes of poor ADR signal detection. Therefore, reviewing the literature can provide a better understanding of the status of knowledge, attitude and practice (KAP) of Pharmacovigilance (PV) activities by health professionals. Methods A systematic review was performed through Pubmed, Scopus, Embase and Google Scholar scientific databases. Studies pertaining to KAP of PV and ADR reporting by Indian health professionals between January 2011 and July 2015 were included in a meta-analysis. Results A total of 28 studies were included in the systematic review and 18 of them were selected for meta-analysis. Overall, 55.6% (95% CI 44.4–66.9; p<0.001) of the population studied were not aware of the existence of the Pharmacovigilance Programme in India (PvPI), and 31.9% (95% CI 16.3–47.4; p<0.001) thought that "all drugs available in the market are safe". Furthermore, 28.7% (95% CI 16.4–40.9; p<0.001) of them were not interested in reporting ADRs and 74.5%, (95% CI 67.9–81.9; p<0.001) never reported any ADR to PV centers. Conclusion There was an enormous gap of KAP towards PV and ADR reporting, particularly PV practice in India. There is therefore an urgent need for educational awareness, simplification of the ADR reporting process, and implementation of imperative measures to practice PV among healthcare professionals. In order to understand the PV status, PvPI should procedurally assess the KAP of health professionals PV activities in India. PMID:27010447

  16. Health Professionals' Knowledge, Attitudes and Practices about Pharmacovigilance in India: A Systematic Review and Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Akshaya Srikanth Bhagavathula

    Full Text Available Spontaneous or voluntary reporting of suspected adverse drug reactions (ADRs is one of the vital roles of all health professionals. In India, under-reporting of ADRs by health professionals is recognized as one of the leading causes of poor ADR signal detection. Therefore, reviewing the literature can provide a better understanding of the status of knowledge, attitude and practice (KAP of Pharmacovigilance (PV activities by health professionals.A systematic review was performed through Pubmed, Scopus, Embase and Google Scholar scientific databases. Studies pertaining to KAP of PV and ADR reporting by Indian health professionals between January 2011 and July 2015 were included in a meta-analysis.A total of 28 studies were included in the systematic review and 18 of them were selected for meta-analysis. Overall, 55.6% (95% CI 44.4-66.9; p<0.001 of the population studied were not aware of the existence of the Pharmacovigilance Programme in India (PvPI, and 31.9% (95% CI 16.3-47.4; p<0.001 thought that "all drugs available in the market are safe". Furthermore, 28.7% (95% CI 16.4-40.9; p<0.001 of them were not interested in reporting ADRs and 74.5%, (95% CI 67.9-81.9; p<0.001 never reported any ADR to PV centers.There was an enormous gap of KAP towards PV and ADR reporting, particularly PV practice in India. There is therefore an urgent need for educational awareness, simplification of the ADR reporting process, and implementation of imperative measures to practice PV among healthcare professionals. In order to understand the PV status, PvPI should procedurally assess the KAP of health professionals PV activities in India.

  17. First Description of the Extended Spectrum-Beta-Lactamase Gene blaCTX-M-109 in Salmonella Grumpensis Strains Isolated from Neonatal Nosocomial Infections in Dakar, Senegal.

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    Amadou Diop

    Full Text Available Nosocomial infections are very common in African hospitals, particularly in neonatal units. These infections are most often caused by bacteria such as Escherichia coli, Klebsiella spp and Staphylococcus spp. Salmonella strains are rarely involved in nosocomial infections. Here, we report the first description of S. Grumpensis in neonatal infections in Senegal. Seventeen Salmonella strains were isolated from hospitalized infants' stool samples. The following resistance phenotype was described in strains: AMXRTICRCFR FOXRCFXRCTXRCAZRIMPSATMRNARNORRCIPRTMRGMRTERSXTR. All isolates were susceptible to imipenem, 15 out of 17 produced an extended spectrum ß-lactamase (ESBL. blaOXA-1, blaSHV-1, blaTEM-1, blaCTX-M1 genes were detected in strains 8, 13, 5 and 8, respectively. blaCTX-M1 sequencing revealed the presence of blaCTX-M-109. Thirteen of the 17 Salmonella Grumpensis strains were analyzed by PFGE. These 13 isolates belonged to a single pulsotype and were genotypically identical. This is the first report of neonatal S. Grumpensis infections in Senegal, and the first report of blaCTX-M-109 in the genus Salmonella.

  18. Farmacovigilância da heparina no Brasil Heparin pharmacovigilance in Brazil

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    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.

  19. Beta-lactam induction of ISEcp1B-mediated mobilization of the naturally occurring bla(CTX-M) beta-lactamase gene of Kluyvera ascorbata

    OpenAIRE

    Nordmann, Patrice; Lartigue, Marie-Frédérique; Poirel, Laurent

    2008-01-01

    ISEcp1B is an insertion element associated with the emerging expanded-spectrum β-lactamase blaCTX-M genes in Enterobacteriaceae. Because ISEcp1B-blaCTX-M positive strains may be identified from humans and animals, the ability of this insertion sequence to mobilize the blaCTX-M-2 gene was tested from its progenitor Kluyvera ascorbata to study the effects of amoxicillin/clavulanic and cefquinome as enhancers of transposition. These β-lactam molecules are administered parenterally to treat infec...

  20. Beta-lactam induction of ISEcp1B-mediated mobilization of the naturally occurring bla(CTX-M) beta-lactamase gene of Kluyvera ascorbata.

    OpenAIRE

    Nordmann, Patrice; Lartigue, Marie-Frédérique; Poirel, Laurent

    2008-01-01

    ISEcp1B is an insertion element associated with the emerging expanded-spectrum beta-lactamase bla(CTX-M) genes in Enterobacteriaceae. Because ISEcp1B-bla(CTX-M)positive strains may be identified from humans and animals, the ability of this insertion sequence to mobilize the bla(CTX-M-2) gene was tested from its progenitor Kluyvera ascorbata to study the effects of amoxicillin/clavulanic and cefquinome as enhancers of transposition. These beta-lactam molecules are administered parenterally to ...

  1. Prevalence of blaZ Gene Types and the Inoculum Effect with Cefazolin among Bloodstream Isolates of Methicillin-Susceptible Staphylococcus aureus

    OpenAIRE

    Livorsi, D. J.; Crispell, E.; Satola, S. W.; Burd, E. M.; Jerris, R.; Wang, Y.F.(Institute of High Energy Physics, Beijing, 100049, People's Republic of China); Farley, M M

    2012-01-01

    We sought to define the prevalence of blaZ gene types and the inoculum effect to cefazolin among methicillin-susceptible Staphylococcus aureus (MSSA) bloodstream infections. The blaZ gene was present in 142/185 (77%) isolates. A total of 50 (27%) isolates had a ≥4-fold increase in the cefazolin MIC from a standard to a high inoculum, and 8 (4%) demonstrated a nonsusceptible cefazolin MIC, all type A blaZ strains. The efficacy of cefazolin in the presence of the inoculum effect requires furthe...

  2. Prevalence of blaCTX-M gene in multi-resistant Escherichia coli isolated from Urinary Tract Infections, Tehran, Iran

    Directory of Open Access Journals (Sweden)

    Mehdi Goudarzi

    2014-11-01

    Full Text Available Background:The emergence and increase in the incidence of Extended-spectrum beta lactamase (ESBL producing Escherichia coli has become an emerging challenge especially in hospitalized patients with UTI. The aim of the present study was to survey the frequency of bla CTX-M genotype in ESBL producing E. coli isolated from hospitalized patients with UTI and determination of their antibiotic resistance pattern.Material and methodsA total of 135 E. coli isolates were collected from isolated from patients with UTI. The isolates were subjected to confirmatory phenotype tests for the presence of ESBL. 75 E. coli isolates were confirmed as ESBL-positive by means of the Double disc synergy test. In vitro susceptibility of ESBL isolates to 15 antimicrobial agents amoxicillin, penicillin, ceftazidime, cefotaxime, cefoxitin, ceftriaxone, cefixime, cephalexin, co-trimoxazole, gentamicin, nalidixic acid, ciprofloxacin, nitrofourantoin, amikacin and imipenem was performed by Kirby-Bauer’s Disk diffusion method according to Clinical and Laboratory Standards Institute (CLSI, 2012 guideline. PCR method was used to identify bla CTX-M gene in 75 ESBL positive strains.Results:PCR and sequence analysis showed that 75 (55.5% isolates produced bla CTX-M genes. In vitro susceptibility of ESBL producing E. coli showed that all of them were resistant to amoxicillin and penicillin and The rates of resistance to the majority of tested antibiotics varied between 61% to 100 %, with the exception of amikacin (14.7% and imipenem (2.7%. Our results showed that the frequency of bla CTX-M was strikingly high (93.3%.Conclusion:These data confirmed that the frequency of bla CTX-M genes were high among E. coli isolated from patients with UTI. The trend of multidrug-resistant profile has been associated with bla CTX-M gene is alarming. Therefore, it is very important to establish a routine screening of ESBL in clinical isolates to prevent dissemination of resistant isolates in health

  3. Molecular characterisation of acquired and overproduced chromosomal blaAmpC in Escherichia coli clinical isolates.

    Science.gov (United States)

    Alonso, Noemí; Miró, Elisenda; Pascual, Vanesa; Rivera, Alba; Simó, Maria; Garcia, Maria Consol; Xercavins, Mariona; Morera, Maria Antonia; Espejo, Elena; Gurguí, Mercè; Pérez, Josefa; Rodríguez-Carballeira, Mònica; Garau, Javier; Calbo, Esther; Navarro, Ferran; Mirelis, Beatriz; Coll, Pere

    2016-01-01

    Escherichia coli recovered from three hospitals in Barcelona (Spain) were studied to determine the prevalence of isolates with acquired AmpC (ac-AmpC) and/or overproduced chromosomal AmpC (c-AmpC). Mechanisms involved in blac-AmpC overexpression, blaac-AmpC and the plasmids associated with their distribution as well as the prevalence of plasmid-mediated quinolone resistance (PMQR) in AmpC-producing isolates were also determined. Isolates were selected according to their resistance phenotype. blaac-AmpC, alterations in the blac-AmpC promoter/attenuator, and PMQR genes [qnrA, qnrB, qnrS, aac(6')-Ib-cr and qepA] were characterised by PCR and sequencing. blac-AmpC expression was determined by qRT-PCR. Population structure analysis was performed using PFGE, MLST and phylogenetic group PCR. Plasmids carrying blaac-AmpC were characterised by PCR-based replicon typing and S1-PFGE. IncI1 and IncF plasmids were also analysed by plasmid MLST and replicon sequence typing, respectively. Among 21563 E. coli isolates, 240 (1.1%) overproduced AmpC β-lactamases, including 180 (75.0%) harbouring ac-AmpC (132 CMY-2 variants and 48 DHA-1) and 60 (25.0%) c-AmpC enzymes. Three mutation profiles in the blac-AmpC promoter/attenuator were associated with a 72.5-, 19.9- and 5.8-fold increased expression, respectively. Moreover, 63.3% of ac-AmpC and 43.3% of c-AmpC isolates belonged to B2, D, E or F phylogenetic groups. PMQR was found in 31% of ac-AmpC isolates [38 qnrB4, 8 aac(6')-Ib-cr, 6 qnrS1 and 3 qnrB19] and in 10% of c-AmpC isolates [5 aac(6')-Ib-cr and 1 qnrS1]. IncI1-ST12 and IncF were associated with blaCMY-2 and blaDHA-1, respectively. These results suggest that ac-AmpC β-lactamases were the main mechanism of AmpC production. Isolates and plasmids both showed high genetic diversity. PMID:26607336

  4. High prevalence of blaOXA-23 in Acinetobacter spp. and detection of blaNDM-1 in A. soli in Cuba: report from National Surveillance Program (2010–2012

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    D. Quiñones

    2015-09-01

    Full Text Available As a first national surveillance of Acinetobacter in Cuba, a total of 500 Acinetobacter spp. isolates recovered from 30 hospitals between 2010 and 2012 were studied. Acinetobacter baumannii–calcoaceticus complex accounted for 96.4% of all the Acinetobacter isolates, while other species were detected at low frequency (A. junii 1.6%, A. lwoffii 1%, A. haemolyticus 0.8%, A. soli 0.2%. Resistance rates of isolates were 34–61% to third-generation cephalosporins, 49–50% to β-lactams/inhibitor combinations, 42–47% to aminoglycosides, 42–44% to carbapenems and 55% to ciprofloxacin. However, resistance rates to colistin, doxycycline, tetracycline and rifampin were less than 5%. Among carbapenem-resistant isolates, 75% harboured different blaOXA genes (OXA-23, 73%; OXA-24, 18%; OXA-58, 3%. The blaNDM-1 gene was identified in an A. soli strain, of which the species was confirmed by sequence analysis of 16S rRNA gene, rpoB, rpoB–rpoC and rpoL–rpoB intergenic spacer regions and gyrB. The sequences of blaNDM-1 and its surrounding genes were identical to those reported for plasmids of A. baumannii and A. lwoffi strains. This is the first report of blaNDM-1 in A. soli, together with a high prevalence of OXA-23 carbapenemase for carbapenem resistance in Acinetobacter spp. in Cuba.

  5. Pharmacovigilance studies on the basic knowledge, practice and attitude among the second year MBBS students of Jawaharlal Nehru institute of medical sciences, Porompat, Manipur, India

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    Varkung Valte

    2016-06-01

    Conclusions: If there is good communication and reports; most of the ADRs are avoidable and plays a pivotal role in minimising the ADRs. Drugs must be prescribed rationally and poly pharmacy should be discouraged and avoided as much as possible. To avoid the ADRs, pharmacovigilance is a matter of great concern for the health care providers and for the general mass too. [Int J Basic Clin Pharmacol 2016; 5(3.000: 820-822

  6. 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; 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

    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 study...

  7. 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)

    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

  8. The sudden dominance of blaCTX-M harbouring plasmids in Shigella spp. Circulating in Southern Vietnam.

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    Nhu Thi Khanh Nguyen

    Full Text Available BACKGROUND: Plasmid mediated antimicrobial resistance in the Enterobacteriaceae is a global problem. The rise of CTX-M class extended spectrum beta lactamases (ESBLs has been well documented in industrialized countries. Vietnam is representative of a typical transitional middle income country where the spectrum of infectious diseases combined with the spread of drug resistance is shifting and bringing new healthcare challenges. METHODOLOGY: We collected hospital admission data from the pediatric population attending the hospital for tropical diseases in Ho Chi Minh City with Shigella infections. Organisms were cultured from all enrolled patients and subjected to antimicrobial susceptibility testing. Those that were ESBL positive were subjected to further investigation. These investigations included PCR amplification for common ESBL genes, plasmid investigation, conjugation, microarray hybridization and DNA sequencing of a bla(CTX-M encoding plasmid. PRINCIPAL FINDINGS: We show that two different bla(CTX-M genes are circulating in this bacterial population in this location. Sequence of one of the ESBL plasmids shows that rather than the gene being integrated into a preexisting MDR plasmid, the bla(CTX-M gene is located on relatively simple conjugative plasmid. The sequenced plasmid (pEG356 carried the bla(CTX-M-24 gene on an ISEcp1 element and demonstrated considerable sequence homology with other IncFI plasmids. SIGNIFICANCE: The rapid dissemination, spread of antimicrobial resistance and changing population of Shigella spp. concurrent with economic growth are pertinent to many other countries undergoing similar development. Third generation cephalosporins are commonly used empiric antibiotics in Ho Chi Minh City. We recommend that these agents should not be considered for therapy of dysentery in this setting.

  9. Dissemination of IncI2 Plasmids That Harbor the blaCTX-M Element among Clinical Salmonella Isolates

    OpenAIRE

    Wong, Marcus Ho-yin; Liu, Lizhang; Yan, Meiying; Chan, Edward Wai-chi; Chen, Sheng

    2015-01-01

    The extended-spectrum-β-lactamase (ESBL) determinant CTX-M-55 is increasingly prevalent in Escherichia coli but remains extremely rare in Salmonella. This study reports the isolation of a plasmid harboring the blaCTX-M-55 element in a clinical Salmonella enterica serotype Typhimurium strain resistant to multiple antibiotics. This plasmid is genetically identical to several known IncI2-type elements harbored by E. coli strains recovered from animals. This finding indicates that IncI2 plasmids ...

  10. Land Use and Land Cover - CEMETERIES_USGS_BLA_IN: Cemetery Locations in Indiana (United States Geological Survey, 1:24000, Point Shapefile)

    Data.gov (United States)

    NSGIC GIS Inventory (aka Ramona) — Cemeteries_USGSs__BLA_IN is a point shapefile showing the locations and attribute values of cemeteries extracted from the Geographic Names Information System (GNIS)...

  11. Association between β-Lactamase-Encoding blaOXA-51 Variants and DiversiLab Rep-PCR-Based Typing of Acinetobacter baumannii Isolates

    Science.gov (United States)

    Zander, Esther; Nemec, Alexandr; Seifert, Harald

    2012-01-01

    This study investigated the correlation between blaOXA-51 variants and Acinetobacter baumannii worldwide clonal lineages 1 to 8 (WW1 to -8). The blaOXA-51-like genes of 102 A. baumannii isolates were sequenced. Using DiversiLab repetitive-sequence-based PCR (rep-PCR) typing, 92 of these isolates had previously been assigned to WW1 to -8 and 10 were unclustered. Clustering of DNA sequences was performed using the neighbor-joining method and the Jukes-Cantor phylogenetic correction. blaOXA-51 variants were in good correlation with DiversiLab-defined clonal lineages. Sequence-based typing of blaOXA-51 variants has the potential to be applied for epidemiologic characterization of A. baumannii and to identify worldwide clonal lineages 1 to 8. PMID:22422849

  12. Molecular Evolution of a Klebsiella pneumoniae ST278 Isolate Harboring blaNDM-7 and Involved in Nosocomial Transmission.

    Science.gov (United States)

    Lynch, Tarah; Chen, Liang; Peirano, Gisele; Gregson, Dan B; Church, Deirdre L; Conly, John; Kreiswirth, Barry N; Pitout, Johann D

    2016-09-01

    During 2013, ST278 Klebsiella pneumoniae with blaNDM-7 was isolated from the urine (KpN01) and rectum (KpN02) of a patient in Calgary, Canada. The same strain (KpN04) was subsequently isolated from another patient in the same unit. Interestingly, a carbapenem-susceptible K. pneumoniae ST278 (KpN06) was obtained 1 month later from the blood of the second patient. Next-generation sequencing (NGS) revealed that the loss of carbapenem-resistance in KpN06 was due to a 5-kb deletion on the blaNDM-7-harboring IncX3 plasmid. In addition, an IncFIB plasmid in KpN06 had a 27-kb deletion that removed genes encoding for heavy metal resistance. Phylogenetic analysis showed that the K. pneumoniae ST278 from patient 2 was likely a descendant of KpN02 and that KpN06 was a close progenitor of an environmental ST278. It is unclear whether KpN06 lost the blaNDM-7 gene in vivo. This study detailed the remarkable plasticity and speed of evolutionary changes in multidrug-resistant K. pneumoniae, demonstrating the highly recombinant nature of this species. It also highlights the ability of NGS to clarify molecular microevolutionary events within antibiotic-resistant organisms. PMID:27284091

  13. Novel Complex Class 1 Integron Bearing an ISCR1 Element in an Escherichia coli Isolate Carrying the blaCTX-M-14 Gene▿

    OpenAIRE

    Bae, Il Kwon; Lee, You-Nae; Lee, Wee Gyo; Lee, Sang Hee; Jeong, Seok Hoon

    2007-01-01

    This work identifies an ISCR1-related blaCTX-M-14 gene, which has never been reported before, from a clinical isolate of Escherichia coli. The blaCTX-M-14 gene was preceded by an ISCR1 element that was followed by a class 1 integron containing three different insert gene cassettes, i.e., dfrA12, orfF, and aadA2.

  14. A novel IS26 structure is surrounding blaCTX-M genes in different plasmids of German clinical isolates of Escherichia coli

    OpenAIRE

    Cullik, Angela; Pfeifer, Yvonne; Prager, Rita; von Baum, Heike; Witte, Wolfgang

    2010-01-01

    This report focuses on the molecular characterization of 22 extended-spectrum beta-lactamase (ESBL) producing E. coli isolates collected in a German university hospital, during a period of nine months in 2006. Relationship analysis of clinical isolates was done via pulsed-field gel-electrophoresis, mulit-locus sequence typing, plasmid profiling and additionally PCR for blaESBL detection and phylogroups. After conjugal transfer plasmid isolation and subsequent PCR for blaESBL detection and inc...

  15. Dispersal of carbapenemase blaVIM-1 gene associated with different Tn402 variants, mercury transposons, and conjugative plasmids in Enterobacteriaceae and Pseudomonas aeruginosa.

    Science.gov (United States)

    Tato, Marta; Coque, Teresa M; Baquero, Fernando; Cantón, Rafael

    2010-01-01

    The emergence of bla(VIM-1) within four different genetic platforms from distinct Enterobacteriaceae and Pseudomonas aeruginosa isolates in an area with a low prevalence of metallo-beta-lactamase producers is reported. Forty-three VIM-1-producing isolates (including 19 Enterobacter cloacae, 2 Escherichia coli, and 2 P. aeruginosa isolates, 18 Klebsiella pneumoniae isolate, and 2 Klebsiella oxytoca isolate) recovered from 2005 to 2007 and corresponding to 15 pulsed-field gel electrophoresis types were studied. The Enterobacteriaceae isolates corresponded to a hospital outbreak, and the P. aeruginosa isolates were sporadically recovered. The genetic context of the integrons carrying bla(VIM-1) (arbitrarily designated types A, B, C, and D) was characterized by PCR mapping based on known Tn402 and mercury transposons and further sequencing. Among Enterobacteriaceae isolates, bla(VIM-1) was part of integrons located either in an In2-Tn402 element linked to Tn21 (type A; In110-bla(VIM-1)-aacA4-aadA1) or in a Tn402 transposon lacking the whole tni module [type B; In113-bla(VIM-1)-aacA4-dhfrII (also called dfrB1)-aadA1-catB2] and the transposon was associated with an IncHI2 or IncI1 plasmid, respectively. Among P. aeruginosa isolates, bla(VIM-1) was part of a new gene cassette array located in a defective Tn402 transposon carrying either tniBDelta3 and tniA (type C; bla(VIM-1)-aadA1) or tniC and DeltatniQ (type D; bla(VIM-1)-aadB), and both Tn402 variants were associated with conjugative plasmids of 30 kb. The dissemination of bla(VIM-1) was associated with different genetic structures and bacterial hosts, depicting a complex emergence and evolutionary network scenario in our facility, Ramón y Cajal University Hospital, Madrid, Spain. Knowledge of the complex epidemiology of bla(VIM-1) is necessary to control this emerging threat. PMID:19901094

  16. Epidemiological characteristics of blaNDM-1 in Enterobacteriaceae and the Acinetobacter calcoaceticus-Acinetobacter baumannii complex in China from 2011 to 2012.

    Directory of Open Access Journals (Sweden)

    Weimei Ou

    Full Text Available OBJECTIVES: The study aimed to investigate the prevalence and epidemiological characteristics of blaNDM-1 (encoding New Delhi metallo-β-lactamase 1 in Enterobacteriaceae and the Acinetobacter calcoaceticus-Acinetobacter baumannii complex (ABC in China from July 2011 to June 2012. METHODS: PCR was used to screen for the presence of blaNDM-1 in all organisms studied. For blaNDM-1-positive strains, 16S rRNA analysis and Analytical Profile Index (API strips were used to identify the bacterial genus and species. The ABCs were reconfirmed by PCR detection of blaOXA-51-like. Antibiotic susceptibilities of the bacteria were assessed by determining minimum inhibitory concentration (MIC of them using two-fold agar dilution test, as recommended by the Clinical and Laboratory Standards Institute (CLSI. Molecular typing was performed using pulsed-field gel electrophoresis (PFGE. S1 nuclease-pulsed-field gel electrophoresis (S1-PFGE and Southern blot hybridization were conducted to ascertain the gene location of blaNDM-1. Conjugation experiments were conducted to determine the transmission of blaNDM-1-positive strains. RESULTS: Among 2,170 Enterobacteriaceae and 600 ABCs, seven Enterobacteriaceae strains and two A. calcoaceticus isolates from five different cities carried the blaNDM-1 gene. The seven Enterobacteriaceae strains comprised four Klebsiella pneumoniae, one Enterobacter cloacae, one Enterobacter aerogen and one Citrobacter freundii. All seven were non-susceptible to imipenem, meropenem or ertapenem. Two A. calcoaceticus species were resistant to imipenem and meropenem. Three K. pneumoniae showed the same PFGE profiles. The blaNDM-1 genes of eight strains were localized on plasmids, while one was chromosomal. CONCLUSIONS: Compared with previous reports, the numbers and species containing the blaNDM-1 in Enterobacteriaceae have significantly increased in China. Most of them are able to disseminate the gene, which is cause for concern. Consecutive

  17. 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. PMID:26518315

  18. Text mining for pharmacovigilance: Using machine learning for drug name recognition and drug-drug interaction extraction and classification.

    Science.gov (United States)

    Ben Abacha, Asma; Chowdhury, Md Faisal Mahbub; Karanasiou, Aikaterini; Mrabet, Yassine; Lavelli, Alberto; Zweigenbaum, Pierre

    2015-12-01

    Pharmacovigilance (PV) is defined by the World Health Organization as the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. An essential aspect in PV is to acquire knowledge about Drug-Drug Interactions (DDIs). The shared tasks on DDI-Extraction organized in 2011 and 2013 have pointed out the importance of this issue and provided benchmarks for: Drug Name Recognition, DDI extraction and DDI classification. In this paper, we present our text mining systems for these tasks and evaluate their results on the DDI-Extraction benchmarks. Our systems rely on machine learning techniques using both feature-based and kernel-based methods. The obtained results for drug name recognition are encouraging. For DDI-Extraction, our hybrid system combining a feature-based method and a kernel-based method was ranked second in the DDI-Extraction-2011 challenge, and our two-step system for DDI detection and classification was ranked first in the DDI-Extraction-2013 task at SemEval. We discuss our methods and results and give pointers to future work. PMID:26432353

  19. Whole-animal imaging of bacterial infection using endoscopic excitation of β-lactamase (BlaC)-specific fluorogenic probe

    Science.gov (United States)

    Nooshabadi, Fatemeh; Yang, Hee-Jeong; Cheng, Yunfeng; Xie, Hexin; Rao, Jianghong; Cirillo, Jeffrey D.; Maitland, Kristen C.

    2016-03-01

    Tuberculosis (TB), caused by Mycobacterium tuberculosis (Mtb), remains one of the most frequent causes of death worldwide. The slow growth rate of Mtb limits progress toward understanding tuberculosis including diagnosis of infections and evaluating therapeutic efficacy. Development of near-infrared (NIR) β-lactamase (BlaC)-specific fluorogenic substrate has made a significant breakthrough in the whole-animal imaging to detect Mtb infection. The reporter enzyme fluorescence (REF) system using a BlaC-specific fluorogenic substrate has improved the detection sensitivity in whole-animal optical imaging down to ~104 colony forming units (CFU) of bacteria, about 100-fold improvement over recombinant strains. However, improvement of detection sensitivity is strongly needed for clinical diagnosis of early stage infection at greater tissue depth. In order to improve detection sensitivity, we have integrated a fiber-based microendoscpe into a whole-animal imaging system to transmit the excitation light from the fiber bundle to the fluorescent target directly and measure fluorescent level using BlaC-specific REF substrate in the mouse lung. REF substrate, CNIR800, was delivered via aerosol route to the pulmonary infected mice with M. bovis BCG strain at 24 hours post-infection and groups of mice were imaged at 1-4 hours post-administration of the substrate using the integrated imaging system. In this study we evaluated the kinetics of CNIR800 substrate using REF technology using the integrated imaging system. Integration of these technologies has great promise for improved detection sensitivity allowing pre-clinical imaging for evaluation of new therapeutic agents.

  20. Ambiente genético del Gen blaCTX-M-12 en aislamientos hospitalarios de Klebsiella pneumoniae

    OpenAIRE

    Yamile Adriana Celis Bustos; Ingrid Yamile Pulido Manrique; Emilia María Valenzuela de Silva; María Teresa Reguero Reza; José Ramón Mantilla Anaya

    2009-01-01

    The blaCTX-M-12 gene’s genetic environmnt in Klebsiella pneumoniae hospital isolates Resumen: En Colombia se han detectado genes del grupo CTX-M-1 con alta frecuencia en aislamientos de Klebsiella pneumoniae causantes de infección intrahospitalaria. El conocimiento de los factores genéticos que pueden favorecer la diseminación de estos genes entre especies bacterianas es un aspecto importante para el control de la resistencia. En este estudio se identificaron los plásmidos portadores del ge...

  1. Draft Genome Sequence of a Multidrug-Resistant blaNDM-1-Producing Acinetobacter soli Isolate in China

    OpenAIRE

    Chen, Yan; Yan, Zhengsong; Wang, Miaojuan; Zheng, Xia; Lu, Yun; Lin, Shaohua

    2014-01-01

    Acinetobacter spp. are one of the most prevalent opportunistic pathogens causing nosocomial infections and have become a major clinical and public health threat. In this study, we presented the first draft genome sequence of A. soli TCM341, a multidrug resistant isolate that carried the blaNDM-1 gene in China. Genome sequencing of A. soli TCM341 was carried out in Illumina Hiseq 2000 next-generation sequencer. The data obtained revealed 74 contigs with genome size of 3.49 Mb and G+C content o...

  2. blaCTX-M Genes in Clinical Salmonella Isolates Recovered from Humans in England and Wales from 1992 to 2003

    OpenAIRE

    Batchelor, M.; Hopkins, K.; Threlfall, E. J.; Clifton-Hadley, F. A.; Stallwood, A. D.; Davies, R. H.; Liebana, E.

    2005-01-01

    Cefotaximases (CTX-M) are a rapidly growing class A β-lactamase family that has been found among a wide range of clinical bacteria. One hundred and six isolates were selected from 278,308 Salmonella isolates based on resistance to ampicillin and cephalosporins and subjected to further characterization. Fourteen isolates were blaCTX-M PCR positive, and cefotaxime MICs for these isolates were ≥16 mg/liter. Furthermore, sequence analysis revealed the presence of type CTX-M9, -15, or -17 to -18. ...

  3. Different IncI1 plasmids from Escherichia coli carry ISEcp1-blaCTX-M-15 associated with different Tn2-derived elements.

    Science.gov (United States)

    Zong, Zhiyong; Ginn, Andrew N; Dobiasova, Hana; Iredell, Jonathan R; Partridge, Sally R

    2015-07-01

    The bla(CTX-M-15) gene, encoding the globally dominant CTX-M-15 extended-spectrum β-lactamase, has generally been found in a 2.971-kb ISEcp1-bla(CTX-M-15)-orf477Δ transposition unit, with ISEcp1 providing a promoter. In available IncF plasmid sequences from Escherichia coli, this transposition unit interrupts a truncated copy of transposon Tn2 that lies within larger multiresistance regions. In E. coli, bla(CTX-M-15) is also commonly associated with IncI1 plasmids and here three such plasmids from E. coli clinical isolates from western Sydney 2006-2007 have been sequenced. The plasmid backbones are organised similarly to those of other IncI1 plasmids, but have insertions and/or deletions and sequence differences. Each plasmid also has a different insertion carrying bla(CTX-M-15). pJIE113 (IncI1 sequence type ST31) is almost identical to plasmids isolated from the 2011 E. coli O104:H4 outbreak in Europe, where the typical bla(CTX-M-15) transposition unit interrupts a complete Tn2 inserted directly in the plasmid backbone. In the novel plasmid pJIE139 (ST88), ISEcp1-blaC(TX-M-15)-orf477Δ lies within a Tn2/3 hybrid transposon. Homologous recombination could explain movement of ISEcp1-bla(CTX-M-15)-orf477Δ between copies of Tn2 on IncF and IncI1 plasmids and generation of the Tn2/3 hybrid. pJIE174 (ST37) is almost identical to pESBL-12 from the Netherlands and in these plasmids bla(CTX-M-15) is flanked by two copies of IS26 that truncate the transposition unit within a larger region bounded by the ends of Tn2. bla(CTX-M-15) and the associated ISEcp1-derived promoter may be able to move from this structure by the actions of IS26, independently of both ISEcp1 and Tn2. PMID:25929173

  4. Complete Nucleotide Sequence of IncP-1β Plasmid pDTC28 Reveals a Non-Functional Variant of the blaGES-Type Gene.

    Science.gov (United States)

    Dang, Bingjun; Mao, Daqing; Luo, Yi

    2016-01-01

    Plasmid pDTC28 was isolated from the sediments of Haihe River using E. coli CV601 (gfp-tagged) as recipient and indigenous bacteria from the sediment as donors. This plasmid confers reduced susceptibility to tetracycline and sulfamethoxazole. The complete sequence of plasmid pDTC28 was 61,503 bp in length with an average G+C content of 64.09%. Plasmid pDTC28 belongs to the IncP-1β group by phylogenetic analysis. The backbones of plasmid pDTC28 and other IncP-1β plasmids are very classical and conserved, whereas the accessory regions of these plasmids are diverse. A blaGES-5-like gene was found on the accessory region, and this blaGES-5-like gene contained 18 silent mutations and 7 missense mutations compared with the blaGES-5 gene. The mutations resulted in 7 amino acid substitutions in GES-5 carbapenemase, causing the loss of function of the blaGES-5-like gene on plasmid pDTC28 against carbapenems and even β-lactams. The enzyme produced by the blaGES-5-like gene cassette may be a new variant of GES-type enzymes. Thus, the plasmid sequenced in this study will expand our understanding of GES-type β-lactamases and provide insights into the genetic platforms used for the dissemination of GES-type genes. PMID:27152950

  5. Complete Nucleotide Sequence of IncP-1β Plasmid pDTC28 Reveals a Non-Functional Variant of the blaGES-Type Gene

    Science.gov (United States)

    Dang, Bingjun; Mao, Daqing; Luo, Yi

    2016-01-01

    Plasmid pDTC28 was isolated from the sediments of Haihe River using E. coli CV601 (gfp-tagged) as recipient and indigenous bacteria from the sediment as donors. This plasmid confers reduced susceptibility to tetracycline and sulfamethoxazole. The complete sequence of plasmid pDTC28 was 61,503 bp in length with an average G+C content of 64.09%. Plasmid pDTC28 belongs to the IncP-1β group by phylogenetic analysis. The backbones of plasmid pDTC28 and other IncP-1β plasmids are very classical and conserved, whereas the accessory regions of these plasmids are diverse. A blaGES-5-like gene was found on the accessory region, and this blaGES-5-like gene contained 18 silent mutations and 7 missense mutations compared with the blaGES-5 gene. The mutations resulted in 7 amino acid substitutions in GES-5 carbapenemase, causing the loss of function of the blaGES-5-like gene on plasmid pDTC28 against carbapenems and even β-lactams. The enzyme produced by the blaGES-5-like gene cassette may be a new variant of GES-type enzymes. Thus, the plasmid sequenced in this study will expand our understanding of GES-type β-lactamases and provide insights into the genetic platforms used for the dissemination of GES-type genes. PMID:27152950

  6. 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.

  7. Specialist Cohort Event Monitoring Studies: A New Study Method for Risk Management in Pharmacovigilance

    OpenAIRE

    Layton, Deborah; Shakir, Saad A W

    2015-01-01

    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 ...

  8. Evaluation of gemtuzumab ozogamycin associated sinusoidal obstructive syndrome: Findings from an academic pharmacovigilance program review and a pharmaceutical sponsored registry

    Science.gov (United States)

    Magwood-Golston, Jametta S.; Kessler, Samuel; Bennett, Charles L.

    2016-01-01

    Background In 2000, the Food and Drug Administration (FDA) approved gemtuzumab ozogamycin for monotherapy for older patients with relapsed AML. A 0.9% rate of hepatic sinusoidal obstructive syndrome (SOS) was noted in licensing trials. In 2001, FDA received reports of 14 GO-associated SOS cases from MD Anderson Cancer Center. A State of South Carolina/National Cancer Institute funded pharmacovigilance program and a manufacturer sponsored registry independently evaluated this concern. Methods The manufacturer’s registry and the academic program focused on risk factors and incidence of GO-associated SOS in routine clinical practice and clinical trial settings, respectively. Comparisons were made of findings and dissemination efforts from the two studies. Results Retrospective analysis of clinical trials by the academic initiative identified 99 cases of SOS among 221 GO-treated stem cell patients and 649 patients who did not undergo HSCTs. SOS rates were 3% when GO was administered at doses ≤6 mg/m2 as monotherapy or with non-hepatotoxic agents; 28% when administered with 6-thioguanine, a hepatotoxic agent; 15% when administered as monotherapy at doses at a dose of 9 mg/m2, and between 15% and 40% if a stem cell transplant (SCT) was performed within 3 months of GO administration. Death from SOS occurred in 33% of the cases. The manufacturer’s registry prospectively evaluated 482 GO-treated patients who received a mean dose of 7.8 mg/m2. Overall, 41% received concomitant chemotherapy, 18% had undergone prior SCT, 9.1% developed SOS, and death from SOS occurred in 60% of the SOS cases. Findings from each initiative were disseminated at national conferences and in peer-reviewed manuscripts beginning in 2003. Conclusion Retrospective review of clinical trials, case series, and FDA reports and prospective registries can provide important information on safety signals initially identified in licensing trials. PMID:27030962

  9. Exploring the potential reservoirs of non specific TEM beta lactamase (blaTEM) gene in the Indo-Gangetic region: A risk assessment approach to predict health hazards.

    Science.gov (United States)

    Singh, Gulshan; Vajpayee, Poornima; Rani, Neetika; Amoah, Isaac Dennis; Stenström, Thor Axel; Shanker, Rishi

    2016-08-15

    The emergence of antimicrobial resistant bacteria is an important public health and environmental contamination issue. Antimicrobials of β-lactam group accounts for approximately two thirds, by weight, of all antimicrobials administered to humans due to high clinical efficacy and low toxicity. This study explores β-lactam resistance determinant gene (blaTEM) as emerging contaminant in Indo-Gangetic region using qPCR in molecular beacon format. Quantitative Microbial Risk Assessment (QMRA) approach was adopted to predict risk to human health associated with consumption/exposure of surface water, potable water and street foods contaminated with bacteria having blaTEM gene. It was observed that surface water and sediments of the river Ganga and Gomti showed high numbers of blaTEM gene copies and varied significantly (pantimicrobial resistant bacteria. PMID:27111425

  10. Multidrug resistance and transferability of blaCTX-M among extended-spectrum β-lactamase-producing enteric bacteria in biofilm.

    Science.gov (United States)

    Maheshwari, Meenu; Ahmad, Iqbal; Althubiani, Abdullah Safar

    2016-09-01

    This study aimed to investigate the occurrence of biofilm-forming extended-spectrum β-lactamase (ESBL)-producing enteric bacteria in hospital wastewater and to evaluate their antibiotic resistance behaviour and transferability of the plasmid-encoded blaCTX-M gene in biofilm. ESBL production was confirmed using the combined disc test and Etest. Amplification of blaCTX-M was performed by PCR. Antibiotic susceptibility was evaluated using the disc diffusion assay and broth dilution method. Transfer of blaCTX-M in planktonic and biofilm state was performed by broth mating and filter mating experiments, respectively. Among 110 enteric bacteria, 24 (21.8%) isolates belonging to Escherichia coli, Klebsiella pneumoniae and Enterobacter cloacae were found to produce ESBL and formed varying levels of biofilm in vitro. Presence of blaCTX-M was detected in 18 (75%) ESBL-producing isolates. A many fold increase in resistance to antibiotics was observed in biofilm. Among ESBL-producers, seven isolates could transfer the blaCTX-M gene by conjugation, with transfer frequencies ranging from 2.22×10(-4) to 7.14×10(-2) transconjugants/recipient cell in the planktonic state and from 3.04×10(-3) to 9.15×10(-1) in biofilm. The transfer frequency of blaCTX-M was significantly higher in biofilm compared with the planktonic state, and co-transfer of ciprofloxacin resistance was also detected in five isolates. This study demonstrates that biofilm-forming ESBL-producing enteric bacteria with a greater transfer frequency of resistance genes will lead to frequent dissemination of β-lactam and fluoroquinolone resistance genes in environmental settings. The emergence and spread of such multidrug resistance is a serious threat to animal and public health. PMID:27530857

  11. Prevalence of the bla CTX-M group and their transferability in resistant clinical isolates of Salmonella serogroups from several hospitals of Tehran

    Directory of Open Access Journals (Sweden)

    Kobra Salimian Rizi

    2015-11-01

    Full Text Available Background and Objectives: Salmonella is an important food-borne pathogen in humans. Strains of Salmonella spp. That producing extended-spectrum β-Lactamases have become a concern in medicine regarding both antimicrobial treatment and infection control program. The objective of this study was to describe the antibiotic susceptibility, ESBL production and determining the prevalence of the blaCTX-M-1 group among clinical isolates of Salmonella spp.Materials and Methods: A total of 110 Salmonella isolates collected from four Tehran hospitals during May 2012 and April 2013. The specific monovalan Salmonella antisera were used for serogrouping of Salmonella isolates. Antibacterial susceptibility was determined by disk diffusion and ESBL phenotype was confirmed by combination disk method. The blaCTX-M-1 group was identified by PCR with specific primers. The transferability of the blaCTX-1 group was tested by conjugation with broth matting method.Results: The prevalence of Salmonella serogroups consist of 56.4% serogroup D, 13.6 % serogroup C, 10 % serogroup B, and 1.8 % serogroup A and 18.2% other serogroups. Maximal resistance in Salmonella isolates was noticed against trimethoprim-sulfamethoxazole (63.6% and nalidixic-acid (47/3%. All isolates were susceptible to imipenem and ciprofloxacin. Four isolates (3.6% showed ESBLs phenotype. All Salmonella spp. that produce ESBls have blaCTX-1 genes group. A conjugative plasmid containing blaCTX-1 group was found in one Salmonella isolate.Conclusion: This study demonstrates the predominant presence of the gene encoding CTX-M-1 group among ESBLs producing of Salmonella spp. They can transmit to bacteria of this genus or even other genera of enteric bacteria.Keywords: Salmonella spp., blaCTX-M-1 group, antibiotic resistance, conjugation, broth matting

  12. Influence of agricultural practice on mobile bla genes: IncI1-bearing CTX-M, SHV, CMY and TEM in Escherichia coli from intensive farming soils.

    Science.gov (United States)

    Jones-Dias, Daniela; Manageiro, Vera; Caniça, Manuela

    2016-01-01

    Many calls have been made to address antibiotic resistance in an environmental perspective. With this study, we showed the widespread presence of high-level antibiotic resistant isolates on a collection of non-susceptible Gram-negative bacteria (n = 232) recovered from soils. Bacteria were selected using amoxicillin, cefotaxime and imipenem, from sites representing different agricultural practices (extensive, intensive and organic). Striking levels of non-susceptibility were noticed in intensive soils for norfloxacin (74%), streptomycin (50.7%) and tetracycline (46.6%); indeed, the exposure to intensive agricultural practices constituted a risk factor for non-susceptibility to many antibiotics, multidrug resistance and production of extended-spectrum β-lactamases (ESBL). Analyses of non-susceptibility highlighted that environmental and clinical bacteria from the same species might not share the same intrinsic resistance patterns, raising concerns for therapy choices in environment-borne infections. The multiple sequence-type IncI1-driven spread of penicillinases (blaTEM-1, blaTEM-135), ESBL (blaSHV-12 and blaCTX-M-1) and plasmid-mediated AmpC β-lactamases (blaCMY-2), produced by isolates that share their molecular features with isolates from humans and animals, suggests contamination of agricultural soils. This is also the first appearance of IncI1/ST28-harbouring blaCTX-M-1, which should be monitored to prevent their establishment as successfully dispersed plasmids. This research may help disclose paths of contamination by mobile antibiotic resistance determinants and the risks for their dissemination. PMID:26279315

  13. The IncI1 plasmid carrying the bla CTX-M-1 gene persists in in vitro culture of a Escherichia coli strain from broilers

    OpenAIRE

    Fischer, E.A.J.; Dierikx, C.M.; Essen-Zandbergen, van, A.; Roermund, van, C.W.T.; Mevius, D.J.; Stegeman, A.; Klinkenberg, D.

    2014-01-01

    Commensal bacteria are a reservoir for antimicrobial-resistance genes. In the Netherlands, bacteria producing Extended Spectrum Beta-Lactamases (ESBL) are found on chicken-meat and in the gut of broilers at a high prevalence and the predominant ESBL-gene is the blaCTX-M-1 located on IncI1 plasmids. We aim to determine the fitness costs of this plasmid for the bacterium. We investigated the conjugation dynamics of IncI1 plasmids carrying the blaCTX-M-1 gene in a batch culture and its impact on...

  14. High Prevalence of SXT/R391-Related Integrative and Conjugative Elements Carrying blaCMY-2 in Proteus mirabilis Isolates from Gulls in the South of France.

    Science.gov (United States)

    Aberkane, Salim; Compain, Fabrice; Decré, Dominique; Dupont, Chloé; Laurens, Chrislène; Vittecoq, Marion; Pantel, Alix; Solassol, Jérôme; Carrière, Christian; Renaud, François; Brieu, Nathalie; Lavigne, Jean-Philippe; Bouzinbi, Nicolas; Ouédraogo, Abdoul-Salam; Jean-Pierre, Hélène; Godreuil, Sylvain

    2016-02-01

    The genetic structures involved in the dissemination of blaCMY-2 carried by Proteus mirabilis isolates recovered from different gull species in the South of France were characterized and compared to clinical isolates. blaCMY-2 was identified in P. mirabilis isolates from 27/93 yellow-legged gulls and from 37/65 slender-billed gulls. It was carried by a conjugative SXT/R391-like integrative and conjugative element (ICE) in all avian strains and in 3/7 human strains. Two clinical isolates had the same genetic background as six avian isolates. PMID:26643344

  15. A Plasmid Bearing the bla(CTX-M-15) Gene and Phage P1-Like Sequences from a Sequence Type 11 Klebsiella pneumoniae Isolate.

    Science.gov (United States)

    Shin, Juyoun; Ko, Kwan Soo

    2015-10-01

    Plasmid pKP12226 was extracted and analyzed from a CTX-M-15-producing Klebsiella pneumoniae sequence type 11 (ST11) isolate collected in South Korea. The plasmid represents chimeric characteristics consisting of a pIP1206-like backbone and lysogenized phage P1-like sequences. It bears a resistance region that includes resistance genes to several antibiotics and is different from previously characterized plasmids from South Korea bearing blaCTX-M-15. It may have resulted from recombination between an Escherichia coli plasmid backbone, a blaCTX-M-15-bearing resistance region, and lysogenized phage P1-like sequences. PMID:26195513

  16. Analysis of blaCTX-M-Carrying Plasmids from Escherichia coli Isolates Collected in the BfT-GermVet Study ▿

    OpenAIRE

    Schink, Anne-Kathrin; Kadlec, Kristina; Schwarz, Stefan

    2011-01-01

    In this study, 417 Escherichia coli isolates from defined disease conditions of companion and farm animals collected in the BfT-GermVet study were investigated for the presence of extended-spectrum β-lactamase (ESBL) genes. Three ESBL-producing E. coli isolates were identified among the 100 ampicillin-resistant isolates. The E. coli isolates 168 and 246, of canine and porcine origins, respectively, harbored blaCTX-M-1, and the canine isolate 913 harbored blaCTX-M-15, as confirmed by PCR and s...

  17. Prevalence of blAbstractP and blaVIM gene carriage in metallo-b-lactamase-producing burn isolates of Pseudomonas aeruginosa in Tehran

    OpenAIRE

    SALIMI, Fatemeh; Eftekhar, Fereshteh

    2014-01-01

    To study the prevalence of blaVIM and blaIMP genes in metallo-b-lactamase (MBL)-producing burn isolates of Pseudomonas aeruginosa in relation with AmpC and extended-spectrum b-lactamase (ESBL) production. Materials and methods: Thirty-two carbapenem-resistant MBL-producing P. aeruginosa burn isolates from Shahid Motahari Burn Hospital in Tehran were employed. Antibiotic susceptibility was determined to 13 antibiotics including imipenem and meropenem by disk diffusion. AmpC and ESBL producti...

  18. Insertion Sequence ISEcp1B Is Involved in Expression and Mobilization of a blaCTX-M β-Lactamase Gene

    OpenAIRE

    Poirel, Laurent; Decousser, Jean-Winoc; Nordmann, Patrice

    2003-01-01

    The genetic structures (ca. 10-kb DNA fragment) surrounding the plasmid-borne extended-spectrum β-lactamase blaCTX-M-19 gene in a Klebsiella pneumoniae clinical isolate were determined. This β-lactamase gene was part of a 4,797-bp transposon inserted inside orf1 of Tn1721. Inside this transposon, blaCTX-M-19 was bracketed upstream and downstream by insertion sequences ISE cp1B and IS903D, respectively, and further downstream by a truncated gene encoding an outer membrane protein for iron tran...

  19. The IncI1 plasmid carrying the bla CTX-M-1 gene persists in in vitro culture of a Escherichia coli strain from broilers

    OpenAIRE

    Fischer, E. A. J.; Dierikx, C.M.; Essen-Zandbergen, van, A.; Roermund, van, AHM Arthur; Mevius, D.J.; Stegeman, A.; Klinkenberg, D.

    2014-01-01

    Background Commensal bacteria are a reservoir for antimicrobial-resistance genes. In the Netherlands, bacteria producing Extended Spectrum Beta-Lactamases (ESBL) are found on chicken-meat and in the gut of broilers at a high prevalence and the predominant ESBL-gene is the bla CTX-M-1 located on IncI1 plasmids. We aim to determine the fitness costs of this plasmid for the bacterium. We investigated the conjugation dynamics of IncI1 plasmids carrying the bla CTX-M-1 gene in a batch culture and ...

  20. TO STUDY THE KNOWLEDGE ATTITUDE AND PRACTICE OF THE PHARMACOVIGILANCE AMONG THE SECOND PROFESSIONAL MBBS STUDENTS OF THE J. N . INSTITUTE OF MEDICAL SCIENCES, IMPHAL

    Directory of Open Access Journals (Sweden)

    Oinam Joychandra

    2015-07-01

    Full Text Available OBJECTIVE: The aim and object of the present study is to assess the knowledge, attitude and practice of ADRs among the 2 nd professional MBBS students and also to find out the ways for implementation of Pharmacovigilance Programme of India (PvPi. MATERIAL AND METHOD : The material is the pretested questionnaire on knowledge, attitude , and practice on Pharmacovigila nce. The design of the study is cross sectional study. Percentage, proportions and means are used for descriptive statistics while the associations are calc ulated using corresponding tests for the associations . RESULTS: The knowledge of the students on Pharmacovig ilence in connection with Over t he Counter/self - medication (52%; minimum need of surveillance on marketing (74%; present surveillance on marketing as low as 60%; need of CME on ADRs along with Pharmacovigil a nce among student at least (64% as the ADRs on elderly (57%, children(58%, Pregnancy (64%. Similarly out of 24 questions on Attitude, only 7 questions on Reporting, Multi National Company, Dr ug Controller of India, Disability and Compensation are selected for statistical analysis. The percentage of the students who has heard and seen ADRs 64.5. CONCLUSION: Most of the ADRs are avoidable if there is good communication and reports which plays a pivotal role in minimizing the ADRs. Drugs must be prescribed rationally and polypharmacy should be avoided as much as possible. To avoid the iatrogenic diseases, Pharm acovigilance is a matter of great concern for the health care providers and for the general mass too.

  1. Use of WGS data for investigation of a long-term NDM-1-producing Citrobacter freundii outbreak and secondary in vivo spread of blaNDM-1 to Escherichia coli, Klebsiella pneumoniae and Klebsiella oxytoca

    DEFF Research Database (Denmark)

    Hammerum, Anette M; Hansen, Frank; Linde Nielsen, Hans;

    2016-01-01

    patients had a history of recent travel abroad and the source of the blaNDM-1 plasmid was unknown. CONCLUSIONS: To our knowledge, this is the first report of an NDM-1-producing C. freundii outbreak and secondary in vivo spread of an IncA/C2 plasmid with blaNDM-1 to other Enterobacteriaceae....

  2. First characterisation of plasmid-mediated quinolone resistance-qnrS1 co-expressed bla CTX-M-15 and bla DHA-1 genes in clinical strain of Morganella morganii recovered from a Tunisian Intensive Care Unit

    Directory of Open Access Journals (Sweden)

    S Mahrouki

    2012-01-01

    Full Text Available Purpose: Aim of this study was to show the emergence of the qnr genes among fluoroquinolone-resistant, AMPC and ESBL (extended-spectrum-beta-lactamase co-producing Morganella morganii isolate. Materials and Methods: A multi resistant Morganella morganii SM12012 isolate was recovered from pus from a patient hospitalized in the intensive care unit at the Military hospital, Tunisia. Antibiotic susceptibility was tested with the agar disk diffusion method according to Clinical and Laboratory Standards Institute guidelines. ESBLs were detected using a standard double-disk synergy test. The characterization of beta-lactamases and associated resistance genes were performed by isoelectric focusing, polymerase chain reaction and nucleotide sequencing. Results: The antimicrobial susceptibility testing showed the high resistance to penicillins, cephalosporins (MICs: 64-512 μg/ml and fluoroquinolones (MICs: 32-512 μg/ml. But M. morganii SM12012 isolate remained susceptible to carbapenems (MICs: 4-<0.25 μg/ml. The double-disk synergy test confirmed the phenotype of extended-spectrum β-lactamases (ESBLs. Three identical β-lactamases with pI values of 6.5, 7.8 and superior to 8.6 were detected after isoelectric focusing analysis. These β-lactamases genes can be successfully transferred by the conjugative plasmid. Molecular analysis demonstrated the co-production of bla DHA-1, bla CTX-M-15 and qnrS1 genes on the same plasmid. The detection of an associated chromosomal quinolone resistance revealed the presence of a parC mutation at codon 80 (Ser80-lle80. Conclusion: This is the first report in Tunisia of nosocomial infection due to the production of CTX-M-15 and DHA-1 β-lactamases in M. morganii isolate with the association of quinolone plasmid resistance. The incidence of these strains invites continuous monitoring of such multidrug-resistant strains and the further study of their epidemiologic evolution.

  3. Risk of gastrointestinal complications associated to NSAIDs, low-dose aspirin and their combinations: Results of a pharmacovigilance reporting system.

    Science.gov (United States)

    Rafaniello, Concetta; Ferrajolo, Carmen; Sullo, Maria Giuseppa; Sessa, Maurizio; Sportiello, Liberata; Balzano, Antonio; Manguso, Francesco; Aiezza, Maria Luisa; Rossi, Francesco; Scarpignato, Carmelo; Capuano, Annalisa

    2016-02-01

    Gastrointestinal (GI) complications are one of the most limiting cause of use of NSAIDs. Beyond others well defined factors, history of peptic ulcer, older age, Helicobacter pylori infection and use of gastrotoxic drugs may affect their GI safety profile. In particular, the risk of GI complications associated to the use of antiplatelet drugs, especially low-dose acetylsalicylic acid (LDA) should deserve much attention. However, only few studies have focused on the effect of combination LDA/NSAIDs on the GI tract compared with the monotherapy and much less studies assessed this effect with multiple NSAIDs use. We aimed to characterize the GI safety profile of NSAIDs and LDA as monotherapy or their combinations in real-life conditions by analysing spontaneous adverse drug reactions (ADRs) reporting system in a Southern Italy. We used the case/non-case method in the Italian Pharmacovigilance Network (RNF). Cases were reports of GI events in the RNF between January 2007 and December 2011. Non-cases were all other reports during the same period. The association between NSAID and suspected GI ADRs was calculated using the reporting odds ratio (ROR) with 95% confidence intervals as a measure of disproportionality while adjusting for age, and concomitant use of antineoplastic agents or drugs for cardiovascular diseases. Sub-analysis were performed within the NSAID class. Among the 2816 adverse drug reactions recorded, we identified 374 (13.3%) cases of GI complications. Upper GI complications were the most frequently reported type of events. The highest associations were found for the combined use of NSAIDs and/or LDA, whilst the lowest associations were for their respective monotherapy. Looking at individual NSAIDs the highest association with GI events was observed for ketorolac exposure followed by nimesulide, diclofenac, aspirin, ketoprofen, and ibuprofen. This study highlights the primary role of the national spontaneous reporting system to bring out potential signals

  4. Draft genome sequence of a multidrug-resistant blaOXA-23-producing Acinetobacter baumannii ST208 isolate from China.

    Science.gov (United States)

    Chen, Yan; Wu, Liyan; Chen, Yu; Xu, Zhijun; Xu, Liqun

    2016-03-01

    Acinetobacter baumannii has emerged worldwide as an important opportunistic nosocomial pathogen and has become a major public health concern. In this study, the draft genome sequence of A. baumannii TCM331 (ST208/CC92), a multidrug-resistant (MDR) isolate harbouring the blaOXA-23 gene isolated in China, was determined. The genome of TCM331 was sequenced via Illumina HiSeq™ 2000, and bioinformatics analysis was performed. Important antimicrobial resistance determinants were observed in an estimated genome size of 4,058,691bp with 3838 predicted coding regions. In conclusion, these data might facilitate further understanding of the specific genomic features of MDR A. baumannii in China. PMID:27436391

  5. The IncI1 plasmid carrying the bla CTX-M-1 gene persists in in vitro culture of a Escherichia coli strain from broilers

    NARCIS (Netherlands)

    Fischer, E.A.J.; Dierikx, C.M.; Essen-Zandbergen, van A.; Roermund, van H.J.W.; Mevius, D.J.; Stegeman, A.; Klinkenberg, D.

    2014-01-01

    Commensal bacteria are a reservoir for antimicrobial-resistance genes. In the Netherlands, bacteria producing Extended Spectrum Beta-Lactamases (ESBL) are found on chicken-meat and in the gut of broilers at a high prevalence and the predominant ESBL-gene is the blaCTX-M-1 located on IncI1 plasmids.

  6. Complete Nucleotide Sequence of pGA45, a 140,698-bp IncFIIY Plasmid Encoding bla IMI-3-Mediated Carbapenem Resistance, from River Sediment.

    Science.gov (United States)

    Dang, Bingjun; Mao, Daqing; Luo, Yi

    2016-01-01

    Plasmid pGA45 was isolated from the sediments of Haihe River using Escherichia coli CV601 (gfp-tagged) as recipients and indigenous bacteria from sediment as donors. This plasmid confers reduced susceptibility to imipenem which belongs to carbapenem group. Plasmid pGA45 was fully sequenced on an Illumina HiSeq 2000 sequencing system. The complete sequence of plasmid pGA45 was 140,698 bp in length with an average G + C content of 52.03%. Sequence analysis shows that pGA45 belongs to IncFIIY group and harbors a backbone region which shares high homology and gene synteny to several other IncF plasmids including pNDM1_EC14653, pYDC644, pNDM-Ec1GN574, pRJF866, pKOX_NDM1, and pP10164-NDM. In addition to the backbone region, plasmid pGA45 harbors two notable features including one bla IMI-3-containing region and one type VI secretion system region. The bla IMI-3-containing region is responsible for bacteria carbapenem resistance and the type VI secretion system region is probably involved in bacteria virulence, respectively. Plasmid pGA45 represents the first complete nucleotide sequence of the bla IMI-harboring plasmid from environment sample and the sequencing of this plasmid provided insight into the architecture used for the dissemination of bla IMI carbapenemase genes. PMID:26941718

  7. Complete nucleotide sequence of pGA45, a 140,698-bp incFIIY plasmid encoding blaIMI-3-mediated carbapenem resistance, from river sediment

    Directory of Open Access Journals (Sweden)

    Bingjun eDang

    2016-02-01

    Full Text Available Plasmid pGA45 was isolated from the sediment of Haihe River using E. coli CV601 (gfp-tagged as recipients and indigenous bacteria from sediment as donors. This plasmid confers reduced susceptibility to imipenem which belongs to carbapenem group. Plasmid pGA45 was fully sequenced on an Illumina HiSeq 2000 sequencing system. The complete sequence of plasmid pGA45 was 140,698 bp in length with an average G+C content of 52.03%. Sequence analysis shows that pGA45 belongs to incFIIY group and harbors a backbone region shares high homology and gene synteny to several other incF plasmids including pNDM1_EC14653, pYDC644, pNDM-Ec1GN574, pRJF866, pKOX_NDM1 and pP10164-NDM. In addition to the backbone region, plasmid pGA45 harbors two notable features including one blaIMI-3-containing region and one type VI secretion system region. The blaIMI-3-containing region is responsible for bacteria carbapenem resistance and the type VI secretion system region is probably involved in bacteria virulence, respectively. Plasmid pGA45 represents the first complete nucleotide sequence of the blaIMI-harboring plasmid from environment sample and the sequencing of this plasmid provided insight into the architecture used for the dissemination of blaIMI carbapenemase genes.

  8. Spread of extended-spectrum beta-lactamase producing Escherichia coli isolates in Swedish broilers mediated by an incI plasmid carrying blaCTX-M-1

    Directory of Open Access Journals (Sweden)

    Börjesson Stefan

    2013-01-01

    Full Text Available Abstract Background The already high and increasing occurrence of extended-spectrum beta-lactamases (ESBL producing Escherichia coli in European broiler populations is of concern due to the fact that third and fourth generation cephalosporins are deemed critically important in human medicine. In Sweden 34% of the broilers carry ESBL/pAmpC producing E. coli in their gut, despite the absence of a known selection pressure such as antimicrobial usages. The aim of the current study was to characterise a selection of E. coli strains carrying the blaCTX-M-1, to determine if the spread was due to a specific clone. Findings Ten isolates carrying blaCTX-M-1 from Swedish broilers belonged to eight different multi-locus sequence types with three isolates belonging to ST155. The ST155 isolates were identical as assessed by PFGE. The blaCTX-M-1 was in all isolates carried on a plasmid of replicon type incI, which also transferred resistance to tetracycline and sulfamethoxazole. Conclusion The occurrence of ESBL-producing E. coli in the Swedish broilers is not due to the emergence of a single clone, but rather the spread of a specific incI plasmid carrying blaCTX-M-1.

  9. Molecular dissection of blaKPC-2-bearing plasmids evolving in Klebsiella pneumoniae isolated at one teaching hospital in Shanghai, China.

    Science.gov (United States)

    Shen, Pinghua; Zhang, Ying; Tang, Yu; Liang, Wei; Jiang, Xiaofei

    2016-08-01

    The presence of carbapenemase gene blaKPC-2 in a wide variety of plasmids, especially conjugative plasmids, is key to the rapid, worldwide spread of carbapenemase enzymes. Thirty-eight, non-duplicated, carbapenem-resistant, clinical Klebsiella pneumoniae isolates were collected, all carrying blaKPC-2-bearing plasmids. Relaxase analysis was used to classify these plasmids; 8 and 30 plasmids belonged to the MOBP3 and MOBF12 subfamilies, respectively. Phylogenetic analysis revealed two genetic subclades in the MOBF12 subfamily and suggested that these subclades might not have originated from the same ancestor. Crossing PCR, used to sequence fully the type IV secretion system (T4SS, essential structures for conjugative plasmids) of the MOBF12 plasmids, found that T4SSs were distinctively different in certain functional genes, e.g. traS and traG. In conclusion, this study delineated the evolution of blaKPC-2-bearing plasmids at Huashan Hospital, Shanghai, China. The plasmids bearing blaKPC-2 were diverse and the MOBF12 plasmids were dominant in clinical K. pneumoniae isolates. PMID:27252157

  10. Molecular identification of CTX-M and blaOXY/K1 β-lactamase genes in Enterobacteriaceae by sequencing of universal M13-sequence tagged PCR-amplicons

    Directory of Open Access Journals (Sweden)

    Tärnberg Maria

    2009-01-01

    Full Text Available Abstract Background Plasmid encoded blaCTX-M enzymes represent an important sub-group of class A β-lactamases causing the ESBL phenotype which is increasingly found in Enterobacteriaceae including Klebsiella spp. Molecular typing of clinical ESBL-isolates has become more and more important for prevention of the dissemination of ESBL-producers among nosocomial environment. Methods Multiple displacement amplified DNA derived from 20 K. pneumoniae and 34 K. oxytoca clinical isolates with an ESBL-phenotype was used in a universal CTX-M PCR amplification assay. Identification and differentiation of blaCTX-M and blaOXY/K1 sequences was obtained by DNA sequencing of M13-sequence-tagged CTX-M PCR-amplicons using a M13-specific sequencing primer. Results Nine out of 20 K. pneumoniae clinical isolates had a blaCTX-M genotype. Interestingly, we found that the universal degenerated primers also amplified the chromosomally located K1-gene in all 34 K. oxytoca clinical isolates. Molecular identification and differentiation between blaCTX-M and blaOXY/K1-genes could only been achieved by sequencing of the PCR-amplicons. In silico analysis revealed that the universal degenerated CTX-M primer-pair used here might also amplify the chromosomally located blaOXY and K1-genes in Klebsiella spp. and K1-like genes in other Enterobacteriaceae. Conclusion The PCR-based molecular typing method described here enables a rapid and reliable molecular identification of blaCTX-M, and blaOXY/K1-genes. The principles used in this study could also be applied to any situation in which antimicrobial resistance genes would need to be sequenced.

  11. Pharmacovigilance in radiopharmaceuticals

    Science.gov (United States)

    Kumar, Rishi; Kalaiselvan, Vivekanandan; Kumar, Rakesh; Verma, Ravendra; Singh, Gyanendra Nath

    2016-01-01

    Indian Pharmacopoeia Commission is Committed for maintaining the standards of drugs including Radiopharmaceuticals (RPs) by publishing Indian Pharmacopoeia. These RPs are being used in India for diagnostic or therapeutic purpose. RPs though contain relatively small quantities of active ingredient and administered in small volumes could cause some adverse reactions to the patients. The objective of presenting this article is to introduce the system of adverse drug reaction reporting to the nuclear medicine fraternity who are dealing with RPs. PMID:27095855

  12. Pharmacovigilance using Clinical Text.

    Science.gov (United States)

    Lependu, Paea; Iyer, Srinivasan V; Bauer-Mehren, Anna; Harpaz, Rave; Ghebremariam, Yohannes T; Cooke, John P; Shah, Nigam H

    2013-01-01

    The current state of the art in post-marketing drug surveillance utilizes voluntarily submitted reports of suspected adverse drug reactions. We present data mining methods that transform unstructured patient notes taken by doctors, nurses and other clinicians into a de-identified, temporally ordered, patient-feature matrix using standardized medical terminologies. We demonstrate how to use the resulting high-throughput data to monitor for adverse drug events based on the clinical notes in the EHR. PMID:24303315

  13. Characterization of IncN plasmids carrying blaCTX-M-1 and qnr genes in Escherichia coli and Salmonella from animals, the environment and humans

    DEFF Research Database (Denmark)

    Dolejska, Monika; Villa, Laura; Hasman, Henrik; Hansen, Lars; Carattoli, Alessandra

    2013-01-01

    were compared using restriction fragment length polymorphism (RFLP), plasmid multilocus sequence typing (pMLST) and hybridization with repN, qnrS1, qnrB19 or blaCTX-M-1 probes. Plasmids pKT58A and pHHA45 were sequenced using the 454-Genome Sequencer FLX platform on a library constructed from plasmid...... DNA purified from the respective E. coli transformants.Results Three types of IncN plasmids carrying blaCTX-M-1, qnrS1 and qnrB19 genes were identified in strains isolated from the Czech Republic, Poland, Slovakia, Denmark, Italy and the Netherlands, corresponding to pMLST sequence type (ST) 1, ST3...

  14. Resistance to Broad-Spectrum Antibiotics in Aquatic Systems: Anthropogenic Activities Modulate the Dissemination of blaCTX-M-Like Genes

    OpenAIRE

    Tacão, Marta; Correia, António; Henriques, Isabel

    2012-01-01

    We compared the resistomes within polluted and unpolluted rivers, focusing on extended-spectrum beta-lactamase (ESBL) genes, in particular blaCTX-M. Twelve rivers from a Portuguese hydrographic basin were sampled. Physicochemical and microbiological parameters of water quality were determined, and the results showed that 9 rivers were classified as unpolluted (UP) and that 3 were classified as polluted (P). Of the 225 cefotaxime-resistant strains isolated, 39 were identified as ESBL-producing...

  15. Emergence of CTX-M-15-Producing Enterobacteria in Cameroon and Characterization of a blaCTX-M-15-Carrying Element

    OpenAIRE

    Gangoue Pieboji, Joseph; Miriagou, V.; Vourli, S.; Tzelepi, E.; Ngassam, P.; Tzouvelekis, L S

    2005-01-01

    CTX-M-15-producing Klebsiella pneumoniae and Escherichia coli emerged recently in Cameroon. CTX-M-15 was encoded by two different multiresistance plasmids, of which one carried an ISEcp1-bla(CTX-M-15) element flanked by a 5-bp target site duplication and inserted within a Tn2-derived sequence. A truncated form of this element in the second plasmid was identified.

  16. Dispersal of Carbapenemase blaVIM-1 Gene Associated with Different Tn402 Variants, Mercury Transposons, and Conjugative Plasmids in Enterobacteriaceae and Pseudomonas aeruginosa

    OpenAIRE

    Tato, M.; Coque, T. M.; Baquero, F.; Canton, R.

    2009-01-01

    The emergence of blaVIM-1 within four different genetic platforms from distinct Enterobacteriaceae and Pseudomonas aeruginosa isolates in an area with a low prevalence of metallo-β-lactamase producers is reported. Forty-three VIM-1-producing isolates (including 19 Enterobacter cloacae, 2 Escherichia coli, and 2 P. aeruginosa isolates, 18 Klebsiella pneumoniae isolate, and 2 Klebsiella oxytoca isolate) recovered from 2005 to 2007 and corresponding to 15 pulsed-field gel electrophoresis types w...

  17. Draft genome sequence of blaVeb-1, blaoxa-10producing multi-drug resistant (MDR Pseudomonas aeruginosastrain VRFPA09 recovered from bloodstream infection

    Directory of Open Access Journals (Sweden)

    Nandagopal Murugan

    2015-09-01

    Full Text Available Pseudomonas aeruginosa (P. aeruginosa bacteremia causes significant mortality rate due to emergence of multidrug resistant (MDR nosocomial infections. We report the draft genome sequence of P. aeruginosa strain VRFPA09, a human bloodstream isolate, phenotypically proven as MDR strain. Whole genome sequencing on VRFPA09, deciphered betalactamase encoding blaveb-1 and blaOXA-10genes and multiple drug resistance, virulence factor encoding genes.

  18. Draft genome sequence of blaVeb-1, blaoxa-10 producing multi-drug resistant (MDR) Pseudomonas aeruginosa strain VRFPA09 recovered from bloodstream infection.

    Science.gov (United States)

    Murugan, Nandagopal; Malathi, Jambulingam; Umashankar, Vetrivel; Madhavan, Hajib NarahariRao

    2015-01-01

    Pseudomonas aeruginosa (P. aeruginosa) bacteremia causes significant mortality rate due to emergence of multidrug resistant (MDR) nosocomial infections. We report the draft genome sequence of P. aeruginosa strain VRFPA09, a human bloodstream isolate, phenotypically proven as MDR strain. Whole genome sequencing on VRFPA09, deciphered betalactamase encoding blav(eb-1) and bla(OXA-10) genes and multiple drug resistance, virulence factor encoding genes. PMID:26413042

  19. Penicillinase-producing Neisseria gonorrhoeae and its blaTEM-135 gene variants at several gonococcal antimicrobial surveillance sites in China:an epidemiological study%中国部分地区淋球菌耐药监测点产青霉素酶淋球菌及其 blaTEM-135突变体的流行调查

    Institute of Scientific and Technical Information of China (English)

    陈绍椿; 朱邦勇; 孙厚华; 陈祥生; 尹跃平; 戴秀芹; 郑和平; 顾伟鸣; 郑钟洁; 吴兴中; 曹文苓; 胡丽华

    2015-01-01

    目的:了解中国不同地区淋球菌耐药监测点产青霉素酶淋球菌(PPNG)的比例及 blaTEM-135突变体在 PPNG 中的分布,比较 PPNG 及 blaTEM-135突变体淋球菌多抗原测序分型(NG-MAST)的型别分布,了解不同地区 PPNG blaTEM-135突变体的差异与联系。方法2012年在江苏、上海、浙江、天津、广东、广西6个淋球菌耐药监测点共收集572株淋球菌,经过分离纯化及鉴定后,采用头孢噻吩纸片法测定 PPNG;菌株培养后利用试剂盒提取 DNA,通过错配扩增突变分析 PCR(MAMA PCR)鉴定 blaTEM-135突变体,采用 NG-MAST 进行分型研究。结果572株淋球菌中 PPNG 总阳性率为38.1%(218/572),PPNG 中相应 blaTEM-135突变体的总比例为52.3%(114/218)。监测点中 PPNG 阳性率从高至低分别为:浙江(45/87,51.7%)、上海(36/79,45.6%)、广东(78/205,38.0%)、广西(12/32,37.5%)、江苏(24/77,31.2%)、天津(23/92,25%);PPNG 中相应 blaTEM-135突变体的阳性率从高至低分别为:浙江(31/45,68.9%)、江苏(14/24,58.3%)、广东(39/78,50.0%)、上海(17/36,47.2%)、天津(9/23,39.1%)、广西(4/12,33.3%)。 NG-MAST 分型研究显示,blaTEM-135突变体中流行菌株型别有 ST2318、ST1768、ST1866、ST1053、ST8726等,其中 ST1768、ST1053和 ST8726与 blaTEM-135突变体有较强的对应关系。天津 PPNG 菌株及 blaTEM-135突变体 ST 分布与其他各监测点有显著差异,江浙沪地区菌株 ST 有一定联系。结论中国淋球菌耐药监测点 PPNG 及相应 blaTEM-135突变体阳性率处于较高水平,不同地区间 PPNG 及相应 blaTEM-135突变体阳性菌株 ST 型别分布差异有统计学意义。%Objective To determine the prevalence of penicillinase-producing Neisseria gonorrhoeae(PPNG) and the distribution of blaTEM-135 gene variants in PPNG at several gonococcal antimicrobial surveillance sites

  20. Characterization of IncN plasmids carrying blaCTX-M-1 and qnr genes in Escherichia coli and Salmonella from animals, the environment and humans

    DEFF Research Database (Denmark)

    Dolejska, Monika; Villa, Laura; Hasman, Henrik; Hansen, Lars; Carattoli, Alessandra

    2013-01-01

    Objectives The aim of the study was to characterize a collection of Escherichia coli and Salmonella harbouring qnr and blaCTX-M-1 genes on IncN plasmids isolated from humans, food-producing, companion and wild animals, and the environment from six European countries.Methods Nineteen IncN plasmids...... were compared using restriction fragment length polymorphism (RFLP), plasmid multilocus sequence typing (pMLST) and hybridization with repN, qnrS1, qnrB19 or blaCTX-M-1 probes. Plasmids pKT58A and pHHA45 were sequenced using the 454-Genome Sequencer FLX platform on a library constructed from plasmid...... DNA purified from the respective E. coli transformants.Results Three types of IncN plasmids carrying blaCTX-M-1, qnrS1 and qnrB19 genes were identified in strains isolated from the Czech Republic, Poland, Slovakia, Denmark, Italy and the Netherlands, corresponding to pMLST sequence type (ST) 1, ST3...

  1. Insertion Sequence ISEcp1B Is Involved in Expression and Mobilization of a blaCTX-M β-Lactamase Gene

    Science.gov (United States)

    Poirel, Laurent; Decousser, Jean-Winoc; Nordmann, Patrice

    2003-01-01

    The genetic structures (ca. 10-kb DNA fragment) surrounding the plasmid-borne extended-spectrum β-lactamase blaCTX-M-19 gene in a Klebsiella pneumoniae clinical isolate were determined. This β-lactamase gene was part of a 4,797-bp transposon inserted inside orf1 of Tn1721. Inside this transposon, blaCTX-M-19 was bracketed upstream and downstream by insertion sequences ISE cp1B and IS903D, respectively, and further downstream by a truncated gene encoding an outer membrane protein for iron transport. The single-copy ISEcp1B element was probably involved alone in the mobilization process that led to a 5-bp duplication at the target site of the transposed fragment. This mobilization event probably involved one inverted repeat of ISE cp1B and a second sequence farther away, resembling its second inverted repeat. Additionally, ISEcp1B provided −35 and −10 promoter sequences, contributing to the high-level expression of the blaCTX-M-19 gene. Southern blot analysis failed to identify a reservoir of ISEcp1-like sequences among a series of gram-negative and gram-positive bacterial species usually found in the skin and intestinal human floras. The ability of ISEcp1-like elements to mobilize and to promote the expression of β-lactamase genes may explain, in part, the current spread of CTX-M-type enzymes worldwide. PMID:12936998

  2. 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

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    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

  3. Uso abusivo de benzidamina no Brasil: uma abordagem em farmacovigilância Use abusive of benzydamine in Brazil: an overview in pharmacovigilance

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    Daniel Marques Mota

    2010-05-01

    Full Text Available O uso abusivo de medicamentos tem sido objeto de crescente interesse em saúde pública e geralmente veiculado na imprensa brasileira. Dentre os medicamentos, objeto de abuso e que causam dependência física e/ou psíquica, incluemse os barbitúricos, benzodiazepínicos, analgésicos opióides e anfetaminas. Os analgésicos, antitérmicos e antiinflamatórios não esteroidais, apesar de não fazerem parte dessa relação de fármacos, estão, geralmente, associados ao uso recreativo ou fins não terapêuticos. O objetivo deste ensaio é apresentar informações sobre o uso abusivo de benzidamina no Brasil. Trata-se de um estudo descritivo do tipo exploratório, em que foram utilizadas diferentes estratégias metodológicas adotadas na prática de regulação em farmacovigilância. O uso abusivo desse fármaco foi constatado na literatura científica, imprensa e internet. Em função da facilidade na compra de medicamentos sujeitos à prescrição médica, entre outros fatores, devem-se exigir meios e formas para monitorar a comercialização e utilização de medicamentos, assegurando seu uso seguro e racional, incluindo o fortalecimento da farmacovigilância no Brasil.The abusive drug use has been object of increasing concern in public health and is commonly issued in the Brazilian press. Amongst medicines, those that are abuse substances and cause physical and/or psychic dependence, barbiturates, benzodiazepines, opioid analgesics and amphetamines are included. Analgesics, antipyretics and non-steroidal anti-inflammatory drugs, even not making part of this list, are generally associated with recreational use or non therapeutical purpose. The objective of this essay is to present information on the abusive use of benzydamine in Brazil. The present study is an exploratory essay in which different methodological strategies adopted in the regulatory practice of pharmacovigilance have been used. The abusive use of this drug was evidenced in

  4. Prevalence of extended-spectrum cephalosporin-resistant Escherichia coli in a farrowing farm: ST1121 clone harboring IncHI2 plasmid contributes to the dissemination of blaCMY-2

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    Hui eDeng

    2015-11-01

    Full Text Available Abstract During a regular monitoring of antimicrobial resistance in a farrowing farm in Southern China, 117 Escherichia coli isolates were obtained from sows and piglets. Compared with the isolates from piglets, the isolates from sows exhibited higher resistance rates to the tested cephalosporins. Correspondingly, the total detection rate of the blaCMY-2/blaCTX-M genes in the sow isolates (34.2% was also significantly higher than that of the piglet isolates (13.6% (p<0.05. The blaCMY-2 gene had a relatively high prevalence (11.1% in the E. coli isolates. MLST and PFGE analysis revealed the clonal spread of ST1121 E. coli in most (7/13 of the blaCMY-2-positive isolates. An indistinguishable IncHI2 plasmid harboring blaCMY-2 was also identified in each of the seven ST1121 E. coli isolates. Complete sequence analysis of this IncHI2 plasmid (pEC5207 revealed that pEC5207 may have originated through recombination of an IncHI2 plasmid with a blaCMY-2-carrying IncA/C plasmid like pCFSAN007427_01. In addtion to blaCMY-2, pEC5207 also carried other resistance determinants for aminoglycosides (aacA7, sulfonamides (sul1, as well as heavy metals ions, such as Cu and Ag. The susceptibility testing showed that the pEC5207 can mediate both antibiotic and heavy metal resistance. This highlights the role of pEC5207 in co-selection of blaCMY-2-positive isolates under the selective pressure of heavy metals, cephalosporins and other antimicrobials. In conclusion, clonal spread of an ST1121 type E. coli strain harboring an IncHI2 plasmid contributed to the dissemination of blaCMY-2 in a farrowing farm in Southern China. We also have determined the first complete sequence analysis of a blaCMY-2-carrying IncHI2 plasmid.

  5. blaCTX-M-152, a Novel Variant of CTX-M-group-25, Identified in a Study Performed on the Prevalence of Multidrug Resistance among Natural Inhabitants of River Yamuna, India

    Science.gov (United States)

    Azam, Mudsser; Jan, Arif T.; Haq, Qazi M. R.

    2016-01-01

    Natural environment influenced by anthropogenic activities creates selective pressure for acquisition and spread of resistance genes. In this study, we determined the prevalence of Extended Spectrum β-Lactamases producing gram negative bacteria from the River Yamuna, India, and report the identification and characterization of a novel CTX-M gene variant blaCTX-M-152. Of the total 230 non-duplicate isolates obtained from collected water samples, 40 isolates were found positive for ESBL production through Inhibitor-Potentiation Disc Diffusion test. Based on their resistance profile, 3% were found exhibiting pandrug resistance (PDR), 47% extensively drug resistance (XDR), and remaining 50% showing multidrug resistant (MDR). Following screening and antimicrobial profiling, characterization of ESBLs (blaTEM and blaCTX-M), and mercury tolerance determinants (merP, merT, and merB) were performed. In addition to abundance of blaTEM-116 (57.5%) and blaCTX-M-15 (37.5%), bacteria were also found to harbor other variants of ESBLs like blaCTX-M-71 (5%), blaCTX-M-3 (7.5%), blaCTX-M-32 (2.5%), blaCTX-M-152 (7.5%), blaCTX-M-55 (2.5%), along with some non-ESBLs; blaTEM-1 (25%) and blaOXY (5%). Additionally, co-occurrence of mercury tolerance genes were observed among 40% of isolates. In silico studies of the new variant, blaCTX-M-152were conducted through modeling for the generation of structure followed by docking to determine its catalytic profile. CTX-M-152 was found to be an out-member of CTX-M-group-25 due to Q26H, T154A, G89D, P99S, and D146G substitutions. Five residues Ser70, Asn132, Ser237, Gly238, and Arg273 were found responsible for positioning of cefotaxime into the active site through seven H-bonds with binding energy of -7.6 Kcal/mol. Despite small active site, co-operative interactions of Ser237 and Arg276 were found actively contributing to its high catalytic efficiency. To the best of our knowledge, this is the first report of blaCTX-M-152 of CTX-M-group-25 from

  6. bla CTX-M-152, a Novel Variant of CTX-M-group-25, Identified in a Study Performed on the Prevalence of Multidrug Resistance among Natural Inhabitants of River Yamuna, India.

    Science.gov (United States)

    Azam, Mudsser; Jan, Arif T; Haq, Qazi M R

    2016-01-01

    Natural environment influenced by anthropogenic activities creates selective pressure for acquisition and spread of resistance genes. In this study, we determined the prevalence of Extended Spectrum β-Lactamases producing gram negative bacteria from the River Yamuna, India, and report the identification and characterization of a novel CTX-M gene variant bla CTX-M-152 . Of the total 230 non-duplicate isolates obtained from collected water samples, 40 isolates were found positive for ESBL production through Inhibitor-Potentiation Disc Diffusion test. Based on their resistance profile, 3% were found exhibiting pandrug resistance (PDR), 47% extensively drug resistance (XDR), and remaining 50% showing multidrug resistant (MDR). Following screening and antimicrobial profiling, characterization of ESBLs (bla TEM and bla CTX-M ), and mercury tolerance determinants (merP, merT, and merB) were performed. In addition to abundance of bla TEM-116 (57.5%) and bla CTX-M-15 (37.5%), bacteria were also found to harbor other variants of ESBLs like bla CTX-M-71 (5%), bla CTX-M-3 (7.5%), bla CTX-M-32 (2.5%), bla CTX-M-152 (7.5%), bla CTX-M-55 (2.5%), along with some non-ESBLs; bla TEM-1 (25%) and bla OXY (5%). Additionally, co-occurrence of mercury tolerance genes were observed among 40% of isolates. In silico studies of the new variant, bla CTX-M-152 were conducted through modeling for the generation of structure followed by docking to determine its catalytic profile. CTX-M-152 was found to be an out-member of CTX-M-group-25 due to Q26H, T154A, G89D, P99S, and D146G substitutions. Five residues Ser70, Asn132, Ser237, Gly238, and Arg273 were found responsible for positioning of cefotaxime into the active site through seven H-bonds with binding energy of -7.6 Kcal/mol. Despite small active site, co-operative interactions of Ser237 and Arg276 were found actively contributing to its high catalytic efficiency. To the best of our knowledge, this is the first report of bla CTX-M-152 of CTX

  7. Prevalence and characterization of plasmid-mediated blaESBL with their genetic environment in Escherichia coli and Klebsiella pneumoniae in patients with pneumonia

    Institute of Scientific and Technical Information of China (English)

    WANG Xiao-rong; CHEN Ji-chao; KANG Yu; JIANG Ning; AN Shu-chang; GAO Zhan-cheng

    2012-01-01

    Background The extended spectrum β-lactamase (ESBL)-producing Escherichia coli (E.coli) and Klebsiella pneumoniae (K.pneumoniae) are the major pathogens causing pneumonia and have a significant impact on the clinical course.Limited data exist on molecular characterization of ESBL-producing E.coli and K.pneumoniae that cause pneumonia.The aim of this study was to investigate the comprehensive multilevel characteristics of E.coli and K.pneumoniae causing pneumonia in China for the first time.Methods E.coli (17) and K.pneumoniae (21) isolates responsible for pneumonia were isolated from 1270 specimens collected in a prospective multi-center study in eight teaching hospitals in China from June to December in 2007.The susceptibilities,ESBL confirmation,sequence typing,blaCTX-M and blaSHV genes,their genetic environment and plasmid Inc/rep types were determined.Results Sixteen E.coli (94.1%) and eleven K.pneumoniae (52.4%) isolates were ESBL producers.About 77.8% and 66.7% of them were resistance to ciprofloxacin and levofloxacin,and 100% were susceptible to imipenem.The most prevalent ESBL gene was CTX-M-14,followed by SHV-2,CTX-M-15,CTX-M-3,CTX-M-65,SHV-12,SHV-26 and SHV-28.SHV-1 and SHV-11 were also detected and coexisted with blaCTX-Ms in five strains,and three strains contained only SHV-1.All CTX-M-14 were detected ISEcp1 upstream and nine were found IS903 downstream and the majority of them (64.3%) were carried by IncF plasmids.All blasHv were flanked by recFand deoR,located on IncF,IncN,IncX and IncH plasmids.Two SHV-2,one SHV-1 and the only SHV-28 were further preceded by IS26.Genes lacYand lacZwere detected at further upstream of two blaSHv-1.The K.pneumoniae carrying SHV-28 was susceptible to β-lactams,and no mutations or deletions in gene or promoter sequences were identified to account for susceptibility.Multilocus sequence typing experiments showed the ESBL-producing strains were genetically diverse.Conclusions The rate of occurrence of bla

  8. Emergence of Multidrug-Resistant Pseudomonas aeruginosa: Detection of Isolates harboring blaCTX gene causing infections in hospital and determination of their susceptibility to antibiotics

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    Z Rabani

    2015-11-01

    Full Text Available Background & aim: Because of its ubiquitous nature, ability to survive in moist environments, and innate resistance to many antibiotics and antiseptics, P. aeruginosa is a common pathogen in hospitals. The goals of this study were detection of Psudomonas aeruginosa harboring blaCTX gene causing infections in hospitals and determination of their susceptibility to antibiotics and ESBL production. Methods: In the present cross-sectional study, clinical samples from hospitalized patients were collected and culture was done on apropriate media. Final identification was performed using biochemical tests and API 20NE system. According to the protocol CLSI 2014 disc diffusion, combination disk, modified hodge test (MHT and E-test were used for antibiotic susceptibility, ESBL production, carbapenemas production, and MIC values of imipenem respectively. The blaCTX gene was detected in the isolates by PCR molecular method. Results: In the current study, 45 isolates of Pseudomonas aeroginosa were obtained from hospitalized patients, consisting of 19 males (42.2% and 26 females (57.8%. As observed, 57.8% (26 strains of isolates were recovered from sputum. The most effective antibiotics against isolates were amikacin and colistin with 97.8% suseptibility whereas the highest resistance was to cefotaxime (97.8%. As revealed 77.8% of isolates showed response to group 2 carbapenems (imipenem, meropenem. All imipenem resistant strains had the MIC more than 32. Seventeen strains (37.7% were  showed resistant to quinolones (ciprofloxacin, norfloxacin. The results of PCR on blaCTX gene indicated that 15.5% of the isolates possess the gene. Conclusion: Carbapenem group of antibiotic in 22% of infections caused by Pseudomonas aeruginosa were ineffective and indiscriminate prescribing of these drugs will increase the ratet of resistance.

  9. Development of a direct ELISA based on carboxy-terminal of penicillin-binding protein BlaR for the detection of β-lactam antibiotics in foods.

    Science.gov (United States)

    Peng, Juan; Cheng, Guyue; Huang, Lingli; Wang, Yulian; Hao, Haihong; Peng, Dapeng; Liu, Zhenli; Yuan, Zonghui

    2013-11-01

    β-Lactam antibiotics, including penicillins and cephalosporins, are commonly used in veterinary medicine. Illegal use and abuse of β-lactams could cause allergy and selected bacterial resistance. BlaR-CTD, the carboxy-terminal of penicillin-recognizing protein BlaR from Bacillus licheniformis ATCC 14580, was utilized in this study to develop a receptor-based ELISA for detection and determination of β-lactam antibiotics in milk, beef, and chicken. This assay was based on directly competitive inhibition of binding of horseradish peroxidase-labeled ampicillin to the immobilized BlaR-CTD by β-lactams. The assay was developed as screening test with the option as semiquantitative assay, when the identity of a single type of residual β-lactam was known. The IC50 values of 15 β-lactam antibiotics, including benzylpenicillin, ampicillin, amoxicillin, dicloxacillin, oxacillin, nafcillin, cefapirin, cefoperazone, cefalotin, cefazolin, cefquinome, ceftriaxone, cefotaxime, cefalexin, ceftiofur and its metabolite desfuroylceftiofur were evaluated and ranged from 0.18 to 170.81 μg L(-1). Simple sample extraction method was carried out with only phosphate-buffered saline, and the recoveries of selected β-lactam antibiotics in milk, beef, and chicken were in the range of 53.27 to 128.29 %, most ranging from 60 to 120 %. The inter-assay variability was below 30 %. Limits of detection in milk, beef, and chicken muscles with cefquinome matrix calibration were 2.10, 30.68, and 31.13 μg kg(-1), respectively. This study firstly established a rapid, simple, and accurate method for simultaneous detection of 15 β-lactams in edible tissues, among which 11 β-lactams controlled by European Union could be detected below maximum residue limits. PMID:24013636

  10. Profiles of phenotype resistance to antibiotic other than β-lactams in Klebsiella pneumoniae ESBLs-producers, carrying blaSHV genes

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    Pawel Sacha

    2010-04-01

    Full Text Available Extended spectrum β-lactamases production is one of the most common mechanism of resistance to extendedspectrum β-lactam antibiotics is increasing worldwide. Twenty five strains of Klebsiella pneumoniae isolated from clinicalspecimens were tested. Based on the phenotypic confirmatory test all these strains were defined as ESBL producers namedESBL(+. The plasmid DNA from each strains was used to investigate the presence of blaSHV genes responsible for extendedspectrum β-lactamases production. Moreover, susceptibility of these strains to antibiotic other than β-lactams in was tested.

  11. The first report of infection with Klebsiella pneumoniae carrying the bla kpc gene in State of Mato Grosso do Sul, Brazil

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    Marilene Rodrigues Chang

    2013-01-01

    Full Text Available The increased frequency and dissemination of enterobacteria resistant to various antimicrobials is currently worldwide concern. In January 2010, a 94-year-old patient with chronic lymphocytic leukemia was admitted to the University Hospital. This patient died 21 days after hospitalization due to the clinical worsening. Klebsiella pneumoniae producing of extended-spectrum β-lactamases (ESBLs was isolated of urine culture. This bacterium demonstrated resistance to ceftazidime, ciprofloxacin, levofloxacin, ertapenem and imipenem. Susceptibility to cefoxitin, cefepime, meropenem, colistin and tigecycline. This study reports the first case of infection by Klebsiella pneumoniae carrying the bla kpc gene in the State of Mato Grosso do Sul, Brazil.

  12. Rapid Detection of blaKPC Carbapenemase Genes by Internally Controlled Real-Time PCR Assay Using Bactec Blood Culture Bottles ▿

    OpenAIRE

    Hindiyeh, Musa; Smollan, Gill; Grossman, Zehava; Ram, Daniela; Robinov, Jana; Belausov, Natasha; Ben-David, Debbie; Tal, Ilana; Davidson, Yehudit; Shamiss, Ari; Mendelson, Ella; Keller, Nathan

    2011-01-01

    Rapid detection of drug-resistant bacteria in clinical samples plays an instrumental role in patients' infection management and in implementing effective infection control policies. In the study described in this report, we validated a multiplex TaqMan real-time quantitative PCR (qPCR) assay for the detection of blaKPC genes and the human RNase P gene in Bactec blood culture bottles. The MagNA Pure LC (version 2.0) instrument was utilized to extract nucleic acids from the inoculated broth, wh...

  13. Investigação em farmacoepidemiologia de campo: uma proposta para as ações de farmacovigilância no Brasil Investigation in field pharmacoepidemiology: a proposal for the actions of pharmacovigilance in Brazil

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    Daniel Marques Mota

    2011-12-01

    Full Text Available O presente artigo tem como objetivos propor e descrever a investigação em farmacoepidemiologia de campo como função primordial de farmacovigilância a ser conduzida pelas vigilâncias sanitárias municipais, estaduais e/ou federal frente à notificação, comunicação e ou rumores nos meios de comunicação social de casos de eventos adversos relacionados com medicamentos. Inicialmente fazemos uma contextualização da farmacovigilância, incluindo definição, eventos de interesse e principais funções. Na sequência, descrevemos a investigação em farmacoepidemiologia de campo orientada para a execução dos doze passos da investigação. Logo a seguir, apresentamos uma caracterização geral de investigações em farmacoepidemiologia de campo realizadas no Brasil. Finalmente, argumentamos que a investigação em farmacoepidemiologia de campo constitui importante instrumento para o aperfeiçoamento das ações de farmacovigilância visando a melhoria da segurança de pacientes no país.The present article aims to propose and to describe the investigation in field pharmacoepidemiology as having a major role in pharmacovigilance by municipal, state and federal governments to manage drug-related reports, communication and information in the media. First, pharmacovigilance is put into context, by including its concepts, events of interest and main functions. Subsequently, field pharmacoepidemiology investigation oriented to the twelve steps is described. Then, we present a general picture of the investigation in field pharmacoepidemiology conducted in Brazil. Finally, we argue that investigation in field pharmacoepidemiology is an important tool to improve measures in pharmacovigilance and to improve patient safety in the country.

  14. Loop-Mediated Isothermal Amplification untuk Mendeteksi Gen blaTEM sebagai Penyandi Extended-Spectrum Beta-Lactamase pada Isolat Enterobacteriaceae

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    Bayu A. P. Wilopo

    2015-12-01

    Full Text Available Extended-spectrum beta-lactamase (ESBL is a beta-lactamase enzyme that is capable of hydrolyzing penicillin, cephalosporin, and monobactam, and can be inhibited by clavulanic acid. This enzyme is encoded by multiple genes, one of them is blaTEM. Polymerase chain reaction (PCR is one of the DNA amplification methods that are frequently used; however, there are other methods that can be used including, among others, loop-mediated isothermal amplification (LAMP. LAMP requires simple equipment with quicker and easy-to-read results compared to PCR. This study was a diagnostic test to explore the sensitivity and specificity of LAMP method compared to PCR in detecting blaTEM gene. Furthermore, the concordance between LAMP and PCR methods was assessed. A total of 92 Enterobacteriaceae isolates were examined by PCR and LAMP methods and compared. The result showed that the LAMP method had a sensitivity of 91.4% and a specificity of 91.2% with a concordance value (kappa of 85.4%. In conclusion, LAMP method has a good validity and a very good conformity compared to the PCR method. Therefore, LAMP method can be used as an alternative diagnostic test, especially in limited settings.

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

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    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.

  16. 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

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

    Science.gov (United States)

    Fujiwara, Masakazu; Kawasaki, Yohei; Yamada, Hiroshi

    2016-01-01

    Background 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. Methods and Findings 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. Conclusions Different combinations of adverse drug reactions were noted between the antidepressants. In addition, the reported

  18. Molecular Epidemiological Analysis of Escherichia coli Sequence Type ST131 (O25:H4) and blaCTX-M-15 among Extended-Spectrum-β-Lactamase-Producing E. coli from the United States, 2000 to 2009

    OpenAIRE

    Johnson, James R.; Urban, Carl; Weissman, Scott J.; Jorgensen, James H.; Lewis, James S.; Hansen, Glen; Edelstein, Paul H.; Robicsek, Ari; Cleary, Timothy; Adachi, Javier; Paterson, David; Quinn, John; Hanson, Nancy D.; Johnston, Brian D.; Clabots, Connie

    2012-01-01

    Escherichia coli sequence type ST131 (from phylogenetic group B2), often carrying the extended-spectrum-β-lactamase (ESBL) gene blaCTX-M-15, is an emerging globally disseminated pathogen that has received comparatively little attention in the United States. Accordingly, a convenience sample of 351 ESBL-producing E. coli isolates from 15 U.S. centers (collected in 2000 to 2009) underwent PCR-based phylotyping and detection of ST131 and blaCTX-M-15. A total of 200 isolates, comprising 4 groups ...

  19. Caracterización molecular de los genes blaAmpC cromosómicos y adquiridos en aislados clínicos de Escherichia coli en el área de Barcelona

    OpenAIRE

    Alonso Louro, Noemí

    2014-01-01

    Escherichia coli presenta un gen blaAmpC cromosómico que se expresa de forma constitutiva a bajo nivel debido a la presencia de un promotor débil y un atenuador. En estas condiciones no confiere resistencia a betalactámicos. Sin embargo, E. coli puede incrementar la expresión de este gen debido a mutaciones en su región promotora/atenuadora (AmpCc) o adquirir genes blaAmpC incluyendo CMY, DHA, ACC, FOX, MOX, ACT, MIR, LAT y CFE (AmpCa), mecanismos que confieren resistencia a penicilinas, cefa...

  20. Human rheumatoid factor crossidiotypes. II. Primary structure-dependent crossreactive idiotype, PSL2-CRI, present on Wa monoclonal rheumatoid factors is present on Bla and other IgM kappa monoclonal autoantibodies

    OpenAIRE

    1987-01-01

    The amino acid sequence of the L-CDR2 (complementarity-determining region) of Bla mRF (monoclonal rheumatoid factor) is identical to that of the Wa mRFs. The PSL2-CRI (crossreactive idiotype), as determined by anti-PSL2, which has been shown to be present on all Wa mRFs, is also present on the Bla mRF and other monoclonal autoantibodies. PSL2-CRI is, therefore, not unique to Wa mRFs and may be present on most IgM kappa monoclonal autoantibodies. Whether PSL2-CRI is a crossidiotype (XId) that ...

  1. Cloning of a Chryseobacterium (Flavobacterium) meningosepticum Chromosomal Gene (blaACME) Encoding an Extended-Spectrum Class A β-Lactamase Related to the Bacteroides Cephalosporinases and the VEB-1 and PER β-Lactamases

    OpenAIRE

    Rossolini, Gian Maria; Franceschini, Nicola; Lauretti, Laura; Caravelli, Berardo; Riccio, Maria Letizia; Galleni, Moreno; Frère, Jean-Marie; Amicosante, Gianfranco

    1999-01-01

    In addition to the BlaB metallo-β-lactamase, Chryseobacterium (Flavobacterium) meningosepticum CCUG 4310 (NCTC 10585) constitutively produces a 31-kDa active-site serine β-lactamase, named CME-1, with an alkaline isoelectric pH. The blaACME gene that encodes the latter enzyme was isolated from a genomic library constructed in the Escherichia coli plasmid vector pACYC184 by screening for cefuroxime-resistant clones. Sequence analysis revealed that the CME-1 enzyme is a new class A β-lactamase ...

  2. In71, an Enterobacter cloacae blaVIM-1-carrying integron related to In70.2 from Italian Pseudomonas aeruginosa isolates: a SENTRY Antimicrobial Surveillance Program report.

    Science.gov (United States)

    Castanheira, Mariana; Sader, Hélio S; Jones, Ronald N; Debbia, Eugenio; Picão, Renata C; Gales, Ana C

    2007-01-01

    An Enterobacter cloacae strain showing decreased susceptibility to carbapenems was isolated from a blood culture of a patient hospitalized in Genoa, Italy, and screened for the presence of metallo-beta-lactamase (MBL) genes as part of the SENTRY Antimicrobial Surveillance Program. A bla(VIM-1)-carrying integron named In71 nearly identical to In70.2 reported in Pseudomonas aeruginosa strains isolated from various Italian cities since 2001 was identified in this strain. Interestingly, the In71 did not carry aadA1 nor possess the ISPa7 usually found in the P. aeruginosa integron In70.2. Mobilization of MBL genes from P. aeruginosa to members of the Enterobacteriaceae family is very worrisome because the rapid and wide dissemination of these potent antimicrobial resistance mechanisms could jeopardize the clinical use of carbapenems for the treatment of multidrug-resistant Enterobacteriaceae infections. PMID:17650966

  3. 铜绿假单胞菌亚胺培南及消毒剂耐药相关基因研究%Study on the genes of bla IMP, bla VIM, oprD, and qacE △ 1-sul I in Pseudomonas aeruginosa resistanted to Imipenam and disinfectants

    Institute of Scientific and Technical Information of China (English)

    黄支密; 糜祖煌; 诸葛青云; 秦玲; 邹玉秀; 熊春林; 沈娟; 王春新

    2005-01-01

    目的了解临床分离的对亚胺培南耐药铜绿假单胞菌中金属β内酰胺酶基因(blaIMP和blaVIM)、外膜孔蛋白D2(OprD2)基因(oprD)、消毒剂-磺胺耐药相关基因(qacE△1-sulⅠ)存在状况.方法采用ATB′PSE 5药敏试验条板微量肉汤法测定28株铜绿假单胞菌对14种抗菌药物的敏感性,采用聚合酶链反应(PCR)技术及序列分析的方法检测耐药基因.结果该28株铜绿假单胞菌对亚胺培南、氨苄西林/舒巴坦、庆大霉素、妥布霉素和复方新诺明均完全耐药,对哌拉西林/他唑巴坦的敏感率最高为64.3%,其余的耐药率在57.1%~92.9%之间.28株Pa中blaIMP和blaVIM基因均阴性,25株(89.3%)oprD基因缺失,24株(85.7%)qacE△1-sulI基因阳性.结论浙江湖州解放军第98医院临床分离的对亚胺培南耐药铜绿假单胞菌多重耐药严重,oprD基因缺失是其对亚胺培南耐药的重要原因,qacE△1-sulI基因携带率很高.

  4. In70 of plasmid pAX22, a bla(VIM-1)-containing integron carrying a new aminoglycoside phosphotransferase gene cassette.

    Science.gov (United States)

    Riccio, M L; Pallecchi, L; Fontana, R; Rossolini, G M

    2001-04-01

    An Achromobacter xylosoxydans strain showing broad-spectrum resistance to beta-lactams (including carbapenems) and aminoglycosides was isolated at the University Hospital of Verona (Verona, Italy). This strain was found to produce metallo-beta-lactamase activity and to harbor a 30-kb nonconjugative plasmid, named pAX22, carrying a bla(VIM-1) determinant inserted into a class 1 integron. Characterization of this integron, named In70, revealed an original array of four gene cassettes containing, respectively, the bla(VIM-1) gene and three different aminoglycoside resistance determinants, including an aacA4 allele, a new aph-like gene named aphA15, and an aadA1 allele. The aphA15 gene is the first example of an aph-like gene carried on a mobile gene cassette, and its product exhibits close similarity to the APH(3')-IIa aminoglycoside phosphotransferase encoded by Tn5 (36% amino acid identity) and to an APH(3')-IIb enzyme from Pseudomonas aeruginosa (38% amino acid identity). Expression of the cloned aphA15 gene in Escherichia coli reduced the susceptibility to kanamycin and neomycin as well as (slightly) to amikacin, netilmicin, and streptomycin. Characterization of the 5' and 3' conserved segments of In70 and of their flanking regions showed that In70 belongs to the group of class 1 integrons associated with defective transposon derivatives originating from Tn402-like elements. The structure of the 3' conserved segment indicates the closest ancestry with members of the In0-In2 lineage. In70, with its array of cassette-borne resistance genes, can mediate broad-spectrum resistance to most beta-lactams and aminoglycosides. PMID:11257042

  5. OXA-46, a new class D beta-lactamase of narrow substrate specificity encoded by a blaVIM-1-containing integron from a Pseudomonas aeruginosa clinical isolate.

    Science.gov (United States)

    Giuliani, Francesco; Docquier, Jean-Denis; Riccio, Maria Letizia; Pagani, Laura; Rossolini, Gian Maria

    2005-05-01

    A novel OXA-type enzyme, named OXA-46, was found to be encoded by a gene cassette inserted into a class 1 integron from a multidrug-resistant Pseudomonas aeruginosa clinical isolate. The variable region of the integron also contained a bla(VIM-1) metallo-beta-lactamase cassette and a duplicated aacA4 aminoglycoside acetyltransferase cassette. OXA-46 belongs to the OXA-2 lineage of class D beta-lactamases. It exhibits 78% sequence identity with OXA-2 and the highest similarity (around 92% identity) with another OXA-type enzyme detected in clinical isolates of Burkholderia cepacia and in unidentified bacteria from a wastewater plant. Expression of bla(OXA-46) in Escherichia coli decreased susceptibility to penicillins and narrow-spectrum cephalosporins but not to extended-spectrum cephalosporins, cefsulodin, aztreonam, or carbapenems. The enzyme was overproduced in E. coli and purified by two anion-exchange chromatography steps (approximate yield, 6 mg/liter). OXA-46 was made of a 28.5-kDa polypeptide and exhibited an alkaline pI (7.8). In its native form OXA-46 appeared to be dimeric, and the oligomerization state was not affected by EDTA. Kinetic analysis of OXA-46 revealed a specificity for narrow-spectrum substrates, including oxacillin, other penicillins (but not temocillin), and narrow-spectrum cephalosporins. The enzyme apparently did not interact with temocillin, oxyimino-cephalosporins, or aztreonam. OXA-46 was inactivated by tazobactam and carbapenems and, although less efficiently, also by clavulanic acid. Enzyme activity was not affected either by EDTA or by divalent cations and exhibited low susceptibility to NaCl. These findings underscore the functional and structural diversity that can be encountered among class D beta-lactamases. PMID:15855521

  6. O sistema de farmacovigilância em Portugal (sua criação e desenvolvimento The pharmacovigilance system in Portugal (establishment and development

    Directory of Open Access Journals (Sweden)

    Ana M. Corrêa-Nunes

    1998-10-01

    Full Text Available O perfil de segurança dos medicamentos não é um conceito estático, ele evolui à medida que aumentam os conhecimentos sobre eles coligidos, antes e após a sua comercialização. Por isso, hoje se reconhece como fundamental que todos os países possuam a capacidade de monitorizar de forma contínua a segurança dos fármacos que autorizam. Isso lhes dá a possibilidade de, mediante os dados que vão coletando, ter o conhecimento necessário que lhes permita, quando adequado, modificar as condições previamente estabelecidas para a utilização de um medicamento, protegendo assim a saúde pública. Neste artigo, descreve-se como, na década de 90, está a ser construído um sistema de farmacovigilância em Portugal. Tendo em conta as características do País e a sua inserção na União Européia, são abordados os programas que estamos a utilizar para a inclusão dos notificadores e o modo como o sistema está a ser desenvolvido. Igualmente são apresentados já alguns resultados desses primeiros anos da aplicação desses métodos. Há muitas semelhanças que permitem extrapolar, de país para país, procedimentos nesta área. Outrossim, quando começamos, transpusemos e adaptamos muitas das experiências já testadas por outros.The safety profile of a drug is not a static concept. It progresses and can change on the basis of scientific data gathered before and after it is marketed. Therefore, it is now considered fundamental that all countries have the capacity to continuously monitor the safety of medicines authorized for sale. Based on the resulting and appropriate data, this allows them to alter the previously authorized conditions for use of a given drug as a public health safeguard. This paper describes how a Pharmacovigilance System is being developed in Portugal in the 1990s. The system is being implemented based on our national characteristics and positions within the European Union. The article includes some results from the

  7. 我院开展药物警戒工作的模式与经验探讨%Work Model and Experience Investigation of the Development of Pharmacovigilance in Our Hospital

    Institute of Scientific and Technical Information of China (English)

    孙培红; 刘晓; 梁雁

    2011-01-01

    OBJECTIVE: To evaluate the work model and experience of the development of pharmacovigilance in our hospital. METHODS: The work model and work flow of the development of pharmacovigilance in our hospital were introduced. RESULTS: By extracting, analyzing and researching "effective early warning signals", we played the role of pharmaceutical management and therapeutics committee, strengthened the adverse drug reaction (ADR) monitoring network and then perfected and extended the scope of ADR monitoring. Persisting in the principle of "to report every suspicious event", we monitored every medical event during the period of medication therapy. The information of ADR was fed back to the doctors and nurses regularly and the package inserts were appended to computerized prescription order entry (CPOE) by information technology. We intensified pharmacy education among doctors, nurses, pharmacist and patients to achieve sound results. CONCLUSION: By developing pharmacovigilance in our hospital, we pay attention to find new and serious ADR early and improve the safety of drug use.%目的:评价我院开展药物警戒工作的模式与经验.方法:介绍我院开展药物警戒工作的流程与模式.结果:我院通过对“有效预警信号”的提取、分析和研究,采取充分发挥药事管理与治疗委员会的作用,加强药品不良反应(ADR)监测网络建设,完善并扩大ADR的监测范围,本着“可疑即报”的原则,对用药期间出现的医疗事件进行监测,定期进行ADR信息反馈,将药品说明书嵌入医师工作站,对医、护、药、患者加强药学教育等药物警戒措施,结果取得了一定成效.结论:我院通过开展药物警戒工作,重视早期发现新的、严重的ADR,提高了安全用药水平.

  8. 肠道定植产KPC酶植生拉乌尔菌的耐药基因环境分析%Genetic Environment of blaKPC-2 in the Intestinal Colonized Raoultella planticolas

    Institute of Scientific and Technical Information of China (English)

    葛超荣

    2013-01-01

    The increasing emergence and spread of Klebsiella pneumoniae carbapenemases ( KPCs ) leaves fewer available therapeutic options due to their broad-spectrum hydrolytic activity. Two KPC-2-producing Raoultella planticola isolates were first identified and analyzed using PCR, Southern hybridization and sequencing in China. Two isolates had an identical antimicrobial susceptibility profile, blaKPC-2 gene as well as its flanking sequences. They were resistant to 16 antimicrobial agents while sensitive to polymyxin B, colistin and minocycline. The results demonstrated that the blaKPC-2 gene was located on a 7 498 bp plasmid segment that encoded five open reading frames with the order of Tn3-transposase, Tn3-resolvase, ISKpn8, blaKPC-2 gene and ISKpn6-like.%碳青霉烯酶编码基因的传播是临床抗菌治疗面临的严重威胁之一。采用PCR、Southern杂交、测序比对等方法筛查和研究了碳青霉烯类抗菌药物的相关耐药基因。首次在国内发现了产KPC酸的植生拉乌尔菌两株。分离到的植生拉乌尔菌对被测试的19种常用抗菌药物中的16种耐药,只对多粘菌素B、粘菌素和米诺环素敏感。它们均产KPC-2型碳青霉烯酶,其编码基因blaKPC-2位于质粒上,两侧(包括blaKPC-2)长度为7498 bp的DNA序列所包含的结构从上游至下游分别为Tn3-transposase, Tn3-resolvase, ISKpn8, blaKPC-2和ISKpn6-like元件。

  9. [Detection of bla(CTX-M) beta-lactamase genes in extended-spectrum beta-lactamase producing gram-negative bacteria].

    Science.gov (United States)

    Bayraktar, Banu; Toksoy, Buket; Bulut, Emin

    2010-04-01

    Widespread production of CTX-M type extended-spectrum beta-lactamases (ESBL) in Enterobacteriaceae strains which are resistant to extended-spectrum cephalosporins is the most remarkable example for rapid and global spread of plasmid mediated antimicrobial resistance in bacteria. Consecutive 200 ESBL producing Enterobacteriaceae strains out of 1640 isolates that were obtained from clinical samples (167 urine, 11 wound, 7 bronchoalveolar lavage, 3 peritoneal fluid, 2 cerebrospinal fluid, 2 biopsy, 2 tracheal aspirate, 2 conjunctiva, 1 abscess, 1 catheter) between February to July 2009 in our laboratory were included to this study. Among the 200 ESBL positive isolates 141 (70.5%) were Escherichia coli, 51 (26%) were Klebsiella pneumoniae, 5 (2.5%) were Enterobacter spp. and one of each (0.5%) Citrobacter freundii, Klebsiella oxytoca and Proteus mirabilis. ESBL positivity was 11% among the 123 community-acquired strains and 13% among the 77 hospital acquired strains, the statistical difference being insignificant (p > 0.05). The prevalence of bla(CTX-M) beta-lactamase genes were detected by multiplex polymerase chain reaction with the use of two general primer sets: CTX-MA1 and CTX-MA2 primers for the amplification of CTX-M-1, CTX-M-2 and CTX-M-9 enzymes group, and CTX825-F and CTX825-R primers for the amplification of CTX-M-8 and CTX-M-25 enzymes group. bla(CTX-M) genes were detected in 167 out of 200 strains (83.5%). CTX-M production rates in community and hospital acquired strains were found as 86.2% and 79.2%, respectively and no statistically significant difference was detected (p > 0.05). CTX-M producing strains were either E. coli (n = 132) or Klebsiella spp. (n = 35) and were expressing one of the enzymes from CTX-M-1, CTX-M-2 or CTX-M-9 groups. No strains carrying CTX-M-8 or CTX-M-25 group enzymes were detected. CTX-M production rates in ESBL producing E. coli strains in community and hospital were found as 92.5% and 95.7%, respectively, whereas the same rates

  10. Occurrence of blaCTX-M-1, qnrB1 and virulence genes in avian ESBL-producing Escherichia coli isolates from Tunisia

    Directory of Open Access Journals (Sweden)

    Mohamed Salah eAbbassi

    2015-05-01

    Full Text Available Avian ESBL-producing Escherichia coli isolates have been increasingly reported worldwide. Animal to human dissemination, via food chain or direct contact, of these resistant bacteria has been reported. In Tunisia, little is known about avian ESBL- producing E. coli and further studies are needed. Seventeen ESBL-producing Escherichia coli isolates from poultry faeces from two farms (Farm 1 and farm 2 in the North of Tunisia have been used in this study. Eleven of these isolates (from farm 1 have the same resistance profile to nalidixic acid, sulfonamides, streptomycin, tetracycline and norfloxacine (intermediately resistant. Out of the six isolates recovered from farm 2, only one was co-resistant to tetracycline. All isolates, except one, harboured blaCTX-M-1 gene, and one strain co-harboured the blaTEM-1 gene. The genes tetA and tetB were carried, respectively, by 11 and 1 amongst the 12 tetracycline-resistant isolates. Sulfonamides resistance was encoded by sul1, sul2 and sul3 genes in 3, 17, and 5 isolates, respectively. The qnrB1 was detected in nine strains, one of which co-harboured qnrS1 gene. The search for the class 1 and 2 integrons by PCR showed that in farm 1, class 1 and 2 integrons were found in one and ten isolates, respectively. In farm 2, class 1 integron was found in only one isolate, class 2 was not detected. Only one gene cassette arrangement was demonstrated in the variable regions (VR of the 10 int2-positive isolates: dfrA1- sat2-aadA1. The size of the VR of the class 1 integron was approximately 250 bp in one int1-positive isolate, whereas in the second isolate, no amplification was observed. All isolates of farm 1 belong to the phylogroup A (sub-group A0. However, different types of phylogroups in farm 2 were detected. Each of the phylogroups A1, B22, B23 was detected in one strain, while the D2 phylogroup was found in 3 isolates. The virulence genes iutA, fimH, and traT were detected in 3, 7 and 3 isolates, respectively

  11. Absence of co-localization between pathovar-associated virulence factors and extended-spectrum β-lactamase (blaCTX-M) genes on a single plasmid.

    Science.gov (United States)

    Valat, Charlotte; Forest, Karine; Billet, Méganne; Polizzi, Charlène; Saras, Estelle; Madec, Jean-Yves; Haenni, Marisa

    2016-08-30

    Extended-spectrum β-lactamases (ESBLs) were reported in virulent food-borne Escherichia coli clones, and numerous genes encoding ESBLs and virulence factors (VFs) are plasmid-mediated. We investigated the plasmidic co-localization of ESBL genes and pathovar-associated VF genes isolated in 18 E. coli isolates from faecal samples of diseased cattle. From the rare ESBL-producing E. coli among the various pathovars, no plasmid co-localization was found between VF and blaCTX-M genes on a single plasmid. However, a link between replicon types and VFs was highlighted: EspP was associated with IncFIB and ToxB with IncB/O. Associations of IncF alleles to VF or CTX-M-types were also identified: CS31A was linked to the allele FIB38 and CTX-M-14 to IncFII2. Also, as illustrated here, IncFII and IncFIB were carried by two different plasmids in a single cell. PMID:27527778

  12. Molecular Characterization of Escherichia coli Strains Isolated from Retail Meat That Harbor blaCTX-M and fosA3 Genes.

    Science.gov (United States)

    Xie, Miaomiao; Lin, Dachuan; Chen, Kaichao; Chan, Edward Wai Chi; Yao, Wen; Chen, Sheng

    2016-04-01

    A total of 55 cefotaxime-resistantEscherichia coliisolates were obtained from retail meat products purchased in Shenzhen, China, during the period November 2012 to May 2013. Thirty-seven of these 55 isolates were found to harbor ablaCTX-Mgene, with theblaCTX-M-1group being the most common type.blaCMY-2was detected in 16 isolates, alone or in combination with other extended-spectrum β-lactamase (ESBL) determinants. Importantly, thefosA3gene, which encodes fosfomycin resistance, was detected in 12 isolates, with several being found to reside in the conjugative plasmid that harbored theblaCTX-Mgene. The insertion sequence IS26was observed upstream of some of theblaCTX-M-55andfosA3genes. Conjugation experiments showed thatblaCTX-Mgenes from 15 isolates were transferrable, with Inc I1 and Inc FII being the most prevalent replicons. High clonal diversity was observed among theblaCTX-Mproducers, suggesting that horizontal transfer of theblaCTX-Mgenes amongE. colistrains in retail meats is a common event and that such strains may constitute an important reservoir ofblaCTX-Mgenes, which may be readily disseminated to other potential human pathogens. PMID:26856843

  13. Successful international clones of blaCTX-M-15-producing Klebsiella pneumoniae with coexpression of plasmid-mediated quinolone resistance (PMQR) determinants in Tehran hospitals.

    Science.gov (United States)

    Nematzadeh, Shoeib; Shahcheraghi, Fereshteh; Iversen, Aina; Giske, Christian G

    2015-12-01

    The dissemination of plasmid-mediated multidrug resistance in Enterobacteriaceae is a major public health concern. We investigated the prevalence of plasmid-mediated quinolone resistance (PMQR), 16S rRNA methylases, CTX-M, and acquired AmpC enzymes in ESBL-producing Klebsiella pneumoniae (n=40) from Tehran hospitals. Plasmid replicon typing, pulsed-field gel electrophoresis (PFGE), and multilocus sequence typing (MLST) were carried out for typing. CTX-M group 1 (confirmed as bla(CTX-M-15) in selected isolates) was found in 35/40 isolates. Thirty-two isolates hosted PMQR genes. Twenty isolates featured aac(6')-Ib-CR only; 9 isolates had aac(6')-Ib-CR and qnrB; 2 isolates had aac(6')-Ib-CR and qnrS; and 1 isolate had aac(6')-Ib-CR, qnrS, and qepA. The 16S rRNA methylase RmtB was found in 1 isolate; and acquired AmpC enzymes, in 6 isolates. PFGE detected 7 pulsotypes, the largest corresponded to sequence type 16. The successful clone ST101 was also found. The emergence of successful clones of K. pneumoniae in Tehran hospitals is concerning. PMID:26458278

  14. Full-Genome Sequence of Escherichia coli K-15KW01, a Uropathogenic E. coli B2 Sequence Type 127 Isolate Harboring a Chromosomally Carried blaCTX-M-15 Gene.

    Science.gov (United States)

    Zurfluh, Katrin; Tasara, Taurai; Stephan, Roger

    2016-01-01

    We present here the full-genome sequence of Escherichia coli K-15KW01, an extended-spectrum-β-lactamase-producing uropathogenic strain. Assembly and annotation of the draft genome resulted in a 5,154,641-bp chromosome and revealed a chromosomally contained blaCTX-M-15 gene embedded at the right-hand extremity of an ISEcp1 element in a plasmid-like structure (36,907 bp). PMID:27587831

  15. Analysis of the beta-lactamase plasmid of borderline methicillin-susceptible Staphylococcus aureus: focus on bla complex genes and cadmium resistance determinants cadD and cadX.

    Science.gov (United States)

    Massidda, Orietta; Mingoia, Marina; Fadda, Daniela; Whalen, Michael B; Montanari, Maria Pia; Varaldo, Pietro E

    2006-03-01

    Borderline methicillin-susceptible Staphylococcus aureus strains are a rather homogeneous group, characterized by MICs of penicillinase-resistant penicillins (PRPs) at or just below the susceptibility breakpoint. Other features unique to this group include the presence of a pBW15-like beta-lactamase plasmid, the association with phage complex 94/96, and the production of a PRP-hydrolyzing beta-lactamase activity in addition to the classical penicillinase activity. The four HindIII fragments of pBORa53, a pBW15-like plasmid from the well-studied borderline S. aureus strain a53, were cloned in Escherichia coli, sequenced and analyzed. The plasmid (17,334 bp in size) contains 14 open reading frames (ORFs) and a complete copy of transposon Tn552, which harbors the three genes of the bla complex (blaZ, blaR1, and blaI) necessary for penicillinase production. Among the other 11 ORFs identified, two were homologous to cadmium resistance determinants of Staphylococcus lugdunensis and to the cadD and cadX genes recently detected in S. aureus. Consistent with this, strain a53 was found to be cadmium resistant. From a collection of 30 S. aureus isolates with borderline PRP MIC levels, 27 matched strain a53 in the positive amplification reactions with all of the four primer pairs targeting the cadD-cadX region, the presence of the 17.3-kb plasmid, and the level of cadmium resistance. The well-established S. aureus laboratory strain ATCC 29213 was also found to express cadD-cadX-mediated cadmium resistance. pBORa53 could be re-isolated from transformants obtained by transferring it into a PRP-susceptible recipient. However, while the transformants demonstrated levels of cadmium and penicillin resistance similar to those of strain a53, they remained fully susceptible to PRPs. PMID:16229889

  16. blaCTX-M-152, a Novel Variant of CTX-M-group-25, Identified in a Study Performed on the Prevalence of Multidrug Resistance among Natural Inhabitants of River Yamuna, India

    OpenAIRE

    Azam, Mudsser; Jan, Arif T.; Haq, Qazi M. R.

    2016-01-01

    Natural environment influenced by anthropogenic activities creates selective pressure for acquisition and spread of resistance genes. In this study, we determined the prevalence of Extended Spectrum β-Lactamases producing gram negative bacteria from the River Yamuna, India, and report the identification and characterization of a novel CTX-M gene variant bla CTX-M-152 . Of the total 230 non-duplicate isolates obtained from collected water samples, 40 isolates were found positive for ESBL produ...

  17. High occurrence of bla CMY-1 AmpC lactamase producing Escherichia coli in cases of complicated urinary tract infection (UTI) from a tertiary health care centre in north India

    OpenAIRE

    Taneja, Neelam; Singh, Gagandeep; Singh, Meenakshi; Madhup, Surendra; Pahil, Sapna; Sharma, Meera

    2012-01-01

    AmpC beta lactamase producing Gram-negative bacteria have emerged worldwide. It is important to distinguish plasmid mediated AmpC β lactamases from chromosomally mediated enzymes for surveillance, epidemiology and hospital infection control as plasmid mediated genes can spread to other organisms. Occurrence of bla CMY-1 AmpC β-lactamase, a plasmid mediated cephamycinase was studied in 100 consecutive isolates of Escherichia coli from cases of complicated urinary tract infection (UTI). Screeni...

  18. Full-Genome Sequence of Escherichia coli K-15KW01, a Uropathogenic E. coli B2 Sequence Type 127 Isolate Harboring a Chromosomally Carried blaCTX-M-15 Gene

    Science.gov (United States)

    Zurfluh, Katrin; Tasara, Taurai

    2016-01-01

    We present here the full-genome sequence of Escherichia coli K-15KW01, an extended-spectrum-β-lactamase-producing uropathogenic strain. Assembly and annotation of the draft genome resulted in a 5,154,641-bp chromosome and revealed a chromosomally contained blaCTX-M-15 gene embedded at the right-hand extremity of an ISEcp1 element in a plasmid-like structure (36,907 bp). PMID:27587831

  19. Bundnir við borðið. Vinnubrögð blaða- og fréttamanna á íslenskum fjölmiðlum

    OpenAIRE

    Svanbjörg H. Einarsdóttir 1964

    2011-01-01

    Viðfangsefni þessarar rannsóknar og ritgerðar er að kanna vinnubrögð blaða- og fréttamanna við dagleg störf á fjölmiðlum. Rannsóknir víða erlendis sýna að blaða- og fréttamenn fara lítið út af vinnustað sínum, flest viðtöl eru símaviðtöl og algengast er að fréttir eigi rót sína að rekja til fréttatilkynninga, almannatengla, upplýsingafulltrúa og hagsmunaaðila. Þar sem blaða- og fréttamenn fari lítið úr húsi gefist lítið færi til fréttaöflunar, að hitta og kynnast fólki og rækta sambönd við he...

  20. „Ég fórnaði bara öllu.“ Starfsaldur, álag og kynjamismunun hjá íslenskum blaðamönnum.

    OpenAIRE

    Svanhvít Ljósbjörg Guðmundsdóttir 1977

    2014-01-01

    Það er eitthvað heillandi við blaðamennskuna og hún hefur löngum þótt vera áhugavert starf. Þrátt fyrir að blaðamenn séu almennt ánægðir í starfi eru hins vegar margir þeirra sem kjósa að hætta störfum og sérstaklega virðist það eiga við um konur, þrátt fyrir að meiri líkur séu á að þær hafi menntað sig í faginu. Markmið þessarar rannsóknar er að skoða aðstöðu blaðamanna á Íslandi, álag í starfi, starfsaldur, vinnustaðamenningu og kynjamismunun og þá með sérstakri áherslu á konur og af hv...

  1. Spatial planning

    OpenAIRE

    Dimitrov, Nikola; Koteski, Cane

    2016-01-01

    The professional book ,, Space planning "processed chapters on: space, concept and definition of space, space as a system, spatial economics, economic essence of space, space planning, social determinants of spatial planning, spatial planning as a process, factors development and elements in spatial planning, methodology, components and content of spatial planning stages and types of preparation of spatial planning, spatial planning and industrialization, industrialization, urbanization and s...

  2. Planning Lessons

    Institute of Scientific and Technical Information of China (English)

    Linda Jensen

    2007-01-01

    @@ Jensen's "Lesson Planning"article serves aS a guide fOr novice teachers who need to create formalized lesson plans.The article covers why,when,and how teachers plan lessons,as well aS basic lesson plan principles and a lesson plan template.

  3. Sequence of pNL194, a 79.3-Kilobase IncN Plasmid Carrying the blaVIM-1 Metallo-β-Lactamase Gene in Klebsiella pneumoniae▿

    Science.gov (United States)

    Miriagou, V.; Papagiannitsis, C. C.; Kotsakis, S. D.; Loli, A.; Tzelepi, E.; Legakis, N. J.; Tzouvelekis, L. S.

    2010-01-01

    The nucleotide sequence of pNL194, a VIM-1-encoding plasmid, is described in this study. pNL194 (79,307 bp) comprised an IncN-characteristic segment (38,940 bp) and a mosaic structure (40,367 bp) including blaVIM-1, aacA7, aadA1, aadA2, dfrA1, dfrA12, aphA1, strA, strB, and sul1. Tn1000 or Tn5501 insertion within fipA probably facilitated recruitment of additional mobile elements carrying resistance genes. PMID:20660690

  4. Sequence of pNL194, a 79.3-kilobase IncN plasmid carrying the blaVIM-1 metallo-beta-lactamase gene in Klebsiella pneumoniae.

    Science.gov (United States)

    Miriagou, V; Papagiannitsis, C C; Kotsakis, S D; Loli, A; Tzelepi, E; Legakis, N J; Tzouvelekis, L S

    2010-10-01

    The nucleotide sequence of pNL194, a VIM-1-encoding plasmid, is described in this study. pNL194 (79,307 bp) comprised an IncN-characteristic segment (38,940 bp) and a mosaic structure (40,367 bp) including bla(VIM-1), aacA7, aadA1, aadA2, dfrA1, dfrA12, aphA1, strA, strB, and sul1. Tn1000 or Tn5501 insertion within fipA probably facilitated recruitment of additional mobile elements carrying resistance genes. PMID:20660690

  5. Sequence of pNL194, a 79.3-Kilobase IncN Plasmid Carrying the blaVIM-1 Metallo-β-Lactamase Gene in Klebsiella pneumoniae▿

    OpenAIRE

    Miriagou, V.; Papagiannitsis, C. C.; Kotsakis, S. D.; Loli, A; Tzelepi, E.; Legakis, N. J.; Tzouvelekis, L. S.

    2010-01-01

    The nucleotide sequence of pNL194, a VIM-1-encoding plasmid, is described in this study. pNL194 (79,307 bp) comprised an IncN-characteristic segment (38,940 bp) and a mosaic structure (40,367 bp) including blaVIM-1, aacA7, aadA1, aadA2, dfrA1, dfrA12, aphA1, strA, strB, and sul1. Tn1000 or Tn5501 insertion within fipA probably facilitated recruitment of additional mobile elements carrying resistance genes.

  6. IncI1 Plasmid Carrying Extended-Spectrum-β-Lactamase Gene blaCTX-M-1 in Salmonella enterica Isolates from Poultry and Humans in France, 2003 to 2008 ▿

    OpenAIRE

    Cloeckaert, Axel; Praud, Karine; Lefevre, Martine; Doublet, Benoît; Pardos, Maria; Granier, Sophie; Brisabois, Anne; Weill, François-Xavier

    2010-01-01

    We report the dissemination of a conjugative IncI1 plasmid carrying bla CTX-M-1 , conferring resistance to extended-spectrum cephalosporins, in Salmonella enterica isolates from poultry and humans in France from 2003 to 2008. By IncI1 plasmid subtyping, this plasmid was shown to be genetically related to that found in Escherichia coli isolates from healthy poultry in France. Food-producing animals are the primary reservoir of zoo-notic pathogens, and the prevalence of resistance to extended-s...

  7. The properties of the single chicken MHC classical class II alpha chain ( B-LA) gene indicate an ancient origin for the DR/E-like isotype of class II molecules

    DEFF Research Database (Denmark)

    Salomonsen, Jan; Marston, Denise; Avila, David;

    2003-01-01

    significantly in the peptide-binding alpha(1) domain. The cDNA and genomic DNA sequences from chickens of diverse origins show few alleles, which differ in only four nucleotides and one amino acid. In contrast, significant restriction fragment length polymorphism is detected by Southern blot analysis of genomic...... DNA, suggesting considerable diversity around the gene. Analysis of a large back-cross family indicates that the class II alpha chain locus ( B-LA) is located roughly 5.6 cM from the MHC locus, which encodes the classical class II beta chains. Thus the chicken class II alpha chain gene is like the...

  8. Characterisation of IncA/C2 plasmids carrying an In416-like integron with the blaVIM-19 gene from Klebsiella pneumoniae ST383 of Greek origin.

    Science.gov (United States)

    Papagiannitsis, Costas C; Dolejska, Monika; Izdebski, Radosław; Giakkoupi, Panagiota; Skálová, Anna; Chudějová, Kateřina; Dobiasova, Hana; Vatopoulos, Alkiviadis C; Derde, Lennie P G; Bonten, Marc J M; Gniadkowski, Marek; Hrabák, Jaroslav

    2016-02-01

    The complete nucleotide sequences of three multidrug resistance (MDR) IncA/C-like plasmids from Enterobacteriaceae isolates carrying the VIM-type carbapenemase-encoding integrons In4863 (blaVIM-19-aacA7-dfrA1-ΔaadA1-smr2) or In4873 (blaVIM-1-aacA7-dfrA1-ΔaadA1-smr2) were determined, which are the first In416-like elements identified in Greece. Plasmids pKP-Gr642 and pKP-Gr8143 were from Klebsiella pneumoniae ST383 isolates, whereas plasmid pEcl-Gr4873 was from an Enterobacter cloacae ST88 isolate. Sequencing showed that pKP-Gr642 (162787bp) and pKP-Gr8143 (154395bp) consisted of the type 1 IncA/C2 conserved backbone, the blaCMY-2-like gene-containing region, and the ARI-B (with the sul2 gene) and ARI-A (with a class 1 integron) resistance islands, like the plasmid pUMNK88_161 from the USA. The third plasmid, pEcl-Gr4873 (153958bp), exhibited extensive similarity with the type 2 IncA/C2 plasmid pR55 from France. pEcl-Gr4873 carried only one resistance island of a hybrid transposon structure inserted in a different location to ARI-A in type 1 A/C2 plasmids. In all three plasmids, the In416-like integrons In4863 or In4873 were identified within non-identical class II transposon structures. All three In416-like-carrying regions presented significant similarities with the MDR region of the IncA/C2 plasmid pCC416 from Italy, carrying the prototype In416 integron (blaVIM-4-aacA7-dfrA1-ΔaadA1-smr2). These findings provided the basis for speculations regarding the evolution of IncA/C2 plasmids with In416-like integrons, and confirmed the rapid evolution of some IncA/C2 plasmid lineages. Considering the broad host range of IncA/C2 molecules, it seems that pKP-Gr642, pKP-Gr8143 and pEcl-Gr4873 plasmids might support the diffusion of In416-like integrons among Enterobacteriaceae. PMID:26795022

  9. Complete sequences of IncHI1 plasmids carrying blaCTX-M-1 and qnrS1 in equine Escherichia coli provide new insights into plasmid evolution

    DEFF Research Database (Denmark)

    Dolejska, Monika; Villa, Laura; Minoia, Marco;

    2014-01-01

    OBJECTIVES: To determine the structure of two multidrug-resistant IncHI1 plasmids carrying blaCTX-M-1 in Escherichia coli isolates disseminated in an equine clinic in the Czech Republic. METHODS: A complete nucleotide sequencing of 239 kb IncHI1 (pEQ1) and 287 kb IncHI1/X1 (pEQ2) plasmids was...... performed using the 454-Genome Sequencer FLX system. The sequences were compared using bioinformatic tools with other sequenced IncHI1 plasmids. RESULTS: A comparative analysis of pEQ1 and pEQ2 identified high nucleotide identity with the IncHI1 type 2 plasmids. A novel 24 kb module containing an operon...... involved in short-chain fructooligosaccharide uptake and metabolism was found in the pEQ backbones. The role of the pEQ plasmids in the metabolism of short-chain fructooligosaccharides was demonstrated by studying the growth of E. coli cells in the presence of these sugars. The module containing the bla...

  10. Lysine N[superscript zeta]-Decarboxylation Switch and Activation of the [beta]-Lactam Sensor Domain of BlaR1 Protein of Methicillin-resistant Staphylococcus aureus

    Energy Technology Data Exchange (ETDEWEB)

    Borbulevych, Oleg; Kumarasiri, Malika; Wilson, Brian; Llarrull1, Leticia I.; Lee, Mijoon; Hesek, Dusan; Shi, Qicun; Peng, Jeffrey; Baker, Brian M.; Mobashery, Shahriar (Notre)

    2012-10-29

    The integral membrane protein BlaR1 of methicillin-resistant Staphylococcus aureus senses the presence of {beta}-lactam antibiotics in the milieu and transduces the information to the cytoplasm, where the biochemical events that unleash induction of antibiotic resistance mechanisms take place. We report herein by two-dimensional and three-dimensional NMR experiments of the sensor domain of BlaR1 in solution and by determination of an x-ray structure for the apo protein that Lys-392 of the antibiotic-binding site is posttranslationally modified by N{sup {zeta}}-carboxylation. Additional crystallographic and NMR data reveal that on acylation of Ser-389 by antibiotics, Lys-392 experiences N{sup {zeta}}-decarboxylation. This unique process, termed the lysine N{sup {zeta}}-decarboxylation switch, arrests the sensor domain in the activated ('on') state, necessary for signal transduction and all the subsequent biochemical processes. We present structural information on how this receptor activation process takes place, imparting longevity to the antibiotic-receptor complex that is needed for the induction of the antibiotic-resistant phenotype in methicillin-resistant S. aureus.

  11. Marketing plan

    OpenAIRE

    Hejňáková, Renata

    2014-01-01

    The aim of this bachelor's work is an exemplification applicability individual aspects of marketing planning Y company in the conclusion is drown a marketing plan up with advising action programs for year 2014. The theoretical part is defined by marketing and stadium of marketing planning using descriptive models and comparison technical literature. At the conclusion is drown a marketing plan up. The practical part is made on the base of gained information by semistructured interview with a m...

  12. Fire Plans

    Science.gov (United States)

    Power, June

    2011-01-01

    Many libraries have disaster recovery plans, but not all have prevention and action plans to prepare for an emergency in advance. This article presents the author's review of the prevention and action plans of several libraries: (1) Evergreen State College; (2) Interlochen Public Library; (3) University of Maryland, Baltimore-Marshall Law Library;…

  13. Business plan

    OpenAIRE

    Monakov, Victor

    2011-01-01

    The aim of this bachelor's thesis is to prepare a business plan for web design courses in Prague and feasibility & efficiency evaluation of this type of business. In the theoretical part of my bachelor's thesis, I focus on important terms, structure and aspects of a business plan. In the practical part, I apply theoretical knowledge and create a real business plan.

  14. Pharmacovigilance Analysis of Serious Adverse Events Reported for Biologic Response Modifiers Used as Prophylaxis against Transplant Rejection: a Real-World Postmarketing Experience from the US FDA Adverse Event Reporting System (FAERS)

    Science.gov (United States)

    Ali, A. K.

    2013-01-01

    Background: Immunosuppression by biologic response modifiers (BRM) is a crucial component for successful organ transplantation. In addition to their variable effectiveness in the prevention of organ rejection, these medications have safety concerns that complicate therapeutic outcomes in organ transplant patients. Objective: This study aims at identifying and characterizing safety signals of serious adverse events associated with exposure to BRM among organ transplant patients in a real-world environment. Methods: The FDA Adverse Event Reporting System was utilized to apply a pharmacovigilance disproportionality analysis to indentify serious adverse events. Associations between drugs and events were measured by empirical Bayes geometric mean (EBGM) and the corresponding 95% confidence intervals (EB05–EB95). Associations with EBGM≥2 were considered significant safety signals. Results: From 1997 to 2012, a total of 12,151 serious adverse event reports for BRM were reported; 15.6% of them (n=1,711) met the safety signal threshold of EB05>1, and 11.6% of these signals (n=199) were significant (EBGM≥2). Sirolimus and mycophenolate accounted for the majority of all signals; antithymocyte immunoglobulin (ATI) and cyclosporine contributed to the majority of significant signals. The following significant signals were identified for ATI (reduced therapeutic response, pulmonary edema, hypotension, serum sickness, infusion-related reaction, and anaphylactic reaction); for azathioprine (alternaria infection, fungal skin infection, and lymphoproliferative disorder); for cyclosporine (neurotoxicity, graft vs. host disease, and thyroid cancer); for cyclophosphamide (disease progression); for daclizumab (cytomegalovirus infection); and for tacrolimus (coma and tremor). 33.6% of these events contributed to patient death (n=67); 6.5% were life-threatening (n=13); 32.1% lead to hospitalization (n=64); and 27.6% resulted in other serious outcomes (n=55). Conclusion: Utilization

  15. Pharmacovigilance Analysis of Serious Adverse Events Reported for Biologic Response Modifiers Used as Prophylaxis against Transplant Rejection: a Real-World Postmarketing Experience from the US FDA Adverse Event Reporting System (FAERS

    Directory of Open Access Journals (Sweden)

    A. K. Ali

    2013-04-01

    Full Text Available Background: Immunosuppression by biologic response modifiers (BRM is a crucial component for successfulorgan transplantation. In addition to their variable effectiveness in the prevention of organ rejection,these medications have safety concerns that complicate therapeutic outcomes in organ transplantpatients.Objective: This study aims at identifying and characterizing safety signals of serious adverse events associatedwith exposure to BRM among organ transplant patients in a real-world environment.Methods: The FDA Adverse Event Reporting System was utilized to apply a pharmacovigilance disproportionalityanalysis to indentify serious adverse events. Associations between drugs and events weremeasured by empirical Bayes geometric mean (EBGM and the corresponding 95% confidence intervals(EB05–EB95. Associations with EBGM≥2 were considered significant safety signals.Results: From 1997 to 2012, a total of 12,151 serious adverse event reports for BRM were reported; 15.6%of them (n=1,711 met the safety signal threshold of EB05>1, and 11.6% of these signals (n=199 weresignificant (EBGM≥2. Sirolimus and mycophenolate accounted for the majority of all signals; antithymocyteimmunoglobulin (ATI and cyclosporine contributed to the majority of significant signals. The followingsignificant signals were identified for ATI (reduced therapeutic response, pulmonary edema, hypotension,serum sickness, infusion-related reaction, and anaphylactic reaction; for azathioprine (alternariainfection, fungal skin infection, and lymphoproliferative disorder; for cyclosporine (neurotoxicity,graft vs. host disease, and thyroid cancer; for cyclophosphamide (disease progression; for daclizumab(cytomegalovirus infection; and for tacrolimus (coma and tremor. 33.6% of these events contributedto patient death (n=67; 6.5% were life-threatening (n=13; 32.1% lead to hospitalization (n=64; and27.6% resulted in other serious outcomes (n=55.Conclusion: Utilization of BRM for the

  16. Tumor necrosis factor inhibitors added to nonbiological immunosuppressants vs. nonbiological immunosuppressants alone: a different signal of cancer risk according to the condition. A disproportionality analysis in a nationwide pharmacovigilance database.

    Science.gov (United States)

    Saliba, Layla; Moulis, Guillaume; Abou Taam, Malak; Rousseau, Vanessa; Chebane, Leila; Petitpain, Nadine; Baldin, Bernadette; Pugnet, Grégory; Montastruc, Jean-Louis; Bagheri, Haleh

    2016-04-01

    We aimed at detecting a signal of an increased risk of cancer in patients treated with TNF inhibitor (TNFi) and nonbiological immunosuppressant (NBIS), compared with NBIS alone for autoimmune diseases. Secondly, we aimed at comparing this risk between the different TNFis. We conducted a disproportionality analysis (case/noncase study) from the French National PharmacoVigilance Database. We selected all the reports of serious adverse drug reactions from 2000 to 2010 in patients treated with NBIS for labeled indications of TNFi. Cases were all the reports of cancer that occurred after a minimal 3-month exposure to NBIS. Noncases were all the other reports. We searched for exposure to TNFi and calculated reporting odds ratios (RORs), stratified by condition and type of cancer and adjusted by age, gender, history of cancer, type of NBIS and year of reporting. Of the 1918 reports included in the study population, 217 were cases (135 solid and 82 blood cancers). A safety signal was found in rheumatoid arthritis (RA) (ROR: 5.43, 95% CI[3.52-8.38]) particularly for nonmelanoma skin cancer (NMSC) (20.17[2.49-163.36]), and in psoriasis/psoriatic arthritis (3.45[1.09-10.92]). No signal was found in inflammatory bowel diseases (IBD) and ankylosing spondylitis, whatever the type of cancer. There was no difference between TNFis. This study puts the argument of an increased risk of cancer (particularly NMSC) in patients with rheumatoid arthritis exposed to TNFi and NBIS compared with NBIS alone, but not in IBD and ankylosing spondylitis patients. No signal was detected for melanoma potentially related to the lack of power. The signal seems similar whatever the TNFi. PMID:26604187

  17. Comparison of CT based-CTV plan and CT based-ICRU38 plan in brachytherapy planning of uterine cervix cancer

    Energy Technology Data Exchange (ETDEWEB)

    Shim, Jin Sup; Jo, Jung Kun; Si, Chang Keun; Lee, Ki Ho; Lee, Du Hyun; Choi, Kye Suk [Proton Therapy Center, National Cancer Center, Seoul (Korea, Republic of)

    2004-09-15

    dose(V80bla) is 12.2%{+-}8.9 cm{sup 3} on ICRU plan, 3.5{+-}4.1 cm{sup 3} on CTV plan. Likewise, CTV plan more less irradiated normal tissue than ICRU38 plan. Although, prove effect and stability about previous ICRU plan, if we use CTV plan by CT image, we will reduce normal tissue dose and irradiated goal-dose at residual tumor on small residual tumor case. But bigger residual tumor case, we need more research about effective 3D-planning.

  18. A evolução da farmacovigilância no Brasil - DOI: 10.4025/actascihealthsci.v27i2.1377 The evolution of the pharmacovigilance in Brazil - DOI: 10.4025/actascihealthsci.v27i2.1377

    Directory of Open Access Journals (Sweden)

    Paula Nishiyama

    2005-03-01

    Full Text Available Este trabalho faz um breve relato sobre os aspectos conceituais e os marcos históricos que envolvem a Farmacovigilância. São abordados os caminhos que levaram ao desenvolvimento da Farmacovigilância no mundo e no Brasil, finalizando com as perspectivas da formação de um serviço de qualidade que contribuirá para minimizar os potenciais danos dos medicamentos e assim servir à saúde pública e aumentar o senso de confiança dos pacientes nos medicamentosThis work makes a brief story on the conceptual aspects and the historical landmarks that involve the Pharmacovigilance. There are related the ways that had taken the development of the Pharmacovigilance in the world and Brazil, concluding with the perspectives of the development of a qualified service that will contribute to minimize the injury caused by drugs use and so serving to the public health and increasing the reliable sense of the patients in drugs use

  19. Business plan

    OpenAIRE

    Bekesheva, Karina

    2013-01-01

    This Bachelor`s thesis is a business plan of the event agency. It consists of two parts: theoretical and practical. Theoretical part is based on theory from books and other re-sources. In theoretical part there are some definitions about entrepreneurship, business plan and some strategic analyses tools. In addition, it includes the history of entrepre-neurship in Kazakhstan. Practical part is focused on creation the business plan. It in-volves some external and internal analyses, marketing st...

  20. Business Plan

    OpenAIRE

    Neterda, Karel

    2012-01-01

    The objective of the diploma thesis is aimed at business plan for real estate agency. Theoretical part of the thesis focuses on basic definitions regarding new company establishment. As follows: business laws, legal form of companies, business grants and structure of the business plan. Practical part describes a business plan for real estate agency and evaluate the business environment and current competition through these methods: Porter Five Force Model, SWOT -- and PEST analyses. Further, ...

  1. Business plan

    OpenAIRE

    Triandafilu, Aneta

    2012-01-01

    The goal of the bachelor thesis is to create a business plan for an emerging company - HEALTHY GARDEN, s.r.o, which is a restaurant with main focus on providing healthy food and gluten free food. The purpose of the plan is verification of the project's feasibility and its competitiveness on the current market. The thesis is divided into two parts - theoretic and practical. The first part explains theoretical background of business plan creation, its implication, purpose and structure. It also...

  2. Inspection planning

    International Nuclear Information System (INIS)

    Slovenian Nuclear Safety Administration (SNSA) division of nuclear and radiological safety inspection has developed systematic approach to their inspections. To be efficient in their efforts regarding regular and other types of inspections, in past years, the inspection plan has been developed. It is yearly based and organized on a such systematic way, that all areas of nuclear safety important activities of the licensee are covered. The inspection plan assures appropriate preparation for conducting the inspections, allows the overview of the progress regarding the areas to be covered during the year. Depending on the licensee activities and nature of facility (nuclear power plant, research reactor, radioactive waste storage, others), the plan has different levels of intensity of inspections and also their frequency. One of the basic approaches of the plan is to cover all nuclear and radiological important activities on such way, that all regulatory requests are fulfilled. In addition, the inspection plan is a good tool to improve inspection effectiveness based on previous experience and allows to have the oversight of the current status of fulfillment of planned inspections. Future improvement of the plan is necessary in the light of newest achievements on this field in the nuclear world, that means, new types of inspections are planned and will be incorporated into plan in next year.(author)

  3. Extended-spectrum beta-lactamase-producing Shiga toxin gene (stx1)-positive Escherichia coli O91:H14 carrying blaCTX-M-15 on an IncI1-ST31 plasmid isolated from a human patient in Germany.

    Science.gov (United States)

    Arvand, Mardjan; Bettge-Weller, Gudrun; Fruth, Angelika; Uphoff, Helmut; Pfeifer, Yvonne

    2015-05-01

    In 2011, the Shiga toxin- and extended-spectrum β-lactamase (ESBL)-producing Escherichia coli O104:H4 caused a serious outbreak of gastroenteritis in Germany. This strain carried bla(CTX-M-15) and bla(TEM-1) on an IncI1-ST31 plasmid. During screening of individuals at risk for acquisition of the epidemic E. coli O104:H4, we isolated another ESBL-producing and Shiga toxin-positive E. coli belonging to serotype O91:H14 from feces of a human patient. Interestingly, the patient also carried a further ESBL-producing but Shiga toxin-negative E. coli. Both strains harbored bla(CTX-M-15) and bla(TEM-1) on an IncI1-ST31 plasmid, which was indistinguishable regarding size and plasmid restriction pattern from the plasmid of the epidemic E. coli O104:H4 strain. The patient had traveled to India 6 months prior to the isolation of the E. coli strains. This is the first report of an ESBL-producing, Shiga toxin-positive E. coli of serogroup O91. Our data suggest a high propensity of the IncI1-ST31 plasmid to spread in the human and/or animal population. PMID:25801683

  4. Nye oplysninger om bl.a. miljømæssig risikovurdering af PAT-protein og glufosinatammonium herbicider. Zea mays (Bt11). Supplerende materiale om Bt11. Modtaget 21-02-2005, deadline 29-03-2005, svar 07-03-2005

    DEFF Research Database (Denmark)

    Strandberg, Morten Tune

    2005-01-01

    Mail: Det tilsendte supplerende materiale om Bt-11 majsen (mail pr. 21-02-2005) omhandler bl.a. eventuelle uønskede konsekvenser ved ulovlig anvendelse af glufosinat ammonium herbicider i forbindelse med dyrkningen. Vi har allerede indraget dette aspekt i forbindelse med den økologiske risikovurd...

  5. Frequency of conjugative transfer of plasmid-encoded ISEcp1 - blaCTX-M-15 and aac(6'-lb-cr genes in Enterobacteriaceae at a tertiary care center in Lebanon - role of transferases

    Directory of Open Access Journals (Sweden)

    Araj George F

    2010-07-01

    Full Text Available Abstract Background The frequency of transfer of genes encoding resistance to antimicrobial agents was determined by conjugation in ESBL-producing and/or fluoroquinolone or aminoglycoside resistant Enterobacteriaceae clinical isolates at a tertiary care center in Lebanon. In addition, the role of tra genes encoding transferases in mediating conjugation was assessed. Methods Conjugation experiments were done on 53 ESBL-producing and/or fluoroquinolone resistant E. coli and K. pneumoniae and ESBL-producing S. sonnei isolates. Antimicrobial susceptibility testing on parent and transconjugant isolates, and PCR amplifications on plasmid extracts of the resistance-encoding genes: blaCTX-M-15 with the ISEcp1 insertion sequence, the aac(6'-lb-cr and qnrS genes, as well as tra encoding transferases genes were done. Random amplified polymorphic DNA (RAPD analysis was performed to demonstrate whether conjugative isolates are clonal and whether they are linked epidemiologically to a particular source. Results Antimicrobial susceptibility testing on transconjugants revealed that 26 out of 53 (49% ESBL-producing Enterobacteriaceae were able to transfer antimicrobial resistance to the recipients. Transfer of high-level resistance to the transconjugants encoded by the blaCTX-M-15 gene downstream the ISEcp1 insertion sequence against 3rd generation cephalosporins, and of low-level resistance against ciprofloxacin, and variable levels of resistance against aminoglycosides encoded by aac(6'-lb-cr gene, were observed in transconjugants. tra encoding transferase genes were detected exclusively in conjugative isolates. Conclusion In conclusion, the frequency of transfer of antimicrobial resistance in non clonal Enterobacteriaceae at the tertiary care center by conjugation was 49%. Conjugation occurred in isolates expressing the tra encoding transferase genes. Multiple conjugative strains harboring the plasmid encoded antimicrobial resistant genes were circulating in

  6. Steel Planning

    Institute of Scientific and Technical Information of China (English)

    2011-01-01

    China releases a new plan for the iron and steel industry centered on industrial upgrades The new 12th Five-Year Plan (2011-15) for China’s iron and steel industry, recently released on the website of the Ministry of Industry and Information

  7. Systemic Planning

    DEFF Research Database (Denmark)

    Leleur, Steen

    This book presents principles and methodology for planning in a complex world. It sets out a so-called systemic approach to planning, among other things, by applying “hard” and “soft” methodologies and methods in combination. The book is written for Ph.D and graduate students in engineering...

  8. Transition Planning

    Science.gov (United States)

    Statfeld, Jenna L.

    2011-01-01

    Post-school transition is the movement of a child with disabilities from school to activities that occur after the completion of school. This paper provides information about: (1) post-school transition; (2) transition plan; (3) transition services; (4) transition planning; (5) vocational rehabilitation services; (6) services that are available…

  9. Interpretace Čechovových her v režiích Petra Lébla v Divadle Na zábradlí

    Czech Academy of Sciences Publication Activity Database

    Jungmannová, Lenka

    Praha: Národní knihovna České republiky, 2005 - (Hříbková, R.; Hrabalová, M.), s. 17-23 ISBN 80-7050-464-1 Institutional research plan: CEZ:AV0Z90560517 Keywords : Petr Lébl * theatre * postmodernism Subject RIV: AJ - Letters, Mass-media, Audiovision

  10. 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

  11. GRIPS Plan

    Energy Technology Data Exchange (ETDEWEB)

    1978-07-31

    The GRIPS (Geothermal Resources Impact Projection Study) Commission was established by a Joint Powers Agreement between the California Counties of Lake, Mendocino, Napa, and Sonoma. The objectives of GRIPS are primarily to develop and use a cooperative environmental data collection and use system including natural, social, and economic considerations to facilitate their independent decisions and those of State and Federal agencies related to the environmental effects of geothermal development. This GRIPS Plan was prepared from a wide range of studies, workshops, and staff analyses. The plan is presented in four parts: summary and introduction; environmental data status report; planned programs; and budget. (MHR)

  12. Marketing Plan

    OpenAIRE

    Jantunen, Essi; Hellman, Annika

    2012-01-01

    The aim of this bachelor’s thesis was to draw up an efficient marketing plan for Pohjolan Vihreä Polku Oy, which offers meeting and nature activity services. The company was in a process of conversion and needed a structured marketing plan. The objectives of the company were perceived through severe research. The main purposes of the marketing plan were to raise the visibility of the company and increase its clientele. The proposed marketing actions are also to be used to improve the company’...

  13. Energy planning and management plan

    International Nuclear Information System (INIS)

    This paper contains printed copies of 60FR 53181, October 12, 1995 and 60 FR 54151. This is a record of decision concerning the Western Area Power Administration's final draft and environmental impact statement, and Energy Planning and Management Program

  14. [Carriage of class 1 and 2 integrons in Acinetobacter baumannii and Pseudomonas aeruginosa isolated from clinical specimens and a novel gene cassette array: blaOXA-11-cmlA7].

    Science.gov (United States)

    Mengeloğlu, Fırat Zafer; Copur Çiçek, Ayşegül; Koçoğlu, Esra; Sandallı, Cemal; Budak, Emine Esra; Ozgümüş, Osman Birol

    2014-01-01

    cassettes. IntI2 gene was not detected in any of the isolates. Resistance to piperacillin/tazobactam, ceftazidime, cefepime, ceftriaxone and ampicillin/sulbactam was detected as the common resistance pattern in all integron-positive A.baumannii strains, whereas resistance to ceftazidime, gentamicin and ciprofloxacin was the common pattern in all integron-positive P.aeruginosa strains. DNA sequence analysis of variable regions of integrons indicated that two separate gene cassette arrays (aacC1-aadA1 and aac(3)-1) were carried by A.baumannii strains, and two types of gene cassette arrays (blaOXA-30-aadA1 and blaOXA-11-cmlA7) were carried by P.aeruginosa strains. To our best knowledge, this is the first report of the gene sequence of blaOXA-11-cmlA7 defined in an integron gene cassette of P.aeruginosa. PMID:24506715

  15. Planning Inequality

    DEFF Research Database (Denmark)

    Mandersheid, Katharina; Richardson, Tim

    2011-01-01

    While traces and techniques of power and contestation around the understanding and production of spaces are clearly recognized in the sociological and planning research literature, there has been little rigorous attention to how socio-spatial inequality is put at stake in strategic mobilization...... around particular spatial imaginaries. In an analysis of the German Spatial Planning Report, the paper examines how inequalities are represented in relation to space and movement in spatial strategy. The analysis shows how, in the report, the spatial dimension of the social is represented as a...... represented as something outside and fluid which is meant to be channelled into the territorial containers by means of regional development and spatial planning. These representations of the social suggest a territorialized culturally integrated society as the unquestioned frame of reference which has lost...

  16. 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. PMID:27080842

  17. Strategic plan

    International Nuclear Information System (INIS)

    In November 1989, the Office of Environmental Restoration and Waste Management (EM) was formed within the US Department of Energy (DOE). The EM Program was born of the recognition that a significant national effort was necessary to clean up over 45 years' worth of environmental pollution from DOE operations, including the design and manufacture of nuclear materials and weapons. Within EM, the Deputy Assistant Secretary for Environmental Restoration (EM-40) has been assigned responsibility for the assessment and cleanup of areas and facilities that are no longer a part of active DOE operations, but may be contaminated with varying levels and quantifies of hazardous, radioactive, and n-mixed waste. Decontamination and decommissioning (D ampersand D) activities are managed as an integral part of Envirorunental Restoration cleanup efforts. The Office of Environmental Restoration ensures that risks to the environment and to human health and safety are either eliminated or reduced to prescribed, acceptable levels. This Strategic Plan has been developed to articulate the vision of the Deputy Assistant Secretary for Environmental Restoration and to crystallize the specific objectives of the Environmental Restoration Program. The document summarizes the key planning assumptions that guide or constrain the strategic planning effort, outlines the Environmental Restoration Program's specific objectives, and identifies barriers that could limit the Program's success

  18. F33: A-: B-, IncHI2/ST3, and IncI1/ST71 plasmids drive the dissemination of fosA3 and blaCTX-M-55/-14/-65 in Escherichia coli from chickens in China

    Directory of Open Access Journals (Sweden)

    Xiaoyun eYang

    2014-12-01

    Full Text Available The purpose of this study was to examine the occurrence of fosfomycin-resistant Escherichia coli from chickens and to characterize the plasmids carrying fosA3. A total of 661 E. coli isolates of chicken origin collected from 2009 to 2011 were screened for plasmid-mediated fosfomycin resistance determinants by PCR. Plasmids were characterized using PCR-based replicon typing, plasmid multilocus sequence typing, and restriction fragment length polymorphisms. Associated addiction systems and resistance genes were identified by PCR. PCR-mapping was used for analysis of the genetic context of fosA3. Fosfomycin resistance was detected in 58 isolates that also carried the fosA3 gene. Fifty-seven, 17, and 52 FosA3-producers also harbored blaCTX-M, rmtB, and floR genes, respectively. Most of the 58 fosA3-carrying isolates were clonally unrelated, and all fosA3 genes were located on plasmids belonged to F33:A-:B- (n=18, IncN-F33:A-:B- (n=7, IncHI2/ST3 (n=10, IncI1/ST71 (n=3, IncI1/ST108 (n=3, and others. The genetic structures, IS26-ISEcp1-blaCTX-M-55-orf477-blaTEM-1-IS26-fosA3-1758bp-IS26 and ISEcp1-blaCTX-M-65- IS903-iroN-IS26-fosA3-536bp-IS26 were located on highly similar F33:A-:B- plasmids. In addition, blaCTX-M-14-fosA3-IS26 was frequently present on similar IncHI2/ST3 plasmids. IncFII plasmids had a significantly higher frequency of addiction systems (mean 3.5 than other plasmids. Our results showed a surprisingly high prevalence of fosA3 gene in E. coli isolates recovered from chicken in China. The spread of fosA3 can be attributed to horizontal dissemination of several epidemic plasmids, especially F33:A-:B- plasmids. Since coselection by other antimicrobials is the major driving force for the diffusion of the fosA3 gene, a strict antibiotic use policy is urgently needed in China.

  19. Multiemployer Pension Plans

    Data.gov (United States)

    Pension Benefit Guaranty Corporation — This spreadsheet lists the active multiemployer pensions plans insured by PBGC. Plans are identified by name, employer identification number (EIN) and plan number...

  20. Detection of staphylococcal cassette chromosome mec type XI carrying highly divergent mecA, mecI, mecR1, blaZ, and ccr genes in human clinical isolates of clonal complex 130 methicillin-resistant Staphylococcus aureus.

    LENUS (Irish Health Repository)

    Shore, Anna C

    2011-08-01

    Methicillin resistance in staphylococci is mediated by penicillin binding protein 2a (PBP 2a), encoded by mecA on mobile staphylococcal cassette chromosome mec (SCCmec) elements. In this study, two clonal complex 130 (CC130) methicillin-resistant Staphylococcus aureus (MRSA) isolates from patients in Irish hospitals were identified that were phenotypically PBP 2a positive but lacked mecA by conventional PCR and by DNA microarray screening. The isolates were identified as methicillin-susceptible S. aureus using the GeneXpert real-time PCR assay. Whole-genome sequencing of one isolate (M10\\/0061) revealed a 30-kb SCCmec element encoding a class E mec complex with highly divergent blaZ-mecA-mecR1-mecI, a type 8 cassette chromosome recombinase (ccr) complex consisting of ccrA1-ccrB3, an arsenic resistance operon, and flanking direct repeats (DRs). The SCCmec element was almost identical to that of SCCmec type XI (SCCmec XI) identified by the Sanger Institute in sequence type 425 bovine MRSA strain LGA251 listed on the website of the International Working Group on the Classification of Staphylococcal Cassette Chromosome Elements. The open reading frames (ORFs) identified within SCCmec XI of M10\\/0061 exhibited 21 to 93% amino acid identity to ORFs in GenBank. A third DR was identified ca. 3 kb downstream of SCCmec XI, indicating the presence of a possible SCC remnant. SCCmec XI was also identified in the second CC130 MRSA isolate by PCR and sequencing. The CC130 MRSA isolates may be of animal origin as previously reported CC130 S. aureus strains were predominantly from bovine sources. The highly divergent nature of SCCmec XI relative to other SCCmec elements indicates that it may have originated in another taxon.

  1. Planning your pregnancy

    Science.gov (United States)

    ... Pregnancy > Before or between pregnancies > Planning your pregnancy Planning your pregnancy E-mail to a friend Please ... partner as you start your family. Why is planning your pregnancy important? Planning your pregnancy can help ...

  2. Crime prevention by urban planning and building

    DEFF Research Database (Denmark)

    Grønlund, Bo; Soomeren, Paul van

    2001-01-01

    Forslag til europæisk normtekst færdiggjort i marts/april 2002. Om kriminalpræventiv by- og bebyggelsesplanlægning. Indfaldsvikler, procesforløb, og gode råd for en række forskellige områdetyper, bl.a. bycentre, boligområder, parker....

  3. Community development planning

    International Nuclear Information System (INIS)

    The focus of this paper will be methods of local community involvement in the community development planning efforts which will be required at the recommended sites. Community development planning will include capital improvement plans, housing plans, zoning changes, business development plans and other community service and fiscal plans required to meet the projected needs of new residents as a result of the repository construction and operation. This paper will present, (1) the need for community planning, (2) methods of responding to community planning needs, (3) current community planning issues to be addressed. 2 references, 1 figure

  4. Hanford Site Development Plan

    Energy Technology Data Exchange (ETDEWEB)

    Rinne, C.A.; Curry, R.H.; Hagan, J.W.; Seiler, S.W.; Sommer, D.J. (Westinghouse Hanford Co., Richland, WA (USA)); Yancey, E.F. (Pacific Northwest Lab., Richland, WA (USA))

    1990-01-01

    The Hanford Site Development Plan (Site Development Plan) is intended to guide the short- and long-range development and use of the Hanford Site. All acquisition, development, and permanent facility use at the Hanford Site will conform to the approved plan. The Site Development Plan also serves as the base document for all subsequent studies that involve use of facilities at the Site. This revision is an update of a previous plan. The executive summary presents the highlights of the five major topics covered in the Site Development Plan: general site information, existing conditions, planning analysis, Master Plan, and Five-Year Plan. 56 refs., 67 figs., 31 tabs.

  5. Hanford Site Development Plan

    International Nuclear Information System (INIS)

    The Hanford Site Development Plan (Site Development Plan) is intended to guide the short- and long-range development and use of the Hanford Site. All acquisition, development, and permanent facility use at the Hanford Site will conform to the approved plan. The Site Development Plan also serves as the base document for all subsequent studies that involve use of facilities at the Site. This revision is an update of a previous plan. The executive summary presents the highlights of the five major topics covered in the Site Development Plan: general site information, existing conditions, planning analysis, Master Plan, and Five-Year Plan. 56 refs., 67 figs., 31 tabs

  6. Comparison of CT based-CTV plan and CT based-ICRU38 plan in brachytherapy planning of uterine cervix cancer

    Energy Technology Data Exchange (ETDEWEB)

    Cho, Jung Keun; Han, Tae Jong [Jeonju Univ., Jeonju (Korea, Republic of)

    2007-09-15

    and 107.6{+-}47.9%, 86.9{+-}30.8% in CTV plan, respectively. Therefore, the radiation dose to normal organ was lower in CTV plan than in ICRU plan. But the normal tissue dose was remarkably higher than a recommended dose in CTV plan in one patient whose residual tumor size was greater than 4cm. The volume of rectum receiving more than 80% isodose (V80rec) was 1.8{+-}2.4cm{sup 3} in ICRU plan and 0.7{+-}1.0cm{sup 3} in CTV plan(p=0.02). The volume of bladder receiving more than 80% isodose(V80bla) was 12.2{+-}8.9cm{sup 3} in ICRU plan and 3.5{+-}4.1cm{sup 3} in CTV plan(p=0.005). According to these parameters, CTV plan couls also save more normal tissue compared to ICRU38 plan. Conclusion : An unnecessary excessive radiation dose is irradiated to normal tissues within 100% isodose area in the traditional ICRU plan in case of a small size of cervix cancer, but if we use CTV plan based on CT image, the normal tissue dose could be reduced remarkably without a compromise of tumor dose. However, in a large tumor case, we need more research on an effective 3D-planing to reduce the normal tissue dose.

  7. 1991 Water Management Plan

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — The Bear River Migratory Bird Refuge Water Management Plan has been developed to meet the station objectives set forth in the Master Plan. The purpose of this plan...

  8. Maintenance Business Plans.

    Science.gov (United States)

    Adams, Matt

    2002-01-01

    Discusses maintenance business plans, statements which provide accountability for facilities maintenance organizations' considerable budgets. Discusses the plan's components: statement of plan objectives, macro and detailed description of the facility assets, maintenance function descriptions, description of key performance indicators, milestone…

  9. Calfornia General Plans

    Data.gov (United States)

    California Department of Resources — We undertook creating the first ever seamless statewide General Plan map for California. All county general plans and many city general plans were integrated into 1...

  10. Calfornia General Plans Rural

    Data.gov (United States)

    California Department of Resources — We undertook creating the first ever seamless statewide General Plan map for California. All county general plans and many city general plans were integrated into 1...

  11. The ground based plan

    International Nuclear Information System (INIS)

    The paper presents a report of ''The Ground Based Plan'' of the United Kingdom Science and Engineering Research Council. The ground based plan is a plan for research in astronomy and planetary science by ground based techniques. The contents of the report contains a description of:- the scientific objectives and technical requirements (the basis for the Plan), the present organisation and funding for the ground based programme, the Plan, the main scientific features and the further objectives of the Plan. (U.K.)

  12. Planning to Plan-Integrating Control Flow

    Institute of Scientific and Technical Information of China (English)

    2003-01-01

    In many planning situations, computation itself becomes a resource to be planned and scheduled. We model such computational resources as conventional resources which are used by control-flow actions, e.g., to direct the planning process. Control-flow actions and conventional actions are planned/scheduled in an integrated way and can interact with each other. Control-flow actions are then executed by the planning engine itself. The approach is illustrated by examples, e.g., for hierarchical planning, in which tasks that are temporally still far away impose only rough constraints on the current schedule, and control-flow tasks ensure that these tasks are refined as they approach the current time. Using the same mechanism, anytime algorithms can change appropriate search methods or parameters over time, and problems like scheduling critical time-outs for garbage collection can be made part of the planning itself.

  13. America's Planning Legacy.

    Science.gov (United States)

    Silver, Christopher

    1985-01-01

    Describes the role of the government in and the direction of social planning in the United States from the late 19th century through the 1980s. Topics discussed include planning style; the balance between planning methodology and social objectives; and the incremental nature of planning in the United States. (CLB)

  14. Conditional Epistemic Planning

    DEFF Research Database (Denmark)

    Andersen, Mikkel Birkegaard; Bolander, Thomas; Jensen, Martin Holm

    2012-01-01

    Recent work has shown that Dynamic Epistemic Logic (DEL) offers a solid foundation for automated planning under partial observability and non-determinism. Under such circumstances, a plan must branch if it is to guarantee achieving the goal under all contingencies (strong planning). Without...... branching, plans can offer only the possibility of achieving the goal (weak planning). We show how to formulate planning in uncertain domains using DEL and give a language of conditional plans. Translating this language to standard DEL gives verification of both strong and weak plans via model checking. In...... addition to plan verification, we provide a tableau-inspired algorithm for synthesising plans, and show this algorithm to be terminating, sound and complete....

  15. Marketing Planning: Feeniks Koulu

    OpenAIRE

    Raut, Biranjan

    2013-01-01

    Degree Thesis “Marketing Planning: Feeniks Koulu” demonstrates structured marketing planning process with the help of case company “Feeniks Koulu”. The central idea of Thesis is to come up with systematic marketing plan following structured process. Thesis employs qualitative research methodology following inductive reasoning approach. Thesis, initiates by outlining theoretical planning methods, which then is materialized into marketing plan with the help of empirical research. Discussion and...

  16. K publicistice poúnorového sociálnědemokratického exilu (1948-1953). Perspektiva Blažeje Vilíma a Bohumila Laušmana

    Czech Academy of Sciences Publication Activity Database

    Horák, Pavel

    2011-01-01

    Roč. 180, 1/2 (2011), s. 32-53. ISSN 1214-0627 Institutional research plan: CEZ:AV0Z70900502 Keywords : Czechoslovakia, 1948-1953 * Czechoslovak exile * Czechoslovak social democracy Subject RIV: AB - History

  17. Changed planning for planned and unplanned change

    NARCIS (Netherlands)

    Woerkum, van C.; Aarts, N.; Herzele, Van A.

    2011-01-01

    Change, planned and unplanned, can be the product of events (change by chance), new language (change from societal interaction), and practices (track-bound change), and can involve many different societal actors. To position planning as an activity within this broader context, we present a model tha

  18. Planned hospital birth versus planned home birth

    DEFF Research Database (Denmark)

    Olsen, O.; Clausen, J.A.

    2012-01-01

    Observational studies of increasingly better quality and in different settings suggest that planned home birth in many places can be as safe as planned hospital birth and with less intervention and fewer complications. This is an update of a Cochrane review first published in 1998....

  19. Radioactive waste management plan. Plan 82

    International Nuclear Information System (INIS)

    The report is the first account of the nuclear power utilities of Sweden about the plans for the final disposal of the radioactive waste products of the nuclear power. Part 1 describes the general background, the plans for research and development, including the necessary facilities. The time schedule and the calculated costs of the operations are presented. (G.B.)

  20. Planning for information systems

    CERN Document Server

    King, William R

    2015-01-01

    Edited by one of the best-known and most widely respected figures in the field, ""Planning for Information Systems"" is a comprehensive, single source overview of the myriad ideas and processes that are identified with IS planning. While many chapters deal with high level strategic planning, the book gives equal attention to on-the-ground planning issues.Part I, 'Key Concepts of IS Planning', focuses on how IS planning has evolved over the years; business-IS strategic alignment; and the role of dynamic organizational capabilities in leveraging IS competencies. Part II, 'The Organizational IS P

  1. Habitat monitoring plan

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — Management of habitat is required in order to achieve the refuge purpose and wildlife objectives. The Upland Habitat Management Plan (1993, Interim Plan) and the...

  2. Familiy Planning and Pregnancy

    Science.gov (United States)

    ... Storage Pool Deficiencies Home About Bleeding Disorders Family planning and pregnancy Carriers should receive genetic counselling about ... Diagnosis When to Test for Carrier Status Family Planning and Pregnancy Conception Options Prenatal Diagnosis Fetal Sex ...

  3. 1999 Water Management Plan

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — The Clarence Cannon National Wildlife Refuge Water Management Plan has been developed to meet the station objectives. The purpose of this plan is to establish a...

  4. Prescriptions and Insurance Plans

    Science.gov (United States)

    MENU Return to Web version Prescriptions and Insurance Plans Prescriptions and Insurance Plans Getting a prescription filled is usually easy. But because of the high cost of prescription medicines, most insurance ...

  5. Understanding health insurance plans

    Science.gov (United States)

    ... medlineplus.gov/ency/patientinstructions/000879.htm Understanding health insurance plans To use the sharing features on this ... for you and your family. Types of Health Insurance Plans Depending on how you get your health ...

  6. COMET communication plan

    OpenAIRE

    Real, A; Howard, B. J.; Robles, B.; Mora, J. C.; Beresford, N.A.; C. L. Barnett

    2013-01-01

    The Communication Plan for COMET is described. The goals of the Plan are to identify COMET’s various stakeholders and to develop a matrix of communication needs, delivery schedules and metrics of success.

  7. Plans Quality Compare

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Plans Quality Data is a publicly available CMS database that contains information on the quality and performance of health plans that offer Medicare Part C and...

  8. NSP Action Plans

    Data.gov (United States)

    Department of Housing and Urban Development — NSP Action Plans, also known as Substantial Amendments, contain a description of a grantee’s intended use for NSP funds. The plans contain information on the...

  9. Human Resource Planning

    Science.gov (United States)

    Hoffman, W. H.; Wyatt, L. L.

    1977-01-01

    By using the total resource approach, we have focused attention on the need to integrate human resource planning with other business plans and highlighted the importance of a productivity strategy. (Author)

  10. Dahomey Plantation Management Plan

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — Plan describing timber, wildlife and recreational assessments and assoicated development costs of the Dahomey Plantion timberlands. Plan details existinig forest...

  11. BOEM Wind Planning Areas

    Data.gov (United States)

    Bureau of Ocean Energy Management, Department of the Interior — This data set represents the most recent changes for the Wind Development Planning Areas in the Atlantic. Wind Planning Areas in this dataset represent up to six...

  12. Technology Implementation Plan

    DEFF Research Database (Denmark)

    Jensen, Karsten Ingerslev; Schultz, Jørgen Munthe

    The Technology Implementation Plan (TIP) describes the main project results and the intended future use. The TIP is confidential.......The Technology Implementation Plan (TIP) describes the main project results and the intended future use. The TIP is confidential....

  13. TECHNOLOGICAL IMPLEMENTATION PLAN

    DEFF Research Database (Denmark)

    Bellini, Anna

    2004-01-01

    This document has the purpose to describe the technological implementation plan in the IDEAL project.......This document has the purpose to describe the technological implementation plan in the IDEAL project....

  14. Pursuing happiness in planning?

    DEFF Research Database (Denmark)

    Lorentzen, Anne Birte

    2015-01-01

    Experience economic planning. Towards an urban staging system? Vancouver's journey form regional ressource periphery to global metropolis. The chaning cityscape of Vancouver. Values guiding urban planning in Vancouver. Governance of urban transformation in Vancouver. Planners as stagers in Vancou...

  15. Systematisation of Corporate Planning

    OpenAIRE

    Mihaylova, Lyudmila

    2011-01-01

    The systematization of corporate planning is a subject that provokes the research interest due to the increased importance of strategic and long-term planning for the corporate development. This article analyzes some problem areas related to the differences between the essence and the procedures of long-term and strategic company planning. The aim is to highlight some views of strategic and long-term planning in companies and the distinguishing features between these categories, draw the atte...

  16. Economic Planning in China

    OpenAIRE

    Gregory C. Chow

    2011-01-01

    This paper provides an up-to-date study of economic planning in China as it affects the economic development, growth and fluctuations of the Chinese economy. Although economic planning has been practiced in China since 1953 when the first Five-Year Plan began, its nature has changed after economic reform started in 1978. Market reform reduced the importance of central planning, but more recently the global economic recession and China’s active macro-economic policy interventions have increase...

  17. Planning Practice Guidance

    OpenAIRE

    Public Health England

    2014-01-01

    The Department for Communities and Local Government has published National Planning Practice Guidance which recognises the importance of local infrastructure planning in the development of healthy communities. The guidance supports the National Planning Policy Framework and now includes a section on health and wellbeing. This guidance sets out the government’s planning policies for England and how these are expected to be applied by local authorities. A significant development in the...

  18. Strategic planning and republicanism

    OpenAIRE

    Mazza Luigi

    2010-01-01

    The paper develops two main linked themes: (i) strategic planning reveals in practice limits that are hard to overcome; (ii) a complete planning system is efficacy only in the framework of a republican political, social and government culture. It is argued that the growing disappointment associated to strategic planning practices, may be due to excessive expectations, and the difficulties encountered by strategic planning are traced to three main issues: (a) the relationship between politics ...

  19. Language Planning and Planned Languages: How Can Planned Languages Inform Language Planning?

    OpenAIRE

    Humphrey Tonkin

    2015-01-01

    The field of language planning (LP) has largely ignored planned languages. Of classic descriptions of LP processes, only Tauli (preceded by Wüster) suggests that planned languages (what Wüster calls Plansprache) might bear on LP theory and practice. If LP aims "to modify the linguistic behaviour of some community for some reason," as Kaplan and Baldauf put it, creating a language de novo is little different. Language policy and planning are increasingly seen as more local and less official, a...

  20. Business plan (tennis school)

    OpenAIRE

    Sirghi, Evgeniya

    2011-01-01

    The main task of this work is to develop a comprehensive business plan for startup sports business that will offer training services. In my final Diploma study I am working on the creation of business plans for the company with a few years vision, I am developing a strategy which takes into account precise construction of finance planning, market penetration and number of employees. The business plan will analyze the current market situation, competition and the probability of company develop...

  1. Business Plan SMEs

    OpenAIRE

    Oppolzerová, Eva

    2009-01-01

    The study presents a business plan for a firm which offers fishing services. The study consist of a theoretical part and a practical part. In the theoretical section the small and medium enterprises are specified, especially the family business and there are characteristics of the form, structure and terms of the business plan. The practical section focuses on elaboration of the business plan for the particular firm. It includes description of all activities, market analysis, financial plan, ...

  2. Disaster Management Plans

    OpenAIRE

    Ikeda, Makoto

    2012-01-01

    Following its devastating experience with recent disasters, Japan has been strengthening or drawing up new disaster management plans at the national and local levels. The Great East Japan Earthquake (GEJE) revealed a number of weaknesses in planning for complex and extraordinary disasters. Central and local governments have been revising their plans to reflect what they learned from the GE...

  3. Understanding health insurance plans

    Science.gov (United States)

    Most insurance companies offer different types of health plans. And when you are comparing plans, it can sometimes seem ... Depending on how you get your health insurance, you may have a ... (HMOs). These plans offer a network of health care providers ...

  4. National Planning Commission Arrangements

    OpenAIRE

    Watkins, Joanna

    2009-01-01

    Based on a review of relevant World Bank materials and outside sources, this note focuses on two questions of critical importance in discussions surrounding the establishment of a planning commission. These are: 1) what planning commission arrangements seem to be effective? 2) What should the role of a planning commission be in a quasi-federal system? It should be recognized that a plannin...

  5. Introduction to planning law

    International Nuclear Information System (INIS)

    The author surveys the planning law in the Federal Republic of Germany. He deals with general regulations of the administrative procedure and land-use planning procedure and the main special rules of planning law, according to the Atomic Energy Act, the Nuclear Installation Ordinance and the Federal Act on the Protection against Nuisances. (WG)

  6. Landmarks in Hybrid Planning

    Directory of Open Access Journals (Sweden)

    Mohamed Elkawkagy

    2013-11-01

    Full Text Available Although planning techniques achieved a significant progress during recent years, solving many planning problem still difficult even for modern planners. In this paper, we will adopt landmark concept to hybrid planning setting - a method that combines reasoning about procedural knowledge and causalities. Land-marks are a well-known concept in the realm of classical planning. Recently, they have been adapted to hierarchical approaches. Such landmarks can be extracted in a pre-processing step from a declarative hierarchical planning domain and problem description. It was shown how this technique allows for a considerable reduction of the search space by eliminating futile plan development options before the actual planning. Therefore, we will present a new approach to in¬tegrate landmark pre-processing technique in the context of hierarchical planning with landmark technique in the classical planning. This integration allows to incorporate the ability of using extracted landmark tasks from hierarchical domain knowledge in the form of HTN and using landmark literals from classical planning. To this end, we will construct a transformation technique to transform the hybrid planning domain into a classical domain model. The method¬ologies in this paper have been implemented successfully, and we will present some experimental results that give evidence for the consid-erable performance increase gained through planning system.

  7. National Planning for Education.

    Science.gov (United States)

    Moon, Rexford G., Jr.

    This report presents the findings of a study on the current status of planning in American higher education and the feasibility of establishing a "national planning congress" for higher education. The study team gathered the views of key people concerned with higher education planning through extensive interviews and seminars throughout the…

  8. The Project of Planning

    DEFF Research Database (Denmark)

    Flyvbjerg, Bent

    1986-01-01

    This article contains an interview with John Friedmann. The interview covers two core areas in John Friedmann's work: (a) The history of planning, from the beginning of the industrial era till today and (b) radical planning and social mobilization. In relation to radical planning and social mobil...

  9. Disaster: Planning, Preparation, Prevention.

    Science.gov (United States)

    Rutherford, Christine

    1990-01-01

    Discusses causes of library disasters and provides several examples of disasters. Emphasis is on the importance of awareness, insurance protection, a written disaster plan, cooperation with the fire marshall and insurance agent in planning, and staff training. Several elements of the written plan are listed. (22 references) (MES)

  10. Sandia Strategic Plan 1997

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-12-01

    Sandia embarked on its first exercise in corporate strategic planning during the winter of 1989. The results of that effort were disseminated with the publication of Strategic Plan 1990. Four years later Sandia conducted their second major planning effort and published Strategic Plan 1994. Sandia`s 1994 planning effort linked very clearly to the Department of Energy`s first strategic plan, Fueling a Competitive Economy. It benefited as well from the leadership of Lockheed Martin Corporation, the management and operating contractor. Lockheed Martin`s corporate success is founded on visionary strategic planning and annual operational planning driven by customer requirements and technology opportunities. In 1996 Sandia conducted another major planning effort that resulted in the development of eight long-term Strategic Objectives. Strategic Plan 1997 differs from its predecessors in that the robust elements of previous efforts have been integrated into one comprehensive body. The changes implemented so far have helped establish a living strategic plan with a stronger business focus and with clear deployment throughout Sandia. The concept of a personal line of sight for all employees to this strategic plan and its objectives, goals, and annual milestones is becoming a reality.

  11. Argumentation driven planning

    OpenAIRE

    Simari, Guillermo Ricardo; García, Alejandro Javier

    2001-01-01

    The research line reported here involves developing an argumentation-based formalism that an agent could use in constructing plans. The argumentation formalism will be combined with well known planning tecniques producing a novel way of constructing a plan. Below, we wil sketch the formalism and introduce some clarifying examples.

  12. Climate plan 2004; Plan climat 2004

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2004-07-01

    The Climate Plan is an action plan drawn up by the French Government to respond to the climate change challenge, first by 2010 (complying with the Kyoto Protocol target), and, secondly, beyond this date. Projections for France show that national emissions could be 10% higher than the Kyoto target in 2010 if no measures are taken. This is particularly due to increasing emissions in the sectors affecting daily life (residential-tertiary sectors, transport, etc.). For this reason, the Climate Plan contains measures affecting all sectors of the economy and the daily life of all French citizens with a view to economizing the equivalent of 54 million tonnes of CO{sub 2} each year by the year 2010, which will help to reverse the trend significantly. Beyond 2010, the Climate Plan sets out a strategy for technological research which will enable France to meet a target of reducing greenhouse gas emissions four or fivefold by 2050. (author)

  13. Tax Planning for Enterprises

    Institute of Scientific and Technical Information of China (English)

    Fan Weiqing

    2011-01-01

    @@ Tax planning is legal planning activities for tax savings, meaning tax payers make operation plans within the national policy framework and choose operation programs favorable to tax savings.Along with a maturing socialist market economy system in China, tax planning is becoming an integral part of enterprise management and operation.For a better tax planning, enterprises have to fully understand the meaning, get proficient at relevant strategies, and apply these methods to save taxes and realize the maximization of enterprise value while considering the actual situation.

  14. Systems Engineering Management Plan

    International Nuclear Information System (INIS)

    The purpose of this Monitored Retrievable Storage (MRS) Project Systems Engineering Management Plan (SEMP) is to define and establish the MRS Project Systems Engineering process that implements the approved policy and requirements of the Office of Civilian Radioactive Waste Management (OCRWM) for the US Department of Energy (DOE). This plan is Volume 5 of the MRS Project Management Plan (PMP). This plan provides the framework for implementation of systems engineering on the MRS Project consistent with DOE Order 4700.1, the OCRWM Program Management System Manual (PMSM), and the OCRWM Systems Engineering Management Plan (SEMP)

  15. Business plans made easy

    CERN Document Server

    Press, Entrepreneur

    2005-01-01

    Business Plans Made Easy, 3rd Edition is the latest incarnation of the essential guide for creating a high-impact business plan that will turn an entrepreneur's dreams into reality. Revised and updated, the book expands the helpful business plan summaries and adds new examples of real-life business plans. Tips about information technology and an added business plan for artists increase the scope of the book. The useful forms, worksheets and financial statements have been updated to reflect recent changes in the business world, and an added "expert advice" section at the end of each chapter giv

  16. Inspection and test planning

    International Nuclear Information System (INIS)

    Purpose of Quality Plan - arrangement of all necessary tests or inspections as far as possible filted to certain components or systems. Subject of Quality Plan - precise determination of tests or inspections and - according to the actual safety significance - the certificates to be done. Disposition of Quality Plan - accommodation of tests to the actual state of fabrication. Application of Quality Plan - to any component or system that is regarded. Supervision of Employment - by authorized personnel of manufacturer, customer or authority providing exact employment of quality plan. Overservance of Instructions - certificates given by authorized personnel. (orig./RW)

  17. Operating plan FY 1998

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-10-01

    This document is the first edition of Argonne`s new Operating Plan. The Operating Plan complements the strategic planning in the Laboratory`s Institutional Plan by focusing on activities that are being pursued in the immediate fiscal year, FY 1998. It reflects planning that has been done to date, and it will serve in the future as a resource and a benchmark for understanding the Laboratory`s performance. The heart of the Institutional Plan is the set of major research initiatives that the Laboratory is proposing to implement in future years. In contrast, this Operating Plan focuses on Argonne`s ongoing R&D programs, along with cost-saving measures and other improvements being implemented in Laboratory support operations.

  18. On strategic spatial planning

    Directory of Open Access Journals (Sweden)

    Tošić Branka

    2014-01-01

    Full Text Available The goal of this paper is to explain the origin and development of strategic spatial planning, to show complex features and highlight the differences and/or advantages over traditional, physical spatial planning. Strategic spatial planning is seen as one of approaches in legally defined planning documents, and throughout the display of properties of sectoral national strategies, as well as issues of strategic planning at the local level in Serbia. The strategic approach is clearly recognized at the national and sub-national level of spatial planning in European countries and in our country. It has been confirmed by the goals outlined in documents of the European Union and Serbia that promote the grounds of territorial cohesion and strategic integrated planning, emphasizing cooperation and the principles of sustainable spatial development. [Projekat Ministarstva nauke Republike Srbije, br. 176017

  19. Epistemic and Doxastic Planning

    DEFF Research Database (Denmark)

    Jensen, Martin Holm

    mathematics and computer science. Planning is the mental capacity that allow us to predict the outcome of our actions, thereby enabling us to exhibit goal-directed behaviour. We often make use of planning when facing new situations, where we cannot rely on entrenched habits, and the capacity to plan is......, beliefs and dynamics, that is, systems that allow us to formally reason about these aspects. By letting these elements be used in a planning context, we obtain a system that extends the degree to which goaldirected behaviour can, at present, be captured by automated planning. In this thesis we concretely...... already incorporated in automated planning, and seen in isolation this result appears mainly as an alternative to existing theory. Our second result underscores the strengths of the first. Here we show how the kinship between the aforementioned logics enable us to extend automated planning with doxastic...

  20. PlanJury: probabilistic plan evaluation revisited

    International Nuclear Information System (INIS)

    Purpose: Over a decade ago, the 'Van Herk margin recipe paper' introduced plan evaluation through DVH statistics based on population distributions of systematic and random errors. We extended this work for structures with correlated uncertainties (e.g. lymph nodes or parotid glands), and considered treatment plans containing multiple (overlapping) dose distributions (e.g. conventional lymph node and hypo-fractionated tumor doses) for which different image guidance protocols may lead to correlated errors. Methods: A command-line software tool 'PlanJury' was developed which reads 3D dose and structure data exported from a treatment planning system. Uncertainties are specified by standard deviations and correlation coefficients. Parameters control the DVH statistics to be computed: e.g. the probability of reaching a DVH constraint, or the dose absorbed at given confidence in a (combined) volume. Code was written in C++ and parallelized using OpenMP. Testing geometries were constructed using idealized spherical volumes and dose distributions. Results: Negligible stochastic noise could be attained within two minutes computation time for a single target. The confidence to properly cover both of two targets was 90% for two synchronously moving targets, but decreased by 7% if the targets moved independently. For two partially covered organs at risk the confidence of at least one organ below the mean dose threshold was 40% for synchronous motion, 36% for uncorrelated motion, but only 20% for either of the organs separately. Two abutting dose distributions ensuring 91% confidence of proper target dose for correlated motions led to 28% lower confidence for uncorrelated motions as relative displacements between the doses resulted in cold spots near the target. Conclusions: Probabilistic plan evaluation can efficiently be performed for complicated treatment planning situations, thus providing important plan quality information unavailable in conventional PTV

  1. PlanJury: probabilistic plan evaluation revisited

    Science.gov (United States)

    Witte, M.; Sonke, J.-J.; van Herk, M.

    2014-03-01

    Purpose: Over a decade ago, the 'Van Herk margin recipe paper' introduced plan evaluation through DVH statistics based on population distributions of systematic and random errors. We extended this work for structures with correlated uncertainties (e.g. lymph nodes or parotid glands), and considered treatment plans containing multiple (overlapping) dose distributions (e.g. conventional lymph node and hypo-fractionated tumor doses) for which different image guidance protocols may lead to correlated errors. Methods: A command-line software tool 'PlanJury' was developed which reads 3D dose and structure data exported from a treatment planning system. Uncertainties are specified by standard deviations and correlation coefficients. Parameters control the DVH statistics to be computed: e.g. the probability of reaching a DVH constraint, or the dose absorbed at given confidence in a (combined) volume. Code was written in C++ and parallelized using OpenMP. Testing geometries were constructed using idealized spherical volumes and dose distributions. Results: Negligible stochastic noise could be attained within two minutes computation time for a single target. The confidence to properly cover both of two targets was 90% for two synchronously moving targets, but decreased by 7% if the targets moved independently. For two partially covered organs at risk the confidence of at least one organ below the mean dose threshold was 40% for synchronous motion, 36% for uncorrelated motion, but only 20% for either of the organs separately. Two abutting dose distributions ensuring 91% confidence of proper target dose for correlated motions led to 28% lower confidence for uncorrelated motions as relative displacements between the doses resulted in cold spots near the target. Conclusions: Probabilistic plan evaluation can efficiently be performed for complicated treatment planning situations, thus providing important plan quality information unavailable in conventional PTV based evaluations.

  2. 30 CFR 784.23 - Operation plan: Maps and plans.

    Science.gov (United States)

    2010-07-01

    ... caused by the proposed operations, if the facility or feature was shown under 30 CFR 783.24 and 783.25... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Operation plan: Maps and plans. 784.23 Section... PLAN § 784.23 Operation plan: Maps and plans. Each application shall contain maps and plans as...

  3. 30 CFR 780.14 - Operation plan: Maps and plans.

    Science.gov (United States)

    2010-07-01

    ... shown under 30 CFR 779.24 through 779.25. (b) The following shall be shown for the proposed permit area... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Operation plan: Maps and plans. 780.14 Section... PLAN § 780.14 Operation plan: Maps and plans. Each application shall contain maps and plans as...

  4. Mission planning for autonomous systems

    Science.gov (United States)

    Pearson, G.

    1987-01-01

    Planning is a necessary task for intelligent, adaptive systems operating independently of human controllers. A mission planning system that performs task planning by decomposing a high-level mission objective into subtasks and synthesizing a plan for those tasks at varying levels of abstraction is discussed. Researchers use a blackboard architecture to partition the search space and direct the focus of attention of the planner. Using advanced planning techniques, they can control plan synthesis for the complex planning tasks involved in mission planning.

  5. Utility planning for decommissioning

    International Nuclear Information System (INIS)

    Though the biggest impact on a utility of nuclear power plant decommissioning may occur many years from now, procrastination of efforts to be prepared for that time is unwarranted. Foresight put into action through planning can significantly affect that impact. Financial planning can assure the recovery of decommissioning costs in a manner equitable to customers. Decision-making planning can minimize adverse affects of current decisions on later decommissioning impacts and prepare a utility to be equipped to make later decommissioning decisions. Technological knowledge base planning can support all other planning aspects for decommissioning and prepare a utility for decommissioning decisions. Informed project planning can ward off potentially significant pitfalls during decommissioning and optimize the effectiveness of the actual decommissioning efforts

  6. Planning Public Transport

    DEFF Research Database (Denmark)

    Andersen, Jonas Lohmann Elkjær; Landex, Alex

    2009-01-01

    This good practice guide is composed for the master course 13120 Public Transport Planning held at the Department of Transport, Technical University of Denmark. It is intended to use as guide in the different planning aspects and assignments of the course. Since the course is about the planning...... of new public transport infrastructure this guide also focuses on the planning of new infrastructure. Furthermore, the new infrastructure in the course is expected to be a light rail and even though this guide aims at being general for public transport some of the issues evidently become more relevant...... will enable a capability for planning both bus and rail. The guide is build as a full sketch investigation of a new public transport project ranging chronological from project clarification to physical and timetable planning to traffic modeling and project appraisal. The same steps that are expected...

  7. Interactive Energy Planning

    DEFF Research Database (Denmark)

    Blarke, Morten Boje

    2006-01-01

    anchoring along the shores of the land of communications and collaboration. Whether or not a particular typology is applicable, theory and praxis are establishing standpoints, which strengthens our understanding of the planning complex, and which should inspire improved energy planning methodologies and......Though it is being questioned whether planning theory should be fitted into neat typologies, some have described evolving planning theory as a journey away from ethnocentrism, through the lands of rationalism, pragmatism, socio-ecological idealism, political-economic mobilization, currently...... tools. This paper presents an “Interactive Energy Planning” framework, which is intended to support interactivity in planning, building on important theoretical and experimental advances in planning. In particular, the paper explores the potential significance of allowing a critical perspective on...

  8. Planning Practice and Research

    DEFF Research Database (Denmark)

    2013-01-01

    practice co- evolve in adapting to the ever-increasing transformation of cities and urban regions? In this context, Planning Practice and Research (PPR) is seeking perspectives from the young academic community in planning. We propose to publish at least one special edition of PPR with a number of short......Urban planning has dramatically shifted when compared with its former logics and styles. Increasingly, the dynamics of large urban agglomerations spanning multiple boundaries put significant pressure on planning institutions to scale up. In this shifting context, how can both planning theory and...... papers from Young Academics. The contributions should address the question of how planning theory and practice can respond to the increasing complexity of cities and regions....

  9. Business plan competition

    CERN Document Server

    2007-01-01

    "Venture – Companies for tomorrow" is a business plan competition, which supports students and other junior entrepreneurs in developing their business plans. The sixth edition of the competition is now taking place. Venture 2008 highlights: - prize money totalling CHF 150’000; - possibility to optimize business ideas and business plans with the help of experienced coaches: around 200 coaches are available, with a wide range of backgrounds, entrepreneurs as well as venture capitalists; -\tpossibility to present business ideas and business plans to potential investors ("Investor Days" - 17 January and 7 May); - active involvement in the start-up community; -\tcontribution to potential independence. The competition consists of two phases: Phase I, Business idea, Deadline for submission of business idea: 5 December 2007 (online at http://www.venture.ch). Award Ceremony: 17 January 2008 Phase II, Business plan Deadline for submission of business plan: 2 April 2008 (online at...

  10. Aggregation in manpower planning

    OpenAIRE

    Wijngaard, J

    1983-01-01

    In manpower planning, as in all other kinds of planning, an important choice is the level of aggregation. The proper level of aggregation depends on the flexibility (mobility) of the personnel. This dependency is investigated in this paper. The manpower system considered is characterized by two dimensions, level and function group. Conditions are derived for aggregate long-term planning (aggregation over function group) combined with one-period disaggregation being optimal.

  11. Travinfo Evaluation Plan

    OpenAIRE

    Yim, Youngbin; Khattak, Asad; Miller, Mark; Hall, Randolph

    1993-01-01

    This document presents an evaluation plan for the TravInfo project, a field operational test of a centralized database in the San Francisco Bay Area. The TravInfo Evaluation Plan is prepared in accordance with the Mitre guidelines adopted by the Federal Highway Administration (FHWA) for IVHS Operational Test Evaluation Plans. The report consists of five major sections: introduction, traveler response component, institutional component, technology assessment, and system evaluation.

  12. IDC Integrated Master Plan.

    Energy Technology Data Exchange (ETDEWEB)

    Clifford, David J.; Harris, James M.

    2014-12-01

    This is the IDC Re-Engineering Phase 2 project Integrated Master Plan (IMP). The IMP presents the major accomplishments planned over time to re-engineer the IDC system. The IMP and the associate Integrated Master Schedule (IMS) are used for planning, scheduling, executing, and tracking the project technical work efforts. REVISIONS Version Date Author/Team Revision Description Authorized by V1.0 12/2014 IDC Re- engineering Project Team Initial delivery M. Harris

  13. Evaluation of Investment Plan

    OpenAIRE

    Němeček, Petr

    2012-01-01

    Subject of this thesis is to evaluate the economic efficiency of the implemented investment plan. The theoretical part of the thesis is focused on presenting the most used methods of evaluation the economic effectivness of investment activity, it is also described the significance of the investment decisions and the investment plans. At the end of the theoretical part are the characteristics of the company and realized investment plan including the SWOT analysis. The practical par...

  14. Marketing business plan

    OpenAIRE

    Puklová, Michaela

    2013-01-01

    The aim of the thesis is to assemble marketing plan for one chosen market subject, an author, who specializes in sale of automatic technique drawing. The thesis is divided into two essential parts. First part is devoted to theoretical summary of the topic using available literary sources. It focuses on definition of marketing planning as a partial process within complex structure of business activity, furthermore defines particular steps of marketing planning. These steps mainly embrace situa...

  15. Strategic Marketing Planning Audit

    OpenAIRE

    Violeta Radulescu

    2012-01-01

    Market-oriented strategic planning is the process of defining and maintaining a viable relationship between objectives, training of personnel and resources of an organization, on the one hand and market conditions, on the other hand. Strategic marketing planning is an integral part of the strategic planning process of the organization. For successful marketing organization to obtain a competitive advantage, but also to measure the effectiveness of marketing actions the company is required to ...

  16. Business Plans For Dummies

    CERN Document Server

    Tiffany, Paul; Barrow, Colin

    2011-01-01

    A full updated and extended second edition of an established UK bestseller Business Plans For Dummies 2nd Edition features new and updated information on formulating a solid business plan to build a secure business - even in an economic downturn. Complete with a brand new business plan template to get you started this expert guide offers fresh advice on reading the competitive marketplace and assessing your business in the current economic climate. It walks you step-by-step through every aspect of planning achievable business goals and diversification strategies, identifying trends, exploring

  17. Fund management plan

    International Nuclear Information System (INIS)

    This revision of the Fund Management Plan updates the original plan published in May 1983. It is derived from and supplements the Mission Plan of the Office of Civilian Radioactive Waste Management. A major purpose in preparing this Plan is to inform the public about management of the Nuclear Waste Fund and the Interim Storage Fund. The purpose of the Interim Storage Fund is to finance the provision of the Federal interim storage capacity of up to 1900 metric tons of spent nuclear fuel. The Nuclear Waste Fund is a separate account for all revenues and expenditures related to the geological disposal and monitored retrieval storage of civilian radioactive waste

  18. Reasoning about plans

    CERN Document Server

    Allen, James; Pelavin, Richard; Tenenberg, Josh

    1991-01-01

    This book presents four contributions to planning research within an integrated framework. James Allen offers a survey of his research in the field of temporal reasoning, and then describes a planning system formalized and implemented directly as an inference process in the temporal logic. Starting from the same logic, Henry Kautz develops the first formal specification of the plan recognition process and develops a powerful family of algorithms for plan recognition in complex situations. Richard Pelavin then extends the temporal logic with model operators that allow the representation to

  19. It's in the Plan.

    Science.gov (United States)

    Bracci, Richard L.

    1999-01-01

    Examines how master planning and participatory process combines to successfully integrate technology into a school's educational system. Discussions on budget setting and environmental design are included. (GR)

  20. Tourism in local planning and development : tourist area product and market plans (destination plans)

    OpenAIRE

    Ørjansen, Dag

    1998-01-01

    The main point in the project was to try to find a better framework for the tourism business units own destination planning and try to find a better co-operation with the local planning. By local planning we mean both the traditional long-term development planning, economical planning and short-term development planning.

  1. What is a good plan?

    OpenAIRE

    Bølviken, Trond; Aslesen, Sigmund; Koskela, Lauri

    2015-01-01

    The word plan is in English both a verb and a noun, reminding us that to plan is a process resulting in a product, a plan. While the Last Planner System (LPS) is primarily focused on how to plan and control production, other planning concepts are more focused on the plan contents (the plan). A more explicit approach to the characteristics of a good plan could improve LPS as a planning concept. The paper proposes such a list, based on a discussion of the plan contents highlighte...

  2. Statistical Analysis Plan

    DEFF Research Database (Denmark)

    Ris Hansen, Inge; Søgaard, Karen; Gram, Bibi;

    2015-01-01

    This is the analysis plan for the multicentre randomised control study looking at the effect of training and exercises in chronic neck pain patients that is being conducted in Jutland and Funen, Denmark. This plan will be used as a work description for the analyses of the data collected....

  3. University City Core Plan.

    Science.gov (United States)

    Philadelphia City Planning Commission, PA.

    A redevelopment plan for an urban core area of about 300 acres was warranted by--(1) unsuitable building conditions, (2) undesirable land usage, and (3) faulty traffic circulation. The plan includes expansion of two universities and creation of a regional science center, high school, and medical center. Guidelines for proposed land use and zoning…

  4. Social Equity in Planning

    OpenAIRE

    Deakin, Elizabeth

    1999-01-01

    Planners are called upon to promote equity in their work, to assure fairness in their procedures and secure justice through their plans and programs. Equity, fairness, justice - what exactly do these terms mean in planning? In this essay I shall use them essentially as synonyms, although there are nuances.

  5. Tornado Preparedness Planning.

    Science.gov (United States)

    National Oceanic and Atmospheric Administration (DOC), Rockville, MD. National Weather Service.

    This pamphlet contains a set of guidelines for community leaders interested in developing preparedness plans for tornadoes and severe thunderstorms. Included in the guide is a list of the types of officials and agencies which should be involved in planning meetings. A set of suggestions for developing a community communications network and…

  6. Planned Change in Education.

    Science.gov (United States)

    Van Meter, Eddy J.

    1979-01-01

    Summarizes the literature on educational change as it is characterized by trends toward increased clarification of strategies relating to planned change, more sophisticated understanding of change-related phenomena, more reports of planned change, greater awareness of the complexities of change, and increased concern for the ethical dimension of…

  7. Values Drive the Plan

    Science.gov (United States)

    Cook, Les P.

    2010-01-01

    Values-integrated strategic planning provides the opportunity to clarify professional values as one envisions a future that is exciting and perhaps a bit provocative. This chapter explores the role and importance of student affairs and institutional values in strategic planning. It also looks at the historical roots of the profession and methods…

  8. Creating a Marketing Plan.

    Science.gov (United States)

    Sevier, Robert A.

    1989-01-01

    A guide to developing a college marketing plan defines key marketing terms, outlines the development of a plan (including institutional analysis, market research, strategy formation and execution, and program evaluation), and provides a list of important principles with which to operate a program. (MSE)

  9. Emergency plan belgian experience

    International Nuclear Information System (INIS)

    The Chernobyl disaster prompted authorities in Belgium to carry out a comprehensive review of all emergency plans and, in particular, those designed specifically for nuclear accidents. This review was aimed at determining what type of plans existed and to what extent such plans were operational. This paper sets out to present a broad overview of different aspects of this problem: organization of public emergency plans, co-ordination of operations, merits and demerits of centralization as opposed to decentralization, planning zones, obligation to release information to the public and relations with the media, and finally the international dimension to the problem. The author expresses the hope that the latter area will inspire practical suggestions

  10. A Plan Is Born

    Institute of Scientific and Technical Information of China (English)

    2010-01-01

    China is one of the few countries that formulate a plan pertaining to economic and social development every five years.From ideas to implementation,creating a five-year plan involves many great minds.It’s a complicated,sometimes drawn out process with thorough procedures-and it should be,since each plan plots the course China will take in its social and economic development over the next five years.Professor Hu Angang,Director of the Center for China Study of Tsinghua University,who took part in drawing up the 11th Five-Year Plan (2006-10) and is participating in the ongoing drafting process of the new one,explained the procedures involved in shaping the 12th Five-Year Plan (2011-15) in an exclusive interview with Beijing Review reporters Lan Xinzhen and Yu Shujun.

  11. Framework for Maintenance Planning

    DEFF Research Database (Denmark)

    Soares, C. Guedes; Duarte, J. Caldeira; Garbatov, Y.;

    2010-01-01

    The present document presents a framework for maintenance planning. Maintenance plays a fundamental role in counteracting degradation effects, which are present in all infrastructure and industrial products. Therefore, maintenance planning is a very critical aspect to consider both during the...... design and during the whole life span of operational use, within an integrated framework founded on risk and reliability based techniques. The document addresses designers, decision makers and professionals responsible for or involved in establishing maintenance plans. The purpose of this document is to...... present maintenance as an integrated approach that needs to be planned, designed, engineered, and controlled by proper qualitative and quantitative techniques. This document outlines the basic premises for maintenance planning and provides the general philosophies that can be followed and points to a best...

  12. Planning and Foucault

    DEFF Research Database (Denmark)

    Flyvbjerg, Bent; Richardson, Tim

    In this paper we argue that the use of the communicative theory of Jürgen Habermas in planning theory is problematic because it hampers an understanding of how power shapes planning. We posit an alternative approach based on the power analytics of Michel Foucault which focuses on "what is actually...... done", as opposed to Habermas`  focus on "what should be done". We discuss how the Foucauldian stance problematises planning, asking difficult questions about the treatment of legitimacy, rationality, knowledge and spatiality. We conclude that Foucault offers a type of analytic planning theory which...... offers better prospects than does Habermas for those interested in understanding and bringing about democratic social change through planning....

  13. Planning and Foucault

    DEFF Research Database (Denmark)

    Flyvbjerg, Bent; Richardson, Tim

    2002-01-01

    In this paper we argue that the use of the communicative theory of Jürgen Habermas in planning theory is problematic because it hampers an understanding of how power shapes planning. We posit an alternative approach based on the power analytics of Michel Foucault which focuses on ?what is actually...... done?, as opposed to Habermas?s focus on ?what should be done?. We discuss how the Foucauldian stance problematises planning, asking difficult questions about the treatment of legitimacy, rationality, knowledge and spatiality. We conclude that Foucault offers a type of analytic planning theory which...... offers better prospects than does Habermas for those interested in understanding and bringing about democratic social change through planning....

  14. Learning Through Scenario Planning

    DEFF Research Database (Denmark)

    Balarezo, Jose

    This project investigates the uses and effects of scenario planning in companies operating in highly uncertain and dynamic environments. Whereas previous research on scenario planning has fallen short of providing sufficient evidence of its mechanisms and effects on individual or organizational...... level variables, this research corrects this void by investigating the dynamics of organizational learning through the lenses of a corporate scenario planning process. This enhances our scientific understanding of the role that scenario planning might play in the context of organizational learning and...... counterintuitive ways in which an organization uses scenario planning in balancing the tension between exploration and exploitation. Moreover, this research proposes two novel mechanisms designed to enhance learning flows. At the core of this dissertation are four papers which in combination solidify our...

  15. Effective Hull IMMR plan

    Energy Technology Data Exchange (ETDEWEB)

    Franco, Mireille

    2010-07-01

    The objective of the Hull Inspection, Maintenance and Repair Plan is to ensure the total integrity of the Floating Production Unit. To be efficient, the Monitoring has to be part of the Hull Inspection, Monitoring, Maintenance and Repair Plan (IMMR). The IMMR Plan should be developed during the design and project phases and take into account the interfaces between the different systems and teams' tasks in operation. The IMMR is multidisciplinary and form part of the hand-over to ensure an efficient and early implementation. Implementation of such a complex plan requires: - Cross-functionality: take advantage of the synergies - Boldness: break the mould and think outside the box - Listening: be attentive, be available, - Mutual support: during good and bad times. This paper presents the way Total believe the Hull IMMR Plan shall be developed, implemented and followed up. (Author)

  16. Can Complexity be Planned?

    Directory of Open Access Journals (Sweden)

    Ilona Koutny

    2015-04-01

    Full Text Available The long accepted complexity invariance of human languages has become controversial within the last decade. In investigations of the problem, both creole and planned languages have often been neglected. After a presentation of the scope of the invariance problem and the proposition of the natural to planned language continuum, this article will discuss the contribution of planned languages. It will analyze the complexity of Esperanto at the phonological, morphological, syntactic and semantic levels, using linguistic data bases. The role of the L2 speech community and development of the language will also be taken into account when discussing the endurance of the same level of simplicity of this planned international language. The author argues that complexity can be variable and to some extent planned and maintained.

  17. Transportation Institutional Plan

    Energy Technology Data Exchange (ETDEWEB)

    1986-08-01

    This Institutional Plan is divided into three chapters. Chapter 1 provides background information, discusses the purposes of the Plan and the policy guidance for establishing the transportation system, and describes the projected system and the plans for its integrated development. Chapter 2 discusses the major participants who must interact to build the system. Chapter 3 suggests mechanisms for interaction that will foster wide participation in program planning and implementation and provides a framework for managing and resolving the issues related to development and operation of the transportation system. A list of acronyms and a glossary are included for the reader's convenience. Also included in this Plan are four appendices. Of particular importance is Appendix A, which includes detailed discussion of specific transportation issues. Appendices B, C, and D provide supporting material to assist the reader in understanding the roles of the involved institutions.

  18. The Sellafield Plan - 12458

    International Nuclear Information System (INIS)

    The Sellafield Performance Plan represents the start of a new era for the Sellafield site. It is a key driver in the Nuclear Management Partners mission to make Sellafield safer, cleaner, more productive, more cost effective and a better neighbour. When published in summer 2011, the Sellafield Performance Plan set out exactly what work would be completed at Sellafield between 2010/11 and 2025/26, how all of the facilities on the site interact, and what new facilities would be needed in order to deliver the risk and hazard reduction mission. The plan is the first credible and underpinned lifetime plan for the Sellafield site - the most complex part of the UK's civil nuclear estate. Under the Sellafield Performance Plan there are projected to be more jobs longer creating opportunities for the site, its workforce and the economic stability of West Cumbria. The Sellafield Ltd performance plan sets out how NMP will apply their global experience to improve operations, generate efficiencies and deliver detailed programmes of work with the aim of accelerating decommissioning and providing value for money. Successful delivery of the plan will also ensure the site continues to effectively operate critical national infrastructure that supports the UK's energy programme, and maintains the safe and secure management and storage of nuclear materials. The NDA and UK Government have demonstrated their confidence in NMP and Sellafield Ltd's capability to deliver this plan by providing the highest-ever Annual Site Funding Limit for the site in 2011/12. The Sellafield Performance Plan also creates both the foundation and the environment for a vibrant West Cumbrian economy through significant opportunities for the local supply chain and real prospects for further inward investment. By working flexibly and accelerating the decommissioning programme, the plan provides the opportunity for significant retraining to adapt to future challenges on the site and for other potential new nuclear

  19. Contingency planning: preparation of contingency plans

    DEFF Research Database (Denmark)

    Westergaard, J M

    2008-01-01

    Outbreaks of infectious animal diseases such as foot-and-mouth disease, classical swine fever, Newcastle disease and avian influenza may have a devastating impact, not only on the livestock sector and the rural community in the directly affected areas, but also beyond agriculture and nation wide....... The risk of introducing disease pathogens into a country and the spread of the agent within a country depends on a number of factors including import controls, movement of animals and animal products and the biosecurity applied by livestock producers. An adequate contingency plan is an important...... instrument in the preparation for and the handling of an epidemic. The legislation of the European Union requires that all Member States draw up a contingency plan which specifies the national measures required to maintain a high level of awareness and preparedness and is to be implemented in the event of...

  20. Public affairs plan

    International Nuclear Information System (INIS)

    The purpose of the Uranium Mill Tailings Remedial Action (UMTRA) Project Public Affairs Plan is to establish goals for the Fiscal Year 1995 UMTRA public affairs program and identify specific activities to be conducted during the year. It also describes the roles of various agencies involved in the conduct of the public affairs program and defines the functions of the Technical Assistance Contractor (TAC) Public Affairs Department. It integrates and replaces the Public Participation Plan (DOE/AL/62350-47D) and Public Information Plan (DOE/AL/623590-71). The plan describes the US Department of Energy's (DOE) plans to keep stakeholders and other members of the public informed about project policies, plans, and activities, and provide opportunities for stakeholders and interested segments of the public to participate in project decision-making processes. The plan applies to the UMTRA Project Office; the DOE Albuquerque Operations Office, Office of Intergovernmental and External Affairs (OIEA); the UMTRA TAC; the UMTRA Remedial Action Contractor (RAC); and other cooperating agencies

  1. EMSL Strategic Plan 2008

    Energy Technology Data Exchange (ETDEWEB)

    Campbell, Allison A.

    2008-08-15

    This Strategic Plan is EMSL’s template for achieving our vision of simultaneous excellence in all aspects of our mission as a national scientific user facility. It reflects our understanding of the long-term stewardship we must work toward to meet the scientific challenges of the Department of Energy and the nation. During the next decade, we will implement the strategies contained in this Plan, working closely with the scientific community, our advisory committees, DOE’s Office of Biological and Environmental Research, and other key stakeholders. This Strategic Plan is fully aligned with the strategic plans of DOE and its Office of Science. We recognize that shifts in science and technology, national priorities, and resources made available through the Federal budget process create planning uncertainties and, ultimately, a highly dynamic planning environment. Accordingly, this Strategic Plan should be viewed as a living document for which we will continually evaluate changing needs and opportunities posed by our stakeholders (i.e., DOE, users, staff, advisory committees), work closely with them to understand and respond to those changes, and align our strategy accordingly.

  2. Strategic planning and republicanism

    Directory of Open Access Journals (Sweden)

    Mazza Luigi

    2010-01-01

    Full Text Available The paper develops two main linked themes: (i strategic planning reveals in practice limits that are hard to overcome; (ii a complete planning system is efficacy only in the framework of a republican political, social and government culture. It is argued that the growing disappointment associated to strategic planning practices, may be due to excessive expectations, and the difficulties encountered by strategic planning are traced to three main issues: (a the relationship between politics and planning; (b the relationship between government and governance; and (c the relationship between space and socioeconomic development. Some authors recently supported an idea of development as consisting in the qualitative evolution of forms of social rationality and argued that a reflection about the relationships between physical transformations and visions of development could be a way of testing innovations. But such strong demands might be satisfied only if we manage to make a 'new social and territorial pact for development', recreating a social fabric imbued with shared values. The re-creation of a social fabric imbued with shared values requires a rich conception of the political community and the possibility that the moral purposes of the community may be incorporated by the state. All this is missing today. Outside a republican scheme planning activities are principally instruments for legitimising vested interests and facilitating their investments, and the resolution of the conflicts that arise between the planning decisions of the various levels of government becomes at least impracticable. A complete planning system can be practised if can be referred to the authority and syntheses expressed in and by statehood, which suggests that in a democratic system planning is republican by necessity rather than by choice.

  3. EMSL Contribution Plan

    Energy Technology Data Exchange (ETDEWEB)

    Campbell, Allison A.

    2008-12-01

    This Contribution Plan is EMSL’s template for achieving our vision of simultaneous excellence in all aspects of our mission as a national scientific user facility. It reflects our understanding of the long-term stewardship we must work toward to meet the scientific challenges faced by the Department of Energy (DOE) and the nation. During the next decade, we will implement the strategies contained in this Plan, working closely with the scientific community, our advisory committees, DOE’s Office of Biological and Environmental Research, and other key stakeholders. This Plan is fully aligned with the strategic plans of DOE, its Office of Science, and the Pacific Northwest National Laboratory (PNNL). We recognize that shifts in science and technology, national priorities, and resources made available through the Federal budget process create planning uncertainties and, ultimately, a highly dynamic planning environment. Accordingly, this Plan should be viewed as a living document and we continually evaluate the changing needs and opportunities posed by our stakeholders (i.e., DOE, users, staff, advisory committees), work closely with them to understand and respond to those changes, and align our strategy accordingly. This Plan is organized around two sections. Section 1 describes our vision and four strategic outcomes: 1) Scientific Innovation, 2) Capabilities that Transform Science, 3) Outstanding Management and Operations, and Engaged and Proactive Users. These outcomes provide the framework for seven critical actions we must take during the next 3 to 5 years: 1) Establishing leadership in EMSL science themes, 2) building and deploying transformational capabilities, 3) integrating computation with experiment, 4) ensuring EMSL’s workforce meets the scientific challenges of the future, 5) creating partnerships, 6) attracting and engaging users in EMSL’s long-term strategy, and 7) building a research infrastructure that meets emerging scientific needs. Section 2

  4. Planning for the future.

    Science.gov (United States)

    Stiewing, Janis

    2002-01-01

    Revising the strategic plan was the beginning of a multiyear initiative that will determine the path of the JRCERT. The key word in the preceding statement is beginning. The strategic plan is an ever-changing document. Although some components, such as the values statements, will stand over time, other components will change as accreditation and educational arenas change. That is the paradox of strategic planning: Remaining true to the vision, values and mission statements requires knowing when to change to keep the JRCERT aligned with the responsive to its communities of interest. PMID:11928169

  5. Undecidability in Epistemic Planning

    DEFF Research Database (Denmark)

    Aucher, Guillaume; Bolander, Thomas

    2013-01-01

    Dynamic epistemic logic (DEL) provides a very expressive framework for multi-agent planning that can deal with nondeterminism, partial observability, sensing actions, and arbitrary nesting of beliefs about other agents’ beliefs. However, as we show in this paper, this expressiveness comes at a...... price. The planning framework is undecidable, even if we allow only purely epistemic actions (actions that change only beliefs, not ontic facts). Undecidability holds already in the S5 setting with at least 2 agents, and even with 1 agent in S4. It shows that multi-agent planning is robustly undecidable...

  6. Business Plan: Elpis Restaurant

    OpenAIRE

    Tran, Luu Quoc Phong

    2016-01-01

    The purpose of this Bachelor’s thesis is to create a business plan for starting up a restaurant in European – Asian style in Helsinki. While the restaurants are in European or Asian style separately, this restaurant will be unique with dishes which are based on local traditional dishes, traditional Asian dishes and mixture between them as well as creation of new dishes. This business plan is created to minimize the risk when starting up a restaurant. The plan will not only help the restaur...

  7. Environmental monitoring plan

    International Nuclear Information System (INIS)

    This Environmental Monitoring Plan was written to fulfill the requirements of Department of Energy (DOE) Order 5400.1 and DOE Environmental Regulatory Guide DOE/EH 0173T. This Plan documents the background, organizational structure, and methods used for effluent monitoring and environmental surveillance at Sandia National Laboratories/California. The design, rationale, and historical results of the environmental monitoring system are discussed in detail. Throughout the Plan, recommendations for improvements to the monitoring system are made. 52 refs., 10 figs., 12 tabs

  8. Heat pump planning handbook

    CERN Document Server

    Bonin, Jürgen

    2015-01-01

    The Heat Pump Planning Handbook contains practical information and guidance on the design, planning and selection of heat pump systems, allowing engineers, designers, architects and construction specialists to compare a number of different systems and options. Including detailed descriptions of components and their functions and reflecting the current state of technology this guide contains sample tasks and solutions as well as new model calculations and planning evaluations. Also economic factors and alternative energy sources are covered, which are essential at a time of rising heat costs. T

  9. Marketing plan business

    OpenAIRE

    Beková, Martina

    2014-01-01

    The aim of the present thesis is the marketing plan of a new Czech-French Restaurant Montmartre in Pilsen. The work is divided into two parts, a theoretical part and a practical part. The theoretical part, which provides the basis for an elaboration of a marketing plan, is a review of literature. It is divided into two chapters. The first chapter defines the concept of marketing and its meaning; the second chapter focuses on the marketing plan, starting at the definition of the different type...

  10. Environmental monitoring plan

    Energy Technology Data Exchange (ETDEWEB)

    Holland, R.C.

    1997-02-01

    This Environmental Monitoring Plan was written to fulfill the requirements of Department of Energy (DOE) Order 5400.1 and DOE Environmental Regulatory Guide DOE/EH 0173T. This Plan documents the background, organizational structure, and methods used for effluent monitoring and environmental surveillance at Sandia National Laboratories/California. The design, rationale, and historical results of the environmental monitoring system are discussed in detail. Throughout the Plan, recommendations for improvements to the monitoring system are made. 52 refs., 10 figs., 12 tabs.

  11. Assembly plans for ITER

    International Nuclear Information System (INIS)

    The assembly of ITER represents an extrapolation of a factor of two or more in size over existing large tokamaks. An assembly plan has been developed based on the ITER Outline Design. This plan was reviewed by technical experts and critical issues were identified. Alternate designs are being developed to address the most serious concerns and to minimize cost and assembly schedule. Because ITER has many characteristics of a full-scale nuclear reactor its assembly has challenges not faced previously by the fusion community. Careful assembly planning and well-designed tooling are required to insure success in the assembly of ITER

  12. Quality Assurance Project Plan for Facility Effluent Monitoring Plan activities

    International Nuclear Information System (INIS)

    This Quality Assurance Project Plan addresses the quality assurance requirements for the activities associated with the Facility Effluent Monitoring Plans, which are part of the overall Hanford Site Environmental Protection Plan. This plan specifically applies to the sampling and analysis activities and continuous monitoring performed for all Facility Effluent Monitoring Plan activities conducted by Westinghouse Hanford Company. It is generic in approach and will be implemented in conjunction with the specific requirements of the individual Facility Effluent Monitoring Plans

  13. Language Planning Theories and Language Planning In China

    Institute of Scientific and Technical Information of China (English)

    许楠

    2006-01-01

    The specialized study of language policies and planning as a part of sociolinguistics is originated in the 1960's. The theories about language planning may give some guidance to the language planning in China. Of course, China's language policy makers should make decisions according to the specific language situation in China. Chinese language is the national language, and there are more than 120 ethnic minority languages. Therefore, language planning in China involves the Chinese language planning and minority languages planning.

  14. BNL status and plans

    International Nuclear Information System (INIS)

    The present status and future plans for the Alternating Gradient Synchrotron are presented. The operating modes, accelerator improvement program, Booster synchrotron status, Stretcher ring proposal, and higher intensity options are described

  15. Medicare Advantage Plans

    Science.gov (United States)

    ... plans Ways to pay Part A & Part B premiums Costs at a glance What Medicare Covers Is ... File a complaint Identity theft: protect yourself Phone numbers & websites Privacy practices Contact Medicare The page could ...

  16. Approximations in Inspection Planning

    DEFF Research Database (Denmark)

    Engelund, S.; Sørensen, John Dalsgaard; Faber, M. H.; Bloch, Allan

    2000-01-01

    . One of the more important of these approximations is the assumption that all inspections will reveal no defects. Using this approximation the optimal inspection plan may be determined on the basis of conditional probabilities, i.e. the probability of failure given no defects have been found by the......Planning of inspections of civil engineering structures may be performed within the framework of Bayesian decision analysis. The effort involved in a full Bayesian decision analysis is relatively large. Therefore, the actual inspection planning is usually performed using a number of approximations...... inspection. In this paper the quality of this approximation is investigated. The inspection planning is formulated both as a full Bayesian decision problem and on the basis of the assumption that the inspection will reveal no defects....

  17. Cropland Management Plan

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — The purpose of this Cropland Management Plan is to describe cropland management activities at Shiawassee National Wildlife Refuge and provide the basis for future...

  18. Upland Management Plan [Draft

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This Upland Management Plan provides guidelines for the methods and tools to manage uplands on the Arrowwood National Wildlife Refuge to provide quality cover and...

  19. Waterfowl disease contingency plan

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — The purpose of this contingency plan is reduce waterfowl losses from disease, primarily avian botulism, along the eastern shore of the Great Salt Lake in Utah. This...

  20. Planning for older workers.

    Science.gov (United States)

    Randolph, Susan A

    2013-12-01

    Occupational and environmental health nurses can improve planning for an aging workforce by reviewing existing programs and services and adding aging and multi-generational workforce issues to ongoing training. PMID:24328920

  1. Climate plan 2004

    International Nuclear Information System (INIS)

    The Climate Plan is an action plan drawn up by the French Government to respond to the climate change challenge, first by 2010 (complying with the Kyoto Protocol target), and, secondly, beyond this date. Projections for France show that national emissions could be 10% higher than the Kyoto target in 2010 if no measures are taken. This is particularly due to increasing emissions in the sectors affecting daily life (residential-tertiary sectors, transport, etc.). For this reason, the Climate Plan contains measures affecting all sectors of the economy and the daily life of all French citizens with a view to economizing the equivalent of 54 million tonnes of CO2 each year by the year 2010, which will help to reverse the trend significantly. Beyond 2010, the Climate Plan sets out a strategy for technological research which will enable France to meet a target of reducing greenhouse gas emissions four or fivefold by 2050. (author)

  2. Advance Care Planning

    Science.gov (United States)

    ... put on a breathing machine. Organ and tissue donation allows organs or body parts from a generally healthy person ... to your driver’s license. Some people also include organ donation in their advance care planning documents. At the ...

  3. Project Planning: An Analysis

    Directory of Open Access Journals (Sweden)

    Dr.S.S.Riaz Ahamed

    2010-01-01

    Full Text Available The purpose of the Planning stage is to analyze the project in terms of work breakdown, cost, resources, and timing. At the end of this stage all team members should be clear on the sub tasks and deliverables with the project, the time constraints they are working too and the roles and responsibilities that are expected from them.Software Project Plan defines what the work is, and how this work can be completed. This plan is developed at the beginning of the software project and is continually refined and improved as the work rocesses. It can be useful to management as a frame work for review and control the process of developing the software. Additionally, the Software Project Plan can define each of the major tasks and estimate the time and resources that are required to complete these tasks.

  4. Environmental Monitoring Plan

    International Nuclear Information System (INIS)

    This Environmental Monitoring Plan was written to fulfill the requirements of Department of Energy (DOE) Order 5400.1 and DOE Environmental Regulatory Guide DOE/EH 0173T. This Plan documents the background, organizational structure, and methods used for effluent monitoring and environmental surveillance at Sandia National Laboratories/California. The design, rationale, and historical results of the environmental monitoring system are discussed in detail. Throughout the Plan, recommendations for improvements to the monitoring system are made. This revision to the Environmental Monitoring Plan was written to document the changes made to the Monitoring Program during 1992. Some of the data (most notably the statistical analyses of past monitoring data) has not been changed

  5. My Reproductive Life Plan

    Science.gov (United States)

    ... write their plan down on a piece of paper or in a journal. Be sure to talk ... your email address: Enter Email Address What's this? Submit What's this? Submit Button Information For... Media Policy ...

  6. Frenchglen Interpretive Plan

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — The purpose of this interpretive plan is to provide guidance for the development of the interpretive exhibits for the Frenchglen Interpretive Center, as well as the...

  7. Planning a Science Fair

    Science.gov (United States)

    Ebert, Jim

    1976-01-01

    Presented are views, on planning science fairs and science fair projects, of a fair coordinator, a science teacher, and students. Also included are 25 questions which might result in science fair projects. (SL)

  8. Cropland Management Plan

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — The Union Slough National Wildlife Refuge Cropland Management Plan focuses on the production of supplemental grain and browse foods to maintain wildlife populations...

  9. MyPlan

    Data.gov (United States)

    California Department of Resources — MyPlan is a map service designed to be a simple interface to California natural hazard data products produced by the California Natural Resources Agency departments...

  10. Environmental Implementation Plan

    Energy Technology Data Exchange (ETDEWEB)

    1993-03-15

    The purpose of the Environmental Implementation Plan (EIP) is to show the current and future (five years) environmental plans from individual site organizations and divisions, as well as site environmental programs and initiatives which are designed to protect the environment and meet or exceed changing environmental/regulatory requirements. Communicating with site organizations, departments, and committees is essential in making the site`s environmental-planning process work. The EIP gives the site the what, when, how, and why for environmental requirements. Through teamwork and proactive planning, a partnership for environmental excellence is formed to achieve the site vision for SRS to become the recognized model for Environmental Excellence in the Department of Energy`s Nuclear Weapons Complex.

  11. Environmental Implementation Plan

    Energy Technology Data Exchange (ETDEWEB)

    1993-03-15

    The purpose of the Environmental Implementation Plan (EIP) is to show the current and future (five years) environmental plans from individual site organizations and divisions, as well as site environmental programs and initiatives which are designed to protect the environment and meet or exceed changing environmental/regulatory requirements. Communicating with site organizations, departments, and committees is essential in making the site's environmental-planning process work. The EIP gives the site the what, when, how, and why for environmental requirements. Through teamwork and proactive planning, a partnership for environmental excellence is formed to achieve the site vision for SRS to become the recognized model for Environmental Excellence in the Department of Energy's Nuclear Weapons Complex.

  12. Crowd Control Plan

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This Crowd Control Plan for Swan Lake National Wildlife Refuge outlines operational procedures in the event of a civil disorder on the Refuge. An inventory of...

  13. Licensee safeguards contingency plans

    International Nuclear Information System (INIS)

    The Nuclear Regulatory Commission is amending its regulations to require that licensees authorized to operate a nuclear reactor (other than certain research and test reactors), and those authorized to possess strategic quantities of plutonium, uranium-233, or uranium-235 develop and implement acceptable plans for responding to threats, thefts, and industrial sabotage of licensed nuclear materials and facilities. The plans will provide a structured, orderly, and timely response to safeguards contingencies and will be an important segment of NRC's contingency planning programs. Licensee safeguards contingency plans will result in organizing licensee's safeguards resources in such a way that, in the unlikely event of a safeguards contingency, the responding participants will be identified, their several responsibilities specified, and their responses coordinated

  14. Grassland Management Plan [Draft

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This grassland management plan is for Bear River Migratory Bird Refuge in Utah. It includes a summary of the refuge, special considerations for endangered species,...

  15. A Planning Palimpsest

    DEFF Research Database (Denmark)

    Carter, Helen Frances Lindsay; Gutzon Larsen, Henrik; Olesen, Kristian

    2015-01-01

    In this article, we analyse the evolution and transformation of Danish spatial planning from its tentative origins in liberalist politics, through its rise as a central feature of the welfare state project, to its more recent entrepreneurial forms in a context of neoliberalisation. The article...... demonstrates how transformations of Danish spatial planning discourses and practices must be understood in context of previous discourses and practices sedimented as layers of meaning and materiality through time and over space. These layers do not completely overlay one another, but present a palimpsest...... saturated with contradictions as well as possibilities. We propose the notion of the ‘planning palimpsest’ as a helpful metaphor for drawing attention to the historical-geographical characteristics of planning discourses and practices....

  16. Environmental Implementation Plan

    International Nuclear Information System (INIS)

    The purpose of the Environmental Implementation Plan (EIP) is to show the current and future (five years) environmental plans from individual site organizations and divisions, as well as site environmental programs and initiatives which are designed to protect the environment and meet or exceed changing environmental/regulatory requirements. Communicating with site organizations, departments, and committees is essential in making the site's environmental-planning process work. The EIP gives the site the what, when, how, and why for environmental requirements. Through teamwork and proactive planning, a partnership for environmental excellence is formed to achieve the site vision for SRS to become the recognized model for Environmental Excellence in the Department of Energy's Nuclear Weapons Complex

  17. Facility Response Plan (FRP)

    Data.gov (United States)

    U.S. Environmental Protection Agency — A Facility Response Plan (FRP) demonstrates a facility's preparedness to respond to a worst case oil discharge. Under the Clean Water Act, as amended by the Oil...

  18. Tulare Basin protection plan

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — The Tulare Basin Protection Plan has been initiated by The Nature Conservancy to elucidate the problems and opportunities of natural diversity protection....

  19. Hanford Site Development Plan

    International Nuclear Information System (INIS)

    The Hanford Site Development Plan (HSDP) provides an overview of land use, infrastructure, and facility requirements to support US Department of Energy (DOE) programs at the Hanford Site. The HSDP's primary purpose is to inform senior managers and interested parties of development activities and issues that require a commitment of resources to support the Hanford Site. The HSDP provides a land use plan for the Hanford Site and presents a picture of what is currently known and anticipated in accordance with DOE Order 4320.1B. Site Development Planning. The HSDP wig be updated annually as future decisions further shape the mission and overall site development process. Further details about Hanford Site development are defined in individual area development plans

  20. Asthma action plan

    OpenAIRE

    Public Health Agency

    2014-01-01

    This action plans allow each child (or parent/carer) to record his or her asthma treatment to help manage their asthma when they are well, when their symptoms get worse and when they are suffering an asthma attack.

  1. Law Enforcement Plan

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — The Union Slough National Wildlife Refuge Law Enforcement Plan clarifies U.S. Fish and Wildlife enforcement policies as they apply to the Refuge. It provides...

  2. Postpartum Depression Action Plan

    Science.gov (United States)

    MENU Return to Web version Postpartum Depression | Postpartum Depression Action Plan Patient __________________________ Physician/NP/PA __________________ Clinic ____________________________ Phone Number ____________________ Choose one area and add other areas as you begin to feel ...

  3. Emergency Preparedness Plan.

    Science.gov (United States)

    Randolph, Susan A

    2015-07-01

    Although some disasters can be predicted, others may occur without much warning. The occupational and environmental health nurse should be involved in all aspects of an emergency response plan. PMID:26187176

  4. DOREMI - Dissemination Plan

    OpenAIRE

    Lupi??ez-Villanueva, Francisco; Vozzi, Federico; Rial, Michela; Morales, Aurora; Parodi, Oberdan; Ferro, Erina; Fortunati, Luigi; Palumbo, Filippo

    2014-01-01

    The deliverable D7.1 "Dissemination plan" aims at formulating the project's dissemination strategy and plan, identifying the specific approaches best suited for contact and interaction with target groups, considering both new (e.g. internet exploitation; cross-posting, cycling references, etc.) and traditional (e.g. press release, newsletters, conferences, etc.) dissemination avenues. The report starts with the identification of the key stakeholders of the projects and the main dissemination ...

  5. Energy and urban planning

    DEFF Research Database (Denmark)

    Fertner, Christian

    How can spatial planning reduce energy use in our cities? How do different geographical, regional, cultural or political contexts influence our options? How can we measure and monitor its effects? And where do we set the boundaries for the definition of action and goals? Findings from the...... international EU-FP7 project PLEEC (‘Planning for energy efficient cities’, 2013-2016) and spin-off projects list options and challenges....

  6. Overview about project planning

    OpenAIRE

    Catalin Drob

    2012-01-01

    The purpose of this article is to present the main aspects regarding project planning. This study is generally based on the fourth edition of the Guide to the Project Management Body of Knowledge (PMBOK Guide) developed by the Project Management Institute (PMI) in 2008. According to this edition of PMBOK, project planning involves a group of processes required to establish the scope of the project, refine the objectives, and define the actions that must be undertaken to attain the objectives ...

  7. Supermarkets and Planning Regulation

    OpenAIRE

    Griffith, Rachel; Harmgart, Heike

    2008-01-01

    We are interested in evaluating the impact of restrictive planning regulation on entry into the UK grocery retail industry. We estimate a model similar to Bresnahan and Reiss (1991) where we allow for multiple store formats. We find that more restrictive planning regulation reduces the number of large format supermarkets in equilibrium. However, the impact is overstated if variation in demographic characteristics across markets is not also controlled for. Our estimates suggest that restrictiv...

  8. Strategic marketing planning

    OpenAIRE

    Plechatý, Josef

    2014-01-01

    The object of this dissertation is to verify the business plan viability as well as its chances for competitive market and branch attractiveness. The business plan consist a creation of web page through which a service called “car pool” is realized. The goal is to catch up as many registered users as possible and to create great basis of potential clients for the advert submitter using the most exact aim. Customers ordering the advertisement are representing revenue of subject....

  9. Environmental implementation plan

    Energy Technology Data Exchange (ETDEWEB)

    Peterson, G.L.

    1994-10-04

    In this document, the Savannah River site environmental programs and plans from DOE contractors and Westinghouse Savannah River Company divisions/departments are presented along with the environmental coordinator for each program. The objectives are to enhase communication of existing or planned programs to do the following: identify activities required for meeting environmental needs; identify needing resources and a schedule to accomplish those activities; promote share-savings and consistency in those activities.

  10. LTE Network Radio Planning

    Directory of Open Access Journals (Sweden)

    I. R. Maravić

    2012-06-01

    Full Text Available In this paper different ways of planning the radio resources within an LTE network are analyzed. All simulations were carried out using 3GPP recommendations. Soft frequency reuse (SFR, soft fractional frequency reuse (SFFR and hard fractional frequency reuse (HFFR radio resource allocation schemes are compared to fixed frequency reuse 1 (R1 and reuse 3 (R3 radio resource allocation schemes. An optimum way of planning radio resources in a LTE network is proposed at the end of paper.

  11. Water resources management plan

    OpenAIRE

    Glauco Maia; Jorge Xavier da Silva; Tiago Marino

    2011-01-01

    Water resources manageWith the mission of providing reliable data for water supply activities in medium and large firefighting operations, the Firefighting Water Supply Tactical Group (GTSAI) represents an important sector of the Rio de Janeiro State Fire Departmentment plan strategic support. Acting proactively, the Tactical Group prepared a Water Resources Management Plan, aiming to set up water resources for each jurisdiction of firefighters in the City of Rio de Janeiro, in order to assis...

  12. Planning rapid transit networks

    OpenAIRE

    G Laporte; Mesa, J. A.; Ortega, F.A.; Perea Rojas Marcos, Federico

    2011-01-01

    Rapid transit construction projects are major endeavours that require long-term planning by several players, including politicians, urban planners, engineers, management consultants, and citizen groups. Traditionally, operations research methods have not played a major role at the planning level but several tools developed in recent years can assist the decision process and help produce tentative network designs that can be submitted to the planners for further evaluation. This article review...

  13. Family planning/contraception

    OpenAIRE

    1985-01-01

    It is the position of the Canadian Medical Association (CMA) that family planning advice and assistance should be readily available to all residents of Canada. This is viewed as a responsibility of practising physicians that is to be shared with other health and educational agencies. CMA has recommended the establishment of facilities in addition to physicians' offices for the dissemination of advice on family planning. These facilities should be developed in consultation with and under the s...

  14. A Good Plan

    Institute of Scientific and Technical Information of China (English)

    2012-01-01

    Now I am a middle school student,and I have some experience on study.I think a good plan is the most important. In the middle school,there are a lot of things to do every day.So you must have a plan to help you do all the things,or you will be very busy and can't do things well.

  15. Planning rationality and relativism

    OpenAIRE

    D van Houten

    1989-01-01

    In traditional planning thought, purposive rationality is a key concept. The assumption is that it reduces uncertainties. Discussion of this positivist planning paradigm is ongoing. Part of the discussion concerns cognitive realism, a key issue in the sociology of knowledge. On the whole, cognitive relativism and purposive rationality are strange bedfellows. Other kinds of rationality pose less of a problem. This paper is an elaboration upon Mannheim's concept of substantial rationality and h...

  16. Human Resource Planning

    OpenAIRE

    Lache Cãtãlina

    2011-01-01

    The objective of human resource planning is to adapt the human capital needed to develop the enterprises’ activities and to accomplish their priority objectives on the medium and/or short term. Human resource planning is a dynamic activity, time being an essential variable, both in what regards the quantitative side (adapting the number of jobs according to the organisation’s evolution in time) and the qualitative side (harmonising the jobs’ complexity with technological changes). The quantit...

  17. Planning for Retail

    OpenAIRE

    Harders, Marian B.

    2004-01-01

    This paper is about retail development and its impact on local and regional communities. As the Big-box phenomena continues to play out in the 21st century, planning departments across the nation have been called to action with respect to addressing negative aspects of retail development. The purpose of this paper is to examine the nature of retail, by tracing the evolving retail form and applying critical analysis to planning practices that no longer safeguard community interests in relati...

  18. Environmental implementation plan

    International Nuclear Information System (INIS)

    In this document, the Savannah River site environmental programs and plans from DOE contractors and Westinghouse Savannah River Company divisions/departments are presented along with the environmental coordinator for each program. The objectives are to enhase communication of existing or planned programs to do the following: identify activities required for meeting environmental needs; identify needing resources and a schedule to accomplish those activities; promote share-savings and consistency in those activities

  19. Energy and urban planning

    OpenAIRE

    Fertner, Christian

    2015-01-01

    How can spatial planning reduce energy use in our cities? How do differentgeographical, regional, cultural or political contexts influence our options? Howcan we measure and monitor its effects? And where do we set the boundaries forthe definition of action and goals? Findings from the international EU-FP7 projectPLEEC (‘Planning for energy efficient cities’, 2013-2016) and spin-off projects listoptions and challenges.

  20. Electricity planning for developing countries

    International Nuclear Information System (INIS)

    The following issues of electricity planning for developing countries are discussed: evolution of planning methodologies; the Latin American Energy Organization's view on energy planning; power sector history and trends; risk and uncertainty in policy formulation