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Sample records for bla pharmacovigilance plan

  1. Risk management plans as a tool for proactive pharmacovigilance

    DEFF Research Database (Denmark)

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

    2014-01-01

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

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

    Directory of Open Access Journals (Sweden)

    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

  3. 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...

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

    Directory of Open Access Journals (Sweden)

    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.

  5. Pharmacovigilance programme of India

    Directory of Open Access Journals (Sweden)

    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.

  6. 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.

  7. 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.

  8. 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.

  9. Forensic pharmacovigilance: Newer dimension of pharmacovigilance.

    Science.gov (United States)

    Sewal, Rakesh K; Saini, Vikas K; Medhi, Bikash

    2015-08-01

    Drug safety for the patients is of paramount importance for a medical professional. Pharmacovigilance attempts to ensure the safety of patients by keeping a close vigil on the pattern of adverse events secondary to drug use. Number of medicolegal cases is at rise since last few years. Forensic sciences and pharmacovigilance need to work hand in hand to unlock the mystery of many criminal and civil proceedings. Pharmacovigilance offers its wide scope in forensic sciences by putting forward its expertise on adverse profile of drugs which may be instrumental in solving the cases and bringing the justice forth. It may range from as simple affairs as defining the adverse drug reaction on one hand to putting expert advice in critical criminal cases on the other one. Pharmacovigilance experts have to abide by the ethics of the practice while executing their duties as expert else it may tarnish the justice and loosen its dependability. As a budding discipline of science, it is confronted with several hurdles and challenges which include reluctance of medical professionals for being involved in court proceedings, extrapolations of facts and data and variations in law across the globe etc. These challenges and hurdles call the medical fraternity come forward to work towards the momentous application of pharmacovigilance in the forensic sciences. Evidence based practice e.g. testing the biological samples for the presence of drugs may prove to be pivotal in the success of this collaboration of sciences.

  10. 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.

  11. 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...

  12. 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

  13. Formulation of Pharmacovigilance Plan of Biological Generic Drug%生物仿制药警戒计划的制订

    Institute of Scientific and Technical Information of China (English)

    张淑兰; 关丽

    2012-01-01

    目的:按照药物临床安全性和警戒性的要求,对生物仿制药的生物利用度、临床疗效安全性进行评价,以制订生物仿制药警戒计划.方法:对我国生物仿制药在前期研究、临床试验、生产等过程存在的问题进行分析.结果与结论:生物仿制药品相似但不相同,生物制剂生产过程复杂,容易出现变异,有必要进行临床安全性评价.国家各卫生医疗机构部门应高度关注,加强药品的自检、抽检、监督管理,在生物仿制药使用过程中发现问题,提高我国生物仿制药的临床安全用药水平.%OBJECTIVE: To evaluate bioavailability and safety of clinical efficacy of biological generic drug according to the requirement of drug safety and pharmacovigilance, and to formulate the pharmacovigilance plan for it. METHODS: Problems of biological generic drug in China were analyzed in terms of preliminary study, clinical trial and production. RESULTS&CONCLU-SION: Biological generic drugs are similar but not same, and the production process is complex and easily results in variable. It is necessary to evaluate clinical safety of drugs. Medical institutions should be intensely focused on self-checking, sampling inspection, supervision and management, find out problems to improve safety of biological generic drugs in China.

  14. Training in post-authorization pharmacovigilance

    Directory of Open Access Journals (Sweden)

    Vivek Ahuja

    2010-01-01

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

  15. PHARMACOVIGILANCE: BARRIERS AND CHALLENGES

    Directory of Open Access Journals (Sweden)

    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.

  16. The new pharmacovigilance legislation and impact on observational studies

    Directory of Open Access Journals (Sweden)

    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.

  17. 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...

  18. 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.

  19. 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...

  20. Evolving paradigms in pharmacovigilance.

    Science.gov (United States)

    Brewster, Wendy; Gibbs, Trevor; Lacroix, Karol; Murray, Alison; Tydeman, Michael; Almenoff, June

    2006-05-01

    All medicines have adverse effects as well as benefits. The aim of pharmacovigilance is to protect public health by monitoring medicines to identify and evaluate issues and ensure that the overall benefits outweigh the potential risks. The tools and processes used in pharmacovigilance are continually evolving. Increasingly sophisticated tools are being designed to evaluate safety data from clinical trials to enhance the likelihood of detecting safety signals ahead of product registration. Methods include integration of safety data throughout development, meta-analytical techniques, quantitative and qualitative methods for evaluation of adverse event data and graphical tools to explore laboratory and biometric data. Electronic data capture facilitates monitoring of ongoing studies so that it is possible to promptly identify potential issues and manage patient safety. In addition, GSK employs a number of proactive methods for post-marketing signal detection and knowledge management using state-of-the-art statistical and analytical tools. Using these tools, together with safety data collected through pharmacoepidemiologic studies, literature and spontaneous reporting, potential adverse drug reactions can be better identified in marketed products. In summary, the information outlined in this paper provides a valuable benchmark for risk management and pharmacovigilance in pharmaceutical development.

  1. 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

  2. Pharmacogenovigilance: a pharmacogenomics pharmacovigilance program.

    Science.gov (United States)

    Awada, Zeinab; Zgheib, Nathalie Khoueiry

    2014-04-01

    In this report, we review the importance of pharmacovigilance in detecting postmarketing adverse drug events and the potential for developing pharmacogenovigilance programs by integrating pharmacogenomics with pharmacovigilance. We propose to start developing such a program in primary healthcare systems that use basic features of electronic medical records and have access to large numbers of patients commonly prescribed drugs. Such programs, if carefully designed, may grow over time and hopefully enhance the collection and interpretation of useful data for the clinical applications of pharmacogenomics testing.

  3. 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...

  4. 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 ...

  5. [Pharmacovigilance of major parmaceutical innovation].

    Science.gov (United States)

    Xiang, Yongyang; Xie, Yanming; Yi, Danhui

    2011-10-01

    With the continuous improvement of international "pharmacovigilance" technology and methods,it becomes the key part of the post-marketing evaluation. This issue is based on this research background, and also means to find out the Chinese medicine safety monitor which consistents with the reality. A common problem is that those who choose a career in pharmacovigilance know how the complex data presented to us are a source of both fascination and frustration. In the 70's, for the first time data mining technology in the international pharmacovigilance turn up, we try to establish new signal detection method to make contributes to post-marketing evaluation of Chinese medicine and establishment of registration. Building the national adverse reaction reporting database is widely used in western country. Nature of the problem is that pharmacovigilance issues can come through a lot of assumptions into the statistical problems, different assumptions are for different statistical tests. Through the traditional imbalance between the proportion of fourfold table for other assumptions, few countries use in practice, this does not involve evidence, but this issue provides the introduce of the principle. Methods include the ratio of the report of the Netherlands (ROR), the proportion of reports than the UK ratio (PRR),WHO's information points (IC), the U.S. Food and Drug Administration empirical Bayes (EBS), etc. Because there is no international gold standard of the signal detection method, at first we use the simulation comparing these four methods of data mining, From the point of specificity, the sample size demand, this issue views the advantages and disadvantages of four methods and application conditions,and from a technical point of view and try to propose a new signal detection method, for example, Hierarchical Bayesian. PMID:22292378

  6. 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

  7. Pharmacovigilance and the Italian Medicines Agency

    Directory of Open Access Journals (Sweden)

    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.

  8. Developing a consumer reporting program in Malaysia: a novel initiative to improve pharmacovigilance.

    Science.gov (United States)

    Palaian, Subish; Alshakka, Mohammed; Mohamed Izham

    2010-02-01

    The national pharmacovigilance program in Malaysia is limited to very few centers and under-reporting of adverse drug reactions (ADRs) is a major limitation. Studies from developed countries have documented the importance and usefulness of consumer reporting of ADRs. Involving consumers in ADR reporting can be very useful in improving the reporting rates in Malaysia. The present article highlights the proposed plan of initiating a consumer based pharmacovigilance program in University Wellness Center located inside the campus of the Universiti Sains Malaysia, Penang, Malaysia.

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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

  15. 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...

  16. Emergence of Klebsiella pneumoniae carrying blaVIM and blaKPC genes

    OpenAIRE

    Meletis, G; Tzampaz, E; Protonotariou, E.; Sofianou, D

    2010-01-01

    A Klebsiella pneumoniae clinical isolate resistant to imipenem was recovered from a wound sample. The patient, a 57-year-old man, underwent a surgical resection of small bowel and sigmoid colon and was treated with multiple courses of antimicrobials. PCR analysis revealed that the clinical isolate was carrying simultaneously blaVIM-1, blaKPC-2, blaSHV and blaTEM genes. The concomitant presence of these genes is alarming and poses therapeutic as well as infection control problems.

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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.

  2. 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...

  3. [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

  4. 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.

  5. 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.

  6. Biosimilar medical products - licensing, pharmacovigilance and interchangeability.

    Science.gov (United States)

    Grozdanova, Aleksandra; Netkovska, Katerina Ancevska; Sterjev, Zoran; Naumovska, Zorica; Zarevski, Rubin; Dimovski, Aleksandar; Suturkova, Ljubica

    2016-01-01

    The use of biological medicine has significantly increased in recent decades and has made substantial contributions to improving the effectiveness of therapies in many diseases. The expiration of patents of biological innovative medicines enables copies of those drugs called similar biological products (biosimilars) to be approved by regulatory authorities and to enter in clinical use. Biosimilars are comparable but not identical and are not a generic version of the innovator biological product. Although biosimilars undergo rigorous characterization as well as clinical studies to prove their safety and effectiveness, specific regulatory requirements for registration apply in the case of biosimilars. They are highly complex molecules and small changes in the production process can have major implications in its safety and effectiveness profile. The availability of biosimilars enhances competition, with the potential to improve patient access to biological medicines and to contribute to the financial sustainability of healthcare systems. In order to be certain that a biosimilar reaches its potential in clinical use, an intensive pharmacovigilance monitoring system must be established in order to prove the true similarity between the original biologic and its biosimilar. There is a need for further guidance and resolution of the ongoing discussions on biosimilar labelling, naming, pharmacovigilance and substitution in order to ensure effective and appropriate use of biosimilars in clinical practice. PMID:27442414

  7. 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

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

    Science.gov (United States)

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

    2015-01-01

    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

  9. 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.

  10. 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...

  11. 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 ...

  12. 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.

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

    Science.gov (United States)

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

    2016-10-01

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

  14. Development of a multiplex PCR system and its application in detection of blaSHV, blaTEM, blaCTX-M-1, blaCTX-M-9 and blaOXA-1 group genes in clinical Klebsiella pneumoniae and Escherichia coli strains.

    Science.gov (United States)

    Ogutu, James O; Zhang, Qingmeng; Huang, Ying; Yan, Huo; Su, Lijie; Gao, Bo; Zhang, Wenli; Zhao, Jizi; Cai, Wenhui; Li, Wenjing; Zhao, Hong; Chen, Yang; Song, Wuqi; Chen, Xiaobei; Fu, Yingmei; Zhang, Fengmin

    2015-12-01

    Resistance to β-lactam antibiotics through β-lactamase production by Enterobacteriaceae continues to burden the health-care sector worldwide. Traditional methods for detection of β-lactamases are time-consuming and labor-intensive and newer methods with varying capabilities continue to be developed. The objective of this study was to develop a multiplex PCR (M-PCR) system for the detection of blaSHV, blaTEM, blaCTX-M-1, blaCTX-M-9 and blaOXA-1 group genes and to apply it in clinical Klebsiella pneumoniae and Escherichia coli strains. To do this, we used group-specific PCR primers in singleplex reactions followed by optimization into multiplex reactions. Specificity and sensitivity of the M-PCR were then evaluated using 58 reference strains before its application to detect bla group genes in 203 clinical Enterobacteriaceae strains. PCR amplicons were sequenced to determine the β-lactamase subtypes. The M-PCR system exhibited 100% specificity and sensitivity. In all, 83.7% of K. pneumoniae and 89.8% of E. coli clinical strains harbored bla group genes with 46.9%, 40.1%, 15.0%, 21.1% and 6.1% of K. pneumoniae having blaSHV, blaTEM, blaCTX-M-1, blaCTX-M-9 and blaOXA-1 group genes, respectively, whereas 12.2%, 77.6%, 22.4%, 36.7% and 8.2% of E. coli had blaSHV, blaTEM, blaCTX-M-1, blaCTX-M-9 and blaOXA-1 group genes, respectively. BlaSHV-1, blaSHV-11, blaSHV-27, blaSHV-33, blaSHV-144, blaTEM-1, blaTEM-135, blaOXA-1, blaCTX-M-3, blaCTX-M-9, blaCTX-M-14, blaCTX-M-15, blaCTX-M-27, blaCTX-M-55, blaCTX-M-65 and blaCTX-M-104 were detected. In conclusion, the M-PCR system was efficient and versatile with an advantage of simultaneously detecting all the targeted bla group genes. Hence, it is a potential candidate for developing M-PCR kits for the screening of these genes for clinical or epidemiological purposes. PMID:26104141

  15. 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.

  16. 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. ...

  17. 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

  18. Automated support for pharmacovigilance: a proposed system.

    Science.gov (United States)

    Bright, Roselie A; Nelson, Robert C

    2002-03-01

    Governments, manufacturers, and other entities are interested in adverse event surveillance of marketed medical products. FDA's Center for Drug Evaluation and Research redesigned the post-marketing adverse reaction surveillance process to use the advantages of new technology. As part of this effort, a 'Pharmacovigilance Working Group' designed a new strategy for the review and analyses of adverse event reports received by FDA. It created requirements which divided signal detection into five tiers: (1) Single 'urgent' reports would be sent to reviewers' workstations nightly for immediate attention. Reviewers would be able to customize definitions of 'urgent' (events that should not wait for aggregate review). (2) Single urgent reports would be placed in a context matrix containing historical counts of similar events to aid in initial interpretation. (3) In this first level of aggregate review, graphical displays would highlight patterns within all the reports, both urgent and non-urgent, and (4) periodic drug-specific tabled-based reports would display the newly received reports across a pre-defined variety of displays. These four tiers would produce passive and criteria-based results which would be presented to safety reviewers' electronic workstations. (5) Active query capabilities (routine, such as age, sex, and year distributions, as well as ad hoc) would be available for exploring alerted issues. The historical database would be migrated into the new format. All historical and new reaction data would be coded with the new MedDRA (Medical Dictionary for Regulatory Activities) scheme. The strategy was to design a full data capture system which effectively exploits current computing advances and technical performance to automate many aspects of initial adverse event review, supporting more efficient and effective clinical assessment of safety signals.

  19. 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.

  20. 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

  1. 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...

  2. 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.

  3. 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...

  4. 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...

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

    Directory of Open Access Journals (Sweden)

    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.

  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. Pharmacovigilance and Moroccan Tuberculosis Public Program: Current Situation

    Directory of Open Access Journals (Sweden)

    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.

  9. 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.

  10. Imipenem-resistant Acinetobacter baumannii carrying the ISAba1-bla OXA-23, 51 and ISAba1-bla ADC-7 genes in Monteria, Colombia

    Directory of Open Access Journals (Sweden)

    Pedro Martínez

    2012-12-01

    Full Text Available The purpose of this study was to identify the genes coding for resistance to ceftazidime and imipenem and describe the molecular epidemiology of A. baumannii strains isolated from a clinical center in Colombia. Twenty isolates of imipenem-resistant A. baumannii from an equal number of patients with nosocomial infections were obtained. Primers were used to amplify genes bla IMP, bla VIM, bla OXA-23, bla OXA-24, bla OXA-58, bla OXA-51 and bla ADC-7. To detect insertion sequences ISAba1/bla OXA-23, ISAba1/bla OXA-51 and ISAba1/bla ADC-7, mapping by PCR using combinations of reverse primers ISAba1 and reverse primers of bla OXA-23, bla OXA-51 and bla ADC-7 were used. The amplification products were purified and cloned into PCR 2.1-TOPO vector and transformed into chemically competent Escherichia coli TOP10. These amplicons were then sequenced. PFGE was performed on DNA of A. baumannii isolates digested with ApaI. Results. The DNA profiles obtained included 9 clusters with, four 2-7 isolates per profile, and 5 single-isolate profiles. Of the 20 isolates resistant to imipenem, 15 carried bla OXA-23 gene, 4 contained ISAba1 upstream of bla OXA-51 gene, and 6 contained ISAba1 upstream of bla OXA-23 gene. Eighteen of these isolates carried the bla ADC-7 gene, with 9 of the isolates having ISAba1 located upstream of this gene. This is the first report of the ISAba1 /ADC-7 associated with OXAs genes in A. baumannii isolates from Colombia.

  11. 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

  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. 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

  14. First Report of bla(IMP-8) in Raoultella planticola.

    Science.gov (United States)

    Tseng, Sung-Pin; Wang, Jann-Tay; Liang, Chih-Yuan; Lee, Pei-Shan; Chen, Yee-Chun; Lu, Po-Liang

    2014-01-01

    Two carbapenem-resistant Raoultella planticola clinical isolates were isolated from patients with pneumonia and Port-A catheter-related bacteremia, respectively, in Taiwan. These isolates remained susceptible to fluoroquinolone, aminoglycoside, and colistin. Though the two isolates had the same antibiogram, plasmidic carbapenemase blaIMP-8, class 1 integron cassette (dfrA12-orfF-aadA2), and qnrB2, they had different pulsed-field gel electrophoresis patterns, plasmid sizes, and outer membrane protein loss profiles. To our knowledge, this is the first report of blaIMP-8 found in R. planticola. Interestingly, blaIMP-8 is the most common carbapenemase found in Klebsiella pneumoniae in Taiwan. In the literature, carbapenemase genes in R. planticola in each country were also found in carbapenem-resistant Enterobacteriaceae in the same country.

  15. Worldwide Diversity of Klebsiella pneumoniae That Produce β-Lactamase blaKPC-2 Gene1

    OpenAIRE

    Cuzon, Gaëlle; Naas, Thierry; Truong, HaVy; Villegas, Maria-Virginia; Wisell, Karin T.; Carmeli, Yehuda; Ana C. Gales; Navon-Venezia, Shiri; Quinn, John P.; Nordmann, Patrice

    2010-01-01

    Klebsiella pneumoniae isolates that produce carbapenemases (KPCs) are rapidly disseminating worldwide. To determine their genetic background, we investigated 16 bla KPC-2-harboring K. pneumoniae isolates from 5 countries. The isolates were multidrug resistant, possessed the bla KPC-2 gene, and differed by additional β-lactamase content. They harbored a naturally chromosome-encoded bla gene (bla SHV-1 [12.5%], bla SHV-11 [68.7%], or bla OKP-A/B [18.8%]) and several acquired and plasmid-encoded...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. Detection of Extended Spectrum B-Lactamases in Urinary Isolates of Klebsiella pneumoniae in Relation to BlaSHV , BlaTEM and BlaCTX-M Gene Carriage

    OpenAIRE

    Eftekhar, F; Rastegar, M; Golalipoor, M; MansourSamaei, N

    2012-01-01

    Background Resistance to contemporary broad-spectrum β-lactam antibiotics mediated by extended-spectrum β-lactamases (ESBLs) is increasing worldwide. Klebsiella pneumoniae, an important cause of nosocomial and community acquired urinary tract infections has rapidly become the most common ESBL producing organism. We examined ESBL production in urinary isolates of K. pneumoniae in relation to the presence of bla SHV , bla TEM and bla CTX-M genes. Methods: Antibiotic resistance of 51 clinical is...

  2. Detection of Extended Spectrum Β-Lactamases in Urinary Isolates of Klebsiella Pneumoniae in Relation to BlaSHV, BlaTEM and BlaCTX-M Gene Carriage

    OpenAIRE

    MansourSamaei, N; Eftekhar, F; Golalipoor, M; Rastegar, M

    2012-01-01

    Background: Resistance to contemporary broad-spectrum b-lactam antibiotics mediated by extended-spectrum b-lactamases (ESBLs) is increasing worldwide. Klebsiella pneumoniae, an important cause of nosocomial and community acquired urinary tract infections has rapidly become the most common ESBL producing organism. We examined ESBL production in urinary isolates of K. pneumoniae in relation to the presence of blaSHV, blaTEM and blaCTX-M genes.Methods: Antibiotic resistance of 51 clinical isolat...

  3. 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...

  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.

    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

  5. 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

  6. Preliminary Study on Traditional Chinese Medicine Pharmacovigilance%中药药物警戒初探

    Institute of Scientific and Technical Information of China (English)

    梁丽娟; 赵奎君

    2011-01-01

    OBJECTIVE:To discuss the theory of traditional Chinese medicine (TCM) pharmacovigilance preliminarily, and to provide reference for the development of TCM pharmacovigilance. METHODS: By summarizing the origin, definition and development of pharmacovigilance theory and comparing with the theory of traditional pharmacovigilance in China, TCM pharmacovigilance was discussed preliminarily. RESULTS: The carrying out of TCM Pharmacovigilance should supervise the whole process from cultivation, collection, processing to production, post-marketing study to rational clinical usage of TCM, especially the supervision of toxic herbs. CONCLUSION: The constant perfection of TCM pharmacovigilance need to pay attention to the safety problems in the application of TCM.%目的:对中药药物警戒理论进行初步探讨,为中药药物警戒工作的开展提供依据.方法:整理药物警戒理论的起源、定叉和发展,与我国传统药物警戒理论进行对比,并进一步对中药药物警戒工作的主要内容进行探讨.结果:开展药物警戒工作除应对中药的种植、采集、加工炮制乃至生产、上市后进行监管外,还应对合理的临床应用的全过程进行监管,尤其应加强对有毒中药的监控.结论:重视中药使用过程中的安全性问题才能不断地完善中药药物警戒工作.

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

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    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

  9. Pharmacovigilance, risks and adverse effects of self-medication.

    Science.gov (United States)

    Montastruc, Jean-Louis; Bondon-Guitton, Emmanuelle; Abadie, Delphine; Lacroix, Isabelle; Berreni, Aurélia; Pugnet, Grégory; Durrieu, Geneviève; Sailler, Laurent; Giroud, Jean-Paul; Damase-Michel, Christine; Montastruc, François

    2016-04-01

    Self-medication means resorting to one or more drugs in order to treat oneself without the help of a doctor. This phenomenon is developing fast. In this review, we will discuss the main definitions of self-medication; we will then present a few important characteristics of this therapeutic practice: prevalence, reasons, populations involved and drugs used. Whilst the theoretical risks of self-medication have been abundantly discussed in the literature (adverse effects, interactions, product, dosage or treatment duration errors, difficulty in self-diagnosis, risk of addiction or abuse…), there is in fact very little detailed pharmacovigilance data concerning the characteristics and the consequences of this usage in real life. This study therefore describes the all too rare data that is available: patients, clinical characteristics, "seriousness" and drugs involved in the adverse effects of self-medication. It also discusses leads to be followed in order to minimize medication risks, which are obviously not well known and clearly not sufficiently notified.

  10. 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

  11. Successful treatment of a Carbapenem-resistant Klebsiella pneumoniae carrying bla OXA-48 , bla VIM-2 , bla CMY-2 and bla SHV- with high dose combination of imipenem and amikacin.

    Science.gov (United States)

    Hajjej, Zied; Gharsallah, Hedi; Naija, Habiba; Boutiba, Ilhem; Labbene, Iheb; Ferjani, Mustapha

    2016-01-01

    We describe a case of 58-year-old man with septic shock due to Carbapenem-resistant Klebsiella pneumoniae (CR-Kp) bloodstream infections (BSI) who was successfully treated with a high dose association of amikacin and imipenem combined with continuous venovenous hemodiafiltration (CVVHDF). A Klebsiella pneumoniae (Kp) was isolated from the catheter culture and from two blood samples, drawn from the catheter before removal and from a peripheral vein. The Kp was intermediate to Amikacin (MIC = 16 μg/ml) and was resistant to all other antibiotics including Imipenem (MIC = 4 μg/ml), Colistin (MIC = 16 μg/ml) and Tigecycline (MIC = 4 μg/ml) according to the Clinical and Laboratory Standards Institute (CLSI) published in 2011. PCR amplification and sequencing verified the presence of blaOXA-48, blaVIM-2, blaCMY-2 and blaSHV-1 genes. Amikacin was given at a dose of 30 mg/kg (2.5 g) in a 30 min infusion and the dose of imipenem was increased to 1 g every 6 h despite patient's altered renal function (Creatinine Clearance = 25 ml/min). To avoid amikacin nephrotoxicity and to allow the use of high doses of imipenem, continuous venovenous hemodiafiltration (CVVHDF) (blood flow, 200 ml/h; dialysate, 1000 ml/h; ultrafiltrate, 2000 ml/h) was initiated 1 h after the start of the amikacin infusion and continued thereafter. The patient improved hemodynamically and norepinephrine was stopped five days after antibiotherapy adaptation.

  12. Successful treatment of a Carbapenem-resistant Klebsiella pneumoniae carrying bla OXA-48 , bla VIM-2 , bla CMY-2 and bla SHV- with high dose combination of imipenem and amikacin.

    Science.gov (United States)

    Hajjej, Zied; Gharsallah, Hedi; Naija, Habiba; Boutiba, Ilhem; Labbene, Iheb; Ferjani, Mustapha

    2016-01-01

    We describe a case of 58-year-old man with septic shock due to Carbapenem-resistant Klebsiella pneumoniae (CR-Kp) bloodstream infections (BSI) who was successfully treated with a high dose association of amikacin and imipenem combined with continuous venovenous hemodiafiltration (CVVHDF). A Klebsiella pneumoniae (Kp) was isolated from the catheter culture and from two blood samples, drawn from the catheter before removal and from a peripheral vein. The Kp was intermediate to Amikacin (MIC = 16 μg/ml) and was resistant to all other antibiotics including Imipenem (MIC = 4 μg/ml), Colistin (MIC = 16 μg/ml) and Tigecycline (MIC = 4 μg/ml) according to the Clinical and Laboratory Standards Institute (CLSI) published in 2011. PCR amplification and sequencing verified the presence of blaOXA-48, blaVIM-2, blaCMY-2 and blaSHV-1 genes. Amikacin was given at a dose of 30 mg/kg (2.5 g) in a 30 min infusion and the dose of imipenem was increased to 1 g every 6 h despite patient's altered renal function (Creatinine Clearance = 25 ml/min). To avoid amikacin nephrotoxicity and to allow the use of high doses of imipenem, continuous venovenous hemodiafiltration (CVVHDF) (blood flow, 200 ml/h; dialysate, 1000 ml/h; ultrafiltrate, 2000 ml/h) was initiated 1 h after the start of the amikacin infusion and continued thereafter. The patient improved hemodynamically and norepinephrine was stopped five days after antibiotherapy adaptation. PMID:27051575

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

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    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.

  14. 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.

  15. [Nalmefene and Opioid Withdrawal Syndrome: Analysis of the Global Pharmacovigilance Database for Adverse Drug Reactions].

    Science.gov (United States)

    Dahmke, Hendrike; Kupferschmidt, Hugo; Kullak-Ublick, Gerd A; Weiler, Stefan

    2015-10-14

    Nalmefene (Selincro®) is a selective opioid receptor antagonist, licensed in April 2014 in Switzerland for the reduction of alcohol consumption in adults with a high drinking risk level. 200 reports of adverse drug reactions of nalmefene have been documented worldwide in the WHO global pharmacovigilance database between 7th March 1997 to 1st March 2015. In 21 cases (10,5%) nalmefene and an opioid were administered concomitantly, causing withdrawal symptoms. Until now, the regional pharmacovigilance center in Zurich received four cases of nalmefene combined with opioids. This combination should be avoided.

  16. Epidemic plasmid carrying bla(CTX-M-15 in Klebsiella penumoniae in China.

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    Chao Zhuo

    Full Text Available 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 analysis and replicon typing. RESULTS: A total of 47CTX-M-15 ESBL-producing isolates of K. pneumoniae were collected from nine hospitals in China from October 2007 to October 2008. Isolates were clustered into various clonal groups. The local spread of bla(CTX-M-15 was mainly mediated by one major conjugative plasmid as determined by S1-PFGE and restriction analysis. A 90-kb plasmid belonging to incompatible group FII was the major carrier of bla(CTX-M-15 in K. pneumoniae. Except bla(TEM-1, the resistance genes such as bla(SHV, bla(DHA-1, bla(OXA-1, qnrB, qnrS, aac(3-II, and aac(6'-Ib were not found in the plasmid. In the comparing of conjugative gene sequence, it is 100% identical with the plasmid pKF3-94, which was found in K. pneumonia from Zhejiang province of china previously. CONCLUSIONS: bla(CTX-M-15 was prevalent in K. pneumonia of southern China. The dissemination of bla(CTX-M-15 appeared to be due to the horizontal transfer of a 90-kb epidemic plasmid.

  17. 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.

  18. 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

  19. 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

  20. 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

  1. 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.

  2. Clinical Performance of Check-Direct CPE, a Multiplex PCR for Direct Detection of bla(KPC), bla(NDM) and/or bla(VIM), and bla(OXA)-48 from Perirectal Swabs.

    Science.gov (United States)

    Lau, Anna F; Fahle, Gary A; Kemp, Margaret A; Jassem, Agatha N; Dekker, John P; Frank, Karen M

    2015-12-01

    We evaluated the clinical performance of Check-Direct CPE for carbapenemase detection directly from 301 perirectal swabs (258 patients) in a nonoutbreak setting. Culture of a PCR-confirmed, carbapenemase-containing organism, or history of colonization with such organism within the previous 2 weeks, was used as the reference standard. Check-Direct CPE demonstrated a sensitivity value, specificity value, positive predictive value (PPV), and negative predictive value (NPV) of 100% (all bla(KPC)), 88%, 21%, and 100%, respectively. False positives accounted for 79% (n = 34) of samples for which a cycle threshold (C(T)) value was reached. Simulated studies to evaluate specimen pooling as an approach to minimize costs showed no difference in C(T) values for pooled groups of three or five that each contained a single specimen spiked with ∼1,500 CFU bla(KPC) Klebsiella pneumoniae; however, the detection rate dropped to 60% at a seeded concentration of ∼150 CFU. When data were pooled, C(T) values for bla(KPC) were higher for heavy-feces-containing than for light-feces-containing liquid-suspended specimens. Furthermore, C(T) values for liquid-suspended specimens were 4 to 5 C(T) values lower (i.e., represented greater sensitivity) than those seen in direct swab analysis. Culture was equivalent to or better than Check-Direct CPE for 13/15 (87%) isolates tested in a limit-of-detection analysis. Detection of a carbapenemase gene at a C(T) cutoff value of ≤35 was culture confirmed in 23/24 (96%) of cases; however, C(T) values of >35 overlapped broadly between culture-positive (n = 21) and culture-negative (n = 36) specimens. Check-Direct CPE will likely prove most useful in high-prevalence areas or in outbreak settings where rapid carbapenemase detection is critical for infection control management. PMID:26338860

  3. 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

  4. 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

  5. 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

  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. 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

  8. 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

    . The localization of blaZ was determined by Southern blotting in 108 isolates. Results: All penicillin-resistant strains carried blaZ and showed a similar organization of blaR1 and blaZ. The blaZ gene was localized to a plasmid in only 16 of the resistant strains. Sixty-nine sequences representing 105 isolates......Objectives: To elucidate the diversity and evolutionary history of plasmid- and chromosomally-located blaZ, to detect indications of frequent exchange of blaZ between human and bovine staphylococci and to estimate the frequency of transfer of blaZ between coagulase-negative staphylococci (Co......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...

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

    DEFF Research Database (Denmark)

    Bielak, Eliza Maria; Bergenholtz, Rikke D.; Jørgensen, Mikael Skaanning;

    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...... of self-transfer to a plasmid-free E. coli recipient. CONCLUSIONS: The blaTEM-52 gene found in humans could have been transmitted on transferable plasmids originating from animal sources. Some of the blaTEM-52 plasmids carry replicons that differ from the classical ones. Two novel replicons were detected...

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

    Directory of Open Access Journals (Sweden)

    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 .

  11. 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.

  12. 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.

  13. Pharmacovigilance of herbal medicines: the potential contributions of ethnobotanical and ethnopharmacological studies.

    Science.gov (United States)

    Rodrigues, Eliana; Barnes, Joanne

    2013-01-01

    Typically, ethnobotanical/ethnopharmacological (EB/EP) surveys are used to describe uses, doses/dosages, sources and methods of preparation of traditional herbal medicines; their application to date in examining the adverse effects, contraindications and other safety aspects of these preparations is limited. From a pharmacovigilance perspective, numerous challenges exist in applying its existing methods to studying the safety profile of herbal medicines, particularly where used by indigenous cultures. This paper aims to contribute to the methodological aspects of EB/EP field work, and to extend the reach of pharmacovigilance, by proposing a tool comprising a list of questions that could be applied during interview and observational studies. The questions focus on the collection of information on the safety profile of traditional herbal medicines as it is embedded in traditional knowledge, as well as on identifying personal experiences (spontaneous reports) of adverse or undesirable effects associated with the use of traditional herbal medicines. Questions on the precise composition of traditional prescriptions or 'recipes', their preparation, storage, administration and dosing are also included. Strengths and limitations of the tool are discussed. From this interweaving of EB/EP and pharmacovigilance arises a concept of ethnopharmacovigilance for traditional herbal medicines: the scope of EB/EP is extended to include exploration of the potential harmful effects of medicinal plants, and the incorporation of pharmacovigilance questions into EB/EP studies provides a new opportunity for collection of 'general' traditional knowledge on the safety of traditional herbal medicines and, importantly, a conduit for collection of spontaneous reports of suspected adverse effects. Whether the proposed tool can yield data sufficiently rich and of an appropriate quality for application of EB/EP (e.g. data verification and quantitative analysis tools) and pharmacovigilance

  14. 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

  15. 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 ...

  16. OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications.

    Science.gov (United States)

    Böhm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Höcker, Jan

    2016-01-01

    Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs. PMID:27326858

  17. 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...

  18. 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 ...

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

    Science.gov (United States)

    Ezaki, Asami; Hori, Akiko

    2013-03-01

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

  20. 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.

  1. 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...

  2. 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...

  3. 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

  4. 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...

  5. 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...

  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. 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

  8. Paediatric pharmacovigilance: use of pharmacovigilance data mining algorithms for signal detection in a safety dataset of a paediatric clinical study conducted in seven African countries.

    Directory of Open Access Journals (Sweden)

    Dan K Kajungu

    Full Text Available BACKGROUND: Pharmacovigilance programmes monitor and help ensuring the safe use of medicines which is critical to the success of public health programmes. The commonest method used for discovering previously unknown safety risks is spontaneous notifications. In this study we examine the use of data mining algorithms to identify signals from adverse events reported in a phase IIIb/IV clinical trial evaluating the efficacy and safety of several Artemisinin-based combination therapies (ACTs for treatment of uncomplicated malaria in African children. METHODS: We used paediatric safety data from a multi-site, multi-country clinical study conducted in seven African countries (Burkina Faso, Gabon, Nigeria, Rwanda, Uganda, Zambia, and Mozambique. Each site compared three out of four ACTs, namely amodiaquine-artesunate (ASAQ, dihydroartemisinin-piperaquine (DHAPQ, artemether-lumefantrine (AL or chlorproguanil/dapsone and artesunate (CD+A. We examine two pharmacovigilance signal detection methods, namely proportional reporting ratio and Bayesian Confidence Propagation Neural Network on the clinical safety dataset. RESULTS: Among the 4,116 children (6-59 months old enrolled and followed up for 28 days post treatment, a total of 6,238 adverse events were reported resulting into 346 drug-event combinations. Nine signals were generated both by proportional reporting ratio and Bayesian Confidence Propagation Neural Network. A review of the manufacturer package leaflets, an online Multi-Drug Symptom/Interaction Checker (DoubleCheckMD and further by therapeutic area experts reduced the number of signals to five. The ranking of some drug-adverse reaction pairs on the basis of their signal index differed between the two methods. CONCLUSIONS: Our two data mining methods were equally able to generate suspected signals using the pooled safety data from a phase IIIb/IV clinical trial. This analysis demonstrated the possibility of utilising clinical studies safety data

  9. 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.

  10. 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

  11. 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.

  12. 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

  13. 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.

  14. 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

  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. How to identify Raoultella spp. including R. ornithinolytica isolates negative for ornithine decarboxylase? The reliability of the chromosomal bla gene.

    Science.gov (United States)

    Walckenaer, Estelle; Leflon-Guibout, Véronique; Nicolas-Chanoine, Marie-Hélène

    2008-12-01

    Although Raoultella planticola and Raoultella ornithinolytica were described more than 20 years ago, identifying them remains difficult. The reliability of the chromosomal bla gene for this identification was evaluated in comparison with that of the 16S rDNA and rpoB genes in 35 Raoultella strains from different origins. Of the 26 strains previously identified as R. planticola by biochemical tests alone or in association with molecular methods, 21 harboured a bla gene with 99.8% identity with the bla gene of two reference R. ornithinolytica strains (bla(ORN) gene) and 5 harboured a bla gene with 99.2% identity with the bla gene of two reference R. planticola strains (bla(PLA) gene). The 9 isolates previously identified as R. ornithinolytica harboured a bla(ORN) gene. The bla gene-based identification was confirmed by 16S rDNA and rpoB sequencing. The 21 isolates newly identified as R. ornithinolytica had a test negative for ornithine decarboxylase (ODC). Molecular experiments suggested one copy of ODC-encoding gene in both ODC-negative R. ornithinolytica and R. planticola strains and two copies in ODC-positive R. orninthinolytica strains. Analysis of the 35 bla genes allowed us (i) to confirm an identity of only 94% between the bla genes of the two Raoultella species while this identity was > 98% for rpoB and > 99% for 16S rDNA genes and (ii) to develop and successfully apply a bla PCR RFLP assay for Raoultella spp. identification. Overall, this study allowed us to discover ODC-negative R. ornithinolytica and to provide a reliable Raoultella identification method widely available as not requiring sequencing equipment.

  17. Identification of Acinetobacter baumannii by detection of the blaOXA-51-like carbapenemase gene intrinsic to this species.

    Science.gov (United States)

    Turton, Jane F; Woodford, Neil; Glover, Judith; Yarde, Susannah; Kaufmann, Mary E; Pitt, Tyrone L

    2006-08-01

    bla(OXA-51-like) was sought in clinical isolates of Acinetobacter species in a multiplex PCR, which also detects bla(OXA-23-like) and class 1 integrase genes. All isolates that gave a band for bla(OXA-51-like) identified as A. baumannii. This gene was detected in each of 141 isolates of A. baumannii but not in those of 22 other Acinetobacter species.

  18. Characterization of the genetic environment of the blaKPC-2 gene among Klebsiella pneumoniae isolates from a Chinese Hospital.

    Science.gov (United States)

    Shen, Pinghua; Zhang, Ying; Li, Gang; Jiang, Xiaofei

    2016-01-01

    Infection caused by carbapenem-resistant Klebsiella pneumoniae has become a major healthcare threat and KPC-2 enzyme is a dominant factor mediating carbapenems resistance in K. pneumoniae. This study was designed to determine the genetic environment of blaKPC-2, which prevailed in clinical K. pneumoniae isolates recovered in Huashan Hospital, Shanghai, China. Forty-two clinical isolates were included in this study by blaKPC-2 screening. After multilocus sequence typing and plasmid analyses of PCR-based replicon typing (PBRT), junction PCR, mapping PCR and crossing PCR assays, primer walking, and amplicon sequencing were used to analyze the genetic environment of the blaKPC-2 gene. ST423, ST65, ST977, and ST11 were all detected in KPC-2-producing K. pneumoniae. Two types of blaKPC-2-bearing genetic structure were found: Tn1721-blaKPC-2-Tn3 and Tn1721-blaKPC-2-ΔTn3-IS26; and were carried in IncX and IncFII plasmids, respectively. In conclusion, the genetic environment of the blaKPC-2 gene was diverse and Tn1721-blaKPC-2-ΔTn3-IS26 was dominant in clinical K. pneumoniae isolates in Huashan Hospital. This study sheds some light on the genetic environment and should foster further studies about the mechanism of the blaKPC-2 dissemination.

  19. Comparison of serious adverse reactions between thalidomide and lenalidomide: analysis in the French Pharmacovigilance database.

    Science.gov (United States)

    Olivier-Abbal, Pascale; Teisseyre, Anne-Charlotte; Montastruc, Jean-Louis

    2013-12-01

    Thalidomide and lenalidomide are structural analogs and immunomodulatory drugs. Lenalidomide appears to have a different safety profile than thalidomide and could be less toxic, and as far as we know, we did not found any study comparing their safety profile. The objective of our study was to review and compare serious adverse drug reactions (SADRs) of thalidomide and lenalidomide spontaneously reported to the French Pharmacovigilance database. We extracted all medically confirmed spontaneous reports of SADR for lenalidomide-based regimens and thalidomide-based regimens from the French Pharmacovigilance database. A "serious" adverse drug reaction (ADR) was defined as an ADR that is fatal or life threatening, which causes hospitalization or prolongation of hospitalization, or permanent or significant disability. The study period was between marketing of 2 drugs and January 15, 2012. A total of 392 SADRs related to thalidomide-based regimens were identified in 244 patients and 377 SADRs related to lenalidomide-based regimens in 220 patients. In spite of their structural analogy, this study highlights interesting differences between lenalidomide and thalidomide's safety profile: nervous system and vascular disorders are more frequent with thalidomide-based regimens while hematologic, skin, infectious disorders and secondary primary cancers are more frequent with lenalidomide-based regimens.

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

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    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.

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

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    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.

  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. Non-O1/Non-O139 Vibrio cholerae Avian Isolate from France Cocarrying the bla(VIM-1) and bla(VIM-4) Genes.

    Science.gov (United States)

    Aberkane, Salim; Compain, Fabrice; Barraud, Olivier; Ouédraogo, Abdoul-Salam; Bouzinbi, Nicolas; Vittecoq, Marion; Jean-Pierre, Hélène; Decré, Dominique; Godreuil, Sylvain

    2015-10-01

    We describe here a non-O1/non-O139 Vibrio cholerae isolate producing both VIM-1 and VIM-4 carbapenemases. It was isolated from a yellow-legged gull in southern France. The blaVIM genes were part of a class 1 integron structure located in an IncA/C plasmid. This study emphasizes the presence of carbapenemase genes in wildlife microbiota.

  4. 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

  5. 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.

  6. 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

  7. Genetic Structure Associated with blaOXA-18, Encoding a Clavulanic Acid-Inhibited Extended-Spectrum Oxacillinase▿

    Science.gov (United States)

    Naas, Thierry; Namdari, Fatemeh; Bogaerts, Pierre; Huang, Te-Din; Glupczynski, Youri; Nordmann, Patrice

    2008-01-01

    The genetic environment of the blaOXA-18 gene encoding a peculiar clavulanic acid-inhibitable Ambler class D extended-spectrum β-lactamase was determined from the prototype OXA-18-producing Pseudomonas aeruginosa MUS clinical isolate. An 8.2-kb genomic DNA fragment containing blaOXA-18 was cloned from P. aeruginosa MUS. Although most oxacillinases are located in integrons, blaOXA-18 lacked gene cassette-specific features. It was bracketed by two duplicated sequences containing ISCR19, a novel insertion sequence of the ISCR family of mobile elements; ΔintI1, a truncated integrase gene; and a truncated Δaac6′-Ib gene cassette. It is likely that ISCR19 was at the origin of the blaOXA-18 gene mobilization by a rolling-circle transposition event followed by homologous recombination. Furthermore, analysis of the cloned genomic DNA fragment revealed the presence of the integron-containing blaOXA-20 gene. Concomitantly, three P. aeruginosa clinical isolates, displaying a synergy image as determined by double-disk diffusion tests on cloxacillin-containing plates, were isolated from three patients hospitalized in different wards over a 9-month period at the Saint-Luc University hospital (Brussels, Belgium). These isolates were positive by PCR for blaOXA-18 and blaOXA-20 genes, genetically related to P. aeruginosa MUS as determined by pulsed-field gel electrophoresis, and carried the same blaOXA-18/blaOXA-20-associated genetic structures. This report characterized the genetic elements likely at the origin of blaOXA-18 gene mobilization in P. aeruginosa and suggests the spread of oxacillin-type extended-spectrum β-lactamases in P. aeruginosa at the Saint-Luc University hospital of Brussels, Belgium. PMID:18663027

  8. 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

  9. Identification of bla KPC-2 on different plasmids of three Morganella morganii isolates.

    Science.gov (United States)

    Shi, D-S; Wang, W-P; Kuai, S-G; Shao, H-F; Huang, M

    2012-05-01

    Three Morganella morganii strains resistant to carbapenems were recovered from the surgical intensive care unit (SICU) in our hospital. Carbapenemases and extended-spectrum β-lactamases (ESBLs) were respectively detected by the modified Hodge test and the modified Clinical and Laboratory Standards Institute (CLSI) ESBL confirmatory test in all isolates. Amplification of whole-cell and plasmid DNAs extracted from isolates with primers specific for the bla (KPC) produced an amplicon confirmed to be bla (KPC-2) by sequence analysis. Pulsed-field gel electrophoresis (PFGE) typing revealed that three isolates belonged to two closely related types. Plasmids electrophoresis and restriction analysis revealed that the bla (KPC-2) was located on different plasmids. The transfer of carbapenem resistance from the three original isolates to Escherichia coli EC600 was successful by conjugation. An examination of the outer membrane proteins showed a lack of a 38-kDa outer membrane protein (OMP) compared with M. morganii susceptible to carbapenems. The production of KPC-2 and ESBLs, combined with OMP deficiency, resulted in high-level carbapenem resistance in the M. morganii strains. The genetic environment around bla (KPC-2) analysis revealed that this β-lactamase was located on the same mobile genetic elements which could transfer between different plasmids.

  10. First report of the blaVIM gene in environmental isolates of Buttiauxella sp.

    Science.gov (United States)

    Pitondo-Silva, André; Martins, Vinicius Vicente; Stehling, Eliana Guedes

    2015-04-01

    Several works have demonstrated the presence of metallo-β-lactamases (MBLs) in clinical bacteria. However, in environmental isolates, few works have reported on these enzymes. In this study, we report for the first time two environmental isolates of Buttiauxella sp. recovered from chrysanthemum plantations in Brazil containing blaVIM gene and producing MBLs.

  11. Pharmacovigilance for antiretroviral drugs in Africa, lessons from a study in Abidjan, Cote d’Ivoire

    Science.gov (United States)

    Jaquet, Antoine; Djima, Mariam Mama; Coffie, Patrick; Kacou, Henri Die; Eholie, Serge P.; Messou, Eugene; Minga, Albert; Guehi, Calixte; Yavo, Jean Claude; Bissagnene, Emmanuel; Dabis, Francois; Ekouevi, Didier K.

    2011-01-01

    Background While antiretroviral treatment (ART)-related adverse drug reactions (ADR) are documented in industrialized countries, there is no pre-existing surveillance system dedicated to ADR monitoring in most African countries. We assessed knowledge towards pharmacovigilance among ART prescribers and available capacity of HIV clinics to conduct ADR monitoring in Abidjan, Côte d’Ivoire. Methods A questionnaire was administered to ART prescribers, to assess their knowledge towards the occurrence of ADRs. A retrospective ADR survey was also conducted, based on a data query of treatment modification/interruptions in three HIV clinics. Clinical monitors went back to medical charts to review and validate the reasons of the treatment modification/interruptions. Results Of the 81 ART prescribers interviewed, 25 (31%) declared not grading ADRs and 12 (14.8%) declared notifying ADRs to the national regulatory authorities. Among 5,252 adult ART-treated patients who attended the participating clinics in 2008, 599 treatment modifications were identified. Reasons for treatment modification/interruptions identified in the electronic database were documented in the medical charts in 554 (92.5%) cases, ADR accounting for 273 (45.5%) cases. Toxicity related to ART was graded in only 58 (21%) cases in the medical charts. Discussion This study describes challenges limiting the implementation of reliable pharmacovigilance activities in HIV clinics in Côte d’Ivoire. The lack of knowledge of ART prescribers concerning ADR grading does not support the spontaneous reporting of ADRs. Using treatment modification/interruptions for ADR monitoring appears feasible but improvements are needed to respond to key questions related to drug toxicities in the context of ART scale up in Africa. PMID:21735508

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

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    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.

  13. Evaluation and pharmacovigilance of projects promoting cultivation and local use of Artemisia annua for malaria

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    Oyweka Rosalia

    2011-04-01

    Full Text Available Abstract Background Several non-governmental organisations (NGOs are promoting the use of Artemisia annua teas as a home-based treatment for malaria in situations where conventional treatments are not available. There has been controversy about the effectiveness and safety of this approach, but no pharmacovigilance studies or evaluations have been published to date. Method A questionnaire about the cultivation of A. annua, treatment of patients, and side-effects observed, was sent to partners of the NGO Anamed in Kenya and Uganda. Some of the respondents were then selected purposively for more in-depth semi-structured interviews. Results Eighteen partners in Kenya and 21 in Uganda responded. 49% reported difficulties in growing the plant, mainly due to drought. Overall about 3,000 cases of presumed malaria had been treated with A. annua teas in the previous year, of which about 250 were in children and 54 were in women in the first trimester of pregnancy. The commonest problem observed in children was poor compliance due to the bitter taste, which was improved by the addition of sugar or honey. Two miscarriages were reported in pregnant patients. Only four respondents reported side-effects in other patients, the commonest of which was vomiting. 51% of respondents had started using A. annua tea to treat illnesses other than malaria. Conclusions Local cultivation and preparation of A. annua are feasible where growing conditions are appropriate. Few adverse events were reported even in children and pregnant women. Where ACT is in short supply, it would make sense to save it for young children, while using A. annua infusions to treat older patients who are at lower risk. An ongoing pharmacovigilance system is needed to facilitate reporting of any adverse events.

  14. 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: ...

  15. 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...

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

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    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.

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

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    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.

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

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    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.

  19. Reversible Amisulpride-induced Elevation of Creatine Kinase (CK): A Case Series from the German AMSP Pharmacovigilance Project.

    Science.gov (United States)

    Laoutidis, Z G; Konstantinidis, A; Grohmann, R; Luckhaus, C; Mobascher, J; Cordes, J

    2015-07-01

    The elevation of creatine kinase (CK) levels without neuroleptic malignant syndrome has been reported for several antipsychotics. We present here 4 cases with CK elevation induced by amisulpride, which have been registered for the German pharmacovigilance project, Arzneimittelsicherheit in der Psychiatrie (AMSP). The magnitude of the CK elevation ranged between 1, 498 IU/L and 21,018 IU/L. All 4 patients reported myalgia. In each case CK returned to normal after amisulpride discontinuation. In the fourth case, fluids were administered intravenously in order to prevent acute renal failure. None of the cases showed deterioration of renal function. Finally, we present recommendations for clinical practice.

  20. Drug-induced hallucination: a case/non case study in the French Pharmacovigilance Database

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    Malak Abou Taam

    2015-03-01

    Full Text Available Background and Objectives: Hallucinations are sensory perceptions which occur without external stimuli. There are associated with psychiatric disease but also can be related to organic disease and drug or toxic exposure. The purpose of our study was to investigate the association between exposure to medications and the reporting of hallucinations using data from the spontaneous-reporting French Pharmacovigilance Database (FPVD. Methods: We used the case/noncase method in the FPVD. Cases were all the observations of hallucination with the LLT term “perception disturbances”, registered into the FPVD from January 1985 to Jan 2013. Data were expressed as odds ratio (OR with their 95% confidence intervals. Results: Among the 469,181 reports of adverse effects recorded between 1985 and 2013, 4,086 are hallucinations. For about 50% of these hallucinations were experimented by patient older than 65 years old. A statistically significant OR was found with several medications included rasagiline (OR 17.6 [95%CI 10.4-29.8], zolpidem (OR 12.9 [95%CI 11.3-14.8], methylphenidate (OR 9.3 [95%CI 5.9-14.6] and baclofene (OR 5.4 [95%CI 3.7-7.8]. An increased risk of hallucinations was also observed with non central nervous system drugs, including ertapenem (OR 24.0 [95%CI 14.2-40.5], voriconazole (OR 12.9[95%CI 10.2-16.5] and valacyclovir (OR 9.1 [95%CI 6.9-11. 9]. Conclusions: This pharmacoepidemiological study describes an association between drugs and hallucinations. This relationship involves not only some already suspected drugs but also other drugs less known to induce such an adverse reaction. Despite the mandatory limits of this kind of study, these data should lead to special precautions in patient at risk.

  1. 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.

  2. 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.

  3. Genetic environments of the transferable plasmid-mediated blaCTX-M-3 gene in Serratia marcescens isolates.

    Science.gov (United States)

    Chu, Pei-Yu; Peng, Chien-Fang

    2014-01-01

    In this study, genetic environments of the transferable plasmid-mediated blaCTX-M-3 gene were characterized among 14 isolates of cefotaxime-resistant Serratia marcescens using PCR and BLAST DNA sequence analysis. A total of 3 types of genetic architectures in the regions surrounding this blaCTX-M-3 gene were identified. Type I architecture was characterized by the presence of a complete insertion sequence of tnpA-ISEcp1, identified as interrupting a reverse IS26 sequence in the upstream region of the blaCTX-M-3 gene. A reverse-directional orf477 fragment was located downstream of the blaCTX-M-3 gene, which was in the same direction of the mucA gene. A common region containing the orf513 element was located upstream of the mucA gene. Moreover, a copy of the 3'-CS2 element was located immediately upstream of the orf513 element. A novel complex class 1 integron was characterized by the presence of the dfrA19 gene, which was flanked by two copies of class 1 integrons. This is the first report to describe the dfrA19 gene within a novel complex class 1 integron in S. marcescens isolates from Taiwan. This novel complex class 1 integron structure was located distantly upstream of the blaCTX-M-3 gene.

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

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    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

  5. 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.

  6. Lessons from gefitinib-induced interstitial lung disease in Japan: Problems in approval, pharmacovigilance, and regulatory decision-making procedures

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    Nishimura T,

    2006-12-01

    Full Text Available Objective: The objective of this study was to identify problems in the approval, pharmacovigilance, and post-approval regulatory decision-making procedures involving gefitinib and to propose countermeasures to prevent further drug-induced suffering in Japan in the future. Methods: We comprehensively reviewed reports regarding gefitinib published during the period from 2000 to 2006 by regulatory agencies, the manufacturer of the gefitinib-containing drug, cancer clinical study groups, and a scientific society.Results: We identified the following major problems in the approval, pharmacovigilance, and regulatory decision-making procedures: 1 the results of animal experiments and pre-marketing clinical trials, and reports of adverse drug reactions from other countries were not properly reflected in the label; 2 indications for the drug were expanded without strict evaluation of the external validity of pre-marketing clinical trials; and 3 despite many serious cases of interstitial lung disease (ILD being spontaneously reported, well-designed post-marketing surveillance was not immediately performed. Conclusions: We propose a mandatory total registry of all drug users and surveillance (i.e. a prospective outcome study as one of the rational solutions for preventing further drug-induced suffering in Japan.

  7. Emergence of Acinetobacter baumannii ST730 carrying the bla OXA-72 gene in Brazil

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    Pagano, Mariana; Rozales, Franciéli P; Bertolini, Diego; Rocha, Lisiane; Sampaio, Jorge LM; Barth, Afonso L; Martins, Andreza F

    2016-01-01

    Over the last decade, Acinetobacter baumannii resistant to carbapenems has emerged in many medical centres and has been commonly associated with high morbimortality. In Brazil, this resistance is mainly attributed to the spread of OXA-23-producing clones and, to a lesser extent, to OXA-143-producing clones. Here, we describe, for the first time, two OXA-72-producing A. baumannii isolates in southern Brazil to a broad spectrum of antibiotics, except polymyxin B and tigecycline. Molecular typing by multilocus sequence typing (MLST) demonstrated that both OXA-72-producing isolates belong to a new sequence type (ST), ST730, which was recently identified in OXA-23-producing A. baumannii isolates in São Paulo, Brazil. We demonstrate that the two A. baumannii ST730 isolates carrying blaOXA-72share a common ancestral origin with the blaOXA-23producers in Brazil. This observation reinforces the importance of strain-typing methods in order to clarify the dynamics of the emergence of new clones in a geographic region. PMID:27653364

  8. 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.

  9. 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

  10. 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

  11. 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.

  12. 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

  13. 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

  14. 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.

  15. 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

  16. 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

  17. 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

  18. First descriptions of blaKPC in Raoultella spp. (R. planticola and R. ornithinolytica): report from the SENTRY Antimicrobial Surveillance Program.

    Science.gov (United States)

    Castanheira, Mariana; Deshpande, Lalitagauri M; DiPersio, Joseph R; Kang, Julia; Weinstein, Melvin P; Jones, Ronald N

    2009-12-01

    Two strains of Raoultella planticola and one of Raoultella ornithinolytica showing carbapenem resistance were recovered from patients hospitalized in New Jersey and Ohio. All patients had received previous antimicrobial treatment, including carbapenems. These strains harbored bla(KPC-2) and bla(KPC-3). Carbapenemase genes were embedded in isoforms of Tn4401 and were plasmidic and chromosomal in location.

  19. Increased prevalence of carbapenem resistant Enterobacteriaceae in hospital setting due to cross-species transmission of the bla NDM-1 element and clonal spread of progenitor resistant strains.

    Science.gov (United States)

    Wang, Xuan; Chen, Gongxiang; Wu, Xiaoyan; Wang, Liangping; Cai, Jiachang; Chan, Edward W; Chen, Sheng; Zhang, Rong

    2015-01-01

    This study investigated the transmission characteristics of carbapenem-resistant Enterobacteriaceae (CRE) strains collected from a hospital setting in China, in which consistent emergence of CRE strains were observable during the period of May 2013 to February 2014. Among the 45 CRE isolates tested, 21 (47%) strains were found to harbor the bla NDM-1 element, and the rest of 24 CRE strains were all positive for bla KPC-2. The 21 bla NDM-1-borne strains were found to comprise multiple Enterobacteriaceae species including nine Enterobacter cloacae, three Escherichia coli, three Citrobacter freundii, two Klebsiella pneumoniae, two Klebsiella oxytoca, and two Morganella morganii strains, indicating that cross-species transmission of bla NDM-1 is a common event. Genetic analyses by PFGE and MLST showed that, with the exception of E. coli and E. cloacae, strains belonging to the same species were often genetically unrelated. In addition to bla NDM-1, several CRE strains were also found to harbor the bla KPC-2, bla VIM-1, and bla IMP-4 elements. Conjugations experiments confirmed that the majority of carbapenem resistance determinants were transferable. Taken together, our findings suggest that transmission of mobile resistance elements among members of Enterobacteriaceae and clonal spread of CRE strains may contribute synergistically to a rapid increase in the population of CRE in clinical settings, prompting a need to implement more rigorous infection control measures to arrest such vicious transmission cycle in CRE-prevalent areas. PMID:26136735

  20. Identification of Achromobacter xylosoxidans by detection of the bla(OXA-114-like) gene intrinsic in this species.

    Science.gov (United States)

    Turton, Jane F; Mustafa, Nazim; Shah, Jayesh; Hampton, Catherine V; Pike, Rachel; Kenna, Dervla T

    2011-07-01

    Achromobacter xylosoxidans is an emerging pathogen among patients with cystic fibrosis. Here we describe a specific PCR for identification of this organism, based on detection of bla(OXA-114-like). Comparison of isolates by pulsed-field gel electrophoresis revealed evidence of cross-infection in some cases, but most patients harbored their own strain.

  1. 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

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

    Directory of Open Access Journals (Sweden)

    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

  3. 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.

  4. 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

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

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    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.

  6. 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.

  7. Chromosomal blaCTX-M-₁₅ associated with ISEcp1 in Proteus mirabilis and Morganella morganii isolated at the Military Hospital of Tunis, Tunisia.

    Science.gov (United States)

    Mahrouki, Sihem; Belhadj, Omrane; Chihi, Hela; Mohamed, Ben Moussa; Celenza, Giuseppe; Amicosante, Gianfranco; Perilli, Mariagrazia

    2012-09-01

    This study investigated the genetic environment of bla(CTX-M) genes and associated resistance genes in seven Proteus mirabilis and six Morganella morganii extended spectrum β-lactamase (ESBL)-positive isolates. The isolates were recovered from hospitalized patients with respiratory or urinary tract infections at the Military Hospital of Tunis, Tunisia. Twenty-one of the 200 strains exhibited non-susceptibility to third generation cephalosporins and, among these strains, the double-disk synergy test confirmed the ESBL phenotype in 13 isolates. These ESBL producers were co-resistant to chloramphenicol, tetracycline and oflaxacin but remained susceptible to ertapenem (MIC<0.25 mg l(-1)). The presence and nature of bla(CTX-M-15), bla(CTX-M-8), bla(TEM-24), bla(TEM-1) and bla(TEM-2) genes was determined by PCR and sequencing. Chromosomal localization of the bla(CTX-M-15) gene was confirmed in all strains, with the exception of M. morganii isolate M-17991, by Southern-blot analysis performed either on chromosomal or plasmid DNA. M. morganii M-12012 and M. morganii M-6019 showed the same PFGE pattern, whereas the remaining CTX-M-15-producing isolates were unrelated. The presence of ISEcp1 was ascertained in CTX-M-15-producing isolates. A class 1 integron with different gene cassettes (dfrA1, orfC and aadB) was found in five P. mirabilis and six M. morganii isolates.

  8. 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.

  9. 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

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

    International Nuclear Information System (INIS)

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

  11. 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...

  12. 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 ...

  13. Double Copies of bla(KPC-3)::Tn4401a on an IncX3 Plasmid in Klebsiella pneumoniae Successful Clone ST512 from Italy.

    Science.gov (United States)

    Fortini, Daniela; Villa, Laura; Feudi, Claudia; Pires, João; Bonura, Celestino; Mammina, Caterina; Endimiani, Andrea; Carattoli, Alessandra

    2016-01-01

    A carbapenem-resistant sequence type 512 (ST512) Klebsiella pneumoniae carbapenemase 3 (KPC-3)-producing K. pneumoniae strain showing a novel variant plasmid content was isolated in Palermo, Italy, in 2014. ST512 is a worldwide successful clone associated with the spread of bla(KPC) genes located on the IncFIIk pKpQIL plasmid. In our ST512 strain, the bla(KPC-3) gene was unusually located on an IncX3 plasmid, whose complete sequence was determined. Two copies of bla(KPC-3)::Tn4401a caused by intramolecular transposition events were detected in the plasmid. PMID:26525794

  14. [Genetic Investigation of bla(CTX-M)-typing in Extended-spectrum β-lactamase-producing Escherichia coli and Klebsiella pneumoniae from Clinical Specimens and Commercially Available Chicken Liver].

    Science.gov (United States)

    Kan, Miki; Shinomiya, Hiroto; Kitao, Takashi

    2016-05-01

    A genetic investigation consisting of the bla(CTX-M) typing was performed using 40 extended spectrum β-lactamase (ESBL)-producing Escherichia coli isolates from chicken liver and 43 ESBL-producing E. coli and 42 ESBL-producing Klebsiella pneumoniae isolates from patients. The types were determined using a sequence analysis. In 31 isolates in the bla(CTX-M-1) group, there were 13 with the bla(CTX-M-1) and all were from chicken liver. Nine E. coli isolates from chicken liver and one E. coli isolate from patients were found to be bla(CTX-M-55). In the bla(CTX-M-15), there were 6 E. coli isolates and one K. pneumoniae isolate from patients. All 39 isolates in the bla(CTX-M-2) group had the blac(CTX-M-2). Fifty-five isolates were found in the bla(CTX-M-9) group, the highest detection frequency, with 36 possessing bla(CTX-M-14) : 20 E. coli and 13 K. pneumoniae from patients and 3 E. coli from chicken liver. There were 17 bla(CTX-M-27) isolates, including 10 E. coli and 7 K. pneumoniae from patients. One bla(CTX-M-90) K. pneumoniae isolate and one bla(CTX-M-9) E. coli isolate were also obtained from patients. These results indicate that the E. coli isolates from chicken liver consist of bla(CTX-M-1), bla(CTX-M-2) and bla(CTX-M-55) ; the E. coli isolates from patients consist of bla(CTX-M-14) and bla(CTX-M-27) ; and the K. pneumoniae isolates from patients consist of bla(CTX-M-2), bla(CTX-M-14) and bla(CTX-M-27). Therefore, the bla(CTX-M) type differs in isolates from chicken liver and those from humans. These results suggest that it is unlikely that ESBL-producing E. coli from chicken liver are firmly established in the human intestinal tract.

  15. [Genetic Investigation of bla(CTX-M)-typing in Extended-spectrum β-lactamase-producing Escherichia coli and Klebsiella pneumoniae from Clinical Specimens and Commercially Available Chicken Liver].

    Science.gov (United States)

    Kan, Miki; Shinomiya, Hiroto; Kitao, Takashi

    2016-05-01

    A genetic investigation consisting of the bla(CTX-M) typing was performed using 40 extended spectrum β-lactamase (ESBL)-producing Escherichia coli isolates from chicken liver and 43 ESBL-producing E. coli and 42 ESBL-producing Klebsiella pneumoniae isolates from patients. The types were determined using a sequence analysis. In 31 isolates in the bla(CTX-M-1) group, there were 13 with the bla(CTX-M-1) and all were from chicken liver. Nine E. coli isolates from chicken liver and one E. coli isolate from patients were found to be bla(CTX-M-55). In the bla(CTX-M-15), there were 6 E. coli isolates and one K. pneumoniae isolate from patients. All 39 isolates in the bla(CTX-M-2) group had the blac(CTX-M-2). Fifty-five isolates were found in the bla(CTX-M-9) group, the highest detection frequency, with 36 possessing bla(CTX-M-14) : 20 E. coli and 13 K. pneumoniae from patients and 3 E. coli from chicken liver. There were 17 bla(CTX-M-27) isolates, including 10 E. coli and 7 K. pneumoniae from patients. One bla(CTX-M-90) K. pneumoniae isolate and one bla(CTX-M-9) E. coli isolate were also obtained from patients. These results indicate that the E. coli isolates from chicken liver consist of bla(CTX-M-1), bla(CTX-M-2) and bla(CTX-M-55) ; the E. coli isolates from patients consist of bla(CTX-M-14) and bla(CTX-M-27) ; and the K. pneumoniae isolates from patients consist of bla(CTX-M-2), bla(CTX-M-14) and bla(CTX-M-27). Therefore, the bla(CTX-M) type differs in isolates from chicken liver and those from humans. These results suggest that it is unlikely that ESBL-producing E. coli from chicken liver are firmly established in the human intestinal tract. PMID:27529965

  16. IncA/C Plasmid Carrying bla(NDM-1), bla(CMY-16), and fosA3 in a Salmonella enterica Serovar Corvallis Strain Isolated from a Migratory Wild Bird in Germany.

    Science.gov (United States)

    Villa, L; Guerra, B; Schmoger, S; Fischer, J; Helmuth, R; Zong, Z; García-Fernández, A; Carattoli, A

    2015-10-01

    A Salmonella enterica serovar Corvallis strain was isolated from a wild bird in Germany. This strain carried the IncA/C2 pRH-1238 plasmid. Complete sequencing of the plasmid was performed, identifying the blaNDM-1, blaCMY-16, fosA3, sul1, sul2, strA, strB, aac(6')-Ib, aadA5, aphA6, tetA(A), mphA, floR, dfrA7, and merA genes, which confer clinically relevant resistance to most of the antimicrobial classes, including β-lactams with carbapenems, fosfomycin, aminoglycosides, co-trimoxazole, tetracyclines, and macrolides. The strain likely originated from the Asiatic region and was transferred to Germany through the Milvus migrans migratory route. PMID:26169417

  17. [The congress of the French Society of Pharmacology and Therapeutics celebrate in Nancy, 20 April 2016, 40 years of French Regional Pharmacovigilance Centres!].

    Science.gov (United States)

    Jonville-Béra, Annie-Pierre; Mallaret, Michel; Sgro, Catherine

    2016-09-01

    In 1976, the Regional Pharmacovigilance Centres were created in France to collect and analyze adverse drug reactions. Even if they have, to date, managed and transmitted more than 583,000 adverse drug reactions to the French and international health authorities, the missions of these university hospital structures supervised by clinical pharmacologists are not limited to this activity. They also provide a consulting and diagnostic aid for drug diseases. Their other main mission is information about drugs and their proper use for health professionals and patients on any matter relating to medicines. These queries are used to adjust and focus the training of health professionals in prevention of drug risks and improvement of drug use. Beside signal detection and identification of alerts, the 31 Regional Pharmacovigilance Centres collaborate with the French Drug Agency (Agence nationale de sécurité du medicament et des produits de santé [ANSM]) by achieving expertise on drugs and participation in various working groups and committees. Finally, Regional Pharmacovigilance Centres participate in scientific advancement through research and publication activities.

  18. 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.

  19. Prevalence of ESBL phenotype,blaCTX-M-1,blaSHV andblaTEM genes among uropathogenicEscherichia coli isolates from 3 military hospitals of Tehran, Iran

    Institute of Scientific and Technical Information of China (English)

    Farshad Nojoomi; Abdolmajid Ghasemian

    2016-01-01

    Objective:To determine the extended-spectrum beta-lactamase (ESBL) production and prevalence ofblaCTX-M-1,blaSHV andblaTEM genes among uropathogenic Escherichia coli(UPEC) isolates from 3 military hospitals of Tehran during 2015–2016. Methods: One-hundred and eleven isolates were adopted. The antibiotic susceptibility testing was conducted according to Clinical and Laboratory Standards Institute guidelines. The combine disk was used for phenotypicESBL production. The ceftazidimeMIC was conducted with the micro-broth dilution test. ThePCR assay was used to detect theblaCTX-M-1,blaSHV and blaTEM genes. Results:In the broth microdilution method, 103 (92.7%) isolates showed minimal inhibitory concentration (MIC)≥1µg/mL, and also in the combined disk method, 89 (80.1% of all) wereESBL positive. On the other hand, among 91 ceftazidime resistant isolates, 86 (77.4% of all) wereESBLpositive. The difference between the two methods forESBL confirmation was not significant. The result ofMIC was similar to the disk diffusion method in the detection of phenotypicESBL production. AmongESBLproducer isolates, the prevalence ofblaCTX-M-1, blaSHV andblaTEM was 77.4% (n= 86), 47.4% (n= 53) and 2.4% (n= 2), respectively. These genes were amplified in a wide rangeMIC of ceftazidime. Conclusions:The prevalence of multi-drug resistantUPEC andESBL positive isolates was high in military hospitals. The majority ofUPEC isolates amplifiedblaCTX-M-I andblaSHV typeβ-lactamase genes. One-third of isolates were positive in presence of both these genes. There was no relation between ceftazidimeMIC and presence of beta-lactamase genes.

  20. Diverse Genetic Array of blaCTXM-15 in Escherichia coli: A Single-Center Study from India.

    Science.gov (United States)

    Maurya, Anand Prakash; Mishra, Shweta; Talukdar, Anupam Das; Dhar Chanda, Debadatta; Chakravarty, Atanu; Bhattacharjee, Amitabha

    2016-01-01

    CTX-M-15 is a chief contributor for expanded-spectrum cephalosporin and monobactam resistance in India, complicating treatment options. In this study, we have investigated genetic context of CTX-M-15 in Escherichia coli and their transmission dynamics in a tertiary referral hospital of India. A total of 198 isolates were collected, of which 66 were harboring blaCTXM-15. Among them, 14 isolates were carrying a single CTX-M-15 gene and 52 were harboring multiple extended-spectrum β-lactamase genes along with blaCTX-M-15. The resistance gene was flanked by tnpA, ISEcp1, IS26, and ORF477 in 10 different arrangements. The resistance determinant was horizontally transferable through F, W, I1, and P Inc types of plasmids. Restriction mapping of plasmids showed a variable band pattern even within the same Inc types. Minimum inhibitory concentration was found above the breakpoint level against expanded-spectrum cephalosporins and monobactam while susceptible against carbapenems. blaCTX-M-15 was highly stable and sustained in the cell after 115 serial passages. In pulse-field gel electrophoresis, eight pulsotypes of E. coli were found to be responsible for the spread of blaCTX-M-15 in the tertiary referral center. We conclude that the presence of CTX-M-15 in the heterogeneous group of E. coli is highly alarming in terms of infection control and it may require regular monitoring, so as to formulate appropriate antibiotic policy to stop the spread of this resistance determinant.

  1. 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 ...

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

    Directory of Open Access Journals (Sweden)

    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.

  3. 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)...

  4. 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

  5. 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

  6. Clonal dissemination of Klebsiella pneumoniae ST512 carrying blaKPC-3 in a hospital in southern Italy.

    Science.gov (United States)

    Pulcrano, Giovanna; Iula, Dora Vita; de Luca, Cristiana; Roscetto, Emanuela; Vollaro, Antonio; Rossano, Fabio; Catania, Maria Rosaria

    2014-01-01

    Strains of Klebsiella pneumoniae producing KPC-carbapenemase have emerged as one of the most important multidrug-resistant Gram-negative nosocomial pathogens. Here, we report the first isolation and subsequent dissemination of a K. pneumoniae ST512 producing KPC-3 carbapenemase in a hospital in southern Italy. Isolates were obtained from blood, throat swabs, sputum, catheters, and urine of patients admitted to different hospital wards. Antimicrobial MICs were determined for all isolates by automated systems and confirmed by Etest. Carbapenemase production was confirmed by the modified Hodge test and by a disc synergy test, and carbapenemase genes were investigated by PCR. All isolates were characterized by pulse-field gel electrophoresis (PFGE) and multilocus sequence typing (MLST) analysis. Most isolates were multidrug resistant with exception of some isolates intermediately susceptible to gentamicin, tigecycline, and trimethoprim-sulfamethoxazole. PCR analysis showed that isolates harbored the bla(KPC-3) gene associated with bla(TEM) and bla(SVH). PFGE and MLST showed that all isolates belonged to the same ST512 clone recently described in Israel.

  7. Complete Sequence of a Novel IncR-F33:A–:B– Plasmid, pKP1034, Harboring fosA3, blaKPC-2, blaCTX-M-65, blaSHV-12, and rmtB from an Epidemic Klebsiella pneumoniae Sequence Type 11 Strain in China

    Science.gov (United States)

    Xiang, Dai-Rong; Li, Jun-Jie; Sheng, Zi-Ke; Yu, Hai-Ying; Deng, Mei; Bi, Sheng; Hu, Fei-Shu; Chen, Wei; Xue, Xiao-Wei; Zhou, Zhi-Bo; Doi, Yohei; Li, Lan-Juan

    2015-01-01

    A high fosfomycin resistance rate was observed in Klebsiella pneumoniae carbapenemase (KPC)-producing K. pneumoniae (KPC-KP) in our previous study, but little is known about its mechanisms. In this study, we explored the prevalence of plasmid-mediated fosfomycin resistance determinants among fosfomycin-resistant KPC-KP strains from a Chinese university hospital and determined the complete sequence of a novel fosA3-carrying plasmid isolated from an epidemic K. pneumoniae sequence type (ST) 11 strain. A total of 97 KPC-KP strains were studied, of which 57 (58.8%) were resistant to fosfomycin, including 44 (45.4%) harboring fosA3 and 1 harboring fosA. All fosA3-positive strains belonged to the dominant ST11-pulse type (PT) A clone according to multilocus sequence typing and pulsed-field gel electrophoresis, suggesting clonal dissemination. The fosA-positive isolate belonged to ST11-PTE. The fosA3-carrying plasmid pKP1034 is 136,848 bp in length and is not self-transmissible. It is a multireplicon plasmid belonging to IncR-F33:A−: B−. Besides fosA3, a variety of other resistance determinants, including blaKPC-2, rmtB, blaCTX-M-65, and blaSHV-12, are identified in pKP1034, which would allow for coselection of fosA3 by most β-lactams and/or aminoglycosides and facilitate its dissemination despite limited use of fosfomycin in China. Detailed comparisons with related plasmids revealed that pKP1034 is highly mosaic and might have evolved from alarming recombination of the blaKPC-2-carrying plasmid pKPC-LK30 from Taiwan and the epidemic fosA3-carrying plasmid pHN7A8 from mainland China. PMID:26666939

  8. Sequence of closely related plasmids encoding bla(NDM-1 in two unrelated Klebsiella pneumoniae isolates in Singapore.

    Directory of Open Access Journals (Sweden)

    Ying-Tsong Chen

    Full Text Available BACKGROUND: Spread of the bla(NDM-1 gene that encodes the New Delhi metallo-β-lactamase (NDM-1 in Enterobacteriaceae is a major global health problem. Plasmids carrying bla(NDM-1 from two different multi-drug resistant Klebsiella pneumonia isolates collected in Singapore were completely sequenced and compared to known plasmids carrying bla(NDM-1. METHODOLOGY/PRINCIPAL FINDINGS: The two plasmids, pTR3 and pTR4, were transferred to Escherichia coli recipient strain J53 and completely sequenced by a shotgun approach using 3-kb paired-end libraries on 454. Although the K. pneumoniae strains were unrelated by molecular typing using PFGE and MLST, complete sequencing revealed that pTR3 and pTR4 are identical. The plasmid sequence is similar to the E. coli NDM-1-encoding plasmid p271A, which was isolated in Australia from a patient returning from Bangladesh. The immediate regions of the bla(NDM-1 gene in pTR3/4 are identical to that of p271A, but the backbone of our plasmid is much more similar to another IncN2 plasmid reported recently, pJIE137, which contained an additional 5.2-kb CUP (conserved upstream repeat regulon region in comparison to p271A. A 257-bp element bounded by imperfect 39-bp inverted repeats (IR and an incomplete version of this element flanking the 3.6-kb NDM-1-encoding region were identified in these plasmids and are likely to be the vestiges of an unknown IS. CONCLUSIONS: Although the hosts are not epidemiologically linked, we found that the plasmids bearing the bla(NDM-1 gene are identical. Comparative analyses of the conserved NDM-1-encoding region among different plasmids from K. pneumoniae and E. coli suggested that the transposable elements and the two unknown IR-associated elements flanking the NDM-1-encoding region might have aided the spreading of this worrisome resistance determinant.

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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 ...

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

    Directory of Open Access Journals (Sweden)

    Helena Lutéscia Coêlho

    1999-09-01

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

  15. 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.

  16. Emerging Carbapenem-Resistant Pseudomonas aeruginosa Isolates Carrying blaIMP Among Burn Patients in Isfahan, Iran

    Science.gov (United States)

    Radan, Mohsen; Moniri, Rezvan; Khorshidi, Ahmad; Gilasi, Hamidreza; Norouzi, Zohreh; Beigi, Fahimeh; Dasteh Goli, Yasaman

    2016-01-01

    Background Metallo-β-lactamase (MBL)-producing Pseudomonas aeruginosa is a significant pathogen in burn patients. Objectives The aim of this study was to determine the prevalence of carbapenem-resistant P. aeruginosa isolates, including those resistant to imipenemase (IMP), in a burn unit in Isfahan, Iran. Patients and Methods One hundred and fifty P. aeruginosa isolates from burn patients were tested for antibiotic susceptibility by the disc diffusion method in accordance with CLSI guidelines. Production of MBL was identified with the EDTA disk method. DNA was purified from the MBL-positive isolates, and detection of the blaIMP gene was performed with PCR. Results Fifty-seven out of 150 (38%) isolates were multi-drug resistant (MDR), and 93 (62%) were extensively-drug resistant (XDR). Among all isolates, the resistance rate to ciprofloxacin, tobramycin, imipenem, meropenem, amikacin, ceftazidime, and cefepime was higher than 90%, while the resistance rates to piperacillin/tazobactam and aztreonam were 70.7% and 86%, respectively. Colistin and polymyxin B remained the most effective studied antibiotics. All of the imipenem-resistant P. aeruginosa isolates were MBL-positive, and 107 out of 144 (74.3%) of the MBL isolates were positive for the blaIMP gene. Conclusions The results of this study show that the rate of P. aeruginosa-caused burn wound infections was very high, and many of the isolates were resistant to three or more classes of antimicrobials. Such extensive resistance to antimicrobial classes is important because few treatment options remain for patients with burn wound infections. blaIMP-producing P. aeruginosa isolates are a rising threat in burn-care units, and should be controlled by conducting infection-control assessments.

  17. [Planning, realization and evaluation of post-marketing surveillance studies. Recommendations of the Society for Phytotherapy].

    Science.gov (United States)

    Kraft, K; Loew, D; Schneider, B; Kemper, F H

    1997-08-01

    Post-marketing-surveillance studies with herbal drugs usually are prospective prescription-epidemiological studies, which should allow statements on quality, efficacy and safety. Until now neither laws nor concrete normative guidelines for the methodology and the evaluation of post-marketing-surveillance studies are existing which could be used for pharmacovigilance. In the present paper guidelines for planning, realisation and evaluation are presented which should allow studies of high quality. The essential components required for the investigational plan are focussed. Also recommendations on the obligatory, optional and special components of the study protocols are made. Additionally statistical methods which allow the evaluation of the therapeutic efficacy are presented.

  18. 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...

  19. 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...

  20. 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.

  1. 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

  2. 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 (privers had high load of blaTEM gene copies. The information on prevalence of environmental reservoirs of blaTEM gene containing bacteria in Indo-Gangetic region and risk associated will be useful for formulating strategies to protect public from menace of clinical risks linked with antimicrobial resistant bacteria. PMID:27111425

  3. 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

  4. Introduction of pharmacovigilance inspection in European Union%欧盟药物警戒检查制度简介

    Institute of Scientific and Technical Information of China (English)

    董铎; 孙利华; 杨晓茹

    2012-01-01

    The aim of this article is to understand the background and implement of pharmacovigilance in-speciton in European Union (EU) , thus to provide reference for inspection in China. In line with EU legislation, EMA has established a set of integrated system including inspection procedure and contents. The establishment of inspection system plays significant roles in supervising and facilitating manufacturers to carry out ADR reporting and monitoring. In China, the Provisions on ADR Reporting and Monitoringhas laid foundation for implementing inspection , but there still lacks of concrete procedures and guidelines which need to be intensively studied in the future.%文章旨在了解欧盟药物警戒检查制度的背景与实施,为我国开展检查工作提供借鉴和参考.根据欧盟法规,欧洲药品管理局建立了一套包括检查程序、检查内容在内的完整体系.建立检查制度对于监督和促进生产企业开展药品不良反应报告和监测工作具有重要作用,我国《药品不良反应报告和监测管理办法》已为此奠定了实施基础,但尚缺乏具体实施的程序与规范,值得今后深入研究和实践.

  5. Persistence of Multidrug-Resistant Acinetobacter baumannii Isolates Harboring blaOXA-23 and bap for 5 Years.

    Science.gov (United States)

    Sung, Ji Youn; Koo, Sun Hoe; Kim, Semi; Kwon, Gye Cheol

    2016-08-28

    The emergence and dissemination of carbapenemase-producing Acinetobacter baumannii isolates have been reported worldwide, and A. baumannii isolates harboring blaOXA-23 are often resistant to various antimicrobial agents. Antimicrobial resistance can be particularly strong for biofilm-forming A. baumannii isolates. We investigated the genetic basis for carbapenem resistance and biofilm-forming ability of multidrug-resistant (MDR) clinical isolates. Ninety-two MDR A. baumannii isolates were collected from one university hospital located in the Chungcheong area of Korea over a 5-year period. Multiplex PCR and DNA sequencing were performed to characterize carbapenemase and bap genes. Clonal characteristics were analyzed using REP-PCR. In addition, imaging and quantification of biofilms were performed using a crystal violet assay. All 92 MDR A. baumannii isolates involved in our study contained the blaOXA-23 and bap genes. The average absorbance of biomass in Bap-producing strains was much greater than that in non-Bap-producing strains. In our study, only three REP-PCR types were found, and the isolates showing type A or type B were found more than 60 times among unique patients during the 5 years of surveillance. These results suggest that the isolates have persisted and colonized for 5 years, and biofilm formation ability has been responsible for their persistence and colonization.

  6. The molecular phenomena of the blaZ genes forming betalactamase enzymes structure in Staphylococcus aureus resistant to beta-lactam antibiotics (ampicillin

    Directory of Open Access Journals (Sweden)

    Mieke Satari

    2010-09-01

    Full Text Available Background: Nowadays, infectious disease still an important problem. One of the bacteria causing infectious diseases is Staphylococcus aureus (S. aureus. In the effort to deal with infections caused by S. aureus, beta-lactam antibiotics, such as ampicillin, are used. In fact, it is unfortunately known that many of S. aureus bacteria are resistant to this group of antibiotics. Because of nucleotide base changes in the structure of the genes blaZ which encode beta-lactamase enzymes in S. aureus. Purpose: The objective of this study was to analyze the nucleotide base changes in the structure of the genes blaZ forming beta-lactamase enzymes in S. aureus resistant to ampicillin based on molecular point of view. Methods: Molecular examinations was conducted by isolating the genes, forming beta-lactamase enzyme, which length was 845bp, from 7 isolates of S. aureus resistant to ampicillin by using PCR technique. The results of blaZ amplification were then subjected to homology by using Tn 552 of S. aureus obtained from bank of genes. Results: Based on the result of the homology, it was found that there was a change in purine base TG, which was a pyrimidine base at the -37 position of the initial codon of blaZ. This change, however, did not affect the strength of the promoter since the number of A and T is still more than the number of G and C. In the structure of the blaZ gene there was even no mutation or deletion or nucleotide base substitution found, so it would not affect the effectiveness of beta-lactamase enzyme. Conclusion: It can be concluded that the resistance of S. aureus towards ampicillin was not caused by nucleotide base deletion/substation. It is suspected that there were other causes leading to the resistance, including the overproduction of beta-lactamase enzyme of the blaZ gene, causing the degradation of beta-lactam antibiotics.Latar belakang: Penyakit infeksi sampai saat ini masih merupakan masalah. Salah satu bakteri penyebab

  7. 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

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    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.

  8. 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

  9. 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.

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

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    Acquavella J

    2016-07-01

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

  11. Complete Nucleotide Sequences of Two blaKPC-2-Bearing IncN Plasmids Isolated from Sequence Type 442 Klebsiella pneumoniae Clinical Strains Four Years Apart

    Science.gov (United States)

    Pérez-Chaparro, Paula Juliana; Cerdeira, Louise Teixeira; Queiroz, Maíse Gomes; de Lima, Clayton Pereira Silva; Levy, Carlos Emílio; Pavez, Mónica; Lincopan, Nilton; Gonçalves, Evonnildo Costa; Mamizuka, Elsa Masae; Sampaio, Jorge Luiz Mello; Nunes, Marcio Roberto Teixeira

    2014-01-01

    We sequenced the oldest blaKPC-2-bearing plasmid isolated in Brazil and another plasmid also carried by a Klebsiella pneumoniae strain of sequence type 442 (ST442), isolated 52 months later. Both plasmids present an IncN backbone and few acquired regions. Because the 2005 plasmid presented deletions and a truncated gene within Tn4401b compared to the 2009 plasmid, we can thus infer that IncN blaKPC-2-bearing plasmids pFCF1305 and pFCF3SP had a common ancestor circulating in Brazil prior to May 2005. PMID:24566176

  12. Complete Nucleotide Sequences of Two blaKPC-2-Bearing IncN Plasmids Isolated from Sequence Type 442 Klebsiella pneumoniae Clinical Strains Four Years Apart

    OpenAIRE

    Paula Juliana PÉREZ-CHAPARRO; Cerdeira, Louise Teixeira; Queiroz, Maíse Gomes; de Lima, Clayton Pereira Silva; Levy, Carlos Emílio; Pavez, Mónica; Lincopan, Nilton; Gonçalves, Evonnildo Costa; Mamizuka, Elsa Masae; Sampaio, Jorge Luiz Mello; Nunes, Marcio Roberto Teixeira; McCulloch, John Anthony

    2014-01-01

    We sequenced the oldest blaKPC-2-bearing plasmid isolated in Brazil and another plasmid also carried by a Klebsiella pneumoniae strain of sequence type 442 (ST442), isolated 52 months later. Both plasmids present an IncN backbone and few acquired regions. Because the 2005 plasmid presented deletions and a truncated gene within Tn4401b compared to the 2009 plasmid, we can thus infer that IncN blaKPC-2-bearing plasmids pFCF1305 and pFCF3SP had a common ancestor circulating in Brazil prior to Ma...

  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

    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 ...

  14. 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

  15. 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

  16. 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

  17. 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

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    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.

  18. 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

  19. 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.

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

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    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.

  1. 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

  2. NDM-1-producing Enterobacteriaceae in a teaching hospital in Shanghai, China: IncX3-type plasmids may contribute to the dissemination of blaNDM-1

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    Hongping Qu

    2015-05-01

    Conclusion: This is the first report of NDM-1-positive Enterobacteriaceae from Shanghai, China. IncX3 plasmids, reported in various species in the United Arab Emirates and China, may contribute to the dissemination of blaNDM-1.. More attention should be devoted to monitoring the dissemination of the NDM-1 gene due to its potential horizontal transfer via mobile genetic elements.

  3. 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

  4. Complete Sequence of Four Multidrug-Resistant MOBQ1 Plasmids Harboring blaGES-5 Isolated from Escherichia coli and Serratia marcescens Persisting in a Hospital in Canada.

    Science.gov (United States)

    Boyd, David; Taylor, Geoffrey; Fuller, Jeff; Bryce, Elizabeth; Embree, Joanne; Gravel, Denise; Katz, Kevin; Kibsey, Pamela; Kuhn, Magdalena; Langley, Joanne; Mataseje, Laura; Mitchell, Robyn; Roscoe, Diane; Simor, Andrew; Thomas, Eva; Turgeon, Nathalie; Mulvey, Michael

    2015-06-01

    The usefulness of carbapenems for gram-negative infections is becoming compromised by organisms harboring carbapenemases, enzymes which can hydrolyze the drug. Currently KPC (class A), NDM (class B), and OXA-48 types (class D) are the most globally widespread carbapenemases. However, among the GES-type class A extended-spectrum β-lactamases (ESBLs) there are variants that hydrolyze carbapenems, with blaGES-5 being the most common. Two Escherichia coli and two Serratia marcescens harboring blaGES-5 on plasmids were isolated by the Canadian Nosocomial Infection Surveillance Program (CNISP) from four different patients in a single hospital over a 2-year period. Complete sequencing of the blaGES-5 plasmids indicated that all four had nearly identical backbones consisting of genes for replication, partitioning, and stability, but contained variant accessory regions consisting of mobile elements and antimicrobial resistance genes. The plasmids were of a novel replicon type, but belonged to the MOBQ1 group based on relaxase sequences, and appeared to be mobilizable, but not self-transmissible. Considering the time periods of bacterial isolation, it would appear the blaGES-5 plasmid has persisted in an environmental niche for at least 2 years in the hospital. This has implications for infection control and clinical care when it is transferred to clinically relevant gram-negative organisms.

  5. A Carbapenem-Resistant Pseudomonas aeruginosa Isolate Harboring Two Copies of blaIMP-34 Encoding a Metallo-β-Lactamase.

    Directory of Open Access Journals (Sweden)

    Tatsuya Tada

    Full Text Available A carbapenem-resistant strain of Pseudomonas aeruginosa, NCGM1984, was isolated in 2012 from a hospitalized patient in Japan. Immunochromatographic assay showed that the isolate was positive for IMP-type metallo-β-lactamase. Complete genome sequencing revealed that NCGM1984 harbored two copies of blaIMP-34, located at different sites on the chromosome. Each blaIMP-34 was present in the same structures of the class 1 integrons, tnpA(ISPa7-intI1-qacG-blaIMP-34-aac(6'-Ib-qacEdelta1-sul1-orf5-tniBdelta-tniA. The isolate belonged to multilocus sequence typing ST235, one of the international high-risk clones. IMP-34, with an amino acid substitution (Glu126Gly compared with IMP-1, hydrolyzed all β-lactamases tested except aztreonam, and its catalytic activities were similar to IMP-1. This is the first report of a clinical isolate of an IMP-34-producing P. aeruginosa harboring two copies of blaIMP-34 on its chromosome.

  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.

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

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    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.

  8. 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

  9. 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

  10. Evaluation of modified hodge test as an indicator of klebsiella pneumoniae carbapenemase (KPC production by using bla kpc gene PCR

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    Priyadarshini Shanmugam, Nirupa Soundararajan, Jeya Meenakshisundaram

    2014-03-01

    Full Text Available Introduction: Carbapenems belong to the Beta Lactam group of antimicrobial agents. They are often used as “last-line agents” or “antibiotics of last resort” in critically ill patients. Carbapenem resistance in Enterobacteriaceae may be due to various reasons but Klebsiella pneumoniae Carbapenemase (KPC enzyme production is the commonest. Phenotypic as well as genotypic methods can be used to detect Carbapenemases. Among the phenotypic tests, Modified Hodge Test (MHT is relatively easy to perform. Aims and Objectives: This study aimed to determine the prevalence of carbapenem resistance among Enterobacteriaceae isolates and calculate the sensitivity of MHT as an indicator of KPC production. Materials and Methods: All Enterobacteriaceae isolates from clinical samples were included in this study and were screened for Carbapenem resistance. 45 randomly chosen Carbapenem Resistant Enterobacteriaceae isolates were subjected to MHT and blaKPC gene detection by PCR. Results: 2035 Enterobacteriaceae isolates were tested and 5.2% were found to be resistant to Imipenem, 22.9 % were resistant to Meropenem and 4.42 % were resistant to both Imipenem and Meropenem. The sensitivity of MHT was calculated to be 90% and specificity was calculated to be 60%

  11. Molecular detection of metallo-β-lactamase gene blaVIM-1 in imipenem-resistant Pseudomonas aeruginosa strains isolated from hospitalized patients in the hospitals of Isfahan

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    Mansour Sedighi

    2015-01-01

    Conclusion: The results demonstrated the serious therapeutic threat of the MBL-producing P. aeruginosa populations. The rate of imipenem resistance due to MBL was increased dramatically. Early detection and infection-control practices are the best antimicrobial strategies for this organism. None of MBL-producing isolates in this study carry the blaVIM-1 gene; therefore, another gene in the MBL family should be investigated.

  12. Sequential isolation in a patient of Raoultella planticola and Escherichia coli bearing a novel ISCR1 element carrying blaNDM-1.

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    Juan Li

    Full Text Available BACKGROUND: The gene for New Delhi metallo-β-lactamase 1 (NDM-1 has been reported to be transmitted via plasmids which are easily transferable and capable of wide distribution. We report the isolation of two NDM-1 producing strains and possible in vivo transfer of blaNDM-1 in a patient. METHODS: Clinical samples were collected for bacterial culture and antibiotic susceptibility testing from a patient during a 34-day hospitalization. The presence of blaNDM-1 was detected by PCR and sequencing. Plasmids of interest were sequenced. Medical records were reviewed for evidence of association between the administration of antibiotics and the acquisition of the NDM-1 resistance. RESULTS: A NDM-1 positive Raoultella planticola was isolated from blood on the ninth day of hospitalization without administration of any carbapenem antibiotics and a NDM-1 positive Escherichia coli was isolated from feces on the 29th day of hospitalization and eight days after imipenem administration. The blaNDM-1 was carried by a 280 kb plasmid pRpNDM1-1 in R. planticola and a 58 kb plasmid pEcNDM1-4 in E. coli. The two plasmids shared a 4812 bp NDM-1-ISCR1 element which was found to be excisable from the plasmid as a free form and transferrable in vitro to a NDM-1 negative plasmid from E. coli. CONCLUSION: blaNDM-1 was embedded in an ISCR1 complex class 1 integron as a novel 4812 bp NDM-1-ISCR1 element. The element was found to be able to self excise to become a free form, which may provide a new vehicle for NDM-1 dissemination. This mechanism could greatly accelerate the spread of NDM-1 mediated broad spectrum β-lactam resistance.

  13. Diversity of the Genetic Environment of the blaKPC-2 Gene Among Klebsiella pneumoniae Clinical Isolates in a Chinese Hospital.

    Science.gov (United States)

    Wang, Lian-Hui; Wei, Dan-Dan; Wan, La-Gen; Yu, Yang; Deng, Qiong; Liu, Yang

    2016-01-01

    KPC-producing Klebsiella pneumoniae (KPC-Kp) has been frequently reported worldwide and constitutes a major healthcare threat, given their extensively drug-resistant phenotypes. In this study, we report the characterization of the genetic environment of blaKPC-2 gene in KPC-Kp clinical strains from China belonging to diverse genotypes. Thirty-five nonduplicated KPC-Kp isolates collected in a Chinese hospital during 2012 were analyzed. All were multidrug resistant due to the presence of other resistance determinants, including metallo-β-lactamases (IMP-4, NDM-1), extended-spectrum β-lactamases (CTX-M-14, -15, -3, -10, and SHV-12), 16S rRNA methylases (armA and rmtB), and plasmid-mediated quinolone resistance determinants [qnrA, B, S, aac(6')-Ib-cr]. Using pulsed-field gel electrophoresis (PFGE), the 35 isolates were grouped into 12 clusters that were further identified as 15 sequence types (STs) by multilocus sequence typing. ST11 K. pneumoniae was the predominant clone attributed to the outbreak. blaKPC-2 was carried in plasmids of various sizes and incompatibility types. The genetic environment analysis, based on genetic structure in the plasmid pKP048, revealed five distinct platforms: the most prevalent structure was the continual occurrence in diverse STs (ST11, ST258, ST340, ST395, ST437, and ST494), harboring plasmid of blaKPC-2 in a genetic environment flanked by ISKpn8 and ISKpn6 like. This study highlights the continued evolution of the genetic environment of the blaKPC-2 gene in our hospital and movement to multiple plasmid backbones that results in acquisition by multiple clones of K. pneumoniae.

  14. 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

  15. Crystal Structure of Cockroach Allergen Bla g 2, an Unusual Zinc Binding Aspartic Protease with a Novel Mode of Self-inhibition

    Energy Technology Data Exchange (ETDEWEB)

    Gustchina, Alla; Li, Mi; Wunschmann, Sabina; Chapman, Martin D.; Pomes, Anna; Wlodawer, Alexander (INDOOR Bio.); (NIH)

    2010-07-19

    The crystal structure of Bla g 2 was solved in order to investigate the structural basis for the allergenic properties of this unusual protein. This is the first structure of an aspartic protease in which conserved glycine residues, in two canonical DTG triads, are substituted by different amino acid residues. Another unprecedented feature revealed by the structure is the single phenylalanine residue insertion on the tip of the flap, with the side-chain occupying the S1 binding pocket. This and other important amino acid substitutions in the active site region of Bla g 2 modify the interactions in the vicinity of the catalytic aspartate residues, increasing the distance between them to {approx}4 {angstrom} and establishing unique direct contacts between the flap and the catalytic residues. We attribute the absence of substantial catalytic activity in Bla g 2 to these unusual features of the active site. Five disulfide bridges and a Zn-binding site confer stability to the protein, which may contribute to sensitization at lower levels of exposure than other allergens.

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

    NARCIS (Netherlands)

    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

    2016-01-01

    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 fi

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

    Directory of Open Access Journals (Sweden)

    Subhrojyoti Bhowmick

    2014-01-01

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

  18. 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

  19. 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.

  20. Outbreak of nosocomial infections due to Klebsiella pneumoniae ST789 isolates harboring blaKPC-2 gene%携带blaKPC-2基因的肺炎克雷伯菌ST789型引起医院感染暴发

    Institute of Scientific and Technical Information of China (English)

    李青; 油丽萍; 陈爱文; 徐茶; 赵辉; 贾楠; 朱元祺

    2016-01-01

    目的 探讨医院耐碳青霉烯类抗菌药物肺炎克雷伯菌和大肠埃希菌的分子流行病学,为医院感染的预防和控制提供指导.方法 收集医院2013年2-4月分离的对厄他培南耐药11株肺炎克雷伯菌和4株大肠埃希菌;细菌的鉴定和药敏试验使用法国生物梅里埃公司VITEK-2 Compact系统;菌株是否产碳青霉烯酶按改良Hodge试验操作,其携带的β-内酰胺类耐药基则通过多重PCR进行检测,并经测序确认基因型;通过多位点序列分型和脉冲场凝胶电泳试验技术对细菌的同源性进行分析.结果 分离的11株耐碳青霉烯类肺炎克雷伯菌多位点序列分型,分别是ST789型7株、ST437株型2和ST258型1株;经测序确认,10株携带有blaKPC-2基因;脉冲场凝胶电泳显示,3种带型A、B和C,7株ST789型肺炎克雷伯菌的带型一致;4株耐碳青霉烯类大肠埃希菌中有2株携带blaKPC-2基因,多位点序列分型均是ST131型;每一株菌可携带不同数目的超广谱β-内酰胺(blaSHV、bla TEM-1和blaCTX)基因.结论 医院内存在携带blaKPC-2基因肺炎克雷伯菌引起的医院感染暴发流行,要加强消毒隔离,防止进一步播散.

  1. War wound treatment complications due to transfer of an IncN plasmid harboring bla(OXA-181) from Morganella morganii to CTX-M-27-producing sequence type 131 Escherichia coli.

    Science.gov (United States)

    McGann, Patrick; Snesrud, Erik; Ong, Ana C; Appalla, Lakshmi; Koren, Michael; Kwak, Yoon I; Waterman, Paige E; Lesho, Emil P

    2015-01-01

    A 22-year-old male developed a recurrent sacral abscess associated with embedded shrapnel following a blast injury. Cultures grew extended-spectrum β-lactamase (ESBL)-producing, carbapenem-susceptible Escherichia coli. Ertapenem was administered, but the infection recurred after each course of antibiotics. Initial surgical interventions were unsuccessful, and subsequent cultures yielded E. coli and Morganella morganii, both nonsusceptible to carbapenems. The isolates were Carba NP test negative, gave ambiguous results with the modified Hodge test, and amplified the bla(OXA48)-like gene by real-time PCR. All E. coli isolates were sequence type 131 (ST131), carried nine resistance genes (including bla(CTX-M-27)) on an IncF plasmid, and were identical by genome sequencing, except for 150 kb of plasmid DNA in carbapenem-nonsusceptible isolates only. Sixty kilobases of this was shared by M. morganii and represented an IncN plasmid harboring bla(OXA-181). In M. morganii, the gene was flanked by IS3000 and ISKpn19, but in all but one of the E. coli isolates containing bla(OXA-181), a second copy of ISKpn19 had inserted adjacent to IS3000. To the best of our knowledge, this is the first report of bla(OXA-181) in the virulent ST131 clonal group and carried by the promiscuous IncN family of plasmids. The tendency of M. morganii to have high MICs of imipenem, a bla(OXA-181) substrate profile that includes penicillins but not extended-spectrum cephalosporins, and weak carbapenemase activity almost resulted in the presence of bla(OXA-181) being overlooked. We highlight the importance of surveillance for carbapenem resistance in all species, even those with intrinsic resistances, and the value of advanced molecular techniques in detecting subtle genetic changes.

  2. 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

  3. 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

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

    Directory of Open Access Journals (Sweden)

    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.

  5. 复合探针实时荧光PCR检测细菌耐药基因blaNDM-1方法的建立%Development of Complex Probe Real-Time Fluorescent PCR for Detection of the Antibiotic Resistance blaNDM-1 Gene

    Institute of Scientific and Technical Information of China (English)

    吕虹; 刘志红; 刘琪琦; 孙晓彦; 陈苏红; 王升启

    2012-01-01

    Objective: To establish a complex probe teal-time fluorescent PCR method to detect the antibiotic resistance blaNDM., gene. Methods: This detection method based on the principles of complex probe, and use blaNDM-1, gene sequences coding New Delhi metallo-β-lactamaee KNDM-1) as the target gene. The PCR amplification system parameters such as the concentration of magnesium ions and PCR annealing temperature were optimized, and the specificity, precision and reproducibility of detection were evaluated. Results: Optimizing the PCR reaction system and the best conditions to test the sensitivity of sensitivity control samples amplified with satisfactory results. The sensitivity of the assay was about 2 copies/system, all of the blaNDM-1 gene containing strains were positively detected and none of the other bacteria was detected by the assay. The coefficient of variation of in-tra-assay and inter-assay was less than 5%. Only Acinetobacter baumannii strain containing blaNDM-1 gene isolated from clinical samples tested positive, other 377 clinical specimens and negative control strains had no response. Conclusion: The established assay detects blaNDM-1 gene containing strains with excellent sensitivity, specificity and reproducibility.%目的:建立一种检测编码新德里金属β内酰胺酶1(NDM-1)的细菌耐药基因blaNDM-1的复合探针实时荧光PCR方法.方法:基于复合探针技术原理,以blaNDM-基因作为待检靶基因建立检测方法,对PCR扩增体系中镁离子浓度、PCR退火温度等进行优化,并对检测的灵敏性、特异性、重复性等进行评价.结果:优化了最佳反应体系和扩增条件;以灵敏度质控品进行灵敏度实验,最低检测限可达2拷贝/体系;非耐药性菌株的检测结果均为阴性;批间批内变异系数均小于5%;只有产NDM-1的鲍曼不动杆菌检测为阳性,其他377株临床分离菌和阴性对照均无响应.结论:建立了检测含blaNDM-1基因的菌株的方法,具

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  8. 产NDM-1型碳青霉烯酶摩根摩根菌的分离及分子背景研究%Isolation and molecular analysis of blaNDM-1-positive Morganella morganii

    Institute of Scientific and Technical Information of China (English)

    王选; 吴晓燕; 李佳萍; 宋国蓉; 邱炳峰; 顾丹霞; 张嵘

    2015-01-01

    Objective To investigate the molecular background of the New Delhi-metallo-1 (NDM-1)-producing Morganella morganii.Methods Two carbapenem-resistant M.morganii named 1 and 2 were isolated in the Second Hospital of Jiaxing,Zhejiang on October 4th and 29th,respectively.Antimicrobial susceptibility was determined by agar dilution method.Pulsed-field gel electrophoresis (PFGE) was performed to analyse the homololgy of isolates.Amplification with specific primers,DNA sequencing,conjugation experiments and genetic environment analysis were conducted to investigate the molecular mechanisms of resistance.Results The two M.morganii isolates were resistant to carbapenem and fluoroquinolones,while susceptible to aztreonam.PFGE analysis indicated that the two isolates were distinguishable.Amplification and DNA sequencing confirmed the coexistence of blaNDM-1,blasHv-12,qnrS1 and aac(6')-Ib-cr in both isolates.Transconjugants were detected with blaNDM.1 and qnrS1 simultaneously.Genetic environment analysis demonstrated that the blaNDM-1-bleMBL-trpF-dsbC-cutA1 structure was in consistence with those from known blaNDM-1-carrying Klebsiella pneumoniae.Conclusion The blaNDM-1 in M.morganii isolates possiblely obtained from K.pneumoniae through translatable plasmids.%目的 对发现的产新德里金属β内酰胺酶1(NDM-1)型碳青霉烯酶摩根摩根菌进行分子背景研究.方法 两株碳青霉烯类抗生素耐药摩根摩根菌1和2分别于2013年10月4日和10月29日分离自浙江省嘉兴市第二医院.琼脂稀释法测定抗生素敏感性;脉冲场凝胶电泳(PFGE)分析两菌株同源性;特异性PCR扩增和序列分析、接合试验和耐药基因周围序列分析进行菌株耐药机制分子水平研究.结果 2株菌对喹诺酮类和碳青霉烯类抗生素耐药,对氨曲南敏感;PFGE结果显示2株菌非同源;特异性PCR扩增和序列分析发现2株菌同时携带耐药基因blaNDM-1、blaSHV-12、qnrS1和aac(6')-Ib-cr;接合子中同时携带bla

  9. 多重PCR检测食源金黄色葡萄球菌nuc、blaZ和mecA基因方法的建立与应用%Multiplex PCR for detection of nuc, blaZ and mecA genes in food-borne Staphylococcus aureus and its application

    Institute of Scientific and Technical Information of China (English)

    刘书亮; 刘冬香; 贾仁勇; 韩新锋

    2010-01-01

    目的 建立快速检测食源金黄色葡萄球菌(Sa)耐热核酸酶基因(nuc)、β-内酰胺酶基因(blaZ)和甲氧西林耐药基因(mecA)的多重PCR方法.方法 根据GenBank Sa的nuc、blaZ和mecA基因序列,设计3对特异性引物,建立鉴定Sa及分析Sa耐β-内酰胺类抗生素三重PCR方法,并对79株食源Sa进行基因检测与表型比较.结果 显示供试Sa中检出nuc、blaZ基因阳性率分别为97.47%、73.42%,mecA基因检出为阴性;nuc基因检出与其表型符合率达97.47%;而blaZ扩增结果与β-内酰胺酶试验、青霉素类敏感试验同时符合率为49.37%,前者与后两者符合率分别为60.76%和75.95%;mecA与耐甲氧西林表型符合率为100%;此次79株食源Sa中无耐甲氧西林Sa.结论 该方法简便、快捷、准确,为食源Sa鉴定和耐药性分子分析提供了参考依据.

  10. 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

    Directory of Open Access Journals (Sweden)

    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.

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

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    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

  12. 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.

  13. [blaVIM-2 gene detection in metallo-beta-lactamase-producing Pseudomonas aeruginosa strains isolated in an intensive care unit in Ciudad Bolívar, Venezuela].

    Science.gov (United States)

    Guevara, Armando; de Waard, Jacobus; Araque, María

    2009-08-01

    Ten Pseudomonas aeruginosa strains with resistance to broad-spectrum cephalosporin and carbapenems were studied to determine the presence of genes that mediate the production of metallo-beta-lactamases. These strains were isolated from patients with nosocomial infection at the Intensive Care Unit of the Complejo Hospitalario "Ruiz y Paéz" of Ciudad Bolívar, Bolívar State, Venezuela, from 2003 to 2006. In all isolates a metallo-enzyme activity was detected by using the double disk synergism test. PCR amplification of genes encoding the families IMP, VIM and SPM metallo-beta-lactamases showed the presence of a blaVIM gene in all strains studied. DNA sequencing revealed that all isolates showed the presence of blaVIM-2. These results suggest that it is necessary to keep these strains under epidemiologic surveillance, establish laboratory strategies for opportune detection and the implementation of new policies to ensure the appropriate use of antibiotics in this institution.

  14. 携带blaNDM-1基因的ST22型肺炎克雷伯菌引起新生儿医院感染%Newborn nosocomial infection caused by New Delhi metallo-beta-lactamase-1 (NDM-1)-producing Klebsiella pneumoniae ST22 isolates

    Institute of Scientific and Technical Information of China (English)

    徐茶; 刘艳飞; 赵辉; 贾楠; 朱元祺

    2015-01-01

    目的 探讨耐碳青霉烯类肺炎克雷伯菌临床株的分子流行病学特征,为医院感染的控制和预防提供指导.方法 3株对碳青霉烯类耐药的肺炎克雷伯菌临床菌株分离自山东某医院新生儿病房患儿的抽吸痰液和血液标本;用Vitek 2 Compact系统进行细菌鉴定和药敏试验;改良Hodge试验检测菌株是否产碳青霉烯酶;PCR检测菌株携带的碳青霉烯酶基因(blaKPC、blaBIC、blaoXA-48、blaNDM、blaIMP、blaVIM、blaSPM、bla AIM、blaGIM、blaSIM和blaDIM)、β-内酰胺酶基因(blaCrX-M、blaSHV、blaTEM和6laoXA-1)、AmpC酶基因(blaMOX、blaCIT、blaDHA、blaACC和blaEBC)、喹诺酮耐药相关基因(qnrA、qnrB、qnrS、oqxA和oqxB和磷霉素耐药基因(fosA3),测序确认其基因型;用多位点序列分型和脉冲场凝胶电泳分析细菌的同源性;质粒接合和Southern杂交试验分析质粒的特性,并进行质粒不相容群检测.结果 3株肺炎克雷伯菌Hodge试验呈阳性,且对大部分抗菌药物耐药,均携带blaNDM-1、blaTEM-1 、rosA3、oqxA和oqxB基因.脉冲场凝胶电泳显示3株菌的带型完全一致,属于同一克隆,而且多位点序列分型也都是ST22,提示存在流行.质粒接合和Southern杂交试验表明供体菌携带blaNDM-1质粒(pTA-NDM)可通过接合方式转移到受体菌,且质粒大小约220 000 bp,不相容群分型属于IncA/C型质粒.结论 同时携带blaNDM-1、6laTEM-1、rosA3、oqxA和oqxB基因的ST22型肺炎克雷伯菌在新生儿病房中的流行属国内外首次报道,应引起重视.

  15. 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 ...

  16. 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...

  17. 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 ...

  18. Farmacovigilancia en medicina veterinaria: una perspectiva desde el punto de vista internacional y situación actual en Chile Pharmacovigilance in veterinary medicine: an international perspective and the current situation in Chile

    Directory of Open Access Journals (Sweden)

    D Iragiien

    2007-01-01

    Full Text Available La farmacovigilancia es una actividad dirigida a la detección y estudio de las reacciones adversas a medicamentos. Una reacción adversa corresponde a una reacción nociva no intencionada y que tiene lugar a las dosis normalmente utilizadas para la profilaxis, diagnóstico o tratamiento de una enfermedad o la modificación de funciones biológicas. A nivel internacional, países como los Estados Unidos de América, la Unión Europea, el Reino Unido y Australia han instaurado sistemas de farmacovigilancia, tanto para la medicina humana como veterinaria. Estos sistemas recopilan la información de reacciones adversas mediante notificaciones espontáneas. Las agencias reguladoras de cada país analizan estos datos y adoptan las medidas necesarias, ya sea para la modificación de los registros de medicamentos o para el retiro de éstos del mercado, como ha ocurrido específicamente para la medicina humana. En Chile, desde el año 1995, existe un programa de farmacovigilancia humana a cargo del Instituto de Salud Pública. Por el contrario, en la medicina veterinaria la evaluación de la seguridad y eficacia de medicamentos sólo se considera en el registro oficial otorgado por el Ministerio de Agricultura (Servicio Agrícola y Ganadero. Como consecuencia, la frecuencia y severidad de las reacciones adversas es desconocida. La experiencia extranjera refleja la importancia de contar con un programa de farmacovigilancia y las acciones necesarias para que éstos cumplan su objetivo. En este artículo se presenta un análisis de las fortalezas y debilidades de los programas internacionales de farmacovigilancia y la situación actual en ChilePharmacovigilance is an activity that involves the detection and evaluation of adverse drug reactions. These are unintended and harmful reactions which occur at doses that are normally used in animals for the prophylaxis, diagnosis or treatment of diseases or the modification of physiological function

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

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    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

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

    Science.gov (United States)

    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 of self-reported gestational exposures and pregnancy outcomes. Methods The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) pregnancy study is a non-interventional, prospective pilot study of self-reported medication use and obstetric outcomes provided by a cohort of pregnant women that was conducted in Denmark, the Netherlands, Poland, and the United Kingdom. Direct-to-participant advertisements were provided via websites, emails, leaflets, television, and social media platforms. Results Over a 70-week recruitment period direct-to-participant advertisements engaged 43,234 individuals with the study website or telephone system; 4.78% (2065/43,234) of which were successfully enrolled and provided study data. Of these 90.4% (1867/2065) were recruited via paid advertising methods, 23.0% (475/2065) of whom were in the first trimester of pregnancy. The overall costs per active recruited participant were lowest for email (€23.24) and website (€24.41) advertisements and highest for leaflet (€83.14) and television (€100.89). Website adverts were substantially superior in their ability to recruit participants during their first trimester of pregnancy (317/668, 47.5%) in comparison with other advertising methods (P<.001). However, we identified international variations in both the cost-effectiveness of the various advertisement methods used and in their ability to recruit participants in early pregnancy. Conclusions Recruitment of a

  1. Detection of blaCTX-M gene in Escherichia coli and Klebsiella pneumoniae which producing ESBLs%产超广谱β-内酰胺酶大肠埃希菌和肺炎克雷伯菌blaCTX-M基因的检测

    Institute of Scientific and Technical Information of China (English)

    张阮章; 王沙燕; 卢月梅; 何林; 陈升汶

    2004-01-01

    目的了解产CTX-M型超广谱β-内酰胺酶 (ESBLs) 大肠埃希菌和肺炎克雷伯菌在深圳市人民医院的分布情况.方法应用美国国家临床实验室标准化委员会(NCCLS)推荐的表型确证试验,从2000年6月~2003年8月该院临床标本分离株中筛选出不重复的产ESBLs菌株215株,其中大肠埃希菌151株,肺炎克雷伯菌64株,应用聚合酶链反应(PCR)检测所有产ESBLs株的bla(CTX-M)基因.结果 PCR结果显示,大肠埃希菌bla(CTX-M)基因阳性率为92.1%(139/151),肺炎克雷伯菌的阳性率为65.6%(42/64).bla(CTX-M)基因阳性菌株主要来源于临床送检尿和痰标本,并广泛分布于20多个临床科室.结论该院临床分离的大肠埃希菌和肺炎克雷伯菌产生的ESBL大多数为CTX-M型,该类酶广泛分布于各临床科室,需引起重视.

  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. Interspecies Dissemination of a Mobilizable Plasmid Harboring blaIMP-19 and the Possibility of Horizontal Gene Transfer in a Single Patient.

    Science.gov (United States)

    Yamamoto, Masaki; Matsumura, Yasufumi; Gomi, Ryota; Matsuda, Tomonari; Tanaka, Michio; Nagao, Miki; Takakura, Shunji; Uemoto, Shinji; Ichiyama, Satoshi

    2016-09-01

    Carbapenemase-producing Gram-negative bacilli have been a global concern over the past 2 decades because these organisms can cause severe infections with high mortality rates. Carbapenemase genes are often carried by mobile genetic elements, and resistance plasmids can be transferred through conjugation. We conducted whole-genome sequencing (WGS) to demonstrate that the same plasmid harboring a metallo-β-lactamase gene was detected in two different species isolated from a single patient. Metallo-β-lactamase-producing Achromobacter xylosoxidans (KUN4507), non-metallo-β-lactamase-producing Klebsiella pneumoniae (KUN4843), and metallo-β-lactamase-producing K. pneumoniae (KUN5033) were sequentially isolated from a single patient and then analyzed in this study. Antimicrobial susceptibility testing, molecular typing (pulsed-field gel electrophoresis and multilocus sequence typing), and conjugation analyses were performed by conventional methods. Phylogenetic and molecular clock analysis of K. pneumoniae isolates were performed with WGS, and the nucleotide sequences of plasmids detected from these isolates were determined using WGS. Conventional molecular typing revealed that KUN4843 and KUN5033 were identical, whereas the phylogenetic tree analysis revealed a slight difference. These two isolates were separated from the most recent common ancestor 0.74 years before they were isolated. The same resistance plasmid harboring blaIMP-19 was detected in metallo-β-lactamase-producing A. xylosoxidans and K. pneumoniae Although this plasmid was not self-transferable, the conjugation of this plasmid from A. xylosoxidans to non-metallo-β-lactamase-producing K. pneumoniae was successfully performed. The susceptibility patterns for metallo-β-lactamase-producing K. pneumoniae and the transconjugant were similar. These findings supported the possibility of the horizontal transfer of plasmid-borne blaIMP-19 from A. xylosoxidans to K. pneumoniae in a single patient. PMID:27381397

  5. 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

  6. 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

  7. 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; Nielsen, Hans Linde;

    2016-01-01

    OBJECTIVES: An outbreak of NDM-1-producing Citrobacter freundii and possible secondary in vivo spread of blaNDM-1 to other Enterobacteriaceae were investigated. METHODS: From October 2012 to March 2015, meropenem-resistant Enterobacteriaceae were detected in 45 samples from seven patients...

  8. 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.

  9. 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。

  10. 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...

  11. 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

  12. Complete Sequence of the FII Plasmid p42-2, Carrying blaCTX-M-55, oqxAB, fosA3, and floR from Escherichia coli.

    Science.gov (United States)

    Yang, Qiu E; Walsh, Timothy Rutland; Liu, Bao Tao; Zou, Meng Ting; Deng, Hui; Fang, Liang Xing; Liao, Xiao Ping; Sun, Jian; Liu, Ya Hong

    2016-07-01

    We sequenced a novel conjugative multidrug resistance IncF plasmid, p42-2, isolated from Escherichia coli strain 42-2, previously identified in China. p42-2 is 106,886 bp long, composed of a typical IncFII-type backbone (∼54 kb) and one distinct acquired DNA region spanning ∼53 kb, harboring 12 antibiotic resistance genes [blaCTX-M-55, oqxA, oqxB, fosA3, floR, tetA(A), tetA(R), strA, strB, sul2, aph(3')-II, and ΔblaTEM-1]. The spread of these multidrug resistance determinants on the same plasmid is of great concern and, because of coresistance to antibiotics from different classes, is therapeutically challenging. PMID:27067314

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. „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...

  19. 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.

  20. Language Planning: Corpus Planning.

    Science.gov (United States)

    Baldauf, Richard B., Jr.

    1989-01-01

    Focuses on the historical and sociolinguistic studies that illuminate corpus planning processes. These processes are broken down and discussed under two categories: those related to the establishment of norms, referred to as codification, and those related to the extension of the linguistic functions of language, referred to as elaboration. (60…

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

    Science.gov (United States)

    Kilani, Hajer; Abbassi, Mohamed Salah; Ferjani, Sana; Mansouri, Riadh; Sghaier, Senda; Ben Salem, Rakia; Jaouani, Imen; Douja, Gtari; Brahim, Sana; Hammami, Salah; Ben Chehida, Noureddine; Boubaker, Ilhem Boutiba-Ben

    2015-01-01

    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 feces 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, harbored blaCTX-M-1 gene, and one strain co-harbored 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-harbored 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. Two types of

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

    Science.gov (United States)

    Kilani, Hajer; Abbassi, Mohamed Salah; Ferjani, Sana; Mansouri, Riadh; Sghaier, Senda; Ben Salem, Rakia; Jaouani, Imen; Douja, Gtari; Brahim, Sana; Hammami, Salah; Ben Chehida, Noureddine; Boubaker, Ilhem Boutiba-Ben

    2015-01-01

    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 feces 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, harbored bla CTX-M-1 gene, and one strain co-harbored the bla TEM-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-harbored 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. Two types of

  3. Clinical Specimen-Direct LAMP: A Useful Tool for the Surveillance of blaOXA-23-Positive Carbapenem-Resistant Acinetobacter baumannii.

    Science.gov (United States)

    Yamamoto, Norihisa; Hamaguchi, Shigeto; Akeda, Yukihiro; Santanirand, Pitak; Kerdsin, Anusak; Seki, Masafumi; Ishii, Yoshikazu; Paveenkittiporn, Wantana; Bonomo, Robert A; Oishi, Kazunori; Malathum, Kumthorn; Tomono, Kazunori

    2015-01-01

    Healthcare-associated infections are a leading cause of morbidity and mortality worldwide. Treatment is increasingly complicated by the escalating incidence of antimicrobial resistance. Among drug-resistant pathogens, carbapenem-resistant Acinetobacter baumannii (CRAb) is of increasing concern because of the limited applicable therapies and its expanding global distribution in developed countries and newly industrialized countries. Therefore, a rapid detection method that can be used even in resource-poor countries is urgently required to control this global public health threat. Conventional techniques, such as bacterial culture and polymerase chain reaction (PCR), are insufficient to combat this threat because they are time-consuming and laborious. In this study, we developed a loop-mediated isothermal amplification (LAMP) method for detecting blaOXA-23-positive CRAb, the most prevalent form of CRAb in Asia, especially in Thailand, and confirmed its efficacy as a surveillance tool in a clinical setting. Clinical samples of sputum and rectal swabs were collected from patients in a hospital in Bangkok and used for LAMP assays. After boiling and centrifugation, the supernatants were used directly in the assay. In parallel, a culture method was used for comparison purposes to evaluate the specificity and sensitivity of LAMP. As a first step, a total of 120 sputum samples were collected. The sensitivity of LAMP was 88.6% (39/44), and its specificity was 92.1% (70/76) using the culture method as the "gold standard". When surveillance samples including sputum and rectal swabs were analyzed with the LAMP assay, its sensitivity was 100.0%. This method enables the direct analysis of clinical specimens and provides results within 40 minutes of sample collection, making it a useful tool for surveillance even in resource-poor countries.

  4. Clinical Specimen-Direct LAMP: A Useful Tool for the Surveillance of blaOXA-23-Positive Carbapenem-Resistant Acinetobacter baumannii.

    Directory of Open Access Journals (Sweden)

    Norihisa Yamamoto

    Full Text Available Healthcare-associated infections are a leading cause of morbidity and mortality worldwide. Treatment is increasingly complicated by the escalating incidence of antimicrobial resistance. Among drug-resistant pathogens, carbapenem-resistant Acinetobacter baumannii (CRAb is of increasing concern because of the limited applicable therapies and its expanding global distribution in developed countries and newly industrialized countries. Therefore, a rapid detection method that can be used even in resource-poor countries is urgently required to control this global public health threat. Conventional techniques, such as bacterial culture and polymerase chain reaction (PCR, are insufficient to combat this threat because they are time-consuming and laborious. In this study, we developed a loop-mediated isothermal amplification (LAMP method for detecting blaOXA-23-positive CRAb, the most prevalent form of CRAb in Asia, especially in Thailand, and confirmed its efficacy as a surveillance tool in a clinical setting. Clinical samples of sputum and rectal swabs were collected from patients in a hospital in Bangkok and used for LAMP assays. After boiling and centrifugation, the supernatants were used directly in the assay. In parallel, a culture method was used for comparison purposes to evaluate the specificity and sensitivity of LAMP. As a first step, a total of 120 sputum samples were collected. The sensitivity of LAMP was 88.6% (39/44, and its specificity was 92.1% (70/76 using the culture method as the "gold standard". When surveillance samples including sputum and rectal swabs were analyzed with the LAMP assay, its sensitivity was 100.0%. This method enables the direct analysis of clinical specimens and provides results within 40 minutes of sample collection, making it a useful tool for surveillance even in resource-poor countries.

  5. 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...

  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. Safety Plan

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — The Swan Lake National Wildlife Refuge Safety Plan discusses policies for the safety of the station employees, volunteers, and public. This plan seeks to identify...

  8. Planning Diseases.

    Science.gov (United States)

    Gabel, Medard

    1984-01-01

    To solve societal problems, both local and global, a global approach is needed. Serious diseases that are crippling present-day problem solving and planning are discussed, and the characteristics of a healthy, effective planning approach are described. (RM)

  9. 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...

  10. 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;…

  11. 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.

  12. Systemic Planning

    DEFF Research Database (Denmark)

    Leleur, Steen

    , business and other fields, and it is useful for all professionals, across a wide range of employment areas, who share an interest in renewing planning practice. Such an endeavour is seen as both important and timely, recognising that many complex planning tasks necessitate organisations – be they public...... or private – to engage in planning to prepare proactive decision-making....

  13. 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.

  14. 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.

  15. 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, ...

  16. 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...

  17. 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)

  18. 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

  19. Test plan :

    Energy Technology Data Exchange (ETDEWEB)

    Dwyer, Stephen F.

    2013-05-01

    This test plan is a document that provides a systematic approach to the planned testing of rooftop structures to determine their actual load carrying capacity. This document identifies typical tests to be performed, the responsible parties for testing, the general feature of the tests, the testing approach, test deliverables, testing schedule, monitoring requirements, and environmental and safety compliance.

  20. 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

  1. 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

    CTX-M-1 gene was formed by a truncated macrolide resistance cluster and flanked by IS26 as previously observed in IncI1 and IncN plasmids. The IncHI1 plasmid changed size and gained the quinolone resistance gene qnrS1 as a result of IS26-mediated fusion with an IncX1 plasmid. CONCLUSIONS: Our data......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...

  2. 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)

  3. 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

  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. Sign Plan

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — The Union Slough National Wildlife Refuge Sign Plan explains how signs are used on the Refuge to help guide and educate visitors. An inventory of current signs is...

  6. 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

  7. 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...... is 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...

  8. VOYAGE PLANNING

    Directory of Open Access Journals (Sweden)

    Kazimierz SKÓRA

    2016-09-01

    Full Text Available A sea voyage can be divided into three parts with varying degrees of risk: - from the berth at the port of departure to the pilot disembarkation point - from the pilot disembarkation to another pilot embarkation point near the port of call/destination - from the pilot embarkation point to the berth Results of statistical research into ship accidents at sea point to an increased number of incidents and accidents, including groundings, especially in restricted areas. Such areas are often narrow and have limited depths, while their short straight sections require frequent course alterations, often in varying hydrometeorological conditions. Due to all these factors, the voyage has to be carefully planned and all watchkeeping officers have to be well prepared to conduct the ship safely. The article presents the objectives, scope, legal basis and stages in the process of voyage planning. The compliance with the outlined principles will reduce the level of risk in maritime transport.

  9. Plan Repair using a Plan Library

    NARCIS (Netherlands)

    Van der Krogt, R.P.J.; De Weerdt, M.M.

    2005-01-01

    Plan library's have proven their added value to the efficiency of planning. In this paper, we present results on the use of a plan library to plan repair. We show that using a relatively simple library, we can already obtain significant improvements in efficiency compared to plan repair without a li

  10. 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.

  11. 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

  12. 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...

  13. Complete Sequence of pEC012, a Multidrug-Resistant IncI1 ST71 Plasmid Carrying bla CTX-M-65, rmtB, fosA3, floR, and oqxAB in an Avian Escherichia coli ST117 Strain.

    Science.gov (United States)

    Pan, Yu-Shan; Zong, Zhi-Yong; Yuan, Li; Du, Xiang-Dang; Huang, Hui; Zhong, Xing-Hao; Hu, Gong-Zheng

    2016-01-01

    A 139,622-bp IncI1 ST71 conjugative plasmid pEC012 from an avian Escherichia coli D-ST117 strain was sequenced, which carried five IS26-bracketed resistance modules: IS26-fosA3-orf1-orf2-Δorf3-IS26, IS26-fip-ΔISEcp1-bla CTX-M-65-IS903D-iroN-IS26, IS26-ΔtnpR-bla TEM-1-rmtB-IS26, IS26-oqxAB-IS26, and IS26-floR-aac(3)-IV-IS26. The backbone of pEC012 was similar to that of several other IncI1 ST71 plasmids: pV408, pM105, and pC271, but these plasmids had different arrangements of multidrug resistance region. In addition, the novel ISEc57 element was identified, which is in the IS21 family. The stepwise emergence of multi-resistance regions demonstrated the accumulation of different resistance determinants through homologous recombination. To the best of our knowledge, this is the first study to identify a multidrug-resistant IncI1 ST71 plasmid carrying bla CTX-M-65, rmtB, fosA3, floR, and oqxAB in an avian E. coli ST117 strain. PMID:27486449

  14. 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 ...

  15. 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.

  16. 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.

  17. Draft Genome Sequence of Klebsiella pneumoniae KGM-IMP216 Harboring bla CTX-M-15, bla DHA-1, bla TEM-1B, bla NDM-1, bla SHV-28, and bla OXA-1, Isolated from a Patient in Lebanon

    OpenAIRE

    Tokajian, Sima; Eisen, Jonathan A.; Jospin, Guillaume; Matar, Ghassan; Araj, George F.; Coil, David A.

    2016-01-01

    We present the draft genome of highly drug-resistant Klebsiella pneumoniae KGM-IMP216, isolated from a urine sample collected from a patient in Lebanon. The draft genome sequence consisted of 77 contigs, including a combined 5,731,500 bases with 57% G+C content.

  18. 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.

  19. 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

  20. 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

  1. 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....

  2. Plan Colombia

    Directory of Open Access Journals (Sweden)

    Noam Chomsky

    2000-12-01

    Full Text Available Colombia recibe más ayuda militar de Estados Unidos que el resto de América Latina y el Caribe unidos, y esta situación puede profundizarse con la ejecución del Plan Colombia, fundamentado en la lucha antidrogas. Sin embargo, el pais ha sido calificado con el récord en violación de derechos humanos. En este contexto se aplica la reforma económica más significativa en la década de los noventa, generando condicionantes en los procesos de integración con sus vecinos. En concordancia con el secretario de Defensa, Henry Stimson, desde los años 60 Estados Unidos estaba autorizado para controlar su propio sistema regional, mientras todos los demás intenlos serian desmantelados. La presentación ambigua de esta política del gobierno estadounidense en Colombia es cómo disociar esta guerra contra la droga y la lucha irregular contrainsurgente En Estados Unidos hay otra opinión que debe conocerse para comprender las divergencias en e! interior de dicho país. Este artículo del prestigioso profesor universitario del MU, Noam Chomsky, es un referente obligado en términos de opinión pública y académica de dimensión internacional, por el inmenso respeto que infunde tanto en América como en Europa

  3. Multi-Agent Planning with Planning Graph

    NARCIS (Netherlands)

    Bui, The Duy; Jamroga, Wojciech

    2003-01-01

    In this paper, we consider planning for multi-agents situations in STRIPS-like domains with planning graph. Three possible relationships between agents' goals are considered in order to evaluate plans: the agents may be collaborative, adversarial or indifferent entities. We propose algorithms to dea

  4. 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...

  5. 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...

  6. 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...

  7. 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…

  8. 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.

  9. 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.)

  10. 11. Strategic planning.

    Science.gov (United States)

    2014-05-01

    There are several types of planning processes and plans, including strategic, operational, tactical, and contingency. For this document, operational planning includes tactical planning. This chapter examines the strategic planning process and includes an introduction into disaster response plans. "A strategic plan is an outline of steps designed with the goals of the entire organisation as a whole in mind, rather than with the goals of specific divisions or departments". Strategic planning includes all measures taken to provide a broad picture of what must be achieved and in which order, including how to organise a system capable of achieving the overall goals. Strategic planning often is done pre-event, based on previous experience and expertise. The strategic planning for disasters converts needs into a strategic plan of action. Strategic plans detail the goals that must be achieved. The process of converting needs into plans has been deconstructed into its components and includes consideration of: (1) disaster response plans; (2) interventions underway or planned; (3) available resources; (4) current status vs. pre-event status; (5) history and experience of the planners; and (6) access to the affected population. These factors are tempered by the local: (a) geography; (b) climate; (c) culture; (d) safety; and (e) practicality. The planning process consumes resources (costs). All plans must be adapted to the actual conditions--things never happen exactly as planned.

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

    OpenAIRE

    A. Zare; A Akya; P Nejat

    2015-01-01

    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 f...

  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. 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....

  14. 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...

  15. 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.......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....

  16. Site Development Planning Handbook

    Energy Technology Data Exchange (ETDEWEB)

    None

    1981-01-01

    The Handbook provides facility managers and site planners at DOE organizations responsible for planning site developments and facilities utilization a step-by-step planning checklist to ensure that planners at each site are focusing on Department-wide goals and objectives. It begins with a brief discussion of a site development-by-objectives program design to promote, recognize, and implement opportunities for improvements in site utilization through planning. Additional information is included on: assembling existing data, plans, programs, and procedures; establishing realistic objectives; identifying site problems, opportunities; and development needs; determining priorities among development needs; developing short and long-range plans; choosing the right development solutions and meeting minimum legal site restrictions; presenting the plan; implementing elements of the plan; monitoring and reporting plan status; and modifying development program plans. (MCW)

  17. LONG RANGE HEALTH PLANNING

    Directory of Open Access Journals (Sweden)

    ST. Motameni

    1974-03-01

    Full Text Available In the past, health planning in Iran has been carried out in the context of short-range economic plans. Although this mechanism has helped a great deal in the achievement of certain health plans however, the said scheme has been short in meeting the health objectives on a comprehensive basis. Most often, the heath programs have lost their values to the priority and cost effectiveness of economic plans. A brief review of heath planning in the past shows that the second development plan has been devoted to the establishment of new hospitals on a scattered pattern. The development of a coordinated hospital and health center system has been accepted and partly implemented during the third plan period. In the fourth plan the whole direction has changed towards the de­velopment of private hospitals on profit making basis, and now the fifth plan calls for the regionalized hospital system. Thus, one can say that the past twenty years have been spent to the experimentation of different schemes with­out a real long-range goal. In the past decade the World Health Organization has ventured in the development of health planning principles, but most of the efforts have been devoted to the short-range planning. The long-range health planning is not only a new look to the prin­ciples of planning, but a thorough examination of the time factor in health planning.

  18. 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

  19. 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

  20. 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...

  1. 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...

  2. 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....

  3. 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....

  4. 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...

  5. 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)

  6. 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...

  7. 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 ...

  8. 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 ...

  9. 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...

  10. 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.

  11. 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...

  12. 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 ...

  13. 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...

  14. 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...

  15. 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...

  16. 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, ...

  17. 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...

  18. 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.

  19. 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...

  20. 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)

  1. 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)

  2. 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.

  3. 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

  4. 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)

  5. Transfusion service disaster planning.

    Science.gov (United States)

    Bundy, K L; Foss, M L; Stubbs, J R

    2008-01-01

    The Mayo Clinic, in Rochester, Minnesota, recently set forth a directive to develop a Mayo Emergency Incident Command System (MEICS) plan to respond to major disasters. The MEICS plan that was developed interfaces with national response plans to ensure effective communication and coordination between our institution and local, state, and federal agencies to establish a common language and communication structure. The MEICS plan addresses multiple aspects of dealing with resource needs during a crisis, including the need for blood and transfusion medicine services. The MEICS plan was developed to supplement our current local emergency preparedness procedures and provide a mechanism for responding to the escalating severity of an emergency to deal with situations of a magnitude that is outside the normal experience. A plan was developed to interface the existing Transfusion Medicine disaster plan standard operating procedures (SOP) with the institutional and Department of Laboratory Medicine (DLMP) MEICS plans. The first step in developing this interface was defining MEICS. Other major steps were defining the chain of command, developing a method for visually indicating who is "in charge," planning communication, defining the actions to be taken, assessing resource needs, developing flowcharts and updating SOPs, and developing a blood rationing team to deal with anticipated blood shortages. Several key features of the interface and updated disaster plan that were developed are calling trees for response personnel, plans for relocating leadership to alternative command centers, and action sheets to assist with resource assessment. The action sheets also provide documentation of key actions by response personnel.

  6. 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 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 context analysis and problem-orientation to define the course of the planning process, and deploying value-rational planning tools primarily as a platform for interactivity. The focus on interactivity in energy planning will allow contemporary government planners, consultants, researchers...

  7. 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

  8. Setup planning for machining

    CERN Document Server

    Hazarika, Manjuri

    2015-01-01

    Professionals as well as researchers can benefit from this comprehensive introduction into the topic of setup planning, which reflects the latest state of research and gives hands-on examples. Starting with a brief but thorough introduction, this book explains the significance of setup planning in process planning and includes a reflection on its external constraints. Step-by-step the different phases of setup planning are outlined and traditional as well as modern approaches, such as fuzzy logic based setup planning, on the solution of setup planning problems are presented. Three detailed examples of applications provide a clear and accessible insight into the up-to-date techniques and various approaches in setup planning.

  9. 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.

  10. 40 CFR 265.112 - Closure plan; amendment of plan.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 25 2010-07-01 2010-07-01 false Closure plan; amendment of plan. 265... DISPOSAL FACILITIES Closure and Post-Closure § 265.112 Closure plan; amendment of plan. (a) Written plan... have a written closure plan. Until final closure is completed and certified in accordance with §...

  11. 40 CFR 264.112 - Closure plan; amendment of plan.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 25 2010-07-01 2010-07-01 false Closure plan; amendment of plan. 264... Closure and Post-Closure § 264.112 Closure plan; amendment of plan. (a) Written plan. (1) The owner or operator of a hazardous waste management facility must have a written closure plan. In addition,...

  12. 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.

  13. 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

  14. Business plan competition

    CERN Multimedia

    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...

  15. 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...

  16. 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...

  17. 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

  18. 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 ...

  19. 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

  20. 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

  1. Research Planning Process

    Science.gov (United States)

    Lofton, Rodney

    2010-01-01

    This presentation describes the process used to collect, review, integrate, and assess research requirements desired to be a part of research and payload activities conducted on the ISS. The presentation provides a description of: where the requirements originate, to whom they are submitted, how they are integrated into a requirements plan, and how that integrated plan is formulated and approved. It is hoped that from completing the review of this presentation, one will get an understanding of the planning process that formulates payload requirements into an integrated plan used for specifying research activities to take place on the ISS.

  2. 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)

  3. Strategic planning for neuroradiologists.

    Science.gov (United States)

    Berlin, Jonathan W; Lexa, Frank J

    2012-08-01

    Strategic planning is becoming essential to neuroradiology as the health care environment continues to emphasize cost efficiency, teamwork and collaboration. A strategic plan begins with a mission statement and vision of where the neuroradiology division would like to be in the near future. Formalized strategic planning frameworks, such as the strengths, weaknesses, opportunities and threats (SWOT), and the Balanced Scorecard frameworks, can help neuroradiology divisions determine their current position in the marketplace. Communication, delegation, and accountability in neuroradiology is essential in executing an effective strategic plan. PMID:22902108

  4. DCOI Strategic Plan

    Data.gov (United States)

    General Services Administration — Under the Data Center Optimization Initiative (DCOI), covered agencies are required to post DCOI Strategic Plans and updates to their FITARA milestones publicly on...

  5. Strategic planning for neuroradiologists.

    Science.gov (United States)

    Berlin, Jonathan W; Lexa, Frank J

    2012-08-01

    Strategic planning is becoming essential to neuroradiology as the health care environment continues to emphasize cost efficiency, teamwork and collaboration. A strategic plan begins with a mission statement and vision of where the neuroradiology division would like to be in the near future. Formalized strategic planning frameworks, such as the strengths, weaknesses, opportunities and threats (SWOT), and the Balanced Scorecard frameworks, can help neuroradiology divisions determine their current position in the marketplace. Communication, delegation, and accountability in neuroradiology is essential in executing an effective strategic plan.

  6. 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.

  7. Guidelines for strategic planning

    Energy Technology Data Exchange (ETDEWEB)

    1991-07-01

    Strategic planning needs to be done as one of the integral steps in fulfilling our overall Departmental mission. The role of strategic planning is to assure that the longer term destinations, goals, and objectives which the programs and activities of the Department are striving towards are the best we can envision today so that our courses can then be set to move in those directions. Strategic planning will assist the Secretary, Deputy Secretary, and Under Secretary in setting the long-term directions and policies for the Department and in making final decisions on near-term priorities and resource allocations. It will assist program developers and implementors by providing the necessary guidance for multi-year program plans and budgets. It is one of the essential steps in the secretary's Strategic Planning Initiative. The operational planning most of us are so familiar with deals with how to get things done and with the resources needed (people, money, facilities, time) to carry out tasks. Operating plans like budgets, capital line item projects, R D budgets, project proposals, etc., are vital to the mission of the Department. They deal, however, with how to carry out programs to achieve some objective or budget assumption. Strategic planning deals with the prior question of what it is that should be attempted. It deals with what objectives the many programs and activities of the Department of Department should be striving toward. The purpose of this document is to provide guidance to those organizations and personnel starting the process for the first time as well as those who have prepared strategic plans in the past and now wish to review and update them. This guideline should not be constructed as a rigid, restrictive or confining rulebook. Each organization is encouraged to develop such enhancements as they think may be useful in their planning. The steps outlined in this document represent a very simplified approach to strategic planning. 9 refs.

  8. Contingency planning: preparation of contingency plans

    DEFF Research Database (Denmark)

    Westergaard, J M

    2008-01-01

    . 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...

  9. Lesson Plays: Planning Teaching versus Teaching Planning

    Science.gov (United States)

    Zazkis, Rina; Liljedahl, Peter; Sinclair, Nathalie

    2009-01-01

    We introduce Lesson Play as an imaginary interaction between teacher and students presented in a form of a dialogue or play. We suggest that lesson plays are a valuable professional development tool in preparing for teaching that can be juxtaposed with, or used as a replacement for, traditional lesson planning. The article begins with an…

  10. Plan Ecuatoriano de Educacion (Ecuadoran Educational Planning).

    Science.gov (United States)

    Ministerio de Educacion Publica, Quito (Ecuador).

    This book provides background information of the educational system in Ecuador and describes the Ecuadoran plan for educational improvement. The first part considers the general conditions of the country and discusses geographic, economic, social, and demographic aspects along with the educational system. The book discusses the social function of…

  11. Planning Your Retirement.

    Science.gov (United States)

    American Association of Retired Persons, Washington, DC.

    This guidebook on retirement planning helps potential retirees by raising important issues in such areas as changing roles and relationships, health and fitness, meaningful use of time, working options, financial and estate planning, and housing and lifestyle. The first section, on attitude and role adjustments, discusses support systems, changing…

  12. Institutional Long Range Planning.

    Science.gov (United States)

    Caldwell Community Coll. and Technical Inst., Lenoir, NC.

    Long-range institutional planning has been in effect at Caldwell Community College and Technical Institute since 1973. The first step in the process was the identification of planning areas: administration, organization, educational programs, learning resources, student services, faculty, facilities, maintenance/operation, and finances. The major…

  13. Natural Resource Management Plan

    Energy Technology Data Exchange (ETDEWEB)

    Green, T. [Brookhaven National Laboratory (BNL), Upton, NY (United States); Schwager, K. [Brookhaven National Laboratory (BNL), Upton, NY (United States)

    2016-10-01

    This comprehensive Natural Resource Management Plan (NRMP) for Brookhaven National Laboratory (BNL) was built on the successful foundation of the Wildlife Management Plan for BNL, which it replaces. This update to the 2003 plan continues to build on successes and efforts to better understand the ecosystems and natural resources found on the BNL site. The plan establishes the basis for managing the varied natural resources located on the 5,265-acre BNL site, setting goals and actions to achieve those goals. The planning of this document is based on the knowledge and expertise gained over the past 15 years by the Natural Resources management staff at BNL in concert with local natural resource agencies including the New York State Department of Environmental Conservation, Long Island Pine Barrens Joint Planning and Policy Commission, The Nature Conservancy, and others. The development of this plan works toward sound ecological management that not only benefits BNL’s ecosystems but also benefits the greater Pine Barrens habitats in which BNL is situated. This plan applies equally to the Upton Ecological and Research Reserve (Upton Reserve). Any difference in management between the larger BNL area and the Upton Reserve are noted in the text.

  14. 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…

  15. Automated process planning system

    Science.gov (United States)

    Mann, W.

    1978-01-01

    Program helps process engineers set up manufacturing plans for machined parts. System allows one to develop and store library of similar parts characteristics, as related to particular facility. Information is then used in interactive system to help develop manufacturing plans that meet required standards.

  16. Fermilab Program and Plans

    Energy Technology Data Exchange (ETDEWEB)

    Denisov, Dmitri [Fermilab

    2014-01-01

    This article is a short summary of the talk presented at 2014 Instrumentation Conference in Novosibirsk about Fermilab's experimental program and future plans. It includes brief description of the P5 long term planning progressing in US as well as discussion of the future accelerators considered at Fermilab.

  17. Planning Practice and Research

    DEFF Research Database (Denmark)

    2013-01-01

    and 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...

  18. Planning in Academic Departments.

    Science.gov (United States)

    Fountoukidis, Dona; And Others

    1995-01-01

    The efforts of the biology department at William Paterson College, a state college in New Jersey, to use strategic planning at the department level are chronicled. Planning focused on establishing a direction for hiring faculty, developing curriculum, purchasing equipment, and training students. Results, unanticipated outcomes, and lessons learned…

  19. Framework for Maintenance Planning

    DEFF Research Database (Denmark)

    Soares, C. Guedes; Duarte, J. Caldeira; Garbatov, Y.;

    2010-01-01

    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...

  20. 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…

  1. 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....

  2. 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)

  3. 'Plans are useless'.

    Science.gov (United States)

    Bland, Michael

    2013-01-01

    An essential element in crisis recovery is the protection and/or recovery of reputation. This calls for a crisis communications function that is of more than passing interest to the business continuity specialist and which presents two major challenges in this era of process-driven management: (1) it is an inexact science, more about common sense, psychology, empathy and 'playing it by ear' than about box ticking; (2) it does not lend itself to detailed, rigid plans, although some degree of planning is essential. This paper outlines a flexible approach that will help the crisis team to develop a workable communications plan that strikes a balance between being too detailed and too sketchy. It argues that the whole management team should be involved in developing the plan and sets a number of questions, which, on being answered, will help a realistic, achievable and effective plan to evolve. PMID:24113637

  4. Epistemic and Doxastic Planning

    DEFF Research Database (Denmark)

    Jensen, Martin Holm

    on 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......This thesis is concerned with planning and logic, which are both core areas of Artificial Intelligence (AI). A wide range of research disciplines deal with AI, including philosophy, economy, psychology, neuroscience, mathematics and computer science. The approach of this thesis is based...... is therefore closely related to the reflective system of humans. Logic is the study of reasoning. From certain fixed principles logic enables us to make sound and rational inferences, and as such the discpline is virtually impossible to get around when working with AI. The basis of automated planning, the term...

  5. 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....

  6. 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....

  7. 'Plans are useless'.

    Science.gov (United States)

    Bland, Michael

    2013-01-01

    An essential element in crisis recovery is the protection and/or recovery of reputation. This calls for a crisis communications function that is of more than passing interest to the business continuity specialist and which presents two major challenges in this era of process-driven management: (1) it is an inexact science, more about common sense, psychology, empathy and 'playing it by ear' than about box ticking; (2) it does not lend itself to detailed, rigid plans, although some degree of planning is essential. This paper outlines a flexible approach that will help the crisis team to develop a workable communications plan that strikes a balance between being too detailed and too sketchy. It argues that the whole management team should be involved in developing the plan and sets a number of questions, which, on being answered, will help a realistic, achievable and effective plan to evolve.

  8. 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.

  9. Complexity Results in Epistemic Planning

    DEFF Research Database (Denmark)

    Bolander, Thomas; Jensen, Martin Holm; Schwarzentruber, Francois

    2015-01-01

    Epistemic planning is a very expressive framework that extends automated planning by the incorporation of dynamic epistemic logic (DEL). We provide complexity results on the plan existence problem for multi-agent planning tasks, focusing on purely epistemic actions with propositional preconditions......-hardness of the plan verification problem, which strengthens previous results on the complexity of DEL model checking....

  10. 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.

  11. Quality Assurance Project Plan for Facility Effluent Monitoring Plan activities

    Energy Technology Data Exchange (ETDEWEB)

    Frazier, T.P.

    1994-10-20

    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.

  12. 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.

  13. 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

  14. 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.

  15. 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

  16. 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

  17. 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.

  18. 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

  19. 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...

  20. 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...

  1. 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...

  2. Single-employer pension plans

    Data.gov (United States)

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

  3. Probabilistic transmission system planning

    CERN Document Server

    Li, Wenyuan

    2011-01-01

    "The book is composed of 12 chapters and three appendices, and can be divided into four parts. The first part includes Chapters 2 to 7, which discuss the concepts, models, methods and data in probabilistic transmission planning. The second part, Chapters 8 to 11, addresses four essential issues in probabilistic transmission planning applications using actual utility systems as examples. Chapter 12, as the third part, focuses on a special issue, i.e. how to deal with uncertainty of data in probabilistic transmission planning. The fourth part consists of three appendices, which provide the basic knowledge in mathematics for probabilistic planning. Please refer to the attached table of contents which is given in a very detailed manner"--

  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. Succeeding with succession planning.

    Science.gov (United States)

    McConnell, C R

    1996-12-01

    Succession planning is the process of identifying people who could presently move into key positions or could do so after specifically targeted development occurs. The process identifies the better people in the organization and takes a consistent approach to assembling, analyzing, and retaining information about potential leaders and planning for their further development. At its simplest level, it is the development of a backup and potential successor to each manager; at is most formal, it is a documented plan for management succession at all levels in the organization. Strongly supportive of a policy of development and promotion from within the organization, succession planning also represents a proactive posture in respect to inevitable management turnover. In these days of rapid change in health care, no modern organization that expects to keep up with increasing competition can afford to drift--or even to let a single department drift--while replacements are recruited for managers who resign, retire, or otherwise leave.

  7. 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 ...

  8. 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,...

  9. 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

  10. Elective course planning

    DEFF Research Database (Denmark)

    Kristiansen, Simon; Sørensen, Matias; Stidsen, Thomas Riis

    2011-01-01

    Efficient planning increasingly becomes an indispensable tool for management of both companies and public organizations. This is also the case for high school management in Denmark, because the growing individual freedom of the students to choose courses makes planning much more complex. Due...... to reforms, elective courses are today an important part of the curriculum, and elective courses are a good way to make high school education more attractive for the students. In this article, the problem of planning the elective courses is modeled using integer programming and three different solution...... for the Elective Course Planning Problem has been described in the literature before. The proposed algorithms are tested on data sets from 98 of the 150 high schools in Denmark. The tests show that for the majority of the problems, the optimal solution can be obtained within the one hour time bound. Furthermore...

  11. 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

  12. 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...

  13. 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...

  14. Land Use Plan

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This plan discusses the main types of land use at Parker River National Wildlife Refuge. Information about geology and water, groundwater, climatic conditions,...

  15. 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.

  16. 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...

  17. 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)

  18. 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.

  19. 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.

  20. 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....

  1. 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...

  2. 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...

  3. 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

  4. Network planning under uncertainties

    Science.gov (United States)

    Ho, Kwok Shing; Cheung, Kwok Wai

    2008-11-01

    One of the main focuses for network planning is on the optimization of network resources required to build a network under certain traffic demand projection. Traditionally, the inputs to this type of network planning problems are treated as deterministic. In reality, the varying traffic requirements and fluctuations in network resources can cause uncertainties in the decision models. The failure to include the uncertainties in the network design process can severely affect the feasibility and economics of the network. Therefore, it is essential to find a solution that can be insensitive to the uncertain conditions during the network planning process. As early as in the 1960's, a network planning problem with varying traffic requirements over time had been studied. Up to now, this kind of network planning problems is still being active researched, especially for the VPN network design. Another kind of network planning problems under uncertainties that has been studied actively in the past decade addresses the fluctuations in network resources. One such hotly pursued research topic is survivable network planning. It considers the design of a network under uncertainties brought by the fluctuations in topology to meet the requirement that the network remains intact up to a certain number of faults occurring anywhere in the network. Recently, the authors proposed a new planning methodology called Generalized Survivable Network that tackles the network design problem under both varying traffic requirements and fluctuations of topology. Although all the above network planning problems handle various kinds of uncertainties, it is hard to find a generic framework under more general uncertainty conditions that allows a more systematic way to solve the problems. With a unified framework, the seemingly diverse models and algorithms can be intimately related and possibly more insights and improvements can be brought out for solving the problem. This motivates us to seek a

  5. 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...

  6. Approximations in Inspection Planning

    DEFF Research Database (Denmark)

    Engelund, S.; Sørensen, John Dalsgaard; Faber, M. H.;

    2000-01-01

    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....... 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 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....

  7. 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...

  8. 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)

  9. 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...

  10. 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.

  11. 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 strategic renewal. Empirical evidence of the various difficulties that learning flows has to overcome as it journeys through organizational and hierarchical levels are presented. Despite various cognitive and social psychological barriers identified along the way, the results show the novel...

  12. 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...

  13. 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 ...

  14. 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....

  15. El plan piloto 1997

    Directory of Open Access Journals (Sweden)

    Fernando Martínez Sandres

    2015-09-01

    Full Text Available Contenido: El proceso de gestación. El primer acercamiento. Las elaboraciones del grupo de trabajo. El segundo escalón. Las ideas llevadas a un proyecto. Hacia una iniciativa integral. La re-programación del proyecto. Las actividades en marcha. El plan piloto1997 funcionando. Los próximos pasos del plan. Recoger, sistematizar y analizar. El escenario futuro. Procurar que los esfuerzos den sus frutos

  16. 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 ...

  17. Cassini science planning process

    Science.gov (United States)

    Paczkowski, Brian G.; Ray, Trina L.

    2004-01-01

    The mission design for Cassini-Huygens calls for a four-year orbital survey of the Saturnian system and the descent into the Titan atmosphere and eventual soft-landing of the Huygens probe. The Cassini orbiter tour consists of 76 orbits around Saturn with 44 close Titan flybys and 8 targeted icy satellite flybys. The Cassini orbiter spacecraft carries twelve scientific instruments that will perform a wide range of observations on a multitude of designated targets. The science opportunities, frequency of encounters, the length of the Tour, and the use of distributed operations pose significant challenges for developing the science plan for the orbiter mission. The Cassini Science Planning Process is the process used to develop and integrate the science and engineering plan that incorporates an acceptable level of science required to meet the primary mission objectives far the orbiter. The bulk of the integrated science and engineering plan will be developed prior to Saturn Orbit Insertion (Sol). The Science Planning Process consists of three elements: 1) the creation of the Tour Atlas, which identifies the science opportunities in the tour, 2) the development of the Science Operations Plan (SOP), which is the conflict-free timeline of all science observations and engineering activities, a constraint-checked spacecraft pointing profile, and data volume allocations to the science instruments, and 3) an Aftermarket and SOP Update process, which is used to update the SOP while in tour with the latest information on spacecraft performance, science opportunities, and ephemerides. This paper will discuss the various elements of the Science Planning Process used on the Cassini Mission to integrate, implement, and adapt the science and engineering activity plans for Tour.

  18. 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.

  19. 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 ...

  20. 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.

  1. 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

  2. A Plan Is Born

    Institute of Scientific and Technical Information of China (English)

    2010-01-01

    @@ Ten steps The first step in making the 12th FiveYear Plan was a midterm review of the 11th Five-Year Plan. In the second half of 2008, the National Development and Reform Commission (NDRC) entrusted the Center for China Study of Tsinghua University, the Development Research Center of the State Council and the World Bank Office, Beijing with the review work. Each of the three then wrote an independent report.

  3. 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.

  4. 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...

  5. International Photovoltaic Program Plan

    Energy Technology Data Exchange (ETDEWEB)

    Costello, D.; Koontz, R.; Posner, D.; Heiferling, P.; Carpenter, P.; Forman, S.; Perelman, L.

    1979-12-01

    The International Photovoltaics Program Plan is in direct response to the Solar Photovoltaic Energy Research, Development, and Demonstration Act of 1978 (PL 95-590). As stated in the Act, the primary objective of the plan is to accelerate the widespread use of photovoltaic systems in international markets. Benefits which could result from increased international sales by US companies include: stabilization and expansion of the US photovoltaic industry, preparing the industry for supplying future domestic needs; contribution to the economic and social advancement of developing countries; reduced world demand for oil; and improvements in the US balance of trade. The plan outlines programs for photovoltaic demonstrations, systems developments, supplier assistance, information dissemination/purchaser assistance, and an informaion clearinghouse. Each program element includes tactical objectives and summaries of approaches. A program management office will be established to coordinate and manage the program plan. Although the US Department of Energy (DOE) had the lead responsibility for preparing and implementing the plan, numerous federal organizations and agencies (US Departments of Commerce, Justice, State, Treasury; Agency for International Development; ACTION; Export/Import Bank; Federal Trade Commission; Small Business Administration) were involved in the plan's preparation and implementation.

  6. Community energy planning

    Energy Technology Data Exchange (ETDEWEB)

    Rees, S. [BC Energy Aware Committee, Richmond, BC (Canada)

    2001-07-01

    The mandate of the BC Energy Aware Committee is to promote and assist in the implementation of community energy planning by working with local governments, developers and utilities to integrate energy into local planning processes and to use local resources in the design and operation of communities. This paper presented the basic concepts of how energy is used in communities and how its use impacts the community. It was demonstrated that designing for energy supports community livability objectives. Energy considerations can be incorporated in existing community planning processes, thereby playing an important role in reducing Canada's greenhouse gas emissions and slowing down climate change. The paper also provided some practical advice that will help communities move toward sustainable energy development. Community energy planning encompasses land use planning and transportation, infrastructure efficiency, and alternative energy supply. The strategies that are related to each of these components were highlighted. The community energy planning program in Kamloops was presented as a case study of a specific initiative to build a community that is socially, environmentally and fiscally sustainable. tabs., figs.

  7. Strategic planning for marketers.

    Science.gov (United States)

    Wilson, I

    1978-12-01

    The merits of strategic planning as a marketing tool are discussed in this article which takes the view that although marketers claim to be future-oriented, they focus too little attention on long-term planning and forecasting. Strategic planning, as defined by these authors, usually encompasses periods of between five and twenty-five years and places less emphasis on the past as an absolute predictor of the future. It takes a more probabilistic view of the future than conventional marketing strategy and looks at the corporation as but one component interacting with the total environment. Inputs are examined in terms of environmental, social, political, technological and economic importance. Because of its futuristic orientation, an important tenant of strategic planning is the preparation of several alternative scenarios ranging from most to least likely. By planning for a wide-range of future market conditions, a corporation is more able to be flexible by anticipating the course of future events, and is less likely to become a captive reactor--as the authors believe is now the case. An example of strategic planning at General Elecric is cited.

  8. Developing a Professionalism Plan

    Directory of Open Access Journals (Sweden)

    Heather Pautler, PharmD

    2013-01-01

    Full Text Available Professionalism is a way of being which underlies all the responsibilities of a pharmacist and associated general and professional abilities. The Student Affairs Committee was charged with developing a college-wide professionalism plan to meet the Accreditation Council for Pharmacy Education (ACPE Standards 15.1 and 23. This plan was developed concurrently with a new curriculum. The plan was developed systematically with the following goals: 1 create a definition of professionalism, 2 determine outcomes of the plan, 3 identify existing components which should be continued and new components to be added, 4 ensure existing and new components are linked to outcomes and 5 develop a continuous assessment process for the plan. The proposed plan consists of curricular, co-curricular and extra-curricular activities designed to help students gain experience in three professionalism pillars: Competence, Connection and Character, as defined by Brown et al in “Taxonomy of Professionalism”. While knowledge and skills will be enhanced, the focus of development will be on student virtues, values and attitudes—that what they do defines who they are. The goal is to help students develop as people and professionals who value the high ideals expected of a pharmacist.

  9. Rulison Monitoring Plan

    International Nuclear Information System (INIS)

    The Project Rulison Monitoring Plan has been developed as part of the U.S. Department of Energy (DOE) Office of Legacy Management's mission to protect human health and the environment. The purpose of the plan is to monitor fluids from gas wells for radionuclides that would indicate contamination is migrating from the Rulison detonation zone to producing gas wells, allowing action to be taken before the contamination could pose a risk. The Monitoring Plan (1) lists the contaminants present and identifies those that have the greatest potential to migrate from the detonation zone (radionuclide source term), (2) identifies locations that monitor the most likely transport pathways, (3) identifies which fluids will be sampled (gas and liquid) and why, (4) establishes the frequency of sampling, and (5) specifies the most practical analyses and where the analysis results will be reported. The plan does not affect the long-term hydrologic sampling conducted by DOE since 1972, which will continue for the purpose of sampling shallow groundwater and surface water near the site. The Monitoring Plan was developed in anticipation of gas wells being drilled progressively nearer the Rulison site. DOE sampled 10 gas wells in 1997 and 2005 at distances ranging from 2.7 to 7.6 miles from the site to establish background concentrations for radionuclides. In a separate effort, gas industry operators and the Colorado Oil and Gas Conservation Commission (COGCC) developed an industry sampling and analysis plan that was implemented in 2007. The industry plan requires the sampling of gas wells within 3 miles of the site, with increased requirements for wells within 1 mile of the site. The DOE plan emphasizes the sampling of wells near the site (Figure 1), specifically those with a bottom-hole location of 1 mile or less from the detonation, depending on the direction relative to the natural fracture trend of the producing formation. Studies indicate that even the most mobile radionuclides

  10. Rulison Monitoring Plan

    Energy Technology Data Exchange (ETDEWEB)

    None

    2010-07-01

    The Project Rulison Monitoring Plan has been developed as part of the U.S. Department of Energy (DOE) Office of Legacy Management's mission to protect human health and the environment. The purpose of the plan is to monitor fluids from gas wells for radionuclides that would indicate contamination is migrating from the Rulison detonation zone to producing gas wells, allowing action to be taken before the contamination could pose a risk. The Monitoring Plan (1) lists the contaminants present and identifies those that have the greatest potential to migrate from the detonation zone (radionuclide source term), (2) identifies locations that monitor the most likely transport pathways, (3) identifies which fluids will be sampled (gas and liquid) and why, (4) establishes the frequency of sampling, and (5) specifies the most practical analyses and where the analysis results will be reported. The plan does not affect the long-term hydrologic sampling conducted by DOE since 1972, which will continue for the purpose of sampling shallow groundwater and surface water near the site. The Monitoring Plan was developed in anticipation of gas wells being drilled progressively nearer the Rulison site. DOE sampled 10 gas wells in 1997 and 2005 at distances ranging from 2.7 to 7.6 miles from the site to establish background concentrations for radionuclides. In a separate effort, gas industry operators and the Colorado Oil and Gas Conservation Commission (COGCC) developed an industry sampling and analysis plan that was implemented in 2007. The industry plan requires the sampling of gas wells within 3 miles of the site, with increased requirements for wells within 1 mile of the site. The DOE plan emphasizes the sampling of wells near the site (Figure 1), specifically those with a bottom-hole location of 1 mile or less from the detonation, depending on the direction relative to the natural fracture trend of the producing formation. Studies indicate that even the most mobile

  11. 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 Facility Monitoring Plans of the overall site-wide environmental monitoring 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 individual Facility Effluent Monitoring Plans. This document is intended to be a basic road map to the Facility Effluent Monitoring Plan documents (i.e., the guidance document for preparing Facility Effluent Monitoring Plans, Facility Effluent Monitoring Plan determinations, management plan, and Facility Effluent Monitoring Plans). The implementing procedures, plans, and instructions are appropriate for the control of effluent monitoring plans requiring compliance with US Department of Energy, US Environmental Protection Agency, state, and local requirements. This Quality Assurance Project Plan contains a matrix of organizational responsibilities, procedural resources from facility or site manuals used in the Facility Effluent Monitoring Plans, and a list of the analytes of interest and analytical methods for each facility preparing a Facility Effluent Monitoring Plan. 44 refs., 1 figs., 2 tabs

  12. Differentiating Bona Fide Strategic Planning from Other Planning.

    Science.gov (United States)

    Meredith, Mark; And Others

    The extent to which a college has been engaged in strategic planning was studied with a sample of 96 institutions which had been identified as using strategic planning in a 1985 study. Survey questions consisted of a mixture of: (1) activities proper and essential to strategic planning; and (2) approaches and views of strategic planning that have…

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

    Directory of Open Access Journals (Sweden)

    Humphrey Tonkin

    2015-04-01

    Full Text Available 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, and occasionally more international and cosmopolitan. Zamenhof's work on Esperanto provides extensive material, little studied, documenting the formation of the language and linking it particularly to issues of supranational LP. Defining LP decision-making, Kaplan & Baldauf begin with context and target population. Zamenhof's Esperanto came shortly before Ben-Yehuda's revived Hebrew. His target community was (mostly the world's educated elite; Ben-Yehuda's was worldwide Jewry. Both planners were driven not by linguistic interest but by sociopolitical ideology rooted in reaction to anti-Semitism and imbued with the idea of progress. Their territories had no boundaries, but were not imaginary. Function mattered as much as form (Haugen's terms, status as much as corpus. For Zamenhof, status planning involved emphasis on Esperanto's ownership by its community - a collective planning process embracing all speakers (cf. Hebrew. Corpus planning included a standardized European semantics, lexical selectivity based not simply on standardization but on representation, and the development of written, and literary, style. Esperanto was successful as linguistic system and community language, less as generally accepted lingua franca. Its terminology development and language cultivation offers a model for language revival, but Zamenhof's somewhat limited analysis of language economy left him unprepared to deal with language as power.

  14. Bioclimate and city planning - open space planning

    Science.gov (United States)

    Mertens, Elke

    The planning and using of open spaces in urban areas very much depend on the shading of the surrounding building structures. This article presents a method for the investigation of the sunlight and the bioclimatic conditions in dependence on the surrounding buildings. It is illustrated for typical courtyards in Berlin, Germany, as one type of open spaces. The programme HelioDat determines the shading of any spot of an open space. It gives the possible duration of direct sunlight for the selected spot for each day of the year. The sunlight conditions in the courtyards differ from one another a lot in dependence on their size the tallness of the surrounding buildings. The calculation of the PMV on the basis of the results of the programme HelioDat determine the bioclimatic situation in the discussed courtyards. Although the results of HelioDat are only one input among the weather conditions and the personal characteristics of the test-person, the bioclimatic conditions correlate very much with the sunlight conditions. In a projected building structure, the sunlight conditions vary a lot between the present situation and the two architectural alternatives. Since the bioclimatic situation is correlated to the sunlight conditions, this example demonstrates the importance for the investigation of the sunlight conditions and the bioclimate already during the planning process of buildings.

  15. Environmental Implementation Plan

    Energy Technology Data Exchange (ETDEWEB)

    1994-02-01

    The Environmental Implementation Plan (EIP) is a dynamic long-range environmental-protection plan for SRS. The EIP communicates the current and future (five year) environmental plans from individual organizations and divisions as well as site environmental initiatives which are designed to protect the environment and meet or exceed compliance with changing environmental/ regulatory requirements. Communication with all site organizations is essential for making the site environmental planning process work. Demonstrating environmental excellence is a high priority embodied in DOE and WSRC policy. Because of your support and participation in the three EIP initiatives; Reflections, Sectional Revision, and Integrated Planning, improvements are being made to the EIP and SRS environmental protection programs. I appreciate the ``Partnership in Environmental Excellence`` formed by the environmental coordinators and professionals who work daily toward our goal of compliance and environmental excellence. I look forward to seeing continued success and improvement in our environmental protection programs through combined efforts of all site organizations to protect our employees, the public health, and the environment. Together, we will achieve our site vision for SRS to be the recognized model for Environmental Excellence in the DOE Nuclear Weapons Complex.

  16. Draft Transportation Institutional Plan

    International Nuclear Information System (INIS)

    The Department of Energy recognizes that the success of its program to develop and implement a national system for nuclear waste management and disposal depends on broad-based public understanding and acceptance. While each program element has its particular sensitivity, the transportation of the waste may potentially affect the greatest number of people, and accordingly is highly visible and potentially issue-laden. Therefore, the Office of Civilian Radioactive Waste Management has developed this Transportation Institutional Plan to lay the foundation for interaction among all interested parties for the purpose of identifying and resolving issues of concern. The Plan is divided into four chapters. Chapter 1 provides bachground information and discusses the purpose of the Plan and the policy guidance for establishing the transportation system. Chapter 2 introduces the major participants who must interact to build both the system itself and the consensus philosophy that is essential for effective operations. Chapter 3 suggests mechanisms for interaction that will ensure wide participation in program planning and implementation. And, finally, Chapter 4 suggests 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. The Plan's appendices provide supporting material to assist the reader in understanding the roles of the involved institutions. 4 figs., 1 tab

  17. Nutritional plans for boars

    Directory of Open Access Journals (Sweden)

    Charles Kiefer

    2012-06-01

    Full Text Available The objective of the present study was to evaluate nutritional plans for boars. Four hundred animals of 67 to 135 days of age and initial weight of 27.75±1.61 kg were distributed in a randomized block design with seven nutritional plans for boars (9.0-8.0; 9.0-9.0; 10.0-9.0; 10.0-10.0; 11.0-10.0; 11.0-11.0 and 12.0-11.0 g/kg of digestible lysine from 67 to 107 days and from 108 to 135 days, respectively with four repetitions and a control plan for barrows (11.0-10.0 g/kg of digestible lysine with eight repetitions and ten animals each. Uncastrated male swine presented better feed conversion; however they showed a lower marbling degree in relation to barrows, regardless of the nutritional plan. The nutritional plan that corresponds to the sequence of 11.0-10.0 g/kg of digestible lysine from the 67 to the 107 days and from the 108 to the 135 days, respectively, meets the nutritional needs of boars.

  18. Piping research program plan

    International Nuclear Information System (INIS)

    This document presents the piping research program plan for the Structural and Seismic Engineering Branch and the Materials Engineering Branch of the Division of Engineering, Office of Nuclear Regulatory Research. The plan describes the research to be performed in the areas of piping design criteria, environmentally assisted cracking, pipe fracture, and leak detection and leak rate estimation. The piping research program addresses the regulatory issues regarding piping design and piping integrity facing the NRC today and in the foreseeable future. The plan discusses the regulatory issues and needs for the research, the objectives, key aspects, and schedule for each research project, or group of projects focussing of a specific topic, and, finally, the integration of the research areas into the regulatory process is described. The plan presents a snap-shot of the piping research program as it exists today. However, the program plan will change as the regulatory issues and needs change. Consequently, this document will be revised on a bi-annual basis to reflect the changes in the piping research program. (author)

  19. Draft Transportation Institutional Plan

    Energy Technology Data Exchange (ETDEWEB)

    1985-09-01

    The Department of Energy recognizes that the success of its program to develop and implement a national system for nuclear waste management and disposal depends on broad-based public understanding and acceptance. While each program element has its particular sensitivity, the transportation of the waste may potentially affect the greatest number of people, and accordingly is highly visible and potentially issue-laden. Therefore, the Office of Civilian Radioactive Waste Management has developed this Transportation Institutional Plan to lay the foundation for interaction among all interested parties for the purpose of identifying and resolving issues of concern. The Plan is divided into four chapters. Chapter 1 provides bachground information and discusses the purpose of the Plan and the policy guidance for establishing the transportation system. Chapter 2 introduces the major participants who must interact to build both the system itself and the consensus philosophy that is essential for effective operations. Chapter 3 suggests mechanisms for interaction that will ensure wide participation in program planning and implementation. And, finally, Chapter 4 suggests 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. The Plan's appendices provide supporting material to assist the reader in understanding the roles of the involved institutions. 4 figs., 1 tab.

  20. Environmental Implementation Plan

    International Nuclear Information System (INIS)

    The Environmental Implementation Plan (EIP) is a dynamic long-range environmental-protection plan for SRS. The EIP communicates the current and future (five year) environmental plans from individual organizations and divisions as well as site environmental initiatives which are designed to protect the environment and meet or exceed compliance with changing environmental/ regulatory requirements. Communication with all site organizations is essential for making the site environmental planning process work. Demonstrating environmental excellence is a high priority embodied in DOE and WSRC policy. Because of your support and participation in the three EIP initiatives; Reflections, Sectional Revision, and Integrated Planning, improvements are being made to the EIP and SRS environmental protection programs. I appreciate the ''Partnership in Environmental Excellence'' formed by the environmental coordinators and professionals who work daily toward our goal of compliance and environmental excellence. I look forward to seeing continued success and improvement in our environmental protection programs through combined efforts of all site organizations to protect our employees, the public health, and the environment. Together, we will achieve our site vision for SRS to be the recognized model for Environmental Excellence in the DOE Nuclear Weapons Complex