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  • VigiFlow
  • For some member states that lack an E2B compatible database for ICSR management, UMC in collaboration with ''Swissmedic'' has developed ''VigiFlow'', a web-based ICSR management system. (wikipedia.org)
  • VigiFlow functions as a national ICSR database management system and analysis tool, through which cases are sent to UMC. (wikipedia.org)
  • data
  • vigiGrade: a tool to identify well-documented individual case reports and highlight systematic data quality issues. (biomedsearch.com)
  • We have developed a novel method, the BInary Characteristics Extractor and biomedical Properties Predictor (BICEPP), to classify properties (characteristics) of drugs (scientific entities) and subsequently validated this approach on data collected from traditional analytical methods derived from the knowledge of field experts (a therapeutic drug reference and a drug interaction database). (biomedcentral.com)
  • Data from Nuclear Regulatory Commission Report, Radiation Dose Estimates for Radiopharmaceuticals, NUREG/CR-6345, page 10, 1996. (bioportfolio.com)
  • This ADR identification system allows us to amass pertinent sADR information from a diverse set of data sources in order to identify and report sADRs in a timely and thorough manner. (wikipedia.org)
  • RADAR has analyzed historical data on many drugs from their initial inception, through approval by the FDA, and to the present. (wikipedia.org)
  • EHR systems are designed to store data accurately and to capture the state of a patient across time. (wikipedia.org)
  • 90% reported that at least 1 data management function was slower after EMRs were adopted, and 64% reported that note writing took longer. (wikipedia.org)
  • A third (34%) reported that it took longer to find and review medical record data, and 32% reported that it was slower to read other clinicians' notes. (wikipedia.org)
  • In addition, data from an electronic system can be used anonymously for statistical reporting in matters such as quality improvement, resource management and public health communicable disease surveillance. (wikipedia.org)
  • The MHRA has been criticised by the House of Commons Health Committee for, among other things, lacking transparency, and for inadequately checking drug licensing data. (wikipedia.org)
  • It is the single largest drug safety data repository in the world. (wikipedia.org)
  • These data are used by pharmaceutical industries, academic institutions and regulatory authorities for statistical signal detection, updating periodic reports, ICSR comparisons with company databases and studying the reporting patterns. (wikipedia.org)
  • Apart from data management, the VigiBase system includes an automated signal detection process using advanced data mining tools (''VigiMine''- a Bayesian Confidence Propagation Neural Network (BCPNN) data mining tool). (wikipedia.org)
  • Type of reports: Most preferred data includes post-marketing spontaneous serious and non-serious cases ICSRs. (wikipedia.org)
  • causality
  • METHODS: The Uppsala Monitoring Centre has developed the vigiGrade completeness score to measure the amount of clinically relevant information in structured format, without reflecting whether the information establishes causality between the drug and adverse event. (biomedsearch.com)
  • Despite a small number of reports for each ADR, causality assessments have been supported by pathology studies, antibody studies, and autopsies. (wikipedia.org)
  • interactions
  • To demonstrate its applicability, we evaluated the performance of BICEPP on many drug characteristics, including therapeutic classes, adverse effects, and their potentials for pharmacokinetic drug-drug interactions. (biomedcentral.com)
  • The possibility of interactions of Sodium Fluoride F 18 Injection with other drugs taken by patients undergoing PET imaging has not been studied. (bioportfolio.com)
  • Adverse effects may cause a reversible or irreversible change, including an increase or decrease in the susceptibility of the individual to other chemicals, foods, or procedures, such as drug interactions. (wikipedia.org)
  • methods
  • William Howard Wallace "Bill" Inman, MRCP, FRCP, FFPHM (1 August 1929 - 20 October 2005), also known as WHW Inman, was a British doctor and pioneer of methods and systems to detect risks of treatment with drugs. (wikipedia.org)
  • event
  • We developed an automated method using natural-language processing (NLP) and a knowledge source to differentiate cases in which the patient's disease is responsible for the event rather than a drug. (biomedsearch.com)
  • An adverse event is any undesirable experience associated with the use of a medical product. (wikipedia.org)
  • As of the summer of 2011, the program had received more than 40,000 adverse event reports. (wikipedia.org)
  • As he was unable to get official support for what became prescription event monitoring, in 1980 he resigned from the CSM secretariat to found the DSRU independently, and start a prescription event monitoring system using the "Green Form" questionnaires. (wikipedia.org)
  • Inman published a series of bulletins entitled 'PEM News' to report on the progress of prescription event monitoring. (wikipedia.org)
  • The RADAR methodology relies on initial recognition of these "sentinel" cases that then prompts hypothesis-driven inquiries as to whether an unrecognized adverse drug event signal is present in the population of those exposed to that drug. (wikipedia.org)
  • For each individual ADR, the number of unique event reports collected by RADAR ranged from 0 to 96. (wikipedia.org)
  • Postmarketing surveillance uses a number of approaches to monitor drug and device safety, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries, and record linkage between health databases. (wikipedia.org)
  • In the United States several reporting systems have been built, such as the Vaccine Adverse Event Reporting System (VAERS), the Manufacturer and User Facility Device Experience Database (MAUDE) and the Special Nutritionals Adverse Event Monitoring System. (wikipedia.org)
  • safety
  • 0.8 as well-documented and identified all such reports in the WHO global individual case safety report database, VigiBase, from 2007 to January 2012. (biomedsearch.com)
  • Prompt ADR reporting is crucial in ensuring drug safety. (semanticscholar.org)
  • He founded Drug Safety Canada to advocate for safe prescription drugs,[citation needed] and also initiated a hundred million dollar class action lawsuit against Johnson & Johnson and Health Canada in 2000, and an individual lawsuit, later settled after a six-year court battle. (wikipedia.org)
  • He introduced a Private member's bill on April 20, 2009, to establish an independent drug agency for Canada similar to the Canadian Nuclear Safety Commission or the Transportation Safety Board of Canada, focussing solely on prescription drug safety. (wikipedia.org)
  • As well as holding positions in health institutions in the UK, he was active in international efforts to co-ordinate drug safety monitoring. (wikipedia.org)
  • Following the thalidomide tragedy, he was invited by Sir Derrick Dunlop, the founding Chairman of the independent Committee on Safety of Drugs, to develop a spontaneous adverse drug reaction reporting system, which became known internationally as the yellow card system. (wikipedia.org)
  • In total Inman published around 100 papers on drug monitoring and safety aspects of various drugs. (wikipedia.org)
  • Its work has identified safety problems with 33 drugs. (wikipedia.org)
  • Thus, the RADAR project has developed into an important adjunct to the current pharmaceutical drug and device safety system. (wikipedia.org)
  • VigiBase is a World Health Organization's (WHO) global Individual Case Safety Report (ICSR) database that contains ICSRs submitted by the participating member states enrolled under WHO's international drug monitoring programme. (wikipedia.org)
  • Monitoring
  • Young became a consumer advocate after this incident, and has been fighting for a more stringent and protective drug-monitoring system in Canada. (wikipedia.org)
  • The pilot phase of the drug monitoring programme was evaluated favourably by the World Health Assembly and became a continuing WHO programme, based until 1978 in Geneva. (wikipedia.org)
  • 2010- 100th country joins the WHO Programme for International Drug Monitoring. (wikipedia.org)
  • healthcare
  • He also directs the product vision for the EHR systems to support Veteran-centric, team-based, quality-driven models of healthcare delivery. (utah.edu)
  • surveillance
  • Dr. Nebeker directs active research projects on translating theory from the cognitive and social sciences to guide the design of software for clinicians, for real-time surveillance of safe operation and safe use of EHR systems, and for design of information systems for real-time analytics. (utah.edu)
  • Health Canada is the regulatory body which approves drugs, and it has a division called "Marketed Health Products Directorate" (MHPD) which coordinates Canadian postmarketing surveillance. (wikipedia.org)
  • respectively
  • From the two regional centres, a total of 898 and 1074 reports were submitted in 2005 and 2010 respectively. (diva-portal.org)
  • The overall rates of drug-related adverse reactions for sparfloxacin 400/200 mg versus comparators and 200/100 mg versus the comparator (amoxicillin/clavulanic acid) were 13.7 versus 17.7%, and 9.5 versus 13.2%, respectively. (wikipedia.org)
  • discontinua- tion of the antibacterial agent because of drug-related adverse reactions occurred in 1.6 versus 1.6%, and 1) versus 1.1%, respectively. (wikipedia.org)
  • patients
  • Lethargy, tremulousness, seizures and delirium have been reported rarely in studies of renally impaired patients. (accopy.com)
  • In clinical studies, about 1% of all patients had to discontinue the drug because of these sensations, which occurred on average 40 days after the drug was started. (wikipedia.org)
  • Other common adverse drug reactions (1-10% of patients) include first-degree AV block, ventricular extrasystoles, dizziness and/or blurred vision. (wikipedia.org)
  • Injection
  • Aseptically withdraw Ammonia N 13 Injection from its container and administer 10-20 mCi (0.368 - 0.736 GBq) of Ammonia N 13 Injection as a bolus at 8 minutes after the administration of the pharmacologic stress-inducing drug. (drugs.com)
  • commonly
  • Ivabradine acts by reducing the heart rate via specific inhibition of the funny channel, a mechanism different from that of beta blockers and calcium channel blockers, two commonly prescribed antianginal drugs. (wikipedia.org)
  • statistical
  • We utilised odds ratios with statistical shrinkage to identify subgroups with unexpectedly high proportions of well-documented reports. (biomedsearch.com)
  • We have developed a statistical text-mining approach (BInary Characteristics Extractor and biomedical Properties Predictor: BICEPP) to help experts screen drugs that may have important clinical characteristics of interest. (biomedcentral.com)
  • These analyses synthesize the various sources of statistical information on the presence of adverse reactions to these drugs and assess whether the actual risk is in line with studies. (wikipedia.org)
  • predict
  • BICEPP first retrieves MEDLINE abstracts containing drug names, then selects tokens that best predict the list of drugs which represents the characteristic of interest. (biomedcentral.com)
  • versus
  • The increased portability and accessibility of electronic medical records may also increase the ease with which they can be accessed and stolen by unauthorized persons or unscrupulous users versus paper medical records, as acknowledged by the increased security requirements for electronic medical records included in the Health Information and Accessibility Act and by large-scale breaches in confidential records reported by EMR users. (wikipedia.org)
  • However
  • however this veterinary use was never approved by the United States Food and Drug Administration (FDA). (wikipedia.org)
  • database
  • setting-up of relational database management system. (wikipedia.org)
  • VigiBase is a relational database management system (RDMS) which is compatible with ODBC (open database connectivity) and uses SQL for the database communication. (wikipedia.org)
  • Health
  • At VA, he is the medical director of VA's program to modernize its electronic health record system. (utah.edu)
  • On the whole, 24 % of the reports from physicians are well-documented compared with only 4 % for consumers/non-health professionals. (biomedsearch.com)
  • Notably, Denmark and Norway have more than 50 % well-documented reports from consumers/non-health professionals and higher rates than for physicians. (biomedsearch.com)
  • Reports from consumers/non-health professionals in specific regions have excellent quality, which illustrates their potential for the future. (biomedsearch.com)
  • If the ability to exchange records between different EMR systems were perfected("interoperability") would facilitate the co-ordination of health care delivery in non-affiliated health care facilities. (wikipedia.org)
  • The American Society of Health-System Pharmacists. (wikipedia.org)
  • Food
  • Food and Drug Administration. (springer.com)
  • In some instances, initial cases are identified at hospital case conferences and reported to the U.S. Food and Drug Administration (FDA) or to the pharmaceutical manufacturer. (wikipedia.org)
  • effects
  • Pharmacoepidemiology is the study of the uses and effects of drugs in well defined populations. (wikipedia.org)
  • Adverse effects are sometimes referred to as "iatrogenic" because they are generated by a physician/treatment. (wikipedia.org)
  • Using a drug or other medical intervention which is contraindicated may increase the risk of adverse effects. (wikipedia.org)
  • Adverse effects may cause complications of a disease or procedure and negatively affect its prognosis. (wikipedia.org)
  • characteristics
  • The identification of drug characteristics is a clinically important task, but it requires much expert knowledge and consumes substantial resources. (biomedcentral.com)
  • In this paper, we have extended the application of text-mining to the task of identifying binary drug characteristics. (biomedcentral.com)