• 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)
  • The conference examined the problems of relying solely on spontaneous reporting systems, and the need for adverse reaction data which included information on the number of patients using a particular drug, which connected with Inman's plans for prescription event monitoring. (wikipedia.org)
  • 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)
  • 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)
  • Voluntary
  • Founded in 1993, this system of voluntary reporting allows such information to be shared with the medical community or the general public. (wikipedia.org)
  • After 1975 he drew up proposals for what he termed 'Recorded Release' monitoring method to supplement the voluntary Yellow Card Scheme, which eventually evolved into the post-marketing system used by the Drug Safety Research Unit (DSRU). (wikipedia.org)
  • programme
  • National cancer registry programme of the Indian Council of Medical Research reported highest number of oral cancers worldwide with up to 80 000 new cases annually [ 9 ]. (ijpsonline.com)
  • 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)
  • 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)
  • 2010- 100th country joins the WHO Programme for International Drug Monitoring. (wikipedia.org)
  • patients
  • It also, amongst other powers, allows the Minister of Health to compel drug companies to make confidential business information (CBI) on their drugs available to specific entities such as the provinces and researchers, when patients are at risk of serious harm. (wikipedia.org)
  • GPs reported 10,200 reasons for stopping bupropion among 9056 patients. (springer.com)
  • Oral cancer patients who received platinum-based cancer chemotherapy were monitored for adverse drug reactions. (ijpsonline.com)
  • 105 patients (87.5%) developed a total of 247 adverse drug reactions. (ijpsonline.com)
  • Part of the task of clinical pharmacology is to provide a risk benefit assessment by effects of drugs in patients: doing the studies needed to provide an estimate of the probability of beneficial effects on populations, or assessing the probability of adverse effects on populations. (wikipedia.org)
  • 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)
  • therapeutic
  • Bupropion was taken in the first trimester of 12 pregnancies and the outcome ascertained in eight cases - five live births (no congenital abnormalities reported), two therapeutic terminations and one intrauterine death (no further details). (springer.com)
  • An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. (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)
  • 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)
  • In total Inman published around 100 papers on drug monitoring and safety aspects of various drugs. (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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Preventability and severity of adverse drug reactions assessed by modified Schumock and Thornton scale, modified Hartwig and Siegel scale respectively. (ijpsonline.com)
  • 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)
  • 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)
  • Food
  • Food and Drug Administration. (springer.com)
  • After earlier government legislation had died on the Order Paper at the dissolution of the 39th Canadian Parliament, Young conceived and sponsored Bill C-17, An Act to amend the Food and Drugs Act - Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), named for his late daughter, which received Royal assent on November 6, 2014. (wikipedia.org)
  • 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
  • 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)
  • Adverse effects of medical treatment resulted in 142,000 deaths in 2013 up from 94,000 deaths in 1990 globally. (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)
  • case
  • It is used mainly in the treatment of hand, foot and mouth disease, diarrhea, upper respiratory tract infections and viral pneumonia, though one case report suggested it may also be useful in the treatment of Zika fever. (wikipedia.org)
  • Investigators have developed a well-coordinated system to accurately compile case report information on sADRs and to identify milestones associated with identification and reporting of the relevant ADR information. (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)
  • According to World Health Organization (WHO) an adverse drug reaction (ADR) is defined as a response to a drug which is noxious and unintended, which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease or for modification of physiological function excluding failure to accomplish the intended purpose [ 1 ]. (ijpsonline.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)