adverse drug reaction reporting systems

Summary

Summary: Systems developed for collecting reports from government agencies, manufacturers, hospitals, physicians, and other sources on adverse drug reactions.

Top Publications

  1. ncbi Novel statistical tools for monitoring the safety of marketed drugs
    J S Almenoff
    Department of Epidemiology and Population Health, Safety Evaluation and Risk Management, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Research Triangle Park, North Carolina, USA
    Clin Pharmacol Ther 82:157-66. 2007
  2. ncbi Under-reporting of adverse drug reactions : a systematic review
    Lorna Hazell
    Drug Safety Research Unit, Southampton, UK
    Drug Saf 29:385-96. 2006
  3. ncbi Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports
    S J Evans
    Post-Licensing Division, Medicines Control Agency, Market Towers, Nine Elms Lane, London SW8 5NQ
    Pharmacoepidemiol Drug Saf 10:483-6. 2001
  4. ncbi Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas
    J P Ioannidis
    Clinical Trials and Evidence-Based Medicine Unit, Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece
    JAMA 285:437-43. 2001
  5. pmc Data-driven prediction of drug effects and interactions
    Nicholas P Tatonetti
    Biomedical Informatics Training Program, Stanford University, Stanford, CA 94305, USA
    Sci Transl Med 4:125ra31. 2012
  6. pmc Adverse drug event trigger tool: a practical methodology for measuring medication related harm
    J D Rozich
    Luther Midelfort, Mayo Health System, Eau Claire, WI 54703, USA
    Qual Saf Health Care 12:194-200. 2003
  7. ncbi Quantitative signal detection using spontaneous ADR reporting
    A Bate
    WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
    Pharmacoepidemiol Drug Saf 18:427-36. 2009
  8. ncbi Adverse events following administration to pregnant women of influenza A (H1N1) 2009 monovalent vaccine reported to the Vaccine Adverse Event Reporting System
    Pedro L Moro
    Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA
    Am J Obstet Gynecol 205:473.e1-9. 2011
  9. pmc Statin-associated muscular and renal adverse events: data mining of the public version of the FDA adverse event reporting system
    Toshiyuki Sakaeda
    Center for Development of Integrative Education in Pharmacy and Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto, Japan
    PLoS ONE 6:e28124. 2011
  10. pmc Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies
    P Impicciatore
    Academic Division of Child Health (Nottingham University) Derbyshire Children's Hospital, Derby, UK
    Br J Clin Pharmacol 52:77-83. 2001

Detail Information

Publications287 found, 100 shown here

  1. ncbi Novel statistical tools for monitoring the safety of marketed drugs
    J S Almenoff
    Department of Epidemiology and Population Health, Safety Evaluation and Risk Management, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Research Triangle Park, North Carolina, USA
    Clin Pharmacol Ther 82:157-66. 2007
    ..We also provide examples of how these tools can be used to identify novel drug interactions and demographic risk factors for adverse drug reactions. Challenges, controversies, and frontiers for future research are discussed...
  2. ncbi Under-reporting of adverse drug reactions : a systematic review
    Lorna Hazell
    Drug Safety Research Unit, Southampton, UK
    Drug Saf 29:385-96. 2006
    ....
  3. ncbi Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports
    S J Evans
    Post-Licensing Division, Medicines Control Agency, Market Towers, Nine Elms Lane, London SW8 5NQ
    Pharmacoepidemiol Drug Saf 10:483-6. 2001
    ..IMPLICATIONS: Proportional reporting ratios are a valuable aid to signal generation from spontaneous reporting data which are easy to calculate and interpret, and various refinements are possible...
  4. ncbi Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas
    J P Ioannidis
    Clinical Trials and Evidence-Based Medicine Unit, Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece
    JAMA 285:437-43. 2001
    ..Current standards for safety reporting in randomized trials should be revised to address this inadequacy...
  5. pmc Data-driven prediction of drug effects and interactions
    Nicholas P Tatonetti
    Biomedical Informatics Training Program, Stanford University, Stanford, CA 94305, USA
    Sci Transl Med 4:125ra31. 2012
    ..We conclude that confounding effects from covariates in observational clinical data can be controlled in data analyses and thus improve the detection and prediction of adverse drug effects and interactions...
  6. pmc Adverse drug event trigger tool: a practical methodology for measuring medication related harm
    J D Rozich
    Luther Midelfort, Mayo Health System, Eau Claire, WI 54703, USA
    Qual Saf Health Care 12:194-200. 2003
    ..The adapted technique appears to increase the rate of ADE detection approximately 50-fold over traditional reporting methodologies...
  7. ncbi Quantitative signal detection using spontaneous ADR reporting
    A Bate
    WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
    Pharmacoepidemiol Drug Saf 18:427-36. 2009
    ..Additionally we discuss three major areas of controversy and ongoing research: stratification, method evaluation and implementation. Finally we give some suggestions as to where emerging research is likely to lead...
  8. ncbi Adverse events following administration to pregnant women of influenza A (H1N1) 2009 monovalent vaccine reported to the Vaccine Adverse Event Reporting System
    Pedro L Moro
    Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA
    Am J Obstet Gynecol 205:473.e1-9. 2011
    ....
  9. pmc Statin-associated muscular and renal adverse events: data mining of the public version of the FDA adverse event reporting system
    Toshiyuki Sakaeda
    Center for Development of Integrative Education in Pharmacy and Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto, Japan
    PLoS ONE 6:e28124. 2011
    ....
  10. pmc Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies
    P Impicciatore
    Academic Division of Child Health (Nottingham University) Derbyshire Children's Hospital, Derby, UK
    Br J Clin Pharmacol 52:77-83. 2001
    ..Further, methodologically sound drug surveillance studies are necessary for an effective promotion of a safer use of drugs in children...
  11. ncbi Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database
    Ana Szarfman
    Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
    Drug Saf 25:381-92. 2002
    ..The application of these tools may ultimately improve usage recommendations...
  12. ncbi Spontaneous adverse event reports of Stevens-Johnson syndrome/toxic epidermal necrolysis: detecting associations with medications
    Julie Papay
    GlaxoSmithKline, Safety Evaluation and Risk Management, Global Clinical Safety and Pharmacovigilance, NC 27709 3398, USA
    Pharmacoepidemiol Drug Saf 21:289-96. 2012
    ....
  13. ncbi Defining 'signal' and its subtypes in pharmacovigilance based on a systematic review of previous definitions
    Manfred Hauben
    Department of Risk Management Strategy, Pfizer Inc, New York, New York 10017, USA
    Drug Saf 32:99-110. 2009
    ..This definition and its accompanying flowchart should inform decision making in considering benefits and harms caused by pharmacological and nonpharmacological interventions...
  14. ncbi Cardiovascular, ocular and bone adverse reactions associated with thiazolidinediones: a disproportionality analysis of the US FDA adverse event reporting system database
    Domenico Motola
    Department of Pharmacology, University of Bologna, Bologna, Italy
    Drug Saf 35:315-23. 2012
    ..The risk of myocardial infarction, macular oedema and bone fractures associated with thiazolidinediones (TZDs) has been extensively investigated...
  15. pmc Hypersensitivity reactions to anticancer agents: data mining of the public version of the FDA adverse event reporting system, AERS
    Kaori Kadoyama
    Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto 606 8501, Japan
    J Exp Clin Cancer Res 30:93. 2011
    ..The present study was performed to confirm whether the database could suggest the hypersensitivity reactions caused by anticancer agents, paclitaxel, docetaxel, procarbazine, asparaginase, teniposide, and etoposide...
  16. pmc Adverse event profiles of platinum agents: data mining of the public version of the FDA adverse event reporting system, AERS, and reproducibility of clinical observations
    Toshiyuki Sakaeda
    Center for Integrative Education in Pharmacy and Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto 606 8501, Japan
    Int J Med Sci 8:487-91. 2011
    ..Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to confirm platinum agent-associated adverse events, and to clarify the rank-order of these drugs in terms of susceptibility...
  17. pmc Assessment of global reporting of adverse drug reactions for anti-malarials, including artemisinin-based combination therapy, to the WHO Programme for International Drug Monitoring
    Andrea Kuemmerle
    Swiss Tropical and Public Health Institute, Department of Medicines Research, Basel, Switzerland
    Malar J 10:57. 2011
    ..This project was undertaken to profile the provenance of the pharmacovigilance reporting of all anti-malarials, including ACT to the WHO adverse drug reaction (ADR) database (Vigibase™) over the past 40 years...
  18. pmc Detection, verification, and quantification of adverse drug reactions
    Bruno H Ch Stricker
    Pharmacoepidemiology Unit, Department of Epidemiology and Biostatistics, Erasmus Medical Center, PO Box 1738, 3000 DR Rotterdam
    BMJ 329:44-7. 2004
  19. pmc Active computerized pharmacovigilance using natural language processing, statistics, and electronic health records: a feasibility study
    Xiaoyan Wang
    Department of Biomedical Informatics, Columbia University, 622 West 168 Street, VC5, New York, NY 10032, USA
    J Am Med Inform Assoc 16:328-37. 2009
    ..Our results demonstrate that the framework is feasible although there are some challenging issues. To the best of our knowledge, this is the first study using comprehensive unstructured data from the EHR for pharmacovigilance...
  20. ncbi National surveillance of emergency department visits for outpatient adverse drug events
    Daniel S Budnitz
    Division of Healthcare Quality Promotion, National Center for Infectious Diseases, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA
    JAMA 296:1858-66. 2006
    ..Adverse drug events are common and often preventable causes of medical injuries. However, timely, nationally representative information on outpatient adverse drug events is limited...
  21. ncbi Clarifying adverse drug events: a clinician's guide to terminology, documentation, and reporting
    Jonathan R Nebeker
    Veterans Affairs Salt Lake City Health Care System and University of Utah School of Medicine, Salt Lake City, Utah, USA
    Ann Intern Med 140:795-801. 2004
    ..Examples and rationale for meaningful documentation of adverse drug events are provided, along with an outline of the types of events that should be reported to regulatory agencies...
  22. ncbi Drug-induced torsades de pointes: data mining of the public version of the FDA Adverse Event Reporting System (AERS)
    Elisabetta Poluzzi
    Department of Pharmacology, University of Bologna, Bologna, Italy
    Pharmacoepidemiol Drug Saf 18:512-8. 2009
    ..To investigate spontaneous reports of TdP present in the public version of the FDA Adverse Event Reporting System (AERS) in the light of what is already known on their TdP-liability...
  23. ncbi Methods for causality assessment of adverse drug reactions: a systematic review
    Taofikat B Agbabiaka
    Complementary Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, Exeter, UK
    Drug Saf 31:21-37. 2008
    ..Because assessment methods are also not entirely devoid of individual judgements, inter-rater reliability can be low. In conclusion, there is still no method universally accepted for causality assessment of ADRs...
  24. ncbi Decision support methods for the detection of adverse events in post-marketing data
    M Hauben
    Pfizer, New York, USA
    Drug Discov Today 14:343-57. 2009
    ....
  25. pmc Platinum agent-induced hypersensitivity reactions: data mining of the public version of the FDA adverse event reporting system, AERS
    Toshiyuki Sakaeda
    Center for Development of Integrative Education in Pharmacy and Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto, Japan
    Int J Med Sci 8:332-8. 2011
    ..Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to confirm the platinum agent-associated mild, severe, and lethal hypersensitivity reactions...
  26. ncbi Adverse drug reactions in childhood: a review of prospective studies and safety alerts
    A Clavenna
    Laboratory for Mother and Child Health, Department of Public Health, Mario Negri Institute for Pharmacological Research, 20156 Milan MI, Italy
    Arch Dis Child 94:724-8. 2009
    ..To assess the incidence of adverse drug reactions (ADRs) in the paediatric population and the safety alerts concerning children and adolescents issued by international drug regulatory agencies since 2001...
  27. pmc Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital
    A Vallano
    Fundacio Institut Catala de Farmacologia, WHO Collaborating Centre for Research and Training in Pharmacoepidemiology, Barcelona, Spain
    Br J Clin Pharmacol 60:653-8. 2005
    ..To describe the opinions of hospital physicians concerning problems regarding the spontaneous reporting of adverse drug reactions (ADRs) and ways to solve them...
  28. ncbi Bevacizumab-induced serious side-effects: a review of the French pharmacovigilance database
    Solène Taugourdeau-Raymond
    Hopital Salvator, Assistance Publique des Hopitaux de Marseille, Centre Regional de Pharmacovigilance, 249 Boulevard Sainte Marguerite, 13009 Marseille, France
    Eur J Clin Pharmacol 68:1103-7. 2012
    ..Well tolerated, bevacizumab is sometimes associated with serious adverse drug reactions (ADRs). The objective of this study is to describe the profile of ADRs related to bevacizumab and reported to the French Pharmacovigilance system...
  29. ncbi Prescription-event monitoring and reporting of adverse drug reactions
    E Heeley
    Drug Safety Research Unit, Bursledon Hall, SO31 1AA, Southampton, UK
    Lancet 358:1872-3. 2001
    ..Our results should not be extrapolated to calculate incidence rates of adverse drug reactions in the community from spontaneous reports...
  30. pmc Aspirin- and clopidogrel-associated bleeding complications: data mining of the public version of the FDA adverse event reporting system, AERS
    Takao Tamura
    Kinki University Nara Hospital, Nara, Japan
    Int J Med Sci 9:441-6. 2012
    ....
  31. ncbi Identifying and preventing adverse drug events in elderly hospitalised patients: a randomised trial of a program to reduce adverse drug effects
    C Trivalle
    Pole Vieillissement, Readaptation et Accompagnement, Hopital Paul Brousse, APHP, Villejuif, France
    J Nutr Health Aging 14:57-61. 2010
    ..Evaluate the impact of educational intervention in decreasing ADEs in elderly patients in a hospital setting...
  32. ncbi Adverse events in pregnant women following administration of trivalent inactivated influenza vaccine and live attenuated influenza vaccine in the Vaccine Adverse Event Reporting System, 1990-2009
    Pedro L Moro
    Immunization Safety Office, Division of Healthcare Quality Promotion National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA
    Am J Obstet Gynecol 204:146.e1-7. 2011
    ..The objective of the study was to characterize reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received seasonal influenza vaccines to assess for potential vaccine safety concerns...
  33. ncbi Impact analysis of signals detected from spontaneous adverse drug reaction reporting data
    Patrick Waller
    Patrick Waller Limited, Consultancy in Pharmacovigilance and Pharmacoepidemiology, Southampton, UK
    Drug Saf 28:843-50. 2005
    ..A computer program has been written to facilitate the process and reduce error. Further work is required to test the feasibility and value of impact analysis in practice...
  34. ncbi Serious adverse drug events reported to the Food and Drug Administration, 1998-2005
    Thomas J Moore
    Institute for Safe Medication Practices, 1800 Byberry Rd, Ste 810, Huntingdon Valley, PA 19006, USA
    Arch Intern Med 167:1752-9. 2007
    ..The US Food and Drug Administration has operated the Adverse Event Reporting System since 1998. It collects all voluntary reports of adverse drug events submitted directly to the agency or through drug manufacturers...
  35. pmc Drug-induced pancreatitis: lessons in data mining
    Manfred Hauben
    Br J Clin Pharmacol 58:560-2. 2004
  36. ncbi Medication-attributed adverse effects in placebo groups: implications for assessment of adverse effects
    Winfried Rief
    Department of Psychiatry, Brigham and Women s Hospital, Harvard Medical School, Boston, Mass, USA
    Arch Intern Med 166:155-60. 2006
    ..In addition, variability of adverse effect ascertainment is considerable and suggests the need for better standardization in research...
  37. ncbi Criteria revision and performance comparison of three methods of signal detection applied to the spontaneous reporting database of a pharmaceutical manufacturer
    Yasuyuki Matsushita
    Faculty of Engineering, Tokyo University of Science, Tokyo, Japan
    Drug Saf 30:715-26. 2007
    ..The objective of this study was to revise the criteria for signal detection to make them suitable for use by pharmaceutical manufacturers...
  38. pmc Reported paediatric adverse drug reactions in the UK 2000-2009
    Daniel B Hawcutt
    Division of Developmental and Reproductive Medicine, University of Liverpool, Liverpool Northwick Park Hospital, Watford Road, Harrow, London Alder Hey Children s Hospital, Liverpool Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK
    Br J Clin Pharmacol 73:437-46. 2012
    ..MHRA advice is to report all suspected ADRs in paediatric (<17 years) patients...
  39. pmc Adverse drug event monitoring at the Food and Drug Administration
    Syed Rizwanuddin Ahmad
    Division of Drug Risk Evaluation, Office of Drug Safety, Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD 20857, USA
    J Gen Intern Med 18:57-60. 2003
    ..The FDA is strengthening its postmarketing surveillance with access to new data sources that have the potential to further improve the identification, quantification, and subsequent management of drug risk...
  40. ncbi Prescribing of rosiglitazone and pioglitazone following safety signals: analysis of trends in dispensing patterns in the Netherlands from 1998 to 2008
    Rikje Ruiter
    Department of Epidemiology, Erasmus MC, Rotterdam, The Netherlands
    Drug Saf 35:471-80. 2012
    ..In the EU, however, relatively little is known about dispensing patterns following DHPCs or other safety signals such as EMA press releases...
  41. ncbi Methods for assessing the preventability of adverse drug events: a systematic review
    Katja Marja Hakkarainen
    Nordic School of Public Health NHV, Gothenburg, Sweden
    Drug Saf 35:105-26. 2012
    ..However, the proportion of preventable ADEs varies considerably in different studies, even when conducted in the same setting, and methods for assessing the preventability of ADEs are diverse...
  42. ncbi Nature, occurrence and consequences of medication-related adverse events during hospitalization: a retrospective chart review in the Netherlands
    Lilian H F Hoonhout
    VU University Medical Centre, EMGO Institute, Department of Public and Occupational Health, Amsterdam, The Netherlands
    Drug Saf 33:853-64. 2010
    ..Detailed information on harm related to drugs administered during hospitalization is scarce. Knowledge of the nature and preventability of MRAEs is needed to prioritize and improve medication-related patient safety...
  43. ncbi Monitoring the safety of influenza A (H1N1) vaccine using web-based intensive monitoring
    Linda Härmark
    Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH s Hertogenbosch, The Netherlands
    Vaccine 29:1941-7. 2011
    ..As part of the monitoring we conducted an anonymous prospective cohort study to identify and quantify the occurrence of AEFIs related to pandemic vaccination among the population immunised in general practice...
  44. ncbi Low quality of reporting adverse drug reactions in paediatric randomised controlled trials
    Tjalling W de Vries
    Department of Paediatrics, Medical Centre Leeuwarden, H Dunantweg 2, 8934 AD Leeuwarden, The Netherlands
    Arch Dis Child 95:1023-6. 2010
    ..To improve the quality of reporting adverse effects, the Consort group published recommendations. The authors studied the application of these recommendations in RCTs performed in children...
  45. ncbi Adverse events and health status following botulinum toxin type A injections in children with cerebral palsy
    Stephen J O'Flaherty
    Kids Rehab, The Children s Hospital at Westmead, Westmead, NSW, Australia
    Dev Med Child Neurol 53:125-30. 2011
    ..The aim of this study was to assess changes in health status before and after, as well as adverse events after, botulinum toxin type A (BoNT-A) injections in children with cerebral palsy (CP)...
  46. pmc Adverse event profiles of 5-fluorouracil and capecitabine: data mining of the public version of the FDA Adverse Event Reporting System, AERS, and reproducibility of clinical observations
    Kaori Kadoyama
    Center for Integrative Education in Pharmacy and Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto 606 8501, Japan
    Int J Med Sci 9:33-9. 2012
    ..The safety profiles of oral fluoropyrimidines were compared with 5-fluorouracil (5-FU) using adverse event reports (AERs) submitted to the Adverse Event Reporting System, AERS, of the US Food and Drug Administration (FDA)...
  47. ncbi Spontaneous reporting of adverse events following immunisation against pandemic influenza in Denmark November 2009-March 2010
    Maja Folkenberg
    Danish Medicines Agency, Copenhagen, Denmark
    Vaccine 29:1180-4. 2011
    ....
  48. pmc Omeprazole- and esomeprazole-associated hypomagnesaemia: data mining of the public version of the FDA Adverse Event Reporting System
    Takao Tamura
    Kinki University Nara Hospital, Nara, Japan
    Int J Med Sci 9:322-6. 2012
    ..In this study, the reports submitted to the Adverse Event Reporting System (AERS) of the US Food and Drug Administration (FDA) were evaluated to assess omeprazole and esomeprazole in terms of susceptibility to hypomagnesaemia...
  49. ncbi Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital
    Jimmy Jose
    Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal 576 104, Karnataka, India
    Pharmacol Res 54:226-33. 2006
    ..Our evaluations revealed opportunities for interventions especially for the preventable ADRs to ensure safer drug use...
  50. ncbi Adverse event profile of tigecycline: data mining of the public version of the U.S. Food and Drug Administration adverse event reporting system
    Kaori Kadoyama
    Center for Integrative Education in Pharmacy and Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Kyoto University, Japan
    Biol Pharm Bull 35:967-70. 2012
    ..The adverse events suggested were in agreement with information provided by the manufacturer, suggesting that off-label use hardly results in unexpected adverse events, presumably due to usage with extreme caution...
  51. ncbi Knowledge, attitudes, and perceptions of pharmacists to adverse drug reaction reporting in Iran
    Ghazal Vessal
    Department of Clinical Pharmacy, Faculty of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran
    Pharm World Sci 31:183-7. 2009
    ..In order to determine whether our pharmacovigilance system could be improved, and identify reasons for under-reporting, a study to investigate the role of pharmacists in ADR reporting was performed in Shiraz...
  52. ncbi Practical pharmacovigilance analysis strategies
    A Lawrence Gould
    Merck Research Laboratories, BL3 2 West Point, PA 19486, USA
    Pharmacoepidemiol Drug Saf 12:559-74. 2003
    ..To compare two recently proposed Bayesian methods for quantitative pharmacovigilance with respect to assumptions and results, and to describe some practical strategies for their use...
  53. pmc Epidemiology of drug exposure and adverse drug reactions in two swiss departments of internal medicine
    K Fattinger
    Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, University Hospital, Zurich, Switzerland
    Br J Clin Pharmacol 49:158-67. 2000
    ..To explore drug exposure, frequency of adverse drug reactions (ADRs), types of ADRs, predisposing risk factors and ADR-related excess hospital stay in medical inpatients...
  54. ncbi Determinants of under-reporting of adverse drug reactions: a systematic review
    Elena Lopez-Gonzalez
    Department of Preventive Medicine and Public Health, University of Santiago de Compostela, Santiago de Compostela, Spain
    Drug Saf 32:19-31. 2009
    ..This result may have important implications in terms of public health, if knowledge and attitudes are viewed as potentially modifiable factors...
  55. ncbi Impact of safety alerts on measures of disproportionality in spontaneous reporting databases: the notoriety bias
    Antoine Pariente
    Department of Pharmacology, Universite Victor Segalen, Bordeaux, France
    Drug Saf 30:891-8. 2007
    ..Disproportionality analysis of spontaneous reporting is increasingly used, but it may be influenced in unknown ways by safety alerts (notoriety bias)...
  56. ncbi Overrides of medication alerts in ambulatory care
    Thomas Isaac
    Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, 330 Brookline Ave, Boston, MA 02215, USA
    Arch Intern Med 169:305-11. 2009
    ..Electronic prescribing systems with decision support may improve patient safety in ambulatory care by offering drug allergy and drug interaction alerts. However, preliminary studies show that clinicians override most of these alerts...
  57. ncbi Antimicrobials and the risk of torsades de pointes: the contribution from data mining of the US FDA Adverse Event Reporting System
    Elisabetta Poluzzi
    Department of Pharmacology, University of Bologna, Bologna, Italy
    Drug Saf 33:303-14. 2010
    ..In this context, the US FDA Adverse Event Reporting System (AERS) is an important source of information, which can be applied to the analysis of TdP liability of marketed drugs...
  58. ncbi The relationship between study characteristics and the prevalence of medication-related hospitalizations: a literature review and novel analysis
    Anne J Leendertse
    Utrecht Institute for Pharmaceutical Sciences UIPS, Department of Pharmacoepidemiology and Pharmacotherapy, Faculty of Science, Utrecht University, Utrecht, The Netherlands
    Drug Saf 33:233-44. 2010
    ..Studies on medication-related hospitalizations differ in study setting, studied population, outcome, and method of data collection. Thus, extrapolations based on a meta-analysis of unselected studies may be biased...
  59. ncbi Pharmacists versus nonpharmacists in adverse drug event detection: a meta-analysis and systematic review
    Shobha Phansalkar
    Department of Biomedical Informatics, University of Utah, Salt Lake City, and Department of Veterans Affairs Medical Center 84132, USA
    Am J Health Syst Pharm 64:842-9. 2007
    ....
  60. pmc The frequency of adverse drug reaction related admissions according to method of detection, admission urgency and medical department specialty
    Miran Brvar
    Poison Control Centre, University Medical Centre Ljubljana, Ljubljana, Slovenia
    BMC Clin Pharmacol 9:8. 2009
    ....
  61. ncbi Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions
    Qing Li
    Institute of Clinical Pharmacology, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
    Chin Med J (Engl) 117:856-61. 2004
    ..In addition, the authors sought to formulate approaches to improve the current ADR reporting system...
  62. ncbi Pharmacovigilance: methods, recent developments and future perspectives
    L Härmark
    Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, s Hertogenbosch, The Netherlands
    Eur J Clin Pharmacol 64:743-52. 2008
    ..On a regulatory level, these include conditional approval and risk management plans; on a scientific level, transparency and increased patient involvement are two important elements...
  63. ncbi Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies
    Chuenjid Kongkaew
    School of Pharmacy and Pharmaceutical Sciences, The University of Manchester, Manchester, UK
    Ann Pharmacother 42:1017-25. 2008
    ..To determine the prevalence of hospital admissions associated with ADRs and examine differences in prevalence rates between population groups and methods of ADR detection...
  64. pmc Assessing the association of pioglitazone use and bladder cancer through drug adverse event reporting
    Carlo Piccinni
    Department of Pharmacology, University of Bologna, Bologna, Italy
    Diabetes Care 34:1369-71. 2011
    ..To analyze the association between pioglitazone use and bladder cancer through a spontaneous adverse event reporting system for medications...
  65. ncbi Nature of preventable adverse drug events in hospitals: a literature review
    Penkarn Kanjanarat
    Department of Pharmacy Health Care Administration, College of Pharmacy, University of Florida, HPNP Building, P O Box 100496, Gainesville, FL 32610 0496, USA
    Am J Health Syst Pharm 60:1750-9. 2003
    ..Targeting these high-priority areas could significantly reduce the overall frequency of pADEs...
  66. pmc Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria
    Kazeem A Oshikoya
    Pharmacology Department, Lagos State University College of Medicine, Ikeja, Lagos, Nigeria
    BMC Clin Pharmacol 9:14. 2009
    ..This study was aimed at investigating the knowledge and attitude of doctors in a teaching hospital in Lagos, Nigeria on spontaneous ADR reporting and to suggest possible ways of improving this method of reporting...
  67. ncbi Pharmacists' role in reporting adverse drug reactions in an international perspective
    Kees van Grootheest
    Netherlands Pharmacovigilance Centre Lareb, s Hertogenbosch, The Netherlands
    Pharmacoepidemiol Drug Saf 13:457-64. 2004
    ..Even today, there are a number of countries, in particular the Scandinavian countries, where pharmacists are not authorised to report ADRs. In those countries in which they are allowed to report, they do not always use this opportunity...
  68. pmc Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting
    C F Green
    School of Pharmacy and Chemistry, Liverpool John Moores University, Byrom Street, Liverpool, L3 3AF
    Br J Clin Pharmacol 51:81-6. 2001
    ..To investigate the attitudes of UK hospital pharmacists towards, and their understanding, of adverse drug reaction (ADR) reporting...
  69. pmc Pharmacovigilance in developing countries
    Munir Pirmohamed
    BMJ 335:462. 2007
  70. ncbi Under-reporting of serious adverse drug reactions in Sweden
    M Backstrom
    Division of Clinical Pharmacology, University Hospital of Umea, Sweden
    Pharmacoepidemiol Drug Saf 13:483-7. 2004
    ..Spontaneous reporting of ADRs is one of the methods for post marketing surveillance of drug safety. Under-reporting can also provide an important obstacle to rapid and relevant signal detection...
  71. ncbi Adverse reactions of selective serotonin reuptake inhibitors: reports from a spontaneous reporting system
    O Spigset
    Adverse Drug Reactions Monitoring Center, Division of Clinical Pharmacology, Norrland University Hospital, Umea, Sweden
    Drug Saf 20:277-87. 1999
    ..The aim of this study was to investigate the pattern of adverse reactions reported on SSRIs in Sweden and assess possible risk factors associated with the occurrence of adverse reactions to these agents...
  72. ncbi Suicide rates in clinical trials of SSRIs, other antidepressants, and placebo: analysis of FDA reports
    Arif Khan
    Northwest Clinical Research Center, Bellevue, Washington, USA
    Am J Psychiatry 160:790-2. 2003
    ..The authors analyzed reports from randomized controlled trials to compare suicide rates among depressed patients assigned to an SSRI, other antidepressants, or placebo...
  73. pmc Can surveillance systems identify and avert adverse drug events? A prospective evaluation of a commercial application
    Ashish K Jha
    Department of Health Policy and Management, Harvard School of Public Health, Boston, MA 02115, USA
    J Am Med Inform Assoc 15:647-53. 2008
    ..Most monitors have been developed in large academic hospitals and are not readily usable in other settings. We assessed the ability of a commercial program to identify and prevent ADEs in a community hospital...
  74. ncbi A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions
    Eugene P van Puijenbroek
    Netherlands Pharmacovigilance Foundation LAREB, s Hertogenbosch, The Netherlands
    Pharmacoepidemiol Drug Saf 11:3-10. 2002
    ....
  75. ncbi Development and validation of a score to assess risk of adverse drug reactions among in-hospital patients 65 years or older: the GerontoNet ADR risk score
    Graziano Onder
    Department of Geriatrics, Policlinico A Gemelli, Catholic University of the Sacred Heart, Rome, Italy
    Arch Intern Med 170:1142-8. 2010
    ..The aim of the present study was to develop and validate a method of identifying elderly patients who are at increased risk for an adverse drug reaction (ADR)...
  76. ncbi Drug-versus-drug adverse event rate comparisons: a pilot study based on data from the US FDA Adverse Event Reporting System
    Alan M Hochberg
    ProSanos Corporation, Harrisburg, Pennsylvania 17101, USA
    Drug Saf 32:137-46. 2009
    ..The accuracy of comparative AERS-based data mining has been questioned, but has not been systematically studied...
  77. ncbi Extent of pharmacovigilance among resident doctors in Edo and Lagos states of Nigeria
    J O Ohaju-Obodo
    Department of Pharmacology and Therapeutics, Faculty of Clinical Sciences, Ambrose Alli University Ekpoma, Edo State, Nigeria
    Pharmacoepidemiol Drug Saf 19:191-5. 2010
    ....
  78. ncbi Was the thrombotic risk of rofecoxib predictable from the French Pharmacovigilance Database before 30 September 2004?
    A Sommet
    Laboratoire de Pharmacologie Medicale et Clinique, Unité de Pharmacoépidémiologie, EA 3696, Universite de Toulouse, Faculte de Medecine, 37 Allees Jules Guesde, Toulouse, France
    Eur J Clin Pharmacol 64:829-34. 2008
    ..The aim of this study was to investigate whether this kind of signal could have been seen using the French Pharmacovigilance Database before this date of rofecoxib withdrawal...
  79. ncbi Who is unlikely to report adverse events after vaccinations to the Vaccine Adverse Event Reporting System (VAERS)?
    Michael M McNeil
    Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta GA 30333, United States
    Vaccine 31:2673-9. 2013
    ..S. licensed vaccines. HCP awareness of and practices regarding reporting of adverse events following immunization (AEFI) is understudied...
  80. ncbi An experimental investigation of masking in the US FDA adverse event reporting system database
    Hsin Wei Wang
    Computational Sciences Centre of Emphasis, Pfizer Global Research and Development, Cambridge, Massachusetts, USA
    Drug Saf 33:1117-33. 2010
    ....
  81. ncbi Patient-reported outcomes and the evolution of adverse event reporting in oncology
    Andy Trotti
    Division of Radiation Oncology, H Lee Moffitt Cancer Center at University of South Florida, Tampa, FL 33612 9416, USA
    J Clin Oncol 25:5121-7. 2007
    ..Therefore, care must be used when developing health outcomes and safety data collection plans...
  82. ncbi Monitoring outcomes of pregnancy following drug exposure: a company-based pregnancy registry program
    Kristine E Shields
    Clinical Risk Management and Safety Surveillance, Merck Research Laboratories, West Point, Pennsylvania 19486, USA
    Drug Saf 27:353-67. 2004
    ..The use of the pregnancy registry design has allowed for the collection and analysis of data on the effects of drug exposures on human pregnancies that have otherwise been difficult to obtain...
  83. ncbi Internet-based reporting to the vaccine adverse event reporting system: a more timely and complete way for providers to support vaccine safety
    Penina Haber
    Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Mail Stop D 26, 1600 Clifton Rd, Atlanta, GA 30333, USA
    Pediatrics 127:S39-44. 2011
    ....
  84. ncbi Experiences with adverse drug reaction reporting by patients: an 11-country survey
    Florence van Hunsel
    Netherlands Pharmacovigilance Centre Lareb, s Hertogenbosch, The Netherlands
    Drug Saf 35:45-60. 2012
    ..If patient reporting is to be recognized as beneficial for pharmacovigilance and further optimized, methodology and best practice must be internationally shared and promoted...
  85. ncbi [Adverse drug reaction surveillance system in Korea]
    Nam Kyong Choi
    Department of Preventive Medicine, Seoul National University College of Medicine, Korea
    J Prev Med Public Health 40:278-84. 2007
    ..The purpose of this paper is to review the current status of Korean ADR surveillance system and suggest the possible solutions for developing active pharmacovigilance system in Korea...
  86. ncbi Evaluation of patient reporting of adverse drug reactions to the UK 'Yellow Card Scheme': literature review, descriptive and qualitative analyses, and questionnaire surveys
    A J Avery
    University of Nottingham, Nottingham, UK
    Health Technol Assess 15:1-234, iii-iv. 2011
    ..There have also been few studies on the views and experiences of patients/consumers on the reporting of suspected ADRs...
  87. ncbi Extraction of adverse drug effects from clinical records
    Eiji Aramaki
    Center for Knowledge Structuring, University of Tokyo, University of Tokyo Hospital, Tokyo, Japan
    Stud Health Technol Inform 160:739-43. 2010
    ..7% of records include adverse event information, and that 59% of them (4.5% in total) can be extracted automatically. This result is particularly encouraging, considering the massive amounts of records, which are increasing daily...
  88. pmc Comparative assessment of four drug interaction compendia
    Agnes I Vitry
    Quality Use of Medicines and Pharmacy Research Centre, Sansom Institute, University of South Australia, GPO Box 2471, Adelaide SA 5001, Australia
    Br J Clin Pharmacol 63:709-14. 2007
    ..Major interactions for a list of 50 drugs were searched in all four compendia...
  89. ncbi Adverse drug reactions in nephrology ward inpatients of a tertiary care hospital
    Lisha Joshua
    Pharmacovigilance Centre, Department of Pharmacology, St John s Medical College, Bangalore, India
    Indian J Med Sci 61:562-9. 2007
    ..Adverse drug reactions (ADRs) are important causes of hospital admissions and inpatient complications. Renal dysfunction has a role in occurrence of ADRs...
  90. ncbi Adverse drug reactions in children in Camagüey Province, Cuba
    Z Bárzaga Arencibia
    Department of Pharmacoepidemiology, Camaguey Children s Hospital, Camagüey Province, Cuba
    Arch Dis Child 95:474-7. 2010
    ..To determine the incidence of adverse drug reactions (ADRs) in children in Camagüey Province, Cuba...
  91. ncbi Database size and power to detect safety signals in pharmacovigilance
    Isaac W Hammond
    GlaxoSmithKline, Global Clinical Safety and Pharmacovigilance, Oncology SERM, 1250 South Collegeville Road, UP 4340, Collegeville, PA 19426, USA
    Expert Opin Drug Saf 6:713-21. 2007
    ....
  92. ncbi Adverse drug reactions in patients in an Iranian department of internal medicine
    Sara Pourseyed
    Immunology, Asthma and Allergy Research Institute, Children Medical Center, Medical Sciences University of Tehran, Tehran, IR Iran
    Pharmacoepidemiol Drug Saf 18:104-10. 2009
    ..The department of internal medicine is not an exception to this issue. This study was performed to determine the nature and frequency of ADRs in an internal medicine ward in Iran...
  93. ncbi Incidence, preventability, and impact of Adverse Drug Events (ADEs) and potential ADEs in hospitalized children in New Zealand: a prospective observational cohort study
    Desiree L Kunac
    School of Pharmacy, University of Otago, Dunedin, New Zealand
    Paediatr Drugs 11:153-60. 2009
    ..Over half of the ADEs were deemed preventable. This highlights the importance of developing strategies to prevent and ameliorate ADEs both to improve the quality of patient care and to reduce healthcare costs...
  94. ncbi Effects of stratification on data mining in the US Vaccine Adverse Event Reporting System (VAERS)
    Emily Jane Woo
    US Food and Drug Administration, Center for Biologics Evaluation and Research, Rockville, Maryland 20852, USA
    Drug Saf 31:667-74. 2008
    ..Stratified empirical Bayesian (EB) methods have been compared with crude, but not stratified, proportional reporting ratios (PRRs) in their performance on adverse event data...
  95. ncbi Reporting of safety results in published reports of randomized controlled trials
    Isabelle Pitrou
    Département d Epidémiologie, Biostatistique, et Recherche Clinique, Groupe Hospitalier Bichat Claude Bernard AP HP, Universite Denis Diderot, INSERM U738, Paris, France
    Arch Intern Med 169:1756-61. 2009
    ..Poor safety reporting can lead to misinterpretation and inadequate conclusions about the interventions assessed. Our aim was to describe the reporting of harm-related results from randomized controlled trials (RCTs)...
  96. ncbi Adverse drug reactions detected by stimulated spontaneous reporting in an internal medicine department in Romania
    Andreea Farcas
    University of Medicine and Pharmacy Iuliu Hatieganu, Drug Information Research Center, Pasteur 6, Cluj Napoca, Romania
    Eur J Intern Med 21:453-7. 2010
    ..The aims of this study were to identify the most frequent ADRs recognized by the attending physicians, study their nature and target these ADRs in order to take future preventive measures...
  97. ncbi Adverse drug reactions in an elderly hospitalised population: inappropriate prescription is a leading cause
    Maria Cristina G Passarelli
    School of Medicine, University of Sao Paulo, Sao Paulo, Brazil
    Drugs Aging 22:767-77. 2005
    ....
  98. ncbi Surveillance of adverse effects following vaccination and safety of immunization programs
    Eliseu Alves Waldman
    Departamento de Epidemiologia, Faculdade de Saude Publica, Universidade de Sao Paulo, Sao Paulo, Brasil
    Rev Saude Publica 45:173-84. 2011
    ..The review was concluded by discussing the challenges to be faced in coming years with respect to ensuring the safety and reliability of vaccination programs...
  99. ncbi Drug-related deaths in a university central hospital
    L Juntti-Patinen
    Department of Clinical Pharmacology, Helsinki University Central Hospital, P O Box 340, 00029 HUS, Helsinki, Finland
    Eur J Clin Pharmacol 58:479-82. 2002
    ..The objectives were to determine the incidence of drug-related deaths in a university hospital and to find out which drugs are most commonly involved in these cases...
  100. ncbi The reporting odds ratio and its advantages over the proportional reporting ratio
    Kenneth J Rothman
    Department of Epidemiology, Boston University Medical Center, 715 Albany Street, MA 02118, USA
    Pharmacoepidemiol Drug Saf 13:519-23. 2004
    ..In this paper, we review the problem with the PRR and show how the corresponding odds ratio represents an improvement over the PRR...
  101. ncbi A review of the Vaccine Adverse Event Reporting System database
    David A Geier
    The Genetic Centers of America, Silver Spirng, MD 20905, USA
    Expert Opin Pharmacother 5:691-8. 2004
    ..In conclusion, VAERS studies will be particularly critical in the evaluation of the safety of many new or radically changed vaccines expected to be introduced in the relative near future...

Research Grants71

  1. Outpatient Prescription Errors
    AMANDA KENNEDY; Fiscal Year: 2007
    ..Additionally, she will work closely with experienced investigators in the fields of Outcomes Research, Technology Assessment, and Human Factors Research. [unreadable] [unreadable] [unreadable]..
  2. Adenosinergic Mechanisms of Intrauterine Growth Retardation
    Scott A Rivkees; Fiscal Year: 2010
    ..The goals of this proposal are to identify the mechanisms by which adenosine acts to protect the embryo in utero and how altered embryonic adenosine action leads to long-term adverse effects in adulthood. ..
  3. Oral Chemotherapy Safety in Ambulatory Oncology: A Proactive Risk Assessment
    SAUL WEINGART; Fiscal Year: 2007
    ..Lessons about oral chemotherapy safety are applicable to other high-alert medications in ambulatory care. [unreadable] [unreadable] [unreadable]..
  4. Allergy Alerts in Computerized Physician Entry
    David Bates; Fiscal Year: 2001
    ..We believe the results of our work will improve patient safety and the overall quality of pharmacotherapy. We also believe that the results of our study will be applicabe to other healthcare systems ..
  5. Statewide Implementation of Electronic Health Records
    David Bates; Fiscal Year: 2006
    ..Dissemination of the results of this work should speed efforts toward the establishment of a national health information infrastructure. [unreadable] [unreadable]..
  6. Racial Segregation & Disparities in Cancer Outcomes
    Jennifer Haas; Fiscal Year: 2007
    ..The proposed study would provide empirical evidence that could give impetus to area-based interventions to reduce cancer disparities. ..
  7. Computerized EMR-Assisted Smoking Cessation (CEASCE)
    Jennifer Haas; Fiscal Year: 2007
    ..Future Directions: Evaluate whether CEASCE can serve as a prototype for other common primary care problems that require counseling for behavior change. [unreadable] [unreadable]..
  8. REDUCING ADVERSE DRUG EVENTS IN THE NURSING HOME
    Jerry Gurwitz; Fiscal Year: 2002
    ..abstract_text> ..
  9. DELIVERY OF THE CGN INFORMATION RESOURCE DATABASE
    Prakash Nadkarni; Fiscal Year: 2006
    ..Informatics assistance will be provided to the individual nodes to assist the task of data exchange, and when necessary, to assist the design of local data collection systems. ..
  10. MATERNAL HEALTH STATUS AND ADVERSE BIRTH OUTCOMES
    Jennifer Haas; Fiscal Year: 2002
    ..Such interventions should begin from the premise that improved maternal and infant outcomes can only come from improved maternal health. ..
  11. DESIGN AND IMPLEMENTATION OF PHARMACOGENETIC DATABASE
    Prakash Nadkarni; Fiscal Year: 2002
    ..Informatics assistance will be provided to the individual nodes to assist the task of data exchange, and when necessary, to assist the design of local data collection systems. ..
  12. Hormone Replacement Therapy and Prothrombotic Variants
    Bruce Psaty; Fiscal Year: 2005
    ..Power for primary and secondary aims is excellent. Information from this project may help physicians counsel women about HRT to maximize either effectiveness, or safety, or both. ..
  13. HMO Research Network Conference
    Jerry Gurwitz; Fiscal Year: 2006
    ..unreadable] [unreadable] [unreadable] [unreadable]..
  14. ROBUST QUERY OF HETEROGENEOUS CLINICAL DATABASES
    Prakash Nadkarni; Fiscal Year: 2002
    ..In particular, research will be performed on utilization of newer database technologies, such as new indexing methods, as well as parallel database implementations. ..
  15. MUTATIONS, HORMONE THERAPY, AND VENOUS THROMBOEMBOLISM
    Bruce Psaty; Fiscal Year: 2001
    ....
  16. Pharmacogenetics and Cardiovascular Events
    Bruce Psaty; Fiscal Year: 2006
    ..The primary defense is replication: we would therefore welcome collaboration from others in the Pharmacogenetics Network in validation efforts. ..
  17. Psychobiology of IV Naloxone & Lactate in Normals
    Donald Klein; Fiscal Year: 2005
    ..This would further validate this model. It may also suggest new approaches to anti-panic agents, such as mixed opiate agonist-antagonist. ..
  18. GERIATRIC CLINICAL EPIDEMIOLOGY TRAINING GRANT
    STEVEN HALBERT; Fiscal Year: 2007
    ..g., clinical trials, case control, cohort research, etc.), and the faculties' commitment to collaborative research. [unreadable] [unreadable]..
  19. Health Information Technology in the Nursing Home
    Jerry Gurwitz; Fiscal Year: 2006
    ..abstract_text> ..
  20. WGA Study to Identify Genetic Variants Associated with CV Events in CHS
    Bruce Psaty; Fiscal Year: 2009
    ..The proposed three-part study is efficient, has excellent power to detect small to modest-sized hazard ratios, provides a large sample of WG scans for aim 2, and includes an external replication. (End of Abstract) ..
  21. Enhancing the Safety of Warfarin in the Nursing Home
    Jerry Gurwitz; Fiscal Year: 2008
    ..abstract_text> ..
  22. Genome-wide case-only study of antihypertensive drug-gene interactions
    Bruce M Psaty; Fiscal Year: 2010
    ....
  23. ANTIHYPERTENSIVE DRUG/GENE INTERACTIONS AND CV EVENTS
    Bruce Psaty; Fiscal Year: 2004
    ..58 (the difference between an odds ratio of 0.46 and 0.79 in subjects with and without the variant, respectively). Power for other primary aims is excellent; power for secondary aims is good to excellent. ..
  24. Trends in and Outcomes of Medication Use in Older Adults
    Bruce Psaty; Fiscal Year: 2004
    ..abstract_text> ..
  25. CLINICAL RESEARCH CURRICULUM
    BRIAN STROM; Fiscal Year: 2004
    ..I. and co-PI s in the three distinct aspects of Clinical Research targeted by this program represent particular features of this proposal. ..
  26. Acupuncture for hot flashes in prostate cancer patients
    TOMASZ BEER; Fiscal Year: 2004
    ..The overall goal is to provide prostate cancer patients an effective, low toxicity, non-pharmacologic treatment modality for hot flashes. ..
  27. Collaborative Pediatric Bipolar Disorder Conference
    Joseph Biederman; Fiscal Year: 2007
    ..While the proposed conference does not intend to solve all outstanding problems associated with pediatric bipolar disorder, it will provide a forum to begin formulating a solution. ..
  28. PEDIATRIC EBM-GETTING EVIDENCE USED AT THE POINT OF CARE
    Robert Davis; Fiscal Year: 2002
    ....
  29. RUPP-PI Project
    Michael Aman; Fiscal Year: 2006
    ..S.U. also plans two pilot studies: (a) a randomized clinical trial in 60 children with PDDs and severe ADHD behavior and (b) a study of ziprasidone in 30 children and adolescents with PDDs and highly irritable behaviors. ..
  30. Adult Outcome of Attention Deficit Hyperactivity Disorder
    Joseph Biederman; Fiscal Year: 2007
    ..For these reasons, we expect the proposed work to clarify the course and outcome of ADHD. ..
  31. BUPROPION AS AN ADJUNCT TO THE NICOTINE PATCH PLUS CBT
    Maurizio Fava; Fiscal Year: 2003
    ....
  32. SaTScan: Spatial Scan Statistic Surveillance Software
    Martin Kulldorff; Fiscal Year: 2008
    ..In this project, we propose to further develop and maintain the SaTScan software to fulfill many of these needs. ..
  33. Follow-up of the PATS Sample
    Laurence Greenhill; Fiscal Year: 2008
    ..Aim 4 is to determine the stability of the ADHD diagnosis and other comorbidities made for study entry at age 3-5 years across subsequent development [unreadable] [unreadable]..
  34. HIV-Related Proteinuria and Endothelial Dysfunction
    Samir Gupta; Fiscal Year: 2007
    ..Dub6) in the fields of HIV metabolic and renal complications, renal vascular and glomerular pathology, and clinical trials design and implementation. ..
  35. FURANOCOUMARINS AND DRUGS EFFECT ON CYP3A4
    Paul Watkins; Fiscal Year: 2007
    ..abstract_text> ..
  36. DEVELOPING CIRCADIAN RHYTHMICITY
    Scott Rivkees; Fiscal Year: 2002
    ..These studies may also lead to the development of new care practices in Neonatal Intensive Care Units and extend the field of developmental chronobiology to the bedside. ..
  37. Racial Differences in Geriatric Antidepressant Adherence
    HELEN KALES; Fiscal Year: 2007
    ..unreadable] [unreadable] [unreadable]..
  38. Tricyclic antidepressants as risks factors for cancer
    Jean Paul Collet; Fiscal Year: 2002
    ....
  39. Effectiveness of Alcohol Interventions Among TB Patients in Tomsk, Russia
    Sonya Shin; Fiscal Year: 2008
    ..Finally, we have a diverse interdisciplinary team that has been able to formulate an integrated biosocial and culturally-appropriate approach to treating AUDs in this population. [unreadable] [unreadable] [unreadable]..
  40. Value of Health Information Exchange in Ambulatory Care
    JOSEPH OVERHAGE; Fiscal Year: 2006
    ..unreadable] [unreadable]..
  41. Comparative Effectiveness Study for Bipolar Disorder
    Andrew A Nierenberg; Fiscal Year: 2010
    ..The two treatments will be the second generation antipsychotic mood stabilizer quetiapine and the classic mood stabilizer lithium. In addition to quetiapine or lithium, participants can be treated with other medications as needed. ..
  42. PREVENTION OF CIGARETTE SMOKING IN ADHD YOUTH
    Joseph Biederman; Fiscal Year: 2001
    ..Since there are estimated to be 3.5 million children with ADHD and 20% have been shown to be smokers, targeting this group could potentially impact 700,000 children and adolescents. ..
  43. A-1 Adenosine Receptor Action in Developing Heart
    Scott Rivkees; Fiscal Year: 2005
    ..We anticipate that these studies will identify Rho and ROCK as critical signaling molecules in heart development and reveal that cardiac GTPase activity transduces the effects of adenosine. ..
  44. The Effect of Statins on Skeletal Muscle Function
    PAUL DAVIS THOMPSON; Fiscal Year: 2010
    ....
  45. Development of Inventory of Depressive Symptomatology
    PUDUGRAMAM DORAISWAMY; Fiscal Year: 2005
    ..g., anxiety, irritability) (IDS-C and SR) that are in the public domain for use with patients across the age spans seen in practice and in research. ..
  46. TARDIVE DYSKINESIA INCIDENCE AND ATYPICAL ANTIPSYCHOTIC
    Scott Woods; Fiscal Year: 2004
    ..The existence of a previous sample at the same site provides a useful additional comparison group. Methods including sample ascertainment and TD assessment are closely modeled after the original work. ..
  47. Discharge Planning and Telehealth for Post CABG Elders
    Ruth Kleinpell; Fiscal Year: 2009
    ....
  48. Alternative endpoints for plague challenge models
    Richard Frothingham; Fiscal Year: 2005
    ..We will use the data generated to refine our hypotheses and to pursue further funding to complete Aim 3. ..
  49. Antipsychotics and Mortality in Older Patients
    HELEN KALES; Fiscal Year: 2009
    ..The results of this study will be of immediate relevance to clinicians and policymakers. ..
  50. Home-Based Blood Pressure Interventions for African Americans
    Penny H Feldman; Fiscal Year: 2011
    ....
  51. MANAGEMENT FOR RISK OF RELAPSE IN SCHIZOPHRENIA
    Stephen Marder; Fiscal Year: 2004
    ..The investigator will evaluate outcome during the next two years with measures of clinical psychopathology, medication side effects, functional outcomes, and quality of life. ..
  52. LIVE, ATTENUATED, RECOMBINANT VACCINE - WEST NILE VIRUS
    Thomas Monath; Fiscal Year: 2002
    ..abstract_text> ..
  53. Child Psychiatry Research Education Program (C-PREP)
    Graham Emslie; Fiscal Year: 2008
    ..unreadable] [unreadable] [unreadable]..
  54. Short-Term vs Long-Term Treatment for GAD
    Karl Rickels; Fiscal Year: 2008
    ..12 months). The proposed study will provide much needed data, lacking from the literature, about the value of long term medication treatment of patients with a DSM-IV GAD diagnosis. ..
  55. Clinical Research in Epilepsy and Associated Disorders
    Frank Gilliam; Fiscal Year: 2007
    ..This program should allow improvement in the quality and quantity of future patient-oriented research in neuroscience through longitudinal intensive training and mentoring of junior investigators. [unreadable] [unreadable] [unreadable]..
  56. Functional neuroanatomical deficits in ADHD families
    Laurence Greenhill; Fiscal Year: 2004
    ..Imaging will be performed at corresponding imaging sites at DUMC, Weill Medical College of Cornell University, and Stanford University respectively. ..
  57. EPIDEMIOLOGY OF BRAIN ABNORMALITIES IN FEBRILE SEIZURES
    Dale Hesdorffer; Fiscal Year: 2002
    ..Answers to these questions may improve the clinical management of subgroups of children at risk for long-term disability so that future at-risk children can benefit from early interventions. ..
  58. ENHANCING MUCOSAL IMMUNE RESPONSES BY MICROENCAPSULATION
    Paul Offit; Fiscal Year: 2005
    ..The availability of microencapsulated virus provides a unique opportunity to understand the relationship between APC and protective mucosal immune responses. ..
  59. CB1 Receptor Action on the Developing Hippocampus
    Scott Rivkees; Fiscal Year: 2005
    ..We anticipate that these studies will result in new insights into the potential effects of cannabinoid action on the developing brain. ..
  60. S-Adenosyl Methionine(SAMe)Augmentation of SSRIs in MDD
    George Papakostas; Fiscal Year: 2008
    ..It is hoped that this project award will provide the critical fund of basic knowledge and practical experience necessary to aid the candidate in becoming an independent investigator in this area. ..
  61. EXCITATORY AMINO ACIDS IN GLAUCOMA
    Alan Laties; Fiscal Year: 2004
    ..These experiments will help test the central hypothesis--for if one can block the effects of IOP elevation with glutamate antagonists, then elevated 10P may toxic glutamate levels ganglion cell loss. ..
  62. Treatment of Early Age Mania (TEAM)
    Graham Emslie; Fiscal Year: 2003
    ..D. (4) University of Texas, Dallas, PI: Graham Emslie, M.D. (5) University of Texas, Galveston, PI: Karen Dineen Wagner, M.D. and (6) Washington University, St. Louis, PI; Joan Luby, M.D. ..
  63. Anti-Adenosine Therapy of Neonatal Brain Injury
    Scott Rivkees; Fiscal Year: 2007
    ..It is anticipated that these studies will lead to novel and practical strategies for directly preventing brain injury. [unreadable] [unreadable]..
  64. Vaccine therapy of congenital adrenal Hyperplasia
    Scott Rivkees; Fiscal Year: 2003
    ..We also anticipate being able to extend this novel approach to the treatment of other receptor-mediated endocrine disorders, such as hyperthyroidism. ..
  65. OLFACTION IN EPILEPSY
    RICHARD DOTY; Fiscal Year: 2004
    ..In addition to providing a better understanding of the influences of TLE and TLR on human olfactory function, this work may lead to the development of a simple and inexpensive non-invasive means for better establishing TLE seizure loci. ..
  66. Pramipexole in Treatment-Resistant Depression
    Roy Perlis; Fiscal Year: 2007
    ..The proposed investigation and training program will provide critical skills, experience and data to aid the candidate in writing an R01 and becoming an independent investigator. ..
  67. Integrating Aging and Cancer Research
    Robert Wallace; Fiscal Year: 2007
    ..Remaining activities include program administration, including ongoing planning and evaluation activities, and provision of variously sized pilot grants to promote research in the areas selected for development. ..
  68. Pharmacotherapy for Minor Depression
    Andrew Nierenberg; Fiscal Year: 2004
    ..The results of this study will have profound public health implications by improving our understanding of the efficacy of SJW and standard antidepressants for the treatment of MinorD. ..
  69. FATIGUE, SLEEP AND CIRCADIAN RHYTHMS IN BREAST CANCER
    Sonia Ancoli Israel; Fiscal Year: 2004
    ..Results will provide a scientific basis for future intervention studies, particularly studies with light therapy which can re-synchronize rhythms. ..
  70. Contributions of sleep/rhythms/fatigue to "chemobrain"
    Sonia Ancoli Israel; Fiscal Year: 2009
    ..The reported phenomena of chemobrain will be examined to see if it is related to the complaint of fatigue or sleep disruptions, both of which are known to contribute to decreases in cognitive functioning. ..