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Pharmacovigilence

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https://www.readbyqxmd.com/read/28334417/pharmacovigilance-database-search-discloses-clc-k-channels-as-a-novel-target-of-the-at1-receptor-blockers-valsartan-and-olmesartan
#1
Paola Imbrici, Domenico Tricarico, Giuseppe Felice Mangiatordi, Orazio Nicolotti, Marcello Diego Lograno, Diana Conte, Antonella Liantonio
BACKGROUND AND PURPOSE: Human ClC-K chloride channels are highly attractive targets for drug discovery for their physiological role and association with genetic disorders. These channels are pivotal in the kidney as they control chloride reabsorption and water diuresis. In addition, loss-of-function mutations of CLCKNB and BSND genes cause Bartter's syndrome (BS), whereas CLCNKA and CLCKNB gain-of-function polymorphisms predispose to a rare form of salt sensitive hypertension. Both disorders lack a personalized therapy that is in most cases only symptomatic...
March 23, 2017: British Journal of Pharmacology
https://www.readbyqxmd.com/read/28334070/detection-of-drug-drug-interactions-through-data-mining-studies-using-clinical-sources-scientific-literature-and-social-media
#2
Santiago Vilar, Carol Friedman, George Hripcsak
Drug-drug interactions (DDIs) constitute an important concern in drug development and postmarketing pharmacovigilance. They are considered the cause of many adverse drug effects exposing patients to higher risks and increasing public health system costs. Methods to follow-up and discover possible DDIs causing harm to the population are a primary aim of drug safety researchers. Here, we review different methodologies and recent advances using data mining to detect DDIs with impact on patients. We focus on data mining of different pharmacovigilance sources, such as the US Food and Drug Administration Adverse Event Reporting System and electronic health records from medical institutions, as well as on the diverse data mining studies that use narrative text available in the scientific biomedical literature and social media...
February 17, 2017: Briefings in Bioinformatics
https://www.readbyqxmd.com/read/28326432/harnessing-scientific-literature-reports-for-pharmacovigilance-prototype-software-analytical-tool-development-and-usability-testing
#3
Alfred Sorbello, Anna Ripple, Joseph Tonning, Monica Munoz, Rashedul Hasan, Thomas Ly, Henry Francis, Olivier Bodenreider
OBJECTIVES: We seek to develop a prototype software analytical tool to augment FDA regulatory reviewers' capacity to harness scientific literature reports in PubMed/MEDLINE for pharmacovigilance and adverse drug event (ADE) safety signal detection. We also aim to gather feedback through usability testing to assess design, performance, and user satisfaction with the tool. METHODS: A prototype, open source, web-based, software analytical tool generated statistical disproportionality data mining signal scores and dynamic visual analytics for ADE safety signal detection and management...
March 22, 2017: Applied Clinical Informatics
https://www.readbyqxmd.com/read/28322168/pediatric-off-label-and-unlicensed-drug-use-and-its-implications
#4
Rajeshwari Gore, Preeta Kaur Chugh, Chakra Dhar Tripathi, Yangshen Lhamo, Sandhya Gautam
BACKGROUND: Worldwide, in the absence of standard pediatric prescribing information, clinicians often use medicines in children in a dosage form or for an indication that has not been approved for use. Inadequate clinical trials increase exposure to drugs that lack safety-efficacy data in pediatric population. Hence, off-label and unlicensed drug use must be regarded as a patient safety-issue that is known to be associated with increased risks of adverse drug reactions apart from under- or over-dosing due to lack of pharmacokinetic data...
March 17, 2017: Current Clinical Pharmacology
https://www.readbyqxmd.com/read/28318723/pan-european-survey-of-the-topical-ocular-use-of-cyclosporine-a
#5
A Labbé, C Baudouin, D Ismail, M Amrane, J-S Garrigue, A Leonardi, F C Figueiredo, G Van Setten, M Labetoulle
OBJECTIVE: To assess medical practices surrounding the use of topical ocular cyclosporine A across European Union nations. METHODS: Key stakeholders (ophthalmologists, hospital pharmacists, regulatory health authorities) from European Union member states were interviewed by telephone using a semi-structured, open-ended questionnaire. Ophthalmologists responded to questions about practice patterns of cyclosporine A use (prescription frequency, indication, dosage), pharmacists about cyclosporine A formulations (composition, manufacturing process, quality control, distribution), and the regulatory authorities about market authorization and pharmacovigilance for various cyclosporine A products...
March 16, 2017: Journal Français D'ophtalmologie
https://www.readbyqxmd.com/read/28314882/a-global-view-of-undergraduate-education-in-pharmacovigilance
#6
Jenny Hartman, Linda Härmark, Eugène van Puijenbroek
PURPOSE: The aim of this study was to gain insight in current pharmacovigilance educational activities and to gather information on which topics should be included in the undergraduate pharmacovigilance core curriculum. METHOD: A web-based questionnaire was carried out containing 45 questions divided over four sections between 28 October 2014 and 31 January 2015. Potential participants working in pharmacovigilance and/or providing training in this field were invited via email and a widespread web link and snowball sampling was used to recruit additional participants...
March 17, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28299610/pharmacovigilance-of-regenerative-medicine-under-the-amended-pharmaceutical-affairs-act-in-japan
#7
Yasuko Inokuma
Two Japanese regulatory agencies, the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency announced the implementation of a new review system called 'Conditional Approval,' specifically for the emerging field of regenerative medicine, in an amendment to the Pharmaceutical Affairs Act in 2014. Regenerative medicine was regulated in the category of 'Medical Devices' prior to the amendment and was not covered by the Relief Service, a system that provides financial aid to people who have experienced an adverse drug reaction and developed serious side effects as a result...
March 15, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28295862/sample-size-of-the-reference-sample-in-a-case-augmented-study
#8
Palash Ghosh, Anup Dewanji
The case-augmented study, in which a case sample is augmented with a reference (random) sample from the source population with only covariates information known, is becoming popular in different areas of applied science such as pharmacovigilance, ecology, and econometrics. In general, the case sample is available from some source (for example, hospital database, case registry, etc.); however, the reference sample is required to be drawn from the corresponding source population. The required minimum size of the reference sample is an important issue in this regard...
March 13, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28291680/epidemiology-of-drug-induced-anaphylaxis-in-a-tertiary-hospital-in-korea
#9
Han-Ki Park, Min-Gyu Kang, Min-Suk Yang, Jae-Woo Jung, Sang-Heon Cho, Hye-Ryun Kang
BACKGROUND: Epidemiology and risk factors of drug-induced anaphylaxis are difficult to estimate due to lack of confirmative diagnosis and under reporting. Here we report the current state of drug-induced anaphylaxis in Korea based on an in-hospital pharmacovigilance database in a tertiary hospital. METHODS: This study is a retrospective analysis of drug-induced anaphylaxis, reported to an in-hospital pharmacovigilance center in Seoul National University Hospital from June 2009 to May 2013...
March 10, 2017: Allergology International: Official Journal of the Japanese Society of Allergology
https://www.readbyqxmd.com/read/28284845/risks-of-malignancies-related-to-tofacitinib-and-biological-drugs-in-rheumatoid-arthritis-systematic-review-meta-analysis-and-network-meta-analysis
#10
José Ramón Maneiro, Alejandro Souto, Juan J Gomez-Reino
OBJECTIVE: To summarize and compare the risks of malignancies accompanying biologic DMARDs (b-DMARDs) and tofacitinib in rheumatoid arthritis (RA) in randomized clinical trials (RCTs) and long-term extension studies (LTEs). METHODS: Articles in Medline, Embase, Cochrane Library, and the Web of Science dated from 2000 to February 2015. Selection criteria were as follows: (1) focus on RCTs or LTEs in RA; (2) treatment with b-DMARDs or tofacitinib; (3) data on malignancies; and (4) a minimum follow-up of 12 weeks...
February 16, 2017: Seminars in Arthritis and Rheumatism
https://www.readbyqxmd.com/read/28279424/cardio-oncology-the-role-of-big-data
#11
REVIEW
Anant Mandawat, Andrew E Williams, Sanjeev A Francis
Despite its challenges, a "big data" approach offers a unique opportunity within the field of cardio-oncology. A pharmacovigilant approach using large data sets can help characterize cardiovascular toxicities of the rapidly expanding armamentarium of targeted therapies. Creating a broad coalition of data sharing can provide insights into the incidence of cardiotoxicity and stimulate research into the underlying mechanisms. Population health necessitates the use of big data and can help inform public health interventions to prevent both cancer and cardiovascular disease...
April 2017: Heart Failure Clinics
https://www.readbyqxmd.com/read/28277227/-red-yeast-rice-induced-muscular-injuries-analysis-of-french-pharmacovigilance-database-and-literature-review
#12
Christelle Philibert, Virginie Bres, Marie-Josèphe Jean-Pastor, Claire Guy, Bénédicte Lebrun-Vignes, Perrine Robin, Véronique Pinzani, Dominique Hillaire-Buys
Red yeast rice (RYR) is a dietary supplement containing monacolins obtained by fermentation of Monascus purpureus strains. Because of its structural homology with lovastatin, monacolin K inhibits HMG-CoA reductase and shows hypocholesterolemic properties comparable to synthetic statins. We studied all cases of myopathy involving RYR reported in the French national pharmacovigilance database (6 cases) and in scientific literature (9 cases). Among these cases, 9 showed elevated creatine kinase, 3 rhabdomyolysis and 2 myalgia...
October 27, 2016: Thérapie
https://www.readbyqxmd.com/read/28270198/large-scale-adverse-effects-related-to-treatment-evidence-standardization-laertes-an-open-scalable-system-for-linking-pharmacovigilance-evidence-sources-with-clinical-data
#13
(no author information available yet)
BACKGROUND: Integrating multiple sources of pharmacovigilance evidence has the potential to advance the science of safety signal detection and evaluation. In this regard, there is a need for more research on how to integrate multiple disparate evidence sources while making the evidence computable from a knowledge representation perspective (i.e., semantic enrichment). Existing frameworks suggest well-promising outcomes for such integration but employ a rather limited number of sources...
March 7, 2017: Journal of Biomedical Semantics
https://www.readbyqxmd.com/read/28255764/erratum-to-pregnancy-outcome-among-partners-of-male-patients-receiving-imatinib-dasatinib-or-nilotinib-in-chronic-myeloid-leukemia-reports-collected-by-the-french-network-pharmacovigilance-centers
#14
Patrick Carlier, Maritza Markarian, Nathalie Bernard, Laurence Lagarce, Anne Dautriche, Johanna Béné, Nathalie Fouilhe Sam-Lai, Pirayeh Eftekhari
No abstract text is available yet for this article.
April 2017: Archives of Gynecology and Obstetrics
https://www.readbyqxmd.com/read/28251276/lack-of-essential-information-in-spontaneous-reports-of-adverse-drug-reactions-in-catalonia-a-restraint-to-the-potentiality-for-signal-detection
#15
Lorraine Plessis, Ainhoa Gómez, Núria García, Gloria Cereza, Albert Figueras
PURPOSE: The aim of this study is to analyze the quality of the information contained in the adverse drug reactions (ADR) reports and to describe the magnitude and characteristics of the lacking information. METHODS: All reports of serious ADR received by the Catalan Center of Pharmacovigilance in 2014 were analyzed using the VigiGrade and a more clinical and qualitative approach. RESULTS: Up to 824 reports describing serious ADR were included in the study; of them, 503 (61...
March 1, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28247363/atypical-fracture-of-the-sternum-after-long-term-alendronate-plus-cholecalciferol-treatment-a-case-report
#16
Luis H Martín Arias, Pilar García Ortega, María Sáinz Gil, Ester Navarro García, Carlos Treceño Lobato, Virginia Delgado Armas
A 55-year-old woman developed an atraumatic sternum fracture during treatment with alendronate for osteoporosis. The woman received alendronate 70 mg in combination with cholecalciferol 5600 IU once weekly, as well as nonsteroidal anti-inflammatory drugs. After 4 years of treatment, following a dorsal flexion with no direct thoracic trauma, the patient suffered a fracture of the sternum, with an X-ray revealing sternal body fracture. This fracture was seen to be transverse, noncomminuted and without displacement...
December 2017: Drug Safety—Case Reports
https://www.readbyqxmd.com/read/28247280/causality-assessment-in-pharmacovigilance-still-a-challenge
#17
I Ralph Edwards
Causality in pharmacovigilance is a difficult and time consuming exercise. This paper presents the challenges in determining causation by drug therapy. The first is that causation is complex and needs to be viewed from the context of the patient treated, rather than the drug product. Multiple causal vectors should be considered if we are to tackle the many issues involved in, for example, medication error and the many other factors that lead to bad outcomes from therapy, including failure to recognise known risk factors...
February 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28247278/a-survey-on-pharmacovigilance-activities-in-asean-and-selected-non-asean-countries-and-the-use-of-quantitative-signal-detection-algorithms
#18
Cheng Leng Chan, Pei San Ang, Shu Chuen Li
INTRODUCTION: Most Countries have pharmacovigilance (PV) systems in place to monitor the safe use of health products. The process involves the detection and assessment of safety issues from various sources of information, communicating the risk to stakeholders and taking other relevant risk minimization measures. OBJECTIVES: This study aimed to assess the PV status in Association of Southeast Asian Nation (ASEAN) countries, sources for postmarket safety monitoring, methods used for signal detection and the need for a quantitative signal detection algorithm (QSDA)...
February 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28242152/-post-licensure-safety-surveillance-for-prevenar-13-%C3%A2-in-france
#19
M-S Agier, S Marchand, N Paret, S Gautier, A-P Jonville-Béra
OBJECTIVE: To describe the profile and the incidence of adverse events (AEs) reported with Prevenar 13(®) since its commercialization. METHOD: Analysis of all adverse events reported with Prevenar 13(®) in France between 1st July 2010 and 31 October 2014. RESULTS: In 4 years and 4 months, 376 AEs, including 252 severe (67%), were recorded, 83 of which occurred following an injection of Prevenar 13(®) alone: 39 cutaneous AEs, 16 neurological AEs, four cases of collapse or shock, nine cases of fever, and one of thrombocytopenia...
February 24, 2017: Archives de Pédiatrie: Organe Officiel de la Sociéte Française de Pédiatrie
https://www.readbyqxmd.com/read/28239922/diverging-approaches-of-pharmacovigilance-and-pharmacoepidemiology-to-assessing-drug-safety-epistemological-and-ethical-implications
#20
Joël Coste
No abstract text is available yet for this article.
February 27, 2017: Pharmacoepidemiology and Drug Safety
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