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Pharmacovigilence

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https://www.readbyqxmd.com/read/29778098/hydrochlorothiazide-and-risk-of-hearing-disorder-a-case-series
#1
Natnael Belai, Selamawit Gebrehiwet, Yodit Fitsum, Mulugeta Russom
BACKGROUND: Hydrochlorothiazide is not known to cause hearing disorder. The Eritrean Pharmacovigilance Centre, however, has received cases of hearing disorder, including irreversible deafness, associated with hydrochlorothiazide. The aim of this study is, therefore, to assess the causal relationship between hydrochlorothiazide and hearing disorder. METHODS: Data was retrieved from the WHO global adverse drug reaction database, VigiBase™. A search on VigiBase™ was made on August 6, 2017 using "hydrochlorothiazide" as drug substance, and "ototoxicity", "decreased hearing", and "vestibular disorder" as reaction terms...
May 20, 2018: Journal of Medical Case Reports
https://www.readbyqxmd.com/read/29776627/introduction-molecular-medicine-in-the-common-era-applications-and-impact-of-molecular-pathology-in-health-and-disease
#2
REVIEW
Martin H Bluth
The unprecedented expansion of molecular pathology continues to affect and influence the clinical laboratory. Technological advances in high-throughput automation, cost containment, and refined methodology have improved the understanding of pathobiology through application of molecular pathology to multiple disease spaces. Incorporation of this field to emerging omics platforms, pharmacovigilance and biomarker discovery, and accessibility by lay consumers demonstrates the widespread reach of molecular pathology in the clinical marketplace...
June 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/29773358/-antidepressive-agents-and-hyponatremia-a-literature-review-and-a-case-non-case-study-in-the-french-pharmacovigilance-database
#3
Michaël Rochoy, Christina Zakhem-Stachera, Johana Béné, Christophe Berkhout, Sophie Gautier
OBJECTIVE: Most antidepressants have been associated with a risk of hyponatremia in the literature. This effect is not always reported in monographs. The aim of our study was to clarify the difference of increased risk of hyponatremia among various antidepressants. METHODS: Retrospective study of such cases/non-cases from observations recorded in the French national pharmacovigilance between 01/01/2004 and 31/12/2013. We studied all antidepressants marketed in 2014 in France, with a positive control (haloperidol) and a negative one (amoxicillin)...
March 1, 2018: Thérapie
https://www.readbyqxmd.com/read/29770702/characterization-of-potentially-unsafe-ambulatory-antibiotic-use-and-associated-outcomes-in-an-adult-kidney-transplant-population
#4
Lindsay M Avery, Cory E Fominaya, Rena C Crawford, Katherine P Pleasants, David J Taber
BACKGROUND: Antibiotics are frequently prescribed to kidney transplant (KTX) recipients in the outpatient setting, but there are limited data assessing the safety and outcomes associated with this practice. OBJECTIVE: The primary objective of this study was to describe ambulatory antibiotic prescribing in a large cohort of adult KTX recipients. The secondary objective was to assess the outcomes associated with potentially unsafe antibiotic use in this population...
May 1, 2018: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/29767853/nicorandil-induced-ulcerations-a-10-year-observational-study-of-all-cases-spontaneously-reported-to-the-french-pharmacovigilance-network
#5
Valérie Babic, Nadine Petitpain, Claire Guy, Philippe Trechot, Anne Claire Bursztejn, Jean Luc Faillie, Thierry Vial, Jean Luc Schmutz, Pierre Gillet
Nicorandil-induced ulcers remain often poorly recognised, with a late diagnosis and an inadequate management. We aimed to provide a clinical overview of the 148 spontaneously reported cases of nicorandil-induced ulcers to the French pharmacovigilance network between 2005 and 2014 and to complete this picture with worldwide published cases over the same period. Spontaneously reported nicorandil-induced ulcers were mainly mucosal (oral and anal) with a previous trauma in 23·0% of patients, revealed by a severe complication in 12·8% of cases...
May 16, 2018: International Wound Journal
https://www.readbyqxmd.com/read/29765326/descriptions-of-adverse-drug-reactions-are-less-informative-in-forums-than-in-the-french-pharmacovigilance-database-but-provide-more-unexpected-reactions
#6
Pierre Karapetiantz, Florelle Bellet, Bissan Audeh, Jérémy Lardon, Damien Leprovost, Rim Aboukhamis, François Morlane-Hondère, Cyril Grouin, Anita Burgun, Sandrine Katsahian, Marie-Christine Jaulent, Marie-Noëlle Beyens, Agnès Lillo-Le Louët, Cédric Bousquet
Background: Social media have drawn attention for their potential use in Pharmacovigilance. Recent work showed that it is possible to extract information concerning adverse drug reactions (ADRs) from posts in social media. The main objective of the Vigi4MED project was to evaluate the relevance and quality of the information shared by patients on web forums about drug safety and its potential utility for pharmacovigilance. Methods: After selecting websites of interest, we manually evaluated the relevance of the content of posts for pharmacovigilance related to six drugs (agomelatine, baclofen, duloxetine, exenatide, strontium ranelate, and tetrazepam)...
2018: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/29756388/semaglutide-for-type-2-diabetes-mellitus-a-systematic-review-and-meta-analysis
#7
Panagiotis Andreadis, Thomas Karagiannis, Konstantinos Malandris, Ioannis Avgerinos, Aris Liakos, Apostolos Manolopoulos, Eleni Bekiari, David R Matthews, Apostolos Tsapas
AIM: To assess the efficacy and safety of semaglutide, a recently approved glucagon-like peptide 1 receptor agonist (GLP-1 RA) for type 2 diabetes. METHODS: We searched major electronic databases and grey literature sources for randomised controlled trials comparing semaglutide with placebo or other antidiabetic agents. Primary outcome was change from baseline in HbA1c . Secondary endpoints included change from baseline in body weight, blood pressure, heart rate, and incidence of hypoglycaemia, gastrointestinal adverse effects, pancreatitis and diabetic retinopathy...
May 13, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29755826/pharmacovigilance-via-baseline-regularization-with-large-scale-longitudinal-observational-data
#8
Zhaobin Kuang, Peggy Peissig, Vítor Santos Costa, Richard Maclin, David Page
Several prominent public health hazards [29] that occurred at the beginning of this century due to adverse drug events (ADEs) have raised international awareness of governments and industries about pharmacovigilance (PhV) [6,7], the science and activities to monitor and prevent adverse events caused by pharmaceutical products after they are introduced to the market. A major data source for PhV is large-scale longitudinal observational databases (LODs) [6] such as electronic health records (EHRs) and medical insurance claim databases...
August 2017: KDD: Proceedings
https://www.readbyqxmd.com/read/29742934/drug-information-association-pharmacovigilance-and-risk-management-strategies-2017-overview-of-the-generic-drug-program-and-surveillance
#9
Howard D Chazin, John R Peters, Debra M Catterson, James L Osterhout, Linda M Forsyth, Jung E Lee, Edward K Kim, Karen B Feibus
The US Food and Drug Administration's (FDA's) generic drug program has dramatically increased the availability of affordable, high quality generic drugs. The foundation of generic drug approvals is a two-tiered regulatory framework of pharmaceutical equivalence and bioequivalence. Intrinsic to both of these is consideration of the clinical relevance of formulation and bioequivalence data to support an inference of therapeutic equivalence, based on clear evidence that there are no significant differences between the generic drug and the brand name drug...
January 1, 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29737502/vitamin-b-6-in-health-supplements-and-neuropathy-case-series-assessment-of-spontaneously-reported-cases
#10
Florence van Hunsel, Sonja van de Koppel, Eugène van Puijenbroek, Agnes Kant
INTRODUCTION: In the literature, vitamin B6 has been linked to the development of polyneuropathy. Most often, these complaints were seen when taking high doses of vitamin B6 for a long time. Evidence as to whether a lower dosage range of vitamin B6 (< 50 mg/day) can also induce neuropathy is scarce. OBJECTIVE: We aim to comprehensively describe the cases of neuropathy associated with vitamin B6 received by the Netherlands Pharmacovigilance Centre Lareb and to assess the case series concerning the use of vitamin B6 and neuropathic complaints...
May 8, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29736796/eurocat-an-update-on-its-functions-and-activities
#11
F D Tucker, J K Morris, A Neville, E Garne, A Kinsner-Ovaskainen, M Lanzoni, M A Loane, S Martin, C Nicholl, J Rankin, A K Rissmann
This paper provides an outline of the development and growth of EUROCAT, the European network of congenital anomaly registers. In recent years the network has been through a period of transition and change. The Central Register of data has transferred from the Ulster University to the EU Joint-Research-Centre, Ispra, Italy.The benefits of combining data from across Europe, from different populations and countries are described by the uses to which these data can be put. These uses include:. surveillance of anomalies at a local, regional or pan-European level...
May 7, 2018: Journal of Community Genetics
https://www.readbyqxmd.com/read/29733072/la-importancia-de-la-farmacovigilancia-intrahospitalaria-en-la-detecci%C3%A3-n-oportuna-de-los-errores-de-medicaci%C3%A3-n
#12
Francisco Villegas, David Figueroa-Montero, Varenka Barbero-Becerra, Eva Juárez-Hernández, Misael Uribe, Norberto Chávez-Tapia, Octavio González-Chon
Introducción: Los pacientes hospitalizados son susceptibles a errores de medicación, que representan entre la cuarta y sexta causa de muerte. El servicio de farmacovigilancia intrahospitalaria interviene en todo el proceso de medicación con el fin prevenir, corregir y evaluar los daños. Objetivo: Analizar los errores de medicación reportados por el sistema de farmacovigilancia de la Fundación Clínica Médica Sur, México, y su impacto en los pacientes. Método: Estudio prospectivo efectuado de 2012 a 2015, en el que se registraron las prescripciones de medicamente a los pacientes...
2018: Gaceta Médica de México
https://www.readbyqxmd.com/read/29729202/non-hemorrhagic-joint-disorders-and-vitamin-k-antagonists-an-under-recognized-adverse-drug-reaction
#13
Johana Béné, Clémentine Rousselin, Haleh Bagheri, Thierry Vial, Sophie Gautier, Marc Lambert
Isolated arthralgia, without hemorrhagic side effect exists and is considered as a very rare adverse drug reaction according to vitamin K antagonists' (VKAs) summary of product characteristics. Up to now, there are no literature reports of isolated, non-hemorrhagic joint complications in patients receiving VKAs. Hence, the objective of this study was to describe cases of VKA-related non-hemorrhagic joint disorders (fluindione, warfarin, and acenocoumarol) reported in the French Pharmacovigilance Database (FPVD)...
May 5, 2018: Fundamental & Clinical Pharmacology
https://www.readbyqxmd.com/read/29721705/knowledge-of-adverse-drug-reaction-reporting-and-the-pharmacovigilance-of-biological-medicines-a-survey-of-healthcare-professionals-in-ireland
#14
J O'Callaghan, B T Griffin, J M Morris, Margaret Bermingham
BACKGROUND: In Europe, changes to pharmacovigilance legislation, which include additional monitoring of medicines, aim to optimise adverse drug reaction (ADR) reporting systems. The legislation also makes provisions related to the traceability of biological medicines. OBJECTIVE: The objective of this study was to assess (i) knowledge and general experience of ADR reporting, (ii) knowledge, behaviours, and attitudes related to the pharmacovigilance of biologicals, and (iii) awareness of additional monitoring among healthcare professionals (HCPs) in Ireland...
May 2, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29718320/a-survey-on-the-knowledge-attitudes-and-practices-of-physicians-towards-pharmacovigilance-in-jordanian-health-centres
#15
Wejdan A Shroukh, Farouq M Shakhatreh, Nada A Yasein, Ghazi F Sharkas
Background: Knowledge, attitudes and practices of health care professionals towards pharmacovigilance are strongly associated with reporting adverse drug reactions, as proven by a number of studies. This study aims to evaluate the levels of knowledge, attitudes and practices towards pharmacovigilance among physicians working at health centres of the Jordanian Ministry of Health. Methods: This took the form of a cross-sectional survey. Questionnaires were distributed by the researcher and research assistant to the physicians...
April 27, 2018: International Health
https://www.readbyqxmd.com/read/29714615/adverse-reactions-to-radiopharmaceuticals-a-survey-based-on-clinical-cases-using-criteria-of-systematic-review
#16
Suyene Rocha Pinto, Luis Filipe Cavalcanti Santos, Sara Rhaissa Rezende Dos Reis, Matheus Keuper Bastos, Vitória da Silva Gomes, Thamires de Oliveira Vieira, Ralph Santos-Oliveira
Adverse reactions to radiopharmaceuticals are still not reported worldwide. However, the type of reaction may be severe and cause death. A review of the literature was performed using some criteria of a systematic review established by the Cochrane Collaboration. The results showed that there are a large number of adverse reactions to radiopharmaceuticals. Nuclear medicine staff must be aware of the possibility of adverse reaction with radiopharmaceuticals and find time to share this information with the radiopharmacist and the national pharmacovigilance system...
January 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29714580/advancing-drug-safety-through-prospective-pharmacovigilance
#17
Peter J Pitts, Hervé Le Louet
Much has changed in a relatively short period of time. There is a raging debate over the level of evidence expected to first introduce a treatment to patients based on smaller, more adaptive data sets. Some argue for less data followed by postapproval follow-up, others for more adaptive clinical trial designs and end-point modification driven by patient-focused drug development and use of real-world evidence. The transition in both the review and postmarketing regulatory framework is happening in front of our eyes in real time...
January 1, 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29714567/patient-reporting-of-adverse-drug-reactions-adrs-survey-of-public-awareness-and-predictors-of-confidence-to-report
#18
Vidhya Hariraj, Zoriah Aziz
BACKGROUND: Many countries incorporate direct patient reporting of adverse drug reactions (ADRs) into their pharmacovigilance systems as patients provide a different insight into drug safety compared to health care professionals. This study aimed to examine public awareness about ADR reporting in Malaysia and patients' confidence in reporting ADRs. METHODS: Using a cross-sectional design and convenient sampling, data were collected in public areas within Kuala Lumpur, Malaysia, via face-to-face interview with a structured questionnaire...
January 1, 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29714004/non-bleeding-adverse-events-with-the-use-of-direct-oral-anticoagulants-a-sequence-symmetry-analysis
#19
Géric Maura, Cécile Billionnet, Joël Coste, Alain Weill, Anke Neumann, Antoine Pariente
INTRODUCTION: Postmarketing pharmacovigilance reports have raised concerns about non-bleeding adverse events associated with direct oral anticoagulants (DOACs), but only limited results are available from large claims databases. OBJECTIVE: The aim of this study was to assess the potential association between DOAC initiation and the onset of four types of non-bleeding adverse events by sequence symmetry analysis (SSA). METHODS: SSA was performed using nationwide data from the French National Healthcare databases (Régime Général, 50 million beneficiaries) to assess a cohort of 386,081 DOAC new users for the first occurrence of four types of non-bleeding outcomes: renal, hepatic, skin outcomes identified by using hospitalization discharge diagnoses, and gastrointestinal outcomes by using medication reimbursement...
April 30, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29713202/derivation-and-validation-of-a-multivariable-model-to-predict-when-primary-care-physicians-prescribe-antidepressants-for-indications-other-than-depression
#20
Jenna Wong, Michal Abrahamowicz, David L Buckeridge, Robyn Tamblyn
Objective: Physicians commonly prescribe antidepressants for indications other than depression that are not evidence-based and need further evaluation. However, lack of routinely documented treatment indications for medications in administrative and medical databases creates a major barrier to evaluating antidepressant use for indications besides depression. Thus, the aim of this study was to derive a model to predict when primary care physicians prescribe antidepressants for indications other than depression and to identify important determinants of this prescribing practice...
2018: Clinical Epidemiology
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