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https://www.readbyqxmd.com/read/28438569/methylprednisolone-liver-toxicity-a-new-case-and-a-french-regional-pharmacovigilance-survey
#1
Jérôme Dumortier, Judith Cottin, Caroline Lavie, Olivier Guillaud, Valérie Hervieu, Christine Chambon-Augoyard, Jean-Yves Scoazec, Sandra Vukusic, Thierry Vial
Reported hepatotoxicity induced by corticosteroids is very rare, and the diagnosis is highly challenging in the context of auto-immune disease. We report here a case of high-dose methylprednisolone (MP)-induced acute hepatitis confirmed by liver histology in a patient with multiple sclerosis (MS) and a case series (n=4) notified to the French Pharmacovigilance center of Lyon. In all 5 cases, other common causes of hepatitis were excluded. The causal relationship with MP pulse therapy was supported by the fact that MP was the only culprit drug...
April 21, 2017: Clinics and Research in Hepatology and Gastroenterology
https://www.readbyqxmd.com/read/28437743/eco-pharmacovigilance-of-non-steroidal-anti-inflammatory-drugs-necessity-and-opportunities
#2
REVIEW
Bing-Shu He, Jun Wang, Juan Liu, Xia-Min Hu
Eco-pharmacovigilance (EPV) is a practical and powerful approach to minimize the potential risks posed by pharmaceutical residues in environment. However, it is impracticable to practise rigorous and unitary EPV process for all the existing and new pharmaceuticals. Here, we focused on non-steroidal anti-inflammatory drugs (NSAIDs), and discussed the necessity and potential opportunities of practising EPV of NSAIDs. We found that the consumption of NSAIDs is huge and ubiquitous across the globe. NSAIDs were worldwidely reported as one of the most dominant and frequently detected groups in environmental matrices including wastewater, surface water, suspended solids, sediments, groundwater, even drinking water...
April 21, 2017: Chemosphere
https://www.readbyqxmd.com/read/28435240/risk-of-pneumonia-with-budesonide-containing-treatments-in-copd-an-individual-patient-level-pooled-analysis-of-interventional-studies
#3
Sally Hollis, Carin Jorup, Dan Lythgoe, Gunnar Martensson, Pontus Regnell, Göran Eckerwall
BACKGROUND: Concerns have been raised that treatment of COPD with inhaled corticosteroids may increase pneumonia risk. Responding to a request from the European Medicines Agency Pharmacovigilance Risk Assessment Committee, a pooled analysis of interventional studies compared pneumonia risk with inhaled budesonide-containing versus non-budesonide-containing treatments and the impact of other clinically relevant factors. METHODS: AstraZeneca-sponsored, parallel-group, double-blind, randomized controlled trials meeting the following criteria were included: >8 weeks' duration; ≥60 patients with COPD; inhaled budesonide treatment arm (budesonide/formoterol or budesonide); and non-budesonide-containing comparator arm (formoterol or placebo)...
2017: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/28429612/a-unique-database-for-gathering-data-from-a-mobile-app-and-medical-prescription-software-a-useful-data-source-to-collect-and-analyse-patient-reported-outcomes-of-depression-and-anxiety-symptoms
#4
Yoshinori Watanabe, Yoko Hirano, Yuko Asami, Maki Okada, Kazuya Fujita
A unique database named 'AN-SAPO' was developed by Iwato Corp. and Japan Brain Corp. in collaboration with the psychiatric clinics run by Himorogi Group in Japan. The AN-SAPO database includes patients' depression/anxiety score data from a mobile app named AN-SAPO and medical records from medical prescription software named 'ORCA'. On the mobile app, depression/anxiety severity can be evaluated by answering 20 brief questions and the scores are transferred to the AN-SAPO database together with the patients' medical records on ORCA...
April 21, 2017: International Journal of Psychiatry in Clinical Practice
https://www.readbyqxmd.com/read/28428206/current-and-emerging-therapies-in-multiple-sclerosis-implications-for-the-radiologist-part-2-surveillance-for-treatment-complications-and-disease-progression
#5
REVIEW
C McNamara, G Sugrue, B Murray, P J MacMahon
An understanding of the new generation of MS drugs in conjunction with the key role MR imaging plays in the detection of disease progression, opportunistic infections, and drug-related adverse effects is of vital importance to the neuroradiologist. Part 1 of this review outlined the current treatment options available for MS and examined the mechanisms of action of the various medications. It also covered specific complications associated with each form of therapy. Part 2, in turn deals with the subject of pharmacovigilance and the optimal frequency of MRI monitoring for each individual patient, depending on his or her unique risk profile...
April 20, 2017: AJNR. American Journal of Neuroradiology
https://www.readbyqxmd.com/read/28417320/patient-reporting-in-the-eu-analysis-of-eudravigilance-data
#6
Marin Banovac, Gianmario Candore, Jim Slattery, Francois Houÿez, David Haerry, Georgy Genov, Peter Arlett
INTRODUCTION: New pharmacovigilance legislation was adopted in the EU in 2010 and became operational in July 2012. The legislation placed an obligation on all national competent authorities (NCAs) and marketing authorisation holders (MAHs) to record and report cases of suspected adverse drug reactions (ADRs) received from patients. OBJECTIVES: This descriptive study aims to provide insight into patient reporting for the totality of the EU by querying the EudraVigilance (EV) database for the period of 3 years before the new pharmacovigilance legislation became operational and the 3 years after as well as comparing patient reports with those from healthcare professionals (HCPs) where feasible...
April 17, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28416298/-epicutaneous-patch-testing-in-delayed-drug-hypersensitivity-reactions-induced-by-antiepileptic-drugs
#7
Lobna Ben Mahmoud, Najla Bahloul, Hanen Ghozzi, Brahim Kammoun, Ahmed Hakim, Zouheir Sahnoun, Sami Kammoun, Khaled Zeghal
INTRODUCTION: Antiepileptic drugs are widely used and are associated with numerous side effects including skin eruptions. Epicutaneous tests have been used with variable success in skin drug reactions. The purpose of this study was to evaluate the profitability of epicutaneous tests in delayed hypersensitivity reactions induced by antiepileptic drugs. METHODS: We analyzed all cases of allergic skin reactions to antiepileptic drugs notified in regional pharmacovigilance center of Sfax (Tunisia) between June 1, 2014 and April 30, 2016...
March 25, 2017: Thérapie
https://www.readbyqxmd.com/read/28412689/simple-rapid-and-highly-sensitive-hplc-method-for-measurement-of-lamotrigine-in-human-plasma-and-its-clinical-applications
#8
Abdul Sami Shaikh, Wenlong Li, Guiyan Yuan, Meimei Gao, Chunmei Geng, Nan Guo, Ruichen Guo
Spikes in Lamotrigine concentrations levels and associated clinical toxicity may occur unpredictably. This study describes the development and validation of a simple, more rapid, highly sensitive and economical method for measuring Lamotrigine (LTG) concentration levels in human plasma using HPLC-UV and its clinical applications. Analyte from plasma was extracted with methanol (protein precipitation) and separated on the analytical column Diamonsil C18 (150mm×4.6mm, 5μm) Waters-Milford, MA, United States...
November 2016: Pakistan Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28411001/interstitial-lung-disease-induced-by-fluoxetine-systematic-review-of-literature-and-analysis-of-vigiaccess-eudravigilance-and-a-national-pharmacovigilance-database
#9
REVIEW
Arianna Deidda, Claudia Pisanu, Laura Micheletto, Alberto Bocchetta, Maria Del Zompo, Maria Erminia Stochino
We investigated a pulmonary adverse drug reaction possibly induced by fluoxetine, the Interstitial Lung Disease, by performing a systematic review of published case reports on this subject, a review of the World Health Organization VigiAccess database, of the European EudraVigilance database and of a national Pharmacovigilance database (Italian Pharmacovigilance Network). The research found a total of seven cases linking fluoxetine to Interstitial Lung Disease in the literature. 36 cases of interstitial lung disease related to fluoxetine were retrieved from the VigiAccess database (updated to July 2016), and 36 reports were found in EudraVigilance database (updated to June 2016)...
April 12, 2017: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/28408630/current-and-emerging-therapies-in-multiple-sclerosis-implications-for-the-radiologist-part-1-mechanisms-efficacy-and-safety
#10
REVIEW
C McNamara, G Sugrue, B Murray, P J MacMahon
Imaging for the diagnosis and follow-up of patients with suspected or confirmed multiple sclerosis is a common scenario for many general radiologists and subspecialty neuroradiologists. The field of MS therapeutics has rapidly evolved with multiple new agents now being used in routine clinical practice. To provide an informed opinion in discussions concerning newer MS agents, radiologists must have a working understanding of the strengths and limitations of the various novel therapies. The role of imaging in MS has advanced beyond monitoring and surveillance of disease activity to include treatment complications...
April 13, 2017: AJNR. American Journal of Neuroradiology
https://www.readbyqxmd.com/read/28408005/balancing-the-optimal-and-the-feasible-a-practical-guide-for-setting-up-patient-registries-for-the-collection-of-real-world-data-for-health-care-decision-making-based-on-dutch-experiences
#11
Saskia de Groot, Naomi van der Linden, Margreet G Franken, Hedwig M Blommestein, Brenda Leeneman, Ellen van Rooijen, J J M Koos van der Hoeven, Michel W Wouters, Hans M Westgeest, Carin A Uyl-de Groot
OBJECTIVES: The aim of this article was to provide practical guidance in setting up patient registries to facilitate real-world data collection for health care decision making. METHODS: This guidance was based on our experiences and involvement in setting up patient registries in oncology in the Netherlands. All aspects were structured according to 1) mission and goals ("the Why"), 2) stakeholders and funding ("the Who"), 3) type and content ("the What"), and 4) identification and recruitment of patients, data handling, and pharmacovigilance ("the How")...
April 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28405899/the-quality-of-clinical-information-in-adverse-drug-reaction-reports-by-patients-and-healthcare-professionals-a-retrospective-comparative-analysis
#12
Leàn Rolfes, Florence van Hunsel, Laura van der Linden, Katja Taxis, Eugène van Puijenbroek
INTRODUCTION: Clinical information is needed to assess the causal relationship between a drug and an adverse drug reaction (ADR) in a reliable way. Little is known about the level of relevant clinical information about the ADRs reported by patients. OBJECTIVE: The aim was to determine to what extent patients report relevant clinical information about an ADR compared with their healthcare professional. METHODS: A retrospective analysis of all ADR reports on the same case, i...
April 12, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28397317/evaluating-the-effectiveness-of-risk-minimisation-measures-the-application-of-a-conceptual-framework-to-danish-real-world-dabigatran-data
#13
REVIEW
Martin Erik Nyeland, Mona Vestergaard Laursen, Torbjörn Callréus
PURPOSE: For both marketing authorization holders and regulatory authorities, evaluating the effectiveness of risk minimization measures is now an integral part of pharmacovigilance in the European Union. The overall aim of activities in this area is to assess the performance of risk minimization measures implemented in order to ensure a positive benefit-risk balance in patients treated with a medicinal product. METHODS: Following a review of the relevant literature, we developed a conceptual framework consisting of four domains (data, knowledge, behaviour and outcomes) intended for the evaluation of risk minimization measures put into practice in the Danish health-care system...
April 11, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28395523/adverse-drug-reactions-reporting-in-calabria-southern-italy-in-the-four-year-period-2011-2014-impact-of-a-regional-pharmacovigilance-project-in-light-of-the-new-european-legislation
#14
Christian Leporini, Giuseppina Marrazzo, Laura Mumoli, Stefania Esposito, Luca Gallelli, Giovanna Mangano, Giacomino Brancati, Emanuela Adele De Francesco, Emilio Russo, Giovambattista De Sarro
BACKGROUND: The number of suspected adverse drug reactions (ADRs) yearly submitted to the Italian Network of Pharmacovigilance (RNF) has progressively increased after the new European Pharmacovigilance legislation (July 2012). These results have mostly reflected the agreements between Italian Medicines Agency (AIFA) and Italian Regions, enabling the implementation of active pharmacovigilance projects. A project was funded by the AIFA in Calabria region (Southern Italy) in 2010 to increase ADRs reporting and promote a safer medicines' use...
April 11, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28395515/long-term-safety-experience-with-bendamustine-for-injection-in-a-real-world-setting
#15
Peter Martin, Paul M Barr, Leonard James, Ashutosh Pathak, Brad Kahl
BACKGROUND: Bendamustine hydrochloride (bendamustine) was approved for first-line treatment of patients with chronic lymphocytic leukemia (CLL) and relapsed indolent B-cell non-Hodgkin's lymphoma (NHL). Pharmacovigilance data have been collected since bendamustine's approval to enhance understanding of its long-term safety profile. Here we provide an overview of the pharmacovigilance data for bendamustine that have led to label updates related to safety and administration since its approval...
April 11, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28392715/positive-predictive-values-of-international-classification-of-diseases-10th-revision-codes-for-dermatologic-events-and-hypersensitivity-leading-to-hospitalization-or-emergency-room-visit-among-women-with-postmenopausal-osteoporosis-in-the-danish-and-swedish
#16
Kasper Adelborg, Lotte Brix Christensen, Troels Munch, Johnny Kahlert, Ylva Trolle Lagerros, Grethe S Tell, Ellen M Apalset, Fei Xue, Vera Ehrenstein
BACKGROUND: Clinical epidemiology research studies, including pharmacoepidemiology and pharmacovigilance studies, use routinely collected health data, such as diagnoses recorded in national health and administrative registries, to assess clinical effectiveness and safety of treatments. We estimated positive predictive values (PPVs) of International Classification of Diseases, 10th revision (ICD-10) codes for primary diagnoses of dermatologic events and hypersensitivity recorded at hospitalization or emergency room visit in the national patient registries of Denmark and Sweden among women with postmenopausal osteoporosis (PMO)...
2017: Clinical Epidemiology
https://www.readbyqxmd.com/read/28391408/informativeness-of-patient-initial-reports-of-adverse-drug-reactions-can-it-be-improved-by-a-pharmacovigilance-centre
#17
F Kheloufi, A Default, F Rouby, D Laugier-Castellan, M Boyer, B Rodrigues, J Ponte-Astoul, M J Jean-Pastor, O Blin, J Micallef
PURPOSE: Little is known about the informativeness of initial patient reports before they are reviewed by a pharmacovigilance centre (PVC). We aim to describe the patterns of patient adverse drug reaction (ADR) reporting in France and estimate the contribution of a review by a PVC assessor on the informativeness of these reports. METHODS: A retrospective study was conducted on patient reports between July 2011 and July 2015. Informativeness of 16 key elements of information (including drug start and end date, duration of treatment, time to onset and duration of the ADR, outcome, medical history and concomitant medication) was assessed in initial reports before and after review by a pharmacovigilance assessor...
April 8, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28390750/implementing-ecopharmacovigilance-epv-from-a-pharmacy-perspective-a-focus-on-non-steroidal-anti-inflammatory-drugs
#18
REVIEW
Jun Wang, Bingshu He, Dan Yan, Xiamin Hu
Environmental experts have made great efforts to control pharmaceutical pollution. However, the control of emerged environmental problems caused by medicines should draw more attention of pharmacy and pharmacovigilance researchers. Ecopharmacovigilance (EPV) as a kind of pharmacovigilance for the environment is recognized worldwide as crucial to minimize the environmental risk of pharmaceutical pollutants. But continuing to treat the pollution of pharmaceuticals as a group of substances instead of targeting individual pharmaceuticals on a prioritized basis will lead to a significant waste of resources...
April 5, 2017: Science of the Total Environment
https://www.readbyqxmd.com/read/28379588/a-focus-on-epidemiology-of-drug-induced-liver-injury-analysis-of-a-prospective-cohort
#19
A Licata, M G Minissale, V Calvaruso, A Craxì
OBJECTIVE: Drug-induced liver injury (DILI) is more often a challenge even for expert clinicians. Presently, there are limited data about the epidemiology, because the real incidence and prevalence of the disorder are underestimated, and further, sometimes the pharmacovigilance chain is unsuccessful as cases are largely underreported. We review available literature data and discuss our clinical experience regarding a prospective cohort of 185 patients with a diagnosis of DILI. MATERIALS AND METHODS: Significant papers were identified by literature search, and selected based on content including the epidemiology of DILI...
March 2017: European Review for Medical and Pharmacological Sciences
https://www.readbyqxmd.com/read/28372493/safety-profile-of-gadoxetate-disodium-in-elderly-patients-%C3%A2-65-years
#20
Jan Endrikat, Carsten Schwenke, Kai Vogtlaender, Susan Dohannish, Josy Breuer
Background Safety data on routine clinical use of gadoxetate disodium in elderly patients is not reported yet. Purpose To assess the safety of liver specific gadoxetate disodium in contrast enhanced magnetic resonance imaging in elderly patients (≥65 years) in comparison to adults (18-64 years). Material and Methods Safety data on gadoxetate disodium were analyzed from 12 clinical phase II-III studies and from our pharmacovigilance database. A comparison between elderly (≥65 years) versus adults (18-64 years) was performed with respect to the frequency of drug-related adverse events (AEs) in clinical phase II-III studies and adverse drug reactions (ADRs) in the pharmacovigilance database...
January 1, 2017: Acta Radiologica
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