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https://www.readbyqxmd.com/read/28646580/biosimilars-for-psoriasis-worldwide-overview-of-regulatory-guidelines-uptake-and-implications-for-dermatology-clinical-practice
#1
REVIEW
A D Cohen, J J Wu, L Puig, S Chimenti, R Vender, M Rajagopalan, R Romiti, C de la Cruz, L Skov, C Zachariae, H S Young, P Foley, J M van der Walt, L Naldi, A Blauvelt
The introduction of biologic drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologic drugs for patients with psoriasis...
June 24, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28645716/guide-to-active-vaccine-safety-surveillance-report-of-cioms-working-group-on-vaccine-safety-executive-summary
#2
U Heininger, K Holm, I Caplanusi, S R Bailey
In 2013, the Council for International Organizations of Medical Sciences (CIOMS) created a Working Group on Vaccine Safety (WG) to address unmet needs in the area of vaccine pharmacovigilance. Generating reliable data about specific vaccine safety concerns is becoming a priority due to recent progress in the development and deployment of new vaccines of global importance, as well as novel vaccines targeting diseases specifically endemic to many resource-limited countries (RLCs), e.g. malaria, dengue. The WG created a Guide to Active Vaccine Safety Surveillance (AVSS) to assist national regulatory authorities and national immunization program officers in RLCs in determining the best course of action with regards to non-routine pharmacovigilance activities, when confronted with a launch of a new vaccine or a vaccine that is new to their country...
June 20, 2017: Vaccine
https://www.readbyqxmd.com/read/28645201/benznidazole-treatment-safety-the-m%C3%A3-decins-sans-fronti%C3%A3-res-experience-in-a-large-cohort-of-bolivian-patients-with-chagas-disease
#3
Gilberto Marcelo Sperandio da Silva, Mauro Felippe Felix Mediano, Alejandro Marcel Hasslocher-Moreno, Marcelo Teixeira de Holanda, Andrea Silvestre de Sousa, Luiz Henrique Conde Sangenis, Pedro Emmanuel Alvarenga Americano do Brasil, Roger Arteaga Mejía, Carina Perotti Fux, Juan-Carlos Cubides, Roberto Magalhães Saraiva, Lucia Maria Brum-Soares
Background: Up to half of patients with Chagas' disease under benznidazole treatment present adverse drug reactions (ADRs) and up to one-third do not complete standard treatment. Objectives: To verify the incidence and possible factors associated with the suspension of benznidazole treatment in a large cohort of patients. Methods: We included 2075 patients treated with benznidazole during the projects managed by the medical humanitarian organization Doctors Without Borders (Médecins Sans Frontières) in Bolivia from 2009 to 2013...
June 22, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/28642988/development-of-pulmonary-hypertension-during-treatment-with-diazoxide-a-case-series-and-literature-review
#4
Matthew R Timlin, Alexander B Black, Heather M Delaney, Renée I Matos, Candace S Percival
Congenital hyperinsulinism (CHI) is the most common cause of persistent hypoglycemia in infancy. The mainstay of medical management for CHI is diazoxide. Diazoxide inhibits insulin release from the pancreas, but also causes smooth muscle relaxation and fluid retention so it is typically given with chlorothiazide. In July 2015, the FDA issued a drug safety communication warning that pulmonary hypertension (PH) had been reported in 11 infants being treated with diazoxide and that the PH resolved with withdrawal of diazoxide...
June 22, 2017: Pediatric Cardiology
https://www.readbyqxmd.com/read/28641055/long-term-safety-evaluation-of-natalizumab-for-the-treatment-of-multiple-sclerosis
#5
Marinella Clerico, Carlo Alberto Artusi, Alessandra Di Liberto, Simona Rolla, Valentina Bardina, Pierangelo Barbero, Stefania Federica De Mercanti, Luca Durelli
Introduction Natalizumab is a humanized monoclonal antibody highly effective in relapsing-remitting multiple sclerosis (MS). Important concerns about its safety have been pointed out because of the risk of progressive multifocal leukoencephalopathy (PML), caused by the opportunistic John-Cunningham virus (JCV). Areas covered This review analyzes all the safety aspects related to the use of natalizumab in MS patients. Fatigue and allergic reactions are not-severe adverse events (AEs) occurring more frequently than placebo and no differences in serious AEs (SAE) have been observed comparing to interferon-β1a during clinical trials...
June 22, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28637576/antimicrobial-use-and-resistance-in-australia-aura-surveillance-system-coordinating-national-data-on-antimicrobial-use-and-resistance-for-australia
#6
John D Turnidge, Kathy T Meleady
Objective The aim of the present study was to describe the process of establishment and coordination of the national Antimicrobial Use and Resistance in Australia (AURA) surveillance system.Methods Existing surveillance programs conducted by health organisations at state or multi-jurisdictional levels were reviewed, and gaps and opportunities identified for the development of a national system. In view of the time frame available as part of the Australian Government Department of Health funding agreement, the strategy used by the Australian Commission on Safety and Quality in Health Care was to commence work with existing surveillance programs, expanding and enhancing them and developing new systems where gaps were identified...
June 22, 2017: Australian Health Review: a Publication of the Australian Hospital Association
https://www.readbyqxmd.com/read/28635672/towards-the-internet-of-smart-trains-a-review-on-industrial-iot-connected-railways
#7
Paula Fraga-Lamas, Tiago M Fernández-Caramés, Luis Castedo
Nowadays, the railway industry is in a position where it is able to exploit the opportunities created by the IIoT (Industrial Internet of Things) and enabling communication technologies under the paradigm of Internet of Trains. This review details the evolution of communication technologies since the deployment of GSM-R, describing the main alternatives and how railway requirements, specifications and recommendations have evolved over time. The advantages of the latest generation of broadband communication systems (e...
June 21, 2017: Sensors
https://www.readbyqxmd.com/read/28632758/safety-and-tolerability-of-elvitegravir-cobicistat-emtricitabine-tenofovir-disoproxil-fumarate-in-a-real-life-setting-data-from-surveillance-cohort-long-term-toxicity-antiretrovirals-antivirals-scolta-project
#8
Nicola Squillace, Elena Ricci, Tiziana Quirino, Andrea Gori, Alessandra Bandera, Laura Carenzi, Giuseppe Vittorio De Socio, Giancarlo Orofino, Canio Martinelli, Giordano Madeddu, Stefano Rusconi, Paolo Maggi, Benedetto Maurizio Celesia, Laura Cordier, Francesca Vichi, Leonardo Calza, Katia Falasca, Antonio Di Biagio, Giovanni Francesco Pellicanò, Paolo Bonfanti
OBJECTIVES: The study aim was to evaluate the impact on Liver and Kidney toxicity of the single tablet regimen Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (EVG/COBI/FTC/TDF) on Antiretroviral Therapy (ART) experienced or naïve patients. METHODS: Patients initiating EVG/COBI/FTC/TDF were enrolled in the SCOLTA project, a multicenter observational study reporting grade 3-4 Adverse Events in subjects beginning new antiretroviral drug regimens...
2017: PloS One
https://www.readbyqxmd.com/read/28628689/aggressive-skin-cancers-occurring-in-patients-treated-with-the-janus-kinase-inhibitor-ruxolitinib
#9
Adam B Blechman, Christine E Cabell, Christine H Weinberger, Anna Duckworth, Justin J Leitenberger, Fiona O Zwald, Mark A Russell
<p>The Food and Drug Administration approved Ruxolitinib in 2011 for the treatment of primary myelofibrosis. Five-year safety data showed a higher incidence of skin cancer in patients treated with Ruxolitinib compared to best available therapy for myelofibrosis. This report presents a series of five patients with history of myelofibrosis treated with Ruxolitinib who subsequently developed numerous skin cancers with aggressive biological behavior. Each patient in this report was treated by a Mohs surgeon affiliated with an academic institution...
May 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/28628185/epidemiology-and-prevention-of-influenza-in-children-in-argentina-and-brazil
#10
(no author information available yet)
A group of influenza experts from Argentina and Brazil got together to discuss the burden of influenza in children, review current vaccine coverage rates in both countries, analyze vaccine effectiveness, and discuss strategies to improve prevention. Active surveillance of respiratory viruses is carried out nationwide in both countries. Years 2014 and 2015 were mild influenza seasons; influenza virus type A/H3N2 prevailed, whereas type B represented less than 30% of isolates. Trivalent inactivated influenza vaccine is included in National Immunization Programs for 1) children 6 months to 2 years old in Argentina; 2) children 6 months to 5 years old in Brazil; and 3) all high-risk individuals...
June 8, 2017: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
https://www.readbyqxmd.com/read/28627937/the-safety-of-intra-articular-injections-for-the-treatment-of-knee-osteoarthritis-a-critical-narrative-review
#11
Christelle Nguyen, François Rannou
International guidelines recommend that the management of knee osteoarthritis (OA) combine both nonpharmacological and pharmacological interventions. Intra-articular (IA) therapies are considered part of this multimodal approach and are well-established Food and Drug Administration (FDA) and European Medicines Agency (EMA)-approved treatments. Areas covered. Safety data for knee OA, including IA corticosteroids, hyaluronic acid, platelet-rich plasma and botulinum toxin are critically reviewed, and evidence- and pratice-based measures to improve safety of IA therapies are discussed...
June 19, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28626539/resistance-to-colistin-in-klebsiella-pneumoniae-a-4-0-strain
#12
REVIEW
Guido Granata, Nicola Petrosillo
The global rise of multidrug-resistant gram-negative bacteria represents an increasing threat to patient safety. From the first observation of a carbapenem-resistant gram-negative bacteria a global spread of extended-spectrum beta-lactamases and carbapenemases producing Klebsiella pneumoniae has been observed. Treatment options for multidrug-resistant K. pneumoniae are actually limited to combination therapy with some aminoglycosides, tigecycline and to older antimicrobial agents. Unfortunately, the prevalence of colistin-resistant and tigecycline-resistant K...
May 31, 2017: Infectious Disease Reports
https://www.readbyqxmd.com/read/28626454/a-syst-omics-approach-to-ensuring-food-safety-and-reducing-the-economic-burden-of-salmonellosis
#13
Jean-Guillaume Emond-Rheault, Julie Jeukens, Luca Freschi, Irena Kukavica-Ibrulj, Brian Boyle, Marie-Josée Dupont, Anna Colavecchio, Virginie Barrere, Brigitte Cadieux, Gitanjali Arya, Sadjia Bekal, Chrystal Berry, Elton Burnett, Camille Cavestri, Travis K Chapin, Alanna Crouse, France Daigle, Michelle D Danyluk, Pascal Delaquis, Ken Dewar, Florence Doualla-Bell, Ismail Fliss, Karen Fong, Eric Fournier, Eelco Franz, Rafael Garduno, Alexander Gill, Samantha Gruenheid, Linda Harris, Carol B Huang, Hongsheng Huang, Roger Johnson, Yann Joly, Maud Kerhoas, Nguyet Kong, Gisèle Lapointe, Line Larivière, Stéphanie Loignon, Danielle Malo, Sylvain Moineau, Walid Mottawea, Kakali Mukhopadhyay, Céline Nadon, John Nash, Ida Ngueng Feze, Dele Ogunremi, Ann Perets, Ana V Pilar, Aleisha R Reimer, James Robertson, John Rohde, Kenneth E Sanderson, Lingqiao Song, Roger Stephan, Sandeep Tamber, Paul Thomassin, Denise Tremblay, Valentine Usongo, Caroline Vincent, Siyun Wang, Joel T Weadge, Martin Wiedmann, Lucas Wijnands, Emily D Wilson, Thomas Wittum, Catherine Yoshida, Khadija Youfsi, Lei Zhu, Bart C Weimer, Lawrence Goodridge, Roger C Levesque
The Salmonella Syst-OMICS consortium is sequencing 4,500 Salmonella genomes and building an analysis pipeline for the study of Salmonella genome evolution, antibiotic resistance and virulence genes. Metadata, including phenotypic as well as genomic data, for isolates of the collection are provided through the Salmonella Foodborne Syst-OMICS database (SalFoS), at https://salfos.ibis.ulaval.ca/. Here, we present our strategy and the analysis of the first 3,377 genomes. Our data will be used to draw potential links between strains found in fresh produce, humans, animals and the environment...
2017: Frontiers in Microbiology
https://www.readbyqxmd.com/read/28626370/donor-safety-in-haemapheresis-development-of-an-internet-based-registry-for-comprehensive-assessment-of-adverse-events-from-healthy-donors
#14
Hans-Gert Heuft, Eike Fischer, Tina Weingand, Thomas Burkhardt, Gerda Leitner, Hagen Baume, Jörg-Peter Schmidt, Andreas Buser, Gabriele Fauchald, Ute Reinicke Voigt, Behrouz Mansouri-Taleghani
BACKGROUND: Currently, there is an extensive but highly inconsistent body of literature regarding donor adverse events (AEs) in haemapheresis. As the reports diverge with respect to types and grading of AEs, apheresis procedures and machines, the range of haemapheresis-related AEs varies widely from about 0.03% to 6.6%. METHODS: The German Society for Transfusion Medicine and Immunohaematology (DGTI) formed a 'Haemapheresis Vigilance Working Party' (Arbeitsgemeinschaft Hämapheresevigilanz; AGHV) to create an on-line registry for comprehensive and comparable AE assessment with all available apheresis devices in all types of preparative haemapheresis: plasmapheresis (PLS), plateletpheresis (PLT), red blood cell apheresis, all kind of leukaphereses (autologous/allogeneic blood stem cell apheresis, granulocyte apheresis, lymphocyte/monocyte apheresis) and all possible types of multi-component apheresis...
June 2017: Transfusion Medicine and Hemotherapy
https://www.readbyqxmd.com/read/28625702/national-trends-in-the-frequency-of-bladder-catheterization-and-physician-diagnosed-catheter-associated-urinary-tract-infections-results-from-the-medicare-patient-safety-monitoring-system
#15
Mark L Metersky, Noel Eldridge, Yun Wang, Eric M Mortensen, Jennifer Meddings
BACKGROUND: It is unclear if bladder catheterization and catheter-associated urinary tract infection (CAUTI) rates have changed since the implementation of public reporting in 2011. METHODS: We analyzed data from the Medicare Patient Safety Monitoring System, a national, chart abstraction-based surveillance system, for hospitalized adults with a principal discharge diagnosis of heart failure (HF), acute myocardial infarction (AMI), or pneumonia and patients who had undergone certain major surgeries...
June 15, 2017: American Journal of Infection Control
https://www.readbyqxmd.com/read/28622609/the-strategic-defense-of-physician-autonomy-state-public-health-agencies-as-countervailing-powers
#16
Laura Senier, Rachael Lee, Lauren Nicoll
Advances in genetic testing and the aggressive marketing of genetic tests by commercial diagnostic laboratories have driven both consumer demand and the need for unbiased information about how tests should guide healthcare delivery. This paper uses the countervailing powers framework to explore the role of state public health agencies as arbiters of quality and safety, specifically through their efforts to encourage physicians to follow evidence-based recommendations for screening for hereditary cancers. Social scientists have often viewed actions by the state to regulate cost, quality, or safety as a threat to physician autonomy...
June 3, 2017: Social Science & Medicine
https://www.readbyqxmd.com/read/28621297/endoscopic-ultrasound-with-or-without-fine-needle-aspiration-has-a-meaningful-impact-on-clinical-care-in-the-pediatric-population
#17
Amit Raina, Maire A Conrad, Benjamin Sahn, Alireza Sedarat, Gregory G Ginsberg, Nuzhat A Ahmad, Vinay Chandrasekhara, Petar Mamula, Michael L Kochman
BACKGROUND AND OBJECTIVES: The safety and utility of endoscopic ultrasound (EUS) for the evaluation and management of gastrointestinal (GI) tract disorders among adults has been established. The literature on safety and efficacy in a pediatric referral population (under 21 years of age) is limited. We hypothesized that EUS is safe and useful in the pediatric population. We reviewed the pediatric EUS experience at a single tertiary-care system. We describe the indications, findings, safety, technical success rate, and impact on clinical outcomes...
May 2017: Endoscopic Ultrasound
https://www.readbyqxmd.com/read/28617686/imaging-adult-patients-with-coarctation-of-the-aorta
#18
Akanksha N Thakkar, Ponraj Chinnadurai, C Huie Lin
PURPOSE OF REVIEW: To provide an overview of current recommendations and techniques used to image coarctations of the aorta. RECENT FINDINGS: Imaging of coarctation of the aorta in adults is moving away from conventional techniques such as echocardiography and invasive angiography. Echocardiography may assist in making the diagnosis but is limited in its ability to quantify the severity of coarctations. Current guidelines recommend that every patient with a coarctation must undergo a computed tomography (CT) or MRI scan for accurate delineation of morphology...
June 15, 2017: Current Opinion in Cardiology
https://www.readbyqxmd.com/read/28616492/the-role-of-environmental-health-in-one-health-a-uganda-perspective
#19
David Musoke, Rawlance Ndejjo, Edwinah Atusingwize, Abdullah Ali Halage
BACKGROUND: One Health is the integrative effort of multiple disciplines working locally, nationally and globally to attain optimal health for people, animals and the environment. As the human population continues to increase across the world, the interface of people, animals and the environment becomes more significant and impactful. For the past few years, the One Health concept has brought together experts in the areas of animal and human health. It has provided a new synthesis for public health and veterinary communities across the world...
December 2016: One Health
https://www.readbyqxmd.com/read/28614925/-investigation-on-standard-application-of-industrial-dust-hazard-classification
#20
Y Lu, M Zhang, W H Chen
Objective: To investigate the application and effectiveness evaluation of the standard of GBZ/T 229.1-2010 in practice, and to explore the applicability, aiming to provide technical evidence for the revision of GBZ/T 229.1-2010. Methods: There were 2 questionnaire surveys carried out in the study, including general survey and specific survey. Databases were established and data were input with Excel 2010 and Epidata version 3.1 software. SPSS version 19.0 software was used for data cleaning and statistical analysis...
April 20, 2017: Chinese Journal of Industrial Hygiene and Occupational Diseases
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