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Livia Puljak
No abstract text is available yet for this article.
2018: Journal of Pain Research
Adel Alharf, Nasser Alqahtani, Ghazi Saeed, Ali Alshahrani, Mubarak Alshahrani, Nasser Aljasser, Mohammed Alquwaizani, Saleh Bawazir
Pharmacovigilance is vital to public health. Adopting a robust spontaneous reporting system for adverse drug events can counteract most hazards that arise from utilizing medicinal products. Prior to the establishment of the Saudi Food and Drug Authority (SFDA), the number of pharmacovigilance-related activities in Saudi Arabia was limited. In 2009, the SFDA established the National Pharmacovigilance and Drug Safety Center (Saudi Vigilance). The pharmacovigilance system has remarkably improved during the past few years...
March 2018: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
Xiao-Meng Zhang, Fan Li, Bing Zhang, Xiao-Fen Chen, Jing-Zhu Piao
The common Aconitum herbs in clinical application mainly include Aconiti Radix(Chuanwu), Aconiti Kusnezoffii Radix(Caowu) and Aconiti Lateralis Radix Praeparaia(Fuzi), all of which have toxicity. Therefore, the safety of using Chinese patent drugs including Aconitum herbs has become an hot topic in clinical controversy. Based on the data-mining methods, this study explored the characteristics and causes of adverse drug reactions/events (ADR/ADE) of the Chinese patent drugs including Aconitum, in order to provide pharmacovigilance and rational drug use suggestions for clinical application...
January 2018: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
Xiao-Meng Zhang, Zhi-Jian Lin, Fan Li, Bing Zhang, Xiao-Xin Guo, Le Yang
Based on the relation of efficacy and toxicity, this study mined the dosage rules and characteristics of Aconitum herbs in oral prescriptions from 48 traditional ancient books from Eastern Han dynasty to Qing dynasty, to provide the basis for strengthening the clinical risk pharmacovigilance. In the 48 traditional ancient books, 4 521 prescriptions with clear daily oral dosage were included to establish a database. SPSS 20.0 software was used for statistics and analysis of the daily dosage characteristics with different kinds of herbs, indications, dose forms, processing, use in special population, and other aspects...
January 2018: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
Gian Paolo Fadini, Mayur Sarangdhar, Angelo Avogaro
INTRODUCTION: In the SAVOR-TIMI trial, the risk of heart failure (HF) was increased by 27% in T2D patients randomized to the dipeptidyl peptidase-4 inhibitor (DPP4i) saxagliptin. Other studies have provided inconsistent results regarding this association. Herein, we performed a pharmacovigilance analysis of the rate of HF associated with DPP4is, focusing on stimulated reporting and moderation by drug-drug interactions. METHODS: We mined the FDA adverse event (AE) reporting system (FAERS) from 2004q1 to 2017q3, including a total of 9906,642 AE reports...
March 16, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Jan Endrikat, Susan Dohanish, Nicolas Schleyer, Susanne Schwenke, Sheela Agarwal, Thomas Balzer
OBJECTIVES: The aim of this study was to critically assess the evaluation and categorization process for nephrogenic systemic fibrosis (NSF) based on reports received by Bayer from 2006 to 2016. MATERIALS AND METHODS: A total of 779 NSF reports received by Bayer globally from 2006 to 2016 were included in the analysis. Arlington Medical Resources provided gadolinium-based contrast agent (GBCA) market share. Reports were conservatively categorized based on the Cowper/Girardi criteria...
March 16, 2018: Investigative Radiology
Andras Inotai, Marcell Csanadi, Guenka Petrova, Maria Dimitrova, Tomasz Bochenek, Tomas Tesar, Kristina York, Leos Fuksa, Alexander Kostyuk, Laszlo Lorenzovici, Vitaly Omelyanovskiy, Katalin Egyed, Zoltan Kalo
This policy research aims to map patient access barriers to biologic treatments, to explore how increased uptake of biosimilars may lower these hurdles and to identify factors limiting the increased utilisation of biosimilars. A policy survey was developed to review these questions in 10 Central and Eastern European (CEE) and Commonwealth of Independent States (CIS) countries. Two experts (one public and one private sector representative) from each country completed the survey. Questions were related to patient access, purchasing, clinical practice, and real-world data collection on both original biologics and biosimilars...
2018: BioMed Research International
D A van Riet-Nales, E D Nijholt-Faber, A de Boer
The Netherlands Medicines Evaluation Board (MEB) was recently informed about a serious pipamperone overdose in a 6-year-old boy, which happened because the boy was given the medication in streams rather than in drops. This article describes the use of drops in pharmaceutical patient care and explains why the MEB has maintained marketing authorization for the product on the basis of currently available information. The MEB urgently requests the healthcare professional groups to report all problems concerning drug use to the Netherlands Pharmacovigilance Centre Lareb, and the Portal for Patient Safety; this is the only way in which it can be verified whether incidental medication errors are actually, and continue to be, incidental...
2018: Nederlands Tijdschrift Voor Geneeskunde
J H C de Roo, T M Bosch, A van Rhijn, R Del Canho
BACKGROUND: Medication is not always delivered in a safe dosing format. Up to 33% of medication errors can be attributed to confusing packaging or labelling. CASE DESCRIPTION: A 6-year-old boy with ADHD, for which he was being treated with methylphenidate and pipamperone drops, was brought to the A&E department with signs of severe encephalopathy. He had apparently been given pipamperone in streams rather than in drops in the previous months. The pipamperone level in his blood was raised to toxic levels...
2018: Nederlands Tijdschrift Voor Geneeskunde
Guillaume Bouzillé, Marie-Noëlle Osmont, Louise Triquet, Natalia Grabar, Cécile Rochefort-Morel, Emmanuel Chazard, Elisabeth Polard, Marc Cuggia
RATIONALE, AIMS, AND OBJECTIVES: The spontaneous reporting system currently used in pharmacovigilance is not sufficiently exhaustive to detect all adverse drug reactions (ADRs). With the widespread use of electronic health records, biomedical data collected during the clinical care process can be reused and analysed to better detect ADRs. The aim of this study was to assess whether querying a Clinical Data Warehouse (CDW) could increase the detection of drug-induced anaphylaxis. METHODS: All known cases of drug-induced anaphylaxis that occurred or required hospitalization at Rennes Academic Hospital in 2011 (n = 19) were retrieved from the French pharmacovigilance database, which contains all reported ADR events...
March 13, 2018: Journal of Evaluation in Clinical Practice
Martijn T Wijburg, Iris Kleerekooper, Birgit I Lissenberg-Witte, Marlieke de Vos, Clemens Warnke, Bernard M J Uitdehaag, Frederik Barkhof, Joep Killestein, Mike P Wattjes
Importance: The JC virus (JCV) was named after the first patient to be described with progressive multifocal leukoencephalopathy (PML), John Cunningham. Detection of JC virus DNA in cerebrospinal fluid (CSF) by polymerase chain reaction (PCR), and of specific lesions by brain magnetic resonance imaging (MRI), are both considered essential for the diagnosis of natalizumab-associated PML (NTZ-PML) in patients with multiple sclerosis. However, strict pharmacovigilance by MRI can result in detection of patients with small lesions and undetectable JCV DNA in CSF...
March 12, 2018: JAMA Neurology
Renaud Sabatier, Emanuel Nicolas, Maria Paciencia, Annie-Pierre Jonville-Béra, Anne Madroszyk, Maud Cecile, Cecile Braticevic, Ségolène Duran, Louis Tassy, Franck Rouby, Joëlle Micallef, Frédérique Rousseau
BACKGROUND: Nivolumab is approved worldwide as second-line treatment for metastatic non-small cell lung cancer (NSCLC). Despite the fact that most of these cancers are being diagnosed in the older patients, few of the patients were included in pivotal trials. We aimed to describe efficacy and safety in a "real-world" older population. PATIENTS AND METHODS: We retrospectively collected data from older patients (≥70 years old) with advanced or metastatic NSCLC treated with Nivolumab in our institution...
March 9, 2018: Journal of Geriatric Oncology
Philip Crispin, Maria Burgess, Amy Beath
Although manufacturers recommend varying infusion rates for differing intravenous immunoglobulin products (IVIg), there may be improved efficiency and reduced potential for error with the application of a single infusion policy for all IVIg products. During the transition from a 6% to a 10% IVIg, we prospectively evaluated patient reported adverse reactions to IVIg with the 10% product (Intragam 10) given at a rate faster than recommended by the manufacturer. While there was a significant increase in the rate of immediate infusion reactions when compared with the previous IVIg preparation (Intragam P), there was no increase in the rate of reactions post infusion...
February 23, 2018: Transfusion and Apheresis Science
Gilles Defer, Florian Le Caignec, Sophie Fedrizzi, François Montastruc, Damien Chevanne, Jean-Jacques Parienti, Laure Peyro-Saint-Paul
BACKGROUND: The reporting of adverse drug reactions (ADR) by patients represents an interesting challenge in the field of pharmacovigilance, but the reporting system is not adequately implemented in France. In 2015, only 20 MS patients in France reported ADR due to first-line disease-modifying drugs (DMD), while more than 3000 patients were initiated on DMD. The aim of this study is to validate a proof-of-concept as to whether the use of a mobile application (App) increases ADR reporting among patients with relapsing-remitting multiple sclerosis (RR-MS) receiving DMD...
March 9, 2018: Trials
Jian-Xiang Wei, Jing Wang, Yun-Xia Zhu, Jun Sun, Hou-Ming Xu, Ming Li
BACKGROUND: Traditional Chinese Medicine (TCM) is a style of traditional medicine informed by modern medicine but built on a foundation of more than 2500 years of Chinese medical practice. According to statistics, TCM accounts for approximately 14% of total adverse drug reaction (ADR) spontaneous reporting data in China. Because of the complexity of the components in TCM formula, which makes it essentially different from Western medicine, it is critical to determine whether ADR reports of TCM should be analyzed independently...
March 9, 2018: BMC Medical Informatics and Decision Making
Tareq Lewis Mukattash, Maysa Wadah Alwadi, Rana K Abu-Farha, Anan Jarab, Sameh A Alzubiedi, Tareq Alwedyan
INTRODUCTION: Parmacovigilance (PV) is the science that responsible for ADRs reporting and accordingly medication safety. Pediatrics age group is a special concern as they have a higher risk for developing ADRs; this put more burdens on pediatricians for early detection and reporting of ADRs. The present study aims to explore pediatricians' knowledge, attitude, and practices of pharmacovigilance. METHOD: A structured validated questionnaire was designed to achieve the study goals...
March 8, 2018: Current Clinical Pharmacology
Rodrigo Postigo, Sabine Brosch, Jim Slattery, Anja van Haren, Jean-Michel Dogné, Xavier Kurz, Gianmario Candore, Francois Domergue, Peter Arlett
The analysis of safety data from spontaneous reporting systems has a proven value for the detection and analysis of the risks of medicines following their placement on the market and use in medical practice. EudraVigilance is the pharmacovigilance database to manage the collection and analysis of suspected adverse reactions to medicines authorised in the European Economic Area. EudraVigilance first operated in December 2001, with access to the database being governed by the EudraVigilance access policy. We performed a literature search including data up to December 2016 to demonstrate how the data from EudraVigilance has been used in scientific publications...
March 9, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Pramod Kumar Sharma, Arup Kumar Misra, Neeraj Gupta, Daisy Khera, Ajay Gupta, Pushpinder Khera
OBJECTIVE: The objective of this study is to determine the nature and severity of adverse drug reactions (ADRs) in pediatric patients. MATERIALS AND METHODS: In this retrospective cohort study, we extracted the data from all the available pediatric ADR forms submitted to ADR monitoring center (AMC) from May 2014 to December 2016. The data including nature, frequency, causality (World Health Organization [WHO] causality scale), and the severity (Hartwig and Siegel scale for severity) of ADR were extracted...
September 2017: Indian Journal of Pharmacology
Vikas Maharshi, Pravesh Nagar
AIM: Different forms and online tools are available in different countries for spontaneous reporting, one of the most widely used methods of pharmacovigilance. Capturing sufficient information and adequate compatibility of online systems with respective reporting form is highly desirable for appropriate reporting of adverse drug reactions (ADRs). This study was aimed to compare three major online reporting systems (US, UK, and WHO) of the world and also to check their compatibility with the respective ADR reporting form...
September 2017: Indian Journal of Pharmacology
Magnhild Sandberg-Wollheim, Orit Neudorfer, Augusto Grinspan, Bianca Weinstock-Guttman, Judith Haas, Guillermo Izquierdo, Claire Riley, Amy Perrin Ross, Peleg Baruch, Talya Drillman, Patricia K Coyle
Background: Appropriate counseling and treatment for women with multiple sclerosis (MS) who may become pregnant requires an understanding of the effects of exposure to disease-modifying therapies (DMTs) during pregnancy. Current reports and studies are limited in their usefulness, mostly by small sample size. Branded glatiramer acetate (GA) is a DMT approved for the treatment of relapsing forms of MS. For more than 2 decades, it has been shown to be efficacious and to have a favorable safety profile...
January 2018: International Journal of MS Care
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