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Drug Safety: An International Journal of Medical Toxicology and Drug Experience

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https://www.readbyqxmd.com/read/28815462/a-new-erice-report-considering-the-safety-of-medicines-in-the-21st-century
#1
Ivor Ralph Edwards
Pharmacovogilance policy, methods and practice require transformation at all levels to create an integrated, comprehensive, continuously improving system, fulfilling the broader remit of overall healthcare vigilance. In pursuit of this vision, energetic measures, including active engagement with patients, are needed to reduce our ignorance about many aspects of patients' experience of medical therapies and their outcomes, including the benefits, but especially the extensive harm known to be caused by medical interventions...
August 17, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28815480/evaluation-of-electronic-healthcare-databases-for-post-marketing-drug-safety-surveillance-and-pharmacoepidemiology-in-china
#2
Yu Yang, Xiaofeng Zhou, Shuangqing Gao, Hongbo Lin, Yanming Xie, Yuji Feng, Kui Huang, Siyan Zhan
INTRODUCTION: Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. METHODS: Three major types of EHDs in China (i.e., a regional community-based database, a national claims database, and an electronic medical records [EMR] database) were selected for evaluation. Forty core variables were derived based on the US Mini-Sentinel (MS) Common Data Model (CDM) as well as the data features in China that would be desirable to support drug safety surveillance...
August 16, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28808959/deaths-from-medicines-a-systematic-analysis-of-coroners-reports-to-prevent-future-deaths
#3
Robin E Ferner, Craig Easton, Anthony R Cox
INTRODUCTION: Since legislation in 2009, coroners in England and Wales must make reports in cases where they believe it is possible to prevent future deaths. We categorised the reports and examined whether they could reveal preventable medication errors or novel adverse drug reactions. METHODS: We examined 500 coroners' reports by pre-defined criteria to identify those in which medicines played a part, and to collect information on coroners' concerns. RESULTS: We identified 99 reports (100 deaths) in which medicines or a part of the medication process or both were mentioned...
August 14, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28795368/the-9th-biennial-conference-on-signal-detection-and-interpretation-in-pharmacovigilance
#4
Vicki Osborne, Saad A W Shakir
No abstract text is available yet for this article.
August 9, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28786036/pharmacovigilance-using-textual-data-the-need-to-go-deeper-and-wider-into-the-con-text
#5
LETTER
Tavpritesh Sethi, Nigam H Shah
No abstract text is available yet for this article.
August 8, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28786035/cardiac-harms-of-sofosbuvir-systematic-review-and-meta-analysis
#6
REVIEW
Daniel Caldeira, Filipe B Rodrigues, Marta M Duarte, Carmelo Sterrantino, Márcio Barra, Nilza Gonçalves, Fausto J Pinto, Joaquim J Ferreira, João Costa
INTRODUCTION: Sofosbuvir is a new direct-acting pyrimidine nucleotide analogue antiviral drug that has shown remarkable efficacy in the treatment of hepatitis C in clinical trials. However, observational anecdotal data have recently suggested an increased risk of serious bradycardia among patients treated with sofosbuvir and amiodarone. OBJECTIVE: We aimed to estimate and characterize the cardiac safety of sofosbuvir by performing a systematic review of randomized controlled trials (RCTs)...
August 7, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28780741/channeling-in-the-use-of-nonprescription-paracetamol-and-ibuprofen-in-an-electronic-medical-records-database-evidence-and-implications
#7
Rachel B Weinstein, Patrick Ryan, Jesse A Berlin, Amy Matcho, Martijn Schuemie, Joel Swerdel, Kayur Patel, Daniel Fife
INTRODUCTION: Over-the-counter analgesics such as paracetamol and ibuprofen are among the most widely used, and having a good understanding of their safety profile is important to public health. Prior observational studies estimating the risks associated with paracetamol use acknowledge the inherent limitations of these studies. One threat to the validity of observational studies is channeling bias, i.e. the notion that patients are systematically exposed to one drug or the other, based on current and past comorbidities, in a manner that affects estimated relative risk...
August 5, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28776179/frequency-and-nature-of-medication-errors-and-adverse-drug-events-in-mental-health-hospitals-a-systematic-review
#8
REVIEW
Ghadah H Alshehri, Richard N Keers, Darren M Ashcroft
INTRODUCTION: Little is known about the frequency and nature of medication errors (MEs) and adverse drug events (ADEs) that occur in mental health hospitals. OBJECTIVES: This systematic review aims to provide an up-to-date and critical appraisal of the epidemiology and nature of MEs and ADEs in this setting. METHOD: Ten electronic databases were searched, including MEDLINE, Embase, CINAHL, International Pharmaceutical Abstracts, PsycINFO, Scopus, British Nursing Index, ASSIA, Web of Science, and Cochrane Database of Systematic Reviews (1999 to October 2016)...
August 3, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28770534/antidepressant-induced-acute-liver-injury-a-case-control-study-in-an-italian-inpatient-population
#9
Carmen Ferrajolo, Cristina Scavone, Monia Donati, Oscar Bortolami, Giovanna Stoppa, Domenico Motola, Alfredo Vannacci, Alessandro Mugelli, Roberto Leone, Annalisa Capuano
INTRODUCTION: Pre-marketing clinical trials show that antidepressant-induced liver injury seems to be a rare adverse event. Because of short follow-up trial duration, the incidence of liver injury due to antidepressant use could be underestimated. OBJECTIVES: We aimed to quantify the risk of acute liver injury associated with antidepressant use through a case-control analysis among an inpatient population. METHODS: A multicenter study was carried out in nine Italian hospitals from October 2010 to January 2014, within the DILI-IT (Drug-Induced Liver Injury in Italy) study project...
August 2, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28766109/treatment-of-medication-related-osteonecrosis-of-the-jaw-and-its-impact-on-a-patient-s-quality-of-life-a-single-center-10-year-experience-from-southern-italy
#10
Giacomo Oteri, Gianluca Trifirò, Matteo Peditto, Loredana Lo Presti, Ilaria Marcianò, Francesco Giorgianni, Janet Sultana, Antonia Marcianò
INTRODUCTION: No official guidelines are available for the management of medication-related osteonecrosis of the jaw (MR-ONJ). The additional benefit of surgery after pharmacological treatment is debated by both clinicians and patients. OBJECTIVE: The aim of this study was to evaluate the changes in patients' MR-ONJ-related quality of life (QoL) after pharmacological treatment with or without surgery in a large cohort affected by MR-ONJ. METHODS: Anonymized data on patients diagnosed with MR-ONJ were extracted from the database of the Osteonecrosis of the Jaw Treatment Center (University of Messina, Italy) in the years 2005-2015...
August 1, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28766108/a-pharmacoepidemiology-database-system-for-monitoring-risk-due-to-the-use-of-medicines-by-new-zealand-primary-care-patients
#11
Andrew M Tomlin, David M Reith, David J Woods, Hywel S Lloyd, Alesha Smith, John S Fountain, Murray W Tilyard
INTRODUCTION: The use of large record-linked healthcare databases for drug safety research and surveillance is now accepted practice. New Zealand's standardized national healthcare datasets provide the potential to automate the conduct of pharmacoepidemiological studies to provide rapid validation of medicine safety signals. OBJECTIVES: Our objectives were to describe the methodology undertaken by a semi-automated computer system developed to rapidly assess risk due to drug exposure in New Zealand's population of primary care patients and to compare results from three studies with previously published findings...
August 1, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28755095/neurological-adverse-effects-attributable-to-%C3%AE-lactam-antibiotics-a-literature-review
#12
REVIEW
Samuel Deshayes, Antoine Coquerel, Renaud Verdon
β-lactam antibiotics are commonly prescribed antibiotic drugs. To describe the clinical characteristics, risk markers and outcomes of β-lactam antibiotic-induced neurological adverse effects, we performed a general literature review to provide updated clinical data about the most used β-lactam antibiotics. For selected drugs in each class available in France (ticarcillin, piperacillin, temocillin, ceftazidime, cefepime, cefpirome, ceftaroline, ceftobiprole, ceftolozane, ertapenem and aztreonam), a systematic literature review was performed up to April 2016 via an electronic search on PubMed...
July 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28752473/safety-profile-of-eslicarbazepine-acetate-as-add-on-therapy-in-adults-with-refractory-focal-onset-seizures-from-clinical-studies-to-6-years-of-post-marketing-experience
#13
Helena Gama, Mariana Vieira, Raquel Costa, Joana Graça, Luís M Magalhães, Patrício Soares-da-Silva
INTRODUCTION: Eslicarbazepine acetate was first approved in the European Union in 2009 as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization. OBJECTIVE: The objective of this study was to review the safety profile of eslicarbazepine acetate analyzing the data from several clinical studies to 6 years of post-marketing surveillance. METHODS: We used a post-hoc pooled safety analysis of four phase III, double-blind, randomized, placebo-controlled studies (BIA-2093-301, -302, -303, -304) of eslicarbazepine acetate as add-on therapy in adults...
July 27, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28748367/commercial-online-social-network-data-and-statin-side-effect-surveillance-a-pilot-observational-study-of-aggregate-mentions-on-facebook
#14
Marco D Huesch
INTRODUCTION: Surveillance of the safety of prescribed drugs after marketing approval has been secured remains fraught with complications. Formal ascertainment by providers and reporting to adverse-event registries, formal surveys by manufacturers, and mining of electronic medical records are all well-known approaches with varying degrees of difficulty, cost, and success. Novel approaches may be a useful adjunct, especially approaches that mine or sample internet-based methods such as online social networks...
July 26, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28744845/drug-induced-dental-caries-a-disproportionality-analysis-using-data-from-vigibase
#15
Emilie Patras de Campaigno, Inès Kebir, Jean-Louis Montastruc, Manuela Rueter, Delphine Maret, Maryse Lapeyre-Mestre, Brigitte Sallerin, Fabien Despas
INTRODUCTION: Dental caries is defined as a pathological breakdown of the tooth. It is an infectious phenomenon involving a multifactorial aetiology. The impact of drugs on cariogenic risk has been poorly investigated. OBJECTIVES: In this study, we identified drugs suspected to induce dental caries as adverse drug reactions (ADRs) and then studied a possible pathogenic mechanism for each drug that had a statistically significant disproportionality. METHODS: We extracted individual case safety reports of dental caries associated with drugs from VigiBase(®) (the World Health Organization global individual case safety report database)...
July 25, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28744844/suspected-adverse-effects-after-human-papillomavirus-vaccination-a-temporal-relationship-between-vaccine-administration-and-the-appearance-of-symptoms-in-japan
#16
Kazuki Ozawa, Akiyo Hineno, Tomomi Kinoshita, Sakiko Ishihara, Shu-Ichi Ikeda
INTRODUCTION: In Japan, after receiving human papillomavirus vaccination, a significant number of adolescent girls experienced various symptoms, the vast majority of which have been ascribed to chronic regional pain syndrome, orthostatic intolerance, and/or cognitive dysfunction. However, a causal link has not been established between human papillomavirus vaccination and the development of these symptoms. OBJECTIVE: The aim of this study was to clarify the temporal relationship between human papillomavirus vaccination and the appearance of post-vaccination symptoms...
July 25, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28735357/promoting-and-protecting-public-health-how-the-european-union-pharmacovigilance-system-works
#17
Aniello Santoro, Georgy Genov, Almath Spooner, June Raine, Peter Arlett
This article provides an overview of the European Union pharmacovigilance system resulting from the rationalisation and strengthening delivered through the implementation of the revised pharmacovigilance legislation. It outlines the system aims, underlying principles, components and drivers for future change. At its core, the Pharmacovigilance Risk Assessment Committee is responsible for assessing all aspects of the risk management of medicinal products, thus ensuring that medicines approved for the European Union market are optimally used by maximising their benefits and minimising risks...
July 22, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28733971/the-fetal-safety-of-enoxaparin-use-during-pregnancy-a-population-based-retrospective-cohort-study
#18
Meital Shlomo, Rafael Gorodischer, Sharon Daniel, Arnon Wiznitzer, Ilan Matok, Boris Fishman, Gideon Koren, Amalia Levy
INTRODUCTION: Enoxaparin is widely used during pregnancy as pregnancy is a hypercoagulable state; however, its fetal safety has scarcely been investigated. OBJECTIVE: Our study aimed to examine fetal safety following enoxaparin exposure during pregnancy. METHODS: A population-based, retrospective cohort study was performed by linking computerized databases, including the drug dispensing registries of Clalit Health Services in Israel and maternal and infant hospital records, between 1998 and 2009...
July 21, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28702803/brian-a-baldo-safety-of-biologics-therapy-monoclonal-antibodies-cytokines-fusion-proteins-hormones-enzymes-coagulation-proteins-vaccines-botulinum-toxins-1st-edition-springer-2016-print-book-isbn-978-3-319-30470-0-e-book-isbn-978-3-319-30472-4
#19
https://www.readbyqxmd.com/read/28698988/medication-errors-a-characterisation-of-spontaneously-reported-cases-in-eudravigilance
#20
Victoria Newbould, Steven Le Meur, Thomas Goedecke, Xavier Kurz
INTRODUCTION: Medication errors recently became the focus of regulatory guidance in pharmacovigilance to support reporting, evaluation and prevention of medication errors. OBJECTIVE: This study aims to characterise spontaneously reported cases of medication errors in EudraVigilance over the period 2002-2015 before the release of EU good practice guidance. METHODS: Case reports were identified through the adverse reaction section where a Medical Dictionary for Regulatory Activities (MedDRA(®)) term is reported and included in the Standardised MedDRA(®) Query (SMQ) for medication errors...
July 11, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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