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

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https://www.readbyqxmd.com/read/28534236/the-new-phase-of-isop
#1
EDITORIAL
Sten Olsson, Ian C K Wong, Jean-Christophe Delumeau, Mira Harrison-Woolrych
No abstract text is available yet for this article.
May 22, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28528487/role-of-medicines-of-unknown-identity-in-adverse-drug-reaction-related-hospitalizations-in-developing-countries-evidence-from-a-cross-sectional-study-in-a-teaching-hospital-in-the-lao-people-s-democratic-republic
#2
Céline Caillet, Chanvilay Sichanh, Gaëtan Assemat, Myriam Malet-Martino, Agnès Sommet, Haleh Bagheri, Noudy Sengxeu, Niphonh Mongkhonmath, Mayfong Mayxay, Lamphone Syhakhang, Maryse Lapeyre-Mestre, Paul N Newton, Anne Roussin
INTRODUCTION: The health dangers of medicines of unknown identity (MUIs) [loose pharmaceutical units repackaged in individual bags without labelling of their identity] have been suspected in L/MICs. Using visual and analytical tools to identify MUIs, we investigated the frequency of, and factors associated with, adverse drug reaction (ADR)-related hospitalizations in a central hospital in Vientiane Capital, Lao People's Democratic Republic (PDR). METHODS: All unplanned admissions, except for acute trauma and intentional overdose, were prospectively recorded during a 7-week period in 2013, leading to include 453 adults hospitalized for ≥24 h...
May 20, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28508325/preliminary-results-of-a-novel-algorithmic-method-aiming-to-support-initial-causality-assessment-of-routine-pharmacovigilance-case-reports-for-medication-induced-liver-injury-the-pv-rucam
#3
Erik Scalfaro, Henk Johan Streefkerk, Michael Merz, Christoph Meier, David Lewis
INTRODUCTION: Data incompleteness in pharmacovigilance (PV) health records limits the use of current causality assessment methods for drug-induced liver injury (DILI). In addition to the inherent complexity of this adverse event, identifying cases of high causal probability is difficult. OBJECTIVE: The aim was to evaluate the performance of an improved, algorithmic and standardised method called the Pharmacovigilance-Roussel Uclaf Causality Assessment Method (PV-RUCAM), to support assessment of suspected DILI...
May 15, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28497250/people-s-understanding-of-verbal-risk-descriptors-in-patient-information-leaflets-a-cross-sectional-national-survey-of-18-to-65-year-olds-in-england
#4
Rebecca K Webster, John Weinman, G James Rubin
INTRODUCTION: Evidence suggests the current verbal risk descriptors used to communicate side effect risk in patient information leaflets (PILs) are overestimated. OBJECTIVES: The aim was to establish how people understand the verbal risk descriptors recommended for use in PILs by the European Commission (EC), and alternative verbal risk descriptors, in the context of mild and severe side effects. METHODS: A cross-sectional online survey was carried out by a market research company recruiting participants aged between 18 and 65 years living in England...
May 11, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28474287/evaluation-of-the-case-crossover-cco-study-design-for-adverse-drug-event-detection
#5
Zachary Burningham, Tao He, Chia-Chen Teng, Xi Zhou, Jonathan Nebeker, Brian C Sauer
INTRODUCTION: The case-crossover (CCO) design was originally intended to study exposures characterized as intermittent with acute effects. The performance of the CCO design is not well characterized under alternative exposure and outcome relationships. OBJECTIVE: The purpose of this study was to evaluate the ability of the CCO to identify simulated treatment effects under different drug exposures and outcomes relationships while varying the duration of the 1:1 matched risk and control windows...
May 4, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28455793/detecting-signals-of-disproportionate-reporting-from-singapore-s-spontaneous-adverse-event-reporting-system-an-application-of-the-sequential-probability-ratio-test
#6
Cheng Leng Chan, Sowmya Rudrappa, Pei San Ang, Shu Chuen Li, Stephen J W Evans
INTRODUCTION: The ability to detect safety concerns from spontaneous adverse drug reaction reports in a timely and efficient manner remains important in public health. OBJECTIVE: This paper explores the behaviour of the Sequential Probability Ratio Test (SPRT) and ability to detect signals of disproportionate reporting (SDRs) in the Singapore context. METHODS: We used SPRT with a combination of two hypothesised relative risks (hRRs) of 2 and 4...
April 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28439716/antipsychotic-prescribing-to-patients-diagnosed-with-dementia-without-a-diagnosis-of-psychosis-in-the-context-of-national-guidance-and-drug-safety-warnings-longitudinal-study-in-uk-general-practice
#7
S Jill Stocks, Evangelos Kontopantelis, Roger T Webb, Anthony J Avery, Alistair Burns, Darren M Ashcroft
INTRODUCTION: Policy interventions to address inappropriate prescribing of antipsychotic drugs to older people diagnosed with dementia are commonplace. In the UK, warnings were issued by the Medicines Healthcare products Regulatory Agency in 2004, 2009 and 2012 and the National Institute for Health and Care Excellence guidance was published in 2006. It is important to evaluate the impact of such interventions. METHODS: We analysed routinely collected primary-care data from 111,346 patients attending one of 689 general practices contributing to the Clinical Practice Research Datalink to describe the temporal changes in the prescribing of antipsychotic drugs to patients aged 65 years or over diagnosed with dementia without a concomitant psychosis diagnosis from 2001 to 2014 using an interrupted time series and a before-and-after design...
April 24, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28425072/comment-on-evaluation-of-facebook-and-twitter-monitoring-to-detect-safety-signals-for-medical-products-an-analysis-of-recent-fda-safety-alerts
#8
LETTER
Viroj Wiwanitkit
No abstract text is available yet for this article.
April 19, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28421551/macrolides-digoxin-toxicity-and-the-risk-of-sudden-death-a-population-based-study
#9
Kieran L Quinn, Erin M Macdonald, Tara Gomes, Muhammad M Mamdani, Anjie Huang, David N Juurlink
INTRODUCTION: Digoxin is commonly prescribed to elderly patients with heart failure and atrial fibrillation, and macrolide antibiotics markedly increase the risk of digoxin toxicity. OBJECTIVE: The aim was to determine whether, in older patients receiving digoxin, macrolide antibiotics are associated with sudden death. METHODS: We used a population-based, nested, case-control design from January 1, 1994 to December 31, 2012 in a cohort of Ontario residents aged 66 years or older prescribed digoxin...
April 18, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28417321/adjuvanted-as03-a-h1n1-2009-pandemic-influenza-vaccines-and-solid-organ-transplant-rejection-systematic-signal-evaluation-and-lessons-learnt
#10
Gaël Dos Santos, Harry A Seifert, Vincent Bauchau, Vivek Shinde, Dominique M Barbeau, Catherine Cohet
INTRODUCTION: We investigated a signal of solid organ transplant (SOT) rejection after immunisation with (AS03) A/H1N1 2009 pandemic influenza vaccines. METHODS: Potential immunological mechanisms were reviewed and quantitative analyses were conducted. The feasibility of pharmacoepidemiological studies was explored. RESULTS: Overall results, including data from a pharmacoepidemiological study, support the safety of adjuvanted (AS03) pandemic influenza vaccination in SOT recipients...
April 17, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28417320/patient-reporting-in-the-eu-analysis-of-eudravigilance-data
#11
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/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/28397186/managing-cardiovascular-risk-of-macrolides-systematic-review-and-meta-analysis
#13
REVIEW
Angel Y S Wong, Esther W Chan, Shweta Anand, Alan J Worsley, Ian C K Wong
INTRODUCTION: It was postulated that antibiotics including macrolides could be used for the secondary prevention of coronary heart disease but recent studies showed that macrolides increase the cardiovascular risk. We aimed to review the evidence of cardiovascular risk associated with macrolides regarding duration of effect and risk factors; and to explore the potential effect of statins for the prevention of cardiovascular events as a result of macrolide use. METHODS: Several electronic databases (PubMed, EMBASE, Cochrane library) were searched to identify eligible studies...
April 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28389980/drug-induced-arrhythmia-bridging-the-gap-between-pathophysiological-knowledge-and-clinical-practice
#14
LETTER
Elisabetta Poluzzi, Emanuel Raschi, Igor Diemberger, Fabrizio De Ponti
No abstract text is available yet for this article.
April 8, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28389979/species-adulteration-in-the-herbal-trade-causes-consequences-and-mitigation
#15
REVIEW
Ramanujam Srirama, J U Santhosh Kumar, G S Seethapathy, Steven G Newmaster, S Ragupathy, K N Ganeshaiah, R Uma Shaanker, Gudasalamani Ravikanth
The global economy of the international trade of herbal products has been increasing by 15% annually, with the raw material for most herbal products being sourced from South and Southeast Asian countries. In India, of the 8000 species of medicinal plants harvested from the wild, approximately 960 are in the active trade. With increasing international trade in herbal medicinal products, there is also increasing concern about the widespread adulteration and species admixtures in the raw herbal trade. The adverse consequences of such species adulteration on the health and safety of consumers have only recently begun to be recognised and documented...
April 8, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28382494/adverse-drug-reaction-related-hospitalizations-in-elderly-australians-a-prospective-cross-sectional-study-in-two-tasmanian-hospitals
#16
Nibu Parameswaran Nair, Leanne Chalmers, Bonnie J Bereznicki, Colin Curtain, Gregory M Peterson, Michael Connolly, Luke R Bereznicki
INTRODUCTION: Adverse drug reactions (ADRs) have been commonly cited as a major cause of hospital admissions in older individuals. However, despite the apparent magnitude of this problem, there are limited prospective data on ADRs as a cause of hospitalization in elderly medical patients. OBJECTIVES: The objective of this study was to evaluate the proportion, clinical characteristics, causality, severity, preventability, and outcome of ADR-related admissions in older patients admitted to two Tasmanian hospitals...
April 6, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28382493/drospirenone-containing-oral-contraceptive-pills-and-the-risk-of-venous-thromboembolism-an-assessment-of-risk-in-first-time-users-and-restarters
#17
Natasha Larivée, Samy Suissa, Janie Coulombe, Vicky Tagalakis, Kristian B Filion
INTRODUCTION: The effects of drospirenone-containing combined oral contraceptives (COCs) on the risk of venous thromboembolism (VTE) remain controversial due to the challenge in distinguishing between first-time users and restarters, and their different underlying VTE risks, in healthcare databases. OBJECTIVES: The aim of this study was to describe the challenge of studying the risk of VTE among first-time users of drospirenone-containing COCs in a healthcare database and assess the risk among first-time users and restarters...
April 5, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28361405/impact-of-safety-related-regulations-on-codeine-use-in-children-a-quasi-experimental-study-using-taiwan-s-national-health-insurance-research-database
#18
Chih-Wan Lin, Ching-Huan Wang, Wei-I Huang, Wei-Ming Ke, Pi-Hui Chao, Wen-Wen Chen, Fei-Yuan Hsiao
INTRODUCTION: Safety concerns regarding potential life-threatening adverse events associated with codeine have resulted in policy decisions to restrict its use in pediatrics. However, whether these drug safety communications have had an immediate and strong impact on codeine use remains in question. OBJECTIVE: We aimed to investigate the impact of the two implemented safety-related regulations (label changes and reimbursement regulations) on the use of codeine for upper respiratory infection (URI) or cough...
March 30, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28342075/evaluation-of-pre-marketing-factors-to-predict-post-marketing-boxed-warnings-and-safety-withdrawals
#19
Andreas Schick, Kathleen L Miller, Michael Lanthier, Gerald Dal Pan, Clark Nardinelli
INTRODUCTION: An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions...
March 24, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28342074/evaluation-of-saefvic-a-pharmacovigilance-surveillance-scheme-for-the-spontaneous-reporting-of-adverse-events-following-immunisation-in-victoria-australia
#20
Hazel J Clothier, Nigel W Crawford, Melissa Russell, Heath Kelly, Jim P Buttery
INTRODUCTION: Australia is traditionally an early adopter of vaccines, therefore comprehensive and effective post-licensure vaccine pharmacovigilance is critical to maintain confidence in immunisation, both nationally and internationally. With adverse event following immunisation (AEFI) surveillance the responsibility of Australian jurisdictions, Victoria operates an enhanced passive AEFI surveillance system integrated with clinical services, called 'SAEFVIC' (Surveillance of Adverse Events Following Vaccination In the Community)...
March 24, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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