journal
MENU ▼
Read by QxMD icon Read
search

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

journal
https://read.qxmd.com/read/31410745/prevalence-and-nature-of-medication-errors-and-preventable-adverse-drug-events-in-paediatric-and-neonatal-intensive-care-settings-a-systematic-review
#1
REVIEW
Anwar A Alghamdi, Richard N Keers, Adam Sutherland, Darren M Ashcroft
INTRODUCTION: Children admitted to paediatric and neonatal intensive care units may be at high risk from medication errors and preventable adverse drug events. OBJECTIVE: The objective of this systematic review was to review empirical studies examining the prevalence and nature of medication errors and preventable adverse drug events in paediatric and neonatal intensive care units. DATA SOURCES: Seven electronic databases were searched between January 2000 and March 2019...
August 13, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31372935/the-association-between-metformin-therapy-and-lactic-acidosis
#2
Isabelle H S Kuan, Ruth L Savage, Stephen B Duffull, Robert J Walker, Daniel F B Wright
INTRODUCTION AND OBJECTIVES: There is increasing evidence to suggest that therapeutic doses of metformin are unlikely to cause lactic acidosis. The aims of this research were (1) to formally evaluate the association between metformin therapy and lactic acidosis in published case reports using two causality scoring systems, (2) to determine the frequency of pre-existing independent risk factors in published metformin-associated lactic acidosis cases, (3) to investigate the association between risk factors and mortality in metformin-associated lactic acidosis cases, and (4) to explore the relationship between prescribed metformin doses, elevated metformin plasma concentrations and the development of lactic acidosis in cases with chronic renal impairment...
August 1, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31368080/a-novel-approach-to-visualize-risk-minimization-effectiveness-peeping-at-the-2012-uk-proton-pump-inhibitor-label-change-using-a-rapid-cycle-analysis-tool
#3
Rachel E Sobel, William Blackwell, David M Fram, Andrew Bate
INTRODUCTION: Evaluation of risk minimization (RM) actions is an emerging area of regulatory science, often without tools to rapidly and systematically assess their effectiveness. PURPOSE: The aim of this study was to evaluate whether chronographs, typically used for rapid signal detection in observational longitudinal databases, could be used to visualize RM effectiveness. We evaluated the UK Medicines and Healthcare products Regulatory Agency (MHRA) 2012 proton-pump inhibitors (PPIs) class-wide label change that warned of increased risk of bone fracture, advocated to limit duration of use, and recommended to treat those at risk for osteoporosis according to clinical guidelines...
July 31, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31321714/non-vitamin-k-antagonist-oral-anticoagulants-and-angioedema-a-cohort-and-case-crossover-study
#4
John G Connolly, Sebastian Schneeweiss, Robert J Glynn, Joshua J Gagne
INTRODUCTION: Patients taking non-vitamin K antagonist oral anticoagulants (NOACs) such as dabigatran, rivaroxaban, and apixaban have reported experiencing angioedema in randomized trials and routine care. OBJECTIVE: The aim of this study was to quantify the association between NOACs and angioedema relative to warfarin among routinely treated patients with atrial fibrillation in a cohort study. We also compared warfarin users with non-users in a case-crossover study...
July 18, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31302896/patient-registries-an-underused-resource-for-medicines-evaluation-operational-proposals-for-increasing-the-use-of-patient-registries-in-regulatory-assessments
#5
Patricia McGettigan, Carla Alonso Olmo, Kelly Plueschke, Mireia Castillon, Daniel Nogueras Zondag, Priya Bahri, Xavier Kurz, Peter G M Mol
INTRODUCTION: Patient registries, 'organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition, or exposure, and that is followed over time', are potentially valuable sources of data for supporting regulatory decision-making, especially for products to treat rare diseases. Nevertheless, patient registries are greatly underused in regulatory assessments. Reasons include heterogeneity in registry design and in the data collected, even across registries for the same disease, as well as unreliable data quality and data sharing impediments...
July 13, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31302895/multimodal-analysis-of-fda-drug-safety-communications-lessons-from-zolpidem
#6
Aaron S Kesselheim, Michael S Sinha, Eric G Campbell, Sebastian Schneeweiss, Paula Rausch, Brian M Lappin, Esther H Zhou, Jerry Avorn, Gerald J Dal Pan
Because clinical trials conducted for US Food and Drug Administration (FDA) approval occur in carefully monitored settings and often have strict inclusion criteria for participation, new information about drug safety is commonly discovered once a medication is FDA approved and used by larger numbers of patients. The FDA issues Drug Safety Communications when new information arises about the safety of marketed drugs that may change decision making by healthcare providers and patients. Since their inception, over 250 Drug Safety Communications have been issued alerting consumers and prescribers in the USA about safety risks related to prescription and over-the-counter medications...
July 13, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31290127/prevalence-of-medication-errors-among-paediatric-inpatients-systematic-review-and-meta-analysis
#7
REVIEW
Peter J Gates, Melissa T Baysari, Madlen Gazarian, Magdalena Z Raban, Sophie Meyerson, Johanna I Westbrook
INTRODUCTION: The risk of medication errors is high in paediatric inpatient settings. However, estimates of the prevalence of medication errors have not accounted for heterogeneity across studies in error identification methods and definitions, nor contextual differences across wards and the use of electronic or paper medication charts. OBJECTIVE: Our aim was to conduct a systematic review and meta-analysis to provide separate estimates of the prevalence of medication errors among paediatric inpatients, depending on hospital ward and the use of electronic or paper medication charts, that address differences in error identification methods and definitions...
July 9, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31240688/evaluating-renal-stress-using-pharmacokinetic-urinary-biomarker-data-in-critically-ill-patients-receiving-vancomycin-and-or-piperacillin-tazobactam-a-secondary-analysis-of-the-multicenter-sapphire-study
#8
Sandra L Kane-Gill, Marlies Ostermann, Jing Shi, Emily L Joyce, John A Kellum
INTRODUCTION: A drug combination that has gained recent attention for an additive risk of nephrotoxicity is vancomycin plus piperacillin-tazobactam. Clinicians need to better understand whether tubular cell stress occurs with piperacillin-tazobactam administration to establish whether renal injury associated with this combination is a valid clinical concern. OBJECTIVE: An evaluation of the pharmacokinetics of urinary tissue inhibitor of metalloproteinase-2 (TIMP-2) and insulin-like growth factor binding-protein 7 (IGFBP7) for patients receiving vancomycin alone, piperacillin-tazobactam alone, and vancomycin plus piperacillin-tazobactam in combination was conducted to understand the impact on acute kidney cell stress and compare the rates of dialysis or death at 9 months among these three drug exposure types...
June 25, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31240687/androgen-deprivation-therapy-for-prostate-cancer-and-the-risk-of-rheumatoid-arthritis-a-population-based-cohort-study
#9
Adi J Klil-Drori, Christina Santella, Koray Tascilar, Hui Yin, Armen Aprikian, Laurent Azoulay
INTRODUCTION: Two recent observational studies have investigated the association between androgen deprivation therapy (ADT) and rheumatoid arthritis (RA), but generated discrepant findings and had important methodological limitations. Thus, the objective of this study was to determine whether the use of ADT is associated with an increased risk of RA in men with prostate cancer. PATIENTS AND METHODS: We conducted a population-based cohort study using the United Kingdom Clinical Practice Research Datalink...
June 25, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31228010/effectiveness-and-safety-of-switching-originator-and-biosimilar-epoetins-in-patients-with-chronic-kidney-disease-in-a-large-scale-italian-cohort-study
#10
Valeria Belleudi, Francesco Trotta, Antonio Addis, Ylenia Ingrasciotta, Valentina Ientile, Michele Tari, Rosa Gini, Maurizio Pastorello, Salvatore Scondotto, Pasquale Cananzi, Giuseppe Traversa, Marina Davoli, Gianluca Trifirò
INTRODUCTION: Real-world data on the comparative effectiveness and safety of switching among different epoetins (including originators and biosimilars) are limited. In light of current debate about interchangeability, prescribers, some patient groups and decision makers are calling for additional post-marketing evidence on the clinical effects of switching between originator and biosimilar epoetins in chronic kidney disease (CKD) patients. OBJECTIVE: The objective of this study was to evaluate the effectiveness and safety of switching versus non-switching and of switching from originator/biosimilar epoetin alpha (ESA α) to any other epoetin in CKD patients...
June 21, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31197746/intravenous-infusion-administration-a-comparative-study-of-practices-and-errors-between-the-united-states-and-england-and-their-implications-for-patient-safety
#11
Ann Blandford, Patricia C Dykes, Bryony Dean Franklin, Dominic Furniss, Galal H Galal-Edeen, Kumiko O Schnock, David W Bates
INTRODUCTION: Intravenous medication administration is widely reported to be error prone. Technologies such as smart pumps have been introduced with a view to reducing these errors. An international comparison could provide evidence of their effectiveness, including consideration of contextual factors such as regulatory systems and local cultures. OBJECTIVES: The aim of this study was to investigate similarities and differences in practices and error types involving intravenous medication administration in the United States and England, and summarise methodological differences necessary to perform these parallel studies...
June 13, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31190237/pooling-different-safety-data-sources-impact-of-combining-solicited-and-spontaneous-reports-on-signal-detection-in-pharmacovigilance
#12
Jeremy D Jokinen, Rosalind J Walley, Michael W Colopy, Thomas S Hilzinger, Peter Verdru
INTRODUCTION: The volume of adverse events (AEs) collected, analysed, and reported has been increasing at a rapid rate for over the past 10 years, largely due to the growth of solicited programmes. The proportion of various forms of solicited case data has evolved over time, with the main relative volume increase coming from Patient Support Programmes. In this study, we sought to examine the impact of the pooling of AE report data from solicited sources with data from spontaneous sources to safety signal detection using disproportionality analysis methods...
June 12, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31187437/randomized-placebo-controlled-trial-evaluating-the-ophthalmic-safety-of-single-dose-tafenoquine-in-healthy-volunteers
#13
Jessica Ackert, Khadeeja Mohamed, Jason S Slakter, Sherif El-Harazi, Alessandro Berni, Hakop Gevorkyan, Elizabeth Hardaker, Azra Hussaini, Siôn W Jones, Gavin C K W Koh, Jyoti Patel, Scott Rasmussen, Deborah S Kelly, David E Barañano, John T Thompson, Keith A Warren, Robert C Sergott, John Tonkyn, Allen Wolstenholme, Hanna Coleman, Alex Yuan, Stephan Duparc, Justin A Green
INTRODUCTION: Tafenoquine has been recently registered for the prevention of relapse in Plasmodium vivax malaria. OBJECTIVE: This study assessed the pharmacodynamic effects of 300-mg single-dose tafenoquine on the retina. METHODS: This phase I, prospective, multicenter, randomized, single-masked, placebo-controlled, parallel-group study was conducted between 2 February 2016 and 14 September 2017 at three US study centers. Adult healthy volunteers were randomized (2:1) to receive either a single 300-mg oral dose of tafenoquine or matched placebo on day 1...
June 11, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31175610/comparative-effectiveness-and-safety-of-direct-oral-anticoagulants-in-patients-with-atrial-fibrillation-a-systematic-review-and-meta-analysis-of-observational-studies
#14
REVIEW
Antonios Douros, Madeleine Durand, Carla M Doyle, Sarah Yoon, Pauline Reynier, Kristian B Filion
BACKGROUND: There are no head-to-head randomized controlled trials comparing different direct oral anticoagulants (DOACs). Thus, we systematically reviewed and meta-analyzed observational studies assessing the comparative effectiveness and safety of DOACs for stroke prevention in patients with atrial fibrillation (AF). METHODS: We systematically searched MEDLINE and EMBASE up to February 2019 for observational studies comparing different DOACs head-to-head in patients with AF...
June 7, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31168709/prevalence-safety-and-long-term-retention-rates-of-biologics-in-hong-kong-from-2001-to-2015
#15
Mengqin Ge, Kenneth K Man, Celine S Chui, Esther W Chan, Ian C Wong, Xue Li
BACKGROUND: Biologic agents were initially introduced as treatment for rheumatoid arthritis (RA) but have since been used for other medical conditions. As new biologics become increasingly widespread in treatment regimens, it is important to understand their safety and utilization in the post-marketing context. PURPOSE: The aim of this study was to investigate long-term prescribing patterns and the safety of biologics in real clinical settings in Hong Kong. METHODS: This was a population-based drug utilization study in Hong Kong using a territory-wide electronic medical database Clinical Data Analysis and Reporting System (CDARS)...
June 5, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31165430/antidepressants-and-the-risk-of-hemorrhagic-stroke-in-the-elderly-a-nested-case-control-study
#16
Wiebke Schäfer, Christina Princk, Bianca Kollhorst, Tania Schink
BACKGROUND AND PURPOSE: Selective serotonin reuptake inhibitors (SSRIs) are frequently prescribed in the elderly due to a more favorable risk profile than other antidepressants (ADs). However, SSRIs are associated with an increased risk of gastrointestinal bleeding, while evidence on the risk of hemorrhagic stroke (HS) is limited. Therefore, we compared the risk of HS associated with the use of ADs in the elderly. METHODS: Based on data from the German Pharmacoepidemiological Research Database (GePaRD), a case-control study matched on age, sex, and health insurance provider, nested in a cohort of incident users of ADs ≥ 65 years of age was performed...
June 4, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31152320/unintended-effects-of-communicating-about-drug-safety-issues-a-critical-review-of-the-literature
#17
Jessica T DeFrank, Lauren McCormack, Suzanne L West, Craig Lefebvre, Olivia Burrus
Communications about the safety and effectiveness of human drugs can influence patients' and prescribers' perceptions and behaviors, which in turn can affect the public's health more broadly. We conducted a critical review of the literature on the unintended effects from communicating information to the public about safety issues with prescription and over-the-counter drugs. We searched PubMed for peer-reviewed studies published from 1990 to 2017 where study authors reported probable unintended effects of communicating drug safety...
May 31, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31134513/study-design-and-cohort-comparability-in-a-study-of-major-cardiovascular-events-in-new-users-of-prucalopride-versus-polyethylene-glycol-3350
#18
Joan Fortuny, Alicia Gilsenan, Miguel Cainzos-Achirica, Oscar F Cantero, Robert W V Flynn, Luis Garcia-Rodriguez, Bianca Kollhorst, Pär Karlsson, Love Linnér, Thomas M MacDonald, Estel Plana, Ana Ruigómez, Tania Schink, Ryan Ziemiecki, Elizabeth B Andrews
INTRODUCTION: Given prior safety experience with other 5-HT4 agonists for chronic constipation, an observational, population-based cohort study in five data sources from Germany, Sweden, and the UK was conducted to evaluate the cardiovascular safety of prucalopride. OBJECTIVES: Our objective is to describe the methods and resulting comparability of cohorts in a multi-database, multinational study of prucalopride initiators and polyethylene glycol 3350 (PEG) initiators following a harmonized protocol...
May 27, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31134512/cardiovascular-safety-of-prucalopride-in-patients-with-chronic-constipation-a-multinational-population-based-cohort-study
#19
Alicia Gilsenan, Joan Fortuny, Miguel Cainzos-Achirica, Oscar F Cantero, Robert W V Flynn, Luis Garcia-Rodriguez, Abenah Harding, Bianca Kollhorst, Pär Karlsson, Love Linnér, Thomas M MacDonald, Ingvild Odsbu, Estel Plana, Ana Ruigómez, Tania Schink, Ryan Ziemiecki, Elizabeth B Andrews
INTRODUCTION: The serotonin 5-HT4 receptor agonist prucalopride is approved in the European Union for the treatment of chronic constipation. This offered the unique opportunity to include real-world observational data on cardiovascular safety in the new drug application for approval of prucalopride in the USA. METHODS: This observational population-based cohort study (EUPAS9200) conducted in five data sources (three in the UK, one in Sweden, and one in Germany [which was subsequently excluded from the pooled analyses]) aimed to estimate the pooled adjusted incidence rate ratio for major adverse cardiovascular events (defined as hospitalization for non-fatal acute myocardial infarction or stroke, and in-hospital cardiovascular death) in adult initiators of prucalopride compared with initiators of polyethylene glycol 3350 (PEG) following a common protocol...
May 27, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31123940/enabling-data-driven-clinical-quality-assurance-predicting-adverse-event-reporting-in-clinical-trials-using-machine-learning
#20
Timothé Ménard, Yves Barmaz, Björn Koneswarakantha, Rich Bowling, Leszek Popko
INTRODUCTION: Adverse event (AE) under-reporting has been a recurrent issue raised during health authorities Good Clinical Practices (GCP) inspections and audits. Moreover, safety under-reporting poses a risk to patient safety and data integrity. The current clinical Quality Assurance (QA) practices used to detect AE under-reporting rely heavily on investigator site and study audits. Yet several sponsors and institutions have had repeated findings related to safety reporting, and this has led to delays in regulatory submissions...
May 23, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
journal
journal
30373
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"