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

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https://read.qxmd.com/read/31119651/auto-generated-physiological-chain-data-for-an-ontological-framework-for-pharmacology-and-mechanism-of-action-to-determine-suspected-drugs-in-cases-of-dysuria
#1
Masayo Hayakawa, Takeshi Imai, Yoshimasa Kawazoe, Kouji Kozaki, Kazuhiko Ohe
INTRODUCTION: Patients often take several different medications for multiple conditions concurrently. Therefore, when adverse drug events (ADEs) occur, it is necessary to consider the mechanisms responsible. Few approaches consider the mechanisms of ADEs, such as changes in physiological states. We proposed that the ontological framework for pharmacology and mechanism of action (pharmacodynamics) we developed could be used for this approach. However, the existing knowledge base contains little data on physiological chains (PCs)...
May 22, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31111340/evaluation-of-use-of-technologies-to-facilitate-medical-chart-review
#2
Loreen Straub, Joshua J Gagne, Judith C Maro, Michael D Nguyen, Nicolas Beaulieu, Jeffrey S Brown, Adee Kennedy, Margaret Johnson, Adam Wright, Li Zhou, Shirley V Wang
INTRODUCTION: While medical chart review remains the gold standard to validate health conditions or events identified in administrative claims and electronic health record databases, it is time consuming, expensive and can involve subjective decisions. AIM: The aim of this study was to describe the landscape of technology-enhanced approaches that could be used to facilitate medical chart review within and across distributed data networks. METHOD: We conducted a semi-structured survey regarding processes for medical chart review with organizations that either routinely do medical chart review or use technologies that could facilitate chart review...
May 20, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31102144/long-term-safety-and-tolerability-of-onabotulinumtoxina-treatment-in-patients-with-chronic-migraine-results-of-the-compel-study
#3
Paul K Winner, Andrew M Blumenfeld, Eric J Eross, Amelia C Orejudos, Debbie L Mirjah, Aubrey Manack Adams, Mitchell F Brin
INTRODUCTION: OnabotulinumtoxinA is approved in the USA for the prevention of headache in adults with chronic migraine, a debilitating neurologic disease characterized by headaches occurring on ≥ 15 days per month for > 3 months and including migraine features on ≥ 8 days per month. OBJECTIVE: The COMPEL Study (NCT01516892), a 108-week, multi-center, open-label study, evaluated the long-term efficacy and safety of onabotulinumtoxinA in adults with chronic migraine...
May 17, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31098918/the-impact-of-litigation-associated-reports-on-signal-identification-in-the-us-fda-s-adverse-event-reporting-system
#4
LETTER
Monica A Muñoz, Gerald J Dal Pan
No abstract text is available yet for this article.
May 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31098917/evaluation-of-potential-drug-drug-interactions-in-adults-in-the-intensive-care-unit-a-systematic-review-and-meta-analysis
#5
REVIEW
Mary Grace Fitzmaurice, Adrian Wong, Hannah Akerberg, Simona Avramovska, Pamela L Smithburger, Mitchell S Buckley, Sandra L Kane-Gill
INTRODUCTION: There is an increased risk of potential drug-drug interactions (pDDIs) in critically ill patients based on the number of drugs received. The occurrence of pDDIs and clinical significance is not well described. OBJECTIVE: The aim was to provide insight into important clinical issues and offer guidance on drug-drug interaction (DDI) surveillance through the performance of a systematic review. METHODS: Five targeted objectives were developed, a priori, which guided study selection and data abstraction...
May 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31077091/fluoroquinolone-use-and-the-risk-of-collagen-associated-adverse-events-a-systematic-review-and-meta-analysis
#6
REVIEW
Xinyu Yu, Ding-Sheng Jiang, Jing Wang, Rui Wang, Taiqiang Chen, Kan Wang, Shiyi Cao, Xiang Wei
INTRODUCTION: It has been suggested that fluoroquinolone antibiotics increase the risk of developing collagen-associated adverse events such as aortic dissection and aortic aneurysm. These are life-threatening emergencies that need to be prevented. OBJECTIVES: We performed this systematic review to clarify the association between fluoroquinolones and three collagen-associated adverse events: aortic aneurysm or aortic dissection, retinal detachment, and tendon disorders...
May 10, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31069704/a-profile-of-adverse-drug-reactions-of-atazanavir-and-lopinavir-based-antiretroviral-regimens-in-namibia
#7
LETTER
Babafunso Aderemi Adenuga, Timothy William Rennie
No abstract text is available yet for this article.
May 8, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31069703/bismuth-concentrations-in-patients-treated-in-real-life-practice-with-a-bismuth-subcitrate-metronidazole-tetracycline-preparation-the-saphary-study
#8
Estelle Guiard, Bénédicte Lelievre, Magali Rouyer, Frank Zerbib, Bertrand Diquet, Francis Mégraud, François Tison, Emmanuelle Bignon, Régis Lassalle, Cécile Droz-Perroteau, Nicholas Moore, Patrick Blin
INTRODUCTION: A fixed-dose association of bismuth subcitrate, metronidazole and tetracycline (BMT) (Pylera® , Allergan, NJ, USA) was made available in France in 2013 for the eradication of Helicobacter pylori. Due to a historical issue of bismuth encephalopathy, the French Health Authorities requested a study of blood and plasma bismuth concentrations with BMT in daily practice. AIMS: The aim of the study was to measure eventual bismuth accumulation and neurological toxicity in patients prescribed BMT...
May 8, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31069702/inflammation-monoclonal-antibodies-and-depression-joining-the-dots
#9
David Hunt
No abstract text is available yet for this article.
May 8, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31069701/advances-in-diagnosis-and-management-of-cutaneous-adverse-drug-reactions-current-and-future-trends-neil-h-shear-and-roni-p-dodiuk-gad-adis-2019-hardcover-isbn-978-981-13-1488-9-ebook-isbn-978-981-13-1489-6
#10
Mark Lebwohl
No abstract text is available yet for this article.
May 8, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31062194/pharmacovigilance-as-scientific-discovery-an-argument-for-trans-disciplinarity
#11
Elena Rocca, Samantha Copeland, I Ralph Edwards
Pharmacovigilance currently faces several unsolved challenges. Of particular importance are issues concerning how to ascertain, collect, confirm, and communicate the best evidence to assist the clinical choice for individual patients. Here, we propose that these practical challenges partially stem from deeper fundamental issues concerning the epistemology of pharmacovigilance. After reviewing some of the persistent challenges, recent measures, and suggestions in the current pharmacovigilance literature, we support the argument that the detection of potential adverse drug reactions ought to be seen as a serendipitous scientific discovery...
May 6, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31054141/identifying-the-dead-development-and-validation-of-a-patient-level-model-to-predict-death-status-in-population-level-claims-data
#12
Jenna M Reps, Peter R Rijnbeek, Patrick B Ryan
INTRODUCTION: US claims data contain medical data on large heterogeneous populations and are excellent sources for medical research. Some claims data do not contain complete death records, limiting their use for mortality or mortality-related studies. A model to predict whether a patient died at the end of the follow-up time (referred to as the end of observation) is needed to enable mortality-related studies. OBJECTIVE: The objective of this study was to develop a patient-level model to predict whether the end of observation was due to death in US claims data...
May 3, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31041671/correction-to-benefit-risk-assessment-of-obesity-drugs-focus-on-glucagon-like-peptide-1-receptor-agonists
#13
Rasmus M Christensen, Christian R Juhl, Signe S Torekov
In the original publication of this article, the following correction should be noted in Table 1.
April 30, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31037651/the-10th-international-congress-on-cutaneous-adverse-drug-reactions-shimane-japan-2018-focus-on-new-discoveries
#14
EDITORIAL
Cristina Olteanu, Neil H Shear, Eishin Morita, Wen-Hung Chung, Hiroyuki Niihara, Setsuko Matsukura, Rena Hashimoto, Roni P Dodiuk-Gad
No abstract text is available yet for this article.
April 29, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31020549/mechanisms-of-severe-cutaneous-adverse-reactions-recent-advances
#15
REVIEW
Teresa Bellón
Cutaneous adverse drug reactions are unpredictable and include various different skin conditions of varying degrees of severity. The most concerning are usually referred to as severe cutaneous adverse reactions (SCARs) and include acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), also known as drug-induced hypersensitivity syndrome (DiHS) or hypersensitivity syndrome (HSS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). All are delayed type IV hypersensitivity reactions in which a T-cell-mediated drug-specific immune response is responsible for causing the disease...
April 24, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31016678/standardising-the-classification-of-harm-associated-with-medication-errors-the-harm-associated-with-medication-error-classification-hamec
#16
Peter J Gates, Melissa T Baysari, Virginia Mumford, Magdalena Z Raban, Johanna I Westbrook
Classifying harm associated with a medication error can be time consuming and labour intensive and limited studies undertake this step. There is no standardised process, and few studies that report harm assessment provide adequate methods to allow for study replication. Studies typically mention that a clinical review panel classified patient harm and provide a reference to a classification tool. Moreover, in many studies it is unclear whether potential or actual harm was classified as studies refer only to 'error severity'...
April 23, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31012051/correction-to-ustekinumab-safety-in-psoriasis-psoriatic-arthritis-and-crohn-s-disease-an-integrated-analysis-of-phase-ii-iii-clinical-development-programs
#17
Subrata Ghosh, Lianne S Gensler, Zijiang Yang, Chris Gasink, Soumya D Chakravarty, Kamyar Farahi, Paraneedharan Ramachandran, Elyssa Ott, Bruce E Strober
In the original publication of this article, the following correction should be noted in Table 5.
April 22, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31006085/pharmacovigilance-systems-in-arab-countries-overview-of-22-arab-countries
#18
REVIEW
Thamir M Alshammari, Neslihan Mendi, Khalidah A Alenzi, Yazed Alsowaida
Pharmacovigilance has received much attention in Arab countries recently due to the development of new regulations. However, there are differences in the progression of pharmacovigilance systems by regulatory agencies in these countries because only some are able to meet the requirements for conducting pharmacovigilance activities. Only 45% of Arab countries are official members of the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring. Countries such as Morocco, Tunisia, Saudi Arabia, Egypt, and Jordan are considered to be advanced pharmacovigilance countries, whereas other countries such as Libya, Yemen, and Palestine remain in the very early stages of implementing and developing pharmacovigilance systems...
April 20, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30989591/correction-to-a-machine-learning-algorithm-to-optimise-automated-adverse-drug-reaction-detection-from-clinical-coding
#19
Christopher McMaster, David Liew, Claire Keith, Parnaz Aminian, Albert Frauman
CK: Principal Investigator. CM and CK were responsible for the study design and conception; all authors were responsible for acquisition and validation of the data; CM was responsible for analysis and interpretation of the data; and all authors contributed to reviewing drafts of the manuscript and approved the final version for publication.
April 15, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/30972641/benefit-risk-assessment-of-obesity-drugs-focus-on-glucagon-like-peptide-1-receptor-agonists
#20
REVIEW
Rasmus M Christensen, Christian R Juhl, Signe S Torekov
The prevalence of obesity and related comorbidities is increasing worldwide. Furthermore, clinically meaningful body weight losses has proven difficult to achieve and especially to maintain through sustained lifestyle change in the form of diet and exercise. Pharmacotherapy against obesity is a non-invasive treatment as an adjunct to lifestyle changes, but approved anti-obesity drugs are currently few. This article reviews the major anti-obesity drugs and the benefit-risk profiles of the long-acting glucagon-like peptide-1 receptor agonists (GLP-1 RAs) liraglutide and semaglutide (a modified version of liraglutide with longer half-life and tripled receptor affinity)...
April 10, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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