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pharmacovigillance

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https://www.readbyqxmd.com/read/29144574/sglt-2-inhibitors-and-ketoacidosis-a-disproportionality-analysis-in-the-world-health-organization-s-adverse-drug-reactions-database
#1
Abdel Nasser Ado Moumouni, Perrine Robin, Dominique Hillaire-Buys, Jean-Luc Faillie
SGLT-2 inhibitors, also called gliflozins, are a new class of drugs used in type 2 diabetes. Since their marketing, several cases of ketoacidosis, including life-threatening conditions, were reported with their use. The objective of this study was to investigate the disproportionality of pharmacovigilance reports of ketoacidosis between gliflozins and other drugs used for type 2 diabetes. We performed a case non-case study within the World Health Organization's pharmacovigilance database, VigiBase. We selected all reports of serious adverse drug reaction associated with a glucose-lowering drug in patients aged 40 years and older, from January 2013 to March 2016...
November 16, 2017: Fundamental & Clinical Pharmacology
https://www.readbyqxmd.com/read/29143369/detection-of-adverse-drug-reactions-evaluation-of-an-automatic-data-processing-applied-in-oncology-performed-in-the-french-drg-database
#2
Alexandre Quillet, Olivier Colin, Nicolas Bourgeois, Sylvie Favrelière, Aurélie Ferru, Laurence Boinot, Claire Lafay-Chebassier, Marie-Christine Perault-Pochat
The aim of this study was to assess an automated detection method of serious adverse reactions induced by oral targeted therapy (OTT) in patients with cancer, performed in the French Diagnosis Related Groups (DRG) database. Cancer patients of the Poitiers hospital who started an OTT between 2014 and 2015 were included. This study focused on adverse drug reaction which required inpatient hospitalization (ADRh ). All diagnoses coded in the DRG database for hospital stays that occurred within three months after OTT initiation were collected (potential ADRh )...
November 15, 2017: Fundamental & Clinical Pharmacology
https://www.readbyqxmd.com/read/29128200/exploring-sociodemographic-and-economic-factors-that-promote-adverse-drug-reactions-reporting-by-patients
#3
Pedro Inácio, João José Gomes, Marja Airaksinen, Afonso Cavaco
BACKGROUND: Adverse drug reactions (ADRs) are recognized as a leading cause of morbidity and mortality, and an important cost factor to health systems. Patient reporting of ADRs has emerged as an important topic in recent years but reporting rates are still low in many countries. OBJECTIVE: To explore different countries' sociodemographic and economic features as explanatory factors for population ADRs reporting, including the propensity of patients' reporting to pharmacovigilance authorities...
November 8, 2017: Health Policy
https://www.readbyqxmd.com/read/29122454/ayurveda-formulations-a-roadmap-to-address-the-safety-concerns
#4
Kishor Patwardhan, Jigyasa Pathak, Rabinarayan Acharya
It is a matter of serious concern that the number of case reports pointing at a possible association between the clinical toxicity and the use of Ayurveda formulations is increasing significantly over the years in scientific medical literature. Though most of these cases are connected with the presence of heavy metals such as lead, mercury and arsenic in these formulations, there are also reports suggesting toxicity due to the presence of toxic chemicals of herbal origin. In the year 2008, the Government of India took an initiative of establishing the National Pharmacovigilance Programme for Ayurveda, Siddha and Unani drugs in a structured way...
November 6, 2017: Journal of Ayurveda and Integrative Medicine
https://www.readbyqxmd.com/read/29111222/ssel-ade-a-semi-supervised-ensemble-learning-framework-for-extracting-adverse-drug-events-from-social-media
#5
Jing Liu, Songzheng Zhao, Gang Wang
With the development of Web 2.0 technology, social media websites have become lucrative but under-explored data sources for extracting adverse drug events (ADEs), which is a serious health problem. Besides ADE, other semantic relation types (e.g., drug indication and beneficial effect) could hold between the drug and adverse event mentions, making ADE relation extraction - distinguishing ADE relationship from other relation types - necessary. However, conducting ADE relation extraction in social media environment is not a trivial task because of the expertise-dependent, time-consuming and costly annotation process, and the feature space's high-dimensionality attributed to intrinsic characteristics of social media data...
October 27, 2017: Artificial Intelligence in Medicine
https://www.readbyqxmd.com/read/29110913/pristinamycin-induced-arthralgia-and-myalgia-analysis-of-the-french-pharmacovigilance-database
#6
M Denis Prevot, E M Thillard, J Walther, G Veyrac, M L Laroche, S Gautier, M Auffret
INTRODUCTION: Pristinamycin is an antibiotic of the streptogramin family; few adverse effects of this drug are reported, only cutaneous and digestive ones. Arthralgia and myalgia may however be observed although not mentioned in the summary of product characteristics. OBJECTIVE: Description and analysis of cases of pristinamycin-induced arthralgia and/or myalgia registered in the French database of pharmacovigilance. METHOD: We carried out a targeted search of the database, selecting case patients presenting with arthralgia and muscle pain and excluding those associated with sensitivities or allergies to pristinamycin...
October 28, 2017: Médecine et Maladies Infectieuses
https://www.readbyqxmd.com/read/29110904/retention-of-gadolinium-compounds-used-in-magnetic-resonance-imaging-a-critical-review-and-the-recommendations-of-regulatory-agencies
#7
L Martí-Bonmatí, E Martí-Bonmatí
The Spanish Agency for Drugs and Healthcare Products (AEMPS), based on the recommendations of the European Committee for Risk Assessment in Pharmacovigilance, established on 13 March 2017 that linear gadolinium-based MR contrast media, such as MultiHance, Omniscan, Magnevist (currently not marketed) and Optimark (no longer marketed in Spain), the clinical benefits do not outweigh the potential risks derived from their use. AEMPS recommends to suspend its marketing for general use based on the retention of these compounds in the brain...
October 27, 2017: Radiología
https://www.readbyqxmd.com/read/29109938/a-day-in-the-life-of-a-pharmacovigilance-case-processor
#8
Ritesh Bhangale, Sayali Vaity, Niranjan Kulkarni
Pharmacovigilance (PV) has grown significantly in India in the last couple of decades. The etymological roots for the word "pharmacovigilance" are "Pharmakon" (Greek for drug) and "Vigilare" (Latin for to keep watch). It relies on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The PV data processing cycle starts with data collection in computerized systems followed by complete data entry which includes adverse event coding, drug coding, causality and expectedness assessment, narrative writing, quality control, and report submissions followed by data storage and maintenance...
October 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/29108928/transitioning-from-first-to-second-generation-biosimilars-an-appraisal-of-regulatory-and-post-marketing-challenges
#9
REVIEW
Corrado Blandizzi, Mauro Galeazzi, Guido Valesini
Second-generation biosimilars (i.e. monoclonal antibodies or proteins generated by fusion of antibody and receptor moieties) differ in several respects as compared to first-generation ones (e.g. epoetins, bone marrow stimulating factors, somatotropins). In this respect, as second-generation biosimilars are endowed with much greater structural and molecular complexity, which might translate into a number of pharmacological and therapeutic issues, they raise new challenges for manufacturers and regulatory authorities as well as new concerns for clinicians...
November 3, 2017: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/29108136/application-and-optimisation-of-the-comparison-on-extreme-laboratory-tests-cert-algorithm-for-detection-of-adverse-drug-reactions-transferability-across-national-boundaries
#10
Mun Yee Tham, Qing Ye, Pei San Ang, Liza Y Fan, Dukyong Yoon, Rae Woong Park, Zheng Jye Ling, James W Yip, Bee Choo Tai, Stephen Jw Evans, Cynthia Sung
PURPOSE: The Singapore regulatory agency for health products (Health Sciences Authority), in performing active surveillance of medicines and their potential harms, is open to new methods to achieve this goal. Laboratory tests are a potential source of data for this purpose. We have examined the performance of the Comparison on Extreme Laboratory Tests (CERT) algorithm, developed by Ajou University, Korea, as a potential tool for adverse drug reaction detection based on the electronic medical records of the Singapore health care system...
November 6, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29105853/measuring-the-impact-of-medicines-regulatory-interventions-systematic-review-and-methodological-considerations
#11
Thomas Goedecke, Daniel Morales, Alexandra Pacurariu, Xavier Kurz
AIM: Evaluating the public health impact of regulatory interventions is important but there is currently no common methodological approach to guide this evaluation. This systematic review provides a descriptive overview of the analytical methods for impact research. METHODS: We searched MEDLINE and EMBASE for articles with an empirical analysis evaluating the impact of European Union or non-European Union regulatory actions to safeguard public health published until March 2017...
November 5, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29090566/-pharmacovigilance-of-chinese-medicine-practice-of-cognition-application-prevention-and-rescue-of-drug-toxicity
#12
Bing Zhang, Zhi-Jian Lin, Xiao-Meng Zhang
Toxicity of traditional Chinese medicine(TCM) is the core of pharmacovigilance of Chinese medicine, whose initiation, development and practice revolves around the toxicity of TCM. Toxicity of TCM has rich meanings, and are influenced by three factors: drug composition, clinical use and patient constitution. With the increasingly deep understanding of toxicity of TCM, the cognition of clinicians is more objective, and the application, prevention and rescue are more complete. Therefore, based on the analysis of large numbers of ancient books, we put forward the whole pharmacovigilance theoretical frame that is formed by cognition, application, prevention and rescue of drug toxicity, which comprehensively reflects the academic Characteristics of safety medication in TCM...
May 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/29080680/differential-drug-survival-of-second-line-biologic-therapies-in-patients-with-psoriasis-observational-cohort-study-from-the-british-association-of-dermatologists-biologic-interventions-register-badbir
#13
Ireny Y K Iskandar, Richard B Warren, Mark Lunt, Kayleigh J Mason, Ian Evans, Kathleen McElhone, Catherine H Smith, Nick J Reynolds, Darren M Ashcroft, Christopher E M Griffiths
Little is known about the drug survival of second-line biologic therapies for psoriasis in routine clinical practice. We assessed drug survival of second-line biologic therapies and estimated the risk of recurrent discontinuation due to adverse events (AEs) or ineffectiveness in psoriasis patients who had failed a first biologic and switched to a second in a large, multi-centre pharmacovigilance registry (n=1239; adalimumab,538; etanercept,104; ustekinumab,597). The overall drug survival rate in the first year after switching was 77% (95% confidence interval (CI): 74%-79%), falling to 58% (55%-61%) in the third year...
October 25, 2017: Journal of Investigative Dermatology
https://www.readbyqxmd.com/read/29080142/correction-to-safety-concerns-with-hpv-vaccines-continue-to-linger-are-current-vaccine-pharmacovigilance-practices-sufficient
#14
Rebecca E Chandler
The following disclaimer was missing from the article.
October 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29077847/drug-drug-interaction-extraction-via-hierarchical-rnns-on-sequence-and-shortest-dependency-paths
#15
Yijia Zhang, Wei Zheng, Hongfei Lin, Jian Wang, Zhihao Yang, Michel Dumontier
Motivation: Adverse events resulting from drug-drug interactions (DDI) pose a serious health issue. The ability to automatically extract DDIs described in the biomedical literature could further efforts for ongoing pharmacovigilance. Most of neural networks-based methods typically focus on sentence sequence to identify these DDIs, however the shortest dependency path (SDP) between the two entities contains valuable syntactic and semantic information. Effectively exploiting such information may improve DDI extraction...
October 25, 2017: Bioinformatics
https://www.readbyqxmd.com/read/29076385/post-marketing-withdrawal-of-analgesic-medications-because-of-adverse-drug-reactions-a-systematic-review
#16
Igho J Onakpoya, Carl J Heneghan, Jeffrey K Aronson
Many analgesics have been withdrawn from the market because of adverse drug reactions. Controversy still surrounds the use of some approved analgesics for pain management. However, the trends and reasons for withdrawal of analgesics when harms are attributed to their use have not been systematically assessed. Areas covered: We conducted searches in PubMed; Embase; Google Scholar; clinicaltrials.gov; WHO databases of withdrawn products; websites of the European Medicines Agency, the US Food and Drug Administration, the UK Medicines and Healthcare products Regulatory Agency; Meyler's Side Effects of Drugs; Stephens' Detection of New Adverse Drug Reactions; the Pharmaceutical Manufacturing Encyclopedia; and the Merck Index...
November 1, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29076063/neuropsychiatric-events-associated-with-leukotriene-modifying-agents-a-systematic-review
#17
REVIEW
Sharon W Y Law, Angel Y S Wong, Shweta Anand, Ian C K Wong, Esther W Chan
INTRODUCTION: Leukotriene-modifying agents (LTMAs) including montelukast, zafirlukast, and zileuton are approved by the US Food and Drug Administration (FDA) for the treatment of asthma and allergic rhinitis. Various neuropsychiatric events (NEs) have been reported; however, the evidence of the association is conflicting. This systematic review investigates the association between NEs and LTMAs by assessing the relevant published literature. METHODS: PubMed, EMBASE, MEDLINE, and Cochrane Library were searched using keywords...
October 26, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29065508/-i-can-step-outside-my-comfort-zone
#18
Morag C E McFadyen, Lesley Diack
On embarking upon such a multifactorial, professional degree as Pharmacy, students often find it difficult to meld the scientific- and practice-based components of the course. In final year of the undergraduate Masters of Pharmacy degree (MPharm) within the School of Pharmacy and Life Sciences at Robert Gordon University (RGU), students undertake a research project within a specific area. The aims of this study were to explore the effectiveness of a novel practice based approach to a biomedical science project, to identify elements of difficulty in the process, and to explore students' perceptions and reflections...
October 22, 2017: Pharmacy (Basel, Switzerland)
https://www.readbyqxmd.com/read/29063255/gadolinium-retention-after-administration-of-contrast-agents-based-on-linear-chelators-and-the-recommendations-of-the-european-medicines-agency
#19
EDITORIAL
Ilona A Dekkers, Rick Roos, Aart J van der Molen
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) earlier this year recommended to suspend some marketing authorisations for Gadolinium Containing Contrast Agents (GCCAs) based on linear chelators due to the potential risk of gadolinium retention in the human body. These recommendations have recently been re-evaluated by EMA's Committee for Medicinal Products for Human Use (CHMP), and confirmed the final opinion of the European Medicines Agency. This editorial provides an overview of the available GCCAs and summarises the recent evidence of gadolinium retention...
October 23, 2017: European Radiology
https://www.readbyqxmd.com/read/29063137/the-adverse-drug-reaction-reporting-assignment-for-specialist-oncology-nurses-a-preliminary-evaluation-of-quality-relevance-and-educational-value-in-a-prospective-cohort-study
#20
Tim Schutte, Rike van Eekeren, Milan Richir, Jojanneke van Staveren, Eugène van Puijenbroek, Jelle Tichelaar, Michiel van Agtmael
In a new prescribing qualification course for specialist oncology nurses, we thought that it is important to emphasize pharmacovigilance and adverse drug reaction (ADR) reporting. We aimed to develop and evaluate an ADR reporting assignment for specialist oncology nurses. The quality of report documentation was assessed with the "Clinical Documentation tool to assess Individual Case Safety Reports" (ClinDoc). The relevance of the reports was evaluated in terms of ADR seriousness, the listing for additional monitoring of the drug by European Medicines Agency (EMA), and lack of labelling information about the ADR...
October 23, 2017: Naunyn-Schmiedeberg's Archives of Pharmacology
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