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https://www.readbyqxmd.com/read/28935617/the-adverse-drug-reactions-from-patient-reports-in-social-media-project-five-major-challenges-to-overcome-to-operationalize-analysis-and-efficiently-support-pharmacovigilance-process
#1
Cedric Bousquet, Badisse Dahamna, Sylvie Guillemin-Lanne, Stefan J Darmoni, Carole Faviez, Charles Huot, Sandrine Katsahian, Vincent Leroux, Suzanne Pereira, Christophe Richard, Stéphane Schück, Julien Souvignet, Agnès Lillo-Le Louët, Nathalie Texier
BACKGROUND: Adverse drug reactions (ADRs) are an important cause of morbidity and mortality. Classical Pharmacovigilance process is limited by underreporting which justifies the current interest in new knowledge sources such as social media. The Adverse Drug Reactions from Patient Reports in Social Media (ADR-PRISM) project aims to extract ADRs reported by patients in these media. We identified 5 major challenges to overcome to operationalize the analysis of patient posts: (1) variable quality of information on social media, (2) guarantee of data privacy, (3) response to pharmacovigilance expert expectations, (4) identification of relevant information within Web pages, and (5) robust and evolutive architecture...
September 21, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28933055/safety-concerns-reported-by-patients-identified-in-a-collaborative-signal-detection-workshop-using-vigibase-results-and-reflections-from-lareb-and-uppsala-monitoring-centre
#2
Sarah Watson, Rebecca E Chandler, Henric Taavola, Linda Härmark, Birgitta Grundmark, Alem Zekarias, Kristina Star, Florence van Hunsel
INTRODUCTION: Patient reporting in pharmacovigilance is important and contributes to signal detection. However, descriptions of methodologies for using patient reports in signal detection are scarce, and published experiences of how patient reports are used in pharmacovigilance are limited to a few individual countries. OBJECTIVE: Our objective was to explore the contribution of patient reports to global signal detection in VigiBase. METHODS: Data were retrieved from VigiBase in September 2016...
September 20, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28933026/17th-isop-annual-meeting-pharmacovigilance-in-the-21st-century-liverpool-uk-15-18-october-2017
#3
(no author information available yet)
No abstract text is available yet for this article.
October 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28932906/safety-study-and-therapeutic-drug-monitoring-of-the-oral-tablet-formulation-of-posaconazole-in-patients-with-haematological-malignancies
#4
C Boglione-Kerrien, S Picard, C Tron, S Nimubona, J-P Gangneux, S Lalanne, F Lemaitre, E Bellissant, M-C Verdier, A Petitcollin
PURPOSE: Posaconazole is a triazole antifungal widely used for prophylaxis of invasive fungal disease (IFI). Posaconazole tablets allow reaching higher plasma levels than the oral suspension, but safety data with this formulation in real life are scarce. This study aimed at evaluating the safety profile, the pharmacokinetic variability, and the concentration-toxicity relationship of posaconazole tablets in patients with haematological malignancies. METHODS: Sixty neutropenic patients treated with posaconazole tablets for prophylaxis of IFI were prospectively included in the study...
September 20, 2017: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/28932122/gadobutrol-in-india-a-comprehensive-review-of-safety-and-efficacy
#5
REVIEW
Jan Endrikat, Nicoletta Anzalone
Gadobutrol is a gadolinium (Gd)-based contrast agent for magnetic resonance imaging (MRI). In India, gadobutrol is approved for MRI of the central nervous system (CNS), liver, kidneys, breast and for MR angiography for patients 2 years and older. The standard dose for all age groups is 0.1 mmol/kg body weight. The safety profile has been demonstrated in 42 clinical phase 2 to 4 studies (>6800 patients), 7 observational studies, and by assessing pharmacovigilance data of 29 million applications. Furthermore, studies in children, adults, and elderly and in patients with impaired liver or kidney function did not show any increased adverse event rate...
2017: Magnetic Resonance Insights
https://www.readbyqxmd.com/read/28929445/physicians-questions-concerning-drug-use-among-older-patients-experience-from-norwegian-drug-information-centres-relis-in-the-period-2010-2015
#6
Jan Schjøtt
Questions from physicians to regional medicines information and pharmacovigilance centres in Norway (RELIS) concerning older patients were described. Question-answer pairs (QAPs) from the RELIS database indexed with the category "older", and concerning individual patients from the period 01 Jan 2010 to 31 Dec 2015, were analysed. Two-hundred and eight QAPs categorized with "older" were retrieved from a total of 16 710 in the study period, and 122 of 208 QAPs fulfilled the inclusion criteria. The most common categories of drugs in question (n = 228) according to the ATC system were N: Nervous system (30...
September 19, 2017: Aging Clinical and Experimental Research
https://www.readbyqxmd.com/read/28927713/risk-factors-of-early-adverse-drug-reactions-with-phenytoin-a-prospective-inpatient-cohort
#7
Reinaldo Uribe-San-Martín, Ethel Ciampi, Wilhelm Uslar, Silvana Villagra, Jaime Godoy, Patricio Mellado
INTRODUCTION: Phenytoin (PHT) is an effective and inexpensive antiepileptic drug (AED). However, its use has been limited for fear of adverse drug reactions (ADRs) and is being replaced by newer AED, increasing the costs and causing major budget problems, particularly for developing countries. OBJECTIVE: The objective of this study was to determine ADR frequency, explore, and establish related risk factors. METHODS: Prospective data were collected from a cohort of inpatients using PHT for the first time...
September 15, 2017: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/28925019/inclusion-of-pregnant-and-breastfeeding-women-in-research-efforts-and-initiatives
#8
Sílvia M Illamola, Christina Bucci-Rechtweg, Maged M Costantine, Katerina Tsilou, Catherine M Sherwin, Anne Zajicek
Pregnant and breastfeeding women have been rendered therapeutic orphans as they have been historically excluded from clinical trials. Labeling for most approved drugs does not provide information about safety and efficacy during pregnancy. This lack of data is mainly due to ethico-legal challenges that have remained entrenched in the post-diethylstilbestrol and thalidomide era, and that have led to pregnancy being viewed in the clinical trial setting primarily through a pharmacovigilance lens. Policy considerations that encourage and/or require the inclusion of pregnant or lactating women in clinical trials may address the current lack of available information...
September 19, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28924350/pharmacovigilance-and-adverse-drug-reaction-reporting-a-perspective-of-community-pharmacists-and-pharmacy-technicians-in-sana-a-yemen
#9
Yaser Mohammed Al-Worafi, Yaman Walid Kassab, Wafa Mohammed Alseragi, Masaad Saeed Almutairi, Ali Ahmed, Long Chiau Ming, Ali Saleh Alkhoshaiban, Muhammad Abdul Hadi
OBJECTIVE: The aim of this study was to compare the knowledge, attitude and barriers of pharmacy technicians and pharmacists toward pharmacovigilance, adverse drug reactions (ADRs) and ADR reporting in community pharmacies in Yemen. METHODS: This cross-sectional survey was conducted among community pharmacists and pharmacy technicians in the capital of Yemen, Sana'a. A total of 289 community pharmacies were randomly selected. The validated and pilot-tested questionnaire consisted of six sections: demographic data, knowledge about pharmacovigilance, experience with ADR reporting, attitudes toward ADR reporting, and the facilitators to improve ADR reporting...
2017: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/28914115/knowledge-attitudes-and-perspective-on-adverse-drug-reaction-reporting-in-a-public-sector-hospital-in-south-africa-baseline-analysis
#10
Antionette Terblanche, Johanna Catharina Meyer, Brian Godman, Robert Stanley Summers
BACKGROUND AND AIMS: Adverse drug reactions (ADRs) can cause significant harm in patients; however, ADRs are under-reported in many countries, including South Africa, where evidence of a pharmacovigilance (PV) system to monitor and manage ADRs is a requirement for compliance with norms and standards for quality healthcare delivery. We conducted an analysis amongst health care professionals (HCPs) at Sebokeng Hospital to assess the situation there. METHODS: Data were collected using a structured self-administered questionnaire, targeting all medical practitioners, nurses, pharmacists and pharmacist assistants in the hospital...
September 15, 2017: Hospital Practice (Minneapolis)
https://www.readbyqxmd.com/read/28913827/when-more-is-less-an-exploratory-study-of-the-precautionary-reporting-bias-and-its-impact-on-safety-signal-detection
#11
Kevin Klein, Joep Hg Scholl, Marie L De Bruin, Eugène P van Puijenbroek, Hubert Gm Leufkens, Pieter Stolk
Concerns have been expressed that large numbers of non-value added reports have been accumulating in ADR databases, for example via patient support programs. We performed an assessment of the impact of such reports, to which we refer to as 'precautionary reports', on safety signal detection in the Netherlands. The case narratives of ADR reports of three case products were screened with text-mining algorithms to identify those reports that lack a causal relationship with the suspected medicinal product. We demonstrate that precautionary reports impede the optimal use of the pharmacovigilance system by, on the one hand, masking safety signals and, on the other hand, creating spurious signals...
September 15, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28904951/diabetic-foot-ulcers-and-epidermal-growth-factor-revisiting-the-local-delivery-route-for-a-successful-outcome
#12
REVIEW
Jorge Berlanga-Acosta, José Fernández-Montequín, Calixto Valdés-Pérez, William Savigne-Gutiérrez, Yssel Mendoza-Marí, Ariana García-Ojalvo, Viviana Falcón-Cama, Diana García Del Barco-Herrera, Maday Fernández-Mayola, Héctor Pérez-Saad, Eulogio Pimentel-Vázquez, Aleida Urquiza-Rodríguez, Moshe Kulikovsky, Gerardo Guillén-Nieto
Soon after epidermal growth factor (EGF) discovery, some in vivo models appeared demonstrating its property to enhance cutaneous wound healing. EGF was the first growth factor (GF) introduced in the clinical arena as a healing enhancer, exerting its mitogenic effects on epithelial, fibroblastoid, and endothelial cells via a tyrosine kinase membrane receptor. Compelling evidences from the 90s documented that, for EGF, locally prolonged bioavailability and hourly interaction with the receptor were necessary for a successful tissue response...
2017: BioMed Research International
https://www.readbyqxmd.com/read/28903545/the-road-from-development-to-approval-evaluating-the-body-of-evidence-to-confirm-biosimilarity
#13
Paul Declerck, Mourad Farouk Rezk
Biosimilars are products that contain a similar version of the active substance of an already authorized original biologic medicinal product (reference medicinal product). Their development requires special consideration, as similarity to the reference agent needs to be established through a comprehensive comparability exercise. Given the complex nature of these agents, minor structural differences may emerge, but the process of biosimilarity determination is designed to ascertain that the nature and impact of these differences are not clinically significant...
August 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28898589/science-of-biosimilars
#14
R Donald Harvey
Biosimilar therapeutic proteins in oncology offer the potential to decrease costs while providing safety and efficacy profiles consistent with their respective reference or originator products. Biosimilars have a number of important differences from generic small-molecule drugs, including manufacturing processes that are unique from their reference products. These differences may affect biosimilars through posttranslational modifications that can occur in specific cellular production lines, and these modifications have potential effects on protein structure, function, clinical pharmacology, and immunogenicity...
September 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28894080/the-portuguese-society-of-rheumatology-position-paper-on-the-use-of-biosimilars-2017-update
#15
Filipe C Araújo, Alexandre Sepriano, Filipa Teixeira, Diogo Jesus, Teresa Martins Rocha, Patrícia Martins, Catarina Tenazinha, Ana Cordeiro, Ana Filipa Mourão, Cândida Silva, Carlos Vaz, Cátia Duarte, Cristina Ponte, Fernando Pimentel Dos Santos, Helena Canhão, Helena Santos, José Bravo Pimentão, José Canas da Silva, Joaquim Pereira, José António Pereira da Silva, Luís Cunha Miranda, Margarida Oliveira, Maria João Saavedra, Pedro Gonçalves, Sandra Falcão, Susana Capela, João Eurico Fonseca
Biosimilars are new and more affordable similar versions of previously approved reference biological drugs. Following the approval of the first monoclonal antibody biosimilar in 2013, the Portuguese Society of Rheumatology issued a position paper on the use of biosimilars in rheumatic conditions covering efficacy, safety, extrapolation, interchangeability, substitution and pharmacovigilance. However, as this is a rapidly evolving field, it was felt that the knowledge and evidence gathered since then justified an update of these statements...
July 21, 2017: Acta Reumatológica Portuguesa
https://www.readbyqxmd.com/read/28887902/atropinic-anticholinergic-burden-in-antipsychotic-treated-patients
#16
François Montastruc, Justine Benevent, Anthony Touafchia, Leila Chebane, Mélanie Araujo, Emmanuelle Guitton-Bondon, Geneviève Durrieu, Christophe Arbus, Laurent Schmitt, Bernard Begaud, Jean-Louis Montastruc
Antipsychotic drugs possess side atropinic (anticholinergic) properties that may induce several adverse drug reactions (ADRs), such as memory loss or cognitive impairment. The aim of the present study was investigating anticholinergic burden in patients treated with antipsychotic drugs. All ADR reports including at least one antipsychotic and registered between 2000 and 2015 in the Midi-Pyrénées PharmacoVigilance Database were extracted and analyzed using the Anticholinergic Duran's list. The primary objective of this cross-sectional study was to calculate anticholinergic burden in antipsychotic-treated patients; the secondary one was to investigate associated factors...
September 9, 2017: Fundamental & Clinical Pharmacology
https://www.readbyqxmd.com/read/28885222/opinions-of-maltese-doctors-and-pharmacists-on-medication-errors
#17
Amy Tanti, Miriam Camilleri, Andrew A Borg, Benjamin Micallef, Gavril Flores, Anthony Serracino-Inglott, John Joseph Borg
BACKGROUND: Pharmacovigilance directive 2010/84/EU focused attention on medication errors and encouraged regulators to identify causing and contributing factors. OBJECTIVES: (1) To study opinions of doctors/pharmacists on factors bearing a causal link to MEs as well as ways to minimise MEs (2) to test whether differences in opinion exist between subgroups of doctors and pharmacists working in community, hospital or office settings. METHODS: Different questionnaires were circulated to doctors and pharmacists...
2017: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/28882026/epidemiology-and-risk-factors-of-voluntary-poisoning-by-pesticides-in-2008-2014-morocco
#18
Zineb Nabih, Latifa Amiar, Zakaria Abidli, Maria Windy, Abdelmajid Soulaymani, Abdelrhani Mokhtari, Rachida Soulaymani Bencheikh
Objectives: To determine the epidemiological profile of voluntary poisoning by pesticides, and determine the risk factors that may affect the life of patients. Methods: A retrospective analysis using all cases of voluntary poisoning by pesticides collected at the Antipoison and Pharmacovigilance Center of Morocco between January 2008 and December 2014. Results: During the study period, 2 690 acute pesticides poisoning cases were collected...
September 1, 2017: Epidemiology and Health
https://www.readbyqxmd.com/read/28880141/-clioquinol-use-for-dientamoeba-fragilis-infections-is-questionable
#19
F van Hunsel, C van Nieuwkoop, B H Ch Stricker
Clioquinol is used for treatment of amoebiasis and infection with Dientamoeba fragilis. In a guideline of the Dutch Working Party on Antibiotic Policy, clioquinol is recommended as a first-choice treatment for Dientamoeba fragilis. This drug, however, is associated with subacute myelo-optico-neuropathy (SMON). It was withdrawn from the market worldwide in 1985 by manufacturer Ciba-Geigy. Although the Dutch Medicines Evaluation Board has registered no products for systemic use of clioquinol since then, the drug is available as a pharmacy-compounded drug and the last few years the use of clioquinol in the Netherlands has risen again...
2017: Nederlands Tijdschrift Voor Geneeskunde
https://www.readbyqxmd.com/read/28867897/extrapyramidal-symptoms-probably-related-to-risperidone-treatment-a-case-series
#20
Sereen Rose Thomson, Bharti Chogtu, Dipanjan Bhattacharjee, Saurabh Agarwal
BACKGROUND: Atypical antipsychotics, like risperidone purportedly, score over their typical counterparts in terms of their lower propensity toward producing extrapyramidal symptoms (EPS). However, recent studies have furnished evidence to the contrary. Hereby, we present a case series implicating risperidone as the causative agent for EPS. METHODS: As a part of the pharmacovigilance programme of India, the authors have assessed 10 physician-reported cases of EPS among the 1,830 patients who were prescribed risperidone within the time period of January 2012-December 2014 in a tertiary care hospital in South India...
July 2017: Annals of Neurosciences
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