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Pharmacovigilance

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https://www.readbyqxmd.com/read/27924687/the-fluad-case-in-italy-could-it-have-been-dealt-differently
#1
Miriam Levi, Ersilia Sinisgalli, Chiara Lorini, Francesca Santomauro, Martina Chellini, Paolo Bonanni
During the influenza vaccination campaign 2014-2015, the reporting of three deaths within 48 hours of vaccination with Fluad brought the Italian Medicines Agency (AIFA) to pronounce the withdrawal of two batches of vaccine, based on the precautionary principle. Investigations by the Istituto Superiore di Sanità, the National Institute of Health, and by the Pharmacovigilance Risk Assessment Committee (PRAC), the committee at the European Medicines Agency (EMA) responsible for monitoring and assessing the safety profiles of human drugs, concluded that there was a lack of causality between the reported deaths and the vaccines administered...
December 7, 2016: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/27922762/nonchemotherapy-drug-induced-agranulocytosis-in-children-detected-by-a-prospective-pharmacovigilance-program
#2
Nicolás Medrano-Casique, Hoi Y Tong, Alberto M Borobia, Antonio J Carcas, Jesús Frías, Elena Ramírez
OBJECTIVES: A prospective evaluation of nonchemotherapy drug-induced agranulocytosis (DIA) cases, which are infrequent in the pediatric population. We characterize agranulocytosis cases and assess lab test differences between drug- and nondrug-induced agranulocytosis. METHODS: Through our Prospective Pharmacovigilance Program from Laboratory Signals at Hospital we detected pediatric agranulocytosis cases from July 2007 to December 2010. This program estimates the incidence, drug causality, clinical features, outcomes of DIA pediatric cases, and assesses laboratory differences with respect to non-DIA...
December 6, 2016: Pediatric Hematology and Oncology
https://www.readbyqxmd.com/read/27914633/what-can-big-data-offer-the-pharmacovigilance-of-orphan-drugs
#3
John Price
The pharmacovigilance of drugs for orphan diseases presents problems related to the small patient population. Obtaining high-quality information on individual reports of suspected adverse reactions is of particular importance for the pharmacovigilance of orphan drugs. The possibility of mining "big data" to detect suspected adverse reactions is being explored in pharmacovigilance generally but may have limited application to orphan drugs. Sources of big data such as social media may be infrequently used as communication channels by patients with rare disease or their caregivers or by health care providers; any adverse reactions identified are likely to reflect what is already known about the safety of the drug from the network of support that grows up around these patients...
November 30, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27914631/some-thoughts-on-pharmacovigilance-and-postmarketing-surveillance
#4
EDITORIAL
Richard I Shader
No abstract text is available yet for this article.
November 30, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27913031/pharmacovigilance-in-the-new-millennium
#5
EDITORIAL
Paul Beninger
No abstract text is available yet for this article.
November 29, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27913029/pharmacovigilance-and-biomedical-informatics-a-model-for-future-development
#6
Paul Beninger, Michael A Ibara
PURPOSE: The discipline of pharmacovigilance is rooted in the aftermath of the thalidomide tragedy of 1961. It has evolved as a result of collaborative efforts by many individuals and organizations, including physicians, patients, Health Authorities, universities, industry, the World Health Organization, the Council for International Organizations of Medical Sciences, and the International Conference on Harmonisation. Biomedical informatics is rooted in technologically based methodologies and has evolved at the speed of computer technology...
November 29, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27895489/health-provider-experiences-with-galactagogues-to-support-breastfeeding-a-cross-sectional-survey
#7
Alessandra N Bazzano, Lisa Littrell, Amelia Brandt, Shelley Thibeau, Kamala Thriemer, Katherine P Theall
BACKGROUND: Exclusive breastfeeding for infants up to 6 months is widely recommended, yet breastfeeding rates are relatively low in the US. The most common reason women stop breastfeeding early is a perceived insufficiency of milk. Galactagogues are herbal and pharmaceutical products that can help increase milk supply; however, data on their efficacy and safety is limited. Lactation consultants, obstetricians, and other health providers are an important point of contact for breastfeeding women experiencing challenges with lactation...
2016: Journal of Multidisciplinary Healthcare
https://www.readbyqxmd.com/read/27889900/unbearable-pruritus-after-withdrawal-of-levo-cetirizine
#8
Corine Ekhart, Petra van der Horst, Florence van Hunsel
Twelve cases of unbearable pruritus several days after withdrawal of (levo)cetirizine were reported to the Netherlands Pharmacovigilance Centre Lareb. Eleven reports concerned women and one report concerned a man, aged 19-58 years. These patients had been using these antihistamines continuously for months or years. They had tried to stop using antihistamines on several occasions but felt unable to withdraw the drug because of the unbearable maddening itch. Finally, slowly tapering the drug or using a short course of corticosteroids helped to withdraw (levo)cetirizine...
December 2016: Drug Safety—Case Reports
https://www.readbyqxmd.com/read/27885364/bidirectional-rnn-for-medical-event-detection-in-electronic-health-records
#9
Abhyuday N Jagannatha, Hong Yu
Sequence labeling for extraction of medical events and their attributes from unstructured text in Electronic Health Record (EHR) notes is a key step towards semantic understanding of EHRs. It has important applications in health informatics including pharmacovigilance and drug surveillance. The state of the art supervised machine learning models in this domain are based on Conditional Random Fields (CRFs) with features calculated from fixed context windows. In this application, we explored recurrent neural network frameworks and show that they significantly out-performed the CRF models...
June 2016: Proceedings of the Conference
https://www.readbyqxmd.com/read/27883270/pharmacovigilance-skills-knowledge-and-attitudes-in-our-future-doctors-a-nationwide-study-in-the-netherlands
#10
Tim Schutte, Jelle Tichelaar, Michael O Reumerman, Rike van Eekeren, Robert Rissmann, Cornelis Kramers, Milan C Richir, Eugène P van Puijenbroek, Michiel A van Agtmael
Pharmacovigilance centres monitor the safety of drugs, based on adverse drug reactions (ADRs) reported by doctors, pharmacists and pharmaceutical companies. However, the underreporting of ADRs remains a major problem. Our aim was to investigate preparedness of future doctors for their role in pharmacovigilance, by assessing their pharmacovigilance awareness, skills and knowledge. The study was a nationwide e-survey among medical students (third to sixth year) of all eight medical schools in the Netherlands...
November 24, 2016: Basic & Clinical Pharmacology & Toxicology
https://www.readbyqxmd.com/read/27881517/overview-of-phase-iv-clinical-trials-for-postmarket-drug-safety-surveillance-a-status-report-from-the-clinicaltrials-gov-registry
#11
Xinji Zhang, Yuan Zhang, Xiaofei Ye, Xiaojing Guo, Tianyi Zhang, Jia He
OBJECTIVE: Phase IV trials are often used to investigate drug safety after approval. However, little is known about the characteristics of contemporary phase IV clinical trials and whether these studies are of sufficient quality to advance medical knowledge in pharmacovigilance. We aimed to determine the fundamental characteristics of phase IV clinical trials that evaluated drug safety using the ClinicalTrials.gov registry data. METHODS: A data set of 19 359 phase IV clinical studies registered in ClinicalTrials...
November 23, 2016: BMJ Open
https://www.readbyqxmd.com/read/27875921/a-retrospective-review-of-paediatric-adverse-drug-reactions-reported-in-lombardy-and-croatia-from-2005-to-2013
#12
Carla Carnovale, Marta Gentili, Marco Matacena, Marina Dimov Di Giusti, Darko Krnic, Barbara Dolinic, Darija Kolaric, Zeljana Margan Koletic, Viola Macolic Sarinic, Maja Culjak, Ida Fortino, Luca Merlino, Emilio Clementi, Sonia Radice
OBJECTIVE: to characterise the adverse drugs reactions (ADRs) reported in the Lombard and Croatian paediatric population and to compare data to specific paediatric age groups, in terms of trend, pattern and severity of ADRs, increasing understanding of paediatric ADRs. RESEARCH DESIGN AND METHODS: We selected and analysed all the spontaneous reports in which children were involved (0 < 18 years old) reported in the Lombardy and in Croatian pharmacovigilance databases from 1(th) March 2005 to 31(th) December 2013...
December 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27875920/italian-monitoring-registries-a-tool-for-a-safer-use-of-innovative-drugs-data-from-the-national-pharmacovigilance-system
#13
Lara Magro, Elena Arzenton, Ugo Moretti, Laura Sottosanti, Simona Potenza, Roberto Leone
OBJECTIVES: Our aim was to investigate the ADR reports of drugs with a monitoring registry (MR drugs), in particular those related to abuse/misuse, medication error, overdose, which might indicate an unsafe use. We compared these reports with those of similar drugs without a registry (non-MR drugs), thus verifying whether the registries could be useful tools for a safer use of innovative drugs. METHODS: All ADR reports included in the Italian Pharmacovigilance Network database from January 1(st) 2013 to December 31(st) 2015 (vaccines and literature cases excluded) were analysed...
December 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27875919/adverse-drug-reactions-associated-with-off-label-use-of-ketorolac-with-particular-focus-on-elderly-patients-an-analysis-of-the-italian-pharmacovigilance-database-and-a-population-based-study
#14
E Viola, G Trifirò, Y Ingrasciotta, L Sottosanti, M Tari, F Giorgianni, U Moretti, R Leone
OBJECTIVE: This study aims to evaluate the frequency of off-label use of ketorolac in Italy and the related suspected adverse drug reactions (ADRs) reported. METHODS: All the suspected cases associated with ketorolac recorded in the Italian Pharmacovigilance database were retrieved. Case evaluations were carried out in order to identify the off-label use of ketorolac. Moreover, an analysis of the inappropriate use of ketorolac was conducted using the 'Arianna' database of Caserta local health unit...
December 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27875914/second-generation-antipsychotics-in-real-life-paediatric-patients-adverse-drug-reactions-and-clinical-outcomes-of-drug-switch
#15
Concetta Rafaniello, Marco Pozzi, Simone Pisano, Carmen Ferrajolo, Silvana Bertella, Liberata Sportiello, Carla Carnovale, Maria Giuseppa Sullo, Dario Cattaneo, Marta Gentili, Renata Rizzo, Antonio Pascotto, Elisa Mani, Laura Villa, Maria Pia Riccio, Serena Sperandeo, Renato Bernardini, Carmela Bravaccio, Emilio Clementi, Massimo Molteni, Francesco Rossi, Sonia Radice, Annalisa Capuano
OBJECTIVE: Gap in knowledge on benefit/risk ratio of second generation antipsychotics (SGA) in the paediatric population represents a challenge for the scientific community. This study aims to analyse all suspected adverse drug reactions (ADRs) to SGA observed during the study period; compare the safety profiles of risperidone and aripiprazole; evaluate the effect of switching from risperidone to aripiprazole or to a first generation antipsychotic (FGA). METHODS: Prospective analysis of spontaneously reported ADRs concerning 184 paediatric outpatients between 2012 and 2014...
December 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27875528/effectiveness-of-seasonal-malaria-chemoprevention-in-children-under-ten-years-of-age-in-senegal-a-stepped-wedge-cluster-randomised-trial
#16
Badara Cissé, El Hadj Ba, Cheikh Sokhna, Jean Louis NDiaye, Jules F Gomis, Yankhoba Dial, Catherine Pitt, Mouhamed NDiaye, Matthew Cairns, Ernest Faye, Magatte NDiaye, Aminata Lo, Roger Tine, Sylvain Faye, Babacar Faye, Ousmane Sy, Lansana Konate, Ekoue Kouevijdin, Clare Flach, Ousmane Faye, Jean-Francois Trape, Colin Sutherland, Fatou Ba Fall, Pape M Thior, Oumar K Faye, Brian Greenwood, Oumar Gaye, Paul Milligan
BACKGROUND: Seasonal Malaria Chemoprevention (SMC) with sulfadoxine-pyrimethamine (SP) plus amodiaquine (AQ), given each month during the transmission season, is recommended for children living in areas of the Sahel where malaria transmission is highly seasonal. The recommendation for SMC is currently limited to children under five years of age, but, in many areas of seasonal transmission, the burden in older children may justify extending this age limit. This study was done to determine the effectiveness of SMC in Senegalese children up to ten years of age...
November 2016: PLoS Medicine
https://www.readbyqxmd.com/read/27874152/healthcare-professionals-awareness-and-knowledge-of-adverse-drug-reactions-and-pharmacovigilance
#17
Noor B Almandil
To document the knowledge of, attitudes toward, and practices of adverse drug reaction (ADR) reporting and pharmacovigilance systems among healthcare professionals. Methods: This descriptive cross-sectional study was conducted using a questionnaire. This study took place at King Fahd Hospital of the University (KFHU), Khobar, Kingdom of Saudi Arabia,  between  April 2015 and  April 2016. Healthcare professionals, including physicians, pharmacists, pharmacy technicians, and nurses, were considered eligible and invited to take part in the study...
December 2016: Saudi Medical Journal
https://www.readbyqxmd.com/read/27868278/differences-in-vigibase%C3%A2-reporting-of-aminoglycoside-and-capreomycin-suspected-ototoxicity-during-tuberculosis-treatment
#18
Evans L Sagwa, Patrick C Souverein, Inês Ribeiro, Hubert G M Leufkens, Aukje K Mantel-Teeuwisse
PURPOSE: To evaluate the association between the use of streptomycin, amikacin, kanamycin and capreomycin in tuberculosis (TB) treatment and the pharmacovigilance reporting of ototoxicity (deafness or hearing loss, tinnitus and vertigo). Second, to analyze patient demographic and geographic factors that influence the reporting of ototoxicity in TB treatment. METHODS: A case/non-case disproportionality analysis of the VigiBase® individual case safety reports (ICSRs) of patients treated for TB using multidrug regimens that contain either of streptomycin, amikacin, kanamycin or capreomycin...
November 20, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27865944/misoprostol-exposure-during-the-first-trimester-of-pregnancy-is-the-malformation-risk-varying-depending-on-the-indication
#19
Marine Auffret, Nathalie Bernard-Phalippon, Joëlle Dekemp, Patrick Carlier, Marie Gervoise Boyer, Thierry Vial, Sophie Gautier
OBJECTIVE: To report the prospective follow-up of pregnancies exposed to misoprostol during the first trimester and analyse the teratogenic risk depending on the indication for use. STUDY DESIGN: Prospective observational study of 265 women exposed to misoprostol during the first 12 weeks of pregnancy and followed until the delivery. Women were included if they or their physician had contacted a French pharmacovigilance centre before 22 weeks of gestation (WG) to obtain information on the risk of misoprostol exposure, and if there had been misoprostol exposure before 13 WG...
November 11, 2016: European Journal of Obstetrics, Gynecology, and Reproductive Biology
https://www.readbyqxmd.com/read/27865436/-improving-adverse-drug-reaction-reporting-by-general-practitioners-through-clinical-research-assistants-visits
#20
Geneviève Durrieu, Julien Jacquot, Dominique Baudrin, Mathilde Mège, Vanessa Rousseau, Haleh Bagheri, Emmanuelle Bondon-Guitton, Delphine Abadie, François Montastruc, Michel Bismuth, Stéphane Oustric, Jean-Louis Montastruc
The main limitation of adverse drug reactions (ADRs) reporting, particularly by general practitioners (GP), to the regional pharmacovigilance centers is under-reporting. The Midi-Pyrénées Regional Pharmacovigilance Center (South western, France) sets up regular visits by a clinical research assistant (CRA) to GP in order to increase the number of ADR reports. The aim of this pilot study was to assess the effect of regular visits of a CRA in GPs offices on the rate of ADR reporting. After one year, CRA visits permit a two-fold increase in ADR reporting...
October 27, 2016: Thérapie
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