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Pharmacovigilence

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https://www.readbyqxmd.com/read/28737220/current-state-of-pharmacovigilance-in-the-arab-and-eastern-mediterranean-region-results-of-a-2015-survey
#1
Danya M Qato
OBJECTIVES: This study describes the current state of pharmacovigilance systems in Arab and Eastern Mediterranean countries. METHODS: A descriptive cross-sectional study was conducted between May and September 2015. Data were gathered from a standardized online survey sent to pharmacovigilance leadership identified as the official national contact for the WHO Programme for International Drug Monitoring. In countries with no specified pharmacovigilance programme or leadership, Ministry of Health officers responsible for drug safety policies were invited to participate in the survey...
July 24, 2017: International Journal of Pharmacy Practice
https://www.readbyqxmd.com/read/28735357/promoting-and-protecting-public-health-how-the-european-union-pharmacovigilance-system-works
#2
Aniello Santoro, Georgy Genov, Almath Spooner, June Raine, Peter Arlett
This article provides an overview of the European Union pharmacovigilance system resulting from the rationalisation and strengthening delivered through the implementation of the revised pharmacovigilance legislation. It outlines the system aims, underlying principles, components and drivers for future change. At its core, the Pharmacovigilance Risk Assessment Committee is responsible for assessing all aspects of the risk management of medicinal products, thus ensuring that medicines approved for the European Union market are optimally used by maximising their benefits and minimising risks...
July 22, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28722163/risk-of-cancer-in-patients-with-psoriasis-on-biologic-therapies-a-systematic-review
#3
REVIEW
E Peleva, L S Exton, K Kelley, K J Mason, C H Smith
Biologic therapies are highly effective in psoriasis, but have profound effects on innate and adaptive immune pathways that may negatively impact on cancer immunosurveillance mechanisms. To investigate the risk of cancer in psoriasis patients treated with biologic therapy we searched Medline, Embase, and the Cochrane Library (up to August 2016) for randomized control trials, prospective cohort studies and systematic reviews that reported cancer incidence in people exposed to biologic therapy for psoriasis compared to a control population...
July 19, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28718898/exposure-to-biologic-therapies-during-conception-and-pregnancy-a-systematic-review
#4
E M Pottinger, R T Woolf, L S Exton, A D Burden, C Nelson-Piercy, C H Smith
Biologic therapies are effective treatments for psoriasis and are often used in women of childbearing age. To evaluate the safety of biologic therapy in conception and/or pregnancy, we have performed a systematic review of Pubmed, MEDLINE, EMBASE and Cochrane databases for multivariable adjusted studies of women exposed to biologic therapy relevant to the treatment of psoriasis during conception and/or pregnancy. We identified four population-based cohort studies involving 1300 women exposed to TNF-α inhibitors (TNFi) 3 months prior to or during the first 3 months of pregnancy...
July 18, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28718062/update-on-biosimilars-in-asia
#5
REVIEW
Wen-Chan Tsai
PURPOSE OF REVIEW: This review provides an update on the evolution of, manufacturing of, and regulations for biosimilars in Asian countries. RECENT FINDINGS: The use of biologics revolutionized the treatment of various diseases. However, the high cost of biologics remained unaffordable for most Asian patients and increases the financial burden of Asian governments. The development of biosimilars provides the best solution for this predicament. A great boom of biosimilars is developing in Asia...
August 2017: Current Rheumatology Reports
https://www.readbyqxmd.com/read/28714489/knowledge-attitude-and-practice-regarding-pharmacovigilance-and-consumer-pharmacovigilance-among-consumers-at-lalitpur-district-nepal
#6
N Jha, D S Rathore, P R Shankar, S Bhandary, M Alshakka, S Gyawali
BACKGROUND: Adverse drug reactions (ADRs) can be a big threat to the health of people in Nepal as a variety of medicines are consumed in the country. Involving consumers in pharmacovigilance can strengthen ADR reporting. The study aims to find out knowledge, attitude and practice regarding pharmacovigilance and consumer pharmacovigilance among consumers at Lalitpur district, Nepal Methods: It was carried out in outpatients visiting in KIST Medical College and Teaching Hospital, Lalitpur, Nepal...
January 2017: Journal of Nepal Health Research Council
https://www.readbyqxmd.com/read/28706402/levocetirizine-induced-psychiatric-disorders-in-a-pediatric-patient-a-case-report-and-a-pharmacovigilance-database-analysis
#7
Carla Carnovale, Simone Russo, Gigliola Biondelli, Marta Gentili, Marco Pozzi, Stefania Antoniazzi, Sonia Radice, Emilio Clementi
No abstract text is available yet for this article.
April 2017: Journal of Pharmacology & Pharmacotherapeutics
https://www.readbyqxmd.com/read/28705498/-hepatonephritis-during-the-treatment-of-malaria-by-the-therapeutic-combinations-from-a-pharmacovigilance-database
#8
Mamadou Kamagaté, Check Oumar Diallo, David Meless, Thérèse Daubrey-Potey, Augustine Kakou, Éric Balayssac, Kanga Sita N'zue, Jean Claude Yavo, Henri Die-Kakou
INTRODUCTION: Prior studies have shown an association between the onset of hepatonephritis and the use of arteminisin-based combination therapy (ACT) during the treatment of uncomplicated malaria. The objective of this study was to identify the risk factors of hepatonephritis occurrence because of the uncertainty regarding the appearance and the aggravation of this syndrome. METHODS: A case-non case study was carried out on 428 notifications of pharmacovigilance extracted from the database of the clinical pharmacology department of the teaching hospital of Cocody from 2008 to 2012...
April 6, 2017: Thérapie
https://www.readbyqxmd.com/read/28702565/identifying-the-common-genetic-networks-of-adr-adverse-drug-reaction-clusters-and-developing-an-adr-classification-model
#9
Youhyeon Hwang, Min Oh, Giup Jang, Taekeon Lee, Chihyun Park, Jaegyoon Ahn, Youngmi Yoon
Adverse drug reactions (ADRs) are one of the major concerns threatening public health and have resulted in failures in drug development. Thus, predicting ADRs and discovering the mechanisms underlying ADRs have become important tasks in pharmacovigilance. Identification of potential ADRs by computational approaches in the early stages would be advantageous in drug development. Here we propose a computational method that elucidates the action mechanisms of ADRs and predicts potential ADRs by utilizing ADR genes, drug features, and protein-protein interaction (PPI) networks...
July 12, 2017: Molecular BioSystems
https://www.readbyqxmd.com/read/28698988/medication-errors-a-characterisation-of-spontaneously-reported-cases-in-eudravigilance
#10
Victoria Newbould, Steven Le Meur, Thomas Goedecke, Xavier Kurz
INTRODUCTION: Medication errors recently became the focus of regulatory guidance in pharmacovigilance to support reporting, evaluation and prevention of medication errors. OBJECTIVE: This study aims to characterise spontaneously reported cases of medication errors in EudraVigilance over the period 2002-2015 before the release of EU good practice guidance. METHODS: Case reports were identified through the adverse reaction section where a Medical Dictionary for Regulatory Activities (MedDRA(®)) term is reported and included in the Standardised MedDRA(®) Query (SMQ) for medication errors...
July 11, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28698923/sequence-symmetry-analysis-in-pharmacovigilance-and-pharmacoepidemiologic-studies
#11
REVIEW
Edward Chia-Cheng Lai, Nicole Pratt, Cheng-Yang Hsieh, Swu-Jane Lin, Anton Pottegård, Elizabeth E Roughead, Yea-Huei Kao Yang, Jesper Hallas
Sequence symmetry analysis (SSA) is a method for detecting adverse drug events by utilizing computerized claims data. The method has been increasingly used to investigate safety concerns of medications and as a pharmacovigilance tool to identify unsuspected side effects. Validation studies have indicated that SSA has moderate sensitivity and high specificity and has robust performance. In this review we present the conceptual framework of SSA and discuss advantages and potential pitfalls of the method in practice...
July 11, 2017: European Journal of Epidemiology
https://www.readbyqxmd.com/read/28697738/an-evaluation-of-the-knowledge-and-perceptions-of-pharmacy-students-on-pharmacovigilance-activities-in-nigeria
#12
Kanayo P Osemene, Margaret O Afolabi
BACKGROUND: The use of the modified-prescription event monitoring technique has facilitated the understanding and reporting of pharmacovigilance (PV). However, in Nigeria, PV activities are largely misunderstood. Furthermore, there is a dearth of information on the knowledge and perceptions of pharmacy students on PV activities in relation to demographics. This study investigated and assessed the knowledge and perceptions of pharmacy students about pharmacovigilance as well as the demographic factors that are related to pharmacovigilance activities...
July 12, 2017: BMC Research Notes
https://www.readbyqxmd.com/read/28694146/can-causality-assessment-fulfill-the-new-european-definition-of-adverse-drug-reaction-a-review-of-methods-used-in-spontaneous-reporting
#13
REVIEW
Annamaria Mascolo, Cristina Scavone, Maurizio Sessa, Gabriella di Mauro, Daniela Cimmaruta, Valentina Orlando, Francesco Rossi, Liberata Sportiello, Annalisa Capuano
Causality assessment is a fundamental biomedical technique for the signal detection performed by Pharmacovigilance centers in a Spontaneous reporting system. Moreover, it is a crucial and important practice for detecting preventable adverse drug reactions. Among different methods for causality assessment, algorithms (such as the Naranjo, or Begaud Methods) seem for their operational procedure and easier applicability one of the most commonly used methods. With the upcoming of the new European Pharmacovigilance legislation including in the definition of the adverse event also effects resulting from abuse, misuse and medication error, all well-known preventable causes of ADRs, there was an emerging need to evaluate whether algorithms could fulfill this new definition...
July 8, 2017: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/28693488/donor-support-for-quality-assurance-and-pharmacovigilance-of-anti-malarials-in-malaria-endemic-countries
#14
Stephanie D Kovacs, Brianna M Mills, Andy Stergachis
BACKGROUND: Malaria control efforts have been strengthened by funding from donor groups and government agencies. The Global Fund to Fight AIDS, Tuberculosis and the Malaria (Global Fund), the US President's Malaria Initiative (PMI) account for the majority of donor support for malaria control and prevention efforts. Pharmacovigilance (PV), which encompasses all activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem, is a necessary part of efforts to reduce drug resistance and improve treatment outcomes...
July 11, 2017: Malaria Journal
https://www.readbyqxmd.com/read/28691218/safety-of-a-pasteurized-plasma-derived-factor-viii-and-von-willebrand-factor-concentrate-analysis-of-33-years-of-pharmacovigilance-data
#15
Peter Kouides, Kathrin Wawra-Hehenberger, Anna Sajan, Henry Mead, Toby Simon
BACKGROUND: Haemate-P/Humate-P (Humate-P) is a pasteurized human plasma-derived concentrate containing both Factor VIII and von Willebrand factor for treatment of hemophilia A and von Willebrand disease (VWD). STUDY DESIGN AND METHODS: We analyzed the safety of Humate-P based on more than 33 years of postmarketing pharmacovigilance data, representing an estimated exposure of approximately 25,000 patient-years. The analysis comprises reports of potential adverse drug reactions (ADRs) from all sources, reported as part of routine pharmacovigilance at CSL Behring...
July 10, 2017: Transfusion
https://www.readbyqxmd.com/read/28689708/the-growing-role-of-biologics-and-biosimilars-in-the-united-states-perspectives-from-the-apha-biologics-and-biosimilars-stakeholder-conference
#16
Judy Crespi-Lofton, Jann B Skelton
OBJECTIVES: The American Pharmacists Association (APhA) convened the Biologics and Biosimilars Stakeholder Conference on November 30, 2016, in Washington DC. The objectives of the Conference were to determine the key issues and challenges within the marketplace for biologics, follow-on biologics (FOBs), and biosimilars, identify potential roles and responsibilities of pharmacists regarding biologic and biosimilar medications, and identify actions or activities that pharmacists may take to optimize the safe and cost-effective use of biologics and biosimilars...
July 6, 2017: Journal of the American Pharmacists Association: JAPhA
https://www.readbyqxmd.com/read/28681444/a-call-to-incorporate-systems-theory-and-human-factors-into-the-existing-investigation-of-harm-in-clinical-research-involving-healthcare-products
#17
Bernard Bégaud, Esther Daemen, Ioannis Dokas, Brian Edwards, Jonathan M Fishbein, Howard E Greenberg, Alan Hochberg, Hervé Le Louet, Jytte Lyngvig, Nataliya Mogles, Kathryn Owen, Christine Prendergast, Martin Rejzek, Sofia Trantza, David Webb, Matthew Whalen, Simon Whiteley
This is a joint statement from individual pharmacology and pharmaceutical professionals acting in their own capacity including members of the Alliance for Clinical Research Excellence and Safety (ACRES) and the International Society of Pharmacovigilance (ISoP). By building on the extensive pharmacological and regulatory investigations that already take place, we are calling for a fuller and more robust systems-based approach to the independent investigation of clinical research when serious incidents of harm occur, starting with first-in-human clinical trials...
July 6, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28681266/muscular-adverse-drug-reactions-associated-with-proton-pump-inhibitors-a-disproportionality-analysis-using-the-italian-national-network-of-pharmacovigilance-database
#18
Alice Capogrosso Sansone, Irma Convertino, Maria Teresa Galiulo, Stefano Salvadori, Stefania Pieroni, Tamara Knezevic, Stefania Mantarro, Alessandra Marino, Manfred Hauben, Corrado Blandizzi, Marco Tuccori
INTRODUCTION: Proton pump inhibitors (PPIs) have been implicated in the occurrence of moderate to severe myopathies in several case reports. AIM: This study was performed to assess the reporting risk of muscular adverse drug reactions (ADRs) associated with PPIs in the Italian National Network of Pharmacovigilance database. METHODS: A disproportionality analysis (case/non-case) was performed using spontaneous reports collected in the database between July 1983 and May 2016...
July 5, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28679898/pharmacovigilance-mobile-tool-design-in-the-field-of-arhroplasty
#19
Hanne Åserød, Ankica Babic
Pharmacovigilance is an important part of the patient safety and it has a great appeal to physicians. It is concerned with the safety of medical devices and treatments in the light of understanding the risks and dangers based on the already reported safety issues. Internet resources such as the Manufacturer And User Facility Device Experience (MAUDE) web-site are often retrieved due to the lack of internal, local safety databases. The research looked at how Human Computer Interaction could improve user experience...
2017: Studies in Health Technology and Informatics
https://www.readbyqxmd.com/read/28678552/acetylcholinesterase-inhibitors-for-treating-dementia-symptoms-a-safety-evaluation
#20
Dana Mohammad, Parco Chan, Janelle Bradley, Krista Lanctôt, Nathan Herrmann
The prevalence of Alzheimer's disease (AD) continues to rise, while treatment options for cognitive impairment are limited. Acetylcholinesterase inhibitors (AChEIs) aim to provide symptomatic benefit for cognitive decline, however these drugs are not without adverse events (AEs). The safety profile of each drug must be taken carefully into consideration before being prescribed, as new dosages and formulations have recently been approved. Areas Covered: Donepezil, galantamine and rivastigmine are the three AChEIs approved for the treatment of varying stages of AD...
July 5, 2017: Expert Opinion on Drug Safety
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