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Pharmacovigilance

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https://www.readbyqxmd.com/read/28345435/predicting-adherence-and-persistence-with-oral-bisphosphonate-therapy-in-an-integrated-health-care-delivery-system
#1
Rita L Hui, Annette L Adams, Fang Niu, Bruce Ettinger, David K Yi, Malini Chandra, Joan C Lo
BACKGROUND: Examining drug exposure is essential to pharmacovigilance, especially for bisphosphonate (BP) therapy. OBJECTIVE: To examine differences in 4 measures of oral BP exposure: treatment discontinuation, adherence, persistence, and nonpersistence. METHODS: Among women aged ≥ 50 years who initiated oral BP therapy during 2002-2007 with at least 3 years of health plan membership follow-up, discontinuation was defined by evidence of no further treatment during the study observation period...
April 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28345368/sponsors-and-investigative-staffs-perceptions-of-the-current-investigational-new-drug-safety-reporting-process-in-oncology-trials
#2
Raymond Perez, Patrick Archdeacon, Nancy Roach, Robert Goodwin, Jonathan Jarow, Nina Stuccio, Annemarie Forrest
BACKGROUND/AIMS: The Food and Drug Administration's final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes...
March 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28344483/pharmacovigilance-system-in-saudi-arabia
#3
REVIEW
Thamir M Alshammari, Mohammed Alshakka, Hisham Aljadhey
Pharmacovigilance plays an important role in ensuring that patients are receiving safe drugs. In Saudi Arabia, Saudi Food and Drug Authority, health institutions, marketing authorization holders and healthcare professional are involved in pharmacovigilance activities regardless of the level of the involvement. Although pharmacovigilance is well established in developed nations and it is considered a new concept in Saudi Arabia. It is a collective effort from various stakeholders to make pharmacovigilance successful toward promoting safe and effective use of medicines among the population...
March 2017: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
https://www.readbyqxmd.com/read/28342074/evaluation-of-saefvic-a-pharmacovigilance-surveillance-scheme-for-the-spontaneous-reporting-of-adverse-events-following-immunisation-in-victoria-australia
#4
Hazel J Clothier, Nigel W Crawford, Melissa Russell, Heath Kelly, Jim P Buttery
INTRODUCTION: Australia is traditionally an early adopter of vaccines, therefore comprehensive and effective post-licensure vaccine pharmacovigilance is critical to maintain confidence in immunisation, both nationally and internationally. With adverse event following immunisation (AEFI) surveillance the responsibility of Australian jurisdictions, Victoria operates an enhanced passive AEFI surveillance system integrated with clinical services, called 'SAEFVIC' (Surveillance of Adverse Events Following Vaccination In the Community)...
March 24, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28339747/deep-learning-for-pharmacovigilance-recurrent-neural-network-architectures-for-labeling-adverse-drug-reactions-in-twitter-posts
#5
Anne Cocos, Alexander G Fiks, Aaron J Masino
Objective: Social media is an important pharmacovigilance data source for adverse drug reaction (ADR) identification. Human review of social media data is infeasible due to data quantity, thus natural language processing techniques are necessary. Social media includes informal vocabulary and irregular grammar, which challenge natural language processing methods. Our objective is to develop a scalable, deep-learning approach that exceeds state-of-the-art ADR detection performance in social media...
February 22, 2017: Journal of the American Medical Informatics Association: JAMIA
https://www.readbyqxmd.com/read/28336242/pacritinib-versus-best-available-therapy-for-the-treatment-of-myelofibrosis-irrespective-of-baseline-cytopenias-persist-1-an-international-randomised-phase-3-trial
#6
Ruben A Mesa, Alessandro M Vannucchi, Adam Mead, Miklos Egyed, Anita Szoke, Aleksandr Suvorov, Janos Jakucs, Andrew Perkins, Ritam Prasad, Jiri Mayer, Judit Demeter, Peter Ganly, Jack W Singer, Huafeng Zhou, James P Dean, Peter A Te Boekhorst, Jyoti Nangalia, Jean-Jacques Kiladjian, Claire N Harrison
BACKGROUND: Available therapies for myelofibrosis can exacerbate cytopenias and are not indicated for patients with severe thrombocytopenia. Pacritinib, which inhibits both JAK2 and FLT3, induced spleen responses with limited myelosuppression in phase 1/2 trials. We aimed to assess the efficacy and safety of pacritinib versus best available therapy in patients with myelofibrosis irrespective of baseline cytopenias. METHODS: This international, multicentre, randomised, phase 3 trial (PERSIST-1) was done at 67 sites in 12 countries...
March 20, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28336160/unexpected-drug-induced-raynaud-phenomenon-analysis-from-the-french-national-pharmacovigilance-database
#7
Émilie Bouquet, Geoffrey Urbanski, Christian Lavigne, Pascale Lainé-Cessac
OBJECTIVE: To estimate the association between exposure to medicinal products and Raynaud phenomenon. METHODS: The study used the data of all adverse drug reactions notified to the French national pharmacovigilance database. All cases reported between 1st January 1995 and 10th December 2012 were selected. A case/non-case method was used to measure disproportionality of the association between drug exposure and Raynaud phenomenon. The cases concerned all observations involving Raynaud phenomenon...
February 22, 2017: Thérapie
https://www.readbyqxmd.com/read/28335786/matching-safety-to-access-global-actors-and-pharmacogovernance-in-kenya-a-case-study
#8
Kathy Moscou, Jillian C Kohler
BACKGROUND: The Kenyan government has sought to address inadequacies in its National Pharmaceutical Policy and the Pharmacy and Poisons Board's (PPB) medicines governance by engaging with global actors (e.g. the World Health Organization). Policy actors have influenced the way pharmacovigilance is defined, how challenges are understood and which norms are requisite to address drug safety issues. In this paper, we investigate the relationship between specific modes of engagement among global (exogenous) and domestic actors at the national and sub-national level to identify the positive or negative effect on pharmacovigilance and pharmacogovernance in Kenya...
March 23, 2017: Globalization and Health
https://www.readbyqxmd.com/read/28334417/pharmacovigilance-database-search-discloses-clc-k-channels-as-a-novel-target-of-the-at1-receptor-blockers-valsartan-and-olmesartan
#9
Paola Imbrici, Domenico Tricarico, Giuseppe Felice Mangiatordi, Orazio Nicolotti, Marcello Diego Lograno, Diana Conte, Antonella Liantonio
BACKGROUND AND PURPOSE: Human ClC-K chloride channels are highly attractive targets for drug discovery for their physiological role and association with genetic disorders. These channels are pivotal in the kidney as they control chloride reabsorption and water diuresis. In addition, loss-of-function mutations of CLCKNB and BSND genes cause Bartter's syndrome (BS), whereas CLCNKA and CLCKNB gain-of-function polymorphisms predispose to a rare form of salt sensitive hypertension. Both disorders lack a personalized therapy that is in most cases only symptomatic...
March 23, 2017: British Journal of Pharmacology
https://www.readbyqxmd.com/read/28334070/detection-of-drug-drug-interactions-through-data-mining-studies-using-clinical-sources-scientific-literature-and-social-media
#10
Santiago Vilar, Carol Friedman, George Hripcsak
Drug-drug interactions (DDIs) constitute an important concern in drug development and postmarketing pharmacovigilance. They are considered the cause of many adverse drug effects exposing patients to higher risks and increasing public health system costs. Methods to follow-up and discover possible DDIs causing harm to the population are a primary aim of drug safety researchers. Here, we review different methodologies and recent advances using data mining to detect DDIs with impact on patients. We focus on data mining of different pharmacovigilance sources, such as the US Food and Drug Administration Adverse Event Reporting System and electronic health records from medical institutions, as well as on the diverse data mining studies that use narrative text available in the scientific biomedical literature and social media...
February 17, 2017: Briefings in Bioinformatics
https://www.readbyqxmd.com/read/28326432/harnessing-scientific-literature-reports-for-pharmacovigilance-prototype-software-analytical-tool-development-and-usability-testing
#11
Alfred Sorbello, Anna Ripple, Joseph Tonning, Monica Munoz, Rashedul Hasan, Thomas Ly, Henry Francis, Olivier Bodenreider
OBJECTIVES: We seek to develop a prototype software analytical tool to augment FDA regulatory reviewers' capacity to harness scientific literature reports in PubMed/MEDLINE for pharmacovigilance and adverse drug event (ADE) safety signal detection. We also aim to gather feedback through usability testing to assess design, performance, and user satisfaction with the tool. METHODS: A prototype, open source, web-based, software analytical tool generated statistical disproportionality data mining signal scores and dynamic visual analytics for ADE safety signal detection and management...
March 22, 2017: Applied Clinical Informatics
https://www.readbyqxmd.com/read/28322168/pediatric-off-label-and-unlicensed-drug-use-and-its-implications
#12
Rajeshwari Gore, Preeta Kaur Chugh, Chakra Dhar Tripathi, Yangshen Lhamo, Sandhya Gautam
BACKGROUND: Worldwide, in the absence of standard pediatric prescribing information, clinicians often use medicines in children in a dosage form or for an indication that has not been approved for use. Inadequate clinical trials increase exposure to drugs that lack safety-efficacy data in pediatric population. Hence, off-label and unlicensed drug use must be regarded as a patient safety-issue that is known to be associated with increased risks of adverse drug reactions apart from under- or over-dosing due to lack of pharmacokinetic data...
March 17, 2017: Current Clinical Pharmacology
https://www.readbyqxmd.com/read/28318723/pan-european-survey-of-the-topical-ocular-use-of-cyclosporine-a
#13
A Labbé, C Baudouin, D Ismail, M Amrane, J-S Garrigue, A Leonardi, F C Figueiredo, G Van Setten, M Labetoulle
OBJECTIVE: To assess medical practices surrounding the use of topical ocular cyclosporine A across European Union nations. METHODS: Key stakeholders (ophthalmologists, hospital pharmacists, regulatory health authorities) from European Union member states were interviewed by telephone using a semi-structured, open-ended questionnaire. Ophthalmologists responded to questions about practice patterns of cyclosporine A use (prescription frequency, indication, dosage), pharmacists about cyclosporine A formulations (composition, manufacturing process, quality control, distribution), and the regulatory authorities about market authorization and pharmacovigilance for various cyclosporine A products...
March 16, 2017: Journal Français D'ophtalmologie
https://www.readbyqxmd.com/read/28314882/a-global-view-of-undergraduate-education-in-pharmacovigilance
#14
Jenny Hartman, Linda Härmark, Eugène van Puijenbroek
PURPOSE: The aim of this study was to gain insight in current pharmacovigilance educational activities and to gather information on which topics should be included in the undergraduate pharmacovigilance core curriculum. METHOD: A web-based questionnaire was carried out containing 45 questions divided over four sections between 28 October 2014 and 31 January 2015. Potential participants working in pharmacovigilance and/or providing training in this field were invited via email and a widespread web link and snowball sampling was used to recruit additional participants...
March 17, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28299610/pharmacovigilance-of-regenerative-medicine-under-the-amended-pharmaceutical-affairs-act-in-japan
#15
Yasuko Inokuma
Two Japanese regulatory agencies, the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency announced the implementation of a new review system called 'Conditional Approval,' specifically for the emerging field of regenerative medicine, in an amendment to the Pharmaceutical Affairs Act in 2014. Regenerative medicine was regulated in the category of 'Medical Devices' prior to the amendment and was not covered by the Relief Service, a system that provides financial aid to people who have experienced an adverse drug reaction and developed serious side effects as a result...
March 15, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28295862/sample-size-of-the-reference-sample-in-a-case-augmented-study
#16
Palash Ghosh, Anup Dewanji
The case-augmented study, in which a case sample is augmented with a reference (random) sample from the source population with only covariates information known, is becoming popular in different areas of applied science such as pharmacovigilance, ecology, and econometrics. In general, the case sample is available from some source (for example, hospital database, case registry, etc.); however, the reference sample is required to be drawn from the corresponding source population. The required minimum size of the reference sample is an important issue in this regard...
March 13, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28291680/epidemiology-of-drug-induced-anaphylaxis-in-a-tertiary-hospital-in-korea
#17
Han-Ki Park, Min-Gyu Kang, Min-Suk Yang, Jae-Woo Jung, Sang-Heon Cho, Hye-Ryun Kang
BACKGROUND: Epidemiology and risk factors of drug-induced anaphylaxis are difficult to estimate due to lack of confirmative diagnosis and under reporting. Here we report the current state of drug-induced anaphylaxis in Korea based on an in-hospital pharmacovigilance database in a tertiary hospital. METHODS: This study is a retrospective analysis of drug-induced anaphylaxis, reported to an in-hospital pharmacovigilance center in Seoul National University Hospital from June 2009 to May 2013...
March 10, 2017: Allergology International: Official Journal of the Japanese Society of Allergology
https://www.readbyqxmd.com/read/28284845/risks-of-malignancies-related-to-tofacitinib-and-biological-drugs-in-rheumatoid-arthritis-systematic-review-meta-analysis-and-network-meta-analysis
#18
José Ramón Maneiro, Alejandro Souto, Juan J Gomez-Reino
OBJECTIVE: To summarize and compare the risks of malignancies accompanying biologic DMARDs (b-DMARDs) and tofacitinib in rheumatoid arthritis (RA) in randomized clinical trials (RCTs) and long-term extension studies (LTEs). METHODS: Articles in Medline, Embase, Cochrane Library, and the Web of Science dated from 2000 to February 2015. Selection criteria were as follows: (1) focus on RCTs or LTEs in RA; (2) treatment with b-DMARDs or tofacitinib; (3) data on malignancies; and (4) a minimum follow-up of 12 weeks...
February 16, 2017: Seminars in Arthritis and Rheumatism
https://www.readbyqxmd.com/read/28279424/cardio-oncology-the-role-of-big-data
#19
REVIEW
Anant Mandawat, Andrew E Williams, Sanjeev A Francis
Despite its challenges, a "big data" approach offers a unique opportunity within the field of cardio-oncology. A pharmacovigilant approach using large data sets can help characterize cardiovascular toxicities of the rapidly expanding armamentarium of targeted therapies. Creating a broad coalition of data sharing can provide insights into the incidence of cardiotoxicity and stimulate research into the underlying mechanisms. Population health necessitates the use of big data and can help inform public health interventions to prevent both cancer and cardiovascular disease...
April 2017: Heart Failure Clinics
https://www.readbyqxmd.com/read/28277227/-red-yeast-rice-induced-muscular-injuries-analysis-of-french-pharmacovigilance-database-and-literature-review
#20
Christelle Philibert, Virginie Bres, Marie-Josèphe Jean-Pastor, Claire Guy, Bénédicte Lebrun-Vignes, Perrine Robin, Véronique Pinzani, Dominique Hillaire-Buys
Red yeast rice (RYR) is a dietary supplement containing monacolins obtained by fermentation of Monascus purpureus strains. Because of its structural homology with lovastatin, monacolin K inhibits HMG-CoA reductase and shows hypocholesterolemic properties comparable to synthetic statins. We studied all cases of myopathy involving RYR reported in the French national pharmacovigilance database (6 cases) and in scientific literature (9 cases). Among these cases, 9 showed elevated creatine kinase, 3 rhabdomyolysis and 2 myalgia...
October 27, 2016: Thérapie
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