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Post marketing surveillance

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https://www.readbyqxmd.com/read/27890848/post-market-clinical-experience-with-the-incraft-aaa-stent-graft-system-for-challenging-access-routes
#1
Masayuki Sugimoto, Giovanni F Torsello, Giovanni B Torsello, Martin Austermann, Arne Stachmann, Theodosios Bisdas
PURPOSE: The INCRAFT system is a new device that has become available in Europe in September 2014 after the announcement of the 2-year results of the INNOVATION trial. However, no data in the "real-world" practice exist. Herein, we report our early series of consecutive patients treated with the INCRAFT after its launch on the market. METHODS: Prospectively collected data of patients enrolled in the INNOVATION trial (group IT) and consecutive patients from CE Mark approval to April 2015 (group CM) were retrospectively evaluated and compared...
November 24, 2016: Annals of Vascular Surgery
https://www.readbyqxmd.com/read/27888478/examining-the-quality-of-medicines-at-kenyan-healthcare-facilities-a-validation-of-an-alternative-post-market-surveillance-model-that-uses-standardized-patients
#2
Francis Wafula, Amy Dolinger, Benjamin Daniels, Njeri Mwaura, Guadalupe Bedoya, Khama Rogo, Ana Goicoechea, Jishnu Das, Bernard Olayo
BACKGROUND: Promoting access to medicines requires concurrent efforts to strengthen quality assurance for sustained impact. Although problems of substandard and falsified medicines have been documented in low- and middle-income countries, reliable information on quality is rarely available. OBJECTIVE: The aim of this study was to validate an alternative post-market surveillance model to complement existing models. METHODS: The study used standardized patients or mystery clients (people recruited from the local community and trained to pose as real patients) to collect medicine samples after presenting a pre-specified condition...
November 25, 2016: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/27875916/new-era-in-treatment-options-of-chronic-hepatitis-c-focus-on-safety-of-new-direct-acting-antivirals-daas
#3
Cristina Scavone, Liberata Sportiello, Concetta Rafaniello, Annamaria Mascolo, Maurizio Sessa, Francesco Rossi, Annalisa Capuano
New direct-acting antivirals have changed hepatitis C virus infection management extremely. Areas covered: The pharmacological management of HCV infection and the main characteristics of new DAA therapies have been discussed. In order to analyse safety data regarding DAA therapies, a narrative review was performed searching for safety results of main second generation DAAs pivotal and post-marketing studies. Data on main DAAs drug-drug interactions have also been discussed. Results of main DAAs pivotal studies revealed that these drugs were frequently associated to adverse events such as asthenia, headache, nausea, and insomnia...
December 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27862608/assessing-prescription-drug-abuse-using-functional-principal-component-analysis-fpca-of-wastewater-data
#4
Stefania Salvatore, Jo Røislien, Jose A Baz-Lomba, Jørgen G Bramness
BACKGROUND: Wastewater-based epidemiology is an alternative method for estimating the collective drug use in a community. We applied functional data analysis, a statistical framework developed for analysing curve data, to investigate weekly temporal patterns in wastewater measurements of three prescription drugs with known abuse potential: methadone, oxazepam and methylphenidate, comparing them to positive and negative control drugs. METHODS: Sewage samples were collected in February 2014 from a wastewater treatment plant in Oslo, Norway...
November 11, 2016: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/27842678/diagnostic-efficacy-and-safety-of-gadoteric-acid-mr-mammography-in-1537-patients
#5
Tim Seithe, Joachim Braun, Michael Wolf, Janis Vahldiek, Dajana Wolny, Jonas Auer, Joanna Pociej, Oliver Heine, Bernd Hamm, Maximilian de Bucourt
OBJECTIVES: To perform a large-scale multicenter post-marketing surveillance study for analyzing diagnostic effectiveness and safety of intravenous (IV) gadoteric acid (Dotarem(®)) in magnetic resonance (MR) mammography under daily practice conditions. MATERIALS AND METHODS: Patients underwent high-resolution MR mammography with gadoteric acid in 15 German centers. Radiologists used a standardized questionnaire to report data including patient demographics and medical history, characteristics of MR examination and results in terms of diagnosis and safety for the patient...
December 2016: European Journal of Radiology
https://www.readbyqxmd.com/read/27829472/post-market-surveillance-to-detect-adverse-events-associated-with-melody%C3%A2-valve-implantation
#6
Kevin D Hill, Bryan H Goldstein, Michael J Angtuaco, Patricia Y Chu, Gregory A Fleming
OBJECTIVE: The aim of this study was to describe previously unrecognised or under-recognised adverse events associated with Melody® valve implantation. BACKGROUND: In rare diseases and conditions, it is typically not feasible to conduct large-scale safety trials before drug or device approval. Therefore, post-market surveillance mechanisms are necessary to detect rare but potentially serious adverse events. METHODS: We reviewed the United States Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database and conducted a structured literature review to evaluate adverse events associated with on- and off-label Melody® valve implantation...
November 10, 2016: Cardiology in the Young
https://www.readbyqxmd.com/read/27819246/21st-century-pharmacovigilance-efforts-roles-and-responsibilities
#7
REVIEW
Peter J Pitts, Hervé Le Louet, Yola Moride, Rena M Conti
In an era when the number of expedited and conditional review pathways for newly available brand-name drugs and biosimilar medicines to treat serious and life-threatening diseases is increasing, defining pharmacovigilance has never been more crucial. 21st century pharmacovigilance is not merely about uncovering, reporting, and addressing adverse events associated with already approved and marketed agents, but can be described as the systematic monitoring of the process of pre-market review and post-market surveillance, which includes the use of medicines in everyday practice...
November 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27818322/an-overview-of-herb-and-dietary-supplement-efficacy-safety-and-government-regulations-in-the-united-states-with-suggested-improvements-part-1-of-5-series
#8
REVIEW
Amy Christine Brown
This is the first of five review articles investigating dietary supplements (DS; includes herbs) that now exceed over 50,000 in the Office of Dietary Supplement's "Dietary Supplement Label Database." Four review articles follow summarizing published medical case reports of DS related to liver toxicity, kidney toxicity, heart toxicity, and cancer. The most popular DS were vitamin or mineral supplements (43%) followed by specialty supplements (20%), botanicals (herbs; 20%), and sports supplements (16%). The 2013 Annual Report of the American Association of Poison Control Centers revealed 1692 fatalities due to drugs and zero deaths due to DS...
November 3, 2016: Food and Chemical Toxicology
https://www.readbyqxmd.com/read/27809913/long-term-safety-and-efficacy-of-omnitrope%C3%A2-a-somatropin-biosimilar-in-children-requiring-growth-hormone-treatment-italian-interim-analysis-of-the-patro-children-study
#9
Lorenzo Iughetti, Gianluca Tornese, Maria Elisabeth Street, Flavia Napoli, Claudia Giavoli, Franco Antoniazzi, Stefano Stagi, Caterina Luongo, Sara Azzolini, Letizia Ragusa, Gianni Bona, Clara Zecchino, Tommaso Aversa, Luca Persani, Laura Guazzarotti, Emiliano Zecchi, Alberto Pietropoli, Stefano Zucchini
BACKGROUND: PATRO Children is an ongoing observational, longitudinal, non-interventional, global post-marketing surveillance study, which is investigating the long-term safety and effectiveness of Omnitrope®, a somatropin biosimilar to Genotropin®, in children with growth disturbances. The primary endpoint of PATRO Children is long-term safety and the secondary endpoint is effectiveness, which is assessed by analysing auxological data such as height (HSDS) and height velocity (HVSDS) standard deviation scores...
November 3, 2016: Italian Journal of Pediatrics
https://www.readbyqxmd.com/read/27809689/two-decades-of-pharmacovigilance-and-clinical-experience-with-highly-purified-rabies-immunoglobulin-f-ab-2-fragments
#10
Elisa Reveneau, Pascale Cottin, Anvar Rasuli
Rabies is a worldwide zoonotic viral disease with no specific treatment once symptoms occur; manifest disease is almost always fatal. WHO recommendations for exposed individuals include immediate attention to the wound and use of rabies immunoglobulin and/or vaccine for post-exposure prophylaxis (PEP). Here, we provide an overview of the clinical experience with a highly purified preparation of F(ab')2 fragments from equine rabies immunoglobulin (F(ab')2 pERIG; Favirab(TM)) in rabies PEP. Areas covered: Our review comprises a retrospective analysis of adverse event reports in the Sanofi Pasteur global pharmacovigilance database for F(ab')2 pERIG, including adverse event reports from eight Sanofi Pasteur-sponsored clinical trials and post-market surveillance data collected between 1995 and 2014...
November 4, 2016: Expert Review of Vaccines
https://www.readbyqxmd.com/read/27801671/fda-approved-medications-that-impair-human-spermatogenesis
#11
REVIEW
Jiayi Ding, Xuejun Shang, Zhanhu Zhang, Hua Jing, Jun Shao, Qianqian Fei, Elizabeth R Rayburn, Haibo Li
We herein provide an overview of the single-ingredient U.S. Food and Drug Administration (FDA)-approved drugs that affect human spermatogenesis, potentially resulting in a negative impact on male fertility. To provide this information, we performed an in-depth search of DailyMed, the official website for FDA-approved drug labels. Not surprisingly, hormone-based agents were found to be the drugs most likely to affect human spermatogenesis. The next category of drugs most likely to have effects on spermatogenesis was the antineoplastic agents...
October 27, 2016: Oncotarget
https://www.readbyqxmd.com/read/27799968/evaluation-of-aryoseven-safety-recombinant-activated-factor-vii-in-patients-with-bleeding-disorders-an-observational-post-marketing-surveillance-study
#12
Gholamreza Toogeh, Hassan Abolghasemi, Peyman Eshghi, Mohammadreza Managhchi, Mohammadreza Shaverdi-Niasari, Katayoon Karimi, Samin Roostaei, Neda Emran, Alireza Abdollahi
BACKGROUND: Recombinant activated factor VII induces hemostasis in patients with coagulopathy disorders. AryoSeven™ as a safe Iranian Recombinant activated factor VII has been available on our market. This study was performed to establish the safety of AryoSeven on patients with coagulopathy disorder. METHODS: This single-center, descriptive, cross sectional study was carried out in Thrombus and Homeostasis Research Center ValiAsr Hospital during 2013-2014. Fifty one patients with bleeding disorders who received at least one dose of Aryoseven were enrolled...
2016: Iranian Journal of Pathology
https://www.readbyqxmd.com/read/27757936/the-concept-of-biofilm-related-implant-malfunction-and-low-grade-infection
#13
Carlo Luca Romanò, Delia Romanò, Ilaria Morelli, Lorenzo Drago
Biofilms have a tremendous impact on industrial machines working in moist environments, while in biological systems their effect is further complicated by the host's response.Implant-related infections are a complex process, starting with bacterial adhesion and biofilm formation, followed by the variable interaction between host, implant, microorganisms and their by-products. Depending on the balance of these factors, different clinical presentations are observed, which may eventually, at times, shift from one into the other...
October 19, 2016: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/27752233/pharmacy-students-knowledge-and-perceptions-about-adverse-drug-reactions-reporting-and-pharmacovigilance
#14
Kingston Rajiah, Mari Kannan Maharajan, Shashina Nair
Pharmacy students' knowledge about adverse drug reaction reporting can impact their attitude towards patient care and issues on patient safety. The aim of this study was to investigate the knowledge and perception of pharmacy students about adverse drug reaction reporting and pharmacovigilance and to study their willingness to report. A cross-sectional study using a validated questionnaire was conducted among the university students. The demographic details of the respondents were studied. The number of female respondents was comparatively higher than the male respondents...
September 2016: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
https://www.readbyqxmd.com/read/27738061/validation-of-defibrillator-lead-performance-registry-data-insight-from-the-danish-pacemaker-and-icd-register
#15
Anders Elgaard Kristensen, Jacob Moesgaard Larsen, Jens Cosedis Nielsen, Jens Brock Johansen, Jens Haarbo, Helen Høgh Petersen, Sam Riahi
AIMS: The validity of registry data on defibrillator lead performance is described only sparsely, despite its clinical importance. This study investigated the validity of defibrillator lead performance registry data in a nationwide and population-based registry. METHODS AND RESULTS: We identified all reported surgical interventions due to defibrillator lead events in the Danish Pacemaker and ICD Register (DPIR) from 2000 to 2013. Medical records of all patients (n = 753) were examined blinded for 5 predefined intervention types and 18 reasons for lead intervention...
October 13, 2016: Europace: European Pacing, Arrhythmias, and Cardiac Electrophysiology
https://www.readbyqxmd.com/read/27716136/linking-swedish-health-data-registers-to-establish-a-research-database-and-a-shared-decision-making-tool-in-hip-replacement
#16
Peter Cnudde, Ola Rolfson, Szilard Nemes, Johan Kärrholm, Clas Rehnberg, Cecilia Rogmark, John Timperley, Göran Garellick
BACKGROUND: Sweden offers a unique opportunity to researchers to construct comprehensive databases that encompass a wide variety of healthcare related data. Statistics Sweden and the National Board of Health and Welfare collect individual level data for all Swedish residents that ranges from medical diagnoses to socioeconomic information. In addition to the information collected by governmental agencies the medical profession has initiated nationwide Quality Registers that collect data on specific diagnoses and interventions...
October 4, 2016: BMC Musculoskeletal Disorders
https://www.readbyqxmd.com/read/27699492/the-safety-and-effectiveness-profile-of-eldecalcitol-in-a-prospective-post-marketing-observational-study-in-japanese-patients-with-osteoporosis-interim-report
#17
Hitoshi Saito, Hiroyuki Kakihata, Yosuke Nishida, Sawako Yatomi, Shigeru Nihojima, Yumiko Kobayashi, Hidehiro Tabata, Makoto Nomura
This large-scale post-marketing surveillance study was conducted to assess the safety and effectiveness of eldecalcitol treatment in patients with osteoporosis in a Japanese clinical setting. A total of 3567 patients with osteoporosis were enrolled and received eldecalcitol 0.75 μg/day for 12 months. For this interim report, 3285 patients were eligible for analysis. Mean age was 74.9 ± 8.7 years; 86.8 % (2854/3285) were women. There were 142 reported adverse drug reactions (ADRs) in 129 patients (3...
October 3, 2016: Journal of Bone and Mineral Metabolism
https://www.readbyqxmd.com/read/27697951/-sweeter-than-a-swisher-amount-and-themes-of-little-cigar-and-cigarillo-content-on-twitter
#18
Ganna Kostygina, Hy Tran, Yaru Shi, Yoonsang Kim, Sherry Emery
OBJECTIVE: Despite recent increases in little cigar and cigarillo (LCC) use-particularly among urban youth, African-Americans and Latinos-research on targeted strategies for marketing these products is sparse. Little is known about the amount or content of LCC messages users see or share on social media, a popular communication medium among youth and communities of colour. METHODS: Keyword rules were used to collect tweets related to LCCs from the Twitter Firehose posted in October 2014 and March-April 2015...
October 2016: Tobacco Control
https://www.readbyqxmd.com/read/27677340/intussusception-hospitalizations-incidence-in-the-pediatric-population-in-italy-a-nationwide-cross-sectional-study
#19
Francesco Trotta, Roberto Da Cas, Antonino Bella, Carmela Santuccio, Stefania Salmaso
BACKGROUND: Study to investigate the intussusception incidence background in the pediatric population and its temporal trend in Italy. METHODS: A cross-sectional study was conducted on the pediatric population aged 0 to 15 years, in the period 1 January 2002 to 31 December 2012. Intussusception cases were identified using the national hospital discharge database. The annual intussusception incidence, the incidence rate ratios (IRRs) and the related 95 % confidence Intervals (CI) were calculated...
September 27, 2016: Italian Journal of Pediatrics
https://www.readbyqxmd.com/read/27677190/pharmacokinetic-drug-evaluation-of-albutrepenonacog-alfa-csl654-for-the-treatment-of-hemophilia
#20
Massimo Morfini
Replacement therapy for FVIII/IX in hemophilia A/B is more than 50 years old following the discovery of cryoprecipitate by Judith Pool in 1964. On-demand therapy and prophylaxis to treat or prevent bleedings is very demanding owing to the short half-life (HL) of factor concentrates (no more than 12-14 h for FVIII or 16-18 h for FIX). Patients are very eager to prolong the intervals between bolus. The enhanced HL of long-acting recombinant FIX (rFIX) concentrates seems to fulfill this expectance. Areas covered: Great improvements have been achieved in the bio-engineering of new rFIX concentrates...
October 2, 2016: Expert Opinion on Drug Metabolism & Toxicology
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