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Post marketing surveillance

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https://www.readbyqxmd.com/read/28548196/-declaration-of-the-chilean-academy-of-medicine-of-law-20-850-%C3%A2-on-clinical-trials-of-pharmaceutical-products-and-medical-devices%C3%A2-and-of-the-bylaw-that-will-regulate-its-application
#1
Gloria López S, Gloria Valdés S, Emilio Roessler B, Vicente Valdivieso D
In Chile, high cost treatments required by selected medical conditions are financed by the State, according to Law 20.850. A bylaw under discussion by the Senate regulates clinical trials, posing complex issues that will endanger local interest in front-line research: 1. The exclusive and mandatory control bestowed to the Institute of Public Health during all stages of the trials and also the surveillance of institutions performing clinical trials, overriding their Clinical Research Review Boards; 2.The 10 year period during which any adverse event is assumed to have been caused by the medication or devise evaluated by the trial, unless the contrary is proven in a judicial process; 3...
March 2017: Revista Médica de Chile
https://www.readbyqxmd.com/read/28532461/national-post-market-surveillance-assessment-of-veterinary-medicines-in-korea-during-the-past-decade
#2
JeongWoo Kang, Hae-Chul Park, Yang Ho Jang, Md Akil Hossain, Kyunghun Jeong, Mi Young Jeong, Seon-Jong Yun, Sung-Won Park, Dae Gyun Kim, Kwang-Jick Lee
BACKGROUND: Veterinary medicines have been widely used for the prevention and treatment of diseases, growth promotion, and to promote feeding efficacy in livestock. As the veterinary medicine industry has steadily grown, it is crucial to set up a baseline for the quality of medicine as well as the insufficiency or excessiveness of the active ingredients in drug products to ensure the compliance, safety and efficacy of these medicines. Thus, the 10 years data of post-marketing quality control study was summarized to determine the rate and extent of non-compliance of these medicines and to establish baseline data for future quality control measures of veterinary medicine...
May 22, 2017: BMC Veterinary Research
https://www.readbyqxmd.com/read/28510606/safety-and-efficacy-of-cell-free-and-concentrated-ascites-reinfusion-therapy-cart-in-refractory-ascites-post-marketing-surveillance-results
#3
Norio Hanafusa, Ayako Isoai, Tomoaki Ishihara, Tetsuya Inoue, Ken Ishitani, Taiju Utsugisawa, Toshihiko Yamaka, Tetsuya Ito, Hiroshi Sugiyama, Atsushi Arakawa, Yosuke Yamada, Yasuo Itano, Hirokazu Onodera, Ryosuke Kobayashi, Naoko Torii, Toyoko Numata, Taihei Kashiwabara, Yoshihiro Matsuno, Michio Kato
We performed post-marketing surveillance to evaluate the safety and efficacy of cell-free and concentrated ascites reinfusion therapy (CART). In total, 356 CART sessions in 147 patients at 22 centers were performed. The most common primary disease was cancer (128 cases, 300 sessions). Mean amount of ascites collected was 3.7 L, and mean concentration ratio was 9.2. Mean amount of reinfused protein was 67.8 g (recovery rate, 72.0%). Performance status, dietary intake, urine volume, body weight and abdominal circumference were significantly improved after CART...
2017: PloS One
https://www.readbyqxmd.com/read/28490974/the-introduction-of-biosimilars-of-low-molecular-weight-heparins-in-europe-a-critical-review-and-reappraisal-endorsed-by-the-italian-society-for-haemostasis-and-thrombosis-siset-and-the-italian-society-for-angiology-and-vascular-medicine-siapav
#4
REVIEW
Davide Imberti, Marco Marietta, Hernan Polo Friz, Claudio Cimminiello
Recently, the European Medicines Agency (EMA) authorized the introduction and marketing of Thorinane® and Inhixa®, biosimilars of the Low Molecular Weight Heparin (LMWH) enoxaparin. The authorization path is considerably different from the guidelines published by the EMA in 2009, as well as from the recommendations from the International Society on Thrombosis and Haemostasis published in 2013. Indeed, both of them recommended that LMWHs biosimilars therapeutic equivalence should be demonstrated in at least one adequately designed clinical trial...
2017: Thrombosis Journal
https://www.readbyqxmd.com/read/28488101/impact-of-chronic-renal-failure-on-safety-and-effectiveness-of-paclitaxel-eluting-stents-for-femoropopliteal-artery-disease-subgroup-analysis-from-zilver-ptx-post-market-surveillance-study-in-japan
#5
Yukihisa Ogawa, Hiroyoshi Yokoi, Takao Ohki, Kimihiko Kichikawa, Masato Nakamura, Kimihiro Komori, Shinsuke Nanto, Erin E O'Leary, Aaron E Lottes, Alan T Saunders, Michael D Dake
PURPOSE: Favorable long-term outcomes of the Zilver PTX drug-eluting stent (DES) in femoropopliteal lesions have been demonstrated. Chronic renal failure (CRF) has been shown to be a risk factor for restenosis and decreased limb salvage. The results of the DES in patients with CRF have not previously been reported. This study compares the results with the DES in patients with CRF and those without CRF. METHODS: This retrospective analysis from the Zilver PTX Japan Post-Market Surveillance Study included 321 patients with CRF and 584 patients without CRF...
May 9, 2017: Cardiovascular and Interventional Radiology
https://www.readbyqxmd.com/read/28480041/risk-of-qt-prolongation-and-torsade-de-pointes-associated-with-exposure-to-hydroxyzine-re-evaluation-of-an-established-drug
#6
Anne-Françoise Schlit, Annie Delaunois, Aurore Colomar, Branderley Claudio, Luca Cariolato, Rossen Boev, Jean-Pierre Valentin, Christopher Peters, Victor S Sloan, Jürgen W G Bentz
Several noncardiac drugs have been linked to cardiac safety concerns, highlighting the importance of post-marketing surveillance and continued evaluation of the benefit-risk of long-established drugs. Here, we examine the risk of QT prolongation and/or torsade de pointes (TdP) associated with the use of hydroxyzine, a first generation sedating antihistamine. We have used a combined methodological approach to re-evaluate the cardiac safety profile of hydroxyzine, including: (1) a full review of the sponsor pharmacovigilance safety database to examine real-world data on the risk of QT prolongation and/or TdP associated with hydroxyzine use and (2) nonclinical electrophysiological studies to examine concentration-dependent effects of hydroxyzine on a range of human cardiac ion channels...
June 2017: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/28473520/examining-the-safety-of-menstrual-cups-among-rural-primary-school-girls-in-western-kenya-observational-studies-nested-in-a-randomised-controlled-feasibility-study
#7
Jane Juma, Elizabeth Nyothach, Kayla F Laserson, Clifford Oduor, Lilian Arita, Caroline Ouma, Kelvin Oruko, Jackton Omoto, Linda Mason, Kelly T Alexander, Barry Fields, Clayton Onyango, Penelope A Phillips-Howard
OBJECTIVE: Examine the safety of menstrual cups against sanitary pads and usual practice in Kenyan schoolgirls. DESIGN: Observational studies nested in a cluster randomised controlled feasibility study. SETTING: 30 primary schools in a health and demographic surveillance system in rural western Kenya. PARTICIPANTS: Menstruating primary schoolgirls aged 14-16 years participating in a menstrual feasibility study. INTERVENTIONS: Insertable menstrual cup, monthly sanitary pads or 'usual practice' (controls)...
May 4, 2017: BMJ Open
https://www.readbyqxmd.com/read/28461912/sequelae-of-large-head-metal-on-metal-hip-arthroplasties-current-status-and-future-prospects
#8
REVIEW
Christiaan P van Lingen, Luigi M Zagra, Harmen B Ettema, Cees C Verheyen
Large-head metal-on-metal (MoM) bearings were re-popularised in the late 1990s with the introduction of modern hip resurfacing (HR), followed closely by large metal head total hip arthroplasty (THA). A worldwide increase in the use of MoM hip arthroplasty subsequently saw a sharp decline, due to serious complications.MoM was rapidly adopted in the early 2000s until medical device alerts were issued by government regulatory agencies and national and international organisations, leading to post-marketing surveillance and discontinuation of these implants...
October 2016: EFORT Open Rev
https://www.readbyqxmd.com/read/28460126/quality-of-artemisinin-based-antimalarial-drugs-marketed-in-nigeria
#9
Oisaemi Izevbekhai, Babatunde Adeagbo, Adeniyi Olagunju, Oluseye Bolaji
Background: Artemisinin combination therapy is first-line therapy for treatment of malaria, which is one of the most significant public health problems in Nigeria. With the increasing level of use of these drugs coupled with the emergence of resistance, there is a need for regular post-market surveillance. Method: Twenty different brands of artesunate-containing antimalarial drugs and 10 brands of artemether-lumefantrine were multi-sourced in the south western part of Nigeria and were subjected to identification, weight uniformity test, and assay using United State pharmacopoeia and International Pharmacopoeia monographs...
February 1, 2017: Transactions of the Royal Society of Tropical Medicine and Hygiene
https://www.readbyqxmd.com/read/28458553/long-term-effect-of-galantamine-on-cognitive-function-in-patients-with-alzheimer-s-disease-versus-a-simulated-disease-trajectory-an-observational-study-in-the-clinical-setting
#10
Ryoko Nakagawa, Takashi Ohnishi, Hisanori Kobayashi, Toshio Yamaoka, Tsutomu Yajima, Ai Tanimura, Toshiya Kato, Kazutake Yoshizawa
BACKGROUND: Long-term maintenance of cognitive function is an important goal of treatment for Alzheimer's disease (AD), but evidence about the long-term efficacy of cholinesterase inhibitors is sparse. To evaluate the long-term efficacy and safety of galantamine for AD in routine clinical practice, we conducted a 72-week post-marketing surveillance study. The effect of galantamine on cognitive function was estimated in comparison with a simulated disease trajectory. PATIENTS AND METHODS: Patients with mild-to-moderate AD received flexible dosing of galantamine (16-24 mg/day) during this study...
2017: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/28448181/blood-pressure-control-with-cilnidipine-treatment-in-japanese-post-stroke-hypertensive-patients-the-ca-attend-study
#11
Shiro Aoki, Naohisa Hosomi, Tomohisa Nezu, Tsukasa Teshima, Hitoshi Sugii, Shinobu Nagahama, Yoshiki Kurose, Hirofumi Maruyama, Masayasu Matsumoto
Blood pressure control is important in post-stroke hypertensive patients and antihypertensive treatment is recommended for such patients. Ca-channel blockers are recommended as the medications of choice for the treatment of post-stroke patients. Here, we report the results of a large-scale prospective post-marketing surveillance study of post-stroke hypertensive patients (n = 2667, male 60.4%, 69.0 ± 10.9 years) treated with cilnidipine, with regard to blood pressure control and adverse reactions. Cilnidipine treatment caused a decrease in both clinic and home blood pressures 2 months after the beginning of treatment, and the decreased blood pressure was maintained until the end of 12 months' observation...
2017: Clinical and Experimental Hypertension: CHE
https://www.readbyqxmd.com/read/28411001/interstitial-lung-disease-induced-by-fluoxetine-systematic-review-of-literature-and-analysis-of-vigiaccess-eudravigilance-and-a-national-pharmacovigilance-database
#12
REVIEW
Arianna Deidda, Claudia Pisanu, Laura Micheletto, Alberto Bocchetta, Maria Del Zompo, Maria Erminia Stochino
We investigated a pulmonary adverse drug reaction possibly induced by fluoxetine, the Interstitial Lung Disease, by performing a systematic review of published case reports on this subject, a review of the World Health Organization VigiAccess database, of the European EudraVigilance database and of a national Pharmacovigilance database (Italian Pharmacovigilance Network). The research found a total of seven cases linking fluoxetine to Interstitial Lung Disease in the literature. 36 cases of interstitial lung disease related to fluoxetine were retrieved from the VigiAccess database (updated to July 2016), and 36 reports were found in EudraVigilance database (updated to June 2016)...
June 2017: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/28392733/implementing-a-regional-integrated-laboratory-proficiency-testing-scheme-for-peripheral-health-facilities-in-east-africa
#13
Stephen Munene, Jackson Songok, Dennis Munene, Jane Carter
INTRODUCTION: Regular participation in external quality assessment (EQA) is critical for maintaining laboratory performance and is required for laboratory accreditation. Proficiency testing (PT) is effective for providing EQA, but available schemes rarely address the range of tests performed by peripheral laboratories in resource-limited settings. The East African Regional External Quality Assessment Scheme (EA-REQAS) was established in 2004 to address this need. MATERIALS AND METHODS: Surveys were distributed biannually comprising seven different panel materials and questions addressing laboratory, clinical and public health topics...
February 15, 2017: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
https://www.readbyqxmd.com/read/28388243/the-current-situation-and-development-of-medical-device-testing-institutes-in-china
#14
Xiaofang Yang, Ruihong Mu, Yubo Fan, Chunren Wang, Deyu Li
This article analyses the current situation and development of Chinese medical device testing institutes from the perspectives of the two most important functions - testing functions and medical device standardization functions. Areas Covered: The objective of the Chinese government regulations for medical device industry is to ensure the safety and effectiveness of medical devices for Chinese patients. To support the regulation system, the Chinese government has established medical device testing institutes at different levels for example, the national, provincial, and municipal levels...
April 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28380251/apremilast-and-suicidality-a-retrospective-analysis-of-three-large-databases-the-faers-eudravigilance-and-a-large-single-center-u-s-patient-population
#15
P P Vakharia, K A Orrell, D Lee, S M Rangel, E Lund, A E Laumann, B Nardone
Apremilast is a small molecule phosphodiesterase-4 inhibitor approved by the United States Food and Drug Administration (FDA) in 2014 for the treatment of adult patients with moderate-to-severe plaque psoriasis and for psoriatic arthritis.(1) Worsening depression, suicide attempts, suicidal ideation, and suicidal behavior have previously been reported in clinical trials and post-marketing surveillance data, and details are included in the Full Prescribing Information.(1) Moreover, a post-marketing statement recently issued now indicates that completed suicide has also been reported...
April 5, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/28377325/optimization-of-the-post-marketing-surveillance-procedure
#16
Parminder Kalle
No abstract text is available yet for this article.
April 1, 2017: Annales de Biologie Clinique
https://www.readbyqxmd.com/read/28376315/safety-and-efficacy-of-a-novel-drug-elores-ceftriaxone-sulbactam-disodium-edetate-in-the-management-of-multi-drug-resistant-bacterial-infections-in-tertiary-care-centers-a-post-marketing-surveillance-study
#17
Manu Chaudhary, Mohd Amin Mir, Shiekh Gazalla Ayub
OBJECTIVE: In India, elores (CSE-1034: ceftriaxone+sulbactam+disodium edetate) was approved as a broad spectrum antibiotic in year 2011 and is used for management of ESBL/MBL infections in tertiary care centers. The objective of this study was to investigate the efficacy of this drug in patients with ESBL/MBL infections and identify the incidence of adverse events in real clinical settings. METHODS: This PMS study was conducted at 17 centers across India and included 2500 patients of all age groups suffering from various bacterial infections and treated with CSE-1034...
April 1, 2017: Brazilian Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28362360/a-risk-assessment-matrix-for-public-health-principles-the-case-for-e-cigarettes
#18
Daniela Saitta, Azim Chowdhury, Giancarlo Antonio Ferro, Federico Giuseppe Nalis, Riccardo Polosa
Besides nicotine replacement therapies, a realistic alternative for smoking cessation or for smoking substitution may come from electronic cigarettes (ECs), whose popularity has been steadily growing. As for any emerging behaviour associated with exposure to inhalational agents, there is legitimate cause for concern and many health organizations and policy makers have pushed for restrictive policy measures ranging from complete bans to tight regulations of these products. Nonetheless, it is important to reframe these concerns in context of the well-known harm caused by cigarette smoking...
March 31, 2017: International Journal of Environmental Research and Public Health
https://www.readbyqxmd.com/read/28353663/use-of-carabids-for-the-post-market-environmental-monitoring-of-genetically-modified-crops
#19
Oxana Skoková Habuštová, Zdeňka Svobodová, Ľudovít Cagáň, František Sehnal
Post-market environmental monitoring (PMEM) of genetically modified (GM) crops is required by EU legislation and has been a subject of debate for many years; however, no consensus on the methodology to be used has been reached. We explored the suitability of carabid beetles as surrogates for the detection of unintended effects of GM crops in general PMEM surveillance. Our study combines data on carabid communities from five maize field trials in Central Europe. Altogether, 86 species and 58,304 individuals were collected...
March 29, 2017: Toxins
https://www.readbyqxmd.com/read/28352456/re-imagining-the-future-of-diagnosis-of-neglected-tropical-diseases
#20
REVIEW
Rosanna W Peeling, Debrah I Boeras, John Nkengasong
Neglected Tropical Diseases (NTDs) affect an estimated 1 billion people in 149 countries. The World Health Organization (WHO) prioritised 17 NTDs for control and elimination by 2020 and defined a Road Map to help countries reach these goals. Improved diagnostics for NTDs are essential for guiding treatment strategies at different thresholds of control, interruption of transmission, elimination and post-elimination surveillance. While substantial progress has been made in the last decade with chemotherapy, the same cannot be said of diagnostics, largely due to the perceived lack of a commercially viable market for NTD diagnostics...
2017: Computational and Structural Biotechnology Journal
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