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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
#1
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)...
April 12, 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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
https://www.readbyqxmd.com/read/28346083/logistic-regression-likelihood-ratio-test-analysis-for-detecting-signals-of-adverse-events-in-post-market-safety-surveillance
#10
Kijoeng Nam, Nicholas C Henderson, Patricia Rohan, Emily Jane Woo, Estelle Russek-Cohen
The Vaccine Adverse Event Reporting System (VAERS) and other product surveillance systems compile reports of product-associated adverse events (AEs), and these reports may include a wide range of information including age, gender, and concomitant vaccines. Controlling for possible confounding variables such as these is an important task when utilizing surveillance systems to monitor post-market product safety. A common method for handling possible confounders is to compare observed product-AE combinations with adjusted baseline frequencies where the adjustments are made by stratifying on observable characteristics...
March 2, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28345151/registries-in-european-post-marketing-surveillance-a-retrospective-analysis-of-centrally-approved-products-2005-2013
#11
Jacoline C Bouvy, Kevin Blake, Jim Slattery, Marie L De Bruin, Peter Arlett, Xavier Kurz
PURPOSE: Regulatory agencies and other stakeholders increasingly rely on data collected through registries to support their decision-making. Data from registries are a cornerstone of post-marketing surveillance for monitoring the use of medicines in clinical practice. This study was aimed at gaining further insight into the European Medicines Agency's (EMA) requests for new registries and registry studies using existing registries and to review the experience gained in their conduct. METHODS: European Public Assessment Reports were consulted to identify products for which a request for a registry was made as a condition of the marketing authorisation...
March 26, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28344964/efficacy-and-safety-of-drospirenone-2-mg-17%C3%AE-estradiol-1-mg-hormone-therapy-in-korean-postmenopausal-women
#12
Bo Ra Park, Hye Na Park, Ji Back Jung, Eun Sil Lee, Jeong Sig Kim, Gyu Yeon Choi, Jeong Jae Lee, Im Soon Lee
This regulatory post-marketing surveillance study aimed to evaluate the therapeutic efficacy and safety of drospirenone (DRSP) 2 mg/estradiol (E2) 1 mg tablet in Korean postmenopausal women. A total of 4,149 patients were enrolled and the study was conducted at 207 clinical research centers. The patients' source data was collected between November 2006 and November 2012. More than 85% of patients experienced improvement of menopausal symptoms. The most frequently reported adverse events were vaginal bleeding and breast pain; most of the women suffering from these symptoms fully recovered...
March 2017: Obstetrics & Gynecology Science
https://www.readbyqxmd.com/read/28335691/cases-of-drug-induced-torsade-de-pointes-a-review-of-belgian-cases-in-the-eudravigilance-database
#13
Eline Vandael, Bert Vandenberk, Joris Vandenberghe, Rik Willems, Veerle Foulon
OBJECTIVES: Post-marketing surveillance is very important, especially for rare adverse drug reactions like QTc-prolongation and Torsade de Pointes (TdP). The objective of this study was to investigate the characteristics of Belgian cases of drug-related TdP reported in the EudraVigilance database. METHODS: The EudraVigilance database was searched for Belgian post-marketing cases of TdP reported between December 2001-April 2015. These cases were identified with MedDRA preferred terms...
March 24, 2017: Acta Clinica Belgica
https://www.readbyqxmd.com/read/28293797/comparative-risk-of-major-bleeding-with-new-oral-anticoagulants-noacs-and-phenprocoumon-in-patients-with-atrial-fibrillation-a-post-marketing-surveillance-study
#14
Stefan H Hohnloser, Edin Basic, Michael Nabauer
BACKGROUND: Non-vitamin K antagonist oral anticoagulants (NOACs) are at least as effective and safe as vitamin K antagonists (VKAs) for stroke prevention in atrial fibrillation (AF). All pivotal trials have compared NOACs to warfarin. However, other VKAs are commonly used, for instance phenprocoumon. PATIENTS AND METHODS: A retrospective cohort study using a German claims database assessed the comparative risks of bleeding leading to hospitalization during therapy with NOACs and phenprocoumon in AF patients...
March 14, 2017: Clinical Research in Cardiology: Official Journal of the German Cardiac Society
https://www.readbyqxmd.com/read/28277870/safety-and-effectiveness-of-tadalafil-in-patients-with-pulmonary-arterial-hypertension-japanese-post-marketing-surveillance-data
#15
Hiroyoshi Yamazaki, Noriko Kobayashi, Masanori Taketsuna, Koyuki Tajima, Masahiro Murakami
OBJECTIVE: To evaluate the long-term safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension (PAH) in real-world clinical practice. METHODS: This prospective, multicenter, noninterventional, post-marketing surveillance included patients with PAH who were observed for up to 2 years after initiation of tadalafil. Safety was assessed by analyzing the frequency of adverse drug reactions (ADRs), discontinuations due to adverse events (AEs), and serious adverse drug reactions (SADRs)...
May 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28268822/using-constrained-information-entropy-to-detect-rare-adverse-drug-reactions-from-medical-forums
#16
Yi Zheng, Chaowang Lan, Hui Peng, Jinyan Li
Adverse drug reactions (ADRs) detection is critical to avoid malpractices yet challenging due to its uncertainty in pre-marketing review and the underreporting in post-marketing surveillance. To conquer this predicament, social media based ADRs detection methods have been proposed recently. However, existing researches are mostly co-occurrence based methods and face several issues, in particularly, leaving out the rare ADRs and unable to distinguish irrelevant ADRs. In this work, we introduce a constrained information entropy (CIE) method to solve these problems...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28266092/six-year-multi-centre-observational-post-marketing-surveillance-of-the-safety-of-the-hpv-16-18-as04-adjuvanted-vaccine-in-women-aged-10-25%C3%A2-years-in-korea
#17
Chul-Jung Kim, Rok Song, Jing Chen, Fernanda Taveres Da Silva, Kusuma B Gopala, Joon Hyung Kim, Dan Bi, Jong Sup Park
PURPOSE: To evaluate the safety of HPV-16/18 AS04-adjuvanted vaccine when administered as per the PI in Korea. METHODS: A total of 3084 women aged 10-25 years were enrolled in this post-marketing surveillance from 2008 to 2014. Subjects were invited to receive three doses of the vaccine (0, 1 and 6 months), and participants who received at least one dose were included in the analysis. Adverse events (AEs), adverse drug reactions (ADRs) and serious AEs (SAEs) were recorded after each dose...
March 7, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28248987/why-do-people-use-electronic-nicotine-delivery-systems-electronic-cigarettes-a-content-analysis-of-twitter-2012-2015
#18
John W Ayers, Eric C Leas, Jon-Patrick Allem, Adrian Benton, Mark Dredze, Benjamin M Althouse, Tess B Cruz, Jennifer B Unger
The reasons for using electronic nicotine delivery systems (ENDS) are poorly understood and are primarily documented by expensive cross-sectional surveys that use preconceived close-ended response options rather than allowing respondents to use their own words. We passively identify the reasons for using ENDS longitudinally from a content analysis of public postings on Twitter. All English language public tweets including several ENDS terms (e.g., "e-cigarette" or "vape") were captured from the Twitter data stream during 2012 and 2015...
2017: PloS One
https://www.readbyqxmd.com/read/28231676/-post-marketing-surveillance-of-tanreqing-injection-in-children-a-real-world-study
#19
X X Li, L Zhuo, Y H Yang, S Y Zhan, S D Zhai
Objective: To evaluate the safety of Tanreqing injection among children in the real world. Methods: A multicenter, large sample, ambispective cohort study, with registration-type clinical safety monitoring. A total of 6 188 inpatients and patients from the emergency units, aged ≤ 14 years who all had been using Tanreqing injection in 59 secondary and tertiary hospitals in China, were recruited between January, 2014 and May, 2015. The main outcomes would include incidence and severity of adverse drug reaction (ADR)/adverse drug event (ADE) of Tanreqing injection...
February 10, 2017: Zhonghua Liu Xing Bing Xue za Zhi, Zhonghua Liuxingbingxue Zazhi
https://www.readbyqxmd.com/read/28227018/using-constrained-information-entropy-to-detect-rare-adverse-drug-reactions-from-medical-forums
#20
Yi Zheng, Chaowang Lan, Hui Peng, Jinyan Li, Yi Zheng, Chaowang Lan, Hui Peng, Jinyan Li, Jinyan Li, Hui Peng, Chaowang Lan, Yi Zheng
Adverse drug reactions (ADRs) detection is critical to avoid malpractices yet challenging due to its uncertainty in pre-marketing review and the underreporting in post-marketing surveillance. To conquer this predicament, social media based ADRs detection methods have been proposed recently. However, existing researches are mostly co-occurrence based methods and face several issues, in particularly, leaving out the rare ADRs and unable to distinguish irrelevant ADRs. In this work, we introduce a constrained information entropy (CIE) method to solve these problems...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
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