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https://www.readbyqxmd.com/read/28815480/evaluation-of-electronic-healthcare-databases-for-post-marketing-drug-safety-surveillance-and-pharmacoepidemiology-in-china
#1
Yu Yang, Xiaofeng Zhou, Shuangqing Gao, Hongbo Lin, Yanming Xie, Yuji Feng, Kui Huang, Siyan Zhan
INTRODUCTION: Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. METHODS: Three major types of EHDs in China (i.e., a regional community-based database, a national claims database, and an electronic medical records [EMR] database) were selected for evaluation. Forty core variables were derived based on the US Mini-Sentinel (MS) Common Data Model (CDM) as well as the data features in China that would be desirable to support drug safety surveillance...
August 16, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28815108/monitoring-biomedical-literature-for-post-market-safety-purposes-by-analyzing-networks-of-text-based-coded-information
#2
Taxiarchis Botsis, Matthew Foster, Kory Kreimeyer, Abhishek Pandey, Richard Forshee
Literature review is critical but time-consuming in the post-market surveillance of medical products. We focused on the safety signal of intussusception after the vaccination of infants with the Rotashield Vaccine in 1999 and retrieved all PubMed abstracts for rotavirus vaccines published after January 1, 1998. We used the Event-based Text-mining of Health Electronic Records system, the MetaMap tool, and the National Center for Biomedical Ontologies Annotator to process the abstracts and generate coded terms stamped with the date of publication...
2017: AMIA Summits on Translational Science Proceedings
https://www.readbyqxmd.com/read/28812471/effectiveness-and-tolerability-of-parenteral-testosterone-undecanoate-a-post-marketing-surveillance-study
#3
Jan Wolf, Dieter Keipert, Heiko Motazedi, Michael Ernst, Joanne Nettleship, Louis Gooren
This observational post-marketing study of parenteral testosterone undecanoate (TU) in a non-selected population aimed to: examine the effectiveness of TU as treatment of hypogonadism; record adverse drug reactions (ADR) quantitatively particularly regarding polycythemia, prostate safety and cardiovascular-related metabolic risk factors; and verify whether recommended injection intervals apply to routine clinical practice. Eight hundred and seventy subjects from 259 outpatient units scheduled to visit the clinic six times were included...
August 16, 2017: Aging Male: the Official Journal of the International Society for the Study of the Aging Male
https://www.readbyqxmd.com/read/28799510/safety-profile-of-the-newest-antiepileptic-drugs-a-curated-literature-review
#4
Caterina Palleria, Giuseppe Cozza, Rajeshree Khengar, Vincenzo Libri, Giovambattista De Sarro
BACKGROUND: Despite the introduction of new antiepileptic drugs (AEDs), the quality of life and therapeutic response for patients with epilepsy remain unsatisfactory. In addition, whilst several antiepileptic drugs (AEDs) have been approved and consequently marketed in recent years, little is known about their long-term safety and tolerability. Availability of the newest AEDs, characterized by improved pharmacokinetic profiles, has positively impacted the treatment approach for patients with partial seizures in clinical practice...
August 9, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/28764191/knowledge-and-perception-about-pharmacovigilance-among-pharmacy-students-of-universities-in-sana-a-yemen
#5
Gamil Qasem Othman, Mohamed Izham Mohamed Ibrahim, Mohammed Alshakka, Mukhtar Ansari, Farouk Al-Qadasi, Abdulsalam M Halboup
INTRODUCTION: Pharmacists in community or hospital setting play a key role in reporting Adverse Drug Reaction (ADRs) during practice. Under reporting is considered as a profession malpractice worldwide. AIM: To determine the level of knowledge and perception about phramacovigilance and ADRs reporting among final year pharmacy students of Universities in Sana'a Yemen. MATERIALS AND METHODS: A cross-sectional study design was conducted among 385 final year pharmacy students...
June 2017: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/28762672/safety-efficacy-and-persistence-of-long-term-mirabegron-treatment-for-overactive-bladder-in-the-daily-clinical-setting-interim-1-year-report-from-a-japanese-post-marketing-surveillance-study
#6
Daisuke Kato, Hiromi Tabuchi, Satoshi Uno
OBJECTIVES: To report interim 1-year results from a 3-year surveillance study evaluating safety, efficacy, and persistence of long-term mirabegron for overactive bladder (OAB). METHODS: Patients starting treatment with mirabegron for urinary urgency, daytime frequency, and urgency incontinence associated with OAB were registered and followed up for 3 years. Data were collected on adverse drug reactions (ADR), changes in OAB symptoms, changes in Overactive Bladder Symptom Score (OABSS), and treatment discontinuations...
August 1, 2017: Lower Urinary Tract Symptoms
https://www.readbyqxmd.com/read/28758813/medication-safety-knowledge-attitudes-and-practices-among-community-pharmacists-in-lebanon
#7
Aline Hajj, Souheil Hallit, Elsy Ramia, Pascale Salameh
BACKGROUND: The effectiveness of a national post-marketing surveillance program depends directly on the active participation of all health professionals. There is no current comprehensive and active pharmacovigilance program available in Lebanon. OBJECTIVES: To assess the knowledge, attitudes, and practices (KAP) among community pharmacists in Lebanon in relevance to potential pharmacovigilance and adverse-drug-reactions reporting in Lebanon. METHODS: A cross-sectional descriptive study, using a self-administered KAP questionnaire and conducted between March and July 2016, included 1857 pharmacists practicing in community settings...
July 31, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28752473/safety-profile-of-eslicarbazepine-acetate-as-add-on-therapy-in-adults-with-refractory-focal-onset-seizures-from-clinical-studies-to-6-years-of-post-marketing-experience
#8
Helena Gama, Mariana Vieira, Raquel Costa, Joana Graça, Luís M Magalhães, Patrício Soares-da-Silva
INTRODUCTION: Eslicarbazepine acetate was first approved in the European Union in 2009 as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization. OBJECTIVE: The objective of this study was to review the safety profile of eslicarbazepine acetate analyzing the data from several clinical studies to 6 years of post-marketing surveillance. METHODS: We used a post-hoc pooled safety analysis of four phase III, double-blind, randomized, placebo-controlled studies (BIA-2093-301, -302, -303, -304) of eslicarbazepine acetate as add-on therapy in adults...
July 27, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28748367/commercial-online-social-network-data-and-statin-side-effect-surveillance-a-pilot-observational-study-of-aggregate-mentions-on-facebook
#9
Marco D Huesch
INTRODUCTION: Surveillance of the safety of prescribed drugs after marketing approval has been secured remains fraught with complications. Formal ascertainment by providers and reporting to adverse-event registries, formal surveys by manufacturers, and mining of electronic medical records are all well-known approaches with varying degrees of difficulty, cost, and success. Novel approaches may be a useful adjunct, especially approaches that mine or sample internet-based methods such as online social networks...
July 26, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28747607/safety-and-effectiveness-of-certolizumab-pegol-in-patients-with-rheumatoid-arthritis-interim-analysis-of-post-marketing-surveillance
#10
Hideto Kameda, Keiichiro Nishida, Toshihiro Nannki, Akira Watanabe, Yukiya Oshima, Shigaki Momohara
  Objective: To evaluate the safety and effectiveness of certolizumab pegol (CZP) in a real-world setting among Japanese patients with rheumatoid arthritis. METHODS: Post-marketing surveillance data from 2,579 patients treated with CZP were analyzed. Adverse events (AEs) observed during the 24-week CZP treatment period were recorded. Disease activity was evaluated using DAS28-ESR and DAS28-CRP at baseline, Week 12, Week 24, or at withdrawal. RESULTS: The total period of exposure to CZP was 1313...
2017: Nihon Rinshō Men'eki Gakkai Kaishi, Japanese Journal of Clinical Immunology
https://www.readbyqxmd.com/read/28747134/reporting-medical-device-safety-incidents-to-regulatory-authorities-an-analysis-and-classification-of-technology-induced-errors
#11
Sari Palojoki, Kaija Saranto, Lasse Lehtonen
The European Union Medical Device Directive 2007/47/EC1 defines software with a medical purpose as a medical device. The implementation of health information technology suffers from patient safety problems that require effective post-market surveillance. The purpose of this study was to review, classify and discuss the incident data submitted to a nationwide database of the Finnish National Competent Authority with other forms of data. We analysed incident reports submitted to the authority database by users of electronic health records from 2010 to 2015...
July 1, 2017: Health Informatics Journal
https://www.readbyqxmd.com/read/28741382/sodium-glucose-co-transporter-2-inhibitor-luseogliflozin-in-the-management-of-type-2-diabetes-a-drug-safety-evaluation
#12
Daisuke Yabe, Yoshiyuki Hamamoto, Yusuke Seino, Hitoshi Kuwata, Takeshi Kurose, Yutaka Seino
Sodium glucose co-transporter-2 (SGLT2) inhibitors have been developed recently as a new class of anti-diabetic drug, and are becoming widely used in the management of type 2 diabetes (T2D). As these agents have a considerably different glucose-lowering mechanism from those of other anti-diabetic drugs, safe use of this drug class needs to be discussed based on data available from preapproval clinical trials as well as real-world studies. The SGLT2 inhibitor luseogliflozin was developed by Taisho Pharmaceutical Co...
July 25, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28726115/the-impact-of-coronary-calcification-on-angiographic-and-3-year-clinical-outcomes-of-everolimus-eluting-stents-results-of-a-xience-v-promus-post-marketing-surveillance-study
#13
Nobuo Shiode, Ken Kozuma, Jiro Aoki, Masaki Awata, Mamoru Nanasato, Kengo Tanabe, Junichi Yamaguchi, Hajime Kusano, Hong Nie, Takeshi Kimura
Coronary calcification (CCA) is one of the independent predictors for major adverse cardiac events (MACEs) in coronary intervention. Post-marketing surveillance study Japan is a prospective registry designed to evaluate the safety and efficacy of the everolimus-eluting stent (EES, XIENCE V/PROMUS Stent) in routine clinical practice at 47 centers. In this study, 1848 lesions (1546 patients) were assessed using quantitative coronary angiography. In these 1546 patients, renal function data were unknown in 26 patients...
July 19, 2017: Cardiovascular Intervention and Therapeutics
https://www.readbyqxmd.com/read/28725912/sglt2-inhibitors-and-risk-of-cancer-in-type-2-diabetes-a-systematic-review-and-meta-analysis-of-randomised-controlled-trials
#14
REVIEW
Huilin Tang, Qi Dai, Weilong Shi, Suodi Zhai, Yiqing Song, Jiali Han
AIMS/HYPOTHESIS: The association between sodium-glucose cotransporter 2 (SGLT2) inhibitors and the risk of cancer in individuals with type 2 diabetes remains uncertain. This study aimed to evaluate the risk of cancer associated with SGLT2 inhibitor treatment of type 2 diabetes. METHODS: We systematically searched PubMed, EMBASE, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov from inception to 15 February 2017 to identify eligible randomised controlled trials (RCTs) that report cancer events in individuals with type 2 diabetes treated with SGLT2 inhibitors for at least 24 weeks...
July 19, 2017: Diabetologia
https://www.readbyqxmd.com/read/28723841/military-civilian-partnership-in-device-innovation-development-commercialization-and-application-of-resuscitative-endovascular-balloon-occlusion-of-the-aorta-reboa
#15
Todd E Rasmussen, Jonathan L Eliason
Noncompressible torso hemorrhage (NCTH) and shock is a leading cause of trauma-related mortality and evidence suggests that survival from this injury pattern has not improved in decades. As such, innovating new approaches and devices, including technologies which can be used by providers within a short of time after severe injury, is a priority for the military. Guided by wartime observations, and through partnerships with civilian academia and private investment, the military has led an effort to define resuscitative endovascular balloon occlusion of the aorta (REBOA) and assess its potential to address this problem...
July 19, 2017: Journal of Trauma and Acute Care Surgery
https://www.readbyqxmd.com/read/28722500/post-marketing-surveillance-study-of-the-long-term-use-of-mizoribine-for-the-treatment-of-lupus-nephritis-2-year-results
#16
Tsutomu Takeuchi, Kenya Okada, Hisao Yoshida, Nobuyuki Yagi
OBJECTIVES: To understand the status of mizoribine use in patients with lupus nephritis (LN) and to collect safety- and efficacy-related data on 2-year treatment with mizoribine. METHODS: A continuous survey was conducted between March 2010 and July 2015. RESULTS: The analysis set included 559 patients (mean age 39.5 years, females 82.6%, mean duration of systemic lupus erythematosus (SLE) 8.4 years, mean duration of LN 5.9 years). Renal function was satisfactory for 6 months, but worsened from 12 months, with significant worsening at 24 months...
July 19, 2017: Modern Rheumatology
https://www.readbyqxmd.com/read/28699846/safety-and-effectiveness-of-tadalafil-in-pediatric-patients-with-pulmonary-arterial-hypertension-a-sub-group-analysis-based-on-japan-post-marketing-surveillance
#17
Hiroyoshi Yamazaki, Noriko Kobayashi, Masanori Taketsuna, Koyuki Tajima, Nahoko Suzuki, Masahiro Murakami
OBJECTIVE: To evaluate the long-term safety and effectiveness of tadalafil in pediatric patients with pulmonary arterial hypertension (PAH) in real-world clinical practice. METHODS: This is an observational surveillance of PAH patients receiving tadalafil in the contracted sites. A sub-group analysis was performed of 391 pediatric PAH patients (<18 years) who were included from 1,704 total patients in this surveillance. Safety was assessed from the frequency of adverse drug reactions (ADRs), discontinuations due to adverse events (AEs), and serious adverse drug reactions (SADRs)...
July 20, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28697849/post-market-surveillance-in-the-german-medical-device-sector-current-state-and-future-perspectives
#18
Claus Zippel, Sabine Bohnet-Joschko
Medical devices play a central role in the diagnosis and treatment of diseases but also bring the potential for adverse events, hazards or malfunction with serious consequences for patients and users. Medical device manufacturers are therefore required by law to monitor the performance of medical devices that have been approved by the competent authorities (post market surveillance). Conducting a nationwide online-survey in the German medical device sector in Q2/2014 in order to explore the current status of the use of post market instruments we obtained a total of 118 complete data sets, for a return rate of 36%...
June 24, 2017: Health Policy
https://www.readbyqxmd.com/read/28676471/patterns-of-twitter-behavior-among-networks-of-cannabis-dispensaries-in-california
#19
Nicholas C Peiper, Peter M Baumgartner, Robert F Chew, Yuli P Hsieh, Gayle S Bieler, Georgiy V Bobashev, Christopher Siege, Gary A Zarkin
BACKGROUND: Twitter represents a social media platform through which medical cannabis dispensaries can rapidly promote and advertise a multitude of retail products. Yet, to date, no studies have systematically evaluated Twitter behavior among dispensaries and how these behaviors influence the formation of social networks. OBJECTIVES: This study sought to characterize common cyberbehaviors and shared follower networks among dispensaries operating in two large cannabis markets in California...
July 4, 2017: Journal of Medical Internet Research
https://www.readbyqxmd.com/read/28658800/a-post-marketing-surveillance-study-to-evaluate-performance-of-the-eximo%C3%A2-blood-glucose-monitoring-system
#20
Sonia R Chandnani, C D Ramakrishna, Bhargav A Dave, Pankaj S Kothavade, Ashok S Thakkar
INTRODUCTION: The performance of Blood Glucose Monitoring System (BGMS) is critical as the information provided by the system guide the patient or health care professional in making treatment decisions. However, besides evaluating accuracy of the BGMS in laboratory setting, it is equally important that the intended users (healthcare professionals and patients) should be able to achieve blood glucose measurements with similar level of high accuracy. AIM: To assess the performance of EXIMO™ (Meril Diagnostics Pvt...
May 2017: Journal of Clinical and Diagnostic Research: JCDR
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