keyword
MENU ▼
Read by QxMD icon Read
search

Post marketing surveillance

keyword
https://www.readbyqxmd.com/read/29913205/ethical-approval-for-multicenter-cohort-studies-on-drug-exposure-during-pregnancy-a-survey-among-members-of-the-european-network-of-teratology-information-services-entis
#1
Ursula Winterfeld, Corinna Weber-Schöndorfer, Christof Schaefer, Erik von Elm, Thierry Buclin
The European Network of Teratology Information Services (ENTIS) is in a privileged position to perform independent post-marketing surveillance of drugs in pregnancy. The aim of this survey was to describe the legal requirements and procedures involved in obtaining ethical approval for collaborative cohort studies. We sent a survey questionnaire to all 28 Teratology Information Services (TIS), of which 25 (89%) in 18 countries completed our questionnaire. For 15 TIS, specific research ethical approval was mandatory...
June 15, 2018: Reproductive Toxicology
https://www.readbyqxmd.com/read/29896850/quality-of-the-antimalarial-medicine-artemether-lumefantrine-in-eight-cities-of-the-democratic-republic-of-the-congo
#2
Jean-Pierre Mufusama, Karine Ndjoko Ioset, Doris Feineis, Ludwig Hoellein, Ulrike Holzgrabe, Gerhard Bringmann
In the context of post-marketing surveillance supporting public-health authorities to take evidence-based decisions to fight the spread of poor-quality medicines, the quality of antimalarial artemether-lumefantrine (AL) medicines was assessed in the Democratic Republic of the Congo (DRC). A total of 150 samples of AL containing products was collected from private pharmaceutical outlets in eight main cities: Goma, Kikwit, Kinshasa, Kisangani, Lubumbashi, Matadi, Mbandaka, and Mbuji-Mayi. All drug samples were successively analyzed by visual inspection, thin-layer chromatography (TLC), and high-performance liquid chromatography (HPLC) following The International Pharmacopoeia...
June 12, 2018: Drug Testing and Analysis
https://www.readbyqxmd.com/read/29866152/comparing-the-application-of-two-theoretical-frameworks-to-describe-determinants-of-adverse-medical-device-event-reporting-secondary-analysis-of-qualitative-interview-data
#3
Laura Desveaux, Anna R Gagliardi
BACKGROUND: Post-market surveillance of medical devices is reliant on physician reporting of adverse medical device events (AMDEs). Few studies have examined factors that influence whether and how physicians report AMDEs, an essential step in the development of behaviour change interventions. This study was a secondary analysis comparing application of the Theoretical Domains Framework (TDF) and the Tailored Implementation for Chronic Diseases (TICD) framework to identify potential behaviour change interventions that correspond to determinants of AMDE reporting...
June 4, 2018: BMC Health Services Research
https://www.readbyqxmd.com/read/29865876/causality-assessment-of-serious-and-severe-adverse-events-following-immunization-in-india-a-4-year-practical-experience
#4
Awnish K Singh, Abram L Wagner, Jyoti Joshi, Bradley F Carlson, Satinder Aneja, Matthew L Boulton
BACKGROUND: India has implemented the World Health Organization's revised causality assessment protocol for adverse events following immunization (AEFI). We describe the number and types of serious/severe AEFIs, including deaths. RESEARCH DESIGN AND METHODS: Analysis of causality classification of reported serious/severe AEFIs from January 1, 2012, to January 7, 2016 was done. Classification includes: (A) consistent with causal association to immunization; (B) indeterminate; (C) coincidental association; or (D) unclassifiable...
June 5, 2018: Expert Review of Vaccines
https://www.readbyqxmd.com/read/29862750/-research-on-the-efficacy-of-fulfillment-of-medical-device-adverse-event-monitoring-entities-and-safeguard-mechanism
#5
Wenxia Ren, Yangdui Mao, Wenhua Luo, Jing Ding, Wen Wang, Qing Zhu
OBJECTIVES: To solve the problem that medical device adverse event monitoring entities perform their duties inadequately, to provide reference for perfecting the post-market surveillance system. METHODS: Through theoretical and empirical research, the paper explored the ways to improve the performance of monitoring the adverse events of medical devices. RESULTS: The survey found that the number of adverse event monitoring reports was few and the quality of report was poor...
January 30, 2018: Zhongguo Yi Liao Qi Xie za Zhi, Chinese Journal of Medical Instrumentation
https://www.readbyqxmd.com/read/29799286/canagliflozin-for-the-treatment-of-type-2-diabetes-a-comparison-between-japanese-and-non-japanese-patients
#6
Nobuya Inagaki, Shin-Ichi Harashima, Hiroaki Iijima
Canagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor, improves various cardiometabolic parameters. Although canagliflozin was originally discovered in Japan, no comprehensive summary of its effects in Japanese patients has been reported. As differences exist in the pathologic features of diabetes between Japanese and non-Japanese populations, it is important to consolidate Japanese data for canagliflozin. Areas covered: The authors summarize Japanese clinical trial and post-marketing surveillance data for canagliflozin, and make comparisons with non-Japanese data...
May 25, 2018: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29796039/initial-results-of-a-prospective-study-and-identification-of-new-strategies-to-increase-traceability-of-plasma-derived-medicines
#7
Sheyda Najafi, Ali Vasheghani Farahani, Hedieh Keshavarz-Bahaghighat
Plasma medicine is an innovative and emerging field used in a broad range of medical conditions. The present study focused on consumption and documentation pattern of plasma-derived medicines in a teaching hospital. A two-step study was conducted from October to December 2015. During the first phase, the patient records receiving plasma-derived medicines including Coagulation Factor VIII, IX, Prothrombin Complex Concentrate, Factor VIII/Von Wilberand Complex, Anti-Hepatitis B Immunoglobulin, Intravenous Immunoglobulin, Anti-Tetanus Immunoglobulin, and Albumin were checked to assess recording details of these medications at the time of administration...
2018: Iranian Journal of Pharmaceutical Research: IJPR
https://www.readbyqxmd.com/read/29787579/conformity-of-package-inserts-information-to-regulatory-requirements-among-selected-branded-and-generic-medicinal-products-circulating-on-the-east-african-market
#8
Hiiti B Sillo, Nelson E Masota, Sunday Kisoma, Lembit Rago, Veronica Mgoyela, Eliangiringa A Kaale
BACKGROUND: Availability of correct and adequate information about medicines is an important aspect in ensuring rational use of medicines and hence facilitating safety and expected efficacy of medicines during therapy. Package inserts have proven to be a good source of information to the prescribers and patients whereby they have been useful in highlighting important information pertaining proper use and handling of the medicines. The present study was aimed at establishing the extent to which package inserts of medicines circulating on the markets of the East African Community (EAC) Partner States conform to medicines information requirements as established in the harmonized guidelines as well as national guidelines...
2018: PloS One
https://www.readbyqxmd.com/read/29777520/relationship-of-eating-patterns-and-metabolic-parameters-and-teneligliptin-treatment-interim-results-from-post-marketing-surveillance-in-japanese-type-2-diabetes-patients
#9
Takashi Kadowaki, Masakazu Haneda, Hiroshi Ito, Kazuyo Sasaki, Sonoe Hiraide, Miyuki Matsukawa, Makoto Ueno
INTRODUCTION: Healthy eating is a critical aspect of the prevention and management of type 2 diabetes (T2DM). Disrupted eating patterns can result in poor glucose control and increase the likelihood of diabetic complications. Teneligliptin inhibits dipeptidyl peptidase-4 activity for 24 h and suppresses postprandial hyperglycemia after all three daily meals. This interim analysis of data from the large-scale post-marketing surveillance of teneligliptin (RUBY) in Japan examined eating patterns and their relationship with metabolic parameters and diabetic complications...
May 17, 2018: Advances in Therapy
https://www.readbyqxmd.com/read/29764795/mapping-of-crowdsourcing-in-health-systematic-review
#10
REVIEW
Perrine Créquit, Ghizlène Mansouri, Mehdi Benchoufi, Alexandre Vivot, Philippe Ravaud
BACKGROUND: Crowdsourcing involves obtaining ideas, needed services, or content by soliciting Web-based contributions from a crowd. The 4 types of crowdsourced tasks (problem solving, data processing, surveillance or monitoring, and surveying) can be applied in the 3 categories of health (promotion, research, and care). OBJECTIVE: This study aimed to map the different applications of crowdsourcing in health to assess the fields of health that are using crowdsourcing and the crowdsourced tasks used...
May 15, 2018: Journal of Medical Internet Research
https://www.readbyqxmd.com/read/29761281/characteristics-quality-and-contribution-to-signal-detection-of-spontaneous-reports-of-adverse-drug-reactions-via-the-web-radr-mobile-application-a-descriptive-cross-sectional-study
#11
Ingrid Oosterhuis, Henric Taavola, Philip M Tregunno, Petar Mas, Sara Gama, Victoria Newbould, Ola Caster, Linda Härmark
INTRODUCTION: Spontaneous reporting of suspected adverse drug reactions is key for efficient post-marketing safety surveillance. To increase usability and accessibility of reporting tools, the Web-Recognising Adverse Drug Reactions (WEB-RADR) consortium developed a smartphone application (app) based on a simplified reporting form. OBJECTIVE: The objective of this study was to evaluate the characteristics, quality and contribution to signals of reports submitted via the WEB-RADR app...
May 14, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29746978/clinical-studies-of-the-effectiveness-and-safety-of-antivenoms
#12
David J Williams, Abdulrazaq G Habib, David A Warrell
In the 1890s, hyperimmune sera proved effective in animals against challenge by the snake venom against which they had been raised. They were first used, apparently successfully, in a human patient in about 1895. Since then, antivenoms have become accepted as the only reliable specific treatment for snake-bite envenoming. Despite decades of accumulated clinical experience and a number of published randomised comparative and observational studies, the clinical effectiveness and safety of some antivenoms remain open to question, due to a lack of robust randomised controlled trial data...
May 7, 2018: Toxicon: Official Journal of the International Society on Toxinology
https://www.readbyqxmd.com/read/29722569/exacerbated-liver-injury-of-antithyroid-drugs-in-endotoxin-treated-mice
#13
Reza Heidari, Fatemeh Ahmadi, Hamid Reza Rahimi, Negar Azarpira, Massood Hosseinzadeh, Asma Najibi, Hossein Niknahad
Drug-induced liver injury is a major concern in clinical studies as well as in post-marketing surveillance. Previous evidence suggested that drug exposure during periods of inflammation could increase an individual's susceptibility to drug hepatoxicity. The antithyroid drugs, methimazole (MMI) and propylthiouracil (PTU) can cause adverse reactions in patients, with liver as a usual target. We tested the hypothesis that MMI and PTU could be rendered hepatotoxic in animals undergoing a modest inflammation. Mice were treated with a nonhepatotoxic dose of LPS (100 µg/kg, i...
May 3, 2018: Drug and Chemical Toxicology
https://www.readbyqxmd.com/read/29721705/knowledge-of-adverse-drug-reaction-reporting-and-the-pharmacovigilance-of-biological-medicines-a-survey-of-healthcare-professionals-in-ireland
#14
J O'Callaghan, B T Griffin, J M Morris, Margaret Bermingham
BACKGROUND: In Europe, changes to pharmacovigilance legislation, which include additional monitoring of medicines, aim to optimise adverse drug reaction (ADR) reporting systems. The legislation also makes provisions related to the traceability of biological medicines. OBJECTIVE: The objective of this study was to assess (i) knowledge and general experience of ADR reporting, (ii) knowledge, behaviours, and attitudes related to the pharmacovigilance of biologicals, and (iii) awareness of additional monitoring among healthcare professionals (HCPs) in Ireland...
May 2, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29718816/a-post-marketing-surveillance-study-of-chronic-wounds-treated-with-a-native-collagen-calcium-alginate-dressing
#15
Matthew Sabo, Lam Le, Raphael A Yaakov, Marissa Carter, Thomas E Serena
Chronic wounds (ie, wounds that fail to progress through a normal, orderly, timely sequence of repair) continue to pose significant clinical and economic burdens. A prospective, descriptive, 3-week post-marketing surveillance study was conducted across 3 wound care centers in the United States to evaluate the effectiveness of a collagen calcium alginate dressing on chronic wounds in conjunction with standard care (SC) practices (eg, offloading, debridement, compression) to support healing. Eligible participants had to be >18 years of age, have at least 1 chronic wound, and no known sensitivity to collagen...
April 2018: Ostomy/wound Management
https://www.readbyqxmd.com/read/29718748/an-update-on-the-toxicological-considerations-for-protease-inhibitors-used-for-hepatitis-c-infection
#16
Lung-Yi Mak, Wai-Kay Seto, Ching-Lung Lai, Man-Fung Yuen
Hepatitis C virus protease inhibitors (PIs) are important components of many direct acting antiviral regimens. Many clinical trials and real-world studies have described the safety data for individual PIs. We aimed to review the safety of both the first and second generation PIs in patients with chronic hepatitis C (CHC). Areas covered: The unique pharmacokinetic properties of PIs partly explain their toxicities. Second generation PIs, when used without interferon and ribavirin, are well-tolerated. Use of PIs in renal impaired patients or those on dialysis appears to be safe...
May 2, 2018: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/29717697/adverse-events-following-immunisation-with-a-meningococcal-serogroup-b-vaccine-report-from-post-marketing-surveillance-germany-2013-to-2016
#17
Dirk Mentzer, Doris Oberle, Brigitte Keller-Stanislawski
Background and aimIn January 2013, a novel vaccine against Neisseria meningitidis serogroup B, the multicomponent meningococcal serogroup B vaccine (4CMenB), was approved by the European Medicines Agency. We aimed to evaluate the safety profile of this vaccine. Methods: All adverse events following immunisation (AEFI) reported from Germany since the vaccine's launch in Germany in November 2013 through December 2016 were reviewed and analysed. Results: Through December 2016, a total of 664 individual case safety reports (ICSR) notifying 1,960 AEFI were received...
April 2018: Euro Surveillance: Bulletin Européen sur les Maladies Transmissibles, European Communicable Disease Bulletin
https://www.readbyqxmd.com/read/29716427/the-safety-of-dual-bronchodilation-on-cardiovascular-serious-adverse-events-in-copd
#18
Paola Rogliani, Josuel Ora, Maria Gabriella Matera, Mario Cazzola, Luigino Calzetta
Introduction Long-acting β2 -adrenoceptor (β2 -AR) agonists (LABAs) plus long-acting muscarinic antagonists (LAMAs) is the cornerstone for treating chronic obstructive pulmonary disease (COPD). LABA/LAMA combinations elicit clinical and functional synergistic interaction, and such an interaction should permit to reduce the dose of each monocomponent in the drug mixture to minimize the risk of adverse events (AEs). Overall, currently available LABA/LAMA fixed-dose combinations (FDCs) combine the drugs at the same doses of formulations designed for a single drug...
May 1, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29715491/recent-updates-and-challenges-on-the-regulation-of-precision-medicine-the-united-states-in-perspective
#19
Lin-Chau Chang, Thomas E Colonna
The rapid progress in "omics", such as genomics, metabolomics, microbiomics, has paved the path for precision medicine and revolutionized the development of drugs and devices promising to meet unmet medical needs. The aim of the present study was to investigate the current regulatory framework established by the United States Food and Drug Administration (USFDA) and to identify challenges and concerns through study of related literatures in the PubMed database. We found that efforts were made to facilitate the implementation of precision medicine through organizational reform, publication of guidance documents, and continuous post-market surveillance...
April 28, 2018: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/29712429/in-silico-pharmacoepidemiologic-evaluation-of-drug-induced-cardiovascular-complications-using-combined-classifiers
#20
Chuipu Cai, Jiansong Fang, Pengfei Guo, Qi Wang, Huixiao Hong, Javid Moslehi, Feixiong Cheng
Drug-induced cardiovascular complications are the most common adverse drug events and account for the withdrawal or severe restrictions on use of multitudinous post-marketed drugs. In this study, we developed new in silico models for systematic identification of drug-induced cardiovascular complications in drug discovery and post-marketing surveillance. Specifically,we collected drug-induced cardiovascular complications covering five most common types of cardiovascular outcomes (hypertension, heart block, arrhythmia, cardiac failure, and myocardial infarction) from four publicly available data resources: Comparative Toxicogenomics Database, SIDER, Offsides, and MetaADEDB...
April 30, 2018: Journal of Chemical Information and Modeling
keyword
keyword
61264
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"